Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments, 37555-37559 [2015-16151]
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Proposed Rules
Federal Register
Vol. 80, No. 126
Wednesday, July 1, 2015
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1211
[Document No. AMS–FV–11–0074; PR–A2
and PR–B2]
RIN 0581–AD24
Hardwood Lumber and Hardwood
Plywood Promotion, Research and
Information Order; Extension of
Comment Period on Supplemental
Notices
Agricultural Marketing Service,
USDA.
ACTION: Extension of comment period.
AGENCY:
Notice is hereby given that
the comment period on a supplemental
notice to amend the 2013 proposed rule
for a Hardwood Lumber and Hardwood
Plywood Promotion, Research and
Information Order (Order) is extended.
Under the proposed Order, assessments
would be collected from hardwood
lumber and plywood manufacturers and
would be used to fund programs to
promote hardwood lumber and
plywood. The comment period is also
extended for the supplemental notice to
amend the 2013 proposed rule on
procedures for conducting a referendum
to determine whether issuance of a
proposed Order is favored by
manufacturers of hardwood lumber and
hardwood plywood.
DATES: Comments must be received by
September 7, 2015.
ADDRESSES: Interested persons are
invited to submit written comments on
the Internet at https://
www.regulations.gov or to the
Promotion and Economics Division,
Fruit and Vegetable Program, AMS,
USDA, 1400 Independence Avenue
SW., Room 1406–S, Stop 0244,
Washington, DC 20250–0244; facsimile:
(202) 205–2800. All comments should
reference the docket number and the
date and page number of this issue of
the Federal Register and will be made
available for public inspection,
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SUMMARY:
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including the name and address if
provided, in the above office during
regular business hours or can be viewed
at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Patricia A. Petrella, Marketing
Specialist, Promotion and Economics
Division, Fruit and Vegetable Program,
AMS, USDA, 1400 Independence
Avenue SW., Room 1406–S, Stop 0244,
Washington, DC 20250–0244; telephone:
(301) 334–2891; or facsimile: (202) 205–
2800; or email: Patricia.Petrella@
ams.usda.gov.
The
proposed rules on the Order and the
referendum procedures were published
in the Federal Register on November 13,
2013 (78 FR 68298 and 78 FR 67979,
respectively). Those rules proposed the
establishment of an industry-funded
promotion, research and information
program for hardwood lumber and
hardwood plywood and referendum
procedures. Those proposals provided
for a 60-day comment period which
ended on January 13, 2014. On January
16, 2014, a notice was published in the
Federal Register that reopened and
extended the comment period on the
proposed Order until February 18, 2014
(79 FR 2805). A total of 939 comments
were received during both comment
periods. As a result of the extensive
comments received, USDA published
supplemental notices of proposed
rulemaking on the proposed Order and
the referendum procedures in the
Federal Register on June 9, 2015 (80 FR
32493 and 80 FR 32488, respectively) to
amend the 2013 proposed rules.
USDA received a request to extend
the comment period to allow additional
time for interested persons to review the
proposals and submit comments. USDA
is therefore extending the comment
period an additional 60 days until
September 7, 2015 to provide interested
persons more time to review these rules,
perform a complete analysis, and submit
written comments.
SUPPLEMENTARY INFORMATION:
Authority: This notice is issued pursuant
to the Commodity Promotion, Research and
Information Act of 1996 (1996 Act) (7 U.S.C.
7411–7425).
Dated: June 26, 2015.
Rex A. Barnes,
Associate Administrator.
[FR Doc. 2015–16184 Filed 6–30–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA–2015–N–1514]
RIN 0910–AH24
Nicotine Exposure Warnings and
Child-Resistant Packaging for Liquid
Nicotine, Nicotine-Containing ELiquid(s), and Other Tobacco
Products; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking.
ACTION:
The Food and Drug
Administration (FDA) is issuing this
advance notice of proposed rulemaking
(ANPRM) to obtain information related
to the regulation of ‘‘tobacco products’’
subject to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), and restrictions
regarding the sale and distribution of
such tobacco products. Specifically, this
ANPRM is seeking comments, data,
research results, or other information
that may inform regulatory actions FDA
might take with respect to nicotine
exposure warnings and child-resistant
packaging for liquid nicotine and
nicotine-containing e-liquid(s) that are
made or derived from tobacco and
intended for human consumption, and
potentially for other tobacco products
including, but not limited to, novel
tobacco products such as dissolvables,
lotions, gels, and drinks. In April 2014,
FDA published a proposed rule seeking
to deem products meeting the statutory
definition of ‘‘tobacco product,’’ except
accessories to proposed deemed tobacco
products, to be subject to the FD&C Act,
as amended by the Tobacco Control Act.
Specifically, the proposed rule seeks to
extend the Agency’s ‘‘tobacco product’’
authorities to those products that meet
the statutory definition of ‘‘tobacco
product,’’ prohibiting the sale of
‘‘covered tobacco products’’ to
individuals under the age of 18, and
requiring the display of health warnings
on certain tobacco product packages and
in advertisements. The deeming
SUMMARY:
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rulemaking does not address the issues
raised in this ANPRM.
DATES: Submit either electronic or
written comments by August 31, 2015.
ADDRESSES: You may submit comments
by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–1514 for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Bryant M. Godfrey, Center for Tobacco
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 1–877–
CTP–1373, bryant.godfrey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
The Tobacco Control Act was enacted
on June 22, 2009, amending the FD&C
Act and providing FDA with the
authority to regulate tobacco products
(Pub. L. 111–31). Specifically, section
101(b) of the Tobacco Control Act
amends the FD&C Act by adding a new
chapter that provides FDA with
authority over tobacco products. Section
901 of the FD&C Act (21 U.S.C. 387a),
as amended by the Tobacco Control Act,
states that the new chapter in the FD&C
Act (chapter IX—Tobacco Products) (21
U.S.C. 387 through 387u) applies to all
cigarettes, cigarette tobacco, roll-yourown tobacco, smokeless tobacco, and
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any other tobacco products that the
Secretary of Health and Human Services
by regulation deems to be subject to this
chapter. Accordingly, in the Federal
Register of April 25, 2014 (79 FR
23142), FDA published a proposed rule
seeking to deem all products meeting
the statutory definition of ‘‘tobacco
product’’ in section 201(rr) of the FD&C
Act (21 U.S.C. 321(rr)), except
accessories to those products, to be
subject to chapter IX of the FD&C Act.
FDA has evaluated data and science
(including all of the evidence submitted
to the docket of the proposed
‘‘deeming’’ rule cited below) related to
the risks, especially to infants and
children, from accidental exposure to
nicotine, including exposure to liquid
nicotine and nicotine-containing eliquid(s), which are primarily used with
electronic nicotine delivery systems
(ENDS), such as electronic cigarettes.
Recent increases in calls and visits to
both poison control centers (see, e.g.,
CDC’s Morbidity and Mortality Weekly
Report, available at https://www.cdc.gov/
mmwr/preview/mmwrhtml/
mm6313a4.htm) and emergency rooms
in the United States involving liquid
nicotine poisonings and exposures has
increased the public health concerns of
these exposure risks. As a result of
FDA’s evaluation and these recent
trends, FDA is considering whether,
based on the acute toxicity of nicotine
(up to and including nicotine
poisoning), it would be appropriate for
the protection of the public health to
warn the public about the dangers of
nicotine exposure, especially due to
inadvertent nicotine exposure in infants
and children, and/or require that some
tobacco products be sold in childresistant packaging. Comments
submitted in response to FDA’s
proposed rule seeking to deem all
tobacco products to be subject to the
FD&C Act support such actions, and
many request that FDA take prompt
action to mitigate nicotine exposure
risks (see Docket No. FDA–2014–N–
0189, https://www.regulations.gov).
As previously discussed, the FD&C
Act provides FDA with authority to
regulate tobacco products. Sections
906(d)(1) and 910(c)(1)(B) of the FD&C
Act provide FDA the authority to, by
regulation or in a marketing
authorization order, require restrictions
on the sale and distribution of a tobacco
product. The restrictions on the sale and
distribution of a tobacco product may
include restrictions on the access to,
and the advertising and promotion of,
the tobacco product, if FDA determines
such restrictions would be appropriate
for the protection of the public health.
The FD&C Act also provides FDA with
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authority to adopt a tobacco product
standard under section 907 of the FD&C
Act if the Secretary finds that it is
appropriate for the protection of the
public health.
In making such a finding under either
section 906(d)(1) or section 907 of the
FD&C Act, the Secretary must consider:
(1) The risks and benefits to the
population as a whole, including users
and nonusers of tobacco products; (2)
the increased or decreased likelihood
that existing users of tobacco products
will stop using such products; and (3)
the increased or decreased likelihood
that those who do not use tobacco
products will start using such products.
FDA intends to use the information
submitted in response to this ANPRM to
further inform its thinking about options
for issuing potential regulations that
would require nicotine exposure
warnings and/or child-resistant
packaging for some tobacco products, as
articulated in this document. For the
purposes of the questions in this
ANPRM:
• ‘‘Liquid nicotine and nicotinecontaining e-liquid(s) (liquid nicotine
combined with colorings, flavorings,
and/or potentially other ingredients)’’
are generally referred to as liquid
nicotine.
• ‘‘Liquid nicotine’’ (as used
throughout this document) refers to
liquid nicotine that is made or derived
from tobacco and intended for human
consumption.
• ‘‘Novel tobacco products’’ (as used
throughout this document) refers to
products such as dissolvables, lotions,
gels, and drinks.
II. Requests for Comments and
Information
FDA is seeking comments, data,
research results, and other information
related to the following questions.
Please explain your responses and
provide any evidence or other
information supporting your responses
to the following questions:
A. Nicotine Exposure Warnings
1. Should FDA consider requiring
nicotine exposure warning(s) text on
liquid nicotine? If so, why?
2. Should FDA consider requiring
nicotine exposure warning(s) text on
tobacco products other than liquid
nicotine, including, but not limited to,
novel tobacco products? If so, which
products and why?
3. On what basis (e.g., physical
characteristics or appearance of the
product or packaging, product risks,
form of marketing, route of exposure,
type of packaging) should FDA
determine which products should be
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required to carry the warning(s)? What
data or information would be helpful to
demonstrate the need for a warning or
warnings?
4. If FDA were to require nicotine
exposure warning(s) text for liquid
nicotine, what issues should the
warning(s) address and what wording
should be used? Please consider: (a)
Whether the warning(s) should be
broad, or directed at specific dangers;
(b) whether the warning(s) should
specifically address oral, ocular, and
dermal exposure dangers; (c) whether
the warning(s) should focus exclusively
on the risks to children and youth, or
include the risks to vulnerable
populations, such as pregnant women,
adults with medical conditions, and
pets; (d) whether the warning(s) should
contain instructions to avoid the
dangers altogether, such as ‘‘keep out of
the reach of children’’; (e) whether there
are other dangers of liquid nicotine
exposure that should be covered by the
warning(s); and (f) whether information
about what to do in the case of an
accidental exposure to liquid nicotine
should be included (e.g., when to seek
medical attention, when to contact a
Poison Control Center). Please submit
data or evidence to support your
position.
5. With preceding question 4 in mind,
should there be multiple textual
warnings that randomly display to
convey different dangers, or should
there be a single, consistent textual
warning that covers all of the different
dangers? Please submit data or evidence
to support your position.
6. If FDA were to require nicotine
exposure warning(s) text for tobacco
products other than liquid nicotine,
including, but not limited to, novel
tobacco products, what issues should
the warning(s) address and what
wording should be used? Please
consider: (a) Whether the warning(s)
should be broad, or directed at specific
dangers; (b) whether the warning(s)
should specifically address oral, ocular,
and dermal exposure dangers; (c)
whether the warning(s) should focus
exclusively on the risks to children and
youth, or include the risks to vulnerable
populations, such as pregnant women,
adults with medical conditions, and
pets; (d) whether the warning(s) should
contain instructions to avoid the
dangers altogether, such as ‘‘keep out of
the reach of children’’; (e) whether there
are other dangers of nicotine exposure
that should be covered by the
warning(s); and (f) whether information
about what to do in the case of an
accidental exposure to liquid nicotine
should be included (e.g., when to seek
medical attention, when to contact a
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Poison Control Center). Please submit
data or evidence to support your
position.
7. With preceding question 6 in mind,
please respond to the following
questions: Should there be multiple
textual warnings that randomly display
to convey different dangers, or should
there be a single, consistent textual
warning that covers all of the different
dangers? Should different types of
tobacco products carry different
warnings? If so, which type(s) of tobacco
products should carry what warning(s)
and what is the reasoning for different
warnings for different types of tobacco
products? Please submit data or
evidence to support your position.
8. If FDA were to require nicotine
exposure warning(s) text for liquid
nicotine, should FDA consider requiring
color(s) or graphic elements, such as
symbols, as part of the warning(s)? If so,
what color or graphic elements should
FDA consider?
(a) Are there data on graphic elements
and/or colors that would be most
effective in communicating the dangers
associated with nicotine exposure? If so,
please provide these data.
(b) Would a graphic element alone (as
opposed to text alone or any
combination of text, color, or graphic
elements) be sufficient to effectively
communicate the dangers associated
with nicotine exposure? Please provide
data or evidence to support your
position.
(c) How could the warning(s) text and
graphic image(s) add to or detract from
each other?
9. If FDA were to require nicotine
exposure warning(s) text for tobacco
products other than liquid nicotine,
including, but not limited to, novel
tobacco products, should FDA consider
requiring color(s) or graphic elements as
part of the warning(s)? If so, what color
or graphic elements should FDA
consider?
(a) Are there data on graphics and/or
colors that would be most effective in
communicating the dangers associated
with nicotine exposure? If so, please
provide these data.
(b) Would a graphic image alone be
sufficient to effectively communicate
the dangers associated with nicotine
exposure? Please provide data or
evidence to support your position.
(c) How could the warning(s) text and
graphic image(s) add to or detract from
each other?
(d) Should different tobacco products
carry different color or graphic
elements? If so, what criteria should
FDA use to determine which type of
tobacco products should carry what
color or graphic elements?
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10. If FDA were to require a nicotine
exposure warning(s) (text and any
applicable color or graphic element) for
liquid nicotine, should FDA adopt a
different nicotine exposure warning(s)
requirement based on the packaging/
containers (e.g., a brief/abbreviated
warning(s) for liquid nicotine in small
packaging/containers, omit the
warning(s) if the tobacco product is in
a child-resistant package)? If so, how
should the warning(s) differ? Please
submit data or evidence to support your
position.
11. With respect to tobacco products
other than liquid nicotine, including,
but not limited to, novel tobacco
products, if FDA were to require a
nicotine exposure warning(s) (text and
any applicable color or graphic
element), should FDA adopt a different
nicotine exposure warning(s)
requirement based on the packaging/
containers (e.g., a brief/abbreviated
warning(s) for tobacco products in small
packaging, omit the warning(s) if the
tobacco product is in a child-resistant
package)? If so, how should the
warning(s) differ? Please submit data or
evidence to support your position.
12. Are you aware of data or
information that would support any
required font sizes, formatting, and
display considerations for nicotine
exposure warnings (textual and/or
graphic)? If so, please provide that
evidence.
13. Should FDA require the inclusion
of the American Association of Poison
Control Centers’ telephone number on
the container labeling and/or packaging
of liquid nicotine and tobacco products
other than liquid nicotine? Why or why
not?
14. Are there any nicotine exposure
warnings (textual and/or graphic) for
liquid nicotine required by authorities
at the local, State, or Federal (i.e., other
agencies) level, or by foreign
governments that you particularly
would like to highlight? If so, which
ones and why? Are there any data
regarding the effectiveness or utility of
these warnings? If so, please provide
these data.
15. Are there any nicotine exposure
warnings (textual and/or graphic) for
tobacco products other than liquid
nicotine required by authorities at the
local, State, or Federal (i.e., other
agencies) level, or by foreign
governments that you particularly
would like to highlight? If so, which
ones and why? Are there any data
regarding the effectiveness or utility of
these warnings? If so, please provide
these data.
16. Are you aware of any existing
evidence regarding whether warnings
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(text and any applicable color or graphic
element) are effective for mitigating the
risks of nicotine exposure? If so, please
provide that evidence.
B. Child-Resistant Packaging
1. Should FDA require child-resistant
packaging for liquid nicotine? If so,
why?
2. Should FDA require child-resistant
packaging for liquid nicotine if the
liquid nicotine product is not intended
to be opened by the consumer (e.g.,
liquid nicotine in permanently sealed,
prefilled, and/or disposable cartridges)?
Please provide the reason for your
response.
3. Should FDA consider requiring
child-resistant packaging for tobacco
products other than liquid nicotine,
including, but not limited to, novel
tobacco products? If so, which ones and
why?
4. If FDA were to require childresistant packaging for liquid nicotine
(including for those products that are
not intended to be opened by the
consumer), what type of exposure risks
(e.g., oral, ocular, dermal) should FDA
seek to mitigate with the requirement?
5. If FDA were to require childresistant packaging for tobacco products
other than liquid nicotine, including,
but not limited to, novel tobacco
products, what risks (e.g., oral, ocular,
dermal) should FDA seek to mitigate
with the requirement?
6. If FDA were to require childresistant packaging for liquid nicotine,
how should the requirement be
articulated? Please consider: (a)
Whether the requirement should be
based on mandated physical
characteristics of the packaging (e.g.,
must have a squeeze-to-turn lid, flow
restrictor); (b) whether the requirement
should be performance based (e.g.,
unable to be opened by 80 percent or
more of 5-year-olds who try to open the
package, and more than 90 percent of
adults on average between the ages of
50–70 can successfully open the
package); or (c) whether the requirement
should be based on a combination of (a)
and (b), or is there some other basis for
the requirement that FDA should
consider? Is your proposal technically
feasible? Please submit data or evidence
to support your position.
7. If FDA were to require childresistant packaging for tobacco products
other than liquid nicotine, including,
but not limited to, novel tobacco
products, how should the requirement
be articulated? Please consider: (a)
Whether the requirement should be
based on mandated physical
characteristics of the packaging (e.g.,
must have a squeeze-to-turn lid, child-
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resistant cap, blister packaging); (b)
whether the requirement should be
performance based (e.g., unable to be
opened by 80 percent or more of 5-yearolds who try to open the package, and
more than 90 percent of adults on
average between the ages of 50–70 can
successfully open the package); or (c)
whether the requirement should be
based on a combination of (a) and (b),
or is there some other basis for the
requirement that FDA should consider?
Is your proposal technically feasible?
Please submit data or evidence to
support your position.
8. Are there other factors FDA should
consider to further prevent or
discourage people (especially infants
and children) from inadvertently
consuming or being exposed to liquid
nicotine? If so, please explain. Examples
of other factors may include:
attractiveness of the product or
packaging (e.g., appealing images,
fragrance, flavors), resemblance of
packaging to food and drink items (e.g.,
candy, fruit), color of the product (e.g.,
resemblance to beverages such as juice),
resemblance of packaging to that of
medications (e.g., eye drops).
9. If FDA were to require childresistant packaging, what should FDA
consider and what actions should FDA
take to mitigate the risk that users of
products with child-resistant packaging
will defeat the purpose of the packaging
by leaving the packaging open, by
disabling the protection mechanism, or
by moving the product to a different
container?
C. Other Actions and Considerations
1. With respect to liquid nicotine,
should FDA require both nicotine
exposure warnings (text and/or any
applicable color or graphic element) and
child-resistant packaging, or should
only one and not the other be required?
Please explain your reasoning and
provide data or evidence to support
your position.
2. With respect to tobacco products
other than liquid nicotine, including,
but not limited to, novel tobacco
products, should FDA require both
nicotine exposure warnings (text and/or
any applicable color or graphic element)
and child-resistant packaging, or should
only one and not the other be required?
Please explain your reasoning and
provide data or evidence to support
your position.
3. With respect to liquid nicotine and
the dangers of nicotine poisoning,
should FDA consider requiring any
additional warnings beyond a nicotine
exposure warning (text and/or any
applicable color or graphic element)? If
so, please describe the warning(s)
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(textual and/or graphic) and provide
evidence or data to support your
recommendation.
4. With respect to tobacco products
other than liquid nicotine, including,
but not limited to, novel tobacco
products, and the dangers of nicotine
poisoning, should FDA consider
requiring any additional warnings
beyond a nicotine exposure warning
(text and/or any applicable color or
graphic element)? If so, for which
products? Also, please describe the
warning(s) (textual and/or graphic) and
provide evidence or data to support
your recommendation.
5. Should FDA consider any
additional measures to mitigate nicotine
exposure risks for people (especially
infants and children) beyond nicotine
exposure warnings (text and any
applicable color or graphic element) and
child-resistant packaging? If so, what
measures should FDA consider and
why? Please provide evidence or data to
support your recommendation.
III. Comments
A. General Information About
Submitting Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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.
B. Public Availability of Comments
Received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to
the docket at https://
www.regulations.gov. As a matter of
Agency practice, FDA generally does
not post comments submitted by
individuals in their individual capacity
on https://www.regulations.gov. This is
determined by information indicating
that the submission is written by an
individual, for example, the comment is
identified with the category ‘‘Individual
Consumer’’ under the field entitled
‘‘Category (Required)’’, on the ‘‘Your
Information’’ page on https://
www.regulations.gov; for this ANPRM,
however, FDA will not be following this
general practice. Instead, FDA will post
on https://www.regulations.gov
comments to this docket that have been
submitted by individuals in their
individual capacity. If you wish to
submit any information under a claim of
confidentiality, please refer to 21 CFR
10.20.
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C. Information Identifying the Person
Submitting the Comment
Please note that your name, contact
information, and other information
identifying you will be posted on https://
www.regulations.gov if you include that
information in the body of your
comments. For electronic comments
submitted to https://
www.regulations.gov, FDA will post the
body of your comment on https://
www.regulations.gov along with your
State/province and country (if
provided), the name of your
representative (if any), and the category
identifying you (e.g., individual,
consumer, academic, industry). For
written submissions submitted to the
Division of Dockets Management, FDA
will post the body of your comments on
https://www.regulations.gov, but you can
put your name and/or contact
information on a separate cover sheet
and not in the body of your comments.
Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16151 Filed 6–30–15; 8:45 am]
receipt, and enables the Department to
make them available to the public.
Comments submitted electronically
through the https://www.regulations.gov
Web site can be viewed by other
commenters and interested members of
the public.
Mail: Send to Department of the
Treasury, Bureau of the Fiscal Service,
Attn: Theodore Simms, 401 14th Street,
SW., Washington, DC 20227–0001. In
general, Treasury will post all
comments to https://www.regulations.gov
without change, including any business
or personal information provided, such
as names, addresses, email addresses, or
telephone numbers. Treasury will also
make such comments available for
public inspection and copying. You can
make an appointment to inspect
comments by telephoning (202) 504–
3710. All comments received, including
attachments and other supporting
materials, will be part of the public
record and subject to public disclosure.
You should only submit information
that you wish to make publicly
available.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Theodore C. Simms II, Senior Attorney,
202–504–3710 or Theodore.Simms@
fiscal.treasury.gov.
DEPARTMENT OF THE TREASURY
SUPPLEMENTARY INFORMATION:
Fiscal Service
I. Background
31 CFR Parts 315, 353, and 360
The Department of the Treasury has
issued savings bonds since 1935 to raise
funds for the operation of the Federal
government, and to encourage savings
by small investors. From the beginning
of the savings bond program, savings
bonds have been registered securities.
Treasury has authorized several forms of
registration, including registration to
individuals, co-owners, fiduciaries,
institutions, and beneficiaries. See 31
CFR 315.7, 353.7, and 360.6. Savings
bonds generally are not transferrable
and are payable only to the registered
owner, except as described in Treasury
regulations. See 31 CFR 315.15, 353.15,
and 360.15. Detailed regulations
describe when payment will be made to
a person or entity that is not the
registered owner.
Ownership of a savings bond is
determined by Treasury’s savings bond
regulations. Federal and state courts,
including the United States Supreme
Court, have upheld these ownership
rights against challenges by parties
asserting claims under state law. See,
e.g., Free v. Bland, 369 U.S. 663 (1962).
The rights of registered owners and
others under Treasury regulations
persist even for bonds that matured
years ago, because Treasury does not
[Docket No.: FISCAL–2015–0002]
RIN 1530–AA11
Regulations Governing United States
Savings Bonds
Bureau of the Fiscal Service,
Fiscal Service, Treasury.
ACTION: Notice of proposed rulemaking.
AGENCY:
The United States Department
of the Treasury, Bureau of the Fiscal
Service, is proposing regulations
governing United States savings bonds
to address certain state escheat claims.
DATES: Comment due date: August 17,
2015.
SUMMARY:
The Bureau of the Fiscal
Service invites comments on this
proposed rule. Comments may be
submitted through one of the following
methods:
Electronic Submission of Comments:
Interested persons may submit
comments electronically through the
Federal eRulemaking Portal at https://
www.regulations.gov. Electronic
submission of comments allows the
commenter maximum time to prepare
and submit a comment, ensures timely
tkelley on DSK3SPTVN1PROD with PROPOSALS
ADDRESSES:
VerDate Sep<11>2014
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37559
require owners to redeem their paper
savings bonds by a certain date.
In some cases, Treasury regulations
determine who is entitled to payment
based on state law. Treasury may look
to state probate law, for example, to
determine who is entitled to payment
for savings bonds in a decedent’s estate.
See 31 CFR 315.71, 353.71, and 360.71.
Treasury may also recognize certain
state judicial proceedings that require
payment to creditors, divorced spouses,
and other claimants specifically listed
in the regulations. See 31 CFR part 315,
subpart E; Part 353, subpart E; part 360,
subpart E. The touchstone for these
claims, however, is Treasury’s savings
bond regulations.
Since at least 1952, Treasury has
acknowledged circumstances when it
will recognize a state’s claim of title to
savings bonds based on a judgment of
escheat. ‘‘Escheat’’ describes a state’s
claim to property that has no owner.
Many state probate laws allow a state to
escheat the property of a person who
dies without a will and without heirs.
Treasury regulations do not specifically
mention escheat, but they do provide
that Treasury will pay a person entitled
to the estate of a deceased savings bond
owner in specified circumstances. When
these circumstances are met, Treasury
will pay a state that has title to savings
bonds in the estate of a deceased owner.
Like all claimants, the state must
present the bonds to Treasury or
otherwise meet Treasury’s requirements
for payment.
In recent years, states have submitted
escheat claims to Treasury for savings
bonds based on state unclaimed
property laws, when there is no
evidence that the savings bond owner
has died. The first claims came from
states whose escheat laws purported to
give them custody, but not title, to
certain unredeemed savings bonds. In
2012, the United States Court of
Appeals for the Third Circuit upheld
Treasury’s position that states are not
entitled to payment for savings bonds
held only in their custody, because such
claims interfere with the rights of
registered owners and others under
Treasury regulations. New Jersey v. U.S.
Dept. of Treasury, 684 F.3d 382 (3rd Cir.
2012).
More recently, the State of Kansas
submitted an escheat claim based upon
a state court judgment that purported to
convey title over certain unredeemed
savings bonds. Kansas sought to redeem
savings bonds in its possession, which
had been turned over to the state as
unclaimed property, and to redeem a
much larger class of savings bonds that
it did not possess. In this class are
matured, unredeemed savings bonds
E:\FR\FM\01JYP1.SGM
01JYP1
]]>Agencies
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Proposed Rules]
[Pages 37555-37559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16151]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA-2015-N-1514]
RIN 0910-AH24
Nicotine Exposure Warnings and Child-Resistant Packaging for
Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco
Products; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing this advance
notice of proposed rulemaking (ANPRM) to obtain information related to
the regulation of ``tobacco products'' subject to the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act), and
restrictions regarding the sale and distribution of such tobacco
products. Specifically, this ANPRM is seeking comments, data, research
results, or other information that may inform regulatory actions FDA
might take with respect to nicotine exposure warnings and child-
resistant packaging for liquid nicotine and nicotine-containing e-
liquid(s) that are made or derived from tobacco and intended for human
consumption, and potentially for other tobacco products including, but
not limited to, novel tobacco products such as dissolvables, lotions,
gels, and drinks. In April 2014, FDA published a proposed rule seeking
to deem products meeting the statutory definition of ``tobacco
product,'' except accessories to proposed deemed tobacco products, to
be subject to the FD&C Act, as amended by the Tobacco Control Act.
Specifically, the proposed rule seeks to extend the Agency's ``tobacco
product'' authorities to those products that meet the statutory
definition of ``tobacco product,'' prohibiting the sale of ``covered
tobacco products'' to individuals under the age of 18, and requiring
the display of health warnings on certain tobacco product packages and
in advertisements. The deeming
[[Page 37556]]
rulemaking does not address the issues raised in this ANPRM.
DATES: Submit either electronic or written comments by August 31, 2015.
ADDRESSES: You may submit comments by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
FDA-2015-N-1514 for this rulemaking. All comments received may be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Bryant M. Godfrey, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 1-877-CTP-1373, bryant.godfrey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Tobacco Control Act was enacted on June 22, 2009, amending the
FD&C Act and providing FDA with the authority to regulate tobacco
products (Pub. L. 111-31). Specifically, section 101(b) of the Tobacco
Control Act amends the FD&C Act by adding a new chapter that provides
FDA with authority over tobacco products. Section 901 of the FD&C Act
(21 U.S.C. 387a), as amended by the Tobacco Control Act, states that
the new chapter in the FD&C Act (chapter IX--Tobacco Products) (21
U.S.C. 387 through 387u) applies to all cigarettes, cigarette tobacco,
roll-your-own tobacco, smokeless tobacco, and any other tobacco
products that the Secretary of Health and Human Services by regulation
deems to be subject to this chapter. Accordingly, in the Federal
Register of April 25, 2014 (79 FR 23142), FDA published a proposed rule
seeking to deem all products meeting the statutory definition of
``tobacco product'' in section 201(rr) of the FD&C Act (21 U.S.C.
321(rr)), except accessories to those products, to be subject to
chapter IX of the FD&C Act.
FDA has evaluated data and science (including all of the evidence
submitted to the docket of the proposed ``deeming'' rule cited below)
related to the risks, especially to infants and children, from
accidental exposure to nicotine, including exposure to liquid nicotine
and nicotine-containing e-liquid(s), which are primarily used with
electronic nicotine delivery systems (ENDS), such as electronic
cigarettes. Recent increases in calls and visits to both poison control
centers (see, e.g., CDC's Morbidity and Mortality Weekly Report,
available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm) and
emergency rooms in the United States involving liquid nicotine
poisonings and exposures has increased the public health concerns of
these exposure risks. As a result of FDA's evaluation and these recent
trends, FDA is considering whether, based on the acute toxicity of
nicotine (up to and including nicotine poisoning), it would be
appropriate for the protection of the public health to warn the public
about the dangers of nicotine exposure, especially due to inadvertent
nicotine exposure in infants and children, and/or require that some
tobacco products be sold in child-resistant packaging. Comments
submitted in response to FDA's proposed rule seeking to deem all
tobacco products to be subject to the FD&C Act support such actions,
and many request that FDA take prompt action to mitigate nicotine
exposure risks (see Docket No. FDA-2014-N-0189, https://www.regulations.gov).
As previously discussed, the FD&C Act provides FDA with authority
to regulate tobacco products. Sections 906(d)(1) and 910(c)(1)(B) of
the FD&C Act provide FDA the authority to, by regulation or in a
marketing authorization order, require restrictions on the sale and
distribution of a tobacco product. The restrictions on the sale and
distribution of a tobacco product may include restrictions on the
access to, and the advertising and promotion of, the tobacco product,
if FDA determines such restrictions would be appropriate for the
protection of the public health. The FD&C Act also provides FDA with
authority to adopt a tobacco product standard under section 907 of the
FD&C Act if the Secretary finds that it is appropriate for the
protection of the public health.
In making such a finding under either section 906(d)(1) or section
907 of the FD&C Act, the Secretary must consider: (1) The risks and
benefits to the population as a whole, including users and nonusers of
tobacco products; (2) the increased or decreased likelihood that
existing users of tobacco products will stop using such products; and
(3) the increased or decreased likelihood that those who do not use
tobacco products will start using such products.
FDA intends to use the information submitted in response to this
ANPRM to further inform its thinking about options for issuing
potential regulations that would require nicotine exposure warnings
and/or child-resistant packaging for some tobacco products, as
articulated in this document. For the purposes of the questions in this
ANPRM:
``Liquid nicotine and nicotine-containing e-liquid(s)
(liquid nicotine combined with colorings, flavorings, and/or
potentially other ingredients)'' are generally referred to as liquid
nicotine.
``Liquid nicotine'' (as used throughout this document)
refers to liquid nicotine that is made or derived from tobacco and
intended for human consumption.
``Novel tobacco products'' (as used throughout this
document) refers to products such as dissolvables, lotions, gels, and
drinks.
II. Requests for Comments and Information
FDA is seeking comments, data, research results, and other
information related to the following questions. Please explain your
responses and provide any evidence or other information supporting your
responses to the following questions:
A. Nicotine Exposure Warnings
1. Should FDA consider requiring nicotine exposure warning(s) text
on liquid nicotine? If so, why?
2. Should FDA consider requiring nicotine exposure warning(s) text
on tobacco products other than liquid nicotine, including, but not
limited to, novel tobacco products? If so, which products and why?
3. On what basis (e.g., physical characteristics or appearance of
the product or packaging, product risks, form of marketing, route of
exposure, type of packaging) should FDA determine which products should
be
[[Page 37557]]
required to carry the warning(s)? What data or information would be
helpful to demonstrate the need for a warning or warnings?
4. If FDA were to require nicotine exposure warning(s) text for
liquid nicotine, what issues should the warning(s) address and what
wording should be used? Please consider: (a) Whether the warning(s)
should be broad, or directed at specific dangers; (b) whether the
warning(s) should specifically address oral, ocular, and dermal
exposure dangers; (c) whether the warning(s) should focus exclusively
on the risks to children and youth, or include the risks to vulnerable
populations, such as pregnant women, adults with medical conditions,
and pets; (d) whether the warning(s) should contain instructions to
avoid the dangers altogether, such as ``keep out of the reach of
children''; (e) whether there are other dangers of liquid nicotine
exposure that should be covered by the warning(s); and (f) whether
information about what to do in the case of an accidental exposure to
liquid nicotine should be included (e.g., when to seek medical
attention, when to contact a Poison Control Center). Please submit data
or evidence to support your position.
5. With preceding question 4 in mind, should there be multiple
textual warnings that randomly display to convey different dangers, or
should there be a single, consistent textual warning that covers all of
the different dangers? Please submit data or evidence to support your
position.
6. If FDA were to require nicotine exposure warning(s) text for
tobacco products other than liquid nicotine, including, but not limited
to, novel tobacco products, what issues should the warning(s) address
and what wording should be used? Please consider: (a) Whether the
warning(s) should be broad, or directed at specific dangers; (b)
whether the warning(s) should specifically address oral, ocular, and
dermal exposure dangers; (c) whether the warning(s) should focus
exclusively on the risks to children and youth, or include the risks to
vulnerable populations, such as pregnant women, adults with medical
conditions, and pets; (d) whether the warning(s) should contain
instructions to avoid the dangers altogether, such as ``keep out of the
reach of children''; (e) whether there are other dangers of nicotine
exposure that should be covered by the warning(s); and (f) whether
information about what to do in the case of an accidental exposure to
liquid nicotine should be included (e.g., when to seek medical
attention, when to contact a Poison Control Center). Please submit data
or evidence to support your position.
7. With preceding question 6 in mind, please respond to the
following questions: Should there be multiple textual warnings that
randomly display to convey different dangers, or should there be a
single, consistent textual warning that covers all of the different
dangers? Should different types of tobacco products carry different
warnings? If so, which type(s) of tobacco products should carry what
warning(s) and what is the reasoning for different warnings for
different types of tobacco products? Please submit data or evidence to
support your position.
8. If FDA were to require nicotine exposure warning(s) text for
liquid nicotine, should FDA consider requiring color(s) or graphic
elements, such as symbols, as part of the warning(s)? If so, what color
or graphic elements should FDA consider?
(a) Are there data on graphic elements and/or colors that would be
most effective in communicating the dangers associated with nicotine
exposure? If so, please provide these data.
(b) Would a graphic element alone (as opposed to text alone or any
combination of text, color, or graphic elements) be sufficient to
effectively communicate the dangers associated with nicotine exposure?
Please provide data or evidence to support your position.
(c) How could the warning(s) text and graphic image(s) add to or
detract from each other?
9. If FDA were to require nicotine exposure warning(s) text for
tobacco products other than liquid nicotine, including, but not limited
to, novel tobacco products, should FDA consider requiring color(s) or
graphic elements as part of the warning(s)? If so, what color or
graphic elements should FDA consider?
(a) Are there data on graphics and/or colors that would be most
effective in communicating the dangers associated with nicotine
exposure? If so, please provide these data.
(b) Would a graphic image alone be sufficient to effectively
communicate the dangers associated with nicotine exposure? Please
provide data or evidence to support your position.
(c) How could the warning(s) text and graphic image(s) add to or
detract from each other?
(d) Should different tobacco products carry different color or
graphic elements? If so, what criteria should FDA use to determine
which type of tobacco products should carry what color or graphic
elements?
10. If FDA were to require a nicotine exposure warning(s) (text and
any applicable color or graphic element) for liquid nicotine, should
FDA adopt a different nicotine exposure warning(s) requirement based on
the packaging/containers (e.g., a brief/abbreviated warning(s) for
liquid nicotine in small packaging/containers, omit the warning(s) if
the tobacco product is in a child-resistant package)? If so, how should
the warning(s) differ? Please submit data or evidence to support your
position.
11. With respect to tobacco products other than liquid nicotine,
including, but not limited to, novel tobacco products, if FDA were to
require a nicotine exposure warning(s) (text and any applicable color
or graphic element), should FDA adopt a different nicotine exposure
warning(s) requirement based on the packaging/containers (e.g., a
brief/abbreviated warning(s) for tobacco products in small packaging,
omit the warning(s) if the tobacco product is in a child-resistant
package)? If so, how should the warning(s) differ? Please submit data
or evidence to support your position.
12. Are you aware of data or information that would support any
required font sizes, formatting, and display considerations for
nicotine exposure warnings (textual and/or graphic)? If so, please
provide that evidence.
13. Should FDA require the inclusion of the American Association of
Poison Control Centers' telephone number on the container labeling and/
or packaging of liquid nicotine and tobacco products other than liquid
nicotine? Why or why not?
14. Are there any nicotine exposure warnings (textual and/or
graphic) for liquid nicotine required by authorities at the local,
State, or Federal (i.e., other agencies) level, or by foreign
governments that you particularly would like to highlight? If so, which
ones and why? Are there any data regarding the effectiveness or utility
of these warnings? If so, please provide these data.
15. Are there any nicotine exposure warnings (textual and/or
graphic) for tobacco products other than liquid nicotine required by
authorities at the local, State, or Federal (i.e., other agencies)
level, or by foreign governments that you particularly would like to
highlight? If so, which ones and why? Are there any data regarding the
effectiveness or utility of these warnings? If so, please provide these
data.
16. Are you aware of any existing evidence regarding whether
warnings
[[Page 37558]]
(text and any applicable color or graphic element) are effective for
mitigating the risks of nicotine exposure? If so, please provide that
evidence.
B. Child-Resistant Packaging
1. Should FDA require child-resistant packaging for liquid
nicotine? If so, why?
2. Should FDA require child-resistant packaging for liquid nicotine
if the liquid nicotine product is not intended to be opened by the
consumer (e.g., liquid nicotine in permanently sealed, prefilled, and/
or disposable cartridges)? Please provide the reason for your response.
3. Should FDA consider requiring child-resistant packaging for
tobacco products other than liquid nicotine, including, but not limited
to, novel tobacco products? If so, which ones and why?
4. If FDA were to require child-resistant packaging for liquid
nicotine (including for those products that are not intended to be
opened by the consumer), what type of exposure risks (e.g., oral,
ocular, dermal) should FDA seek to mitigate with the requirement?
5. If FDA were to require child-resistant packaging for tobacco
products other than liquid nicotine, including, but not limited to,
novel tobacco products, what risks (e.g., oral, ocular, dermal) should
FDA seek to mitigate with the requirement?
6. If FDA were to require child-resistant packaging for liquid
nicotine, how should the requirement be articulated? Please consider:
(a) Whether the requirement should be based on mandated physical
characteristics of the packaging (e.g., must have a squeeze-to-turn
lid, flow restrictor); (b) whether the requirement should be
performance based (e.g., unable to be opened by 80 percent or more of
5-year-olds who try to open the package, and more than 90 percent of
adults on average between the ages of 50-70 can successfully open the
package); or (c) whether the requirement should be based on a
combination of (a) and (b), or is there some other basis for the
requirement that FDA should consider? Is your proposal technically
feasible? Please submit data or evidence to support your position.
7. If FDA were to require child-resistant packaging for tobacco
products other than liquid nicotine, including, but not limited to,
novel tobacco products, how should the requirement be articulated?
Please consider: (a) Whether the requirement should be based on
mandated physical characteristics of the packaging (e.g., must have a
squeeze-to-turn lid, child-resistant cap, blister packaging); (b)
whether the requirement should be performance based (e.g., unable to be
opened by 80 percent or more of 5-year-olds who try to open the
package, and more than 90 percent of adults on average between the ages
of 50-70 can successfully open the package); or (c) whether the
requirement should be based on a combination of (a) and (b), or is
there some other basis for the requirement that FDA should consider? Is
your proposal technically feasible? Please submit data or evidence to
support your position.
8. Are there other factors FDA should consider to further prevent
or discourage people (especially infants and children) from
inadvertently consuming or being exposed to liquid nicotine? If so,
please explain. Examples of other factors may include: attractiveness
of the product or packaging (e.g., appealing images, fragrance,
flavors), resemblance of packaging to food and drink items (e.g.,
candy, fruit), color of the product (e.g., resemblance to beverages
such as juice), resemblance of packaging to that of medications (e.g.,
eye drops).
9. If FDA were to require child-resistant packaging, what should
FDA consider and what actions should FDA take to mitigate the risk that
users of products with child-resistant packaging will defeat the
purpose of the packaging by leaving the packaging open, by disabling
the protection mechanism, or by moving the product to a different
container?
C. Other Actions and Considerations
1. With respect to liquid nicotine, should FDA require both
nicotine exposure warnings (text and/or any applicable color or graphic
element) and child-resistant packaging, or should only one and not the
other be required? Please explain your reasoning and provide data or
evidence to support your position.
2. With respect to tobacco products other than liquid nicotine,
including, but not limited to, novel tobacco products, should FDA
require both nicotine exposure warnings (text and/or any applicable
color or graphic element) and child-resistant packaging, or should only
one and not the other be required? Please explain your reasoning and
provide data or evidence to support your position.
3. With respect to liquid nicotine and the dangers of nicotine
poisoning, should FDA consider requiring any additional warnings beyond
a nicotine exposure warning (text and/or any applicable color or
graphic element)? If so, please describe the warning(s) (textual and/or
graphic) and provide evidence or data to support your recommendation.
4. With respect to tobacco products other than liquid nicotine,
including, but not limited to, novel tobacco products, and the dangers
of nicotine poisoning, should FDA consider requiring any additional
warnings beyond a nicotine exposure warning (text and/or any applicable
color or graphic element)? If so, for which products? Also, please
describe the warning(s) (textual and/or graphic) and provide evidence
or data to support your recommendation.
5. Should FDA consider any additional measures to mitigate nicotine
exposure risks for people (especially infants and children) beyond
nicotine exposure warnings (text and any applicable color or graphic
element) and child-resistant packaging? If so, what measures should FDA
consider and why? Please provide evidence or data to support your
recommendation.
III. Comments
A. General Information About Submitting Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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.
B. Public Availability of Comments
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov. As a matter of Agency
practice, FDA generally does not post comments submitted by individuals
in their individual capacity on https://www.regulations.gov. This is
determined by information indicating that the submission is written by
an individual, for example, the comment is identified with the category
``Individual Consumer'' under the field entitled ``Category
(Required)'', on the ``Your Information'' page on https://www.regulations.gov; for this ANPRM, however, FDA will not be following
this general practice. Instead, FDA will post on https://www.regulations.gov comments to this docket that have been submitted by
individuals in their individual capacity. If you wish to submit any
information under a claim of confidentiality, please refer to 21 CFR
10.20.
[[Page 37559]]
C. Information Identifying the Person Submitting the Comment
Please note that your name, contact information, and other
information identifying you will be posted on https://www.regulations.gov if you include that information in the body of your
comments. For electronic comments submitted to https://www.regulations.gov, FDA will post the body of your comment on https://www.regulations.gov along with your State/province and country (if
provided), the name of your representative (if any), and the category
identifying you (e.g., individual, consumer, academic, industry). For
written submissions submitted to the Division of Dockets Management,
FDA will post the body of your comments on https://www.regulations.gov,
but you can put your name and/or contact information on a separate
cover sheet and not in the body of your comments.
Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16151 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-P
