Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 937 [2016-113]
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Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices
Board of Governors of the Federal Reserve
System, January 5, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–153 Filed 1–7–16; 8:45 am]
[Docket No. FDA–2015–D–5073]
Food and Drug Administration
BILLING CODE 6210–01–P
Use of Nucleic Acid Tests To Reduce
the Risk of Transmission of Hepatitis
B Virus From Donors of Human Cells,
Tissues, and Cellular and TissueBased Products; Draft Guidance for
Industry; Availability
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
AGENCY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting
for the initial review of applications in
response to Funding Opportunity
Announcement (FOA) PAR15–352,
Occupational Safety and Health
Training Project Grants.
Time and Date: 8:00 a.m.–7:00 p.m.,
January 26–28, 2016 (Closed).
Place: Internet Assisted Meeting
(IAM)/Virtual Meeting.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in section 552b(c)(4)
and (6), title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
Occupational Safety and Health
Training Project Grants, FOA PAR15–
352, initial review.
Contact Person For More Information:
Donald Blackman, Ph.D., Scientific
Review Officer, CDC, 2400 Century
Center Parkway NE., 4th Floor, Room
4204, Mailstop E–74, Atlanta, Georgia
30345, Telephone: (404) 498–6185,
DYB7@CDC.GOV.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–113 Filed 1–7–16; 8:45 am]
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20:40 Jan 07, 2016
Jkt 238001
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Use of Nucleic Acid
Tests to Reduce the Risk of
Transmission of Hepatitis B Virus from
Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products;
Draft Guidance for Industry.’’ The draft
guidance document provides
establishments that make donor
eligibility determinations for donors of
human cells, tissues, and tissue-based
products (HCT/Ps), with
recommendations concerning the use of
FDA-licensed nucleic acid tests (NAT)
in donor testing for hepatitis B virus
(HBV) deoxyribonucleic acid (DNA).
The draft guidance, when finalized, is
intended to supplement previous FDA
recommendations to HCT/P
establishments concerning donor testing
for hepatitis B surface antigen (HBsAg)
and total antibody to hepatitis B core
antigen (anti-HBc), in the document
entitled ‘‘Guidance for Industry:
Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
August 2007 (2007 Donor Eligibility
Guidance).
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 7, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
PO 00000
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937
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–5073 for ‘‘Use of Nucleic Acid
Tests to Reduce the Risk of
Transmission of Hepatitis B Virus from
Donors of Human Cells, Tissues, and
Cellular and Tissue Based Products;
Draft 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 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
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Notices]
[Page 937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-113]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Initial Review
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the aforementioned meeting for the initial
review of applications in response to Funding Opportunity Announcement
(FOA) PAR15-352, Occupational Safety and Health Training Project
Grants.
Time and Date: 8:00 a.m.-7:00 p.m., January 26-28, 2016 (Closed).
Place: Internet Assisted Meeting (IAM)/Virtual Meeting.
Status: The meeting will be closed to the public in accordance with
provisions set forth in section 552b(c)(4) and (6), title 5 U.S.C., and
the Determination of the Director, Management Analysis and Services
Office, CDC, pursuant to Public Law 92-463.
Matters for Discussion: The meeting will include the initial
review, discussion, and evaluation of applications received in response
to Occupational Safety and Health Training Project Grants, FOA PAR15-
352, initial review.
Contact Person For More Information: Donald Blackman, Ph.D.,
Scientific Review Officer, CDC, 2400 Century Center Parkway NE., 4th
Floor, Room 4204, Mailstop E-74, Atlanta, Georgia 30345, Telephone:
(404) 498-6185, DYB7@CDC.GOV.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 2016-113 Filed 1-7-16; 8:45 am]
BILLING CODE 4163-18-P
