[Federal Register Volume 63, Number 229 (Monday, November 30, 1998)]
[Notices]
[Pages 65794-65795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0996]


Draft Guidance for Industry on General Considerations for 
Pediatric Pharmacokinetic Studies for Drugs and Biological Products; 
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availability of a draft guidance for industry entitled ``General 
Considerations for Pediatric Pharmacokinetic Studies for Drugs and 
Biological Products.'' This document is intended to assist applicants 
who plan to conduct pharmacokinetic (PK) studies in the pediatric 
population so that drugs and biological products can be labeled for 
pediatric use.

DATES: Written comments may be submitted on the draft guidance by 
January 29, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or 
``http://www.fda.gov/cber/guidelines.htm''. Submit written requests for 
single copies of ``General Considerations for Pediatric Pharmacokinetic 
Studies for Drugs and Biological Products'' to the Drug Information 
Branch (HFD-210), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 or 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 one 
self-addressed adhesive label to assist the office in processing your 
requests. Copies of this guidance may also be obtained by fax from 1-
888-CBERFAX or 301-827-3844 or by mail from the CBER Voice Information 
System at 800-835-4709 or 301-827-1800.
    Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Leanne Cusumano, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2330.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``General Considerations for 
Pediatric Pharmacokinetic Studies for Drugs and Biological Products.'' 
The guidance is intended to assist applicants who plan to conduct 
pharmacokinetic (PK) studies in the pediatric population so that drugs 
and biological products can be labeled for pediatric use.
    In the past few years, the agency has addressed the need for 
greater information on the use of drugs in the pediatric population. In 
the Federal

[[Page 65795]]

Register of December 13, 1994 (59 FR 64240), FDA published a final rule 
that encouraged manufacturers to provide more information in the 
labeling on the use of a drug in the pediatric population. The rule 
recognized several methods of establishing substantial evidence to 
support pediatric labeling claims, including relying in certain cases 
on studies carried out in adults. Under the final rule, products may be 
labeled for pediatric use based on adequate and well-controlled studies 
in adults together with other information supporting pediatric use 
(e.g., pharmacokinetic data, safety data, pharmacodynamic data). In the 
Federal Register of August 15, 1997 (62 FR 43899), FDA published a 
proposed rule that would require new drugs and biological products to 
be labeled for use in the pediatric population. The enactment of the 
Food and Drug Modernization Act of 1997 (Pub. L. 105-111) 
(Modernization Act) on November 21, 1997, further addressed this need 
by providing incentives to sponsors for conducting pediatric studies 
(21 U.S.C. 355a). This draft guidance addresses general considerations 
for conducting PK studies in the pediatric population.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on pediatric pharmacokinetic studies. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute, 
regulations, or both.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). 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 draft 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.

    Dated: November 19, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-31691 Filed 11-27-98; 8:45 am]
BILLING CODE 4160-01-F