[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68277-68278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements imposed on firms that intend to export to countries that 
require an export certificate as a condition of entry for FDA regulated 
products, pharmaceuticals, biologics, and devices as indicated in the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.

DATES: Submit either electronic or written comments on the collection 
of information by January 13, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, <a href="/cdn-cgi/l/email-protection#91c1c3d0c2e5f0f7f7d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="82d2d0c3d1f6e3e4e4c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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)

[[Page 68278]]

and 802 of the FD&C Act. FDA has developed five 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:

                     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
                                          States.
                                         ``Exporter's Certification
                                          Statement 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.
------------------------------------------------------------------------

    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.
    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                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...................
Center for Devices and                     6,463               1           6,463               2          12,926
 Radiological Health............
Center for Veterinary Medicine..             855               1             855               1             855
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,895
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26999 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P


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