[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6728-6729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02348]


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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 
9, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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, a law entitled ``The FDA Export Reform and 
Enhancement Act of 1996'' (FDAERA) amended sections 801(e) and 802 of 
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 FDAERA provides 
that persons exporting certain FDA regulated products may request FDA 
to certify that the products meet the requirements of 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.
    This section of the FD&C Act authorizes FDA to issue export 
certificates for regulated 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 four types of certificates that satisfy the 
requirements of section 801(e)(4)(B) of the FD&C Act: (1) Certificates 
to Foreign Governments, (2) Certificates of Exportability, (3) 
Certificates of a Pharmaceutical Product, and (4) Non-Clinical Research 
Use Only Certificates. Table 1 of this document lists the different 
certificates and details their use:

[[Page 6729]]



                     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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    FDA will continue to rely on self-certification by manufacturers 
for the first three types of certificates listed in table 1 of this 
document. 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 FDA's Office of Criminal 
Investigations for follow up. Making or submitting to FDA false 
statements on any documents may constitute violations of 18 U.S.C. 
1001, with penalties including up to $250,000 in fines and up to 5 
years imprisonment.
    In the Federal Register of November 14, 2014 (79 FR 68277), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of
     FDA center and FDA form         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Center for Biologics Evaluation            2,114               1           2,114               1           2,114
 and Research...................
    FDA 3613....................
    FDA 3613a...................
    FDA 3613b...................
    FDA 3613c...................
Center for Devices and                    10,528               1          10,528               2          21,056
 Radiological Health............
    FDA 3613....................
    FDA 3613a...................
    FDA 3613c...................
Center for Veterinary Medicine..             855               1             855               1             855
    FDA 3613....................
    FDA 3613a...................
    FDA 3613b...................
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    Total.......................  ..............  ..............  ..............  ..............          24,025
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: January 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02348 Filed 2-5-15; 8:45 am]
BILLING CODE 4164-01-P