Federal Register / Vol. 62, No. 69 / Thursday, April 10, 1997 / Notices 17625

development of combination vaccines

for licensure in the United States.

Topics addressed in this document

include: (1) Manufacturing issues for

combination vaccines; (2) preclinical

studies; (3) clinical studies to support

the licensure of combination vaccines;

and (4) vaccines administered

simultaneously with combination

vaccine. This document does not cover

therapeutic combination vaccines. In

addition, not all issues outlined in the

document will pertain to all types of

combination vaccines, e.g., some issues

related to live vaccines may not apply

to inactivated vaccines.

As with other guidance documents,

FDA does not intend this document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. This document is intended to

provide information and does not set

forth requirements. FDA anticipates that

manufacturers and other interested

parties may develop alternative methods

and procedures, and discuss them with

FDA. FDA recognizes that advances will

continue in the area of combination

vaccines, and FDA intends to update

and revise this document in order to

improve its usefulness. This guidance

document represents the agency’s

current thinking on combination

vaccines. 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.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on this 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. A copy of this document and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Received comments will be

considered in determining whether

further revision of this document is

warranted.

Dated: April 1, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–9169 Filed 4–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung and Blood

Institute; Proposed Collection;

Comment Request; The

Atherosclerosis Risk in Communities

Study

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

the 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 Atherosclerosis Risk in

Communities (ARIC) Study. Type of

Information Collection Request:

Revision of a currently approved

collection (OMB No. 0925–0281). Need

and Use of Information Collection: This

project involves a physical examination

and a survey of a new sample of 45–64

year olds living in the same

communities as the original ARIC Study

participants. Information from this

sample and from the original cohort

collected 10 years earlier will be used to

assess temporal trends in selected

atherosclerosis risk factor domains.

Frequency of Response: The recruited

individuals will participate in a home

interview and an in-clinic examination.

Affected Public: Individuals or

households. Type of Respondents:

Adults 45–64 years old. The annual

reporting burden is as follows:

Type of respondents

Estimated

number of respondents

Estimated

number of responses per

respondent

Average burden hours per

response

Estimated total

annual burden

hours requested

Individuals participating in home interview only ............................................... 2,400 1 0.0501 120

Individuals participating in both home interview and clinic examination ......... 1,200 1 1.8851 2,262

Total ....................................................................................................... ........................ ........................ ........................ 2,382

The cost to the respondents consists of their time; time is estimated using a rate of $10.00 per hour. The annualized cost to respondents is estimated at: $23,820. There are no Capital Costs. The Operating and Maintenance Costs are $682,000.

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies are invited

on one or more of the following points:

(1) 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;

(2) The accuracy of the agency’s

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used; (3) Ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4)

Ways to minimize the burden of the

collection of information on those who

are to respond, including the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the

proposed project, to obtain a copy of the

data collection plans and instruments,

or to submit comments, contact Ms.

Suzanne Anthony, Project Clearance

Liaison, National Heart, Lung, and

Blood Institute, NIH, Building 31, Room

5A10, MSC 2490, 31 Center Dr.,

Bethesda, MD 20892–2490 or call nontoll free number (301) 496–9737, or Email your request or comments,

including your address, to:

AnthonyS@nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collect are

best assured of having their full effect if

received by June 9, 1997.

Dated: April 4, 1997.

Sheila E. Merritt,

Executive Officer, NHLBI.

[FR Doc. 97–9296 Filed 4–9–97; 8:45 am]

BILLING CODE 4140–01–M