[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13686-13687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0169]


Draft Guidance for Industry and Review Staff on Pediatric 
Information Incorporated Into Human Prescription Drug and Biological 
Products Labeling; 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availability of a draft guidance for industry and review staff entitled 
``Pediatric Information Incorporated into Human Prescription Drug and 
Biological Products Labeling.'' This draft guidance is intended to 
assist applicants and FDA review staff in making decisions about the 
placement and content of pediatric information in human prescription 
drug and biological products labeling in accordance with the Best 
Pharmaceuticals for Children Act (BPCA) and the Pediatric Research 
Equity Act (PREA), as amended by the Food and Drug Administration 
Safety and Innovation Act (FDASIA), as well as FDA prescription drug 
and biological product labeling regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 29, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or 
the Office of Communication, Outreach, and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
Matthew Bacho, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6420, Silver 
Spring, MD 20993-0002, 301-796-0067; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and review staff entitled ``Pediatric Information Incorporated into 
Human Prescription Drug and Biological Products Labeling.'' In July 
2012, FDASIA (Pub. L. 112-144) reauthorized and made permanent the BPCA 
and PREA. The goal of both the BPCA and PREA is to provide pediatric 
information in drug labeling to encourage the appropriate use of drugs 
in treating pediatric patients.
    Data submitted in response to a pediatric Written Request under the 
BPCA and assessments submitted in response to a PREA study requirement 
must be described in labeling, whether the findings are positive, 
negative, or inconclusive (sections 505A and 505B of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a) and 21 U.S.C. 
355(c)) as amended by

[[Page 13687]]

FDASIA). In addition, when pediatric studies under PREA are fully or 
partially waived by FDA because there is evidence that a drug would be 
ineffective or unsafe in a pediatric population or pediatric 
subpopulation, the safety concern or lack of efficacy must be reflected 
in the prescription drug labeling (section 505B(a)(4)(D) of the FD&C 
Act). All useful information on the use of drugs and biological 
products in the pediatric population should be consistently placed in 
the proper sections within prescription labeling so that the 
information is clear and accessible to health care providers.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on 
incorporating pediatric information into human prescription drug and 
biological products labeling. 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 statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 201.56 and 201.57 have 
been approved under OMB control number 0910-0572.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04625 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P