Meeting of the Secretary's Advisory Committee on Human Research Protections, 35655-35656 [2015-15286]

Download as PDF 35655 Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices the following authorities vested in the Secretary: • The authorities vested under Section 343 of the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA) of 1996, [8 U.S.C. 1182(a)(5)], as amended, titled ‘‘Certification Requirements for Foreign Healthcare Workers.’’ These authorities may be redelegated. Exercise of these authorities is concurrent and does not supplant existing delegations of authority from the Secretary. Exercise of these authorities shall be in accordance with established policies, procedures, guidelines, and regulations as prescribed by the Secretary. This delegation is effective immediately upon date of signature. Dated: June 16, 2015. Sylvia M. Burwell, Secretary. [FR Doc. 2015–15288 Filed 6–19–15; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS–OS–0990–0388– 30D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with section 3507(a)(1)(D) of the Paperwork SUMMARY: Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990–0388, scheduled to expire on July 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. DATES: Comments on the ICR must be received on or before July 22, 2015. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the OMB control number 0990–0388 and document identifier HHS–OS–0990– 0388 30D for reference. Information Collection Request Title: Let’s Move! Cities, Towns, and Counties Abstract: The Office of the Assistant Secretary for Health (OASH) is requesting an approval on an extension by Office of Management and Budget (OMB) on a currently approved information collection; the OMB number is 0990–0388. The project on, Let’s Move! Cities, Towns and Counties (LMCTC), seeks to continue to conduct a survey of local government organizations for the Initiative. Let’s Move is a comprehensive initiative, launched by the First Lady, Michelle Obama, dedicated to solving the challenge of childhood obesity within a generation. The online survey is the mechanism by which Let’s Move! Cities, Towns and Counties report progress on the initiative’s goals and are recognized for that progress. LMCTC calls on local elected officials to adopt long-term, sustainable, and holistic approaches to addressing childhood obesity. Local elected officials who sign up for the initiative are willing to commit to five goals that are intended to create healthier, more livable communities. Therefore, the online survey is essential to the successful operation of the initiative. Since July 2012 until January 31 2015, 463 sites had signed up for Let’s Move! Cities, Towns and Counties. Sites who have completed the online survey report that they have implemented a total of 2170 promising practices intended to promote healthy eating and active living for community residents. Likely Respondents: This activity is requesting comment on the burden for a survey for local government officials who have chosen to participate in Let’s Move! Cities, Towns and Counties. The survey requests information about the activities the locality has undertaken against the initiative’s goals. The responses to these questions are used to show progress, and to recognize municipal and county sites’ success in participating in Let’s Move! Cities, Towns and Counties. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Government Official (city, town, county) .......................................................... 500 1 30/60 250 ........................ ........................ ........................ ........................ Total .......................................................................................................... Terry S. Clark, Asst Information Collection Clearance Officer. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–15225 Filed 6–19–15; 8:45 am] Meeting of the Secretary’s Advisory Committee on Human Research Protections tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4150–28–P Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. AGENCY: ACTION: VerDate Sep<11>2014 17:45 Jun 19, 2015 Jkt 235001 PO 00000 Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C., 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/. SUMMARY: Notice. Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1 35656 Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices The meeting will be held on Tuesday, July 21, 2015, from 8:30 a.m. until 5:00 p.m. and Wednesday, July 22, 2015, from 8:30 a.m. until 4:30 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 through 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. on Tuesday, July 21, 2015. Following opening remarks from Dr. Jerry Menikoff, Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, the Subpart A Subcommittee (SAS) will present their report on informed consent for minimal risk research. SAS was established by SACHRP in October 2006 and 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. In the afternoon of July 21, the Subcommittee on Harmonization (SOH) will present their report, including recommendations pertaining to waiver of consent in cluster randomized trials, the application of the HHS regulations to data registries, and the topic of ‘‘benchmarking’’ in human subjects research. 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. On July 22, the SOH will discuss the return of individual research results with special considerations regarding HIPAA and CLIA. In the afternoon special guest speaker Dr. Robert Klitzman will present on his recent work, The Ethics Police. The meeting will adjourn at 4:30 p.m. on tkelley on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 17:45 Jun 19, 2015 Jkt 235001 July 22, 2015. Time for public comment sessions will be allotted both days. 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 one of the designated SACHRP points of contact 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: June 17, 2015. Jerry Menikoff, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections, Director, Office for Human Research Protections. [FR Doc. 2015–15286 Filed 6–19–15; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Developing Technologies and Tools to Monitor HIV Brain Reservoirs and How They May be Altered by Exposure to Substances of Abuse (R21/R33). Date: July 16, 2015. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Susan O. McGuire, Ph.D., Scientific Review Officer, Office of PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Blvd., Room 4245, Rockville, MD 20852, 301–435–1426, mcguireso@mail.nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, NIDA I/ START Small Grant Review. Date: July 21, 2015. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Virtual Meeting). Contact Person: Jagadeesh S. Rao, Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Boulevard, Room 4234, MSC 9550, Bethesda, MD 02892, 301– 443–9511, jrao@nida.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: June 16, 2015. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–15168 Filed 6–19–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grants (R34) and NIAID Clinical Trial Implementation Cooperative Agreement (U01). Date: July 17, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\22JNN1.SGM 22JNN1

Agencies

[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35655-35656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15286]


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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.

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

SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, 5 U.S.C., 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/.

[[Page 35656]]


DATES: The meeting will be held on Tuesday, July 21, 2015, from 8:30 
a.m. until 5:00 p.m. and Wednesday, July 22, 2015, from 8:30 a.m. until 
4:30 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 through 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. on Tuesday, July 
21, 2015. Following opening remarks from Dr. Jerry Menikoff, Executive 
Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP 
Chair, the Subpart A Subcommittee (SAS) will present their report on 
informed consent for minimal risk research. SAS was established by 
SACHRP in October 2006 and 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.
    In the afternoon of July 21, the Subcommittee on Harmonization 
(SOH) will present their report, including recommendations pertaining 
to waiver of consent in cluster randomized trials, the application of 
the HHS regulations to data registries, and the topic of 
``benchmarking'' in human subjects research. 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. On July 22, the SOH will discuss the return of 
individual research results with special considerations regarding HIPAA 
and CLIA.
    In the afternoon special guest speaker Dr. Robert Klitzman will 
present on his recent work, The Ethics Police. The meeting will adjourn 
at 4:30 p.m. on July 22, 2015. Time for public comment sessions will be 
allotted both days.
    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 one of the designated SACHRP points of contact 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: June 17, 2015.
Jerry Menikoff,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections, Director, Office for Human Research Protections.
[FR Doc. 2015-15286 Filed 6-19-15; 8:45 am]
BILLING CODE 4150-36-P
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