[Federal Register Volume 80, Number 1 (Friday, January 2, 2015)]
[Proposed Rules]
[Pages 21-24]
[FR Doc No: 2014-30784]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-1029]
RIN 1625-AA09

Drawbridge Operation Regulation; Hoquiam River, Hoquiam, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to temporarily change the operating
schedule that governs the Simpson Avenue Bridge on the Hoquiam River,
mile 0.5, at Hoquiam, Washington. The proposed rule change is necessary
to accommodate Washington State Department of Transportation's (WSDOT)
extensive maintenance and restoration efforts on that bridge. The
bridge is currently scheduled to open on signal if at least one hour of
notice is given. From April 1, 2015 to November 30, 2015, the Coast
Guard proposes to only open half of the bascule, a single leaf, of the
bridge when at least two hours of notice is given.

DATES: Comments and related material must reach the Coast Guard on or
before February 2, 2015.

ADDRESSES:  You may submit comments identified by docket number USCG-
2014-1029 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.

    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of three
methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule change, call or email Steven M. Fischer, Bridge
Administrator, Thirteenth Coast Guard District Bridge Program Office,
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Cheryl
Collins, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
U.S.C. United States Code

A. Public Participation and Request for Comments

    We encourage you to participate in this proposed rulemaking by
submitting comments and related materials. All comments received will
be posted, without change to http://www.regulations.gov and will
include any personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
proposed rulemaking (USCG-2014-1029), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online (http://www.regulations.gov), or by fax, mail or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2014-1029] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking. 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 them by mail
and would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period, and may
change the rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2014-1029) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting, but you may submit a
request for a meeting that reaches the Coast Guard on or before January
20, 2015 using one of the three methods specified under ADDRESSES.
Please explain why one would be beneficial. If we determine that one
would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

B. Basis and Purpose

    The Washington State Department of Transportation (WSDOT), who owns
and operates the Simpson Avenue Bridge on the Hoquiam River in Hoquiam,
Washington, has requested a temporary change to the bridge's existing
operating regulations in order to facilitate the maintenance and
restoration of it. The restoration project will entail painting, rust
removal, and steel repairs which require a full containment system to
keep paint and debris out of the Hoquiam River.
    In an effort to accommodate both the needs of the waterway and
highway users, WSDOT has requested a temporary rule change in order to
eliminate the need to repeatedly uninstall and reinstall the
containment system. As such, the Coast Guard is proposing to change the
bridge's current operating regulation from April 1, 2015 to November
30, 2015. During that time the drawbridge would be maintained in the
closed position except that, upon at least two hours advance notice,
half of the bascule (a single leaf) would be opened.
    Vessels that are able to transit under the bridge without an
opening will be free to do so. However, the existing navigation
clearance of the bridge will be reduced from approximately 35 feet to
approximately 25 feet at mean high tide due to the required containment
system.
    Vessel traffic along this part of the Hoquiam River consists of
vessels ranging from commercial tug and barge to small pleasure craft.
WSDOT has examined bridge opening logs and contacted all waterway users
that have requested bridge openings throughout the last year. The input
WSDOT received from waterway users indicated that the proposed change
will have no impact on users.

C. Discussion of Proposed Rule

    The Coast Guard would temporarily revise the operating regulations
at 33 CFR 117.1047. The regulation currently states that the Simpson
Avenue Bridge shall open on signal if at least one hour notice is
given. The Coast Guard proposes to temporarily change the regulation
such that from 7 a.m. on April 1, 2015 to 6 p.m. on November 30, 2015,
the draw of the Simpson Avenue Bridge, on the Hoquiam River at mile
0.5, at Hoquiam, Washington, shall open half of the bascule (single
leaf) when at least two hours of advance notice is given. No alternate
routes are available for this waterway. Vessels that can transit under
the bridge without an opening may do so at any time although the
existing navigation clearance of the bridge will be reduced from
approximately 35 feet to approximately 25 feet at mean high tide.

D. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking.

Below we summarize our analyses based on these statutes or executive
orders.

1. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders. The Coast Guard has made this
finding based on the fact that all requested bridge openings will be
granted with advance notification and vessels that can safely transit
under the bridge may do so at any time.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. This proposed rule would affect
the following entities, some of which might be small entities: The
owners or operators of vessels needing to transit the bridge at any
time of day. This rulemaking will not have a significant economic
impact on a substantial number of small entities for the following
reasons: The bridge will still be able to open upon advance
notification. Additionally, three commercial maritime businesses use
this waterway and bridge. All three have stated to WSDOT a single leaf
operation will not impact their business.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such expenditure, we do discuss the effects of this
rulemaking elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed rule is not an economically significant rulemaking
and would not create an environmental risk to health or risk to safety
that might disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rulemaking under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This proposed rule simply
promulgates the operating regulations or procedures for drawbridges.
This rulemaking is categorically excluded, under figure 2-1, paragraph
(32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical

exclusion determination are not required for this rulemaking. We seek
any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 117

    Bridges.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Effective 7 a.m. on April 1, 2015 until 6 p.m. on November 30, 2015,
suspend Sec.  117.1047(c) and add Sec.  117.T1047(c) to read as
follows:

Sec.  117.T1047  Hoquiam River

* * * * *
    (c) Half of the draw (single leaf) of the Simpson Avenue Bridge,
mile 0.5, at Hoquiam, WA, shall open on signal if at least a two hour
notice is given by telephone or VHF radio to the Washington State
Department of Transportation. The opening signal is two prolonged
blasts followed by one short blast.
* * * * *

    Dated: December 16, 2014.
R.T. Gromlich,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.

[FR Doc. 2014-30784 Filed 12-31-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3158-3161]
[FR Doc No: 2018-01121]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0071]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Draft Guidance for Industry: Modified Risk Tobacco
Product Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed collection of information, and to allow 60 days for
public comment in response to the notice. This notice solicits comments
on ``Draft Guidance for Industry: Modified Risk Tobacco Product
Applications'' (MRTPA).

DATES: Submit either electronic or written comments on the collection
of information by March 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 26, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-D-0071 for ``Draft Guidance for Industry: Modified Risk
Tobacco Product Applications'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,

Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Draft Guidance for Industry: Modified Risk Tobacco Product Applications

OMB Control Number 0910--NEW

    In the Federal Register of April 3, 2012 (77 FR 20026), FDA
published a notice of availability including the PRA analysis. FDA is
republishing the paperwork analysis with updates to satisfy the
requirements of the PRA.
    This draft guidance describes the information that the Federal
Food, Drug, and Cosmetic Act (FD&C Act) requires in an MRTPA submission
as well as FDA's recommendations regarding the scientific evidence that
should be contained in a MRTPA for FDA to make an assessment and
conduct an ongoing review of modified risk tobacco products (MRTPs).
The draft guidance also permits the filing of a single application for
any MRTP that is also a new tobacco product under section 910 of the
FD&C Act (21 U.S.C. 387k). The draft guidance discusses, among other
things: (1) Who submits MRTPAs; (2) when to submit a MRTPA; (3) what
information section 911 of the FD&C Act (21 U.S.C. 387j) requires
applicants to submit in a MRTPA; (4) what scientific evidence FDA
recommends applicants include in a MRTPA; (5) what information should
be collected through postmarket surveillance and studies; and (6) how
to organize and submit a MRTPA. The purpose of the proposed information
collection is to allow FDA to collect statutorily mandated information
regarding modified risk tobacco products and other information that
will facilitate FDA's effective and efficient review of MRTPAs.
    Modified risk tobacco products are tobacco products that are sold
or distributed for use to reduce harm or the risk of tobacco-related
disease associated with commercially marketed tobacco products (section
911(b)(1) of the FD&C Act). No person may introduce or deliver for
introduction into interstate commerce any MRTP unless an order issued
pursuant to section 911(g) is effective with respect to that product
(section 911(a) of the FD&C Act).
    Under section 911(d) of the FD&C Act, a MRTPA must contain:
     A description of the proposed product and any proposed
advertising and labeling;
     The conditions for using the product;
     The formulation of the product;
     Sample product labels and labeling;
     All documents (including underlying scientific
information) relating to research findings conducted, supported, or
possessed by the tobacco product manufacturer relating to the effect of
the product on tobacco-related diseases and health-related conditions,
including information both favorable and unfavorable to the ability of
the product to reduce risk or exposure and relating to human health;
     Data and information on how consumers actually use the
tobacco product; and
     Such other information as the Secretary may require.
    Further, FDA's regulation implementing the National Environmental
Policy Act of 1969 requires that ``[a]ll applications or petitions
requesting agency action require the submission of an [environmental
assessment] or a claim of categorical exclusion'' (21 CFR 25.15(a)).
    Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA. Section 911(g)(1) and
(2) of the FD&C Act set forth two bases for FDA to issue an order.
    A ``risk modification order'' is an order permitting the
introduction or delivery for introduction into interstate commerce of a
tobacco product that FDA has found meets the criteria for an order
under section 911(g)(1) of the FD&C Act. In order for FDA to issue a
risk modification order under section 911(g)(1) of the FD&C Act, the
applicant must demonstrate that the proposed modified risk tobacco
product, as it is actually used by consumers, will:
     Significantly reduce harm and the risk of tobacco-related
disease to individual tobacco users and
     Benefit the health of the population as a whole taking
into account both users of tobacco products and persons who do not
currently use tobacco products.
    An ``exposure modification order'' is an order permitting the
introduction or delivery for introduction into interstate commerce of a
tobacco product that reduces or eliminates exposure to a substance and
for which the available scientific evidence suggests that a measurable
and substantial reduction in morbidity and mortality is likely to be
demonstrated in future studies. In order for FDA to issue an exposure
modification order, the applicant must satisfy all of the criteria for
issuance of an order under section 911(g)(2) of the FD&C Act.
    FDA may issue an exposure modification order under section
911(g)(2) of the FD&C Act (the ``special rule'') if it determines that
the applicant has demonstrated that:
     Such an order would be appropriate to promote the public
health;
     Any aspect of the label, labeling, and advertising for the
product that would cause the product to be a 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 obtaining an order under section 911(g)(1); and
     The scientific evidence that is available without
conducting long-term epidemiological studies demonstrates

that a measurable and substantial reduction in morbidity or mortality
among individual tobacco users is reasonably likely in subsequent
studies (section 911(g)(2)(A) of the FD&C Act).
    Furthermore, for FDA to issue an exposure modification order, FDA
must find that the applicant has demonstrated that:
     The magnitude of overall reductions in exposure to the
substance or substances, which are the subject of the application is
substantial, such substance or substances are harmful, and the product
as actually used exposes consumers to the specified reduced level of
the substance or substances;
     The product as actually used by consumers will not expose
them to higher levels of other harmful substances compared to the
similar types of tobacco products then on the market unless such
increases are minimal and the reasonably likely overall impact of use
of the product remains a substantial and measurable reduction in
overall morbidity and mortality among individual tobacco users;
     Testing of actual consumer perception shows that, as the
applicant proposes to label and market the product, consumers will not
be misled into believing that the product is or has been demonstrated
to be less harmful, or presents or has been demonstrated to present
less of a risk of disease than one or more other commercially marketed
tobacco products; and
     Issuance of the exposure modification order is expected to
benefit the health of the population as a whole taking into account
both users of tobacco products and persons who do not currently use
tobacco products (section 911(g)(2)(B) of the FD&C Act).
    In evaluating the benefit to health of individuals and of the
population as a whole under section 911(g)(1) and (2) of the FD&C Act,
FDA must 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 modified risk tobacco product;
     The increased or decreased likelihood that persons who do
not use tobacco products will start using the modified risk tobacco
product;
     The risks and benefits to persons from the use of the MRTP
compared to the use of smoking cessation drug or device products
approved by FDA to treat nicotine dependence; and
     Comments, data, and information submitted to FDA by
interested persons (section 911(g)(4) of the FD&C Act).
    Furthermore, FDA must ensure that the advertising and labeling of
the MRTP enable the public to comprehend the information concerning
modified risk and to understand the relative significance of such
information in the context of total health and in relation to all of
the tobacco-related diseases and health conditions (section 911(h)(1)
of the FD&C Act).
    FDA intends to determine whether it will issue an order under
section 911(g) within 360 days after the receipt of a complete
application and will issue such an order only if the application
satisfies all the applicable requirements in section 911 of the FD&C
Act.
    A risk modification order issued under section 911(g)(1) will be
effective for the period of time specified in the order issued by FDA
(section 911(h)(4) of the FD&C Act). An applicant to whom a risk
modification order is issued under section 911(g)(1) must conduct
postmarket surveillance and studies (section 911(i)(1) of the FD&C
Act).
    An exposure modification order issued under section 911(g)(2) of
the FD&C Act will be effective for a term of not more than 5 years. FDA
may renew an exposure modification order if the applicant files a new
application, and FDA finds that the requirements for such order under
section 911(g)(2) continue to be satisfied (section 911(g)(2)(C)(i) of
the FD&C Act). Further, an exposure modification order will be
conditioned on the applicant's agreement to conduct postmarket
surveillance and studies and to submit the results of such surveillance
and studies to FDA annually (section 911(g)(2)(C)(ii) and (iii) of the
FD&C Act).
    The postmarket surveillance and studies that all applicants who
receive orders are required to conduct are intended to determine the
effect of issuance of an order on consumer perception, behavior, and
health, and enable FDA to review the accuracy of the determinations
upon which an order was based (section 911(g)(2)(C)(ii) and 911(i)(1)
of the FD&C Act). An applicant who receives a risk modification order
must also conduct postmarket surveillance and studies that provide
information FDA determines is otherwise necessary regarding the use or
health risks involving the tobacco product (section 911(i)(1) of the
FD&C Act).
    If the proposed MRTP is a new tobacco product within the meaning of
section 910(a)(1), the new tobacco product must satisfy any applicable
premarket review requirements under section 910 of the FD&C Act, in
addition to any requirements under section 911 of the FD&C Act. A new
tobacco product must be found to be substantially equivalent, exempt
from the requirement to obtain a substantial equivalence determination,
or have a marketing authorization order under section 910(c)(1)(A)(i)
of the FD&C Act. The collections of information relating to premarket
review described in the ``Guidance for Industry: Section 905(j)
Reports: Demonstrating Substantial Evidence for Tobacco Products'' (OMB
control number 0910-0673), 21 CFR part 1107 (``Establishment
Registration, Product Listing, and Substantial Equivalence Reports'')
(OMB control number 0910-0684), and ``Deeming Tobacco Products To Be
Subject to the FD&C Act '' (OMB control number 0910-0768) have been
previously approved by OMB. An applicant may file the appropriate
report or application to satisfy any applicable premarket review
requirements and a separate application under section 911 of the FD&C
Act. To the extent data or information contained in the premarket
review portion of the application is also relevant to or required for
the modified risk determination, FDA encourages the applicant to cross-
reference that data or information rather than duplicate it in the
modified risk portion of the application. Additionally, due to the many
similarities between the content requirements of sections 910(b)(1)
(for premarket tobacco applications (PMTAs)) and 911(d) (for MRTPAs) of
the FD&C Act, we recommend submitting a single application to seek both
a marketing order under section 910 of the FD&C Act and a modified risk
order under section 911 of the FD&C Act. The single application must
include the information required for premarket review under section
910(b) of the FD&C Act, as well as the information required to support
issuance of an order under section 911(g) of the FD&C Act.
    Description of Respondents: The respondents to this collection of
information are applicants who are responsible for creating and
submitting MRTP applications and who wish to obtain an FDA order to
allow them to market their product. While it is expected that many of
the respondents will be manufacturers, respondents could include
importers, distributors, and retailers of tobacco products.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
MRTPA (section 911(d) of FD&C                  3               1               3          10,000          30,000
 Act)...........................
Environmental analysis (21 CFR                 3               1               3             320             960
 25.15).........................
Request for a meeting prior to                 8               1               8              40             320
 submitting a MRTPA.............
All activities related to                      5               1               5           5,000          25,000
 postmarket surveillance
 studies, including submission
 of protocols, conduct of
 studies, and annual reporting
 (section 911(g)(2)(C)(ii),
 911(i)(1) and (2)).............
Requests for renewal (section                  1               1               1           1,000           1,000
 911(g)(2)(C)(i) and 911(h)(4)).
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............          57,280
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 describes the annual reporting burden as a result of
submitting a MRTPA. FDA estimates that it will receive three MPRTAs
annually and that it will take the applicant 10,000 hours per response
to conduct studies and collect the information needed to support an
MRTPA. FDA is also including an estimation of the burden associated
with preparing environmental analyses. FDA estimates that it will take
an additional 320 hours to prepare any environmental analyses. FDA
encourages persons considering developing a MRTPA to meet with the
Center for Tobacco Products to discuss MRTPA submission and
investigational requirements. FDA anticipates that eight respondents
considering developing MRTPAs may request meetings with FDA. FDA
estimates it will take 40 hours per response to prepare a meeting
request, including background information.
    Section 911 of the FD&C Act requires applicants to whom FDA issues
orders to conduct postmarket surveillance and studies and submit
relevant information to FDA on an annual basis. Applicants must submit
and receive FDA approval of surveillance protocols. FDA estimates that
it will take 5,000 hours per response to collect and submit the
protocol information to FDA, conduct the postmarket surveillance and
studies and to submit results of postmarket surveillance and studies to
FDA annually. FDA expects five respondents to carry out postmarket
surveillance and studies annually.
    Because orders issued under section 911(g) of the FD&C Act are
valid for only a set number of years, FDA expects applicants will
submit requests for renewal. Because the dates on which orders are
issued and the length of the period for which the order is valid will
vary, FDA expects one request for renewal annually. FDA estimates that
it will take 1,000 hours to prepare the request for renewal.
    The estimated total burden hours for this collection of information
is estimated to be 57,280. These burden estimates were computed using
FDA staff expertise and by reviewing comments received from recent FDA
information collections for other tobacco-related initiatives. In
addition, FDA notes that due to the many similarities between the
content requirements of sections 910(b)(1) (from PMTAs) and 911(d) (for
MRTPAs) of the FD&C Act, and the likelihood that many respondents will
submit joint PMTAs and MRTPAs, or cross-reference the applications,
that part of the collection of information burden for respondents
submitting an MRTPA will be captured in the preparation of the PMTA.

    Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01121 Filed 1-22-18; 8:45 am]
 BILLING CODE 4164-01-P