[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44890-44891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2700]


Food for Human Consumption; Export Certificates; Food and Drug 
Administration Food Safety Modernization Act of 2011; Certification 
Fees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
fees we will assess for issuing export certificates for food for human 
consumption, with the exception of dietary supplements, medical foods, 
and foods for special dietary use. The FDA Food Safety Modernization 
Act (FSMA) of 2011 authorizes us to charge fees to cover our costs 
associated with issuing export certificates for food. This notice 
provides the fee schedule for issuing these certificates and the basis 
for the fees. We have not previously exercised our FSMA authority to 
collect fees for export certificates issued for food for human 
consumption.

DATES: The fees described in this document for export certificates for 
food for human consumption, with the exception of dietary supplements, 
medical foods, and foods for special dietary use, will be effective 
October 1, 2018.

FOR FURTHER INFORMATION CONTACT: Kate Meck, International Affairs 
Staff, Center for Food Safety and Applied Nutrition (HFS-550), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2307, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In April 1996, the ``FDA Export Reform and Enhancement Act of 
1996'' (Pub. L. 104-134, amended by Pub. L. 104-180) amended sections 
801 and 802 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 381 and 382). As a result of the 1996 amendments, section 
801(e)(4) of the FD&C Act provides that persons exporting a drug, 
animal drug, or device may request FDA to certify that the product 
meets the requirements of section 801(e)(1), section 802, or other 
applicable requirements of the FD&C Act. Upon a showing that the 
product meets the applicable requirements, the law provides that FDA 
shall issue export certification within 20 days of the receipt of a 
request for such certification. The law also authorizes us to charge up 
to $175 for each certification issued within the 20-day period.
    In January 2011, section 801(e)(4) of the FD&C Act was further 
amended by FSMA (Pub. L. 111-353) to authorize FDA to issue, and charge 
fees for, export certificates for food. Under section 801(e)(4)(C) of 
the FD&C Act, an export certification can be made in such form 
(including a publicly available listing) as FDA determines appropriate.
    This notice focuses on the fees to be assessed with respect to 
export certificates issued by the Center for Food Safety and Applied 
Nutrition (CFSAN) for food for human

[[Page 44891]]

consumption, with the exception of dietary supplements, medical foods, 
and foods for special dietary use. This notice applies to foods such as 
produce, grains, processed foods, food additives, color additives, food 
contact substances, generally regarded as safe ingredients, infant 
formula, and all other foods not specifically excluded. Dietary 
supplements, medical foods, and foods for special dietary use are 
excluded from this notice.

II. Fees To Be Assessed for Export Certificates

    CFSAN estimates the annual costs of the export certification 
program for food for human consumption, with the exception of dietary 
supplements, medical foods, and foods for special dietary use, to be 
approximately $975,000 per year for preparing and issuing export 
certificates. The costs are due to payroll and operating expenses. 
Specifically, there are four cost categories for preparing and issuing 
export certificates in general: (1) Direct personnel for research, 
review, tracking, writing, and assembly; (2) an information technology 
system used for tracking and processing certificates; (3) billing and 
collection of fees; and (4) overhead and administrative support. In 
fiscal year (FY) 2017 CFSAN issued approximately 4,072 export 
certificates for food for human consumption, with the exception of 
dietary supplements, medical foods, and foods for special dietary use. 
Because CFSAN has not been charging fees for issuing these export 
certificates, the program has been covered by appropriated funds.
    As mentioned previously, FDA may charge up to $175 for each 
certificate. Certificates for some of the foods that are the subject of 
this notice cost us more than $175 to prepare. Subsequent certificates 
issued for the same product(s) in response to the same request 
generally cost FDA less than $175 to prepare. The fee for all 
subsequent certificates for the same product(s) issued in response to 
the same request reflects reduced FDA costs for preparing those 
certificates.
    The following fees will be assessed starting October 1, 2018, for 
export certificates for food for human consumption, with the exception 
of dietary supplements, medical foods, and foods for special dietary 
use:

      Table 1--CFSAN Fees for First, Second, and Subsequent Export
                              Certificates
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                   Type of certificate                    Fee  (dollars)
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First certificate.......................................             175
Second certificate for the same product(s) issued in                 155
 response to the same request...........................
Subsequent certificates for the same product(s) issued               100
 in response to the same request........................
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    The fee for issuing the first export certificate for food for human 
consumption, with the exception of dietary supplements, medical foods, 
and foods for special dietary use, will be at the maximum allowable 
amount and consistent with the export certification fees assessed since 
FY 1997 by other FDA Centers that provide export certification for 
drugs and devices. It is also consistent with the export certification 
fees assessed by the Center for Veterinary Medicine (CVM) for 
certificates for animal food, which CVM began assessing in FY 2016 
because the FSMA amendments to section 801(e)(4) of the FD&C Act also 
apply to animal food. The fees for issuing subsequent certificates 
continue to differ among the Centers, based on varying costs.

    Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19064 Filed 8-31-18; 8:45 am]
BILLING CODE 4164-01-P