Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, Exemptions From Substantial Equivalence Requirements, 76838-76840 [2013-30137]
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Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices
as test results or material review and
disposition records, because such
records are part of records, if they are
necessary, that will be kept for every
batch.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
111.14, records of personnel practices, including documentation of training .........................................................
111.23, records of physical plant sanitation practices, including pest control and water quality .............................
111.35, records of equipment and utensils calibration and
sanitation practices ...........................................................
111.95, records of production and process control systems
111.140, records that quality control personnel must make
and keep ...........................................................................
111.180, records associated with components, packaging,
labels, and product received for packaging and labeling
as a dietary supplement ...................................................
111.210, requirements for what the master manufacturing
record must include ..........................................................
111.260, requirements for what the batch record must include .................................................................................
111.325, records that quality control personnel must make
and keep for laboratory operations ..................................
111.375, records of the written procedures established for
manufacturing operations .................................................
111.430, records of the written procedures for packaging
and labeling operations ....................................................
111.475, records of product distribution and procedures
for holding and distributing operations .............................
111.535, records for returned dietary supplements ............
111.570, records regarding product complaints ..................
Total ..............................................................................
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
Number of
records per
recordkeeper
Total annual
records
Avg. burden
per recordkeeping
Total hours
15,000
4
60,000
1
60,000
15,000
1
15,000
0.2
3,000
400
250
1
1
400
250
12.5
45
5,000
11,250
240
1163
279,120
1
279,120
240
1163
279,120
1
279,120
240
1
240
2.5
600
145
1408
204,160
1
204,160
120
1
120
15
1,800
260
1
260
2
520
50
1
50
12.6
630
15,000
110
240
1
4
600
15,000
440
144,000
0.4
13.5
0.5
6,000
5,940
72,000
........................
........................
........................
........................
929,140
are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping
estimates in Table 1 of this document
are based on those in the June 25, 2007,
final rule, which were based on our
institutional experience with other
CGMP requirements and on data
provided by Research Triangle Institute
in the ‘‘Survey of Manufacturing
Practices in the Dietary Supplement
Industry’’ cited in that rule.
The estimates in Table 1 of the
number of firms affected by each
provision of part 111 are based on the
percentage of manufacturers, packagers,
labelers, holders, distributors, and
warehousers that reported in the survey
that they have not established written
SOPs or do not maintain records that
were later required by the June 25, 2007,
final rule. Because we do not have
survey results for general warehouses,
we entered the approximate number of
facilities in that category for those
provisions covering general facilities.
For the dietary supplement industry, the
survey estimated that 1,460 firms would
be covered by the final rule, including
manufacturers, packagers, labelers,
holders, distributors, and warehousers.
The time estimates include the burden
involved in documenting that certain
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requirements are performed and in
recordkeeping. We used an estimated
annual batch production of 1,408
batches per year to estimate the burden
of requirements that are related to the
number of batches produced annually,
such as § 111.260, ‘‘What must the batch
production record include?’’ The
estimate of 1,408 batches per year is
near the midpoint of the number of
annual batches reported by survey
firms.
The length of time that CGMP records
must be maintained is set forth in
§ 111.605. Table 1 of this document
reflects the estimated burdens for
written procedures, record maintenance,
periodically reviewing records to
determine if they may be discarded, and
for any associated documentation for
that activity for records that are required
under part 111. We have not included
a separate estimate of burden for those
sections that require maintaining
records in accordance with § 111.605,
but have included those burdens under
specific provisions for keeping records.
For example, § 111.255(a) requires that
the batch production records be
prepared every time a batch is
manufactured, and § 111.255(d) requires
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
that batch production records be kept in
accordance with § 111.605. The
estimated burdens for both § 111.255(a)
and (d) are included under § 111.260
(what the batch record must include).
Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30185 Filed 12–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1588]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Tobacco Products,
Exemptions From Substantial
Equivalence Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
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Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices
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
exemptions from substantial
equivalence requirements for tobacco
products.
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.
DATES:
Exemptions From Substantial
Equivalence Requirements for Tobacco
Products (OMB Control Number 0910–
0684)—Extension
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
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a chapter
granting FDA important authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
The FD&C Act, as amended by the
Tobacco Control Act, requires that
before a new tobacco product may be
introduced or delivered for introduction
into interstate commerce, a
manufacturer must submit a premarket
application to FDA, and FDA must issue
an order finding that the new product
may be introduced or delivered for
introduction into interstate commerce
(section 910 of the FD&C Act (21 U.S.C.
387j)). An order under section 910 is not
required, however, if a manufacturer
submits a report under section 905(j) of
the FD&C Act (21 U.S.C. 387e(j)
demonstrating the new tobacco
product’s substantial equivalence to an
appropriate predicate product, and FDA
issues an order finding the new product
to be substantially equivalent to the
predicate product and in compliance
with the requirements of the FD&C Act.
FDA has established a pathway for
manufacturers to request exemptions
from the substantial equivalence
requirements of the FD&C Act in
§ 1107.1 (21 CFR 1107.1) of the
Agency’s regulations. As described in
§ 1107.1(a), FDA may exempt tobacco
products that are modified by adding or
deleting a tobacco additive, or
increasing or decreasing the quantity of
an existing tobacco additive, from the
requirement of demonstrating
substantial equivalence if the Agency
determines that: (1) The modification
would be a minor modification of a
tobacco product; (2) a report
demonstrating substantial equivalence
is not necessary for the protection of
Submit either electronic or
written comments on the collection of
information by February 18, 2014.
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
emcdonald on DSK67QTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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76839
public health; and (3) an exemption is
otherwise appropriate.
Section 1107.1(b) states that a request
for exemption under section 905(j)(3) of
the FD&C Act may be made only by the
manufacturer of a legally marketed
tobacco product for a minor
modification to that tobacco product
and that the manufacturer must submit
the request and all information
supporting it to FDA. The request must
be made in an electronic format that
FDA can process, review, and archive
(or a written request must be made by
the manufacturer explaining in detail
why the company cannot submit the
request in an electronic format and
requesting an alternative means of
submission to the electronic format).
An exemption request must contain:
(1) The manufacturer’s address and
contact information; (2) identification of
the tobacco product(s); (3) a detailed
explanation of the purpose for the
modification; (4) a detailed description
of the modification, including a
statement as to whether the
modification involves adding or
deleting a tobacco additive, or
increasing or decreasing the quantity of
the existing tobacco additive; (5) a
detailed explanation of why the
modification is a minor modification of
a tobacco product that can be sold under
the FD&C Act; (6) a detailed explanation
of why a report under section 905(j)(1)
of the FD&C Act intended to
demonstrate substantial equivalence is
not necessary to ensure that permitting
the tobacco product to be marketed
would be appropriate for protection of
the public health; (7) a certification (i.e.,
a signed statement by a responsible
official of the company) summarizing
the supporting evidence and providing
the rationale for the official’s
determination that the modification
does not increase the tobacco product’s
appeal to or use by minors, toxicity,
addictiveness, or abuse liability; (8)
other information justifying an
exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR
part 25) prepared in accordance with
the requirements of § 25.40.
The National Environmental Policy
Act (NEPA) (42 U.S.C. 4321–4347) states
national environmental objectives and
imposes upon each Federal agency the
duty to consider the environmental
effects of its actions. Section 102(2)(C)
of NEPA requires the preparation of an
environmental impact statement for
every major Federal action that will
significantly affect the quality of the
human environment.
The FDA NEPA regulations are
contained in part 25. All applications
for exemption from substantial
E:\FR\FM\19DEN1.SGM
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76840
Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices
equivalence require the submission of
an EA. An EA provides information that
is used to determine whether an FDA
action could result in a significant
environmental impact. Section 25.40(a)
and (c) specifies the content
requirements for EAs for nonexcluded
actions.
The information required by
§ 1107.1(b) is submitted to FDA so FDA
can determine whether an exemption
from substantial equivalence to the
product is appropriate for the protection
of the public health. Section 1107.1(c)
states that FDA will review the
information submitted and determine
whether to grant or deny an exemption
based on whether the criteria in section
905(j)(3) of the FD&C Act are met. FDA
may request additional information if
necessary to make a determination and
may consider the exemption request
withdrawn if the information is not
provided within the requested
timeframe.
Section 1107.1(d) provides that FDA
may rescind an exemption where
necessary to protect the public health.
Section 905(j)(1)(A)(ii) of the FD&C
Act states that if an exemption has been
requested and granted, a report must be
submitted to FDA that demonstrates that
the tobacco product is modified within
the meaning of section 905(j)(3), the
modifications are to a product that is
commercially marketed and in
compliance with the requirements of the
FD&C Act, and all of the modifications
are covered by exemptions granted by
the Secretary pursuant to section
905(j)(3).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
21 CFR 1107.1(b): Preparation of tobacco product exemption from substantial equivalence request .......................
21 CFR 1107.1(c): Preparation of additional information
for tobacco product exemption from substantial equivalence request ....................................................................
21 CFR 25.40: Preparation of an environmental assessment ..................................................................................
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption
granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are
to a product that is commercially marketed and compliant product, and modifications are covered by exemptions granted by Secretary pursuant to section 905(j)(3).
Total ..............................................................................
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
500
1
500
12
6,000
150
1
150
3
450
500
1
500
12
6,000
750
1
750
3
2,250
........................
........................
........................
........................
14,700
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 500 requests for
exemption will be submitted annually,
and that it will take approximately 12
hours to prepare an exemption request.
FDA also estimates that up to 30 percent
(150) of the initial requests for
information may require additional
information in support of the initial
exemption request, and it is expected
that it will take an average of 3 hours
to prepare the additional information.
FDA also estimates that 750
manufacturers will take approximately
12 hours to prepare and submit an EA
under part 25 in accordance with the
requirements of § 25.40, as referenced in
§ 1107.1(b)(9).
FDA estimates that 750 respondents
will take 3 hours to prepare a report
under section 905(j)(1)(A)(ii) of the
FD&C Act, which requires a
manufacturer to submit a report at least
90 days prior to making an introduction
or delivery into interstate commerce for
commercial distribution of a tobacco
product. The report will contain the
manufacturer’s basis that the tobacco
product is modified within the meaning
of section 905(j)(3) of the FD&C Act, the
modifications are to a product that is
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Jkt 232001
commercially marketed and compliant
with the FD&C Act, the modifications
are covered by exemptions granted
pursuant to section 905(j)(3), and a
listing of actions taken to comply with
any applicable requirements of section
907 of the FD&C Act. FDA’s estimates
are based on experience with and
information on other FDA-regulated
products and indications from industry.
Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30137 Filed 12–18–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0636]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Unique Device Identification System
Food and Drug Administration,
HHS.
PO 00000
Frm 00031
Fmt 4703
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Unique Device Identification System’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUMMARY:
On
September 30, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Unique Device
Identification System’’ to OMB for
review and clearance under 44 U.S.C.
3507. 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. OMB has now
approved the information collection and
has assigned OMB control number
0910–0720. The approval expires on
December 31, 2016. A copy of the
supporting statement for this
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–P
AGENCY:
ACTION:
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]]>Agencies
[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76838-76840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1588]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Products, Exemptions From Substantial
Equivalence Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the
[[Page 76839]]
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 exemptions from substantial equivalence requirements for tobacco
products.
DATES: Submit either electronic or written comments on the collection
of information by February 18, 2014.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Exemptions From Substantial Equivalence Requirements for Tobacco
Products (OMB Control Number 0910-0684)--Extension
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by adding a chapter granting FDA
important authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, a manufacturer must submit a
premarket application to FDA, and FDA must issue an order finding that
the new product may be introduced or delivered for introduction into
interstate commerce (section 910 of the FD&C Act (21 U.S.C. 387j)). An
order under section 910 is not required, however, if a manufacturer
submits a report under section 905(j) of the FD&C Act (21 U.S.C.
387e(j) demonstrating the new tobacco product's substantial equivalence
to an appropriate predicate product, and FDA issues an order finding
the new product to be substantially equivalent to the predicate product
and in compliance with the requirements of the FD&C Act.
FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec. 1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec. 1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that: (1) The modification would be a minor modification of
a tobacco product; (2) a report demonstrating substantial equivalence
is not necessary for the protection of public health; and (3) an
exemption is otherwise appropriate.
Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
tobacco product and that the manufacturer must submit the request and
all information supporting it to FDA. The request must be made in an
electronic format that FDA can process, review, and archive (or a
written request must be made by the manufacturer explaining in detail
why the company cannot submit the request in an electronic format and
requesting an alternative means of submission to the electronic
format).
An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec. 25.40.
The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347)
states national environmental objectives and imposes upon each Federal
agency the duty to consider the environmental effects of its actions.
Section 102(2)(C) of NEPA requires the preparation of an environmental
impact statement for every major Federal action that will significantly
affect the quality of the human environment.
The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial
[[Page 76840]]
equivalence require the submission of an EA. An EA provides information
that is used to determine whether an FDA action could result in a
significant environmental impact. Section 25.40(a) and (c) specifies
the content requirements for EAs for nonexcluded actions.
The information required by Sec. 1107.1(b) is submitted to FDA so
FDA can determine whether an exemption from substantial equivalence to
the product is appropriate for the protection of the public health.
Section 1107.1(c) states that FDA will review the information submitted
and determine whether to grant or deny an exemption based on whether
the criteria in section 905(j)(3) of the FD&C Act are met. FDA may
request additional information if necessary to make a determination and
may consider the exemption request withdrawn if the information is not
provided within the requested timeframe.
Section 1107.1(d) provides that FDA may rescind an exemption where
necessary to protect the public health.
Section 905(j)(1)(A)(ii) of the FD&C Act states that if an
exemption has been requested and granted, a report must be submitted to
FDA that demonstrates that the tobacco product is modified within the
meaning of section 905(j)(3), the modifications are to a product that
is commercially marketed and in compliance with the requirements of the
FD&C Act, and all of the modifications are covered by exemptions
granted by the Secretary pursuant to section 905(j)(3).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
21 CFR 1107.1(b): Preparation of 500 1 500 12 6,000
tobacco product exemption from
substantial equivalence request
21 CFR 1107.1(c): Preparation of 150 1 150 3 450
additional information for
tobacco product exemption from
substantial equivalence request
21 CFR 25.40: Preparation of an 500 1 500 12 6,000
environmental assessment.......
Section 905(j)(1)(A)(ii) of the 750 1 750 3 2,250
FD&C Act: If exemption granted,
report submitted to demonstrate
tobacco product is modified
under section 905(j)(3),
modifications are to a product
that is commercially marketed
and compliant product, and
modifications are covered by
exemptions granted by Secretary
pursuant to section 905(j)(3)..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 14,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that 500 requests for exemption will be submitted
annually, and that it will take approximately 12 hours to prepare an
exemption request. FDA also estimates that up to 30 percent (150) of
the initial requests for information may require additional information
in support of the initial exemption request, and it is expected that it
will take an average of 3 hours to prepare the additional information.
FDA also estimates that 750 manufacturers will take approximately 12
hours to prepare and submit an EA under part 25 in accordance with the
requirements of Sec. 25.40, as referenced in Sec. 1107.1(b)(9).
FDA estimates that 750 respondents will take 3 hours to prepare a
report under section 905(j)(1)(A)(ii) of the FD&C Act, which requires a
manufacturer to submit a report at least 90 days prior to making an
introduction or delivery into interstate commerce for commercial
distribution of a tobacco product. The report will contain the
manufacturer's basis that the tobacco product is modified within the
meaning of section 905(j)(3) of the FD&C Act, the modifications are to
a product that is commercially marketed and compliant with the FD&C
Act, the modifications are covered by exemptions granted pursuant to
section 905(j)(3), and a listing of actions taken to comply with any
applicable requirements of section 907 of the FD&C Act. FDA's estimates
are based on experience with and information on other FDA-regulated
products and indications from industry.
Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30137 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P
