26188 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Science Board to the Food and Drug

Administration

Date, time, and place. June 13, 1996,

8:30 a.m., Sheraton—Crystal City,

Ballroom A, 1800 Jefferson Davis Hwy.,

Arlington, VA.

Type of meeting and contact person.

Open committee discussion, 8:30 a.m. to

2:30 p.m.; open public hearing, 2:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5 p.m.; Susan Homire, Office of Science

(HF–33), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–3340, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Science Board to the Food and Drug

Administration, code 12603. Please call

the hotline for information concerning

any possible changes.

General function of the board. The

board shall provide advice primarily to

the agency’s Senior Science Advisor,

and, as needed, to the Commissioner

and other appropriate officials on

specific complex and technical issues as

well as emerging issues within the

scientific community in industry and

academia. Additionally, the board will

provide advice to the agency on keeping

pace with technical and scientific

evolutions in the fields of regulatory

science; on formulating an appropriate

research agenda; and on upgrading its

scientific and research facilities to keep

pace with these changes. It will also

provide the means for critical review of

agency-sponsored intramural and

extramural scientific research programs.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

board. Those desiring to make formal

presentations must notify the contact

person before June 6, 1996, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, and the names and addresses of

proposed participants. Each presenter

will be limited in time and not all

requests to speak may be able to be

accommodated. All written statements

submitted in a timely fashion will be

provided to the board.

Open board discussion. The board

will continue its discussions related to

FDA’s approach to toxicity,

carcinogenicity and biomaterials testing.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: May 20, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–13105 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory
Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices 26189

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Ear, Nose, and Throat Devices Panel

of the Medical Devices Advisory

Committee

Date, time, and place. June 11, 1996,

8:30 a.m., Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD. A limited number of

overnight accommodations have been

reserved at the Marriott Courtyard

Hotel, 2500 Research Blvd., Rockville,

MD. Attendees requiring overnight

accommodations may contact the hotel

at 301–670–6700 and reference the FDA

Panel meeting block. Reservations will

be confirmed at the group rate based on

availability. Attendees with a disability

requiring special accommodations

should notify the contact person listed

below. The availability of special

accommodations cannot be assured

unless prior written notification is

received.

Type of meeting and contact person.

Open public hearing, 8:30 a.m. to 9:45

a.m., unless public participation does

not last that long; open committee

discussion, 9:45 a.m. to 4 p.m.; closed

committee deliberations, 4 p.m. to 5

p.m.; Marilyn N. Flack, Center for

Devices and Radiological Health (HFZ–

470), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–2080, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Ear, Nose, and

Throat Devices Panel, code 12522.

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before May 29, 1996, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

required to make their comments.

Open committee discussion. The

committee will discuss a premarket

approval application that seeks to

substantiate the safety and effectiveness

of a bronchoscope device utilizing

autofluorescence to aid in detection of

abnormal lung tissue.

Closed committee deliberations. FDA

staff will present to the committee trade

secret and/or confidential commercial

information regarding present and

future FDA issues. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Oncologic Drugs Advisory Committee

Date, time, and place. June 13 and 14,

1996, 8:30 a.m., Holiday Inn—

Gaithersburg, Walker and Whetstone

Rooms, Two Montgomery Village Ave.,

Gaithersburg, MD.

Type of meeting and contact person.

Open public hearing, June 13, 1996,

8:30 a.m. to 9:30 a.m., unless public

participation does not last that long;

open committee discussion, 9:30 a.m. to

4:30 p.m.; open committee discussion,

June 14, 1996, 8:30 a.m. to 1 p.m.;

closed committee deliberations, 1 p.m.

to 3:30 p.m.; Jannette O’Neill-Gonzalez,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Oncologic Drugs Advisory Committee,

code 12542. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in treatment of cancer.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before June 7, 1996, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

required to make their comments.

Open committee discussion. On June

13, 1996, the committee will discuss: (1)

New drug application (NDA) 20–571

CamptosarTM (irinotecan hydrochloride

injection, The Upjohn Co.), indicated for

the treatment of patients with metastatic

carcinoma of the colon or rectum whose

disease has recurred or progressed

following 5–FU-based therapy; and (2)

NDA 20–036/S–011 Aredia

(pamidronate disodium for injection,

Ciba-Geigy Corp.), indicated for use in

conjunction with standard

antineoplastic therapy for treatment of

osteolytic bone metastases. On the

morning of June 14, 1996, the committee

will discuss NDA 20–637, Gliadel

Wafer (polifeprosan 20 with

carmustine, Guilford Pharmaceuticals),

indicated for use as an adjunct to

surgery to prolong survival in patients

with a malignant glioma.

Closed committee deliberations. On

the afternoon of June 14, 1996, the

committee will review trade secret and/

or confidential commercial information

relevant to pending investigational new

drug applications and NDA’s. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).

Blood Products Advisory Committee

Date, time, and place. June 20 and 21,

1996, 8 a.m., Holiday Inn—Bethesda,

Versailles Ballrooms II and III, 8120

Wisconsin Ave., Bethesda, MD.

Type of meeting and contact person.

Open committee discussion, June 20,

1996, 8 a.m. to 11 a.m.; open public

hearing, 11 a.m. to 11:30 a.m., unless

public participation does not last that

long; open committee discussion, 11:30

a.m. to 1:30 p.m.; closed committee

deliberations, 1:30 p.m. to 2:30 p.m.;

open committee discussion, 2:30 p.m. to

3:30 p.m.; open public hearing, 3:30

p.m. to 4 p.m., unless public

participation does not last that long;

open committee discussion, 4 p.m. to

5:30 p.m.; open committee discussion,

June 21, 1996, 8 a.m. to 10:30 a.m.; open

public hearing, 10:30 a.m. to 11:30 a.m.,

unless public participation does not last

that long; open committee discussion,

11:30 a.m. to 2:30 p.m.; open public

hearing, 2:30 p.m. to 3 p.m., unless

public participation does not last that

long; open committee discussion, 3 p.m.

to 4 p.m.; Linda A. Smallwood, Center

for Biologics Evaluation and Research

(HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–3514, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area), Blood

Products Advisory Committee, code

12388. Please call the hotline for

information concerning any possible

changes.
26190 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Notices

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness, and

appropriate use of blood products

intended for use in the diagnosis,

prevention, or treatment of human

diseases.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before June 14, 1996, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

required to make their comments.

Open committee discussion. On the

morning of June 20, 1996, updates on

relevant public health issues will be

presented and an overview of draft

reviewer guidance for blood

establishment computer software will be

presented and discussed. In the

afternoon, there will be discussion of

use of hemoglobin solutions in fluid

rescuscitation from hemorrhagic shock;

in particular, issues in clinical trials. On

the morning of June 21, 1996, proposed

revisions to the human

immunodeficiency virus (HIV) re-entry

algorithm will be reviewed and

discussed. In the afternoon, the Calypte

Laboratories test for anti-HIV in urine

will be presented and discussed.

Closed committee deliberations. On

June 20, 1996, the committee will

review trade secret and/or confidential

commercial information relevant to

current or pending products. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.
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