Federal Register / Vol. 62, No. 188 / Monday, September 29, 1997 / Notices 50953

ACTION: Notice of availability; request

for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment on a draft

Level 1 guidance document entitled

‘‘FDA Approval of Animal Drugs for

Minor Uses and for Minor Species.’’ The

guidance document defines minor

species and minor uses and sets forth

suggestions for generating safety and

effectiveness data to support the

approval of minor use and minor

species drugs. The draft Level 1

guidance document sets forth

substantive changes in policy that

warrant input from affected parties.

DATES: Submit written comments on the

draft guidance document by December

29, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr., rm

1–23, Rockville, MD 20857. Comments

should be identified with the full title

of the draft guidance document and the

docket number found in brackets in the

heading of this document.

Submit written requests for single

copies of the draft guidance document

to the Communications and Education

Team (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Oeller, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1650. Email: moeller@bangate.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA’s draft guidance document

entitled ‘‘FDA Approval of Animal

Drugs for Minor Uses and for Minor

Species,’’ is a Level 1 guidance

document by definition in the Good

Guidance Practices (62 FR 8961,

February 27, 1997). This notice of

availability for comment should not be

confused with the Federal Register

document of June 23, l997 (62 FR

33781), entitled ‘‘Request for Comments

on Development of Options to

Encourage Animal Drug Approvals for

Minor Species and for Minor Uses,’’

which dealt with the same subject

matter but was issued to seek comment

and suggestions on legislative and

regulatory options which could be

utilized if adopted in the future to

facilitate approval of new animal drugs

for minor uses and minor species.

This draft, when finalized, will

replace the previous guidance entitled

‘‘Guidelines for the Preparation of Data

to Satisfy the Requirements of Section

512 of the Act Regarding Minor Use of

Animal Drugs,’’ (guidelines) dated April

1986. In the Federal Register of May 30,

l986 (51 FR 19612), FDA issued a notice

of availability of the guidelines. No

comments were received on the

guidelines. A previous version of the

draft guidance document was made

available in November 1996 to

interested parties who requested a copy.

The draft guidance document suggests

procedures that could be used to

demonstrate the safety and efficacy of a

minor use animal drug. Minor use

animal drugs are defined as: (1) New

animal drugs used in minor animal

species or (2) new animal drugs used in

any animal species for the control of a

disease that occurs infrequently or in

limited geographic areas. ‘‘Minor

species’’ are defined by regulation as

animals other than cattle, horses, swine,

chickens, turkeys, dogs, and cats.

According to current regulations, sheep

are a minor species except with respect

to human food safety data collection

requirements, for which sheep are

considered a major species. FDA

intends to issue a proposed regulation

in which sheep would be considered a

minor species for all requirements of the

drug approval process.

The procedures set forth in the draft

guidance document for demonstrating

the safety and efficacy of a minor use

animal drug apply to production drugs

as well as therapeutic drugs.

The draft guidance document has

been organized in two parts. Part 1

includes general information on the

document, an overview of the approval

process, data extrapolation, advice on

working with the Center for Veterinary

Medicine (CVM), and definitions. Part 2

presents specific options for satisfying

data requirements for minor uses in

major species, minor avian species

(gamebirds, semi-domestic waterfowl,

and ratites), minor ruminants (goats,

bison, semi-domestic deer), rabbits, and

aquatic species (finfish, aquatic

invertebrates, alligators, etc.). Each

section in part 2 contains information

on efficacy, target animal safety, human

food safety, and environmental data

requirements. The major data

components, excluding manufacturing

chemistry, of the animal drug approval

process are represented in part 2.

When finalized, the draft guidance

document will represent the agency’s

current thinking on the means of

generating efficacy and safety data to

support approval of new animal drug

applications for minor use of new

animal drugs. This draft guidance

document will not create or confer any

rights for or on any person and will 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.

II. Request for Comments

Interested persons may, on or before

December 29, 1997, submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance document. 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, and with the

full title of the guidance document. The

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. After

review of these comments, FDA will

implement the guidance document with

any appropriate changes. Thereafter,

interested persons may submit written

comment on the guidance document

directly to the CVM Communications

and Education Team (address above).

III. Electronic Access

A copy of the draft guidance

document may be obtained from the

CVM Home Page (http://

www.cvm.fda.gov) on the Internet.

Dated: September 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25667 Filed 9–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0282]

General Principles of Software

Validation; Draft Guidance; Extension

of the Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

December 30, 1997, the comment period

for the notice announcing the

availability of a draft guidance entitled

‘‘General Principles of Software

Validation’’ that published in the

Federal Register of July 25, 1997 (62 FR
50954 Federal Register / Vol. 62, No. 188 / Monday, September 29, 1997 / Notices

40099). The draft guidance discusses

how the general provisions of the

Quality System Regulation apply to

software and the agency’s current

approach to evaluating a software

validation system. The agency is taking

this action in response to a request for

an extension to allow additional time

for comment on this draft guidance

document.

DATES: Written comments by December

30, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT: E.

Stewart Crumpler, Center for Devices

and Radiological Health (HFZ–343),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

594–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 25, 1997 (62 FR

40099), FDA announced the availability

of a draft guidance entitled ‘‘General

Principles of Software Validation.’’ The

draft guidance discusses how the

general provisions of the Quality System

Regulation apply to software and the

agency ’s current approach to evaluating

a software validation system. Interested

persons were given until October 1,

1997, to submit written comments on

the notice. FDA received a request from

the Health Industry Manufacturers

Association to extend the comment

period for 90 days. This would give

them sufficient time to review the

document and ensure quality comments

on the document.

FDA is extending the comment period

for 90 days to assure adequate time for

preparation of comments. Accordingly,

FDA finds under section 520(d) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C 360j(d)) that there is good

cause for such an extension.

Interested persons may, on or before

December 30, 1997, submit to the

Docket Management Branch (address

above) written comments regarding the

notice. 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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: August 28, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25669 Filed 9–26–97; 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: Application and

Annual Report, Maternal and Child

Health Block Grant Program (OMB No.

0915–0172)—Extension and Revision

The Health Resources and Services

Administration (HRSA) has revised and

reformatted the Maternal and Child

Health Block Grant Guidance. This

guidance is used annually by the 50

States and 9 jurisdictions in making

application for Block Grants under Title

V of the Social Security Act, and in

preparing the required annual report.

The revisions are designed to simplify

and clarify the guidance and required

forms and to reduce duplication, while

still allowing for clear, concise, useful,

and accurate communication about the

States’ programs. More specifically, the

revisions are designed to: (1) Make the

program descriptions more readable; (2)

alleviate the disconnect between the

application for the next fiscal year and

the annual report for the previous fiscal

year that makes programmatic and data

reviews difficult; (3) clarify budget and

expense tables, through better design of

forms and by carrying totals from form

to form; (4) report objectives in a

standard format, including the

relationship to Healthy People 2000

goals, to facilitate year-to-year

comparisons and multi-State

tabulations; and, (5) incorporate

uniform performance measures across

all States and jurisdictions as well as

State/jurisdiction-specific performance

measures.

The HRSA revision also combines the

current three guidance documents into

one document by eliminating the

separate annual application and annual

report in favor of a combined document,

and every fifth year explicitly including

the results of the needs assessment,

which would be incorporated only by

reference in the intervening years. The

HRSA revision efforts are intended not

only to simplify and expedite the

rational submission of necessary data

and reports, but also to reduce the

burden on States and jurisdictions by

eliminating duplicative requirements

and streamlining the presentation of

information. Estimates of burden to

complete the application and annual

report are as follows:

Type of form Number of respondents

Responses

per respondent

Burden hours

per response

Total burden

hours

Application and Annual Report, 1998–99 (without needs assessment):*

States ........................................................................................................ 50 1 500 25,000

Jurisdictions ............................................................................................... 9 1 200 1,800

Five-Year Application and Annual Report, 2000 (with needs assessment): *

States ........................................................................................................ 50 1 750 37,500

Jurisdictions ............................................................................................... 9 1 400 3,600

Weighted Annual Average (over next three years):

States ........................................................................................................ 50 1 555 29,167

Jurisdictions ............................................................................................... 9 1 267 2,400

* The Annual Application and Annual Report, without needs assessment, will be submitted in FY 1998 and FY 1999. The five-year Annual Application and Annual Report will be submitted in FY 2000. The average annual response burden for the next three years is 31,567 hours.