27976 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices

collection of information upon the

respondents, including the use of

automated collection techniques or

other forms of information technology.

Comments submitted in response to

this notice will be summarized and

included in the request for OMB

approval of the proposed information

collection. All comments will become a

matter of public record.

Copies of these proposed collection

plans and instruments can be obtained

from the AHRQ Reports Clearance

Officer (see above).

Dated: May 10, 2001.

John M. Eisenberg,

Director.

[FR Doc. 01–12754 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Healthcare Research and

Quality

Notice of Meetings

In accordance with section 10(d) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2), announcement is

made of Special Emphasis Panel

meetings.

A Special Emphasis Panel (SEP) is a

committee of experts selected to

conduct scientific reviews of

applications related to their areas of

expertise. The committee members are

drawn from a list of experts designated

to serve for particular individual

meetings rather than for extended fixed

terms of services

Substantial segments of the upcoming

SEP meetings listed below will be

closed to the public in accordance with

the Federal Advisory Committee Act,

section 10(d) of 5 U.S.C., Appendix 2

and 5 U.S.C., 552b(c)(6). Grant

applications are to be reviewed and

discussed at these meetings. These

discussions are likely to include

personal information concerning

individuals associated with these

applications. This information is

exempt from mandatory disclosure

under the above-cited statutes.

1. Name of SEP: Centers of Excellence

for Patient Safety Research and Practice.

Date: June 18–19, 2001 (Open on June

18 from 8 a.m. to 8:15 a.m. and closed

for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

2. Name of SEP: Developmental

Centers for Evaluation and Research in

Patient Safety.

Date: June 20–21, 2001 (Open on June

20 from 8 a.m. to 8:15 a.m. and closed

for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

3. Name of SEP: Primary Care PBRN:

Competitive Continuations.

Date: July 13, 2001 (Open on July 13

from 8 a.m. to 8:15 a.m. and closed for

remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

4. Name of SEP: Building Research

Infrastructure and Capacity (BRIC)

Program.

Date: July 30–31, 2001 (Open on July

30 from 8 a.m. to 8:15 a.m. and closed

for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

5. Name of SEP: Clinical Informatics

to Promote Patient Safety RFA.

Date: August 2–3, 2001 (Open on

August 2 from 8 a.m. to 8:15 a.m. and

closed for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

6. Name of SEP: Improving Patient

Safety: Health Systems Reporting,

Analysis and Safety Improvement

Research Demonstrations.

Date: August 6–7, 2001 (Open on

August 6 from 8 a.m. to 8:15 a.m. and

closed for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

7. Name of SEP: Patient Safety

Research Dissemination and Education.

Date: August 16–17, 2001 (Open on

August 16 from 8 a.m. to 8:15 a.m. and

closed for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

8. Name of SEP: The Effect of Health

Care Working Conditions on Quality of

Care.

Date: August 23–24, 2001 (Open on

August 23 from 8 a.m. to 8:15 a.m. and

closed for remainder of the meeting).

Place: Four Point Sheraton Hotel,

8400 Wisconsin Avenue, Conference

Room TBD, Bethesda, Maryland 20814.

Contact Person: Anyone wishing to

obtain a roster of members of minutes of

these meetings should contact Ms. Jenny

Griffith, Committee management

Officer, Office of Research Review,

Education and Policy, AHRQ, 2101 East

Jefferson Street, Suite 400, Rockville,

Maryland 20852, Telephone (301) 594–

1847.

Agenda items for these meetings are

subject to change as priorities dictate.

Dated: May 14, 2001.

John M. Eisenberg,

Director.

[FR Doc. 01–12753 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Notice of Award of Non-Competitive

Grant

AGENCY: Administration on Children,

Youth and Families (ACYF)

Administration for Children and

Families (ACF), Department of Health

and Human Services.

ACTION: Notice.

SUMMARY: Notice is hereby given that

ACYF will award grant funds without

competition to Western Kentucky

University Head Start Quality

Improvement Center (QIC) in the

amount of $300,000. This award is made

to the QIC to further the provision of

technical assistance services nationally

to grantees and regional offices when

they undertake the purchase,

construction or major renovation of

Head Start program facilities. The award

will be made for the budget period

beginning September 1, 2001 for a

twelve month period, under existing

grant award 90YQ0016.

Authority: This award will be made

pursuant to the Head Start Act, amended, 42

U.S.C. 9801 et seq. (CFDA 93.600)

FOR FURTHER INFORMATION CONTACT:

Douglas Klafehn, Acting Associate

Commissioner, Head Start Bureau,

Administration for Children, Youth and

Families, 330 C Street SW, Washington,

D.C. 20447; (202) 205–8572.

Dated: May 15, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–12684 Filed 5–18–01; 8:45 am]

BILLING CODE 4184–01–M

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.

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices 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 FDAregulated 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 crosscontamination 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, email: mstepha1@oc.fda.gov.

(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:

john.newland@cfsan.fda.gov.

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.

27978 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices

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-toeat 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 producerelated 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 CrossContamination in the Retail

Environment

The objective of this project is to

quantify the potential for Listeria crosscontamination 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

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices 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 forprofit 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

27980 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Innovative Food Safety Projects;

Availability of Grants; Request for

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Office of

Regulatory Affairs (ORA), Division of

Federal-State Relations (DFSR) is