Meeting of the Secretary's Advisory Committee on Human Research Protections, 59772 [2014-23664]

Download as PDF 59772 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395–5806. David C. Shonka, Principal Deputy General Counsel. [FR Doc. 2014–23601 Filed 10–2–14; 8:45 am] BILLING CODE 6750–01–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: The meeting will be held on Wednesday, October 29, 2014, from 8:30 a.m. until 5:00 p.m. and Thursday, October 30, 2014, from 8:30 a.m. until 4:00 p.m. ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers Lane, Rockville, Maryland 20852. 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: SACHRP@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 mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:08 Oct 02, 2014 Jkt 235001 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, October 29. Following opening remarks from Dr. Jerry Menikoff, Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, new members will be introduced. The Subpart A Subcommittee (SAS) will then give their report on the new SAS initiative examining informed consent. 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. SAS was established by SACHRP in October 2006. Following this report, an OHRP staff member will present and discuss OHRP data addressing incidental findings and corrective action plans. On October 30, the Subcommittee on Harmonization (SOH) will discuss their work on the topic of the intersection of the HHS and FDA regulations and ‘‘big data’’; this will be followed by a presentation of SOH work on the topic of return of general results. SOH was established by SACHRP at its July 2009 meeting. SOH 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 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 number listed above at least one week prior to the meeting. Pre-registration is required for participation in the on-site public comment session; individuals may preregister the day of the meeting. Individuals who would like to submit written statements should email or fax their comments to SACHRP at SACHRP@hhs.gov at least five business days prior to the meeting. Dated: September 29, 2014. Jerry Menikoff, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections, Director, Office for Human Research Protections. [FR Doc. 2014–23664 Filed 10–2–14; 8:45 am] BILLING CODE 4150–36–P PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10538] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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. DATES: Comments must be received by December 2, 2014: ADDRESSES: When commenting, please reference the document identifier or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are 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 lll, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. SUMMARY: E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Notices]
[Page 59772]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23664]


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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.

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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, October 29, 2014, from 
8:30 a.m. until 5:00 p.m. and Thursday, October 30, 2014, from 8:30 
a.m. until 4:00 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

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: SACHRP@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.
    The meeting will open to the public at 8:30 a.m., Wednesday, 
October 29. Following opening remarks from Dr. Jerry Menikoff, 
Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey 
Botkin, SACHRP Chair, new members will be introduced. The Subpart A 
Subcommittee (SAS) will then give their report on the new SAS 
initiative examining informed consent. 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. SAS 
was established by SACHRP in October 2006. Following this report, an 
OHRP staff member will present and discuss OHRP data addressing 
incidental findings and corrective action plans.
    On October 30, the Subcommittee on Harmonization (SOH) will discuss 
their work on the topic of the intersection of the HHS and FDA 
regulations and ``big data''; this will be followed by a presentation 
of SOH work on the topic of return of general results. SOH was 
established by SACHRP at its July 2009 meeting. SOH 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 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 number listed above at least one 
week prior to the meeting. Pre-registration is required for 
participation in the on-site public comment session; individuals may 
pre-register the day of the meeting. Individuals who would like to 
submit written statements should email or fax their comments to SACHRP 
at SACHRP@hhs.gov at least five business days prior to the meeting.

    Dated: September 29, 2014.
Jerry Menikoff,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections, Director, Office for Human Research Protections.
[FR Doc. 2014-23664 Filed 10-2-14; 8:45 am]
BILLING CODE 4150-36-P
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