Meeting of the Secretary's Advisory Committee on Human Research Protections, 12061-12062 [2013-03976]

Download as PDF Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices PERSON TO CONTACT FOR INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. Shelley E. Garr, Deputy Secretary of the Commission. [FR Doc. 2013–04159 Filed 2–19–13; 4:15 pm] BILLING CODE 6715–01–P FEDERAL MARITIME COMMISSION Notice of Agreement Filed The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the Federal Register. A Copy of the agreement is available through the Commission’s Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)–523–5793 or tradeanalysis@fmc.gov. Agreement No.: 011550–013. Title: ABC Discussion Agreement. Parties: Hamburg Sud; King Ocean Services Limited; Seafreight Line, Ltd. Filing Party: Wayne R. Rohde, Esq.; Cozen O’Connor; 1627 I Street, NW., Suite 1100; Washington, DC 20006– 4007. Synopsis: The amendment would add Seaboard Marine Ltd. as a party to the agreement. By Order of the Federal Maritime Commission. Dated: February 15, 2013. Rachel E. Dickon, Assistant Secretary. Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be 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 18, 2013. A. Federal Reserve Bank of Dallas (E. Ann Worthy, Vice President) 2200 North Pearl Street, Dallas, Texas 75201– 2272: 1. R Corp Financial, Round Rock, Texas, to become a bank holding company by acquiring 100 percent of R Bank, Round Rock, Texas. Board of Governors of the Federal Reserve System, February 15, 2013. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2013–03951 Filed 2–20–13; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–03986 Filed 2–20–13; 8:45 am] Meeting of the Secretary’s Advisory Committee on Human Research Protections BILLING CODE P AGENCY: FEDERAL RESERVE SYSTEM erowe on DSK2VPTVN1PROD with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the VerDate Mar<15>2010 14:47 Feb 20, 2013 Jkt 229001 Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. 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: http:// www.dhhs.gov/ohrp/sachrp/mtgings/ index.html. SUMMARY: The meeting will be held on Tuesday, March 12, 2013 from 10:30 a.m. until 5:00 p.m. and Wednesday, March 13, 2013 from 8:30 a.m. until 4:30 p.m. Tuesday morning will begin DATES: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 12061 with a two-hour closed administrative session, with the meeting opening to the public at 10:30 a.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: Jerry Menikoff, M.D., J.D., Director, 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 and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects. On Tuesday, March 12, following opening remarks from Dr. Jerry Menikoff, OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, there will be a presentation from HHS staff describing the history of SACHRP and the process for creating regulatory guidance and regulatory change; a discussion of SACHRP members’ priorities for future discussion topics will follow. Subpart A Subcommittee will next discuss their recent work, including considerations for revisions to the expedited review list. Subpart A Subcommittee 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. Following opening remarks on the morning of March 13, a special panel of experts will discuss Improving the Informed Consent Process; this discussion will initiate a new SACHRP spotlight on this topic. The Subcommittee on Harmonization (SOH) will next give a report and discuss their recent work, including an examination of human subject research issues affecting cluster randomized trials, and issues associated with the use of differing agencies’ certificates of confidentiality. 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 E:\FR\FM\21FEN1.SGM 21FEN1 12062 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination. SACHRP will conclude Wednesday afternoon with discussion of a revised document on the issue of the use of the internet in human subjects research. Public attendance at the meeting is limited to space available. Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact persons. Members of the public will have the opportunity to provide comments on both days of the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed materials distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business March 8, 2013. Dated: February 15, 2013. Jerry Menikoff, Director, Office for Human Research Protections, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2013–03976 Filed 2–20–13; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Nominations to the Advisory Committee on Blood and Tissue Safety and Availability Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The ACBTSA is a federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to fouryear terms. erowe on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:47 Feb 20, 2013 Jkt 229001 All nominations must be received not later than 4:00 p.m. EDT on March 15, 2013, at the address listed below. ADDRESSES: All nominations should be mailed or delivered to Mr. James Berger, Senior Advisor for Blood Policy; Division of Blood and Tissue Safety and Availability, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health; Department of Health and Human Services; 1101 Wootton Parkway, Suite 250; Rockville, MD 20852. Telephone: (240) 453–8803. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy. Contact information for Mr. Berger is provided above. A copy of the Committee charter and roster of the current membership can be obtained by contacting Mr. Berger or by accessing the ACBTSA Web site at http://www.hhs.gov/bloodsafety.http:// www.hhs.gov/bloodsafety. SUPPLEMENTARY INFORMATION: The ACBTSA provides advice to the Secretary, through the Assistant Secretary for Health. The Committee provides advice on a range of policy issues to include: (1) Identification of public health issues through surveillance of blood, and tissue safety issues with national biovigilance data tools; (2) identification of public health issues that effect availability of blood, blood products, and tissues; (3) broad public health, ethical and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood, blood products, and tissues; (5) risk communications related to blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and tissues. The Committee consists of 23 voting members: there are 14 public members, including the Chair, and nine (9) individuals designated to serve as official representative members of the blood, blood products, tissue and organ professional organizations or business sectors. The public members are selected from state and local organizations, patient advocacy groups, provider organizations, academic researchers, ethicists, physicians, surgeons, scientists, risk communication experts, consumer advocates, legal organizations, and from among communities of persons who are frequent recipients of blood or blood products or who have received tissues or organs. DATES: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 All ACBTSA members are authorized to receive the prescribed per diem allowance and reimbursement for travel expenses that are incurred to attend meetings and conduct committeerelated business, in accordance with Standard Government Travel Regulations. Individuals who are appointed to serve as public members are authorized also to receive a stipend for attending Committee meetings and to carry out other Committee-related business. Individuals who are appointed to serve as representative members for a particular interest group or industry are not authorized to receive a stipend for the performance of these duties. This announcement is to solicit nominations of qualified candidates to fill two positions in the public member category that will be vacated during the 2013 calendar year. Nominations In accordance with the charter, persons nominated for appointment as members of the ACBTSA should be among authorities knowledgeable in blood banking, transfusion medicine, plasma therapies, transfusion and transplantation safety, bioethics, public health economics and/or related disciplines and/or related consumer/ patient advocacy. Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration of appointment: (a) The name, return address, daytime telephone number, and affiliation(s) of the individual being nominated, the basis for the individual’s nomination, the nominated individual’s area of expertise, and a statement bearing an original signature of the nominated individual that, if appointed, he or she is willing to serve as a member of the committee; (b) the name, return address, and daytime telephone number at which the nominator may be contacted. Organizational nominators must identify a principal contact person in addition to the contact; and (c) a copy of a current curriculum vitae or resume for the nominated individual. Individuals can nominate themselves for consideration of appointment to the committee. All nominations must include the required information. Incomplete nominations will not be processed for consideration. The letter from the nominator and certification of the nominated individual must bear original signatures; reproduced copies of these signatures are not acceptable. The Department makes every effort to ensure that the membership of HHS federal advisory committees is fairly E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12061-12062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03976]


=======================================================================
-----------------------------------------------------------------------

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: 
http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

DATES: The meeting will be held on Tuesday, March 12, 2013 from 10:30 
a.m. until 5:00 p.m. and Wednesday, March 13, 2013 from 8:30 a.m. until 
4:30 p.m. Tuesday morning will begin with a two-hour closed 
administrative session, with the meeting opening to the public at 10:30 
a.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: Jerry Menikoff, M.D., J.D., Director, 
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 and the Assistant Secretary for 
Health on issues and topics pertaining to or associated with the 
protection of human research subjects.
    On Tuesday, March 12, following opening remarks from Dr. Jerry 
Menikoff, OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, there 
will be a presentation from HHS staff describing the history of SACHRP 
and the process for creating regulatory guidance and regulatory change; 
a discussion of SACHRP members' priorities for future discussion topics 
will follow. Subpart A Subcommittee will next discuss their recent 
work, including considerations for revisions to the expedited review 
list. Subpart A Subcommittee 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. Following opening remarks on 
the morning of March 13, a special panel of experts will discuss 
Improving the Informed Consent Process; this discussion will initiate a 
new SACHRP spotlight on this topic. The Subcommittee on Harmonization 
(SOH) will next give a report and discuss their recent work, including 
an examination of human subject research issues affecting cluster 
randomized trials, and issues associated with the use of differing 
agencies' certificates of confidentiality. 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

[[Page 12062]]

offices within HHS would benefit from harmonization, consistency, 
clarity, simplification and/or coordination. SACHRP will conclude 
Wednesday afternoon with discussion of a revised document on the issue 
of the use of the internet in human subjects research. Public 
attendance at the meeting is limited to space available. Individuals 
who plan to attend the meeting and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the designated contact persons. Members of the public will have 
the opportunity to provide comments on both days of the meeting. Public 
comment will be limited to five minutes per speaker. Any members of the 
public who wish to have printed materials distributed to SACHRP members 
for this scheduled meeting should submit materials to the Executive 
Director, SACHRP, prior to the close of business March 8, 2013.

    Dated: February 15, 2013.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2013-03976 Filed 2-20-13; 8:45 am]
BILLING CODE 4150-36-P