2021-14650. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificates

AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or we) 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:

Submit written comments (including recommendations) on the collection of information by August 9, 2021.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0793. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [e-mail].

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 Certificates

OMB Control Number 0910-0793—Extension

Some countries may require manufacturers of FDA-regulated products to provide certificates for products they wish to export to that country. Accordingly, firms exporting products from the United States often ask FDA to provide such a “certificate.” In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States, or that they meet specific U.S. requirements. In some cases, review of an FDA export certificate may be required as part of the process to register or import a product into another country. An export certificate generally indicates that the particular product is marketed in the United States or otherwise 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 export certificates for human food and cosmetic products. Interested persons may request a certificate electronically via the CFSAN Export Certification Application and Tracking System (CFSAN eCATS) or Certificate Application Process (CAP), components of the FDA Industry Systems, or by contacting CFSAN for assistance. Health certificates are the exception and are requested via email. To facilitate the application process, we have eliminated paper-based forms. For food products, respondents are able to identify facilities using their Food Facility Registration, an FDA Establishment Identifier number, or a Data Universal Numbering System number. The system uses these identifiers to locate and auto-populate name and address information, eliminating the need for users to manually enter this information and reducing the time to complete the application. For some applications, respondents can also upload product information via a spreadsheet, which reduces the time needed to enter product information, particularly for applications that include multiple products.

All information is entered using electronic Forms FDA 3613d, 3613e, and 3613k and used to evaluate certificate requests. The eCATS Module is Form FDA 3613k, where Form FDA 3613e is the Certificate of Free Sale (https://www.fda.gov/​food/​food-export-certificates/​online-applications-export-certificates-food). All “forms” are electronic and part of the eCATS or CAP portal accessed via https://www.access.fda.gov. To view representations of the forms, you have to download the instructions, which are accessible from the following links: https://www.fda.gov/​cosmetics/​cosmetics-exporters/​online-applications-export-certificates-cosmetics and https://www.fda.gov/​food/​food-export-certificates/​online-applications-export-certificates-food.

While burden associated with information collection activities for export certificates issued for other FDA-regulated products is approved under OMB control number 0910-0498, this collection specifically supports export certificates issued by CFSAN. Also, because we have eliminated paper-based forms, respondents who require assistance with completing export certificate applications online may contact CFSAN directly by email ([e-mail]) or telephone [phone]). Instructions for requesting export certificates for cosmetics (Form FDA 3613d) are available online at https://www.fda.gov/​cosmetics/​cosmetics-exporters/​online-applications-export-certificates-cosmetics and instructions for requesting export certificates for food (Forms FDA 3613e and 3613k) are available online at https://www.fda.gov/​food/​food-export-certificates/​online-applications-export-certificates-food.

Description of Respondents: The respondents to this collection of information are firms interested in exporting U.S.-manufactured human food and cosmetic products to foreign countries that require export certificates.

In the Federal Register of March 16, 2021 (86 FR 14452), we published a 60-day notice requesting public comment on the proposed collection of information. We received one comment offering general support for our cosmetic export certificate program. The comment also recommended FDA consider providing certificates that allow exporters to use an exemption from requirements in China for animal testing for certain imported cosmetic products. We appreciate the comment and continue to seek ways to increase the utility of the information collection as our limited resources permit. At the same time, the comment did not suggest we revise the burden we attribute to the associated information collection activity.

We estimate the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

Type of respondent	Form No. 2	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response (in hours)	Total hours
Cosmetics	FDA 3613d	113	3	339	0.5 (30 minutes)	170
Food	FDA 3613e, 3613k	468	9	4,212	0.5 (30 minutes)	2,106
Total						2,276
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 All forms are submitted electronically via FDA Industry Systems.

Based on a review of the information collection since our last OMB approval, we have reduced our burden estimate. The burden estimate has been lowered due to a reduced number of respondents. We base our estimates on our experience with certificate applications received in the past 3 fiscal years.

Dated: July 2, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.