Document ID: FDA-2013-D-0814-0016
Agency: fda
Document Type: Notice
Title: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans; Draft Guidance for Industry; Availability
Posted Date: 2016-03-09T05:00Z

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12508-12509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05223]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Pediatric Study Plans: Content of and Process for Submitting 
Initial Pediatric Study Plans and Amended Initial Pediatric Study 
Plans; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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the availability of a draft guidance for industry entitled ``Pediatric 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 Initial Pediatric Study Plans.'' This draft 
guidance is intended to provide information to sponsors regarding the 
submission of an initial pediatric study plan (iPSP) and any amendments 
to the iPSP as required under the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) as amended by the Food and Drug Administration Safety 
and Innovation Act (FDASIA). This guidance revises the draft guidance 
entitled ``Pediatric Study Plans: Content of and Process for Submitting 
Initial Pediatric Study Plans and Amended Pediatric Study Plans'' 
issued July 15, 2013.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0814 for ``Pediatric Study Plans: Content of and Process for 
Submitting Initial Pediatric Study Plans and Amended Initial Pediatric 
Study Plans; Draft Guidance for Industry; Availability.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office 
of Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.

[[Page 12509]]

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.

FOR FURTHER INFORMATION CONTACT: Rosemary Addy, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6430, Silver Spring, MD 20993-0002, 301-
796-1640; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

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 Initial Pediatric Study 
Plans.'' The purpose of this draft guidance is to assist sponsors in 
the submission of an iPSP and any amendments to an iPSP. Specifically, 
this guidance addresses FDA's current thinking regarding the 
requirement for sponsors to submit an iPSP under section 505B of the 
FD&C Act (21 U.S.C. 355c) as amended by FDASIA.
    This guidance revises the draft guidance entitled ``Pediatric Study 
Plans: Content of and Process for Submitting Initial Pediatric Study 
Plans and Amended Pediatric Study Plans'' issued July 15, 2013 (78 FR 
42085). Changes made in this draft guidance were based largely on 
public comments received by FDA on the 2013 draft guidance.
    The following topics are addressed in this draft guidance: (1) Who 
must submit an iPSP; (2) when an iPSP must be submitted; (3) what 
should be included in an iPSP; (4) what should be included in a 
requested amendment to an iPSP; (5) the relationship of an agreed iPSP 
to the requirement to submit a pediatric study plan with a marketing 
application; (6) what is meant by a non-agreed iPSP; and (7) processes 
for reaching agreement with FDA on a non-agreed iPSP. This draft 
guidance also includes a revised template that should be used for 
submission of an iPSP.
    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 current thinking of FDA on the content of 
and process for submitting iPSPs and amended iPSPs. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it 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 (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 biologics 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.

III. Electronic Access

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

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05223 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P