Document ID: FDA-2008-N-0606-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-03-03T05:00Z

[Federal Register: March 3, 2009 (Volume 74, Number 40)]
[Notices]               
[Page 9247-9249]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr09-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0606]

 
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 April 
2, 2009.

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: 202-395-6974, or e-mailed 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 (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

[[Page 9248]]

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) or 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 $175.00 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:

                                Table 1.
------------------------------------------------------------------------
        Type of Certificate                          Use
------------------------------------------------------------------------
``Supplementary Information          For the export of products legally
 Certificate to Foreign Government    marketed in the United States
 Requests''
``Exporter's Certification
 Statement Certificate to Foreign
 Government''
``Exporter's Certification
 Statement Certificate to Foreign
 Government (For Human Tissue
 Intended for Transplantation)''
------------------------------------------------------------------------
``Supplementary Information          For the export of products not
 Certificate of Exportability         approved for marketing in the
 Requests''                           United States (unapproved
``Exporter's Certification            products) that meet the
 Statement Certificate of             requirements of sections 801(e) or
 Exportability''                      802 of the act
------------------------------------------------------------------------
``Supplementary Information          Conforms to the format established
 Certificate of a Pharmaceutical      by the World Health Organization
 Product''                            and is intended for use by the
``Exporter's Certification            importing country when the product
 Statement Certificate of a           in question is under consideration
 Pharmaceutical Product''             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
 Clinical Research Use Only           research use only product,
 Certificate''                        material, or component that is not
``Exporter's Certification            intended for human use which may
 Statement Non-Clinical Research      be marketed in, and legally
 Use Only''                           exported from the United States
                                      under the act
------------------------------------------------------------------------
Certificates 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 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 December 17, 2008 (73 FR 76655), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                              Table 2.--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
----------------------------------------------------------------------------------------------------------------
Center for                  1,501                     1              1,501                  1              1,501
 Biologics
 Evaluation
 and Research
----------------------------------------------------------------------------------------------------------------
Center for                  7,046                     1              7,046                  1              7,046
 Drug
 Evaluation
 and Research
----------------------------------------------------------------------------------------------------------------
Center for                  6,091                     1              6,091                  2             12,182
 Devices and
 Radiological
 Health
----------------------------------------------------------------------------------------------------------------
Center for                    664                     1                664                  1                664
 Veterinary
 Medicine
----------------------------------------------------------------------------------------------------------------

[[Page 9249]]

Center for                  1,794                     5              8,970                  2             17,940
 Food Safety
 and Applied
 Nutrition
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Total                      14,853  ....................             24,272  .................             39,333
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates were averaged based on the approximate number 
of requests for certificates the agency received over the past 3 years. 
The burden estimate for the Center for Drug Evaluation and Research was 
increased to reflect a more accurate average number of requests for 
certificates.

    Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4457 Filed 3-2-09; 8:45 am]

BILLING CODE 4160-01-S