0793 CFSAN Export Certs SSA 2018 Rev

U.S. Food and Drug Administration
Food and Cosmetic Export Certificate Applications Process
OMB Control Number 0910-0793
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides that the Food and
Drug Administration (FDA, us or we) shall, upon request, issue certificates for FDAregulated products that either meet applicable requirements and may be legally marketed in
the United States, or may be legally exported under the FD&C Act although they may not be
legally marketed in the United States. While the FD&C Act does not require FDA to issue
certificates for food, including animal feeds, food and feed additives, and dietary
supplements, or cosmetics, foreign governments may require certificates for these types of
products and the agency intends to provide this service as resources permit.
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 Certificates of Free Sale for food, food additives,
seafood, dietary supplements, and cosmetics.
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.
CFSAN issues export certificates for food and cosmetic products. Interested persons may
request a certificate via an electronic system, a component of the FDA Unified Registration
and Listing System (FURLS), or by contacting CFSAN for assistance. To facilitate the
application process, FDA has eliminated paper-based forms. For food products, FDA has
expanded the electronic options for providing facility and product information. Respondents
will now be able to identify facilities based on a food facility registration number, FDA
Establishment Identification (FEI) number, or Data Universal Numbering System (DUNS)
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. 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.
We therefore request approval for the information collection supporting FDA’s Food and
Cosmetic Export Certificate program and included in associated electronic Forms FDA
3613d, FDA 3613e, FDA 3613g, and FDA 3613k.
2. Purpose and Use of the Information Collection
We use the information provided in the applicable forms to determine whether certificates
may be issued. Interested persons may request a certificate by using FDA’s electronic
system, which is part of FURLS. Information requested on the forms allows the agency to
determine whether the requested certificate may be issued.
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.
3. Use of Improved Information Technology and Burden Reduction
We estimate that one hundred percent (100%) of firms will use information technology
(electronic means) to assist them in requesting export certificates in the next three years.
Respondents who require assistance with completing export certificate applications online
may contact CFSAN directly by email (CFSANExportCertification@ fda.hhs.gov) or
telephone (240-402-2307). Instructions for Form FDA 3613d are available online at
https://www.fda.gov/cosmetics/internationalactivities/exporters/ucm353912.htm and
instructions for Form FDA 3613e are available online at
https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260280.htm.
Draft screenshots of Form FDA 3613g and 3613k are available for comment online at
https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
4. Efforts to Identify Duplication and Use of Similar Information
While burden associated with information collection activities for export certificates issued
for other FDA-regulated products is approved under OMB Control No. 0910-0498; and
burden associated with information collection activities for the export of tobacco products is
approved under OMB Control No. 0910-0482; this collection specifically supports export
certificates issued by CFSAN. We are otherwise unaware of duplicative information
collection.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that approximately ten percent (10%) of the respondents are small
businesses. However, we do not believe the information collection imposes undue burden
on any small entities. Rather, we gather what we believe is the minimum information
necessary to issue requested certificates. In addition, we assist small businesses through

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Regional Small Business Representatives and through the scientific and administrative staffs
within the agency. We also have provided a Small Business Guide on the agency’s website
at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. The data in new requests for certificates are submitted
only once. If the information collection is not conducted, U.S. exporters could be delayed or
prevented by the government authorities of a foreign country from participating in
commerce in that country.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice requesting public
comment in the Federal Register of January 2, 2018 (83 FR 133). FDA received two
comments regarding the information collection.
Comments and Responses
One comment noted that it was vital to properly document cosmetics that
may be exported.
FDA export certificates are voluntary for exporters of cosmetics, so the
CAP does not include a record of all cosmetics that may be exported. However, FDA does
maintain a record of all active FDA-issued cosmetic export certificates.
Another comment agreed with FDA’s statements that some countries may
require manufacturers of FDA-regulated products to provide certificates for products that
they wish to export those countries, as countries often seek official assurance that products
exported to their countries can be marketed in the United States, or meet specific U.S.
requirements. FDA’s export certificates or certificates of free sale generally indicate the
particular product is marketed in the United States or eligible for export, and has no
unresolved enforcement actions pending before or taken by the FDA. The comment noted
that the request for official federal assurance is increasingly necessary for dietary
supplement products, and most dietary supplement manufacturers currently use FDA’s
electronic export certificate/certificate of free sale CAP.
While the comment indicated agreement with the information collected for these certificates,
it stated that there should always be the option to review and edit auto-populated fields, as
the information could change. The comment also agreed that the proposed collection of
information is necessary for the proper performance of FDA’s functions and the information

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will have practical utility. It also urged FDA to improve the performance and practical
utility through a more complex and revised Export Certificate/Certificate of Free Sale
process.
FDA appreciates the support from these comments, and notes that we are
continually working to improve the export certificate/certificate of free sale experience. We
agree that some countries do require certification that products they import are safe, and our
certificate process is one way to assure that the product could be marketed in the United
States, meet specific U.S. requirements, or be intended solely for export to another country.
FDA will take into consideration the comment’s request to modify auto-populated fields and
appreciates that the comment recognizes that the information collected for these certificates
does have practical utility and is necessary for assuring
that exported products from the Unites States meet specific standards of safety.
Subsequent to publication of our 30 day notice (83 FR 22984) we received
additional comment. The comment appeared to communicate some uncertainty regarding
the scope of the information collection. Specifically that, “[i]f the FDA certification
program described in the Federal Register notice is limited to transitioning an existing
certificate program from paper to electronic applications, USDEC has no concerns,” while
conversely that, “[i]f the intention of the FDA notice is to develop a new certification
program for animal-derived products using form FDA 3613G, or other foods using form
FDA 3613k, we urge that the scope of the FDA certification program be limited to certifying
foods that are not already under existing FDA, USDA or other government certification
programs.” To clarify, our decision to transition from paper-based forms to electronic
submissions is intended to improve the efficiency of the program. As communicated in our
notice, while we have expanded the electronic options for providing facility and product
information through proposed Forms FDA 3613g and 3613l, we have not otherwise altered
the information collection. If a respondent is unable to submit information electronically,
CFSAN will provide assistance.
The comment also suggested that “FDA consider the benefits to its mandate of ‘ensuring
that the nation's food supply is safe, sanitary, wholesome, and honestly labeled’ that could
be achieved by outsourcing additional export-related functions …” and questioned whether
other government agencies might be able to issue certificates more expediently and at a
lower cost. Regarding the first suggestion, the agency always considers how best to allocate
limited resources as appropriate and will continue to do so. Regarding the second
suggestion, we take note that the commenter acknowledges, “[u]nder the current structure
in place with respect to FDA’s role in export issues, we do understand that there may be a
need for FDA to provide certificates for products that are not eligible for USDA’s existing
dairy certificates. Accordingly, we will continue to respond to requests for export
certificates promptly, consistent with section 801(e)(4) of the FD&C Act, and, in a manner
similar to other FDA components, charge fees that are reflective of the costs.

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Internal Agency Discussion Regarding Export Certificate Fees
In January, 2011, section 801(e)(4)(A) of the FD&C Act was amended by the FDA Food
Safety and Modernization Act (FSMA) (Pub. L. 111-353) authorizing FDA to charge firms
export certification fees for food and animal feed for export certificates issued pursuant to
that section. Section 801(e)(4)(B) further authorizes FDA to charge firms up to $175 for
export certificates issued pursuant to that section of the FD&C Act.
FDA has updated the export certificates for food as part of this information collection of
information to account for the January, 2011 FSMA amendment authorizing export
certification fees for food and animal feed. CFSAN does not currently charge a fee for
export certificates for food products. Section 801(e)(4) of the FD&C Act provides that
persons exporting certain FDA-regulated products may request FDA to certify that the
products meet the requirements of sections 801(e) or other requirements of the FD&C Act.
FDA is authorized to charge firms up to $175 for export certificates that certify the
certificate meets the requirements of section 801(e), and FDA may implement this fee in the
future for food products.
We so advised respondents in our 30-day notice, which published in the Federal Register of
May 17, 2018 (83 FR 22984).
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
Trade secret or confidential commercial information is safeguarded by Section 301(j) of the
FD&C Act and protected from disclosure under the Freedom of Information Act (FOIA)
under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and under our regulations at 21 CFR
Part 20.
11. Justification for Sensitive Questions
This collection of information does not contain questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:

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Type of
Respondent

Cosmetics
Food

Table 1. --Estimated Annual Reporting Burden1
Form No.
No. of
No. of
Total
Respondents Responses
Annual
per
Responses
Respondent
Form FDA
3613d
Forms FDA
3613e, 3613g,
3613k

270

3

881

5

Average
Burden
per
Response
(in hours)
810
0.5

4,405

Total
1

0.5

Total
Hours

405
2,203
2,608

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

Our estimate of the average burden per response in column 6 assumes that the use of the
electronic system will substantially reduce the time to prepare an application for a certificate
from 1.5 to 0.5 hours. Our estimate of the total annual responses in column 5 is based on
our experience with certificate applications received in the past 3 fiscal years. We also note
that some respondents send in requests as often as three or four times a month while others
may submit only periodic requests.
We expect that all firms requesting export certificates in the next three years will choose to
submit via the electronic system. Our burden estimates in Table 1 are based on the
expectation of one-hundred percent (100%) participation in the electronic submission
process. The opportunity to provide the information in electronic format reduces the
agency’s previous estimates for the time to prepare each submission.
Based on our experience with the information collection, we have reduced the estimated
time to prepare a submission from 1.5 hours to 0.5 hour. The previous estimate was based
on the time necessary to prepare a paper submission, but all firms requesting export
certificates now provide submissions via the electronic system. We believe that the time to
prepare an electronic submission is under 0.25 hour, but are estimating 0.5 hour as a
conservative approach for this analysis. We base our estimates of the total annual responses
on our experience with certificate applications received in the past 3 fiscal years.
If a firm is unable to submit their information via the electronic system, they may contact
CFSAN to request assistance. CFSAN will assist firms in entering their information into the
electronic system so that the firm may receive their export certificates in a timely manner.
12b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of
information to be approximately $217,403 (rounded from $217,402.88). FDA estimates that
new requests for certificates will be prepared by an employee making an average wage
similar that of a Federal government employee at the GS-12/Step-3 rate for the Washington-

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Baltimore Locality Pay Area for the year 2018, which is $41.68 per hour. To account for
overhead, this cost is increased by 100 percent, which is $83.36 per hour. Thus, the annual
wage cost for completion and submission of these requests and updates is approximately
$217,403 (2,608 hours x $83.36 per hour).
Type of Respondent

Table 2 – Cost of Collection to Respondents
Total Burden
Hourly Wage Rate
Hours

Manufacturers/Processors 2,608
seeking an export
certificate

$83.36

Total
Respondent
Costs
$217,403

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
While we do not currently charge for export certificates classified as Certificates of Free
Sale, section 801(e)(4)(B) of the FD&C Act authorizes a fee up to $175 for export
certificates. Accordingly, upon implementation of this provision, we estimate an annual cost
of $770,875, using the number of annual export certificates for food (4,405) multiplied by
$175.
14. Annualized Cost to the Federal Government
Reviewing and responding to requests for export certificates involves the expenditure of
resources by technicians, consumer safety officers and managers. These positions range
from GS-4 to GS-15 and contractors. FDA estimates the annual personnel costs to be
$1,250,000 and the annual information technology costs to be $300,000, for a total of
$1,550,000.
15. Explanation for Program Changes or Adjustments
The information collection reflects both adjustment and revision. Specifically, the number
of annual responses has increased by 1,921 responses (from 3,294 to 5,215 responses), while
the number of annual burden hours has decreased by 2,334 hours (from 4,942 to 2,608
hours). We attribute this to the implementation of electronic forms and the elimination of
paper-based forms, as discussed more fully under Question 12.
Also, for food products, we have expanded the electronic options for providing facility and
product information through proposed Forms FDA 3613g and 3613l. Respondents can then
identify facilities based on a food facility registration number, FDA Establishment
Identification (FEI) number, or Data Universal Numbering System (DUNS) 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.

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We have also consolidated two individual ICs for dietary supplements and food additives,
respectively, into the more broad category of food.
Finally, we have revised this supporting statement to include our response to a comment that
was received after submission to OMB. This can be found on page 4 under Question 8
above.
16. Plans for Tabulation and Publication and Project Time Schedule
These information collection requirements will not be published, tabulated, or manipulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval not to display the OMB expiration date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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