72188 Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 074126 .... Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg ................ Do. 

ANDA 074589 .... Minoxidil Topical Solution, 2% ................................................. Teva Pharmaceuticals USA. 

ANDA 074828 .... Acyclovir Capsules, 200 mg .................................................... Do. 

ANDA 074849 .... Clomipramine HCl Capsules, 25 mg, 50 mg, and 75 mg ....... Do. 

ANDA 074879 .... Ketoprofen Extended-Release Capsules, 200 mg .................. Alkermes Gainesville LLC, 1300 Gould Dr., Gainesville, GA 

30504. 

ANDA 074976 .... Acyclovir Tablets USP, 400 mg and 800 mg .......................... Mylan Pharmaceuticals, Inc. 

ANDA 074977 .... Acyclovir Capsules USP, 200 mg ............................................ Do. 

ANDA 075161 .... Ticlopidine HCl Tablets USP, 250 mg ..................................... Do. 

ANDA 075472 .... Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 

mg.

Do. 

ANDA 075934 .... Nizatidine Capsules USP, 150 mg and 300 mg ...................... Do. 

ANDA 076036 .... Quinapril Tablets USP, 5 mg, 10 mg, 20 mg, and 40 mg ....... Do. 

ANDA 076969 .... Metoprolol Succinate Extended-Release Tablets USP, 25 

mg, 50 mg, 100 mg, and 200 mg.

Sandoz, Inc. 

ANDA 077136 .... Terbinafine HCl Tablets, 250 mg ............................................. Mylan Pharmaceuticals, Inc. 

ANDA 077163 .... Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg .. Do. 

ANDA 077254 .... Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 

250 mg, and 500 mg.

Do. 

ANDA 077486 .... Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mg ................... Do. 

ANDA 077705 .... Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/

12.5 mg and 20 mg/12.5 mg.

Do. 

ANDA 077934 .... Meloxicam Tablets USP, 7.5 mg and 15 mg ........................... Do. 

ANDA 077976 .... Cromolyn Sodium Nasal Solution USP, 5.2 mg/1 spray ......... HH & P LLC, c/o Kuker Regulatory Consulting, LLC, 18 Dunbar Way, Mahtomedi, MN 55115. 

ANDA 078638 .... Alendronate Sodium Tablets USP, 35 mg and 70 mg ............ Mylan Pharmaceuticals, Inc. 

ANDA 078731 .... Levetiracetam Tablets, 250 mg, 500 mg, 750 mg, and 1,000 

mg.

Do. 

ANDA 079184 .... Ursodiol Tablets USP, 250 mg and 500 mg ............................ Teva Pharmaceuticals USA. 

ANDA 081295 .... Estradiol Tablets USP, 0.5 mg ................................................ Bristol-Myers Squibb Co. 

ANDA 084499 .... Estradiol Tablets USP, 1 mg ................................................... Do. 

ANDA 084500 .... Estradiol Tablets USP, 2 mg ................................................... Do. 

ANDA 085794 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/30 mg.

Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124. 

ANDA 085795 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/15 mg.

Do. 

ANDA 087176 .... Chlorthalidone Tablets USP, 50 mg ........................................ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, 

NJ 07677. 

ANDA 087653 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 

mg/60 mg.

Mutual Pharmaceutical Co., Inc. 

ANDA 088833 .... Triprolidine HCl, pseudoephedrine HCl, and Codeine Phosphate Cough Syrup, 1.25 mg/5 mL, 30 mg/5 mL, and 10 

mg/5 mL.

Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 

6451 Main St., Morton Grove, IL 60053. 

ANDA 088896 .... Promethazine VC with Codeine (promethazine HCl, phenylephrine HCl, and codeine phosphate) Cough Syrup, 6.25 

mg/5 mL, 5 mg/5 mL, and 10 mg/5 mL.

Do. 

NDA 202343 ...... Juvisync (sitagliptin and simvastatin) Tablets, 100 mg/10 mg, 

100 mg/20 mg, and 100 mg/40 mg.

Merck Sharp & Dohme Corp., 351 North Sumneytown Pike, 

P.O. Box 1000, UG2CD–015, North Wales, PA 19454. 

1This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no 

longer be used as a propellant for any flunisolide metered-dose inhalers (see 75 FR 19213, April 14, 2010). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 355(e)) and 

under authority delegated to the 

Director, Center for Drug Evaluation and 

Research, by the Commissioner, 

approval of the applications listed in 

table 1 in this document, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective January 

5, 2015. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the FD&C Act (21 U.S.C. 331(a) 

and (d)). Drug products that are listed in 

Table 1 that are in inventory on the date 

that this notice becomes effective (see 

the DATES section) 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: December 1, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28541 Filed 12–4–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 72189 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than January 5, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Health Professions Student Loan (HPSL) 

Program and Nursing Student Loan 

(NSL) Program Administrative 

Requirements (Regulations and Policy). 

OMB No. 0915–0047—Extension. 

Abstract: The statutory authorities for 

the Health Professions Student Loan 

(HPSL) Program, as authorized by 

Public Health Service (PHS) Act 

sections 721–722, and 725–735, and the 

Nursing Student Loan (NSL) Program, as 

authorized by PHS Act sections 835– 

842, contain a number of recordkeeping 

and reporting requirements for 

academic institutions and loan 

applicants. The applicable regulations 

for these programs under 42 CFR part 57 

details the various requirements (see 

chart below). 

Need and Proposed Use of the 

Information: The requirements are 

essential for assuring that borrowers are 

aware of their rights and 

responsibilities, academic institutions 

have accurate records of the history and 

status of each loan account in order to 

pursue aggressive collection efforts to 

reduce default rates, and that academic 

institutions maintain adequate records 

for audit and assessment purposes to 

help the U.S. Department of Health and 

Human Services safeguard federal funds 

made through the Federal Capital 

Contribution (FCC). Academic 

institutions are free to use improved 

information technology to manage the 

information required by the regulations. 

Likely Respondents: Financial Aid 

Directors working at institutions 

participating in the HPSL and NSL 

Programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

RECORDKEEPING REQUIREMENTS

Regulatory/section requirements Number of 

record keepers Hours per year Total burden hours 

HPSL Program: 

57.206(b)(2), Documentation of Cost of Attendance ........................................................... 50 325 16,250 

57.208(a), Promissory Note ................................................................................................. 90 325 29,250 

57.210((b)(1)(i), Documentation of Entrance Interview ........................................................ 40 325 13,000 

57.210(b)(1)(ii), Documentation of Exit Interview ................................................................. 80 334 26,720

57.215(a)&(d), Program Records ......................................................................................... 140 334 46,760 

57.215(b), Student Records ................................................................................................. 70 334 23,380 

57.215(c), Repayment Records ........................................................................................... 150 334 50,100 

HPSL Subtotal ............................................................................................................... ........................ ........................ 205,460 

NSL Program: 

57.306(b)(2)(ii), Documentation of Cost of Attendance ....................................................... 16.0 282 4,512 

57.308(a), Promissory Note ................................................................................................. 4.5 282 1,269 

57.310(b)(1)(i), Documentation of Entrance Interview ......................................................... 1.5 282 423 

57.310(b)(1)(ii), Documentation of Exit Interview ................................................................. 1.5 348 522 

57.315(a)(1)&(a)(4), Program Records ................................................................................ 21.0 348 7,308 

57.315(a)(2), Student Records ............................................................................................. 8.5 348 2,958 

57.315(a)(3), Repayment Records ....................................................................................... 5.0 348 1,740 

NSL Subtotal ................................................................................................................. ........................ ........................ 18,732 

* Includes active and closing schools. 

HPSL data includes active and closing Loans for Disadvantaged Students (LDS) program schools. 

REPORTING REQUIREMENTS

Regulatory/section requirements Number of 

respondents 

Responses 

per 

respondent 

Total annual 

responses 

Hours per 

response 

Total hour 

burden 

HPSL Program: 

57.206(a)(2), Student Financial Aid Transcript ............ n/a ........................ ........................ ........................ ........................

57.208(c), Loan Information Disclosure ....................... 325 299.5 97,338 0.63 60,836 

57.210(b)(1)(i), Entrance Interview ............................... 325 139.5 45,338 0.50 22,669 

57.210(b)(1)(ii), Exit Interview ...................................... 334 113.5 37,909 1.00 37,909 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
72190 Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 

REPORTING REQUIREMENTS—Continued 

Regulatory/section requirements Number of 

respondents 

Responses 

per 

respondent 

Total annual 

responses 

Hours per 

response 

Total hour 

burden 

57.210(b)(1)(iii), Notification of Repayment .................. 334 862.5 288,075 0.38 108,028 

57.210(b)(1)(iv), Notification During Deferment ........... 334 17.0 5,678 0.63 3,549 

57.210(b)(1)(vi), Notification of Delinquent Accounts ... 334 172.5 57,615 1.25 72,019 

57.210(b)(1)(x), Credit Bureau Notification .................. 334 6 2,004 0.50 1,002 

57.210(b)(4)(i), Write-off of Uncollectible Loans .......... 5 1 5 3.00 15 

57.211(a) Disability Cancellation .................................. 3 1 3 1.00 3 

57.215(a)(2), Administrative Hearings .......................... 0 0 0 0 0 

57.215(a)(d), Administrative Hearings .......................... 0 0 0 0 0 

HPSL Subtotal ....................................................... ........................ ........................ ........................ ........................ 306,029 

NSL Program: 

57.306(a)(2), Student Financial Aid Transcript ............ ........................ ........................ ........................ ........................ ........................

57.310(b)(1)(i), Entrance Interview ............................... 282 17.5 4,935 0.42 2,048 

57.310(b)(1)(ii), Exit Interview ...................................... 348 9.0 3,132 0.42 1,300 

57.301(b)(1)(iii), Notification of Repayment .................. 348 9.0 3,132 0.27 830 

57.310(b)(1)(iv), Notification During Deferment ........... 348 1.5 522 0.29 151 

57.310(b)(1)(vi), Notification of Delinquent Accounts ... 348 42.5 14,790 0.04 592 

57.310(b)(1)(x), Credit Bureau Notification .................. 348 709.0 246,732 0.00 86 

57.310(b)(4)(i), Write-off of Uncollectible Loans .......... 23 1.0 23 3.00 69 

57.311(a), Disability Cancellation ................................. 16 1.0 16 1.00 16 

57.315(a)(1)(ii), Administrative Hearings ...................... 0 0 0 0 0 

57.316(a)(d), Administrative Hearings .......................... 0 0 0 0 0 

NSL Subtotal ......................................................... ........................ ........................ ........................ ........................ 5,092 

*Includes active and closing schools. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–28555 Filed 12–4–14; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

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 meetings. 

The meetings 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: National Cancer 

Institute Special Emphasis Panel; 

Outstanding Investigator Award 2. 

Date: March 24–26, 2015. 

Time: 6:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washingtonian 

Boulevard, Gaithersburg, MD 20878. 

Contact Person: Peter J. Wirth, Ph.D., 

Scientific Review Officer, Research Programs 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, 9609 

Medical Center Drive, Room 7W154, 

Rockville, MD 20850, 240–276–6434, pw2q@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Outstanding Investigator Award 1. 

Date: March 24–26, 2015. 

Time: 6:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washingtonian 

Boulevard, Gaithersburg, MD 20878. 

Contact Person: Michael B. Small, Ph.D., 

Chief, Program and Review Extramural Staff 

Training Office, Division of Extramural 

Activities, National Cancer Institute, 9609 

Medical Center Drive, Room 7W412, 

Rockville, MD 20850, 240–276–6438, 

smallm@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Outstanding Investigator Award 3. 

Date: March 24–26, 2015. 

Time: 6:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washingtonian 

Boulevard, Gaithersburg, MD 20878. 

Contact Person: Shamala K. Srinivas, 

Ph.D., Scientific Review Officer, Office of 

Referral, Review, and Program Coordination, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, 7W530, Rockville, MD 20850, 240– 

276–6442, ss537t@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http://

deainfo.nci.nih.gov/advisory/sep/sep.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: December 1, 2014. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–28530 Filed 12–4–14; 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 Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


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