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
43172 Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Notices

Act (the act) requires that

advertisements for prescription drugs

for humans and animals and human

biological products include information

in brief summary relating to side effects,

contraindications, and effectiveness.

This is known as the ‘‘brief summary’’

requirement. The prescription drug

advertising regulations in § 202.1(e)(1)

and (e)(3)(iii) (21 CFR 202.1(e)(1) and

(e)(3)(iii)) further require that the brief

summary disclose all the risk-related

information in a product’s approved

package labeling (package insert or

product package insert).

The regulations for advertising

prescription drugs through broadcast

media, such as radio, television, or

telephone communications systems,

however, modify the disclosure

requirements somewhat. All

prescription drug broadcast

advertisements must include

information about the major risks of the

advertised drug (the ‘‘major statement’’)

in either the audio or audio and visual

parts of the presentation. Instead of

presenting a ‘‘brief summary’’ in

connection with the broadcast

advertisement, a sponsor may make

adequate provision for the

dissemination of the approved package

labeling in connection with the

broadcast presentation (§ 202.1(e)(1)).

This alternative requirement is referred

to as the ‘‘adequate provision’’

requirement.

The ‘‘adequate provision’’

requirement recognizes the inability of

broadcast advertisements of reasonable

length to present and communicate

effectively the extensive information

that would be included in a brief

summary; it instead specifies that

presentation of the advertised product’s

most important risk information as part

of the ‘‘major statement,’’ together with

‘‘adequate provision’’ for the

dissemination of the approved labeling,

can fulfill the risk information

disclosure mandated by the act.

B. History

Although direct-to-consumer (DTC)

advertising has been practiced by the

prescription drug industry since the

early 1980’s, it has become increasingly

popular in the 1990’s. As a result, FDA

has consulted recently with industry,

consumers, health care professionals,

and other interested parties regarding

DTC prescription drug advertising.

In the Federal Register of August 16,

1995 (60 FR 42581), FDA published a

document explaining the background of

DTC promotion, asking for feedback on

a number of DTC-related issues and

questions, and announcing a public

hearing regarding DTC promotion. The

hearing was held on October 18 and 19,

1995, in Silver Spring, MD. In the

Federal Register of May 14, 1996 (61 FR

24314), FDA published a followup

document to address the erroneous

belief expressed by some during the

public hearing that FDA required

preclearance of DTC promotion and to

request feedback on several issues

concerning DTC promotion. The notice

clarified that FDA has never required

DTC promotional materials to be

precleared before use.

II. FDA’s Plans Concerning ConsumerDirected Advertisements

As mentioned in section I.A of this

document, the regulations addressing

prescription drug and biological product

advertisements are highly specific with

regard to the kind and amount of

information required to be disclosed or

disseminated in connection with

advertisements. Either a highly

inclusive brief summary must be

presented or, in the case of broadcast

advertisements, substitution may be

made by ensuring dissemination of

approved package labeling. In response

to recent agency requests for input,

many comments have expressed

concerns about the value for consumers

of the complex, detailed information in

the brief summary for print

advertisements and approved package

labeling for broadcast advertisements.

FDA will initiate any rulemaking

necessary to address these concerns. In

the interim, FDA encourages product

sponsors to provide consumers with

nonpromotional, consumer-friendly

information that is consistent with

approved product labeling, in addition

to the information currently required by

the regulations (package insert for

broadcast advertisements or brief

summary for print advertisements). FDA

suggests that this information follow the

guidelines outlined in the ‘‘Action Plan

for the Provision of Useful Prescription

Medicine Information’’ coordinated by

The Keystone Center, as accepted by the

Secretary of the Department of Health

and Human Services in January 1996. In

cases where an advertised product has

FDA-approved patient labeling, FDA

encourages its inclusion as part of full

prescribing information. In cases where

the regulations require a brief summary,

FDA encourages sponsors to write the

brief summary in consumer-friendly

language. This applies to consumerdirected print advertisements and

broadcast advertisements that present a

brief summary.

III. Consumer-Directed Broadcast

Advertisements

Previously, FDA had not described

how prescription drug and biological

product sponsors could fulfill the

‘‘adequate provision’’ requirement for

consumer-directed broadcast

advertising. However, over the past

several years, FDA has vastly expanded

its experience in regulating DTC

advertising that communicates

important information and is not false

or misleading. In light of the agency’s

increased experience and recent public

input, FDA has reconsidered the issue

of adequate provision as it relates to

consumer-directed broadcast

advertising. Therefore, FDA is

publishing a draft guidance entitled,

‘‘Consumer-Directed Broadcast

Advertisements.’’ It is directed to all

new drug application, abbreviated new

drug application, and abbreviated

antibiotic drug application holders;

biological product license holders; and

new animal drug application and

abbreviated new animal drug

application holders. This draft guidance

is intended to provide consumers with

adequate communication of required

risk information, while facilitating the

process used by sponsors to advertise

their products to consumers. This draft

guidance describes an approach that

sponsors can use to fulfill the

requirement for adequate provision for

dissemination of the approved package

labeling in connection with consumerdirected broadcast advertisements for

drug and biological products, as long as

the advertisement itself includes a

thorough major statement describing the

product’s most important risk

information.

Within 2 years of publication of the

final guidance, FDA intends to evaluate

the effects of the guidance, including

effects on the public health, of DTC

promotion, and specifically of

consumer-directed broadcast

advertising. At the end of this

evaluation period, FDA will determine

whether this guidance should be

withdrawn, continued, or modified to

reflect the agency’s current thinking.

During this period, FDA will continue

to collect information. The agency will

keep the docket open to encourage the

collection and submission of additional

information from the public. FDA

requests that sponsors and other

interested parties collect relevant data

on the impact of DTC promotional

messages and make their findings

known to the agency. FDA specifically

solicits feedback on questions such as:

(1) How has DTC promotion generally

affected the public health; (2) to what
Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Notices 43173

extent are consumers taking advantage

of the mechanisms for obtaining

approved package labeling in

connection with broadcast

advertisements; and (3) how risk

messages can best be integrated into

broadcast advertisements.

This draft guidance represents the

agency’s current thinking on procedures

to fulfill the requirements for the

disclosure of product information in

connection with consumer-directed

broadcast advertisements for

prescription human and animal drugs,

and human biological products. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirement of the

applicable statute, regulations, or both.

IV. Request for Comments

Interested persons may, on or before

October 14, 1997 submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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. The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday. An electronic

version of this draft guidance is also

available on the Internet at http://

www.fda.gov/cder/guidance.htm.

Dated: August 5, 1997.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

[FR Doc. 97–21291 Filed 8–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions

and Delegations of Authority

This notice amends Part R of the

Statement of Organization, Functions

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (60 FR 56605

as amended November 6, 1995; as last

amended at 62 FR 27613–16 dated May

20, 1997). This notice reflects the

establishment of the HIV/AIDS Bureau

and the Office of Special Programs.

The changes are as follows:

I. Delete the Bureau of Health

Resources Development, and the AIDS

Program Office (RAA), Office of the

Administrator, in its entirety and

replace with the following:

Section RV–00 Mission

The mission of the HIV/AIDS Bureau

is to administer national policies and

programs pertaining to HIV infection

and acquired immune deficiency

syndrome (AIDS) activities.

Section RV–10 Organization. The

HIV/AIDS Bureau (HAB) is headed by

an Associate Administrator who reports

directly to the Administrator, HRSA.

The (HAB) includes the following

components:

(A) Associate Administrator for HIV/

AIDS (RV)

(B) Office of Communications (RV1)

(C) Office of Program Support (RV2)

(D) Office of Policy and Program

Development (RV3)

(E) Office of Science & Epidemiology

(RV4)

(F) Division of Service Systems (RV5)

(G) Division of Community Based

Programs (RV6)

(H) Division of Training and Technical

Assistance (RV7)

Section RV–20 Function

A. Associate Administrator, HIV/AIDS

Bureau (RV)

Provides leadership and direction for

the Agency’s HIV/AIDS programs and

activities and oversees their relationship

with other national health programs.

Specifically: (1) Coordinates the

formulation of an overall strategy and

policy for HRSA AIDS programs; (2)

coordinates the internal functions of the

Bureau and its relationships with other

national health programs; (3) establishes

HIV/AIDS program objectives,

alternatives, and policy positions

consistent with legislation and broad

Administration guidelines; (4)

administers the Agency’s HIV/AIDS

grants and contracts programs; (5)

reviews HIV/AIDS-related program

activities to assure consistency with

established policies; (6) represents the

Agency and the Department at HIV/

AIDS related meetings, conferences and

task forces; (7) serves as principal

contact and advisor to the Agency,

Department, and other parties

concerned with matters relating to

planning and development of health

delivery systems relating to HIV/AIDS;

(8) develops and administers operating

policies and procedures for the Bureau;

(9) directs and coordinates the Bureau

activities in support of the Department/

Agency/Bureau’s Affirmative Action

and Equal Employment Opportunity

programs by ensuring that all internal

employment practices provide an equal

opportunity to all qualified persons and

its employment practices do not

discriminate on the basis of race, color,

sex, age, handicapping conditions,

national origin, religious or political

affiliation, marital status, and that all

external benefits and service oriented

activities relative to the recipients of

Federal funds are likewise addressed in

accordance with applicable laws,

Executive Orders, DHHS regulations

and policies; and (10) provides direction

to the Bureau’s Civil Rights compliance

activities.

B. Office of Communications (RV1)

The Office of Communications serves

as the Bureau’s clearinghouse on all

HIV/AIDS grant and program data and

information, directing, coordinating and

managing the preparation and

dissemination of newsletters, program

profiles, and reports on the uses of grant

funds and services provided.

Specifically: (1) Collects, compiles, and

distributes various data and information

on HIV/AIDS health care issues and

programs related to the activities of the

Bureau; (2) develops and provides

information materials to HIV/AIDS

health program planners, providers, and

consumers to assist in decisionmaking

and in effective, efficient operations; (3)

develops and produces in-house

communications to help ensure the

understanding of current AIDS issues

and Bureau program activities; (4)

maintains information about primary

sources of data and information on the

health industry, disease trends, and

public and private programs; (5) fosters

and maintains relationships with and

provides a referral service to Federal

agencies, State and local governmental

units, and private health and medical

organizations with which the Bureau

has mutual interests; (6) provides

technical assistance to Bureau program

managers and project officers in

identifying data and information needs

and developing information products;

(7) provides technical assistance to

Bureau program managers in

information and communications

product packaging, desktop publishing,

and media relations; (8) provides

Bureau liaison with HRSA’s Office of

Communications with respect to

information and communications policy

and management, product development,

and media relations; (9) produces

reports, articles, briefings, speeches, and

exhibits on Bureau services and on

programs directed at the Bureau service

and provider populations; and, (10)

utilizes automated methods and

electronic media in carrying out its