Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 7164-7165 [2012-3114]

Download as PDF 7164 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 27, 2012. A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261–4528: 1. Live Oak Bancshares, Inc., Wilmington, North Carolina; to engage de novo through its subsidiary, BANKR, LLC, Wilmington, North Carolina, in data processing activities, pursuant to section 225.28(b)(14)(i) of Regulation Y. B. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Waytru Bancorp, Cambridge City, Indiana; to continue to engage in extending credit and servicing loans, pursuant to section 225.28(b)(1) of Regulation Y. Dated: Board of Governors of the Federal Reserve System, February 7, 2012. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 2012–3130 Filed 2–9–12; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES srobinson on DSK4SPTVN1PROD with NOTICES Meeting of the National Biodefense Science Board Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the SUMMARY: VerDate Mar<15>2010 21:29 Feb 09, 2012 Jkt 226001 National Biodefense Science Board (NBSB) will be holding a closed session by teleconference under exemption 9(B) of the Government in Sunshine Act, 5 U.S.C. 552b(c). DATES: The February 28, 2012 NBSB closed session by teleconference is tentatively scheduled from 9 a.m. to 1 p.m. The agenda and time is subject to change as priorities dictate. ADDRESSES: The closed session will occur by teleconference and will not be open to the public as stipulated under exemption 9(B) of the Government in Sunshine Act, 5 U.S.C. 552b(c). FOR FURTHER INFORMATION CONTACT: MacKenzie Robertson, Acting Executive Director, NBSB, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; 202–260–0447; fax 202–205–8508; Email: NBSB@HHS.GOV. SUPPLEMENTARY INFORMATION: Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d–7f) and section 222 of the Public Health Service Act (42 U.S.C. 217a), the Department of Health and Human Services established the National Biodefense Science Board. The Board shall provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The Board may also provide advice and guidance to the Secretary and/or the Assistant Secretary for Preparedness and Response on other matters related to public health emergency preparedness and response. Background: The Board is being asked to review and evaluate the 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP). Until a final document is approved by the Secretary of the Department of Health and Human Services (HHS), the development of PHEMCE SIP requires consideration and discussion of procurement-sensitive information that should not be released to the public prior to the Secretary’s final decision. Premature public disclosure of the draft PHEMCE SIP would limit the Secretary’s decision-making ability to effectively prioritize HHS expenditures on critical medical countermeasures. Therefore, the Board’s deliberations on the new task will be conducted in closed session in accordance with provisions set forth under exemption 9(B) of the Government in Sunshine Act, 5 U.S.C. section 552b(c), and with PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 approval by the Assistant Secretary for Preparedness and Response. Availability of Materials: The meeting materials will be posted on the NBSB Web site at www.phe.gov/nbsb. Procedures for Providing Public Input: All written comments should be sent by email to NBSB@HHS.GOV with ‘‘NBSB Public Comment’’ as the subject line. Dated: February 6, 2012. Nicole Lurie, Assistant Secretary for Preparedness and Response. [FR Doc. 2012–3127 Filed 2–9–12; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The meeting announced below concerns Member Conflict Review, Program Announcement (PA) 07–318, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 1 p.m.–3 p.m., March 7, 2012 (Closed). Place: National Institute for Occupational Safety and Health (NIOSH), CDC, 1095 Willowdale Road Morgantown, West Virginia 26506, Telephone: (304) 285–6143. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Member Conflict Review, PA 07–318.’’ Contact Person for More Information: Bernadine Kuchinski, Ph.D., Scientific Review Administrator, Office of Extramural Programs, National Institute for Occupational Safety and Health, CDC, Robert A. Taft Laboratories, 4676 Columbia Pkwy, MS C–7, Cincinnati, Ohio 45226; Telephone: (513) 533–8511. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry. E:\FR\FM\10FEN1.SGM 10FEN1 7165 Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices Dated: February 6, 2012. Elaine L. Baker, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. 2012–3114 Filed 2–9–12; 8:45 am] OMB control number 0910–0432. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0793] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Device Recall Authority—21 CFR Part 810 (OMB Control Number 0910–0432)—Extension SUPPLEMENTARY INFORMATION: Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 March 12, 2012. 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 SUMMARY: This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and part 810 (21 CFR part 810), medical device recall authority provisions. Section 518(e) of the FD&C Act provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious adverse health consequences or death, to: (1) Immediately cease distribution of such device, (2) immediately notify health professionals and device-user facilities of the order, and (3) instruct such professionals and facilities to cease use of such device. Further, the provisions under section 518(e) of the FD&C Act set out the following three-step procedure for issuance of a mandatory device recall order: 1. If there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, FDA may issue a cease distribution and notification order requiring the appropriate person to immediately: • Cease distribution of the device, • Notify health professionals and device user facilities of the order, and • Instruct those professionals and facilities to cease use of the device; 2. FDA will provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be modified, vacated, or amended to require a mandatory recall of the device; and 3. After providing the opportunity for an informal hearing, FDA may issue a mandatory recall order if the Agency determines that such an order is necessary. The information collected under the recall authority provisions will be used by FDA to do the following: (1) Ensure that all devices entering the market are safe and effective, (2) accurately and immediately detect serious problems with medical devices, and (3) remove dangerous and defective devices from the market. In the Federal Register of November 16, 2011 (76 FR 71041), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section Number of responses per respondent Total annual responses Average burden per response Total hours srobinson on DSK4SPTVN1PROD with NOTICES 810.10(d) .............................................................................. 810.11(a) .............................................................................. 810.12(a) and (b) ................................................................. 810.14 .................................................................................. 810.15(a), (b), and (c) .......................................................... 810.15(d) .............................................................................. 810.15(e) .............................................................................. 810.16(a) and (b) ................................................................. 810.17(a) .............................................................................. 2 1 1 2 2 2 10 2 2 1 1 1 1 1 1 1 12 1 2 1 1 2 2 2 10 24 2 8 8 8 16 12 4 1 40 8 16 8 8 32 24 8 10 960 16 Total Hours ................................................................... ........................ ........................ ........................ ........................ 1,082 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 21:29 Feb 09, 2012 Jkt 226001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7164-7165]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3114]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Disease, Disability, and Injury Prevention and Control Special 
Emphasis Panel (SEP): Initial Review

    The meeting announced below concerns Member Conflict Review, 
Program Announcement (PA) 07-318, initial review.
    In accordance with Section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces the aforementioned meeting:

    Time and Date: 1 p.m.-3 p.m., March 7, 2012 (Closed).
    Place: National Institute for Occupational Safety and Health 
(NIOSH), CDC, 1095 Willowdale Road Morgantown, West Virginia 26506, 
Telephone: (304) 285-6143.
    Status: The meeting will be closed to the public in accordance 
with provisions set forth in Section 552b(c) (4) and (6), Title 5 
U.S.C., and the Determination of the Director, Management Analysis 
and Services Office, CDC, pursuant to Public Law 92-463.
    Matters To Be Discussed: The meeting will include the initial 
review, discussion, and evaluation of applications received in 
response to ``Member Conflict Review, PA 07-318.''
    Contact Person for More Information: Bernadine Kuchinski, Ph.D., 
Scientific Review Administrator, Office of Extramural Programs, 
National Institute for Occupational Safety and Health, CDC, Robert 
A. Taft Laboratories, 4676 Columbia Pkwy, MS C-7, Cincinnati, Ohio 
45226; Telephone: (513) 533-8511.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining 
to announcements of meetings and other committee management 
activities, for both the Centers for Disease Control and Prevention, 
and the Agency for Toxic Substances and Disease Registry.


[[Page 7165]]


    Dated: February 6, 2012.
Elaine L. Baker,
Director, Management Analysis and Services Office Centers for Disease 
Control and Prevention.
[FR Doc. 2012-3114 Filed 2-9-12; 8:45 am]
BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.