[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42085-42086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0814]


Draft Guidance for Industry on Pediatric Study Plans: Content of 
and Process for Submitting Initial Pediatric Study Plans and Amended 
Pediatric Study Plans; 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availability of a draft guidance for industry entitled ``Pediatric 
Study Plans: Content of and Process for Submitting Initial Pediatric 
Study Plans and Amended Pediatric Study Plans.'' This draft guidance is 
intended to provide information to industry on how to submit initial 
and amended pediatric study plans (PSPs) as required under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug 
Administration Safety and Innovation Act (FDASIA).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 13, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
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

[[Page 42086]]

for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Rosemary Addy, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-1640; 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 
entitled ``Pediatric Study Plans: Content of and Process for Submitting 
Initial Pediatric Study Plans and Amended Pediatric Study Plans.'' The 
purpose of this draft guidance is to assist sponsors in the submission 
of an initial PSP and any amendments to the PSP. Specifically, this 
guidance addresses FDA's current thinking regarding implementation of 
the requirement for sponsors to submit an initial PSP under section 
505B of the FD&C Act as amended by FDASIA (Pub. L. 112-144, 126 Stat. 
993 (enacted July 9, 2012)).
    This draft guidance addresses topics related to the submission of 
an initial PSP and any amendments to the PSP, including who must submit 
an initial PSP, when a PSP must be submitted, what is expected to be 
included in an initial PSP, and what is expected to be included in a 
requested amendment to an initial PSP. The guidance also includes a 
template that should be used for submission of an initial PSP.
    This draft guidance does not contain a discussion of general 
requirements for pediatric drug development under the Pediatric 
Research Equity Act. That topic is addressed in the draft guidance for 
industry entitled ``How to Comply With the Pediatric Research Equity 
Act.'' \1\
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    \1\ When final, this guidance will represent the FDA's current 
thinking on this topic. For the most recent version of a guidance, 
check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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    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 the content 
of and process for submitting initial PSPs and amended PSPs. 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 draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information referenced in this draft guidance that 
are related to the burden on the submission of investigational new drug 
applications are covered under 21 CFR Part 312, including plans for 
pediatric studies under 21 CFR 312.47(b)(1)(iv) and waiver requests 
under 21 CFR 312.10, and have been approved under OMB control number 
0910-0014. The collections of information referenced in this draft 
guidance that are related to the burden on the submission of new drug 
applications are covered under 21 CFR Part 314, including pediatric use 
information under 21 CFR 314.50(d)(7) and waiver requests under 21 CFR 
314.90, and have been approved under OMB control number 0910-0001. The 
collections of information referenced in this draft guidance that are 
related to the burden on the submission of biologic license 
applications are covered under 21 CFR Part 601, including pediatric use 
information and waiver requests under 21 CFR 601.27, and have been 
approved under OMB control number 0910-0338.
    Sponsors are already required to submit plans for pediatric studies 
and often provide the information outlined in this guidance pursuant to 
the regulations noted above. The new FDASIA provisions primarily serve 
to establish a more precise timeline for the submission of that 
information; however, some of the information may be considered a new 
collection of information. Federal law at 44 U.S.C. 3506(c)(2)(A) 
requires Federal Agencies to publish a 60-day notice in the Federal 
Register for each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA will publish a 60-day notice of the proposed collection of 
information in a future issue of the Federal Register for any 
information collections recommended in this guidance that may be 
considered new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

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: July 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16825 Filed 7-12-13; 8:45 am]
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