National Institute of Mental Health; Notice of Closed Meeting, 19791-19792 [2019-09202]
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Federal Register / Vol. 84, No. 87 / Monday, May 6, 2019 / Notices
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to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 under 21 CFR part 312
(Investigational New Drug Application)
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755. The
collection of information in 21 CFR part
314, including the submission of
labeling under 21 CFR 314.50(e)(2)(ii)
and (l)(1)(i), has been approved under
OMB control number 0910–0001. The
submission of prescription drug labeling
under 21 CFR 201.56 and 201.57 has
been approved under OMB control
number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09193 Filed 5–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1422]
Advisory Committee; Medical Imaging
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Medical Imaging Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Medical Imaging
Drugs Advisory Committee for an
additional 2 years beyond the charter
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expiration date. The new charter will be
in effect until May 18, 2021.
DATES: Authority for the Medical
Imaging Drugs Advisory Committee will
expire on May 18, 2019, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, and email: MIDAC@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Medical Imaging Drugs Advisory
Committee (the Committee). The
committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in diagnostic and therapeutic
procedures using radioactive
pharmaceuticals and contrast media
used in diagnostic radiology and makes
appropriate recommendations to the
Commissioner.
The Committee shall consist of a core
of 12 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of nuclear
medicine, radiology, epidemiology or
statistics, and related specialties.
Members will be invited to serve for
overlapping terms of up to four years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
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information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
MedicalImagingDrugsAdvisory
Committee/ucm273284.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09217 Filed 5–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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
Mental Health Initial Review Group; Mental
Health Services Research Committee.
Date: June 11, 2019.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco, 700 F Street NW,
Washington, DC 20001.
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6136, MSC 9606,
Bethesda, MD 20852, 301–443–1225,
aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
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Federal Register / Vol. 84, No. 87 / Monday, May 6, 2019 / Notices
Dated: May 1, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: May 1, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HOMELAND
SECURITY
[FR Doc. 2019–09202 Filed 5–3–19; 8:45 am]
[FR Doc. 2019–09200 Filed 5–3–19; 8:45 am]
[Docket No. USCG–2019–0040]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
AGENCY:
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council on Aging, May 21, 2019, 3:00
p.m. to May 22, 2019, 12:45 p.m.,
National Institutes of Health, Building
60, Lecture Hall, One Cloister Court,
Bethesda, MD 20892 which was
published in the Federal Register on
February 15, 2019, 84 FR 4504.
The meeting notice is amended to
change the previously listed incorrect
institution name from NATIONAL
INSTITUTE OF GENERAL MEDICAL
SCIENCES to NATIONAL INSTITUTE
ON AGING. The meeting is partially
Closed to the public.
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.
Dated: May 1, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; CCCR P30
Review Meeting.
Date: May 8–9, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn by Marriott Bethesda,
7335 Wisconsin Ave, Bethesda, MD 20814.
Contact Person: Yin Liu, MD, Ph.D.,
Scientific Review Branch, National Institutes
of Health, National Institute of Arthritis and
Musculoskeletal and Skin Diseases, 6701
Democracy Blvd. Room 824, Bethesda, MD
20892, 301–594–8919, 301–402–2406 (fax).
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council on Aging, September 10, 2019,
3:00 p.m. to September 11, 2019, 1:00
p.m., National Institutes of Health,
Neuroscience Center Building (NSC),
North Bethesda, 6001 Executive
Boulevard, Rockville, MD 28052 which
was published in the Federal Register
on February 15, 2019, 84 FR 4503.
The meeting notice is amended to
change the previously listed incorrect
institution name from NATIONAL
INSTITUTE OF GENERAL MEDICAL
SCIENCES to NATIONAL INSTITUTE
ON AGING. The meeting is partially
Closed to the public.
19:35 May 03, 2019
Coast Guard, DHS.
Thirty-day notice requesting
comments.
ACTION:
[FR Doc. 2019–09199 Filed 5–3–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Collection of Information Under
Review by Office of Management and
Budget; OMB Control Number: 1625–
0112
National Institute on Aging; Amended
Notice of Meeting
VerDate Sep<11>2014
Coast Guard
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Dated: April 30, 2019.
Sylvia L. Neal,
Program Analyst,Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–09201 Filed 5–3–19; 8:45 am]
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In compliance with the
Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an
Information Collection Request (ICR),
abstracted below, to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs
(OIRA), requesting approval for
reinstatement, without change, of the
following collection of information:
1625–0112, Enhanced Maritime Domain
Awareness via Electronic Transmission
of Vessel Transit Data. Our ICR
describes the information we seek to
collect from the public. Review and
comments by OIRA ensure we only
impose paperwork burdens
commensurate with our performance of
duties.
DATES: Comments must reach the Coast
Guard and OIRA on or before June 5,
2019.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2019–0040] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
Alternatively, you may submit
comments to OIRA using one of the
following means:
(1) Email: dhsdeskofficer@
omb.eop.gov.
(2) Mail: OIRA, 725 17th Street NW,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–612), ATTN: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE, STOP
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: Mr.
Anthony Smith, Office of Information
Management, telephone 202–475–3532,
or fax 202–372–8405, for questions on
these documents.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Public Participation and Request for
Comments
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
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Agencies
[Federal Register Volume 84, Number 87 (Monday, May 6, 2019)]
[Notices]
[Pages 19791-19792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09202]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; 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 Mental Health Initial
Review Group; Mental Health Services Research Committee.
Date: June 11, 2019.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Monaco, 700 F Street NW, Washington, DC 20001.
Contact Person: Aileen Schulte, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room
6136, MSC 9606, Bethesda, MD 20852, 301-443-1225,
[email protected].
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
[[Page 19792]]
Dated: May 1, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-09202 Filed 5-3-19; 8:45 am]
BILLING CODE 4140-01-P