80_FR_35774 80 FR 35655 - Meeting of the Secretary's Advisory Committee on Human Research Protections

80 FR 35655 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 119 (June 22, 2015)

Page Range35655-35656
FR Document2015-15286

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: http:// www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

Federal Register, Volume 80 Issue 119 (Monday, June 22, 2015) 
[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35655-35656]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

[[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: [email protected].

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 [email protected] 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

Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices 35655 the following authorities vested in the Reduction Act of 1995, the Office of the a survey of local government Secretary: Secretary (OS), Department of Health organizations for the Initiative. Let’s • The authorities vested under and Human Services, has submitted an Move is a comprehensive initiative, Section 343 of the Illegal Immigration Information Collection Request (ICR), launched by the First Lady, Michelle Reform and Immigrant Responsibility described below, to the Office of Obama, dedicated to solving the Act (IIRIRA) of 1996, [8 U.S.C. Management and Budget (OMB) for challenge of childhood obesity within a 1182(a)(5)], as amended, titled review and approval. The ICR is for generation. The online survey is the ‘‘Certification Requirements for Foreign renewal of the approved information mechanism by which Let’s Move! Cities, Healthcare Workers.’’ collection assigned OMB control Towns and Counties report progress on These authorities may be redelegated. number 0990–0388, scheduled to expire the initiative’s goals and are recognized Exercise of these authorities is on July 31, 2015. Comments submitted for that progress. LMCTC calls on local concurrent and does not supplant during the first public review of this ICR elected officials to adopt long-term, existing delegations of authority from will be provided to OMB. OMB will sustainable, and holistic approaches to the Secretary. Exercise of these accept further comments from the addressing childhood obesity. Local authorities shall be in accordance with public on this ICR during the review elected officials who sign up for the established policies, procedures, and approval period. initiative are willing to commit to five guidelines, and regulations as DATES: Comments on the ICR must be goals that are intended to create prescribed by the Secretary. received on or before July 22, 2015. This delegation is effective healthier, more livable communities. ADDRESSES: Submit your comments to immediately upon date of signature. Therefore, the online survey is OIRA_submission@omb.eop.gov or via essential to the successful operation of Dated: June 16, 2015. facsimile to (202) 395–5806. Sylvia M. Burwell, the initiative. Since July 2012 until FOR FURTHER INFORMATION CONTACT: January 31 2015, 463 sites had signed Secretary. Information Collection Clearance staff, up for Let’s Move! Cities, Towns and [FR Doc. 2015–15288 Filed 6–19–15; 8:45 am] Information.CollectionClearance@ Counties. Sites who have completed the BILLING CODE 4165–15–P hhs.gov or (202) 690–6162. online survey report that they have SUPPLEMENTARY INFORMATION: When implemented a total of 2170 promising submitting comments or requesting practices intended to promote healthy DEPARTMENT OF HEALTH AND information, please include the OMB HUMAN SERVICES eating and active living for community control number 0990–0388 and residents. document identifier HHS–OS–0990– Office of the Secretary Likely Respondents: This activity is 0388 30D for reference. [Document Identifier: HHS–OS–0990–0388– Information Collection Request Title: requesting comment on the burden for 30D] Let’s Move! Cities, Towns, and Counties a survey for local government officials - who have chosen to participate in Let’s Agency Information Collection Abstract: The Office of the Assistant Move! Cities, Towns and Counties. The Activities; Submission to OMB for Secretary for Health (OASH) is survey requests information about the Review and Approval; Public Comment requesting an approval on an extension activities the locality has undertaken Request by Office of Management and Budget against the initiative’s goals. The AGENCY: Office of the Secretary, HHS. (OMB) on a currently approved responses to these questions are used to ACTION: Notice. information collection; the OMB show progress, and to recognize number is 0990–0388. The project on, municipal and county sites’ success in SUMMARY: In compliance with section Let’s Move! Cities, Towns and Counties participating in Let’s Move! Cities, 3507(a)(1)(D) of the Paperwork (LMCTC), seeks to continue to conduct Towns and Counties. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Average Number of Number of burden per Total burden Form name responses per respondents response hours respondent (in hours) Government Official (city, town, county) .......................................................... 500 1 30/60 250 Total .......................................................................................................... ........................ ........................ ........................ ........................ Terry S. Clark, DEPARTMENT OF HEALTH AND SUMMARY: Pursuant to Section 10(a) of Asst Information Collection Clearance HUMAN SERVICES the Federal Advisory Committee Act, 5 Officer. U.S.C., notice is hereby given that the [FR Doc. 2015–15225 Filed 6–19–15; 8:45 am] Meeting of the Secretary’s Advisory Secretary’s Advisory Committee on BILLING CODE 4150–28–P Committee on Human Research Human Research Protections (SACHRP) Protections will hold a meeting that will be open to tkelley on DSK3SPTVN1PROD with NOTICES the public. Information about SACHRP AGENCY: Office of the Assistant and the full meeting agenda will be Secretary for Health, Office of the posted on the SACHRP Web site at: Secretary, Department of Health and http://www.dhhs.gov/ohrp/sachrp/ Human Services. mtgings/index.html. ACTION: Notice. VerDate Sep<11>2014 17:45 Jun 19, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1

35656 Federal Register / Vol. 80, No. 119 / Monday, June 22, 2015 / Notices DATES: The meeting will be held on July 22, 2015. Time for public comment Extramural Affairs, National Institute on Tuesday, July 21, 2015, from 8:30 a.m. sessions will be allotted both days. Drug Abuse, National Institutes of Health, until 5:00 p.m. and Wednesday, July 22, Public attendance at the meeting is DHHS, 6001 Executive Blvd., Room 4245, 2015, from 8:30 a.m. until 4:30 p.m. limited to space available. Individuals Rockville, MD 20852, 301–435–1426, who plan to attend and need special mcguireso@mail.nih.gov. ADDRESSES: Fishers Lane Conference assistance, such as sign language Name of Committee: National Institute on Center, Terrace Level, 5635 Fishers Drug Abuse Special Emphasis Panel, NIDA I/ Lane, Rockville, Maryland 20852. interpretation or other reasonable START Small Grant Review. FOR FURTHER INFORMATION CONTACT: Jerry accommodations, should notify one of Date: July 21, 2015. Menikoff, M.D., J.D., Director, Office for the designated SACHRP points of Time: 12:00 p.m. to 2:00 p.m. Human Research Protections (OHRP), or contact at the address/phone number Agenda: To review and evaluate grant Julia Gorey, J.D., Executive Director, listed above at least one week prior to applications. SACHRP; U.S. Department of Health the meeting. Pre-registration is required Place: National Institutes of Health, for participation in the on-site public Neuroscience Center, 6001 Executive and Human Services, 1101 Wootton Boulevard, Rockville, MD 20852, (Virtual comment session; individuals may pre- Parkway, Suite 200, Rockville, Meeting). register the day of the meeting. Maryland 20852; 240–453–8141; fax: Contact Person: Jagadeesh S. Rao, Ph.D., Individuals who would like to submit 240–453–6909; email address: Scientific Review Officer, Office of written statements should email or fax SACHRP@hhs.gov. Extramural Affairs, National Institute on their comments to SACHRP at Drug Abuse, National Institutes of Health, SUPPLEMENTARY INFORMATION: Under the SACHRP@hhs.gov at least five business authority of 42 U.S.C. 217a, Section 222 DHHS, 6001 Executive Boulevard, Room days prior to the meeting. 4234, MSC 9550, Bethesda, MD 02892, 301– of the Public Health Service Act, as Dated: June 17, 2015. 443–9511, jrao@nida.nih.gov. amended, SACHRP was established to provide expert advice and Jerry Menikoff, (Catalogue of Federal Domestic Assistance Executive Secretary, Secretary’s Advisory Program Nos.: 93.279, Drug Abuse and recommendations to the Secretary of Addiction Research Programs, National Health and Human Services through the Committee on Human Research Protections, Director, Office for Human Research Institutes of Health, HHS) Assistant Secretary for Health on issues Protections. Dated: June 16, 2015. and topics pertaining to or associated [FR Doc. 2015–15286 Filed 6–19–15; 8:45 am] Michelle Trout, with the protection of human research BILLING CODE 4150–36–P Program Analyst, Office of Federal Advisory subjects. The meeting will open to the public Committee Policy. at 8:30 a.m. on Tuesday, July 21, 2015. [FR Doc. 2015–15168 Filed 6–19–15; 8:45 am] DEPARTMENT OF HEALTH AND Following opening remarks from Dr. BILLING CODE 4140–01–P HUMAN SERVICES Jerry Menikoff, Executive Secretary of SACHRP and OHRP Director, and Dr. National Institutes of Health Jeffrey Botkin, SACHRP Chair, the DEPARTMENT OF HEALTH AND Subpart A Subcommittee (SAS) will National Institute on Drug Abuse; HUMAN SERVICES present their report on informed consent Notice of Closed Meetings for minimal risk research. SAS was National Institutes of Health established by SACHRP in October 2006 Pursuant to section 10(d) of the Federal Advisory Committee Act, as National Institute of Allergy and and is charged with developing Infectious Diseases; Notice of Closed recommendations for consideration by amended (5 U.S.C. App), notice is hereby given of the following meetings. Meetings SACHRP regarding the application of The meetings will be closed to the subpart A of 45 CFR part 46 in the Pursuant to section 10(d) of the public in accordance with the current research environment. Federal Advisory Committee Act, as provisions set forth in sections In the afternoon of July 21, the amended (5 U.S.C. App.), notice is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Subcommittee on Harmonization (SOH) hereby given of the following meetings. as amended. The grant applications and will present their report, including the discussions could disclose The meetings will be closed to the recommendations pertaining to waiver confidential trade secrets or commercial public in accordance with the of consent in cluster randomized trials, property such as patentable materials, provisions set forth in sections the application of the HHS regulations and personal information concerning 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., to data registries, and the topic of individuals associated with the grant as amended. The grant applications and ‘‘benchmarking’’ in human subjects applications, the disclosure of which the discussions could disclose research. SOH was established by would constitute a clearly unwarranted confidential trade secrets or commercial SACHRP at its July 2009 meeting and is invasion of personal privacy. property such as patentable material, charged with identifying and Name of Committee: National Institute on and personal information concerning prioritizing areas in which regulations Drug Abuse Special Emphasis Panel, individuals associated with the grant and/or guidelines for human subjects Developing Technologies and Tools to applications, the disclosure of which research adopted by various agencies or Monitor HIV Brain Reservoirs and How They would constitute a clearly unwarranted offices within HHS would benefit from May be Altered by Exposure to Substances of invasion of personal privacy. harmonization, consistency, clarity, Abuse (R21/R33). simplification and/or coordination. On Date: July 16, 2015. Name of Committee: National Institute of July 22, the SOH will discuss the return Time: 1:30 p.m. to 3:30 p.m. Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial tkelley on DSK3SPTVN1PROD with NOTICES of individual research results with Agenda: To review and evaluate grant applications. Planning Grants (R34) and NIAID Clinical special considerations regarding HIPAA Trial Implementation Cooperative Agreement Place: National Institutes of Health, and CLIA. Neuroscience Center, 6001 Executive (U01). In the afternoon special guest speaker Boulevard, Rockville, MD 20852, (Telephone Date: July 17, 2015. Dr. Robert Klitzman will present on his Conference Call). Time: 1:00 p.m. to 5:00 p.m. recent work, The Ethics Police. The Contact Person: Susan O. McGuire, Ph.D., Agenda: To review and evaluate grant meeting will adjourn at 4:30 p.m. on Scientific Review Officer, Office of applications. VerDate Sep<11>2014 17:45 Jun 19, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1


Document Created: 2018-02-22 11:13:35
Document Modified: 2018-02-22 11:13:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe 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.
ContactJerry 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;
FR Citation80 FR 35655 
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