Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates, 7195-7196 [2018-03346]
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Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
Persons interested in seeing the
complete Staff Manual Guide can find it
on FDA’s website at: https://
www.fda.gov/AboutFDA/Reports
ManualsForms/StaffManualGuides/
default.htm.
Dated: December 21, 2017.
Eric D. Hargan
Acting Secretary of Health and Human
Services.
[FR Doc. 2018–03402 Filed 2–16–18; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0161]
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.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
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 March 22,
2018.
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–
395–7285, or emailed to oira_
submission@omb.eop.gov. 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:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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, 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
7195
designed to ease restrictions on
exportation of unapproved
pharmaceuticals, biologics, and devices
regulated by FDA. Section 801(e)(4) of
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:
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
sradovich on DSK3GMQ082PROD with NOTICES
‘‘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)’’
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17:55 Feb 16, 2018
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Frm 00060
Fmt 4703
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.
Sfmt 4703
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20FEN1
7196
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
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
FD&C Act, not only at the time that they
submit their request to the appropriate
In the Federal Register of November
27, 2017 (82 FR 56031), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. The burden hours have
decreased from the previous approval.
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
Total
annual
responses
Average
burden per
response
Total hours
Biologics Evaluation and Research ....................
Devices and Radiological Health .......................
Drug Evaluation and Research ..........................
Veterinary Medicine ............................................
2,651
11,175
3,680
1,925
1
1
1
1
2,651
11,175
3,680
1,925
1
2
1
1
2,651
22,350
3,680
1,925
Total ..............................................................................
........................
........................
........................
........................
30,606
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03346 Filed 2–16–18; 8:45 am]
during the regulatory review period by
August 20, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
BILLING CODE 4164–01–P
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–1187]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MAESTRO
RECHARGEABLE SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Electronic Submissions
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for MAESTRO RECHARGEABLE
SYSTEM and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
medical device.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 23, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:55 Feb 16, 2018
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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 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.
Jkt 244001
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
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.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
• 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–
2016–E–1187 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; MAESTRO
RECHARGEABLE SYSTEM.’’ 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
E:\FR\FM\20FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7195-7196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03346]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0161]
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.
-----------------------------------------------------------------------
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 March
22, 2018.
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: 202-395-7285, or emailed 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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, 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 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:
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''. product, material, or
``Exporter's Certification Statement component that is not intended
(Non-Clinical Research Use Only)''. for human use which may be
marketed in, and legally
exported from the United
States under the FD&C Act.
------------------------------------------------------------------------
[[Page 7196]]
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.
In the Federal Register of November 27, 2017 (82 FR 56031), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. The burden hours
have decreased from the previous approval.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FDA Center Number of responses per Total annual burden per Total hours
respondents respondent responses 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.. 1,925 1 1,925 1 1,925
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 30,606
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03346 Filed 2-16-18; 8:45 am]
BILLING CODE 4164-01-P
