[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56031-56033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25456]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 export certificates for the export of FDA-
regulated products.

DATES: Submit either electronic or written comments on the collection 
of information by January 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 26, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such

[[Page 56032]]

as a manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0161 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Export of Food and Drug 
Administration-Regulated Products: Export Certificates.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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, the FDA Export, Reform, and Enhancement Act of 1996 
(FDAERA) (Pub. L. 104-134) amended sections 801(e) and 802 of the 
Federal Food, Drug, and Cosmetic Act (FD&C 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 sections 801(e) and 802 or other requirements of 
the FD&C 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. In January 2011, section 
801(e)(4)(A) was amended by the FDA Food Safety Modernization Act (Pub. 
L. 111-353) to provide authorization for export certification fees for 
food and animal feed.
    This section of the FD&C Act authorizes FDA to issue export 
certificates for regulated food, animal feed, 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 FD&C Act. FDA has developed various types of 
certificates that satisfy the requirements of section 801(e)(4)(B) of 
the FD&C Act. Four of those certificates are discussed in this notice: 
(1) Certificates to Foreign Governments, (2) Certificates of 
Exportability, (3) Certificates of a Pharmaceutical Product, and (4) 
Non-Clinical Research Use Only Certificates. FDA has updated the 
certificates as part of the proposed collection of information to 
account for the amendment authorizing export certification fees for 
food and animal feed. Table 1 lists the different certificates and 
details their uses:

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                     Table 1--Certificates and Uses
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          Type of certificate                          Use
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``Supplementary Information Certificate  For the export of products
 to Foreign Government Requests``,        legally marketed in the United
 ``Exporter's Certification Statement     States.
 Certificate to Foreign Government``,
 ``Exporter's Certification Statement
 Certificate to Foreign Government (For
 Human Tissue Intended for
 Transplantation)``.
``Supplementary Information Certificate  For the export of products not
 of Exportability Requests``,             approved for marketing in the
 Exporter's Certification Statement       United States (unapproved
 Certificate of Exportability''.          products) that meet the
                                          requirements of sections
                                          801(e) or 802 of the FD&C Act.
``Supplementary Information Certificate  Conforms to the format
 of a Pharmaceutical Product``,           established by the World
 ``Exporter's Certification Statement     Health Organization and is
 Certificate of a Pharmaceutical          intended for use by the
 Product``.                               importing country when the
                                          product in question is under
                                          consideration 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 Research Use Only               clinical research use only
 Certificate``, ``Exporter's              product, material, or
 Certification Statement (Non-Clinical    component that is not intended
 Research Use Only)``.                    for human use which may be
                                          marketed in, and legally
                                          exported from the United
                                          States under the FD&C Act.
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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. 
Manufacturers are requested to self-certify that they are in compliance 
with all applicable requirements of the FD&C 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 the appropriate offices.

                                  Table 2--Estimated Annual Reporting Burden 1
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                                                     Number of
           FDA center                Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
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Center for Biologics Evaluation            2,651               1           2,651               1           2,651
 and Research...................
Center for Devices and                    11,175               1          11,175               2          22,350
 Radiological Health............
Center for Drug Evaluation and             3,680               1           3,680               1           3,680
 Research.......................
Center for Veterinary Medicine..           1,819               1           1,819               1           1,819
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    Total.......................  ..............  ..............  ..............  ..............          30,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25456 Filed 11-24-17; 8:45 am]
 BILLING CODE 4164-01-P