Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates, 68277-68278 [2014-26999]
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Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices
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with the FD&C Act. In the past,
commenters have argued that FDA’s
burden estimate is too low. FDA
carefully considered the issue and
believes that burden estimates of greater
than 20 hours are likely to include the
burden associated with researching and
generating safety data for a new dietary
ingredient. Under section 413(a)(2) of
the FD&C Act, a dietary supplement that
contains a new dietary ingredient is
deemed to be adulterated unless there is
a history of use or other evidence of
safety establishing that the new dietary
ingredient will reasonably be expected
to be safe under the conditions of use
recommended or suggested in the
labeling of the dietary supplement. This
requirement is separate from and
additional to the requirement to submit
a premarket notification for the new
dietary ingredient. FDA’s regulation on
new dietary ingredient notifications,
§ 190.6(a), requires the manufacturer or
distributor of the dietary supplement or
of the new dietary ingredient to submit
to FDA the information that forms the
basis for its conclusion that a dietary
supplement containing the new dietary
ingredient will reasonably be expected
to be safe. Thus, § 190.6 only requires
the manufacturer or distributor to
extract and summarize information that
should have already been developed to
meet the safety requirement in section
413(a)(2) of the FD&C Act. FDA
estimates that extracting and
summarizing the relevant information
from what exists in the company’s files
and presenting it in a format that meets
the requirements of § 190.6 will take
approximately 20 hours of work per
notification. However, FDA seeks
comments on this estimate. FDA
encourages comments offering
alternative burden estimates to include
documentation to support the
alternative estimate.
FDA further estimates that 55
respondents will submit 1 premarket
notification each. FDA bases its estimate
of the number of respondents on
notifications received over the past 3
years, which averaged about 55
notifications per year.
Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26998 Filed 11–13–14; 8:45 am]
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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.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
information collection requirements
imposed on firms that intend to export
to countries that require an export
certificate as a condition of entry for
FDA regulated products,
pharmaceuticals, biologics, and devices
as indicated in the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) as
amended.
DATES: Submit either electronic or
written comments on the collection of
information by January 13, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: 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
SUMMARY:
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68277
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, 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)
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68278
Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices
and 802 of the FD&C Act. FDA has
developed five 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:
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
‘‘Supplementary Information Certificate to Foreign Government Requests’’.
‘‘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’’ ................
For the export of products legally marketed in the United States.
‘‘Exporter’s Certification Statement Certificate to Foreign Government.’’
‘‘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
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.
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA center
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Center for Biologics Evaluation and Research ....................
Center for Devices and Radiological Health .......................
Center for Veterinary Medicine ............................................
2,114
6,463
855
1
1
1
2,114
6,463
855
1
2
1
2,114
12,926
855
Total ..............................................................................
........................
........................
........................
........................
15,895
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26999 Filed 11–13–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1819]
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Agency Information Collection
Activities; Proposed Collection;
Comment Request; Spousal Influence
on Consumer Understanding of and
Response to Direct-To-Consumer
Prescription Drug Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
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information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Spousal Influence on
Consumer Understanding of and
Response to Direct-To-Consumer (DTC)
Prescription Drug Advertisements.’’
This study will examine differences
between consumers viewing
prescription drug ads with a spouse or
partner versus alone through empirical
research.
Submit either electronic or
written comments on the collection of
information by January 13, 2015.
DATES:
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]]>Agencies
[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68277-68278]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26999]
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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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 information collection
requirements imposed on firms that intend to export to countries that
require an export certificate as a condition of entry for FDA regulated
products, pharmaceuticals, biologics, and devices as indicated in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.
DATES: Submit either electronic or written comments on the collection
of information by January 13, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: 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, 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)
[[Page 68278]]
and 802 of the FD&C Act. FDA has developed five 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:
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
States.
``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 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.
FDA estimates the burden of this collection of information as
follows:
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 2,114 1 2,114 1 2,114
and Research...................
Center for Devices and 6,463 1 6,463 2 12,926
Radiological Health............
Center for Veterinary Medicine.. 855 1 855 1 855
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Total....................... .............. .............. .............. .............. 15,895
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26999 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P
