Secretary's Advisory Committee on Human Research Protections, 52491-52492 [E9-24482]

Download as PDF 52491 Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices 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. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on (202) 690–6162. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 60days. Proposed Project: The Hospital Preparedness Program—Revision-OMB No. 0990–0326–OS—Assistant Secretary for Preparedness and Response (ASPR). Abstract: The Office of the Assistant Secretary for Preparedness and Response (ASPR), Division of Healthcare Preparedness Program (HPP) and the State and Local Initiative— Program Evaluation Section (SLI-PES), is proposing a Web-based reporting system to gather critical information and data from the 62 Awardees participating in the National Bioterrorism Hospital Preparedness Program (NBHPP). The reporting system will capture information related on performance measures, critical benchmarks, minimal levels of readiness, program statistics, policies and procedures, surge capacity elements, surge capacity as measured by exercises, and other pertinent information for programmatic fiscal management, improvement and tracking performance. The data submitted to HPP will be gathered for mid-year reports and end of year reports on annual activities and progress. Awardees will indicate the progress made toward each of the financial and programmatic objectives noted on their cooperative agreement application (CAA) on the mid-year progress report. The end of year report on annual activities will require Awardees to provide additional details on objective achievement and budget/fiscal management. The end of year report will also require Awardees to present improvements made toward achieving the program’s critical benchmarks. In addition, the reporting will increase ASPR’s ability to quickly and efficiently analyze data, identify trends, make timely program decisions, and provide the Department of Health and Human Services (HHS), Congress, and other Operating Divisions with data and information. ESTIMATED ANNUALIZED BURDEN TABLE Forms (if necessary) Type of respondent Form is Web-based interface .............................................. Number of respondents Number of responses per respondent Average burden hours per response Total burden hours 62 1 2 124 Form is Web-based interface .............................................. Mid-Year Report Final Report 62 1 16 992 Total .............................................................................. ........................ ........................ ........................ ........................ 1,116 Seleda Perryman, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. E9–24474 Filed 10–9–09; 8:45 am] October 28, 2009 from 8:30 a.m. until 5 p.m. BILLING CODE 4150–37–P The Sheraton National Hotel, 900 South Orme Street, Arlington, Virginia 22204. Phone: 703– 521–1900. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FUTHER 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. Secretary’s Advisory Committee on Human Research Protections erowe on DSK5CLS3C1PROD with NOTICES AGENCY: Office of Public Health and Science, 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 its twenty-first meeting. The meeting will be open to the public. DATES: The meeting will be held on Tuesday, October 27, 2009 from 8:30 a.m. until 5 p.m. and Wednesday, VerDate Nov<24>2008 15:29 Oct 09, 2009 Jkt 220001 ADDRESSES: 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 On October 27, 2009, the Committee will be briefed on harmonization efforts undertaken by the National Institutes of Health and discuss possible implications for future SACHRP committee work. Following this, Dr. Marjorie Speers will present and discuss the Association for the Accreditation of Human Research Protection Programs’ recently revised standards for accreditation. The day will conclude with a report from the Subpart A Subcommittee focusing on issues surrounding consent for future use of specimens or data; this subcommittee 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 4–5, 2006 meeting. On October 28, 2009, SACHRP will hear remarks from the Assistant Secretary for Health, Dr. Howard Koh. This will be followed by a panel presentation focusing on types of informed consent tools and mechanisms E:\FR\FM\13OCN1.SGM 13OCN1 52492 Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices that strive to augment the informed consent document and increase a subject’s understanding of research participation. The meeting will conclude with a panel of speakers focusing on the regulatory barriers that may be associated with Community Based and Participatory Research. 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, October 22, 2009. Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at: https:// www.hhs.gov/ohrp/sachrp/. Dated: October 6, 2009. Jerry Menikoff, Director, Office for Human Research Protections, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. E9–24482 Filed 10–9–09; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability erowe on DSK5CLS3C1PROD with NOTICES AGENCY: Department of Health and Human Services, Office of the Secretary. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public. DATES: The meeting will take place Thursday, November 19 and Friday, November 20, 2009 from 8:30 a.m. to 5 p.m. ADDRESSES: The Universities at Shady Grove, 9630 Gudelsky Drive, Rockville, MD 20850, Phone: 301–738–6000. FOR FURTHER INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive Secretary, VerDate Nov<24>2008 15:29 Oct 09, 2009 Jkt 220001 Advisory Committee on Blood Safety and Availability, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240) 453–8803, FAX (240) 453– 8456, e-mail ACBSA@hhs.gov. SUPPLEMENTARY INFORMATION: The Advisory Committee on Blood Safety and Availability provides advice to the Secretary and the Assistant Secretary for Health on a range of policy issues that impact (1) Definition of public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related to transfusion and transplantation safety, and (3) the implications for safety and the availability of various economic factors affecting product cost and supply. In keeping with its established mission, the ACBSA has been asked to review and comment on the current processes and parameters which should be used in the decision-making process for transplantation safety policy. At the November 19 and 20, 2009 meeting, the Committee will be asked to comment and make recommendations on current safety decision making processes within the Department of Health and Human Services while considering those same processes within the Private Sector. During the meeting, the ACBSA will be provided a briefing on Biovigilance (surveillance of blood, organs, and tissues safety). Specifically, the committee will be asked to comment on the white paper entitled, ‘‘Biovigilance in the United States: Efforts to Bridge a Critical Gap in Patient Safety and Donor Health.’’ The public will have opportunity to present their views to the Committee on both meeting days. A public comment session has been scheduled for November 19 and 20, 2009. Comments will be limited to five minutes per speaker and must be pertinent to the discussion. Pre-registration is required for participation in the public comment session. Any member of the public who would like to participate in this session is encouraged to contact the Executive Secretary at his/her earliest convenience. It is requested that those who wish to have printed material distributed to the Committee provide thirty (30) copies of the document to be distributed to the Executive Secretary, ACBSA, prior to close of business November 16, 2009. If it is not possible to provide 30 copies of the material to be distributed, then individuals are requested to provide at a minimum one (1) copy of the document(s) to be PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 distributed prior to the close of business November 16, 2009. It also is requested that any member of the public who wishes to provide comments to the Committee utilizing electronic data projection submit the necessary material to the Executive Secretary prior to close of business November 16, 2009. Dated: September 25, 2009. Jerry A. Holmberg, Executive Secretary, Advisory Committee on Blood Safety and Availability. [FR Doc. E9–24483 Filed 10–9–09; 8:45 am] BILLING CODE 4150–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–10–0612] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Maryam Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System (OMB #0920–0612, exp. 1/31/2010)—Revision—National Center E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52491-52492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Human Research Protections

AGENCY: Office of Public Health and Science, 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 its 
twenty-first meeting. The meeting will be open to the public.

DATES: The meeting will be held on Tuesday, October 27, 2009 from 8:30 
a.m. until 5 p.m. and Wednesday, October 28, 2009 from 8:30 a.m. until 
5 p.m.

ADDRESSES: The Sheraton National Hotel, 900 South Orme Street, 
Arlington, Virginia 22204. Phone: 703-521-1900.

FOR FUTHER 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 October 27, 2009, the Committee will be briefed on harmonization 
efforts undertaken by the National Institutes of Health and discuss 
possible implications for future SACHRP committee work. Following this, 
Dr. Marjorie Speers will present and discuss the Association for the 
Accreditation of Human Research Protection Programs' recently revised 
standards for accreditation. The day will conclude with a report from 
the Subpart A Subcommittee focusing on issues surrounding consent for 
future use of specimens or data; this subcommittee 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 
4-5, 2006 meeting.
    On October 28, 2009, SACHRP will hear remarks from the Assistant 
Secretary for Health, Dr. Howard Koh. This will be followed by a panel 
presentation focusing on types of informed consent tools and mechanisms

[[Page 52492]]

that strive to augment the informed consent document and increase a 
subject's understanding of research participation. The meeting will 
conclude with a panel of speakers focusing on the regulatory barriers 
that may be associated with Community Based and Participatory Research. 
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, October 22, 2009. Information about SACHRP and the 
draft meeting agenda will be posted on the SACHRP Web site at: https://www.hhs.gov/ohrp/sachrp/.

    Dated: October 6, 2009.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. E9-24482 Filed 10-9-09; 8:45 am]
BILLING CODE 4150-36-P
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