83 FR 5117 - Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 83, Issue 24 (February 5, 2018)

Page Range		5117-5118
FR Document		2018-02173

Federal Register, Volume 83 Issue 24 (Monday, February 5, 2018)

[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5117-5118]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02173]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

Notice of Meeting

Pursuant to Public Law 92-463, notice is hereby given of the
meeting on February 16, 2018, of the Substance Abuse and Mental Health
Services Administration's (SAMHSA) National Advisory Council (SAMHSA
NAC).
The SAMHSA NAC was established to advise the Secretary, Department
of Health and Human Services (HHS), and the Assistant Secretary for
Mental Health and Substance Use, SAMHSA, to improve the provision of
treatments and related services to individuals with respect to
substance use and to improve prevention services, promote mental
health, and protect legal rights of individuals with mental illness and
individuals who are substance users.
The meeting will include remarks from the Assistant Secretary for
Mental Health and Substance Use; updates from the Department of Health
and Human Services' Operating Divisions; updates from the ex-officio
members, and a council discussion.
The meeting is open to the public and will be held at the Substance
Abuse and Mental Health Services Administration, 5600 Fishers Lane,
Rockville, MD 20857. Attendance by the public will be limited to space
available. Interested persons may present data, information, or views
orally or in writing, on issues pending before the Council. Written
submissions should be forwarded to the contact person by February 8,
2018. Oral presentations from the public will be scheduled at the
conclusion of the meeting. Individuals interested in making oral
presentations must notify the contact person by February 8, 2017. Five
minutes will be allotted for each presentation.
The meeting may be accessed via telephone. To attend on site;
obtain the call-in number, access code, and/or web access link; submit
written or brief oral comments; or request special accommodations for
persons with disabilities, please register on-line at: http://nac.samhsa.gov/Registration/meetingsRegistration.aspx, or communicate
with SAMHSA's Committee Management Officer, CDR Carlos Castillo (see
contact information below).
Meeting information and a roster of Council members may be obtained
either by accessing the SAMHSA Council's website at http://www.samhsa.gov/about-us/advisory-councils/ or by contacting CDR
Castillo. Substantive program information may be obtained after the
meeting by accessing the SAMHSA Council's website, http://nac.samhsa.gov/, or by contacting CDR Castillo.
Council Name: Substance Abuse and Mental Health Services
Administration National Advisory Council.
Date/Time/Type: February 16, 2018, 9:00 a.m. to 3:45 p.m. EDT,
Open.
Place: Substance Abuse and Mental Health Services Administration,
5600 Fishers Lane, Rockville, Maryland 20857.
Contact: CDR Carlos Castillo, Committee Management Officer and
Designated Federal Official, SAMHSA National Advisory Council, Room

[[Page 5118]]

18E77A, 5600 Fishers Lane, Rockville, Maryland 20857 (mail), Telephone:
(240) 276-2787, Email: carlos.castillo@samhsa.hhs.gov.

Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2018-02173 Filed 2-2-18; 8:45 am]
BILLING CODE 4162-20-P

Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices 5117

Secretary, Department of Health and meetingsRegistration.aspx, or improve the provision of treatments and
Human Services (HHS); the Assistant communicate with SAMHSA’s related services to individuals with
Secretary for Mental Health and Committee Management Officer, CDR respect to substance use and to improve
Substance Use, SAMHSA; and Carlos Castillo (see contact information prevention services, promote mental
SAMHSA’s Center Directors concerning below). health, and protect legal rights of
matters relating to the activities carried Meeting information and a roster of individuals with mental illness and
out by and through the Centers and the Council members may be obtained individuals who are substance users.
policies respecting such activities. either by accessing the SAMHSA The meeting will include remarks
Under Section 501 of the Public Council’s website at http:// from the Assistant Secretary for Mental
Health Service Act, the ACWS is www.samhsa.gov/about-us/advisory- Health and Substance Use; updates from
statutorily mandated to advise the councils/ or by contacting CDR Castillo. the Department of Health and Human
SAMHSA Assistant Secretary for Mental Substantive program information may Services’ Operating Divisions; updates
Health and Substance Use and the be obtained after the meeting by from the ex-officio members, and a
Associate Administrator for Women’s accessing the SAMHSA Council’s council discussion.
Services on appropriate activities to be website, http://nac.samhsa.gov/, or by The meeting is open to the public and
undertaken by SAMHSA and its Centers contacting CDR Castillo. will be held at the Substance Abuse and
with respect to women’s substance Mental Health Services Administration,
Council Names:
abuse and mental health services. 5600 Fishers Lane, Rockville, MD
Substance Abuse and Mental Health
Pursuant to Presidential Executive 20857. Attendance by the public will be
Services Administration National
Order No. 13175, November 6, 2000, limited to space available. Interested
Advisory Council
and the Presidential Memorandum of persons may present data, information,
Center for Mental Health Services
September 23, 2004, SAMHSA or views orally or in writing, on issues
National Advisory Council
established the TTAC for working with pending before the Council. Written
Center for Substance Abuse Prevention
Federally-recognized Tribes to enhance submissions should be forwarded to the
National Advisory Council
the government-to-government contact person by February 8, 2018. Oral
relationship, and honor Federal trust Center for Substance Abuse Treatment
presentations from the public will be
responsibilities and obligations to National Advisory Council
scheduled at the conclusion of the
Tribes and American Indian and Alaska Advisory Committee for Women’s
meeting. Individuals interested in
Natives. The SAMHSA TTAC serves as Services Tribal Technical Advisory
making oral presentations must notify
an advisory body to SAMHSA. Committee
the contact person by February 8, 2017.
The meeting will include remarks Date/Time/Type: February 15, 2018, Five minutes will be allotted for each
from the Assistant Secretary for Mental 9:00 a.m. to 4:25 p.m. EDT, Open. presentation.
Health and Substance Use; SAMHSA’s Place: Substance Abuse and Mental The meeting may be accessed via
priorities and updates by the Centers Health Services Administration, 5600 telephone. To attend on site; obtain the
and Office Directors; a presentation on Fishers Lane, Rockville, Maryland call-in number, access code, and/or web
the Report to Congress on the 20857. access link; submit written or brief oral
Interdepartmental Serious Mental Contact: CDR Carlos Castillo, comments; or request special
Illness Coordinating Committee Committee Management Officer and accommodations for persons with
(ISMICC); a presentation on SAMHSA’s Designated Federal Official, SAMHSA disabilities, please register on-line at:
role in recent behavioral health National Advisory Council, Room http://nac.samhsa.gov/Registration/
responses to disasters; and a council 18E77A, 5600 Fishers Lane, Rockville, meetingsRegistration.aspx, or
discussion. Maryland 20857 (mail), Telephone: communicate with SAMHSA’s
The meeting is open to the public and (240) 276–2787, Email: carlos.castillo@ Committee Management Officer, CDR
will be held at the Substance Abuse and samhsa.hhs.gov. Carlos Castillo (see contact information
Mental Health Services Administration, below).
Carlos Castillo,
5600 Fishers Lane, Rockville, MD Meeting information and a roster of
20857. Attendance by the public will be Committee Management Officer, SAMHSA.
Council members may be obtained
limited to space available. Interested [FR Doc. 2018–02172 Filed 2–2–18; 8:45 am]
either by accessing the SAMHSA
persons may present data, information, BILLING CODE 4162–20–P
Council’s website at http://
or views orally or in writing, on issues www.samhsa.gov/about-us/advisory-
pending before the Council. Written councils/ or by contacting CDR Castillo.
submissions should be forwarded to the DEPARTMENT OF HEALTH AND
Substantive program information may
contact person by February 8, 2018. Oral HUMAN SERVICES
be obtained after the meeting by
presentations from the public will be accessing the SAMHSA Council’s
Substance Abuse and Mental Health
scheduled at the conclusion of the website, http://nac.samhsa.gov/, or by
Services Administration
meeting. Individuals interested in contacting CDR Castillo.
making oral presentations are Notice of Meeting Council Name: Substance Abuse and
encouraged to notify the contact by Mental Health Services Administration
February 8, 2018. Five minutes will be Pursuant to Public Law 92–463, National Advisory Council.
allotted for each presentation. notice is hereby given of the meeting on Date/Time/Type: February 16, 2018,
The meeting may be accessed via February 16, 2018, of the Substance 9:00 a.m. to 3:45 p.m. EDT, Open.
telephone and web conferencing will be Abuse and Mental Health Services
sradovich on DSK3GMQ082PROD with NOTICES

Place: Substance Abuse and Mental
available. To attend on site: Obtain the Administration’s (SAMHSA) National Health Services Administration, 5600
call-in number, access code, and/or web Advisory Council (SAMHSA NAC). Fishers Lane, Rockville, Maryland
access link; submit written or brief oral The SAMHSA NAC was established 20857.
comments; or request special to advise the Secretary, Department of Contact: CDR Carlos Castillo,
accommodations for persons with Health and Human Services (HHS), and Committee Management Officer and
disabilities, please register on-line at: the Assistant Secretary for Mental Designated Federal Official, SAMHSA
http://nac.samhsa.gov/Registration/ Health and Substance Use, SAMHSA, to National Advisory Council, Room

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5118 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices

18E77A, 5600 Fishers Lane, Rockville, determinations (H289700, H289701, tablets. We note that Acetris is a party-at-
Maryland 20857 (mail), Telephone: H289702, H289704, H289706, H289710, interest within the meaning of 19 C.F.R.
(240) 276–2787, Email: carlos.castillo@ H289711, H289712, H289713, H289714, § 177.22(d)(1) and is entitled to request this
samhsa.hhs.gov. and H289715), were issued under final determination.
procedures set forth at 19 CFR part 177, You have asked that certain information
Carlos Castillo, submitted in connection with this ruling
subpart B, which implements Title III of
Committee Management Officer, SAMHSA. request be treated as confidential. Inasmuch
the Trade Agreements Act of 1979, as as this request conforms to the requirements
[FR Doc. 2018–02173 Filed 2–2–18; 8:45 am] amended (19 U.S.C. 2511–18). In the of 19 C.F.R. § 177.2(b)(7), the request for
BILLING CODE 4162–20–P final determinations, CBP concluded confidentiality is approved. The information
that the processing in the United States contained within brackets in your request
does not result in a substantial will not be released to the public and will be
DEPARTMENT OF HOMELAND transformation. Therefore, the country withheld from published versions of this
SECURITY of origin for purposes of U.S. ruling.
Government procurement of the FACTS:
U.S. Customs and Border Protection pharmaceutical products is India, the
country where the active The merchandise at issue are Rosuvastatin
Notice of Issuance of Final Calcium tablets. You state that Acetris is a
pharmaceutical ingredient was
Determinations Concerning Certain generic pharmaceutical distributor
produced. specializing in providing cost effective
Pharmaceutical Products Section 177.29, CBP Regulations (19 products to the U.S. Government. Acetris has
AGENCY: U.S. Customs and Border CFR 177.29), provides that a notice of its principal place of business in Allendale,
Protection, Department of Homeland final determination shall be published NJ. Among the products Acetris sells to the
Security. in the Federal Register within 60 days U.S. Government are Rosuvastatin Calcium
ACTION: Notice of final determinations.
of the date the final determination is tablets, members of a family of statin drugs
issued. Section 177.30, CBP Regulations prescribed for the reduction of cholesterol
SUMMARY: This document provides (19 CFR 177.30), provides that any and triglyceride levels and prevention of
notice that U.S. Customs and Border party-at-interest, as defined in 19 CFR heart attacks and strokes.
Protection (‘‘CBP’’) has issued 11 final 177.22(d), may seek judicial review of a You state that Acetris procures the
determinations concerning the country final determination within 30 days of Rosuvastatin Calcium tablets from Aurolife
of origin of certain pharmaceutical publication of such determination in the Pharma LLC (‘‘Aurolife’’), located in Dayton,
NJ. Aurolife, which is a wholly-owned
products. Based upon the facts Federal Register.
subsidiary of company X in India, is a
presented, CBP has concluded that the Dated: January 30, 2018. generic pharmaceutical product
country of origin of the Rosuvastatin Alice A. Kipel, manufacturer in the specialty and niche
Calcium Tablets, Levofloxacin Tablets, Executive Director, Regulations and Rulings, areas. Aurolife manufactures the
Levetiracetam Tablets, Metoprolol Office of Trade. Rosuvastatin Calcium tablets supplied to
Tartrate Tablets, Gabapentin Capsules, Acetris in a U.S. Food & Drug Administration
Carvedilol Tablets, Paroxetine HQ H289700 (‘‘FDA’’) approved cGMP compliant
Hydrochloride Tablets, Entecavir January 30, 2018 manufacturing facility, located in Dayton, NJ,
Tablets, Montelukast Sodium Tablets, from several active and inactive ingredients
OT:RR:CTF: VS H289700 EE
Simvastatin Tablets, Donepezil procured domestically and abroad. The
CATEGORY: Origin active pharmaceutical ingredient (‘‘API’’) of
Hydrochloride Tablets is India for Stephen E. Ruscus the Rosuvastatin Calcium tablets is
purposes of U.S. Government Morgan, Lewis & Bockius LLP Rosuvastatin Calcium, which Aurolife
procurement. 1111 Pennsylvania Avenue, NW sources from company X in India.
DATES: These final determinations were Washington, DC 20004 You state that the Rosuvastatin Calcium
issued on January 30, 2018. Copies of RE: U.S. Government Procurement; Title III, tablets supplied to Acetris are the result of
the final determinations are attached. Trade Agreements Act of 1979 (19 U.S.C. a complex production process that occurs in
§ 2511); Subpart B, Part 177, CBP Aurolife’s New Jersey facility involving the
Any party-at-interest, as defined in 19 Regulations; Rosuvastatin Calcium tablets
CFR 177.22(d), may seek judicial review combination of the API with several inactive
Dear Mr. Ruscus: ingredients, including some intermediates
of these final determinations within
This is in response to your correspondence that are mixed in order to aid the conversion
March 7, 2018. of the multiple ingredients. The production
of July 7, 2017, requesting a final
FOR FURTHER INFORMATION CONTACT: Elif determination on behalf of Acetris Health, of Rosuvastatin employs processes that
Eroglu, Valuation and Special Programs (‘‘Acetris’’) 1, pursuant to subpart B of Part convert these ingredients into finished,
Branch, Regulations and Rulings, Office 177, U.S. Customs and Border Protection medically effective dosage tablets (5 mg, 10
of Trade, (202) 325–0277. (‘‘CBP’’) Regulations (19 C.F.R. 177.21 et mg, 20 mg, and 40 mg tablets). You state that
SUPPLEMENTARY INFORMATION: Notice is
seq.). A meeting was held with the counsel this processing changes the properties and
for Acetris on August 8, 2017. characteristics of the API, materially
hereby given that on January 30, 2018 This final determination concerns the enhancing the pharmacokinetics of the
CBP issued 11 final determinations country of origin of the Rosuvastatin Calcium resulting drug.
concerning the country of origin of You state that the process of converting
certain pharmaceutical products, which 1 Counsel for Acetris states that on May 19, 2017,
these multiple ingredients into the
may be offered to the U.S. Government Acetris executed a novation with Lucid Pharma Rosuvastatin Calcium tablets occurs entirely
under an undesignated government LLC and the Department of Veterans Affairs within the United States. The ingredients
whereby the VA recognized Acetris as the successor
sradovich on DSK3GMQ082PROD with NOTICES

procurement contract pursuant to in interest to Department of Veterans Affairs
processed in the United States are sourced
subpart B of part 177, CBP Regulations Contract No. VA 797P–16–C–0034, the subject from a variety of suppliers, both United
(19 CFR part 177, subpart B). These final contract of the underlying request. States and foreign, as follows:

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Document Created: 2018-02-03 01:25:03
Document Modified: 2018-02-03 01:25:03

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
FR Citation		83 FR 5117

83 FR 5117 - Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESSubstance Abuse and Mental Health Services Administration

Federal Register Volume 83, Issue 24 (February 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration