69030 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices

Item

Number Title of Standard Reference Number and Date

53 Sterilization of Health Care Products—Chemical Indicators—

Part 2: Class 2 Indicators for Air Removal Test Sheets and

Packs

ANSI/AAMI ST66: 1999

54 Sterilization of Medical Devices—Microbiological Methods—

Part 2: Tests of Sterility Performed in the Validation of a

Sterilization Process

ANSI/AAMI/ISO 11737–2: 1998

55 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin—Validation and Routine Control of

Sterilization by Liquid Chemical Sterilants

ANSI/AAMI/ISO 14160: 1998

56 Standard Test Method for Determination of Leaks in Flexible

Packaging by Bubble Emission

ASTM D3078: 1994

57 Standard Practice for Performance Testing of Shipping Containers and SystemsASTM D4169: 1999

58 Standard Test Method for Seal Strength of Flexible Barrier MaterialsASTM F88: 1999

59 Standard Test Methods for Failure Resistance of Unrestrained

and Nonrigid Packages for Medical Applications

ASTM F1140: 1996

60 Standard Terminology Relating to Barrier Materials for Medical

Packaging

ASTM F1327: 1998

61 Standard Guide for Integrity Testing of Porous Barrier Medical

Packages

ASTM F1585: 1995

62 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)ASTM F1608: 1995

63 Standard Test Method for Determining Integrity of Seals for

Medical Packaging by Visual Inspection

ASTM F1886: 1998

64 Standard Test Method for Detecting Seal Leaks in Porous

Medical Packaging by Dye Penetration

ASTM F1929: 1998

65 Standard Guide for Accelerated Aging of Sterile Medical Device

Packages

ASTM F1980: 1999

66 Transfusion and Infusion Assemblies and Similar Medical Devices <161>USP 24: 2000

Dated: October 31, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29165 Filed 11–14–00; 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: Scholarship

Program for Students of Exceptional

Financial Need (EFN) and Program of

Financial Assistance for Disadvantaged

Health Professions Students (FADHPS):

Regulatory Requirements (OMB No.

0915–0028)—Reinstatement, with

change.

The EFN Scholarship Program,

authorized by section 736 of the Public

Health Service (PHS) Act, and the

FADHPS Program, authorized by section

740(a)(2)(F) of the PHS Act, provides

financial assistance to schools of

allopathic and osteopathic medicine

and dentistry for awarding tuition

scholarships to health professions

students who are of exceptional

financial need. To be eligible for

support under the FADHPS Program, a

student must also be from a

disadvantaged background. In return for

this support, students of allopathic and

osteopathic medicine must agree to

complete residency training in primary

care in 4 years, and practice in primary

care for 5 years after completing

residency training.

The program regulations contain

recordkeeping requirements designed to

ensure that schools maintain adequate

records for the Government to monitor

program activity and that funds are

spent as intended.

The estimate of burden for the

regulatory requirements of this

clearance are as follows:

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Notices 69031

Form Number of

respondents

Responses

per

respondents

Total

responses

Minutes per

response

Total burden

(in hours)

EFN/FADHPS ...................................................................... 80 1 80 10 13

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: November 7, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–29108 Filed 11–14–00; 8:45 am]

BILLING CODE 4160–15–U

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: Social Support for

Homeless Mothers: Implications for

Best Practices and Program Design—

New

The Health Care for the Homeless

Clinicians’ Network (HCHCN) of the

National Health Care for the Homeless

Council, Inc., through a cooperative

agreement with the Bureau of Primary

Health Care, Health Resources and

Services Administration, proposes to

conduct a study on the social support

available to homeless mothers, most of

whom are parenting children alone. The

study will be of adult homeless women

and will be conducted by convening

focus groups and administering a

questionnaire to focus group members.

The study is designed to look at clients’

life events, histories of violence,

medical and physical illness, social

support, children’s needs, and services

use. The results will help to define best

practices as they relate to social support

processes and enable HCH programs to

offer the appropriate mix of supports

necessary to help mothers transition

into permanent housing. The

participants will be recruited from ten

sites of the national Health Care for the

Homeless program.

The estimated response burden is as

follows:

Type of respondent Number of

respondents

Responses

per

respondent

Hours per

response

Total hour burden

Focus Group (including survey) ....................................................................... 100 1 1.5 150

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

John Morrall, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington, DC

20503.

Dated: November 7, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–29107 Filed 11–14–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Proposed Collection;

Comment Request, The Jackson Heart

Study, Annual Follow-Up Component—

Phase III

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Heart, Lung, and Blood

Institute (NHLBI), the National

Institutes of Health (NIH) will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

PROPOSED COLLECTION: Title: The

Jackson Heart Study, Annual Follow-Up

Component—Phase III. Type of

Information Collection Request:

Revision (OMB 0925–0464; expiration

04/30/2002). Need and use of

Information Collection: The Jackson

Heart Study (JHS) Clinical Component

will involve 6,500 African-American

men and women aged 35–84,

representative of African-American

residents of Jackson, Mississippi.

Family members are to be included in

order to permit future studies of familial

and genetic contributions to

cardiovascular disease (CVD). The

examination includes a series of

questionnaires, physical assessments

and laboratory measurements. Data

collected in this study includes both

conventional risk factors and new or

emerging factors that may be related to

CVD. Some of the newer areas of focus

include early indicators of disease,

genetics, sociocultural influences such

as socioeconomic status and

discrimination, and physiological

relations between common disorders

such as high blood pressure, obesity and

diabetes and their influence on CVD and

will take three years to complete. The

JHS Clinical Component has received

Clinical Exemption (CE–99–11–09) from

the NIH Clinical Exemption Review