Meeting of the Secretary's Advisory Committee on Human Research Protections, 45033-45034 [2017-20651]

Download as PDF Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Notices Dated: September 20, 2017. John R. Graham, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2017–20613 Filed 9–26–17; 8:45 am] BILLING CODE 4151–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the 2018 Physical Activity Guidelines Advisory Committee Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the fifth and final meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public via videocast. DATES: The meeting will be held on October 17, 2017, from 1:00 p.m. E.D.T. to 4:30 p.m. E.D.T., on October 18, 2017, from 8:00 a.m. to 11:15 a.m. E.D.T., on October 19, 2017, from 8:00 a.m. to 11:15 a.m. E.D.T., and on October 20, 2017, from 8:00 a.m. E.D.T. to 11:15 a.m. E.D.T. ADDRESSES: The meeting will be accessible by videocast on the Internet. FOR FURTHER INFORMATION CONTACT: Designated Federal Officer, 2018 Physical Activity Guidelines Advisory Committee, Richard D. Olson, M.D., M.P.H. and/or Alternate Designated Federal Officer, Katrina L. Piercy, Ph.D., R.D., Office of Disease Prevention and Health Promotion (ODPHP), Office of the Assistant Secretary for Health (OASH), HHS; 1101 Wootton Parkway, Suite LL–100; Rockville, MD 20852; Telephone: (240) 453–8280. Additional information is available at www.health.gov/paguidelines. SUPPLEMENTARY INFORMATION: The inaugural Physical Activity Guidelines for Americans (PAG), issued in 2008, represents the first comprehensive guidelines on physical activity issued by the federal government. The PAG serves as the benchmark and primary, authoritative voice of the federal government for providing science-based guidance on physical activity, fitness, and health for Americans. The second edition of the PAG will build upon the first edition and provide a foundation for federal recommendations and education for physical activity programs asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:59 Sep 26, 2017 Jkt 241001 for Americans, including those at risk for chronic disease. Description of the Committee’s Mission and Composition: The 2018 PAGAC was established to perform a single, time-limited task. The work of the Committee is solely advisory in nature. The Committee is charged to examine the current PAG, take into consideration new scientific evidence and current resource documents, and develop a scientific report to the Secretary of HHS that outlines its science-based advice and recommendations for development of the second edition of the PAG. The Committee consists of 17 members, who were appointed by the Secretary in June 2016. Information on the Committee membership is available at www.health.gov/paguidelines/secondedition/committee/. It has been planned for the Committee to hold five meetings to accomplish its mission. The first meeting was held in July 2016, the second meeting was held in October 2016, the third meeting was held in March 2017, the fourth meeting was held in July 2017, and the fifth meeting will be held in October 2017. It is stipulated in the charter that the Committee will be terminated after delivery of its report to the Secretary of HHS or two years from the date the charter was filed, whichever comes first. Purpose of the Meeting: In accordance with FACA and to promote transparency of the process, deliberations of the Committee will occur in a public forum. At this meeting, the Committee will conclude its deliberations. Meeting Agenda: The meeting will include subcommittee reports on the remainder of their literature review questions, discussion of overarching issues, and discussion of plans for finalizing the Committee’s report to the Secretary. Meeting Registration: The meeting is open to the public via videocast; preregistration is required. To register, please visit www.health.gov/ paguidelines. After registration, individuals will receive videocast access information via email. To request a special accommodation, please email jennifer.gillissen@kauffmaninc.com. Public Comments and Meeting Documents: Written comments from the public to the Committee will continue to be accepted until November 10, 2017; they can be submitted and/or viewed at www.health.gov/paguidelines/pcd/. Documents pertaining to Committee deliberations, including meeting agendas and summaries are available on www.health.gov/paguidelines. Meeting information will continue to be PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 45033 accessible online and upon request at the Office of Disease Prevention and Health Promotion, OASH/HHS; 1101 Wootton Parkway, Suite LL100 Tower Building; Rockville, MD 20852; Telephone: (240) 453–8280; Fax: (240) 453–8281. Dated: September 21, 2017. Don Wright, Deputy Assistant Secretary for Health (Deputy Prevention and Health Promotion). [FR Doc. 2017–20607 Filed 9–26–17; 8:45 am] BILLING CODE 4150–32–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-committee/ meetings/. DATES: The meeting will be held on Tuesday, October 17, 2017, from 8:30 a.m. until 5:00 p.m., and Wednesday, October 18, 2017, 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: Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 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. SUMMARY: E:\FR\FM\27SEN1.SGM 27SEN1 asabaliauskas on DSKBBXCHB2PROD with NOTICES 45034 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Notices The Subpart A Subcommittee (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. The Subcommittee on Harmonization (SOH) was established by SACHRP at its July 2009 meeting and 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 SACHRP meeting will open to the public at 8:30 a.m., on Tuesday, October 17, 2017, followed by opening remarks from Dr. Jerry Menikoff, Director, Office for Human Research Protections (OHRP) and Dr. Stephen Rosenfeld, SACHRP Chair. The SAS will present their recommendations regarding the revised Common Rule’s (https://www.gpo.gov/ fdsys/pkg/FR-2017-01-19/html/201701058.htm) expedited review requirements, followed by a discussion of the meaning of ‘‘context’’ when considering requirement for single IRB review. This will be followed by a discussion of SOH recommendations on the revised Common Rule’s HIPAA exemption, section 104(d)(4)(iii), and a panel discussion with a representative of the Office for Civil Rights. The day will conclude with a presentation by OHRP staff on a new public outreach Web site, About Participation. The Tuesday meeting will adjourn at approximately 5:00 p.m. The Wednesday, October 18, meeting will begin at 8:30 a.m. with a presentation and discussion led by FDA staff on a recent FDA experience with IRB review under 21 CFR 50.54, and the lessons learned. Time is allotted for review of the previous day’s recommendations. The meeting will adjourn at approximately 4:00 p.m., October 18, 2017. Time for public comment sessions will be allotted both days. On-site registration is required for participation in the live public comment session. Note that public comment must be relevant to issues currently being addressed by the SACHRP. Individuals submitting written statements as public comment should email or fax their comments to SACHRP at SACHRP@ hhs.gov at least five business days prior to the meeting. Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language VerDate Sep<11>2014 18:59 Sep 26, 2017 Jkt 241001 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. Dated: September 21, 2017. Julia G. Gorey, Executive Director, Secretary’s Advisory Committee on Human Research Protections. [FR Doc. 2017–20651 Filed 9–26–17; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 60 Day Notice for Extension of Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys Indian Health Service, HHS. Notice and request for comments. Request for extension of approval. AGENCY: ACTION: In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917–0036, ‘‘Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery’’ for approval under the Paperwork Reduction Act. This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to the Office of Management and Budget (OMB) for approval and solicits comments on specific aspects for the proposed information collection. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001-[insert number]). DATES: Consideration will be given to all comments received by November 27, 2017. For Comments: Submit comments to Evonne Bennett-Barnes by one of the following methods: • Mail: Evonne Bennett-Barnes, Information Collection Clearance Officer, Indian Health Service, 5600 Fishers Lane, Rockville, MD 20857. • Phone: 301–443–4750. SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 • Email: Evonne.Bennett-Barnes@ ihs.gov. • Fax: 301–594–0899. Comments submitted in response to this notice will be made available to the public by publishing them in the 30 day Federal Register notice for this information collection. For this reason, please do not include information of a confidential nature, such as sensitive personal information or proprietary information. If comments are submitted via email, the email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice. FOR FURTHER INFORMATION CONTACT: To request additional information, please contact Evonne Bennett-Barnes, Evonne.Bennett-Barnes@ihs.gov or 301– 443–4750. SUPPLEMENTARY INFORMATION: The IHS is submitting the proposed information collection to OMB for review, as required by section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995. This notice is soliciting comments from members of the public and affected agencies as required by 44 U.S.C. 3506(c)(2)(A) concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques of other forms of information technology, e.g., permitting electronic submission of responses. Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys. Type of Information Collection Request: Three year extension approval of this information collection. OMB Control Number: 0917–0036. Abstract: The proposed information collection activity provides a means to garner qualitative customer and E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Notices]
[Pages 45033-45034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20651]


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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, 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-committee/meetings/.

DATES: The meeting will be held on Tuesday, October 17, 2017, from 8:30 
a.m. until 5:00 p.m., and Wednesday, October 18, 2017, 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: Julia Gorey, J.D., Executive Director, 
SACHRP; U.S. Department of Health and Human Services, 1101 Wootton 
Parkway, Suite 200, Rockville, Maryland 20852; telephone: 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.

[[Page 45034]]

    The Subpart A Subcommittee (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.
    The Subcommittee on Harmonization (SOH) was established by SACHRP 
at its July 2009 meeting and 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 SACHRP meeting will open to the public at 8:30 a.m., on 
Tuesday, October 17, 2017, followed by opening remarks from Dr. Jerry 
Menikoff, Director, Office for Human Research Protections (OHRP) and 
Dr. Stephen Rosenfeld, SACHRP Chair.
    The SAS will present their recommendations regarding the revised 
Common Rule's (https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm) expedited review requirements, followed by a discussion of 
the meaning of ``context'' when considering requirement for single IRB 
review. This will be followed by a discussion of SOH recommendations on 
the revised Common Rule's HIPAA exemption, section 104(d)(4)(iii), and 
a panel discussion with a representative of the Office for Civil 
Rights. The day will conclude with a presentation by OHRP staff on a 
new public outreach Web site, About Participation. The Tuesday meeting 
will adjourn at approximately 5:00 p.m.
    The Wednesday, October 18, meeting will begin at 8:30 a.m. with a 
presentation and discussion led by FDA staff on a recent FDA experience 
with IRB review under 21 CFR 50.54, and the lessons learned. Time is 
allotted for review of the previous day's recommendations. The meeting 
will adjourn at approximately 4:00 p.m., October 18, 2017.
    Time for public comment sessions will be allotted both days. On-
site registration is required for participation in the live public 
comment session. Note that public comment must be relevant to issues 
currently being addressed by the SACHRP. Individuals submitting written 
statements as public comment should email or fax their comments to 
SACHRP at SACHRP@hhs.gov at least five business days prior to the 
meeting.
    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.

    Dated: September 21, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2017-20651 Filed 9-26-17; 8:45 am]
 BILLING CODE 4150-36-P

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