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1. DATE ISSUED |2. CFDA No. |
| |
09/29/95 | 93.856 | DEPARTMENT OF HEALTH AND HUMAN SERVICES
- -----------------------------------------------------------| PUBLIC HEALTH SERVICE
|
3. SUPERSEDES AWARD NOTICE dated ______________________ | NATIONAL INSTITUTES OF HEALTH
except that any additions or restrictions previously |
imposed remain in effect unless specifically rescinded.| NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES EXTRAMURAL
- -----------------------------------------------------------|
4. GRANT NO. | 5. ADMINISTRATIVE CODES| NOTICE OF GRANT AWARD
| |
1 U01 AI39223-01 | 37X750B | AUTHORIZATION (Legislation/Regulation)
| |
- -----------------------------------------------------------| 42 USC 241 31 USC 6305 & 6306
6. GRANT PERIOD Mo./Day/Yr. | Mo./Day/Yr. | RESEARCH PROJECT COOPERATIVE AGREEMENT
From 09/30/95 | Through 08/31/98 |
- -----------------------------------------------------------|
7. BUDGET PERIOD Mo./Day/Yr. | Mo./Day/Yr. |
From 09/30/95 | Through 08/31/96 |
- ------------------------------------------------------------------------------------------------------------------------------------
8. TITLE OF PROJECT (OR PROGRAM) (Limit to 56 spaces)
CHLAMYDIA OIA FOR TESTING NON-INVASIVE GENITAL S SRC (48)
- ------------------------------------------------------------------------------------------------------------------------------------
9. GRANTEE NAME AND ADDRESS |10. DIRECTOR OF PROJECT (PROGRAM DIRECTOR/PRINCIPAL
| INVESTIGATOR) (LAST NAME FIRST AND ADDRESS)
|
a. BIOSTAR INC | CROSBY, MARK A BS
b. 6655 LOOKOUT ROAD | BIOSTAR INC
c. | RESEARCH AND DEVELOPMENT
d. BOULDER e. CO f. 80301 | 6655 LOOKOUT ROAD
| BOULDER, CO 80301
|
- ------------------------------------------------------------------------------------------------------------------------------------
11. GRANTEE NAME AND ADDRESS |12. AWARD COMPUTATION FOR FINANCIAL ASSISTANCE
- -----------------------------------------------------------|------------------------------------------------------------------------
I PHS Grant Funds Only [ I ] | a. Amount of PHS Financial Assistance (from Item 11.0)...$ 553,544
|
II Total project costs including grant funds and | b. Less Unobligated Balance From Prior Budget Periods....$ 0
all other financial participation |
| c. Less Cumulative Prior Award(s) This Budget Period.....$ 0
(Select one and place NUMERAL in box.) | -------------
- -----------------------------------------------------------| d. AMOUNT OF FINANCIAL ASSISTANCE THIS ACTION..........| $ 553,544
a. Salaries and Wages...........$ 137,000 |------------------------------------------------------------------------
|13. RECOMMENDED FUTURE SUPPORT (SUBJECT TO THE AVAILABILITY OF FUNDS AND
b. Fringe Benefits.............. 24,210 | SATISFACTORY PROGRESS OF THE PROJECT.)
|------------------------------------------------------------------------
c. Total Personnel Costs....$ 161,210 | YEAR | TOTAL DIRECT COSTS/STIPENDS | YEAR | TOTAL DIRECT COSTS/STIPENDS
|------|-----------------------------|------|----------------------------
d. Consultant Costs.............$ 0 |a. 02 | 434,979 |d. |
| | | |
e. Equipment....................$ 102,500 |b. 03 | 428,513 |e. |
| | | |
f. Supplies.....................$ 22,500 |c. | |f. |
|------------------------------------------------------------------------
g. Travel.......................$ 31,500 |14. APPROVED DIRECT ASSISTANCE BUDGET (IN LIEU OF CASH)
|
h. Patient Care - Inpatient.....$ 0 | a. Amount of PHS Direct Assistance.......................$
|
i. Patient Care - Outpatient....$ 0 | b. Less Unobligated Balance From Prior Budget Periods....$
|
j. Alterations and Renovations..$ 20,000 | c. Less Cumulative Prior Award(s) This Budget Period.....$
| -------------
k. Other........................$ 31,200 | d. AMOUNT OF DIRECT ASSISTANCE THIS ACTION.............| $
|------------------------------------------------------------------------
l. Consortium/Contractual Costs.$ 81,339 |15. PROGRAM INCOME SUBJECT TO 45 CFR PART 74, SUBPART F, OR 45 CFR
| 92.25, SHALL BE USED IN ACCORD WITH ONE OF THE FOLLOWING
m. Trainee Related Expenses.....$ | ALTERNATIVES (Select One and Place LETTER in box.)
|
n. Trainee Supplies.............$ 0 | a. DEDUCTION
|
o. Trainee Tuition and Fees.....$ 0 | b. ADDITIONAL COSTS
|
p. Trainee Travel...............$ 0 | c. MATCHING [ D ]
|
-----------------------| d. OTHER RESEARCH (Add/Deduct Option)
| |
q. TOTAL DIRECT COSTS.....| $ 450,249 | e. OTHER (See REMARKS)
- ------------------------------------|-----------------------------------------------------------------------------------------------
r. INDIRECT COSTS | |16. THIS AWARD IS BASED ON AN APPLICATION SUBMITTED TO, AND AS APPROVED
(Rate * % of S&W/TADC)...| $ 103,295 | BY, THE PHS ON THE ABOVE TITLED PROJECT AND IS SUBJECT TO THE TERMS
- ------------------------------------|----------------------| AND CONDITIONS INCORPORATED EITHER DIRECTLY OR BY REFERENCE IN THE
| | FOLLOWING:
s. TOTAL APPROVED BUDGET......| $ 553,544 | a. The grant program legislation cited above.
- ------------------------------------|----------------------| b. The grant program regulation cited above.
| | c. This award notice including terms and conditions, if any, noted
t. SBIR Fee...................| $ 0 | below under REMARKS.
- -----------------------------------------------------------| d. PHS Grants Policy Statement including addenda in effect as of the
| beginning date of the budget period.
u. Federal Share................$ 553,544 | e. 45 CFR Part 74 or 45 CFR Part 92 as applicable.
| IN THE EVENT THERE ARE CONFLICTING OR OTHERWISE INCONSISTENT
v. Non-Federal Share............$ | POLICIES APPLICABLE TO THE GRANT, THE ABOVE ORDER OF PRECEDENCE
| SHALL PREVAIL. ACCEPTANCE OF THE GRANT TERMS AND CONDITIONS IS
| ACKNOWLEDGED BY THE GRANTEE WHEN FUNDS ARE DRAWN OR OTHERWISE
| OBTAINED FROM THE GRANT PAYMENT SYSTEM.
- ------------------------------------------------------------------------------------------------------------------------------------
REMARKS: (Other Terms and Conditions Attached - [X] Yes [ ] No)
BASE X RATE ($413,179 X 25.00)
TS GRANT IS EXCLUDED FROM EXPANDED AUTHORITIES.
- ------------------------------------------------------------------------------------------------------------------------------------
TS GRANTS MANAGEMENT OFFICER: (Signature) (Name-Typed/Print) (Title)
/s/ Victoria C. Putprush TODD C. BALL, MICROBIOLOGY GMO, GMB, DEA, NIAID
- ------------------------------------------------------------------------------------------------------------------------------------
17. CBJ CLASS |18. CRS - EIN |19. LIST NO:
41.4I | 184200265A1 |
- ------------------------------------------------------------------------------------------------------------------------------------
FY-CAN | DOCUMENT NO. | ADMINISTRATIVE CODE | AMT. ACTION FIN. ASST. | AMT. ACTION DIR. ASST.
| | | |
20. a. 95 8425921 | b. U1AI39223A | c. | d. | e.
| | | |
21. a. | b. | c. | d. | e.
| | | |
22. a. | b. | c. | d. | e.
- ------------------------------------------------------------------------------------------------------------------------------------
PHS-5152-5 (Rev. 7/92) 950926 1356 (Note: See reverse for payment information.) LAB
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ATTACHMENT GRANT #: 1 U01 AI 39223-01
TERMS OF AWARD
General program income that may be generated from this grant is subject to the
deductive alternative as defined in CFR Title 45, Part 74, Subpart F.
Pursuant to the NIH Revitalization Act (P.L. 103-43, June 10, 1993), section
2004, when purchasing equipment or products under this assistance award, the
recipient should, whenever possible, purchase only American-made items.
"NOTICE: Under governing policy, Federal funds administered by the Public Health
Service (PHS) shall not be expended for research involving live vertebrate
animals without prior approval by the Office for Protection from Research Risks
of an assurance to comply with the PHS policy on humane care and use of
laboratory animals. This restriction applies to all performance sites without
OPRR-approved assurances, whether domestic or foreign.
"NOTICE: Under governing regulations, Federal funds administered by the
Department of Health and Human Services shall not be expended for and
individuals shall not be enrolled in research involving human subjects, without
prior approval by the Office for Protection from Research Risks of an assurance
to comply with the requirements of 45 CFR 46 to protect human research subjects.
This restriction applies to all performance sites without OPRR-Approved
assurances, whether domestic or foreign.
All funds awarded for indirect costs ($103,295) are restricted pending the
negotiation of an approved indirect cost rate agreement with the NIH Financial
Advisory Services Branch.
Approved travel funds must include travel for the Principal Investigator and two
other scientists to two Steering Committee meetings in Bethesda, MD for two
meetings per year.
Budgets for projects at University of California, Irvine are shown on attached
spreadsheet.
Use of funds for the subcontract are restricted pending acceptance of a properly
endorsed consortium agreement between the University of California, Irvine and
BioStar, Inc.
Indirect Costs for the subcontract for future years are calculated at the
currently effective rate. Adjustments will be made due to fluctuations at time
of award.
Estimated indirect costs for future years for the subcontract are not available
for direct cost purposes.
Consortia are to be established and administered in accordance with the NIH
Consortium Policy (NIH Guide for Grants and Contracts Vol. 14 No. 7, June 21,
1985)
No funds may be used for consortium activity at University of Alabama,
Birmingham. All evaluation activity will be handled by the evaluation site
funded under this RFA.
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No funds may be used for Alterations and Renovations until additional
justification is provided to and approved by the NIAID.
Future year escalation has been calculated at 4%.
Additional justification must be provided for consultant costs budgeted for
future years.
Grants Management Contact:
Sharie Bernard
(301) 402-5540
(301) 480-3780 (Fax)
Program Official Contact
Penelope J. Hitchcock, D.V.M.
(301) 402-0443
Please see attached for Terms and Conditions and spreadsheets specific to this
cooperative agreement.
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SPECIAL TERMS AND CONDITIONS OF AWARD - RFA 95-001
These special Terms of Award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements.
The administrative and funding instrument used for this program is the
Cooperative Agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during the performance
of the activity.
Under the Cooperative Agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working jointly with
the award recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime responsibility for the
activity resides with the awardee(s) for the project as a whole, although
specific tasks and activities in carrying out the study will be shared among the
awardees and the NIAID Scientific Coordinator.
Under the cooperative agreement, a relationship will exist between the award
recipient(s) and the NIAID in which the performers of the activities (1) are
responsible for the requirements and conditions described below and (2) agree to
accept program assistance from the named NIAID Scientific Coordinator in
achieving project objectives.
Failure of an awardee to meet the performance requirements, including these
special terms and conditions of award, or significant changes in the level of
performance, may result in a reduction in budget, withholding of support, or
suspension and/or termination of the award.
1. AWARDEE RIGHTS AND RESPONSIBILITIES
The awardee is responsible for:
a. Research design and development, including definition of objectives and
approaches, planning, implementation, data collection, quality control, interim
data and safety monitoring, final data analysis and interpretation, and
publication of results.
b. Establishing a mandatory Steering Committee to coordinate and manage the
test development and test evaluation studies.
c. Implementing the data collection strategy and methods collectively
decided upon by the Steering Committee. For each study involving multiple
institutions, it is the responsibility of each awardee/site to ensure that data
will be collected and submitted in a timely way following such procedures as
agreed to by the Steering Committee.
d. Establishing mechanisms for quality control and monitoring. Awardees are
responsible for ensuring the accurate and timely assessment of the progress of
the study, including development of procedures to ensure that data collection
and management are adequate for quality control and analysis.
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e. Preparing and submitting interim progress reports, when requested (not
more than quarterly), to the NIAID Scientific Coordinator including, as a
minimum, summary data on diagnostic test performance results. Such reports are
in addition to the annual awardee noncompeting continuation progress reports.
f. Establishing procedures, where applicable, for all participating
institutions in coordinated awards to comply with FDA regulations for studies
involving investigational agents or devices and to comply with the requirements
of 45 CFR Part 46 for the protection of human subjects.
g. Cooperating in the reporting of the study findings. The NIAID will have
access to and may periodically review all data generated under an award. Where
warranted by appropriate participation, plans for joint publication with NIAID
of pooled data and conclusions, are to be developed by the Principal
Investigator or Steering Committee, as applicable. NIH policies governing
possible co-authorship of publications with NIAID staff will apply in all cases.
In general, to warrant co-authorship, NIAID staff must have contributed to each
of following areas: (a) design of the experiments or concepts being tested; (b)
performance of significant portions of the activity; and (c) preparation and
authorship of pertinent manuscripts. The awardee will retain custody of and have
primary rights to the data developed under these awards, subject to Government
right of access consistent with current HHS, PHS, and NIH policies. Contents of
reports of study results are solely the responsibility of the authors and do not
necessarily represent the views of NIAID.
2. NIAID STAFF RESPONSIBILITIES
It is expected that the dominant role and prime responsibility for the activity
will reside with the awardee(s) for the project as a whole. However, specific
tasks and activities will be shared among the awardee(s) and the NIAID
Scientific Coordinator. As required for the coordination of activities and to
expedite progress, the NIAID Scientific Coordinator may designate additional
NIAID staff to provide advice or assistance to the awardee(s) on specific
scientific, technical, or management issues. The NIAID Scientific Coordinator
shall retain overall programmatic responsibility for the award(s) and will
clearly specify to the awardee(s) the name(s) and role(s) of any such additional
individuals and the lines of reporting authority.
a. Interacting with the principal investigator(s) on a regular basis to
monitor study progress. Monitoring may include: (a) regular communications with
the principal investigator and staff, (b) periodic site visits for discussions
with awardee research teams, (c) observation of laboratory, manufacturing, data
collection and management techniques, quality control, fiscal review, and other
relevant matters, as well as (d) attendance at and participation in Scientific
Steering Committee.
b. Convening the first meeting of and subsequent participation in the
Scientific Steering Committee that oversees study conduct. The NIAID Scientific
Coordinator will be a full participant and voting member of the Scientific
Steering Committee.
c. Serving as a resource with respect to ongoing NIAID activities that may
be relevant to the research to facilitate compatibility and avoid unnecessary
duplication.
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[FN]
d. Substantial assistance in the design and coordination of research
activities for awardees including:
1. Assisting by providing advice on the management and technical
performance of the investigations.
2. Providing access to and use of, when appropriate, reagents and
assays, and other resources available through NIAID contractors and awardees.
3. Technical advice and assistance with meeting FDA requirements.
4. Reviewing and approving study designs to insure that they are within
the scope of peer review and for adequacy of safety, human subjects, and
representation of women and minorities, as required by Federal regulations.
5. Reviewing and providing advice regarding the establishment of
mechanisms for quality control and study monitoring.
e. Making recommendations for continued funding based on: (1) overall study
progress, including study subject and/or data accrual; (2) cooperation in
carrying out the research (e.g., attendance at Steering Committee meetings,
implementation of group decisions, compliance with terms of award and reporting
requirements); and/or (3) maintenance of a high quality of research which will
allow pooling of data and comparisons across multiple cooperative agreement
awards for common data elements.
3. JOINT RESPONSIBILITIES
In addition to the interactions defined above, awardees and NIAID staff shall
share responsibility for the organization of and participation on a Scientific
Steering Committee. A Scientific Steering Committee for each SDDG organized by
the Principal Investigators of a test development awardee and the test
evaluation awardee and the NIAID Scientific Coordinator will be the main
oversight body of the study. The steering committee will be comprised of the
Principal Investigators from a development and the evaluation cooperative
agreements, the NIAID Scientific Coordinator, and two to three peers from the
scientific community. The peers from the scientific community shall be selected
jointly by the Principal Investigators and the NIAID Scientific Coordinator.
The Steering Committee has primary responsibility to design joint research
activities, establish priorities, develop common methods and procedures
including data recording forms, establish and maintain quality control among
awardees, review progress, coordinate and standardize data management, and
cooperate on the publication of results. Major scientific decisions regarding
data will be determined by the Steering Committee. The Steering Committee will
document progress in written reports to the NIAID Scientific Coordinator and
will provide periodic supplementary reports upon NIAID request.
An initial meeting of the Steering Committee will be convened early after award
by the NIAID Scientific Coordinator. The final structure of the Steering
Committee will be established at the
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first meeting. The NIAID Program Officer will have voting membership on the
Steering Committee. After the initial meeting, the Steering Committee will meet
1-2 times per year.
A Chairperson, other than the NIAID Program Officer, will be selected by vote of
the members. The Chairperson is responsible for coordinating the Committee
activities, for preparing meeting agendas, for scheduling and chairing meetings,
and for preparing and disseminating a concise summary of each meeting to members
of the Committee.
4. PATENT COVERAGE
Because the discovery of innovative, non-invasive, rapid, sensitive, specific
and reliable diagnostic tests to identify active infection due to N. gonorrhoeae
or C. trachomatis is the goal of this effort, and since active involvement by
the private sector is facilitated by the existence of adequate patent coverage,
it is essential that applicants provide plans to ensure such coverage. With the
potential for involvement of several institutions, the patent situation could be
complicated. Each applicant for a test development award must, therefore,
provide a detailed description of the approach to be used for obtaining patent
coverage and for licensing where appropriate, in particular where the invention
may involve investigators from more than one institution. Each applicant must
provide a detailed description of the procedures to be followed for the
resolution of legal problems that may develop. Attention is drawn to the
reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR
52.227-11. Instructions were also published in the NIH Guide for Grants and
Contracts, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations
(including universities) and small business firms retain the rights to any
patent resulting from Government contracts, grants, or cooperative agreements.
It is also noted that a Presidential memorandum of February 18, 1983 extended to
all business concerns, regardless of size, the first option to the ownership of
rights to inventions as provided in P.L. 96-517. As a result of this memorandum,
the relationships among industrial organizations and other participants are
simplified, since all Group members can now be full partners in the research and
in any inventions resulting therefrom. The specific patenting arrangements among
institutions may vary and could include joint patent ownership, exclusive
licensing arrangements, etc. Applicants are encouraged to develop an arrangement
that is most suitable for their own particular circumstances.
Federal regulation clause 37 CFR 401 and HHS Inventions regulations at 45 CFR
Parts 6 and 8 require that NIH be informed of inventions and licensing occurring
under NIH funded research. Invention and licensing reports must be submitted to
Extramural Invention Reports Office, Office of Extramural Research, Building 31,
Room 5B41, NIH, 9000 Rockville Pike, Bethesda, MD 20892.
5. ARBITRATION PROCESS
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NIAID may be brought to
arbitration. An arbitration panel will be composed of three members -- one
awardee designee, one NIAID designee, and a third designee with expertise in the
relevant area and chosen by the other two. This special arbitration procedure in
no way affects the awardee's right to appeal an adverse action that is
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otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart
D and HHS regulation at 45 CFR Part 16.
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NIAID GRANTS MANAGEMENT 10/16/95
DETAILED BUDGET RECOMMENDATIONS
Prepared by: SHARIE BERNARD
GRANT NUMBER: I U01 AI 39223-01
P.I.: CROSBY, MARK A
INSTITUTION: BIOSTAR, INC.
MAIN BUDGET YEAR 1 YEAR 2 YEAR 3
========================================================================================
Salaries 137,000 167,480 174,179
Fringe Benefits 24,210 30,146 31,352
========================================================================================
PERSONNEL 161,210 197,626 205,531
CONSULTANTS 0 20,000 10,000
EQUIPMENT 102,500 75,000 65,000
SUPPLIES 22,500 23,400 24,336
TRAVEL, D. 31,500 32,760 34,070
TRAVEL, F. 0 0 0
INPATIENT 0 0 0
OUTPATIENT 0 0 0
ALTERATIONS 20,000 0 0
3RD PARTY DIRECT 54,262 56,433 58,690
3RD PARTY INDIRECT 27,077 28,160 29,286
OTHER 31,200 1,600 1,600
========================================================================================
TOTAL DIRECT COSTS 450,249 434,979 428,513
FUNDING PLAN 100% 450,249 434,979 428,513
Annual increases for personnel, consultants, supplies, travel, and other
expenses have been calculated at 4%.
REVIEWERS' RECOMMENDATIONS
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1 UO1 AI 39223-01
CONSORTIUM YEAR 1 YEAR 2 YEAR 3
=====================================================================================
Salaries 37,415 38,912 40,468
Fringe Benefits 9,154 9,520 9,901
=====================================================================================
PERSONNEL 46,569 48,432 50,369
CONSULTANTS 0 0 0
EQUIPMENT 0 0 0
SUPPLIES 7,325 7,618 7,923
TRAVEL, D. 0 0 0
TRAVEL, F. 0 0 0
INPATIENT 0 0 0
OUTPATIENT 0 0 0
ALTERATIONS 0 0 0
THIRD PARTY 0 0 0
OTHER 368 383 398
=====================================================================================
TOTAL DIRECT COSTS 54,262 56,433 58,690
TOTAL INDIRECT COST 27,077 28,160 29,286
=====================================================================================
TOTAL COSTS 81,339 84,593 87,976
9.