National Merchant Marine Personnel Advisory Committee; Vacancy, 46141-46142 [2020-16652]
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Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Notices
SADBE, and TCA, and we therefore
propose to include them on the 503B
Bulks List as described in this notice.
At this time, we find no basis to
conclude that there is a clinical need for
outsourcing facilities to compound drug
products using the bulk drug substances
diazepam, dobutamine HCl, dopamine
HCl, edetate calcium disodium, folic
acid, glycopyrrolate, hydroxyzine HCl,
ketorolac tromethamine, labetalol HCl,
mannitol, metoclopramide HCl,
moxifloxacin HCl, nalbuphine HCl,
polidocanol, potassium acetate,
procainamide HCl, sodium
nitroprusside, sodium thiosulfate, and
verapamil HCl. We therefore propose
not to include these bulk drug
substances on the 503B Bulks List.
VII. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
*1. FDA, Guidance for Industry, ‘‘Interim
Policy on Compounding Using Bulk Drug
Substances Under Section 503B of the
Federal Food, Drug, and Cosmetic Act,’’
January 2017 (available at https://
www.fda.gov/media/94402/download).
*2. FDA, Guidance for Industry,
‘‘Evaluation of Bulk Drug Substances
Nominated for Use in Compounding Under
Section 503B of the Federal Food, Drug, and
Cosmetic Act,’’ March 2019 (available at
https://www.fda.gov/media/121315/
download).
*3. FDA Memorandum to File, Clinical
Need for Diphenylcyclopropenone (DPCP) in
Compounding Under Section 503B of the
FD&C Act, July 2020.
*4. FDA Memorandum to File, Clinical
Need for Glycolic Acid in Compounding
Under Section 503B of the FD&C Act, July
2020.
*5. FDA Memorandum to File, Clinical
Need for Squaric Acid Dibutyl Ester (SADBE)
in Compounding Under Section 503B of the
FD&C Act, July 2020.
*6. FDA Memorandum to File, Clinical
Need for Trichloroacetic Acid (TCA) in
Compounding Under Section 503B of the
FD&C Act, July 2020.
7. Leheta, T.M., A. El Tawdy, R.M. Abdel
Hay, and S. Farid, 2011, ‘‘Percutaneous
VerDate Sep<11>2014
18:33 Jul 30, 2020
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Collagen Induction Versus FullConcentration Trichloroacetic Acid in the
Treatment of Atrophic Acne Scars,’’
Dermatologic Surgery, 37(2):207–216.
8. Kumari, R. and D.M. Thappa, 2010,
‘‘Comparative Study of Trichloroacetic Acid
Versus Glycolic Acid Chemical Peels in the
Treatment of Melasma,’’ Indian Journal of
Dermatology, Venereology and Leprology,
76:447, available at https://www.ijdvl.com/
text.asp?2010/76/4/447/66602.
9. Nigwekar, S.U., S.M. Brunelli, D. Meade,
et al., 2013, ‘‘Sodium Thiosulfate Therapy for
Calcific Uremic Arteriolopathy,’’ Clinical
Journal of the American Society of
Nephrology, 8(7):1162–1170.
10. Generali, J.A. and D.J. Cada, 2015,
‘‘Sodium Thiosulfate: Calciphylaxis,’’
Hospital Pharmacy, 50(11):975–977.
*11. Udomkarnjananun, S., K.
Kongnatthasate, K. Praditpornsilpa, et al.,
2019, ‘‘Treatment of Calciphylaxis in CKD: A
Systematic Review and Meta-Analysis,’’
Kidney International Reports, 4(2):231–244.
*12. Schulz, L.T., E.J. Elder, Jr, K.J. Jones,
et al., 2010, ‘‘Stability of Sodium
Nitroprusside and Sodium Thiosulfate 1:10
Intravenous Admixture,’’ Hospital Pharmacy,
45(10):779–784.
Dated: July 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–16649 Filed 7–30–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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; Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19) (R21,
R01 Clinical Trials Not Allowed).
Date: August 21, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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46141
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 4F30,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Chelsea D. Boyd, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 4F30, Rockville, MD
20892–9834, 301–761–6664, chelsea.boyd@
nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19) (R21,
R01 Clinical Trials Not Allowed).
Date: August 26, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41B,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Brenda Lange-Gustafson,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G41B,
Bethesda, MD 20892–9834, (240) 669–5047,
bgustafson@niaid.nih.gov.
(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: July 27, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–16585 Filed 7–30–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2020–0041]
National Merchant Marine Personnel
Advisory Committee; Vacancy
U.S. Coast Guard, Department
of Homeland Security.
ACTION: Request for applications; Resolicitation for members credentialed
with ratings.
AGENCY:
The Coast Guard is resoliciting applications from persons
interested in membership on the
National Merchant Marine Personnel
Advisory Committee (Committee). This
recently established Committee will
advise the Secretary of the Department
SUMMARY:
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Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Notices
of Homeland Security on matters
relating to personnel in the United
States merchant marine, including the
training, qualifications, certification,
documentation, and fitness of mariners.
Please read the notice for description of
Committee positions we are seeking to
fill.
DATES: Your completed application
should reach the Coast Guard on or
before August 14, 2020.
ADDRESSES: Applicants should send a
cover letter expressing interest in an
appointment to the Committee and a
resume detailing their experience. We
will not accept a biography.
Applications should be submitted: via
the following method:
• By Email: Megan.C.Johns@uscg.mil.
Subject Line: N–MERPAC (preferred)
FOR FURTHER INFORMATION CONTACT:
Megan Johns Henry, Alternate
Designated Federal Officer of the
Merchant Marine Personnel Advisory
Committee; Telephone 202–372–1255;
or Email at Megan.C.Johns@uscg.mil.
SUPPLEMENTARY INFORMATION: On May
15, 2020, the Coast Guard published a
request in the Federal Register (85 FR
29467) for applications for membership
in the National Merchant Marine
Personnel Advisory Committee. Due to
a lack of applications received for the
membership positions representing
credentialed ratings, the Coast Guard is
re-soliciting applications from persons
interested in membership on the
National Merchant Marine Personnel
Advisory Committee. Applicants who
responded to the initial notice do not
need to reapply.
The National Merchant Marine
Personnel Advisory Committee is a
Federal advisory committee. It will
operate under the provisions of the
Federal Advisory Committee Act, 5
U.S.C. Appendix, and the
administrative provisions in Section 601
of the Frank LoBiondo Coast Guard
Authorization Act of 2018 (specifically,
46 U.S.C. 15109).
The Committee was established on
December 4, 2019, by the Frank
LoBiondo Coast Guard Authorization
Act of 2018, which added section
15103, National Merchant Marine
Personnel Advisory Committee, to Title
46 of the U.S. Code. The Committee will
advise the Secretary of Homeland
Security on matters relating to
personnel in the United States merchant
marine, including the training,
qualifications, certification,
documentation, and fitness of mariners.
The Committee is required to meet at
least once a year in accordance with 46
U.S.C. 15109(a). We expect the
Committee to meet at least twice a year,
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but it may meet more frequently. The
meetings are generally held in cities that
have high concentrations of maritime
personnel and related marine industry
businesses.
All members serve at their own
expense and receive no salary or other
compensation from the Federal
Government. Members may be
reimbursed, however, for travel and per
diem in accordance with Federal Travel
Regulations.
Under provisions in 46 U.S.C.
15109(f)(6), if you are appointed as a
member of the Committee, your
membership term will expire on
December 31 of the third full year after
the effective date of your appointment.
The Secretary may require an individual
to have passed an appropriate security
background examination before
appointment to the Committee, 46
U.S.C. 15109(f)(4).
In this solicitation for Committee
members, we will consider applications
for positions, which include:
• United States citizens holding
active licenses or certificates issued
under 46 U.S.C. chapter 71 or merchant
mariner documents issued under 46
U.S.C. chapter 73, including two
credentialed with ratings: one of which
shall be endorsed as an able bodied
seamen; and one that shall be endorsed
as a qualified member of the engine
department.
The Department of Homeland
Security does not discriminate in
selection of Committee members based
on race, color, religion, sex, national
origin, political affiliation, sexual
orientation, gender identity, marital
status, disabilities and genetic
information, age, membership in an
employee organization, or any other
non-merit factor. The Department of
Homeland Security strives to achieve a
widely diverse candidate pool for all of
its recruitment selections.
If you are interested in applying to
become a member of the Committee,
send your cover letter and resume to
Megan Johns Henry, Alternate
Designated Federal Officer of the
National Merchant Marine Personnel
Advisory Committee via one of the
transmittal methods in the ADDRESSES
section by the deadline in the DATES
section of this notice. When you send
your application to us via email, we will
send you an email confirming receipt of
your application.
DEPARTMENT OF HOMELAND
SECURITY
Dated: July 28, 2020.
Jeffrey G. Lantz,
Director of Commercial Regulations and
Standards.
ADDRESSES:
[FR Doc. 2020–16652 Filed 7–30–20; 8:45 am]
BILLING CODE 9110–04–P
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Federal Emergency Management
Agency
[Docket ID FEMA–2020–0002; Internal
Agency Docket No. FEMA–B–2044]
Changes in Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice lists communities
where the addition or modification of
Base Flood Elevations (BFEs), base flood
depths, Special Flood Hazard Area
(SFHA) boundaries or zone
designations, or the regulatory floodway
(hereinafter referred to as flood hazard
determinations), as shown on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports,
prepared by the Federal Emergency
Management Agency (FEMA) for each
community, is appropriate because of
new scientific or technical data. The
FIRM, and where applicable, portions of
the FIS report, have been revised to
reflect these flood hazard
determinations through issuance of a
Letter of Map Revision (LOMR), in
accordance with Federal Regulations.
The LOMR will be used by insurance
agents and others to calculate
appropriate flood insurance premium
rates for new buildings and the contents
of those buildings. For rating purposes,
the currently effective community
number is shown in the table below and
must be used for all new policies and
renewals.
SUMMARY:
These flood hazard
determinations will be finalized on the
dates listed in the table below and
revise the FIRM panels and FIS report
in effect prior to this determination for
the listed communities.
From the date of the second
publication of notification of these
changes in a newspaper of local
circulation, any person has 90 days in
which to request through the
community that the Deputy Associate
Administrator for Insurance and
Mitigation reconsider the changes. The
flood hazard determination information
may be changed during the 90-day
period.
DATES:
The affected communities
are listed in the table below. Revised
flood hazard information for each
community is available for inspection at
both the online location and the
respective community map repository
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]]>Agencies
[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Notices]
[Pages 46141-46142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16652]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2020-0041]
National Merchant Marine Personnel Advisory Committee; Vacancy
AGENCY: U.S. Coast Guard, Department of Homeland Security.
ACTION: Request for applications; Re-solicitation for members
credentialed with ratings.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is re-soliciting applications from persons
interested in membership on the National Merchant Marine Personnel
Advisory Committee (Committee). This recently established Committee
will advise the Secretary of the Department
[[Page 46142]]
of Homeland Security on matters relating to personnel in the United
States merchant marine, including the training, qualifications,
certification, documentation, and fitness of mariners. Please read the
notice for description of Committee positions we are seeking to fill.
DATES: Your completed application should reach the Coast Guard on or
before August 14, 2020.
ADDRESSES: Applicants should send a cover letter expressing interest in
an appointment to the Committee and a resume detailing their
experience. We will not accept a biography.
Applications should be submitted: via the following method:
By Email: [email protected]. Subject Line: N-MERPAC
(preferred)
FOR FURTHER INFORMATION CONTACT: Megan Johns Henry, Alternate
Designated Federal Officer of the Merchant Marine Personnel Advisory
Committee; Telephone 202-372-1255; or Email at [email protected].
SUPPLEMENTARY INFORMATION: On May 15, 2020, the Coast Guard published a
request in the Federal Register (85 FR 29467) for applications for
membership in the National Merchant Marine Personnel Advisory
Committee. Due to a lack of applications received for the membership
positions representing credentialed ratings, the Coast Guard is re-
soliciting applications from persons interested in membership on the
National Merchant Marine Personnel Advisory Committee. Applicants who
responded to the initial notice do not need to reapply.
The National Merchant Marine Personnel Advisory Committee is a
Federal advisory committee. It will operate under the provisions of the
Federal Advisory Committee Act, 5 U.S.C. Appendix, and the
administrative provisions in Section 601 of the Frank LoBiondo Coast
Guard Authorization Act of 2018 (specifically, 46 U.S.C. 15109).
The Committee was established on December 4, 2019, by the Frank
LoBiondo Coast Guard Authorization Act of 2018, which added section
15103, National Merchant Marine Personnel Advisory Committee, to Title
46 of the U.S. Code. The Committee will advise the Secretary of
Homeland Security on matters relating to personnel in the United States
merchant marine, including the training, qualifications, certification,
documentation, and fitness of mariners.
The Committee is required to meet at least once a year in
accordance with 46 U.S.C. 15109(a). We expect the Committee to meet at
least twice a year, but it may meet more frequently. The meetings are
generally held in cities that have high concentrations of maritime
personnel and related marine industry businesses.
All members serve at their own expense and receive no salary or
other compensation from the Federal Government. Members may be
reimbursed, however, for travel and per diem in accordance with Federal
Travel Regulations.
Under provisions in 46 U.S.C. 15109(f)(6), if you are appointed as
a member of the Committee, your membership term will expire on December
31 of the third full year after the effective date of your appointment.
The Secretary may require an individual to have passed an appropriate
security background examination before appointment to the Committee, 46
U.S.C. 15109(f)(4).
In this solicitation for Committee members, we will consider
applications for positions, which include:
United States citizens holding active licenses or
certificates issued under 46 U.S.C. chapter 71 or merchant mariner
documents issued under 46 U.S.C. chapter 73, including two credentialed
with ratings: one of which shall be endorsed as an able bodied seamen;
and one that shall be endorsed as a qualified member of the engine
department.
The Department of Homeland Security does not discriminate in
selection of Committee members based on race, color, religion, sex,
national origin, political affiliation, sexual orientation, gender
identity, marital status, disabilities and genetic information, age,
membership in an employee organization, or any other non-merit factor.
The Department of Homeland Security strives to achieve a widely diverse
candidate pool for all of its recruitment selections.
If you are interested in applying to become a member of the
Committee, send your cover letter and resume to Megan Johns Henry,
Alternate Designated Federal Officer of the National Merchant Marine
Personnel Advisory Committee via one of the transmittal methods in the
ADDRESSES section by the deadline in the DATES section of this notice.
When you send your application to us via email, we will send you an
email confirming receipt of your application.
Dated: July 28, 2020.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2020-16652 Filed 7-30-20; 8:45 am]
BILLING CODE 9110-04-P
