Meeting of the Secretary's Advisory Committee on Human Research Protections, 10523-10524 [2014-04091]

Download as PDF Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than March 21, 2014. A. Federal Reserve Bank of St. Louis (Yvonne Sparks, Community Development Officer) P.O. Box 442, St. Louis, Missouri 63166–2034: 1. Bank of the Ozarks, Inc., Little Rock, Arkansas; to merge with Summit Bancorp, Inc., Arkadelphia, Arkansas, and thereby indirectly acquire Summit Bank, Arkadelphia, Arkansas, which will merge into Bank of the Ozarks, Little Rock, Arkansas. Board of Governors of the Federal Reserve System, February 20, 2014. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2014–04018 Filed 2–24–14; 8:45 am] BILLING CODE 6210–01–P 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 March 12, 2014. A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309: 1. Perry Banking Company, Inc., Perry, Florida; to engage in making, acquiring, brokering, or servicing loans, or other extensions of credit, pursuant to section 225.28(b)(1). Board of Governors of the Federal Reserve System, February 20, 2014. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2014–04017 Filed 2–24–14; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https:// www.dhhs.gov/ohrp/sachrp/mtgings/ index.html. SUMMARY: FEDERAL RESERVE SYSTEM emcdonald on DSK67QTVN1PROD with NOTICES Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 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 VerDate Mar<15>2010 17:58 Feb 24, 2014 Jkt 232001 The meeting will be held on Wednesday, March 12, 2014 from 8:30 a.m. until 5:00 p.m. and Thursday, March 13, 2014 from 8:30 a.m. until 4:30 p.m. ADDRESSES: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Hubert H. Humphrey Building, Room 800, Washington, DC 20201. DATES: Ivor Pritchard, Ph.D., Director (Acting), Office for Human Research Protections (OHRP), or Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240–453–8141; fax: FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 10523 240–453–6909; email address: Julia.Gorey@hhs.gov. SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The meeting will open to the public at 8:30 a.m., Wednesday March 12. Following opening remarks from Dr. Jerry Menikoff, OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, the Subcommittee on Harmonization (SOH) will give their report, presenting recommendations on cluster randomized trials and informed consent. SOH was established by SACHRP at its July 2009 meeting and is charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/ or coordination. The afternoon presentation will focus on a discussion of cluster randomization, risk assessment, and consent requirements. Following opening remarks on the morning of March 13, the Subpart A Subcommittee (SAS) will give their report, focusing on recommendations for a remodeled concept of engagement in human subjects research. SAS is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment; this subcommittee was established by SACHRP in October 2006. Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the SACHRP at the address/phone listed above at least one week prior to the meeting. Members of the public will have the opportunity to provide comment during the public comment periods; pre-registration is required for participation in the public comment session. Individuals who are on-site may pre-register the day of the meeting; individuals participating through webcast should pre-register by contacting the Executive Director, SACHRP, by COB March 6. Individuals E:\FR\FM\25FEN1.SGM 25FEN1 10524 Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices who would like to submit written statements should email or fax their comments to SACHRP at least five business days prior to the meeting. Dated: February 18, 2014. Ivor Pritchard, Director (Acting), Office for Human Research Protections, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2014–04091 Filed 2–24–14; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Comments on the Proposed 2020 Targets for the National Action Plan To Prevent Health CareAssociated Infections: Road Map To Elimination (Phase I: Acute Care Hospital) Measures Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The Office of Disease Prevention and Health Promotion (ODPHP), on behalf of the U.S. Department of Health and Human Services’ (HHS) Federal Steering Committee for the Prevention of Health Care-Associated Infections (HAI), proposes new targets for the acute care hospital measures for the National Action Plan to Prevent Health CareAssociated Infections: Road Map to Elimination (HAI Action Plan). The fiveyear targets identified in the initial HAI Action Plan expired at the end of 2013; therefore, new targets are being proposed, taking into consideration the progress made since the HAI Action Plan was initially released in 2009. Similar to the initial HAI Action Plan, the proposed targets will reflect improvement efforts over a five-year period. As such, the Department is proposing a baseline of January 2015 and individualized targets for each of the health care-associated infections identified in the HAI Action Plan to be achieved by December 2020. HHS invites public and private health-related professionals, organizations, and consumer representatives to submit written comments on the proposed 2020 HAI acute care hospital targets, found at https://www.health.gov/hai/prevent_ hai.asp#hai_measures. DATES: Comments on the proposed HAI 2020 acute care hospital targets must be emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:58 Feb 24, 2014 Jkt 232001 received no later than 5 p.m. on March 27, 2014. ADDRESSES: Interested persons or organizations are invited to submit written comments by any of the following methods: • Email: ohq@hhs.gov. • Mail/Courier: Office of Disease Prevention and Health Promotion, Attn: Division of Health Care Quality, Department of Health and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Daniel Gallardo, Health Policy Fellow, Office of Disease Prevention and Health Promotion via electronic mail at ohq@ hhs.gov. SUPPLEMENTARY INFORMATION: In recognition of HAIs as an important public health and patient safety issue, in July 2008 HHS established the Federal Steering Committee for the Prevention of Health Care-Associated Infections, led by Dr. Don Wright, Deputy Assistant Secretary for Health, Disease Prevention and Health Promotion. The Steering Committee was charged with developing a comprehensive strategy to prevent and reduce HAIs and developing a plan which established national five-year targeted goals for HAI prevention and outlined key actions for achieving identified short- and longterm objectives. The first iteration of the HAI Action Plan was published in 2009 and focused on addressing six high priority HAIrelated areas within the acute care hospital setting: Surgical site infections, central line-associated bloodstream infections, ventilator-associated events (formerly ventilator-associated pneumonia), catheter-associated urinary tract infections, Clostridium difficile infections, and methicillin-resistant Staphylococcus aureus infections. In April 2013, ODPHP, on behalf of the Steering Committee, released a revised HAI Action Plan reflecting a significant update and expansion from the initial version. In addition to documenting the progress toward achieving the original five-year acute care hospital HAI targets, the updated HAI Action Plan included new sections specific to infection reduction in ambulatory surgical centers, end-stage renal disease facilities, and long-term care facilities, as well as a section on increasing influenza vaccination of health care personnel. With the expiration of the HAI Action Plan acute care hospitals time period for measuring the initial goals occurring at the end of 2013, the Steering Committee has identified new five-year goals to measure national progress in HAI PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 reduction. The new goals will continue to use data from the Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) as well as data from the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Program (HCUP). The new targets will set baseline rates using data from 2015 and establish goals to be achieved by December 2020. The proposed targets take into account HAI reductions to date and will reflect progress that takes place between 2013 and 2015. Selecting a single baseline year for measuring progress toward the targeted goals in acute care hospitals—and using that same baseline year for purposes of quality measure reporting to the Centers for Medicare and Medicaid Services (CMS) and public reporting on CMS’s Hospital Compare Web site—will improve consistency in federal HAI measurement and reporting efforts. The proposed targets are intended to align with the HAI targets in Healthy People 2020 as well as other Departmental initiatives. The Steering Committee has provided a template for all acute care hospital HAI targets, which is available at https:// www.health.gov/hai/prevent_ hai.asp#hai_measures. The template identifies the proposed target or recommended action (i.e., suspension of target) for each of the acute care hospital measures identified in the revised HAI Action Plan. Interested persons or organizations are invited to submit written comments for each acute care hospital HAI measure. Written feedback should not exceed more than two pages per HAI measure. To be considered, the person or representative from the organization must self-identify and submit the written comments by close of business on March 27, 2014. Dated: February 19, 2014. Don Wright, Deputy Assistant Secretary for Health, Director, Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health. [FR Doc. 2014–04069 Filed 2–24–14; 8:45 am] BILLING CODE 4150–32–P E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10523-10524]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's 
Advisory Committee on Human Research Protections (SACHRP) will hold a 
meeting that will be open to the public. Information about SACHRP and 
the full meeting agenda will be posted on the SACHRP Web site at: 
https://www.dhhs.gov/ohrp/sachrp/mtgings/.

DATES: The meeting will be held on Wednesday, March 12, 2014 from 8:30 
a.m. until 5:00 p.m. and Thursday, March 13, 2014 from 8:30 a.m. until 
4:30 p.m.

ADDRESSES: U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Hubert H. Humphrey Building, Room 800, 
Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Ivor Pritchard, Ph.D., Director 
(Acting), Office for Human Research Protections (OHRP), or Julia Gorey, 
J.D., Executive Director, SACHRP; U.S. Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 
240-453-8141; fax: 240-453-6909; email address: Julia.Gorey@hhs.gov.

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as amended, SACHRP was 
established to provide expert advice and recommendations to the 
Secretary of Health and Human Services, through the Assistant Secretary 
for Health, on issues and topics pertaining to or associated with the 
protection of human research subjects.
    The meeting will open to the public at 8:30 a.m., Wednesday March 
12. Following opening remarks from Dr. Jerry Menikoff, OHRP Director, 
and Dr. Jeffrey Botkin, SACHRP Chair, the Subcommittee on Harmonization 
(SOH) will give their report, presenting recommendations on cluster 
randomized trials and informed consent.
    SOH was established by SACHRP at its July 2009 meeting and is 
charged with identifying and prioritizing areas in which regulations 
and/or guidelines for human subjects research adopted by various 
agencies or offices within HHS would benefit from harmonization, 
consistency, clarity, simplification and/or coordination.
    The afternoon presentation will focus on a discussion of cluster 
randomization, risk assessment, and consent requirements.
    Following opening remarks on the morning of March 13, the Subpart A 
Subcommittee (SAS) will give their report, focusing on recommendations 
for a remodeled concept of engagement in human subjects research. SAS 
is charged with developing recommendations for consideration by SACHRP 
regarding the application of subpart A of 45 CFR part 46 in the current 
research environment; this subcommittee was established by SACHRP in 
October 2006.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the SACHRP at the address/phone listed above at least one week 
prior to the meeting. Members of the public will have the opportunity 
to provide comment during the public comment periods; pre-registration 
is required for participation in the public comment session. 
Individuals who are on-site may pre-register the day of the meeting; 
individuals participating through webcast should pre-register by 
contacting the Executive Director, SACHRP, by COB March 6. Individuals

[[Page 10524]]

who would like to submit written statements should email or fax their 
comments to SACHRP at least five business days prior to the meeting.

    Dated: February 18, 2014.
Ivor Pritchard,
Director (Acting), Office for Human Research Protections, Executive 
Secretary, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2014-04091 Filed 2-24-14; 8:45 am]
BILLING CODE 4150-28-P
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