Document ID: FDA-2010-N-0161-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Export of Food and Drug Administration Regulated Products; Export Certificates
Posted Date: 2010-10-05T04:00Z

[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]               
[Page 61495-61497]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc10-109]                         

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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 
November 4, 2010.

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 oira_submission@omb.eop.gov. 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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-

[[Page 61496]]

400B, Rockville, MD 20850, 301-796-3794, 
Jonnalynn.Capezzuto@fda.hhs.gov.

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 & Enhancement 
Act of 1996'' (FDAERA) amended sections 801(e) and 802 of the 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 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 new section of the 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 act. 
FDA has developed five types of certificates that satisfy the 
requirements of section 801(e)(4)(B) of the act: (1) Certificates to 
Foreign Governments, (2) Certificates of Exportability, (3) 
Certificates of a Pharmaceutical Product, (4) Non-Clinical Research Use 
Only Certificates, and (5) Certificates of Free Sale. Table 1 of this 
document lists the different certificates and details their use:

------------------------------------------------------------------------
          Type of Certificate                          Use
------------------------------------------------------------------------
``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)''
------------------------------------------------------------------------
                                         For the export of products not
``Supplementary Information Certificate   approved for marketing in the
 of Exportability Requests''              United States (unapproved
``Exporter's Certification Statement      products) that meet the
 Certificate of Exportability''           requirements of sections
                                          801(e) or 802 of the act
------------------------------------------------------------------------
                                         Conforms to the format
``Supplementary Information Certificate   established by the World
 of a Pharmaceutical Product''            Health Organization and is
``Exporter's Certification Statement      intended for use by the
 Certificate of a Pharmaceutical          importing country when the
 Product''                                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
------------------------------------------------------------------------
                                         For the export of a non-
``Supplementary Information Non-          clinical research use only
 Clinical Research Use Only               product, material, or
 Certificate''                            component that is not intended
``Exporter's Certification Statement      for human use which may be
 (Non-Clinical Research Use Only)''       marketed in, and legally
                                          exported from the United
                                          States under the act
------------------------------------------------------------------------
Certificate of Free Sale                 For food, cosmetic products,
                                          and dietary supplements that
                                          may be legally marketed in the
                                          United States
------------------------------------------------------------------------

    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 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 followup. 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 March 31, 2010 (75 FR 16137), 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 1--Total Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                      FDA Center                           Respondents         per Response          Responses           Response         Total Hours
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Center for Biologics Evaluation and Research                        2,114                     1              2,114                  1              2,114
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Center for Drug Evaluation and Research                             5,251                     1              5,251                  2             10,502
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Center for Devices and Radiological Health                          6,463                     1              6,463                  2             12,926
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Center for Veterinary Medicine                                        855                     1                855                  1                855
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[[Page 61497]]

Center for Food Safety and Applied Nutrition (Three different product categories)
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                                                                      386                     2                772                1.5              1,158
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                                                                      247                    47             11,609                  2             23,218
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                                                                      337                     1                337                0.5                169
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Total                                                              15,653  ....................             27,401  .................             50,942
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25009 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S