[Federal Register Volume 67, Number 70 (Thursday, April 11, 2002)]
[Notices]
[Pages 17701-17703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8777]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety Research: Availability of Cooperative Agreements; 
Request for Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), in its request for 
applications (RFA), is announcing the availability of approximately 
$500,000 in research funds for fiscal year (FY) 2002. These funds will 
be used to support collaborative research efforts between the Center 
for Food Safety and Applied Nutrition (CFSAN) and scientists and to 
complement and accelerate ongoing research in the area of transmissible 
spongiform encephalopathies (TSE) in order to avoid their presence in 
the nation's food supply, food additives, and dietary supplements.

DATES: Submit applications by June 10, 2002.

ADDRESSES: Submit completed applications to: Maura Stephanos, Grants 
Management Specialist, Grants Management Staff (HFA-520), Division of 
Contracts and Procurement Management, Food and Drug Administration, 
5630 Fishers Lane, rm. 2129, Rockville, MD 20857, 301-827-7183, FAX 
301-827-7101, e-mail: [email protected].
    Application forms are available either from Maura Stephanos (see 
previous paragraph) or on the Internet at http://www.grants.nih.gov/grants/funding/phs398/phs398.html.

FOR FURTHER INFORMATION CONTACT:   
    Regarding the administrative and financial management aspects of 
this notice: Maura Stephanos (see ADDRESSES).
    Regarding the programmatic aspects of this notice: John W. Newland, 
Microbial Research Coordinator, Office of Science (HFS-06), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1915, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to reducing the incidence of foodborne illness to 
the greatest extent feasible and to protecting the integrity of the 
nation's food supply. Research in food safety seeks to prevent 
foodborne illness by improving our ability to detect and quantitate 
foodborne pathogens, toxins and chemicals that could jeopardize the 
safety of the food supply, and to find new and improved ways to control 
these agents. CFSAN supports multiyear cooperative agreements intended 
to help achieve these research goals of reducing the incidence of 
foodborne illness and ensuring the integrity of foods, food additives, 
and dietary supplements. This extramural program supports novel 
collaborative research efforts between CFSAN and scientists, and 
leverages expertise not found within CFSAN to complement and accelerate 
ongoing research. Collaborations such as these provide information 
critical to food safety guidance and policymaking, and stimulate 
fruitful interactions between FDA scientists and those within the 
greater research community.
    In continuation of this effort, FDA is announcing the availability 
of research funds for FY 2002 to support research in the following 
category: The development of proteinase-resistant proteins that can be 
used as surrogates of infectious prions associated with the family of 
diseases known as TSE. Approximately $500,000 will be available in FY 
2002. FDA anticipates making awards of $100,000 to $250,000 (direct 
plus indirect costs) per award per year. Support of these agreements 
may be up to 4 years in duration with the total budget amount not to 
exceed $250,000 (direct plus indirect costs) per year or a total of $1 
million for a 4-year award. Any application received that exceeds the 
amounts stated previously will not be considered responsive and will be 
returned to the applicant without being reviewed. The number of 
agreements funded will depend on the availability of Federal funds to 
support the projects and on the quality of the applications received. 
After the first year, additional years of noncompetitive support are 
predicated upon performance and the availability of Federal funds.
    FDA will support the research studies covered by this notice under 
section 301 of the Public Health Service Act (42 U.S.C. 241). FDA's 
research program is described in the Catalog of Federal Domestic 
Assistance, No. 93.103.
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort to 
reduce morbidity and mortality and to improve quality of life. 
Applicants may obtain a hard copy of the ``Healthy People 2010'' 
objectives, vols. I and II, conference edition (B0074) for $22 per set, 
by writing to the Office of Disease Prevention and Health Promotion 
Communication Support Center (Center), P.O. Box 37366, Washington, DC 
20013-7366. Each of the 28 chapters of ``Healthy People 2010'' is $2 
per copy. Telephone orders can be placed at the Center on 301-468-5690. 
The Center also sells the complete conference edition in CD-ROM format 
(B0071) for $5. This publication also is available on the Internet at 
http://health.gov/healthypeople under ``Publications.''
    The Public Health Service (PHS) strongly encourages all award 
recipients to provide a smoke-free workplace and to discourage the use 
of all tobacco products. This is consistent with the PHS mission to 
protect and advance the physical and mental health of the American 
people.

II. Research Goals and Objectives

    Proposed projects designed to fulfill the specific objectives of 
the following requested project will be considered for funding. 
Applicants may submit more than one application. It should be 
emphasized that in the following project there is a particular desire 
to promote the development of surrogate agents and techniques to 
facilitate studies that will reliably predict the ability of treatments 
or manufacturing processes to inactivate the infectivity and biological 
activity of prions associated with the family of diseases known as TSE. 
None of the proposed projects should involve human research subjects 
that are not exempt from the Department of Health and Human Services 
(DHHS) regulations (45 CFR part 46) for the protection of human 
research subjects. The project and its objectives are as follows:
    There are two objectives to this project. The first objective of 
this project is to develop proteinase resistant proteins that can serve 
as surrogates for

[[Page 17702]]

infectious prions associated with the family of TSE diseases. These 
proteinase resistant surrogate proteins must be suitable for reliably 
measuring the efficacy of treatments or manufacturing processes 
intended to inactivate the infectivity and biological activity of TSE-
related prions. The second objective of this project is to devise a 
system that will demonstrate that the surrogates will accurately 
predict the efficacy of prion-targeted inactivation methods in the 
context of FDA-regulated foods, food additives, dietary supplements or 
cosmetics, or the equipment used to manufacture or process them. For 
example, the surrogates should be evaluated in a regulated product 
wherein processing helps assure the elimination of infectious prion 
particles, such as a gelatin-based model test system with potential 
applicability to a wide range of these FDA-regulated products. 
Theoretically, such a system could rely upon the ability to unfold beta 
sheets that are structurally more stable than prion protein to 
correlate surrogate performance with prion inactivation. Alternatively, 
a system may rely upon a direct demonstration of the correlation 
between surrogate performance and prion inactivation through the use of 
bioassays. Emphasis will be placed on creative solutions capable of 
both developing the desired surrogates and providing evidence of their 
performance.

III. Mechanism of Support

A. Award Instrument

    Support for this program will be in the form of cooperative 
agreements. These cooperative agreements will be subject to all 
policies and requirements that govern the research grant programs of 
the PHS, including the provisions of 42 CFR part 52 and 45 CFR parts 74 
and 92. The regulations issued under Executive Order 12372 do not apply 
to this program. The NIH modular grant program does not apply to this 
FDA program.

B. Eligibility

    These cooperative agreements are available to any foreign or 
domestic, public or private non-profit entity (including State and 
local units of government) and any foreign or domestic, for-profit 
entity. For-profit entities must commit to excluding fees or profit in 
their request for support to receive awards. Organizations described in 
section 501(c)(4) of the Internal Revenue Code of 1968 that engage in 
lobbying are not eligible to receive awards.

C. Length of Support

    The length of support will be for up to 4 years. Funding beyond the 
first year will be noncompetitive and will depend on:
    1. Satisfactory performance during the preceding year, and
    2. Availability of Federal FY funds.

IV. Reporting Requirements

    Annual Financial Status Reports (FSR) (SF-269) are required. An 
original FSR and two copies shall be submitted to FDA's Grants 
Management Officer (see ADDRESSES section) within 90 days of the budget 
expiration date of the cooperative agreement. Failure to file the FSR 
on time may be grounds for suspension or termination of the agreement. 
Program Progress Reports will be required quarterly and will be due 30 
days following each quarter of the applicable budget period except that 
the fourth quarterly report which will serve as the annual report will 
be due 90 days after the budget expiration date. For continuing 
agreements, an annual Program Progress Report is also required. 
Submission of the noncompeting continuation application (PHS 2590) will 
be considered as the annual Program Progress Report. The recipient will 
be advised of the suggested format for the Program Progress Report at 
the time an award is made. In addition, the principal investigator will 
be required to present the progress of the study at an annual FDA 
extramural research review workshop in Washington, DC. Travel costs for 
this requirement should be specifically requested by the applicant as 
part of their application. A final FSR, Program Progress Report, and 
Invention Statement, must be submitted within 90 days after the 
expiration of the project period, as noted on the Notice of Grant 
Award.
    Program monitoring of recipients will be conducted on an ongoing 
basis and written reports will be reviewed and evaluated at least 
quarterly by the Project Officer and the Project Advisory Group. 
Project monitoring may also be in the form of telephone conversations 
between the Project Officer/Grants Management Specialist and the 
Principal Investigator and/or a site visit with appropriate officials 
of the recipient organization. A record of these monitoring activities 
will be duly made in an official file specific for each cooperative 
agreement and may be available to the recipient of the cooperative 
agreement upon request.

V. Delineation of Substantive Involvement

    Inherent in the cooperative agreement award is substantive 
involvement by the awarding agency. Accordingly, FDA will have a 
substantive involvement in the programmatic activities of all the 
projects funded under this RFA. Substantive involvement may include, 
but is not limited to the following:
    1. FDA will provide guidance and direction with regard to the 
scientific approach and methodology that may be used by the 
investigator.
    2. FDA will participate with the recipient in determining and 
executing any: (a) Methodological approaches to be used, (b) procedures 
and techniques to be performed, (c) sampling plans proposed, (d) 
interpretation of results, and (e) microorganisms and commodities to be 
used.
    3. FDA will collaborate with the recipient and have final approval 
on the experimental protocols. This collaboration may include protocol 
design, data analysis, interpretation of findings, coauthorship of 
publications, and the development and filing of patents.

VI. Review Procedure and Criteria

A. Review Method

    All applications submitted in response to this RFA will first be 
reviewed by grants management and program staff for responsiveness. To 
be responsive, an application must: (1) Be received by the specified 
due date; (2) be submitted in accordance with sections III.B, VII, and 
VIII.A of this document; (3) not exceed the recommended funding amount 
stated in section I of this document; (4) address the specific 
requirements of the project stated in section II of this document; and 
(5) bear the original signatures of both the principal investigator and 
the institution's/organization's authorized official. If applications 
are found to be not responsive to this announcement, they will be 
returned to the applicant without further consideration.
    Responsive applications will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts in the 
subject field of the specific application.
    Responsive applications will also be subject to a second level of 
review by a National Advisory Council for concurrence with the 
recommendations made by the first level reviewers. Final funding 
decisions will be made by the Commissioner of Food and Drugs or his 
designee.

[[Page 17703]]

B. Review Criteria

    Applications will be evaluated by program and grants management 
staff for responsiveness. Applications will be reviewed and ranked. 
Funding will start with the highest ranked application and additional 
awards will be made based on an application's standing within the 
review rankings. All questions of a technical or scientific nature 
should be directed to the CFSAN program staff, and all questions of an 
administrative or financial nature should be directed to the grants 
management staff. (See the FOR FURTHER INFORMATION CONTACT section of 
this document for addresses.)
    All applications will be reviewed and scored on the following 
criteria:
    1. Soundness of the scientific rationale for the proposed study and 
appropriateness of the study design and its ability to address all of 
the objectives of the RFA;
    2. Availability and adequacy of laboratory facilities, equipment, 
and support services, e.g., bio-statistics computational support, 
databases, etc.;
    3. Research experience, training, and competence of the principal 
investigator and support staff; and
    4. Whether the proposed study is within the budget guidelines and 
proposed costs have been adequately justified and fully documented.

VII. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS 398 (Rev. 4/98 or Rev. 5/01) or the original and two copies of PHS 
5161-1 (Rev. 7/00) for State and local governments, with copies of the 
appendices for each of the copies, should be delivered to Maura 
Stephanos (see ADDRESSES). State and local governments may choose to 
use the PHS 398 application form in lieu of PHS 5161-1. The application 
receipt date is June 10, 2002. No supplemental or addendum material 
will be accepted after the receipt date. The outside of the mailing 
package and item 2 of the application face page should be labeled: 
``Response to RFA FDA CFSAN-02-3.''

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted during normal business hours, 8 a.m. 
to 4:30 p.m., Monday through Friday, on or before the established 
receipt date. Applications will be considered received on time if sent 
or mailed on or before the receipt date as evidenced by a legible U.S. 
Postal Service dated postmark or a legible date receipt from a 
commercial carrier, unless they arrive too late for orderly processing. 
Private metered postmarks shall not be acceptable as proof of timely 
mailing. Applications not received on time will not be considered for 
review and will be returned to the applicant. (Applicants should note 
that the U.S. Postal Service does not uniformly provide dated 
postmarks. Before relying on this method, applicants should check with 
their local post office.) NOTE: Do not send applications to the Center 
for Scientific Research, National Institutes of Health (NIH). Any 
application that is sent to NIH, and is then forwarded to FDA and not 
received in time for orderly processing will be deemed not responsive 
and returned to the applicant. Applications must be submitted via mail 
or hand delivery as stated previously. FDA is unable to receive 
applications electronically. Applicants are advised that FDA does not 
adhere to the page limitations or the type size and line spacing 
requirements imposed by NIH on its applications.

B. Format for Application

    Submission of the application must be on Grant Application Form PHS 
398 (Rev. 4/98 or Rev. 5/01) or PHS 5161-1 (Rev. 7/00). All ``General 
Instructions'' and ``Specific Instructions'' in the application kit 
should be followed with the exception of the receipt dates and the 
mailing label address.
    The face page of the application should reflect the request for 
applications number, RFA-FDA-CFSAN-02-3. Data included in the 
application, if restricted with the legend specified below, may be 
entitled to confidential treatment as trade secret or confidential 
commercial information within the meaning of the Freedom of Information 
Act (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 
20.61).
    Information collection requirements requested on Form PHS 398 and 
the instructions have been submitted by PHS to the Office of Management 
and Budget (OMB) and were approved and assigned OMB control number 
0925-0001. The requirements requested on Form PHS 5161-1 were approved 
and assigned OMB control number 0348-0043.

C. Legend

    Unless disclosure is required by the Freedom of Information Act as 
amended (5 U.S.C. 552) as determined by the freedom of information 
officials of DHHS or by a court, data contained in the portions of this 
application that have been specifically identified by page number, 
paragraph,etc., by the applicant as containing restricted information 
shall not be used or disclosed except for evaluation purposes.

    Dated: April 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8777 Filed 4-10-02; 8:45 am]
BILLING CODE 4160-01-S