Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices 24313

McNeil, M.D.; Walter J. McNerney,

M.H.A.; Edward B. Perrin, Ph.D; Louis

F. Rossiter, Ph.D.; Albert L. Siu, M.D.;

and Ellen B. White, M.B.A.

There also are Federal ex-officio

members. These members are:

Administrator, Substance Abuse and

Mental Health Services Administration;

Director, National Institutes of Health;

Director, Centers for Disease Control

and Prevention; Administrator, Health

Care Financing Administration;

Commissioner, Food and Drug

Administration; Assistant Secretary of

Defense (Health Affairs); and Chief

Medical Director, Department of

Veterans Affairs.

II. Agenda

On Thursday, May 30, 1996, the

meeting will begin at 9:00 a.m. with the

call to order by the Council Chairman.

The Administrator, AHCPR, will update

the status of current Agency issues and

program initiatives. The Council will

then discuss issues concerning the

guideline program, public/private sector

collaboration, and improvements to the

large grant program. The Council will

recess at 3:45 p.m. The Council will

begin the closed portion of the meeting

to review grant applications from 4:00

p.m. to 5:00 p.m.

The meeting will adjourn at 5:00 p.m.

Agenda items are subject to change as

priorities dictate.

Dated: May 8, 1996.

Clifton R. Gaus,

Administrator.

[FR Doc. 96–12066 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–90–M

Administration for Children and

Families

Agency Recordkeeping/Reporting

Requirements Under Emergency

Review by the Office of Management

and Budget (OMB)

Title: Request for Emergency OMB

Approval of Information Collection

Under the Paperwork Reduction Act.

OMB No.: New.

Description: The State and Tribal

JOBS plans are statutorily mandated and

serve as the agreement between the

State or the Tribal grantee and the

Federal government for how JOBS

programs will operate. The State/Tribal

plans provide assurances that the JOBS

program will be administered and

operated in conformity with titles IV–A

and IV–F of the Social Security Act,

pertinent Federal regulations, and other

applicable instructions or guidelines

issued by ACF. This new State and

Tribal JOBS plan section is being added

in response to the President’s recent

directive requiring States to address the

needs of teen parents so that they stay

in school and become self-sufficient.

Respondents: State, Local or Tribal

Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

Tribal JOBS ...................................................................................................................... 76 1 5 380

State JOBS ....................................................................................................................... 54 1 5 270

Estimated Total Annual Burden

Hours: 650.

Additional Information

ACF is requesting that OMB grant a 90

day approval for this information

collection under procedures for

emergency processing by May 9, 1996.

A copy of this information collection,

with applicable supporting

documentation, may be obtained by

calling the Administration for Children

and Families, Reports Clearance Officer,

Roberta Katson at (202) 401–5756.

Comments and questions about the

information collection described above

should be directed to the Office of

Information and Regulatory Affairs,

Attn: OMB Desk Officer for ACF, Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street NW.,

Washington, DC 20503, (202) 395–7316.

Dated: May 8, 1996.

Roberta Katson,

Director, Office of Information Resource

Management Services.

[FR Doc. 96–11946 Filed 5–13–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

FDA Form 3439, Interim Form for

Application to Market a New Drug,

Biologic, or Antibiotic Drug for Human

Use; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of FDA Form 3439 entitled,

‘‘Application to Market a New Drug,

Biologic, or Antibiotic Drug for Human

Use.’’ This form is intended for use by

applicants for licenses for specified

biotechnology and specified synthetic

biological products. FDA Form 3439 has

received interim approval from the

Office of Management and Budget

(OMB) for use by applicants pending the

availability of a harmonized form for

use by applicants requesting approval of

drugs, biological products, and

antibiotics. The development of the

harmonized form and this action are

part of FDA’s continuing effort to

achieve the objectives of the President’s

‘‘Reinventing Government’’ initiatives.

EFFECTIVE DATE: The FDA Form 3439

may be used May 24, 1996.

ADDRESSES: Submit written requests for

single copies of FDA Form 3439 to

Division of Congressional and Public

Affairs (HFM–44), Center for Biologics

Evaluation and Research (CBER), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive

label to assist that office in processing

your requests. The form may also be

obtained by FAX by calling the CBER

Voice Information System at 1–800–

835–4709. FDA Form 3439 is available

for public examination in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Annette A. Ragosta, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

making available FDA Form 3439,

Application to Market a New Drug,
24314 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices

Biologic, or Antibiotic Drug for Human

Use, for use in accordance with part 601

(21 CFR part 601), by applicants for

licenses for specified biotechnology and

specified synthetic biological products.

In the final rule, ‘‘Elimination of

Establishment License Application for

Specified Biotechnology and Specified

Synthetic Biological Products,’’

published elsewhere in this issue of the

Federal Register, FDA is amending

§ 601.2 (a) and adding new § 601.2 (c) to

create a licensing scheme for specified

biotechnology and specified synthetic

biological products. The final rule

requires an applicant seeking marketing

approval for specified biotechnology

and specified synthetic biological

products to submit a single biologics

license application to CBER. FDA Form

3439 has received interim approval from

OMB for use by applicants subject to the

above-referenced final rule.

In the November 1995 report entitled,

‘‘Reinventing the Regulation of Drugs

Made from Biotechnology’’ report, the

President and Vice-President

announced a series of regulatory reform

initiatives, including FDA’s intention to

use a single harmonized application

form for all licensed biological products

and all drug products. The harmonized

form will be made available for public

comment and submitted to OMB for

review and approval. FDA also intends

to develop guidance to assist applicants

in completing the harmonized

application. Once it is approved for use

by OMB, the harmonized form will

supersede FDA Form 3439. Until that

time, applicants for licenses for

specified biotechnology and specified

synthetic biological products may use

the interim FDA Form 3439.

Under the Paperwork Reduction Act

of 1995 (Pub. L. 104–13), all forms

requesting a collection of information

on identical items from 10 or more

public respondents must be approved

by OMB and must display a valid OMB

control number and expiration date.

FDA Form 3439 was approved under

OMB control number 0910–0316. The

expiration date for the form is December

31, 1997.

Dated: May 9, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–12145 Filed 5–10–96; 10:13 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0227]

Direct-to-Consumer Promotion

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

notice making clear that the agency does

not require preclearance of prescription

product promotion (advertising and

promotional labeling) of human or

animal drugs, biologics, or restricted

medical devices directed toward

consumers. FDA is also requesting

comments on its intent to consider

certain FDA-approved patient labeling

as adequate to fulfill the brief summary

requirement in consumer-directed

advertisements. Finally, FDA is

soliciting comments concerning several

issues related to consumer-directed

promotion of prescription biologics,

human and animal drugs, and restricted

medical devices to help guide policy

decisions.

DATES: Written comments by August 12,

1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

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. 17–B04, Rockville, MD 20857,

301–827–2828, or via Internet at

Ostrove@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Under the Federal Food, Drug, and

Cosmetic Act (act) and the Public Health

Service Act, the Food and Drug

Administration (FDA) has responsibility

for regulating the labeling and

advertising of prescription drugs

(animal and human), biologics, and

restricted medical devices. Labeling and

advertising must follow certain

requirements, as defined by the Act and

implementing regulations.

Under section 502(n)of the act (21

U.S.C. 352(n)), an advertisement for a

prescription drug must contain, in

addition to the product’s established

name and quantitative composition,

‘‘such other information in brief

summary relating to side effects,

contraindications, and effectiveness * *

*.’’ This requirement is further defined

in prescription drug advertising

regulations at § 202.1(e) (21 CFR

202.1(e)). Under section 502(r) of the act

(21 U.S.C. 352(r)), an advertisement for

a restricted medical device must

contain, in addition to the established

name, ‘‘a brief statement of the intended

uses of the device and relevant

warnings, precautions, side effects, and

contraindications * * *.’’

The act and FDA’s advertising

regulations do not distinguish between

targeted audiences. FDA recognizes,

however, that there are differences

between the information needs of health

care professionals and consumers

resulting from differences in medical

and pharmaceutical expertise, and

differences in roles as potential

recipients of medications or prescribers

of medications, that may affect their

perceptions, comprehension, and

interpretation of promotional claims. In

light of these differences, FDA is

continuing to evaluate its policies and

regulations.

In the Federal Register of August 16,

1995 (60 FR 42581), FDA announced a

part 15 (21 CFR part 15) hearing to be

held on October 18 and 19, 1995. In that

document, the agency solicited oral

testimony and written responses to a

series of questions concerning direct-toconsumer (DTC) promotion of

prescription drugs. At the hearing, the

agency heard testimony from

representatives of consumer and patient

groups, advertising associations, and

foreign governments, as well as from

individual academicians, attorneys,

marketers, and pharmaceutical

manufacturers. The agency accepted

written comments until December 29,

1995. FDA is currently evaluating the

testimony, comments, and issues raised

by both the public hearing and citizen

petitions submitted prior to the hearing.

While this evaluation proceeds, FDA

is providing clarification of two of its

policies and soliciting additional

information to help in the development

of overall policy. FDA views these

efforts as part of a comprehensive

process designed to encourage

meaningful communication to

consumers about prescription drugs,

biologics, and restricted medical

devices, while continuing to help

ensure that consumers are adequately

protected from false, misleading or

otherwise violative promotion.

II. Preclearance

One issue raised in oral testimony,

written comments, and citizen petitions

was an objection to the perceived

requirement for manufacturers to obtain

prior clearance from the agency for all

prescription drug and biological DTC

promotion. There is, in fact, no such

requirement. Given public and

congressional concern since the early

1980’s about prescription drug DTC

promotion, together with the

inexperience of the pharmaceutical

industry in producing DTC advertising,

FDA had informally requested

manufacturers to submit, on a voluntary

basis, proposed DTC promotional