[Federal Register Volume 67, Number 104 (Thursday, May 30, 2002)]
[Notices]
[Pages 37836-37837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13585]


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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://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