40536 Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Notices

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–19893 Filed 7–28–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0453]

Guidance for Screening and Testing of

Donors of Human Tissue Intended for

Transplantation; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for Screening and

Testing of Donors of Human Tissue

Intended for Transplantation.’’ The

purpose of the guidance document is to

assist facilities involved in recovery,

infectious disease testing, screening,

processing, storing, or distributing

human tissue intended for

transplantation. The guidance document

provides information on procedures and

practices for donor screening and

testing. FDA prepared the guidance

document after receiving public input.

The topics included in the guidance

document were contained in a draft

document ‘‘Screening and Testing of

Donors of Human Tissue Intended for

Transplantation’’ made available for

discussion at a public workshop on

human tissue held on June 20 and 21,

1995.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the ‘‘Guidance for

Screening and Testing of Donors of

Human Tissue Intended for

Transplantation’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844.

Persons with access to the Internet

may obtain the document using File

Transfer Protocol (FTP), the World Wide

Web (WWW), or bounce–back e–mail.

For FTP access, connect to CBER at

‘‘ftp://ftp.fda.gov/cber/’’. For WWW

access, connect to CBER at ‘‘http://

www.fda.gov/cber/publications.htm’’.

To receive the document by bounce–

back e–mail, send a message to

‘‘tissue2@a1.cber.fda.gov’’.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Two copies of any comments are

to be submitted, except individuals may

submit one copy. Requests and

comments are to be identified with the

docket number found in brackets in the

heading of this document. The guidance

document and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 14, 1993

(58 FR 65514), FDA published an

interim rule on human tissue intended

for transplantation to reduce the risk of

transmission of human

immunodeficiency virus (HIV) and

hepatitis through human tissue

intended for transplantation. The

interim rule was issued under the

authority of sections 215, 311, 361, and

368 of the Public Health Service Act (42

U.S.C. 216, 243, 264, 271) because of an

immediate need to protect the public

health from the transmission of

communicable diseases through the

transplantation of human tissue. The

interim rule established requirements

for the testing of donors of human tissue

for HIV Type 1 virus, HIV Type 2 virus,

hepatitis B virus, and hepatitis C virus.

The interim rule also required that

donors be screened for medical history,

including behaviors that carry an

increased risk of exposure to these

viruses (behavioral and high risk

information) and for signs and

symptoms of infection with these

viruses.

In the Federal Register of June 20,

1995 (60 FR 32128), FDA announced the

availability for public comment of a

draft document entitled ‘‘Screening and

Testing of Donors of Human Tissue

Intended for Transplantation.’’ The

availability of the draft document

coincided with the workshop on Human

Tissue for Transplantation and Human

Reproductive Tissue: Scientific and

Regulatory Issues and Perspectives

which was held on June 20 and 21,

1995. Comments received on this draft

document and the issues discussed at

the workshop were considered in the

development of the guidance document

being announced in this notice.

This guidance document provides

general information on the following

procedures: (1) Determination of donor

suitability, (2) evaluation of screening

test performance, (3) application of a

plasma dilution algorithm to determine

the acceptability of the blood specimen

used for testing, (4) screening for

behavioral and high risk information,

and (5) evaluation of clinical and

physical evidence of infection with HIV

or hepatitis.

As technical standards change over

time due to an increased understanding

of infectious diseases and improved

technology for testing, FDA may issue

future guidance to help ensure that the

regulatory process reflects the current

level of knowledge. The

recommendations in this guidance

document should be considered in

addition to voluntary standards

developed and used by human tissue

organizations.

This document is not being issued

under the authority of 21 CFR 10.90(b)

because FDA is in the process of

revising this section. As with other

guidance documents, FDA does not

intend this document to be all–

inclusive. This document does not bind

the agency and does not create or confer

any rights, privileges, or benefits for or

on any person. Tissue facilities may

follow the guidance document or may

choose to use alternative procedures not

provided in the guidance document. If

a tissue facility chooses to use

alternative procedures, the facility may

wish to discuss the matter further with

the agency to prevent expenditure of

resources on activities that may be

unacceptable to FDA.

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above)

regarding 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. Continued comment by the

human tissue industry is encouraged,

and comments will be continuously

accepted by the Dockets Management

Branch.

FDA periodically will review written

comments on the guidance document to
Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Notices 40537

determine whether future revisions to

the guidance document are warranted.

Dated: January 21, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–19821 Filed 7-28-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–P–15A]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summaries of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicare

Current Beneficiary Survey (MCBS)

Rounds: 20–32; Form No.: HCFA–P–

15A (OMB# 0938–0568); Use: The

MCBS is a continuous, multipurpose

survey of a nationally representative

sample of aged and disabled persons

enrolled in Medicare. The survey

provides a comprehensive source of

information on beneficiary

characteristics, needs, utilization, and

satisfaction with Medicare-related

activities; Frequency: Other (3 times a

year per respondent); Affected Public:

Individuals and households; Number of

Respondents: 16,000; Total Annual

Responses: 48,000; Total Annual Hours:

48,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: July 9, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–19924 Filed 7–28–97; 8:45 am]

BILLING CODE 4120–03–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

National Cancer Institute Special

Emphasis Panel (SEP) meeting:

Name of SEP: Genetic Epidemiology of

Lung Cancer I and II.

Date: August 4, 1997.

Time: 11:00 a.m. to 12:30 p.m.

Place: Teleconference, National Cancer

Institute, Executive Plaza North, Room 635G,

6130, Executive Boulevard, Bethesda, MD

20892.

Contact Person: Sally A. Mulhern, Ph.D.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 635G, 6130 Executive Boulevard, MSC

7410, Bethesda, MD 20892–7410, Telephone:

301/496–7413.

Purpose/Agenda: To evaluate and review

grant applications.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

The meeting 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 the discussions could

reveal confidential trade secrets or

commercial property such as patentable

material and personal information

concerning individuals associated with the

applications, the disclosure of which would

constitute a clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control)

Dated: July 22, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–19848 Filed 7–28–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer 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

National Cancer Institute Special

Emphasis Panel (SEP) meetings:

Name of SEP: Pivotal Clinical Trials for

Chemoprevention Agent Development.

Date: August 18–19, 1997.

Time: August 18—7:00 a.m.–5:00 p.m.;

August 19—8:00 a.m.–5:00 p.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, Md 20852.

Contact Person: Ray Bramhall, PhD.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 636, 6130 Executive Boulevard, MSC

7410, Bethesda, Md 20892–7410, Telephone:

301/496–3428.

Purpose/Agenda: To evaluate and review

grant applications.

Name of SEP: Chemoprevention in

Genetically-Identified High-Risk Groups:

Interactive Research and Development

Project.

Date: August 25–26, 1997.

Time: August 25—8:30 a.m.–5:00 p.m.;

August 26—8:00 a.m.–5:00 p.m.

Place: Hyatt Regency Bethesda, 1 Bethesda

Metro Center, Bethesda, Md 20814.

Contact Person: Ray Bramhall, PhD.,

Scientific Review Administrator, National

Cancer Institute, NIH, Executive Plaza North,

Room 636, 6130 Executive Boulevard, MSC

7410, Bethesda, Md 20892–7410, Telephone:

301/496–3428.

Purpose/Agenda: To evaluate and review

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 the discussions could

reveal confidential trade secrets or

commerical property such as patentable

material and personal information

concerning individuals associated with the

applications, the disclosure of which would

constitute a clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,