Meeting of the Secretary's Advisory Committee on Human Research Protections, 7481 [2010-3271]

Download as PDF Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Notices seconded by Director John E. Bowman (Acting Director, Office of Thrift Supervision), concurred in by Director Thomas J. Curry (Appointive), and Chairman Sheila C. Bair, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days’ notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the ‘‘Government in the Sunshine Act’’ (5 U.S.C. 552b(c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10)). The meeting was held in the Board Room of the FDIC Building located at 550 - 7th Street, NW., Washington, DC. Dated: February 17, 2010. Federal Deposit Insurance Corporation. By: Robert E. Feldman, Executive Secretary. [FR Doc. 2010–3391 Filed 2–17–10; 4:15 pm] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections pwalker on DSK8KYBLC1PROD with NOTICES AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science. 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 its twenty-second meeting. The meeting will be open to the public. DATE: The meeting will be held on Tuesday, March 9, 2010 from 8:30 a.m. until 5 p.m. and Wednesday, March 10, 2010 from 8:30 a.m. until 5 p.m. ADDRESSES: U.S. Department of Health & 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 VerDate Nov<24>2008 18:05 Feb 18, 2010 Jkt 220001 and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240–453–8141; fax: 240–453–6909; e-mail address: sachrp@osophs.dhhs.gov. 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 9, 2010, OHRP staff will provide a summary of public comments received on two recent draft guidance documents: Institutional Review Board (IRB) Continuing Review of Research and IRB Approval of Research with Conditions. Following this presentation, there will be a panel that will examine the context for resolution of regulatory harmonization issues through the Clinical Trials Transformation Initiative and the International Council on Harmonization and Good Clinical Practice. After lunch, the day will conclude with a report from the Subpart A Subcommittee (SAS) focusing on issues surrounding consent for future use of specimens or data. 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. On March 10, 2010, co-chairs of the Subcommittee on Harmonization (SOH) will discuss the charge, initial steps, and membership of this new group. 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. The remainder of March 10 will be devoted to continuing the previous day’s focus on the work of the Subpart A Subcommittee. 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 7481 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 Thursday, March 4, 2010. Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at: https://www.hhs.gov/ohrp/ sachrp/. Dated: February 16, 2010. Jerry Menikoff, Director, Office for Human Research Protections, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2010–3271 Filed 2–18–10; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The Health Education Assistance Loan (HEAL) Program Regulations (OMB No. 0915–0108) Extension The Health Education Assistance Loan (HEAL) Program has regulations that contain notification, reporting and recordkeeping requirements to ensure that the lenders, holders and schools participating in the HEAL program follow sound management procedures in the administration of federallyinsured student loans. While the regulatory requirements are approved under the OMB number referenced above, much of the burden associated with the submission of required HEAL forms and certain reporting requirements is approved under E:\FR\FM\19FEN1.SGM 19FEN1

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[Federal Register Volume 75, Number 33 (Friday, February 19, 2010)]
[Notices]
[Page 7481]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science.

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 its 
twenty-second meeting. The meeting will be open to the public.

DATE: The meeting will be held on Tuesday, March 9, 2010 from 8:30 a.m. 
until 5 p.m. and Wednesday, March 10, 2010 from 8:30 a.m. until 5 p.m.

ADDRESSES: U.S. Department of Health & 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; e-mail address: 
sachrp@osophs.dhhs.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 9, 2010, OHRP staff will provide a summary of public 
comments received on two recent draft guidance documents: Institutional 
Review Board (IRB) Continuing Review of Research and IRB Approval of 
Research with Conditions. Following this presentation, there will be a 
panel that will examine the context for resolution of regulatory 
harmonization issues through the Clinical Trials Transformation 
Initiative and the International Council on Harmonization and Good 
Clinical Practice. After lunch, the day will conclude with a report 
from the Subpart A Subcommittee (SAS) focusing on issues surrounding 
consent for future use of specimens or data. 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.
    On March 10, 2010, co-chairs of the Subcommittee on Harmonization 
(SOH) will discuss the charge, initial steps, and membership of this 
new group. 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. The remainder of March 10 will be devoted to continuing 
the previous day's focus on the work of the Subpart A Subcommittee. 
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 Thursday, March 4, 2010. Information about SACHRP and the 
draft meeting agenda will be posted on the SACHRP Web site at: https://www.hhs.gov/ohrp/sachrp/.

    Dated: February 16, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2010-3271 Filed 2-18-10; 8:45 am]
BILLING CODE 4150-36-P
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