0917-0034, Correction Notice for BPPPLE (Published 12-15-2015)

asabaliauskas on DSK5VPTVN1PROD with NOTICES

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Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices

Submissions,’’ publicly viewable at
http://www.regulations.gov or at the
Division of Dockets Management
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
http://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. 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: http://www.fda.gov/
regulatoryinformation/dockets/default.
htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to http://
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the Office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 The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.

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FOR FURTHER INFORMATION CONTACT:

Jonathan McKnight, 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 draft document entitled ‘‘Use of
Nucleic Acid Tests to Reduce the Risk
of Transmission of West Nile Virus
From Living Donors of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps); Draft Guidance for
Industry.’’ The draft guidance document
provides establishments that make
donor eligibility determinations for
donors of HCT/Ps with
recommendations for testing living
donors for WNV. The draft guidance
recommends an FDA-licensed NAT to
test living donors of HCT/Ps for
evidence of infection with WNV. The
guidance does not provide
recommendations regarding testing of
cadaveric HCT/P donors for WNV. FDA
believes that the use of an FDA-licensed
NAT will reduce the risk of
transmission of WNV from living donors
of HCT/Ps and therefore recommends
that you use an FDA-licensed NAT for
testing living donors of HCT/Ps for
infection with WNV. The 2007 Donor
Eligibility Guidance indicated that FDA
may recommend routine use of an
appropriate, licensed donor screening
test(s) to detect acute infections with
WNV using NAT technology, once such
tests were available.
In the Federal Register of October 24,
2013 (78 FR 63476), FDA announced the
availability of the draft guidance
entitled ‘‘Draft Guidance for Industry:
Use of Nucleic Acid Tests to Reduce the
Risk of Transmission of West Nile Virus
from Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
(HCT/Ps)’’ dated October 2013 (October
2013 draft guidance). FDA received
several comments on the draft guidance
and those comments were considered as
this draft guidance was developed.
In the Federal Register of February
28, 2007 (72 FR 9007), FDA announced
the availability of the 2007 Donor
Eligibility Guidance. FDA issued a
revised version of this guidance under
the same title, dated August 2007 (2007
Donor Eligibility Guidance).
The draft guidance announced in this
notice replaces the October 2013 draft
guidance and when finalized, will
supplement sections IV.E.
(recommendations 15 and 16), IV.F.
(recommendation 5), and supersede the
‘‘West Nile Virus (WNV)’’ section in

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Appendix 6 of the 2007 Donor
Eligibility Guidance.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Use of Nucleic Acid Tests to
Reduce the Risk of Transmission of
West Nile Virus from Living Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps); Draft
Guidance for Industry.’’ 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.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
http://www.fda.gov/Biologics
BloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or http://
www.regulations.gov.
Dated: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31405 Filed 12–14–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[OMB Control Number 0917–0034]

Request for Public Comment: 30-Day
Proposed Information Collection:
Indian Health Service (IHS) Sharing
What Works—Best Practice, Promising
Practice, and Local Effort (BPPPLE)
Form
Indian Health Service, HHS.
Notice; correction.

AGENCY:
ACTION:

The Indian Health Service
published a 30 day Federal Register
notice in the Federal Register (FR) on
November 17, 2015 (80 FR 71813) to
solicit comments from the general
public on the information collection
titled, ‘‘Indian Health Service (IHS)
Sharing What Works—Best Practice,
Promising Practice, and Local Effort
(BPPPLE) Form,’’ Office of Management
and Budget (OMB) Control Number
0917–0034. The notice was submitted
before the 60 day FR notice comment
period for the same information
collection ends on December 8, 2015.
Therefore, the correct date for the
deadline to submit comments regarding
the 30 day FR notice is January 9, 2016.

SUMMARY:

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Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
Direct Your Comments to
OMB: Send your comments and
suggestions regarding the proposed
information collection contained in this
notice, especially regarding the
estimated public burden and associated
response time to: Office of Management
and Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Desk Officer for IHS.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Tamara Clay by one of the
following methods:
• Mail: Tamara Clay, Information
Collection Clearance Officer, Indian
Health Service, Office of Management
Services, Division of Regulatory Affairs,
5600 Fishers Lane, Rockville, Mail Stop
09E70, MD 20857.
• Phone: 301–443–4750.
• Email: [email protected].
SUPPLEMENTARY INFORMATION:
ADDRESSES:

Corrections
In the Federal Register of November
17, in FR Doc. 2015–29251, on page
71814, in the middle column, under the
heading Comment Due Date, the due
date is corrected to read as January 9,
2016.
Dated: December 4, 2015.
Robert G. McSwain,
Principal Deputy Director, Indian Health
Service.

Implementation Cooperative Agreement
(U01).
Date: January 22, 2016.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Paul A. Amstad, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G41, NIAID/NIH/DHHS, 5601 Fishers
Lane, Bethesda, MD 20892–7616, 240–669–
5067, [email protected].
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Investigator Initiated
Program Project Applications (P01).
Date: January 22, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Paul A. Amstad, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G41, NIAID/NIH/DHHS, 5601 Fishers
Lane, Bethesda, MD 20892–7616, 240–669–
5067, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 9, 2015.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.

[FR Doc. 2015–31534 Filed 12–14–15; 8:45 am]
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[FR Doc. 2015–31434 Filed 12–14–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

asabaliauskas on DSK5VPTVN1PROD with NOTICES

National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Clinical Trial

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National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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.

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Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel.
Date: January 28, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
4H100, 5601 Fishers Lane, Rockville, MD
20892, (Virtual Meeting).
Contact Person: Amir Emanuel Zeituni,
Ph.D., Scientific Review Program, DEA/
NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–
9834, Rockville, MD 20852, 301–496–2550.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 9, 2015.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–31435 Filed 12–14–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; The Impact of Clinical
Research Training and Medical
Education at the Clinical Center on
Physician Careers in Academia and
Clinical Research (CC)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Clinical Center, the National Institutes
of Health (NIH) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
To Submit Comments and for Further
Information: Written comments and/or
suggestions from the public and affected
agencies should address one or more of
the following points: (1) Evaluate
whether the proposed collection of
information is necessary for the proper
performance of the function 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, including the
validity of the methodology and
assumptions used; (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 the use of
appropriate automated, electronic,

SUMMARY:

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