Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices 5561 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved, (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved, and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for safety or 

effectiveness reasons, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicants, FDA 

withdrew approval of NDA 018310 for 

LYMPHAZURIN (isosulfan blue) 

Injectable in the Federal Register of 

December 5, 2014 (79 FR 72186) and 

NDA 020151 for EFFEXOR (venlafaxine 

HCl) Tablets in the Federal Register of 

July 19, 2013 (78 FR 43210).) 

Application No. Drug Applicant 

NDA 018310 ................. LYMPHAZURIN (isosulfan blue) Injectable; Injection, 1% Covidien, 60 Middletown Ave., North Haven, CT 06473. 

NDA 019966 ................. TEMOVATE (clobetasol propionate) Solution; Topical, 

0.05%.

Fougera Pharmaceuticals Inc., 1 Health Plaza, Bldg. 434, 

East Hanover, NJ 07936. 

NDA 020151 ................. EFFEXOR (venlafaxine hydrochloride (HCl)) Tablet; Oral, 

Equivalent to (EQ) 12.5 milligram (mg) Base; EQ 25 

mg Base; EQ 37.5 mg Base; EQ 50 mg Base; EQ 75 

mg Base; EQ 100 mg Base.

Wyeth Pharmaceuticals Inc., 235 East 42nd St., New 

York, NY 10017. 

NDA 020214 ................. ZEMURON (rocuronium bromide) Injectable; Injection 100 

mg/10 milliliter (mL); 50 mg/5 mL; 10 mg/mL.

Organon USA Inc., 351 North Sunmeytown Pike, North 

Wales, PA 19454. 

NDA 021040 ................. PREFEST (estradiol; norgestimate) Tablet; Oral, 1 mg, 1 

mg/0.09 mg.

Teva Branded Pharmaceutical Products R&D, Inc., 41 

Moores Rd., P.O. Box 4011, Frazer, PA 19355. 

NDA 021621 ................. CHILDREN’S ZYRTEC ALLERGY (cetirizine HCl) and 

CHILDREN’S ZYRTEC HIVES RELIEF (cetirizine HCl) 

Chewable Tablet; Oral, 5 mg; 10 mg.

McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort 

Washington, PA 19034. 

NDA 050783 ................. PERIOSTAT (doxycycline hyclate) Tablet; Oral, EQ 20 

mg Base.

Galderma Laboratories, L.P., 14501 North Freeway, Fort 

Worth, TX 76177. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the Agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs listed in this document are 

unaffected by the discontinued 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the Agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: January 26, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01859 Filed 1–30–15; 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 

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 March 4, 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: 

Evaluation and Initial Assessment of the 

HRSA Teaching Health Centers 

Graduate Medical Education Program. 

OMB No. 0906–xxxx—New. 

Abstract: Section 5508 of the 

Affordable Care Act of 2010 amended 

section 340H of the Public Health 

Service Act to establish the Teaching 

Health Center Graduate Medical 

Education (THCGME) program to 

provide funding support for new and 

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5562 Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices 

the expansion of existing primary care 

residency training programs in 

community-based settings. The primary 

goals of this program are to increase the 

production of primary care providers 

who are better prepared to practice in 

community settings, particularly with 

underserved populations, and improve 

the geographic distribution of primary 

care providers. 

Statute requires the Secretary to 

determine an appropriate THCGME 

program payment for indirect medical 

expenses (IME) as well as to update, as 

deemed appropriate, the per resident 

amount used to determine the Program’s 

payment for direct medical expenses 

(DME). To inform these determinations 

and to increase understanding of this 

model of residency training, the George 

Washington University (GW) is 

conducting an evaluation of the costs 

associated with training residents in the 

Teaching Health Center (THC) model. 

GW has developed a standardized 

costing instrument to gather data from 

all THCGME programs. The information 

gathered in the standardized costing 

instrument includes, but is not limited 

to, resident and faculty full-time 

equivalents, salaries and benefits, 

residency administration costs, 

educational costs, residency clinical 

operations and administrative costs, and 

patient visits and clinical revenue 

generated by medical residents. 

Need and Proposed Use of the 

Information: HRSA is collecting costing 

information related to both DME and 

IME in an effort to establish a THC’s 

total cost of running a residency 

program, to assist the Secretary in 

determining an appropriate update to 

the per resident amount used to 

calculate the payment for DME and an 

appropriate IME payment. The 

described data collection activities will 

serve to inform these statutory 

requirements for the Secretary in a 

uniform and consistent manner. 

Likely Respondents: THCGME 

grantees. 

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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Teaching Health Center Costing Instrument ....................... 60 1 60 10 600 

Total .............................................................................. 60 1 60 10 600 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–01882 Filed 1–30–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

[CFDA Number: 93.164] 

Loan Repayment Program for 

Repayment of Health Professions 

Educational Loans Announcement 

Type: Initial 

DATES: Key Dates: February 13, 2015 

first award cycle deadline date; August 

14, 2015 last award cycle deadline date; 

September 11, 2015 last award cycle 

deadline date for supplemental loan 

repayment program funds; September 

30, 2015 entry on duty deadline date. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

estimated budget request for Fiscal Year 

(FY) 2015 includes $16,721,135 for the 

IHS Loan Repayment Program (LRP) for 

health professional educational loans 

(undergraduate and graduate) in return 

for full-time clinical service as defined 

in the IHS LRP policy clarifications at 

http://www.ihs.gov/loanrepayment/

documents/LRP_Policy_Updates.pdf in 

Indian health programs. 

This program announcement is 

subject to the appropriation of funds. 

This notice is being published early to 

coincide with the recruitment activity of 

the IHS which competes with other 

Government and private health 

management organizations to employ 

qualified health professionals. 

This program is authorized by the 

Indian Health Care Improvement Act 

(IHCIA) Section 108, codified at 25 

U.S.C. 1616a. 

II. Award Information 

The estimated amount available is 

approximately $16,721,135 to support 

approximately 387 competing awards 

averaging $43,182 per award for a two 

year contract. One year contract 

extensions will receive priority 

consideration in any award cycle. 

Applicants selected for participation in 

the FY 2015 program cycle will be 

expected to begin their service period 

no later than September 30, 2015. 

III. Eligibility Information 

A. Eligible Applicants 

Pursuant to 25 U.S.C. 1616(b), to be 

eligible to participate in the LRP, an 

individual must: 

(1)(A) Be enrolled — 

(i) In a course of study or program in an 

accredited institution, as determined by the 

Secretary, within any State and be scheduled 

to complete such course of study in the same 

year such individual applies to participate in 

such program; or 

(ii) In an approved graduate training 

program in a health profession; or 

(B) Have a degree in a health profession 

and a license to practice in a State; and 

(2)(A) Be eligible for, or hold an 

appointment as a commissioned officer in the 

Regular Corps of the Public Health Service 

(PHS); or 

(B) Be eligible for selection for service in 

the Regular Corps of the PHS; or 

(C) Meet the professional standards for 

civil service employment in the IHS; or 

(D) Be employed in an Indian health 

program without service obligation; and 

(E) Submit to the Secretary an application 

for a contract to the LRP. The Secretary must 

approve the contract before the disbursement 

of loan repayments can be made to the 

participant. Participants will be required to 

fulfill their contract service agreements 

through full-time clinical practice at an 

Indian health program site determined by the 

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