75720 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Notices

1On November 4, 1999, FDA received a citizen

petition raising issues associated with the

relationship between the pediatric rule and ANDA

suitability petitions. The issues raised in the

petition are still under consideration by the agency.

Therefore, this guidance does not address pediatric

studies associated with suitability petitions.

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1595]

Draft Guidance for Industry on

Recommendations for Complying With

the Pediatric Rule; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Recommendations for

Complying With the Pediatric Rule (21

CFR 314.55(a) and 601.27(a)).’’ The draft

guidance provides recommendations for

sponsors of new drug applications

(NDA’s) and biologics license

applications (BLA’s) on how to meet the

requirements of the final rule requiring

manufacturers to assess the safety and

effectiveness of new drugs and

biological products in pediatric patients

(pediatric rule).

DATES: Submit written comments on the

draft guidance by March 5, 2001.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance for industry are available on

the Internet at http://www.fda.gov/cder/

guidance/index.htm. Submit written

requests for single copies of the draft

guidance 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

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Terrie L. Crescenzi, Center for Drug

Evaluation and Research (HFD–

104), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

7337, FAX 301–827–2520, e-mail

crescenzit@cder.fda.gov, or

Elaine C. Esber, Center for Biologics

Evaluation and Research (HFM–30),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852, 301–827–0641, FAX 301–

827–0644, e-mail

esber@cber.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled

‘‘Recommendations for Complying With

the Pediatric Rule (21 CFR 314.55(a) and

601.27(a)).’’ In the Federal Register of

December 2, 1998 (63 FR 66632), FDA

published the pediatric rule. Under the

pediatric rule, applications for new

active ingredients, new indications, new

dosage forms, new dosing regimens, and

new routes of administration must

contain a pediatric assessment unless

the applicant has obtained a waiver or

deferral of pediatric studies (21 CFR

314.55(a) and 601.27(a)). The rule

became effective on April 1, 1999.

Under the compliance dates in the final

rule, pediatric assessments must be

included in applications after December

2, 2000, for: (1) NDA’s; (2) BLA’s; and

(3) abbreviated new drug applications

(ANDA’s) that are based on suitability

petitions for a change in active

ingredient, dosage form, or route of

administration.1 This draft guidance

describes how the pediatric rule will be

implemented. Areas covered include an

overview of pediatric assessments,

pediatric plans, waivers and deferrals,

compliance issues, pediatric exclusivity,

and the role of FDA’s Pediatric Advisory

Subcommittee.

This Level 1 draft guidance is being

issued consistent with FDA’s good

guidance regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

draft guidance represents the agency’s

current thinking on how to comply with

the pediatric rule. 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

requirements of the applicable statutes

and regulations.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. 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 are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: November 22, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30697 Filed 12–1–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1156–N]

Medicare Program; Request for

Nominations for the Practicing

Physicians Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice requests

nominations from physician medical

organizations for individuals to serve on

the Practicing Physicians Advisory

Council.

Section 4112 of the Omnibus Budget

Reconciliation Act of 1990 established

the Council to advise the Secretary of

the Department of Health and Human

Services on proposed regulations and

manual issuances related to physicians’

services. There will be three Council

vacancies on February 28, 2001.

EFFECTIVE DATE: Nominations will be

considered if we receive them at the

appropriate address, provided below, no

later than 5 p.m., E.S.T., on December

30, 2000.

ADDRESSES: Mail or deliver nominations

to the following address: Health Care

Financing Administration, Center for

Health Plans and Providers, Office of

Professional Relations, Attention: Paul

Rudolf, MD, JD, Executive Director,

Practicing Physicians Advisory Council,

Room 435–H, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Paul

Rudolf, MD, JD, Executive Director,

Practicing Physicians Advisory Council,

(202) 690–7418.

SUPPLEMENTARY INFORMATION: Section

4112 of the Omnibus Budget

Reconciliation Act of 1990 (Public Law

101–508) added a new section 1868 to

the Social Security Act (the Act), which

established the Practicing Physicians

Advisory Council (the Council). The

Council advises the Secretary of the

Department of Health and Human

Services (the Secretary) on proposed

regulations and manual issuances

related to physicians’ services. An

advisory committee created by the

Congress, such as this one, is subject to