80 FR 75868 - National Institute on Drug Abuse; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 233 (December 4, 2015)

Page Range		75868-75869
FR Document		2015-30603

Federal Register, Volume 80 Issue 233 (Friday, December 4, 2015)

[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75868-75869]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30603]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Drug Abuse; 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 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

[[Page 75869]]

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: National Institute on Drug Abuse Special 
Emphasis Panel; R13 Conference Grant Review (PA 13-347).
    Date: December 8, 2015.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852, (Virtual Meeting).
    Contact Person: Susan O. McGuire, Ph.D., Scientific Review 
Officer, Office of Extramural Affairs, National Institute on Drug 
Abuse, National Institutes of Health, DHHS, 6001 Executive Blvd., 
Room 4245, Rockville, MD 20852, 301-435-1426. 
mcguireso@mail.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.

(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug 
Abuse and Addiction Research Programs, National Institutes of 
Health, HHS)

    Dated: November 27, 2015.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-30603 Filed 12-3-15; 8:45 am]
 BILLING CODE 4140-01-P

75868 Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices

that FDA will not begin procedures to exceptions, show that the drug for was withdrawn from sale for reasons of
withdraw approval of abbreviated new which they are seeking approval safety or effectiveness (21 CFR 314.162).
drug applications (ANDAs) that refer to contains the same active ingredient in Under § 314.161(a) (21 CFR
these drug products, and it will allow the same strength and dosage form as 314.161(a)), the Agency must determine
FDA to continue to approve ANDAs that the ‘‘listed drug,’’ which is a version of whether a listed drug was withdrawn
refer to the products as long as they the drug that was previously approved. from sale for reasons of safety or
meet relevant legal and regulatory ANDA applicants do not have to repeat effectiveness: (1) Before an ANDA that
requirements. the extensive clinical testing otherwise refers to that listed drug may be
necessary to gain approval of a new
FOR FURTHER INFORMATION CONTACT: approved, (2) whenever a listed drug is
drug application (NDA).
Stacy Kane, Center for Drug Evaluation The 1984 amendments include what voluntarily withdrawn from sale and
and Research, Food and Drug is now section 505(j)(7) of the Federal ANDAs that refer to the listed drug have
Administration, 10903 New Hampshire Food, Drug, and Cosmetic Act (21 U.S.C. been approved, and (3) when a person
Ave., Bldg. 51, Rm. 6236, Silver Spring, 355(j)(7)), which requires FDA to petitions for such a determination under
MD 20993–0002, 301–796–8363, publish a list of all approved drugs. 21 CFR 10.25(a) and 10.30. Section
Stacy.Kane@fda.hhs.gov. FDA publishes this list as part of the 314.161(d) provides that if FDA
SUPPLEMENTARY INFORMATION: In 1984, ‘‘Approved Drug Products With determines that a listed drug was
Congress enacted the Drug Price Therapeutic Equivalence Evaluations,’’ withdrawn from sale for safety or
Competition and Patent Term which is generally known as the effectiveness reasons, the Agency will
Restoration Act of 1984 (Pub. L. 98–417) ‘‘Orange Book.’’ Under FDA regulations, initiate proceedings that could result in
(the 1984 amendments), which a drug is removed from the list if the the withdrawal of approval of the
authorized the approval of duplicate Agency withdraws or suspends ANDAs that refer to the listed drug.
versions of drug products approved approval of the drug’s NDA or ANDA FDA has become aware that the drug
under an ANDA procedure. ANDA for reasons of safety or effectiveness, or products listed in the table in this
applicants must, with certain if FDA determines that the listed drug document are no longer being marketed.

Application No. Drug Applicant

NDA 008883 ...... OPHTHAINE (proparacaine hydrochloride) Solution/Drops; Apothecon, Inc.
Ophthalmic, 0.5%.
NDA 009053 ...... PURINETHOL (mercaptopurine) Tablet; Oral, 50 milligrams Teva Pharmaceuticals USA.
(mg).
NDA 012427 ...... DIDREX (benzphetamine hydrochloride) Tablet; Oral, 50 mg Pharmacia & Upjohn Co.
NDA 012583 ...... OPHTHETIC (proparacaine hydrochloride) Solution/Drops; Allergan Pharmaceutical.
Ophthalmic, 0.5%.
NDA 017716 ...... OVCON–35 (ethinyl estradiol; norethindrone) Tablet; Oral-28, Warner Chilcott LLC.
0.035 mg; 0.4 mg.
NDA 018782 ...... NORDETTE–28 (ethinyl estradiol; levonorgestrel) Tablet; Teva Branded Pharmaceutical Products R and D, Inc.
Oral-28, 0.03 mg; 0.15 mg.
NDA 021199 ...... QUIXIN (levofloxacin) Solution/Drops; Ophthalmic, 0.5% ....... Santen, Inc.
NDA 021595 ...... SANCTURA (trospium chloride) Tablet; Oral, 20 mg .............. Allergan, Inc.
NDA 021664 ...... BROMDAY (bromfenac sodium) Solution/Drops; Ophthalmic, Bausch & Lomb, Inc.
EQ 0.09% acid.
NDA 022103 ...... SANCTURA XR (trospium chloride) Extended-Release Cap- Allergan, Inc.
sule; Oral, 60 mg.
ANDA 060571 .... MYCOSTATIN (nystatin) Ointment; Topical, 100,000 units/ Delcor Asset Corp.
gram (g).
ANDA 060575 .... MYCOSTATIN (nystatin) Cream; Topical, 100,000 units/g ..... Do.
ANDA 060578 .... MYCOSTATIN (nystatin) Powder; Topical 100,000 units/g ..... Do.
ANDA 063116 .... TOBRAMYCIN SULFATE (PHARMACY BULK) (tobramycin Hospira, Inc.
sulfate) Injectable; Injection, EQ 40 mg base/milliliter.

FDA has reviewed its records and, document are unaffected by the DEPARTMENT OF HEALTH AND
under § 314.161, has determined that discontinued marketing of the products HUMAN SERVICES
the drug products listed in this subject to those NDAs and ANDAs.
document were not withdrawn from Additional ANDAs that refer to these National Institutes of Health
sale for reasons of safety or products may also be approved by the
effectiveness. Accordingly, the Agency Agency if they comply with relevant National Institute on Drug Abuse;
legal and regulatory requirements. If Notice of Closed Meeting
will continue to list the drug products
listed in this document in the FDA determines that labeling for these
Pursuant to section 10(d) of the
‘‘Discontinued Drug Product List’’ drug products should be revised to meet
Federal Advisory Committee Act, as
asabaliauskas on DSK5VPTVN1PROD with NOTICES

section of the Orange Book. The current standards, the Agency will
amended (5 U.S.C. App), notice is
‘‘Discontinued Drug Product List’’ advise ANDA applicants to submit such
hereby given of the following meeting.
identifies, among other items, drug labeling.
The meeting will be closed to the
products that have been discontinued Dated: November 30, 2015.
public in accordance with the
from marketing for reasons other than Leslie Kux, provisions set forth in sections
safety or effectiveness. Associate Commissioner for Policy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Approved ANDAs that refer to the [FR Doc. 2015–30628 Filed 12–3–15; 8:45 am] as amended. The grant applications and
NDAs and ANDAs listed in this BILLING CODE 4164–01–P the discussions could disclose

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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices 75869

confidential trade secrets or commercial Time: 8:00 a.m. to 12:30 p.m. to obtain a copy of the information
property such as patentable material, Agenda: To review and evaluate contract collection plans, call the SAMHSA
and personal information concerning proposals. Reports Clearance Officer on (240) 276–
Place: National Institutes of Health,
individuals associated with the grant 1243.
Neuroscience Center, 6001 Executive
applications, the disclosure of which Boulevard, Rockville, MD 20852, (Telephone
Comments are invited on: (a) Whether
would constitute a clearly unwarranted Conference Call). the proposed collection of information
invasion of personal privacy. Contact Person: Nadine Rogers, Ph.D., is necessary for the proper performance
Name of Committee: National Institute on Scientific Review Officer, Office of of the functions of the agency, including
Drug Abuse Special Emphasis Panel; R13 Extramural Affairs, National Institute on whether the information shall have
Conference Grant Review (PA 13–347). Drug Abuse, NIH, DHHS, 6001 Executive practical utility; (b) the accuracy of the
Date: December 8, 2015. Blvd., Room 4229, MSC 9550, Bethesda, MD agency’s estimate of the burden of the
Time: 1:00 p.m. to 4:00 p.m. 20892–9550, 301–402–2105, rogersn2@ proposed collection of information; (c)
nida.nih.gov.
Agenda: To review and evaluate grant ways to enhance the quality, utility, and
applications. This notice is being published less than 15 clarity of the information to be
Place: National Institutes of Health, days prior to the meeting due to the timing
limitations imposed by the review and
collected; and (d) ways to minimize the
Neuroscience Center, 6001 Executive burden of the collection of information
Boulevard, Rockville, MD 20852, (Virtual funding cycle.
Meeting). Name of Committee: National Institute on
on respondents, including through the
Contact Person: Susan O. McGuire, Ph.D., Drug Abuse Special Emphasis Panel; Pain use of automated collection techniques
Scientific Review Officer, Office of Mobile Remote Pain Management System or other forms of information
Extramural Affairs, National Institute on (4434). technology.
Drug Abuse, National Institutes of Health, Date: December 14, 2015.
DHHS, 6001 Executive Blvd., Room 4245, Time: 1:00 p.m. to 5:00 p.m.
Proposed Project—Strategic Prevention
Rockville, MD 20852, 301–435–1426. Agenda: To review and evaluate contract Framework State Incentive Grant (SPF
mcguireso@mail.nih.gov. proposals. SIG) Program, Cohorts IV and V—NEW
This notice is being published less than 15 Place: National Institutes of Health, The Substance Abuse and Mental
days prior to the meeting due to the timing Neuroscience Center, 6001 Executive Health Services Administration’s
limitations imposed by the review and Boulevard, Rockville, MD 20852, (Telephone
(SAMHSA) Center for Substance Abuse
funding cycle. Conference Call).
Contact Person: Nadine Rogers, Ph.D., Prevention (CSAP) requests OMB
(Catalogue of Federal Domestic Assistance approval to collect community
Scientific Review Officer, Office of
Program Nos.: 93.279, Drug Abuse and outcomes data for the cross-site
Extramural Affairs, National Institute on
Addiction Research Programs, National
Drug Abuse, NIH, DHHS, 6001 Executive evaluation of the Strategic Prevention
Institutes of Health, HHS)
Blvd., Room 4229, MSC 9550, Bethesda, MD Framework State Incentive Grant (SPF
Dated: November 27, 2015. 20892–9550, 301–402–2105, rogersn2@ SIG) program, Cohorts IV and V. CSAP
Natasha M. Copeland, nida.nih.gov. has previously funded two cross-site
Program Analyst, Office of Federal Advisory This notice is being published less than 15 evaluations of the Strategic Prevention
Committee Policy. days prior to the meeting due to the timing Framework State Incentive Grant (SPF
[FR Doc. 2015–30603 Filed 12–3–15; 8:45 am]
limitations imposed by the review and SIG), one focused on Cohorts I and II
funding cycle.
BILLING CODE 4140–01–P and the other on Cohorts III, IV, and V.
(Catalogue of Federal Domestic Assistance Collectively, these evaluations provide
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
an important opportunity to inform the
DEPARTMENT OF HEALTH AND Institutes of Health, HHS) prevention field on current practices
HUMAN SERVICES and their association with community-
Dated: November 27, 2015. and state-level outcomes.
National Institutes of Health Natasha M. Copeland, Data are collected at the grantee,
Program Analyst, Office of Federal Advisory community, and participant levels. The
National Institute on Drug Abuse Committee Policy. collection of community outcomes data
Notice of Closed Meetings [FR Doc. 2015–30602 Filed 12–3–15; 8:45 am] is the focus of the current request. The
Pursuant to section 10(d) of the BILLING CODE 4140–01–P primary cross-site evaluation objective
Federal Advisory Committee Act, as is to determine the impact of SPF SIG
amended (5 U.S.C. App), notice is on building prevention capacity and
hereby given of the following meetings. DEPARTMENT OF HEALTH AND infrastructure, and preventing the onset
The meetings will be closed to the HUMAN SERVCES and reducing the progression of
public in accordance with the substance abuse, as measured by the
provisions set forth in sections Substance Abuse and Mental Health SAMHSA National Outcome Measures
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Services Administration (NOMs).
as amended. The contract proposals and The SPF SIG grant program is a major
Agency Information Collection
the discussions could disclose investment by the federal government to
Activities: Proposed Collection;
confidential trade secrets or commercial improve substance abuse prevention
Comment Request
property such as patentable material, systems and enhance the quality of
and personal information concerning In compliance with Section prevention programs, primarily through
3506(c)(2)(A) of the Paperwork the implementation of the SPF process.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

individuals associated with the contract
proposals, the disclosure of which Reduction Act of 1995 concerning The goal of this initiative is to provide
would constitute a clearly unwarranted opportunity for public comment on states, jurisdictions, tribal entities, and
invasion of personal privacy. proposed collections of information, the the communities within them with the
Name of Committee: National Institute on
Substance Abuse and Mental Health tools necessary to develop an effective
Drug Abuse Special Emphasis Panel; Services Administration (SAMHSA) prevention system with attention to the
Therapeutic Cannabidiol Pulmonary Delivery will publish periodic summaries of processes, directions, goals,
Device (8929). proposed projects. To request more expectations, and accountabilities
Date: December 14, 2015. information on the proposed project or necessary for functionality. SAMHSA/

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Document Created: 2015-12-14 13:52:56
Document Modified: 2015-12-14 13:52:56

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		December 8, 2015.
FR Citation		80 FR 75868

80 FR 75868 - National Institute on Drug Abuse; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 233 (December 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health