[Federal Register Volume 66, Number 98 (Monday, May 21, 2001)]
[Notices]
[Pages 27976-27980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12623]


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

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.

[[Page 27977]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of research funds for fiscal year (FY) 2001 to support 
research in the following areas: Analytical detection of bovine 
spongiform encephalopathy and other transmissible spongiform 
encephalopathies (BSE/TSE) in FDA-regulated products, consumer 
refrigeration storage length practices for unopened and opened packages 
of ready-to-eat foods, microbial contamination of agricultural water, 
and transfer coefficients to describe the potential for Listeria cross-
contamination in the retail environment. Approximately $700,000 will be 
available in FY 2001. FDA anticipates making up to four awards of 
$100,000 to $200,000 (direct plus indirect costs) per award per year. 
Support of these agreements may be up to 3 years. Budgets for all years 
requested may not exceed $200,000 (direct plus indirect costs). Any 
application received that exceeds this amount will not be considered 
responsive and will be returned to the applicant without being 
reviewed. The number of agreements funded will depend on the quality of 
the applications received and the availability of Federal funds to 
support the projects. After the first year, additional years of 
noncompetitive support are predicated upon performance and the 
availability of Federal funds.

DATES: Submit applications by July 5, 2001.

ADDRESSES: Completed applications should be submitted to: Maura C. 
Stephanos, Grants Management Specialist, Grants Management Staff (HFA-
520), Division of Contracts and Procurement Management, Food and Drug 
Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 20857, 301-
827-7183, FAX 301-827-7106, e-mail: [email protected]. (Applications 
hand-carried or commercially delivered should be addressed to rm. 2129, 
5630 Fishers Lane, Rockville, MD 20857).
    Application forms are available either from Maura C. Stephanos 
(address above) or via the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. NOTE: Do not send applications to the 
Center for Scientific Research (CSR), National Institutes of Health 
(NIH).

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Maura C. Stephanos (address above).
    Regarding the programmatic aspects of this notice: John W. Newland, 
Microbial Research Coordinator, Office of Science (HFS-32), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-260-0536, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 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.
    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.
    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 
(ODPHP) Communication Support Center (Center), P.O. Box 37366, 
Washington, DC 20013-7366. Each of the 28 chapters of ``Healthy People 
2010'' is priced at $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 is available 
as well on the Internet at http://health.gov/healthypeople. Internet 
viewers should proceed to ``Publications.''

I. Background

    FDA is committed to reducing the incidence of foodborne illness to 
the greatest extent feasible. Research in food safety seeks to reduce 
the incidence of foodborne illness by improving our ability to detect 
and enumerate pathogens in the food supply and to find new and improved 
ways to control them. The Center for Food Safety and Applied Nutrition 
(CFSAN) supports multiyear cooperative agreements intended to help 
achieve the goal of reducing the incidence of foodborne illness. 
President Clinton's food safety initiative (FSI) inaugurated this 
extramural program that supports a novel collaborative research effort 
between CFSAN and academic scientists, and leveraged expertise not 
found within FDA, 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 CFSAN/FSI will provide FY 2001 funds 
to be used for research to help ensure the agency has the following 
capacities: To detect the presence of human pathogens that may become 
present in FDA regulated products; to more fully understand how 
consumer practices in the handling of ready-to-eat food products may 
affect their microbiological safety; to obtain a more precise 
understanding of the potential for cross contamination by Listeria 
monocytogenes between foods and food contact surfaces; and to 
understand mechanisms of microbial contamination of agricultural water 
that subsequently result in the occurrence of pathogens on raw produce.

II. Research Goals and Objectives

    Proposed projects designed to fulfill the specific objectives of 
any one of the following requested projects will be considered for 
funding. Applications may address only one project and its objectives 
per application. However, applicants may submit more than one 
application for more than one project. The projects and their 
objectives are as follows.

A. Project 1: Analytical Detection of Bovine Spongiform Encephalopathy 
and Other Transmissible Spongiform Encephalopathies (BSE/TSE) in 
Products Regulated by CFSAN

    The objective of this project is the development of a practical 
analytical technique for the detection of the BSE/TSE infective agent 
in products regulated by CFSAN (i.e., foods, including infant formula, 
dietary supplements, and cosmetics). Diagnostic tests to detect the 
BSE/TSE infective agent in a variety of FDA regulated products are 
currently unavailable. FDA's high priority products include milk and 
dairy products, food grade gelatin, dietary supplements, and foods 
containing beef at less than 3 percent. This research will provide 
detection methodology critical to support food surveillance programs 
designed to keep BSE and other TSEs out of U.S. foods, cosmetics, and 
dietary supplements.

[[Page 27978]]

B. Project 2: Consumer Refrigeration Storage Length Practices for 
Unopened and Opened Packages of Ready-to-Eat Foods

    The objective of this project is to understand more fully how 
consumer practices in the handling of ready-to-eat food products may 
affect the microbiological safety of these foods. Values that were used 
in the Department of Health and Human Services (DHHS)/U.S. Department 
of Agriculture (USDA) draft Listeria monocytogenes risk assessment to 
estimate time of storage in the home before consumption were largely 
based on expert opinion. The agency seeks to improve the estimates of 
risk associated with consumer storage practices through survey data on 
the storage of ready-to-eat foods (as specified in the draft risk 
assessment, see http://www.foodsafety.gov) in home refrigerators. 
Proposed investigations should focus on the duration of refrigerated 
storage of unopened and opened food packages of ready-to-eat foods.

C. Project 3: Microbial Contamination of Agricultural Water

    The objective of this project is to understand mechanisms of 
microbial contamination of agricultural water that subsequently result 
in the occurrence of pathogens on raw produce. In produce-related 
outbreak investigations and produce pathogen surveys agricultural water 
quality has been repeatedly identified as a potential source of 
microbial pathogen contamination. Farm investigations have found 
examples where water used for agriculture purposes was contaminated by 
raw human or animal waste. There are no guidelines for microbiological 
criteria for water used in agriculture. Research must specifically 
focus on characterizing the role of agricultural water on pathogen (and 
possibly fecal indicator) occurrence, survival, propagation, and 
attachment to raw produce. The effects of farm production practices, 
such as spray and furrow irrigation and pesticide applications, on 
microbial pathogen occurrence, survival, propagation, and attachment 
should also be addressed. Applications should include the following 
pathogens of concern, Salmonella, Shigella, Escherichia coli O157:H7, 
and Cyclospora.

D. Project 4: Transfer Coefficients to Describe the Potential for 
Listeria Cross-Contamination in the Retail Environment

    The objective of this project is to quantify the potential for 
Listeria cross-contamination in the retail environment. The presence of 
Listeria in ready-to-eat foods is well established. Specific 
information is lacking, however, about the mechanism(s) and frequency 
of cross-contamination within the retail and food service environment, 
especially in food preparation and dispensing areas. Information is 
needed about the potential for transfer from microbially contaminated 
food to soiled and unsoiled surfaces, from microbially contaminated 
surfaces (soiled and unsoiled) to food, and the potential involvement 
of surface biofilms on cross-contamination potential. Specifically, 
this transfer potential should be quantified and expressed as transfer 
coefficients that apply to Listeria cross contamination that occurs 
within the retail environment.

III. Human Subject Protection and Informed Consent

A. Protection of Human Research Subjects

    Some activities carried out by a recipient under this announcement 
may be governed by DHHS regulations for the protection of human 
research subjects (45 CFR part 46), as well as by the FDA Risk in Human 
Subjects Committee (RIHSC) (21 CFR parts 50 and 56). These regulations 
require recipients to establish procedures for the protection of 
subjects involved in any research activities. Prior to funding and upon 
request of the Office for Human Research Protection (OHRP) (formerly 
the Office for Protection from Research Risks (OPRR), prospective 
recipients must have on file with OHRP an assurance to comply with 45 
CFR part 46. This assurance to comply is called an assurance document. 
It includes the designated institutional review board (IRB) for review 
and approval of procedures for carrying out any research activities 
occurring in conjunction with this award. If an applicable assurance 
document for the applicant is not already on file with OHRP, a formal 
request for the required assurance will be issued by OHRP at an 
appropriate point in the review process, prior to award, and examples 
of required materials will be supplied at that time. No applicant or 
performance site without an approved and applicable assurance on file 
with OHRP may spend funds on human subject activities or accrue 
subjects. No performance site, even with an OHPR-approved and 
applicable assurance, may proceed without approval by OHRP of an 
applicable assurance for the recipients. Applicants may wish to visit 
the OHRP website at http://ohrp.osophs.dhhs.gov to obtain preliminary 
guidance on human subject issues. Applicants wishing to contact OHRP 
should provide their institutional affiliation, geographic location, 
and all available request for applications (RFA) citation information.
    Applicants are advised that the section on human subjects in the 
application kit entitled ``Section C. Specific Instructions--Forms, 
Item 4, Human Subjects,'' on pages 7 and 8 of the application kit, 
should be carefully reviewed for the certification of IRB approval 
requirements. Documentation of IRB approval for every participating 
center is required to be on file with the grants management officer, 
FDA. The goal should be to include enough information on the protection 
of human subjects in a sufficiently clear fashion so reviewers will 
have adequate material to make a complete review. Those approved 
applicants who do not have a current multiple project assurance with 
OHRP will be required to obtain a single project assurance from OHRP 
prior to award.

B. Informed Consent

    Consent and/or assent forms, and any additional information to be 
given to a subject, should accompany the application. Information that 
is given to the subject or the subject's representative must be in 
language that the subject or his or her representative can understand. 
No informed consent, whether oral or written, may include any language 
through which the subject or the subject's representative is made to 
waive any of the subject's legal rights, or by which the subject or 
representative releases or appears to release the investigator, the 
sponsor, or the institution or its agent from liability.
    If a study involves both adults and children, separate consent 
forms should be provided for the adults and the parents or guardians of 
the children.

C. Elements of Informed Consent

    The regulations on informed consent are set forth in 45 CFR 46.116 
and 21 CFR 50.25. The basic elements of informed consent are as 
follows:
1. Basic Elements of Informed Consent
    In seeking informed consent, the following information shall be 
provided to each subject:
     A statement that the study involves research, an 
explanation of the purposes

[[Page 27979]]

of the research and the expected duration of the subject's 
participation, a description of the procedures to be followed, and 
identification of any procedures which are experimental.
     A description of any reasonably foreseeable risks or 
discomforts to the subject.
     A description of any benefits to the subject or to others 
which may reasonably be expected from the research.
     A disclosure of appropriate alternative procedures or 
courses of treatment, if any, that might be advantageous to the 
subject.
     A statement that describes the extent, if any, to which 
confidentiality of records identifying the subject will be maintained, 
and that notes the possibility that FDA may inspect the records.
     For research involving more than minimal risk, an 
explanation as to whether any compensation and any medical treatments 
are available if injury occurs and, if so, what they consist of or 
where further information may be obtained.
     An explanation of whom to contact for answers to pertinent 
questions about the research and research subject's rights, and whom to 
contact in the event of research-related injury to the subject.
     A statement that participation is voluntary, that refusal 
to participate will involve no penalty or loss of benefits to which the 
subject is otherwise entitled, and that the subject may discontinue 
participation at any time without penalty or loss of benefits to which 
the subject is otherwise entitled.
2. Additional Elements of Informed Consent
    When appropriate, one or more of the following elements of 
information shall also be provided to each subject.
     A statement that the particular treatment or procedure may 
involve risks to the subject (or to the embryo or fetus, if the subject 
is or may become pregnant) which are currently unforeseeable.
     Anticipated circumstances under which the subject's 
participation may be terminated by the investigator without regard to 
the subject's consent.
     Any costs to the subject that may result from 
participation in the research.
     The consequences of a subject's decision to withdraw from 
the research and procedures for orderly termination of participation by 
the subject.
     A statement that significant new findings developed during 
the course of the research that may relate to the subject's willingness 
to continue participation will be provided to the subject.
     The approximate number of subjects involved in the study.
     The informed consent requirements are not intended to 
preempt any applicable Federal, State, or local laws which require 
additional information to be disclosed for informed consent to be 
legally effective.
     Nothing in the notice is intended to limit the authority 
of a physician to provide emergency medical care to the extent that a 
physician is permitted to do so under applicable Federal, State, or 
local law.

IV. 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 
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 public or private 
nonprofit entity (including State and local units of government) and 
any 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 3 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.

V. 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 (address same as given above for grants management 
specialist) 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 and 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 recorded in an official file specific for each cooperative 
agreement and may be available to the recipient of the cooperative 
agreement upon request.

VI. 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 includes 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

[[Page 27980]]

design, data analysis, interpretation of findings, coauthorship of 
publications and the development and filing of patents.

VII. 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. 
Applications will be considered not responsive if they are not in 
compliance with sections VII.B and VIII of this document. 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/her 
designee.

B. Review Criteria

    Applicants must clearly state in their application for which of the 
requested projects they are applying. Applications will be reviewed, 
and ranked. There is no assurance that awards will be made in all 
projects. Funding will start with the highest ranked application, and 
additional awards will be made based on the next highest ranking 
application, etc., until all available funds have been exhausted. All 
applications will be evaluated by program and grants management staff 
for responsiveness. Applicants are strongly encouraged to contact FDA 
to resolve any questions regarding criteria prior to the submission of 
their application. 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 at 
the beginning 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., biostatistics 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.

VIII. Submission Requirements

    The original and two copies of the completed grant application form 
PHS 398 (Rev. 4/98) 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 C. Stephanos 
(address above). State and local governments may choose to use the PHS 
398 application form in lieu of PHS 5161-1. The application receipt 
date is July 5, 2001. 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-01-3, Project 1, 2, 3 or 4.''

IX. 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.) Do not send applications to CSR, NIH. Any 
application that is sent to NIH, that 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 above. 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 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-01-3, Project 1, 2, 3, or 4. 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: May 15, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12623 Filed 5-18-01; 8:45 am]
BILLING CODE 4160-01-S