80 FR 20230 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 72 (April 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 72 (April 15, 2015)
| Page Range | 20230-20231 | |
| FR Document | 2015-08617 |
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)] [Notices] [Pages 20230-20231] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08617] ----------------------------------------------------------------------- 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 [email protected]. 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 [email protected]. 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 ``product-specific''); 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 [[Page 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average Category FDA form Number of responses per Total annual burden per Total hours No.\2\ respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- 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, 3613e 2,129 4 2,129 1.5 3,194 Infant Formula, & Medical Foods........................ Food Additives and Food Contact Substances.............. 3613e 167 1 167 1.5 251 ----------------------------------------------------------------------------------------------- Total............................................... .............. .............. .............. .............. .............. 4,942 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no operating and maintenance costs associated with this collection of information. \2\ Forms 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
![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
Number of Average
Number of Total annual
CVM Guidance for industry #171 responses per burden per Total hours
respondents responses
respondent response
Same API/solubility approach .............................................. 10 10 10 20 200
Total .............................................................................. ........................ ........................ ........................ ........................ 210
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 8, 2015. has submitted the following proposed FDA 3613d and FDA 3613e and the
Leslie Kux, collection of information to OMB for CFSAN Certificate Application Process
Associate Commissioner for Policy. review and clearance. approved under OMB control number
[FR Doc. 2015–08635 Filed 4–14–15; 8:45 am] 0910–0498.
Food and Cosmetic Export Certificate
BILLING CODE 4164–01–P We request the following information
Application Process (21 U.S.C. 381(e))
on Form FDA 3613d and the CFSAN
(OMB Control Number 0910–NEW)
Certificate Application Process, as
DEPARTMENT OF HEALTH AND Some foreign countries require currently approved by OMB: The name
HUMAN SERVICES manufacturers of FDA-regulated of and contact information for the
products to provide an export certificate requester; the name of and contact
Food and Drug Administration for the products they wish to export to information for the exporting company
[Docket No. FDA–2014–N–2347] that country. A Certificate of Free Sale (if different from requester); a
is a certificate (not pertaining to a designation of the type of certificate
Agency Information Collection particular production lot or export requested (‘‘general’’ or ‘‘product-
Activities; Submission for Office of consignment) that indicates that the specific’’); if product-specific, a list of
Management and Budget Review; particular product is marketed in the the exact brand names of the products;
Comment Request; Food and United States or eligible for export, and the contact person, company name and
Cosmetic Export Certificate that the particular manufacturer has no address where the requested certificate
Application Process unresolved enforcement actions should be sent; and, the name and
pending before or taken by FDA. FDA’s account number (if applicable) of the
AGENCY: Food and Drug Administration, Center for Food Safety and Applied requester’s preferred carrier for delivery
HHS. Nutrition (CFSAN) issues such of the certificate. Finally, Form FDA
ACTION: Notice. certificates for food, food additives, 3613d and the CFSAN Certificate
SUMMARY: The Food and Drug seafood, dietary supplements, and Application Process requires the
Administration (FDA) is announcing cosmetics. Interested persons may requester’s signature, the name and title
that a proposed collection of request a certificate by using the of the person signing the form, as well
information has been submitted to the electronic CFSAN Certificate as the date signed.
Office of Management and Budget Application Process, which is part of We request the following information
(OMB) for review and clearance under FDA Unified Registration and Listing on Form FDA 3613e and the CFSAN
the Paperwork Reduction Act of 1995. System, or by submitting a paper Form Certificate Application Process, as
DATES: Fax written comments on the
FDA 3613d for cosmetic products or a currently approved by OMB: The name
collection of information by May 15, paper Form FDA 3613e for food of and contact information for the
2015. products. We use the information manufacturer, as well as the
submitted to determine whether to issue manufacturer’s state license or
ADDRESSES: To ensure that comments on the requested certificate. registration number; the name of and
the information collection are received, OMB has approved the submission of contact information for the exporting
OMB recommends that written requests for export certificates on paper company (if different from
comments be faxed to the Office of Forms FDA 3613d and FDA 3613e and, manufacturer), as well as the exporting
Information and Regulatory Affairs, electronically, via the CFSAN Certificate company’s state license or registration
OMB, Attn: FDA Desk Officer, FAX: Application Process under OMB control number; a description of the shipment
202–395–7285, or emailed to oira_ number 0910–0498. This notice including the product, the common
submission@omb.eop.gov. All announces that, to ensure the efficient name, the manufacturer, and a
comments should be identified with the review of the information collection by description or additional comments; the
OMB control number 0910–NEW and OMB under the PRA, we are seeking to name of the country to which the
title ‘‘Food and Cosmetic Export obtain a new OMB Control Number for requester of the certificate intends to
Certificate Application Process (21 Forms FDA 3613d and FDA 3613e and ship the product; the contact person,
U.S.C. 381(e)).’’ Also include the FDA the CFSAN Certificate Application firm name and address where the
docket number found in brackets in the Process to reflect that the electronic requested certificate should be sent;
heading of this document. submission system for food and and, the name and account number (if
FOR FURTHER INFORMATION CONTACT: FDA cosmetic export certificates is separate applicable) of the requester’s preferred
PRA Staff, Office of Operations, Food
tkelley on DSK3SPTVN1PROD with NOTICES
from the electronic submission system carrier for delivery of the certificate.
and Drug Administration, 8455 associated with export certificates for Form FDA 3613e and the CFSAN
Colesville Road; COLE–14526, Silver other FDA-regulated products approved Certificate Application Process requires
Spring, MD 20993–0002 PRAStaff@ under OMB control number 0910–0498. the requestor to submit an original or
fda.hhs.gov. Upon OMB approval of this information copy of the applicable product label or
SUPPLEMENTARY INFORMATION: In collection request, we will adjust the labels. Finally, Form FDA 3613e and the
compliance with 44 U.S.C. 3507, FDA burden hours associated with Forms CFSAN Certificate Application Process
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![Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20231
requires the submitter’s signature, the unauthorized access to confidential Certificates of Free Sale that we issue for
name and title of the person signing the commercial information. We appreciate food, including incorporating
form, as well as the date signed. this comment and note that we do not pagination to indicate the number of
Description of Respondents: The place the firm’s state license or sequential pages that would be part of
respondents to this collection of registration numbers on the certificates the certificate; adding statements that
information are firms interested in we issue. In addition, confidential the product is fit for human
exporting U.S.-manufactured food and commercial information is protected consumption, may be freely sold or
cosmetic products to foreign countries from disclosure under the Freedom of exported in the United States, and, is
that require export certificates. Information Act under sections 552(a) produced in a manner consistent with
In the Federal Register of January 9, and (b) (5 U.S.C. 552(a) and (b)), and good manufacturing practice; and
2015 (80 FR 1422), FDA published a 60- under our regulations at 21 CFR part 20. providing the applicant the ability to
day notice requesting public comment At the same time, the state license or request the type of certificate referenced
on the proposed collection of registration number is necessary for our on the header of the document and to
information. We received four review of the application. We verify the request additional services, such as a
comments in response to the notice. The license or registration and investigate notarized certificate document or
comments generally supported the inspection data on the listed products. expedited processing. While we are not
necessity and practical utility of the One comment suggested ways we able to accommodate the suggested
information collected during the export might modify the electronic submission modifications at this time, we will
certificate application process for food, system, including expanding the consider them as we contemplate future
however no comments were received number of characters that may be revisions to the relevant forms and
regarding the export certificate entered per data field; developing solicit additional comments at that time
application process for cosmetics. Our corporate identification numbers and through a notice published in the
responses to the comments are passwords, permitting a product label to Federal Register.
discussed below. be submitted electronically through the
One comment had concerns about our CFSAN Certificate Application Process; Finally, one comment was received
request for the manufacturer’s (and and, permitting a submitter to pay the that did not respond to any of the four
exporter’s, if different from application fees electronically within information collection topics solicited
manufacturer) state license or the CFSAN Certificate Application and is therefore not addressed by the
registration number on Form FDA Process. Similarly, another comment Agency.
3613e, stating that doing so could allow discussed possible changes to the FDA estimates the burden of this
third parties unnecessary and/or content of the Export Certificates or the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Category FDA form No.2 responses per burden per Total hours
respondents responses
respondent response
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 Sub-
stances ................................................. 3613e 167 1 167 1.5 251
Total .................................................. ........................ ........................ ........................ ........................ ........................ 4,942
1 There are no operating and maintenance costs associated with this collection of information.
2 Forms FDA 3613d and FDA 3613e may be submitted electronically via the Certificate Application Process.
For the purpose of this information We expect that most if not all firms Dated: March 8, 2015.
collection request, we are basing our requesting export certificates in the next Leslie Kux,
estimate of the average burden per 3 years will choose to take advantage of Associate Commissioner for Policy.
response in column 6 of table 1 on the the option of electronic submission via [FR Doc. 2015–08617 Filed 4–14–15; 8:45 am]
estimates previously submitted to and the CFSAN Certificate Application
BILLING CODE 4164–01–P
approved by OMB under control Process. Thus, our burden estimates in
number 0910–0498. Our estimate of the table 1 are based on the expectation of
average burden per response in column 100 percent participation in the
6 of table 1 varies according to the electronic submission process. The
product category for which the opportunity to provide the information
certificate is requested. We base our in electronic format could reduce the
estimates of the total annual responses Agency’s previous estimates for the time
tkelley on DSK3SPTVN1PROD with NOTICES
in column 5 of table 1 on our experience to prepare each submission. However,
with certificate applications received in as a conservative approach for the
the past 2 fiscal years. Some purpose of this analysis, we are
respondents send in requests as often as assuming that the opportunity to submit
three or four times a month while others the information in electronic format will
may submit only periodic requests. have no effect on the average time to
prepare a submission.
VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/80_FR_20302/page/2.svg)
Document Created: 2015-12-18 11:13:30
Document Modified: 2015-12-18 11:13:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 15, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver Spring, MD 20993-0002 [email protected] | |
| FR Citation | 80 FR 20230 |
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