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 Pharmaceuticals 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 

mg base/vial and EQ 1 g/vial.

Teva Pharmaceuticals USA, Inc., 425 Privet Rd., 

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 Pharmaceuticals USA, Inc.. 

ANDA 086308 ...................... Homapin-10 (homatropine methylbromide) Tablets 

USP, 10 mg.

Mission Pharmacal Co. 

ANDA 086309 ...................... Homapin-5 (homatropine methylbromide) Tablets USP, 

5 mg.

Do. 

ANDA 086310 ...................... Equipin (homatropine methylbromide) Chewable Tablets, 3 mg.Do. 

ANDA 086711 ...................... Beta-2 (isoetharine hydrochloride (HCl)) Inhalation Solution, 1%.Nephron Pharmaceuticals, Corp., 4500 12th St. Extension, 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 Pharmaceuticals USA, Inc. 

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is hereby withdrawn as of September 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 

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, 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: 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 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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. 

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

Form name Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average time 

per response 

(in hours) 

Total annual 

burden hours 

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. 

[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 

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 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

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] 

BILLING CODE 4140–01–P 

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. 


sradovich on DSK3GMQ082PROD with NOTICES