[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