5560 Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices 

in the Federal Register of December 8, 

2014. In the notice, FDA requested that 

any industry organizations interested in 

participating in the selection of a 

nonvoting industry representative to 

serve on the Food Advisory Committee 

(the Committee) for the Center for Food 

Safety and Applied Nutrition (CFSAN) 

notify FDA in writing. FDA is also 

requesting nominations for a nonvoting 

industry representative(s) to serve on 

the Committee. The Agency is taking 

this action in response to requests for an 

extension to allow interested persons 

additional time to submit letters of 

interests and nominations. 

DATES: FDA is extending the closing 

date in the notice published December 

8, 2014 (79 FR 72690). Any industry 

organization interested in participating 

in the selection of an appropriate 

nonvoting member to represent industry 

interests must send a letter stating that 

interest to FDA by February 27, 2015. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA by February 27, 2015. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nomination should be sent to Karen 

Strambler (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives may 

be submitted electronically by accessing 

the FDA Advisory Committee 

Membership Nomination Portal: https:// 

www.accessdata.fda.gov/scripts/

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site at http://www.

fda.gov/AdvisoryCommittees/

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Karen Strambler, Office of Regulations, 

Policy, and Social Science, Center for 

Food Safety and Applied Nutrition, 

5100 Paint Branch Pkwy., Rm. 1C–016, 

College Park, MD 20740, 240–402–2589, 

karen.strambler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

following advisory committee: 

I. CFSAN Advisory Committee, Food 

Advisory Committee 

The Committee reviews and evaluates 

emerging food safety, nutrition and 

other food- or cosmetic-related health 

issues that FDA considers of primary 

importance for its food and cosmetics 

programs. The Committee may be 

charged with reviewing and evaluating 

available data and making 

recommendations on matters such as 

those relating to: (1) Broad scientific and 

technical food- or cosmetic-related 

issues; (2) the safety of food ingredients 

and new foods; (3) labeling of foods and 

cosmetics; (4) nutrient needs and 

nutritional adequacy; and (5) safe 

exposure limits for food contaminants. 

The Committee may also be asked to 

provide advice and make 

recommendations on ways of 

communicating to the public the 

potential risks associated with these 

issues and on approaches that might be 

considered for addressing the issues. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current curriculum vitae. The 

letter will also state that it is the 

responsibility of the interested 

organizations to confer with one another 

and to select a candidate, within 60 

days after the receipt of the FDA letter, 

to serve as the nonvoting member to 

represent industry interests for the 

committee. The interested organizations 

are not bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

III. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, a current curriculum vitae, 

and the name of the committee of 

interest should be sent to the FDA 

Advisory Committee Membership 

Nomination Portal (see ADDRESSES) 

within 30 days of publication of this 

document (see DATES). FDA will forward 

all nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA seeks to include the views of 

women, and men, members of all racial 

and ethnic groups and individuals with 

and without disabilities on its advisory 

committees and, therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: January 26, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01881 Filed 1–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0175] 

Determination That LYMPHAZURIN 

(Isosulfan Blue) Injectable and Other 

Drug Products Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that the drug products listed 

in this document were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Amy Hopkins, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6223, 

Silver Spring, MD 20993–0002, 301– 

796–5418, Amy.Hopkins@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

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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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