Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 1423 

requires the submitter’s signature, the 

name and title of the person signing the 

form, as well as the date signed. 

Description of Respondents: The 

respondents to this collection of 

information are firms interested in 

exporting U.S.-manufactured food and 

cosmetic products to foreign countries 

that require export certificates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent FDA form 

number 2

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Cosmetics ................................................ 3613d 600 1 600 1.5 900 

Conventional Food (Including Seafood) .. 3613e 398 1 398 1.5 597 

Dietary Supplements, Food for Special 

Dietary Use, Infant Formula, and Medical Foods ............................................. 3613e 2,129 4 2,129 1.5 3,194 

Food Additives and Food Contact Substances ................................................. 3613e 167 1 167 1.5 251 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 4,942 

1There are no operating and maintenance costs associated with this collection of information. 

2Form FDA 3613d and Form FDA 3613e may be submitted electronically via the Certificate Application Process. 

For the purpose of this information 

collection request, we are basing our 

estimate of the average burden per 

response in column 6 of Table 1 on the 

estimates previously submitted to and 

approved by OMB under control 

number 0910–0498. Our estimate of the 

average burden per response in column 

6 of Table 1 varies according to the 

product category for which the 

certificate is requested. We base our 

estimates of the total annual responses 

in column 5 of Table 1 on our 

experience with certificate applications 

received in the past 2 fiscal years. Some 

respondents send in requests as often as 

three or four times a month while others 

may submit only periodic requests. 

We expect that most if not all firms 

requesting export certificates in the next 

3 years will choose to take advantage of 

the option of electronic submission via 

the CFSAN Certificate Application 

Process. Thus, our burden estimates in 

Table 1 are based on the expectation of 

100 percent participation in the 

electronic submission process. The 

opportunity to provide the information 

in electronic format could reduce the 

Agency’s previous estimates for the time 

to prepare each submission. However, 

as a conservative approach for the 

purpose of this analysis, we are 

assuming that the opportunity to submit 

the information in electronic format will 

have no effect on the average time to 

prepare a submission. 

Dated: January 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00130 Filed 1–8–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2258] 

Determination That TAGAMET 

(Cimetidine) Tablets 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) 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 

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. 


rljohnson on DSK3VPTVN1PROD with NOTICES
1424 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 

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 017920 for 

TAGAMET (cimetidine) Tablets in the 

Federal Register of June 8, 2011 (76 FR 

33310), and NDA 018709 for CAPOZIDE 

(captopril and hydrochlorothiazide) 

Tablets in the Federal Register of March 

19, 2012 (77 FR 16039).) 

Application No. Drug Applicant 

NDA 017920 ...... TAGAMET (cimetidine) Tablet; Oral, 200 milligram (mg); 300 

mg; 400 mg; 800 mg.

GlaxoSmithKline, 5 Moore Dr., P.O. Box 13398, Research 

Triangle Park, NC 27709. 

NDA 018155 ...... OPTICROM (cromolyn sodium) Solution/Drops; Ophthalmic, 

4%.

Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623. 

NDA 018709 ...... CAPOZIDE (captopril and hydrochlorothiazide) Tablet; Oral, 

25 mg/15 mg; 25 mg/25 mg; 50 mg/15 mg; 50 mg/25 mg.

Apothecon Inc., P.O. Box 4500, Princeton, NJ 08543. 

NDA 018976 ...... LEVATOL (penbutolol sulfate) Tablet; Oral, 10 mg; 20 mg .... Auxilium Pharmaceuticals LLC, 640 Lee Rd., Chesterbrook, 

PA 19087. 

NDA 019958 ...... CUTIVATE (fluticasone propionate) Cream; Topical, 0.05% .. Fougera Pharmaceuticals Inc., 1 Health Plaza, Bldg. 434, 

East Hanover, NJ 07936. 

NDA 020713 ...... MIRCETTE (desogestrel and ethinyl estradiol, and ethinyl estradiol) Tablet; Oral-28, 0.15 mg/0.02 mg; 0.01 mg.Teva Pharmaceutical Products Inc., 41 Moores Rd, P.O. Box 

4011, Frazer, PA 19355. 

NDA 021410 ...... AVANDAMET (metformin hydrochloride (HCl) and 

rosiglitazone maleate) Tablet; Oral, 500 mg/Equivalent to 1 

mg Base.

SmithKline Beecham Cork Ltd., Ireland, 2301 Renaissance 

Blvd., MC RN 0420, King of Prussia, PA 19406. 

NDA 021571 ...... IQUIX (levofloxacin) Solution/Drops; Ophthalmic, 1.5% .......... Santen Inc., 555 Gateway Dr., Napa, CA 94558. 

NDA 021726 ...... NIRAVAM (alprazolam) Orally Disintegrating Tablets; Oral, 

0.25 mg; 0.5 mg; 1 mg; 2 mg.

UCB Inc., 1950 Lake Park Dr., Smyrna, GA 30080. 

NDA 021768 ...... FLUDEOXYGLUCLOSE F–18 Injectable; Intravenous 10–100 

millicuries/milliliter.

Weill Medical College Cornell University, 516 East 72nd St., 

New York, NY 10065. 

ANDA 076699 .... PARCOPA (carbidopa and levodopa) Orally Disintegrating 

Tablets; Oral, 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 

mg.

UCB Inc., 1950 Lake Park Dr., Smyrna, GA 30080. 

ANDA 080248 .... ALBALON (naphazoline HCl) Solution/Drops; Ophthalmic, 

0.1%.

Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623. 

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 and ANDAs listed in this 

document are unaffected by the 

discontinued marketing of the products 

subject to those NDAs and ANDAs. 

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 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00116 Filed 1–8–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1021] 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web Site Location of Fiscal Year 2015 

Proposed Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the Web site location where 

the Agency will post two lists of 

guidance documents that the Center for 

Devices and Radiological Health (CDRH 

or the Center) is intending to publish in 

Fiscal Year (FY) 2015. In addition, FDA 

has established a docket, identified in 

brackets in the heading of this 

document, where stakeholders may 

comment on the priority of topics for 

guidance, provide comments and/or 

propose draft language for those topics, 

suggest topics for new or different 

guidance documents, and comment on 

the applicability of guidance documents 

that have issued previously. 

DATES: You may submit either electronic 

or written comments at any time. FDA 

would appreciate if stakeholders 

provide feedback by March 10, 2015. 

ADDRESSES: Submit electronic 

comments on the proposed guidance to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gadiock, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5452, Silver Spring, 

MD 20993–0002, 301–796–5736. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the Medical 

Device User Fee Amendments of 2012 

(MDUFA III), title II, Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–114), FDA agreed, in 

return for additional funding from 

industry, to meet a variety of 

quantitative and qualitative goals 

intended to help get safe and effective 

medical devices to market more quickly. 

These commitments included: 

• Annually posting a list of priority 

medical device guidance documents 

that the Agency intends to publish 

within 12 months of the date this list is 

published each fiscal year (the ‘‘A-list’’) 

and 


rljohnson on DSK3VPTVN1PROD with NOTICES