83 FR 40071 - Office of the Director, National Institutes of Health; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 156 (August 13, 2018)

Page Range		40071-40071
FR Document		2018-17345

Federal Register, Volume 83 Issue 156 (Monday, August 13, 2018)

[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Page 40071]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 other reasonable 
accommodations in order to do so, should notify the Contact Person 
listed below in advance of the meeting.

    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, 
[email protected].

    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: http://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)

    Dated: August 8, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-17345 Filed 8-10-18; 8:45 am]
 BILLING CODE 4140-01-P

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) ....... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 077251 ...................... Finasteride Tablets USP, 5 mg ....................................... Gedeon Richter Plc., c/o Gedeon Richter USA, Inc.,
119 Cherry Hill Rd., Suite 325, Parsippany, NJ
07054.
ANDA 077983 ...................... Gemcitabine for Injection USP, Equivalent to (EQ) 200 Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
mg base/vial and EQ 1 g/vial. Horsham, PA 19044.
ANDA 080425 ...................... Texacort (hydrocortisone) Topical Solution, 1% ............. Mission Pharmacal Co., 10999 IH 10 West, Suite 1000,
San Antonio, TX 78230.
ANDA 083242 ...................... Amen (medroxyprogesterone acetate) Tablets, 10 mg .. Valeant Pharmaceuticals North America, LLC, 400
Somerset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 085455 ...................... Dexamethasone Tablets USP, 0.25 mg ......................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc..
ANDA 086308 ...................... Homapin-10 (homatropine methylbromide) Tablets Mission Pharmacal Co.
USP, 10 mg.
ANDA 086309 ...................... Homapin-5 (homatropine methylbromide) Tablets USP, Do.
5 mg.
ANDA 086310 ...................... Equipin (homatropine methylbromide) Chewable Tab- Do.
lets, 3 mg.
ANDA 086711 ...................... Beta-2 (isoetharine hydrochloride (HCl)) Inhalation So- Nephron Pharmaceuticals, Corp., 4500 12th St. Exten-
lution, 1%. sion, West Columbia, SC 20172.
ANDA 087438 ...................... Folicet (folic acid) Tablets USP, 1 mg ............................ Mission Pharmacal Co.
ANDA 087939 ...................... Trimethobenzamide HCl Injection, 100 mg/mL .............. Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.

Therefore, approval of the other reasonable accommodations in Dated: August 8, 2018.
applications listed in the table, and all order to do so, should notify the Contact David D. Clary,
amendments and supplements thereto, Person listed below in advance of the Program Analyst, Office of Federal Advisory
is hereby withdrawn as of September meeting. Committee Policy.
12, 2018. Introduction or delivery for Name of Committee: Advisory Committee [FR Doc. 2018–17345 Filed 8–10–18; 8:45 am]
introduction into interstate commerce of to the Director, National Institutes of Health. BILLING CODE 4140–01–P
products without approved new drug Date: August 24, 2018.
applications violates section 301(a) and Time: 9:15 a.m. to 9:45 a.m.
(d) of the Federal Food, Drug, and Agenda: Updates on ACD Working Groups. DEPARTMENT OF HEALTH AND
Cosmetic Act (21 U.S.C. 331(a) and (d)). Place: National Institutes of Health, HUMAN SERVICES
Drug products that are listed in the table Building 1, One Center Drive, Bethesda, MD
that are in inventory on September 12, 20892 (Telephone Conference Call), 800– National Institutes of Health
369–1915, Access Code: 6496247.
2018 may continue to be dispensed Contact Person: Gretchen Wood, Staff
until the inventories have been depleted Proposed Collection; 60-Day Comment
Assistant, National Institutes of Health, Request; National Cancer Institute
or the drug products have reached their Office of the Director, One Center Drive,
expiration dates or otherwise become Building 1, Room 126, Bethesda, MD 20892,
(NCI) Future Fellows Resume Databank
violative, whichever occurs first. 301–496–4272, Woodgs@od.nih.gov. AGENCY: National Institutes of Health,
Dated: August 7, 2018. This notice is being published less than 15 HHS.
Leslie Kux, days prior to the meeting due to scheduling ACTION: Notice.
difficulties.
Associate Commissioner for Policy. Any interested person may file written SUMMARY: In compliance with the
[FR Doc. 2018–17226 Filed 8–10–18; 8:45 am] comments with the committee by forwarding requirement of the Paperwork
BILLING CODE 4164–01–P the statement to the Contact Person listed on
this notice. The statement should include the
Reduction Act of 1995 to provide
name, address, telephone number and when opportunity for public comment on
DEPARTMENT OF HEALTH AND applicable, the business or professional proposed data collection projects, the
HUMAN SERVICES affiliation of the interested person. National Institutes of Health, National
Information is also available on the Cancer Institute (NCI) will publish
National Institutes of Health Institute’s/Center’s home page: http:// periodic summaries of propose projects
acd.od.nih.gov, where an agenda and any to be submitted to the Office of
Office of the Director, National additional information for the meeting will Management and Budget (OMB) for
be posted when available.
Institutes of Health; Notice of Meeting review and approval.
(Catalogue of Federal Domestic Assistance
DATES: Comments regarding this
Pursuant to section 10(a) of the Program Nos. 93.14, Intramural Research
Federal Advisory Committee Act, as Training Award; 93.22, Clinical Research information collection are best assured
amended, notice is hereby given of a Loan Repayment Program for Individuals of having their full effect if received
from Disadvantaged Backgrounds; 93.232, within 60 days of the date of this
sradovich on DSK3GMQ082PROD with NOTICES

meeting of the Advisory Committee to
the Director, National Institutes of Loan Repayment Program for Research publication.
Generally; 93.39, Academic Research
Health. FOR FURTHER INFORMATION CONTACT: To
Enhancement Award; 93.936, NIH Acquired
The meeting will be held as a Immunodeficiency Syndrome Research Loan obtain a copy of the data collection
teleconference call only and is open to Repayment Program; 93.187, Undergraduate plans and instruments, submit
the public to dial-in for participation. Scholarship Program for Individuals from comments in writing, or request more
Individuals who plan to dial-in to the Disadvantaged Backgrounds, National information on the proposed project,
meeting and need special assistance or Institutes of Health, HHS) contact: Angela Jones, Program

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Document Created: 2018-08-11 00:27:08
Document Modified: 2018-08-11 00:27:08

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 24, 2018.
FR Citation		83 FR 40071

83 FR 40071 - Office of the Director, National Institutes of Health; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 156 (August 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health