9584 Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices 

early phase clinical studies. 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 requirement of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

201.57 have been approved under OMB 

control number 0910–0572. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances, or 

http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances, or http:// 

www.regulations.gov. 

Dated: February 14, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3679 Filed 2–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0528] 

Unapproved Animal Drugs; Extension 

of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

April 19, 2011, the comment period for 

the notice that appeared in the Federal 

Register of December 20, 2010 (75 FR 

79383). In the notice FDA requested 

comments on strategies to address the 

prevalence of animal drug products 

marketed in the United States without 

approval or other legal marketing status. 

The Agency is taking this action in 

response to requests for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: Submit electronic or written 

comments by April 19, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0528 by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2010–N–0528. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

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 Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Tracey H. Forfa, Center for Veterinary 

Medicine (HFV–1), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9000, 

e-mail: Tracey.Forfa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 

20, 2010 (75 FR 79383), FDA published 

a notice with a 60-day comment period 

to request comments from stakeholders 

on strategies to address the prevalence 

of animal drug products marketed in the 

United States without approval or other 

legal marketing status. The notice 

expressed FDA’s interest in receiving 

comments on strategies that utilize 

FDA’s existing regulatory framework for 

addressing this issue as well as on novel 

strategies not currently employed by the 

Agency. 

The Agency has received requests for 

a 60-day extension of the comment 

period. The requests conveyed concern 

that the current 60-day comment period 

does not allow respondents sufficient 

time to address fully the many 

important issues FDA raised in the 

notice. 

FDA has considered the requests and 

is extending the comment period for the 

notice for 60 days, until April 19, 2011. 

The Agency believes that a 60-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying the 

Agency’s consideration of these 

important issues. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: February 15, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–3712 Filed 2–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Correction of Burden Table. 

SUMMARY: The Health Resources and 

Services Administration published an 

Agency Information Collection 

document in the Federal Register of 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES