17624 Federal Register / Vol. 62, No. 69 / Thursday, April 10, 1997 / Notices

diagnosis of TB; impact of managed care on

TB control efforts; and surveillance efforts

relating to TB control. Agenda items are

subject to change as priorities dictate.

Contact Person for More Information: Beth

Wolfe, Program Analyst, National Center for

HIV, STD, and TB Prevention, 1600 Clifton

Road, NE, M/S E–07, Atlanta, Georgia 30333,

telephone 404/639–8008.

Dated: March 31, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–9195 Filed 4–9–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95F–0122]

Hempel Coatings (USA), Inc.;

Withdrawal of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 5B4457), proposing that the food

additive regulations be amended to

provide for the safe use of metaxylylenediamine and 3-

diethylaminopropylamine as

components of articles intended for

food-contact use.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

June 22, 1995 (60 FR 32526), FDA

announced that a food additive petition

(FAP 5B4457) had been filed by Hempel

Coatings (USA), Inc., 6901 Cavalcade

St., Houston, TX 77028. The petition

proposed to amend the food additive

regulations in § 175.300 Resinous and

polymeric coatings (21 CFR 175.300) to

provide for the safe use of metaxylylenediamine and 3-

diethylaminopropylamine as

components of articles intended for

food-contact use. Hempel Coatings

(USA), Inc., has now withdrawn the

petition without prejudice to a future

filing (21 CFR 171.7).

Dated: March 26, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–9168 Filed 4–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0029]

‘‘Guidance for Industry for the

Evaluation of Combination Vaccines

for Preventable Diseases: Production,

Testing and Clinical Studies;’’

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled

‘‘Guidance for Industry for the

Evaluation of Combination Vaccines for

Preventable Diseases: Production,

Testing and Clinical Studies.’’ This

document provides information

regarding the manufacture and clinical

study of combination vaccines. This

document is intended to assist

manufacturers and other interested

parties with the development and

licensure of combination vaccines.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry

for the Evaluation of Combination

Vaccines for Preventable Diseases:

Production, Testing and Clinical

Studies’’ 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 the World Wide

Web (WWW), or bounce-back e-mail.

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

cberftp.html’’. To receive the document

by bounce-back e-mail, send a message

to ‘‘COMBVAC@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 that individuals

may submit one copy. Comments

should be identified with the docket

number found in brackets in the

heading of this document. A copy of

this 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:

Stephen M. Ripley, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

document entitled ‘‘Guidance for

Industry for the Evaluation of

Combination Vaccines for Preventable

Diseases: Production, Testing and

Clinical Studies.’’ In the Federal

Register of June 25, 1993 (58 FR 34469),

FDA announced the July 28 and 29,

1993, scientific workshop entitled

‘‘Combined Vaccines and Simultaneous

Administration: Current Issues and

Perspectives.’’ Issues discussed and

information gathered in this workshop

were considered in preparing this

document. Prior to making this

document available for industry use,

FDA presented the issues discussed in

this document at the October 27, 1995,

Vaccines and Related Biological

Products Advisory Committee meeting.

FDA announced the advisory committee

meeting and the availability of a draft

guidance document in the Federal

Register of October 2, 1995 (60 FR

51481 at 51482). Comments received

from the meeting were considered in

further preparation of this document.

For the purposes of this guidance

document, a combination vaccine

consists of two or more live organisms,

inactivated organisms or purified

antigens combined either by the

manufacturer or mixed immediately

before administration, and it is intended

to: (1) Prevent multiple diseases, or (2)

prevent one disease caused by different

strains or serotypes of the same

organism. Vectored vaccines and

conjugated vaccines are combination

vaccines, if the prevention of the disease

caused by the vector organism or the

carrier moiety is to be one of the

combination’s indication.

This guidance document discusses

the approach manufacturers, sponsors,

and investigators should follow in the