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

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices 27981

announcing the availability of grant

funds for the support of an innovative

food safety program. Approximately

$200,000 will be available in fiscal year

2001. FDA anticipates making at least

four awards, not to exceed $50,000

(direct and indirect costs combined) per

award per year. Support of these grants

will be for 1 year. The number of grants

funded will depend on the quality of the

applications received and the

availability of Federal funds to support

the grant. These grants are not intended

to fund or conduct food inspections.

DATES: Submit applications by July 5,

2001.

ADDRESSES: Application forms are

available from, and completed

applications should be submitted to

Cynthia M. Polit, Grants Management

Office, Food and Drug Administration

(HFA–520), 5600 Fishers Lane, rm.

2129, Rockville, MD 20857, 301–827–

7180, e-mail: cpolit@oc.fda.gov.

Applications hand-carried or

commercially delivered should be

addressed to 5630 Fishers Lane, rm.

2129, Rockville, MD 20857. Application

forms PHS–5161–1 (7/00) are available

via the Internet at: http://www.psc.gov/

forms (revised 7/00).

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Cynthia M. Polit

(address and telephone number

given above).

Regarding the programmatic aspects

of this notice: Paul M. Raynes or

Anne Hope Scott, Division of

Federal-State Relations (HFC–150),

Office of Regulatory Affairs, Food

and Drug Administration, 5600

Fishers Lane, rm. 12–07, Rockville,

MD 20857, 301–827–6906. Internet

site: http://www.fda.gov/ora/

fedlstate/default.htm.

SUPPLEMENTARY INFORMATION:

I. Introduction

FDA will support projects covered by

this notice under section 1701 [300u] of

the Public Health Service Act (42 U.S.C.

241). FDA’s project program is

described in the Catalog of Federal

Domestic Assistance, No. 93.245 and

applicants are limited to food safety

regulatory agencies of State and local

governments. FDA strongly encourages

all award recipients to provide a smokefree workplace and to discourage the

use of all tobacco products. This is

consistent with the FDA mission to

protect and advance the physical and

mental health of the American people.

FDA urges applicants to submit work

plans that address specific objectives of

‘‘Healthy People 2010.’’ Potential

applicants may obtain a copy of

‘‘Healthy People 2010’’ (full report,

stock No. 017–001–00547–9) through

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, 202–512–

1800.

II. Background

ORA is the inspection component of

FDA and has some 1,100 investigators

and inspectors who cover the country’s

approximately 95,000 FDA-regulated

businesses. These investigators inspect

more than 15,000 facilities a year. In

addition to the standard inspection

program, they conduct special

investigations, food inspection recall

audits, perform consumer complaint

inspections and sample collections.

FDA has relied on the States in assisting

with the above duties through formal

contracts, partnership agreements, and

other informal arrangements. Under the

Food Safety Initiative (FSI), the

demands on both the agency and the

States will increase. Procedures need to

be reviewed and innovative changes

made that will increase effectiveness

and efficiency and conserve resources.

ORA will support FSI by providing: (1)

Effective and efficient compliance of

regulatory products, and (2) high

quality, science-based work that results

in maximizing consumer protection.

Under FSI, FDA is mandated to

develop innovative food safety programs

that would be utilized nationally by

State and local food safety regulatory

agencies. Even though the American

food supply is among the safest in the

world, millions of Americans are

stricken by illness each year caused by

the food they consume, and some 7,000

Americans a year, primarily the very

young and elderly, die as a result. The

goal of FSI is to further reduce the

incidence of foodborne disease to the

greatest extent possible. Innovative food

safety programs that are developed at

the State and local levels and have

national implication could enhance

programs that are developed at the

Federal level.

A. Project Goals, Definitions, and

Examples

The specific objective of this program

will be to complement, develop, or

improve State and local food safety

programs that would have applicability

to food safety programs nationwide.

Applications that fulfill the following

specific project objectives will be

considered for funding. Each

application must address only one

project. Applicants may apply for more

than one project area, but must submit

a separate application for each project.

These grants are not to fund or conduct

food inspections for food safety

regulatory agencies. Applications

relating to the retail food program area

should be applicable to program

improvement processes for FDA’s draft

entitled ‘‘Recommended National Retail

Food Regulatory Program Standards’’

(http://vm.cfsan.fda.gov/dms/rettoc.html) (see review criteria).

There are two key project areas

identified for this effort:

1. Inspection

Development of innovative regulatory

inspection methods or techniques for

the inspection process of various food

establishments in order to improve

effectiveness and efficiency. Innovative

regulatory program methodology

projects must demonstrate an effect on

factors which contribute to foodborne

illness in all, or a segment of, food

industry programs. For example,

projects could address key elements

from the draft entitled ‘‘Recommended

National Retail Food Regulatory

Program Standards,’’ such as the five

Food Code interventions (management

knowledge, employee health, hands as a

vehicle of contamination, time/

temperature relationships, and

consumer advisory), or the five Centers

for Disease Control and Prevention risk

factors (improper holding temperature,

inadequate cooking, contaminated

equipment, unsafe source, and poor

personal hygiene). Other examples of

projects in this area could include

prevention and control of Listeria

monocytogenes in retail and food

service environments and projects that

address shell egg safety, such as

refrigeration, safe handling, or labeling.

The goal of these projects should be to

achieve efficient and effective

compliance with regulations that impact

contributing factors to foodborne illness.

2. Education and Health Information

Dissemination

Development of innovative education

projects and materials for State and

local food safety regulatory officials that

foster consistency and uniform

application of State and local food

regulations. These education projects

and/or materials must be reproducible

by other State and local food safety

regulatory agencies. These projects may

incorporate concurrent education of

both State and local food safety

regulatory agencies and the food

industry.

B. Applicability

All grant application projects that are

developed at State and local levels must

have national implication or application

27982 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices

that can enhance Federal, State, and

local food regulatory programs and

reduce factors that cause foodborne

illness. At the discretion of FDA,

successful project formats will be made

available to interested Federal, State,

and local food safety regulatory

agencies. No grant will be awarded for

projects that do not support the FDA

Food Code.

III. Reporting Requirements

Semiannual progress reports as well

as a final program progress report and

a final financial status report (FSR) (SF–

269) are required. An original FSR and

two copies shall be submitted to FDA’s

grants management officer within 90

days of the expiration date of the grant.

The final program progress report must

provide full written documentation of

the project, copies of any results, as

described in the grant application, and

an analysis and evaluation of the results

of the project. The documentation must

be in a form and contain sufficient

detail that other State and local food

safety regulatory agencies could

reproduce the final project.

Program monitoring of recipients will

be conducted on an ongoing basis and

written reports will be reviewed and

evaluated at least semiannually by the

project officer. 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. The results of

these monitoring activities will be duly

recorded in the official file and may be

available to the recipient upon request.

IV. Mechanism of Support

A. Award Instrument

Support for this program will be in

the form of a grant. These grants will be

subject to all policies and requirements

that govern the project grant programs of

FDA, including the provisions of 42

CFR part 52 and 45 CFR parts 74 and

92. The regulations issued under

Executive Order 12372 also apply to this

program and are implemented through

Department of Health and Human

Services (DHHS) regulations at 45 CFR

part 100. Executive Order 12372 sets up

a system for State and local government

review of applications for Federal

financial assistance. Applicants (other

than federally recognized Indian tribal

governments) should contact the State’s

single point of contact (SPOC) as early

as possible to alert them to the

prospective application(s) and to receive

any necessary instructions on the State’s

review process. A current listing of

SPOCs is included in the application

kit. The SPOC should send any State

review process recommendations to

FDA’s administrative contact (address

listed above). The due date for the State

process recommendations is no later

than 60days after the deadline date for

the receipt of applications. FDA does

not guarantee to accommodate or

explain SPOC comments that are

received after the 60-day cut-off.

B. Eligibility

This grant program is only available

to State and local government food

regulatory agencies and federally

recognized Indian tribal governments.

(See SPOC requirements stated in

section IV. A of this document.)

C. Length of Support

The length of support will be for 1

year from date of award.

V. Review Procedure and Criteria

All applications submitted in

response to this request for application

(RFA) will first be reviewed by grants

management and program staff for

responsiveness. If applications are

found to be nonresponsive, they will be

returned to the applicant without

further consideration. An application

will be considered nonresponsive if any

of the following criteria are not met: (1)

If it is received after the specified

receipt date; (2) if the total dollar

amount requested exceeds $50,000; (3)

if all required signatures are not on the

face page or assurance pages of the

application; (4) if there is no original

signature copy; (5) if it is illegible; (6)

if the material presented is insufficient

to permit an adequate review; or (7) if

the application demonstrates an

inadequate understanding of the intent

of the RFA.

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. Applications will

be considered for funding on the basis

of their overall technical merit as

determined through the review process.

Other award criteria will include

availability of funds and overall

program balance in terms of geography.

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.

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

programmatic nature must be directed

to ORA’s program staff (address above)

and all questions of an administrative or

financial nature must be directed to the

grants management staff (address

above). Applications will be given an

overall score and judged based on all of

the following criteria:

1. Applications relating to the retail

food program (http://vm.cfsan.fda.gov/

dms/ret-toc.html) only: The outcomes of

the project should be applicable to

program improvement process for FDA’s

draft entitled ‘‘Recommended National

Retail Food Regulatory Program

Standards’’ (http://vm.cfsan.fda.gov/

dms/ret-toc.html). These standards will

serve as a guide to regulatory retail food

program managers for the design and

management of a regulatory retail food

program. The standards apply to the

operation, management, and promotion

of a regulatory retail food program

focused on the reduction of risk factors

known and suspected to cause

foodborne illness. FDA’s draft entitled

‘‘Recommended National Retail Food

Regulatory Program Standards’’ is found

on the Internet site at http://

www.cfsan.fda.gov/dms/ret-toc.html or

contact your local FDA regional retail

food specialist from the list provided in

the application packet.

2. Application budgets must remain

within the $50,000 cap for combined

direct and indirect costs. Applications

exceeding this dollar amount will be

returned as nonresponsive.

3. Applications must provide in

detail, a sound rationale and

appropriate grant design to address the

objectives of RFA and the project must

be reproducible within the national

regulatory framework.

4. Applications must include a

detailed explanation of the desired goals

and outcomes of the project.

5. Applications must include a full

description of the project design, a

detailed implementation plan, methods

of execution, and timeline for

completion. The application must

include a detailed description of

measures of effectiveness and a

description of the source documents or

data collection methods for establishing

the baseline for measurement.

6. Applications must address the

adequacy of facilities, expertise of

project staff, equipment, databases, and

support services needed for the project.

VI. Submission Requirements

The original and two copies of the

completed grant application form PHS–

5161–1 (revised 7/00) for State and local

governments, with copies of the

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices 27983

appendices for each of the copies,

should be delivered to Cynthia M. Polit

(address above). The application receipt

date is July 5, 2001. If the receipt date

falls on a weekend, or if the date falls

on a holiday, the date of submission

will be extended to the following

workday. 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–ORA–01–Project I’’ or ‘‘RFA–

FDA–ORA–01–Project II.’’ Submit only

one project application (an original and

two copies) per package.

VII. Method of Application

A. Submission Instructions

Each application must be submitted

under separate cover. Do NOT submit

more than one application (with copies)

per envelope. Applications will be

accepted during working 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 the Center

for Scientific Research, National

Institutes of Health (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 unresponsive and returned to

the applicant. Instructions for

completing the application are included

in form PHS–5161–1. FDA is unable to

receive applications via Internet.

B. Format for Application

Submission of the application must be

on grant application form PHS 5161–1

(revised 7/00). All instructions for the

enclosed Standard Form 424 (SF–424)

should be followed using the

nonconstruction application pages.

The face page of the application

should indicate ‘‘RFA–FDA–ORA–01–

Project I,’’ or ‘‘RFA–FDA–ORA–01–

Project II.’’

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 (FOIA) (5 U.S.C. 552(b)(4)) and

FDA’s implementing regulations (21

CFR 20.61).

Information collection requirements

requested on PHS Form 5161–1 were

approved and issued under Office of

Management and Budget Circular A–

102.

C. Legend

Unless disclosure is required by FOIA

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 which have been

specifically identified by page number,

paragraph, etc., by the applicant as

containing restricted and/or proprietary

information shall not be used or

disclosed except for evaluation

purposes.

Dated: May 15, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12626 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0103]

Issues Associated With the

Intersection of 180-Day Generic Drug

Exclusivity and Pediatric Exclusivity;

Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is establishing the

public docket identified in brackets in

the heading of this document to receive

comments related to the interpretation

of provisions of the Federal Food, Drug,

and Cosmetic Act (the act) and

regulations governing the intersection of

180-day generic drug exclusivity and

pediatric exclusivity. To date, there has

not been a situation where pediatric

exclusivity and 180-day generic

exclusivity have actually overlapped.

However, FDA has received a large

number of inquiries about its

interpretation of these provisions and,

therefore, is establishing this docket to

give the public an opportunity to

comment on these issues.

DATES: Submit written or electronic

comments by June 20, 2001.

ADDRESSES: Submit electronic

comments to http://www.fda.gov/

ohrms/dockets/default.htm. Submit

written comments to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT: Rose

Cunningham, Center for Drug

Evaluation and Research (HFD–6), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5468, FAX 301–594–5493.

SUPPLEMENTARY INFORMATION:

I. Background

Recently FDA has been asked to

evaluate the intersection of 180-day

generic drug exclusivity and pediatric

exclusivity, specifically with respect to

whether the exclusivity periods should

run concurrently or consecutively. FDA

has received written correspondence

and telephone inquiries from

pharmaceutical firms, organizations,

individuals, and members of Congress

concerning FDA’s interpretation of these

provisions. FDA is seeking broader

public comment on the intersection of

these two statutory provisions.

The 180-day generic drug exclusivity

provision was created by the 1984 Drug

Price Competition and Patent Term

Restoration Act (also known as the

Hatch-Waxman Amendments), enacted

on September 24, 1984. This provision,

contained in section 505(j)(5)(B)(iv) of

the act (21 U.S.C. 355(j)(5)(B)(iv)),

provides an incentive for generic drug

applicants to challenge innovator patent

claims and thereby speed the entry of

generic competition onto the market.

This benefit is available to the first

abbreviated new drug application

(ANDA) received that is a substantially

complete application that contains a

‘‘paragraph IV’’ certification. This type

of certification states the ANDA

applicant’s belief that a patent listed for

the innovator drug is invalid or

unenforceable or that the ANDA

product seeking approval will not

infringe a listed patent. Under the terms

of the statute, 180-day generic drug

exclusivity is triggered by and begins to

run from either: (1) A court decision

finding the challenged patent invalid,

unenforceable, or not infringed; or (2)

the date of first commercial marketing of

the ANDA drug product, whichever is

earlier. During the 180-day generic drug

exclusivity period, FDA is prohibited