[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28623-28624]
[FR Doc No: 2019-13014]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0139]

Entry-Level Driver Training: United Parcel Service, Inc. (UPS);
Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: FMCSA announces that it has received an application for
exemption from United Parcel Service, Inc. (UPS) from two provisions in
the entry-level driver training (ELDT) final rule published on December
8, 2016. These provisions are the following: (1) The requirement that a
driver training instructor have two years' experience and have held a
Commercial Driver's License (CDL) for two years as set forth in the
definitions of behind-the-wheel (BTW) instructor and theory instructor;
and (2) the requirement to register each training location for a unique
Training Provider Registry (TPR) number. FMCSA requests public comment
on the applicant's request for exemption.

DATES: Comments must be received on or before July 19, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Number FMCSA-2019-0139 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The online FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards, FMCSA, at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>
If you have questions on viewing or submitting material to the docket,
contact Docket Services at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2019-0139), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2019-0139'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may grant or not grant this application
based on your comments.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The Agency must
publish its decision in the Federal Register (49 CFR 381.315(b)) with
the reasons for denying or granting the application and, if granted,
the name of the person or class of persons receiving the exemption and
the regulatory provision from which the exemption is granted. The
notice must specify the effective period and explain the terms and
conditions of the exemption. The exemption may be renewed (49 CFR
381.300(b)).

III. Request for Exemption

    An exemption application has been submitted by United Parcel
Service, Inc. (UPS). The applicant seeks an exemption from the
following two provisions in the entry-level driver training (ELDT)
final rule: (1) The requirement in 49 CFR 380.713 that a driver
training instructor have two years' experience and have held a
commercial driver's license (CDL) for two years as set forth in the
definitions of behind-the-wheel (BTW) instructor and theory instructor
in 49 CFR 380.605(b); and (2) the requirement in 49 CFR 380.703(a)(7)
to register each training location for a unique Training Provider
Registry (TPR) number.
    According to UPS, it has a driver training school (DTS) that trains
its

employees to become driver instructors. UPS describes its DTS as a
success, as the school has trained hundreds of driver instructors, many
of whom did not have previous CDL experience. UPS DTS instructors have,
on average, 20 years of UPS experience, hold a CDL of the same (or
higher) class and with all endorsements necessary to operate a CMV for
which training is provided, have completed the DTS program, have
maintained their DTS certification through quarterly additional
training, and are employed by UPS as supervisors or managers. The DTS
conducts an 8-week program designed to train supervisors and managers
in UPS' long-haul operations to deliver driver training to drivers at
their ``home'' worksites. The curriculum covers all the topics set
forth in Part 380 Appendix A for the new ELDT rule. The UPS instructor
trainees are assessed in progress reviews at days 5, 10, and 15, and a
current DTS instructor monitors the quality of the training and trainee
progress. According to UPS, the DTS program produces highly qualified
driver instructors. Additionally, all UPS driver instructors are
required to be recertified every 90 days to demonstrate the same skill
level shown for their original DTS certification. UPS further performs
internal quality assessments to validate that instructor skillsets are
maintained throughout the organization.
    UPS requests that it be exempted from the ELDT driver instructor
qualification requirements. According to UPS, under the new ELDT
regulations no one could be an instructor at the time these regulations
go into effect unless he/she had obtained a CDL and had begun driving
by February 7, 2018. UPS states that if it must comply with the
instructor qualification requirements in the ELDT rule, it would not be
able to use 25% of its current certified driver instructors, at
minimum. Looking ahead two more years, that number would likely
increase to 50% due to its changing workforce. UPS sees an increase in
growth through volume demand, as well as an aging workforce that will
lead to retiring CDL drivers and certified driver instructors. Without
an exemption from the [ELDT] trainer requirements, UPS's inability to
use its current driver instructors will impede substantially its
ability to meet the demand for new drivers. UPS adds that the exemption
is needed to meet Union contractual requirements, as under its
collective bargaining agreement with the International Brotherhood of
Teamsters (Teamsters), six current UPS employees must be provided with
a promotion opportunity for every new hire.
    The second part of UPS's application for exemption requests an
exemption from the requirement in 49 CFR 380.703(a)(7), to register
each training location for a unique Training Provider Registry (TPR)
number. According to UPS, training for new drivers takes place in many
locations. In each location, instructors who have been trained in the
same way pursuant to UPS' DTS program will use a common FMCSR-compliant
curriculum developed at a corporate level. UPS's Director of Driver
Training is responsible for UPS's firm-wide training program. UPS is
operating a single training program in multiple locations. UPS states
that it needs this exemption due to the significant administrative
burden that would result if it had to register every UPS location at
which a new driver could be trained. In addition, having separate TPR
numbers for multiple locations offering essentially the same training
could create internal confusion for UPS, drivers, and the Agency. UPS
new driver training may occur at as many as 1,800 separate locations a
year. UPS estimates that the cost to register all of these locations
would be substantial, and that it would incur additional costs to keep
track of the various registrations, file updates, and new driver
registrations.

IV. Method To Ensure an Equivalent or Greater Level of Safety

    UPS offers its ``train the trainer'' program within its DTS to
assure an equivalent level of safety. According to UPS, its DTS
produces highly skilled instructors who know how to drive tractor-
trailers and how to teach others to operate tractor-trailers in a safe
manner. UPS believes that graduates of its DTS training program are
better prepared to impart knowledge and skills on new drivers than
someone who has had two years of driving experience. According to UPS,
experience over time has shown that their instructors produce expertly
trained, safe entry-level drivers. All DTS certified driver instructors
are re-certified every 90 days and UPS conducts periodic (minimum
annual) internal quality assessments of the DTS program. In regards to
the registration requirements, UPS assures that the registration
requirements will be fulfilled by a single registration for UPS' driver
training program managed by UPS, if the exemption granted. UPS'
requested exemption is for 5 years from the ELDT provisions 49 CFR
380.713 and 49 CFR 380.703(a)(7).
    A copy of UPS's application for exemption is available for review
in the docket for this notice.

    Issued on: June 12, 2019.
Larry W. Minor,
Associate Administrator of Policy.
[FR Doc. 2019-13014 Filed 6-18-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Notices]
[Pages 74003-74004]
[FR Doc No: 2012-30023]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0539; FRL-9362-3]

Pesticides; Draft Guidance for Pesticide Registrants on
Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice
of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Agency is announcing the availability of and seeking
public comment on a draft Pesticide Registration Notice (PR Notice)
titled ``Guidance on Antimicrobial Pesticide Products with Mold-Related
Label Claims.'' PR Notices are issued by EPA's Office of Pesticide
Programs (OPP) to inform pesticide registrants and other interested
persons about important policies, procedures, and registration-related
decisions, and serve to provide guidance to pesticide registrants and
OPP personnel. This particular draft PR Notice, once final, will
provide guidance to the registrant concerning product performance
(efficacy) data and labeling for ``mold-related'' pesticide products.
EPA believes that the label improvements described in this draft
document, once final, will provide consumers better product information
with which to make an informed choice in selecting mold-related
products that best suit their needs and thereby help improve protection
of public health.

DATES: Comments must be received on or before February 11, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0539, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-5448; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are required
to submit data under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) or are required to register pesticides. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Producers of pesticide products (NAICS 32532).
     Producers of antimicrobial pesticides (NAICS 32561).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

C. How can I get copies of this document and other related information?

    A copy of the draft PR notice is available in the docket,
identified by docket identification (ID) number EPA-HQ-OPP-2010-0539.

II. What guidance does this PR notice provide?

    This draft PR Notice, once final, will provide guidance to the
registrant concerning product performance (efficacy) data and labeling
for ``mold-related'' pesticide products. Mold-related pesticides are
antimicrobial pesticides that bear a label claim to inhibit or destroy
mold or mildew growth on hard, nonporous and porous surfaces in indoor
environments (hereinafter referred to as ``mold-related pesticides'').
``Fungicides'' are antimicrobial pesticides that destroy fungi
(including yeasts) and fungal spores pathogenic to humans.
``Fungistats'' are antimicrobial pesticides intended for aesthetic or
cosmetic purposes and only inhibit fungal growth.
    This guidance, once final, will explain when the Agency expects to
require applicants or registrants to submit efficacy data in support of
the registration of mold-related pesticides. In accordance with 40 CFR
part 161,

EPA pursuant to FIFRA requires the submission of efficacy data for
fungicides. EPA also requires the submission of efficacy data when any
specific species of fungus is listed on the label of fungicides, or
when ``residual'' or ``prevention'' claims are made for fungicides. For
fungistats, registrants must conduct efficacy studies but are not
required under 40 CFR part 161 to submit them to EPA except upon
request.
    This guidance, once final, will also describe appropriate label
language for fungicides and fungistats, and for products used for mold
remediation, on nonporous and porous surfaces, for residual activity,
for mold prevention, and in heating, ventilation, air conditioning and
refrigeration systems. All of these recommended label changes are
designed to improve protection of public health through proper use of
mold-related pesticides.

III. Do PR notices contain binding requirements?

    The PR Notice discussed in this notice is intended to provide
guidance to EPA personnel and decisionmakers and to pesticide
registrants. While the requirements in the statutes and Agency
regulations are binding on EPA and the applicants, this PR Notice is
not binding on either EPA or pesticide registrants, and EPA may depart
from the guidance where circumstances warrant and without prior notice.
Likewise, pesticide registrants may assert that the guidance is not
appropriate generally or not applicable to a specific pesticide or
situation.

    Authority: Sections 2 through 34 of FIFRA (7 U.S.C. 136-136y).

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.

    Dated: November 29, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2012-30023 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36544-36548]
[FR Doc No: 2011-15601]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0443]

Scientific Evaluation of Modified Risk Tobacco Product
Applications; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), Center for Tobacco Products
is announcing a public workshop to obtain input on specific issues
associated with the scientific evaluation of modified risk tobacco
product (MRTP) applications. The Family Smoking Prevention and Tobacco
Control Act (the Tobacco Control Act) establishes a requirement for
persons to obtain an order from FDA before they can introduce or
deliver for introduction into interstate commerce MRTPs and outlines
the requirements that must be met before FDA will issue such an order.
The Tobacco Control Act also directs FDA to get input from appropriate
scientific and medical experts on the design and conduct of studies and
surveillance required for assessment and ongoing review of MRTP
applications. The purpose of the public workshop is to create a forum
for appropriate scientific and medical experts and other interested
stakeholders to provide input on these topics. FDA will take the
information it obtains from the public workshop into account as it
determines how best to implement the MRTPs provisions of the Tobacco
Control Act. FDA is also opening a public docket to receive comments on
these topics.

DATES: Dates and Times: The public workshop will be held on August 25,
2011, from 8:30 a.m. to 5:30 p.m., and on August 26, 2011, from 8:30
a.m. to 4 p.m. Individuals who wish to make a presentation at the
public workshop must register by close of business on August 3, 2011.
Submit either electronic or written comments to the docket by September
23, 2011.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993-0002. Information regarding
special accommodations due to a disability, visitor parking, and
transportation may be accessed at: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Contact Person: Anuja Patel, Office of
Science, Center for Tobacco Products, Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373 (choose
option 4), FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>    Registration to Attend the Workshop and Requests for Oral
Presentation: If you wish to attend the workshop or make an oral
presentation at the workshop, please e-mail your registration to
<EMAIL_ADDRESS>by close of business on August 3, 2011.
Those without e-mail access may register by contacting Anuja Patel (see
Contact Person). Please provide contact information for each attendee,
including name, title, affiliation, address, e-mail address, and
telephone number. Registration is free and will be on a first-come-
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization as well as the total number of participants based on space
limitations. Registrants will receive confirmation once they have been
accepted for the workshop. Onsite registration on the day of the
workshop will be based on space availability. If registration reaches
maximum capacity, FDA will post a notice closing registration for the
workshop at http://www.fda.gov/TobaccoProducts/default.htm.
    An open comment session will be held during the public workshop on
August 25, 2011, from 11 a.m. to 12:30 p.m., during which comments from
the public will be accepted. If you would like to make an oral
presentation during the open comment session, you must indicate this at
the time of registration. FDA has included questions for comment in
section II of this document. You should identify the question number(s)
you will address in your presentation and the approximate time
requested for your presentation.
    FDA will do its best to accommodate requests to speak. Individuals
and organizations with common interests are urged to consolidate or
coordinate their presentations and request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. Persons registered to make a formal presentation
must check in at the registration table by 10 a.m. on August 25, 2011.
In addition, we strongly encourage submitting comments to the docket
(see Comments).
    If you need special accommodations because of a disability, please
contact Anuja Patel (see Contact Person) at least 7 days before the
workshop.
    Comments: Regardless of attendance at the public workshop,
interested persons may submit comments on any questions for comment in
section II of this document by September 23, 2011. Submit electronic
comments to http://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. It is only necessary
to send one set of comments. It is no longer necessary to send two
copies of mailed 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.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, President Obama signed into law the Tobacco
Control Act, providing FDA with the authority to regulate tobacco
products (Pub. L. 111-31; 123 Stat. 1776). The Tobacco Control Act
amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by
adding section 911 (21 U.S.C. 387k), which prohibits the introduction
or delivery for introduction of an MRTP into interstate commerce
without an order from FDA.
    MRTPs 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. According to section 911(b)(1)
of the FD&C Act, a tobacco product is considered to be sold or
distributed for use to reduce harm or the risk of tobacco-related
disease if its label, labeling, or advertising represents, either
explicitly or implicitly, that:
     The product is less harmful or presents a lower risk of
tobacco-related disease than one or more commercially marketed tobacco
products; or
     The product or its smoke contains a reduced level of,
presents a reduced exposure to, or is free of a substance.
    A tobacco product is also considered to be sold or distributed for
use to reduce harm or the risk of tobacco-related disease if the
product's:
     Label, labeling, or advertising uses the words ``light,''
``mild,'' or ``low,'' or similar descriptors; or
     Manufacturer has taken any action after June 22, 2009,
directed to consumers through the media or otherwise (other than
through the product's label, labeling, or advertising) that would be
reasonably expected to result in consumers believing that the tobacco
product or its smoke may present a reduced risk of harm, tobacco-
related disease, or exposure to a substance than one or more
commercially marketed tobacco products.

Section 911(b)(2) of the FD&C Act

    Before an MRTP can be introduced or delivered for introduction into
interstate commerce, an application for the product must be filed with
FDA, and the Agency must review the application and determine whether
it is appropriate to issue an order under section 911(g). (See section
911(a), (d), and (g) of the FD&C Act.) Section 911(d) of the FD&C Act
describes the required contents of an MRTP application, while section
911(g) of the FD&C Act describes the requirements for obtaining an
order.
    Section 911(g) of the FD&C Act sets forth two bases for obtaining
an order from FDA for an MRTP application. Under section 911(g)(1), FDA
shall issue an order only if FDA determines that an applicant has
demonstrated that the 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.
    Under section 911(g)(2), FDA may issue an order for MRTPs that may
not satisfy the requirements under section 911(g)(1) (described
previously) if FDA determines that an 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 an MRTP 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 an order set forth in section 911(g)(1) of the FD&C
Act; 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.
    Furthermore, for FDA to issue an order under section 911(g)(2), FDA
must find that the applicant has demonstrated that:
     The magnitude of overall reductions in exposure to the
substance or substances that 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 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 an 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.
    In making determinations regarding the benefit to the health of
individuals and the population as a whole under section 911(g)(1) or
(g)(2), FDA will take into account:
     The relative health risks the MRTP 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 MRTP;
     The increased or decreased likelihood that persons who do
not use tobacco products will start using the MRTP;
     The risks and benefits to persons from the use of the MRTP
as 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

    Each applicant receiving an order from FDA under section 911(g)(1)
or (g)(2) will conduct postmarket surveillance and studies, either as a
condition of receiving an order under section 911(g)(2), or as required
by FDA for products receiving an order under section 911(g)(1). (See
section 911(g)(2)(C)(ii) and 911(i)(1) of the FD&C Act.)
    Section 911(h) of the FD&C Act describes additional conditions for
marketing MRTPs. For example, under section 911(h)(1) of the FD&C Act,
the advertising and labeling of an MRTP must enable the public to
comprehend the information concerning modified risk and understand the
relative significance of such information in the context of total
health and in relation to all the diseases and health-related
conditions associated with the use of tobacco products. Under section
911(h)(2) of the FD&C Act, FDA may require that a claim comparing an
MRTP

to one or more commercially marketed tobacco products compare the MRTP
to a commercially marketed tobacco product that is representative of
that type of tobacco product on the market. Under that section, FDA may
also require that the identity of the reference tobacco product and the
percentage change and a quantitative comparison of the amount of the
substance claimed to be reduced be stated in immediate proximity to the
most prominent claim. Under section 911(h)(3) of the FD&C Act, FDA may
require that an MRTP's label disclose other substances in the tobacco
product, or substances that may be produced by the consumption of that
tobacco product, that may affect a disease or health-related condition
or increase the risk of other diseases or health-related conditions
associated with the use of tobacco products. Under that section, FDA
may also require an applicant to label the product with conditions of
use if the conditions of use may affect the risk of the product to
human health. Section 911(h)(4) of the FD&C Act requires than an order
issued under section 911(g)(1) of the FD&C Act be effective for a
specified period of time. Furthermore, under section 911(h)(5) of the
FD&C Act, FDA may require that MRTPs that are granted an order under
section 911(g)(1) of the FD&C Act comply with requirements relating to
advertising and promotion of the product.
    Section 911(l) of the FD&C Act requires FDA to issue regulations or
guidance (or any combination thereof) regarding the scientific evidence
required for assessment and ongoing review of modified risk tobacco
products. Among other things, the regulations or guidance must:
     To the extent that adequate scientific evidence exists,
establish minimum standards for scientific studies needed prior to
issuing an order under section 911(g) to show that a substantial
reduction in morbidity or mortality among individual tobacco users
occurs (under 911(g)(1)) or is reasonably likely (under 911(g)(2));
     Include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as appropriate;
     Establish minimum standards for postmarket studies, that
shall include regular and long-term assessments of health outcomes and
mortality, intermediate clinical endpoints, consumer perception of harm
reduction, and the impact on quitting behavior and new use of tobacco
products, as appropriate; and
     Establish minimum standards for required postmarket
surveillance, including ongoing assessments of consumer perception.

Section 911(l) of the FD&C Act

    Section 911(l)(2) of the FD&C Act directs FDA to get input from
appropriate scientific and medical experts on the design and conduct of
studies and surveillance required for assessment and ongoing review of
modified risk tobacco products.

II. Workshop Objectives and Issues for Discussion

    The purpose of this public workshop is to obtain information and
comments from appropriate medical and scientific experts, which may
include academia, public health groups, regulators, manufacturers of
tobacco products, health care professionals, interested industry, and
professional associations, and the public about the scientific issues
associated with assessment and ongoing review of MRTPs. The input from
the public workshop is expected to provide valuable information to
assist the Agency in developing guidance or regulations.
    At the public workshop, FDA will provide relevant background
information, including a brief summary of section 911 of the FD&C Act,
as added by the Tobacco Control Act. The meeting will include
scientific and medical expert speakers who will present on scientific
and technical factors related to the evaluation of MRTPs. FDA
anticipates that the key questions that will be considered at the
public workshop are those listed in the paragraphs that follow. FDA is
interested in receiving substantive scientific input on these questions
at the meeting and in the docket. FDA will post the agenda and
additional workshop background material 5 days before the workshop at:
http://www.fda.gov/TobaccoProducts/default.htm.

A. Benefit to Individual Tobacco Users

    Modified risk tobacco products have the potential to benefit
individual tobacco users by reducing harm and the risk of tobacco-
related disease compared to conventional tobacco products. FDA seeks
comments and information on the following issues:
    1. What scientific evidence would inform a determination that an
MRTP, as actually used, will significantly reduce harm and the risk of
tobacco-related disease to users? What types (if any) of scientific
studies other than long-term epidemiological studies could show a
significant reduction in harm and the risk of tobacco-related disease
to users?
    2. What scientific evidence would inform a determination that an
MRTP, as actually used, presents a reasonable likelihood of a
measurable and substantial reduction in tobacco-related morbidity or
mortality among individual tobacco users?

B. Impact on the Health of the Population as a Whole

    MRTPs may offer the potential for benefitting individual tobacco
users by reducing the risk of tobacco-related morbidity or mortality
associated with conventional tobacco products. However, these products
could harm the health of the population as a whole if they lead to
continued use of tobacco products in individuals who would otherwise
have quit, resumption of tobacco use in individuals who previously quit
(i.e., relapse), dual use among current tobacco users, or initiation of
tobacco use among individuals who otherwise would not have used tobacco
products. FDA seeks comments and information on the following issues
related to the impact of an MRTP on the health of the population as a
whole:
    1. What scientific evidence would inform a determination of how an
MRTP will actually be used by consumers once it is commercially
marketed, and what are the strengths and limitations of different
methods of studying actual consumer use?
    2. What scientific evidence, including consumer perception data,
would inform a determination of the effect an MRTP as it is proposed to
be labeled and marketed will have on increasing initiation of tobacco
use among non-users, decreasing or delaying cessation due to switching
to the MRTP among current tobacco users, encouraging use of multiple
tobacco products instead of complete switching among current tobacco
users, and increasing relapse among previous tobacco users who have
quit?
    3. What scientific evidence would inform the measurement of
potential benefits relative to potential harms to the general
population to achieve an overall public health benefit?

C. Comparisons of MRTPs to Other Products

    In making determinations regarding the benefit to the health of
individuals and the population as a whole under either section
911(g)(1) or (g)(2), FDA will take into account, among other things,
the relative health risks to individuals of the MRTP and the risks and
benefits to users of the MRTP as compared to the use of smoking
cessation drugs or devices approved to

treat nicotine dependence. (See section 911(g)(4) of the FD&C Act.) FDA
seeks comments and information on the following issues:
    1. What comparisons should be used in scientific studies intended
to inform a determination of the effects of an MRTP on reducing the
risk of tobacco-related disease to individual users relative to one or
more commercially marketed tobacco products?
    2. What comparisons should be used in scientific studies intended
to inform a determination of the effects of an MRTP on reducing
exposure to a harmful substance or substances?
    3. What comparisons should be used in scientific studies intended
to inform a determination of whether an MRTP will benefit or is likely
to benefit the health of the population as a whole?
    4. What scientific evidence would inform the evaluation of the
risks and benefits of the use of an MRTP as compared to use of drug or
device products approved to treat nicotine dependence?

D. Reduced Substance Exposure

    Tobacco products are considered MRTPs if their label, labeling, or
advertising represents, either explicitly or implicitly, that the
product or its smoke contains a reduced level of a substance or
presents a reduced exposure to a substance, or that the product or its
smoke does not contain or is free of a substance. (See section
911(b)(2)(A)(i) of the FD&C Act.) For FDA to issue an order regarding
an MRTP application under section 911(g)(2), FDA must determine that
the applicant has demonstrated that, among other things, the magnitude
of the overall reductions in exposure to the substance or substances
that 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. Moreover, FDA must determine that the applicant has
demonstrated that the MRTP, 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 the
increases are minimal and the reasonably likely overall impact of the
use of the MRTP remains a substantial and measurable reduction in
overall morbidity and mortality. FDA seeks comments and information on
the following issues:
    1. What scientific evidence would inform a determination that an
MRTP (or its smoke) does not contain or contains a reduced level of a
substance?
    2. What scientific evidence would inform a determination that the
reduction in exposure to a substance presented by an MRTP is
substantial?
    3. What scientific evidence would inform a determination that an
MRTP as it is actually used by consumers will expose consumers to the
specified reduced level of a substance?
    4. What scientific evidence would inform a determination that an
MRTP does not increase exposure to other harmful substances? If an MRTP
does increase exposure to another harmful substance, what scientific
evidence would inform a determination that any increase is minimal and,
overall, there is still a likelihood of a measurable and substantial
reduction in morbidity and mortality among individual tobacco users?

E. Consumer Perception of MRTPs

    To issue an order under section 911(g)(2), FDA must find that the
applicant has demonstrated that testing of actual consumer perceptions
of the tobacco product, as it is proposed to be labeled and marketed,
shows that consumers will not be misled into believing that the product
is or has been demonstrated to be less harmful or that it presents or
has been demonstrated to present less risk of disease than one or more
commercially marketed tobacco products. (See section 911(g)(2)(B)(iii)
of the FD&C Act.) Furthermore, section 911(h)(1) requires FDA to ensure
that any advertising or labeling concerning modified risk products
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 diseases and
health-related conditions associated with the use of tobacco products.
(See section 911(h)(1) of the FD&C Act.) FDA seeks comments and
information on the following issues related to consumer perception:
    1. What scientific evidence would inform a determination that
consumers will not be misled by a representation that an MRTP or its
smoke does not contain or contains a reduced level of a substance into
believing that the product is or has been demonstrated to be less
harmful, or presents, or has been demonstrated to present, less risk of
disease than one or more other commercially marketed tobacco products?
    2. What scientific evidence would inform a determination that
consumers will comprehend the information concerning modified risk in
an MRTP's advertising and labeling and understand the relative
significance of such information in the context of total health and in
relation to all the diseases and health-related conditions associated
with the use of tobacco products?

F. Postmarket Surveillance and Studies of Commercially Marketed MRTPs

    Each applicant receiving an order from FDA under section 911(g)(1)
or (g)(2) will conduct postmarket surveillance and studies, either as a
condition of receiving an order under section 911(g)(2), or as required
for products receiving an order under section 911(g)(1). (See section
911(g)(2)(C)(ii) and 911(i)(1) of the FD&C Act.) Such surveillance and
studies are designed to, among other things, determine the impact of an
FDA order on consumer perception, behavior, and health, and enable FDA
to review the accuracy of the determinations upon which the Agency
based its order. (See section 911(g)(2)(C)(ii) and (i)(1) of the FD&C
Act.) FDA seeks comments and information on the following issues
related to postmarket surveillance and studies:
    1. What types of postmarket studies could provide regular and long-
term assessments of patterns of product use (e.g., dual use, product
switching) and the impact of the MRTP on quitting behavior, relapse,
and initiation of tobacco use?
    2. What types of postmarket studies could provide regular and long-
term assessments of exposure levels to harmful substances?
    3. What types of postmarket studies could provide regular and long-
term assessments of applicable validated biomarkers and intermediate
clinical endpoints?
    4. What types of postmarket studies could provide regular and long-
term assessments of health outcomes and mortality?
    5. What types of postmarket studies could provide regular and long-
term assessments of consumer perception of the MRTP and other tobacco
products?
    6. What types of postmarket surveillance (other than postmarket
studies) could be used to ensure appropriate collection of data
regarding the use, consumer perception, and health risks of an MRTP?

III. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Comments). A transcript will
also be available in either hard copy or on CD-ROM, after submission of
a

Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

    Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15601 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P