Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon; Extension of Comment Period, 10620-10621 [2013-03445]

Download as PDF 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 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 sroberts on DSK5SPTVN1PROD with NOTICES AGENCY: VerDate Mar<15>2010 17:16 Feb 13, 2013 Jkt 229001 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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. 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. SUMMARY: 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 E:\FR\FM\14FEN1.SGM 14FEN1 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Notices Atlantic salmon and a preliminary FONSI for those specific conditions of use. Comments on the draft EA and FONSI will inform FDA’s decision whether to require an environmental impact statement (EIS) or finalize the EA and FONSI for this NADA. The Agency has received a request for a 60-day extension of the comment period for the draft EA and FONSI. The request conveyed concern that the current 60-day comment period does not allow sufficient time to respond. FDA has considered the request and is extending the comment period for the draft EA and FONSI for 60 days, until April 26, 2013. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying the Agency’s decision on whether to finalize these documents or prepare an EIS. II. Request for Comments Interested persons may submit either electronic comments regarding these documents 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. applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Initial Review Group; Training and Workforce Development Subcommittee A. Date: March 12, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: John J. Laffan, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.18J, Bethesda, MD 20892, 301–594–2773, laffanjo@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) Dated: February 8, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–03361 Filed 2–13–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Dated: February 11, 2013. Leslie Kux, Assistant Commissioner for Policy. National Institute on Minority Health and Health Disparities; Notice of Closed Meeting [FR Doc. 2013–03445 Filed 2–13–13; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health sroberts on DSK5SPTVN1PROD with NOTICES National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant VerDate Mar<15>2010 17:16 Feb 13, 2013 Jkt 229001 Name of Committee: National Institute on Minority Health and Health Disparities Special Emphasis Panel; NIMHD Conference Grant Review (R13). Date: March 15, 2013. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 10621 Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Hui Chen, M.D., Scientific Review Officer, National Institute on Minority Health and Health Disparities, 6707 Democracy Blvd., Suite 800, Bethesda, MD 20892, (301) 594–7784, chenhui@mail.nih.gov. Dated: February 7, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–03357 Filed 2–13–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Vestibular Prosthesis Research Application. Date: March 25, 2013. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). Contact Person: Andrea B. Kelly, Ph.D., Scientific Review Officer Division of Extramural Activities, National Institutes of Health/NIDCD 6120 Executive Blvd.—MSC 7180, Rockville, MD 20892, (301) 496–8683, kellya2@nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Outcome Research Application. Date: March 26, 2013. Time: 12:30 p.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 78, Number 31 (Thursday, February 14, 2013)]
[Notices]
[Pages 10620-10621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03445]


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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

[[Page 10621]]

Atlantic salmon and a preliminary FONSI for those specific conditions 
of use. Comments on the draft EA and FONSI will inform FDA's decision 
whether to require an environmental impact statement (EIS) or finalize 
the EA and FONSI for this NADA.
    The Agency has received a request for a 60-day extension of the 
comment period for the draft EA and FONSI. The request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to respond.
    FDA has considered the request and is extending the comment period 
for the draft EA and FONSI for 60 days, until April 26, 2013. The 
Agency believes that a 60-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
the Agency's decision on whether to finalize these documents or prepare 
an EIS.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
these documents 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: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03445 Filed 2-13-13; 8:45 am]
BILLING CODE 4160-01-P