National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 46141 [2020-16585]
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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
Jkt 250001
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.
PO 00000
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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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31JYN1
]]>Agencies
[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Notices]
[Page 46141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16585]
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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.
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, [email protected].
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, [email protected].
(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
