Proposed Collection; 60-Day Comment Request; National Cancer Institute (NCI) Future Fellows Resume Databank, 40071-40072 [2018-17339]
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Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
40071
Application No.
Drug
Applicant
ANDA 074945 ......................
Atracurium Besylate Injection, 10 mg/milliliter (mL) .......
ANDA 077251 ......................
Finasteride Tablets USP, 5 mg .......................................
ANDA 077983 ......................
ANDA 080425 ......................
Gemcitabine for Injection USP, Equivalent to (EQ) 200
mg base/vial and EQ 1 g/vial.
Texacort (hydrocortisone) Topical Solution, 1% .............
ANDA 083242 ......................
Amen (medroxyprogesterone acetate) Tablets, 10 mg ..
ANDA 085455 ......................
Dexamethasone Tablets USP, 0.25 mg .........................
ANDA 086308 ......................
Homapin-10 (homatropine methylbromide) Tablets
USP, 10 mg.
Homapin-5 (homatropine methylbromide) Tablets USP,
5 mg.
Equipin (homatropine methylbromide) Chewable Tablets, 3 mg.
Beta-2 (isoetharine hydrochloride (HCl)) Inhalation Solution, 1%.
Folicet (folic acid) Tablets USP, 1 mg ............................
Trimethobenzamide HCl Injection, 100 mg/mL ..............
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Gedeon Richter Plc., c/o Gedeon Richter USA, Inc.,
119 Cherry Hill Rd., Suite 325, Parsippany, NJ
07054.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
Mission Pharmacal Co., 10999 IH 10 West, Suite 1000,
San Antonio, TX 78230.
Valeant Pharmaceuticals North America, LLC, 400
Somerset Corporate Blvd., Bridgewater, NJ 08807.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc..
Mission Pharmacal Co.
ANDA 086309 ......................
ANDA 086310 ......................
ANDA 086711 ......................
ANDA 087438 ......................
ANDA 087939 ......................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of September
12, 2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on September 12,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17226 Filed 8–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee to
the Director, National Institutes of
Health.
The meeting will be held as a
teleconference call only and is open to
the public to dial-in for participation.
Individuals who plan to dial-in to the
meeting and need special assistance or
VerDate Sep<11>2014
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Do.
Do.
Nephron Pharmaceuticals, Corp., 4500 12th St. Extension, West Columbia, SC 20172.
Mission Pharmacal Co.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
other reasonable accommodations in
order to do so, should notify the Contact
Person listed below in advance of the
meeting.
Dated: August 8, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: August 24, 2018.
Time: 9:15 a.m. to 9:45 a.m.
Agenda: Updates on ACD Working Groups.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892 (Telephone Conference Call), 800–
369–1915, Access Code: 6496247.
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 126, Bethesda, MD 20892,
301–496–4272, Woodgs@od.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
difficulties.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
acd.od.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
[FR Doc. 2018–17345 Filed 8–10–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; National Cancer Institute
(NCI) Future Fellows Resume Databank
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health, National
Cancer Institute (NCI) will publish
periodic summaries of propose projects
to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Angela Jones, Program
SUMMARY:
E:\FR\FM\13AUN1.SGM
13AUN1
40072
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
Coordinator, Center for Cancer Training,
National Cancer Institute, 9609 Medical
Center Drive, Room 2W–236, Bethesda,
Maryland, 20892 or call non-toll-free
number (240) 276–5659 or Email your
request, including your address to:
jonesangel@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
SUPPLEMENTARY INFORMATION:
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: National
Cancer Institute Future Fellows Resume
Databank, 0925–XXXX, Exp., Date XX/
XXXX, EXISTING COLLECTION IN USE
WITHOUT OMB NUMBER, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute, Center for Cancer Training
mission is to catalyze the development
of the 21st century workforce capable of
advancing cancer research through a
scientifically integrated approach. This
is accomplished by, (1) coordinating
and providing research training and
career development activities for fellows
and trainees in NCI’s laboratories,
clinics, and other research groups, (2)
developing, coordinating, and
implementing opportunities in support
of cancer research training, career
development, and education at
institutions nationwide, and (3)
identifying workforce needs in cancer
research and adapting NCI’s training
and career development programs and
funding opportunities to address these
needs. The proposed information
collection involves a website to collect
and maintain resumes of interested
candidates to be considered for
postdoctoral fellowships and
internships in science. After posting
their resume in the database, NCI
Scientists can view and select
candidates for current fellowship and
internship opportunities offered at NCI.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden are 200
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
Form name
Type of respondent
Resume Databank Application ........
Postdoctoral Fellows .......................
200
2
30/60
200
Total ..........................................
..........................................................
200
400
........................
200
Dated: July 24, 2018.
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2018–17339 Filed 8–10–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Center for Inherited
Disease Research Access Committee.
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
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
VerDate Sep<11>2014
20:42 Aug 10, 2018
Jkt 244001
Name of Committee: Center for Inherited
Disease Research Access Committee.
Date: September 7, 2018.
Time: 8:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Center for Inherited Disease
Research (CIDR), McHenry Conference Room,
1812 Ashland Avenue, Baltimore, MD 21205.
Contact Person: Barbara J. Thomas, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 5635
Fishers Lane, Ste. 4076, MSC 9306, Bethesda,
MD 20892–9306, 301–402–0838,
barbara.thomas@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: August 7, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–17340 Filed 8–10–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
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: Environmental Health
Sciences Review Committee; Environmental
Health Sciences Core Centers P30 Clinical
Trial Optional.
Date: August 21–22, 2018.
E:\FR\FM\13AUN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40071-40072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17339]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; National Cancer
Institute (NCI) Future Fellows Resume Databank
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health, National Cancer
Institute (NCI) will publish periodic summaries of propose projects to
be submitted to the Office of Management and Budget (OMB) for review
and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Angela
Jones, Program
[[Page 40072]]
Coordinator, Center for Cancer Training, National Cancer Institute,
9609 Medical Center Drive, Room 2W-236, Bethesda, Maryland, 20892 or
call non-toll-free number (240) 276-5659 or Email your request,
including your address to: [email protected]. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimizes the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: National Cancer Institute Future Fellows
Resume Databank, 0925-XXXX, Exp., Date XX/XXXX, EXISTING COLLECTION IN
USE WITHOUT OMB NUMBER, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The National Cancer
Institute, Center for Cancer Training mission is to catalyze the
development of the 21st century workforce capable of advancing cancer
research through a scientifically integrated approach. This is
accomplished by, (1) coordinating and providing research training and
career development activities for fellows and trainees in NCI's
laboratories, clinics, and other research groups, (2) developing,
coordinating, and implementing opportunities in support of cancer
research training, career development, and education at institutions
nationwide, and (3) identifying workforce needs in cancer research and
adapting NCI's training and career development programs and funding
opportunities to address these needs. The proposed information
collection involves a website to collect and maintain resumes of
interested candidates to be considered for postdoctoral fellowships and
internships in science. After posting their resume in the database, NCI
Scientists can view and select candidates for current fellowship and
internship opportunities offered at NCI.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden are 200 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Resume Databank Application.. Postdoctoral 200 2 30/60 200
Fellows.
----------------------------------------------------------------------------------
Total.................... ................ 200 400 .............. 200
----------------------------------------------------------------------------------------------------------------
Dated: July 24, 2018.
Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2018-17339 Filed 8-10-18; 8:45 am]
BILLING CODE 4140-01-P
