[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34147-34154]
[FR Doc No: 2021-13212]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2020-0474; FRL-10020-38]
RIN 2070-AB11

Health and Safety Data Reporting; Addition of 20 High-Priority
Substances and 30 Organohalogen Flame Retardants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule, issued pursuant to the Toxic Substances
Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule,
requires manufacturers (including importers) of 50 specified chemical
substances to report certain lists and copies of unpublished health and
safety studies to EPA. The chemical substances subject to this rule are
listed in this document and consist of the 20 designated by EPA as
High-Priority Substances and the 30 organohalogen flame retardants
being evaluated for risks by the Consumer Product Safety Commission
(CPSC) under the Federal Hazardous Substances Act (FHSA). EPA is taking
this action because the TSCA Interagency Testing Committee (ITC) added
these chemical substances to the Priority Testing List through its 69th
and 74th Reports and EPA will use this information to inform the risk
evaluations currently underway for 20 High-Priority Substances and for
future prioritization.

DATES: This final rule is effective July 29, 2021. For purposes of
judicial review, this final rule shall be promulgated at 1 p.m. eastern
daylight/standard time July 13, 2021
    A request to withdraw a chemical substance from this final rule
pursuant to 40 CFR 716.105(c) must be received on or before July 13,
2021. (See Unit IV. of the SUPPLEMENTARY INFORMATION.)
    Dates for the reporting requirements are enumerated in Unit III.B.
of the SUPPLEMENTARY INFORMATION.

ADDRESSES:
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0474, by using the Federal eRulemaking
Portal at 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.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
    Withdrawal requests. For submission of a withdrawal request, see
Unit IV. of this document. Each withdrawal request must be identified
by docket ID number EPA-HQ-OPPT-2020-0474.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Diana Fahning, Data Gathering
and Analysis Division (7410M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture
(defined by statute to include import) any of the chemical substances
that are listed in 40 CFR 716.120(d) of the regulatory text of this
document. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
Chemical manufacturers (including importers), (NAICS codes 325 and
324110), e.g., persons who manufacture (defined by statute to include
import) one or more of the subject chemical substances.

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

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in 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 https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. What action is the Agency taking?

    EPA is issuing a final rule pursuant to TSCA section 8(d) to
require manufacturers (including importers) of chemical substances
listed in this document and on the ITC's TSCA section 4(e) Priority
Testing List to submit lists and copies of certain unpublished health
and safety studies to EPA. The regulatory text of this document lists
the chemical substances and their Chemical Abstracts Service Registry
Numbers (CASRN) that are being added to the Health and Safety Data
Reporting rule. It also lists the specific data reporting requirements
imposed by this final rule.

B. What is the Agency's authority for taking this action?

    EPA promulgated the Health and Safety Data Reporting rule under
TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR
part 716. EPA is using this TSCA section 8(d) rule in accordance with
40 CFR 716.105 to gather information on chemical substances. These
studies are expected to provide EPA with useful information for
conducting TSCA activities such as prioritization and risk evaluation.
    The Agency adds substances to the rule via rule or notice, in
accordance with 40 CFR 716.105(a) or (b), respectively. The rule
requires certain past, current, and prospective manufacturers (which
under TSCA includes importers) to submit copies and/or lists of
unpublished health and safety studies on the listed chemical substances
that they manufacture. In some cases, EPA may also require processors
to comply with the rule.
    The TSCA section 8(d) Health and Safety Data Reporting rule
provides for the addition of TSCA section 4(e) Priority Testing List
chemical substances to the list of chemical substances subject to the
rule (see Table of Chemicals, 40 CFR 716.120) (Ref. 1). Whenever EPA
announces the receipt of an ITC Report, EPA may, amend the TSCA section
8(d) Health and Safety Data Reporting rule by adding the recommended
(or designated) chemical substances to the TSCA section 4(e) list. In
doing so, EPA must provide a 14-day period (measured from the date of
publication of the Federal Register document announcing the rule) for
persons to submit information showing why a chemical substance,
mixture, or category of chemical substances should be withdrawn from
the amendment. The amendment adding these chemical substances to the
Health and Safety Data Reporting rule is effective July 29, 2021. If
EPA withdraws a chemical substance from the amendment, a Federal
Register document announcing this decision is to be published no later
than July 29, 2021.

C. Comments Received on the 74th Report of the ITC

    EPA received seven public comments on the 74th Report of the ITC.
One comment requested additional information be provided for why
certain organohalogen flame retardants being added to the Priority
Testing List (PTL). Several comments questioned whether requiring 8(d)
reporting for a chemical substance for which EPA has issued a Section 4
Test Order would be redundant and/or produce data in time for use in a
risk evaluation under TSCA section 6 on the applicable chemical
substance. EPA also received a comment on chemicals substances to
remove from the PTL. Additionally, one commenter recommended additional
activities for EPA to conduct related to fulfilling data needs (e.g.,
via the use of Test Orders pursuant to section 4 of TSCA).
    EPA has reviewed the comments and continues to believe that it is
appropriate to list these chemical substances in this document onto the
ITC's TSCA section 4(e) Priority Testing List to prompt EPA to
implement their authority pursuant to TSCA section 8(d), to require
manufacturers (including importers) to submit lists and copies of
certain unpublished health and safety studies to EPA. The 74th ITC
Report provided the basis for its inclusion of all chemical substances
that were added to the PTL. Regarding possible redundancies of
published and previously submitted information under other TSCA
programs, under 40 CFR 716.20(a) certain studies are exempt from the
copy and list submission requirements of 40 CFR 716.30 and 716.35.
Within EPA's current timeline for risk evaluations under TSCA section
6, data received via this 8(d) action would be received in time for use
in risk evaluations for chemical substances that have been designated
as high-priority substances, and data received on the other chemical
substances listed in this document would help inform future
prioritization activities, as well as help inform other agency
decisions involving such chemical substances. In regard to chemical
substances being recommended for deletion from the PTL and for requests
for certain activities to be undertaken in regard to certain chemical
substances, EPA will consider such recommendations during future ITC
discussions and during decision-making related to its various TSCA
statutory authorities.

D. Why is this action issued as a Final Rule?

    The regulations at 40 CFR 716.105(b) and (c) establish the process
for this action to amend the TSCA section 8(d) Health and Safety Data
Reporting rule.

III. Final Rule

A. What chemical substances are added?

    In this document, EPA is adding chemical substances to the TSCA
section 8(d) Health and Safety Data Reporting rule. This addition
implements 40 CFR 716.105(b), which generally provides that ``chemical
substances, mixtures, and categories of

chemical substances that have been added to the TSCA section 4(e)
Priority List by the Interagency Testing Committee, established under
section 4 of TSCA, will be added to Sec.  716.120 . . .'' This addition
also addresses the request of the TSCA ITC in its 74th Report (Ref. 2)
to add certain chemical substances listed in that report to the TSCA
section 8(d) Health and Safety Data Reporting rule. The specific
chemical substances being added to the rule are listed in the
regulatory text at the end of this document.

B. What are the reporting requirements?

    Listed in this unit are the reporting requirements for the chemical
substances added by this final rule to the TSCA section 8(d) model
Health and Safety Data Reporting rule. The specific types of health and
safety studies that must be reported for each of the chemical
substances added to the Health and Safety Data Reporting rule as a
result of this document can be found in Unit III.C.
    1. Persons who, in the 10 years preceding the date a chemical
substance is listed, either have proposed to manufacture (including
import) or have manufactured (including imported) the listed chemical
substance must submit to EPA, during the 60-day reporting period
specified in 40 CFR 716.65 and according to the reporting schedule set
forth at 40 CFR 716.60, a copy of each specified type of health and
safety study which is in their possession at the time the chemical
substance is listed in part 716.
    2. Persons who, at the time the chemical substance is listed in
part 716, propose to manufacture (including import) or are
manufacturing (including importing) the listed chemical substance must
submit to EPA during the 60-day reporting period specified in 40 CFR
716.65 and according to the reporting schedule set forth at 40 CFR
716.60:
    i. A list of the specified types of health and safety studies known
to them but not in their possession at the time the chemical substance
is listed.
    ii. A list of the specified types of health and safety studies that
are ongoing at the time the chemical substance is listed and are being
conducted by or for them.
    iii. A list of the specified types of health and safety studies
that are initiated after the date the chemical substance is listed and
will be conducted by or for them.
    iv. A copy of each specified type of health and safety study which
is in their possession at the time the chemical substance is listed.
    v. A copy of each specified type of health and safety study that
was previously listed as ongoing or subsequently initiated (i.e.,
listed in accordance with reporting requirements in Unit III.B.2.iii.
and iv., respectively) and is now complete--regardless of completion
date.
    3. Persons who, after the time the chemical substance is listed in
part 716, propose to manufacture (including import) the listed chemical
substance must submit to EPA during the reporting period specified in
40 CFR 716.65 and according to the reporting schedule set forth at 40
CFR 716.60:
    i. A list of the specified types of health and safety studies known
to them but not in their possession at the time they propose to
manufacture (including import) the listed chemical substance.
    ii. A list of the specified types of health and safety studies that
are ongoing at the time they propose to manufacture (including import)
the listed chemical substance and are being conducted by or for them.
    iii. A list of the specified types of health and safety studies
that are initiated after the time they propose to manufacture
(including import) the listed chemical substance and will be conducted
by or for them.
    iv. A copy of each specified type of health and safety study which
is in their possession at the time they propose to manufacture
(including import) the listed chemical substance.
    v. A copy of each specified type of health and safety study that
was previously listed as ongoing or subsequently initiated (i.e.,
listed in accordance with reporting requirements in Unit III.B.3.iii.
and 3.iv., respectively) and is now complete--regardless of the
completion date.
    The reporting described in Unit III.B. is required by September 27,
2021. Any person who manufactures (including imports) or who proposes
to manufacture (including import) the listed chemical substance from
July 29, 2021 to September 27, 2021 must inform EPA (by submitting a
list) of any studies initiated during the period from July 29, 2021 to
September 27, 2021 within 30 days of their initiation, but in no case
later than October 27, 2021. In addition, if any such person has
submitted lists of studies that were ongoing or initiated during the
period from July 29, 2021 to September 27, 2021 to EPA, such person
must submit a copy of each study within 30 days after its completion,
regardless of the study's completion date. See 40 CFR 716.60 and
716.65.
    Detailed guidance for reporting unpublished health and safety data
and explanations of reporting exemptions is provided at 40 CFR part
716.
    Persons reporting under this rule may also assert CBI claims for
certain information included in their submission. TSCA section imposes
the following requirements:
     CBI claims must be asserted must be asserted at the time
the information claimed as CBI is submitted to EPA. Information
submitted with a confidentiality claim may be made public without
further notice.
     Information claimed as CBI must be substantiated at the
time of submission, with the exception of those types of information
exempt from substantiation under TSCA section 14(c)(2).
     All persons making a CBI claim must provide a standard
statement concerning the need for the CBI claim and a certification
that the statement of need is true and correct.
     Where a specific chemical identity is claimed as CBI, a
structurally descriptive generic name must be provided for disclosure
to the public.
    The 8(d) reporting application accommodates these requirements,
incorporating the required statements and certifications, and will
prompt the submitter to provide substantiation prior to making a
submission that includes CBI claims.

C. What types of studies must be submitted?

    Pursuant to 40 CFR 716.20(b)(5) and 716.50, the types of
unpublished health and safety studies that must be reported and the
chemical grade/purity requirements that must be met or exceeded in
individual studies for the chemical substances added to the Health and
Safety Data Reporting rule as a result of this document are as follows:
    Under this rule, manufacturers (including importers) of High-
Priority Substances are required to submit the following:
     Lists and copies of unpublished health and safety studies
for all High-Priority Substances specified in this rule on health
effects, such as toxicity studies (in vivo and in vitro) on
carcinogenicity, reproductive and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity, endocrine effects, and other systemic
toxicity and toxicokinetics (absorption, distribution, metabolism, or
elimination), including modelling studies, in humans or animals.
     All unpublished studies on environmental effects,
environmental fate, and physical-chemical properties if performed as
described in 40 CFR 716.50 are also required under this rule.

     All unpublished studies on occupational (both users and
non-users), general population, consumer, and environmental exposure,
such as: Unpublished studies on inhalation and dermal exposure, human
biomonitoring, environmental monitoring of indoor and outdoor air,
soil, water, and household dust, chamber emission rates from products
or polymeric matrices, and unpublished modelling studies that estimate
environmental concentrations or human exposures.
     Studies showing any measurable content of the High-
Priority Substance in the tested substance (single substances or
mixture) must be reported. The composition and purity of test
substances must be reported if included as part of the study.
     Studies previously submitted to EPA pursuant to a
requirement under TSCA or of the submitter's own accord and studies
conducted or to be conducted pursuant to a TSCA section 4 action are
exempt from the submission of lists of health and safety studies
required under 40 CFR 716.35 and the submission of studies required
under this rule.
    Under this rule, manufacturers (including importers) of
organohalogen flame retardants are required to submit the following:
     Lists and copies of unpublished health and safety studies
for all organohalogen flame retardants specified in this rule on health
effects, such as toxicity studies (in vivo and in vitro) on
carcinogenicity, reproductive and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity, endocrine effects, and other systemic
toxicity and toxicokinetics (absorption, distribution, metabolism, or
elimination), including modelling studies, in humans or animals.
     All unpublished studies on environmental effects,
environmental fate, and physical-chemical properties if performed as
described in 40 CFR 716.50 are also required under this rule.
     All unpublished studies on occupational (both users and
non-users), general population, consumer, and environmental exposure,
such as unpublished studies on inhalation and dermal exposure, human
biomonitoring, environmental monitoring of indoor and outdoor air,
soil, water, and household dust, chamber emission rates from products
or polymeric matrices, and unpublished modelling studies that estimate
environmental concentrations or human exposures, must be submitted.
     Studies showing any measurable content of the
organohalogen flame retardant in the tested substance (single
substances or mixture) must be reported. The composition and purity of
test substances must be reported if included as part of the study.
     Studies previously submitted to EPA pursuant to a
requirement under TSCA or of the submitter's own accord and studies
conducted or to be conducted pursuant to a TSCA section 4 action are
exempt from the submission of lists of health and safety studies
requirements under 40 CFR 716.35 and the submission of studies
requirements under this rule.

D. Rationales and Background for Chemical Additions and Reporting
Requirements

1. High-Priority Substances
    The 20 High-Priority Substances identified in this rule have been
designated High-Priority under TSCA section 6(b) because EPA has found
that each of these chemical substances may present an unreasonable risk
of injury to health or the environment (Ref. 3). EPA is seeking
unpublished health and safety studies to ensure that such studies are
available to EPA to inform its risk evaluation findings of whether any
of these High-Priority Substances present an unreasonable risk of
injury to health or the environment. Further, this information will be
considered, as appropriate, when reviewing potential analogue data for
read across and/or category development in assessing new chemicals.
2. Organohalogen Flame Retardants
    EPA requests this information to help support prioritization and
evaluation activities under TSCA (see TSCA section 6(b), and as
discussed above). Further, this information will be considered, as
appropriate, when reviewing potential analogue data for read across
and/or category development in assessing new chemicals. Additionally,
CPSC, a representative member of the ITC, needs information on a group
of organohalogen flame retardants because the Commission voted to grant
a petition to begin rulemaking for this class of chemicals under the
Federal Hazardous Substances Act (FHSA), (Ref. 5). Organohalogen flame
retardants may be added to consumer products to prevent or slow
combustion, but are additive, i.e., not covalently bound to the
substrate, which can be textiles, polymers, or foam. Most organohalogen
flame retardants are semi-volatile compounds (SVOCs), that can migrate
into air, where they bind to airborne particles and surfaces in the
home. In addition to direct contact with organohalogen flame retardant-
containing products, a substantial portion of exposure is believed to
occur from exposure to household dust, especially in children.
Biomonitoring studies and measurements of household dust and indoor air
demonstrate that exposure to organohalogen flame retardants is nearly
ubiquitous.
    Many organohalogen flame retardants have been shown to cause health
effects. Health effects associated with organohalogen flame retardants
include carcinogenicity (e.g., halogenated alkyl phosphates),
developmental effects (e.g., polybrominated diphenyl ethers (PBDEs)),
and developmental neurotoxicity (e.g., Decabromodiphenyl ether
(decaBDE)).
    In 2015, CPSC was petitioned by a number of organizations and
individuals, such as consumer groups, medical associations, workers,
and firefighter organizations, to ban the use of all additive, non-
polymeric organohalogen flame retardants under the authority of the
FHSA in the following consumer products: (1) Durable infant or toddler
products, children's toys, child care articles, or other children's
products (other than car seats, which are under Department of
Transportation's jurisdiction); (2) Residential upholstered furniture;
(3) Mattresses and mattress pads; and (4) The plastic casings of
electronic devices (Ref. 5).
    CPSC granted the petition in 2017 and directed staff to complete a
scoping and feasibility study in cooperation with the National Academy
of Sciences, Engineering, and Medicine (NASEM). The task for this
project was to develop a scientifically based scoping plan to identify
the potential health hazards associated with additive, nonpolymeric
organohalogen flame retardants as a class. The NASEM Committee
published the report, ``A Class Approach to Hazard Assessment of
Organohalogen Flame Retardants'' in May 2019 (Ref. 6). A key conclusion
of the NASEM Committee is that organohalogen flame retardants cannot be
treated as a single class. Rather, the NASEM Committee identified 14
subclasses of organohalogen flame retardants, based on chemical
structure, physicochemical properties of the chemicals, and predicted
biologic activity. The NASEM Committee identified 161 organohalogen
flame retardants and more than 1,000 analog chemicals. CPSC staff is
undertaking the risk assessment of 14 classes of organohalogen flame
retardants following the recommendations of the NASEM Committee.
    Because preliminary searches show that little or no health and
safety

information is available for many of the 161 organohalogen flame
retardants, including the organohalogen flame retardants being added
here to the TSCA section 8(d) Health and Safety Data Reporting rule,
the submission of the lists and copies of the unpublished health and
safety studies specified in this rule is being required under the TSCA
section 8(d) Health and Safety Data Reporting rule for these OFR
additions. As indicated above, this information will also inform TSCA
activities such as future prioritization efforts and, with potential
read-across data, new chemical reviews. Further, EPA will coordinate
with ITC members to share information received, as appropriate (e.g.,
to help inform CPSC's evaluation of specific chemicals).

E. What are the incremental economic implications of this action?

    EPA prepared an economic analysis for the addition of the 50
chemical substances to the TSCA section 8(d) Health and Safety Data
Reporting rule, entitled, ``TSCA Section 8(d): Economic Impact Analysis
for Adding 50 Chemicals from the 74th ITC Report of the TSCA
Interagency Testing Committee to the Health and Safety Data Reporting
Rule.'' (Economic Analysis, Ref. 7) a copy of which is included in the
docket for this rulemaking. The total one-time cost associated with
this final rule is estimated to be approximately $185,000 based on
approximately 1,900 and 420 hours of industry and EPA burden,
respectively.

IV. Requesting a Chemical Substance Be Withdrawn From This Final Rule

    As specified in 40 CFR 716.105(c), EPA may, in its discretion,
remove a chemical substance, mixture, or category of chemical
substances from this final rule for good cause prior to the effective
date of this final rule. Any person who believes that the reporting
required by this final rule is not warranted for a chemical substance
listed in this final rule must submit to EPA detailed reasons for that
belief. You must submit your request to EPA on or before July 13, 2021
and in accordance with the instructions provided in 40 CFR 716.105(c)
and (d). In addition, to ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPPT-2020-0474. If the EPA
Administrator withdraws a chemical substance, mixture, or category of
chemical substances from the amendment, in accordance with 40 CFR
716.105(c), a Federal Register document announcing this decision will
be published no later than July 29, 2021.

V. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA. For more information about these
references, please consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.

1. EPA. 40 CFR 716.120. Substances and listed mixtures to which this
subpart applies. Available online at: https://www.ecfr.gov/cgibin/textidx?SID=94b50835053a07b80c3517fff641aeba&mc=true&node=pt40.33.716&rgn=div5#se40.33.716_1120.
2. ITC. Notice; Seventy-Fourth Report of the TSCA Interagency
Testing Committee to the Administrator of the Environmental
Protection Agency; Receipt of Report and Request for Comments.
Federal Register (86 FR 22414, April 28, 2021) (FRL-10020-39).
Available online at: https://www.govinfo.gov/content/pkg/FR-2021-04-28/pdf/2021-08839.pdf.
3. EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register
(84 FR 71924, December 30, 2019) (FRL-10003-15). Available online
at: https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/2019-28225.pdf.
4. EPA. Procedures for Prioritization of Chemicals for Risk
Evaluation Under the Toxic Substances Control Act; Final Rule.
Federal Register (82 FR 33753, December 20, 2017) (FRL-9964-24).
Available online at: https://www.federalregister.gov/documents/2017/07/20/2017-14325/procedures-for-prioritization-of-chemicals-for-risk-evaluation-under-the-toxic-substances-control.
5. CPSC. U.S. Consumer Product Safety Commission Petition: Products
Containing Organohalogen Flame Retardants. Docket ID number: CPSC-
2015-0022. Available online at: https://www.regulations.gov/docket?D=CPSC-2015-0022.
6. CPSC. National Academies of Sciences, Engineering, and Medicine
2019. A Class Approach to Hazard Assessment of Organohalogen Flame
Retardants. Washington, DC: The National Academies Press. https://doi.org/10.17226/25412. Available online at: http://nap.edu/25412.
7. EPA. TSCA Section 8(d): Economic Impact Analysis for Adding 50
Chemicals From the 74th ITC Report of the TSCA Interagency Testing
Committee to the Health and Safety Data Reporting Rule. September
10, 2020.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) has exempted actions
under TSCA section 8(d) related to the Health and Safety Data Reporting
rule from the requirements of Executive Order 12866 (58 FR 51735,
October 4, 1993). As such, this final rule was not reviewed by OMB
under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct
or sponsor, and a person is not required to respond to a collection of
information that requires OMB approval under PRA, unless it has been
approved by OMB and displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations in title 40 of the CFR, after
appearing in the Federal Register, are listed in 40 CFR part 9, and
included on the related collection instrument or form, if applicable.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0004. This action does not impose any burden requiring additional
OMB approval. You can find a copy of the ICR in the docket for this
rule, and it is briefly summarized here.
    This action requires the reporting of health and safety data to EPA
by manufacturers (including importers) of certain chemical substances
requested by the ITC to be added to the Health and Safety Data
Reporting Rule in its Seventy-Fourth Report of the ITC (Ref. 2). EPA
intends to use information collected under the rule to assist in
chemical assessments under TSCA, and to inform any additional work
necessary under environmental protection mandates beyond TSCA.
Submitters may designate information as confidential, trade secret, or
proprietary. EPA has implemented procedures to protect any
confidential, trade secret or proprietary information from disclosure.
These procedures comply with TSCA section 14 and EPA's confidentiality
regulation, 40 CFR part 2, subpart B.
    Respondents/affected entities: Manufacturers (including importers)
of 50 chemical substances requested by the ITC to be included in the
Health and Safety Data Reporting Rule.
    Respondents' obligation to respond: Mandatory (15 U.S.C. 2607(d)).
    Estimated number of respondents: 23.
    Frequency of response: Once.

    Total estimated burden: 1,854 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $146,745 (per year), with no annualized
capital or operation and maintenance costs.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby
certify that this action will not have a significant economic impact on
a substantial number of small entities as defined by the RFA. The small
entities subject to the requirements of this action are manufacturers
(including importers) of 50 chemicals requested by the ITC to be added
to the Health and Safety Data Reporting Rule. EPA estimates that 106 of
the 129 firms in the affected universe are small entities. Of those
small firms, all would have cost impacts of less than 1% of annual
revenue. Details of this analysis are presented in the Economic
Analysis of this rule (Ref. 7), which can be found in the docket.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The requirements of
this action would primarily affect manufacturers (including importers)
of 50 chemical substances listed in 40 CFR 716.120(d) of the regulatory
text of this document. The total quantified one-time costs of this
final rule are approximately $183,812.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

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

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, E.O. 13175 does not apply to this
action.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that the Agency has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not a covered regulatory action because it is not
``economically significant'' under Executive Order 12866 and it does
not concern an environmental health risk or safety risk. Although this
action would not establish an environmental standard intended to
mitigate health or safety risks, the information that would be
submitted to EPA in accordance with this rule would be used to inform
the Agency's decision-making process regarding chemical substances to
which children may be disproportionately exposed. This information may
also assist the Agency and others in determining whether the chemical
substances covered in this proposed rule present potential risks, which
would allow the Agency and others to take appropriate action to
investigate and mitigate those risks.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy and has not otherwise been designated by
the Administrator of OMB's Office of Information and Regulatory Affairs
as a ``significant energy action.''

I. National Technology Transfer and Advancement Act (NTTAA)

    Because this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

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

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994). However, the Agency believes that the
information collected through this rule will inform the TSCA risk
evaluations that are planned for these chemicals and will thereby
enable the Agency to better protect human health and the environment,
including in low-income and minority communities.

L. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 716

    Environmental protection, Chemicals, Hazardous substances, Health
and safety, Reporting and recordkeeping requirements.

    Dated: June 17, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 716--HEALTH AND SAFETY DATA REPORTING

0
1. The authority citation for part 716 continues to read as follows:

    Authority:  15 U.S.C. 2607(d).

0
2. In Sec.  716.21, add paragraphs (a)(9) and (10) to read as follows:

Sec.  716.21  Chemical specific reporting requirements.

    (a) * * *
    (9) For 1,3-Butadiene (106-99-0), Butyl benzyl phthalate (BBP)--
1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (85-68-
7), Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2-
dibutyl ester) (84-74-2), o-Dichlorobenzene (95-50-1), p-
Dichlorobenzene (106-46-7), trans-1,2-Dichloroethylene (156-60-5), 1,2-
Dichloropropane (78-87-5), Dicyclohexyl phthalate (84-61-7), Di-
ethylhexyl phthalate (DEHP)--(1,2-Benzene- dicarboxylic acid, 1,2-
bis(2-ethylhexyl) ester) (117-81-7), Di-isobutyl phthalate (DIBP)--
(1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (84-
69-5), Formaldehyde (50-00-0), 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta [g]-2-benzopyran (HHCB) (1222-05-5), Phthalic
anhydride (85-44-9), 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol]
(TBBPA) (79-94-7), and 1,1,2-Trichloroethane (79-00-5), all unpublished
studies on health effects (including toxicity studies (in vivo and in
vitro) on carcinogenicity,

reproductive and developmental effects, genotoxicity, neurotoxicity,
immunotoxicity, endocrine effects, and other systemic toxicity);
toxicokinetics (absorption, distribution, metabolism, or elimination),
including modelling studies, in humans or animals; environmental
effects; environmental fate; physical-chemical properties if performed
as described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental
exposure must be submitted. Studies showing any measurable content of
the High-Priority Substance in the tested substance (single substances
or mixture) must be reported. The composition and purity of test
substances must be reported if included as part of the study. Studies
previously submitted to EPA pursuant to a requirement under TSCA or of
the submitter's own accord and studies conducted or to be conducted
pursuant to a TSCA section 4 action are exempt from the submission of
lists of health and safety studies required under 40 CFR 716.35 and the
submission of studies required under this rule.
    (10) For purposes of this paragraph, the term organohalogen flame
retardant includes any substances listed in paragraph(d) of this
section under the category ``Organohalogen flame retardants''. For any
organohalogen flame retardant, all unpublished studies on health
effects (including toxicity studies (in vivo and in vitro) on
carcinogenicity, reproductive and developmental effects, genotoxicity,
neurotoxicity, immunotoxicity, endocrine effects, and other systemic
toxicity); toxicokinetics (absorption, distribution, metabolism, or
elimination), including modelling studies, in humans or animals;
environmental fate; physical-chemical properties if performed as
described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental
exposure must be submitted. Studies showing any measurable content of
the organohalogen flame retardant in the tested substance (single
substances or mixture) must be reported. The composition and purity of
test substances must be reported if included as part of the study.
Studies previously submitted to EPA pursuant to a requirement under
TSCA or of the submitter's own accord and studies conducted or to be
conducted pursuant to a TSCA section 4 action are exempt from the
submission of lists of health and safety studies requirements under 40
CFR 716.35 and the submission of studies requirements under this rule.
* * * * *

0
3. In Sec.  716.120, amend the table in paragraph (d) by:
0
a. Adding in alphabetical order the category ``High-Priority
Substances'' and entries ``1,3-Butadiene'', ``Butyl benzyl phthalate
(BBP)--1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester'',
``Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl
ester)'', ``o-Dichlorobenzene'', ``p-Dichlorobenzene'', ``1,1-
Dichloroethane'', ``1,2-Dichloroethane'', ``Trans-1,2-
Dichloroethylene'', ``1,2-Dichloropropane'', ``Dicyclohexyl
phthalate'', ``Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-
dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)'', ``Di-isobutyl
phthalate (DIBP)--(1,2-Benzene- dicarboxylic acid, 1,2- bis-
(2methylpropyl) ester)'', ``Ethylene dibromide'', ``Formaldehyde'',
``1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-
benzopyran (HHCB)'', ``4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol]
(TBBPA)'', ``Phosphoric acid, triphenyl ester (TPP)'', ``Phthalic
anhydride'', ``1,1,2-Trichloroethane'', and ``Tris(2-chloroethyl)
phosphate (TCEP)''; and
0
b. Adding in alphabetical order the category ``Organohalogen flame
retardants'' and entries ``Bis(2-ethylhexyl) tetrabromophthalate'',
``Bis(hexachlorocyclopentadieno)cyclooctane'', ``1,2-Bis(2,4,6-
tribromophenoxy)ethane'', ``1,1'-Ethane-1,2-
diylbis(pentabromobenzene)'', ``2-Ethylhexyl-2,3,4,5-
tetrabromobenzoate'', ``2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl
3,4,5,6-tetrabromophthalate'', ``2,2'-[(1-Methylethylidene)bis[(2,6-
dibromo-4,1-phenylene)oxymethylene]]bis[oxirane]'', ``Mixture of
chlorinated linear alkanes C14-17 with 45-52% chlorine'', ``N,N-
Ethylene-bis(tetrabromophthalimide)'', ``Pentabromochlorocyclohexane'',
``(Pentabromophenyl)methyl acrylate'', ``Pentabromotoluene'',
``Perbromo-1,4-diphenoxybenzene'', ``Phosphonic acid, (2-chloroethyl)-,
bis(2-chloroethyl) ester'', ``Phosphoric acid, 2,2-bis(chloromethyl)-
1,3-propanediyl tetrakis(2-chloroethyl) ester'', ``Propanoic acid, 2-
bromo-, methyl ester'', ``Tetrabromobisphenol A-bis(2,3-dibromopropyl
ether)'', ``Tetrabromobisphenol A bis(2-hydroxyethyl) ether'',
``Tetrabromobisphenol A diallyl ether'', ``Tetrabromobisphenol A
dimethyl ether'', ``2,4,6-Tribromoaniline'', ``1,3,5-Tribromo-2-(prop-
2-en-1-yloxy)benzene'', ``Tris(2-chloroethyl) phosphite'', ``Tris(1-
chloro-2-propyl)phosphate'', ``Tris(2-chloro-1-propyl)phosphate'',
``Tris(2,3-dibromopropyl) phosphate'', ``1,3,5-Tris(2,3-dibromopropyl)-
1,3,5-triazine-2,4,6(1H,3H,5H)-trione'', ``Tris(1,3-dichloro-2-
propyl)phosphate'', ``Tris(tribromoneopentyl)phosphate'', and ``2,4,6-
Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine''.
    The additions read as follows:

Sec.  716.120  Substances and listed mixtures to which this subpart
applies.

* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                Effective
                    Category                          CAS No.      Special exemptions       date     Sunset date
----------------------------------------------------------------------------------------------------------------
High-Priority Substances:
    1,3-Butadiene...............................        106-99-0   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Butyl benzyl phthalate (BBP)--1,2-Benzene-           85-68-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1- butyl 2(phenylmethyl)
     ester......................................
    Dibutyl phthalate (DBP) (1,2-Benzene-                84-74-2   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1,2-dibutyl ester)......
    o-Dichlorobenzene...........................         95-50-1   Sec.   716.21(a)(9)      7/29/21      9/27/21
    p-Dichlorobenzene...........................        106-46-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,1-Dichloroethane..........................         75-34-3   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,2-Dichloroethane..........................        107-06-2   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Trans-1,2-Dichloroethylene..................        156-60-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,2-Dichloropropane.........................         78-87-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Dicyclohexyl phthalate......................         84-61-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-       117-81-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1,2- bis(2-ethylhexyl)
     ester).....................................

    Di-isobutyl phthalate (DIBP)--(1,2-Benzene-          84-69-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dicarboxylic acid, 1,2- bis-(2methylpropyl)
     ester).....................................
    Ethylene dibromide..........................        106-93-4   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Formaldehyde................................         50-00-0   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-                 1222-05-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
     hexamethylcyclopenta [g]-2-benzopyran
     (HHCB).....................................
    4,4'-(1-Methylethylidene)bis[2, 6-                   79-94-7   Sec.   716.21(a)(9)      7/29/21      9/27/21
     dibromophenol] (TBBPA).....................
    Phosphoric acid, triphenyl ester (TPP)......        115-86-6   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Phthalic anhydride..........................         85-44-9   Sec.   716.21(a)(9)      7/29/21      9/27/21
    1,1,2-Trichloroethane.......................         79-00-5   Sec.   716.21(a)(9)      7/29/21      9/27/21
    Tris(2-chloroethyl) phosphate (TCEP)........        115-96-8   Sec.   716.21(a)(9)      7/29/21      9/27/21

                                                  * * * * * * *
Organohalogen flame retardants:
    Bis(2-ethylhexyl) tetrabromophthalate.......      26040-51-7  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Bis(hexachlorocyclopentadieno)cyclooctane...      13560-89-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,2-Bis(2,4,6-tribromophenoxy)ethane........      37853-59-1  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,1'-Ethane-1,2-diylbis(pentabromobenzene)..      84852-53-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2-Ethylhexyl-2,3,4,5-tetrabromobenzoate.....     183658-27-7  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl          20566-35-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     3,4,5,6-tetrabromophthalate................
    2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-        3072-84-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     4,1-phenylene)oxymethylene]]bis[oxirane]...
    Mixture of chlorinated linear alkanes C14-17      85535-85-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
     with 45-52% chlorine.......................
    N,N-Ethylene-bis(tetrabromophthalimide).....      32588-76-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Pentabromochlorocyclohexane.................         87-84-3  Sec.   716.21(a)(10)      7/29/21      9/27/21
    (Pentabromophenyl)methyl acrylate...........      59447-55-1  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Pentabromotoluene...........................         87-83-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Perbromo-1,4-diphenoxybenzene...............      58965-66-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Phosphonic acid, (2-chloroethyl)-, bis(2-          6294-34-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
     chloroethyl) ester.........................
    Phosphoric acid, 2,2-bis(chloromethyl)-1,3-       38051-10-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
     propanediyl tetrakis(2-chloroethyl) ester..
    Propanoic acid, 2-bromo-, methyl ester......       5445-17-0  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tetrabromobisphenol A-bis(2,3-dibromopropyl       21850-44-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     ether).....................................
    Tetrabromobisphenol A bis(2-hydroxyethyl)          4162-45-2  Sec.   716.21(a)(10)      7/29/21      9/27/21
     ether......................................
    Tetrabromobisphenol A diallyl ether.........      25327-89-3  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tetrabromobisphenol A dimethyl ether........      37853-61-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2,4,6-Tribromoaniline.......................        147-82-0  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene.       3278-89-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(2-chloroethyl)phosphite................        140-08-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(1-chloro-2-propyl)phosphate............      13674-84-5  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(2-chloro-1-propyl)phosphate............       6145-73-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(2,3-dibromopropyl)phosphate............        126-72-7  Sec.   716.21(a)(10)      7/29/21      9/27/21
    1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-     52434-90-9  Sec.   716.21(a)(10)      7/29/21      9/27/21
     2,4,6(1H,3H,5H)-trione.....................
    Tris(1,3-dichloro-2-propyl)phosphate........      13674-87-8  Sec.   716.21(a)(10)      7/29/21      9/27/21
    Tris(tribromoneopentyl)phosphate............      19186-97-1  Sec.   716.21(a)(10)      7/29/21      9/27/21
    2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-         25713-60-4  Sec.   716.21(a)(10)      7/29/21      9/27/21
     triazine...................................
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-13212 Filed 6-28-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31048-31050]
[FR Doc No: 2015-13063]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1798]

Patient-Focused Drug Development for Alpha-1 Antitrypsin
Deficiency; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for Alpha-1 Antitrypsin Deficiency (AATD).
Patient-Focused Drug Development is an FDA performance commitment under
the fifth authorization of the Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to provide FDA with patients'
perspectives on the impact on daily life of AATD. FDA also is seeking
patients' perspectives on the available therapies for this disorder.

DATES: The public meeting will be held on September 29, 2015, from 9
a.m. to 3:30 p.m. Registration to attend the meeting must be received
by September 15, 2015. Registration from those individuals interested
in presenting comments as part of the panel discussions should be
received by July 31, 2015. See the SUPPLEMENTARY INFORMATION section
for instructions on how to register for the meeting. Submit either
electronic or written comments by November 30, 2015.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993. Entrance for public meeting
participants (non-FDA employees) is through Building 1, where routine
security checks will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Barbara Kass, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, rm. 1125, Silver Spring, MD 20993, 240-402-
6887, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected AATD as the focus of a public meeting under the
Patient-Focused Drug Development initiative. This initiative involves
obtaining a better understanding of patients' perspectives on the
challenges posed by AATD and the impact of current therapies for this
condition. The Patient-Focused Drug Development initiative is being
conducted to fulfill FDA performance commitments that are part of the
PDUFA reauthorization under Title I of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144). The full set of
performance commitments is available on the FDA Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA has committed to obtaining the patient perspective on 20
disease areas during the course of PDUFA V. For each disease area, the
Agency will conduct a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefits that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 21613) that announced the disease areas for meetings in fiscal
years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V
timeframe. The Agency used several criteria outlined in the April 11,
2013, notice to develop the list of disease areas. FDA obtained public
comment on the Agency's proposed criteria and potential disease areas
through a public docket and a public meeting that was convened on
October 25, 2012. In selecting the set of disease areas, FDA carefully
considered the public comments received and the perspectives of review
divisions at FDA. FDA has initiated a second public process for
determining the disease areas for meetings in FY 2016-2017 and
published a notice in the Federal Register on October 8, 2014 (79 FR
60857). More information, including the list of disease areas and a
general schedule of meetings, is posted on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Purpose and Scope of the Meeting

    The purpose of this Patient-Focused Drug Development meeting is to
obtain input on the symptoms and other impacts that matter most to
patients with AATD. FDA also intends to seek patients' perspectives on
current approaches to treating this disorder. FDA expects that this
information will come directly from patients, caregivers, and patient
advocates.
    Individuals with AATD have low serum levels of Alpha-1-Antitrypsin
(AAT, also known as Alpha-1 proteinase inhibitor (A1-PI)) and increased
risks of developing a form of chronic obstructive lung disease called
emphysema and, less frequently, liver disease. Some AATD patients with
emphysema have symptoms of asthma. There are different genetic forms of
the disease, but even among people with the same genetic form and
similar levels of AAT in their blood, there is tremendous diversity in

clinical severity. A substantial percentage of individuals with severe
AATD never develop symptomatic lung disease during their lifetimes.
Others may develop the first signs and symptoms of lung disease between
the ages of approximately 25 and 50 years, or older. Affected
individuals often develop emphysema, which is a lung disease caused by
damage to the small air sacs in the lung. Progression of emphysema in
AATD may lead to respiratory failure, a need for lung transplantation,
and eventually death. The only specific medication approved for raising
the blood levels of AAT in severe AATD patients with emphysema is
weekly intravenous treatment with A1-PI (Human) purified from human
blood plasma.
    Severe AATD patients may also develop liver disease as infants,
during childhood, or as adults. There is wide variation in the severity
of liver disease among affected patients. Currently, no specific
therapy for AATD-related liver disease is available other than liver
transplantation, so the focus in these patients is on the prevention
and management of other types of liver damage.
    The questions that will be asked of patients and patient caregivers
at the meeting are provided in this document. The meeting will be
divided into two main topics: (1) The effects of Alpha-1 Antitrypsin
Deficiency that matter most to you, and (2) perspectives on current
approaches to treatment. For each topic, a brief patient panel
discussion will begin the dialogue. This will be followed by a
facilitated discussion inviting comments from other patient and patient
caregiver participants. In addition to input generated through this
public meeting, FDA is interested in receiving patient input addressing
these questions through electronic or written comments, which can be
submitted to the Division of Dockets Management (see ADDRESSES). For
context, please indicate if you are commenting as a patient with AATD
or on behalf of a child or loved one.
    Topic 1: The effects of Alpha-1 Antitrypsin Deficiency that matter
most to you.
     Of all of the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include:
    (a) For lung disease: shortness of breath during specific
activities or at rest, chronic cough, wheezing, weight loss,
exacerbations of particular symptoms;
    (b) For liver disease: abdominal pain, loss of appetite, height and
weight concerns.)
     Are there specific activities that are important to you,
but that you cannot do at all, or as well as you would like, because of
your condition? Please describe, using specific examples. (Examples may
include: Participating in physical activities, attending work/school
and family/social activities.)
     How have your condition and its symptoms changed over
time?
     What worries you most about your condition?
    Topic 2: Perspectives on current approaches to treatment.
     What are you currently doing to treat your condition or
its symptoms? (Examples may include:
    (a) For lung disease: Inhaled bronchodilators, inhaled
corticosteroids, intravenous augmentation therapy with A1-PI (Human) on
a regular or intermittent basis;
    (b) For liver disease: Ursodiol.)
    [cir] How well do these treatments work for you?
    [cir] What are the most significant disadvantages or complications
of your current treatments, and how do they affect your daily life?
    [cir] How has your treatment changed over time and why?
    [cir] What aspects of your condition are not improved by your
current treatment regimen?
    [cir] What treatment has had the most positive impact on your life?
     If you could create your ideal treatment, what would it do
for you (i.e., what specific things would you look for in an ideal
treatment)?
     If you had the opportunity to consider participating in a
clinical trial studying experimental treatments, what things would you
consider when deciding whether or not to participate?

III. Attendance and Registration

    If you wish to attend this meeting, visit https://www.eventbrite.com/e/public-meeting-on-patient-focused-drug-development-for-alpha-1-antitrypsin-deficiency-tickets-15617092143. If
you do not have access to the Internet, you may mail or fax your
registration information (including name, title, affiliation, address,
email address, telephone, and fax numbers) to Barbara Kass (see FOR
FURTHER INFORMATION CONTACT) by September 15, 2015. There is no
registration fee for the public meeting. Early registration is
recommended because seating is limited. FDA may limit the number of
participants from each organization based on space limitations.
Registrants will receive confirmation once they have been accepted.
Registration on the day of the public meeting will be provided on a
space available basis beginning at 8 a.m. Those who are unable to
attend the meeting in person can register to view a live Web cast of
the meeting. You will be asked to indicate in your registration if you
plan to attend in person or via the Web cast.
    If you need special accommodations because of disability, please
contact Barbara Kass at least 7 days in advance. FDA will post the
agenda approximately 5 days before the meeting at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/MeetingsMeetingsConferences/ucm435242.htm.

IV. Comments

    Patients and patient caregivers who are interested in presenting
comments as part of the panel discussions should register by July 31,
2015. You will be asked to indicate in your registration which topic(s)
you wish to address and to send a brief summary of responses to the
topic questions to<EMAIL_ADDRESS>by July 31, 2015.
Panelists will be notified of their selection soon after August 28,
2015. FDA will try to accommodate all patients and patient caregivers
who wish to speak, either through the panel discussion or audience
participation; however, the duration of comments may be limited by time
constraints.
    Regardless of attendance at the public meeting, interested persons
may submit either electronic or written responses to any or all of the
questions pertaining to topics 1 and 2 to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. To ensure consideration, submit comments
by November 30, 2015. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm435242.htm and at http://www.regulations.gov. It may also be viewed at the Division of Dockets
Management (see ADDRESSES). A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent

to the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: May 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13063 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 53 (Monday, March 19, 2018)]
[Rules and Regulations]
[Pages 11871-11873]
[FR Doc No: 2018-05016]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0903; Product Identifier 2017-NM-074-AD; Amendment
39-19225; AD 2018-06-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 737-300 and -500 series airplanes. This AD was
prompted by a report indicating that fatigue cracks were found in the
lower wing skin of an airplane with winglets installed. This AD
requires repetitive inspections for cracking of the lower wing skin,
and repair if necessary. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective April 23, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 23,
2018.

ADDRESSES: For service information identified in this final rule,
contact Aviation Partners Boeing, 2811 South 102nd St., Suite 200,
Seattle, WA 98168; phone: 1-206-830-7699; fax: 1-206-767-3355; email:
[email protected]; internet: http://www.aviationpartnersboeing.com. You may view this service information
at the FAA, Transport Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0903.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0903; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the regulatory evaluation, any comments
received, and other information. The address for the Docket Office
(phone:<PHONE_NUMBER>) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Lu Lu, Aerospace Engineer, Airframe
Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA
98198; phone and fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 737-300 and -500 series airplanes. The NPRM published in the
Federal Register on October 6, 2017 (82 FR 46725). The NPRM was
prompted by a report indicating that fatigue cracks were found in the
lower wing skin of an airplane with winglets installed. The NPRM
proposed to require repetitive inspections for cracking of the lower
wing skin, and repair if necessary.
    We are issuing this AD to detect and correct fatigue cracking of
the lower wing skin common to the runout of stringer L-5. Such cracking
could grow and result in loss of structural integrity of the wing, and
consequent reduced, or complete loss of, controllability of the
airplane.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment. Aviation Partners Boeing
concurred with the proposed AD.

Request for Manufacturer To Share Expense

    One commenter, Mary Lou Allen, requested that the airplane
manufacturer share in the expense with the airplane's purchaser or
owner, because of the high costs associated with supplemental type
certificates. We infer that the commenter wants manufacturers to be
required to help pay for compliance with the proposed AD.
    We do not agree to this request. We provide estimates of the cost
on U.S. operators for AD compliance, but do not determine who is
responsible for payment. We are aware that airplane manufacturers and
modifiers often have warranty agreements with owners and operators to
cover some or all of the costs of modifications or repairs, but we do
not participate in these agreements. We have not changed this AD in
this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed, except for minor editorial changes. We
have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Aviation Partners Boeing Service Bulletin AP737C-57-
002, dated April 5, 2017. The service information describes procedures
for repetitive inspections for cracking of the lower wing skin, and
repair if necessary. 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.

Costs of Compliance

    We estimate that this AD affects 93 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Repetitive inspection............  1 work-hour x $85                $0  $85 per inspection   Up to $7,905 per
                                    per hour = $85 per                   cycle.               inspection cycle.
                                    inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

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,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-06-05 The Boeing Company: Amendment 39-19225; Docket No. FAA-
2017-0903; Product Identifier 2017-NM-074-AD.

(a) Effective Date

    This AD is effective April 23, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 737-300 and -500
series airplanes, certificated in any category, with blended winglet
kits installed in accordance with Supplemental Type Certificate
(STC) ST01219SE.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report indicating that fatigue cracks
were found in the lower wing skin at stringer L-5 of a Boeing Model
737-300 airplane with winglets installed. We are issuing this AD to
detect and correct fatigue cracking of the lower wing skin common to
the runout of stringer L-5. Such cracking could grow and result in
loss of structural integrity of the wing, and consequent reduced, or
complete loss of, controllability of the airplane.

(f) Compliance

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

(g) Repetitive Inspection

    Within 18 months after the effective date of this AD: Do a
detailed inspection for cracking of the lower wing skin external
surface at the stringer L-5 location on the left and right wings, in
accordance with the Accomplishment Instructions of Aviation Partners
Boeing Service Bulletin AP737C-57-002, dated April 5, 2017. Repeat
the inspection thereafter at intervals not to exceed 6,000 flight
cycles or 9,000 flight hours, whichever occurs first.

(h) Repair

    If any crack is found during any inspection required by
paragraph (g) of this AD, repair before further flight using a
method approved in accordance with the procedures specified in
paragraph (i) of this AD. Although Aviation Partners Boeing Service
Bulletin AP737C-57-002, dated April 5, 2017, specifies to contact
Boeing for repair instructions, and specifies that action as ``RC''
(Required for Compliance), this AD requires repair as specified in
this paragraph.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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. Information may be
emailed to: [email protected].
    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) Except as required by paragraph (h) of this AD: For service
information that contains steps that are labeled as RC, the
provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    For more information about this AD, contact Lu Lu, Aerospace
Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Aviation Partners Boeing Service Bulletin AP737C-57-002,
dated April 5, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Aviation Partners Boeing, 2811 South 102nd St., Suite 200, Seattle,
WA 98168; phone: 1-206-830-7699; fax: 1-206-767-3355; email:
[email protected]; internet: http://www.aviationpartnersboeing.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 5, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-05016 Filed 3-16-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Proposed Rules]
[Pages 21964-21966]
[FR Doc No: 2018-09982]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0418; Product Identifier 2017-SW-016-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Helicopters Model AS-365N2 and AS 365 N3 helicopters with a
lower strobe light installed. This proposed AD would require installing
a cable mount, inspecting the lower strobe light wiring harness, and
re-routing the wiring harness. This proposed AD is prompted by reports
of interference between the lower strobe light wiring harness and the
helicopter structure. The actions of this proposed AD are intended to
prevent an unsafe condition on these helicopters.

DATES: We must receive comments on this proposed AD by July 10, 2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0418; 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 proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: George Schwab, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2016-0258, dated December 16,
2016, to correct an unsafe condition for Airbus Helicopters Model AS
365 N2 and AS 365 N3 helicopters with certain serial numbers and
configurations. EASA advises of in-production helicopters with lower
strobe light wiring harnesses that were interfering with either the
helicopter structure or the adjacent fuel tank support. EASA further
states that an investigation determined that the electrical harnesses
of these lower strobe lights were manufactured with additional length
to facilitate removal and installation of the lower strobe light
assembly. However, the additional length of wiring in the harness was
not properly secured to the helicopter structure. According to EASA,
this could result in chafing of the harness on the helicopter
structure, creating an ignition source adjacent to the inboard fuel
tank vapor space, and result in a fuel tank fire.
    To address this unsafe condition, the EASA AD requires installing a
cable mount, inspecting the lower strobe light electrical harness for
damage, and re-routing the electrical harness.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin (ASB) No.
AS365-05.00.73, Revision 1, dated December 12, 2016 (ASB AS365-
05.00.73), which specifies procedures for inspecting the lower strobe
light electrical harness for interference and chafing with the
helicopter structure and also specifies procedures for installing a
cable mount to secure the electrical harness. These procedures
correspond to Airbus Helicopters modification (MOD) 365P084778.00.
    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.

Proposed AD Requirements

    This proposed AD would require, within 50 hours time-in-service
(TIS), installing a cable mount on the helicopter structure and
inspecting the lower strobe light electrical harness and the electrical
harness between the cut-off connector and Frame 2000 for torn spiral
tape and for any chafing on the harness cables. If the spiral tape is
torn, the proposed AD would require, before further flight, replacing
the spiral tape.

If there is any chafing on the cable the proposed AD would require,
before further flight, replacing the harness.
    Helicopters in a MOD 365P084778.00 configuration have already
accomplished the actions required by this proposed AD.

Differences Between This Proposed AD and the EASA AD

    The EASA AD limits the applicability to helicopters with a lower
strobe light installed and with certain serial numbers or that are in a
configuration based upon a modification, service information, or
engineering drawings. This proposed AD would apply to all Model AS 365
N2 and AS 365 N3 helicopters with a lower strobe light installed.

Costs of Compliance

    We estimate that this proposed AD would affect 30 helicopters of
U.S. Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD. At an average labor rate of $85 per work-hour,
installing a cable mount and inspecting the strobe light wiring
harnesses would require about 1 hour, and required parts would cost
about $50, for a cost per helicopter of $135 and a total cost of $4,050
to all U.S. operators.
    If required, replacing torn spiral tape would require about 1 work-
hour, and required parts would cost $45, for a cost per helicopter of
$130.
    If required, replacing a chafed wiring harness between the cut-off
connector and Frame 2000 would require about 3 work-hours, and required
parts would cost $90, for a cost per helicopter of $345.
    If required, replacing a chafed lower strobe light wiring harness
would require about 3 work-hours, and required parts would cost $154,
for a cost per helicopter of $409

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus Helicopters: Docket No. FAA-2018-0418; Product Identifier
2017-SW-016-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model AS-365N2 and AS 365
N3 helicopters, certificated in any category, with a lower strobe
light installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as interference between the
lower strobe light electrical harness wiring and the helicopter
structure. This condition could result in chafing of an electrical
harness adjacent to the inboard fuel tank vapor space, a fuel tank
fire, and subsequent loss of control of the helicopter.

(c) Comments Due Date

    We must receive comments by July 10, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 50 hours time-in-service:
    (1) Install cable mount part number (P/N) ASMS-A to the
helicopter structure as depicted in Figure 1, Detail A and Detail C,
of Airbus Helicopters Alert Service Bulletin No. AS365-05.00.73,
Revision 1, dated December 12, 2016 (ASB AS365-05.00.73).
    (2) Inspect the lower strobe light harness and the harness
between the cut-off connector and Frame 2000 for tears in the spiral
tape and for chafing of the harness wires. If there is a tear in the
spiral tape, before further flight, replace the spiral tape. If
there is any chafing, before further flight, replace the chafed
harness.
    (3) Route the lower strobe light harness and the harness between
the cut-off connector and Frame 2000 and secure as depicted in
Figure 1, Detail A and Section B-B, of ASB AS365-05.00.73.

    Note 1 to paragraph (e) of this AD:  Airbus Helicopters
identifies the actions in ASB AS365-05.00.73 as Modification
365P084778.00.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
George Schwab, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2016-0258, dated December 30, 2016. You may
view the EASA AD on the internet at http://www.regulations.gov in
the AD Docket.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 3340 Lights.

    Issued in Fort Worth, Texas, on May 1, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-09982 Filed 5-10-18; 8:45 am]
 BILLING CODE 4910-13-P