Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates, 6728-6729 [2015-02348]
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ACTION:
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
Notice of meeting.
Thursday, February 19, 2015
from 9:00 a.m. to 4:30 p.m.; and Friday,
February 20, 2015 from 9:00 a.m. to 2:00
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when prompted enter pass code:
3656064. Individuals whose full
participation in the meeting will require
special accommodations (e.g., sign
language interpreting services, assistive
listening devices, materials in
alternative format such as large print or
Braille) should notify Dr. MJ Karimi,
PCPID Team Lead, via email at
MJ.Karimie@acl.hhs.gov, or via
telephone at 202–357–3588, no later
than Friday, February 13, 2015. The
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Agenda: The Committee Members
will discuss preparation of the PCPID
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its content and format, and related data
collection and analysis required to
complete the writing of the Report. They
will also receive presentations from
selected experts in the field of
Technology for People with Intellectual
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Additional Information: For further
information, please contact Dr. MJ
Karimi, Team Lead, President’s
Committee for People with Intellectual
Disabilities, One Massachusetts Avenue
NW., Room 4206, Washington, DC
20201. Telephone: 202–357–3588. Fax:
202–205–8037. Email: MJ.Karimie@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: The
PCPID acts in an advisory capacity to
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the Administration on Intellectual and
Developmental Disabilities, on a broad
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DATES:
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range of topics relating to programs,
services and supports for persons with
intellectual disabilities. The PCPID
Executive Order stipulates that the
Committee shall: (1) Provide such
advice concerning intellectual
disabilities as the President or the
Secretary of Health and Human Services
may request; and (2) provide advice to
the President concerning the following
for people with intellectual disabilities:
(A) Expansion of educational
opportunities; (B) promotion of
homeownership; (C) assurance of
workplace integration; (D) improvement
of transportation options; (E) expansion
of full access to community living; and
(F) increasing access to assistive and
universally designed technologies.
Dated: January 28, 2015.
Aaron Bishop,
Commissioner, Administration on Intellectual
and Developmental Disabilities (AIDD).
[FR Doc. 2015–02514 Filed 2–5–15; 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
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 9,
2015.
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
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
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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.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 and Enhancement
Act of 1996’’ (FDAERA) amended
sections 801(e) and 802 of the 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 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.
This section of the FD&C 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 FD&C Act. FDA has
developed four types of certificates that
satisfy the requirements of section
801(e)(4)(B) of the FD&C Act: (1)
Certificates to Foreign Governments, (2)
Certificates of Exportability, (3)
Certificates of a Pharmaceutical Product,
and (4) Non-Clinical Research Use Only
Certificates. Table 1 of this document
lists the different certificates and details
their use:
E:\FR\FM\06FEN1.SGM
06FEN1
6729
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / 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 of this document. 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
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.
penalties including up to $250,000 in
fines and up to 5 years imprisonment.
In the Federal Register of November
14, 2014 (79 FR 68277), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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. Making or
submitting to FDA false statements on
any documents may constitute
violations of 18 U.S.C. 1001, with
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA center and FDA form
Center for Biologics Evaluation and Research ....................
FDA 3613.
FDA 3613a.
FDA 3613b.
FDA 3613c.
Center for Devices and Radiological Health .......................
FDA 3613.
FDA 3613a.
FDA 3613c.
Center for Veterinary Medicine ............................................
FDA 3613.
FDA 3613a.
FDA 3613b.
Total ..............................................................................
1 There
Total annual
responses
Average
burden per
response
Total hours
2,114
1
2,114
1
2,114
10,528
1
10,528
2
21,056
855
1
855
1
855
........................
........................
........................
........................
24,025
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02348 Filed 2–5–15; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Number of
responses per
respondent
BILLING CODE 4164–01–P
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2014–N–1168]
Generic Drug User Fee Amendments of
2012; September 2014 Public Hearing
on Policy Development; Reopening of
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
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19:53 Feb 05, 2015
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Notice; reopening of docket;
request for comments.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
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The Food and Drug
Administration (FDA) is announcing the
reopening of the docket to solicit public
comment on certain topics related to
implementation of the Generic Drug
User Fee Amendments of 2012 (GDUFA)
and the GDUFA Commitment Letter that
accompanies the legislation. A public
hearing in September 2014 provided an
opportunity for public input on future
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]]>Agencies
[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6728-6729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02348]
-----------------------------------------------------------------------
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
9, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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, a law entitled ``The FDA Export Reform and
Enhancement Act of 1996'' (FDAERA) amended sections 801(e) and 802 of
the 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 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.
This section of the FD&C 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 FD&C
Act. FDA has developed four types of certificates that satisfy the
requirements of section 801(e)(4)(B) of the FD&C Act: (1) Certificates
to Foreign Governments, (2) Certificates of Exportability, (3)
Certificates of a Pharmaceutical Product, and (4) Non-Clinical Research
Use Only Certificates. Table 1 of this document lists the different
certificates and details their use:
[[Page 6729]]
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.
------------------------------------------------------------------------
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 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 FDA's Office of Criminal
Investigations for follow up. 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.
In the Federal Register of November 14, 2014 (79 FR 68277), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FDA center and FDA form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation 2,114 1 2,114 1 2,114
and Research...................
FDA 3613....................
FDA 3613a...................
FDA 3613b...................
FDA 3613c...................
Center for Devices and 10,528 1 10,528 2 21,056
Radiological Health............
FDA 3613....................
FDA 3613a...................
FDA 3613c...................
Center for Veterinary Medicine.. 855 1 855 1 855
FDA 3613....................
FDA 3613a...................
FDA 3613b...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 24,025
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: January 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02348 Filed 2-5-15; 8:45 am]
BILLING CODE 4164-01-P
