[Federal Register: September 9, 2002 (Volume 67, Number 174)]
[Notices]
[Page 57241-57242]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se02-61]
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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.
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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\
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Annual
No. of [chyph]Frequency Total Annual Hours per Total
FDA Centers [chyph]Respondents per [chyph]Responses [chyph]Response Hours
[chyph]Response
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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
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\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