Center for Scientific Review; Notice of Closed Meetings, 34853-34854 [2018-15606]
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Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when
CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current
thinking of FDA on, among other things,
UCTS—Continued
Beclomethasone dipropionate.
Betamethasone dipropionate.
Betrixaban.
Ciprofloxacin.
Deferasirox.
Dexamethasone; Neomycin sulfate; Polymyxin b sulfate.
Epinephrine.
Ethinyl estradiol; Norethindrone acetate.
Finafloxacin.
Fluocinolone acetonide.
Loteprednol etabonate.
Mecamylamine hydrochloride.
Methscopolamine bromide.
Methylphenidate.
Metyrosine.
Moxifloxacin hydrochloride.
Nebivolol hydrochloride; Valsartan.
Nimodipine.
Nitisinone.
Omeprazole.
Rifapentine.
Ritonavir.
Sodium polystyrene sulfonate.
Triamcinolone acetonide.
Valbenazine tosylate.
III. Drug Products for Which Revised
Draft Product-Specific Guidances are
Available
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
amozie on DSK3GDR082PROD with NOTICES1
Abiraterone acetate.
Dapagliflozin propanediol; Metformin hydrochloride.
Diclofenac sodium.
Donepezil hydrochloride; Memantine hydrochloride.
Esomeprazole strontium.
Ethosuximide.
Glatiramer acetate.
Hydrocodone bitartrate.
Lansoprazole.
Latanoprost.
Leucovorin calcium.
Methylphenidate hydrochloride.
Morphine sulfate; Naltrexone hydrochloride.
Nisoldipine.
Oxycodone hydrochloride.
Ticagrelor.
Triamcinolone acetonide.
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
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the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15735 Filed 7–20–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; PAR–17–
031: Role of Age-Associated Metabolic
Changes in Alzhemimer’s Disease.
Date: July 31, 2018.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
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34853
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 17, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–15605 Filed 7–20–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Urologic
and Urogynecologic Applications.
Date: July 20, 2018.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Ganesan Ramesh, Ph.D.,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 2182, MSC 7818, Bethesda, MD 20892,
301–827–5467, ganesan.ramesh@nih.gov.
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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Review of Aging Applications.
Date: August 13, 2018.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
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34854
Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–
RM18–018: Somatic Cell Genome Editing
Dissemination and Coordinating Center
(U24).
Date: August 16, 2018.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Elena Smirnova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187,
MSC 7840, Bethesda, MD 20892, 301–357–
9112, smirnove@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 16, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–15606 Filed 7–20–18; 8:45 am]
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5625 Fishers Lane, Bethesda,
MD 20892.
Contact Person: George Kunos, M.D., Ph.D.
Scientific Director, National Institutes of
Health, National Institute on Alcohol Abuse
and Alcoholism, 5625 Fishers Lane, Room
2s–24a Rockville, MD 20852 301–443–2069
gkunos@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NIAAA.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute on Alcohol Abuse and
Alcoholism, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIAAA.
Date: October 2, 2018.
Time: 8:00 a.m. to 6:00 p.m.
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–15610 Filed 7–20–18; 8:45 am]
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 Heart,
Lung, and Blood Institute Special
Emphasis Panel Opportunities for
Collaborative Research at the NIH
Clinical Center.
Date: August 9, 2018.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
6701 Rockledge Drive, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: William J Johnson,
Ph.D., Scientific Review Officer, Office
of Scientific Review/DERA, National
Heart, Lung, and Blood Institute, 6701
Rockledge Drive, Room 7178, Bethesda,
MD 20892–7924, (301–827–7938)
johnsonwj@nhlbi.nih.gov.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
[FR Doc. 2018–15620 Filed 7–20–18; 8:45 am]
National Institutes of Health
National Institutes of Health
National Institutes of Health
Dated: July 17, 2018
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: July 17, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
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 section
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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
NHLBI R13 Conference Review.
Date: August 2–3, 2018.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
PO 00000
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National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
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]]>Agencies
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34853-34854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific Review Special Emphasis
Panel; Urologic and Urogynecologic Applications.
Date: July 20, 2018.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Ganesan Ramesh, Ph.D., Center for Scientific
Review, National Institutes of Health, 6701 Rockledge Drive, Room
2182, MSC 7818, Bethesda, MD 20892, 301-827-5467,
[email protected].
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.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Review of Aging Applications.
Date: August 13, 2018.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
[[Page 34854]]
Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-
1246, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; RFA-RM18-018: Somatic Cell Genome Editing Dissemination and
Coordinating Center (U24).
Date: August 16, 2018.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Elena Smirnova, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD
20892, 301-357-9112, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: July 16, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-15606 Filed 7-20-18; 8:45 am]
BILLING CODE 4140-01-P
