77498 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 

Dated: December 18, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–30027 Filed 12–23–14; 8:45 am] 

BILLING CODE 4120–01–P 

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. 

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single copies of the draft guidance to the 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electronic access to the draft guidance 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draft guidance to http://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] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0155] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 23, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0363. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Veterinary Feed Directive—21 CFR 558 

(OMB Control Number 0910–0363)— 

(Extension) 

With the passage of the Animal Drug 

Availability Act of 1996 (Public Law 

104–250), Congress enacted legislation 

establishing a new class of restricted 

feed use drugs, VFD drugs, which may 

be distributed without involving State 

pharmacy laws. Although controls on 

the distribution and use of VFD drugs 

are similar to those for prescription 

drugs regulated under section 503(f) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 353(f)), the implementing 

VFD regulation (21 CFR 558.6) was 

tailored to the unique circumstances 

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