Document ID: FDA-2010-N-0161-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
Posted Date: 2018-02-20T05:00Z

[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7195-7196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03346]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Export of Food and 
Drug Administration-Regulated Products: Export Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by March 
22, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0498. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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.

Export of Food and Drug Administration-Regulated Products: Export 
Certificates

OMB Control Number 0910-0498--Extension

    In April 1996, the FDA Export, Reform, and Enhancement Act of 1996 
(FDAERA) (Pub. L. 104-134) amended sections 801(e) and 802 of the 
Federal Food, Drug, and Cosmetic Act (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 FDAERA provides that persons exporting certain FDA-
regulated products may request FDA to certify that the products meet 
the requirements of sections 801(e) and 802 or other requirements of 
the FD&C Act. This section of the law requires FDA to issue 
certification within 20 days of receipt of the request and to charge 
firms up to $175 for the certifications. In January 2011, section 
801(e)(4)(A) was amended by the FDA Food Safety Modernization Act (Pub. 
L. 111-353) to provide authorization for export certification fees for 
food and animal feed.
    This section of the FD&C Act authorizes FDA to issue export 
certificates for regulated food, animal feed, pharmaceuticals, 
biologics, and devices that are legally marketed in the United States, 
as well as for these same products that are not legally marketed but 
are acceptable to the importing country, as specified in sections 
801(e) and 802 of the FD&C Act. FDA has developed various types of 
certificates that satisfy the requirements of section 801(e)(4)(B) of 
the FD&C Act. Four of those certificates are discussed in this notice: 
(1) Certificates to Foreign Governments, (2) Certificates of 
Exportability, (3) Certificates of a Pharmaceutical Product, and (4) 
Non-Clinical Research Use Only Certificates. FDA has updated the 
certificates as part of the proposed collection of information to 
account for the amendment authorizing export certification fees for 
food and animal feed. Table 1 lists the different certificates and 
details their uses:

                     Table 1--Certificates and Uses
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          Type of certificate                          Use
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``Supplementary Information Certificate  For the export of products
 to Foreign Government Requests''.        legally marketed in the United
``Exporter's Certification Statement      States.
 Certificate to Foreign Government''.
``Exporter's Certification Statement
 Certificate to Foreign Government (For
 Human Tissue Intended for
 Transplantation)''.
 
``Supplementary Information Certificate  For the export of products not
 of Exportability Requests''.             approved for marketing in the
``Exporter's Certification Statement      United States (unapproved
 Certificate of Exportability''.          products) that meet the
                                          requirements of sections
                                          801(e) or 802 of the FD&C Act.
 
``Supplementary Information Certificate  Conforms to the format
 of a Pharmaceutical Product''.           established by the World
``Exporter's Certification Statement      Health Organization and is
 Certificate of a Pharmaceutical          intended for use by the
 Product''.                               importing country when the
                                          product in question is under
                                          consideration for a product
                                          license that will authorize
                                          its importation and sale or
                                          for renewal, extension,
                                          amending, or reviewing a
                                          license.
 
``Supplementary Information Non-         For the export of a non-
 Clinical Research Use Only               clinical research use only
 Certificate''.                           product, material, or
``Exporter's Certification Statement      component that is not intended
 (Non-Clinical Research Use Only)''.      for human use which may be
                                          marketed in, and legally
                                          exported from the United
                                          States under the FD&C Act.
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[[Page 7196]]

    FDA will continue to rely on self-certification by manufacturers 
for the first three types of certificates listed in table 1. 
Manufacturers are requested to self-certify that they are in compliance 
with all applicable requirements of the FD&C Act, not only at the time 
that they submit their request to the appropriate center, but also at 
the time that they submit the certification to the foreign government.
    The appropriate FDA centers will review product information 
submitted by firms in support of their certificate and any suspected 
case of fraud will be referred to the appropriate offices.
    In the Federal Register of November 27, 2017 (82 FR 56031), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. The burden hours 
have decreased from the previous approval.

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
           FDA Center                Number of    responses  per   Total  annual    burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation            2,651               1           2,651               1           2,651
 and Research...................
Center for Devices and                    11,175               1          11,175               2          22,350
 Radiological Health............
Center for Drug Evaluation and             3,680               1           3,680               1           3,680
 Research.......................
Center for Veterinary Medicine..           1,925               1           1,925               1           1,925
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          30,606
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03346 Filed 2-16-18; 8:45 am]
 BILLING CODE 4164-01-P