Center for Scientific Review; Notice of Closed Meeting, 34853 [2018-15605]
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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
VerDate Sep<11>2014
17:59 Jul 20, 2018
Jkt 244001
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.
PO 00000
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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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[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Page 34853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15605]
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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, [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.
(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
