Document ID: FDA-2015-N-3106-0001
Agency: fda
Document Type: Notice
Title: Animal Food; Export Certificates; Food and Drug Administration Food Safety Modernization Act of 2011; Certification Fees
Posted Date: 2015-09-10T04:00Z

[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Page 54569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22795]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3106]

Animal Food; 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 animal food. 
The FDA Food Safety Modernization Act (FSMA) of 2011 authorizes us to 
charge fees to cover our costs associated with issuing export 
certificates for regulated food including animal food. This notice 
provides the fee schedule for issuing these certificates and the basis 
for the fees. We have not previously collected fees to issue export 
certificates for animal food.

DATES: The fees described in this document for export certificates for 
animal food will be effective October 1, 2015.

FOR FURTHER INFORMATION CONTACT: Joanne Kla, Office of Surveillance and 
Compliance, Center for Veterinary Medicine (HFV-235), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5605, 
CVMExportCertification@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In April 1996, a law entitled the ``FDA Export Reform and 
Enhancement Act of 1996'' (Pub. L. 104-134, amended by Pub. L. 104-180) 
amended sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 381(e) and 382). It was designed to ease 
restrictions on exportation of unapproved pharmaceuticals, biologics, 
and devices regulated by FDA. 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 
section 801(e)(1), section 802, or other applicable requirements of the 
FD&C Act. Section 801(e)(4) of the FD&C Act also requires FDA to issue 
certification within 20 days of receipt of the request and authorizes 
us to charge up to $175 for each certification issued within 20 days. 
In January 2011, section 801(e)(4)(A) of the FD&C Act was amended by 
FSMA (Pub. L. 111-353) to provide authorization for export 
certification fees for regulated food, including animal food (referred 
to as animal feed in section 107(b) of FSMA). Section 801(e)(4) of the 
FD&C Act authorizes FDA to issue export certificates for regulated 
food, drugs, and devices that are legally marketed in the United 
States, as well as for these same products that are not legally 
marketed but are legally exported under section 801(e) or 802 of the 
FD&C Act. The focus of this notice is on export certificates issued by 
the Center for Veterinary Medicine (CVM) for animal food.

II. Fees To Be Assessed for Export Certificates

    CVM estimates the costs of the export certification program for 
animal food to be approximately $548,000 per year for payroll and 
operating expenses. There are four cost categories for preparing and 
issuing export certificates in general. They are: (1) Direct personnel 
for research, review, tracking, writing, and assembly; (2) purchase of 
equipment and supplies used for tracking, processing, printing, and 
packaging. Recovery of the cost of the equipment is calculated over its 
useful life; (3) billing and collection of fees; and (4) overhead and 
administrative support. In fiscal year (FY) 2014 CVM issued 
approximately 933 animal food export certificates. Because CVM has not 
been charging fees for issuing export certificates for animal food, the 
program has been covered by appropriated funds.
    As mentioned previously in this document, FDA may charge up to $175 
for each certificate. Certificates for some classes of products, 
including animal food, cost the Agency 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, 2015, for 
animal food export certificates:

 Table 1--CVM 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                70
 in response to the same request........................
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    The fee for issuing the first export certificate for animal food 
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. The fees for 
issuing subsequent certificates continue to differ among the Centers, 
based on varying costs.

    Dated: September 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22795 Filed 9-9-15; 8:45 am]
BILLING CODE 4164-01-P