[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Proposed Rules]
[Pages 65352-65356]
[FR Doc No: 2012-26353]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 595

[Docket No. NHTSA-2012-0149]
RIN 2127-AL17

Make Inoperative Exemptions; Vehicle Modifications To Accommodate
People With Disabilities, Ejection Mitigation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This NPRM proposes to amend NHTSA's regulation regarding,
``Make Inoperative Exemptions, Vehicle Modifications to Accommodate
People With Disabilities,'' to include a new exemption relating to the
Federal motor vehicle safety standard for ejection mitigation. The
regulation facilitates the mobility of physically disabled drivers and
passengers. This document responds to a petition from Bruno Independent
Living Aids.

DATES: You should submit your comments early enough to ensure that the
Docket receives them not later than December 26, 2012.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the SUPPLEMENTARY INFORMATION section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
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 DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477 through 78).
    For access to the docket to read background documents or comments
received, go to http://www.regulations.gov or the street address listed
above. Follow the online instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: Gayle Dalrymple, NHTSA Office of Crash
Avoidance Standards, NVS-123 (telephone<PHONE_NUMBER>), or Deirdre
Fujita, NHTSA Office of Chief Counsel, NCC-112 (telephone<PHONE_NUMBER>)
The mailing address for these officials is: National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE., Washington, DC
20590.

SUPPLEMENTARY INFORMATION:

Background

    The National Traffic and Motor Vehicle Safety Act (49 U.S.C.
Chapter 301) (``Safety Act'') and NHTSA's regulations require vehicle
manufacturers to certify that their vehicles comply with all applicable
Federal motor vehicle safety standards (FMVSSs) (see 49 U.S.C. 30112;
49 CFR part 567) at the time of manufacture. A vehicle manufacturer,
distributor, dealer, or repair business, except as indicated below, may
not knowingly make inoperative any part of a device or element of
design installed in or on a motor vehicle in compliance with an
applicable FMVSS (see 49 U.S.C. 30122). NHTSA has the authority to
issue regulations that exempt regulated entities from the ``make
inoperative'' provision (49 U.S.C. 30122(c)). The agency has used that
authority to promulgate 49 CFR part 595 subpart C, ``Make Inoperative
Exemptions, Vehicle Modifications to Accommodate People with
Disabilities.''
    49 CFR part 595 subpart C sets forth exemptions from the make
inoperative provision to permit, under limited circumstances, vehicle
modifications that take the vehicles out of compliance with certain
FMVSSs when the vehicles are modified to be used by persons with
disabilities after the first retail sale of the vehicle for purposes
other than resale. The regulation was promulgated to facilitate the
modification of motor vehicles so that persons with disabilities can
drive or ride in them. The regulation involves information and
disclosure requirements and limits the

extent of modifications that may be made.
    Under the regulation, a motor vehicle repair business that modifies
a vehicle to enable a person with a disability to operate or ride as a
passenger in the motor vehicle and that avails itself of the exemption
provided by 49 CFR part 595 subpart C must register itself with NHTSA.
The modifier is exempted from the make inoperative provision of the
Safety Act, but only to the extent that the modifications affect the
vehicle's compliance with the FMVSSs specified in 49 CFR 595.7(c) and
only to the extent specified in 595.7(c). Modifications that would take
the vehicle out of compliance with any other FMVSS, or with an FMVSS
listed in 595.7(c) but in a manner not specified in that paragraph, are
not exempted by the regulation. The modifier must affix a permanent
label to the vehicle identifying itself as the modifier and the vehicle
as no longer complying with all FMVSS in effect at original
manufacture, and must provide and retain a document listing the FMVSSs
with which the vehicle no longer complies and indicating any reduction
in the load carrying capacity of the vehicle of more than 100 kilograms
(220 pounds).

FMVSS No. 226 ``Ejection Mitigation'' and Part 595

    On January 19, 2011,\1\ the agency published a final rule which
established a new Federal Motor Vehicle Safety Standard No. 226,
``Ejection Mitigation,'' to reduce the partial and complete ejection of
vehicle occupants through side windows in crashes, particularly
rollover crashes. The standard applies to passenger cars, and to
multipurpose passenger vehicles, trucks and buses with a gross vehicle
weight rating of 4,536 kg (10,000 pounds) or less, except walk-in vans,
vehicles with modified roofs and convertibles. Also excluded from this
standard are law enforcement vehicles, correctional institution
vehicles, taxis and limousines, if they have a fixed security partition
separating the first and second or second and third rows and if they
are produced by more than one manufacturer or are altered (within the
meaning of 49 CFR 567.7).
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    \1\ 76 FR 3212.
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    To assess compliance with FMVSS No. 226, the agency adopted a test
in which an impactor is propelled from inside a test vehicle toward the
windows. The ejection mitigation safety system is required to prevent
the impactor from moving more than a specified distance beyond the
plane of a window. In the test, the countermeasure must retain the
linear travel of the impactor such that the impactor must not travel
100 millimeters (mm) beyond the location of the inside surface of the
vehicle glazing. This displacement limit serves to control the size of
any gaps forming between the countermeasure (e.g., the ejection
mitigation side curtain air bag) and the window opening, thus reducing
the potential for both partial and complete ejection of an occupant.
    To ensure that the systems cover the entire opening of each window
for the duration of a rollover, each side window will be impacted at up
to four locations around its perimeter at two time intervals following
NHTSA's manual deployment of the countermeasure. The agency anticipated
that manufacturers will meet the standard by means of air bag
technology, and possibly supplement the technology with advanced
glazing. Vehicle manufacturers may newly install ejection mitigation
air bag curtains, or will more likely modify existing side impact air
bag curtains. The existing side impact air bag curtains will be made
larger so that they cover more of the window opening, made more robust
to remain inflated longer, and made to deploy in both side impacts and
in rollovers using sensors. In addition, after deployment the curtains
will be tethered near the base of the vehicle's pillars or otherwise
designed to keep the impactor within the boundaries established by the
performance test.
    We estimated the new requirements will save 373 lives and prevent
476 serious injuries per year. The final rule adopted a phase-in of the
new requirements, starting September 1, 2013.
    FMVSS No. 226 is a new regulation and currently, 49 CFR Part 595
does not provide for an exemption for vehicles that are modified to
accommodate people with disabilities.

Petition for Rulemaking

    On May 17, 2011, Bruno Independent Living Aids (Bruno) submitted a
petition for rulemaking to amend Sec.  595.7 to include an exemption
from the requirements of FMVSS No. 226. Bruno manufactures a product
line it calls ``Turning Automotive Seating (TAS).'' A TAS seat replaces
the seat installed by the original equipment manufacturer (OEM). Bruno
states that the purpose of the TAS is--

    To provide safe access to private motor vehicles for mobility-
impaired drivers or passengers, semi-ambulatory or transferring from
a wheelchair. The Bruno TAS replaces the OEM seat in a sedan,
minivan, van, pickup, or SUV. In its various configurations the
Bruno TAS seat pivots from the forward-facing driving position to
the side-facing entry position, extends outward and lowers to a
suitable transfer height, providing the driver and/or passengers a
convenient and safe entry into the vehicle. The transfer into the
seat takes place safely, while outside the vehicle, and the occupant
remains in the seat during the entry process, using the OEM
seatbelts while traveling in the vehicle. Exiting the vehicle is
accomplished by reversing the process. A further TAS option is a
mobility base, which converts the automotive seat into a wheelchair,
that eliminates a need for transferring from the seat altogether.

    The petitioner believes that the TAS method of vehicle entry and
exit is safer than using a platform lift to enter a vehicle or entering
and exiting unassisted.
    Bruno refers to a September 2010 notice of proposed rulemaking \2\
(NPRM) that was published in response to a previous petition from Bruno
to amend part 595.7(c)(15) to expand a reference in the exemption
relating to FMVSS No. 214 ``Side impact protection.'' In June 2011,\3\
the agency published a final rule in that rulemaking. The final rule
provided an exemption from FMVSS No. 214's moving deformable barrier
and pole tests as applied to a designated seating position that must be
modified by changing the restraint system and/or seat at that position
to accommodate a person with a disability.
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    \2\ 75 FR 59674.
    \3\ 76 FR 37025.
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    Bruno states in its current petition that FMVSS No. 226 will
enhance the side air bag technology of FMVSS No. 214 and that these
enhanced side air bags present much of the same difficulties when
accommodating the transportation needs of mobility impaired persons as
those discussed in the rulemaking for FMVSS No. 214. Bruno states:
``Where the FMVSS 226 ejection mitigation system is an OEM seat
component (e.g., seat back), it cannot be replaced within [sic] the TAS
replacement seat due to the large variety of seat designs and ICU
interfaces encountered. Also, the OEM seat can rarely, if ever, be
structurally modified to fit the TAS mechanism.'' Thus, Bruno believes
that an exemption from FMVSS No. 226 is warranted.

Response to Petition

    NHTSA proposes to amend Sec.  595.7(c) to add an exemption for
FMVSS No. 226. However, we request comments on the necessity of the
exemption.
    In the June 2011 final rule amending 49 CFR 595.7(c) to update and
expand a reference in an exemption relating to FMVSS No. 214, we
stated:

    Removing an OEM seat that has a side air bag and replacing it
with an aftermarket seat that does not would likely make inoperative
the system installed in compliance with FMVSS No. 214. Making some
other substantive modification of the OEM seat or restraint system
to accommodate a person with a disability could also affect the
measurement of the injury criteria specified in the standard. We
believe that an exemption from the make inoperative provision with
regard to the pole test in FMVSS No. 214 is needed to permit
modification of the vehicle's seating system to accommodate a person
with a disability. This is comparable to the position taken by NHTSA
with regard to the make inoperative exemption for frontal air bags
required by FMVSS No. 208. See 595.7(c)(14). Thus, we conclude today
that the inclusion of S9 of FMVSS No. 214 in Sec.  595.7(c)(15) is
needed.

    Bruno states that FMVSS No. 226 will enhance side curtain and torso
air bags, and that ``these enhanced side curtain and torso air bags
present much the same difficulties when accommodating the
transportation needs of mobility impaired person as those discussed in
the cited [FMVSS No. 214] NPRM.''
    We do not quite agree with the petitioner's statements. FMVSS No.
226 is likely to affect side curtain air bags but will not affect torso
air bags or seat components. Further, there are significant differences
between the requirements in FMVSS Nos. 214 and 226. The MDB and pole
tests specified in FMVSS No. 214 are full vehicle dynamic crash tests
conducted with instrumented 5th percentile adult female and 50th
percentile adult male dummies. To meet the performance requirement of
FMVSS No. 214, side air bags providing head and torso protection are
typically provided in the seat. The seating procedures for locating the
dummies in the vehicle are specified in the standard. By removing the
seat that contains an air bag to accommodate a person with a disability
or installing a seat at a different location when compared to the
original seat position, as Bruno does when installing the TAS seat, the
vehicle may no longer be compliant with the FMVSS No. 214 requirements.
    In contrast, the performance requirements specified in FMVSS No.
226 are based on a component test of the ejection mitigation
countermeasure (which heretofore consists of curtain air bags that
deploy from the headliner and not the seat). The ejection mitigation
air curtain retains the impactor within the vehicle. Impact locations
would be determined based on the shape of the window opening and are
not dependent on the location of dummies and/or seat position.
Therefore, it is possible, and maybe likely, that removing the original
seat and replacing it with a seat to accommodate a person with a
disability will have no negative impact on the performance of the
curtain air bags in the context of FMVSS No. 226. If this were just a
matter affecting ``those vehicles manufactured in compliance with FMVSS
No. 226 where the ejection mitigation system is an OEM seat component''
as petitioner describes the order requested, we do not see an obvious
need for an exemption.
    However, the agency does recognize the possibility that the side
impact sensing and electronic architecture system could be integrated
with that of the ejection mitigation rollover protection system.
Because of this integration, if a seat is modified or replaced to
accommodate a person with a disability and the FMVSS No. 214 side
impact air bag system is deactivated, tangentially the FMVSS No. 226
rollover ejection mitigation system could also be deactivated. For this
reason, even though the ejection mitigation side curtain air bags'
performance in a component test would not necessarily be compromised by
installing a new seat, the electronics that would deploy the restraint
in a rollover could be. Thus, for vehicles in which the seat is
modified or replaced, it may not be practical to exempt them from the
side impact requirements and not from ejection mitigation requirements.
    We realize that FMVSS No. 226 requires side window coverage
extending over the first three rows of vehicles, which among other
things does help protect rear seat passengers from partial and full
ejection. Vehicle manufacturing designs generally utilize one ejection
mitigation curtain air bag per side to protect the front and the rear
rows. If the side curtain air bag must be made inoperative to
accommodate a disabled person in the driver's position or in a rear
passenger position (e.g., to install a TAS seat in the driver's
position or the rear seat position), ejection mitigation protection
provided by the curtain would be made inoperative for the other
occupants as well (even those not using a TAS seat). If a TAS seat were
installed at the driver's seat, exempting only the front window opening
from FMVSS No. 226 requirements would not be possible because the rear
seat on the same side where the front seat was modified makes use of
the same ejection mitigation curtain air bag.
    We thus recognize that the petitioner's request presents a trade-
off of substantial ejection mitigation protection in exchange for
continued mobility for people with disabilities and some enhancement in
easier and possibly safer vehicle entry and exit. Comments are
requested on the proposed exemption. To achieve the maximum safety
benefit of the regulations, it is our desire to provide the narrowest
exemption possible to accommodate the needs of disabled persons,
without unreasonably expanding its use to situations where the benefits
of the exemption may be outweighed by the drawbacks of nonconformance
with the safety standard.
    We seek comment on whether the requested exemption is needed. Would
deactivating the side impact protection system also deactivate the
ejection mitigation system on vehicles? If the ejection mitigation
window curtains are controlled by a sensor that is separate from the
FMVSS No. 214 side impact sensor system, is the requested exemption
needed? If the sensor systems are distinct, could the vehicle seating
system be removed or modified without negatively affecting the
performance of ejection mitigation curtains? Could the exemption be
only for the ejection mitigation countermeasure (curtains) on the side
of the vehicle affected by the modification, rather than for both
sides?

Dates

    We are providing a 60-day comment period. In view of the September
1, 2013 phase-in date for FMVSS No. 226, and because this rulemaking
would remove a restriction on the modification of vehicles for persons
with disabilities, if a final rule is issued NHTSA anticipates making
the amendment effective in less than 180 days following publication of
the rule.

Rulemaking Analyses and Notices

Executive Order (E.O.) 12866 (Regulatory Planning and Review), E.O.
13563, and DOT Regulatory Policies and Procedures

    The agency has considered the impact of this rulemaking action
under E.O. 12866, E.O. 13563, and the Department of Transportation's
regulatory policies and procedures. This rulemaking document was not
reviewed by the Office of Management and Budget under E.O. 12866,
``Regulatory Planning and Review.'' It is not considered to be
significant under E.O. 12866 or the Department's Regulatory Policies
and Procedures (44 FR 11034; February 26, 1979). NHTSA has determined
that the effects are so minor that a regulatory evaluation is not
needed to support the subject rulemaking. This rulemaking would impose
no costs on the vehicle modification industry. If anything, there

could be a cost savings due to the proposed exemption.
    Modifying a vehicle in a way that makes inoperative the performance
of ejection mitigation air bags would be detrimental for the occupants
of the vehicle in a rollover. However, the number of vehicles
potentially modified would be very few in number. This is essentially
the trade-off that NHTSA is faced with when increasing mobility for
persons with disabilities: when necessary vehicle modifications are
made, some safety may unavoidably be lost to gain personal mobility. We
have requested comments on how the agency may make the exemption as
narrow as reasonably possible.

Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996), whenever an agency is required to publish a notice
of proposed rulemaking or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis that
describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
The Small Business Administration's regulations at 13 CFR part 121
define a small business, in part, as a business entity ``which operates
primarily within the United States.'' (13 CFR 121.105(a)). No
regulatory flexibility analysis is required if the head of an agency
certifies the rule will not have a significant economic impact on a
substantial number of small entities. SBREFA amended the Regulatory
Flexibility Act to require Federal agencies to provide a statement of
the factual basis for certifying that a rule will not have a
significant economic impact on a substantial number of small entities.
    NHTSA has considered the effects of this proposed rule under the
Regulatory Flexibility Act. Most dealerships and repair businesses are
considered small entities, and a substantial number of these businesses
modify vehicles to accommodate individuals with disabilities. I certify
that this proposed rule would not have a significant economic impact on
a substantial number of small entities. While most dealers and repair
businesses would be considered small entities, the proposed exemption
would not impose any new requirements, but would instead provide
additional flexibility. Therefore, the impacts on any small businesses
affected by this rulemaking would not be substantial.

Executive Order 13132 (Federalism)

    NHTSA has examined today's proposed rule pursuant to Executive
Order 13132 (64 FR 43255; Aug. 10, 1999) and concluded that no
additional consultation with States, local governments, or their
representatives is mandated beyond the rulemaking process. The agency
has concluded that the proposed rule does not have sufficient
federalism implications to warrant consultation with State and local
officials or the preparation of a federalism summary impact statement.
The proposal does not have ``substantial direct effects 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.'' This proposed rule would not impose any
requirements on anyone. This proposal would lessen a burden on
modifiers.
    NHTSA rules can have preemptive effect in two ways. First, the
National Traffic and Motor Vehicle Safety Act contains an express
preemption provision:

    When a motor vehicle safety standard is in effect under this
chapter, a State or a political subdivision of a State may prescribe
or continue in effect a standard applicable to the same aspect of
performance of a motor vehicle or motor vehicle equipment only if
the standard is identical to the standard prescribed under this
chapter.

49 U.S.C. 30103(b)(1). This provision is not relevant to this
rulemaking as it does not involve the establishing, amending or
revoking or a Federal motor vehicle safety standard.
    Second, the Supreme Court has recognized the possibility, in some
instances, of implied preemption of State requirements imposed on motor
vehicle manufacturers, including sanctions imposed by State tort law.
We are unaware of any State law or action that would prohibit the
actions that this proposed rule would permit.

Civil Justice Reform

    When promulgating a regulation, agencies are required under
Executive Order 12988 to make every reasonable effort to ensure that
the regulation, as appropriate: (1) Specifies in clear language the
preemptive effect; (2) specifies in clear language the effect on
existing Federal law or regulation, including all provisions repealed,
circumscribed, displaced, impaired, or modified; (3) provides a clear
legal standard for affected conduct rather than a general standard,
while promoting simplification and burden reduction; (4) specifies in
clear language the retroactive effect; (5) specifies whether
administrative proceedings are to be required before parties may file
suit in court; (6) explicitly or implicitly defines key terms; and (7)
addresses other important issues affecting clarity and general
draftsmanship of regulations.
    Pursuant to this Order, NHTSA notes as follows. The preemptive
effect of this proposed rule is discussed above. NHTSA notes further
that there is no requirement that individuals submit a petition for
reconsideration or pursue other administrative proceeding before they
may file suit in court.

National Technology Transfer and Advancement Act

    Under the National Technology Transfer and Advancement Act of 1995
(NTTAA) (Pub. L. 104-113), ``all Federal agencies and departments shall
use technical standards that are developed or adopted by voluntary
consensus standards bodies, using such technical standards as a means
to carry out policy objectives or activities determined by the agencies
and departments.'' Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies, such as the Society of Automotive
Engineers (SAE). The NTTAA directs us to provide Congress, through OMB,
explanations when we decide not to use available and applicable
voluntary consensus standards. No voluntary standards exist regarding
this proposed exemption for modification of vehicles to accommodate
persons with disabilities.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 requires agencies to
prepare a written assessment of the costs, benefits and other effects
of proposed or final rules that include a Federal mandate likely to
result in the expenditure by State, local or tribal governments, in the
aggregate, or by the private sector, of more than $100 million annually
(adjusted for inflation with base year of 1995). This proposed
exemption would not result in expenditures by State, local or tribal
governments, in the aggregate, or by the private sector in excess of
$100 million annually.

National Environmental Policy Act

    NHTSA has analyzed this rulemaking action for the purposes of the
National Environmental Policy Act. The agency has determined that
implementation of this action would not have any

significant impact on the quality of the human environment.

Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA), a person is not
required to respond to a collection of information by a Federal agency
unless the collection displays a valid OMB control number. This
proposal does not contain new reporting requirements or requests for
information beyond what is already required by 49 CFR part 595 subpart
C. An entity taking advantage of the exemption would simply list FMVSS
No. 226 in the document described in 49 CFR 595.7(b).

Plain Language

    Executive Order 12866 requires each agency to write all rules in
plain language. Application of the principles of plain language
includes consideration of the following questions:
     Have we organized the material to suit the public's needs?
     Are the requirements in the rule clearly stated?
     Does the rule contain technical language or jargon that
isn't clear?
     Would a different format (grouping and order of sections,
use of headings, paragraphing) make the rule easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or
diagrams?
     What else could we do to make the rule easier to
understand?
    If you have any responses to these questions, please include them
in your comments on this proposal.

Regulation Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.

List of Subjects in 49 CFR Part 595

    Motor vehicle safety, Motor vehicles.

    In consideration of the foregoing, we propose to amend 49 CFR part
595 to read as follows:

PART 595--MAKE INOPERATIVE EXEMPTIONS

    1. The authority citation for Part 595 would be revised to read as
follows:

    Authority:  49 U.S.C. 322, 30111, 30115, 30117, 30122 and 30166;
delegation of authority at 49 CFR 1.95.

    2. Amend Sec.  595.7 by adding paragraph (c)(17) to read as
follows:

Sec.  595.7  Requirements for vehicle modifications to accommodate
people with disabilities.

* * * * *
    (c) * * *
    (17) S4.2 and S5 of 49 CFR 571.226, on the side of the vehicle
where a seat on that side of the vehicle must be changed to accommodate
a person with a disability.
* * * * *

    Issued on: October 23, 2012.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2012-26353 Filed 10-25-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 76, Number 238 (Monday, December 12, 2011)]
[Notices]
[Pages 77283-77284]
[FR Doc No: 2011-31761]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65896; File No. SR-FINRA-2011-067]

 Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to
Whistleblower Claims in Arbitration

December 6, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 21, 2011, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 13201 of the Code of
Arbitration Procedure for Industry Disputes (``Industry Code'') to
align the rule with statutes that invalidate predispute arbitration
agreements for whistleblower claims. The proposed rule change also
would make a conforming amendment to FINRA Rule 2263.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The proposed rule change would amend FINRA Rule 13201 (Statutory
Employment Discrimination Claims) of the Industry Code, and FINRA Rule
2263 (Arbitration Disclosure to Associated Persons Signing or
Acknowledging Form U4), to align the rules with statutes that
invalidate predispute arbitration agreements for whistleblower claims.
    The Dodd-Frank Wall Street Reform and Consumer Protection Act
(``Dodd-Frank Act'') \3\ amended the Sarbanes-Oxley Act of 2002
(``SOX'') by adding a new paragraph (e) to 18 U.S.C. 1514A \4\ to
provide that:
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    \3\ See Dodd-Frank Wall Street Reform and Consumer Protection
Act, Public Law 111-203, Sec.  919 (2010).
    \4\ See Dodd-Frank Section 922(c)(2), adding 18 U.S.C. 1514A(e)
(Nonenforceability of Certain Provisions Waiving Rights and Remedies
or Requiring Arbitration of Disputes).
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    (1) WAIVER OF RIGHTS AND REMEDIES--The rights and remedies provided
for in this section may not be waived by any agreement, policy form, or
condition of employment, including by a predispute arbitration
agreement.
    (2) PREDISPUTE ARBITRATION AGREEMENTS--No predispute arbitration
agreement shall be valid or enforceable, if the agreement requires
arbitration of a dispute arising under this section.
    Prior to the Dodd-Frank Act, it was FINRA staff's articulated
position that parties were required to arbitrate SOX whistleblower
claims under the Industry Code.\5\
---------------------------------------------------------------------------

    \5\ See Arbitrability of Sarbanes-Oxley Whistleblower Claims by
Laurence S. Moy, Pearl Zuchlewski, Linda A. Neilan and Katherine
Blostein, The Neutral Corner (Volume 1--2008).
---------------------------------------------------------------------------

    In light of the changes set forth in the Dodd-Frank Act that
invalidate predispute arbitration agreements in the case of SOX
whistleblower claims, the proposed rule change would amend FINRA Rule
13201 of the Industry Code to make clear that parties are not required
to arbitrate SOX whistleblower claims, superseding the existing
guidance to the contrary. While the main impetus for the proposed rule
change is the need to update FINRA staff's stated position on SOX
whistleblower claims, FINRA proposes to make the rule text broad enough
to cover any statutes that prohibit predispute arbitration agreements
for whistleblower claims.\6\
---------------------------------------------------------------------------

    \6\ The Dodd-Frank Act also invalidated predispute arbitration
agreements in other whistleblower statutes, including, for example,
7 USCA Sec.  26(n) relating to Commodity Exchange Whistleblower
Incentives and Protections.
---------------------------------------------------------------------------

    Rule 13201 of the Industry Code currently provides that a claim
alleging employment discrimination, including sexual harassment, in
violation of a statute, is not required to be arbitrated under the
Industry Code. Such a claim may be arbitrated only if the parties have
agreed to arbitrate it, either before or after the dispute arose. The
proposed rule change would amend Rule 13201 to add a new provision to
provide that a dispute arising under a whistleblower statute that
prohibits the use of predispute arbitration agreements is not required
to be arbitrated under the Industry Code. The rule would state that
such a dispute may be arbitrated only if the parties have agreed to
arbitrate it after the dispute arose.
    FINRA also would amend the title of Rule 13201 to reflect the
addition of the new provision relating to whistleblower claims. FINRA
structured the proposed rule change to separate the provision relating
to statutory employment discrimination claims from the provision
relating to whistleblower claims. While parties may agree to arbitrate
a statutory employment discrimination claim either before or after a
dispute arises, the Dodd-Frank Act invalidates predispute agreements to
arbitrate certain whistleblower claims.
    The proposed rule change also would make a conforming amendment to
FINRA Rule 2263, which requires firms

to provide each associated person with certain written disclosures
regarding the nature and process of arbitration proceedings whenever
the firm asks an associated person, pursuant to FINRA Rule 1010
(Electronic Filing Requirements for Uniform Forms), to manually sign a
new or amended Form U4, or to otherwise provide written acknowledgment
of an amendment to the form. The proposed rule change would amend FINRA
Rule 2263 to add a disclosure provision stating that a dispute arising
under a whistleblower statute that prohibits the use of predispute
arbitration agreements is not required to be arbitrated under FINRA
rules, and that such a dispute may be arbitrated at FINRA only if the
parties have agreed to arbitrate it after the dispute arose.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\7\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed amendments are
consistent with the provisions of the Act noted above because they
serve to align FINRA rules with those provisions in the Dodd-Frank Act
that invalidate predispute arbitration agreements in the context of
certain whistleblower claims.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-067 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2011-067. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-FINRA-2011-067 and
should be submitted on or before January 3, 2012.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31761 Filed 12-9-11; 8:45 a.m.]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 204 (Tuesday, October 24, 2023)]
[Notices]
[Pages 73031-73034]
[FR Doc No: 2023-23372]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0053]

Communications From Firms to Health Care Providers Regarding
Scientific Information on Unapproved Uses of Approved/Cleared Medical
Products: Questions and Answers; Revised Draft Guidance for Industry;
Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Communications From Firms to Health Care Providers Regarding
Scientific Information on Unapproved Uses of Approved/Cleared Medical
Products: Questions and Answers.'' This revised draft guidance, when
finalized, will provide FDA's current thinking on common questions
regarding certain communications by firms to health care providers
(HCPs) of scientific information on unapproved use(s) of approved/
cleared medical products (the scope of the italicized terms is further
explained in the revised draft guidance). This revised guidance
supersedes the revised draft guidance entitled ``Distributing
Scientific and Medical Publications on Unapproved New Uses--Recommended
Practices'' issued in 2014 (2014 revised draft guidance).

DATES: Submit either electronic or written comments on the draft
guidance by December 26, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by December
26, 2023.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2008-D-0053 for ``Communications From Firms to Health Care
Providers Regarding Scientific Information on Unapproved Uses of
Approved/Cleared Medical Products: Questions and Answers.'' Received
comments 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; the
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002; or the Policy and Regulations Staff,
(HFV-6), Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855. Send one self-addressed
adhesive label to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance:
Kathleen David, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Room 3203, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903

New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911; Ana Loloei, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5504, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Office of
Surveillance and Compliance, Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl. (HFV-6), Rockville, MD 20855,
240-402-7082; Julie Finegan, Office of Policy, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852,
301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Communications From Firms to Health Care Providers
Regarding Scientific Information on Unapproved Uses of Approved/Cleared
Medical Products: Questions and Answers.'' Specifically, this revised
draft guidance relates to firms sharing the following types of
communications with HCPs:
     published scientific or medical journal articles
(reprints),
     published clinical reference resources, as follows:
    [cir] clinical practice guidelines (CPGs),
    [cir] scientific or medical reference texts (reference texts),
    [cir] materials from independent clinical practice resources, and
     firm-generated presentations of scientific information
from an accompanying published reprint.
    For the purposes of this revised draft guidance, these specific
types of communications from firms to HCPs of scientific information on
unapproved uses (SIUU) of approved/cleared medical products in
combination with the disclosures recommended in the guidance are
referred to as ``SIUU communications.'' We acknowledge that firms share
SIUU communications through different media (e.g., paper, digital), and
the recommendations in this guidance apply regardless of the medium of
the communication. Other communications by firms are not specifically
addressed by this revised draft guidance, and we do not intend to
convey any views on such communications in issuing this revised draft
guidance.
    This revised draft guidance represents a continuation of FDA's
ongoing efforts to consider, develop, and refine its policies and
recommendations relating to communications by firms about unapproved
uses of their approved/cleared medical products. In 2009, FDA issued a
final guidance for industry entitled ``Good Reprint Practices for the
Distribution of Medical Journal Articles and Medical or Scientific
Reference Publications on Unapproved New Uses of Approved Drugs and
Approved or Cleared Medical Devices'' (74 FR 1694) to provide guidance
to firms on distributing ``journal articles'' and ``scientific or
medical reference publications.'' Then, FDA issued the 2014 revised
draft guidance (79 FR 11793) to clarify the Agency's position on firms
disseminating scientific or medical reference texts and CPGs that
include information on unapproved uses of the firm's medical products
and to provide additional explanation on these topics.
    In developing this revised draft guidance, FDA considered
stakeholder feedback, including comments received on the 2014 revised
draft guidance. This revised draft guidance will supersede the 2014
revised draft guidance. Changes include a revised title, a question-
and-answer format, and certain changes in scope.
    The Federal Food, Drug, and Cosmetic Act, the Public Health Service
Act, and their implementing regulations prohibit, among other things,
the introduction (or causing the introduction) into interstate commerce
of a medical product that fails to comply with applicable premarket
requirements or is otherwise misbranded or adulterated. This
prohibition includes introducing (or causing the introduction) into
interstate commerce a medical product that is intended for a use that
has not been approved or cleared by FDA, even if that same product is
approved or cleared for a different use. These premarket requirements
further multiple important government interests and distributing
approved/cleared medical products for unapproved uses can undermine
these interests. In certain circumstances, however, HCPs may be
interested in scientific information about unapproved uses of approved/
cleared medical products to inform clinical practice decisions for the
care of an individual patient. In developing this draft guidance, FDA
has sought to strike a careful balance between supporting HCP interest
in scientific information about unapproved uses of approved/cleared
medical products to inform clinical practice decisions for the care of
an individual patient, and mitigating the potential that the government
interests advanced by these statutory requirements will be undermined.
    In light of those goals, FDA believes it is critical that SIUU
communications be truthful, non-misleading, factual and unbiased and
provide all information necessary for HCPs to interpret the strengths
and weaknesses and validity and utility of the information in the SIUU
communication. In addition, any study or analysis described in a source
publication that serves as the basis for an SIUU communication should
be scientifically sound. The studies or analyses should also provide
information that is relevant to HCPs engaged in making clinical
practice decisions for the care of an individual patient (as used in
this revised draft guidance, ``clinically relevant''). The manner of
presentation of SIUU communications is also critical to consider. This
revised draft guidance provides recommendations addressing all of these
considerations.
    If a firm shares an SIUU communication with HCPs in a manner that
is consistent with the recommendations in this revised draft guidance,
FDA does not intend to use such communication standing alone as
evidence of a new intended use.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Communications From Firms to Health Care Providers Regarding
Scientific Information on Unapproved Uses of Approved/Cleared Medical
Products: Questions and Answers.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), 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.

Recommendations for Drug and Device Manufacturer Communications With
Payors, Formulary Committees, and Similar Entities; and Communications
From Firms to Health Care Providers Regarding Scientific Information on
Unapproved Uses of Approved/Cleared Medical Products

Questions and Answers
OMB Control Number 0910-0857--Revision
    The revised draft guidance document, ``Communications From Firms to
Health Care Providers Regarding Scientific Information on Unapproved
Uses of Approved/Cleared Medical Products: Questions and Answers,''
discusses information disclosures that we recommend firms include in
SIUU communications if the firms choose to publicly share such
communications.
    We estimate the burden of the information collection as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    Recommended disclosure         Number of      disclosures    Total annual    Average burden     Total hours
  activity; guidance section      respondents   per respondent    disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
A statement that the                     1,008              30          30,240  0.1 (6 minutes).           3,024
 unapproved use(s) of the
 medical product has not been
 approved by FDA and that the
 safety and effectiveness of
 the medical product for the
 unapproved use(s) has not
 been established; Q2.
A statement disclosing the FDA-          1,008              27          27,216  0.1 (6 minutes).         2,721.6
 approved use(s) of the
 medical product, including
 any limitations of use
 specified in the FDA-required
 labeling; Q2.
A statement disclosing any               1,008               5           5,040  0.2 (12 minutes)           1,008
 limitations, restrictions,
 cautions, or warnings
 described in the FDA-required
 labeling about the unapproved
 use(s); Q2.
A copy of the most current FDA-          1,008              27          27,216  0.1 (6 minutes).         2,721.6
 required labeling (or a
 mechanism for obtaining this
 labeling, as appropriate); Q2.
A statement describing any               1,008               3           3,024  0.1 (6 minutes).           302.4
 contraindication(s) in the
 FDA-required labeling for the
 medical product; Q2.
A statement describing any               1,008              25          25,200  0.2 (12 minutes)           5,040
 serious, life-threatening, or
 fatal risks posed by the
 medical product that are in
 the FDA-required labeling for
 the medical product or known
 by the firm and that are
 relevant to the unapproved
 use(s). If a risk evaluation
 and mitigation strategy
 (REMS) has been established
 under 21 U.S.C. 355-1, the
 statement should disclose
 that fact and should describe
 the goal(s) of the REMS; Q2.
A statement identifying any              1,008              20          20,160  0.2 (12 minutes)           4,032
 authors, editors, or other
 contributors to
 publication(s) included in
 the SIUU communication who
 were employees of or
 consultants to or who
 received compensation from
 the firm at the time of
 writing, editing, or
 contributing to the
 publication, to the extent
 that a firm acting reasonably
 would know of such
 relationship; Q2.
In the case of an SIUU                   1,008              20          20,160  2.75............          55,440
 communication that is based
 on a source publication that
 is primarily focused on a
 particular scientific study
 or studies, for each such
 study where the following
 information is not included
 in the publication, provide a
 description of:
    --All material aspects of
     study design,
     methodology, and results;
    --All material limitations
     related to the study
     design, methodology, and
     results; and
    --When applicable,
     conclusions from other
     relevant studies that are
     contrary to, or cast
     doubt on, the results
     shared, including
     citations for any such
     studies; Q2.

The publication date of any              1,008               3           3,024  0.1 (6 minutes).           302.4
 referenced or included
 publication(s) (if not
 specified in the publication
 or citation); Q2.
When firms share an SIUU                 1,008               3           3,024  0.1 (6 minutes).           302.4
 communication in the form of
 an unabridged CPG or
 reference text in its
 entirety that discusses a
 wide range of medical
 products and that discussion
 is not primarily focused on
 one or more of a firm's
 medical products, the firm
 should include, in lieu of
 some of the specific
 disclosures listed above, a
 more general statement in the
 SIUU communication, such as
 ``This [CPG/reference text]
 describes some uses of
 medical products that are not
 approved by the FDA and the
 safety and effectiveness of
 any unapproved use(s) have
 not been established.''; Q4.
When firms share an SIUU                 1,008              10          10,080  0.1 (6 minutes).           1,008
 communication in the form of
 a firm-generated presentation
 of scientific information
 from an accompanying reprint
 that SIUU communication
 should clearly disclose what
 portions of the communication
 are firm-generated; Q4.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         174,384  ................        75,902.4
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a current listing of firms promoting approved/cleared
human and animal drug products (747), combined with an estimated number
of device firms marketing products (261), we assume 1,008 firms
(``number of respondents'' in table (1) may each choose to publicly
share 30 SIUU communications annually. Our estimate of the burden per
disclosure (2.5 hours) reflects what we believe is the average burden
based on the number and content and complexity of disclosures as
recommended in the guidance.

III. Request for Comment on Other Issues for Consideration

    FDA is interested in additional matters related to communications
by firms about scientific information on unapproved use(s) of approved/
cleared medical products. This revised draft guidance pertains to these
communications by firms to HCPs engaged in making clinical practice
decisions for the care of an individual patient. FDA is specifically
seeking input on the following:
    1. What considerations, if any, exist that are unique to
communications of scientific information about unapproved use(s) of
approved/cleared medical products by firms to researchers (including
HCPs working in their capacity as researchers)?
    2. What other factors should firms consider when sharing firm-
generated presentations (as described in the draft guidance) to ensure
that presentations are truthful, non-misleading, factual and unbiased
and provide all information necessary for HCPs to interpret the
strengths and weaknesses and validity and utility of the presented
information?

IV. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23372 Filed 10-23-23; 8:45 am]
BILLING CODE 4164-01-P


Year State Species Metric TonsPounds $ 1980 ConnecticuFLOUNDER 227.5 501,600 125,540 1980 Maine FLOUNDER 566.3 1,248,500 387,285 1980 MassachusFLOUNDER11,752.20 25,909,000 9,912,806 1980 New HampsFLOUNDER 26.5 58,500 19,132 1980 Rhode IslanFLOUNDER 3,971.10 8,754,700 2,725,112 1981 ConnecticuFLOUNDER 523.1 1,153,200 426,740 1981 Maine FLOUNDER 668.8 1,474,400 535,949 1981 MassachusFLOUNDER11,668.20 25,723,800 11,830,996 1981 New HampsFLOUNDER 44.5 98,100 31,745 1981 Rhode IslanFLOUNDER 4,178.20 9,211,200 3,384,719 1982 ConnecticuFLOUNDER 514.6 1,134,500 465,199 1982 Maine FLOUNDER 897.6 1,978,800 692,667 1982 MassachusFLOUNDER 9,599.20 21,162,400 11,078,705 1982 New HampsFLOUNDER 104.1 229,600 72,327 1982 Rhode IslanFLOUNDER 3,480.00 7,672,000 2,879,406 1983 ConnecticuFLOUNDER 531.4 1,171,500 586,000 1983 Maine FLOUNDER 677.7 1,494,000 496,189 1983 MassachusFLOUNDER10,138.70 22,351,700 12,505,732 1983 New HampsFLOUNDER 76.7 169,100 71,014 1983 Rhode IslanFLOUNDER 3,087.50 6,806,700 2,521,612 1984 ConnecticuFLOUNDER 593.7 1,308,900 654,450 1984 Maine FLOUNDER 424.8 936,600 392,591 1984 MassachusFLOUNDER 9,522.50 20,993,400 16,225,023 1984 New HampsFLOUNDER 94.6 208,500 91,933 1984 Rhode IslanFLOUNDER 3,295.20 7,264,700 4,019,750 1985 ConnecticuFLOUNDER 541.5 1,193,900 596,950 1985 Maine FLOUNDER 332.5 733,000 418,496 1985 MassachusFLOUNDER 6,332.50 13,960,700 14,217,356 1985 New HampsFLOUNDER 74.8 165,000 88,306 1985 Rhode IslanFLOUNDER 2,888.80 6,368,700 4,242,712 1986 ConnecticuFLOUNDER 258.3 569,400 341,640 1986 Maine FLOUNDER 294 648,100 512,126 1986 MassachusFLOUNDER 4,834.50 10,658,200 12,625,020 1986 New HampsFLOUNDER 51.3 113,200 88,209 1986 Rhode IslanFLOUNDER 1,948.20 4,294,900 3,184,471 1987 ConnecticuFLOUNDER 646.1 1,424,300 1,324,599 1987 Maine FLOUNDER 243 535,800 605,560 1987 MassachusFLOUNDER 5,631.10 12,414,400 17,015,316 1987 New HampsFLOUNDER 95.5 210,600 242,865 1987 Rhode IslanFLOUNDER 1,751.30 3,861,000 3,554,098 1988 ConnecticuFLOUNDER 340.2 749,900 697,407 1988 Maine FLOUNDER 280 617,200 664,452 1988 MassachusFLOUNDER 5,688.70 12,541,200 16,739,943 1988 New HampsFLOUNDER 116.6 257,100 292,875 1988 Rhode IslanFLOUNDER 1,180.70 2,602,900 2,311,614 1989 ConnecticuFLOUNDER 251 553,300 514,569 1989 Maine FLOUNDER 235 518,000 584,983 1989 MassachusFLOUNDER 4,665.40 10,285,300 15,497,433 1989 New HampsFLOUNDER 116.9 257,700 304,217 1989 Rhode IslanFLOUNDER 1,089.20 2,401,200 2,281,081 1990 ConnecticuFLOUNDER 482.2 1,063,090 988,675 1990 Maine FLOUNDER 164 361,636 341,216 1990 MassachusFLOUNDER 5,048.40 11,129,732 13,343,566 1990 New HampsFLOUNDER 83.6 184,306 162,050 1990 Rhode IslanFLOUNDER 804.9 1,774,451 1,563,848 1991 ConnecticuFLOUNDER 383.2 844,700 785,571 1991 Maine FLOUNDER 166.7 367,539 373,026 1991 MassachusFLOUNDER 5,627.60 12,406,600 14,986,080 1991 New HampsFLOUNDER 73.4 161,841 171,968 1991 Rhode IslanFLOUNDER 831 1,831,971 1,718,582 1992 ConnecticuFLOUNDER 319.5 704,300 654,999 1992 Maine FLOUNDER 121.8 268,549 282,693 1992 MassachusFLOUNDER 4,528.10 9,982,728 12,101,594 1992 New HampsFLOUNDER 57 125,714 134,087 1992 Rhode IslanFLOUNDER 840.4 1,852,674 1,730,613 1993 ConnecticuFLOUNDER 250.4 552,113 513,465 1993 Maine FLOUNDER 57.8 127,378 126,857 1993 MassachusFLOUNDER 3,927.00 8,657,466 12,076,208 1993 New HampsFLOUNDER 38.9 85,869 88,709 1993 Rhode IslanFLOUNDER 575.1 1,267,796 1,413,608 1994 ConnecticuFLOUNDER 139.3 307,000 285,000 1994 Maine FLOUNDER 36.6 80,670 98,524 1994 MassachusFLOUNDER 2,582.20 5,692,648 8,635,446 1994 New HampsFLOUNDER 36.6 80,684 87,114 1994 Rhode IslanFLOUNDER 426.9 941,126 1,160,824 1995 ConnecticuFLOUNDER 161.5 356,133 430,921 1995 Maine FLOUNDER 23.6 51,994 64,894 1995 MassachusFLOUNDER 2,850.60 6,284,370 9,397,519 1995 New HampsFLOUNDER 28.8 63,514 69,113 1995 Rhode IslanFLOUNDER 459.4 1,012,903 1,300,747 1996 Maine FLOUNDER 7.5 16,595 18,707 1996 MassachusFLOUNDER 3,753.50 8,274,996 11,755,320 1996 New HampsFLOUNDER 28 61,825 67,879 1996 Rhode IslanFLOUNDER 505.7 1,114,772 1,415,577 1997 ConnecticuFLOUNDER 193.4 426,474 501,364 1997 Maine FLOUNDER 20.9 46,004 48,421 1997 MassachusFLOUNDER 4,213.20 9,288,508 12,527,138 1997 New HampsFLOUNDER 13.7 30,199 38,264 1997 Rhode IslanFLOUNDER 560.2 1,235,102 1,569,042 1998 Maine FLOUNDER 4.7 10,364 10,658 1998 MassachusFLOUNDER 3,888.80 8,573,318 11,663,740 1998 New HampsFLOUNDER 13.6 29,878 32,873 1998 Rhode IslanFLOUNDER 560.8 1,236,309 1,535,610 1999 ConnecticuFLOUNDER 171.2 377,403 389,180 1999 Maine FLOUNDER 4.4 9,798 9,812 1999 MassachusFLOUNDER 3,355.80 7,398,168 9,634,903 1999 New HampsFLOUNDER 6.5 14,437 15,769 1999 Rhode IslanFLOUNDER 525 1,157,440 1,374,505 2000 ConnecticuFLOUNDER 202 445,239 383,356 2000 Maine FLOUNDER 14.9 32,854 35,700 2000 MassachusFLOUNDER 4,078.40 8,991,331 8,898,326 2000 New HampsFLOUNDER 14.6 32,276 31,077 2000 Rhode IslanFLOUNDER 813.1 1,792,498 1,756,369 2001 ConnecticuFLOUNDER 187.9 414,278 327,722 2001 Maine FLOUNDER 13.2 29,065 28,414 2001 MassachusFLOUNDER 5,296.10 11,675,879 10,300,090 2001 New HampsFLOUNDER 19 41,897 37,957 2001 Rhode IslanFLOUNDER 658.5 1,451,787 1,396,536 2002 ConnecticuFLOUNDER 120 264,477 280,472 2002 Maine FLOUNDER 31.7 69,955 64,088 2002 MassachusFLOUNDER 4,725.10 10,416,894 11,005,454 2002 New HampsFLOUNDER 12 26,528 32,020 2002 Rhode IslanFLOUNDER 602 1,327,164 1,575,380 2003 ConnecticuFLOUNDER 104.2 229,809 237,811 2003 Maine FLOUNDER 51.7 114,071 122,479 2003 MassachusFLOUNDER 4,838.10 10,666,114 9,787,675 2003 New HampsFLOUNDER 13.5 29,666 36,202 2003 Rhode IslanFLOUNDER 470.6 1,037,421 1,210,720


[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Rules and Regulations]
[Pages 19680-19681]
[FR Doc No: 2019-08628]

Vol. 84

Friday,

No. 86

May 3, 2019

Part III

Environmental Protection Agency

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40 CFR Part 52

Air Plan Revisions; California; Correcting Amendments; Final Rule

Federal Register / Vol. 84 , No. 86 / Friday, May 3, 2019 / Rules and
Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0133; FRL-9992-71-Region 9]

Air Plan Revisions; California; Correcting Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule, correcting amendment.

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SUMMARY: On February 12, 2019, the EPA published two final rules in the
Federal Register approving certain other revisions to the California
SIP. In these final rules, the EPA included inaccurate amendatory
instructions that have prevented incorporation of the final actions
into the CFR. The error will be corrected in this action.

DATES: This action is effective on May 3, 2019.

FOR FURTHER INFORMATION CONTACT: Kevin Gong, EPA Region IX, (415) 972-
3073<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This action corrects an inadvertent error in
the amendatory instructions in final rulemakings affecting 40 CFR part
52.
    On December 31, 2018 (83 FR 67696), the EPA published a final rule
approving the Reasonably Available Control Technology (RACT)
demonstration for the El Dorado County Air Quality Management District.
This action added paragraph (c)(513) to Sec.  52.220 for the state plan
revision submitted on January 4, 2017. On February 12, 2019, the EPA
published two final rules at 84 FR 3302 and 84 FR 3305 approving
various air quality planning provisions from the California Air
Resources Board (CARB) for the South Coast Air Quality Management
District (SCAQMD) and the San Joaquin Valley Air Pollution Control
District (SJVAPCD) as revisions to the California SIP. These documents
were submitted on April 27, 2017. Due to inaccurate amendatory
instructions in both of the February 12, 2019 documents, the approval
of the two sets of additional material was erroneously set out into 40
CFR 52.220(c)(513), which, as noted above, with respect to the RACT
demonstration for El Dorado County, is designated for the approvals of
the SIP submittals made on January 4, 2017. The EPA is correcting the
error by removing the SCAQMD and SJVAPCD provisions from paragraph
(c)(513) and adding them in paragraph (c)(517) in this action.
    The EPA has determined that this action falls under the ``good
cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedures Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation where public notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest. Public notice and comment for this action is
unnecessary because the underlying rules for which this correcting
amendment have been prepared were already subject to 30-day comment
periods. Further, this action is consistent with the purposes and
rationales of the final rules for which typesetting errors and
inaccurate amendatory instructions are being corrected herein. Because
this action does not change the EPA's analyses or overall actions, no
purpose would be served by additional public notice and comment.
Consequently, additional public notice and comment are unnecessary.
    The EPA also finds that there is good cause under APA section
553(d)(3) for this correction to become effective on the date of
publication of this action. Section 553(d)(3) of the APA allows an
effective date of less than 30 days after publication ``as otherwise
provided by the agency for good cause found and published with the
rule.'' 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period
prescribed in APA section 553(d)(3) is to give affected parties a
reasonable time to adjust their behavior and prepare before the final
rule takes effect. This rule does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. This action merely corrects typesetting
errors and inaccurate amendatory instructions in previous rulemakings.
For these reasons, the EPA finds good cause under APA section 553(d)(3)
for this correction to become effective on the date of publication of
this action.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and is therefore not
subject to review by the Office of Management and Budget. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4), or require prior consultation with state
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or involve special consideration of environmental justice
related issues as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
    Because this action is not subject to notice-and-comment
requirements under the APA or any other statute, it is not subject to
the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.).
    Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives and the Comptroller General
of the General Accounting Office prior to publication of this rule in
the Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Carbon monoxide, Nitrogen
dioxide, Ozone, Particulate matter, Sulfur oxides, Volatile organic
compounds, Reporting and recordkeeping requirements.

    Dated: April 15, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by removing and reserving paragraph
(c)(513)(ii)(B) and adding reserved paragraph (c)(516) and paragraph
(c)(517) to read as follows:

Sec.  52.220   Identification of plan--in part.

* * * * *
    (c) * * *
    (517) The following plan was submitted on April 27, 2017, by the
Governor's designee.
    (i) [Reserved]
    (ii) Additional materials. (A) California Air Resources Board.
    (1) Resolution 17-7, 2016 State Strategy for the State
Implementation Plan, March 23, 2017, commitments to a rulemaking
schedule and to achieve aggregate emission reductions of 8 tons per day
of NOX in San Joaquin Valley by 2031, and the rulemaking
schedule included in attachment A to Resolution 17-7, only.

    (2) Revised Proposed 2016 State Strategy for the State
Implementation Plan, adopted on March 23, 2017, except for the
subchapter titled ``South Coast Commitment'' in chapter 3 (``Proposed
SIP Commitment'').
    (B) South Coast Air Quality Management District.
    (1) The following portions of the ``Final 2016 Air Quality
Management Plan (March 2017),'' adopted March 3, 2017: Chapter 5
(``PM2.5 Modeling Approach''), pages 5-17 through 5-27;
Appendix III (``Base and Future Emission Inventory''), Attachment A
(``Annual Average Emissions by Source Category in South Coast Air
Basin'') for PM2.5, NOX, SO2, VOC, and
NH3 for years 2012, 2017, 2019, and 2020 and Attachment D, tables D-1,
D-3, D-7 and D-9; Appendix IV-A (``SCAQMD's Stationary and Mobile
Source Control Measures''), Table IV-A-4 and section 2
(``PM2.5 Control Measures''); Appendix IV-C (``Regional
Transportation Strategy and Control Measures''), section IV (``TCM Best
Available Control Measure (BACM) Analysis for 2006 24-Hour and 2012
Annual PM2.5 NAAQS''); Appendix V (``Modeling and Attainment
Demonstration''), Chapter 7 (``24-hour PM2.5
Demonstration'') and Attachment 8 (``24-hour Unmonitored Area Analysis
Supplement''); Appendix VI-A (``Reasonably Available Control Measures
(RACM)/Best Available Control Measures (BACM) Demonstration''), pages
VI-A-13 through VI-A-42, Attachment VI-A-1 (``Evaluation of SCAQMD
Rules and Regulations''), Attachment VI-A-2 (``Control Measure
Assessment''), and Attachment VI-A-3 (``California Mobile Source
Control Program Best Available Control Measures/Reasonably Available
Control Measures Assessment''); Appendix VI-C (``Reasonable Further
Progress (RFP) and Milestone Years''), pages VI-C-5 through VI-C-8, and
Attachment VI-C-1 (``California Existing Mobile Source Control
Program''); Appendix VI-D (``General Conformity and Transportation
Conformity Budget''), pages VI-D-2 through VI-D-6 and excluding tables
VI-D-1 through 3; and Appendix VI-F (``Precursor Requirements'').
    (2) Letter dated March 14, 2018 from Philip Fine, Deputy Executive
Officer, Planning, Rule Development, and Area Sources, South Coast Air
Quality Management District, to Amy Zimpfer, Associate Director, Air
Division, EPA Region IX.
    (3) Letter dated June 15, 2018 from Philip Fine, Deputy Executive
Officer, Planning, Rule Development, and Area Sources, South Coast Air
Quality Management District, to Amy Zimpfer, Associate Director, Air
Division, EPA Region IX, regarding ``Condensable and Filterable
Portions of PM2.5 Emissions in the 2016 AQMD.''

[FR Doc. 2019-08628 Filed 5-2-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Rules and Regulations]
[Page 77512]
[DOCID:fr19de08-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 147 and 165

[USCG-2008-0181]

Quarterly Listings; Anchorages, Safety Zones, Security Zones,
Special Local Regulations, Regulated Navigation Areas, and Drawbridge
Operation Regulations; Correction

AGENCY: Coast Guard, DHS.

ACTION: Notice of expired temporary rules issued; correction.

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SUMMARY: The Coast Guard published a document in the Federal Register
of October 14, 2008, concerning expired temporary rules. The document
contained an incorrect contact telephone number, an incorrect table
entry, and an omission.

FOR FURTHER INFORMATION CONTACT: For questions on this notice contact
Ms. Lesley Mose, Office of Regulations and Administrative Law,
telephone<PHONE_NUMBER>. For questions on viewing, or on submitting
material to the docket, contact Ms. Angie Ames, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

Correction

    In the Federal Register of October 14, 2008, in FR Doc. E8-23956,
on page 60629, in the second column under FOR FURTHER INFORMATION
CONTACT, correct the Office of Regulations and Administrative Law
telephone number to read ``202-372-3863''; on the same page, in the
table, remove the entry for Docket No. USCG-2008-0102; and on page
60630, in the table insert the entry for Docket No. USCG-2008-0402
reading ``Boca Grande, FL, Safety Zones (Parts 147 and 165), 6/7/2008''
in numerical order.

    Dated: December 9, 2008.
S.G. Venckus,
Chief, Office of Regulations and Administrative Law.
[FR Doc. E8-29736 Filed 12-18-08; 8:45 am]

BILLING CODE 4910-15-P