3720 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

State Food Safety Task Force

Meetings; Availability of Conference

Grants; Request for Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

anticipated availability of conference

grant funds for the support of State Food

Safety Task Force meetings contingent

on the availability of fiscal year (FY)

2000 funds. This initiative is intended

to support and encourage State food

regulatory agencies to establish (or

provide support of existing) regularly

scheduled Food Safety Task Force

meetings. These meetings should foster

communication and cooperation within

the State among State and local food

safety regulatory agencies and is part of

the President’s Food Safety Initiative

(FSI).

DATES: For States with existing State

Food Safety Task Forces, the lead/

champion/food regulatory agency must

submit applications by March 24, 2000.

For States in the process of developing

a State Food Safety Task Force, submit

applications by April 15, 2000. If the

closing date falls on a weekend, or the

date falls on a holiday, the date of

submission will be extended to the

following workday.

ADDRESSES: Application forms are

available from, and completed

applications should be submitted to

Cynthia M. Polit, Grants Management

Office, Division of Contracts and

Procurement Management (HFA–520),

Food and Drug Administration, 5600

Fishers Lane, rm. 2129, Rockville, MD

20857, 301–827–7180, e-mail:

cpolit@oc.fda.gov. Applications handcarried or commercially delivered

should be addressed to 5630 Fishers

Lane, rm. 2129, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of this

notice: Cynthia M. Polit (address above).

Regarding the programmatic aspects

of this notice: Paul M. Raynes, or Glenn

E. Johnson, Division of Federal-State

Relations (DFSR), Office of Regulatory

Affairs (ORA), Food and Drug

Administration (HFC–150), 5600 Fishers

Lane, rm. 12–07, Rockville, MD 20857,

301–827–6906, or access the Internet at

www.fda.gov/ora/fedlstate/

default.htm.

SUPPLEMENTARY INFORMATION: FDA will

support meetings covered by this notice

under section 1701 (300u-300u-5) of the

Public Health Service (PHS) Act (42

U.S.C. 241) or the Radiation Control for

Health and Safety Act of 1968 (Public

Law 90–602) (42 U.S.C. 263b-n). FDA’s

Conference Grant Program is described

in the Catalog of Federal Domestic

Assistance, No. 93–103 and applicants

are limited to State food safety

regulatory agencies. Applications

submitted under this program are

subject to the requirements of Executive

Order 12372. Requirements under the

original FDA request for applications for

its Conference Grant Program (52 FR

12257, April 15, 1987) apply. 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.

PHS urges applicants to submit

workplans that address specific

objectives of ‘‘Healthy People 2000.’’

Potential applicants may obtain a copy

of ‘‘Health People 2000’’ (Full Report,

stock No. 017–0010–0474–0) through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, 202–512–

1800.

I. Background

ORA is the inspection component of

FDA and has 1,000 investigators and

inspectors who cover the country’s

approximately 95,000 FDA-regulated

businesses. These investigators and

inspectors inspect more that 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 FSI,

the demands on both the agency and the

States will increase. Procedures need to

be reviewed and innovative changes

made that increase effectiveness and

efficiency and conserve resources. ORA

will support FSI by: (1) Providing

effective and efficient compliance of

regulated products, and (2) providing

high quality, science-based work that

maximizes consumer protection.

Under the FSI, FDA is encouraging

State food safety regulatory agencies to

establish (or provide support of existing)

regularly scheduled Food Safety Task

Force meetings. These meetings should

foster communication and cooperation

within the State among State and local

food safety regulatory agencies. The

purpose of the meetings should be to

discuss/resolve issues at the State and

local level relating to: (1) State/local

agency roles and responsibilities, (2)

capacity and resource needs, (3)

outbreak coordination and

investigations, (4) information sharing

and data collection, (5) uniform

regulatory standards, (6)

communications and education, (7)

State/local laboratory operations and

coordination, and (8) adoption/

implementation of the Food Code.

II. Project Goals, Definitions, and

Examples

The purpose of these meetings is to

foster communication and cooperation

within the State among State and local

food safety regulatory agencies. The

meetings should: (1) Provide a forum for

all the stakeholders of the food safety

initiative; (2) assist in adopting or

implementing the Food Code; and (3)

promote the integration of a Statewide

food safety system to become a cost

effective, efficient system to maximize

the protection of the public health.

Grant funds will be awarded for 1

year for direct costs only to secure

meeting facility rental/expenses and instate travel expenses for meeting

attendees during the 1-year period. FDA

and the U.S. Department of Agriculture

region/district representatives may be

invited to be a non-member liaison or

advisor at the meetings but the task

force should develop its own guidelines

for work, consensus decisionmaking,

size, and format at the initial meeting.

Conference grant funds may not be used

for Federal employees to travel to these

meetings.

DFSR will provide meeting guidelines

and other meeting organization

documents as requested. Information on

‘‘Productive Meeting Fundamentals’’ is

available via the Fax-on-Demand system

by calling 301–827–4352 and requesting

document #1606. A model partnership

agreement may be obtained from Faxon-Demand by requesting document

#1605. FDA encourages at least two

meetings a year for these task forces and

recommends one each quarter.

III. Reporting Requirements

A final Program Progress Report or

conference proceedings and a final

Financial Status Report (FSR) (SF–269)

are required within 90 days of the

expiration date of the project period as

noted on the Notice of Grant Award. An

original and two copies of each report

shall be submitted to FDA’s Grants

Management Office. Failure to file these

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices 3721

reports in a timely fashion may

jeopardize future grant support.

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 conference 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

also apply to this program and are

implemented through the U.S.

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

SPOC’s is included in the application

kit. The SPOC should send any State

review process recommendations to the

FDA Grants Management Office

(address above). The due date for the

State process recommendations is no

later than 60 days 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 cutoff.

B. Eligibility

These grants are available to State

food regulatory agencies (see section

IV.A of this document).

C. Length of Support

The length of support will be for 1

year from the date of issuance of the

award.

V. Review Procedure and Criteria

All applications submitted in

response to this 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.

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. Final funding

decisions will be made by the

Commissioner of Food and Drugs or 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 the ORA 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. Participant determination of the

size and membership of the meetings’

operating rules and goals in relation to

the mission and priorities of FDA;

2. Makeup of the participants to

include State and local food safety

agencies, industry, consumers,

legislators (State and local) and other

interested associations or groups.

Recommended attendance at meetings is

approximately 15 to 20 persons;

3. Information dissemination to

constituents regarding the existence of

the meetings and information regarding

the goals and outcomes;

4. Biannual or quarterly meetings as

necessary to accomplish the established

goals;

5. Yearly self-evaluation concerning

the progress toward achieving goals and

outcomes.

VI. Submission Requirements

The original and two copies of the

completed grant application Form PHS–

5161–1 (Revised 5/96) for State and

local governments should be delivered

to the Grants Management Office

(address above). The application receipt

date is March 24, 2000, for applicants

with an established task force and April

15, 2000, for applicants in the process

of developing a task force. 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

material or addenda will be accepted

after the receipt date.

The outside of the mailing package

and item 2 of the application facepage

should be labeled ‘‘Response to RFA–

FDA–ORA–00–1.’’

Note: A lead/champion/initiating State

food regulatory agency who will coordinate/

host and take the lead in establishing the

Food Safety Task Force must be determined

within the State prior to submission of an

application. That lead/champion/initiating

State food regulatory agency would prepare

and submit the application. Only one grant

will be awarded per State. Approximately

$250,000 will be available in FY 2000,

subject to the availability of funds. FDA

anticipates making awards, not to exceed

$5,000 in direct costs per award. 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 available to State food

regulatory agencies that have an existing

State Food Safety Task Force as well as State

food regulatory agencies that are in the

process of developing a State Food Safety

Task Force. The formation of these Food

Safety Task Force meetings will not interfere

with existing advisory mechanisms within

the Federal/State/local system and is not a

mandatory requirement of FDA.

VII. Method of Application

A. Submission Instructions

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 nonresponsive and returned to

the applicant. Instructions for

completing the application are included

in Form PHS–5161–1. FDA is unable to

receive applications via the Internet.

B. Format for Application

When using Form PHS 5161–1

(Revised 5/96), all instructions for the

enclosed Standard Form 424 (SF424)

should be followed using the

nonconstruction application pages. The

facepage of the application should be

labeled ‘‘RFA–FDA–ORA–00–1.’’

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 the Office of

Management and Budget Circular A–

102.

3722 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Notices

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

an application that 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: January 12, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1539 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Allergenic Products Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Allergenic

Products Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on February 10, 2000, 8:30 a.m. to

3:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: William Freas or

Pearline K. Muckelvene, Center for

Biologics Evaluation and Research

(HFM–71), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12388. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will receive

an update on the organizational changes

of the Laboratory of

Immunobiochemistry, its regulatory

activities (including reference

replacements and lot release statistics)

and its research activities. The

committee will hear presentations and

discuss the following regulatory issues:

(1) Potency limits for standardized

allergen vaccines, (2) selection of

allergen extracts for standardization,

and (3) a proposed algorithm for the

standardization of new allergens.

Procedure: On February 10, 2000,

from 8:30 a.m. to 3:30 p.m., the meeting

is open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by January 26, 2000. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before February 3, 2000, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 11, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–1543 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0132]

FDA Modernization Act of 1997;

Guidance on Medical Device Tracking;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the revised guidance

document entitled ‘‘Guidance on

Medical Device Tracking.’’ This

guidance document, which replaces the

previous guidance issued on February

12, 1999, provides guidelines to

manufacturers and distributors

concerning their responsibilities for

medical device tracking under the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA).

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

guidance document entitled ‘‘Guidance

on Medical Device Tracking’’ to the

Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Submit

written comments on ‘‘Guidance on

Medical Device Tracking’’ to the contact

person (address below). See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Chester T. Reynolds, Center for Devices

and Radiological Health (HFZ–300),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

594–4618.

SUPPLEMENTARY INFORMATION:

I. Background

Section 211 of FDAMA (Public Law

105–115) amended the tracking

provisions of section 519(e) of the act

(21 U.S.C. 360i(e)) to authorize FDA, at

its discretion, to issue orders that

require a manufacturer to track a class

II or class III device if: (1) The failure

of the device would be reasonably likely

to have serious adverse health

consequences; (2) the device is intended

to be implanted in the body for more

than 1 year; or (3) the device is life

sustaining or life supporting and used

outside a device user facility. The

FDAMA tracking provisions became

effective on February 19, 1998.

The revised final guidance replaces

the February 1999 guidance and

clarifies the devices that must be

tracked. Agency experience indicates

that industry and other interested

parties are confused about the term

‘‘replacement heart valves’’ because

there is more than one type. The

category of replacement heart valves

that must be tracked is limited to

mechanical heart valves only and does

not include human allograft (tissue)

heart valves. The revised guidance

document includes this descriptive

limitation.

Agency experience also indicates that

industry and other interested parties are

confused about which infusion pumps

are subject to medical device tracking

because the types of fluids the pumps

are intended to deliver may not be clear

from indications for use set out in

labeling. The previous guidance stated

that infusion pumps, except those

designated and labeled for use