10620 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Notices 

OS specifically requests comments on 

(1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Keith A. Tucker, 

Information Collection Clearance Officer. 

[FR Doc. 2013–03401 Filed 2–13–13; 8:45 am] 

BILLING CODE 4150–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–576A] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Organ 

Procurement Organization’s (OPOs) 

Health Insurance Benefits Agreement 

and Supporting Regulations at 42 CFR 

486.301–486.348; Use: The Medicare 

and Medicaid Programs Final 

Conditions for Coverage for Organ 

Procurement Organizations (OPOs) 

require OPOs to sign agreements with 

the Center for Medicare and Medicaid 

Services (CMS) in order to be 

reimbursed and perform their services. 

The information provided on this form 

serves as a basis for continuing the 

agreements with CMS and the OPOs for 

participation in the Medicare and 

Medicaid programs for reimbursement 

of service. Form Number: CMS–576A 

(OCN: 0938–0512); Frequency: 

Occasionally; Affected Public: Private 

Sector: Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 58; Total Annual 

Responses: 58; Total Annual Hours: 

116. (For policy questions regarding this 

collection contact Peggye Wilkerson at 

410–786–4857. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by April 15, 2013: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number llll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: February 11, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–03452 Filed 2–13–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0899] 

Draft Environmental Assessment and 

Preliminary Finding of No Significant 

Impact Concerning a Genetically 

Engineered Atlantic Salmon; Extension 

of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for two draft 

environmental review documents for 

which a notice of availability appeared 

in the Federal Register of December 26, 

2012. In that notice, FDA made 

available for comment the Agency’s 

draft environmental assessment (EA) of 

the proposed conditions of use specified 

in materials submitted by AquaBounty 

Technologies, Inc., in support of a new 

animal drug application (NADA) 

concerning a genetically engineered 

(GE) Atlantic salmon and a preliminary 

finding of no significant impact (FONSI) 

for those specific conditions of use. The 

Agency is taking this action in response 

to a request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: Submit either electronic or 

written comments by April 26, 2013. 

ADDRESSES: Submit electronic 

comments 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Eric 

Silberhorn, Center for Veterinary 

Medicine (HFV–162), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855; 240–276–8247; 

abig@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 

26, 2012 (77 FR 76050), FDA published 

a notice of availability with a 60-day 

comment period to make available for 

public comment the Agency’s draft EA 

of the proposed conditions of use 

specified in materials submitted by 

AquaBounty Technologies, Inc., in 

support of an NADA concerning a GE 


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