80 FR 10686 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 39 (February 27, 2015)

Page Range		10686-10686
FR Document		2015-04120

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 39 (Friday, February 27, 2015)

[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Page 10686]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04120]


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

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

DATES: The meeting will be held on Tuesday, March 24, 2015, from 8:30 
a.m. until 5:00 p.m. and Wednesday, March 25, 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 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; 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, March 
24. Following opening remarks from Dr. Jerry Menikoff, Executive 
Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP 
Chair, Dr. Botkin and invited speakers will discuss issues surrounding 
the use of newborn dried bloodspots in research. The Subpart A 
Subcommittee (SAS) report will follow; SAS will discuss draft 
recommendations on the research uses of newborn dried bloodspots and 
the Newborn Screening Saves Lives Reauthorization Act of 2014. 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 March 24, the Subcommittee on Harmonization 
(SOH) will present their report; 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. SOH will present recommendations on the research use of 
``big data'' and the intersection of the HHS and FDA regulations.
    On March 25, the SOH will discuss the return of individual research 
results with special considerations regarding HIPAA and CLIA; this will 
be followed by presentation of SOH recommendations on the FDA draft 
guidance ``General Clinical Pharmacology Considerations for Pediatric 
Studies for Drugs and Biologics.'' The meeting will adjourn at 4:30 
p.m. March 25, 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: February 23, 2015.
Jerry Menikoff,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections, Director, Office for Human Research Protections.
[FR Doc. 2015-04120 Filed 2-26-15; 8:45 am]
BILLING CODE 4150-36-P

10686 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices

security of United States citizens living Julia Gorey, J.D., Executive Director, who plan to attend and need special
abroad and that involves EV–D68. SACHRP; U.S. Department of Health assistance, such as sign language
and Human Services, 1101 Wootton interpretation or other reasonable
III. Declaration of the Secretary of
Parkway, Suite 200, Rockville, accommodations, should notify one of
Health and Human Services
Maryland 20852; 240–453–8141; fax: the designated SACHRP points of
Also on February 6, 2015, on the basis 240–453–6909; email address: contact at the address/phone number
of my determination of a significant SACHRP@hhs.gov. listed above at least one week prior to
potential for a public health emergency SUPPLEMENTARY INFORMATION: Under the the meeting. Pre-registration is required
that has a significant potential to affect authority of 42 U.S.C. 217a, Section 222 for participation in the on-site public
national security or the health and of the Public Health Service Act, as comment session; individuals may pre-
security of United States citizens living amended, SACHRP was established to register the day of the meeting.
abroad and that involves EV–D68, I provide expert advice and Individuals who would like to submit
declared that circumstances exist recommendations to the Secretary of written statements should email or fax
justifying the authorization of Health and Human Services, through their comments to SACHRP at
emergency use of new in vitro the Assistant Secretary for Health, on SACHRP@hhs.gov at least five business
diagnostics for detection of EV–D68 issues and topics pertaining to or days prior to the meeting.
pursuant to section 564 of the FD&C associated with the protection of human Dated: February 23, 2015.
Act, subject to the terms of any research subjects. Jerry Menikoff,
authorization issued under that section. The meeting will open to the public
Executive Secretary, Secretary’s Advisory
Notice of the EUAs issued by the FDA at 8:30 a.m., on Tuesday, March 24. Committee on Human Research Protections,
Commissioner pursuant to this Following opening remarks from Dr. Director, Office for Human Research
determination and declaration will be Jerry Menikoff, Executive Secretary of Protections.
provided promptly in the Federal SACHRP and OHRP Director, and Dr. [FR Doc. 2015–04120 Filed 2–26–15; 8:45 am]
Register as required under section 564 Jeffrey Botkin, SACHRP Chair, Dr. BILLING CODE 4150–36–P
of the FD&C Act. Botkin and invited speakers will discuss
Dated: February 6, 2015. issues surrounding the use of newborn
Sylvia M. Burwell,
dried bloodspots in research. The DEPARTMENT OF HEALTH AND
Subpart A Subcommittee (SAS) report HUMAN SERVICES
Secretary.
will follow; SAS will discuss draft
[FR Doc. 2015–04121 Filed 2–26–15; 8:45 am]
recommendations on the research uses Centers for Medicare & Medicaid
BILLING CODE 4150–37–P of newborn dried bloodspots and the Services
Newborn Screening Saves Lives
[Document Identifier: CMS–1696 and CMS–
Reauthorization Act of 2014. SAS was 10417]
DEPARTMENT OF HEALTH AND established by SACHRP in October 2006
HUMAN SERVICES and is charged with developing Agency Information Collection
Meeting of the Secretary’s Advisory recommendations for consideration by Activities: Proposed Collection;
Committee on Human Research SACHRP regarding the application of Comment Request
Protections subpart A of 45 CFR part 46 in the
current research environment. AGENCY: Centers for Medicare &
AGENCY: Office of the Assistant In the afternoon of March 24, the Medicaid Services, HHS.
Secretary for Health, Office of the Subcommittee on Harmonization (SOH) ACTION: Notice.
Secretary, Department of Health and will present their report; SOH was
established by SACHRP at its July 2009 SUMMARY: The Centers for Medicare &
Human Services.
meeting and charged with identifying Medicaid Services (CMS) is announcing
ACTION: Notice. an opportunity for the public to
and prioritizing areas in which
SUMMARY: Pursuant to Section 10(a) of regulations and/or guidelines for human comment on CMS’ intention to collect
the Federal Advisory Committee Act, subjects research adopted by various information from the public. Under the
U.S.C. Appendix 2, notice is hereby agencies or offices within HHS would Paperwork Reduction Act of 1995 (the
given that the Secretary’s Advisory benefit from harmonization, PRA), federal agencies are required to
Committee on Human Research consistency, clarity, simplification and/ publish notice in the Federal Register
Protections (SACHRP) will hold a or coordination. SOH will present concerning each proposed collection of
meeting that will be open to the public. recommendations on the research use of information (including each proposed
Information about SACHRP and the full ‘‘big data’’ and the intersection of the extension or reinstatement of an existing
meeting agenda will be posted on the HHS and FDA regulations. collection of information) and to allow
SACHRP Web site at: http:// On March 25, the SOH will discuss 60 days for public comment on the
www.dhhs.gov/ohrp/sachrp/mtgings/ the return of individual research results proposed action. Interested persons are
index.html. with special considerations regarding invited to send comments regarding our
HIPAA and CLIA; this will be followed burden estimates or any other aspect of
DATES: The meeting will be held on this collection of information, including
by presentation of SOH
Tuesday, March 24, 2015, from 8:30 recommendations on the FDA draft any of the following subjects: (1) The
a.m. until 5:00 p.m. and Wednesday, guidance ‘‘General Clinical necessity and utility of the proposed
March 25, 2015, from 8:30 a.m. until
mstockstill on DSK4VPTVN1PROD with NOTICES

Pharmacology Considerations for information collection for the proper
4:30 p.m. Pediatric Studies for Drugs and performance of the agency’s functions;
ADDRESSES: Fishers Lane Conference Biologics.’’ The meeting will adjourn at (2) the accuracy of the estimated
Center, Terrace Level, 5635 Fishers 4:30 p.m. March 25, 2015. Time for burden; (3) ways to enhance the quality,
Lane, Rockville, Maryland 20852. public comment sessions will be utility, and clarity of the information to
FOR FUTHER INFORMATION CONTACT: Jerry allotted both days. be collected; and (4) the use of
Menikoff, M.D., J.D., Director, Office for Public attendance at the meeting is automated collection techniques or
Human Research Protections (OHRP), or limited to space available. Individuals other forms of information technology to

VerDate Sep<11>2014 18:05 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1

Document Created: 2015-12-18 13:14:52
Document Modified: 2015-12-18 13:14:52

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 Tuesday, March 24, 2015, from 8:30 a.m. until 5:00 p.m. and Wednesday, March 25, 2015, from 8:30 a.m. until 4:30 p.m.
FR Citation		80 FR 10686