80 FR 70827 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 220 (November 16, 2015)

Page Range		70827-70828
FR Document		2015-29001

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

Federal Register, Volume 80 Issue 220 (Monday, November 16, 2015)

[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70827-70828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29001]


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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 Secretary, Office of the Assistant Secretary for 
Health, Department of Health and Human Services.

ACTION: Notice.

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

DATES: The meeting will be held on Thursday, December 3, 2015, from 
8:30 a.m. until 5:00 p.m. and Friday, December 4, 2015, from 8:30 a.m. 
until 4:30 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

[[Page 70828]]


FOR FURTHER INFORMATION CONTACT:  Julia Gorey, J.D., Executive 
Secretary, SACHRP, or Jerry Menikoff, M.D., J.D., Director, Office for 
Human Research Protections (OHRP); 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.
    The meeting will open to the public at 8:30 a.m., on Thursday, 
December 3, followed by opening remarks from Dr. Jerry Menikoff, OHRP 
Director, and Dr. Jeffrey Botkin, SACHRP Chair. The Committee will hear 
the Subpart A Subcommittee (SAS) and Subcommittee on Harmonization 
(SOH) reports on the recent Notice of Proposed Rulemaking (NPRM) 
entitled Federal Policy for the Protection of Human Subjects (80 FR 
53933, Sep. 8, 2015). Both days will be devoted to the discussion of 
the NPRM.
    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.
    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 meeting will adjourn at 4:30 p.m. on December 4, 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 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 comment should 
be relevant to agenda topics being discussed.

    Dated: November 9, 2015.
Julia Gorey,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2015-29001 Filed 11-13-15; 8:45 am]
BILLING CODE 4150-36-P

Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices 70827

DEPARTMENT OF HEALTH AND and bring forward and anticipate future and (3) the name, address, daytime
HUMAN SERVICES program issues and concerns through telephone number, and email address at
ongoing communication with program which the nominator can be contacted.
Health Resources and Services staff, professional organizations, Nominations will be considered as
Administration communities and program participants; vacancies occur on the NACNHSC.
(2) functioning as a sounding board for Nominations should be updated and
The National Advisory Council on the proposed policy changes by utilizing the resubmitted every 3 years to continue to
National Health Service Corps; Notice varying levels of expertise represented be considered for committee vacancies.
for Request for Nominations on the Council to advise on specific HHS strives to ensure that the
SUMMARY: The Health Resources and program areas; (3) developing and membership of HHS federal advisory
Services Administration (HRSA) is distributing white papers and briefs that committees is balanced in terms of
requesting nominations to fill vacancies clearly state issues and/or concerns points of view represented and the
on The National Advisory Council on relating to the NHSC with specific committee’s function. Every effort is
the National Health Service Corps recommendations for necessary policy made to ensure that the views of
(hereafter referred to as NACNHSC). The revisions. women, all ethnic and racial groups,
Specifically, HRSA is requesting and people with disabilities are
NACNHSC was established under 42
nominations for voting members of the represented on HHS federal advisory
U.S.C. 254j (Section 337 of the Public
NACNHSC representing primary care, committees. The Department also
Health Service Act), as amended by
dental health, and mental health that encourages geographic diversity in the
Section 10501 of the Affordable Care
demonstrate the following areas of composition of the committee. The
Act. The NAC is governed by provisions expertise: (1) Working with underserved
of 92 (5 U.S.C. App. 2), also known as Department encourages nominations of
populations; (2) health care policy, qualified candidates from all groups and
the Federal Advisory Committee Act, recruitment and retention; (3) site
which sets forth standards for the locations. Appointment to the
administration; (4) customer service; (5) NACNHSC shall be made without
formation and use of advisory marketing; (6) organizational
committees. discrimination on the basis of age, race,
partnerships; (7) research; (8) and ethnicity, gender, sexual orientation,
DATES: The agency will receive clinical practice. We are looking for disability, and cultural, religious, or
nominations on a continuous basis. nominees that either currently hold or socioeconomic status.
ADDRESSES: All nominations should be have previously filled a role as site
submitted to Regina Wilson, Advisory administrators, physicians, dentists, Jackie Painter,
Council Operations, Bureau of Health mid-level professionals (i.e., nurses, Director, Division of the Executive Secretariat.
Workforce, HRSA, 11w45c, 5600 Fishers physician assistants), mental or [FR Doc. 2015–28917 Filed 11–13–15; 8:45 am]
Lane, Rockville, Maryland 20857. Mail behavioral health professionals, and BILLING CODE 4165–15–P
delivery should be addressed to Regina National Health Service Corps scholars
Wilson, Advisory Council Operations, or loan repayors.
Bureau of Health Workforce, HRSA, at The Department of Health and Human DEPARTMENT OF HEALTH AND
the above address, or via email to: Services (HHS) will consider HUMAN SERVICES
RWilson@hrsa.gov. nominations of all qualified individuals
with the areas of subject matter Meeting of the Secretary’s Advisory
FOR FURTHER INFORMATION CONTACT:
expertise noted above. Individuals may Committee on Human Research
CAPT Shari Campbell, Designated nominate themselves or other Protections
Federal Official, National Advisory individuals, and professional
Council on National Health Service associations and organizations may AGENCY: Office of the Secretary, Office
Corps at (301) 594–4251 or email nominate one or more qualified persons of the Assistant Secretary for Health,
scampbell@hrsa.gov. A copy of the for membership. Nominations shall state Department of Health and Human
current committee membership, charter that the nominee is willing to serve as Services.
and reports can be obtained by a member of the NACNHSC and appears ACTION: Notice.
accessing the http://nhsc.hrsa.gov/ to have no conflict of interest that
corpsexperience/aboutus/ would preclude the NACNHSC SUMMARY: Pursuant to Section 10(a) of
nationaladvisorycouncil/index.html. membership. Potential candidates will the Federal Advisory Committee Act,
SUPPLEMENTARY INFORMATION: The be asked to provide detailed information U.S.C. Appendix 2, notice is hereby
NACNHSC is a group of health care concerning financial interests, given that the Secretary’s Advisory
providers and health care site consultancies, research grants, and/or Committee on Human Research
administrators who are experts in the contracts that might be affected by Protections (SACHRP) will hold a
issues that communities with a shortage recommendations of the NACNHSC to meeting that will be open to the public.
of primary care professionals face in permit evaluation of possible sources of Information about SACHRP and the full
meeting their health care needs. The conflicts of interest. meeting agenda will be posted on the
NACNHSC is committed to effectively A nomination package should include SACHRP Web site at: http://
implementing its mandate to advise the the following information for each www.dhhs.gov/ohrp/sachrp/mtgings/
Secretary of the Department of Health nominee: index.html.
and Human Services (HHS) and, by (1) A letter of nomination stating the
designation, the Administrator of the name, affiliation, and contact DATES: The meeting will be held on
Thursday, December 3, 2015, from 8:30
tkelley on DSK3SPTVN1PROD with NOTICES

Health Resources and Services information for the nominee, the basis
Administration (HRSA). for the nomination (i.e., what specific a.m. until 5:00 p.m. and Friday,
The NACNHSC consists of 15 attributes, perspectives, and/or skills December 4, 2015, from 8:30 a.m. until
members who are Special Government does the individual possess that would 4:30 p.m.
Employees. Responsibilities of the benefit the workings of the NACNHSC); ADDRESSES: Fishers Lane Conference
Council include: (1) Serving as a forum (2) a biographical sketch of the nominee Center, Terrace Level, 5635 Fishers
to identify the priorities for the NHSC and a copy of his/her curriculum vitae; Lane, Rockville, Maryland 20852.

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70828 Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices

FOR FURTHER INFORMATION CONTACT: Julia should email or fax their comments to Room 706, 6707 Democracy Boulevard,
Gorey, J.D., Executive Secretary, SACHRP at SACHRP@hhs.gov at least Bethesda, MD 20892–5452, 301–594–4721,
SACHRP, or Jerry Menikoff, M.D., J.D., five business days prior to the meeting. rw175w@nih.gov.
Director, Office for Human Research Public comment should be relevant to Name of Committee: National Institute of
Protections (OHRP); U.S. Department of agenda topics being discussed. Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, R01 Diabetes
Health and Human Services, 1101 Dated: November 9, 2015. Ancillary Study.
Wootton Parkway, Suite 200, Rockville, Julia Gorey, Date: December 8, 2015.
Maryland 20852; telephone: 240–453– Executive Secretary, Secretary’s Advisory Time: 5:00 p.m. to 6:00 p.m.
8141; fax: 240–453–6909; email address: Committee on Human Research Protections. Agenda: To review and evaluate grant
SACHRP@hhs.gov. [FR Doc. 2015–29001 Filed 11–13–15; 8:45 am]
applications.
SUPPLEMENTARY INFORMATION: Under the Place: National Institutes of Health, 6100
BILLING CODE 4150–36–P Executive Boulevard, Rockville, MD 20852,
authority of 42 U.S.C. 217a, Section 222
(Telephone Conference Call).
of the Public Health Service Act, as Contact Person: Robert Wellner, Ph.D.,
amended, SACHRP was established to DEPARTMENT OF HEALTH AND Scientific Review Officer, Review Branch,
provide expert advice and HUMAN SERVICES DEA, NIDDK, National Institutes of Health,
recommendations to the Secretary of Room 706, 6707 Democracy Boulevard,
Health and Human Services, through National Institutes of Health Bethesda, MD 20892–5452, 301–594–4721,
the Assistant Secretary for Health, on rw175w@nih.gov.
issues and topics pertaining to or National Institute of Diabetes and Name of Committee: National Institute of
associated with the protection of human Digestive and Kidney Diseases; Notice Diabetes and Digestive and Kidney Diseases
research subjects. of Closed Meetings Special Emphasis Panel, T1D Ancillary
Studies.
The meeting will open to the public Pursuant to section 10(d) of the Date: December 11, 2015.
at 8:30 a.m., on Thursday, December 3, Federal Advisory Committee Act, as Time: 10:00 a.m. to 12:00 p.m.
followed by opening remarks from Dr. amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant
Jerry Menikoff, OHRP Director, and Dr. hereby given of the following meetings. applications.
Jeffrey Botkin, SACHRP Chair. The The meetings will be closed to the Place: National Institutes of Health, 6100
Committee will hear the Subpart A public in accordance with the Executive Boulevard, Rockville, MD 20852,
Subcommittee (SAS) and Subcommittee provisions set forth in sections (Telephone Conference Call).
on Harmonization (SOH) reports on the Contact Person: Carol J. Goter-Robinson,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Ph.D., Scientific Review Officer, Review
recent Notice of Proposed Rulemaking as amended. The grant applications and Branch, DEA, NIDDK, National Institutes of
(NPRM) entitled Federal Policy for the the discussions could disclose Health, Room 748, 6707 Democracy
Protection of Human Subjects (80 FR confidential trade secrets or commercial Boulevard, Bethesda, MD 20892–5452, (301)
53933, Sep. 8, 2015). Both days will be property such as patentable material, 594–7791, goterrobinsonc@
devoted to the discussion of the NPRM. and personal information concerning extra.niddk.nih.gov.
SAS was established by SACHRP in individuals associated with the grant (Catalogue of Federal Domestic Assistance
October 2006 and is charged with applications, the disclosure of which Program Nos. 93.847, Diabetes,
developing recommendations for would constitute a clearly unwarranted Endocrinology and Metabolic Research;
consideration by SACHRP regarding the invasion of personal privacy. 93.848, Digestive Diseases and Nutrition
application of subpart A of 45 CFR part Research; 93.849, Kidney Diseases, Urology
Name of Committee: National Institute of and Hematology Research, National Institutes
46 in the current research environment. Diabetes and Digestive and Kidney Diseases of Health, HHS)
SOH was established by SACHRP at Special Emphasis Panel, PAR–13–266-
its July 2009 meeting and charged with Biomarkers for Kidney and Liver Diseases Dated: November 9, 2015.
identifying and prioritizing areas in (R01). David Clary,
which regulations and/or guidelines for Date: February 4, 2016. Program Analyst, Office of Federal Advisory
human subjects research adopted by Time: 11:00 a.m. to 1:00 p.m. Committee Policy.
Agenda: To review and evaluate grant
various agencies or offices within HHS [FR Doc. 2015–28834 Filed 11–13–15; 8:45 am]
applications.
would benefit from harmonization, Place: National Institutes of Health, Two BILLING CODE 4140–01–P
consistency, clarity, simplification and/ Democracy Plaza, 6707 Democracy
or coordination. Boulevard, Bethesda, MD 20892, (Telephone
The meeting will adjourn at 4:30 p.m. Conference Call). DEPARTMENT OF HEALTH AND
on December 4, 2015. Time for public Contact Person: Najma Begum, Ph.D., HUMAN SERVICES
comment sessions will be allotted both Scientific Review Officer, Review Branch,
days. DEA, NIDDK, National Institutes of Health, National Institutes of Health
Room 749, 6707 Democracy Boulevard,
Public attendance at the meeting is
Bethesda, MD 20892–5452, (301) 594–8894, National Institute on Minority Health
limited to space available. Individuals begumn@niddk.nih.gov.
who plan to attend and need special and Health Disparities; Notice of
Name of Committee: National Institute of Closed Meeting
assistance, such as sign language Diabetes and Digestive and Kidney Diseases
interpretation or other reasonable Special Emphasis Panel, Fatty Liver Pursuant to section 10(d) of the
accommodations, should notify one of Ancillary Studies. Federal Advisory Committee Act, as
the designated SACHRP points of Date: December 7, 2015. amended (5 U.S.C. App.), notice is
contact at the address/phone number Time: 10:00 a.m. to 12:00 p.m. hereby given of the following meeting.
tkelley on DSK3SPTVN1PROD with NOTICES

listed above at least one week prior to Agenda: To review and evaluate grant The meeting will be closed to the
the meeting. Pre-registration is required applications. public in accordance with the
Place: National Institutes of Health, 6100
for participation in the on-site public Executive Boulevard, Rockville, MD 20852,
provisions set forth in sections
comment session; individuals may pre- (Telephone Conference Call). 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
register the day of the meeting. Contact Person: Robert Wellner, Ph.D., as amended. The grant applications and
Individuals who would like to submit Scientific Review Officer, Review Branch, the discussions could disclose
written statements as public comment DEA, NIDDK, National Institutes of Health, confidential trade secrets or commercial

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Document Created: 2015-12-14 14:13:05
Document Modified: 2015-12-14 14:13:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on Thursday, December 3, 2015, from 8:30 a.m. until 5:00 p.m. and Friday, December 4, 2015, from 8:30 a.m. until 4:30 p.m.
Contact		Julia Gorey, J.D., Executive Secretary, SACHRP, or Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP); U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852;
FR Citation		80 FR 70827