[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Rules and Regulations]
[Pages 36911-36913]
[FR Doc No: 2015-15620]

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Rules and Regulations
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Federal Register / Vol. 80, No. 124 / Monday, June 29, 2015 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0951; Directorate Identifier 2015-CE-007-AD;
Amendment 39-18190; AD 2015-13-03]
RIN 2120-AA64

Airworthiness Directives; Przedsiebiorstwo Doswiadczalno-
Produkcyjne Szybownictwa ``PZL-Bielsko'' Sailplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Przedsiebiorstwo Doswiadczalno-Produkcyjne Szybownictwa ``PZL-Bielsko''
Model SZD-50-3 ``Puchacz'' sailplanes. This AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as detachment of the rudder cable fitting block from the
fuselage. We are issuing this AD to require actions to address the
unsafe condition on these products.

DATES: This AD is effective August 3, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of August 3,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0951; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact Allstar PZL
Glider, Sp. z o. o., ul. Cieszynska 325, 43-300 Bielsko-Biala, Poland;
telephone: +48 33 812 50 26; fax: +48 33 812 37 39; email:
<EMAIL_ADDRESS>Internet: http://szd.com.pl/en/products/szd-50-3-puchacz. You may view this referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA, call
(816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0951.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to add an AD that would apply to all Przedsiebiorstwo
Doswiadczalno-Produkcyjne Szybownictwa ``PZL-Bielsko'' Model SZD-50-3
``Puchacz'' sailplanes. The NPRM was published in the Federal Register
on April 17, 2015 (80 FR 21191). The NPRM proposed to correct an unsafe
condition for the specified products and was based on mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country. The MCAI states:

    An occurrence was reported involving a SZD-50-3 ``Puchacz''
sailplane, where a rudder cable fitting block, located in the
forward part of the fuselage, detached after application of a high
load on the steering pedal during spin recovery operation.
Subsequent investigations determined that the failure was either
caused by a manufacturing deficiency or originated by a crack.
    This condition, if not detected and corrected, could lead to
further cases of rudder cable fitting block detachment, resulting in
reduced control of the sailplane.
    To address this unsafe condition, Allstar PZL issued Service
Bulletin (SB) No. BE-063/SZD-50-3/2014, to provide inspection and
reinforcement instructions.
    For the reasons described above, this AD requires accomplishment
of a one-time inspection of both (right hand (RH) and left hand
(LH)) rudder cable fitting blocks to verify proper attachment to the
fuselage shell and, depending on finding(s), a repair. This AD also
requires reinforcement of the affected structural area.

The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2015-0951-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 21191, April 17,
2015) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 21191, April 17, 2015) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 21191, April 17, 2015).

Related Service Information Under 1 CFR Part 51

    We reviewed Allstar PZL Glider Service Bulletin BE-063/SZD-50-3/
2014 ``Puchacz'', dated December 14, 2014. The service bulletin
describes procedures for inspecting the area around the left-hand and
right-hand rudder cable fitting blocks for cracks and detachment and
making all necessary repairs. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section of this AD.

Costs of Compliance

    We estimate that this AD will affect 5 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the inspection requirement of this AD. The average labor
rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the inspection
requirement of this AD on U.S. operators to be $425, or $85 per
product.

    In addition, we estimate that it will take about 2 work-hours per
product to comply with the modification requirement of this AD and will
require parts costing $100, for a cost of $270 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0951; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2015-13-03 Przedsiebiorstwo Doswiadczalno-Produkcyjne Szybownictwa
``PZL-Bielsko'': Amendment 39-18190; Docket No. FAA-2015-0951;
Directorate Identifier 2015-CE-007-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective August 3,
2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Przedsiebiorstwo Doswiadczalno-Produkcyjne
Szybownictwa ``PZL-Bielsko'' Model SZD-50-3 ``Puchacz'' sailplanes,
all serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as detachment of
the rudder cable fitting block from the fuselage. We are issuing
this AD to prevent detachment of the rudder cable fitting block from
the fuselage, which if not detected and corrected, could result in
reduced control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(f)(3) of this AD:
    (1) Within 30 days after August 13, 2015 (the effective date of
this AD), inspect the area around both the left-hand (LH) and the
right-hand (RH) rudder cable fitting blocks following paragraph 3.1.
of the INSTRUCTIONS section in Allstar PZL Glider Service Bulletin
BE-063/SZD-50-3/2014 ``Puchacz'', dated December 14, 2014.
    (2) If, during the inspection required in paragraph (f)(1) of
this AD, any crack or fitting block detachment is found, before
further flight, repair and reinforce the attachment of both the LH
and RH rudder cable fitting blocks. Do this repair and reinforcement
following paragraph 3.2. of the INSTRUCTIONS section in Allstar PZL
Glider Service Bulletin BE-063/SZD-50-3/2014 ``Puchacz'', dated
December 14, 2014.
    (3) Unless already done following the requirement in paragraph
(f)(2) of this AD, within the next 12 months after August 3, 2015
(the effective date of this AD), reinforce the attachment of both
the LH and RH rudder cable fitting blocks. Do this reinforcement
following paragraph 3.2. of the INSTRUCTIONS section in Allstar PZL
Glider Service Bulletin BE-063/SZD-50-3/2014 ``Puchacz'', dated
December 14, 2014.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
sailplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2015-0046, dated March 16, 2015, for related information. You may
examine the MCAI on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2015-0951-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Allstar PZL Glider Service Bulletin BE-063/SZD-50-3/2014
``Puchacz'', dated December 14, 2014.
    (ii) Reserved.
    (3) For PZL-Bielsko service information identified in this AD,
contact Allstar PZL Glider, Sp. z o. o., ul. Cieszynska 325, 43-300
Bielsko-Biala, Poland; telephone: +48 33 812 50 26; fax: +48 33 812
37 39; email:

<EMAIL_ADDRESS>Internet: http://szd.com.pl/en/products/szd-50-3-puchacz.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-0951.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html

    Issued in Kansas City, Missouri, on June 18, 2015.
William Schinstock,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-15620 Filed 6-26-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 16, 2008 (Volume 73, Number 201)]
[Rules and Regulations]
[Page 61358-61363]
[DOCID:fr16oc08-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-2005-0036; FRL-8729-7]
RIN 2060-A089

Control of Hazardous Air Pollutants From Mobile Sources:Early
Credit Technology Requirement Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to revise the February 26, 2007
mobile source air toxics rule's requirements that specify which benzene
control technologies a refiner may utilize to qualify to generate early
benzene credits. This action will allow another specific benzene
control technology, benzene alkylation, in addition to the four
operational or technological changes specified in the current rule.
This action also includes a general provision that allows a refiner to
submit a request to EPA to approve other benzene-reducing operational
changes or technologies for the purpose of generating early credits.

DATES: This final rule is effective on December 15, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-2005-0036. All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy at the Air Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/
DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Eastern
Standard Time, Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Christine Brunner, Office of
Transportation and Air Quality, Assessment and Standards Division,
Environmental Protection Agency, 2000 Traverwood, Ann Arbor, MI 48105;
telephone number:<PHONE_NUMBER>; fax

number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
Alternative contact: Assessment and Standards Division Hotline,
telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Does This Action Apply to Me?

    This action may affect you if you produce gasoline. The following
table gives some examples of entities that may have to follow the
regulations.

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                                             NAICS \1\   SIC \2\
                  Category                     codes      codes      Examples of potentially regulated entities
----------------------------------------------------------------------------------------------------------------
Industry...................................     324110       2911  Petroleum Refiners.
----------------------------------------------------------------------------------------------------------------
\1\ North American Industry Classification System (NAICS).
\2\ Standard Industrial Classification (SIC) system code.

    This table is not intended to be exhaustive, but provides a guide
for readers regarding entities likely to be regulated by this action.
This table lists the types of entities that EPA is now aware could
potentially be affected by this action. Other types of entities not
listed in the table could also be affected. To decide whether your
organization might be affected by this action, you should carefully
examine today's action and the existing regulations in 40 CFR part 80.
If you have any questions regarding the applicability of this action to
a particular entity, consult the persons listed in the preceding FOR
FURTHER INFORMATION CONTACT section.

Outline of This Preamble

I. Background
II. Response to Comments
III. This Action
IV. Environmental and Economic Impact
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health & Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act
VI. Statutory Provisions and Legal Authority

I. Background

    The Control of Hazardous Air Pollutants From Mobile Sources final
rule (also known as the Mobile Source Air Toxics rule or MSAT2) was
published on February 26, 2007 (72 FR 8428). That rule requires that
refiners and importers produce gasoline that has an annual average
benzene content of 0.62 volume percent (vol%) or less, beginning in
2011. (See Sec.  80.1230(a).) The rule also requires that no refiner or
importer have an actual average gasoline benzene level greater than 1.3
vol%. After achieving an actual annual average benzene level of 1.3
vol%, refiners and importers may use benzene credits to reduce their
average benzene level to 0.62 vol%. Refiners may generate benzene
credits for their own use or to sell to others, in two ways. Once the
program begins in 2011, a refiner generates credits (known as standard
credits) when its average annual gasoline benzene level is less than
0.62 vol%.
    Refiners may also generate credits prior to 2011. These credits are
called early credits, and are the subject of this final rule. The MSAT2
rule allows early benzene credits to be generated in any annual
averaging period prior to 2011 (i.e., 2008, 2009, and 2010), as well as
for the partial year period June 1-December 31, 2007. Early credits are
generated on a refinery basis. In order to generate early credits, a
refinery must meet several requirements:
    (1) Establish a benzene baseline based on the average benzene level
of the gasoline produced at the refinery during the two-year period
2004-05. (See Sec.  80.1285.)
    (2) Achieve an annual average benzene level at least 10% lower than
its baseline level. (See Sec.  80.1275(a).)
    (3) Make operational changes or improvements in benzene control
technology that will result in real benzene reductions. (See Sec.
80.1275(d).)
    Any refining or operational changes may be utilized to comply with
the average benzene content requirement. However, in order to generate
early credits, the rule specifies four types of operational changes and
benzene control technology improvements that would allow a refinery to
qualify if it implemented the changes/improvements after 2005 (and if
it also met the other related requirements). Sec.  80.1275(d)(1). These
operational changes and technology improvements are:
    (1) Treating the heavy straight run naphtha entering the reformer
using light naphtha splitting and/or isomerization.
    (2) Treating the reformate stream exiting the reformer using
benzene extraction or benzene saturation.
    (3) Directing additional refinery streams to the reformer for
treatment as described in (1) and (2) above.
    (4) Directing reformate streams to other refineries with treatment
capabilities as described in (2) above.
    A refinery needs to implement at least one of these listed changes/
improvements in order to generate early credits.
    This list includes all the strategies we thought would reduce fuel
benzene (and thus benzene emissions) and be cost-effective. The
provision was intended to preclude refineries from generating early
credits solely by benzene reductions achieved through ethanol blending.
    The final rule does not provide a way for EPA to consider
alternative means of reducing fuel benzene and generating early
credits, no matter how effective the alternative. Soon after the rule
was finalized, it was brought to our attention that at least one
refinery had plans to install benzene alkylation technology (also known
as reformate alkylation). Benzene alkylation involves converting
benzene into other aromatic compounds by the addition of alkyl groups
to the benzene ring. Xylene, toluene and cumene are typical products
formed by benzene alkylation. Benzene alkylation is not one of the four
operational or technological changes enumerated in the final rule.
Although EPA regarded benzene alkylation as a legitimate benzene
reduction technology, and one which can be used to comply with the
standard, we did not include it in the list of technologies for
generation of early credits merely because we did not expect refiners
to use it. (See the Regulatory Impact Analysis (EPA420-R-07-002,
February 2007), Chapter 6, page 36.)
    We therefore considered a request to include benzene alkylation on
the list of

early credit-generating technologies to have merit, and on March 12,
2008, we published a direct final rulemaking and a parallel proposal
that would have revised the February 26, 2007 MSAT2 requirement
regarding the benzene control technologies that qualify a refiner to
generate early benzene credits to allow benzene alkylation in addition
to the four operational or technological changes allowed by the MSAT2
rule. The direct final rule would have also allowed a refiner to submit
a request to EPA to approve other benzene-reducing operational changes
or technologies for the purpose of generating early credits.
    We stated that if we received adverse comment by April 11, 2008,
the direct final rule would not take effect and we would publish a
timely withdrawal in the Federal Register. Commenters did in fact
submit significant adverse comment and we accordingly published a
withdrawal of the direct final rule on May 9, 2008. (See 73 FR 26325.)
We stated in the direct final rule and the parallel proposed rule that
we would address comments in any subsequent final action, which would
be based on the parallel proposed rule, without a second comment period
on the action. Today's action is based on the parallel proposed rule,
and finalizes that proposal, so that refiners using benzene alkylation
may generate early credits, and refiners can make site-specific
demonstrations to EPA which may result in other technologies being
eligible to generate early credits.

II. Response to Comments

    We received comments from the Northeast States for Coordinated Air
Use Management (NESCAUM) and the New York State Department of
Environmental Conservation (NYDEC). The commenters expressed several
concerns with the rule. First, they were concerned that the rule
continued the 2007 rule's focus on gasoline benzene content rather than
benzene vehicle emissions. Second, commenters expressed the related
concern that although benzene alkylation reduces gasoline benzene
levels, it may not reduce benzene vehicle emissions. One commenter
suggested that early credits be discounted to account for vehicular
benzene emissions attributable to re-formed benzene. Commenters also
expressed concern about increased aromatics emissions from vehicles.
Finally, commenters opposed allowing other future refinery operational
changes to be approved after petition to and review by EPA for the
purpose of generating early credits.
    As will be discussed below, benzene alkylation meaningfully reduces
gasoline benzene levels and thus directly reduces benzene emissions.
For this reason, we believe that allowing refiners to qualify to
generate early credits through the use of benzene alkylation is
consistent with the intent of technology requirement associated with
the early credit provisions. Use of benzene alkylation will not have
the adverse effects of concern to the commenters: benzene vehicle
emissions will be reduced, and there will not be appreciable increases
in aromatics emissions from vehicles.
    Fuel aromatics and fuel benzene levels both affect vehicle benzene
emissions, but not to anywhere near the same degree. Fuel benzene has
more than a 20-fold \1\ greater impact on benzene emissions from
vehicles than other fuel components, including fuel aromatics levels.
In the March 29, 2006 proposed rule, we discussed how non-benzene
aromatics account for about 30% by volume of gasoline and contribute
about 30% of benzene emissions while benzene constitutes only about one
volume percent of the fuel but is responsible for about 25% of the
benzene emissions. (The remaining benzene emissions are formed from
other (non-aromatic) compounds. See 71 FR 15864). Based on evaluations
using the Complex Model, we concluded there that a 20% reduction in
aromatics would be needed to achieve the same level of benzene
emissions reductions as the 0.62 vol% standard. (See 71 FR 15864.) \2\
Thus, in the 2007 final rule, we concluded that fuel benzene control is
the most effective means of reducing benzene and overall MSAT emissions
because it offers measurable and certain benzene reductions that are
not affected by ``changes in fuel composition or vehicle technology.''
(See 72 FR 8477.)
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    \1\ Based on mg/mi benzene emissions per volume fraction of the
fuel component (benzene, aromatics, other) in gasoline.
    \2\ Though this effect can be seen through Complex Model runs
(which is based on 1990 vehicle technology), in the 2007 rulemaking,
we found that tailpipe benzene emissions from Tier 2 vehicles have a
similar response, in that significantly greater reductions in fuel
aromatics levels are needed to get the same benzene reduction
emissions impact that results from the MSAT2 benzene standard. See
Control of Hazardous Air Pollutants from Mobile Sources, Regulatory
Impact Analysis, Chapter 6, ``Feasibility of the Benzene Control
Program,'' February 2007.
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    Reducing fuel benzene through alkylation or any other benzene
reduction technology results in greater than 95% reduction in benzene
exhaust emissions compared to the benzene emissions caused by the fuel
benzene removed. We estimate that there is less than a 1% difference
among benzene reduction technologies in their effectiveness at reducing
benzene emissions.\3\ Because benzene emissions reductions are
significant regardless of the fuel benzene reduction technology, there
is no reason to discourage the use of one technology over another. For
the same reason, we do not agree with the suggestion to discount early
credits generated by use of benzene alkylation to account for vehicular
emissions.
---------------------------------------------------------------------------

    \3\ Data collected from a recent test program (described in
Chapter 6.11 of the Regulatory Impact Analysis of the 2007 MSAT
rule) suggest that a typical Tier 2 vehicle emits approximately 3.10
mg/mi of benzene when burning gasoline with 1 vol% benzene and 30
vol% aromatics. Simulations done using the Complex Model for
gasoline compliance (described in 40 CFR 80.45) suggest that
approximately 25 wt% of exhaust benzene emission is due to benzene
in the fuel (typically about 1 vol%), about 30 wt% of exhaust
benzene emission is due to aromatics in the fuel (typically about 30
vol%), and the remaining 45 wt% of exhaust benzene emission is from
the rest of the fuel (i.e., non-aromatic compounds). Given this
information, and making the assumption that alkylation would be used
to convert 0.4 vol% of benzene to 0.4 vol% aromatics (to take pool
benzene from 1.0 vol% to 0.60 vol%, slightly overcomplying with the
new standard), we can estimate that a vehicle's tailpipe benzene
emissions would be reduced from 3.10 mg/mi to 2.80 mg/mi if
alkylation were used to reduce fuel benzene, compared to 2.79 mg/mi
if another method of benzene reduction were used that did not create
additional aromatics. This difference is less than 1%, and is
relatively insensitive to the original emission level of the vehicle
or the amount of fuel benzene reduction occurring. The difference is
even smaller if one includes evaporative benzene emission, which is
reduced by an identical amount for any method of benzene reduction.
---------------------------------------------------------------------------

    The commenters' concern about increases in vehicle non-benzene
aromatic emissions is also somewhat misplaced. Again, given the small
amount of benzene in gasoline (1 vol%) relative to total aromatics (20-
40 vol%), the additional contribution of aromatics attributable to
alkylating the benzene is minimal, as would be any increase in aromatic
emissions. In addition, as we discussed in the 2007 rule, fuel
aromatics levels are expected to decrease because of increased ethanol
use, so aromatics emission levels should be dropping in any event.
    Thus, based on the analyses in the 2007 rule of the impacts of fuel
benzene and aromatics reductions on emissions, the slight increase in
fuel aromatics content that could result from refineries using benzene
alkylation for the purposes of generating early credits under this rule
should reduce benzene emissions that would otherwise not be reduced at
this time. No deleterious vehicle emissions impacts are expected. It
thus is appropriate for refiners using benzene alkylation to reduce
fuel benzene levels to be eligible to generate early credits.
    With respect to the other portion of today's rule, we continue to
believe that allowing a refiner to petition us to use

an operating change not currently listed in order to qualify to
generate early benzene credits is appropriate. A refiner would have to
show in the petition that the operating change would reduce fuel
benzene levels which, as just discussed, is the best means of reducing
benzene vehicle emissions. The MSAT2 program encourages early fuel
benzene reductions in order to get early benzene emissions reductions.
This action is not about permitting a refinery to implement a new
technology or make an operating change--those actions can happen at any
time within or outside of the early credit generation window,
regardless of the refinery's intent vis-a-vis generating early credits.
Today's action requires the petitioner to show that the change they
intend to make reduces fuel benzene levels which directly and
significantly reduces benzene vehicle emissions more than any other
fuel compositional change. The petition process has the added value of
being more timely than a rulemaking, which is important since early
credits can only be generated through 2010, and refiners must apply to
generate early credits before the start of the annual averaging period
in which they first want to generate early credits.

III. This Action

    We published a Questions and Answers document related to the MSAT2
program on August 16, 2007. (http://epa.gov/otaq/regs/toxics/
420f07053.pdf) In that document, we specifically addressed benzene
alkylation and indicated that benzene alkylation meets the intent of
the technology requirement for early credits. As discussed in the
preamble of the final rule, early credits are generated based on
innovations in gasoline benzene control technology that result in real
benzene reductions prior to the start of the program in 2011. (See 72
FR 8486.) The use of benzene alkylation directly results in lower
gasoline benzene levels.
    Today's action revises Sec.  80.1275(d)(1) to include benzene
alkylation in the list of acceptable reduction operational and
technological strategies. We have also included a general provision
that allows a refiner to petition EPA to use an operational or
technological change that is not listed in the regulation for the
purpose of generating early credits. The refiner must demonstrate that
the benzene control technology improvement or operational change
results in a net reduction in the refinery's average gasoline benzene
level, exclusive of benzene reductions due simply to blending
practices. The petition must be submitted to EPA prior to the start of
the first averaging period in which the refinery plans to generate
early credits. EPA expects it would act on such a petition before the
end of that averaging period. The refiner must also provide additional
information requested by EPA.
    The other requirements for generating early credits are unchanged.
These include submitting a benzene baseline, reducing the refinery's
baseline benzene level by at least 10% in a given averaging period, and
not moving gasoline or blendstock streams between refineries for the
purpose of generating early credits. (See 72 FR 8486.)

IV. Environmental and Economic Impact

    This action allows companies that have alternative means or
strategies for reducing gasoline benzene to request EPA approval to use
them for the purpose of generating early benzene credits. Average
gasoline benzene levels from such refiners will decrease faster and
earlier than if they had not generated early credits leading to lower
benzene emissions than would have been achieved otherwise. Such credits
will also help provide for a robust credit pool when the program starts
in 2011. Vehicle benzene emissions will be reduced and there will not
be significant increases in vehicle emissions of other aromatics.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action revises the February 26, 2007 mobile source air toxics
rule's requirements that specify the benzene control technologies that
qualify a refiner to generate early benzene credits. It allows another
specific benzene control technology, benzene alkylation, to be used for
the purpose of generating early credits, and allows a refiner to submit
a request to EPA to approve other benzene-reducing operational changes
or technologies for the purpose of generating early credits. This
action is not a ``significant regulatory action'' under the terms of
Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore
not subject to review under the Executive Order.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
because the amendments in this rule do not change the information
collection requirements of the underlying rule.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR Part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this action on small
entities, small entity is defined as: (1) A petroleum refining company
with fewer than 1,500 employees or a petroleum wholesaler or broker
with fewer than 100 employees, based on the North American Industrial
Classification System (NAICS); (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of today's final rule, I
certify that this action will not have a significant economic impact on
a substantial number of small entities.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-

1538 for State, local, or tribal governments or the private sector. EPA
has determined that this rule does not contain a Federal mandate that
may result in expenditures of $100 million or more for State, local,
and tribal governments, in the aggregate, or the private sector in any
one year. Today's action simply modifies the original rule in a limited
manner, and does not significantly change the original rule. Therefore,
this action is not subject to the requirements of sections 202 or 205
of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This action only
applies to parties that produce gasoline.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that 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 final rule does not have federalism implications. It will 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,
as specified in Executive Order 13132. The rule amends existing
regulatory provisions applicable only to producers of gasoline and does
not alter State authority to regulate these entities. The amendments
will impose no direct costs on State or local governments. Thus,
Executive Order 13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on tribal governments, 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, as specified in Executive Order 13175.
This rule amends existing regulatory provisions applicable only to
producers of gasoline and will impose no direct costs on tribal
governments. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health & Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    This rule is not subject to Executive Order 13045 because it is not
an economically significant regulatory action as defined in Executive
Order 12866.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 18355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. 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. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This rule provides additional means for refiners to
qualify to generate early credits by implementing a benzene reducing
technology or operational mode. This in turn will reduce vehicle
benzene emissions.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 United States prior
to publication of the rule in the Federal Register. A Major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This final rule will be effective on December 15, 2008.

VI. Statutory Provisions and Legal Authority

    The statutory authority for the fuels controls in today's final
rule can be found in sections 202(l) and 211(c) of the Clean Air Act
(CAA), as amended. Support for any procedural and enforcement-related
aspects of the fuel controls in today's rule, including

recordkeeping requirements, comes from sections 114(a) and 301(a) of
the CAA.

List of Subjects in 40 CFR Part 80

    Environmental protection, Administrative practice and procedure,
Air pollution control, Confidential business information, Fuel
additives, Gasoline, Imports, Labeling, Motor vehicle fuel, Motor
vehicle pollution, Penalties, Reporting and recordkeeping requirements.

    Dated: October 9, 2008.
Stephen L. Johnson,
Administrator.

0
For the reasons set forth in the preamble, 40 CFR part 80 is amended as
set forth below:

PART 80--REGULATION OF FUELS AND FUEL ADDITIVES

0
1. The authority citation for part 80 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7542, 7545 and 7601(a).

0
2. Section 80.1275 is amended as follows:
0
a. By adding paragraph (d)(1)(v).
0
b. By redesignating paragraph (d)(2) as paragraph (d)(3).
0
c. By adding paragraph (d)(2).

Sec.  80.1275  How are early benzene credits generated?

* * * * *
    (d) * * *
    (1) * * *
    (v) Providing for benzene alkylation.
    (2)(i) A refiner may petition EPA to approve, for purposes of
paragraph (d)(1) of this section, the use of operational changes and/or
improvements in benzene control technology that are not listed in
paragraph (d)(1) of this section to reduce gasoline benzene levels at a
refinery.
    (ii) The petition specified in paragraph (d)(2)(i) of this section
must be sent to: U.S. EPA, NVFEL-ASD, Attn: MSAT2 Early Credit Benzene
Reduction Technology, 2000 Traverwood Dr., Ann Arbor, MI 48105.
    (iii) The petition specified in paragraph (d)(2)(i) of this section
must show how the benzene control technology improvement or operational
change results in a net reduction in the refinery's average gasoline
benzene level, exclusive of benzene reductions due simply to blending
practices.
    (iv) The petition specified in paragraph (d)(2)(i) of this section
must be submitted to EPA prior to the start of the first averaging
period in which the refinery plans to generate early credits.
    (v) The refiner must provide additional information as requested by
EPA.
* * * * *

 [FR Doc. E8-24591 Filed 10-15-08; 8:45 am]

BILLING CODE 6560-50-P


March 28, 2006 Re: Correction to Draft Guidance Document " Criteria For Assessing Whether an Ozone Nonattainment Area is Affected by Overwhelming Transport"

From: John J. Silvasi Environmental Engineer State and Local Programs Group ( C539 02) Office of Air Quality Planning and Standards U. S. Environmental Protection Agency Research Triangle Park, NC 27711 919 541 5666 In the June 29, 2005, draft of the subject draft guidance document, footnote 9 inadvertently contained the following sentence: " Paragraph ( a)( 1) indicates an OTA must meet the criteria as specified for rural transport areas under section 182( h) of the CAA; however, EPA is proposing to revise this to allow for an area that meets the section 182( h) criteria except it is adjacent to a county or counties in an adjacent C/ MSA, where the adjacent county/ counties is/ are designated attainment."

The clause following the semicolon was erroneously included and the entire footnote should read: " Paragraph ( a)( 1) indicates an OTA must meet the criteria as specified for rural transport areas under section 182( h) of the CAA."


[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72491-72493]
[FR Doc No: 2023-23161]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2316]

Benefit-Risk Assessment for New Drug and Biological Products;
Guidance for Industry; Availability

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 final guidance for industry entitled ``Benefit-
Risk Assessment for Human Drug and Biological Products.'' FDA has
developed this guidance document in accordance with goals associated
with the sixth authorization of the Prescription Drug User Fee Act
(PDUFA VI) under Title I of the FDA Reauthorization Act of 2017 and
requirements under the 21st Century Cures Act. The intent of this
guidance is to provide drug sponsors and other stakeholders with better
clarity on how considerations about a drug's benefits, risks, and risk
management options factor into FDA's pre- and postmarket regulatory
decisions about new drug applications (NDAs) or biologics license
applications (BLAs). This guidance finalizes the draft guidance of the
same title issued in September 2021.

DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2020-D-2316 for ``Benefit-Risk Assessment for New Drug and
Biological Products.'' 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, 240-
402-7500.
     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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Benefit-Risk Assessment for Human Drug and Biological
Products.'' This guidance articulates the key considerations that
factor into CDER's and CBER's benefit-risk assessments, including how
patient experience data may be used to inform benefit-risk assessment.
It discusses how sponsors, through their decisions and activities
throughout the drug lifecycle, can inform FDA's benefit-risk
assessment, as well as opportunities for interaction between FDA and
sponsors to discuss benefit-risk considerations. It also discusses
unique considerations for benefit-risk assessments that inform
regulatory decision-making that occurs in the postmarket setting.
    Industry stakeholders have indicated having a clearer understanding
of FDA's decision-making context and benefit-risk considerations can
help inform sponsors' decisions about their drug development programs
and the evidence they generate in support of their NDA or BLA. Patients
and other stakeholders may gain further insight into the key issues
that inform FDA's assessment of benefit and risk, and a clearer
understanding of how these issues fit into the regulatory framework of
drug development and evaluation.
    This guidance finalizes the draft guidance entitled ``Benefit-Risk
Assessment for New Drug and Biological Products'' issued on September
30, 2021 (86 FR 54211). FDA considered comments received on the draft
guidance in developing the final guidance. Changes from the draft to
the final guidance include clarifying language on FDA's approach to
benefit-risk assessment of new drugs and biologics, clarifying language
on important considerations for FDA's premarket benefit-risk assessment
of drugs and biologics, clarifying language on activities that occur in
premarket development that inform benefit-risk assessment, and other
editorial changes.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Benefit-Risk Assessment for New Drug and
Biological Products.'' 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 314 have been approved under OMB control number 0910-
0001 as follows: (1) the content and format of investigational new
drugs applications, (2) expanded access uses and treatment of patients
with immediately life-threatening conditions or serious diseases or
conditions, (3) regulatory requirements pertaining to postmarketing
study commitments, and (4) risk evaluation and mitigation strategies
pertaining to benefit-risk assessments. The collections of information
in 21 CFR part 312 have been approved under OMB control number 0910-
0014 as follows: (1) the content and format of NDAs, (2) the submission
of the patient population, (3) the submission of clinical trial data,
and (4) benefit-risk planning, including early consultations with FDA
meetings in end-of-phase 2 and pre-NDA meetings. The collections of
information for good laboratory practices for nonclinical laboratory
studies have been approved under OMB control number 0910-0119. The
collections of information for the submission of postmarketing adverse
drug experience reporting have been approved under OMB control number
0910-0230. The collections of information in 21 CFR 201.56 and 201.57
for the content and format requirements for labeling of drugs and
biologics have been approved under OMB control number 0910-0572. The
collections of information in the guidance for industry entitled
``Expedited Programs for Serious Conditions--Drugs and Biologics'' have
been approved under OMB control number 0910-0765. The collections of
information in the guidance for industry entitled ``Providing
Postmarket Periodic Safety Reports in the International Conference on
Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation
Report)'' have been approved under OMB control number 0910-0230.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23161 Filed 10-19-23; 8:45 am]
BILLING CODE 4164-01-P