[Federal Register Volume 67, Number 174 (Monday, September 9, 2002)]
[Notices]
[Pages 57241-57242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22793]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0215]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Export of FDA Regulated Products--Export 
Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
October 9, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1471.

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 Certificates for FDA Regulated Products Under Sections 801(e) 
and 802 of the Federal Food, Drug, and Cosmetic Act--New Collection

    FDA is requesting approval from OMB for the collection of 
information from the public associated with the export of FDA regulated 
products as indicated in sections 801(e) and 802 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 381(e) and 382), as 
amended.
    In April 1996, a new law entitled ``The FDA Export Reform and 
Enhancement Act of 1996'' was enacted. It was designed to ease 
restrictions on exportation of unapproved products regulated by FDA and 
to facilitate such exportation by provide foreign governments 
certificates verifying that the products may be legally exported. 
Specifically, section 801(e)(4) of the act provides that persons 
exporting certain

[[Page 57242]]

FDA-regulated products may request FDA to certify that the products 
meet the requirements of sections 801(e) or 802 of the act, or other 
requirements of the act. Section 801(e)(4) of the act requires FDA to 
issue export certificates within 20 days of receipt of the request and 
to charge firms up to $175 for the certificates.
    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'' are issued for legally marketed products that are 
in compliance with the requirements of the act; (2) ``certificates of 
exportability'' are for the export of products that cannot be marketed 
legally in the United States, but meet the requirements of sections 
801(e) or 802 of the act and may be exported legally; (3) 
``certificates of a pharmaceutical product'' are used for the export of 
drug products that are legally marketed in the United States. They 
conform to the format established by the World Health Organization 
(WHO) and attest to the acceptable current good manufacturing practice 
status of the manufacturing facility of the drug product; (4) 
``nonclinical research use only certificates'' for the export of 
nonclinical research use only product, material, or component that is 
not intended for human use which may be marketed in and legally 
exported from the Untied States under the act; and (5) ``certificates 
of free sale.''
    FDA has relied and will continue to rely on information provided by 
manufacturers for all types of export certificates. Manufacturers are 
requested to state that they are in compliance with all applicable 
requirements of the act, at the time that they submit their request to 
the appropriate center.
    FDA will check all information submitted by firms in support of 
their certificates and any suspected case of fraud will be referred to 
FDA's Office of Criminal Investigations for followup. Firms making or 
submitting false statements on any documents submitted to FDA may be 
violating the United States Code title 18, chapter 47, section 1001 and 
be subject to penalties including up to $250,000 in fines and up to 5 
years imprisonment.
    In the Federal Register of May 30, 2002 (67 FR 37836), the agency 
requested comments on the proposed collection of information. FDA 
received four comments, three did not pertain to the information 
collection requirements and one talked to requirements of the U.S. 
Department of Agriculture and State agencies.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                           Annual
                                        No. of        [chyph]Frequency    Total Annual       Hours per     Total
           FDA Centers            [chyph]Respondents         per        [chyph]Responses  [chyph]Response  Hours
                                                       [chyph]Response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation        1,479                  1             1,479                1         1,479
 and Research
Center for Drug Evaluation and         4,187                  1             4,187                1         4,187
 Research
Center for Devices and                 3,500                  1             3,500             2\2\         7,000
 Radiological Health (CDRH)                                                                                \2\
Center for Veterinary Medicine           621                  1               621                1         621
Total                                  9,787          ................      9,787         ...............  13,28
                                                                                                            7
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Based on the CDRH policy of allowing multiple devices to appear on the certificate.

    The estimates provided in table 1 are based on each center's latest 
calendar year counts.

    Dated: September 3, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy
[FR Doc. 02-22793 Filed 9-6-02; 8:45 am]
BILLING CODE 4160-01-S