Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development; Correction, 56656 [2016-19874]
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Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
It is expected that ORR will continue
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29, 2015, in FR Doc. 2015–32726, the
following correction is made:
1. On page 81336, in the third
column, in the 13th sentence of the
second paragraph under section II.
CDRH Guidance Development Initiative,
‘‘2 years’’ is corrected to read ‘‘3 years’’.
Dated: August 16, 2016.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
[FR Doc. 2016–19874 Filed 8–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary M. Wayland,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
Food and Drug Administration
[FR Doc. 2016–19923 Filed 8–19–16; 8:45 am]
BILLING CODE 4184–01–P
[Docket No. FDA–2016–N–2473]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Adapting Regulatory Oversight of Next
Generation Sequencing-Based Tests;
Public Workshop; Request for
Comments
Food and Drug Administration
AGENCY:
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2016
Proposed Guidance Development;
Correction
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Medical Device User Fee and
Modernization Act; Notice to Public of
Web Site Location of Fiscal Year 2016
Proposed Guidance Development’’ that
appeared in the Federal Register of
December 29, 2016 (80 FR 81335). The
document announced the Web site
location where the Agency will post two
lists of guidance documents that the
Center for Devices and Radiological
Health (CDRH or the Center) intends to
publish in Fiscal Year (FY) 2016. The
document was published with the
incorrect number of years in which
CDRH committed to finalize, withdraw,
re-open the comment period, or issue
another draft guidance on the topic for
80 percent of the documents. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Planning,
Legislation, and Analysis, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993–0002, 301–
796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, December
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SUMMARY:
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17:13 Aug 19, 2016
Jkt 238001
Food and Drug Administration,
HHS.
[Docket No. FDA–2012–N–1021]
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Adapting Regulatory Oversight of Next
Generation Sequencing-Based Tests.’’
The purpose of this workshop is to
obtain feedback on two FDA draft
guidances, ‘‘Use of Standards in FDA
Regulatory Oversight of Next Generation
Sequencing (NGS)-Based In Vitro
Diagnostics (IVDs) Used for Diagnosing
Germline Diseases’’ and ‘‘Use of Public
Human Genetic Variant Databases to
Support Clinical Validity for Next
Generation Sequencing (NGS)-Based In
Vitro Diagnostics’’ that describes new
approaches to regulate NGS-based tests.
DATES: The public workshop will be
held on September 23, 2016, from 9
a.m.to 3 p.m. Submit either electronic or
written comments on the public
workshop by October 6, 2016.
ADDRESSES: The workshop will be held
in Masur Auditorium at the NIH
Campus, 9000 Rockville Pike, Bldg. 10,
Bethesda, MD 20814. For parking and
security information, please refer to the
NIH Campus Visitor Information: https://
www.nih.gov/icd/od/ocpl/VIC/
index.htm.
You may submit comments as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
PO 00000
Frm 00080
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instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
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–
2016–N–2473 for ‘‘Adapting Regulatory
Oversight of Next Generation
Sequencing-Based Tests.’’ 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
E:\FR\FM\22AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Page 56656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19874]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1021]
Medical Device User Fee and Modernization Act; Notice to Public
of Web Site Location of Fiscal Year 2016 Proposed Guidance Development;
Correction
AGENCY: Food and Drug Administration, HHS
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Medical Device User Fee and Modernization Act; Notice to
Public of Web Site Location of Fiscal Year 2016 Proposed Guidance
Development'' that appeared in the Federal Register of December 29,
2016 (80 FR 81335). The document announced the Web site location where
the Agency will post two lists of guidance documents that the Center
for Devices and Radiological Health (CDRH or the Center) intends to
publish in Fiscal Year (FY) 2016. The document was published with the
incorrect number of years in which CDRH committed to finalize,
withdraw, re-open the comment period, or issue another draft guidance
on the topic for 80 percent of the documents. This document corrects
that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Planning, Legislation, and Analysis, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-
0002, 301-796-9115.
SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, December
29, 2015, in FR Doc. 2015-32726, the following correction is made:
1. On page 81336, in the third column, in the 13th sentence of the
second paragraph under section II. CDRH Guidance Development
Initiative, ``2 years'' is corrected to read ``3 years''.
Dated: August 16, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19874 Filed 8-19-16; 8:45 am]
BILLING CODE 4164-01-P
