[Federal Register Volume 71, Number 16 (Wednesday, January 25, 2006)]
[Notices]
[Pages 4147-4148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0190]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Export Certificates 
for FDA Regulated Products

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 
February 24, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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 FDA Regulated Products--Export Certificates--(OMB Control 
Number 0910-0498)--Extension

    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 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. Section 801(e)(4) of the act provides that FDA shall, 
upon request, issue certificates for human drugs and biologics, animal 
drugs, and devices that either meet the applicable requirements of the 
act and may be legally marketed in the United States or may be legally 
exported under the act although they may not be legally marketed in the 
United States. The act does not require FDA to issue certificates for 
food, including animal feeds, food and feed additives, and dietary 
supplements, or cosmetics. However, because foreign governments may 
require certificates for these types of products, the agency intends to 
continue to provide this service as resources permit. FDA issues six 
types of certificates: (1) Certificate to Foreign Government (FDA 
3613), (2) Certificate of Exportability (FDA 3613a), (3) Certificate of 
a Pharmaceutical Product (FDA 3613b), (4) Non-clinical Research Use 
Only Certificate (FDA 3613c), Office of Cosmetics and Colors 
``Certificate'' (Exports) Application (FDA 3613d), and Food Export 
Certificate Application (FDA 3613e). Table 1 of this document lists the 
different certificates and details their uses:

                Table 1. List of FDA Export Certificates
------------------------------------------------------------------------
                       Form
  Certificate Name     FDA             Use           Issuing FDA Center
------------------------------------------------------------------------
Certificate to          3613  For the export of     Center for Biologic
 Foreign Government            products that can     Evaluation and
                               be legally marketed   Research (CBER);
                               in the United         Center for Devices
                               States.               and Radiological
                                                     Health (CDRH);
                                                     Center for
                                                     Veterinary Medicine
                                                     (CVM)
------------------------------------------------------------------------
Certificate of         3613a  For the export of     CBER; CDRH; CVM
 Exportability                 products that
                               cannot be legally
                               marketed in the
                               United States but
                               meet the
                               requirements of
                               sections 801(e) or
                               802 of the act and
                               may be legally
                               exported.
------------------------------------------------------------------------
Certificate of a       3613b  For use by the        CBER; Center for
 Pharmaceutical                importing country     Drug Evaluation and
 Product                       when considering      Research; CVM
                               whether to license
                               the product in
                               question for sale
                               in that country.
                               Conforms to the
                               format established
                               by the World Health
                               Organization.
------------------------------------------------------------------------
Non-Clinical           3613c  For the export of     CBER; CDRH
 Research Use Only             non-clinical
 Certificate                   research use only
                               product, material,
                               component that is
                               not intended for
                               human use which may
                               be marketed in, and
                               legally exported
                               from the United
                               States under the
                               act.
------------------------------------------------------------------------
Office of Cosmetics    3613d  For the export of     Center for Food
 and Colors                    products that are     Safety and Applied
 ``Certificate''               identified by the     Nutrition (CFSAN)
 (Exports)                     requester as
 Application                   cosmetics.
------------------------------------------------------------------------

[[Page 4148]]

 
Food Export            3613e  For food products     CFSAN
 Certificate                   and dietary
 Application                   supplements that
                               may be legally
                               marketed in the
                               United States.
------------------------------------------------------------------------

    In the Federal Register of June 21, 2005 (70 FR 35678), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions involving export certificates. FDA received three 
comments; however, only one was related to the information collection.
    The commenter suggested that extending the ``Certificate to Foreign 
Government'' 2-year expiration date to 3, 4 or 5 years would reduce 
their financial burden. The export certificate expiration date is based 
on the agency inspection schedule. At this time FDA is not considering 
reevaluating the inspection schedule.
    FDA will continue to rely on self-certification by manufacturers 
for the first three types of certificates listed in Table 1 of this 
notice. 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. 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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CBER                                                                1,501                     1              1,501                  1              1,501
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CDER                                                                4,803                     1              4,803                  1              4,803
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CDRH                                                                5,674                     1              5,674               2\2\             11,348
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CFSAN, Office of Cosmetics and Colors                                 730                     1                730                  1                730
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CFSAN, Office of Plant and Dairy Foods                                181                     1                181                1.5              271.5
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CFSAN, Office of Nutritional Products, Labeling and                   660                     1                660                1.5                990
 Dietary Supplements
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CFSAN, Office of Seafood                                              575                     1                575                1.5              862.5
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CVM                                                                   664                     1                664                  1                664
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Total                                                                                                                                             21,170
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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.


    Dated: January 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-845 Filed 1-24-06; 8:45 am]
BILLING CODE 4160-01-S