[Federal Register Volume 61, Number 102 (Friday, May 24, 1996)]
[Notices]
[Pages 26191-26192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13175]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0133]


Guidance for Industry; The Content and Format for Pediatric Use 
Supplements; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="551211100510111534647b161710077b1311147b121a03">[email protected]</a>. 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 Sec. 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 Sec. 201.57(f)(9)(iv); the age categories for which 
pediatric data are being submitted; identification of the kind of 
pediatric data submitted within

[[Page 26192]]

each age category; a summary of the information submitted to support 
the pediatric labeling statements and an integrated summary of the 
pediatric safety data with a risk/benefit assessment; and presentation 
of the data.-
    Although this guidance does not create or confer any rights for or 
on any person and does not operate to bind FDA, it does represent the 
agency's current thinking on how to prepare ``pediatric use'' labeling 
supplements for submission to FDA.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the guidance. 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. The guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday. If written comments demonstrate that 
changes to the guidance are appropriate, such changes to the guidance 
will be made.

    Dated: May 17, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-13175 Filed 5-23-96; 8:45 am]
BILLING CODE 4160-01-F

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