Center for Scientific Review; Notice of Closed Meetings, 32557 [2017-14751]
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Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices
and announced periodically in the
Federal Register. The public is
encouraged to submit comments on
those recommendations within 60 days
of their announcement in the Federal
Register. FDA considers any comments
received and either publishes final
guidances or publishes revised draft
guidances for comment. Guidances were
last announced in the Federal Register
on May 17, 2017 (82 FR 22668). This
notice announces draft product-specific
guidances, either new or revised, that
are posted on FDA’s Web site.
TABLE 2—REVISED DRAFT PRODUCT- applications, the disclosure of which
SPECIFIC GUIDANCES FOR DRUG would constitute a clearly unwarranted
invasion of personal privacy.
PRODUCTS—Continued
Metoprolol tartrate.
Minocycline HCl (multiple reference listed
drugs).
Minoxidil.
Pimozide.
Propafenone hydrochloride.
Tetrabenazine.
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
II. Drug Products for Which New Draft
enter Docket No. FDA–2007–D–0369.
Product-Specific Guidances Are
These draft guidances are being
Available
issued consistent with FDA’s good
FDA is announcing the availability of guidance practices regulation (21 CFR
a new draft product-specific guidance
10.115). These draft guidances, when
for industry for drug products
finalized, will represent the current
containing the following active
thinking of FDA on, among other things,
ingredients:
the product-specific design of BE
studies to support ANDAs. They do not
TABLE 1—NEW DRAFT PRODUCT-SPE- establish any rights for any person and
CIFIC GUIDANCES FOR DRUG PROD- are not binding on FDA or the public.
You can use an alternative approach if
UCTS
it satisfies the requirements of the
applicable statutes and regulations. This
Aspirin.
Aspirin; omeprazole.
guidance is not subject to Executive
Brexpiprazole.
Order 12866.
Brivaracetam.
Cefdinir.
Clocortolone pivalate.
Cyanocobalamin.
Dasabuvir sodium; Ombitasvir; Paritaprevir;
Ritonavir.
Dextroamphetamine sulfate.
Diclofenac sodium.
Fluphenazine hydrochloride.
Gentamicin sulfate.
Glycopyrrolate.
Obeticholic acid.
Silver sulfadiazine.
Tenofovir alafenamide fumarate.
Tiopronin.
Tipiracil hydrochloride; Trifluridine.
Triamcinolone acetonide (multiple reference
listed drugs).
Uridine triacetate.
III. Drug Products for Which Revised
Draft Product-Specific Guidances Are
Available
mstockstill on DSK30JT082PROD with NOTICES
FDA is announcing the availability of
a revised draft product-specific
guidance for industry for drug products
containing the following active
ingredients:
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Brimonidine tartrate.
Dabigatran etexilate mesylate.
Dorzolamide hydrochloride.
Gefitinib.
Latanoprost.
Methoxsalen.
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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 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–14781 Filed 7–13–17; 8:45 am]
BILLING CODE 4164–01–P
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Spinal Cord
Injury, Epilepsy, and Other Neurological
Disorders.
Date: August 3–4, 2017.
Time: 9:00 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).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, Brain Disorders and Clinical
Neuroscience, 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; Member
Conflict: Glioblastoma, Multiple Sclerosis.
Date: August 4, 2017.
Time: 11:00 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
(Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, Brain Disorders and Clinical
Neuroscience, 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.
(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 10, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–14751 Filed 7–13–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of
Closed Meetings
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
PO 00000
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National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Mental Health
Council.
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/or contract proposals and the
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[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Page 32557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14751]
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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 (5 U.S.C. App.), 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; Spinal Cord Injury, Epilepsy, and Other Neurological
Disorders.
Date: August 3-4, 2017.
Time: 9:00 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).
Contact Person: Samuel C. Edwards, Ph.D., Chief, Brain Disorders
and Clinical Neuroscience, 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; Member Conflict: Glioblastoma, Multiple Sclerosis.
Date: August 4, 2017.
Time: 11:00 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 (Telephone Conference Call).
Contact Person: Samuel C. Edwards, Ph.D., Chief, Brain Disorders
and Clinical Neuroscience, 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.
(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 10, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-14751 Filed 7-13-17; 8:45 am]
BILLING CODE 4140-01-P
