[Federal Register Volume 74, Number 40 (Tuesday, March 3, 2009)]
[Notices]
[Pages 9247-9249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4457]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0606]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
2, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0498.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
[[Page 9248]]
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 of Food and Drug Administration Regulated Products: Export
Certificates (OMB Control Number 0910-0498)--Extension
In April 1996 a law entitled ``The FDA Export Reform & Enhancement
Act of 1996'' (FDAERA) 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 FDAERA provides that persons
exporting certain FDA-regulated products may request FDA to certify
that the products meet the requirements of 801(e) or 802 or other
requirements of the act. This section of the law requires FDA to issue
certification within 20 days of receipt of the request and to charge
firms up to $175.00 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 these same
products 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) Certificates of Exportability, (3)
Certificates of a Pharmaceutical Product, (4) Non-Clinical Research Use
Only Certificates, and (5) Certificates of Free Sale. Table 1 of this
document lists the different certificates and details their use:
Table 1.
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Type of Certificate Use
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``Supplementary Information For the export of products legally
Certificate to Foreign Government marketed in the United States
Requests''
``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 For the export of products not
Certificate of Exportability approved for marketing in the
Requests'' United States (unapproved
``Exporter's Certification products) that meet the
Statement Certificate of requirements of sections 801(e) or
Exportability'' 802 of the act
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``Supplementary Information Conforms to the format established
Certificate of a Pharmaceutical by the World Health Organization
Product'' and is intended for use by the
``Exporter's Certification importing country when the product
Statement Certificate of a in question is under consideration
Pharmaceutical Product'' for a product license that will
authorize its importation and sale
or for renewal, extension,
amending, or reviewing a license
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``Supplementary Information Non- For the export of a non-clinical
Clinical Research Use Only research use only product,
Certificate'' material, or component that is not
``Exporter's Certification intended for human use which may
Statement Non-Clinical Research be marketed in, and legally
Use Only'' exported from the United States
under the act
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Certificates of Free Sale For food, 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 table 1 of this
document. 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 follow-up. 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.
In the Federal Register of December 17, 2008 (73 FR 76655), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 2.--Total 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 1,501 1 1,501 1 1,501
Biologics
Evaluation
and Research
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Center for 7,046 1 7,046 1 7,046
Drug
Evaluation
and Research
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Center for 6,091 1 6,091 2 12,182
Devices and
Radiological
Health
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Center for 664 1 664 1 664
Veterinary
Medicine
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[[Page 9249]]
Center for 1,794 5 8,970 2 17,940
Food Safety
and Applied
Nutrition
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Total 14,853 .................... 24,272 ................. 39,333
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates were averaged based on the approximate number
of requests for certificates the agency received over the past 3 years.
The burden estimate for the Center for Drug Evaluation and Research was
increased to reflect a more accurate average number of requests for
certificates.
Dated: February 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4457 Filed 3-2-09; 8:45 am]
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