[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Page 77498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1461]


Rare Pediatric Disease Priority Review Vouchers; 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) is extending the 
comment period for the notice of availability (NOA) that appeared in 
the Federal Register of November 17, 2014. In the NOA, FDA requested 
comments on the Agency's implementation of the Rare Pediatric Disease 
Priority Review Vouchers Program. This action will allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period on the NOA published 
November 17, 2014 (79 FR 68451). Submit either electronic or written 
comments by February 16, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communications, Division of Drug Information, 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, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; 
or Office of Orphan Products Development, Office of Special Medical 
Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5295, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist the office that will be processing your 
requests. See the SUPPLEMENTARY INFORMATION section 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Henry Startzman III, Office of Orphan 
Products Development, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993-0002, 301-796-8660.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 17, 2014, FDA published a NOA 
with a 60-day comment period to request comments on FDA's 
implementation of the Rare Pediatric Disease Priority Review Vouchers 
Draft Guidance. Comments on the draft guidance will inform FDA's 
drafting of its final guidance for this program.
    The Agency has recognized a discrepancy between the 90-day comment 
period included in the draft guidance and the 60-day comment period 
written in the November 17, 2014, NOA. Thus, it is publishing this NOA 
to extend the comment period cited in the previous NOA by 30 days.
    The Agency believes that a 30-day extension allows adequate time 
for interested persons to submit comments without significantly 
delaying drafting of the final guidance on these important issues.

II. Request for 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.

    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30154 Filed 12-23-14; 8:45 am]
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