Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, 33196-33197 [2014-13434]
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33196
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
General population ..........................................
CMEP-Respect grantees ................................
General Population .........................................
CMEP-Respect grantees ................................
90-Day Follow-Up Survey ..............................
90-Day SDN Submission ...............................
180-day Follow-up Survey .............................
180-Day SDN Submission .............................
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
Dr., PI50–400B, Rockville, MD 20850,
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.
[FR Doc. 2014–13396 Filed 6–9–14; 8:45 am]
BILLING CODE 4163–18–P
Guidance for Industry and Food and
Drug Administration Staff on Section
905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products—(OMB Control Number 0910–
0673)—(Extension)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1558]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
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 July 10,
2014.
SUMMARY:
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 0910–0673. Also
include the FDA docket number found
in brackets in the heading of this
document.
emcdonald on DSK67QTVN1PROD with NOTICES
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
FOR FURTHER INFORMATION CONTACT:
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On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the 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 new chapter
granting FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 905(j) of the FD&C Act (21
U.S.C. 387e(j)) authorizes FDA to
establish the form for the submission of
information related to substantial
equivalence. In a level 1 guidance
document issued under the Good
Guidances Practices regulation (21 CFR
10.115), FDA provides
recommendations intended to assist
persons submitting reports under
section 905(j) of the FD&C Act and
explains, among other things, FDA’s
interpretation of the statutory sections
related to substantial equivalence.
In the Federal Register of December
27, 2013 (78 FR 78974), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Six comment submissions
were received, some of which included
multiple comments. Two of the six
comment submissions were in favor of
FDA’s regulation of tobacco products.
Three comment submissions were
considered to contain PRA-related
comments and three comment
submission were not considered to
contain PRA-related comments. The
three comment submissions not
considered to contain PRA-related
PO 00000
Frm 00026
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320
4
320
4
Number of
responses per
respondent
1
12
1
12
Average
burden per
response
(in hrs)
18/60
5/60
18/60
5/60
comments are beyond the scope of this
Federal Register notice.
(Comment 1) One commenter
supported FDA in its mission to regulate
tobacco products for the benefit of
public health and safety and indicated
that language in the guidance be
strengthened to assist in FDA reviews.
The commenter also suggested that the
respondents provide additional
information to minimize future Freedom
of Information Act requests.
(Response 1) FDA agrees that the
request in this collection of information
is necessary to fulfill the requirements
of the FD&C Act. The type of data for
a given new product may vary
depending on whether the
characteristics of the product are the
same or different from a predicate
tobacco product, and the information is
needed to allow FDA to make informed
decisions when reviewing a substantial
equivalence application.
(Comment 2) Several commenters
indicated that FDA has improperly
implemented the substantial
equivalence provisions of the statute
(the FD&C Act, as amended by the
Family Smoking Prevention and
Tobacco Control Act (FSPTCA)), and
maintain that FDA is asking for reports
that are neither authorized nor relevant
to a substantial equivalence
determination.
(Response 2) FDA disagrees with the
comment. The information FDA is
requesting is related to new products
using the substantial equivalence
pathway to assist FDA in making a
determination of whether a product is
substantially equivalent.
(Comment 3) Several commenters
asserted that FDA was not asking for
enough information, while other
commenters asserted that FDA was
asking for too much information.
(Response 3) FDA believes that the
collection of information is necessary
and the burden estimates are
appropriate and reflect the amount of
time a respondent would need to
prepare a substantial equivalence
submission.
(Comment 4) One commenter noted
that under FDA’s interpretation, every
new, including modified, product
E:\FR\FM\10JNN1.SGM
10JNN1
33197
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
automatically will be evaluated. Other
commenters questioned FDA’s
implementation and Congress’ intent of
the FSPTCA and its definition of
substantial equivalence and new
products.
(Response 4) The FD&C Act as
amended by the FSPTCA establishes the
definition of ‘‘new tobacco product’’
and the premarket pathways, of which
substantial equivalence is one. FDA
believes the information collection
estimates are appropriate and reflect
estimates of the time it would take to
put together and report the information
needed in a substantial equivalence
submission required by the statute.
(Comment 5) One commenter stated
that the commenter believes that
substantial equivalence reports should
be exempt from environmental
assessment requirements.
(Response 5) The National
Environmental Policy Act and FDA
implementing regulations require
environmental assessment
requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act sections
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
905(j)(1)(A)(i) and 910(a) .....................................................
1,000
1
1,000
360
360,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
Food and Drug Administration
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 for
humanitarian use devices (HUDs).
DATES: Submit either electronic or
written comments on the collection of
information by August 11, 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
[Docket No. FDA–2011–N–0619]
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
This collection of information
implements the HUD provision of
section 520(m) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360j(m)) and subpart H, part
814 (21 CFR part 814). Under section
520(m) of the FD&C Act, FDA is
authorized to exempt an HUD from the
effectiveness requirements of sections
514 and 515 of the FD&C Act (21 U.S.C.
360d and 360e) provided that the
device: (1) Is used to treat or diagnose
a disease or condition that affects fewer
than 4,000 individuals in the United
States; (2) would not be available to a
FDA has based these estimates on
information it now has available from
interactions with the industry,
information related to other regulated
products, and FDA’s expectations
regarding the tobacco industry’s use of
the section 905(j) pathway to market
their products. Table 1 describes the
annual reporting burden as a result of
the implementation of the substantial
equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21
U.S.C. 387j(a)). FDA estimates that it
will receive 1,000 section 905(j) reports
each year and that it will take a
manufacturer approximately 360 hours
to prepare a report of substantial
equivalence for a new tobacco product.
Therefore, FDA estimates the burden for
submission of substantial equivalence
information will be 360,000 hours.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13434 Filed 6–9–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK67QTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Humanitarian Use Devices
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
SUMMARY:
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16:55 Jun 09, 2014
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Medical Devices; Humanitarian Use
Devices—21 CFR 814 (OMB Control
Number 0910–0332)—Extension
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]]>Agencies
[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33196-33197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1558]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products
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 July
10, 2014.
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 0910-0673.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Guidance for Industry and Food and Drug Administration Staff on Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products--(OMB Control Number 0910-0673)--(Extension)
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the 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 new chapter granting
FDA authority to regulate the manufacture, marketing, and distribution
of tobacco products to protect the public health generally and to
reduce tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C.
387e(j)) authorizes FDA to establish the form for the submission of
information related to substantial equivalence. In a level 1 guidance
document issued under the Good Guidances Practices regulation (21 CFR
10.115), FDA provides recommendations intended to assist persons
submitting reports under section 905(j) of the FD&C Act and explains,
among other things, FDA's interpretation of the statutory sections
related to substantial equivalence.
In the Federal Register of December 27, 2013 (78 FR 78974), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Six comment submissions were received, some
of which included multiple comments. Two of the six comment submissions
were in favor of FDA's regulation of tobacco products. Three comment
submissions were considered to contain PRA-related comments and three
comment submission were not considered to contain PRA-related comments.
The three comment submissions not considered to contain PRA-related
comments are beyond the scope of this Federal Register notice.
(Comment 1) One commenter supported FDA in its mission to regulate
tobacco products for the benefit of public health and safety and
indicated that language in the guidance be strengthened to assist in
FDA reviews. The commenter also suggested that the respondents provide
additional information to minimize future Freedom of Information Act
requests.
(Response 1) FDA agrees that the request in this collection of
information is necessary to fulfill the requirements of the FD&C Act.
The type of data for a given new product may vary depending on whether
the characteristics of the product are the same or different from a
predicate tobacco product, and the information is needed to allow FDA
to make informed decisions when reviewing a substantial equivalence
application.
(Comment 2) Several commenters indicated that FDA has improperly
implemented the substantial equivalence provisions of the statute (the
FD&C Act, as amended by the Family Smoking Prevention and Tobacco
Control Act (FSPTCA)), and maintain that FDA is asking for reports that
are neither authorized nor relevant to a substantial equivalence
determination.
(Response 2) FDA disagrees with the comment. The information FDA is
requesting is related to new products using the substantial equivalence
pathway to assist FDA in making a determination of whether a product is
substantially equivalent.
(Comment 3) Several commenters asserted that FDA was not asking for
enough information, while other commenters asserted that FDA was asking
for too much information.
(Response 3) FDA believes that the collection of information is
necessary and the burden estimates are appropriate and reflect the
amount of time a respondent would need to prepare a substantial
equivalence submission.
(Comment 4) One commenter noted that under FDA's interpretation,
every new, including modified, product
[[Page 33197]]
automatically will be evaluated. Other commenters questioned FDA's
implementation and Congress' intent of the FSPTCA and its definition of
substantial equivalence and new products.
(Response 4) The FD&C Act as amended by the FSPTCA establishes the
definition of ``new tobacco product'' and the premarket pathways, of
which substantial equivalence is one. FDA believes the information
collection estimates are appropriate and reflect estimates of the time
it would take to put together and report the information needed in a
substantial equivalence submission required by the statute.
(Comment 5) One commenter stated that the commenter believes that
substantial equivalence reports should be exempt from environmental
assessment requirements.
(Response 5) The National Environmental Policy Act and FDA
implementing regulations require environmental assessment requirements.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FD&C Act sections Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
905(j)(1)(A)(i) and 910(a)......................................... 1,000 1 1,000 360 360,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA's expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA estimates
that it will receive 1,000 section 905(j) reports each year and that it
will take a manufacturer approximately 360 hours to prepare a report of
substantial equivalence for a new tobacco product. Therefore, FDA
estimates the burden for submission of substantial equivalence
information will be 360,000 hours.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13434 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P
