20230 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1—Continued 

CVM Guidance for industry #171 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Same API/solubility approach .............................................. 10 10 10 20 200 

Total .............................................................................. ........................ ........................ ........................ ........................ 210 

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

Dated: April 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08635 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2347] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 15, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Food and Cosmetic Export 

Certificate Application Process (21 

U.S.C. 381(e)).’’ Also include the FDA 

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 Road; COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20231 

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. 

In the Federal Register of January 9, 

2015 (80 FR 1422), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. We received four 

comments in response to the notice. The 

comments generally supported the 

necessity and practical utility of the 

information collected during the export 

certificate application process for food, 

however no comments were received 

regarding the export certificate 

application process for cosmetics. Our 

responses to the comments are 

discussed below. 

One comment had concerns about our 

request for the manufacturer’s (and 

exporter’s, if different from 

manufacturer) state license or 

registration number on Form FDA 

3613e, stating that doing so could allow 

third parties unnecessary and/or 

unauthorized access to confidential 

commercial information. We appreciate 

this comment and note that we do not 

place the firm’s state license or 

registration numbers on the certificates 

we issue. In addition, confidential 

commercial information is protected 

from disclosure under the Freedom of 

Information Act under sections 552(a) 

and (b) (5 U.S.C. 552(a) and (b)), and 

under our regulations at 21 CFR part 20. 

At the same time, the state license or 

registration number is necessary for our 

review of the application. We verify the 

license or registration and investigate 

inspection data on the listed products. 

One comment suggested ways we 

might modify the electronic submission 

system, including expanding the 

number of characters that may be 

entered per data field; developing 

corporate identification numbers and 

passwords, permitting a product label to 

be submitted electronically through the 

CFSAN Certificate Application Process; 

and, permitting a submitter to pay the 

application fees electronically within 

the CFSAN Certificate Application 

Process. Similarly, another comment 

discussed possible changes to the 

content of the Export Certificates or the 

Certificates of Free Sale that we issue for 

food, including incorporating 

pagination to indicate the number of 

sequential pages that would be part of 

the certificate; adding statements that 

the product is fit for human 

consumption, may be freely sold or 

exported in the United States, and, is 

produced in a manner consistent with 

good manufacturing practice; and 

providing the applicant the ability to 

request the type of certificate referenced 

on the header of the document and to 

request additional services, such as a 

notarized certificate document or 

expedited processing. While we are not 

able to accommodate the suggested 

modifications at this time, we will 

consider them as we contemplate future 

revisions to the relevant forms and 

solicit additional comments at that time 

through a notice published in the 

Federal Register. 

Finally, one comment was received 

that did not respond to any of the four 

information collection topics solicited 

and is therefore not addressed by the 

Agency. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Category FDA form No.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, & 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. 

2Forms FDA 3613d and 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: March 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08617 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 


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