[Federal Register Volume 70, Number 118 (Tuesday, June 21, 2005)]
[Notices]
[Pages 35678-35680]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0190]
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 August 22, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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 Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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 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 FDA Regulated Products--Export Certificates (OMB Control
Number 0910-0498)
In April 1996 a law entitled ``The FDA Export Reform and
Enhancement Act of 1996'' 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 act provides that persons
exporting certain FDA-regulated products may request that FDA certify
that the products meet the requirements of sections 801(e) or 802 or
other requirements of the act. This section of the law requires that
FDA issue certification within 20 days of receipt of the request and
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
pharmaceuticals, biologics, and devices 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)
[[Page 35679]]
Certificates of Exportability, (3) Certificates of a Pharmaceutical
Product, (4) Nonclinical Research Use Only Certificates, and (5)
Certificates of Free Sale. Table 1 of this document lists the different
certificates and details their uses:
Table 1.
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Type of Certificate Use
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``Supplementary Information Certificate to Foreign Government For the export of products legally marketed
Requests'' in the United States.
``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 Certificate of Exportability For the export of products not approved for
Requests'' marketing in the United States (unapproved
``Exporter's Certification Statement Certificate of products) that meet the requirements of
Exportability'' sections 801(e) or 802 of the act.
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``Supplementary Information Certificate of a Pharmaceutical Conforms to the format established by the
Product'' World Health Organization and is intended
``Exporter's Certification Statement Certificate of a for use by the importing country when the
Pharmaceutical Product'' product in question is under consideration
for a product license that will authorize
its importation and sale or for renewal,
extension, amendment, or review of a
license.
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``Supplementary Information Nonclinical Research Use Only For the export of a nonclinical research use
Certificate'' only product, material, or component that is
``Exporter's Certification Statement Nonclinical Research Use not intended for human use which may be
Only'' marketed in, and legally exported from the
United States under the act.
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Certificates of Free Sale For food and cosmetic products and dietary
supplements that may be legally marketed in
the United States.
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FDA will continue to rely on self-certification by manufacturers
for the first three types of certificates listed in the previous
paragraph. 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. Firms 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.
FDA estimates the burden of this collection of information as
follows:
Table 2.--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 Biologics 1,501 1 1,501 1 1,501
Evaluation and Research
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Center for Drug Evaluation 4,803 1 4,803 1 4,803
and Research
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Center for Devices and 5,674 1 5,674 2\2\ 11,348
Radiological Health
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Center for Veterinary 664 1 664 1 664
Medicine
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Total 12,642 ................. 12,642 ......... 18,316
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Based on center policy that allows multiple devices to appear on one certificate.
[[Page 35680]]
Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12109 Filed 6-20-05; 8:45 am]
BILLING CODE 4160-01-S