Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2017 Performance Review Board (PRB), 42350-42351 [2017-18899]
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Federal Register / Vol. 82, No. 172 / Thursday, September 7, 2017 / Notices
1271; Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
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for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Deviation
Reporting for Human Cells, Tissues, and
Cellular and Tissue-Based Products
Regulated Solely Under Section 361 of
the Public Health Service Act and 21
CFR part 1271; Guidance for Industry.’’
The document provides establishments
that manufacture HCT/Ps, regulated
solely under section 361 of the PHS Act
and the regulations under 21 CFR part
1271, with recommendations and
relevant examples for complying with
the requirements under 21 CFR
1271.350(b) to investigate and report
HCT/P deviations. The examples
provided in the guidance are intended
to illustrate those HCT/P deviations that
have been most frequently reported to
FDA, CBER.
The guidance does not apply to
reproductive HCT/Ps or to HCT/Ps
regulated under 21 CFR part 1270 and
recovered before May 25, 2005. The
guidance does not apply to healthcare
professionals who implant, transplant,
infuse, or transfer HCT/Ps into
recipients. The guidance also does not
apply to HCT/Ps that are regulated as
drugs, devices, and/or biological
products under section 351 of the PHS
Act and/or the Federal Food, Drug, and
Cosmetic Act, nor does it apply to
investigational HCT/Ps subject to an
investigational new drug application or
an investigational device exemption.
In the Federal Register of December
24, 2015 (80 FR 80364), FDA announced
the availability of the draft guidance of
the same title dated December 2015.
FDA received a few comments on the
draft guidance and those comments
were considered as the guidance was
finalized. A summary of changes
includes additional examples and
editorial changes to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
December 2015.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Deviation
Reporting for Human Cells, Tissues, and
Cellular and Tissue-Based Products
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Regulated Solely Under section 361 of
the Public Health Service Act and 21
CFR part 1271.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 1271 have been approved
under OMB control number 0910–0543.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: August 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18737 Filed 9–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Listing of Members of the
National Institutes of Health’s Senior
Executive Service 2017 Performance
Review Board (PRB)
The National Institutes of
Health (NIH) announces the persons
who will serve on the National
Institutes of Health’s Senior Executive
Service 2017 Performance Review
Board.
FOR FURTHER INFORMATION CONTACT: For
further information about the NIH
Performance Review Board, contact the
Office of Human Resources, Division of
Senior and Scientific Executive
Management, National Institutes of
Health, Building 2, Room 5E18,
Bethesda, Maryland 20892, telephone
301–402–7999 (not a toll-free number).
SUPPLEMENTARY INFORMATION: This
action is being taken in accordance with
Title 5, U.S.C., Section 4314(c)(4),
which requires that members of
performance review boards be
appointed in a manner to ensure
SUMMARY:
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Federal Register / Vol. 82, No. 172 / Thursday, September 7, 2017 / Notices
consistency, stability, and objectivity in
performance appraisals and requires
that notice of the appointment of an
individual to serve as a member be
published in the Federal Register.
The following persons will serve on
the NIH Performance Review Board,
which oversees the evaluation of
performance appraisals of NIH Senior
Executive Service (SES) members:
Alfred Johnson, Chair
Joellen Austin
Michael Gottesman
Richard Ikeda
Michael Lauer
Ellen Rolfes
LaVerne Stringfield
Lawrence Tabak
Timothy Wheeles
Dated: August 30, 2017.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2017–18899 Filed 9–6–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK30JT082PROD with NOTICES
National Center for Complementary
and Integrative Health; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Complementary and
Integrative Health.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting 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 Advisory
Council for Complementary and Integrative
Health
Date: October 6, 2017
Closed: 8:30 a.m. to 9:45 a.m.
Agenda: To review and evaluate grant
applications
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Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Open: 10:00 a.m. to 3:00 p.m.
Agenda: A report from the Institute
Director and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Partap Singh Khalsa,
Ph.D., DC, Director, Division of Extramural
Activities, National Center for
Complementary and Integrative Health, NIH,
National Institutes of Health, 6707
Democracy Blvd., Ste. 401, Bethesda, MD
20892–5475, (301) 594–3462, khalsap@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
nccih.nih.gov/about/naccih/, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Integrative Health,
National Institutes of Health, HHS)
Dated: August 31, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–18897 Filed 9–6–17; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[CBP Dec. 17–11]
Western Hemisphere Travel Initiative:
Designation of an Approved Native
American Tribal Card Issued by the
Pokagon Band of Potawatomi Indians
as an Acceptable Document To Denote
Identity and Citizenship for Entry in the
United States at Land and Sea Ports of
Entry
U.S. Customs and Border
Protection; DHS.
ACTION: Notice.
AGENCY:
This notice announces that
the Commissioner of U.S. Customs and
SUMMARY:
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Border Protection is designating an
approved Native American Tribal Card
issued by the Pokagon Band of
Potawatomi Indians (Pokagon Band) to
U.S. and Canadian citizens as an
acceptable travel document for purposes
of the Western Hemisphere Travel
Initiative. The approved card may be
used to denote identity and citizenship
of Pokagon Band members entering the
United States from contiguous territory
or adjacent islands at land and sea ports
of entry.
DATES: This designation will become
effective on September 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Colleen Manaher, Executive Director,
Planning, Program Analysis, and
Evaluation, Office of Field Operations,
U.S. Customs and Border Protection, via
email at Colleen.M.Manaher@
cbp.dhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The Western Hemisphere Travel
Initiative
Section 7209 of the Intelligence
Reform and Terrorism Prevention Act of
2004 (IRTPA), Public Law 108–458, as
amended, required the Secretary of
Homeland Security (Secretary), in
consultation with the Secretary of State,
to develop and implement a plan to
require U.S. citizens and individuals for
whom documentation requirements
have previously been waived under
section 212(d)(4)(B) of the Immigration
and Nationality Act (8 U.S.C.
1182(d)(4)(B)) to present a passport or
other document or combination of
documents as the Secretary deems
sufficient to denote identity and
citizenship for all travel into the United
States. See 8 U.S.C. 1185 note. On April
3, 2008, the Department of Homeland
Security (DHS) and the Department of
State promulgated a joint final rule,
effective on June 1, 2009, that
implemented the plan known as the
Western Hemisphere Travel Initiative
(WHTI) at U.S. land and sea ports of
entry. See 73 FR 18384 (the WHTI Land
and Sea Final Rule). It amended various
sections of the Code of Federal
Regulations (CFR), including 8 CFR
212.0, 212.1, and 235.1. The WHTI Land
and Sea Final Rule specifies the
documents that U.S. citizens and
nonimmigrant aliens from Canada,
Bermuda, and Mexico are required to
present when entering the United States
at land and sea ports of entry.
Under the WHTI Land and Sea Final
Rule, one type of citizenship and
identity document that may be
presented upon entry to the United
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]]>Agencies
[Federal Register Volume 82, Number 172 (Thursday, September 7, 2017)]
[Notices]
[Pages 42350-42351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18899]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Listing of Members of the National Institutes of
Health's Senior Executive Service 2017 Performance Review Board (PRB)
SUMMARY: The National Institutes of Health (NIH) announces the persons
who will serve on the National Institutes of Health's Senior Executive
Service 2017 Performance Review Board.
FOR FURTHER INFORMATION CONTACT: For further information about the NIH
Performance Review Board, contact the Office of Human Resources,
Division of Senior and Scientific Executive Management, National
Institutes of Health, Building 2, Room 5E18, Bethesda, Maryland 20892,
telephone 301-402-7999 (not a toll-free number).
SUPPLEMENTARY INFORMATION: This action is being taken in accordance
with Title 5, U.S.C., Section 4314(c)(4), which requires that members
of performance review boards be appointed in a manner to ensure
[[Page 42351]]
consistency, stability, and objectivity in performance appraisals and
requires that notice of the appointment of an individual to serve as a
member be published in the Federal Register.
The following persons will serve on the NIH Performance Review
Board, which oversees the evaluation of performance appraisals of NIH
Senior Executive Service (SES) members:
Alfred Johnson, Chair
Joellen Austin
Michael Gottesman
Richard Ikeda
Michael Lauer
Ellen Rolfes
LaVerne Stringfield
Lawrence Tabak
Timothy Wheeles
Dated: August 30, 2017.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2017-18899 Filed 9-6-17; 8:45 am]
BILLING CODE 4140-01-P
