82 FR 32557 - National Institute of Mental Health; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 134 (July 14, 2017)

Page Range		32557-32558
FR Document		2017-14752

Federal Register, Volume 82 Issue 134 (Friday, July 14, 2017)

[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Notices]
[Pages 32557-32558]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14752]


-----------------------------------------------------------------------

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, [email protected].

    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]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices 32557

and announced periodically in the TABLE 2—REVISED DRAFT PRODUCT- applications, the disclosure of which
Federal Register. The public is SPECIFIC GUIDANCES FOR DRUG would constitute a clearly unwarranted
encouraged to submit comments on PRODUCTS—Continued invasion of personal privacy.
those recommendations within 60 days Name of Committee: Center for Scientific
of their announcement in the Federal Metoprolol tartrate. Review Special Emphasis Panel; Spinal Cord
Register. FDA considers any comments Minocycline HCl (multiple reference listed Injury, Epilepsy, and Other Neurological
received and either publishes final drugs). Disorders.
Minoxidil. Date: August 3–4, 2017.
guidances or publishes revised draft Pimozide.
guidances for comment. Guidances were Time: 9:00 a.m. to 1:00 p.m.
Propafenone hydrochloride. Agenda: To review and evaluate grant
last announced in the Federal Register Tetrabenazine.
on May 17, 2017 (82 FR 22668). This applications.
Place: National Institutes of Health, 6701
notice announces draft product-specific For a complete history of previously Rockledge Drive, Bethesda, MD 20892
guidances, either new or revised, that published Federal Register notices (Virtual Meeting).
are posted on FDA’s Web site. related to product-specific guidances, go Contact Person: Samuel C. Edwards, Ph.D.,
II. Drug Products for Which New Draft to https://www.regulations.gov and Chief, Brain Disorders and Clinical
enter Docket No. FDA–2007–D–0369. Neuroscience, Center for Scientific Review,
Product-Specific Guidances Are National Institutes of Health, 6701 Rockledge
These draft guidances are being
Available Drive, Room 5210, MSC 7846, Bethesda, MD
issued consistent with FDA’s good
FDA is announcing the availability of guidance practices regulation (21 CFR 20892, (301) 435–1246, edwardss@
a new draft product-specific guidance 10.115). These draft guidances, when csr.nih.gov.
for industry for drug products finalized, will represent the current Name of Committee: Center for Scientific
containing the following active thinking of FDA on, among other things, Review Special Emphasis Panel; Member
ingredients: Conflict: Glioblastoma, Multiple Sclerosis.
the product-specific design of BE Date: August 4, 2017.
studies to support ANDAs. They do not Time: 11:00 a.m. to 2:00 p.m.
TABLE 1—NEW DRAFT PRODUCT-SPE- establish any rights for any person and Agenda: To review and evaluate grant
CIFIC GUIDANCES FOR DRUG PROD- are not binding on FDA or the public. applications.
UCTS You can use an alternative approach if Place: National Institutes of Health, 6701
it satisfies the requirements of the Rockledge Drive, Bethesda, MD 20892
Aspirin. applicable statutes and regulations. This (Telephone Conference Call).
Aspirin; omeprazole. guidance is not subject to Executive Contact Person: Samuel C. Edwards, Ph.D.,
Brexpiprazole. Order 12866. Chief, Brain Disorders and Clinical
Brivaracetam. Neuroscience, Center for Scientific Review,
Cefdinir. IV. Electronic Access National Institutes of Health, 6701 Rockledge
Clocortolone pivalate. Drive, Room 5210, MSC 7846, Bethesda, MD
Persons with access to the Internet 20892, (301) 435–1246, edwardss@
Cyanocobalamin. may obtain the draft guidances at either
Dasabuvir sodium; Ombitasvir; Paritaprevir; csr.nih.gov.
http://www.fda.gov/Drugs/Guidance (Catalogue of Federal Domestic Assistance
Ritonavir.
Dextroamphetamine sulfate. ComplianceRegulatoryInformation/ Program Nos. 93.306, Comparative Medicine;
Diclofenac sodium. Guidances/default.htm or https:// 93.333, Clinical Research, 93.306, 93.333,
Fluphenazine hydrochloride. www.regulations.gov. 93.337, 93.393–93.396, 93.837–93.844,
Gentamicin sulfate. Dated: July 10, 2017. 93.846–93.878, 93.892, 93.893, National
Glycopyrrolate. Institutes of Health, HHS)
Anna K. Abram,
Obeticholic acid. Dated: July 10, 2017.
Silver sulfadiazine. Deputy Commissioner for Policy, Planning,
Tenofovir alafenamide fumarate. Legislation, and Analysis. Sylvia L. Neal,
Tiopronin. [FR Doc. 2017–14781 Filed 7–13–17; 8:45 am] Program Analyst, Office of Federal Advisory
Tipiracil hydrochloride; Trifluridine. BILLING CODE 4164–01–P Committee Policy.
Triamcinolone acetonide (multiple reference [FR Doc. 2017–14751 Filed 7–13–17; 8:45 am]
listed drugs). BILLING CODE 4140–01–P
Uridine triacetate. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Drug Products for Which Revised DEPARTMENT OF HEALTH AND
Draft Product-Specific Guidances Are National Institutes of Health HUMAN SERVICES
Available
Center for Scientific Review; Notice of National Institutes of Health
FDA is announcing the availability of Closed Meetings
a revised draft product-specific National Institute of Mental Health;
guidance for industry for drug products Pursuant to section 10(d) of the
Notice of Closed Meeting
containing the following active Federal Advisory Committee Act, as
ingredients: amended (5 U.S.C. App.), notice is Pursuant to section 10(d) of the
hereby given of the following meetings. Federal Advisory Committee Act, as
TABLE 2—REVISED DRAFT PRODUCT- The meetings will be closed to the amended (5 U.S.C. App.), notice is
SPECIFIC GUIDANCES FOR DRUG public in accordance with the hereby given of a meeting of the
provisions set forth in sections National Advisory Mental Health
mstockstill on DSK30JT082PROD with NOTICES

PRODUCTS
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Council.
as amended. The grant applications and The meeting will be closed to the
Brimonidine tartrate.
Dabigatran etexilate mesylate. the discussions could disclose public in accordance with the
Dorzolamide hydrochloride. confidential trade secrets or commercial provisions set forth in sections
Gefitinib. property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Latanoprost. and personal information concerning as amended. The grant applications
Methoxsalen. individuals associated with the grant and/or contract proposals and the

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32558 Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Notices

discussions could disclose confidential (Mail Code 4875), Telephone (301) 496– are designed to collect information at
trade secrets or commercial property 2123, or spaethj@od.nih.gov. the state-level and site-level.
such as patentable material, and Dated: July 10, 2017. The projects were previously named
personal information concerning State Adolescent Treatment
Michelle Trout,
individuals associated with the grant Enhancement and Dissemination (SAT–
Program Analyst, Office of Federal Advisory
applications and/or contract proposals, ED) and State Youth Treatment
Committee Policy.
the disclosure of which would Enhancement and Dissemination (SYT–
[FR Doc. 2017–14750 Filed 7–13–17; 8:45 am]
constitute a clearly unwarranted ED) Programs and are now called State
BILLING CODE 4140–01–P Adolescent And Transitional Aged
invasion of personal privacy.
Youth Treatment Enhancement and
Name of Committee: National Advisory
Mental Health Council. Dissemination Implementation (SYT–I)
DEPARTMENT OF HEALTH AND and Adolescent and Transitional Aged
Date: August 2, 2017. HUMAN SERVICES
Time: 2:00 p.m. to 4:00 p.m. Youth Treatment Implementation (YT–I)
Agenda: To review and evaluate grant Substance Abuse and Mental Health Programs.
applications and/or proposals. Services Administration No changes have been made to the
Place: National Institutes of Health, Biannual Infrastructure Development
Neuroscience Center, 6001 Executive Agency Information Collection Measures Report. The only revision to
Boulevard, Rockville, MD 20852 (Telephone the biannual progress report is due to
Activities: Proposed Collection;
Conference Call). the decrease in the number of
Contact Person: Jean G. Noronha, Ph.D., Comment Request
respondents.
Director, Division of Extramural Activities, In compliance with Section The infrastructure development
National Institute of Mental Health, NIH, 3506(c)(2)(A) of the Paperwork
Neuroscience Center, 6001 Executive Blvd.,
measures are based on the programmatic
Room 6154, MSC 9609, Bethesda, MD 20892–
Reduction Act of 1995 concerning requirements conveyed in TI–15–004,
9609, 301–443–3367, jnoronha@mail.nih.gov. opportunity for public comment on Cooperative Agreements for SYT–I and
Information is also available on the
proposed collections of information, the TI–17–002, Cooperative Agreements for
Institute’s/Center’s home page: Substance Abuse and Mental Health YT–I.
www.nimh.nih.gov/about/advisory-boards- Services Administration (SAMHSA) The purpose of this program is to
and-groups/namhc/index.shtml., where an will publish periodic summaries of provide funding to States/Territories/
agenda and any additional information for proposed projects. To request more Tribes to improve treatment for
the meeting will be posted when available. information on the proposed projects or adolescents and transitional age youth
(Catalogue of Federal Domestic Assistance to obtain a copy of the information through the development of a learning
Program No. 93.242, Mental Health Research collection plans, call the SAMHSA laboratory with collaborating local
Grants, National Institutes of Health, HHS) Reports Clearance Officer at (240) 276– community-based treatment provider
Dated: July 10, 2017. 1243. sites. Through the shared experience
Melanie A. Pantoja, Comments are invited on: (a) Whether between the State/Territory/Tribe and
Program Analyst, Office of Federal Advisory
the proposed collections of information the local community-based treatment
Committee Policy. are necessary for the proper provider sites, an evidence-based
performance of the functions of the practice (EBP) will be implemented,
[FR Doc. 2017–14752 Filed 7–13–17; 8:45 am]
agency, including whether the youth and families will be provided
BILLING CODE 4140–01–P
information shall have practical utility; services, and a feedback loop will be
(b) the accuracy of the agency’s estimate developed to enable the State/Territory/
DEPARTMENT OF HEALTH AND of the burden of the proposed collection Tribe and the sites to identify barriers
HUMAN SERVICES of information; (c) ways to enhance the and test solutions through a services
quality, utility, and clarity of the component operating in real time. The
National Institutes of Health information to be collected; and (d) expected outcomes of these cooperative
ways to minimize the burden of the agreements will include needed changes
Office of the Director Notice of Charter collection of information on to State/Territorial/Tribal policies and
Renewal respondents, including through the use procedures; development of financing
of automated collection techniques or structures that work in the current
In accordance with Title 41 of the other forms of information technology. environment; and a blueprint for States/
U.S. Code of Federal Regulations, Territories/Tribes and providers that
Section 102–3.65(a), notice is hereby Proposed Project: Biannual can be used throughout the State/
given that the Charter for the Sickle Cell Infrastructure Development Measures Territory/Tribe to widen the use of
Disease Advisory Council (SCDAC) was for State Adolescent and Transitional effective substance use treatment EBPs.
renewed for an additional two-year Aged Youth Treatment Enhancement Additionally, adolescents (ages 12 to
period on June 30, 2017. and Dissemination Implementation 18), transitional age youth (ages 18 to
It is determined that the SCDAC is in (SYT–I) and Adolescent and 24), and their families/primary
the public interest in connection with Transitional Aged Youth Treatment caregivers who are provided services
the performance of duties imposed on Implementation (YT–I) Programs— through grant funds will inform the
the National Institutes of Health by law, (OMB No. 0930–0344)—Revision process to improve systems issues.
and that these duties can best be The Substance Abuse and Mental Estimates for response burden were
performed through the advice and Health Services Administration calculated based on the methodology
mstockstill on DSK30JT082PROD with NOTICES

counsel of this group. (SAMHSA), Center for Substance Abuse (survey data collection) being used and
Inquires may be directed to Jennifer Treatment has developed a set of are based on previous experience
Spaeth, Director, Office of Federal infrastructure development measures in collecting similar data and results of the
Advisory Committee Policy, Office of which recipients of cooperative pilot study. For emailed biannual
the Director, National Institutes of agreements will report on various surveys, burden estimates of 12.0 hours
Health, 6701 Democracy Boulevard, benchmarks on a semi-annual basis. The were used for Project Directors and/or
Suite 1000, Bethesda, Maryland 20892 infrastructure development measures Program Managers and burden estimates

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Document Created: 2018-10-24 11:18:55
Document Modified: 2018-10-24 11:18:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		August 2, 2017.
FR Citation		82 FR 32557

82 FR 32557 - National Institute of Mental Health; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 134 (July 14, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health