National Institute of Mental Health; Notice of Closed Meeting, 32557-32558 [2017-14752]
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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
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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]
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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]
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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
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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 / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: August 2, 2017.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Jean G. Noronha, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–3367, jnoronha@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml., where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: July 10, 2017.
Melanie A. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–14752 Filed 7–13–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK30JT082PROD with NOTICES
Office of the Director Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Sickle Cell
Disease Advisory Council (SCDAC) was
renewed for an additional two-year
period on June 30, 2017.
It is determined that the SCDAC is in
the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquires may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
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(Mail Code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: July 10, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–14750 Filed 7–13–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer at (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Biannual
Infrastructure Development Measures
for State Adolescent and Transitional
Aged Youth Treatment Enhancement
and Dissemination Implementation
(SYT–I) and Adolescent and
Transitional Aged Youth Treatment
Implementation (YT–I) Programs—
(OMB No. 0930–0344)—Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment has developed a set of
infrastructure development measures in
which recipients of cooperative
agreements will report on various
benchmarks on a semi-annual basis. The
infrastructure development measures
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are designed to collect information at
the state-level and site-level.
The projects were previously named
State Adolescent Treatment
Enhancement and Dissemination (SAT–
ED) and State Youth Treatment
Enhancement and Dissemination (SYT–
ED) Programs and are now called State
Adolescent And Transitional Aged
Youth Treatment Enhancement and
Dissemination Implementation (SYT–I)
and Adolescent and Transitional Aged
Youth Treatment Implementation (YT–I)
Programs.
No changes have been made to the
Biannual Infrastructure Development
Measures Report. The only revision to
the biannual progress report is due to
the decrease in the number of
respondents.
The infrastructure development
measures are based on the programmatic
requirements conveyed in TI–15–004,
Cooperative Agreements for SYT–I and
TI–17–002, Cooperative Agreements for
YT–I.
The purpose of this program is to
provide funding to States/Territories/
Tribes to improve treatment for
adolescents and transitional age youth
through the development of a learning
laboratory with collaborating local
community-based treatment provider
sites. Through the shared experience
between the State/Territory/Tribe and
the local community-based treatment
provider sites, an evidence-based
practice (EBP) will be implemented,
youth and families will be provided
services, and a feedback loop will be
developed to enable the State/Territory/
Tribe and the sites to identify barriers
and test solutions through a services
component operating in real time. The
expected outcomes of these cooperative
agreements will include needed changes
to State/Territorial/Tribal policies and
procedures; development of financing
structures that work in the current
environment; and a blueprint for States/
Territories/Tribes and providers that
can be used throughout the State/
Territory/Tribe to widen the use of
effective substance use treatment EBPs.
Additionally, adolescents (ages 12 to
18), transitional age youth (ages 18 to
24), and their families/primary
caregivers who are provided services
through grant funds will inform the
process to improve systems issues.
Estimates for response burden were
calculated based on the methodology
(survey data collection) being used and
are based on previous experience
collecting similar data and results of the
pilot study. For emailed biannual
surveys, burden estimates of 12.0 hours
were used for Project Directors and/or
Program Managers and burden estimates
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Agencies
[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32557-32558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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
[[Page 32558]]
discussions could disclose confidential trade secrets or commercial
property such as patentable material, and personal information
concerning individuals associated with the grant applications and/or
contract proposals, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
Name of Committee: National Advisory Mental Health Council.
Date: August 2, 2017.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications and/or
proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Jean G. Noronha, Ph.D., Director, Division of
Extramural Activities, National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd., Room 6154, MSC 9609,
Bethesda, MD 20892-9609, 301-443-3367, jnoronha@mail.nih.gov.
Information is also available on the Institute's/Center's home
page: www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/index.shtml., where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: July 10, 2017.
Melanie A. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-14752 Filed 7-13-17; 8:45 am]
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