Federal Register / Vol. 62, No. 194 / Tuesday, October 7, 1997 / Notices 52345

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On June 20, 1997, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before November 6, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: September 11, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–26563 Filed 10–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0411]

Bovine Spongiform Encephalopathy

(BSE) in Products for Human Use;

Guidance for Industry on the Sourcing

and Processing of Gelatin to Reduce

Potential Risk; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘The Sourcing and Processing

of Gelatin to Reduce the Potential Risk

Posed by Bovine Spongiform

Encephalopathy (BSE) in FDARegulated Products for Human Use.’’

This guidance is intended to provide

information to industry on reducing the

risk of transmission of BSE in gelatin for

human use.

DATES: Submit written comments on

this guidance by December 22, 1997.

ADDRESSES: Submit written requests for

single copies of the guidance document

to the Executive Secretariat (HF–40),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857.

Send one self-addressed adhesive label

to assist that office in processing your

request. 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.

FOR FURTHER INFORMATION CONTACT:

Linda H. Gangloff, Executive Secretariat

(HF–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4450.

SUPPLEMENTARY INFORMATION: In 1994,

representatives of the gelatin industry

presented preliminary data to FDA

concerning an experimental study of the

infectivity of tissue infected with a

transmissible spongiform

encephalopathy (TSE). TSE’s are rare,

fatal, neurological diseases that occur in

a number of animals (e.g., scrapie in

sheep) and in humans (e.g., CreutzfeldtJakob disease). Based on the data

presented, FDA decided that

recommendations concerning bovine

ingredients from countries that have

reported BSE in FDA-regulated products

would not include gelatin. A notice in

the Federal Register of August 29, 1994

(59 FR 44584), summarized FDA’s

recommendations to reduce any

potential BSE risk to humans from FDAregulated products and clarified that

FDA did not object at that time to

gelatin for human use produced from

bovine materials from countries

reporting BSE.

FDA is committed to amending

previous guidance to industry as new

information becomes available. On

April 23 and 24, 1997, FDA’s TSE

Advisory Committee discussed

information on gelatin manufacturing

practices and final results of the

research study. At the end of the

meeting, a majority of the advisory

committee members agreed that current

scientific evidence did not justify

continued exemption of gelatin from

restrictions recommended by FDA for

other bovine-derived materials from

BSE countries. They also stated that the

potential risk of BSE transmission from

bovine-derived gelatin varies depending

on the country of origin of the raw

materials, type of tissue used, the

gelatin processes used, and the route of

administration or exposure.

FDA has adopted ‘‘Good Guidance

Practices’’ (GGP’s) that set forth the

agency’s policies and procedures for the

development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). The guidance

announced in this document is issued

as a Level 1 guidance consistent with

GGP’s. The agency is accepting public

comments, but it is implementing this

guidance immediately because of public

health concerns related to the use of

gelatin. This guidance represents the

agency’s current thinking on reducing

the potential risk of transmission of BSE

related to the use of gelatin in FDAregulated products for human use. It

does not create or confer any rights for

or on any person and does not operate

to bind the FDA or the public. An

alternative approach may be used if

such an approach satisfies the

requirements of the applicable statute,

regulations, or both.

Interested persons may, on or before

December 22, 1997, submit to the

Dockets Management Branch (address

above) written comments regarding this

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
52346 Federal Register / Vol. 62, No. 194 / Tuesday, October 7, 1997 / Notices

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Persons with access to the Internet

may obtain the guidance document

using the World Wide Web (WWW). For

WWW access, go to ‘‘http://

www.fda.gov/opacom/morechoices/

industry/guidance/gelguide.htm’’.

Dated: October 1, 1997.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

[FR Doc. 97–26501 Filed 10–2–97; 12:02 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; 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 Center for Research Resources

Special Emphasis Panel (SEP) meeting:

Name of SEP: Resource Related Research

Project—R24.

Date: October 21, 1997.

Time: 9:30 a.m.—Until Adjournment.

Place: Woodfin Suites Hotel, Virginia

Room, 1380 Piccard Drive, Rockville, MD

20850 (301) 590–9880.

Contact Person: Dr. Jill Carrington,

Scientific Review Administrator, 6705

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965 (301) 435–0811.

Purpose/Agenda: To evaluate and review

grant applications.

This 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/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

Program No. 93.306, Laboratory Animal

Science and Primate Research.)

Dated: October 1, 1997.

Laverne Y. Stringfield,

Committee Management Office, NIH.

[FR Doc. 97–26505 Filed 10–6–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Amended Notice of

Meeting

Notice is hereby given of a change in

the meeting of the National Center for

Research Resources Initial Review

Group—General Clinical Research

Centers Review Committee, October 15–

16, 1997, Bethesda Ramada Hotel,

Ambassador 2 Room, 8400 Wisconsin

Avenue, Bethesda, Maryland, which

was published in the Federal Register

on September 23 (62 FR 49697).

This committee was scheduled to

meet on October 15–16, 1997, from 8:00

a.m. to 9:30 a.m. in open session, and

from 9:30 a.m. until adjournment in

closed session. The meeting has been

changed to add an additional open

session on October 16, 1997.

The session on October 16 will be

open to the public from 10:30 a.m. to

11:30 a.m., and will be closed from

11:30 a.m. until adjournment for the

review, discussion, and evaluation of

individual grant applications.

Dated: October 1, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26506 Filed 10–6–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Notice of Closed Meeting

Purusant 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 Center for Research Resources

Special Emphasis Panel (SEP) meeting:

Name of SEP: General Clinical Research

Centers

Date: October 30, 1997

Time: 8:00 a.m.–Until Adjournment

Place: City of Hope National Medical

Center, 1500 East Duarte Road, Duarte, CA

90027, (626) 301–8434

Contact Person: Dr. Charles Hollingsworth,

Scientific Review Administrator, 6705

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965, (301) 435–0806

Purpose/Agenda: To evaluate and review

grant applications.

This 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/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

Program No. 93.306, Laboratory Animal

Science and Primate Research.)

Dated: September 30, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26507 Filed 10–6–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 United States Code

Appendix 2), notice is hereby given of

the following National Institute of Child

Health and Human Development

Special Emphasis Panel (SEP) meeting:

Name of SEP: Perinatal Studies of

Disorders of Fetal Metabolism.

Date: October 6–7, 1997.

Time: October 6–7:30 p.m.–10:00 p.m.;

October 7—8:30 a.m.–adjournment.

Place: The Glidden House Inn, 1901 Ford

Drive, Cleveland, Ohio 44106.

Contact Person: Gopal Bhatnagar, Ph.D.,

Scientific Review Administrator, NICHD,

6100 Executive Boulevard, 6100 Building–

Room 5E01, Rockville, Maryland 20852;

Telephone: 301–496–1485.

Purpose/Agenda: To evaluate and review a

grant application.

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. the

discussions of this application could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the application, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

This notice is 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.

(Catalog of Federal Domestic Assistance

Program Nos. [93.864, Population Research

and No. 93.865, Research Mothers and

Children], National Institutes of Health.)

Dated: October 1, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–26503 Filed 10–6–97; 8:45 am]

BILLING CODE 4140–01–M