[Federal Register: May 30, 2002 (Volume 67, Number 104)]
[Notices]
[Page 37836-37837]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my02-103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0215]
Agency Information Collection Activities; Proposed Collection;
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 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 the proposed 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.
DATES: Submit written or electronic comments on the collection of
information by July 29, 2002.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: 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: 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.
With respect to the following collection of information, FDA
invites comments on: (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.
Requesting Export Certificates for FDA Regulated Products under U.S.C.
Sections 801(e) and 802--New Collection
FDA is requesting approval from the Office of Management and Budget
(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 FDA-regulated products may request that FDA certify
that the products meet the requirements of section 801(e) or
[[Page 37837]]
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 seven 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 section
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 United States
under the act; (5) certificate of free sale; (6) health certificates
for food/feed; and (7) specified risk materials of bovine, ovine, and
caprine origin certificate.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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FDA Annual Frequency Per Hours per
Centers No. of Respondents Response Total Annual Responses Response Total Hours
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Center for 1,479 1 1,479 1 1,479
Biologics
Evaluatio
n and
[chyph]Re
search
Center for 4,542 1 4,542 1 4,542
Drug
[chyph]Ev
aluation
and
[chyph]Re
search
Center for 3,500 1 3,500 2\2\ 7,000\2\
Devices
and
Radiologi
cal
Health
(CDRH)
Center for 621 1 621 1 621
Veterinar
y
Medicine
Total 10,142 .................... 10,142 .......... 13,642
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information. The above estimates are based on each center's [chyph]latest calendar year counts.
\2\ Based on the CDRH policy of allowing multiple devices to appear on the certificate.
Dated: May 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-13585 Filed 5-29-02; 8:45 am]
BILLING CODE 4160-01-S