20998 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

literature may be the basis for approval

of an original application. The draft

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 approval.

DATES: Submit written comments on the

draft guidance for industry by July 18,

2000.

ADDRESSES: Submit written requests for

single copies of the draft guidance to the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 draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Copies of

the draft guidance may be obtained on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

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This draft guidance for industry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 draft

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This draft guidance represents the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 approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both. The agency has

developed this draft guidance in

accordance with the agency’s good

guidance practices (62 FR 8961,

February 27, 1997), which set forth the

policies and procedures for the

development, issuance, and use of

guidance documents.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance by July 18, 2000. Two copies

of any comments are to be submitted,

except individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. A copy of 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: April 10, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–9713 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources And Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) publishes periodic summaries

of proposed projects being developed

for submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: National Donor

Sabbath Organ Procurement

Organization Survey—New

November 10–12, 2000, will mark the

fifth annual National Donor Sabbath

(NDS), a time for clergy throughout the

Nation to help increase awareness about

the critical need for organs and tissues.

In support of the 1999 NDS, the Health

Resources and Services Administration,

Office of Special Programs, Division of

Transplantation (DoT) distributed to 61

Organ Procurement Organizations

(OPO) in the U.S. more than 300,000

organ donor awareness lapel pins

attached to paper backings containing

NDS information. The OPOs were asked

to distribute the pins to their local

clergy to be used for further distribution

and education of their congregation.

DoT plans to replicate this activity for

2000 NDS.

While DoT believed the 1999 pin

distribution to be a positive educational

tool there exists a need to properly

investigate the efficacy of the pins as an

aid in promoting NDS. The Division

wishes to examine the pin distribution

in 2000 NDS in order to plan the most

effective, efficient, and cost effective

role for DoT in subsequent observances

of NDS. Investigation will consist of

requesting each OPO to complete a short

survey concerning usage, distribution,

and impact of the pins. This is a onetime survey.

Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20999

ESTIMATES OF ANNUALIZED HOUR BURDEN

Subjects Number of

respondents

Responses

per

respondent

Total

responses

Hrs. per

response

Total hour

burden

Organ Procurement Organizations ...................................... 60 1 60 .33 20

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–33, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: April 13, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–9757 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–15–P

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: Grants for Hospital

Construction and Modernization—

Federal Right of Recovery and Waiver

of Recovery (42 CFR, Subpart H) (OMB

No. 0915–0099)—Extension

The regulation known as ‘‘Federal

Right of Recovery and Waiver of

Recovery,’’ provides a means for the

Federal Government to recover grant

funds and a method of calculating

interest when a grant-assisted facility

under Titles VI and XVI is sold or

leased, or there is a change in use of the

facility. It also allows for a waiver of the

right of recovery under certain

circumstances. Facilities are required to

provide written notice to the Federal

Government when such a change

occurs; and to provide copies of sales

contracts, lease agreements, estimates of

current assets and liabilities, value of

equipment, expected value of land on

the new owner’s books and remaining

depreciation for all fixed assets involved

in the transactions, and other

information and documents pertinent to

the change of status.

ESTIMATES OF ANNUALIZED HOUR BURDEN

Regulation Number of

respondents

Responses

per

respondent

Hours per

response

Total burden

hours

124.704(b) and 707 ......................................................................................... 20 1 3 60

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Wendy A. Taylor, Human Resources

and Housing Branch, Office of

Management and Budget, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: April 13, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–9756 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), title 5 U.S.C.,

as amended. The contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute Special Emphasis Panel, Early

Therapeutics Development with Phase 2

Emphasis.

Date: May 8–9, 2000.

Time: 8 am to 5 pm.

Agenda: To review and evaluate contract

proposals.

Place: Ramada Inn Rockville, 1775

Rockville Pike, Rockville, MD 20852.

Contact Person: Lalita D. Palekar, Scientific

Review Administrator, Special Review,

Referral and Resources Branch, Division of

Extramural Activities, National Cancer

Institute, National Institutes of Health, 6116

Executive Boulevard, Room 8066, Bethesda,

MD 20892–7405, 301–496–7575.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology