[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16137-16138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7111]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0161]
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.
-----------------------------------------------------------------------
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 June 1, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3794,
[email protected].
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 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) and 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 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:
[[Page 16138]]
Table 1.--Export Certificates
------------------------------------------------------------------------
Type of Certificate Use
------------------------------------------------------------------------
``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)''
------------------------------------------------------------------------
``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
------------------------------------------------------------------------
``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
------------------------------------------------------------------------
``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
------------------------------------------------------------------------
Certificate of Free Sale For food, cosmetic products, and
dietary supplements that may be
legally marketed in the United
States
------------------------------------------------------------------------
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 followup. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
FDA Center Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research 2,114 1 2,114 1 2,114
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation and Research 5,251 1 5,251 2 10,502
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health 6,463 1 6,463 2 12,926
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Veterinary Medicine 855 1 855 1 855
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Food Safety and Applied Nutrition 1,794 5 8,970 2 17,940
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 44,337
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7111 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-01-S