[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Draft Guidance for Industry on Pediatric Study Plans: Content of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availability of a draft guidance for industry entitled ``Pediatric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 This draft guidance is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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 13, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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