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 The draft guidance discusses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for comment on this draft guidance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of a draft guidance entitled ‘‘General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draft guidance discusses how the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.
Federal Register / Vol. 62, No. 188 / Monday, September 29, 1997 / Notices 50955

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Laura Oliven, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: September 22, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–25727 Filed 9–26–97; 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: Ryan White

Comprehensive AIDS Resources and

Emergency (CARE) Act Women’s

Initiatives (WIN)—New

The Health Resources and Services

Administration’s HIV-AIDS Bureau

proposes to collect information about

HIV-related services provided to women

of child-bearing age and their children.

Information will be collected annually

from eight grantees funded under

Sections 2671 and 2691 of the Public

Health Service Act and 320 of the

individual and institutional providers

who provide services to HIV-infected

pregnant women in the grantee service

areas. The eight funded sites will collect

the information in person or by

telephone from the providers in their

service areas, and forward the data

collection forms to a HRSA contractor.

There are no plans to collect or transmit

the data electronically.

The purpose is to document current

care system characteristics and facilitate

planning for services to women with

HIV and their children. The information

will be used within and outside HRSA

to inform the administration and

Congress about HIV counseling and

testing services for pregnant women,

services and referral resources for

pregnant women with HIV,

antiretroviral therapies, and outreach

related to perinatal HIV transmission

reduction. Annual burden estimates are

as follows:

Type of respondent Number of respondents

Responses

per respondent

Burden hours

per response

Total burden

hours

Providers ........................................................................................................... 320 1 .75 240

Funded Sites .................................................................................................... 8 40 1 320

Total ....................................................................................................... 328 ........................ ........................ 560

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Laura Oliven, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: September 22, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–25729 Filed 9–26–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meetings

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 Heart,

Lung, and Blood Special Emphasis

Panel (SEP) meetings:

Name of SEP: Magnesium in Coronaries

(MAGIC).

Date: October 15–16, 1997.

Time: 7:00 p.m.

Place: Holiday Inn Gaithersburg, 2

Montgomery Village Avenue, Gaithersburg,

Maryland 20814.

Contact Person: Anthony M. Coelho, Ph.D.,

Two Rockledge Center, Room 7182, 6701

Rockledge Drive, Bethesda, MD 20892–7956,

(301) 435–0288.

Purpose/Agenda: To review and evaluate

contract proposals.

Name of SEP: Demonstration and

Education Research Applications (R18).

Date: October 28, 1997.

Time: 8:30 a.m.

Place: Washington National Airport Hilton,

2399 Jefferson Davis Highway, Arlington,

Virginia 22202.

Contact Person: Louise Corman, Ph.D.,

Two Rockledge Center, Room 7180, 6701

Rockledge Drive, Bethesda, MD 20892–7924,

(301) 435–0270.

Purpose/Agenda: To review and evaluate

grant applications.

These meetings will be closed in

accordance with the provisions set forth in

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

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: September 22, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–25704 Filed 9–26–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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