Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices 26191

Dated: May 20, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–13177 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

Compressed Medical Gas Industry;

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA) (Office of

Regulatory Affairs, Office of the

Southeast Region, and the Center for

Drug Evaluation and Research) is

announcing a free public workshop on

FDA regulatory requirements for the

compressed medical gas industry. The

workshop is designed to assist the

industry in complying with regulations

for manufacturing and repacking

medical gases.

DATES: The public workshop will be

held on Tuesday, June 4, 1996, from

8:30 a.m. to 4 p.m.

ADDRESSES: The public workshop will

be held at the Rural Development

Center, UGA Cooperative Extension

Service, U.S. 41 North and I–75 (exit

21), Tifton, GA.

FOR FURTHER INFORMATION CONTACT:

Douglas B. Brogden or Jackie M.

Douglas, FDA Atlanta District Office,

225 Tift Ave., rm. 107, Tifton, GA

31794, 912–382–5963, FAX 912–386–

9610. Those persons interested in

attending this meeting should FAX their

registration including name(s), firm

name, address, telephone and FAX

numbers, and any specific questions

about the workshop to Douglas B.

Brogden or Jackie M. Douglas (address

above) by May 15, 1996. There is no

registration fee for this workshop.

Advance registration is required. Space

is limited and all interested parties are

encouraged to register early.

SUPPLEMENTARY INFORMATION: FDA’s

survey of the medical gas industry

shows that many medical gas firms are

either unaware of applicable regulations

and guidelines or not in compliance

with applicable requirements. This

workshop is designed to assist the

medical gas industry in complying with

regulations for manufacturing and

repacking medical gases. This workshop

is free of charge to attendees.

Dated: May 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13104 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96D–0133]

Guidance for Industry; The Content

and Format for Pediatric Use

Supplements; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance for Industry; The Content

and Format for Pediatric Use

Supplements.’’ This guidance was

prepared by the Pediatric Subcommittee

of the Medical Policy Coordinating

Committee (MPCC) of the Center for

Drug Evaluation and Research (CDER) in

collaboration with the Center for

Biologics Evaluation and Research

(CBER). The availability of this

document is intended to provide

guidance on the format and content of

‘‘pediatric use’’ labeling supplements to

approved applications for drugs and

licensed biological products. This

labeling information is intended to

provide practitioners with sufficient

‘‘pediatric use’’ information upon which

to base a decision to prescribe a drug for

use in pediatric patients.

DATES: Written comments on the

guidance may be submitted at any time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance for Industry; The Content

and Format For Pediatric Use

Supplements’’ to the Division of

Communications Management, Center

for Drug Evaluation and Research (HFD–

210), Food and Drug Administration,

7500 Standish Pl., Rockville, MD 20855

or to the Office of Communication,

Training and Manufacturers Assistance

(HFM–40), Center for Biologics

Evaluation and Research, Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448. Send

two self-addressed adhesive labels to

assist that office in processing your

requests. Persons with access to the

INTERNET may request that the

guidance document be sent by ‘‘bounce

back e-mail’’ using the following

address: GDEPED@a1.CBER.FDA.GOV.

The guidance document may also be

obtained through the INTERNET via

File Transfer Protocol (FTP). Requesters

should connect to the CDER FTP server

at ‘‘CDVS2.CDER.FDA.GOV’’ and

change to the ‘‘guidance’’ directory. The

‘‘READ.ME’’ file in that subdirectory

describes the available documents that

may be available as an ASCII text file

(*.TXT), or a WordPerfect 5.1 document

(*.w51), or both. Further, the guidance

document is available via the World

Wide Web (WWW) and Gopher. To

obtain the guidance document via the

WWW requesters should connect to the

FDA home page at ‘‘WWW.FDA.GOV’’

and go to the CDER ‘‘Human Drugs’’

icon. To obtain the guidance document

via Gopher requesters should connect to

CDER’s Gopher server at

‘‘GOPHER.CDER.FDA.GOV’’ and select

the ‘‘Industry Guidance’’ menu option.

Finally, the guidance document is

available via FAX by calling the Center

for Biologics Evaluation and Research

Voice Information System at 1–800–

835–4709.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the guidance 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:

Regarding human drugs: Terry Martin,

Center for Drug Evaluation and

Research (HFD–6), Food and Drug

Administration, 1451 Rockville

Pike, Rockville, MD 20852, 301–

594–5460.

Regarding biological products: Elaine

Esber, Center for Biologics

Evaluation and Research (HFM–30),

Food and Drug Administration,

8800 Rockville Pike, Bethesda, MD

20892, 301–827–0641.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance entitled ‘‘Guidance for

Industry; The Content and Format For

Pediatric Use Supplements.’’ The

guidance is intended to provide

sponsors with format and content

information for submitting ‘‘pediatric

use’’ labeling supplements to approved

applications for drugs or licensed

biological products. The guidance

provides a general description of the

information that should be submitted in

a ‘‘pediatric use’’ supplement, including

draft revised labeling and a marked-up

copy of the current labeling, clearly

showing all revisions; the appropriate

paragraph of § 201.57(f)(9) (21 CFR

201.57(f)(9)) that applies and a

justification for the paragraph; a basis

for concluding that the course of the

disease and the effects of the drug are

similar in the pediatric and adult

population if changes in labeling fall

under § 201.57(f)(9)(iv); the age

categories for which pediatric data are

being submitted; identification of the

kind of pediatric data submitted within