[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Notices]
[Pages 2746-2747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4752]


Pediatric Study Plans for Oncology Drugs: Questions and Answers; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Pediatric 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 for Oncology Drugs: Questions and Answers.'' This draft 
guidance provides information to sponsors regarding the submission of 
an initial pediatric study plan (iPSP), as required by the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. 
Specifically, when finalized, this draft guidance will provide FDA's 
current thinking regarding iPSPs for oncology drugs in light of the 
amendments to the FD&C Act made by the FDA Reauthorization Act of 2017 
(FDARA). FDA has received a number of questions on this topic and, as a 
result, is providing this draft guidance in a question and answer 
format, addressing the most frequently asked questions.

DATES: Submit either electronic or written comments on the draft 
guidance by March 16, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2019-D-4752 for ``Pediatric Study Plans for Oncology Drugs: 
Questions and Answers.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), Food and Drug Administration, 10001

[[Page 2747]]

New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002 or the Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. The draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gregory Reaman, Oncology Center of 
Excellence, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 2202, Silver Spring, MD 20993-0002, 301-796-0785; 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 for Oncology Drugs: Questions and 
Answers.'' This draft guidance provides information regarding the 
submission of an iPSP, as required by section 505B(e) of the FD&C Act 
(21 U.S.C. 355c(e)), for oncology drugs only. When finalized, this 
draft guidance will provide FDA's current thinking regarding iPSPs for 
oncology drugs in light of the amendments to section 505B of the FD&C 
Act (also referred to as the Pediatric Research Equity Act, or PREA) 
made by section 504 of FDARA (Pub. L. 115-52). This draft guidance does 
not contain a complete discussion of general requirements for 
development of drugs for pediatric use under PREA or section 505A of 
the FD&C Act (21 U.S.C. 355a) (also referred to as the Best 
Pharmaceuticals for Children Act or BPCA (Pub. L. 107-109)).
    Section 504 of FDARA amended section 505B of the FD&C Act to 
require--for original applications submitted on or after August 18, 
2020--pediatric investigations of certain targeted cancer drugs with 
new active ingredients, based on molecular mechanism of action rather 
than clinical indication. FDARA thus created a mechanism to require 
evaluation of certain novel medicines that may have the potential to 
address an unmet medical need in the pediatric population. Timely 
investigation in children of the antitumor activity of potentially 
effective targeted drugs under development in adults and of those 
drugs' toxicities relative to the unique growth and developmental 
considerations of pediatric patients, is intended to accelerate early 
pediatric evaluation of these products and ultimately facilitate 
development of appropriate new therapies for pediatric patients.
    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 ``Pediatric 
Study Plans for Oncology Drugs: Questions and Answers.'' 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001. The collections of information in 21 CFR 
part 312 have been approved under OMB control number 0910-0014. The 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

III. Electronic Access

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

    Dated: January 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00592 Filed 1-15-20; 8:45 am]
 BILLING CODE 4164-01-P


