National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 4333-4334 [2020-01137]
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Notices
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank, 0925–
0586, Expiration Date 02/29/2020—
EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered and results information
submitted voluntarily, 42 CFR part 11
requires the registration and submission
of results information for certain
applicable clinical trials of drug,
biological, and device products whether
or not they are approved, licensed, or
cleared by the Food and Drug
Administration.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,072,306.
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) and by the Clinical
Trials Registration and Results
Information Submission regulations at
42 CFR part 11. ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies
to the benefit of public health. It is
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Submission type
Registration—attachment 2:
Initial .........................................................................................................
Updates ....................................................................................................
Triggered, voluntary ..................................................................................
Initial, non-regulated, NIH Policy ..............................................................
Updates, non-regulated, NIH Policy .........................................................
Initial, voluntary and non-regulated ..........................................................
Updates, voluntary and non-regulated .....................................................
Results Information Submission—attachment 5:
Initial .........................................................................................................
Updates ....................................................................................................
Triggered, voluntary—also attachment 2 .................................................
Initial, non-regulated, NIH Policy ..............................................................
Updates, non-regulated, NIH Policy .........................................................
Initial, voluntary and non-regulated ..........................................................
Updates, voluntary and non-regulated .....................................................
Other:
Certification to delay results—attachment 6 .............................................
Extension request—attachment 7 ............................................................
Initial, expanded access—attachment 3 ...................................................
Updates, expanded access—attachment 3 ..............................................
Total ...................................................................................................
Dated: January 21, 2020.
David H. Sharlip,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
lotter on DSKBCFDHB2PROD with NOTICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
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Total annual
burden hours
1
8
1
1
8
1
8
8
2
8
8
2
8
2
59,200
118,400
704
5,256
10,512
89,952
179,904
7,400
7,400
30
657
657
2,000
2,000
1
2
1
1
2
1
2
40
10
45
40
10
40
10
296,000
148,000
1,350
26,280
13,140
80,000
40,000
5,150
250
213
213
1
1
1
2
30/60
2
2
15/60
2,575
500
426
107
64,660
210,037
........................
1,072,306
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–19–505:
Limited Competition for the Accelerating
Medicines Partnership (AMP) in Type 2
Diabetes Knowledge Portal (UM1 Clinical
Trial Not Allowed).
Date: March 12, 2020.
PO 00000
Average time
per response
(in hours)
7,400
7,400
88
657
657
11,244
11,244
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.
[FR Doc. 2020–01157 Filed 1–23–20; 8:45 am]
Number of
responses per
respondent
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Dianne Camp, Ph.D.,
Scientific Review Officer, Review Branch,
Division of Extramural Activities, NIDDK,
National Institutes of Health, Room 7013,
6707 Democracy Boulevard, Bethesda, MD
20892–2542, (301) 594–7682, campd@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
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4334
Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Notices
Dated: January 17, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–01137 Filed 1–23–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. CISA–2019–0017]
Notice of the President’s National
Infrastructure Advisory Council
Meeting
Cybersecurity and
Infrastructure Security Agency (CISA),
Department of Homeland Security
(DHS).
ACTION: Announcement of meeting;
request for comments.
AGENCY:
CISA announces a public
meeting of the President’s National
Infrastructure Advisory Council (NIAC).
To facilitate public participation, CISA
invites public comments on the agenda
items and any associated briefing
materials to be considered by the
council at the meeting.
DATES:
Meeting Registration: Individual
registration to attend the meeting in
person is required and must be received
no later than 5:00 p.m. EST on February
18, 2020.
Speaker Registration: Individuals may
register to speak during the meeting’s
public comment period must be
received no later than 5:00 p.m. EST on
February 18, 2020.
Written Comments: Written comments
must be received no later than 5:00 p.m.
EST on February 21, 2020.
NIAC Meeting: The meeting will be
held on Friday, February 28, 2020 from
2:00 p.m.–4:00 p.m. HST.
ADDRESSES: The NIAC meeting will be
held at 1001 Bishop Street, Honolulu,
HI 96813.
Comments: Written comments may be
submitted on the issues to be considered
by the NIAC as described in the
SUPPLEMENTARY INFORMATION section
below and any briefing materials for the
meeting. Any briefing materials that will
be presented at the meeting will be
made publicly available on Friday,
February 21, 2020 at the following
website: https://www.dhs.gov/nationalinfrastructure-advisory-council.
Comments identified by docket
number ‘‘CISA–2019–0017’’ may be
submitted by any of the following
methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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instructions for submitting written
comments.
• Email: NIAC@hq.dhs.gov. Include
docket number CISA–2019–0017 in the
subject line of the message.
• Fax: 703–235–9707, ATTN: Ginger
K. Norris.
• Mail: Ginger K. Norris, Designated
Federal Officer, National Infrastructure
Advisory Council, Cybersecurity and
Infrastructure Security Agency,
Department of Homeland Security, 245
Murray Lane, Mail Stop 0612,
Arlington, VA 20598–0612.
Instructions: All submissions received
must include the agency name and
docket number for this notice. All
written comments received will be
posted without alteration at
www.regulations.gov, including any
personal information provided. For
detailed instructions on sending
comments and additional information
on participating in the upcoming NIAC
meeting, see the ‘‘PUBLIC
PARTICIPATION’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket and
comments received by the NIAC, go to
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Ginger K. Norris, 202–441–5885,
ginger.norris@cisa.dhs.gov.
SUPPLEMENTARY INFORMATION: The NIAC
is established under Section 10 of E.O.
13231 issued on October 16, 2001.
Notice of this meeting is given under the
Federal Advisory Committee Act
(FACA), 5 U.S.C. Appendix (Pub. L. 92–
463). The NIAC shall provide the
President, through the Secretary of
Homeland Security, with advice on the
security and resilience of the Nation’s
critical infrastructure sectors.
The NIAC will meet in an open
meeting on February 28, 2020, to
discuss the following agenda items with
DHS leadership.
Agenda
I. Call to Order
II. Opening Remarks
III. Discussion on Previous NIAC
Studies
IV. Public Comment
V. New NIAC Business
VI. Closing Remarks
VII. Adjournment
Public Participation
Meeting Registration Information
Due to additional access requirements
and limited seating, requests to attend
in person will be accepted and
processed in the order in which they are
received. Individuals may register to
attend the NIAC meeting by sending an
email to NIAC@hq.dhs.gov.
PO 00000
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Public Comment
While this meeting is open to the
public, participation in FACA
deliberations are limited to council
members. A public comment period will
be held during the meeting from
approximately 3:00 p.m.–3:15 p.m. HST.
Speakers who wish to comment must
register in advance and can do so by
emailing NIAC@hq.dhs.gov no later than
Friday, February 21, 2019, at 5:00 p.m.
EST. Speakers are requested to limit
their comments to three minutes. Please
note that the public comment period
may end before the time indicated,
following the last call for comments.
Information on Services for Individuals
With Disabilities
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meeting, contact NIAC@hq.dhs.gov as
soon as possible.
Dated: January 15, 2020.
Ginger K. Norris,
Designated Federal Official National
Infrastructure Advisory Council,
Cybersecurity and Infrastructure Security
Agency, Department of Homeland Security.
[FR Doc. 2020–01192 Filed 1–23–20; 8:45 am]
BILLING CODE 9110–9P–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[Docket No. FWS–R3–ES–2019–0100;
FXES11130300000–190–FF03E00000]
Endangered and Threatened Wildlife
and Plants; Draft Recovery Plan for the
Rusty Patched Bumble Bee
Fish and Wildlife Service,
Interior.
ACTION: Notice of availability and
request for public comment.
AGENCY:
We, the U.S. Fish and
Wildlife Service, announce the
availability of the draft recovery plan for
rusty patched bumble bee for public
review and comment. We request
review and comment on this draft
recovery plan from local, State, and
Federal agencies, and the public.
DATES: We must receive comments by
February 24, 2020.
ADDRESSES: Document availability: The
draft recovery plan, along with any
comments and other materials that we
receive, will be available for public
inspection at https://
www.regulations.gov in Docket No.
FWS–R3–ES–2019–0100.
SUMMARY:
E:\FR\FM\24JAN1.SGM
24JAN1
]]>Agencies
[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Notices]
[Pages 4333-4334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01137]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, 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.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; RFA-DK-19-505: Limited
Competition for the Accelerating Medicines Partnership (AMP) in Type
2 Diabetes Knowledge Portal (UM1 Clinical Trial Not Allowed).
Date: March 12, 2020.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Dianne Camp, Ph.D., Scientific Review Officer,
Review Branch, Division of Extramural Activities, NIDDK, National
Institutes of Health, Room 7013, 6707 Democracy Boulevard, Bethesda,
MD 20892-2542, (301) 594-7682, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
[[Page 4334]]
Dated: January 17, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-01137 Filed 1-23-20; 8:45 am]
BILLING CODE 4140-01-P
