43170 Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Notices

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Food Safety Survey

Under section 903(b)(2) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

393(b)(2)), FDA is authorized to conduct

research relating to foods and to

conduct educational and public

information programs relating to the

safety of the nation’s food supply. FDA

is planning to conduct a consumer

survey about food safety under this

authority. The food safety survey will

provide information about consumers’

food safety awareness, knowledge,

concerns, and practices. A nationally

representative sample of 2,000 adults in

households with telephones and

cooking facilities will be selected at

random and interviewed by telephone.

Participation will be voluntary. Detailed

information will be obtained about risk

perception, perceived sources of food

contamination, knowledge of particular

micro-organisms, safe care label use,

food handling practices, consumption of

raw foods from animals, information

sources, and perceived foodborne

illness experience. Most of the questions

asked are identical to ones asked in a

1992–1993 survey so that changes over

this time period can be assessed.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

2,000 1 2,000 .5 1,000

There are no operating and maintenance costs or capital costs associated with this information collection.

This will be a one-time survey. The

burden estimate is based on FDA’s

experience with the 1992–1993 survey

mentioned previously.

Dated: August 6, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21293 Filed 8–11–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[FDA–225–97–4000]

Memorandum of Understanding

Between the Food and Drug

Administration and the Department of

Defense

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of a memorandum of

understanding (MOU) between the FDA

and the Department of Defense (DoD).

The purpose of the MOU is for FDA to

provide the quality assurance support

for DoD centrally managed contracts for

drugs, biologics, and medical devices.

This MOU supersedes the agreement

concerning drugs and biologics, dated

December 17, 1975, and the agreement

concerning devices, dated December 23,

1981.

DATES: The agreement became effective

January 14, 1997.

FOR FURTHER INFORMATION CONTACT: Paul

Donnelly, Medical Products Quality

Assurance Staff, Office of Regulatory

Affairs (HFC–240), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–0383.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and MOU’s between FDA and others

shall be published in the Federal

Register, the agency is publishing notice

of an MOU.

Dated: August 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

Memorandum of Understanding Quality

Assurance Support for Medical Products

Between the Department of Defense and the

Food and Drug Administration

I. Purpose

To formalize a memorandum of

understanding (MOU) between the

Department of Defense (DoD) and the Food

and Drug Administration (FDA) whereby

FDA provides the quality assurance support

for DoD centrally managed contracts for

drugs, biologics, and medical devices

(hereinafter referred to as medical products),

as defined by the Federal Food, Drug and

Cosmetic Act (FDC Act), as amended, 21

U.S.C. 301 et seq. (1972 & Supp. 1979). This

agreement supersedes the two currently

effective agreements, the drug agreement

dated 12/17/75 and the device agreement

dated 12/23/81.

II. Background

The Office of Management and Budget

(OMB) and the General Accounting Office

(GAO) completed separate studies in late

1973 of nonperishable subsistence supplies.

Both OMB and GAO recommended that the

FDA be the agency responsible for quality

assurance of all medical products procured

by Federal agencies. In June 1974, the

Director of OMB requested that the

Department of Health, Education and Welfare

(HEW) take the lead in developing an

Executive Branch Plan for the governmentwide quality assurance program for medical

products. FDA was made responsible for

developing and implementing the plan. In

December 1975, FDA and DoD signed a

quality assurance agreement covering drugs

and biologics, and in December 1981, a

corresponding agreement covering medical

devices was signed. Both agreements were

implemented and have been operational.

However, some portions of the original

agreements have become obsolete and there

is a need to encompass new DoD initiatives

and business practices. This updated

memorandum of understanding encompasses

all medical products under FDA regulatory

control, and supersedes the two currently

effective interagency agreements.

III. Responsibilities

A. Under the authority of DoD Directive

4140.26, the Defense Personnel Support

Center (DPSC) is assigned and designated as

the integrated manager for medical products.

The DPSC agrees to:

(1) Furnish FDA copies of medical product

quality complaints, incident reports

under the Safe Medical Device Act of

1990, and other information which may

impact adversely on the quality of a

medical product.

(2) Provide a written request for

evaluations, testing, and other work to be

performed by FDA under this program.

(3) Furnish FDA copies of specifications

for review, solicitations and copies of

contracts requiring FDA source

inspection.
Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Notices 43171

(4) Notify the FDA liaison officer in writing

of changes in acquisition regulations and

practices which would affect the

program covered by this MOU.

B. The Food and Drug Administration (FDA)

agrees to:

(1) Furnish DPSC reports of complaint

investigations.

(2) Upon request, provide pre-award

quality evaluations for firms.

(3) Promptly advise DPSC when firms

supplying medical products to DoD

become unacceptable from a quality

assurance standpoint.

(4) Determine the amount and nature of

work it will perform to fulfill its

responsibilities under this MOU.

(5) Make available FDA inspectional and

analytical personnel as witnesses and

supply information and data to DoD for

GAO protests, Boards of Contract

Appeals, SBA and similar cases.

(6) Review proposed specifications and

provide comments on the quality

assurance aspects.

(7) Notify the DPSC liaison officer in

writing of changes arising from statutes

or regulations which would affect this

program.

(8) Promptly notify DPSC of product recalls

and other pertinent information that

affects government contracts or stocks.

(9) Advise DPSC of instances where fraud

or other criminal conduct involving

government contractors is found.

(10) Be responsible for determining that

medical products offered for delivery

were produced in accordance with the

contract requirements, and for signing

the acceptance document when source

inspection is required.

(11) Conduct laboratory testing as

necessary and, as expeditiously as

possible, furnish DPSC analytical results.

If testing cannot be accomplished, FDA

will notify DPSC.

(12) Advise DPSC when FDA determines

that it is necessary to convert a contract

from destination to source inspection.

IV. Administration

A. Resources required to support this MOU

will be provided by the performing party.

B. Nothing in this MOU will preclude DoD

representatives from making visits to

suppliers with FDA or separately.

C. The DPSC contracts for medical products

will include a provision requiring

compliance with the FDC and implementing

regulations promulgated thereunder. The

Good Manufacturing Practice Regulations

will be the quality standard applied to

industry for the manufacturing, processing,

packaging or holding of medical products

acquired on government contracts. The FDA

will be the agency responsible for the

administrative interpretation and

enforcement of these statutes and regulations.

D. The DPSC may authorize the FDA to act

as its agent for purposes of inspecting and

accepting centrally acquired medical

products, performance of preaward surveys,

and related quality assurance actions.

E. As a general rule, the quality standards

prescribed by the United States

Pharmacopeia (USP), the National Formulary

(NF), and FDA will satisfy the DoD quality

requirements for products covered by the

MOU; however, this does not preclude the

development and utilization by DoD of

additional standards when deemed essential

to satisfy a unique or special requirement of

DoD or any of the Military Services.

F. The FDA and DPSC, as necessary, will

jointly prepare procedures covering

operations that interface.

V. Participating Activity Liaison Officers

A. For the Department of Defense: Director,

Medical Material, DPSC–M, Defense

Personnel Support Center, Defense

Logistics Agency, 2800 South 20th Street,

Philadelphia, Pennsylvania 19101–8419,

215–737–2100.

B. For the Food and Drug Administration:

Director, Medical Products Quality

Assurance Staff, HFC–240, Office of

Regulatory Affairs, Food and Drug

Administration, 12720 Twinbrook

Parkway, Bldg. #4, Room 408, Rockville,

Maryland 20852, 301–827–0390.

VI. Period of Memorandum of Understanding

a. This MOU will become effective upon

final signature and will remain in effect

indefinitely.

b. The MOU will be reviewed every two (2)

years to ensure adequacy and currency;

however, it may be amended by mutual

consent at any time.

c. The MOU may be unilaterally

terminated by providing the other party with

180 days written notice of intent.

Approved and Accepted for the

Department of Defense

By: Edward D. Martin, M.D.

Title: Principal Deputy Assistant Secretary of

Defense, Health Affairs

Date: January 14, 1997

Approved and Accepted for the Food and

Drug Administration

By: M. A. Friedman

Title: Deputy Commissioner for Operations

Date: November 27, 1996

[FR Doc. 97–21242 Filed 8-11-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0302]

Draft Guidance for Industry;

Consumer-Directed Broadcast

Advertisements; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Consumer-Directed Broadcast

Advertisements.’’ The draft guidance is

intended to provide information to

enable product sponsors to fulfill the

requirements for consumer-directed

broadcast advertisements, while

providing consumers with required risk

information about the advertised

products. This draft guidance represents

the agency’s current thinking on

consumer-directed broadcast

advertisements for prescription drugs

for humans and animals, and human

biological products. The agency requests

comments on this draft guidance.

DATES: Written comments may be

submitted on the draft guidance

document by October 14, 1997. General

comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFD–305), Food and Drug

Administration, 12420 Parklawn Dr., rm

1–23, Rockville, MD 20857. Submit

written requests for single copies of the

draft guidance entitled ‘‘ConsumerDirected Broadcast Advertisements’’ to

the Drug Information Branch (HFD–

210), Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Regarding prescription human drugs:

Nancy M. Ostrove, Division of Drug

Marketing, Advertising and

Communications (HFD–40), Center

for Drug Evaluation and Research,

Food and Drug Administration,

5600 Fishers Lane, rm. 17B04,

Rockville, MD 20857, 301–827–

2828, or via e-mail at

ostrove@cder.fda.gov.

Regarding prescription human

biological products: Toni M.

Stifano, Center for Biologics

Evaluation and Research (HFM–

200), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–827–3028, or via e-mail at

stifano@cber.fda.gov.

Regarding prescription animal drugs:

Edward Spenser, Center for

Veterinary Medicine (HFV–216),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD,

20855, 301–594–1722, or via e-mail

at espenser@bangate.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory and Regulatory

Requirements

Section 502(n) (21 U.S.C. 352(n)) of

the Federal Food, Drug, and Cosmetic