[Federal Register Volume 73, Number 243 (Wednesday, December 17, 2008)]
[Notices]
[Pages 76655-76657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 act) as amended.

DATES: Submit written or electronic comments on the collection of 
information by February 17, 2009.

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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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.

[[Page 76656]]

    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 & 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 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
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        Type of Certificate                          Use
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``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)''
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``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
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``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
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``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
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(5) 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 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.

                              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
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Center for                  1,501                     1              1,501                  1              1,501
 Biologics
 Evaluation
 and Research
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Center for                  4,803                     1              4,803                  1              4,803
 Drug
 Evaluation
 and Research
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[[Page 76657]]

 
Center for                  6,091                     1              6,091                  2             12,182
 Devices and
 Radiological
 Health
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Center for                    664                     1                664                  1                664
 Veterinary
 Medicine
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Center for                  1,794                     5              8,876                  2             17,752
 Food Safety
 and Applied
 Nutrition
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Total                      14,853  ....................             21,935  .................             36,902
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29897 Filed 12-16-08; 8:45 am]
BILLING CODE 4160-01-S