Document ID: FDA-2017-D-6380-0005
Agency: fda
Document Type: Notice
Title: Guidance: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
Posted Date: 2018-01-12T05:00Z

[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1619-1620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00418]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6380]

Clarification of Orphan Designation of Drugs and Biologics for 
Pediatric Subpopulations of Common Diseases; Draft Guidance for 
Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the notice of availability that appeared in the 
Federal Register of December 20, 2017. In the notice of availability, 
FDA requested comments on the draft guidance for industry entitled 
``Clarification of Orphan Designation of Drugs and Biologics for 
Pediatric Subpopulations of Common Diseases.'' The Agency is taking 
this action in response to public interest in the draft guidance and to 
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of 
availability published December 20, 2017 (82 FR 60402). Submit either 
electronic or written comments on the draft guidance by February 18, 
2018, to ensure that the Agency considers your comment on this draft 
guidance before it begins work on the final version of the guidance.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-2017-D-6380 for ``Clarification of Orphan Designation of Drugs and 
Biologics for Pediatric Subpopulations of Common Diseases.'' 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Aaron Friedman, Office of Orphan 
Products Development, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993, 301-796-8660.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 20, 
2017, FDA published a notice of availability with a 30-day comment 
period to request comments on the draft guidance for industry entitled 
``Clarification of Orphan Designation of Drugs and Biologics for 
Pediatric Subpopulations of Common Diseases.''
    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 orphan 
designation of drugs and biologics for pediatric subpopulations of 
common diseases. It does not establish any rights for any person and is 
not binding on FDA or the public. You can

[[Page 1620]]

use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. This draft guidance is not subject 
to Executive Order 12866.
    Based on public interest in the draft guidance, FDA is extending 
the comment period for the notice of availability for 30 days, until 
February 28, 2018. The Agency believes that a 30-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying guidance on these important issues.

    Dated: January 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00418 Filed 1-11-18; 8:45 am]
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