Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 20026-20030 [2012-7908]
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20026
Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices
6004. The draft guidance notifies
entities covered by section 6004 that
FDA does not intend to object until at
least October 1, 2012, if manufacturers
and ADRs do not submit information
under section 6004 and that we intend
to provide notice before revising our
exercise of discretion with respect to
compliance. The draft guidance also
notifies covered entities that FDA plans
to use its Electronic Submission
Gateway (the Gateway) for submissions
under section 6004 and that revisions to
allow the Gateway to receive such
submissions should be complete by
April 1, 2012. Should covered entities
wish to make such submissions
notwithstanding FDA’s compliance
policy, the draft guidance provides
information about accessing the
Gateway. The Agency expects to issue
further draft guidance concerning the
requirements of section 6004 later in
2012.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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III. Paperwork Reduction Act of 1995
This draft guidance regarding Agency
compliance policy refers to information
collections under section 6004 that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). As
noted, the Agency is also preparing a
draft guidance for release later this year
to provide additional information
regarding submissions under section
6004. In accordance with the PRA, prior
to publication of a final guidance
document, FDA intends to solicit public
comment and obtain OMB approval for
any new information collections under
section 6004.
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IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: March 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–7912 Filed 3–29–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0071]
Draft Guidance for Industry: Modified
Risk Tobacco Product Applications;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Modified Risk
Tobacco Product Applications.’’ The
draft guidance provides information
about submitting applications for
modified risk tobacco products under
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act). The draft guidance
describes the information that the FD&C
Act requires you to submit in your
modified risk tobacco product
application and the scientific evidence
FDA recommends you submit to
support your application. The draft
guidance also permits the filing of a
single application for any modified risk
tobacco product that is also a new
tobacco product under the FD&C Act.
DATES: Although you can submit written
or electronic comments on this guidance
at any time (see 21 CFR 10.115(g)(5)), to
ensure that the Agency considers your
comment on this draft guidance before
it begins work on the final version of the
guidance, submit electronic or written
comments on the draft guidance by June
4, 2012. Submit electronic or written
comments on the proposed collection of
information by June 4, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance
SUMMARY:
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document entitled ‘‘Modified Risk
Tobacco Product Applications’’ to the
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229. Send
one self-addressed adhesive label to
assist that office in processing your
request or include a fax number to
which the draft guidance may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance, including comments on
the proposed collection of information,
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Gail
Schmerfeld or Kristin Davis, Center for
Tobacco Products, 9200 Corporate
Blvd., Rockville, MD 20850–3229, 1–
877–287–1373,
gail.schmerfeld@fda.hhs.gov or
kristin.davis@fda.hhs.gov.
With regard to the proposed collection
of information: Daniel Gittleson, Office
of Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Pub. L. 111–
31) (Tobacco Control Act) into law. The
Tobacco Control Act grants FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health
generally and to reduce tobacco use by
minors. Congress found that it is
essential that, prior to marketing
tobacco products for use to reduce harm
or the risk of tobacco-related disease or
to reduce exposure to harmful
substances associated with tobacco
products, manufacturers be required to
‘‘demonstrate that such products * * *
meet a series of rigorous criteria, and
will benefit the health of the population
as a whole’’ (section 2(36) of the
Tobacco Control Act). Thus, section 101
of the Tobacco Control Act added
section 911 (21 U.S.C. 387k) to the
FD&C Act to prohibit the introduction
or delivery for introduction into
interstate commerce of any modified
risk tobacco product unless an order
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issued by FDA pursuant to section
911(g) of the FD&C Act is effective with
respect to such product. A modified risk
tobacco product is any tobacco product
that is sold or distributed for use to
reduce harm or the risk of tobaccorelated disease associated with
commercially marketed tobacco
products (section 911(b)(1) of the FD&C
Act).
Section 911(l)(1) of the FD&C Act
directs FDA to issue regulations or
guidance (or any combination thereof)
on the scientific evidence required for
assessment and ongoing review of
modified risk tobacco products. FDA is
issuing this draft guidance in
compliance with section 911(l)(1).
When finalized, the draft guidance will
provide industry with information on
who submits modified risk tobacco
product applications (MRTPAs), when
to submit a MRTPA, what information
section 911 of the FD&C Act requires
applicants to submit in a MRTPA, what
scientific evidence FDA recommends
applicants include in a MRTPA, what
information should be collected through
postmarket surveillance and studies,
how to organize and submit the
MRTPA, and FDA’s timeframe for
review of a MRTPA. It will also provide
for the filing of a single application for
any modified risk tobacco product that
is also a new tobacco product.
Section 911(l)(2) of the FD&C Act
directs FDA to consult with the Institute
of Medicine (IOM), and get the input of
other appropriate scientific and medical
experts, on the design and conduct of
studies required for the assessment and
ongoing review of modified risk tobacco
products. FDA gave IOM its charge on
February 2, 2011. IOM published its
report on December 14, 2011. The report
is available through https://
www.iom.edu/Reports/2011/ScientificStandards-for-Studies-on-ModifiedRisk-Tobacco-Products.aspx and will be
placed in the docket for this draft
guidance. In order to get input from
other experts, FDA held a public
workshop on August 25 and 26, 2011,
and established a docket, FDA–2011–N–
0443, to receive public comments. FDA
intends to consider the IOM report and
comments submitted to the public
workshop docket in preparing the final
guidance.
II. Significance of Guidance
FDA is issuing this draft guidance
document consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on ‘‘Modified Risk
Tobacco Product Applications.’’ It does
not create or confer any rights for or on
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any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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
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.
Draft Guidance for Industry: Modified
Risk Tobacco Product Applications
(OMB Control Number 0910–NEW)
This draft guidance describes the
information that the FD&C Act requires
you to submit in your MRTPA as well
as FDA’s recommendations regarding
the scientific evidence that should be
contained in a MRTPA for FDA to make
an assessment and conduct an ongoing
review of modified risk tobacco
products. The draft guidance also
permits the filing of a single application
for any modified risk tobacco product
that is also a new tobacco product under
section 910 of the FD&C Act. The draft
guidance document discusses, among
other things: Who submits MRTPAs,
when to submit a MRTPA, what
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information section 911 of the FD&C Act
requires applicants to submit in a
MRTPA, what scientific evidence FDA
recommends applicants include in a
MRTPA, what information should be
collected through postmarket
surveillance and studies, and how to
organize and submit a MRTPA. The
purpose of the proposed information
collection is to allow FDA to collect
statutorily mandated information
regarding modified risk tobacco
products and other information that will
facilitate FDA’s effective and efficient
review of MRTPAs.
Modified risk tobacco products are
tobacco products that are sold or
distributed for use to reduce harm or the
risk of tobacco-related disease
associated with commercially marketed
tobacco products (section 911(b)(1) of
the FD&C Act). No person may
introduce or deliver for introduction
into interstate commerce any modified
risk tobacco product unless an order
issued pursuant to section 911(g) of the
FD&C Act is effective with respect to
that product (section 911(a) of the FD&C
Act).
Under section 911(d) of the FD&C Act,
a MRTPA must contain:
• A description of the proposed
product and any proposed advertising
and labeling;
• The conditions for using the
product;
• The formulation of the product;
• Sample product labels and labeling;
• All documents (including
underlying scientific information)
relating to research findings conducted,
supported, or possessed by the tobacco
product manufacturer relating to the
effect of the product on tobacco-related
diseases and health-related conditions,
including information both favorable
and unfavorable to the ability of the
product to reduce risk or exposure and
relating to human health;
• Data and information on how
consumers actually use the tobacco
product; and
• Such other information as the
Secretary may require.
Further, FDA’s regulation
implementing the National
Environmental Policy Act of 1969
requires that ‘‘[a]ll applications or
petitions requesting agency action
require the submission of an
[environmental assessment] or a claim
of categorical exclusion’’ (21 CFR
25.15(a)).
Section 911(g) of the FD&C Act
describes the demonstrations applicants
must make to obtain an order from FDA.
Sections 911(g)(1) and (2) of the FD&C
Act set forth two bases for FDA to issue
an order.
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A ‘‘risk modification order’’ is an
order permitting the introduction or
delivery for introduction into interstate
commerce of a tobacco product that
FDA has found meets the criteria for an
order under section 911(g)(1) of the
FD&C Act. In order for FDA to issue a
risk modification order under section
911(g)(1) of the FD&C Act, the applicant
must demonstrate that the proposed
modified risk tobacco product, as it is
actually used by consumers, will:
• Significantly reduce harm and the
risk of tobacco-related disease to
individual tobacco users; and
• Benefit the health of the population
as a whole taking into account both
users of tobacco products and persons
who do not currently use tobacco
products.
An ‘‘exposure modification order’’ is
an order permitting the introduction or
delivery for introduction into interstate
commerce of a tobacco product that
reduces or eliminates exposure to a
substance and for which the available
scientific evidence suggests that a
measurable and substantial reduction in
morbidity and mortality is likely to be
demonstrated in future studies. In order
for FDA to issue an exposure
modification order, the applicant must
satisfy all of the criteria for issuance of
an order under section 911(g)(2) of the
FD&C Act.
FDA may issue an exposure
modification order under section
911(g)(2) of the FD&C Act (the ‘‘special
rule’’) if it determines that the applicant
has demonstrated that:
• Such an order would be appropriate
to promote the public health;
• Any aspect of the label, labeling,
and advertising for the product that
would cause the product to be a
modified risk tobacco product is limited
to an explicit or implicit representation
that the tobacco product or its smoke
does not contain or is free of a substance
or contains a reduced level of a
substance, or presents a reduced
exposure to a substance in tobacco
smoke;
• Scientific evidence is not available
and, using the best available scientific
methods, cannot be made available
without conducting long-term
epidemiological studies for an
application to meet the standards for
obtaining an order under section
911(g)(1); and
• The scientific evidence that is
available without conducting long-term
epidemiological studies demonstrates
that a measurable and substantial
reduction in morbidity or mortality
among individual tobacco users is
reasonably likely in subsequent studies
(section 911(g)(2)(A) of the FD&C Act).
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Furthermore, for FDA to issue an
exposure modification order, FDA must
find that the applicant has demonstrated
that:
• The magnitude of overall
reductions in exposure to the substance
or substances, which are the subject of
the application is substantial, such
substance or substances are harmful,
and the product as actually used
exposes consumers to the specified
reduced level of the substance or
substances;
• The product as actually used by
consumers will not expose them to
higher levels of other harmful
substances compared to the similar
types of tobacco products then on the
market unless such increases are
minimal and the reasonably likely
overall impact of use of the product
remains a substantial and measurable
reduction in overall morbidity and
mortality among individual tobacco
users;
• Testing of actual consumer
perception shows that, as the applicant
proposes to label and market the
product, consumers will not be misled
into believing that the product is or has
been demonstrated to be less harmful, or
presents or has been demonstrated to
present less of a risk of disease than one
or more other commercially marketed
tobacco products; and
• Issuance of the exposure
modification order is expected to benefit
the health of the population as a whole
taking into account both users of
tobacco products and persons who do
not currently use tobacco products
(section 911(g)(2)(B) of the FD&C Act).
In evaluating the benefit to health of
individuals and of the population as a
whole under sections 911(g)(1) and
(g)(2) of the FD&C Act, FDA must take
into account:
• The relative health risks the
modified risk tobacco product presents
to individuals;
• The increased or decreased
likelihood that existing tobacco product
users who would otherwise stop using
such products will switch to using the
modified risk tobacco product;
• The increased or decreased
likelihood that persons who do not use
tobacco products will start using the
modified risk tobacco product;
• The risks and benefits to persons
from the use of the modified risk
tobacco product compared to the use of
smoking cessation drug or device
products approved by FDA to treat
nicotine dependence; and
• Comments, data, and information
submitted to FDA by interested persons
(section 911(g)(4) of the FD&C Act).
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Furthermore, FDA must ensure that
the advertising and labeling of the
MRTP enable the public to comprehend
the information concerning modified
risk and to understand the relative
significance of such information in the
context of total health and in relation to
all of the tobacco-related diseases and
health conditions (section 911(h)(1) of
the FD&C Act).
FDA intends to determine whether it
will issue an order under section 911(g)
within 360 days after the receipt of a
complete application and will issue
such an order only if the application
satisfies all the applicable requirements
in section 911.
A risk modification order issued
under section 911(g)(1) will be effective
for the period of time specified in the
order issued by FDA (section 911(h)(4)
of the FD&C Act). An applicant to whom
a risk modification order is issued under
section 911(g)(1) must conduct
postmarket surveillance and studies
(section 911(i)(1) of the FD&C Act).
An exposure modification order
issued under section 911(g)(2) will be
effective for a term of not more than 5
years. FDA may renew an exposure
modification order if the applicant files
a new application, and FDA finds that
the requirements for such order under
section 911(g)(2) continue to be satisfied
(section 911(g)(2)(C)(i) of the FD&C Act).
Further, an exposure modification order
will be conditioned on the applicant’s
agreement to conduct postmarket
surveillance and studies and to submit
the results of such surveillance and
studies to FDA annually (section
911(g)(2)(C)(ii) and (iii) of the FD&C
Act).
The postmarket surveillance and
studies that all applicants who receive
orders are required to conduct are
intended to determine the effect of
issuance of an order on consumer
perception, behavior, and health, and
enable FDA to review the accuracy of
the determinations upon which an order
was based (section 911(g)(2)(C)(ii) and
(i)(1) of the FD&C Act). An applicant
who receives a risk modification order
must also conduct postmarket
surveillance and studies that provide
information FDA determines is
otherwise necessary regarding the use or
health risks involving the tobacco
product (section 911(i)(1) of the FD&C
Act).
If the proposed modified risk tobacco
product is a new tobacco product within
the meaning of section 910(a)(1), the
new tobacco product must satisfy any
applicable premarket review
requirements under section 910 of the
FD&C Act, in addition to any
requirements under section 911 of the
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FD&C Act. A new tobacco product must
be found to be substantially equivalent,
exempt from the requirement to obtain
a substantial equivalence determination,
or have a marketing authorization order
under section 910(c)(1)(A)(i). The
collections of information relating to
premarket review described in the
‘‘Guidance for Industry: Section 905(j)
Reports: Demonstrating Substantial
Evidence for Tobacco Products’’ (OMB
control number 0910–0673), 21 CFR
part 1107 (Establishment Registration,
Product Listing, and Substantial
Equivalence Reports) (OMB control
number 0910–0684), and ‘‘Draft
Guidance for Industry: Applications for
Premarket Review of New Tobacco
Products’’ (OMB control number 0910–
NEW) have been previously approved,
or are pending approval, by OMB. An
applicant may file the appropriate
report or application to satisfy any
applicable premarket review
requirements and a separate application
under section 911. In the alternative, the
applicant may file a single application.
The single application must include the
information required for the applicable
premarket review (i.e., substantial
equivalence report, request of
exemption from substantial equivalence
requirements, or the information
required for premarket review under
section 910(b) of the FD&C Act), as well
as the information required to support
issuance of an order under section
911(g) of the FD&C Act. To the extent
data or information contained in the
premarket review portion of the
application is also relevant to or
required for the modified risk
determination, the applicant may crossreference that data or information rather
than duplicate it in the modified risk
portion of the application.
Description of respondents: The
respondents to this collection of
information are applicants who are
responsible for creating and submitting
modified risk tobacco product
applications and who wish to obtain an
FDA order to allow them to market their
product. While it is expected that many
of the respondents will be
manufacturers, respondents could
include importers, distributors, and
retailers of tobacco products.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
3
3
8
1
1
1
3
3
8
45,200
10
8
135,600
30
64
3
1
3
30
90
5
1
5
40,200
201,000
5
1
1
1
5
1
140
140
700
140
........................
........................
........................
........................
337,624
MRTPA (911(d) of FD&C Act) .............................................
Environmental analysis (21 CFR 25.15) ..............................
Request for a meeting prior to submitting a MRTPA ..........
Submission of postmarket surveillance and study protocols
(911(g)(2)(C)(ii) and 911(i)(2)) .........................................
Conduct of postmarket surveillance and studies
(911(g)(2)(C)(ii) and 911(i)(1)) .........................................
Annual submission of results of postmarket surveillance
and studies (911(g)(2)(C)(iii) and 911(i)(1)) .....................
Requests for renewal (911(g)(2)(C)(i) and 911(h)(4)) .........
Total Reporting Burden Hours ......................................
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1There
Average
burden per
response
(in hours)
Number of respondents
Information collected (section(s))
Total annual
responses
Total annual
hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 describes the annual reporting
burden as a result of submitting a
MRTPA. FDA estimates that it will
receive 3 MRTPAs annually and that it
will take the applicant 200 hours to
collect the information necessary to
submit a MRTPA under section 911 of
the FD&C Act. FDA estimates it will
take the applicant an additional 45,000
hours to conduct studies needed to
support its MRTPA. FDA is also
including an estimation of the burden
associated with preparing
environmental analyses. FDA estimates
that it will take an additional 10 hours
to prepare any environmental analyses.
FDA encourages persons considering
developing a MRTPA to meet with CTP
to discuss MRTPA submission and
investigational requirements. FDA
anticipates that eight persons
considering developing MRTPAs may
request meetings with FDA. FDA
estimates it will take 8 hours to prepare
a meeting request, including
background information.
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Section 911 of the FD&C Act requires
applicants to whom FDA issues orders
to conduct postmarket surveillance and
studies and submit relevant information
to FDA on an annual basis. Applicants
must submit and receive FDA approval
of surveillance protocols. FDA estimates
that it will take 30 hours to collect and
submit the protocol information to FDA.
FDA estimates it will take the applicant
an additional 40,200 hours to conduct
the postmarket surveillance and studies.
FDA estimates 5 applicants will submit
results of postmarket surveillance and
studies annually and it will take 140
hours to prepare each submission.
Because orders issued under section
911(g) are valid for only a set number
of years, FDA expects applicants will
submit requests for renewal. Because
the dates on which orders are issued
and the length of the period for which
the order is valid will vary, FDA expects
one request for renewal annually. FDA
estimates that it will take 140 hours to
prepare the request for renewal.
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The total number of hours for this
collection of information is estimated to
be 337,624 ((3 × (45,200 + 10)) + (8 ×
8) + (3 × 30) + (5 × 40,200) + (5 × 140)
+ (1 × 140)). These burden estimates
were computed using FDA staff
expertise and by reviewing comments
received from recent FDA information
collections for other tobacco-related
initiatives.
IV. Request for Comments
FDA requests comments from
interested parties on any of the topics
addressed in the draft guidance. In
addition, as stated in the ‘‘I.
Background’’ section, FDA intends to
consider the IOM report in preparing
the final guidance. Therefore, FDA
requests comments from interested
parties on the IOM report, which was
issued on December 14, 2011. FDA
specifically requests comments on:
• IOM’s Recommendation 2: ‘‘The
FDA should establish guidance that
conveys an expected sequencing of
studies, such that preclinical work is
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completed and submitted to the FDA
before clinical (human subjects) work
commences, and [FDA should establish]
that there is a reasonable expectation
based on preclinical work that a
reduction or lack of harm will be seen
in humans.’’ Should FDA address
expected sequencing of studies in its
guidance? If the Agency should, what
guidance should the Agency provide?;
and
• IOM’s Recommendation 10: ‘‘MRTP
sponsors should consider use of
independent third parties to undertake
one or more key functions, including
the design and conduct of research, the
oversight of specific studies, and the
distribution of sponsor funds for
research. Such independent third
parties should be approved by the FDA
in advance of the research.’’ Should
FDA recommend such an approach in
its guidance? If the Agency should, what
guidance should the Agency provide?
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
draft guidance document at https://
www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceCompliance
RegulatoryInformation/default.htm.
Dated: March 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–7908 Filed 3–30–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2012–D–0049]
Draft Guidance for Industry: Reporting
Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke Under the Federal
Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
16:19 Apr 02, 2012
Jkt 226001
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Reporting Harmful
and Potentially Harmful Constituents in
Tobacco Products and Tobacco Smoke
Under Section 904(a)(3) of the Federal
Food, Drug, and Cosmetic Act.’’ The
purpose of this draft guidance is to
assist persons reporting to FDA the
quantities of harmful and potentially
harmful constituents (HPHCs) in
tobacco products and tobacco smoke
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). The draft
guidance explains that FDA does not
intend, at this time, to enforce reporting
on the entire established HPHC list
where a manufacturer or importer
completes testing and reporting for an
abbreviated list of HPHCs within the
timeframes specified in the guidance.
DATES: Although you can comment on
any guidance at any time (21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by June 4, 2012.
Submit either electronic or written
comments on the proposed collection of
information by June 4, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document to the Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229. Send one
self-addressed adhesive label to assist
that office in processing your request or
a fax number to which the draft
guidance may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance, including comments on
the proposed collection of information
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: James
Flahive, Center for Tobacco Products,
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850–
3229, 1–877–287–1373,
james.flahive@fda.hhs.gov.
With regard to the proposed
collection of information: Daniel
Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
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 amends the
FD&C Act and grants FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect public health generally and to
reduce tobacco use by minors. Section
904(a)(3) of the FD&C Act (21 U.S.C.
387d(a)(3)) requires each tobacco
product manufacturer or importer, or an
agent, to begin reporting to FDA no later
than June 22, 2012, ‘‘all constituents,
including smoke constituents, identified
by [FDA] as harmful or potentially
harmful to health in each tobacco
product, and as applicable in the smoke
of each tobacco product.’’ Reports must
be by the brand and by quantity in each
brand and subbrand. Section 904(c)(1)
states that manufacturers of tobacco
products not on the market as of June
22, 2009, must also provide information
reportable under section 904(a)(3) at
least 90 days prior to introducing the
product into interstate commerce.
FDA has taken several steps to
identify HPHCs to be reported under
section 904(a)(3), including issuing a
final guidance discussing FDA’s current
thinking on the meaning of ‘‘harmful
and potentially harmful constituent’’ in
the context of implementing the HPHC
list requirement (76 FR 5387, January
31, 2011). The guidance is available on
the Internet at https://www.fda.gov/
TobaccoProducts/
GuidanceComplianceRegulatory
Information/ucm241339.htm. In
addition, on August 12, 2011, FDA
issued a document (the HPHC notice; 76
FR 50226) in the Federal Register
describing the criteria we tentatively
concluded we would use in identifying
the HPHCs for the established list,
including a table of the 96 HPHCs we
identified using those criteria, and
asking the public and interested parties
to submit relevant scientific and other
information by October 11, 2011. FDA
reviewed comments received in
response to the HPHC notice. Elsewhere
in this issue of the Federal Register,
FDA is publishing a notice announcing
the established list of HPHCs as
required by section 904(e) of the FD&C
Act.
This draft guidance discusses the
information to be reported on HPHCs in
tobacco products and tobacco smoke
under section 904(a)(3) of the FD&C Act.
This draft guidance document
discusses, among other things: The
statutory requirement for testing and
E:\FR\FM\03APN1.SGM
03APN1
]]>Agencies
[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Notices]
[Pages 20026-20030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7908]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0071]
Draft Guidance for Industry: Modified Risk Tobacco Product
Applications; Availability; Agency Information Collection Activities;
Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Modified Risk
Tobacco Product Applications.'' The draft guidance provides information
about submitting applications for modified risk tobacco products under
the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft
guidance describes the information that the FD&C Act requires you to
submit in your modified risk tobacco product application and the
scientific evidence FDA recommends you submit to support your
application. The draft guidance also permits the filing of a single
application for any modified risk tobacco product that is also a new
tobacco product under the FD&C Act.
DATES: Although you can submit written or electronic comments on this
guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance, submit electronic or written
comments on the draft guidance by June 4, 2012. Submit electronic or
written comments on the proposed collection of information by June 4,
2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Modified Risk Tobacco Product
Applications'' to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive label to assist that office in processing
your request or include a fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
Submit electronic comments on the draft guidance, including
comments on the proposed collection of information, to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
Gail Schmerfeld or Kristin Davis, Center for Tobacco Products, 9200
Corporate Blvd., Rockville, MD 20850-3229, 1-877-287-1373,
gail.schmerfeld@fda.hhs.gov or kristin.davis@fda.hhs.gov.
With regard to the proposed collection of information: Daniel
Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-
796-5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control
Act) into law. The Tobacco Control Act grants FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect public health generally and to reduce tobacco use by minors.
Congress found that it is essential that, prior to marketing tobacco
products for use to reduce harm or the risk of tobacco-related disease
or to reduce exposure to harmful substances associated with tobacco
products, manufacturers be required to ``demonstrate that such products
* * * meet a series of rigorous criteria, and will benefit the health
of the population as a whole'' (section 2(36) of the Tobacco Control
Act). Thus, section 101 of the Tobacco Control Act added section 911
(21 U.S.C. 387k) to the FD&C Act to prohibit the introduction or
delivery for introduction into interstate commerce of any modified risk
tobacco product unless an order
[[Page 20027]]
issued by FDA pursuant to section 911(g) of the FD&C Act is effective
with respect to such product. A modified risk tobacco product is any
tobacco product that is sold or distributed for use to reduce harm or
the risk of tobacco-related disease associated with commercially
marketed tobacco products (section 911(b)(1) of the FD&C Act).
Section 911(l)(1) of the FD&C Act directs FDA to issue regulations
or guidance (or any combination thereof) on the scientific evidence
required for assessment and ongoing review of modified risk tobacco
products. FDA is issuing this draft guidance in compliance with section
911(l)(1). When finalized, the draft guidance will provide industry
with information on who submits modified risk tobacco product
applications (MRTPAs), when to submit a MRTPA, what information section
911 of the FD&C Act requires applicants to submit in a MRTPA, what
scientific evidence FDA recommends applicants include in a MRTPA, what
information should be collected through postmarket surveillance and
studies, how to organize and submit the MRTPA, and FDA's timeframe for
review of a MRTPA. It will also provide for the filing of a single
application for any modified risk tobacco product that is also a new
tobacco product.
Section 911(l)(2) of the FD&C Act directs FDA to consult with the
Institute of Medicine (IOM), and get the input of other appropriate
scientific and medical experts, on the design and conduct of studies
required for the assessment and ongoing review of modified risk tobacco
products. FDA gave IOM its charge on February 2, 2011. IOM published
its report on December 14, 2011. The report is available through https://www.iom.edu/Reports/2011/Scientific-Standards-for-Studies-on-Modified-Risk-Tobacco-Products.aspx and will be placed in the docket for this
draft guidance. In order to get input from other experts, FDA held a
public workshop on August 25 and 26, 2011, and established a docket,
FDA-2011-N-0443, to receive public comments. FDA intends to consider
the IOM report and comments submitted to the public workshop docket in
preparing the final guidance.
II. Significance of Guidance
FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on
``Modified Risk Tobacco Product Applications.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 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.
Draft Guidance for Industry: Modified Risk Tobacco Product Applications
(OMB Control Number 0910-NEW)
This draft guidance describes the information that the FD&C Act
requires you to submit in your MRTPA as well as FDA's recommendations
regarding the scientific evidence that should be contained in a MRTPA
for FDA to make an assessment and conduct an ongoing review of modified
risk tobacco products. The draft guidance also permits the filing of a
single application for any modified risk tobacco product that is also a
new tobacco product under section 910 of the FD&C Act. The draft
guidance document discusses, among other things: Who submits MRTPAs,
when to submit a MRTPA, what information section 911 of the FD&C Act
requires applicants to submit in a MRTPA, what scientific evidence FDA
recommends applicants include in a MRTPA, what information should be
collected through postmarket surveillance and studies, and how to
organize and submit a MRTPA. The purpose of the proposed information
collection is to allow FDA to collect statutorily mandated information
regarding modified risk tobacco products and other information that
will facilitate FDA's effective and efficient review of MRTPAs.
Modified risk tobacco products are tobacco products that are sold
or distributed for use to reduce harm or the risk of tobacco-related
disease associated with commercially marketed tobacco products (section
911(b)(1) of the FD&C Act). No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco product
unless an order issued pursuant to section 911(g) of the FD&C Act is
effective with respect to that product (section 911(a) of the FD&C
Act).
Under section 911(d) of the FD&C Act, a MRTPA must contain:
A description of the proposed product and any proposed
advertising and labeling;
The conditions for using the product;
The formulation of the product;
Sample product labels and labeling;
All documents (including underlying scientific
information) relating to research findings conducted, supported, or
possessed by the tobacco product manufacturer relating to the effect of
the product on tobacco-related diseases and health-related conditions,
including information both favorable and unfavorable to the ability of
the product to reduce risk or exposure and relating to human health;
Data and information on how consumers actually use the
tobacco product; and
Such other information as the Secretary may require.
Further, FDA's regulation implementing the National Environmental
Policy Act of 1969 requires that ``[a]ll applications or petitions
requesting agency action require the submission of an [environmental
assessment] or a claim of categorical exclusion'' (21 CFR 25.15(a)).
Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA. Sections 911(g)(1)
and (2) of the FD&C Act set forth two bases for FDA to issue an order.
[[Page 20028]]
A ``risk modification order'' is an order permitting the
introduction or delivery for introduction into interstate commerce of a
tobacco product that FDA has found meets the criteria for an order
under section 911(g)(1) of the FD&C Act. In order for FDA to issue a
risk modification order under section 911(g)(1) of the FD&C Act, the
applicant must demonstrate that the proposed modified risk tobacco
product, as it is actually used by consumers, will:
Significantly reduce harm and the risk of tobacco-related
disease to individual tobacco users; and
Benefit the health of the population as a whole taking
into account both users of tobacco products and persons who do not
currently use tobacco products.
An ``exposure modification order'' is an order permitting the
introduction or delivery for introduction into interstate commerce of a
tobacco product that reduces or eliminates exposure to a substance and
for which the available scientific evidence suggests that a measurable
and substantial reduction in morbidity and mortality is likely to be
demonstrated in future studies. In order for FDA to issue an exposure
modification order, the applicant must satisfy all of the criteria for
issuance of an order under section 911(g)(2) of the FD&C Act.
FDA may issue an exposure modification order under section
911(g)(2) of the FD&C Act (the ``special rule'') if it determines that
the applicant has demonstrated that:
Such an order would be appropriate to promote the public
health;
Any aspect of the label, labeling, and advertising for the
product that would cause the product to be a modified risk tobacco
product is limited to an explicit or implicit representation that the
tobacco product or its smoke does not contain or is free of a substance
or contains a reduced level of a substance, or presents a reduced
exposure to a substance in tobacco smoke;
Scientific evidence is not available and, using the best
available scientific methods, cannot be made available without
conducting long-term epidemiological studies for an application to meet
the standards for obtaining an order under section 911(g)(1); and
The scientific evidence that is available without
conducting long-term epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity or mortality among
individual tobacco users is reasonably likely in subsequent studies
(section 911(g)(2)(A) of the FD&C Act).
Furthermore, for FDA to issue an exposure modification order, FDA
must find that the applicant has demonstrated that:
The magnitude of overall reductions in exposure to the
substance or substances, which are the subject of the application is
substantial, such substance or substances are harmful, and the product
as actually used exposes consumers to the specified reduced level of
the substance or substances;
The product as actually used by consumers will not expose
them to higher levels of other harmful substances compared to the
similar types of tobacco products then on the market unless such
increases are minimal and the reasonably likely overall impact of use
of the product remains a substantial and measurable reduction in
overall morbidity and mortality among individual tobacco users;
Testing of actual consumer perception shows that, as the
applicant proposes to label and market the product, consumers will not
be misled into believing that the product is or has been demonstrated
to be less harmful, or presents or has been demonstrated to present
less of a risk of disease than one or more other commercially marketed
tobacco products; and
Issuance of the exposure modification order is expected to
benefit the health of the population as a whole taking into account
both users of tobacco products and persons who do not currently use
tobacco products (section 911(g)(2)(B) of the FD&C Act).
In evaluating the benefit to health of individuals and of the
population as a whole under sections 911(g)(1) and (g)(2) of the FD&C
Act, FDA must take into account:
The relative health risks the modified risk tobacco
product presents to individuals;
The increased or decreased likelihood that existing
tobacco product users who would otherwise stop using such products will
switch to using the modified risk tobacco product;
The increased or decreased likelihood that persons who do
not use tobacco products will start using the modified risk tobacco
product;
The risks and benefits to persons from the use of the
modified risk tobacco product compared to the use of smoking cessation
drug or device products approved by FDA to treat nicotine dependence;
and
Comments, data, and information submitted to FDA by
interested persons (section 911(g)(4) of the FD&C Act).
Furthermore, FDA must ensure that the advertising and labeling of
the MRTP enable the public to comprehend the information concerning
modified risk and to understand the relative significance of such
information in the context of total health and in relation to all of
the tobacco-related diseases and health conditions (section 911(h)(1)
of the FD&C Act).
FDA intends to determine whether it will issue an order under
section 911(g) within 360 days after the receipt of a complete
application and will issue such an order only if the application
satisfies all the applicable requirements in section 911.
A risk modification order issued under section 911(g)(1) will be
effective for the period of time specified in the order issued by FDA
(section 911(h)(4) of the FD&C Act). An applicant to whom a risk
modification order is issued under section 911(g)(1) must conduct
postmarket surveillance and studies (section 911(i)(1) of the FD&C
Act).
An exposure modification order issued under section 911(g)(2) will
be effective for a term of not more than 5 years. FDA may renew an
exposure modification order if the applicant files a new application,
and FDA finds that the requirements for such order under section
911(g)(2) continue to be satisfied (section 911(g)(2)(C)(i) of the FD&C
Act). Further, an exposure modification order will be conditioned on
the applicant's agreement to conduct postmarket surveillance and
studies and to submit the results of such surveillance and studies to
FDA annually (section 911(g)(2)(C)(ii) and (iii) of the FD&C Act).
The postmarket surveillance and studies that all applicants who
receive orders are required to conduct are intended to determine the
effect of issuance of an order on consumer perception, behavior, and
health, and enable FDA to review the accuracy of the determinations
upon which an order was based (section 911(g)(2)(C)(ii) and (i)(1) of
the FD&C Act). An applicant who receives a risk modification order must
also conduct postmarket surveillance and studies that provide
information FDA determines is otherwise necessary regarding the use or
health risks involving the tobacco product (section 911(i)(1) of the
FD&C Act).
If the proposed modified risk tobacco product is a new tobacco
product within the meaning of section 910(a)(1), the new tobacco
product must satisfy any applicable premarket review requirements under
section 910 of the FD&C Act, in addition to any requirements under
section 911 of the
[[Page 20029]]
FD&C Act. A new tobacco product must be found to be substantially
equivalent, exempt from the requirement to obtain a substantial
equivalence determination, or have a marketing authorization order
under section 910(c)(1)(A)(i). The collections of information relating
to premarket review described in the ``Guidance for Industry: Section
905(j) Reports: Demonstrating Substantial Evidence for Tobacco
Products'' (OMB control number 0910-0673), 21 CFR part 1107
(Establishment Registration, Product Listing, and Substantial
Equivalence Reports) (OMB control number 0910-0684), and ``Draft
Guidance for Industry: Applications for Premarket Review of New Tobacco
Products'' (OMB control number 0910-NEW) have been previously approved,
or are pending approval, by OMB. An applicant may file the appropriate
report or application to satisfy any applicable premarket review
requirements and a separate application under section 911. In the
alternative, the applicant may file a single application. The single
application must include the information required for the applicable
premarket review (i.e., substantial equivalence report, request of
exemption from substantial equivalence requirements, or the information
required for premarket review under section 910(b) of the FD&C Act), as
well as the information required to support issuance of an order under
section 911(g) of the FD&C Act. To the extent data or information
contained in the premarket review portion of the application is also
relevant to or required for the modified risk determination, the
applicant may cross-reference that data or information rather than
duplicate it in the modified risk portion of the application.
Description of respondents: The respondents to this collection of
information are applicants who are responsible for creating and
submitting modified risk tobacco product applications and who wish to
obtain an FDA order to allow them to market their product. While it is
expected that many of the respondents will be manufacturers,
respondents could include importers, distributors, and retailers of
tobacco products.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Information collected Number of Number of Total annual burden per Total annual
(section(s)) respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
MRTPA (911(d) of FD&C Act)...... 3 1 3 45,200 135,600
Environmental analysis (21 CFR 3 1 3 10 30
25.15).........................
Request for a meeting prior to 8 1 8 8 64
submitting a MRTPA.............
Submission of postmarket 3 1 3 30 90
surveillance and study
protocols (911(g)(2)(C)(ii) and
911(i)(2)).....................
Conduct of postmarket 5 1 5 40,200 201,000
surveillance and studies
(911(g)(2)(C)(ii) and
911(i)(1)).....................
Annual submission of results of 5 1 5 140 700
postmarket surveillance and
studies (911(g)(2)(C)(iii) and
911(i)(1)).....................
Requests for renewal 1 1 1 140 140
(911(g)(2)(C)(i) and 911(h)(4))
-------------------------------------------------------------------------------
Total Reporting Burden Hours .............. .............. .............. .............. 337,624
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 describes the annual reporting burden as a result of
submitting a MRTPA. FDA estimates that it will receive 3 MRTPAs
annually and that it will take the applicant 200 hours to collect the
information necessary to submit a MRTPA under section 911 of the FD&C
Act. FDA estimates it will take the applicant an additional 45,000
hours to conduct studies needed to support its MRTPA. FDA is also
including an estimation of the burden associated with preparing
environmental analyses. FDA estimates that it will take an additional
10 hours to prepare any environmental analyses. FDA encourages persons
considering developing a MRTPA to meet with CTP to discuss MRTPA
submission and investigational requirements. FDA anticipates that eight
persons considering developing MRTPAs may request meetings with FDA.
FDA estimates it will take 8 hours to prepare a meeting request,
including background information.
Section 911 of the FD&C Act requires applicants to whom FDA issues
orders to conduct postmarket surveillance and studies and submit
relevant information to FDA on an annual basis. Applicants must submit
and receive FDA approval of surveillance protocols. FDA estimates that
it will take 30 hours to collect and submit the protocol information to
FDA. FDA estimates it will take the applicant an additional 40,200
hours to conduct the postmarket surveillance and studies. FDA estimates
5 applicants will submit results of postmarket surveillance and studies
annually and it will take 140 hours to prepare each submission.
Because orders issued under section 911(g) are valid for only a set
number of years, FDA expects applicants will submit requests for
renewal. Because the dates on which orders are issued and the length of
the period for which the order is valid will vary, FDA expects one
request for renewal annually. FDA estimates that it will take 140 hours
to prepare the request for renewal.
The total number of hours for this collection of information is
estimated to be 337,624 ((3 x (45,200 + 10)) + (8 x 8) + (3 x 30) + (5
x 40,200) + (5 x 140) + (1 x 140)). These burden estimates were
computed using FDA staff expertise and by reviewing comments received
from recent FDA information collections for other tobacco-related
initiatives.
IV. Request for Comments
FDA requests comments from interested parties on any of the topics
addressed in the draft guidance. In addition, as stated in the ``I.
Background'' section, FDA intends to consider the IOM report in
preparing the final guidance. Therefore, FDA requests comments from
interested parties on the IOM report, which was issued on December 14,
2011. FDA specifically requests comments on:
IOM's Recommendation 2: ``The FDA should establish
guidance that conveys an expected sequencing of studies, such that
preclinical work is
[[Page 20030]]
completed and submitted to the FDA before clinical (human subjects)
work commences, and [FDA should establish] that there is a reasonable
expectation based on preclinical work that a reduction or lack of harm
will be seen in humans.'' Should FDA address expected sequencing of
studies in its guidance? If the Agency should, what guidance should the
Agency provide?; and
IOM's Recommendation 10: ``MRTP sponsors should consider
use of independent third parties to undertake one or more key
functions, including the design and conduct of research, the oversight
of specific studies, and the distribution of sponsor funds for
research. Such independent third parties should be approved by the FDA
in advance of the research.'' Should FDA recommend such an approach in
its guidance? If the Agency should, what guidance should the Agency
provide?
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet may obtain an electronic
version of the draft guidance document at https://www.regulations.gov
and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: March 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7908 Filed 3-30-12; 11:15 am]
BILLING CODE 4160-01-P
