[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62571-62573]
[FR Doc No: 2018-26344]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0750; FRL-9985-62]

Registration Review Proposed Interim Decisions for Several
Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed
interim registration review decisions and opens a 60-day public comment
period on the proposed interim decisions for the following pesticides:
2,4-xylenol, Abamectin, Ametryn, Bacteriophage active against
Xanthomonas campestris pv. vesicatoria, Bacteriophage active against
Pseudomonas syringae pv. tomato, Barium metaborate, Bicarbonates,
Biobor, Butralin, Chondrostereum Purpureum, Corn glutens, Cyhalofop-
butyl, Diphenylamine, Indole-3-acetic acid, L-glutamic acid and gamma
aminobutyric acid, Lysophosphatidylethanolamine, Meta-cresol,
Methiocarb, Methyl anthranilate, Oil of black pepper, Oryzalin,
Phosphoric acid and its salts, Potato leaf roll virus resistance gene,
Predator urines, Prodiamine, Pyrithiobac-sodium, Sodium cyanide, Sodium
fluoroacetate, Straight chain lepidopteran pheromones, Verticillium
isolate WCS850, Yeast extract hydrolysate, and Zinc borate.

DATES: Comments must be received on or before February 4, 2019.

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

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in the Table in Unit IV.
    For general information on the registration review program,
contact: Dana Friedman, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 347-8827; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager for the pesticide of interest
identified in the Table in Unit IV.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information on a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed proposed interim decisions for all pesticides
listed in the Table in Unit IV. Through this program, EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's proposed interim registration review decisions for the
pesticides shown in the following table, and opens a 60-day public
comment period on the proposed interim decisions. For barium
metaborate, cyhalofop-butyl, prodiamine, sodium cyanide, and sodium
fluoroacetate this notice also opens a comment period on the ecological
and human health risk assessments. For diphenylamine, this notice also
opens a comment period on the human health risk assessment.

------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Docket ID number   manager and  contact
            and No.                                     information
------------------------------------------------------------------------
2,4-Xylenol, Case 4098........  EPA-HQ-OPP-2010-0  Jonathan Williams,
                                 240.               [email protected], (703) 347-
                                                    0670.
Abamectin, Case 7430..........  EPA-HQ-OPP-2013-0  Julie Javier,
                                 360.               [email protected]
                                                    ,<PHONE_NUMBER>.
Ametryn, Case 2010............  EPA-HQ-OPP-2013-0  Christian Bongard,
                                 249.               [email protected], (703) 347-
                                                    0337.
Bacteriophage active against    EPA-HQ-OPP-2015-0  Susanne Cerrelli
 Xanthomonas campestris pv.      702.               [email protected]
 vesicatoria, Case 6509 and,                        .gov, (703) 308-
 Bacteriophage active against                       8077.
 Pseudomonas syringae pv.
 Tomato, Case 6510.
Barium Metaborate, Case 0632..  EPA-HQ-OPP-2008-0  Daniel Halpert,
                                 047.               [email protected],<PHONE_NUMBER>.
Bicarbonates, Case 4048.......  EPA-HQ-OPP-2012-0  Maggie Rudick,
                                 407.               [email protected],<PHONE_NUMBER>.
Biobor, Case 3029.............  EPA-HQ-OPP-2008-0  Megan Snyderman,
                                 453.               [email protected],<PHONE_NUMBER>.
Butralin, Case 2075...........  EPA-HQ-OPP-2011-0  Lauren Bailey,
                                 720.               [email protected],<PHONE_NUMBER>.
Chondrostereum Purpureum, Case  EPA-HQ-OPP-2015-0  Daniel Schoeff,
 6091.                           051.               [email protected],<PHONE_NUMBER>.
Corn Glutens, Case 6040.......  EPA-HQ-OPP-2016-0  Maggie Rudick,
                                 253.               [email protected],<PHONE_NUMBER>.
Cyhalofop-butyl, Case 7255....  EPA-HQ-OPP-2014-0  Rachel Fletcher,
                                 115.               [email protected],<PHONE_NUMBER>.
Diphenylamine, Case 2210......  EPA-HQ-OPP-2015-0  Samantha Thomas,
                                 749.               [email protected],<PHONE_NUMBER>.
Indole-3-Acetic acid, Case      EPA-HQ-OPP-2016-0  Maggie Rudick,
 6205.                           665.               [email protected],<PHONE_NUMBER>.
L-Glutamic Acid (LGA) and       EPA-HQ-OPP-2014-0  Cody Kendrick
 Gamma Aminobutyric Acid         109.               [email protected]
 (GABA), Case 6025.                                 v,<PHONE_NUMBER>.
Lysophosphatidylethanolamine    EPA-HQ-OPP-2017-0  Maggie Rudick,
 (LPE), Case 6043.               059.               [email protected],<PHONE_NUMBER>.
meta-Cresol, Case 4027........  EPA-HQ-OPP-2010-0  Jonathan Williams,
                                 244.               [email protected], (703) 347-
                                                    0670.
Methiocarb, Case 0577.........  EPA-HQ-OPP-2010-0  Veronica Dutch,
                                 278.               [email protected],<PHONE_NUMBER>.
Methyl Anthranilate, Case 6056  EPA-HQ-OPP-2011-0  Susanne Cerrelli
                                 678.               [email protected], (703) 308-
                                                    8077.
Oil of Black Pepper, Case 6004  EPA-HQ-OPP-2017-0  Cody Kendrick
                                 262.               [email protected],<PHONE_NUMBER>.
Oryzalin, Case 0186...........  EPA-HQ-OPP-2010-0  Christina Scheltema,
                                 940.               [email protected], (703) 308-
                                                    2201.
Phosphoric Acid and Its Salts   EPA-HQ-OPP-2012-0  Cody Kendrick
 Case 6072.                      672.               [email protected],<PHONE_NUMBER>.
Potato Leaf Roll Virus          EPA-HQ-OPP-2012-0  Michael Glikes,
 Resistance Gene, Case 6505.     416.               [email protected],<PHONE_NUMBER>.
Predator Urines: Coyote Urine   EPA-HQ-OPP-2016-0  Alexandra Boukedes,
 and Fox Urine, Case 6202.       086.               [email protected], (703) 347-
                                                    0305.
Prodiamine, Case 7201.........  EPA-HQ-OPP-2010-0  Jordan Page,
                                 920.               [email protected],
<PHONE_NUMBER>.
Pyrithiobac-sodium, Case 7239.  EPA-HQ-OPP-2011-0  Linsey Walsh,
                                 661.               [email protected]
                                                    ,<PHONE_NUMBER>.
Sodium Cyanide, Case 3086.....  EPA-HQ-OPP-2010-0  Leigh Rimmer,
                                 752.               [email protected]
                                                    ,<PHONE_NUMBER>.
Sodium Fluoroacetate, Case      EPA-HQ-OPP-2010-0  Leigh Rimmer,
 3073.                           753.               [email protected]
                                                    ,<PHONE_NUMBER>.
Straight Chain Lepidopteran     EPA-HQ-OPP-2012-0  Maggie Rudick,
 Pheromones (SCLP), Case 8200.   127.               [email protected],<PHONE_NUMBER>.
Verticillium isolate WCS850     EPA-HQ-OPP-2016-0  Maggie Rudick,
 Case 6508.                      306.               [email protected],<PHONE_NUMBER>.
Yeast Extract Hydrolysate,      EPA-HQ-OPP-2017-0  Daniel Schoeff,
 Case 6081.                      282.               [email protected],<PHONE_NUMBER>.
Zinc Borate, Case 5025........  EPA-HQ-OPP-2007-0  Stephen Savage,
                                 675.               [email protected],<PHONE_NUMBER>.
------------------------------------------------------------------------

    The registration review docket for a pesticide includes earlier
documents related to the registration review case. For example, the
review opened with a Preliminary Work Plan, for public comment. A Final
Work Plan was placed in the docket following public comment on the
Preliminary Work Plan.
    The documents in the dockets describe EPA's rationales for
conducting additional risk assessments for the registration review of
the pesticides included in the table in Unit IV, as well as the
Agency's subsequent risk findings and consideration of possible risk
mitigation measures. These proposed interim registration review
decisions are supported by the rationales included in those documents.
Following public comment, the Agency will issue interim or final
registration review decisions for the pesticides listed in the table in
Unit IV.
    The registration review final rule at 40 CFR 155.58(a) provides for
a minimum 60-day public comment period on all proposed interim
registration review decisions. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the proposed interim decision. All

comments should be submitted using the methods in ADDRESSES, and must
be received by EPA on or before the closing date. These comments will
become part of the docket for the pesticides included in the Table in
Unit IV. Comments received after the close of the comment period will
be marked ``late.'' EPA is not required to consider these late
comments.
    The Agency will carefully consider all comments received by the
closing date and may provide a ``Response to Comments Memorandum'' in
the docket. The interim registration review decision will explain the
effect that any comments had on the interim decision and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
http://www.epa.gov/pesticide-reevaluation.

    Authority: 7 U.S.C. 136 et seq.

    Dated: October 25, 2018.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2018-26344 Filed 12-3-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60749-60750]
[FR Doc No: 2017-27538]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6395]

Request for Nominations of Members for the Clinical Trials
Transformation Initiative/Food and Drug Administration Patient
Engagement Collaborative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency), in
collaboration with the Clinical Trials Transformation Initiative
(CTTI), is requesting nominations of patient advocates interested in
participating on the Patient Engagement Collaborative (PEC). The PEC
will be an ongoing, collaborative forum coordinated through the Patient
Affairs Staff, Office of Medical Products and Tobacco (OMPT), Office of
the Commissioner, and will be hosted by CTTI. Through the PEC, the
patient community and regulators will be able to discuss an array of
topics regarding increasing meaningful patient engagement in medical
product development and regulatory discussions at FDA. The activities
of the PEC may include, but are not limited to, providing diverse
perspectives on topics such as systematic patient engagement,
transparency, and communication; providing considerations for
implementing new strategies to enhance patient engagement at FDA; and
proposing new models of collaboration in which patients and patient
advocates are partners in certain aspects of the medical product
development and FDA review process.

DATES: Nominations received by 11:59 p.m. Eastern Time on or before
January 29, 2018, will be given first consideration for membership on
the PEC. Nominations received after the submission deadline will be
retained for future consideration.

ADDRESSES: All nominations should be submitted to the FDA's Patient
Affairs Staff in the OMPT. Email nominations are preferred and should
be submitted to [email protected]. Though not
required, it is appreciated if all nomination materials are compiled
into a single PDF file and attached to the submission email.
Nominations may also be submitted by mail or delivery service to
Patient Affairs Staff, Office of Medical Products and Tobacco, Office
of the Commissioner, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 1316, Silver Spring, MD 20993. Only complete
applications, as described in section ``IV. Nomination Process'' of
this document, will be considered.

FOR FURTHER INFORMATION CONTACT: Andrea Furia-Helms, Office of Medical
Products and Tobacco, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1316, Silver
Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

    The CTTI is a public-private partnership co-founded by FDA and Duke
University whose mission is to develop and drive adoption of practices
that will increase the quality and efficiency of clinical trials. FDA
and CTTI have long involved patients and considered patient
perspectives in their work. Furthering the engagement of patients as
valued partners across the medical product research and development
continuum requires an open forum for patients and regulators to discuss
and exchange ideas.
    The PEC will be an ongoing, collaborative forum in which the
patient community and regulators will discuss an array of topics
regarding increasing patient engagement in medical product development
and regulatory discussions at FDA. The PEC will be a joint endeavor
between the CTTI and FDA. The activities of the PEC may inform relevant
FDA and CTTI activities. The PEC is not intended to advise or otherwise
direct the activities of either organization, and membership will not
constitute employment by either organization.
    The Food and Drug Administration Safety and Innovation Act (Pub. L.
112-144), section 1137, entitled ``Patient Participation in Medical
Product Discussions,'' added section 569C to the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-8c). This provision directs the
Secretary of Health and Human Services to develop and implement
strategies to solicit the views of patients during the medical product
development process and consider the perspectives of patients during
regulatory discussions. On November 4, 2014, FDA issued a Federal
Register notice establishing a docket (FDA-2014-N-1698) for public
commenters to submit information related to FDA's implementation of
this provision (79 FR 65410). Upon review of the comments received, one
common theme, among others, included establishing an external group to
provide input on patient engagement strategies across FDA's Centers.
    Recent legislation in both section 3001 of the 21st Century Cures
Act and section 605 of the Food and Drug Administration Reauthorization
Act of 2017 supports tools for fostering patient participation in the
regulatory process.
    The purpose of this notice is to announce that the nomination
process for the PEC is now open, and to invite and encourage
nominations by the submission deadline for appropriately qualified
individuals. Self-nominations are accepted.

II. Criteria for Membership

    The PEC will include up to 16 diverse representatives of the
patient community. Selected members will include the following: (1)
Patients who have personal disease experience; (2) caregivers who
support patients, such as a parent, child, partner, other family
member, or friend, and who have personal disease experience through
this caregiver role; and (3) representatives from patient groups who,
through their role in the patient group, have direct or indirect
disease experience. Please note that for purposes of this activity, the
term ``caregiver'' is not intended to include individuals who are
engaged in caregiving as health care professionals; and the term
``patient group'' is used herein to encompass patient advocacy

organizations, disease advocacy organizations, voluntary health
agencies, nonprofit research foundations, and public health
organizations. The ultimate goal of the nomination and selection
process is to identify individuals who can represent a collective
patient voice for their patient community.
    Selection criteria include the nominee's potential to meaningfully
contribute to the activities of the PEC, ability to represent and
express the patient voice for his or her constituency, ability to work
in a constructive manner with involved stakeholders, and understanding
of the clinical research enterprise. Consideration will also be given
to ensuring the PEC includes diverse perspectives and experiences,
including but not limited to, sociodemographic and disease experience
diversity. It is anticipated that approximately half of the PEC
membership will be selected from eligible CTTI member organizations and
individuals, and half will be selected from other nominees. Members are
required to be citizens and residents of the United States.
    Financial and other conflicts of interest will not necessarily make
nominees ineligible for membership in the PEC. However, nominees cannot
be direct employees of the medical product development industry.

III. Responsibilities and Expectations

    Meetings of the PEC will typically be held four times per year,
either in-person (in the Washington, DC area) or by webinar, and
additional meetings may be organized as needed. Accommodations will be
made for members with special needs for travel or for participation in
a meeting (e.g., accommodations for physical mobility impairments,
dietary restrictions, etc.). Nominations for PEC membership are
encouraged for individuals of all racial, ethnic, sexual orientation,
and cultural groups with and without disabilities. Travel support will
be provided.
    To help ensure continuity in its activities and organizational
knowledge, the PEC will maintain staggered membership terms for patient
community representatives. Membership terms are anticipated as 1- to 2-
year appointments, and will be determined during the process of
selecting members. Members may serve up to two terms, with the
possibility of extensions.
    Additional responsibilities and expectations are set forth in the
Patient Engagement Collaborative Framework, which should be reviewed
prior to submitting a nomination. The full text of the Patient
Engagement Collaborative Framework is available at https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative.

IV. Nomination Process

    Any interested person may nominate one or more qualified
individuals for membership on the PEC. Self-nominations are also
accepted.
    Nominations should include the following: (1) A personal statement
(maximum 800 words) from the nominee explaining his or her interest in
becoming a member of the PEC; (2) a current, complete curriculum vitae
or resume that shows relevant activities and experience; and (3) an
optional letter of endorsement (maximum 800 words) from a patient group
with which the nominee has worked closely on activities relevant to the
PEC.
    The personal statement and optional letter of endorsement (if
provided) should emphasize information relevant to the criteria for
membership described above. The letter may address topics such as the
nominee's involvement in patient advocacy activities, experiences that
stimulated an interest in participating in discussions about patient
engagement in medical product development and regulatory decision-
making, and other information that may be helpful in evaluating the
nominee's qualifications as a potential member of the PEC.
    Nominations must provide the nominee's contact information (phone
and email preferred), as well as state that the nominee is aware of the
nomination (unless self-nominated) and is willing to serve as a member
of the PEC.
    Additional information may be needed from nominees, including
information relevant to understanding potential sources of conflict of
interest, in which case nominees will be contacted directly.

    Dated: December 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27538 Filed 12-20-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Proposed Rules]
[Pages 23244-23247]
[FR Doc No: 2018-10599]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2017-0052; FRL-9977-89-Region 6]

Approval and Promulgation of Implementation Plans; Oklahoma;
Interstate Transport Requirements for the 2012 PM2.5 NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or Act), the
Environmental Protection Agency (EPA) is proposing to approve portions
of the Oklahoma State Implementation Plan (SIP) submittal addressing
the CAA requirement that SIPs address the potential for interstate
transport of air pollution to significantly contribute to nonattainment
or interfere with maintenance of the 2012 fine particulate matter
(PM2.5) National Ambient Air Quality Standards (NAAQS) in
other states. EPA is proposing to determine that emissions from
Oklahoma sources do not contribute significantly to nonattainment in,
or interfere with maintenance by, any other state with regard to the
2012 PM2.5 NAAQS.

DATES: Written comments must be received on or before June 18, 2018.

ADDRESSES: Submit your comments, identified by Docket Number EPA-R06-
OAR-2017-0052, at http://www.regulations.gov or via email to
[email protected]. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary

submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact Sherry Fuerst, 214-665-
6454, [email protected]. For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at the EPA
Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Sherry Fuerst,<PHONE_NUMBER>,
[email protected]. To inspect the hard copy materials, please
schedule an appointment with Ms. Fuerst or Mr. Bill Deese at 214-665-
7253.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

A. The PM2.5 NAAQS and Interstate Transport of Air Pollution

    Under section 109 of the CAA, we establish NAAQS to protect human
health and public welfare. In 2012, we established a new annual NAAQS
for PM2.5 of 12 micrograms per cubic meter ([mu]g/m\3\), (78
FR 3085, January 15, 2013). The CAA requires states to submit, within
three years after promulgation of a new or revised standard, SIPs
meeting the applicable ``infrastructure'' elements of sections
110(a)(1) and (2). One of these applicable infrastructure elements, CAA
section 110(a)(2)(D)(i), requires SIPs to contain provisions to
prohibit certain adverse air quality effects on neighboring states due
to interstate transport of pollution. There are four sub-elements
within CAA section 110(a)(2)(D)(i). This action reviews how the first
two sub-elements, contained in CAA section 110(a)(2)(D)(i)(I), were
addressed in an infrastructure SIP submission from Oklahoma for the
2012 PM2.5 NAAQS. These sub-elements require that each SIP
for a new or revised NAAQS contain adequate provisions to prohibit any
source or other type of emissions activity in one state that will
``contribute significantly to nonattainment'' or ``interfere with
maintenance'' of the applicable air quality standard in any other
state.
    The EPA has addressed the interstate transport requirements of CAA
section 110(a)(2)(D)(i)(I) with respect to PM2.5 in several
past regulatory actions. In 2011, we promulgated the Cross-State Air
Pollution Rule (CSAPR, 76 FR 48208, August 8, 2011) in order to address
the obligations of states--and of the EPA when states have not met
their obligations--under CAA section 110(a)(2)(D)(i)(I) to prohibit air
pollution contributing significantly to nonattainment in, or
interfering with maintenance by, any other state with regard to several
NAAQS, including the 1997 annual and 2006 24-hour PM2.5
NAAQS.\1\ In that rule, we considered states linked to downwind
nonattainment or maintenance receptors \2\ if they were projected by
air quality modeling to contribute more than the threshold amount (1%
of the standard) of PM2.5 pollution for the 1997 and 2006
PM2.5 NAAQS (76 FR 48208, 48239-43). The EPA has not
established a threshold amount for the 2012 PM2.5 NAAQS. In
2016 we provided an informational memorandum (the memo) about the steps
states should follow as they develop and review SIPs that address this
provision of the CAA for the 2012 PM2.5 NAAQS.\3\
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    \1\ Federal Implementation Plans; Interstate Transport of Fine
Particulate Matter and Ozone and Correction of SIP Approvals, 76 FR
48207 (August 8, 2011) (codified as amended at 40 CFR 52.38 and
52.39 and 40 CFR part 97).
    \2\ Nonattainment or maintenance receptors are monitors
projected to have air quality problems.
    \3\ Information on the Interstate Transport ``Good Neighbor''
Provision for the 2012 Fine Particulate Matter National Ambient Air
Quality Standards under Clean Air Act Section 110(a)(2)(D)(i)(I)
March 17, 2016 from Stephen D. Page.
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B. Oklahoma SIP Submittal Pertaining to the 2012 PM2.5 NAAQS and
Interstate Transport of Air Pollution

    On December 19, 2016, Oklahoma submitted a SIP revision to address
the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2012
PM2.5 NAAQS. In the submittal Oklahoma used a weight of
evidence analysis to assess interstate transport of Oklahoma emissions
to locations projected in the 2016 EPA memo as receptors of concern. In
their analysis Oklahoma concluded that emissions from Oklahoma did not
significantly contribute to interference with attainment or maintenance
of the 1997 annual PM2.5 NAAQS or the 2006 24-hour
PM2.5 NAAQS in another state. A copy of the Oklahoma SIP
submittal is available in the electronic docket for this action.
    We propose to approve the December 19, 2016 SIP revision submittal
intended to ensure that the SIP met the requirements of the CAA section
110(a)(2)(D)(i)(I) for the 2012 PM2.5 NAAQS.

II. The EPA's Evaluation

    As stated above, Section 110(a)(2)(D)(i) requires SIPS to include
adequate provisions prohibiting any source or other type of emissions
activity in one state that will (I) contribute significantly to
nonattainment, or interfere with maintenance of the NAAQs in another
state, and (II) interfering with measures required to prevent
significant deterioration of air quality, or to protective visibility
in another state. This action address only CAA section
110(a)(2)(D)(i)(I).
    The 2016 EPA memo outlined the four-step framework EPA has
historically used to evaluate interstate transport under section
110(a)(2)(D)(i)(I), including the EPA's CSAPR.
    (1) Identification of potential downwind nonattainment and
maintenance receptors;
    (2) Identification of upwind states contributing to downwind
nonattainment and maintenance receptors;
    (3) For states identified as contributing to downwind air quality
problem, identification of upwind emissions reductions necessary to
prevent upwind states from significantly contributing to nonattainment
or interfering with maintenance of receptors, and;
    (4) For states that are found to have emissions that significantly
contribute to non-attainment or interfere with maintenance downwind,
reducing the identified upwind emissions through adoption of permanent
and enforceable measures.
    We will be following the framework outlined in the memo for our
evaluation. Based on this approach, the potential receptors are
outlined in Table 1 in the memo. Most of the potential receptors are in
California, located in the San Joaquin Valley or South Coast
nonattainment areas. However, there is also one potential receptor in
Shoshone County, Idaho, and one potential receptor in Allegheny County,
Pennsylvania.
    The memo did note that because of data quality problems
nonattainment and maintenance projections were not completed for all or
portions of Florida, Illinois, Idaho, Tennessee and Kentucky. After
issuance of the memo, data quality problems were resolved for Idaho,
Tennessee, Kentucky and most of Florida, identifying no additional
potential receptors, with those areas

having design values (DV) below the 2012 PM2.5 NAAQS and
expected to maintain the NAAQS due to downward emission trends for
NOX and SO2 (www.epa.gov/air-trends/air-quality-design-values and www.epa.gov/air-emissions-inventories/air-pollutant-emissions-trends-data). Florida certified its 2017 PM2.5
ambient air data for the counties in Florida with 2009-2013 data gaps
in March, 2018 allowing us to develop 2015-2017 preliminary design
values. The highest preliminary design value in Florida is 8 [mu]g/m\3\
and the highest monitored value in Florida is 7.5 [mu]g/m\3\, well
below the NAAQS. For these reasons, we find that none of the counties
in Florida with monitoring gaps between 2009-2013 should be considered
either nonattainment or maintenance receptors for the 2012
PM2.5 NAAQS. Therefore, as of April, 2018, only Illinois
still has data quality issues preventing projections of nonattainment
and maintenance receptors. Illinois will be evaluated to determine if
they have potential nonattainment or maintenance receptors for 2012
PM2.5 NAAQS.
    Therefore, for ``Step 1'' of this evaluation, the areas identified
as ``potential downwind nonattainment and maintenance receptors'' are:
     Seventeen potential receptors in California, located in
the San Joaquin Valley or South Coast nonattainment areas;
     Shoshone County, Idaho;
     Allegheny County, Pennsylvania; and,
     All of Illinois
    As stated above, ``Step 2'' is the identification of states
contributing to downwind nonattainment and maintenance receptors, such
that further analysis is required to identify necessary upwind
reductions. For this step, we will be specifically determining if
Oklahoma emissions contribute to downwind nonattainment and maintenance
receptors.
    Each of the potential receptors is discussed below, with a more in
depth discussion provided in the Technical Support Document (TSD) for
this notice. For additional information, links to the documents relied
upon for this analysis can be found throughout the document, more
information is available in the TSD and the documents can be found in
the docket for this action.

California

    As described in our TSD, our analysis shows that Oklahoma's
PM2.5 emissions and/or PM2.5 precursors do not
significantly impact the California potential receptors identified in
the memo. In our analysis we found specifically that the majority of
the emissions impacting PM2.5 levels in California are
directly emitted PM2.5 and/or PM2.5 precursors
from within the state, and that meteorological and topographic
conditions serve as barriers to transport from Oklahoma. We note that
air quality designations are not relevant to our evaluation of
interstate transport, however, the analysis developed for the 2012
annual PM2.5 NAAQS designations process provides an in depth
evaluation of factors critical in evaluating transport of
PM2.5 and PM2.5 precursors, including evaluation
of local emissions, wind speed and direction, topographical and
meteorological conditions and seasonal variations recorded at the
monitors, which all support the conclusion that Oklahoma's
PM2.5 and PM2.5 precursors do not significantly
contribute to nonattainment or interfere with maintenance of the
California potential receptors. Furthermore, Oklahoma is more than 800
miles to the east and generally downwind of the California
receptors.\4\
---------------------------------------------------------------------------

    \4\ California: Imperial County, Los Angeles-South Coast Air
Basin, Plumas County, San Joaquin Valley Area Designations for the
2012 Primary Annual PM2.5 National Ambient Air Quality
Standard Technical Support Document https://www.regulations.gov/document?D=EPA-HQ-OAR-2012-0918-0330.
---------------------------------------------------------------------------

    For these reasons, we propose to find that Oklahoma does not
significantly contribute to nonattainment, nor will it interfere with
maintenance of the 2012 PM2.5 NAAQS for California.

Shoshone County, Idaho

    As discussed in the TSD, our analysis shows that Oklahoma's
PM2.5 emissions and/or PM2.5 precursors do not
significantly impact the Idaho potential receptor identified in the
memo. In our analysis, we found specifically that the majority of the
emissions impacting PM2.5 levels, came during the winter
time and could be attributed to residential wood combustion. We note
that air quality designations are not relevant to our evaluation of
interstate transport; however, the analysis developed for the 2012
annual PM2.5 NAAQS designations process provide an in depth
evaluation of factors critical in evaluating transport of
PM2.5 and PM2.5 precursors, including evaluation
of local emissions, wind speed and direction, topographical and
meteorological conditions and seasonal variations recorded at the
monitor, which all support the conclusion that Oklahoma
PM2.5 and PM2.5 precursors do not significantly
contribute to nonattainment nor interfere with maintenance of the Idaho
potential receptor.\5\ Furthermore, Oklahoma is more than 1,000 miles
to the southeast and downwind of this receptor.
---------------------------------------------------------------------------

    \5\ Idaho: West Silver Valley Nonattainment Area- 2012 Primary
Annual PM2.5 National Ambient Air Quality Standard
Technical Support Document. Prepared by EPA Region 10.
---------------------------------------------------------------------------

    For these reasons, we propose to find that Oklahoma does not
significantly contribute to nonattainment, nor will it interfere with
maintenance of the 2012 PM2.5 NAAQS for Shoshone, Idaho.

Allegheny County, Pennsylvania

    As discussed in the TSD, our analysis shows that Oklahoma's
PM2.5 emissions and/or PM2.5 precursors do not
significantly impact the Allegheny County, Pennsylvania (Liberty
monitor) potential receptor identified in the memo. In our analysis, we
found that there were strong local influences throughout Allegheny
County and contributions from nearby states that contributed to its
nonattainment for both the 1997 and 2006 PM2.5 NAAQS.
Contributors to the Liberty monitor in Allegheny County, Pennsylvania
in recent years, have taken steps to improve air quality which will
likely bring the monitor into compliance with the 2012 PM2.5
annual NAAQS by the 2021 attainment date.
    Another compelling fact is that in previous modeling, Oklahoma
emissions were not linked to Allegheny County.\6\
---------------------------------------------------------------------------

    \6\ Air Quality Modeling for 2011 Cross-State Air Pollution Rule
(CSAPR) (76 FR 48207, August 8, 2011).
---------------------------------------------------------------------------

    For these reasons, we propose to find that Oklahoma does not
significantly contribute to nonattainment, nor will it interfere with
maintenance of the 2012 PM2.5 NAAQS for Allegany County,
Pennsylvania.

Illinois

    Due to ambient monitoring data gaps in the 2009-2013 data that
should have been used to identify potential PM2.5
nonattainment and maintenance receptors in Illinois and the modeling
analysis of potential receptors could not be completed for the state,
therefore the entire state is considered unclassifiable. Illinois did
have a nonattainment receptor identified through the CSAPR modeling
analysis for the 1997 PM2.5 NAAQS. The receptor was in
Madison, Illinois, located near St. Louis, Missouri.
    As stated above, Oklahoma was included in the CSAPR modeling
analysis for the 1997 PM2.5 NAAQS. The modeling did not show
a linkage for nonattainment or maintenance between Oklahoma and
Illinois. Recent DV for the monitors in Madison, Illinois have shown
downward trends. There are

three active monitors in Madison. The DVs for the monitors are shown in
Table 1 below.

              Table 1--Annual Standard 3-Year Averages ([mu]g/m\3\) for Madison, Illinois Monitors
----------------------------------------------------------------------------------------------------------------
                           Monitor No.                               2012-2014       2013-2015       2014-2016
----------------------------------------------------------------------------------------------------------------
171191007.......................................................            12.9            11.6            10.8
171192009.......................................................            10.4             9.7             9.4
171193007.......................................................            12.5            10.8            10.1
----------------------------------------------------------------------------------------------------------------

    For these reasons, we propose that Oklahoma will not significantly
contribute to nonattainment, nor will it interfere with maintenance of
the 2012 PM2.5 NAAQS in Illinois.
    Since we determined that Oklahoma's SIP includes provisions
prohibiting any source or other type of emissions activity from
contributing significantly to nonattainment in, or interfering with
maintenance of the NAAQS, in another state, steps 3 and 4 of this
evaluation are not necessary.
    In conclusion, based on our review of the potential receptors
presented in the March 17, 2016 informational memo, an evaluation
identifying likely emission sources affecting these potential
receptors, and the 2014 base case modeling in CSAPR final rule, we
propose to determine that emissions from Oklahoma sources will not
contribute significantly to nonattainment in, nor interfere with
maintenance by, any other state with regard to the 2012 annual
PM2.5 NAAQS.

III. Proposed Action

    For the reasons discussed above and in the TSD, we are proposing to
approve the December 19, 2016 Oklahoma SIP submittal concluding that
emissions from Oklahoma will not significantly contribute to
nonattainment or interfere with maintenance of the 2012
PM2.5 NAAQS in any other state.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter.

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

    Dated: May 14, 2018.
Anne Idsal,
Regional Administrator, Region 6.
[FR Doc. 2018-10599 Filed 5-17-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 28, 2008 (Volume 73, Number 209)]
[Notices]
[Page 63959]
[DOCID:fr28oc08-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

October 22, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP91-203-076, RP92-132-064.
    Applicants: Tennessee Gas Pipeline Company.
    Description: Tennessee Gas Pipeline Company submits a report
regarding the status of Tennessee's discussions with its customers etc
re over-collections pursuant to the 5/15/95 Settlement.
    Filed Date: 10/01/2008.
    Accession Number: 20081021-0059.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 28, 2008.

    Docket Numbers: RP96-200-198.
    Applicants: CenterPoint Energy Gas Transmission Company.
    Description: CenterPoint Energy Gas Transmission Company submits a
notice of the termination of negotiated rate agreement with Anadarko
Energy Services Company, effective 10/31/08.
    Filed Date: 10/21/2008.
    Accession Number: 20081022-0323.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Docket Numbers: RP96-272-083.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits 13 Revised Sheet
66B.01 et al. to FERC Gas Tariff, Fifth Revised Volume 1 and a non-
conforming and negotiated rate service agreement with Chevron USA, Inc.
    Filed Date: 10/17/2008.
    Accession Number: 20081021-0058.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 29, 2008.

    Docket Numbers: RP99-176-169.
    Applicants: Natural Gas Pipeline Co of America LLC.
    Description: Natural Gas Pipeline Company of America LLC. submits
First Revised Sheet 34C to FERC Gas Tariff, Seventh Revised Volume 1,
to be effective 11/1/08.
    Filed Date: 10/21/2008.
    Accession Number: 20081022-0324.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Docket Numbers: RP01-205-019.
    Applicants: Southern Natural Gas Company.
    Description: Southern Natural Gas Company submits Eighth Revised
Sheet 23A to FERC Gas Tariff, Seventh Revised Volume 1, to be effective
11/1/08.
    Filed Date: 10/20/2008.
    Accession Number: 20081021-0328.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Docket Numbers: RP07-690-004.
    Applicants: Southern Natural Gas Company.
    Description: Southern Natural Gas Company submits Sixth Revised
Sheet 123 to FERC Gas Tariff, Seventh Revised Volume 1, to be effective
11/1/08.
    Filed Date: 10/20/2008.
    Accession Number: 20081021-0327.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Docket Numbers: RP09-26-000.
    Applicants: Williston Basin Interstate Pipeline Company.
    Description: Williston Basin Interstate Pipeline Company submits
Fifteenth Revised Sheet 374 et al. to FERC Gas Tariff, Second Revised
Volume 1, to be effective 10/20/08.
    Filed Date: 10/20/2008.
    Accession Number: 20081021-0127.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Docket Numbers: RP09-27-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: National Fuel Gas Supply Corporation submits First
Revised Sheet 455 et al. to FERC Gas Tariff, Fourth Revised Volume 1,
to effective 10/21/08.
    Filed Date: 10/21/2008.
    Accession Number: 20081022-0322.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Docket Numbers: RP09-28-000.
    Applicants: Northern Natural Gas Company.
    Description: Petition of Northern Natural Gas Company for limited
waiver of tariff provisions.
    Filed Date: 10/21/2008.
    Accession Number: 20081022-0321.
    Comment Date: 5 p.m. Eastern Time on Monday, November 3, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-25605 Filed 10-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 161 (Tuesday, August 22, 2023)]
[Notices]
[Pages 57116-57117]
[FR Doc No: 2023-18026]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances 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 additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by October 23, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on May 19, 2023 (88 FR 32231). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active Ingredient(s).
-------------------------------------------------------------------------
Abrocitinib.
Asciminib hydrochloride.
Atogepant.
Atropine sulfate.
Avacopan.
Chloroprocaine hydrochloride.
Daridorexant hydrochloride.
Epinephrine.
Lidocaine hydrochloride.
Lumasiran sodium.
Lutetium Lu-177 vipivotide tetraxetan.
Maralixibat chloride.
Mavacamten.
Midazolam hydrochloride.
Mitapivat sulfate.
Mobocertinib succinate.
Oteseconazole.
Pacritinib citrate.
Pilocarpine hydrochloride.
Ruxolitinib phosphate.
Tirzepatide.
Vutrisiran sodium.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active Ingredient(s)
-------------------------------------------------------------------------
Beclomethasone dipropionate (multiple reference listed drugs).
Beclomethasone dipropionate monohydrate.
Budesonide.
Ciclesonide (multiple reference listed drugs).
Clascoterone.
Diclofenac epolamine.
Epinephrine.
Estradiol; Levonorgestrel.
Fluvoxamine maleate.
Glucagon.
Ipratropium bromide.
Mometasone furoate; Olopatadine Hydrochloride.
Triamcinolone acetonide.
Voxelotor.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that these draft guidances contain no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

V. Electronic Access

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

    Dated: August 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18026 Filed 8-21-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 91 (Thursday, May 10, 2012)]
[Notices]
[Pages 27539-27540]
[FR Doc No: 2012-11338]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Recordkeeping Requirements; Agency
Information Collection Activity Under OMB Review

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

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collection and the expected
burden. The Federal Register Notice with a 60-day comment period was
published on November 16, 2011 (76 FR 71122-71123).

DATES: Comments must be submitted on or before June 11, 2012.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Jessica Cicchino, Ph.D., Contracting
Officer's Technical Representative, Office of Behavioral Safety
Research (NTI-131), National Highway Traffic Safety Administration,
1200 New Jersey Ave. SE., W46-491, Washington, DC 20590. Dr. Cicchino's
phone number is<PHONE_NUMBER> and her email address is
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:
    Title: Instrumented On-Road Study of Motorcycle Riders.
    Type of Request: New information collection request.
    Abstract: Motorcycle crashes and fatalities have become a rapidly
escalating traffic safety problem on our Nation's roads. In 2010, 4,502
motorcyclists were killed in the United States, which is more than
double the 2,106 motorcyclist fatalities that occurred when fatalities
reached a low in 1997. Motorcycles made up 3% of the registered
vehicles in the United States in 2010 but motorcyclists accounted for
14% of the total traffic fatalities.
    Knowledge of both how riders successfully avoid crashes and of
behaviors that correlate with and contribute to crash risk is crucial
to developing effective countermeasures to reduce motorcycle crashes
and fatalities. Data describing actual events are difficult to collect.
Riders and law enforcement officers are not always aware of what caused
a crash after the fact. It is even more difficult to identify
behavioral factors associated with safe riding, and the actions of
riders during evasive maneuvers that did not result in a police-
reportable crash. Studies using instrumented vehicles to collect data
on the real-world driving of passenger car and truck drivers have
provided unprecedented information describing actual events occurring
for drivers as they negotiate the roadway system. The goal of this
study is to collect similar data from motorcycle operators using
instrumented motorcycles.
    The National Highway Traffic Safety Administration (NHTSA) will be
conducting on-road instrumented vehicle data collection with a total of
160 motorcycle riders to examine motorcycle riders' behaviors as they
typically ride. Volunteers will be recruited to have their motorcycles
outfitted for one year with instrumentation such as cameras, GPS, and
accelerometers that will capture data on normal riding behavior
whenever their motorcycles are ridden.
    Before participating in the on-road portion of the study,
participating motorcycle riders will be asked to complete intake
questionnaires that will ask about their demographics, riding history,
self-reported behavior, and perceptions. After completing the on-road
study, participants will be asked to complete a short debriefing
questionnaire that will focus on their experiences riding with the
instrumentation in the past year. This subjective data will be combined
with the objective data from the instrumentation on actual riding
behavior to help NHTSA develop a better understanding of if a rider's
demographic characteristics, riding history, self-reported behavior,
and perceptions are linked to his or her behavior on the road.
    Affected Public: Participation in the study will be voluntary. Each
of the 160 participants in the on-road instrumented motorcycle portion
of the study will be asked to complete intake questionnaires, capturing
demographic characteristics, riding history, self-reported behavior,
and perceptions, during his or her instrumentation session and to
complete a debriefing questionnaire as the instrumentation is being
removed from his or her motorcycle one year later.
    Estimated Total Burden: The intake questionnaires are estimated to
take 75 minutes to complete, and the debriefing questionnaire is
estimated to last 15 minutes. Intake questionnaires will be completed
during the time when the respondent's motorcycle is being instrumented,
and the debriefing questionnaire will be completed while the
instrumentation is being removed from the respondent's motorcycle after
the one-year period of on-road data collection. This results in an
estimated burden of 200 hours of burden for the intake questionnaires
(160 respondents x 75 minutes), and 40 hours of burden for the
debriefing questionnaires (160 respondents x 15 minutes).
    The total estimated information collection burden for this project
is 240 hours over one year: 200 hours for the intake questionnaires and
40 hours for the debriefing interviews. The respondents will not incur
any record-keeping burden or record-keeping cost from the information
collection.
    Comments are invited on the following: (i) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (ii) the accuracy of the agency's estimate of
the burden of the proposed information collection; (iii) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (iv) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.

    Authority: 44 U.S.C. 3506(c)(2)(A).

    Issued on: May 7, 2012.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2012-11338 Filed 5-9-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Rules and Regulations]
[Pages 19571-19574]
[FR Doc No: 2021-07687]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0305; Project Identifier AD-2021-00334-R;
Amendment 39-21512; AD 2021-08-18]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2021-04-16
which applied to certain Sikorsky Aircraft Corporation (Sikorsky) Model
S-92A helicopters. AD 2021-04-16 required a one-time inspection of the
landing gear for components with non-conforming threads and removal of
any non-conforming threaded hinge pin and main landing gear (MLG) and
nose landing gear (NLG) actuator pins. AD 2021-04-16 also prohibited
installing certain part-numbered hinge and actuator pins on any
helicopter. This AD requires the same actions but corrects erroneous
part numbers. This AD was prompted by the discovery that certain part
numbers listed in AD 2021-04-16 are incorrect. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD is effective April 29, 2021
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of April
14, 2021 (86 FR 13631, March 10, 2021).
    The FAA must receive any comments on this AD by June 1, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact your
local Sikorsky Field Representative or Sikorsky's Service Engineering
Group at Sikorsky Aircraft Corporation, Mailstop K100, 124 Quarry Road,
Trumbull, CT 06611; telephone 1-800-946-4337 (1-800-Winged-S); email
<EMAIL_ADDRESS>Operators may also log on to the
Sikorsky 360 website at https://www.sikorsky360.com. You may view this
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0305.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0305; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Dorie Resnik, Aviation Safety
Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued AD 2021-04-16, Amendment 39-21438 (86 FR 13631,
March 10, 2021) (AD 2021-04-16), for Sikorsky Model S-92A helicopters
with serial numbers (S/Ns) 920006 through 920334 inclusive. AD 2021-04-
16 required a one-time inspection of the landing gear and the removal
from service of certain serial-numbered threaded hinge pins part number
(P/N) 92250-12281-101 and certain serial-numbered MLG and NLG actuator
pins P/N 92250-12287-101 and 92250-12287-103. AD 2021-04-16 was
prompted by the manufacturer discovering nonconforming threads,
resulting in a life limit reduction on multiple landing gear components
including threaded hinge pins and MLG and NLG actuator pins. The FAA
issued AD 2021-04-16 to prevent failure of components on the MLG and
NLG. The unsafe condition, if not addressed, could result in damage to
the helicopter and reduced ability to control the helicopter during
landing.

Actions Since AD 2021-04-16 Was Issued

    Since the FAA issued AD 2021-04-16, it was discovered that the P/Ns
for the actuator pins were incorrect in certain paragraphs. Portions of
the Required Actions paragraph incorrectly identified the actuator pin
P/Ns as 92240-12287-101 and 92240-12287-103; the correct P/Ns are
92250-12287-101 and 92250-12287-103. The Installation Prohibition
paragraph incorrectly identified the actuator pin P/Ns as 92240-12287-
101 and 92240-12287-103; the correct P/Ns are 92250-12287-101 and
92250-12287-103. The FAA is issuing this AD to correct these P/N errors
and address the unsafe condition on these products.

FAA's Determination

    The FAA is issuing this AD because the agency determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Sikorsky Alert Service Bulletin 92-32-008, Basic
Issue, dated January 21, 2020 (the ASB). The ASB describes procedures
for a one-time inspection and replacement of non-conforming components
on the MLG and NLG.
    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.

AD Requirements

    This AD requires, within 300 hours time-in-service (TIS) after the
effective date of this AD, visually inspecting the components of the
right MLG assembly, left MLG assembly, and NLG kit for threaded hinge
pins P/N 92250-12281-101 and actuator pins P/N 92250-12287-101 and
92250-12287-103 with an S/N as specified in the ASB. If there is any
threaded hinge pin P/N 92250-12281-101 or any MLG or NLG actuator pin
P/N 92250-12287-101 or P/N 92250-12287-103 with an S/N as specified in
the ASB, removing it from service is required before further flight.
This AD also prohibits, as of the effective date of this AD, installing
any threaded hinge pin P/N 92250-12281-101 or actuator pin P/N 92250-
12287-101 or 92250-12287-103 with an S/N as specified in the ASB, on
any helicopter.

Differences Between This AD and the Service Information

    This AD requires replacing only affected hinge pins and MLG and NLG
actuator pins. The ASB requires replacing additional parts such as the
MLG and NLG crossbolt and the MLG and NLG upper nut. The FAA has
determined that the MLG and NLG crossbolt and the MLG and NLG upper nut
fail in a safe and contained manner and therefore are not subject to
this AD.
    Additionally, this AD requires the one-time inspection within 300
hours TIS after the effective date of this AD and requires that any
affected hinge pins and MLG and NLG actuator pins be removed from
service before further flight. The ASB specifies inspecting and
replacing the affected hinge pins and MLG and NLG actuator pins occur
no later than January 21, 2021.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    This AD corrects an obvious error in AD 2021-04-16 that affects
compliance and the public was previously provided opportunity for
comment on the costs of the AD and required actions.
    Accordingly, notice and opportunity for prior public comment are
unnecessary pursuant to 5 U.S.C. 553(b)(3)(B). In addition, the FAA
finds that good cause exists pursuant to 5 U.S.C. 553(d) for making
this amendment effective in less than 30 days, for the same reasons the
FAA found good cause to forgo notice and comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0305 and Project Identifier
AD-2021- 00334-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Dorie
Resnik, Aerospace Engineer, Boston ACO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: (781) 238-
7199; email<EMAIL_ADDRESS>Any commentary that the FAA receives
which is not specifically designated as CBI will be placed in the
public docket for this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 85 helicopters of U.S.
registry and estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                     Labor cost          Parts cost      Cost per  product      operators
----------------------------------------------------------------------------------------------------------------
Visually inspect landing gear       1 work-hour x $85                 $0   $255 (three landing          $21,675
 (right MLG assembly, left MLG       per hour = $85 (per                    gear installed on
 assembly, and NLG kit).             landing gear).                         each helicopter).
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that are required based on the results of the inspection.
The FAA has no way of determining the number of helicopters that might
need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace threaded hinge pin, P/N 92250-12281-    1 work-hour x $85 per hour = $85          $4,535          $4,620
 101.
Replace MLG/NLG actuator pin, P/N 92250-12287-  1 work-hour x $85 = $85.........             557             642
 101.
Replace MLG/NLG actuator pin, P/N 92250-12287-  1 work-hour x $85 = $85.........             609             694
 103.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. The FAA does not control warranty coverage for affected
individuals. As a result, the FAA has included all costs in its cost
estimate.

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.
    The FAA is 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

    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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

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:
0
a. Removing Airworthiness Directive 2021-04-16, Amendment 39-21438 (86
FR 13631, March 10, 2021); and
0
b. Adding the following new airworthiness directive:

2021-08-18 Sikorsky Aircraft Corporation (Sikorsky): Amendment 39-
21512; Docket No. FAA-2021-0305; Project Identifier AD-2021-00334-R

(a) Effective Date

    This airworthiness directive (AD) is effective April 29, 2021.

(b) Affected ADs

    This AD replaces AD 2021-04-16, Amendment 39-21438 (86 FR 13631,
March 10, 2021) (AD 2021-04-16).

(c) Applicability

    This AD applies to Sikorsky Model S-92A helicopters,
certificated in any category, with serial numbers (S/Ns) 920006
through 920334 inclusive.

(d) Subject

    Joint Aircraft System Component (JASC) Code 3220, Nose/Tail
Landing Gear and 3210, Main Landing Gear.

(e) Unsafe Condition

    This AD was prompted by the discovery that certain part numbers
listed in AD 2021-04-16 were incorrect. AD 2021-04-16 was issued
after the manufacturer determined that because of non-conforming
threads, due to a quality escape, the life limit of the threaded
hinge pin and main landing gear (MLG) and nose landing gear (NLG)
actuator pins was reduced. The FAA is issuing this AD to correct the
errors in AD 2021-04-16 and prevent failure of components on the MLG
and NLG. The unsafe condition, if not addressed, could result in
damage to the helicopter and reduced ability to control the
helicopter during landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within 300 hours time in service after the effective date of
this AD, visually inspect the components of the right MLG assembly,
left MLG assembly, and NLG kit for threaded hinge pins part number
(P/N) 92250-12281-101 and actuator pins P/N 92250-12287-101 and P/N
92250-12287-103 with S/Ns identified in Table 1 or 2 (threaded hinge
pins) or in Table 1 (actuator pins), in Section 3, the
Accomplishment Instructions, in the Sikorsky Aircraft Corporation
Alert Service Bulletin 92-32-008, Basic Issue, dated January 21,
2020 (the ASB).
    Note 1 to the introductory text of paragraph (g): See Figures 1
and 2 in Section 3, the Accomplishment Instructions, in the ASB for
guidance on performing the visual inspection.
    (1) If there is any threaded hinge pin, P/N 92250-12281-101,
with an S/N listed in Table 1 or 2 in the ASB, before further
flight, remove the threaded hinge pin from service.
    (2) If there is any MLG or NLG actuator pin, P/N 92250-12287-101
or P/N 92250-12287-103, with an S/N listed in Table 1 in the ASB,
before further flight, remove the actuator pin from service.

(h) Installation Prohibition

    As of the effective date of this AD, do not install any threaded
hinge pin 92250-12281-101 or actuator pin, P/N 92250-12287-101 or
92250-12287-103 with an S/N listed in Table 1 or 2 in Section 3, the
Accomplishment Instructions, in the ASB, on any helicopter.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (j) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Dorie Resnik,
Aviation Safety Engineer, Boston ACO Branch, Compliance &
Airworthiness Division, FAA, 1200 District Avenue, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register previously 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.
    (3) The following service information was approved for IBR on
April 14, 2021 (86 FR 13631, March 10, 2021).
    (i) Sikorsky Aircraft Corporation Alert Service Bulletin 92-32-
008, Basic Issue, dated January 21, 2020.
    (ii) [Reserved]
    (4) For Sikorsky Aircraft Corporation service information
identified in this AD, contact your local Sikorsky Field
Representative or Sikorsky's Service Engineering Group at Sikorsky
Aircraft Corporation, Mailstop K100, 124 Quarry Road, Trumbull, CT
06611; telephone 1-800-946-4337 (1-800-Winged-S); email
<EMAIL_ADDRESS>Operators may also log on to
the Sikorsky 360 website at https://www.sikorsky360.com.
    (5) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (6) 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, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 9, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-07687 Filed 4-12-21; 11:15 am]
BILLING CODE 4910-13-P