Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates, 56031-56033 [2017-25456]
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Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
Estimated Total/Annual Burden
Hours: 244.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017–25444 Filed 11–24–17; 8:45 am]
BILLING CODE 4184–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–N–0601, FDA–
2010–N–0598, FDA–2010–N–0600, FDA–
2007–N–0037, FDA–2010–N–0597, FDA–
2011–N–0017, and FDA–2016–N–2496]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in Table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Current Good Manufacturing Practice for Medicated Feeds ......................................................................
Current Good Manufacturing Practice for Type A Medicated Articles ........................................................
Animal Drug User Fee Cover Sheet, Form FDA 3546 ...............................................................................
Animal Drug User Fee Waivers and Reductions ........................................................................................
Index of Legally Marketed Unappropriated New Animal Drugs for Minor Species ....................................
Voluntary National Retail Food Regulatory Program Standards ................................................................
Impact Trade Auxiliary Communication System .........................................................................................
Dated: November 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25452 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
[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.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
VerDate Sep<11>2014
16:59 Nov 24, 2017
Jkt 244001
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.
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
DATES:
PO 00000
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Fmt 4703
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0910–0152
0910–0154
0910–0539
0910–0540
0910–0620
0910–0621
0910–0842
Date
approval
expires
8/31/2020
8/31/2020
8/31/2020
8/31/2020
8/31/2020
8/31/2020
8/31/2020
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
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Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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 AdministrationRegulated 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
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16:59 Nov 24, 2017
Jkt 244001
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/201523389.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, PRAStaff@
fda.hhs.gov.
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
PO 00000
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Fmt 4703
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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) NonClinical 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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Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
‘‘Supplementary Information Certificate to Foreign Government 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 Certificate of Exportability Requests‘‘, Exporter’s Certification Statement Certificate of Exportability’’.
‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘,
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical
Product‘‘.
‘‘Supplementary Information Non-Clinical Research Use Only Certificate‘‘, ‘‘Exporter’s Certification Statement (Non-Clinical Research
Use Only)‘‘.
FDA will continue to rely on selfcertification 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
For the export of products legally marketed in the United States.
For the export of products not approved for marketing in the United
States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act.
Conforms to the format established by the World Health Organization
and is intended for use by the 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.
For the export of a non-clinical research use only product, material, or
component that is not intended for human use which may be marketed in, and legally exported from the United States under the
FD&C Act.
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
Number of
respondents
FDA center
Center
Center
Center
Center
for
for
for
for
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Biologics Evaluation and Research ....................
Devices and Radiological Health .......................
Drug Evaluation and Research ..........................
Veterinary Medicine ............................................
2,651
11,175
3,680
1,819
1
1
1
1
2,651
11,175
3,680
1,819
1
2
1
1
2,651
22,350
3,680
1,819
Total ..............................................................................
........................
........................
........................
........................
30,500
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.
Homogenous Cases of Product Without
a Product Identifier.’’ This draft
guidance specifies whether and under
what circumstances packages and
homogenous cases of product not
labeled with a product identifier shall
be exempted, as grandfathered, from
certain requirements of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
[FR Doc. 2017–25456 Filed 11–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Grandfathering Policy for Packages
and Homogenous Cases of Product
Without a Product Identifier; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
VerDate Sep<11>2014
16:59 Nov 24, 2017
Jkt 244001
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
draft guidance for industry entitled
‘‘Grandfathering Policy for Packages and
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by January 26, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments concerning the collection of
information proposed in the draft
guidance by January 26, 2018.
DATES:
[Docket No. FDA–2017–D–6526]
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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Sfmt 4703
• 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
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
E:\FR\FM\27NON1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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,
PRAStaff@fda.hhs.gov.
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:
[[Page 56033]]
Table 1--Certificates and Uses
------------------------------------------------------------------------
Type of certificate Use
------------------------------------------------------------------------
``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.
------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of
FDA center Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
