Secretary's Advisory Committee on Human Research Protections; Notice of Meeting, 11248 [2011-4473]

Download as PDF 11248 Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Notices Board of Governors of the Federal Reserve System, February 24, 2011. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2011–4487 Filed 2–28–11; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Secretary’s Advisory Committee on Human Research Protections; Notice of Meeting Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, Office for Human Research Protections. ACTION: Notice. AGENCY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, Public Law 92–463, as amended (5 U.S.C. App.), notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-fourth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https:// www.dhhs.gov/ohrp/sachrp/mtgings/ index.html. DATES: The meeting will be held on Tuesday, March 8, 2011 from 8:30 a.m. until 5 p.m. and Wednesday, March 9, 2011 from 8:30 a.m. until 5 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: Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections, or Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240–453–6900, fax: 240–453–6909; e-mail 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 March 8, 2011, SACHRP will hear a panel presentation on the work of the Federal Demonstration Partnership, jlentini on DSKJ8SOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:42 Feb 28, 2011 Jkt 223001 followed by discussion. This will be followed by the report of the Subpart A Subcommittee (SAS), focusing on improvements to the informed consent process. SAS is charged with developing recommendations for consideration by SACHRP about the application of subpart A of 45 CFR part 46 in the current research environment. This subcommittee was established by SACHRP at its October 2006 meeting. The afternoon will close with a panel presentation on the reporting and return of individual research results, including issues associated with the Clinical Laboratory Improvement Amendments. On March 9, 2011, the morning will open with a panel discussion on the reporting and return of aggregate research results, including a report on the status of ClinicalTrials.gov. The Subcommittee on Harmonization (SOH) will end the meeting with a report on their work to date. The 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. Public comment will be heard on both days. 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 on March 4, 2011. An unforeseen administrative matter delayed this notice being submitted to the Federal Register for publication. Dated: February 23, 2011. Jerry Menikoff, Director, Office for Human Research Protections, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2011–4473 Filed 2–28–11; 8:45 am] BILLING CODE 4150–36–P PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–R–185, CMS– 10303 and CMS–10379] 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 currently approved collection; Title of Information Collection: Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regulations; Form No.: CMS–R–185 (OMB#: 0938–0686); Use: The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). If an accreditation organization is approved, the laboratories that it accredits are ‘‘deemed’’ to meet the CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements. The information collected will be used by HHS to: determine comparability/equivalency of the accreditation organization standards AGENCY: E:\FR\FM\01MRN1.SGM 01MRN1

Agencies

[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Page 11248]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Human Research Protections; 
Notice of Meeting

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

ACTION: Notice.

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

SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby 
given that the Secretary's Advisory Committee on Human Research 
Protections (SACHRP) will hold its twenty-fourth meeting. The meeting 
will be open to the public. Information about SACHRP and the 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 Tuesday, March 8, 2011 from 8:30 
a.m. until 5 p.m. and Wednesday, March 9, 2011 from 8:30 a.m. until 5 
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: Jerry Menikoff, M.D., J.D., Director, 
Office for Human Research Protections, or Julia Gorey, J.D., Executive 
Director, SACHRP; U.S. Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240-453-6900, 
fax: 240-453-6909; e-mail 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 March 8, 2011, SACHRP will hear a panel presentation on the work 
of the Federal Demonstration Partnership, followed by discussion. This 
will be followed by the report of the Subpart A Subcommittee (SAS), 
focusing on improvements to the informed consent process. SAS is 
charged with developing recommendations for consideration by SACHRP 
about the application of subpart A of 45 CFR part 46 in the current 
research environment. This subcommittee was established by SACHRP at 
its October 2006 meeting. The afternoon will close with a panel 
presentation on the reporting and return of individual research 
results, including issues associated with the Clinical Laboratory 
Improvement Amendments.
    On March 9, 2011, the morning will open with a panel discussion on 
the reporting and return of aggregate research results, including a 
report on the status of ClinicalTrials.gov. The Subcommittee on 
Harmonization (SOH) will end the meeting with a report on their work to 
date. The 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. Public 
comment will be heard on both days. 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 on March 4, 2011.
    An unforeseen administrative matter delayed this notice being 
submitted to the Federal Register for publication.

    Dated: February 23, 2011.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2011-4473 Filed 2-28-11; 8:45 am]
BILLING CODE 4150-36-P
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