1422 Federal Register / Vol. 80, No. 6 / Friday, January 9, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2347] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and 

Cosmetic Export Certificate 

Application Process 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice invites comments on 

the information collection provisions 

associated with export certificate 

applications for FDA regulated food and 

cosmetic products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 10, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Food and Cosmetic Export Certificate 

Application Process (21 U.S.C. 381(e)) 

(OMB Control Number 0910–NEW) 

Some foreign countries require 

manufacturers of FDA regulated 

products to provide an export certificate 

for the products they wish to export to 

that country. A Certificate of Free Sale 

is a certificate (not pertaining to a 

particular production lot or export 

consignment) that indicates that the 

particular product is marketed in the 

United States or eligible for export, and 

that the particular manufacturer has no 

unresolved enforcement actions 

pending before or taken by FDA. FDA’s 

Center for Food Safety and Applied 

Nutrition (CFSAN) issues such 

certificates for food, food additives, 

seafood, dietary supplements, and 

cosmetics. Interested persons may 

request a certificate by using the 

electronic CFSAN Certificate 

Application Process, which is part of 

FDA Unified Registration and Listing 

System, or by submitting a paper Form 

FDA 3613d for cosmetic products or a 

paper Form FDA 3613e for food 

products. We use the information 

submitted to determine whether to issue 

the requested certificate. 

OMB has approved the submission of 

requests for export certificates on paper 

Forms FDA 3613d and FDA 3613e and, 

electronically, via the CFSAN Certificate 

Application Process under OMB control 

number 0910–0498. This notice 

announces that, to ensure the efficient 

review of the information collection by 

OMB under the PRA, we are seeking to 

obtain a new OMB control number for 

Forms FDA 3613d and FDA 3613e and 

the CFSAN Certificate Application 

Process to reflect that the electronic 

submission system for food and 

cosmetic export certificates is separate 

from the electronic submission system 

associated with export certificates for 

other FDA regulated products approved 

under OMB control number 0910–0498. 

Upon OMB approval of this information 

collection request, we will adjust the 

burden hours associated with Forms 

FDA 3613d and FDA 3613e and the 

CFSAN Certificate Application Process 

approved under OMB control number 

0910–0498. 

We request the following information 

on Form FDA 3613d and the CFSAN 

Certificate Application Process, as 

currently approved by OMB: The name 

of and contact information for the 

requester; the name of and contact 

information for the exporting company 

(if different from requester); a 

designation of the type of certificate 

requested (‘‘general’’ or ‘‘productspecific’’); if product-specific, a list of 

the exact brand names of the products; 

the contact person, company name and 

address where the requested certificate 

should be sent; and, the name and 

account number (if applicable) of the 

requester’s preferred carrier for delivery 

of the certificate. Finally, Form FDA 

3613d and the CFSAN Certificate 

Application Process requires the 

requester’s signature, the name and title 

of the person signing the form, as well 

as the date signed. 

We request the following information 

on Form FDA 3613e and the CFSAN 

Certificate Application Process, as 

currently approved by OMB: The name 

of and contact information for the 

manufacturer, as well as the 

manufacturer’s state license or 

registration number; the name of and 

contact information for the exporting 

company (if different from 

manufacturer), as well as the exporting 

company’s state license or registration 

number; a description of the shipment 

including the product, the common 

name, the manufacturer, and a 

description or additional comments; the 

name of the country to which the 

requester of the certificate intends to 

ship the product; the contact person, 

firm name and address where the 

requested certificate should be sent; 

and, the name and account number (if 

applicable) of the requester’s preferred 

carrier for delivery of the certificate. 

Form FDA 3613e and the CFSAN 

Certificate Application Process requires 

the requestor to submit an original or 

copy of the applicable product label or 

labels. Finally, Form FDA 3613e and the 

CFSAN Certificate Application Process 


rljohnson on DSK3VPTVN1PROD with NOTICES
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