66758 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0790]

Final Guidance for Industry: The Use

of Published Literature in Support of

New Animal Drug Approval;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a final guidance for

industry (#106) entitled ‘‘The Use of

Published Literature in Support of New

Animal Drug Approval.’’ The final

guidance is intended to fulfill the

section of the FDA Modernization Act of

1997 (FDAMA) that requires the agency

to issue guidance to clarify the

circumstances in which published

matter may be the basis for approval of

a supplemental application. The final

guidance also clarifies the

circumstances in which published

literature may be the basis for approval

of an original application. The final

guidance is intended to provide specific

advice on when FDA may be able to rely

on published literature, with or without

the submission of underlying data, to

support new animal drug approvals.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the final guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on this final

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Copies of

the final guidance may be obtained on

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

fda/TOCs/guideline.html.

FOR FURTHER INFORMATION CONTACT: Gail

L. Schmerfeld, Center for Veterinary

Medicine (HFV–100), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20850, 301–594–1620, email: gschmer1@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of April 19,

2000 (65 FR 20997), FDA published the

draft guidance entitled ‘‘The Use of

Published Literature in Support of New

Animal Drug Approval’’ giving

interested persons until July 18, 2000, to

submit comments. No comments were

received.

Section 403(b) of FDAMA (Public Law

105–115) requires FDA to issue

guidances to clarify the requirements

for, and facilitate the submission of data

to support, the approval of

supplemental applications for articles

approved under the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 301 et seq.)

or section 351 of the Public Health

Service Act (42 U.S.C. 262). This

provision includes a requirement that

FDA publish guidance to clarify

circumstances in which published

matter may be the basis for approval of

a supplemental application.

This final guidance for industry

clarifies the circumstances in which

published literature may be the basis for

approval of both original and

supplemental new animal drug

applications. Specifically, the final

guidance describes the circumstances

under which FDA could rely on

published literature without access to

the underlying data and the

circumstances under which the

applicant should provide additional

information about a published study.

II. Significance of Guidance

This final guidance represents the

agency’s current thinking with regard to

the use of published literature in

support of new animal drug approval. 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 method may be used as long

as it satisfies the requirements of the

applicable statutes and regulations. The

agency has developed this final

guidance in accordance with the

agency’s good guidance practices

published in the Federal Register of

September 19, 2000 (65 FR 56468),

which set forth the policies and

procedures for the development,

issuance, and use of guidance

documents.

III. Comments

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this guidance.

FDA will periodically review the

comments in the docket and, where

appropriate, will amend the guidance.

The public will be notified of any such

amendments through a notice in the

Federal Register.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28448 Filed 11–6–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Children’s Hospital

Graduate Medical Education Program

(OMB No. 0915–0247)

Public Law 106–129 amended the

Public Health Service Act to provide for

the support of graduate medical

education (GME) in children’s hospitals.

The provision authorizes payments for

direct and indirect expenses associated

with operating approved GME

programs. Section 340E(c)(1) of the PHS

Act, as amended, states that the amount

determined under this subsection for

payments for direct medical expenses

for a fiscal year is equal to the product

of (a) the updated per resident amount

as determined, and (b) the average

number of FTE residents in the

hospital’s approved graduate medical

residency training programs as

determined under section 1886(h)(4) of

the Social Security Act during the fiscal

year. Section 340E(d)(2) requires the

Secretary to determine the appropriate

amount of indirect medical education

for expenses associated with the

treatment of more severely ill patients

and the additional costs relating to

teaching residents in such programs to

a children’s hospital by considering

variations in case mix among children’s

hospitals, and the hospitals’ number of

FTE residents in approved training

programs.

Administration of the Children’s

Hospital Graduate Medical Education