U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended August 31, 1997
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT
For the transition period from TO
Commission file number 0-13281
DIAGNON CORPORATION
(Exact name of small business issuer as specified in its charter)
State of Delaware 13-3078199
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
9600 Medical Center Drive, Rockville, Maryland 20850
(Address of principal executive office) (Zip Code)
Issuer's telephone number, including area code (301) 251-2801
Not Applicable
(Former name, former address and former fiscal year, if changed since last
report)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Securities Exchange Act during the past 12 months, and (2)
has been subject to such filing requirement for the past 90 days.
Yes X No
Common Stock, $.01 par value per share; authorized 25,000,000 shares; 5,398,244
shares outstanding as of October 9, 1997.
Convertible Preferred Stock, $1.00 par value per share; authorized 325,000
shares; no shares outstanding as of October 9, 1997.
Transitional Small Business Disclosure Format (Check one): Yes No X
DIAGNON CORPORATION
INDEX
Part I. Financial Information Page
Item 1. Financial Statements.
Consolidated Balance Sheets, May 31, 1997 and
August 31, 1997 (Unaudited) . . . . . . . . . . . . . . 2
Unaudited Statements of Consolidated Operations for
the Three Months Ended August 31, 1997 and
August 31, 1996 . . . . . . . . . . . . . . . . . . . . 3
Unaudited Statements of Consolidated Cash Flows
for the Three Months Ended August 31, 1997 and
August 31, 1996 . . . . . . . . . . . . . . . . . . . . 4
Notes to Financial Statements . . . . . . . . . . . . . . 5
Item 2. Management's Discussion and Analysis . . . . . . . . . 5
Part II. Other Information
Item 1. Legal Proceedings . . . . . . . . . . . . . . . . 7
Item 6. Exhibits . . . . . . . . . . . . . . . . . . . . 7
DIAGNON CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS, MAY 31, 1997 AND AUGUST 31, 1997 (UNAUDITED)
AUGUST 31, MAY 31,
ASSETS 1997 1997
- ------ ---------- -------
CURRENT ASSETS:
Cash and cash equivalents $ 65,409 $ 62,638
Accounts receivable:
Trade 1,288,152 1,245,292
Unbilled 515,993 598,922
Other 23,831 49,999
Prepaid expenses 147,147 76,444
Inventories 43,961 44,961
Deferred income taxes - current 50,000 50,000
------------- --------------
Total current assets 2,134,493 2,128,256
------------- --------------
LOANS TO OFFICERS 90,000 90,000
------------- --------------
FIXED ASSETS:
Leasehold improvements 695,675 670,899
Furniture, fixtures and equipment 3,141,998 2,985,508
------------- --------------
Total 3,837,673 3,656,407
Less accumulated depreciation
and amortization 2,252,468 2,182,091
------------- --------------
Fixed assets, net 1,585,205 1,474,316
------------- --------------
DEFERRED INCOME TAXES - NONCURRENT 796,850 797,400
OTHER NONCURRENT ASSETS 150,549 204,549
------------- --------------
TOTAL $ 4,757,097 $ 4,694,521
============= ==============
LIABILITIES
- -----------
CURRENT LIABILITIES:
Borrowings under line of credit $ 792,569 $ 536,120
Current maturities of long-term debt 124,153 124,153
Accounts payable 218,867 250,767
Accrued compensation and related costs 171,337 292,956
Accrued income taxes 3,243 5,543
Other accrued liabilities 3,606 12,641
------------- --------------
Total current liabilities 1,313,775 1,222,180
LONG-TERM DEBT 134,187 164,192
------------- --------------
Total liabilities 1,447,962 1,386,372
------------- --------------
STOCKHOLDERS' EQUITY
- --------------------
Convertible preferred stock - par value of $1.00
per share, 325,000 shares authorized; no shares
issued and outstanding
Common stock - par value of $.01 per share;
25,000,000 shares authorized; 9,602,452 shares
issued; 5,398,244 shares outstanding 96,024 96,024
Additional paid-in capital 7,395,015 7,395,015
Accumulated deficit (3,554,547) (3,555,533)
------------- --------------
Total 3,936,492 3,935,506
Less - treasury stock 4,204,208 shares, at cost (627,357) (627,357)
------------- --------------
Total stockholders' equity 3,309,135 3,308,149
------------- --------------
TOTAL $ 4,757,097 $ 4,694,521
============= ==============
See notes to financial statements.
2
DIAGNON CORPORATION AND SUBSIDIARIES
UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS FOR THE
THREE MONTHS ENDED AUGUST 31, 1997 AND AUGUST 31, 1996
AUGUST 31, AUGUST 31,
1997 1996
---------- ----------
REVENUES AND SALES:
Contract revenues $ 2,336,141 $ 2,289,307
Product sales 1,073 1,080
------------ ------------
Total Revenues and Sales 2,337,214 2,290,387
------------ ------------
OPERATING EXPENSES:
Contract 1,764,299 1,727,562
Cost of goods sold 16,478 620
Research and development 117,850 81,733
General and administrative 426,168 440,563
------------ ------------
Total 2,324,795 2,250,478
------------ ------------
OPERATING INCOME 12,419 39,909
INTEREST INCOME 1,338 1,801
INTEREST EXPENSE (12,121) (11,815)
------------ ------------
INCOME BEFORE INCOME TAX 1,636 29,895
PROVISION FOR INCOME TAX 650 12,000
------------ ------------
NET INCOME $ 986 $ 17,895
============ ============
INCOME PER SHARE $ 0.00 $ 0.00
============ ============
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING 5,398,244 5,398,244
============ ============
See notes to financial statements.
3
DIAGNON CORPORATION AND SUBSIDIARIES
UNAUDITED STATEMENTS OF CONSOLIDATED CASH FLOWS FOR THE
THREE MONTHS ENDED AUGUST 31, 1997 AND AUGUST 31, 1996
Three Months Three Months
Ended Ended
August 31, 1997 August 31, 1996
--------------- ---------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Income $ 986 $ 17,895
--------------- ---------------
Adjustments to reconcile net income to net cash
used for operating activities:
Depreciation and amortization 70,377 62,506
Deferred income taxes 550 3,000
Decrease (increase) in accounts receivable 66,237 (184,920)
Increase in prepaid expenses (70,703) (24,669)
Decrease in inventories 1,000 620
Decrease in other assets 54,000
Decrease in accounts payable and accrued expenses (162,554) (201,119)
(Decrease) increase in income taxes payable (2,300) 7,800
--------------- ---------------
Total Adjustments (43,393) (336,782)
--------------- ---------------
NET CASH USED FOR OPERATING ACTIVITIES (42,407) (318,887)
--------------- ---------------
CASH FLOWS USED FOR INVESTING ACTIVITIES:
Capital expenditures (181,266) (118,908)
--------------- ---------------
NET CASH USED FOR INVESTING ACTIVITIES (181,266) (118,908)
--------------- ---------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds under line-of-credit agreement 256,449 327,931
Principal payments under capital lease obligations (30,005) (27,100)
--------------- ---------------
NET CASH PROVIDED BY FINANCING ACTIVITIES 226,444 300,831
--------------- ---------------
NET DECREASE IN CASH AND CASH EQUIVALENTS 2,771 (136,964)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 62,638 218,543
--------------- ---------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 65,409 $ 81,579
=============== ===============
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest $ 11,538 $ 10,385
=============== ===============
Income taxes $ 2,400 $ 1,200
=============== ===============
SUPPLEMENTAL SCHEDULE OF NONCASH INVESTING AND
FINANCING ACTIVITIES:
See notes to financial statements.
4
NOTES TO FINANCIAL STATEMENTS
Interim Financial Statements
In the opinion of management, all adjustments consisting only of normal
recurring accruals necessary for a fair presentation of such amounts have been
included. The results of operations for the quarter are not necessarily
indicative of results for the year.
Inventories
Inventories are stated at the lower of cost or market.
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS
Summary Analysis
In this first quarter of fiscal year 1998, Diagnon realized net income of $986.
On June 11, 1997, the Company was granted United States Department of
Agriculture approval to sell and distribute the oral/IV version of its equine
immunoglobulin product, Lyphomune(R). Previously, Lyphomune(R) could only be
administered orally. The highly purified equine IgG is used for treatment for
Failure of Passive Transfer (FPT) of immunity in newborn foals. During the first
twenty-four hours postpartum foals showing symptoms of FPT can be, under normal
circumstances, administered IgG orally; however, after twenty-four hours
postpartum, the foals, generally, must be treated using intravenous (IV)
methods.
To complement the Company's distribution agreement with The Butler Co., Diagnon
has entered into Lyphomune(R) distribution agreements with Milburn
Distributions, Inc. and Burns Veterinary Supply, Inc. as additional distributors
of Lyphomune(R) to veterinary practitioners and with Jeffers Veterinary Supply,
Inc. to distribute the product to over-the-counter retail customers. To this
date, Diagnon has only sold Lyphomune(R) to veterinarians and the Jeffers
agreement represents increased market exposure for the product.
The following developments occurred after the end of the quarter and therefore
are not reflected in the results of operations of the quarter:
o On September 30, 1997, the Company's subsidiary, BIOQUAL, Inc., was
awarded a National Cancer Institute (NCI) Small Business Innovation
Research (SBIR) Grant titled "Nonhuman Primate Model for Helicobacter
Pylori Infection". This six month grant totals $100,000.
o Also on September 30, 1997, BIOQUAL was awarded a National Institute of
Diabetes and Digestive and Kidney Diseases SBIR Grant titled
"Identification of Helicobacter pylori Protective Antigens". The six
month grant totals $99,673.
o On October 1, 1997, BIOQUAL was awarded and began work on the sole
source renewal of the NCI contract "Facility for Preparing and Housing
Virus Infected Mice, Genetically Manipulated Mice and Chimeric Mice".
This four year contract totals $3,161,223.
5
Results of Operations
For the three months of operations ended August 31, 1997 (the Company's first
quarter), Contract Revenues increased by 2.0% compared to the first quarter of
fiscal year 1997 (FY97) while Product Sales were relatively the same. Contract
Operating Expenses increased 2.1% compared to the first quarter of FY97
primarily due to increased contract activity. Cost of Goods Sold increased to
$16,478 from $620 in the first quarter of FY97. This increase was primarily due
to the expensing, from inventory, of 147 units of Lyphomune(R) used in a sales
promotion. Research and Development (R&D) expenses increased to $117,850
compared to $81,733 in the first quarter of FY97. This increase was primarily
due to increased costs associated with the Company's ongoing Helicobacter pylori
research program. General and Administrative (G&A) Expenses decreased 3.3%
compared to the first quarter of FY97 primarily due to a temporary reduction of
staff compensation during this quarter. Total Operating Expenses increased 3.3%
due to the above.
Operating Income decreased 68.9% compared to the prior year as Total Operating
Expenses increased at a greater rate than Total Revenues and Sales. The
operating expense increase was primarily due to the increases in Cost of Goods
Sold and R&D expenses mentioned above.
For this quarter, Diagnon had Interest Expense of $12,121 compared to Interest
Expense of $11,815 in the prior year.
Liquidity and Capital Resources
Assets
The changes in Cash and Cash Equivalents are detailed in the Statements of
Consolidated Cash Flows on page 4. Total Assets increased $62,576 as compared to
May 31, 1997. This increase is primarily attributable to 1) an increase in Fixed
Assets, net of Accumulated Depreciation and Amortization of $110,889, reflecting
fixed asset purchases of $181,266 (mainly nonhuman primate enclosures) offset by
depreciation and amortization of $70,377 during this quarter, and 2) Prepaid
Expenses increased $70,703 primarily due to the prepayment of $17,400 in life
insurance premiums, $18,000 in business insurance premiums, a $25,000 salary
advance to the President during the negotiation of his employment agreement, and
the prepayment of $7,000 in real estate and personal property taxes.
The increase above is partially offset by a decrease in Accounts Receivable of
$66,237 consisting primarily of 1) a decrease of $82,929 to Unbilled Accounts
Receivable reflecting a decrease in prior year unbilled direct costs of $125,440
that were billed in June 1997 and an increase in reimbursable indirect rate
variances of $42,511 during this quarter, 2) an increase of $42,860 to Trade
Receivables, and 3) a $26,168 decrease to Other Accounts Receivable due to the
collection of a prior year receivable from the Medical Center Dr. facility
landlord. Other Noncurrent Assets decreased $54,000 due to the completion of a
nonhuman primate housing unit order from the previous fiscal year.
6
Liabilities
In the first three months of operations, Total Liabilities increased $61,590 as
compared to May 31, 1997. This increase is primarily attributable to an increase
to Borrowings Under Line-of-Credit of $256,449 reflecting the increase in Fixed
Assets and Prepaid Expenses stated above.
The above increase is partially offset by 1) a decrease in Accounts Payable of
$31,900, 2) a decrease in Accrued Compensation and Related Costs of $121,619
reflecting a shorter accrual period this quarter when compared to the prior year
end, and 3) payments totalling $30,005 on capital leases reducing Long-Term
Debt.
The Company believes it has sufficient cash and financing sources to provide for
its ongoing operations and the Company continues to believe that the impact of
inflation, or the absence of it, will have no significant effect on its
operations.
PART II. Other Information
Item 1. LEGAL PROCEEDINGS
On September 3, 1997 Lourdes Weisgerber, a former employee, filed a Complaint in
The United States District Court for the District of Maryland (Southern
Division) Case No. PJM 972970 alleging that BIOQUAL, Inc. violated her
employment rights under the American With Disabilities Act. This allegation was
previously reported as an administrative law matter within the Equal Employment
Opportunity Commission (EEOC) and the Montgomery County Human Relations
Commission. The joint investigation conducted by the Montgomery County Human
Relations Commission found no discrimination. Ms. Weisgerber asked for and
received a Notice of Right to Sue upon the dismissal of the administrative
complaint by Montgomery County and the EEOC. The Plaintiff has sued for backpay,
emotional distress, pain and suffering, punitive damages, and attorneys' fees
and costs. While the Company intends to defend this action vigorously and
believes that it will not have a material effect on its financial condition, it
can not give any assurance of the results of this pending litigation.
Item 6. EXHIBITS
(10) Government Contracts.
1. Title: Facility for Preparing and
Housing Virus Infected Mice,
Genetically Manipulated Mice,
and Chimeric Mice.
Institute: National Cancer Institute
Dates Funded: 10/1/97 - 9/30/01
7
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused the report to be signed on its behalf by the
undersigned thereunto duly authorized.
DIAGNON CORPORATION
DATE October 14, 1997 /s/ John C. Landon, Ph.D.
-------------------- -------------------------
Chairman of the Board,
President and Chief Executive
Officer
DATE October 14, 1997 /s/ Michael P. O'Flaherty
-------------------- -------------------------
Chief Operating Officer and
Secretary
DATE October 14, 1997 /s/ David A. Newcomer
-------------------- -------------------------
Chief Financial Officer
8
EXHIBITS
9
(10) Government Contracts.
1. Title: Facility for Preparing and
Housing Virus Infected Mice,
Genetically Manipulated Mice, and
Chimeric Mice.
Institute: National Cancer Institute
Dates Funded: 10/1/97 - 9/30/01
10
OMB NO. 0990-0115
====================================================================================================================================
1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 350) 1 25
- ------------------------------------------------------------------------------------------------------------------------------------
2. CONTRACT (Proc. Inst Ident.) NO. 3. EFFECTIVE DATE 4. REQUISITION PURCHASE REQUEST/PROJECT NO.
N02-BC-81041 10/01/97
- ------------------------------------------------------------------------------------------------------------------------------------
5. ISSUED BY CODE 261981041 6. ADMINISTERED BY (If other than item 5) CODE
------------------ --------------------
National Cancer Institute Experimental Immunology
Research Contracts Branch, CECS
Executive Plaza South, Room 620
9000 Rockville Pike MSC 7224 Division of Basic Sciences
Bethesda Maryland 20892-7224 (RFP No. N02BC71041-21)
- ------------------------------------------------------------------------------------------------------------------------------------
7. NAME AND ADDRESS OF THE CONTRACTOR (No., street, city, county, State and ZIP Code) 8. DELIVERY
[X] FOB Destination [ ] FOB Origin
Bioqual, Inc. ----------------------------------------
9600 Medical Center Drive 9. DISCOUNT FOR PROMPT PAYMENT
Rockville, Maryland 20850-3336
----------------------------------------
10. SUBMIT INVOICES ITEM
(4 copies unless otherwise
specified)
PLACE OF PERFORMANCE: Rockville, Maryland TO THE ADDRESS SHOWN IN
- ------------------------------------------------------------------------------------------- SEE SECTION G
CODE FACILITY CODE (RIGHT ARROW) ARTICLE G.
- ------------------------------------------------------------------------------------------------------------------------------------
11. SHIP TO/MARK FOR CODE 12. PAYMENT WILL BE MADE BY CODE
SEE SECTION F, ARTICLE F.1. SEE SECTION G, ARTICLE G.3. --------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
CAN1 88322363 TIN 1521244771A1
---------------- ---------------
[ ] 10 U.S.C. 2304(c) ( ) [X] 41 U.S.C. 253(c) (1) CAN2 DOC NO. N2BC81041A
---------------- ---------------
OC CODE 25.2E LOC
---------------- ---------------
- ------------------------------------------------------------------------------------------------------------------------------------
15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
- ------------------------------------------------------------------------------------------------------------------------------------
TITLE: Facility for Preparing and Housing Virus Infected Mice, Genetically Manipulated Mice CAN1: $ 744,748
and Chimeric Mice CAN2: $
-----------------
CURRENT OBLIGATION: $ 744,748
CONTRACT PERIOD: 10/01/97 through 09/30/98 $
CONTRACT TYPE: Cost-Plus Fixed Fee, COMPLETION $
- ------------------------------------------------------------------------------------------------------------------------------------
15G. TOTAL AMOUNT OF CONTRACT $ 744,748
- ------------------------------------------------------------------------------------------------------------------------------------
16. TABLE OF CONTENTS
- ------------------------------------------------------------------------------------------------------------------------------------
(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)
- ------------------------------------------------------------------------------------------------------------------------------------
PART I--THE SCHEDULE PART II--CONTRACT CLAUSES
- ------------------------------------------------------------------------------------------------------------------------------------
X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 19
- ------------------------------------------------------------------------------------------------------------------------------------
X B SUPPLIES OF SERVICES AND PRICES/COSTS 4 PART III--LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
- ------------------------------------------------------------------------------------------------------------------------------------
X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 24
- ------------------------------------------------------------------------------------------------------------------------------------
X D PACKAGING AND MARKING 12 PART IV--REPRESENTATIONS AND INSTRUCTIONS
- ------------------------------------------------------------------------------------------------------------------------------------
X E INSPECTION AND ACCEPTANCE 12 REPRESENTATIONS, CERTIFICATIONS AND
- ----------------------------------------------------------------- X K 25
X F DELIVERIES OR PERFORMANCE 13 OTHER STATEMENTS OF OFFERORS
- ------------------------------------------------------------------------------------------------------------------------------------
X G CONTRACT ADMINISTRATION DATA 14 [ ] L INSTRS., CONDS., AND NOTICES TO OFFERORS
- ------------------------------------------------------------------------------------------------------------------------------------
X H SPECIAL CONTRACT REQUIREMENTS 17 [ ] M EVALUATION FACTORS FOR AWARD
- ------------------------------------------------------------------------------------------------------------------------------------
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
- ------------------------------------------------------------------------------------------------------------------------------------
17. [X] CONTRACTORS NEGOTIATED AGREEMENT (Contractor is required 18. [ ] AWARD (Contractor is not required to sign this
to sign this document and return 1 copies to issuing office.) document.)
Contractor agrees to furnish and deliver all items or perform all Your offer on Solicitation Number ________________________
the services set forth or otherwise identified above and on any including the additions or changes made by you which
continuation sheets for the consideration stated herein. The rights additions or changes are set forth in full above, is herein
and obligations of the parties to this contract shall be subject to accepted as to the items listed above and on any continu-
and governed by the following documents: (a) this award/contract, ation sheets. This award consummates the contract which
(b) the solicitation, if any, and (c) such provisions, representations, consists of the following documents: (a) the Government's
certifications, specifications, as are attached or incorporated by solicitation and your offer and (b) this award/contract.
reference herein. (Attachments are listed herein.) No further contractual document is necessary.
- ------------------------------------------------------------------------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
/s/ Michael P. O'Flaherty COO BARBARA A. SHADRICK
- ------------------------------------------------------------------------------------------------------------------------------------
19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
BY /s/ Michael P. O'Flaherty 9/29/97 BY /s/ Barbara A. Shadrick 10/1/97
-------------------------- --------------------------
(Signature of person (Signature of Contracting
authorized to sign) Officer)
- ------------------------------------------------------------------------------------------------------------------------------------
NSN 7540-01-152-8069 26-107 STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE Prescribed by GSA
GPO : 1985 O - 461-275 (418) FAR (48 CFR) 53.214(a)
Contract No. N02-BC-81041
Page 2
DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.....................................4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES.......................4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE....................................4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS...........................5
ARTICLE B.4. ADVANCE UNDERSTANDINGS..........................................5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.................................6
ARTICLE C.1. STATEMENT OF WORK...............................................6
ARTICLE C.2. REPORTING REQUIREMENTS.........................................11
SECTION D - PACKAGING, MARKING AND SHIPPING..........................................12
SECTION E - INSPECTION AND ACCEPTANCE................................................12
SECTION F - DELIVERIES...............................................................13
SECTION G - CONTRACT ADMINISTRATION DATA.............................................14
ARTICLE G.1. PROJECT OFFICER................................................14
ARTICLE G.2. KEY PERSONNEL..................................................15
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND
CONTRACT FINANCIAL REPORT...............................15
ARTICLE G.4. INDIRECT COST RATES............................................16
ARTICLE G.5. GOVERNMENT PROPERTY............................................16
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE......................17
SECTION H - SPECIAL CONTRACT REQUIREMENTS............................................17
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND
DEVELOPMENT PROJECTS.....................................17
ARTICLE H.2. HUMAN SUBJECTS.................................................18
ARTICLE H.3. INTRODUCTION OF RODENTS AND RODENT PRODUCTS....................18
ARTICLE H.4. ANIMAL WELFARE ASSURANCE.......................................18
ARTICLE H.5. OPTION PROVISION...............................................18
ARTICLE H.6. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE.............18
Contract No. N02-BC-81041
Page 3
PART II - CONTRACT CLAUSES....................................................................19
SECTION I - CONTRACT CLAUSES............................................................19
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT ..........19
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES..................................22
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES.........................................23
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT...............23
PART III......................................................................................24
SECTION J - LIST OF ATTACHMENTS.........................................................24
1. Invoice/Financing Request and Contract Financial Reporting Instructions
for NIH Cost-Reimbursement Type Contracts....................................24
2. Safety and Health............................................................24
3. Procurement of Certain Equipment.............................................24
4. Government Property - Schedule II-A..........................................24
5 Pathology Report.............................................................24
6. Animal Health Diagnostic Serology Submission Form............................25
7. Animal Health Diagnostic Request Form........................................25
8. Introduction of Rodents and Rodent Products, NIH Manual 3043-1...............25
9. Application for Permit to Introduce Rodent and Rodent Produce, NIH 2369-1....25
10. Permit to Introduce Rodents and Rodent Products, NIH 2369-2..................25
11. Material Transfer Agreement..................................................25
12. Animal Inventory Summary.....................................................25
13. Animal Mortality Sheet.......................................................25
PART IV.......................................................................................25
SECTION K - REPRESENTATIONS AND CERTIFICATIONS..........................................25
Representations and Certifications...............................................25
Animal Welfare Assurance Number..................................................25
Contract No. N02-BC-81041
Page 4
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The Contractor shall provide an animal facility which shall be capable of: (1)
maintaining a colony of mice to support ongoing research in the areas of
immunobiology, immunogenetics, tumor biology and diagnosis and transplantation;
(2) breeding special strains of mice; and (3) providing a technical staff to
perform animal manipulations. All animals will be supplied by the Government
except sentinel mice.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of the base year of this contract is $696,026.
b. The fixed fee for the base year of this contract is $48,722. The fixed fee
shall be paid in installments based on the percentage of completion of
work, as determined by the Contracting Officer, and subject to the
withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED
FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of
this contract. Payment of fixed fee shall not be made in less than monthly
increments.
c. The Government's obligation, represented by the sum of the estimated cost
plus the fixed fee for the base year of this contract is $744,748.
d. If the Government exercises its option pursuant to ARTICLE H.5. of this
contract, the Government's obligation represented by the sum of the
estimated cost plus the fixed fee of this contract will be increased as
follows:
Estimated Cost Effective
Option Period Estimated Cost Fixed Fee Plus Fixed Fee Date
------------- -------------- --------- -------------- -------
Option 1 (12 months) $ 724,541 $ 50,718 $ 775,259 10/01/1998
Option 2 (12 months) $ 752,980 $ 52,709 $ 805,689 10/01/1999
Option 3 (6 months) $ 386,056 $ 27,024 $ 413,080 10/01/2000
Option 4 (6 months) $ 394,810 $ 27,637 $ 422,447 04/01/2001
--------- -------- ---------
TOTAL $2,954,414 $206,809 $3,161,223
(Including Base Year)
e. Total funds currently available for payment and allotted to this contract
are $744,748 of which $696,026 represents the estimated costs, and of
which $48,722 represents the fixed fee. For further provisions on funding,
see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2.
Authorized Substitutions of Clauses.
f. It is estimated that the amount currently allotted will cover performance
of the contract through September 30, 1998.
g. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
Contract No. N02-BC-81041
Page 5
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE,
incorporated in this contract by reference, unless authorized in writing
by the Contracting Officer, the costs of the following items or activities
shall be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real
property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture
or office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.). All requests for
computer equipment shall be screened to ensure compliance with EPA
Energy Star requirements.
(4) Travel to attend general scientific meetings;
(5) Foreign travel - (Not applicable)
(6) Patient care costs;
(7) Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life
expectancy of more than two years) and "sensitive items" (defined
and listed in the Contractor's Guide for Control of Government
Property) 1990, regardless of acquisition value.
(8) Consultants; and
(9) Subcontracts.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.
a. Overtime
Overtime (premium) pay for the animal caretaker staff not to exceed a
total of:
Base Year: $1,997 (effective 10/01/1997)
Option 1: $2,097 (effective 10101/1998)
Option 2: $2,202 (effective 10/01/1999)
Option 3: $1,138 (effective 10/01/2000)
Option 4: $1,157 (effective 04/01/2001)
______
Total (not to exceed): $8,580
Contract No. N02-BC-81041
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b. Consultants
Consultant fee to be paid to the following individual:
Total Cost
Rate Number of Including Travel Effective
Name Per Hour Hours Not to Exceed Period Date
---- -------- --------- ---------------- ------ ----------
Robert J. Russell, DVM $60.00 104 $ 6,240 Base Year 10/01/1997
$60.00 104 $ 6,240 Option 1 10/01/1998
$60.00 104 $ 6,240 Option 2 10/01/1999
$60.00 52 $ 3,120 Option 3 10/01/2000
$60.00 52 $ 3,120 Option 4 04/01/2001
--- -------
Totals (not to exceed): 416 $24,960
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work below:
a. Animal Maintenance and Space Requirements
1) The Contractor shall supply animal care and maintenance for
approximately 3,000 - 4,000 mice according to standards outlined in
the Guide for the Care and Use of Laboratory Animals as published
in DHHS Publication No. (NIH 86-23), the Public Health Service
Policy on Humane Care and Use of Laboratory Animals (September
1986) and the Animal Welfare Act in 1976 and amendments thereto.
The animals shall be maintained in microisolator cages in a
contiguous multi-roomed facility that shall include the following:
a) One separate room to receive and hold stock mice. Air
pressure in this room shall be positive with respect to
corridors.
b) A separate room for housing mice which have been irradiated
and injected with cells. Air pressure in this room shall be
positive with respect to corridors.
c) A separate small laboratory for preparing and injecting cells
into irradiated mice, which is adjacent to b), above. This
laboratory shall be equipped with sink, work benches, chairs,
one centrifuge, one refrigerator (approximately 10 cu. Ft.),
one water bath, one CO2 incubator, one 20o freezer, one
binocular microscope and hemacytometers.
d) One separate room for housing severe combined immune
deficiency (SCID) mice and mice involved in transgenic
experiments. Air pressure in this room shall be positive with
respect to corridors.
e) One separate room for housing mice which have been infected
with murine viruses. Air pressure in this room shall be
negative to the corridors with respect to the rest of the
facility.
Contract No. N02-BC-81041
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f) One small laboratory which adjoins the virus mouse room
described above in e). The lab shall contain sink, work
bench, chairs, one refrigerator (at least 16 cu. ft.), one
-70 degrees C freezer, one water bath, one CO2 incubator,
one centrifuge, one 4-ft. Biosafety Cabinet, one binocular
microscope, one egg incubator for culturing viruses and
hemacytometers. This laboratory and biohazard hood are to be
suitable for working with murine viruses.
g) All animal rooms shall be equipped with either biosafety
cabinets or laminar flow change stations and all cage
changing shall occur in these units.
h) Space to house one Gammacell 40 137Cs Irradiation Unit
(provided by the Government) and shall be responsible for the
safe use and monitoring of this irradiator. This irradiator
shall be located in a room separate from the animals and
shall be used solely for this contract.
i) Virus-free rooms and virus-positive rooms shall be separated
by, and separate from, the cleaning area and air flow shall
be in the direction of virus-free to virus-positive areas.
The cleaning area shall contain mouse cage, bottle and rack
washer and shall be used for cleaning and sterilizing
equipment. The cleaning area shall also be equipped with an
autoclave, installed in such a way that all equipment and
supplies coming out of the virus-positive areas shall pass
through the autoclave before entering the cleaning area. The
cleaning area shall also have an area for removing clothing
of personnel working in the virus-positive area, and a
shower.
j) Rooms utilized by this contract shall be used exclusively for
the mice maintained by this contract.
2) The Contractor shall test for common pathogens in the rodents. The
mice shall be maintained as a conventional colony, rather than as
specific pathogen free. Routine screening of all mice in the colony
shall be performed at three-month or more frequent intervals, as
follows:
a) Sentinel mice, provided by the Contractor, shall be used to
screen for viral and bacterial pathogens, ova and parasites,
mites, pinworms, Giardia and mycoplasma.
b) Notify the Project Officer, within 72 hours, of any animals
exhibiting disease.
c) Sentinel animals shall be submitted in accordance with
SECTION F - DELIVERIES for testing described in 2)a), above.
Test results from the NCI will be provided to the Contractor.
3) The Contractor shall submit all diseased animals identified within
the holding colony in accordance with SECTION F - DELIVERIES. The
NCI will be responsible for performing autopsies and carrying out
pathologic examinations of tissues in order to determine the basis
for the disease. Results of the autopsies and pathologic
examinations will be provided by NCI to the Contractor.
4) The Contractor shall, in accordance with the delivery schedule,
provide the Project Officer with the results of all autopsies or
other diagnostic tests performed in 2)a) and 3), above. Autopsy and
test results shall be submitted in accordance with the delivery
schedule and in the formats specified in Pathology Report
(ATTACHMENT 5), Animal Health Diagnostic Serology Submission Form
(ATTACHMENT 6) and Animal Health Diagnostic Request Form
(ATTACHMENT 7).
5) The Contractor shall follow the procedures listed below for
introducing new mice from non-approved sources into the colony.
Animals entering the colony from approved sources shall not require
quarantine. A current list of approved sources shall be provided
from time to time by the Project Officer. The Contractor shall
comply with the policies stated in NIH Manual Chapter 3043-1,
Introduction of Rodents and Rodent Products, incorporated herein as
ATTACHMENT 8.
Contract No. N02-BC-81041
Page 8
a) The Contractor shall obtain a history of all incoming mice
prior to admission to the quarantine facility. Mice coming
from outside facilities with a history of ectromelia,
lymphocytic choriomeningitis or other serious infections
shall not be admitted.
b) Mice from non-approved sources shall be maintained in micro
isolators in a room used only for mouse quarantine. The mice
shall be in contact with sentinel mice through the use of
mixed bedding. Mice shall be maintained in quarantine for a
sufficient period to ensure the absence of infection with
ectromelia and lymphocytic choriomeningitis and to evaluate
their potential disease status before they are placed in the
holding rooms. Sentinel mice shall be submitted to the NCI in
accordance with SECTION F - DELIVERIES for the above testing.
Test results from the NCI will be provided to the Contractor.
c) Technicians working with the mice in the virus-positive room
shall wear a gown, gloves and foot coverings and shall not
enter any rooms in the conventional colony after working in
the virus- positive facility on that day.
d) No mice shall be introduced into the colony without the
specific approval of the Project Officer.
6) Maintenance requirements:
a) All animal care and laboratory personnel shall change into
clean lab clothing (including shirt, pants and shoes) upon
entering the facility, prior to performing assigned tasks.
Gloves and face masks must be worn by all Contractor staff
when handling animals. In the event of disease outbreak,
disposable gowns, shoe covers, bouffant caps, gloves and face
masks shall be worn by all employees working in the infected
area. The Contractor shall take precautions, approved by the
Project Officer, to avoid contamination of mice in the colony
with diseases from any other animals maintained by the
Contractor.
b) Feed shall be a standard mouse ration as prepared by a
reputable commercial company, unless other arrangements are
approved by the Project Officer.
c) The Contractor shall discard old feed in animal cages no less
than once a week.
d) The Contractor shall thoroughly wash all cages, racks and
feeding apparatuses at least once a week, using appropriate
detergents and water at no less than 180 degrees Fahrenheit.
The watering apparatus shall be washed twice a week using
appropriate detergents and water at no less than 180 degrees
Fahrenheit.
e) The Contractor shall mop all animal rooms and hallways daily.
The mop head shall be changed at least once a month.
f) The Contractor shall wash each animal room every month
according to the following procedures:
(1) All equipment shall be moved out of the room into the
central corridor and the floor swept thoroughly.
(2) Ceilings and walls shall be washed using an appropriate
cleaning solution.
(3) Ceilings and walls shall be rinsed thoroughly with clean
water.
(4) Excess water shall be removed from the floors.
Contract No. N02-BC-81041
Page 9
(5) An appropriate disinfectant shall be applied to the
ceilings and all walls, allowing the solution to dry
(SHALL NOT RINSE).
g) the ambient temperature of the colony shall be maintained
year round at 74 degrees +/- 3 degrees Fahrenheit with
monitored alarm system for temperatures above 85 degrees
Fahrenheit. The Contractor shall maintain a plan for
immediate correction of ambient temperature outside the
specified range that is satisfactory to the Project Officer.
Relative humidity of the colony shall be maintained year
round at 50% +/- 10%.
h) Cage litter shall be changed at least once a week.
i) The ventilation system in each animal room shall provide for
10 air changes per hour.
j) Animal drinking water shall be acidified to six parts per
million (ppm) (pH 2.5-3.0) with Hydrochloric Acid.
k) Animal care supplies and feed shall not be stored in the
animal holding rooms of the colony.
7) Shipping:
a) The Contractor shall provide, in accordance with the delivery
schedule, for the rapid exchange of animals and reagents
between the Contractor's facility and the Experimental
Immunology Branch (EIB) laboratories and animal facilities in
Building 10 on the National Institutes of Health (NIH)
campus, in a vehicle designed to maintain reasonable
temperature in summer and winter (75 degrees +/- 5 degrees
Fahrenheit). Reagents shall be shipped on wet ice, dry ice or
liquid nitrogen, as required by the Project Officer. Reagent
shipments shall not exceed the trip requirements for animals
and these shipments may be done simultaneously.
b) The Contractor shall provide two (2) trips per day, Monday
through Friday, except Government holidays, between the
colony and the EIB laboratories and animal facilities on the
NIH campus (Building 10, 9000 Rockville Pike, Bethesda,
Maryland 20892).
c) To meet requirements of the experiments, arrival times of the
shipments in a.7)b), above, will be specified by the Project
Officer, approximately 8:00 a.m. and 1:30 p.m. The Project
Officer may call in requests for animals or reagents as late
as 4:00 p.m. the day before a morning shipment or as late as
11:00 a.m. on the morning of an afternoon shipment.
d) The Contractor shall ship mice and reagents in accordance
with the delivery schedule to investigators outside of NIH at
the direction of the Project Officer. The cost of shipments
to other investigators shall be at the expense of the
recipient, unless specified otherwise by the Project Officer.
The Contractor shall process and maintain Material Transfer
Agreements, incorporated herein as ATTACHMENT 11, on
shipments to other investigators, as specified by the Project
Officer. Directions for shipping mice will be specified by
the Project Officer, such as the need to inform the recipient
about the health of the mice at the Contractor's facility
prior to shipment. The Contractor shall be responsible for
appropriately packing the shipments and arranging for
shipment from the Contractors facility. The Government will
pay for these shipments.
b. Mouse Breeding
1) The Contractor shall breed mice according to standard production
procedures, as opposed to pedigree breeding, as required by the
Project Officer. The Contractor shall maintain up to 300 cages of
breeding mice and segregate offspring as required by the Project
Officer. These mice are included in the totals listed in paragraph
a.1), above.
Contract No. N02-BC-81041
Page 10
2) The Contractor shall pair mice for breeding at the direction of the
Project Officer. Mouse pairings requested for breeding shall be
established within seven calendar days of the Project Officer's
request.
3) The Contractor shall carry gut special procedures as requested by
the Project Officer, including the use of micro isolator cages for
breeding, setting up timed pregnancies, ear-tagging parents and
progeny, sacrificing progeny and collecting tail snips or
peripheral blood leukocytes.
4) The Contractor shall inspect cages at least three times a week. If
in any cage the production of lifters has stopped for a period of
two months, the cage shall be labeled as nonproductive and the
Project Officer shall be notified in writing or verbally within
seven calendar days.
C. Experimental Procedures
Perform experimental procedures as directed by the Project Officer,
including, but not limited to, the following:
1) Adoptive transfer of spleen and/or lymph node cells (5 to 50x10 to
the sixth power/recipient) (prepared by the Contractor) into either
unirradiated or irradiated recipient mice.
2) Exposure of mice to g-irradiation, preparation of bone marrow cell
suspensions and i.v. inoculation of bone marrow cells (1 to
3x10 to the seventh power/recipient) into irradiated recipients
(bone marrow chimeria preparation).
3) Sterile preparation of lymphoid cell suspensions. The white blood
cell samples may be stained for fluorescence analysis.
4) The bleeding and preparation of mouse serum samples.
5) Intra-peritoneal injections.
6) Subcutaneous injections.
7) Foot pad inoculations.
8) Thymectomies.
9) Acites preparations in mice.
10) Foster nursing of mice for exposure to murine mammary tumor
viruses.
11) Injection of mice with murine retroviruses.
12) Harvesting milk from pregnant mice.
13) Performance of survival surgery to remove mammary glands from
pregnant mice.
14) Preparation of pseudo-pregnant mice and embryo transfer
experiments.
15) Tail snips.
16) Palpation for tumors.
17) Growth and harvest of influenza A virus in chicken eggs.
Contract No. N02-BC-81041
Page 11
d. Meetings
The Contractor shall provide for frequent (at least once a week)
consultation between the Principal Investigator and the Project Officer.
ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Reports
In addition to those reports required by the other terms of this contract,
the Contractor shall prepare and submit the following reports in the
manner stated below and in accordance with SECTION F - DELIVERIES of this
contract:
1) Annual Progress Report
This report shall:
a) provide a concise summary, not to exceed 200 words, or the
progress since the last reporting period;
b) contain a comprehensive report of progress during the last
one-year period including, as a minimum:
(1) the number of animals received;
(2) the number of animals disbursed;
(3) the number of mortalities;
(4) pertinent clinical data on animal tests and diseases;
(5) listing of all procedures performed and the numbers
of animals used in a particular procedure and the
number of times the procedure was performed during
the reporting period.
c) proposed activity under the contract for the ensuing year.
Tables, graphs or other methods may be used to organize and
summarize data. The first Annual Report shall cover the period
October 1, 1997 through September 30,1998, and shall be due
on/before the 30th of the month following the anniversary date of
the contract(1). Thereafter, Annual Reports shall be due on or
before the 30th calendar day following each Annual reporting
period.
(1) If an option is NOT exercised, the Annual Report shall be
treated as the Final Report and the information requested in
paragraph 2), below, shall be provided on/before the completion
date of the contract. An Annual Report will not be required for the
period when the Final Report is due.
Contract No. N02-BC-81041
Page 12
2) Final Report
This report is to include a summation of the work performed
and results obtained for the entire contract period of
performance. This report shall be in sufficient detail to
describe comprehensively the research and accomplishments and
the results achieved, covering the entire contract period,
including all applicable Option periods. The Final Report
shall be submitted in accordance with SECTION F - DELIVERIES
of this contract. An Annual Report will not be required for
the period when the Final Report is due at the completion of
all exercised options.
b. Other Reports/Deliverables
1) Animal Inventory Summary
The Animal Inventory Summary shall contain a summary of the
animal inventory and shall be delivered in the format
specified in ATTACHMENT 12. This report is to be delivered
only to the Project Officer (see SECTION F - DELIVERIES.,
below).
2) Animal Mortality Sheet
The Animal Mortality Sheet shall contain data concerning the
mortality of animals within the colony and shall be delivered
in the format specified in ATTACHMENT 13. This report is to
be delivered only to the Project Officer (see SECTION F -
DELIVERIES, below).
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. The Contractor shall
guarantee that all required materials shall be delivered in immediate usable and
acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.
b. For the purpose of this ARTICLE, the Project Officer identified in ARTICLE
G. 1., below, is the authorized representative of the Contracting Officer.
c. Inspection and acceptance will be performed at Building 1O, Room 4B17,
National Institutes of Health, Bethesda, Maryland.
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
d. This contract incorporates the following clause by reference, with the
same force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT (APRIL 1984).
Contract No. N02-BC-81041
Page 13
SECTION F - DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated delivery
schedule:
a. The items specified below as described in SECTION C. ARTICLE C.2. will be
required to be delivered F.O.B. Destination as set forth in FAR 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in
accordance with and by the dates specified below and any specifications
stated in SECTION D. PACKAGING, MARKING AND SHIPPING, of the contract:
Item Description Quantity Delivery Schedule
---- ----------- -------- -----------------
1) Annual Progress Report Original - C.O. 30 calendar days after
specified in ARTICLE C.2. 3 Copies - P.O. each reporting period.
2) Final Report specified Original - C.O. On/before the completion
in ARTICLE C.2. 3 Copies - P.O. date of contract.
3) Sentinel Animals and As required. As directed by the
diseased animals specified Project Officer.
in ARTICLE C.l., paragraphs
a.2), a.3) and a.4).
4) Test Results from Sentinel 1 Copy of Within 7 calendar days
animals as specified in required form of performance.
ARTICLE C.1., para. a.4).
Utilize forms provided as
ATTACHMENTS 5, 6 & 7.
5) Animal Inventory Summary 2 Copies - P.O. First report is due 7
specified in ARTICLE C.2., calendar days after the
paragraph b.1). Utilize form effective date of the
provided as ATTACHMENT 12. contract and every 7
calendar days thereafter.
6) Animal Mortality List 1 Copy - P.O. First report is due 7
specified in ARTICLE C.2., calendar days after the
paragraph b.2). Utilize form Effective date of the
provided as ATTACHMENT 13. contract and every 7
calendar days thereafter.
7) Animals and Reagents As directed by 2 per day as specified
specified in ARTICLE C.1., the P.0. in ARTICLE C.1.,
paragraph a.7)a). paragraph a.7)a).
8) Animals and Reagents To be shipped to investigators outside of NIH
specified in ARTICLE C.1., at the direction of the Project Officer.
paragraph a.7)d).
Contract No. N02-BC-81041
Page 14
b. The above items shall be addressed and delivered to:
Originals only of Items 1) and 2), above, shall be addressed and delivered
to:
Contracting Officer
Cancer Epidemiology Contracts Section
Research Contracts Branch, OEM
National Cancer Institute
Executive Plaza South, Room 620
6120 Executive Boulevard, MSC 7224
Bethesda, MD 20892-7224
The specified number of copies of Items 1), 2), 4), 5), 6) and 7), above,
shall be delivered to:
Project Officer (as identified in Article G. 1.)
Experimental Immunology Branch
Division of Basic Sciences
National Cancer Institute
Building 10, Room 4B17
9000 Rockville Pike, MSC 1360
Bethesda, MD 20892-1360
Item 3), above, shall be delivered to:
Senior Manager for Technical Operations
Animal Health Diagnostic Laboratory
PRI, Inc.
Frederick Cancer Research and Development Center (FCRDC)
Post Office Box B
Frederick, MD 21702-1201
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose
of this contract:
Dr. Gene M. Shearer, Project Officer
The Project Officer is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance and
recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
The Contracting Officer is the only person with authority to act as agent of the
Government under this contract. Only the Contracting Officer has authority to:
(1) direct or negotiate any changes in the Statement of Work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.
The Government may unilaterally change its Project Officer designation.
Contract No. N02-BC-81041
Page 15
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work being
performed hereunder:
NAME TITLE
---- -----
Kinta Diven Principal Investigator (Project Manager)
Mary Adams Senior Laboratory Technician
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT
a. Invoice/Financing Request Instructions and Contract Financial Reporting
for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made
part of this contract. The instructions and the following directions for
the submission of invoices/financing request must be followed to meet the
requirements of a "proper" payment request pursuant to FAR 32.9.
b. These instructions also provide for the submission of financial and
personnel reporting required by HHSAR 342.7002. Unless otherwise stated in
that part of the Instructions for Completing Form NIH(RC)-4 (see
ATTACHMENT 1), all columns A through H shall be completed for each invoice
submitted.
c. The Contracting Officer may require the Contractor to submit detailed
support for costs contained in one or more interim financial invoices.
This clause does not supersede the record retention requirements of FAR
Part 4.7.
d. The contractor agrees to provide a detailed breakdown on invoices of cost
and personnel reporting and variances from the negotiated budget in the
following cost categories:
1) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount
claimed.
2) Fringe Benefits
3) Sentinel Animals
4) Laundry/Clothing
5) Cleaning Supplies
6) Animal Housing
7) Laboratory and Technician Supplies
8) Media and Reagents
9) Overtime Premium
10) Transportation
11) Equipment Maintenance
12) Consultant Veterinarian
13) Total Direct Costs
14) Overhead
15) Total Direct Cost plus Overhead
16) G&A
17) Total Cost
18) Fixed Fee
19) Total Amount Claimed (CPFF)
20) Adjustments
21) Grand Total
Contract No. N02-BC-81041
Page 16
e. Invoices must include the cumulative total expenses to date, adjusted (as
applicable) to reflect any amounts suspended by the Government.
f. The Contractor agrees to immediately notify the Contracting Officer, in
writing, if there is an anticipated overrun (any amount) or unexpended
balance (greater than 10 percent) of the amount currently allotted to the
contract and the reasons for the variance. Also, refer to the requirements
of FAR 52.232-20, Limitation of Cost, referenced in the contract.
g. Invoices/financing requests shall be submitted in the form of an original
and two copies to the following designated billing office:
Contracting Officer
Cancer Epidemiology Contracts Section
Research Contracts Branch, OEM
National Cancer Institute, NIH
Executive Plaza South (EPS), Room 620
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MD 20892-7224
h. Inquiries regarding approval of invoices should be directed to the
designated billing office, (301) 496-8611.
i. Inquiries regarding actual payment of invoices should be directed to the
designated payment office, (301) 496-6452.
ARTICLE G.4. INDIRECT COST RATES
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in Part II, Section I, the cognizant Contracting Officer
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Chief, Division of Financial Advisory Services
Office of Contract Management, OA
National Institutes of Health
6100 EXECUTIVE BLVD ROOM 6BO5 MSC 7540
BETHESDA MD 20892-7540
These rates are hereby incorporated without further action of the Contracting
Officer.
These rates are hereby incorporated without further action of the Contracting
Officer. The above information notwithstanding, the notifications required to be
submitted to the Contracting Officer pursuant to FAR 52.232-22, Limitation of
Funds, of this contract shall remain in effect.
ARTICLE G.5. GOVERNMENT PROPERTY
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in Section I of this contract, the Contractor shall comply
with the provisions of DHHS Publication, Contractor's Guide for Control of
Government Property, (1990), which is incorporated into this contract by
reference. Among other issues, this publication provides a summary of the
Contractor's responsibilities regarding purchasing authorizations and
inventory and reporting requirements under the contract. A copy of this
publication is available upon request to the Contract Property
Administrator.
Contract No. N02-BC-81041
Page 17
This contracts Contract Property Administrator is:
David A. Hubbard, II
Contracts Property Administrator
Research Contracts Property Administration, NIH
Building 13, Room 2E-65
13 SOUTH DR MSC 5748
BETHESDA MD 20892-5748
(301) 496-6467
b. Government Furnished Property - Schedule II-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor is hereby authorized to retain custody of the
property listed in Schedule II-A (ATTACHMENT 4) for use in direct
performance of this contract. Accountability for the items listed in
Schedule II-A is hereby transferred to this contract from predecessor
Contract No. N02-BC-40537, under which these items were provided by the
Government. Title to this property shall remain in the Government.
The property listed in Schedule II-A shall be dedicated 100% for use under
this contract.
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE
Interim and final evaluations of contractor performance shall be conducted on
this contract in accordance with OFPP Policy Letter 92-5, issued January 11,
1993 and HHSAR 342.7002(c)(2)(iv). A final performance evaluation shall be
completed at the time of completion of work. In addition to the final
evaluation, interim evaluations will be prepared by the Project Officer annually
to coincide with the anniversary date of the contract.
Interim and final evaluations will be initiated by the Project Officer and
submitted to the Contracting Officer. The Contracting Officer will concur by
initialing the appropriate block of the NIH Contractor Performance Report, and
will submit the document to the Contractor as soon as practicable. The
Contractor will be permitted thirty days to review the document and to submit
additional information or a rebutting statement.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.l. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
PROJECTS
The primary purpose of the Public Health Service (PHS) is to support and advance
independent research within the scientific community. This support is provided
in the form of contracts and grants totaling approximately 7 billion dollars
annually. PHS has established effective, time tested and well recognized
procedures for stimulating and supporting this independent research by selecting
from multitudes of applications those research projects most worthy of support
within the constraints of its appropriations. The reimbursement through the
indirect cost mechanism of independent research and development costs not
incidental to product improvement would circumvent this competitive process.
To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.
Contract No. N02-BC-81041
Page 18
ARTICLE H.2. HUMAN SUBJECTS
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, shall be used by the Contractor or made available
by the Contractor for use by anyone other than the Government, for experimental
or therapeutic use involving humans without the prior written approval of the
Contracting Officer.
ARTICLE H.3. INTRODUCTION OF RODENTS AND RODENT PRODUCTS
No rodent or rodent product shall be delivered into the NIH, NCI environment
(NIH) directly, or through collaborative research or holding facilities under
contract to NCI except by permit. Direct shipments to NIH from a commercial
colony will be considered exempt. Non-exempt sources must be approved by permit
issued through the National Center for Research Resources (NCRR). The permit
must be obtained by the Contractor prior to the shipment to NIH of the rodents
and/or rodent products. The Contractor must be sure that this permit exists and
is current before transferring rodents or rodent products into the NIH, NCI
environment. Refusal or negligence to do so will be considered a material breach
of contract and may be treated as any other such material breach. Applications
for permits should be submitted not less than 30 days prior to shipping date to:
NIH Veterinary Resources Branch (VRP), National Center for Research Resources
(NCRR), Scientific Services Branch, Laboratory Sciences Section, Building 28A,
Room 11 1, 28 LIBRARY DR MSC 5210, BETHESDA MD 20892-5210, (301)496-4463.
ARTICLE H.4. ANIMAL WELFARE ASSURANCE
The Contractor shall obtain, prior to the start of any work under this contract,
an approved Animal Welfare Assurance from the Office of Protection from Research
Risks (OPRR), Office of the Director, NIH, as required by Section 1-43-30 of the
Public Health Service Policy on Humane Care and Use of Laboratory Animals. The
Contractor shall maintain such assurance for the duration of this contract, and
any subcontractors performing work under this contract involving the use of
animals shall also obtain and maintain an approved Animal Welfare Assurance.
ARTICLE H.5. OPTION PROVISION
Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., the contract will consist only of the work required in
accordance with the Statement of Work, as defined in Sections C and F, for the
Base Year (Year 1) of the contract. Pursuant to FAR 52.217-9, set forth in
ARTICLE 1.3. of this contract, the Government may, by unilateral contract
modification, require the Contractor to perform the work required in accordance
with the Statement of Work, as defined in Sections C and F, for Options 1
through 4 (Years 2 through 4) of the of the contract. If the Government
exercises these options, notice must be given at least 60 days prior to the
expiration date of this contract, and the estimated cost plus fixed fee of the
contract will be increased as set forth in ARTICLE B.2.
ARTICLE H.6. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing
address is:
Contract No. N02-BC-81041
Page 19
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (http://www1.od.nih.gov/oma/oma.htm)
PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - CLAUSES
INCORPORATED BY REFERENCE (APRIL 1984)
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available [FAR52.252-2 (JUNE
1988)].
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. TITLE AND DATE
---------- --------------
52.202-1 Definitions (OCTOBER 1995)
52.203-3 Gratuities (Over $100,000) (APRIL 1984)
52.203-5 Covenant Against Contingent Fees (Over $100,000)
(APRIL 1984)
52.203-6 Restrictions on Subcontractor Sales to the Government
(Over $100,000) (JULY 1995)
52.203-7 Anti-Kickback Procedures (Over $100, 000) (JULY 1995)
52.203-8 Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000) (JANUARY
1997)
52.203-10 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000) (JANUARY 1997)
52.203-12 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000) (JUNE 1997)
52.204-4 Printing/Copying Double-Sided on Recycled Paper (Over
$100,000) (JUNE 1996)
52.209-6 Protecting the Government's Interests when
Subcontracting with Contractors Debarred, Suspended,
or Proposed for Debarment (Over $25,000) (JULY 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000)
(AUGUST 1996)
Contract No. N02-BC-81041
Page 20
52.215-22 Price Reduction for Defective Cost or Pricing Data
(OCTOBER 1995)
52.215-24 Subcontractor Cost or Pricing Data (Over $500,000)
(OCTOBER 1995)
52.215-26 Integrity of Unit Prices (Over $100,000) (JANUARY
1997)
52.215-27 Termination of Defined Benefit Pension Plans (MARCH
1996)
52.215-33 Order of Precedence (JANUARY 1986)
52.215-39 Reversion or Adjustment of Plans for Post-Retirement
Benefits other than Pensions (PRB) (MARCH 1996)
52.215-40 Notification of Ownership Changes (FEBRUARY 1995)
52.215-42 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data--Modifications
(JANUARY 1997)
52.216-7 Allowable Cost and Payment (MARCH 1997)
52.216-8 Fixed Fee (MARCH 1997)
52.219-8 Utilization of Small, Small Disadvantaged, and
Women-Owned Small Business Concerns (Over $100,000)
(JUNE 1997)
52.219-9 Small, Small Disadvantaged, and Women-Owned Small
Business Subcontracting Plan (Over $500,000) (AUGUST
1996)
52.219-16 Liquidated Damages - Subcontracting Plan (Over
$500,000) (OCTOBER 1995)
52.222-2 Payment for Overtime Premium (Over $100,000) (JULY
1990) (NOTE: The dollar amount in paragraph (a) of
this clause is $0 unless otherwise specified in the
contract.)
52.222-3 Convict Labor (AUGUST 1996)
52.222-26 Equal Opportunity (APRIL 1984)
52.222-28 EEO Preaward Clearance of Subcontracts (Over
$1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for Special Disabled and Vietnam
Era Veterans (APRIL 1984)
52.222-36 Affirmative Action for Handicapped Workers (APRIL
1984)
52.222-37 Employment Reports on Special Disabled Veterans and
Veterans of the Vietnam Era (JANUARY 1988)
52.223-2 Clean Air and Water (Over $100,000) (APRIL 1984)
52.223-6 Drug Free Workplace (JANUARY 1997)
52.223-14 Toxic Chemical Release Reporting (OCTOBER 1996)
Contract No. N02-BC-81041
Page 21
52.225-11 Restrictions on Certain Foreign Purchases (OCTOBER
1996)
52.227-1 Authorization and Consent (Over $50,000) (JULY 1995)
52.227-2 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000) (AUGUST 1996)
52.227-3 Patent Indemnity (APRIL 1984)
52.227-14 Rights in Data - General (JUNE 1987)
52.232-9 Limitation on Withholding of Payments (APRIL 1984)
52.232-17 Interest (Over $100,000) (JUNE 1996)
52.232-20 Limitation of Cost (APRIL 1984)
52.232-23 Assignment of Claims (JANUARY 1986)
52.232-25 Prompt Payment (JUNE 1997)
52.232-33 Mandatory Information for Electronic Funds Transfer
Payment (AUGUST 1996)
52.233-1 Disputes (OCTOBER 1995)
52.233-3 Protest After Award (AUGUST 1996) With Alternate I
(JUNE 1985)
52.242-1 Notice of Intent to Disallow Costs (APRIL 1984)
52.242-3 Penalties for Unallowable Costs (Over $500,000)
(OCTOBER 1995)
52.242-4 Certification of Final Indirect Costs (JANUARY 1997)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate
I (APRIL 1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter
Contracts) (FEBRUARY 1997) *If written consent to
subcontract is required, the identified subcontracts
are listed in ARTICLE B, Advance Understandings of
the contract.
52.244-5 Competition in Subcontracting (Over $100,000)
(DECEMBER 1996)
52.245-5 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract) (JANUARY 1986)
52.246-25 Limitation of Liability - Services (Over $100,000)
(FEBRUARY 1997)
52.249-6 Termination (Cost-Reimbursement) (SEPTEMBER 1996)
52.249-14 Excusable Delays (APRIL 1984)
52.253-1 Computer Generated Forms (JANUARY 1991)
Contract No. N02-BC-81041
Page 22
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES.
HHSAR
CLAUSE NO. TITLE AND DATE
---------- --------------
352.202-1 Definitions (APRIL 1984) Alternate I (APRIL 1984)
352.228-7 Insurance - Liability to Third Persons (DECEMBER
1991)
352.232-9 Withholding of Contract Payments (APRIL 1984)
352.233-70 Litigation and Claims (APRIL 1984)
352.242-71 Final Decisions on Audit Findings (APRIL 1984)
352.270-5 Key Personnel (APRIL 1984)
352.270-6 Publication and Publicity (JULY 1991)
352.270-7 Paperwork Reduction Act (APRIL 1984)
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - Rev. 6/97]
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
ALTERNATE I (JANUARY 1997) of FAR 52.215-26, INTEGRITY OF UNIT PRICES (JANUARY
1997) is added.
FAR 52.225-3, BUY AMERICAN ACT - SUPPLIES (JANUARY 1994) is deleted in its
entirety and FAR 52.225-7 BALANCE OF PAYMENTS PROGRAM (APRIL 1984) is
substituted therefor.
FAR 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR 52.232-22,
LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
FAR 52.232-33, MANDATORY INFORMATION FOR ELECTRONIC FUNDS TRANSFER PAYMENT
(AUGUST 1996) is deleted, and FAR 52.232-34, OPTIONAL INFORMATION FOR ELECTRONIC
FUNDS TRANSFER PAYMENT (AUGUST 1996) is substituted therefor.
Contract No. N02-BC-81041
Page 23
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
Contracting Officer will make their full text available.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
1) FAR 52.215-31, Waiver of Facilities Capital Cost of Money (SEPTEMBER
1987).
2) FAR 52.217-9, Option to Extend the Term of the Contract (MARCH 1989).
"(a) The Government may extend the term of this contract by
written notice to the Contractor within 60 days prior to the
expiration date of this contract.
(c) The total duration of this contract, including the exercise
of any options under this clause, shall not exceed 60
months."
3) FAR 52.219-6, Notice of Total Small Business Set-Aside (JULY 1996).
4) FAR 52.219-14, Limitations on Subcontracting (DECEMBER 1996).
5) FAR 52.223-12, Refrigeration Equipment and Air Conditioners (MAY 1995).
6) FAR 52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL
1984).
7) FAR 52.251-1, Government Supply Sources (APRIL 1984).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC
HEALTH SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3)
CLAUSES:
1) PHS 352.223-70, Safety and Health (Deviation) (AUGUST 1997).
2) PHS 352.280-2b, Care of Live Vertebrate Animals (OCTOBER 1986).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
a. FAR 52.223-11, OZONE-DEPLETING SUBSTANCES (JUNE 1996)
(a) Definitions. Ozone-depleting substance, as used in this clause,
means any substance designated as Class I by the Environmental
Protection Agency (EPA) (40 CFR Part 82), including but not limited
to chlorofluorocarbons, halons, carbon tetrachloride, and methyl
chloroform; or any substance designated as class II by EPA (40 CFR
Part 82), including but not limited to hydrochlorofluorocarbons.
(b) The Contractor shall label products which contain or are
manufactured with ozone-depleting substances in the manner and to
the extent required by 42 U.S.C. 7671j (b), (c), and (d) and 40 CRF
Part 82, Subpart E as follows:
Contract No. N02-BC-81041
Page 24
"WARNING: Contains (or manufactured with, if applicable) a
substance(s) which harm(s) public health and environment by
destroying ozone in the upper atmosphere."
*The Contractor shall insert the name of the substance(s).
b. FAR 52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL
COMPONENTS (OCTOBER 1995)
(a) Definition.
Commercial item, as used in this clause, has the meaning contained
in the clause at 52.202-1, Definitions.
Subcontract, as used in this clause, includes a transfer of
commercial items between divisions, subsidiaries, or affiliates of
the Contractor or subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall
incorporate, and require its subcontractors at all tiers to
incorporate, commercial items or nondevelopmental items as
components of items to be supplied under this contract.
(c) Notwithstanding any other clause of this contract, the Contractor
is not required to include any FAR provision or clause, other than
those listed below to the extent they are applicable and as may be
required to establish the reasonableness of prices under Part 15,
in a subcontract at any tier for commercial items or commercial
components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Special Disabled and Vietnam
Era Veterans (38 U.S.C. 4212(a));
(3) 52.222-36, Affirmative Action for Handicapped Workers (29
U.S.C. 793); and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged
Commercial Vessels (46 U.S.C. 1241)
(flow down not required for subcontracts awarded beginning May
1, 1996).
(d) The Contractor shall include the terms of this clause, including
this paragraph (d), in subcontracts awarded under this contract.
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Invoice/Financing Request and Contract Financial Reporting Instructions for
NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97), 5 pages.
2. Safety and Health, PHSAR Clause 352.223-70, (8/97), 1 pages.
3. Procurement of Certain Equipment, NIH(RC)-7, 4/l/84, 1 page.
4. Government Property - Schedule II-A, 8/4/97, 1 page.
5. Pathology Report, 1 page.
Contract No. N02-BC-81041
Page 25
6. Animal Health Diagnostic Serology Submission Form, 1 page.
7. Animal Health Diagnostic Request Form, 1 page.
8. Introduction of Rodents and Rodent Products, NIH Manual 3043-1 dated 9/30/95,
10 pages.
9. Application for Permit to Introduce Rodent and Rodent Produce, NIH 2369-1
(Rev. 10/91), 1 page.
10. Permit to Introduce Rodents and Rodent Products, NIH 2369-2 (Rev. 10191), 1
page.
11. Material Transfer Agreement, 3 pages.
12. Animal Inventory Summary, 11/92, 1 page.
13. Animal Mortality Sheet, 11/92, 1 page.
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated August 15, 1997.
2. Animal Welfare Assurance Number A3086-01.
END of the SCHEDULE
(CONTRACT)
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4
General: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
Format: Standard Form 1034, "Public Voucher for Purchases and Services Other
Than Personal", and Standard Form 1035, "Public Voucher for Purchases and
Services Other Than Personal- Continuation Sheet," or reproduced copies of such
forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1035, claims may be submitted on the payee's letter-head or
self-designed form provided that it contains the information shown on the sample
invoice/financing request.
Number of Copies: As indicated in the Invoice Submission Clause in the contract.
Frequency: Invoices/financing requests submitted in accordance with the Payment
Clause shall be submitted monthly unless otherwise authorized by the contracting
officer.
Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.
Billing of Costs Incurred: If billed costs include: (1) costs of a prior billing
period, but not previously billed; or (2) costs incurred during the contract
period and claimed after the contract period has expired, the amount and
month(s) in which such costs were incurred shall be cited.
Contractor's Fiscal Year: Invoices/financing requests shall be prepared in such
a manner that costs claimed can be identified with the contractors fiscal year.
Currency: All NIH contracts are expressed in United States dollars. When
payments are made in a currency other than United States dollars, billings on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with actual costs
incurred. Currency fluctuations may not be a basis of gain or loss to the
contractor. Notwithstanding the above, the total of all invoices paid under this
contract may not exceed the United States dollars authorized.
Costs Requiring Prior Approval: Costs requiring the contracting officer's
approval, which are not set forth in an Advance Understanding in the contract
shall be so identified and reference the Contracting Officer's Authorization
(COA) Number. In addition, any cost set forth in an Advance Understanding shall
be shown as a separate line item on the request.
Invoice/Financing Request Identification: Each invoice/financing request shall
be identified as either:
(a) Interim Invoice/Contract Financing Request - These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice - The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final indirect
cost rates covering the year in which this contract is physically complete
(whichever date is later). The completion invoice should be submitted when
all costs have been assigned to the contract and all performance
provisions have been completed.
(c) Final Invoice - A final invoice may be required after the amounts owed
have been settled between the Government and the contractor (e.g.,
resolution of all suspensions and audit exceptions).
Preparation and Itemization of the Invoice/Financing Request: The contractor
shall furnish the information set forth in the explanatory notes below. These
notes are keyed to the entries on the sample invoice/financing request.
NIH(RC)-4 ATTACHMENT I
Rev. 5/97
(a) Designated Billing Office Name and Address - Enter the designated billing
office and address, identified in the Invoice Submission Clause of the
contract, on all copies of the invoice/financing request.
(b) Invoice/Financing Request Number - Insert the appropriate serial number of
the invoice/financing request.
(c) Date Invoice/Financing Request Prepared - Insert the date the
invoice/financing request is prepared.
(d) Contract Number and Date - Insert the contract number and the effective
date of the contract.
(e) Payee's Name and Address - Show the contractors name (as it appears in the
contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved
assignment has been made by the contractor, or a different payee has been
designated, then insert the name and address of the payee instead of the
contractor.
(f) Total Estimated Cost of Contract - Insert the total estimated cost of the
contract, exclusive of fixed-fee. For incrementally funded contracts,
enter the amount currently obligated and available for payment.
(g) Total Fixed-Fee - Insert the total fixed-fee (where applicable). For
incrementally funded contracts, enter the amount currently obligated and
available for payment.
(h) Billing Period - Insert the beginning and ending dates (month, day, and
year) of the period in which costs were incurred and for which
reimbursement is claimed.
(i) Incurred Cost - Current - Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the current period.
(j) Incurred Cost - Cumulative - Insert the cumulative amounts billed for the
major cost elements and adjusted amounts claimed during this contract.
(k) Direct Costs - Insert the major cost elements. For each element, consider
the application of the paragraph entitled "Costs Requiring Prior Approval"
on page 1 of these instructions.
(1) Direct Labor - Include salaries and wages paid (or accrued) for
direct performance of the contract. For Key Personnel, list each
employee on a separate line. List other employees as one amount
unless otherwise required by the contract.
(2) Fringe Benefits - List any fringe benefits applicable -to direct
labor and billed as a direct cost. Fringe benefits included in
indirect costs should not be identified here.
(3) Accountable Personal Property - Include permanent research
equipment and general purpose equipment having a unit acquisition
cost of $1,000 or more and having an expected service life of more
than two years, and sensitive property regardless of cost (see the
DHHS Contractors Guide for Control of Government Property). Show
permanent research equipment separate from general purpose
equipment. Prepare and attach Form HHS-565, "Report of Accountable
Property," in accordance with the following instructions:
List each item for which reimbursement is requested. A reference
shall be made to the following (as applicable):
- The item number for the specific piece of equipment listed in
the Property Schedule.
- The Contracting Officer's Authorization letter and number, if
the equipment is not covered by the Property Schedule.
- Be preceded by an asterisk (*) if the equipment is below the
approval level.
NIH(RC)-4 ATTACHMENT I
Rev. 5/97
(4) Materials and Supplies - Include equipment with unit costs of less
than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.
(5) Premium Pay - List remuneration in excess of the basic hourly rate.
(6) Consultant Fee - List fees paid to consultants. Identify consultant
by name or category as set forth in the contract's Advance
Understanding or in the COA letter, as well as the effort (i.e.,
number of hours, days, etc.) and rate being billed.
(7) Travel - Include domestic and foreign travel. Foreign travel is
travel outside of Canada, the United States and its territories and
possessions. However, for an organization located outside Canada,
the United States and its territories and possessions, foreign
travel means travel outside that country. Foreign travel must be
billed separately from domestic travel.
(8) Subcontract Costs - List subcontractor(s) by name and amount
billed.
(9) Other - List all other direct costs in total unless exceeding
$1,000 in amount. If over $1,000, list cost elements and dollar
amounts separately. If the contract contains restrictions on any
cost element, that cost element must be listed separately.
(l) Cost of Money (COM) - Cite the COM factor and base in effect during the
time the cost was incurred and for which reimbursement is claimed.
(m) Indirect Costs--Overhead - Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.
(n) Fixed-Fee Earned - Cite the formula or method of computation for the
fixed-fee (if any). The fixed-fee must be claimed as provided for by the
contract.
(o) Total Amounts Claimed - Insert the total amounts claimed for the current
and cumulative periods.
(p) Adjustments - Include amounts conceded by the contractor, outstanding
suspensions, and/or disapprovals subject to appeal.
(q) Grand Totals
The contracting officer may require the contractor to submit detailed support
for costs claimed on one or more interim invoices/financing requests.
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the sample invoice/financing
request.
Column A--Expenditure Category - Enter the expenditure categories required by
the contract.
Column B--Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the percentage
of effort or number of hours agreed to doing contract negotiations for each
employee or labor category listed in Column A.
Column C--Cumulative Percentage of Effort/Hrs.-Actual - Enter the percentage of
effort or number of hours worked by each employee or labor category listed in
Column A.
NIH(RC)-4 ATTACHMENT 1
Rev. 5/97
Column D--Incurred Cost-Current - Enter the costs, which were incurred during
the current period.
Column E--incurred Cost-Cumulative - Enter the cumulative cost to date.
Column F-Cost at Completion - Enter data only when the contractor estimates that
a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.
Column G- Contract Amount - Enter the costs agreed to during contract
negotiations for all expenditure categories listed in Column A.
Column H-Variance (Over or Under) - Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost Clause of
the contract.
Modifications: Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.
Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G. Column H will of course show a 100 percent variance
along with those identified under H above.
NIH(RC)-4 ATTACHMENT 1
Rev. 5197
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
====================================================================================================================================
(a) Billing Office Name and Address (b) Invoice/Financing Request No. ___________________________________
NATIONAL INSTITUTES OF HEALTH (c) Date Invoice Prepared ___________________________________________
National Cancer Institute, RCB
EPS, Room 620 (d) Contract No. ____________________________________________________
6120 EXECUTIVE BLVD MSC 7224
Bethesda, MD 20892-7224 Effective Date __________________________________________________
(e) Payee's Name and Address
ABC CORPORATION
100 Main Street (f) Total Estimated Cost ____________________________________________
Anywhere, USA zip code
(g) Total Fixed Fee _________________________________________________
Attn: Name, Title, & Phone Number of Official to Whom
Payment is Sent
====================================================================================================================================
(h) This invoice/financing request represents reimbursable costs for the period from __________ to _________
====================================================================================================================================
Cumulative Percentage of
Effort/Hrs. Incurred Cost
--------------------------------------------------------- Cost at Contract
Expenditure Category* Negotiated Actual (i) Current (j) Cumulative Completion Amount Variance
A B C D E F G H
- ------------------------------------------------------------------------------------------------------------------------------------
(k) Direct Costs:
- ------------------------------------------------------------------------------------------------------------------------------------
(1) Direct Labor $ 753,635
- ------------------------------------------------------------------------------------------------------------------------------------
(2) Fringe Benefts
(40.5% DL) 305,222
- ------------------------------------------------------------------------------------------------------------------------------------
(3) Sentinal Animals 924
- ------------------------------------------------------------------------------------------------------------------------------------
(4) Laundry/Clothing 26,084
- ------------------------------------------------------------------------------------------------------------------------------------
(5) Cleaning Supplies 3,796
- ------------------------------------------------------------------------------------------------------------------------------------
(6) Animal Housing 159,535
- ------------------------------------------------------------------------------------------------------------------------------------
(7) Lab & Tech Supplies 31,032
- ------------------------------------------------------------------------------------------------------------------------------------
(8) Media & Reagents 17,522
- ------------------------------------------------------------------------------------------------------------------------------------
(9) Overtime Premium 8,580
- ------------------------------------------------------------------------------------------------------------------------------------
(10) Transportation 16,064
- ------------------------------------------------------------------------------------------------------------------------------------
(11) Equip. Maintenance 40,000
- ------------------------------------------------------------------------------------------------------------------------------------
(12) Consultant Vet. 24,960
- ------------------------------------------------------------------------------------------------------------------------------------
(l) Total Direct Cost $1,387,356
- ------------------------------------------------------------------------------------------------------------------------------------
(m) Overhead (99% DL+FB) 1,048,269
- ------------------------------------------------------------------------------------------------------------------------------------
(n) Total Direct Cost + OH $2,435,625
- ------------------------------------------------------------------------------------------------------------------------------------
(o) G&A (21.3% TDC+OH) 518,788
- ------------------------------------------------------------------------------------------------------------------------------------
(p) Total Cost $2,954,414
- ------------------------------------------------------------------------------------------------------------------------------------
(q) Fixed Fee (7%) 206,809
- ------------------------------------------------------------------------------------------------------------------------------------
(r) Total Amount Claimed $3,161,223
- ------------------------------------------------------------------------------------------------------------------------------------
(s) Adjustments 0
- ------------------------------------------------------------------------------------------------------------------------------------
(t) Grand Total $3,161,223
- ------------------------------------------------------------------------------------------------------------------------------------
I certify that all payments are for appropriate purposes and in accordance with the contract.
_______________________________ ___________________________
(Name of Official) (Title)
* Attach details as specified in the contract
====================================================================================================================================
PHS 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
(a) To help ensure the protection of the life and health of all persons, and
to help prevent damage to property, the Contractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken additional safety
measures as the Contracting Officer in conjunction with the project or
other appropriate officer, determines to be reasonably necessary. If
compliance with these additional safety measures results in an increase or
decrease in the cost or time required for performance of any part of work
under this contract, an equitable adjustment will be made in accordance
with the applicable "Changes" Clause set forth in this contract.
(c) The Contractor shall maintain an accurate record of, and promptly report
to the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for
which the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local Regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by
the Contractor.
(e) The Contractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or
operations. Compliance with the provisions of this clause by
subcontractors will be the responsibility of the Contractor.
(End of clause)
Safety and Health Clause (Deviation) ATTACHMENT 2
PHS 352.223-70, (8/97)
PROCUREMENT OF CERTAIN EQUIPMENT
Notwithstanding any other clause in this contract, the Contractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed in
the following Federal Supply Groups, regardless of the dollar value, without the
prior written approval of the Contracting Officer.
67 - Photographic Equipment
69 - Training Aids and Devices
70 - General Purpose ADP Equipment, Software, Supplies and Support
(Excluding 7045-ADP Supplies and Support Equipment.)
71 - Furniture
72 - Household and Commercial Furnishings and Appliances
74 - Office Machines and Visible Record Equipment
77 - Musical Instruments, Phonographs, and Home-type Radios
78 - Recreational and Athletic Equipment
When equipment in these Federal Supply Groups is requested by the Contractor and
determined essential by the Contracting Officer, the Government will endeavor to
fulfill the requirement with equipment available from its excess personal
property sources, provided the request is made under a cost-reimbursement
contract. Extensions or renewals of approved existing leases or rentals for
equipment in these Federal Supply Groups are excluded from the provisions of
this article.
NIH(RC)-7 (4/1/84) ATTACHMENT 3
OMB Bulletin 81-16
GOVERNMENT PROPERTY--SCHEDULE
-----------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
Date: August 4, 1997 BIOQUAL, INC. Report No.4
Person Responsible for Report: Nancy A. Madden 9600 Medical Center Drive Page No. 1 of 1
Telephone No.: (301) 251-0633 Rockville, Maryland 20850-3336 ANNUAL REPORT
- ------------------------------------------------------------------------------------------------------------------------------------
ITEM GFP MODEL OR MRF. SERIAL UNIT ACQ. GOVERNMENT ACQUISITION DATE REC'D.
NO. DESCRIPTION & NSN OR CAP MANUFACTURER TYPE NUMBER COST ID NUMBER AUTHORITY MO/YR.
- ------------------------------------------------------------------------------------------------------------------------------------
1 Microscope GFP Bausch & Lomb Unknown LN3737 $700.00 01029829 II-A 10/3
- ------------------------------------------------------------------------------------------------------------------------------------
2 Survey Meter GFP Eberline E520 2898 $554.45 01029830 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
3 Balance GFP Ohaus Harvard Unknowvn $250.00 01029831 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
4 Mixer GFP Vortex 58223 Unknown $175.00 01029832 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
5 Mixer GFP Vortex 58223 Unknown $175.00 01029833 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
6 Laminar Flow Hood GFP CCI 740 12134-A Surplus 01029834 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
7 Laminar Flow Hood GFP CCI Unknown 17069 Surplus 01029835 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
8 Laminar Flow Hood GFP CCI Unknown 17781 Surplus 01029836 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
9 Microscope GFP American Optical Unknown 269203 $900.00 01029837 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
10 Cesium Irradiator GFP Gemmacell GC40 66 $75,358.15 01029838 II-A 10/93
(with Accessory Animal
Irrad. Box)
- ------------------------------------------------------------------------------------------------------------------------------------
11 Autoclave GFP Consolidated SR24DV 31783 $41,356.41 01029839 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
12 4 ft Laminar Flow Hood GFP CCI 240 17067 $3,710.00 01029840 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
13 Freezer (-80Deg.C) GFP Revco ULT1185B OT10350A $4,161.60 01029841 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
14 Microforge GFP Narishige MF-9 8803034 $4,750.00 01029844 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
15 Micro-Pipette Grinder GFP Narishige EG-4 8809136 $1,438.00 01029845 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
16 Biological Safety GFP Belen 8001-74000 801-5026 $5,276.25 01029849 II-A 10/93
Hood
- ------------------------------------------------------------------------------------------------------------------------------------
Thomas Locator 8
17 Liquid Nitrogen Tank GFP Scientific CY50945 4753 $2,042.42 00070090 II-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
18 Stay Clean Workbench GFP Lab Products 30909-B 090690 $7,118.00 00070091 Il-A 10/93
- ------------------------------------------------------------------------------------------------------------------------------------
Government Property Schedule II-A ATTACHMENT 4
(8/4/97)
INVESTIGATOR ______________ NCI-FREDERICK CANCER RESEARCH FACILITY HISTO.# _______________
PROJECT ___________________ PATHOLOGY/HISTOTECHNOLOGY LABORATORY AHDL# _________________
PO/H# _____________________ LOG BOOK# _____________
BLDG./TELE. _______________ DATE __________________
PATHOLOGY REPORT
- -------------------------------------------------------------------------------------------------------
Animal Species ____________ Strain ____________ Age ______ Sex ______ Weight _________
I.D. ____________________ Supplier ___________________ Housing Bldg. ___________ Room ______
- -------------------------------------------------------------------------------------------------------
Supporting Studies: (circle) Serology, Parasitology, Microbiology _______________ Other _________
- -------------------------------------------------------------------------------------------------------
Mode of Death: Natural ___________________ Euthanasia Method __________________
Fixative Used __________________
- -------------------------------------------------------------------------------------------------------
Organs Submitted: (circle) Organs Examined Microscopically (check)
Lungs, Heart, Liver, Spleen, Kidneys, Adrenals, Pancreas, Stomach, S. Intestine, Colon, Gut Roll,
Lymph Nodes, Bladder, Skin Muscle, Head, Brain, Eyes, Thyroid, Parathyroid, Salivary Glands, Pituitary,
Thymus, Bone, Uterus, Gonads, Prostate, Tumor, Other __________________
- -------------------------------------------------------------------------------------------------------
Animal History and Clinical Summary (Include information as to injections, experimental manipulations
and biohazards):
- -------------------------------------------------------------------------------------------------------
Gross Necropsy Observations, Comments and Requests:
=======================================================================================================
DO NOT WRITE BELOW THIS LINE
- -------------------------------------------------------------------------------------------------------
Rec'd _________________ Comments:
Trimmed _______________
Embedded ______________
Cut ___________________ # of slides___________ ck-out _________
- -------------------------------------------------------------------------------------------------------
Microscopic Observations, Diagnosis and Comments:
- -------------------------------------------------------------------------------------------------------
PATHOLOGIST: DATE:
- -------------------------------------------------------------------------------------------------------
096-90
Pathology Report
- ------------------------------------------------------------------------------------------------------------------------------------
ANIMAL HEALTH DIAGNOSTIC SEROLOGY SUBMISSION FORM Reviewed by______________________
Name________________________________,
Quarantine #________________________, AHDL #________________
Request Date_______, APO #_______, Project # _______, Page _____ of ______
Building__________, Room______, I.D. #____________, Species/Strain____________________________ , Age_______, Sex_______
- ------------------------------------------------------------------------------------------------------------------------------------
Circle Test Requested HAI ELISA IFA Lab Use Only
One --------------------------------------------------------------------------------------------------------
# of Samples
P R K
o S S C R
l E e E e G M V V
______________ y c n c n R D y L / / E L
K H S M o t d M t d P e M V c C S H D C D
Diluted ______________ R - V V m r a H r a V o V I o M D - I M H
V 1 5 M a o i V o i M 3 M I p V A 1 M V V
1:5 Y N ______________ --------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
Room # ACC # Inves ID 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Comments
0 1 0 0 0 0 1 4 5 4 4 4 5 5 4 5 2 5 5 5 5 5 1
4 5 2 3 5 7 8 3 2 7 8 9 0 1 5 4 4 3 7 8 5 5 9
- -------------------------------------------------------------------------------------------------------------------------
01/
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20/
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21/ Completed:
- -------------------------------------------------------------------------------------------------------------------------
22/ _________
- -------------------------------------------------------------------------------------------------------------------------
23/
- -------------------------------------------------------------------------------------------------------------------------
24/
- ------------------------------------------------------------------------------------------------------------------------- Box #____
25/
- ------------------------------------------------------------------------------------------------------------------------------------
- - or Blank Space = Negative AC = Anticomplementary serum AE - Serum Autoagglutinates NT - No test
IS - Insufficient serum NS = Sample not submitted for test TC - Reacts with tissue culture NSR - Non-specific reaction
- ------------------------------------------------------------------------------------------------------------------------------------
Animal Health Diagnostic Serology Submission Form ATTACHMENT 6
- -------------------------------------------------------------------------------------------------------------------------------
ANIMAL HEALTH DIAGNOSTIC REQUEST FORM
Name ______________________, Reviewed by ____________
Quarantine # ______________, AHDL # ____________
Request Date ______, APO/H # ___________, Project # __________, Page __ of __
Building _______________, Room _________, I.D. # ________, Species/Strain ______________________, Age ______, Sex _____
- -------------------------------------------------------------------------------------------------------------------------------
Circle first and Sample Type D. Hair 90 Hair 33 D. Cecum 85 Anal Tape 32 Feces 30 Intest. Content 37
and last ACC #
Maximum # Samples ---------- ------- ----------- ------------ -------- ------------------
of 11 per
page. Test Requested Ecto 9550 Ecto 9550 Endo 9350 Endo 9350 Endo 9350 Endo 9350
===============================================================================================================================
Room # Inves ID
- -------------------------------------------------------------------------------------------------------------------------------
01/ 12/
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02/ 13/
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10/ 21/
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11/ 22/
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Cecum 74 N/P Wash 51 HP/05
- -------------------------------------------------------------------------------------------------------------------------------
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Bact 9050 Bact 9050 99
- -------------------------------------------------------------------------------------------------------------------------------
01/ 12/
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Animal Health Diagnostic Request Form ATTACHMENT 7
NIH MANUAL 3043-1
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
Table of Contents
A. Purpose
B. Background
C. Applicability
D. Definitions
E. Responsibilities
F. Policy
G. Procedure for Introduction of Rodents
H. Procedure for Introduction of Rodent Products
I. Quarantine Permit Service Office (QPSO)
J. Additional Information
APPENDICES
1. Introduction of Rodents or Rodent Products from Non-Approved Sources
2. Form NIH 2369- 1, "Application for Permit to Introduce Rodents and Rodent
Products"
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 1
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
A. Purpose. This Policy Manual establishes procedures designed to prevent the
introduction of infected rodents and rodent products into the National
Institutes of Health which could: (1) adversely affect the health of
rodents used in research; (2) directly or indirectly interfere with
research; or (3) pose a health hazard to personnel.
B. Background. The conduct of a vigorous research program necessitates the
movement of animals and their tissues from animal colony to animal colony
and between laboratories. This creates the possibility of introducing
agents that are pathogenic to either animals or humans. Examples of the
latter include the lymphocytic choriomeningitis (LCM) virus and the
hantaviruses, which can have serious implications for human health.
Hantaviruses infect wild rodents and have been detected in laboratory rats
in Europe and Asia; humans in contact with infected animals can become ill
and occasionally die.
Federal regulations pertaining to the movement of laboratory rodents or
their products relate mainly to organisms causing diseases in humans or
domestic poultry or livestock. Thus, it is important for the NIH to
supplement these regulations with policies that address concerns relating
to protection of its intramural animal colonies and scientific and support
staff in contact with animals or animal products.
C. Applicability. The policies and procedures in this chapter apply when
introducing into any National Institutes of Health (NIH) facility rodents
and rodent products that originate from sources other than those approved
by the Veterinary Resources Program (VRP), National Center for Research
Resources (NCRR). This policy also applies to facilities of other Agencies
on NIH property.
D. Definitions.
1. Animal Program Director (APD). The individual (usually a
veterinarian) who receives delegated program authority from the
Director or Scientific Director for all activities involving
animals in the ICD.
2. Approved Source. A source of rodents or rodent products which has a
contract established with, and maintained by, the NCRR. VRP or a
comparable contract with other programs within the NIH to supply
genetically-defined, specific pathogen-free
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 2
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
animals to NIH investigators. These contracts characteristically require
barrier production practices, genetic management and monitoring,
microbiologic standards and health surveillance, and regular site visits
to ensure the availability of high-quality animals suitable for NIH
research Proposals for additions to the list of approved sources are
evaluated by the VRP.
3. Blanket Purchase Agreement (BPA). Contract agreement with a vendor to
facilitate anticipated repetitive purchases for supplies and services.
4. Domestic Source. A source of rodents or rodent products located within the
United States.
5. Facility Veterinarian. The veterinarian who has direct or delegated
responsibility for the management of the animal facility.
6. NIH Facility. Any building, trailer, research laboratory or other facility
or part of a facility, whether or not animals are housed or used there,
associated with the NIH intramural research program. This includes any
facility on the Bethesda, Maryland, campus, the NIH Animal Center near
Poolesville, Maryland, off-campus leased facilities and other sites where
intramural research is performed.
7. Nondomestic Source. A source of rodents or rodent products not located
within the United States.
8. Nonapproved Source. A source of rodents or rodent products that does not
meet the definition of an approved source.
9. Rodent. Any species of small gnawing mammals, including but not limited to
mice, rats, guinea pigs. and hamsters.
10. Rodent Import Officer. The individual appointed by the Director of the
VRP, NCRR, to have delegated responsibility for activities defined in this
policy.
11. Rodent Products. Any rodent tissue or derivative, such as antibodies
(polyclonal or monoclonal), body fluids, proteins, or cells unless
contained in commercially available test kits when these reagents have
been produced or processed in a manner that will exclude or inactivate all
pathogenic agents.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 3
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
12. Quarantine Permit Service Office (QPSO). An office in the
Occupational Safety and Health Branch of the Division of Safety
which assists investigators obtain permits often required when
importing/exporting animals, animal products, etiologic agents, or
vectors of human or animal disease (Building 13/3KO4, 496-3353).
E. Responsibilities.
1. Animal Program Director (APD). (a) Assists the principal
investigator/applicant in securing approvals, permits,
transportation, etc., related to the introduction of rodents or
rodent products to an animal facility or laboratory; (b) reviews
and approves or disapproves applications for introduction of
rodents from nonapproved domestic sources into laboratories of the
ICD; and (c) reviews, provides concurrences, and forwards to the
facility veterinarian applications for introduction of rodents or
rodent products from nonapproved sources into animal facilities.
These responsibilities may be delegated to the facility or
subordinate veterinarians under the APD's supervision.
2. Director, VRP, NCRR. Implements those aspects of this policy
relating to the VRP and the Rodent Import Officer.
3. Facility Veterinarian. Reviews, provides concurrence and forwards
to VRP applications for the introduction of rodents or rodent
products from nonapproved sources into animal facilities which are
under his/her authority and responsibility, including central or
shared facilities.
4. ICD Scientific Director. Ensures compliance with this policy by
intramural staff within his/her Institute, Center, or Division
(ICD).
5. Laboratory/Branch Chief Reviews and approves or disapproves the
introduction of rodent products into the laboratory by a principal
investigator under his or her supervision after assessing the
zoonotic potential of the material and determining if testing is
required prior to importation and use.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 4
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
6. NIH/NCRR/VRP Rodent Import Officer. (a) Reviews and approves or
disapproves applications for introduction of rodents or rodent
products from nonapproved sources into NIH animal facilities; (b)
designates the quarantine location and release criteria for animals
being introduced into NIH animal facilities; and (c) coordinates
the use of the VRP Rodent and Rabbit Quarantine Unit at the NIH
Animal Center near Poolesville, Maryland.
7. Ordering Official. Assures that receipt of all orders, including
b@et purchase agreements (BPAs), are entered into DELPRO. The ICD
ordering official will not place an order (BPAS) for rodent
products into DELPRO unless a copy of the Permit to Introduce
Rodents and Rodent Products is received from the ICD APD.
8. Principal Investigator/Applicant. (a) Submits applications and/or
secures approvals prior to the ordering and introduction of rodents
or rodent products, including rodent products purchased on blanket
purchase agreements, into NIH laboratories or animal facilities;
(b) secures any additional permits which may be required, such as
USDA permits, when necessary (refer to Section I); and (c) arranges
through the ICD veterinary staff transportation which is in
compliance with federal and state regulations and NIH policy.
F. Policy. Rodents or rodent products from a nonapproved source shall not be
introduced into NIH animal facilities without prior written approval of
the ICD Scientific Director or a delegate thereof (i.e., the APD) and/or
the VRP Director, NCRR, or delegate thereof (i.e., the Rodent Import
Officer). Similarly, no living or nonliving material derived from rodents
from a nonapproved source will be introduced into NIH laboratories without
specific approval of the Laboratory/Branch Chief or the APD. Rodents or
rodent products known to be infected with LCM, ectromelia virus, a
hantavirus, or other major zoonotic rodent agents are excluded from NTH
facilities. Under special circumstances, the Deputy Director for
Intramural Research (DDIR) can approve exceptions to this restriction.
G. Procedure for Introduction of Rodents. (See Appendix I for schematic of
procedures.) The introduction of rodents from nonapproved sources requires
submission and approval of NIH Form 2369-1, Application for Permit to
Introduce Rodents and Rodent Products(see Appendix 2). In situations where
quarantine is likely to be required, applications should be submitted at
least 60 days prior to the anticipated date of entry into an NIH animal
facility to allow time for diagnostic testing. Procedures for submission
and approval are as follows:
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 5
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
1. Animals from nondomestic sources:
j. The principal investigator must complete and submit the
application to his/her APD. The APD will obtain the
concurrence of the facility veterinarian and then forward it
to the Rodent Import Officer. In most cases, importation from
nondomestic sources will require quarantine and health
assessment at the VRP Rodent and Rabbit Quarantine Unit
located at the NIH Animal Center near Poolesville, Maryland.
If animals are being brought to NIH for tissue harvesting
only, quarantine may be minimal, but tissues must be
harvested at the Poolesville Quarantine Facility.
k. If the animals are destined for an NIH animal facility, the
APD will obtain additional health status information to be
attached to the application. The facility veterinarian must
specify on the application the animal health requirements to
be met, in addition to negative test results for LCM and
ectromelia viruses, prior to release from quarantine.
c. Animals will be quarantined at the VRP Rodent and Rabbit
Quarantine Unit located at the NIH Animal Center near
Poolesville, Maryland or an alternative site approved by the
Rodent Import Officer. The Rodent Import Officer will
maintain a list of recognized rodent agents developed with
the Animal Program Directors and approved by the Animal
Research Advisory and Safety Committee which must be excluded
from NIH animal facilities. The Rodent Import Officer, in
consultation with the facility veterinarian, will: (1)
specify the criteria for release from quarantine; (2) conduct
tests and review results; and (3) release animals as
appropriate. Copies of all results from tests performed
during quarantine will be provided to the facility
veterinarian by the Rodent Import Officer.
2. Animals from nonapproved domestic sources.
a. The principal investigator must complete and submit the
application to his/her APD.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 6
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
b. 1) If animals are destined for a laboratory for holding
less than 12 hours, where no contact with other
animals is planned and no materials from the animals
will be inoculated into rodents or used in materials
destined for introduction into rodents, then the
application can be approved by the APD. A permit
number will be obtained from the Rodent Import
Officer and the APD will provide the Rodent Import
Officer with a copy of the application and the
permit.
2) If animals are destined for a laboratory for holding
more than 12 hours, where no contact with other
animals is planned and no material from those animals
will be introduced into rodents or used in materials
destined for introduction into rodents, the ICD
Animal Care and Use Committee (ACUC) must approve the
holding of the animals in the laboratory. The
application can then be evaluated by the APD and
approved if appropriate.
3) If animals are destined for an animal facility or
will come into contact with other rodents, or if
materials derived from the imported rodents will be
inoculated into rodents or used in materials destined
for introduction into rodents, the APD will obtain
additional health status information and attach it to
the application. Concurrence of the facility
veterinarian must also be obtained. Prior to
forwarding the application to the Rodent Import
Officer, the facility veterinarian must specify on
the application the animal health requirements
necessary for entry into the designated animal
facility, including the mandatory negative test
results for LCM and ectromelia viruses.
C. The Rodent Import Officer, in consultation with the facility
veterinarian and principal investigator, will: (1) designate
the quarantine location; and (2) specify the criteria for
release from quarantine. If the VRP Rodent and Rabbit
Quarantine Unit, located at the NIH Animal Center is used,
the Rodent Import Officer will: (1) conduct testing and
review results; (2) provide results to the facility
veterinarian; and (3) release animals as appropriate. Non-VRP
quarantine locations must provide the NIH Rodent Import
Officer with documentation that release criteria have been
met prior to release of the animals.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 7
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
H. Procedure for Introduction of Rodent Products. (See Appendix 1 for
schematic of procedures.) The introduction of rodent products into NIH
laboratories or animal facilities also requires the submission and
approval of an application, NIH Form 2369- 1, or receipt of permission
from the principal investigator's laboratory or branch chief, as described
below:
1. Procedure for Introduction of Rodent Products into an NIH Animal
Facility.
The principal investigator must complete and submit the application
through the APD, or his/her designee, to the facility veterinarian.
This includes the purchase of rodent products on BPAS. Unless a
recent Mouse Antibody Production (MAP)/Rat Antibody Production
(RAP)/Hamster Antibody Production (HAP) test result is available,
cells must be maintained frozen until tested and determined to be
free of LCM and ectromelia viruses, at a minimum, before
introduction into an NIH animal facility. The facility veterinarian
will issue a permit listing the agents that the product must be
free of, including the agents listed above. The permit number will
be obtained from the Rodent Import Officer. The facility
veterinarian will provide a copy of the application and permit to
the Rodent Import Officer. Alternatively, a permit may be issued if
the product will be inoculated into animals within an appropriate
quarantine facility such as the VRP Rodent and Rabbit Quarantine
Unit at the NIH Animal Center near Poolesville, Maryland.
The principal investigator will not introduce the animal product
into an NIH animal facility unless the facility veterinarian
receives the test results and approves the introduction.
2. Procedure for Introduction of Rodent Products into an NIH
Laboratory.
If rodent products will not be introduced into, or come in contact
with live animals, a permit is not required. The Quarantine Permit
Service Office (QPSO), Occupational Safety and Health Branch,
Division of Safety, should be consulted to determine if a USDA
permit is required (for reasons stated below). It is the
responsibility of the principal investigator's laboratory or branch
chief to assess the zoonotic potential of the material and
determine if testing is required prior to importation and use.
Assistance in making this determination is available from the NIH
Biosafety Officer, Occupational Safety and Health Branch Division
of Safety (496-2960).
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 8
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
3. Alternative Methods for Introduction of Non-living Rodent Products.
As an alternative to conducting MAP/RAP/HAP testing of nonliving
rodent products coming to the NIH from an unapproved or nondomestic
source, the laboratory or branch chief and/or the APD or his/her
designee, may approve the sterilization of the products. It is the
responsibility of the individuals designated above to ensure that
the method of sterilization is appropriate and adequate/effective
prior to introduction of the material into NIH facilities. In the
case of materials being introduced into laboratories, the
Laboratory Chief is the approving official; in the case of an
animal facility, the facility veterinarian is the approving
official.
I. Quarantine Permit Service Office (QPSO), Occupational Safety and Health
Branch, Division of Safety.
Several agencies of the United States Government regulate and require
permits for the importation, shipment, or exportation of animals, animal
products, or etiologic agents or vectors of human or animal diseases. The
Quarantine Permit Service Office (QPSO) of the NIH Occupational Safety and
Health Branch, Division of Safety, will provide investigators with
assistance and appropriate application forms necessary to import, export,
or transport regulated materials or animals.
1. The United States Department of Agriculture (USDA) Animal and Plant
Health Inspection Service (APHIS) has statutory authority to
regulate the importation of any animal-derived material or
biological material that has been in contact with material of
animal origin. Thus, USDA permits are required for the importation
of monoclonal antibodies, hybridoma cell lines, cell cultures, and
other biologic materials that have been in contact with material of
animal origin, such as fetal bovine serum.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
NIH MANUAL 3043-1 PAGE 9
DATE: 09/30/95
REPLACES: 11/22/91
ISSUING OFFICE: NCRR/VRP 402-2799
INTRODUCTION OF RODENTS AND RODENT PRODUCTS
2. The Public Health Service (PHS) is responsible for regulations
involving the importation into the United States or distribution
after importation, of any etiologic agent or any arthropod or other
animal host or vector of human disease (see NIH Manual Chapter
1340-1, Permits for Import or Export of Biological Materials). A
PHS permit must be obtained for importation and/or distribution of
these materials. The Chief, QPSO, or his/her designee, is
authorized to issue PHS import permits.
3. The United States Fish and Wildlife Service (USFWS), United States
Department of Interior, is responsible for regulations involving
the prevention and control of wildlife diseases, and the
importation of wildlife or products derived from threatened or
endangered wildlife species. Permits for designated port exemptions
are issued through the QPSO.
4. Finally, the QPSO must be notified, and a USDA permit obtained, if
transgenic rodents, carrying receptors which enable those rodents
to develop productive infection with human pathogens, are imported
into the United States or transported within the United States by
NIH investigators (496-3353).
J. Additional Information.
For further information on this policy, contact the Rodent Import Officer,
Veterinary Resources Program, NCRR, on 402-2799 or the applicable ICD
Animal Program Director. Additional copies of this policy may be obtained
by submitting the request to Printing and Reproduction Branch (P&RB), DSS,
Stonestreet, Room 115.
For additional information on the importation or transportation of any
etiologic agent or host or vector of human or animal diseases, or the
importation of wildlife, contact the Quarantine Permit Service Office,
Division of Safety (496-3353).
Refer to paper copy for Appendix information.
NIH Manual 3043-1 (9/30/95) ATTACHMENT 8
Application for Permit to Introduce
Rodent and Rodent Produce
- -------------------------------------------------------------------------------------------------------------------------------
Department of Health and Human Services 1. Request Permit To (check one) 2. Mode of Transportation
Public Health Service
National Institutes of Health ___ Import into U.S.
___ Introduce from within U.S.
Application for Permit to Introduce -------------------------------------------------------------
Rodents and Rodent Products 3. Delivery Point (Port of entry, airport, city, state, etc.)
(Use prescribed by NIH Manual 3043-1)
INSTRUCTIONS: Send one copy of this form to veterinary Resources
Program, Building 28A, Room 111. Use additional sheets if needed.
- -------------------------------------------------------------------------------------------------------------------------------
4a. To (Name of requester) 4b. Institute 6. From (Individual's name, address, and phone no. of source)
- ------------------------------------------------------------------
4c. NIH Mailing Address (Bldg./Rm.) 4c. Phone No.
- ------------------------------------------------------------------
4e. FAX No. 5. CAN
- -------------------------------------------------------------------------------------------------------------------------------
7. Genus and species and Common Name(s), Color, Strain (if applicable), Tumor Line Designation (if applicable).
- -------------------------------------------------------------------------------------------------------------------------------
8a. Number of Animals to be Received 8b. Approximate Date of Arrival
Male: Female:
- -------------------------------------------------------------------------------------------------------------------------------
9. Origin and Brief History of the Source Colony or Tissue
- -------------------------------------------------------------------------------------------------------------------------------
10a. Medical History of the Originating Colony or Tissue. Attach the most recent health surveillance report, if available. Has
colony or tissue been checked for Ectromelia (mouse pox), Lymphocytic Choriomeningitis (LCM), or other murine viruses?
(If "yes", specify which agents were tested for, when, and results).
____ Yes ____ No ____ Unknown
- -------------------------------------------------------------------------------------------------------------------------------
10b. What diseases or parasites are known to be present in the originating colony?
- -------------------------------------------------------------------------------------------------------------------------------
10c. Other pertinent colony history
- -------------------------------------------------------------------------------------------------------------------------------
11. Name, title, address, and phone no. Of sending institution's facility veterinarian or other professional person responsible
for animal health and care:
- -------------------------------------------------------------------------------------------------------------------------------
12. Specific location at NIH animals or tissue will be housed and/or used
- -------------------------------------------------------------------------------------------------------------------------------
13. Special requirements for handling animals or tissue during the quarantine period
===============================================================================================================================
(right arrow) I certify that these animals or tissues will be used in accordance with all restrictions and precautions as may
be specified in the permit.
- -------------------------------------------------------------------------------------------------------------------------------
14. Signature of Requester 15. Degree(s) 16. Title 17. Date Signed
- -------------------------------------------------------------------------------------------------------------------------------
18. Signature of ICD Director 19. Date Signed
- -------------------------------------------------------------------------------------------------------------------------------
NIH 2369-1 (Rev. 10/91) ATTACHMENT 9
Permit to Introduce Rodents and Rodent Products
- -------------------------------------------------------------------------------------------------------------------------------
Department of Health and Human Services | Permit Number
Public Health Service |
National Institutes of Health |
Permit to Introduce |------------------------------------------------------------------------------------
Rodents and Rodent Products | Date Issued Date Expires (for purposes of movement from
| shipper to permittee)
|
(Use prescribed by NIH Manual 3043-1) |
- -------------------------------------------------------------------------------------------------------------------------------
Name and Address of Source
- -------------------------------------------------------------------------------------------------------------------------------
To (Name and address of requester) | Mode of Transportation (requester must notify NCRR Rodent Import Office of shipping
| information.)
|
|
|
- ------------------------------------------|------------------------------------------------------------------------------------
Name and Address of Recipient | Delivery Point
(if other than requester) |
|
|------------------------------------------------------------------------------------
| Quarantine Location
|
|
- -------------------------------------------------------------------------------------------------------------------------------
As requested in your application, you are authorized to introduce the following rodents or rodent tissues:
===============================================================================================================================
Restrictions and Precautions for Transporting Rodents and Rodent Tissues
- -------------------------------------------------------------------------------------------------------------------------------
This permit is issued under the authority contained in NIH Manual 3043-1. The authorized rodents or rodent tissues or their
progeny shall be used only in accordance with the restrictions and precautions specified below. Alterations of restrictions can
be made only when authorized by the NCRR Rodent Import Office.
____ NCRR quarantine waived. ____NCRR quarantine required.
- -------------------------------------------------------------------------------------------------------------------------------
Comments
===============================================================================================================================
(right arrow) Signature of NCRR Rodent Import Officer | Date Signed
|
|
- -------------------------------------------------------------------------------------------------------------------------------
NIH 2369-2 (Rev. 10/91) ATTACHMENT 10
NIH/ADAMHA Patent Policy Board May 22,1989 (OTT rev 1017/910
National Institutes of Health
Alcohol, Drug Abuse and Mental Health Administration
MATERIAL TRANSFER AGREEMENT
This Material Transfer Agreement ("MTA") has been adopted for use by the
National Institutes of Health ("NIH") and the Alcohol, Drug Abuse and Mental
Health Administration (ADAMHA) in all transfers of research material ("Research
Material") whether NIH or ADAMHA is identified below as its Provider or
Recipient.
5. Provider agrees to transfer to recipient's investigator named below the
following Research Material:
- --------------------------------------------------------------------------------
2. THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMAN SUBJECTS. This
Research Material will only be used for research purposes by Recipient's
investigator in his/her laboratory, for the Research Project described below,
under suitable containment conditions. This Research Material will not be used
for commercial purposes such as screening, production or sale, for which a
commercialization license may be required. Recipient agrees to comply with all
Federal rules and regulations applicable to the Research Project and the
handling of the Research Material.
2.(a) Are Research Materials of human origin? ___ Yes ___ No
2.(b) If Yes in 2.(a), were Research Materials collected according to 45
CFR 46 "Protection of Human Subjects?" ___ Yes ___ No. Please provide
Assurance Number: _________________.
3. This Research Material will be used by recipient's investigator solely
in connection with the following research project ('Research Project") described
with specificity as follows (use an attachment page if necessary:
________________________________________________________________________________
________________________________________________________________________________
4. In all oral presentations or written publications concerning the
Research Project, Recipient will acknowledge Provider's contribution of this
Research Material unless requested otherwise. To the extent permitted by law,
Recipient agrees to treat in confidence, for a period of three (3) years from
the date of its disclosure, any of Provider's written information about this
Research Material that is stamped "CONFIDENTIAL," except for information that
was previously known to recipient or that is or becomes publicly available or
which is disclosed to Recipient without a confidentiality obligation. Recipient
may publish or otherwise publicly disclose the results of the Research Project,
but if Provider has given CONFIDENTIAL information to Recipient such public
disclosure may be made only after Provider has had thirty (30) days to review
the proposed disclosure, except when a shortened time period under court order
or the Freedom of Information Act pertains.
5. This Research Material represents a significant investment on the part
of Provider, and is considered proprietary to Provider. Recipient's investigator
therefore agrees to retain control over this Research Material, and further
agrees not to transfer the Research Material to other people not under her or
his direct supervision without advance written approval of Provider. Provider
reserves the right to distribute the Research Material to others and to use it
for its own purposes. When the Research Project is completed, or three (3) years
have elapsed, whichever occurs first, the Research Material will be destroyed by
Recipient or otherwise disposed of as mutually agreed by Provider and Recipient.
6. This Research Material is provided as a service to the research
community. IT IS BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING ANY
Material Transfer Agreement (NIH/ADAMHA) ATTACHMENT 11
NIH/ADAMHA Patent Policy Board May 22, 1989 (0TT rev 1017/910
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Provider makes
no representations that the use of the Research Material will not infringe any
patent or proprietary rights of third parties.
7. When Provider is the NIH/ADAMHA: Recipient shall retain title to any
patent or other intellectual property rights in inventions made by its employees
in the course of the Research Project Recipient agrees not to claim, infer, or
imply Governmental endorsement of the Research Project, the institution or
personnel conducting the Research Project or any resulting commercial
product(s). Recipient agrees to hold the United States Government harmless and
to indemnify the Government for all liabilities, demands, damages, expenses and
losses arising out of Recipient's use for any purpose of the Research Material.
8. When Recipient is the NIH/ADAMHA: The NIH/ADAMHA shall retain tit e to
any patent or other intellectual property rights in, inventories made by its
employees in the course of the Research Project. The NIH/ADAMHA are not
authorized to promise rights in advance for inventions developed through this
Research Project, except under a Cooperative Research and Development Agreement
("CRADA") pursuant to the Federal Technology Transfer Act of 1986. Except as may
be accorded through Paragraph 9., below, Provider acquires no intellectual
property rights under this MTA, but may apply for license rights to any
patentable invention that might result from this Research Project. It is the
intention of NIH/ADAMHA that Provider not be liable to NIH/ADAMHA for any claims
or damages arising from NIH/ADAMHA's use of the Research Material; however, no
indemnification is provided or intended.
9. Pursuant to their "Policy Statement or Cooperative Research and
Development Agreements and Intellectual Property Licensing," NIH and ADAMHA may
permit their investigators to enter into CRADAs (and thereby promise an option
to acquire intellectual property rights) in exchange for the contribution of
"essential research materials ... not otherwise reasonably available." If the
Research Material transferred by this MTA is so certified below, Provider and
the NIH/ADAMHA (when Recipient) investigator should submit a formal CRADA for
NIH/ADAMHA approval. For nongovernmental entities that regularly provide
research materials to NIH or ADAMHA, it is suggested that a master CRADA be
negotiated under which a certification below will suffice to invoke the
provisions of the CRADA. If Provider and Recipient otherwise decide to engage in
a cooperative research or development project using the Research Material, a
formal CRADA must also be negotiated. For general inquiries regarding CRADAs or
NIH/ADAMHA technology transfer policies, contact the Office of Invention
Development at (301) 496-0750.
For receipt of Research Material under this Paragraph, when a
master CRADA governing material transfers is in effect between NIH or ADAMHA and
Provider, the NIH/ADAMHA investigator must identify the CRADA by NIH/ADAMHA
reference number: , and provide a more detailed description
than in Paragraph 2., above, of the specific extent of activities within the
overall Research Project to which the provisions of the CRADA will pertain (use
an attachment page if necessary). Signature by the investigator and authorized
official below constitutes certification that the Research Material transferred
by this MTA is essential and not otherwise reasonably available for the
following activities:
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
10. This MTA shall be construed in accordance with Federal law as applied
by the Federal courts in the District of Columbia.
11. Any additional _______________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Material Transfer Agreement (NIH/ADAMHA) ATTACHMENT 11
NIH/ADAMHA Patent Policy Board May 22, 1989 (OTT rev 1017/910
================================================================================
Date:
___________________ ____________________________________________
Recipient's Investigator and Title
Date:
___________________ ____________________________________________
Authorized signature for Recipient and Title
Recipient's mailing address:
________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Date:
___________________ ____________________________________________
Provider's Investigator and Title
Date:
___________________ ____________________________________________
Authorized signature for Provider and Title
Provider's mailing address:
________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Material Transfer Agreement (NIH/ADAMHA) ATTACHMENT 11
ANIMAL INVENTORY SUMMARY
WEEK ENDING: (DATE)
- --------------------------------------------------------------------------------
INVESTIGATOR MICE RATS RABBITS HAMSTERS
- --------------------------------------------------------------------------------
(INFORMATION)
- --------------------------------------------------------------------------------
PRESENT TOTALS:
Animal Inventory Summary
November 1992
ATTACHMENT 12
ANIMAL MORTALITY SHEET
WEEK ENDING: (DATE)
- --------------------------------------------------------------------------------------------------------
DATE DATE DATE STRAIN SOURCE SEX CAGE EAR TAG NUMBER INVESTIGATOR
REMOVED RECEIVED BORN NUMBER NUMBER DISCARDED
- --------------------------------------------------------------------------------------------------------
(INFORMATION)
- --------------------------------------------------------------------------------------------------------
Animal Mortality Sheet
November 1992
ATTACHMENT 13