[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Proposed Rules]
[Pages 25536-25543]
[FR Doc No: 2018-11643]

Vol. 83

Friday,

No. 106

June 1, 2018

Part III

Department of Labor

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Occupational Safety and Health Administration

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29 CFR Part 1910

Limited Extension of Select Compliance Dates for Occupational Exposure
to Beryllium in General Industry; Proposed Rules

Federal Register / Vol. 83 , No. 106 / Friday, June 1, 2018 /
Proposed Rules

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket ID-OSHA-H005C-2006-0870]
RIN 1218-AB76

Limited Extension of Select Compliance Dates for Occupational
Exposure to Beryllium in General Industry

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Proposed rule.

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SUMMARY: OSHA is proposing a nine-month extension of the compliance
date for certain ancillary requirements of the general industry
beryllium standard (from March 12, 2018 to December 12, 2018). This
proposal would not extend the compliance date for the permissible
exposure limits (PELs), exposure assessment, respiratory protection,
medical surveillance, or medical removal protection provisions, or for
any provisions for which the standard already establishes compliance
dates in 2019 and 2020. OSHA has preliminarily determined that this
proposal will maintain essential safety and health protections for
workers while OSHA prepares an NPRM to clarify specific provisions of
the beryllium standard that would both maintain the standard's worker
safety and health protections and address employers' compliance
burdens.

DATES: Submit comments to this proposed rule, hearing requests, and
other information by July 2, 2018. All submissions must bear a postmark
or provide other evidence of the submission date.

ADDRESSES: Submit comments, hearing requests, and other material,
identified by Docket No. OSHA-H005C-2006-0870, using any of the
following methods:
    Electronically: Submit comments and attachments, as well as hearing
requests and other information, electronically at https://www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the instructions online for submitting comments. Note that this docket
may include several different Federal Register notices involving active
rulemakings, so it is extremely important to select the correct notice
or its ID number when submitting comments for this rulemaking. After
accessing ``all documents and comments'' in the docket (OSHA-H005C-
2006-0870), check the ``proposed rule'' box in the column headed
``Document Type,'' find the document posted on the date of publication
of this document, and click the ``Submit a Comment'' link. Additional
instructions for submitting comments are available from the https://www.regulations.gov homepage.
    Facsimile: OSHA allows facsimile transmission of comments that are
10 pages or fewer in length (including attachments). Fax these
documents to the OSHA Docket Office at<PHONE_NUMBER>. OSHA does not
require hard copies of these documents. Instead of transmitting
facsimile copies of attachments that supplement these documents (e.g.,
studies, journal articles), commenters must submit these attachments to
the OSHA Docket Office, Docket No. OSHA-H005C-2006-0870, Room N-3653,
Occupational Safety and Health Administration, U.S. Department of
Labor, 200 Constitution Avenue NW, Washington, DC 20210. These
attachments must clearly identify the sender's name, the date, the
subject, and the docket number (OSHA-H005C-2006-0870) so that the
Docket Office can attach them to the appropriate document.
    Regular mail, express delivery, hand delivery, and messenger
(courier) service: Submit comments and any additional material to the
OSHA Docket Office, Docket No. OSHA-H005C-2006-0870, Room N-3653,
Occupational Safety and Health Administration, U.S. Department of
Labor, 200 Constitution Avenue NW, Washington, DC 20210; telephone:
(202) 693-2350 (TTY<PHONE_NUMBER>). Contact the OSHA Docket Office for
information about security procedures concerning delivery of materials
by express delivery, hand delivery, and messenger service. The Docket
Office will accept deliveries (express delivery, hand delivery,
messenger service) during the Docket Office's normal business hours,
10:00 a.m. to 3:00 p.m., ET.
    Instructions: All submissions must include the Agency's name, the
title of the rulemaking (Limited Extension of Select Compliance Dates
for Occupational Exposure to Beryllium in General Industry), and the
docket number (OSHA-H005C-2006-0870). OSHA will place comments and
other material, including any personal information, in the public
docket without revision, and the comments and other material will be
available online at https://www.regulations.gov. Therefore, OSHA
cautions commenters about submitting statements they do not want made
available to the public, or submitting comments that contain personal
information (either about themselves or others), such as Social
Security Numbers, birth dates, and medical data.
    In this preamble, OSHA cites to documents in Docket No. OSHA-H005C-
2006-0870, the docket for this rulemaking. To simplify these document
cites, OSHA uses ``Document ID'' followed by the last four digits of
the full docket identification number. For example, if a document's
full docket identification number is ID-OSHA-H005C-2006-0870-1234, the
citation used in this preamble would be Document ID 1234. The docket is
available at https://www.regulations.gov, the Federal eRulemaking
Portal.
    Docket: To read or download comments or other material in the
docket, go to https://www.regulations.gov or to the OSHA Docket Office
at the above address. The electronic docket for this proposed rule
established at https://www.regulations.gov contains most of the
documents in the docket. However, some information (e.g., copyrighted
material) is not available publicly to read or download through this
website. All submissions, including copyrighted material, are available
for inspection at the OSHA Docket Office. Contact the OSHA Docket
Office for assistance in locating docket submissions.

FOR FURTHER INFORMATION CONTACT:
    Press inquiries: Mr. Frank Meilinger, OSHA Office of
Communications; telephone:<PHONE_NUMBER>; email:
[email protected].
    General information and technical inquiries: William Perry or
Maureen Ruskin, Directorate of Standards and Guidance; telephone (202)
693-1950; email: [email protected].
    Copies of this Federal Register document and news releases:
Electronic copies of these documents are available at OSHA's web page
at https://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Explanation of Regulatory Action

A. Introduction

    OSHA is publishing this Notice of Proposed Rulemaking (NPRM) to
propose a nine-month extension of the compliance date for certain
requirements of the general industry beryllium standard (29 CFR
1910.1024), which was promulgated on January 9, 2017 (82 FR 2470). The
standard provides that the compliance date for the affected
requirements is March 12, 2018, but on March 2, 2018, OSHA issued a
memorandum stating that no provisions of the standard would be enforced
until May 11, 2018. Then, on

May 9, 2018, OSHA issued an enforcement memorandum stating that the
ancillary requirements that are affected by the planned NPRM will not
be enforced until June 25, 2018. Neither memorandum was published in
the Federal Register.
    This proposed action would revise the standard to extend the
compliance date for the affected provisions until December 12, 2018.
OSHA is proposing to extend the compliance date for select ancillary
requirements of the general industry standard, but this proposal would
not extend the compliance date for PELs, exposure assessment,
respiratory protection, medical surveillance, or medical removal
protection provisions, or for any provisions for which the standard
already establishes compliance dates in 2019 and 2020. It also would
not affect the applicability of the scope and application paragraph or
the definitions, except to allow employers to comply with the
definitions of ``CBD diagnostic center,'' ``chronic beryllium
disease,'' and ``confirmed positive'' that will be proposed in the
later substantive rulemaking NPRM (Document ID 2156).\1\ As explained
in more detail in the following sections, OSHA believes the proposed
action is necessary to provide sufficient time for preparation and
publication of a planned NPRM that will affect the provisions of the
rule covered by this proposed extension.
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    \1\ CBD is the acronym for chronic beryllium disease.
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    As described in Section I.D, Explanation of Proposed Action and
Request for Comment, OSHA is planning to propose revisions to the
beryllium standard in accordance with a settlement agreement entered
into with stakeholders on April 24, 2018 (Document ID 2156). The
upcoming rulemaking will affect select ancillary provisions in the
standard. OSHA is concerned that beginning enforcement of those
provisions before publication of the substantive proposal may result in
employer confusion or improper implementation of the relevant
provisions of the rule.

B. Summary of Economic Impact

    This proposed rule is not economically significant. OSHA is
revising 29 CFR 1910.1024(o)(2) to extend the deadline for compliance
with certain provisions of the beryllium rule for nine months. This
proposed rule is expected to be an Executive Order (E.O.) 13771
deregulatory action. Details on OSHA's cost/cost savings estimates for
this proposed rule can be found in the rule's preliminary economic
analysis in the ``Agency Determinations'' section of this preamble.
OSHA has estimated that, at a 3 percent discount rate over 10 years,
there are net annual cost savings of $0.76 million per year for this
proposed rule; at a discount rate of 7 percent there are net annual
cost savings of $1.73 million per year. When the Department uses a
perpetual time horizon, the annualized cost savings of the proposed
rule is $1.65 million with 7 percent discounting.

C. Regulatory Background

    OSHA published an NPRM for occupational exposure to beryllium in
the Federal Register on August 7, 2015 (80 FR 47566). In the NPRM, the
Agency made a preliminary determination that employees exposed to
beryllium and beryllium compounds at the previous PEL faced a
significant risk to their health and that promulgating the proposed
standard would substantially reduce that risk. The NPRM invited
interested stakeholders to submit comments on a variety of issues.
    OSHA held a public hearing in Washington, DC, on March 21 and 22,
2016. The Agency heard testimony from several organizations, including
public health groups, industry representatives, and labor unions.
Following the hearing, participants had an opportunity to submit
additional evidence and data, as well as final briefs, arguments, and
summations (Document ID 1756, Tr. 326).
    On January 9, 2017, after considering the entire record, OSHA
issued a final rule with three separate standards for general industry,
shipyards, and construction, in order to tailor requirements to the
circumstances found in these sectors. See 82 FR 2470 (January 9, 2017).
The final beryllium standards established new PELs of 0.2 [mu]g/m\3\ as
an 8-hour time-weighted average (TWA) and 2.0 [mu]g/m\3\ as a short-
term exposure limit (STEL) determined over a sampling period of 15
minutes. The standards also established other provisions to protect
employees, such as requirements for exposure assessment, methods for
controlling exposure, respiratory protection, personal protective
clothing and equipment, housekeeping, medical surveillance, medical
removal, hazard communication, and recordkeeping. The general industry
standard established a compliance date (when obligations of the
standard commence and become enforceable) of March 12, 2018, for all
obligations except change rooms and showers required by paragraph (i)
(compliance date of March 11, 2019) and engineering controls required
by paragraph (f) (compliance date of March 10, 2020). See 29 CFR
1910.1024(o)(2).
    Following promulgation of the final standard, representatives of
general industry employers, including Materion Corporation, along with
representatives of the coal-fired power industry and the aluminum
production industry, challenged the rule in federal court and
approached OSHA with questions and concerns about some of the
provisions in the final rule.
    In response to the stakeholder feedback, and to resolve the pending
litigation, OSHA is planning to propose revisions to certain provisions
in the general industry standard and rely on its de minimis policy
while the rulemaking is pending so that employers may comply with the
proposed provisions without risk of a citation.\2\ The revisions OSHA
plans to propose are generally designed to clarify the standard in
response to stakeholder questions or to simplify compliance, while in
all cases maintaining a high degree of protection from the adverse
health effects of beryllium exposure (Document ID 2156). For example,
the proposed changes include modifying certain definitions to clarify
the meaning of the terms, including a list of operations that trigger
the requirement for beryllium work areas so that employers understand
when they must set up a beryllium work area, and modifying the disposal
and recycling provisions to clarify that items designated for disposal
must be in containers that prevent the release of beryllium under
ordinary conditions rather than sealed, impermeable containers. The
proposed compliance date extension will give OSHA time to prepare and
publish the planned NPRM to amend the standard before employers must
comply with the affected provisions of the rule so that, until any such
changes are finalized, employers may comply with the proposed
provisions without risk of a citation.
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    \2\ The OSH Act allows the Secretary of Labor to prescribe
procedures to issue notices instead of citations for ``de minimis
violations'' that have no direct or immediate relationship to safety
or health. 29 U.S.C. 658(a). The Secretary's de minimis policy is
set forth in its Field Operations Manual (FOM), available at https://www.osha.gov/OshDoc/Directive_pdf/CPL_02-00-160.pdf. Under the de
minimis policy, compliance ``with a proposed OSHA standard or
amendment or a consensus standard rather than with the standard in
effect at the time of the inspection and the employer's action
clearly provides equal or greater employee protection'' is a de
minimis condition. De minimis conditions result in no citation or
penalties. See 29 CFR 1903.15 (``Penalties shall not be proposed for
de minimis violations which have no direct or immediate relationship
to safety or health.''); https://www.osha.gov/Publications/osha3000.pdf.

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D. Explanation of Proposed Action and Request for Comment

    OSHA is proposing to revise the ``Dates'' provision of the
beryllium standard (at 29 CFR 1910.1024(o)(2)) to extend the deadline
for compliance with most of the ancillary requirements of the standard
from March 12, 2018, to December 12, 2018. As previously discussed,
this proposed action would provide time for preparation and publication
of a planned NPRM that will impact the provisions covered by this
extension so that employers may comply with the proposed provisions
without risk of a citation (Document ID 2156).
    OSHA will be proposing modifications to ancillary provisions of the
beryllium standard in response to stakeholder questions and concerns.
These concerns were raised during lengthy settlement discussions among
OSHA, the United Steelworkers of America (the union representing the
largest proportion of beryllium-exposed workers), Materion Corporation
(the leading producer of beryllium and beryllium products), some of
Materion's customers, and the National Association of Manufacturers
(Document ID 2156). In addition to agreeing on the proposed revisions,
the parties agreed that if OSHA was not able to finalize the
substantive NPRM before December 12, 2018, compliance with the
beryllium standard as modified by the proposal would be accepted as
compliance with the standard under OSHA's de minimis policy (Document
ID 2156).
    The revisions OSHA plans to propose are primarily clarifying or
simplifying in nature (Document ID 2156). They are designed to enhance
worker protections by ensuring that the rule is well-understood and
compliance is simple and straightforward. All of the provisions covered
by this extension will be affected by the planned rulemaking.
    OSHA has preliminarily determined that it would be undesirable, for
both the Agency and the regulated community, to begin enforcement of
the ancillary provisions of the standard that will be affected by the
upcoming rulemaking. Enforcing compliance with the relevant ancillary
requirements, as currently written, before publishing the agreed-upon
proposal, is likely to result in employers taking unnecessary measures
to comply with provisions that OSHA intends to clarify. This proposed
compliance date extension will give OSHA time to prepare and publish
the planned substantive NPRM to amend the standard before employers
must comply with the affected provisions of the rule, at which point
OSHA may rely on its de minimis policy and employers may comply with
the proposed provisions without risk of a citation.
    Therefore, OSHA is proposing this short extension of the compliance
date for the following provisions: Beryllium work areas and regulated
areas (paragraph (e)), written exposure control plans (paragraph
(f)(1)), personal protective clothing and equipment (paragraph (h)),
hygiene areas and practices (paragraph (i) except for change rooms and
showers; see below), housekeeping (paragraph (j)), communication of
hazards (paragraph (m)), and recordkeeping (paragraph (n)).
    Not every provision in the standard will be covered by the proposed
extension. First, the proposal will not affect the compliance date for
the updated TWA PEL and STEL (paragraph (c)), exposure assessment
(paragraph (d)), or respiratory protection (paragraph (g)). These
paragraphs are not affected by the regulatory revisions OSHA plans to
propose, and are essential to ensure employers are controlling worker
exposures to beryllium while OSHA works on the rulemaking to amend
other aspects of the standard. The compliance dates for paragraphs (c),
(d), and (g) are unaffected by this proposal.
    Second, the proposal will not affect the compliance date for
medical surveillance (paragraph (k)) or medical removal protection
(paragraph (l)). Although OSHA plans to propose clarifications to
certain definitions pertaining to paragraph (k) (Medical Surveillance),
OSHA has preliminarily determined that the proposed clarifications
would not substantially affect the actions that employers must take to
comply with the medical surveillance provisions of the beryllium
standard (Document ID 2156).\3\ OSHA has also preliminarily determined
that access to medical surveillance should not be delayed because, as
explained in the preamble to the 2017 beryllium rule, the early
identification of beryllium-related health effects can contribute to
effective management of early signs and symptoms (82 FR at 2546, 2720-
2721; Document ID 1756, Tr. 111, 132). Therefore, the compliance date
for medical surveillance (paragraph (k)) is unaffected by this
proposal. Until the substantive rulemaking is proposed, however,
employers may comply with the medical surveillance provisions as
clarified by the definitions of ``CBD diagnostic center,'' ``chronic
beryllium disease,'' and ``confirmed positive'' that OSHA has agreed to
propose in the substantive rulemaking NPRM, which are available in the
docket (Document ID 2156) and in OSHA's interim enforcement guidance on
the OSHA website (https://www.osha.gov/laws-regs/standardinterpretations/2018-05-09). OSHA has also determined,
preliminarily, that this compliance date extension should have no
effect on medical removal protection (paragraph (l)), because
compliance with medical removal protection is not directly affected by
the changes OSHA is planning to propose to the rule (Document ID 2156).
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    \3\ OSHA plans to propose revisions to the definition of ``CBD
diagnostic center'' to prevent confusion about staffing requirements
for CBD diagnostic centers. OSHA plans to propose a change to the
definition of ``chronic beryllium disease'' to narrow the scope and
avoid confusion with other lung diseases. OSHA also plans to propose
a change to the definition of ``confirmed positive'' to clarify that
the results must be obtained within the 30 day follow-up test period
required after a first abnormal or borderline BeLPT test result
(Document ID 2156).
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    Third, the proposal will not affect paragraph (a), Scope and
application. It will also not affect paragraph (b), Definitions, except
as described above to allow employers to comply with the definitions of
``CBD diagnostic center,'' ``chronic beryllium disease,'' and
``confirmed positive'' that are included in the settlement agreement
and will be proposed in the substantive rulemaking NPRM (Document ID
2156).
    Finally, the compliance date for change rooms and showers required
by paragraph (i) of the standard will remain March 11, 2019 (29 CFR
1910.1024(o)(2)(i)), and the compliance date to implement engineering
controls required by paragraph (f) of the standard will remain March
10, 2020 (29 CFR 1910.1024(o)(2)(ii)). OSHA expects to publish the
planned NPRM well in advance of these compliance dates.
    Although OSHA is proposing to extend the compliance date for
paragraph (m), Communication of Hazards--which includes specific
labeling requirements--manufacturers, importers, and employers are
still obligated to label hazardous chemicals containing beryllium,
ensure that safety data sheets are readily available, and train workers
on the hazards of beryllium in accordance with the Hazard Communication
Standard (HCS), 29 CFR 1910.1200. OSHA encourages employers to review
their hazard communication program, employee training, and other hazard
communication practices (such as workplace labeling) to ensure
continued compliance with the HCS. Also, while OSHA is proposing to
extend the compliance date for the recordkeeping requirements of
paragraph (n), OSHA expects employers to continue to comply with 29 CFR
1910.1020 (Access

to Employee Exposure and Medical Records).
    OSHA seeks comment on this proposal to revise paragraph (o) of the
general industry beryllium standard to extend the compliance date for
select ancillary provisions. OSHA welcomes comment on both the duration
and scope of the proposed compliance date extension. OSHA encourages
commenters to include a rationale for any concerns raised with this
proposal, as well as for alternatives that they propose. OSHA also
requests comment on the ``Agency Determinations'' section that follows,
including the preliminary economic analysis and other regulatory
impacts of this rule on the regulated community. Please note that
comments on the changes OSHA plans to propose to the ancillary
requirements of the general industry standard should be reserved for
submission during the public comment period for that NPRM.

II. Agency Determinations

A. Preliminary Economic Analysis and Regulatory Flexibility
Certification

    Executive Orders 12866 and 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act (UMRA) (2 U.S.C.
1532(a)) require that OSHA estimate the benefits, costs, and net
benefits of regulations, and analyze the impacts of certain rules that
OSHA promulgates. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, reducing costs, harmonizing rules,
and promoting flexibility.
    This proposed rule is not an ``economically significant regulatory
action'' under Executive Order 12866 or UMRA, or a ``major rule'' under
the Congressional Review Act (5 U.S.C. 801 et seq.). Neither the
benefits nor the costs of this proposal would exceed $100 million in
any given year. This proposed rule to extend the compliance date for
certain ancillary provisions in the beryllium standard would result in
cost savings. Cost savings arise in this context because a delay in
incurred costs for employers would allow them to invest the funds (and
earn an expected return at the going interest rate) that would
otherwise have been spent to comply with the beryllium standard.
    At a discount rate of 3 percent, this proposed compliance date
extension would yield annualized cost savings of $0.76 million per year
for 10 years. At a discount rate of 7 percent, this proposal would
yield an annualized cost savings of $1.73 million per year for 10
years. When the Department uses a perpetual time horizon to allow for
cost comparisons under Executive Order 13771 (82 FR 9339, Jan. 30,
2017), the annualized cost savings of this proposed compliance date
extension is $1.65 million at a discount rate of 7 percent.
1. Changes to the Baseline: Updating to 2017 Dollars and Removing
Ramiliarization Costs; Discussion of Overhead Costs
    More than one year has elapsed since promulgation of the beryllium
standard on January 9, 2017, so OSHA has updated the projected costs
for general industry contained in the final economic analysis (FEA)
that accompanied the rule from 2015 to 2017 dollars, using the latest
Occupational Employment Statistics (OES) wage data (for 2016) and
inflating them to 2017 dollars. Additionally, although familiarization
costs were included in the cost estimates developed in the beryllium
FEA, OSHA expects that those costs have already been incurred by
affected employers, and is excluding them from its analysis of the cost
savings associated with the proposed extension of compliance dates.
Thus, baseline costs for this preliminary economic analysis (PEA) are
the projected costs from the 2017 FEA, updated to 2017 dollars, less
familiarization costs.
    OSHA notes that it did not include an overhead labor cost in the
2017 FEA, and has not accounted for such costs in this PEA. There is
not one broadly accepted overhead rate, and the use of overhead to
estimate the marginal costs of labor raises a number of issues that
should be addressed before applying overhead costs to analyze the cost
implications of any specific regulation. There are several ways to look
at the cost elements that fit the definition of overhead, and there is
a range of overhead estimates currently used within the federal
government--for example, the Environmental Protection Agency has used
17 percent,\4\ and government contractors have been reported to use an
average of 77 percent.\5\ Some overhead costs, such as advertising and
marketing, may be more closely correlated with output than with labor.
Other overhead costs vary with the number of new employees. For
example, rent or payroll processing costs may change little with the
addition of 1 employee in a 500-employee firm, but may change
substantially with the addition of 100 employees. If an employer is
able to rearrange current employees' duties to implement a rule, then
the marginal share of overhead costs, such as rent, insurance, and
major office equipment (e.g., computers, printers, copiers), would be
very difficult to measure with accuracy.
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    \4\ Grant Thornton, LLP, 2015 Government Contractor Survey
(Document ID OSHA-H005C-2006-0870-2153). The application of this
overhead rate was based on an approach used by the Environmental
Protection Agency (EPA), as described in EPA's ``Wage Rates for
Economic Analyses of the Toxics Release Inventory Program,'' June
10, 2002. This analysis itself was based on a survey of several
large chemical manufacturing plants: Heiden Associates, Final
Report: A Study of Industry Compliance Costs Under the Final
Comprehensive Assessment Information Rule, Prepared for the Chemical
Manufacturers Association, December 14, 1989.
    \5\ For further examples of overhead cost estimates, please see
the Employee Benefits Security Administration's guidance at https://www.dol.gov/sites/default/files/ebsa/laws-and-regulations/rules-and-regulations/technical-appendices/labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-august-2016.pdf.
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    If OSHA had included an overhead rate when estimating the marginal
cost of labor, without further analyzing an appropriate quantitative
adjustment, and adopted for these purposes an overhead rate of 17
percent on base wages, the cost savings of this proposal would increase
to approximately $0.82 million per year, at a discount rate of 3
percent, or to approximately $1.87 million per year, at a discount rate
of 7 percent.\6\ The addition of 17 percent overhead on base wages
would therefore increase cost savings by approximately 8 percent above
the primary estimate at either discount rate.
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    \6\ OSHA used an overhead rate of 17 percent on base wages in a
sensitivity analysis in the FEA (OSHA-2010-0034-4247, p. VII-65) in
support of the March 25, 2016 final respirable crystalline silica
standards (81 FR 16286) and in the PEA in support of the June 27,
2017 beryllium proposal for the construction and shipyard sectors
(82 FR 29201).
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2. Changes to the Standard: Nine-Month Extension of the Compliance Date
for Some Ancillary Provisions
    The beryllium standard went into effect on May 20, 2017, with most
compliance obligations beginning on March 12, 2018. OSHA is proposing
to extend the compliance date for specific provisions until December
12, 2018. The compliance dates for the updated PELs, exposure
assessment, respiratory protection, medical surveillance, and medical
removal protection requirements, and for some other provisions for
which the standard already establishes compliance dates in 2019 and
2020, would not change as a result of this proposal. The applicability
of the scope and application paragraph and the definitions would also
not change as a result of this proposal, except to allow employers to
comply with the definitions of ``CBD diagnostic center,'' ``chronic
beryllium disease,'' and ``confirmed positive'' that will be

proposed in the later substantive rulemaking NPRM (Document ID 2156).
As discussed previously, the purpose of this proposal is to provide
time for OSHA to issue a planned NPRM that would affect the parts of
the standard that are covered by this proposed compliance date
extension before that compliance date is reached, so that OSHA may rely
on its de minimis policy and employers may comply with the proposed
provisions without risk of a citation.
    OSHA estimated cost savings of the proposed extension relative to
baseline costs, where baseline costs reflect the costs of compliance
without the proposed change to the compliance date provision. OSHA
calculated the cost savings by lagging the first-year costs for the
affected provisions by nine months and then calculating the present
value of the delayed costs over the 10 years following the proposed
compliance date. Annualizing the present value of cost savings over ten
years, the result is an annualized cost savings of $0.76 million per
year at a discount rate of 3 percent, or $1.73 million per year at a
discount rate of 7 percent. When the Department uses a perpetual time
horizon to allow for cost comparisons under Executive Order 13771, the
annualized cost savings of this proposed compliance date extension is
$1.65 million at a discount rate of 7 percent.
    The undiscounted cost savings by provision and year are presented
below in Table 1. As shown in Table 1, and described elsewhere in this
notice, the cost savings described in this PEA reflect savings only for
provisions covered by the proposed compliance date extension. OSHA
estimated no cost savings for the PELs, exposure assessment,
respiratory protection, medical surveillance, or medical removal
protection provisions (as they are not covered by the proposed
extension), or for any provisions for which the rule already
establishes compliance dates in 2019 (change rooms/showers) or 2020
(engineering controls).\7\ The cost savings by year and discount rate
are shown below in Table 2.
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    \7\ Note that the labor costs associated with time spent
changing clothes are generally triggered by wearing personal
protective equipment, as required by paragraph (h) of the beryllium
standard. OSHA is proposing to extend the compliance date for
paragraph (h). If the proposal is adopted, the rule would not
require employers to incur the labor costs associated with changing
time for personal protective equipment until December 12, 2018, so
OSHA is generally accounting for those cost savings in this PEA.
OSHA has not accounted for any cost savings related to the use of
head covers, however. Head covers may be used to prevent
contamination of employees' hair, potentially precluding the need
for showers under paragraph (i)(3) of the standard. Because this
proposal would not extend the compliance date for showers, OSHA has
not accounted for head covers for purposes of estimating the cost
savings associated with this proposal.
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3. Economic and Technological Feasibility
    In the FEA for the beryllium standard, OSHA concluded that the rule
was technologically feasible. OSHA has preliminarily determined that
this proposal is also technologically feasible because it does not
change any of the rule's substantive requirements, and, if adopted,
would simply give employers more time to comply with some of the rule's
ancillary requirements. Furthermore, OSHA previously concluded that the
beryllium standard was economically feasible. As this proposal does not
impose any new substantive requirements, and results in cost savings,
OSHA has preliminarily concluded that the proposal is also economically
feasible.
4. Effects on Benefits
    The planned rulemaking to revise the general industry beryllium
standard is intended to be responsive to questions and concerns
expressed by stakeholders regarding ancillary provisions of the rule.
Safety and health programs can be inefficacious if employers and other
stakeholders are unclear about OSHA requirements. Hence, by addressing
stakeholder questions and concerns, the planned rulemaking will make it
more likely that the regulated community will realize the full benefits
of the rule, as estimated in the 2017 beryllium FEA. Although it is not
possible to quantify the effect of stakeholder uncertainty on the
projected benefits of the rule, OSHA preliminarily believes that the
short term loss of benefits associated with this proposed extension of
initial compliance dates will be more than offset in the long term by
the benefits that will be realized as a result of the Agency's effort
to provide additional clarity in the rule. OSHA has preliminarily
determined that this proposal will maintain essential safety and health
protections for workers.
5. Certification of No Significant Impact on a Substantial Number of
Small Entities
    This proposal will result in cost savings for affected employers,
and those savings fall below levels that could be said to have a
significant positive economic impact on a substantial number of small
entities.\8\ Therefore, OSHA certifies that this proposed standard
would not have a significant impact on a substantial number of small
entities.
---------------------------------------------------------------------------

    \8\ OSHA investigated whether the projected cost savings would
exceed 1 percent of revenues or 5 percent of profits for small
entities and very small entities for every industry. To determine if
this was the case, OSHA returned to its original regulatory
flexibility analysis (in the 2017 FEA) for small entities and very
small entities. OSHA found that the cost savings of this proposal
are such a small percentage of revenues and profits for every
affected industry that OSHA's criteria would not be exceeded for any
industry.
---------------------------------------------------------------------------

BILLING CODE 4510-26-P

[GRAPHIC] [TIFF OMITTED] TP01JN18.003

BILLING CODE 4510-26-C

                             Table 2--Cost Savings Due to Compliance Date Extension
----------------------------------------------------------------------------------------------------------------
                                                                   Undiscounted     Discounted      Discounted
                      Year                               t         costs by year     costs--3%       costs--7%
----------------------------------------------------------------------------------------------------------------
                                                    Baseline
----------------------------------------------------------------------------------------------------------------
1...............................................            1.00     $53,861,070     $52,292,301     $50,337,449
2...............................................            2.00      31,965,865      30,130,893      27,920,224
3...............................................            3.00      31,965,865      29,253,295      26,093,668
4...............................................            4.00      31,965,865      28,401,257      24,386,605
5...............................................            5.00      31,965,865      27,574,036      22,791,220
6...............................................            6.00      31,965,865      26,770,909      21,300,205
7...............................................            7.00      31,965,865      25,991,173      19,906,734
8...............................................            8.00      31,965,865      25,234,149      18,604,424
9...............................................            9.00      31,965,865      24,499,174      17,387,312
10..............................................           10.00      31,965,865      23,785,605      16,249,825
    Total.......................................  ..............  ..............     293,932,792     244,977,667
    Annualized--10 Years........................  ..............  ..............      34,457,890      34,879,308
----------------------------------------------------------------------------------------------------------------
                                              Discounting Option 1
----------------------------------------------------------------------------------------------------------------
1...............................................            1.75      53,861,070      51,145,783      47,846,852
2...............................................            2.75      31,965,865      29,470,268      26,538,787
3...............................................            3.75      31,965,865      28,611,911      24,802,605
4...............................................            4.75      31,965,865      27,778,554      23,180,004
5...............................................            5.75      31,965,865      26,969,470      21,663,556
6...............................................            6.75      31,965,865      26,183,952      20,246,314
7...............................................            7.75      31,965,865      25,421,312      18,921,788
8...............................................            8.75      31,965,865      24,680,886      17,683,914
9...............................................            9.75      31,965,865      23,962,025      16,527,023
10..............................................           10.75      31,965,865      23,264,102      15,445,816
    Total.......................................  ..............  ..............     287,488,264     232,856,658
    Annualized--10 Years........................  ..............  ..............      33,702,395      33,153,550
    Difference from Baseline....................  ..............  ..............        -755,495      -1,725,759
----------------------------------------------------------------------------------------------------------------

B. Paperwork Reduction Act

    This NPRM does not propose changes to the information collections
already approved by Office of Management and Budget (OMB). OMB approved
the information collection requirements for the general industry
beryllium standard under OMB Control Number 1218-0267, with an
expiration date of April 30, 2020.

C. Federalism

    OSHA reviewed this proposed rule in accordance with Executive Order
13132 on Federalism (64 FR 43255, (Aug. 10, 1999)), which requires that
Federal agencies, to the extent possible, refrain from limiting state
policy options, consult with states prior to taking any actions that
would restrict state policy options, and take such actions only when
clear constitutional authority exists and the problem is national in
scope. Executive Order 13132 provides for preemption of state law only
with the expressed consent of Congress. Federal agencies must limit any
such preemption to the extent possible.
    Under Section 18 of the Occupational Safety and Health Act of 1970
(OSH Act; 29 U.S.C. 651 et seq.), Congress expressly provides that
states and U.S. territories may adopt, with Federal approval, a plan
for the development and enforcement of occupational safety and health
standards. OSHA refers to such states and territories as ``State Plan
States.'' Occupational safety and health standards developed by State
Plan States must be at least as effective in providing safe and
healthful employment and places of employment as the Federal standards.
29 U.S.C. 667. Subject to these requirements, State Plan States are
free to develop and enforce under state law their own requirements for
safety and health standards.
    OSHA previously concluded from its analysis that promulgation of
the beryllium standard complies with Executive Order 13132 (82 FR at
2633). In states without an OSHA-approved State Plan, any standard
developed from this proposed rule would limit state policy options in
the same manner as every standard promulgated by OSHA. For State Plan
States, Section 18 of the OSH Act, as noted in the previous paragraph,
permits State Plan States to develop and enforce their own beryllium
standards provided these requirements are at least as effective in
providing safe and healthful employment and places of employment as the
requirements specified in this proposal.

D. State Plans

    When Federal OSHA promulgates a new standard or more stringent
amendment to an existing standard, State Plans must amend their
standards to reflect the new standard or amendment, or show OSHA why
such action is unnecessary, e.g., because an existing state standard
covering this area is ``at least as effective'' as the new Federal
standard or amendment (29 CFR 1953.5(a)). The state standard must be at
least as effective as the final Federal rule. State Plans must adopt
the Federal standard or complete their own standard within six months
of the promulgation date of the final Federal rule. When OSHA
promulgates a new standard or amendment that does not impose additional
or more stringent requirements than an existing standard, State Plans
do not have to amend their standards, although OSHA may encourage them
to do so. The 21 states and 1 U.S. territory with OSHA-approved
occupational safety and health plans covering private sector and state
and local government are: Alaska, Arizona, California, Hawaii, Indiana,
Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico,
North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Washington, and Wyoming.

Connecticut, Illinois, Maine, New Jersey, New York, and the Virgin
Islands have OSHA-approved State Plans that apply to state and local
government employees only.
    The proposed amendments to OSHA's beryllium standard would not
impose any new requirements on employers. Accordingly, State Plans
would not have to amend their standards to extend the compliance dates
for their beryllium rules, but they may do so within the limits of any
extension adopted by Federal OSHA.

E. Unfunded Mandates Reform Act

    When OSHA issued the final rule establishing standards for
occupational exposure to beryllium, it reviewed the rule according to
the Unfunded Mandates Reform Act of 1995 (UMRA; 2 U.S.C. 1501 et seq.)
and Executive Order 13132 (64 FR 43255 (Aug. 10, 1999)). OSHA concluded
that the final rule did not meet the definition of a ``Federal
intergovernmental mandate'' under the UMRA because OSHA standards do
not apply to state or local governments except in states that
voluntarily adopt State Plans. OSHA further noted that the rule did not
impose costs of over $100 million per year on the private sector. (82
FR at 2634.)
    As discussed above in Section II. A (Preliminary Economic Analysis
and Regulatory Flexibility Certification) of this preamble, this
proposed extension does not impose any costs on private-sector
employers beyond those costs already identified in the final rule for
beryllium in general industry. Because OSHA reviewed the total costs of
the final rule under UMRA, no further review of those costs is
necessary. Therefore, for purposes of UMRA, OSHA certifies that this
proposed rule does not mandate that state, local, or tribal governments
adopt new, unfunded regulatory obligations of, or increase expenditures
by the private sector by, more than $100 million in any year.

F. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this proposed rule in accordance with Executive Order
13175 (65 FR 67249) and determined that it does not have ``tribal
implications'' as defined in that order. As proposed, the rule does not
have substantial direct effects on one or more Indian tribes, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes.

G. Legal Considerations

    The purpose of the Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.) is ``to assure so far as possible every working man
and woman in the nation safe and healthful working conditions and to
preserve our human resources.'' 29 U.S.C. 651(b). To achieve this goal,
Congress authorized the Secretary of Labor to promulgate and enforce
occupational safety and health standards. 29 U.S.C. 654(b), 655(b). A
safety or health standard is a standard ``which requires conditions, or
the adoption or use of one or more practices, means, methods,
operations, or processes, reasonably necessary or appropriate to
provide safe or healthful employment or places of employment.'' 29
U.S.C. 652(8). A standard is reasonably necessary or appropriate within
the meaning of Section 652(8) when a significant risk of material harm
exists in the workplace and the standard would substantially reduce or
eliminate that workplace risk. See Industrial Union Department, AFL-CIO
v. American Petroleum Institute, 448 U.S. 607 (1980). In the beryllium
rulemaking, OSHA made such a determination with respect to beryllium
exposure in general industry (82 FR at 2479). This proposed rule does
not impose any new requirements on employers. Therefore, this proposal
does not require an additional significant risk finding. See Edison
Electric Institute v. OSHA, 849 F.2d 611, 620 (D.C. Cir. 1988).
    In addition to materially reducing a significant risk, a health
standard must be technologically and economically feasible. United
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1251 (D.C.
Cir. 1980) (OSHA must reduce risk ``as far as it c[an] within the
limits of [technological and economic] feasibility.'') A standard is
technologically feasible when the protective measures it requires
already exist, when available technology can bring the protective
measures into existence, or when that technology is reasonably likely
to develop. See American Textile Mfrs. Institute v. OSHA, 452 U.S. 490,
513 (1981); American Iron and Steel Institute v. OSHA, 939 F.2d 975,
980 (D.C. Cir. 1991). And a rule is economically feasible if it does
not ``threaten massive dislocation to, or imperil the existence of,
[an] industry.'' United Steelworkers, 647 F.2d at 1265 (internal
citations and quotation marks omitted). In the 2017 FEA for the
beryllium standard, OSHA found the standard to be technologically and
economically feasible (82 FR at 2471). This proposed rule would be
technologically and economically feasible as well because it would not
require employers to implement any additional protective measures and
would not impose any additional costs on employers.

List of Subjects in 29 CFR Part 1910

    Beryllium, Occupational safety and health.

    Signed at Washington, DC, on May 25, 2018.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.

Amendments to Standards

    For the reasons stated in the preamble of this proposed rule, OSHA
proposes to amend 29 CFR part 1910 as follows:

PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS

Subpart Z--Toxic and Hazardous Substances

0
1. The authority citation for subpart Z of 29 CFR part 1910 is revised
to read as follows:

    Authority:  29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR
65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR
3912); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
    Section 1910.1030 also issued under Public Law 106-430, 114
Stat. 1901.
    Section 1910.1201 also issued under 40 U.S.C. 5101 et seq.

0
2. Amend Sec.  1910.1024 by revising paragraph (o)(2) to read as
follows:

Sec.  1910.1024  Beryllium.

* * * * *
    (o) * * *
    (2) Compliance dates. (i) Obligations contained in paragraphs (c),
(d), (g), (k), and (l) of this standard: March 12, 2018;
    (ii) Change rooms and showers required by paragraph (i) of this
standard: March 11, 2019;
    (iii) Engineering controls required by paragraph (f) of this
standard: March 10, 2020; and
    (iv) All other obligations of this standard: December 12, 2018.
* * * * *
[FR Doc. 2018-11643 Filed 5-31-18; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Notices]
[Pages 40534-40536]
[FR Doc No: 2022-14430]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-2269 and FDA-2020-E-2270]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XEGLYZE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for XEGLYZE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination September 6, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by January 3, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 6, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2020-E-2269 and FDA-2020-E-2270 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; XEGLYZE.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, XEGLYZE
(abametapir). XEGLYZE is indicated for the topical treatment of head
lice infestation in patients 6 months of age and older. XEGLYZE should
be used in the context of an overall lice management program.
Subsequent to this approval, the USPTO received patent term restoration
applications for XEGLYZE (U.S. Patent Nos. 7,812,163; 8,212,038) from
Dr. Reddy's Laboratories, S.A., and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated April 5, 2021, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of XEGLYZE represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
XEGLYZE is 4,573 days. Of this time, 2,797 days occurred during the
testing phase of the regulatory review period, while 1,776 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 18, 2008. The applicant claims July 9, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was January 18, 2008,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: September 14,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for XEGLYZE (NDA 206966) was initially submitted on
September 14, 2015.
    3. The date the application was approved: July 24, 2020. FDA has
verified the applicant's claim that NDA 206966 was approved on July 24,
2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,826 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21

CFR 60.30), any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period. To meet its burden, the petition
must comply with all the requirements of Sec.  60.30, including but not
limited to: must be timely (see DATES), must be filed in accordance
with Sec.  10.20, must contain sufficient facts to merit an FDA
investigation, and must certify that a true and complete copy of the
petition has been served upon the patent applicant. (See H. Rept. 857,
part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14430 Filed 7-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56955-56957]
[FR Doc No: 2013-22400]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70360; File No. SR-BATS-2013-049]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Fees for Use of BATS Exchange, Inc.

September 10, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 30, 2013, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the

Exchange pursuant to BATS Rules 15.1(a) and (c). While changes to the
fee schedule pursuant to this proposal will be effective upon filing,
the changes will become operative on September 3, 2013.
---------------------------------------------------------------------------

    \5\ A Member is any registered broker or dealer that has been
admitted to membership in the Exchange.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to modify its fee schedule applicable to use
of the Exchange effective September 3, 2013, in order to modify pricing
related to executions that occur on NASDAQ OMX BX, Inc. (``NASDAQ BX'')
through the Exchange's TRIM routing strategy.\6\ NASDAQ BX implemented
certain pricing changes effective September 3, 2013, including
modification from a highest potential rebate \7\ of $0.0014 per share
when removing liquidity to a highest potential rebate of $0.0013 per
share when removing liquidity. To maintain a direct pass through of the
applicable economics for TRIM executions at NASDAQ BX (assuming the
Exchange is able to achieve the highest potential rebate), the Exchange
proposes to rebate $0.0013 per share for an order routed through its
TRIM routing strategy and executed on NASDAQ BX, rather than the rebate
of $0.0014 per share that it currently offers for such orders. The
Exchange is not proposing any other changes to its routing fees at this
time.
---------------------------------------------------------------------------

    \6\ As defined in BATS Rule 11.13(a)(3)(G).
    \7\ NASDAQ BX maintains a tiered pricing structure that results
in variable rebates and fees depending on the amount of liquidity
added or removed.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\8\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\9\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive. The Exchange believes that the
proposed changes to the Exchange's routing fee for TRIM executions at
NASDAQ BX are equitably allocated, fair and reasonable, and non-
discriminatory in that they are equally applicable to all Members and
are designed to mirror the rebate applicable to the execution if such
routed orders were executed directly by the Member at NASDAQ BX.
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    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
Because the market for order execution is extremely competitive,
Members may readily opt to disfavor the Exchange's routing services if
they believe that alternatives offer them better value. For orders
routed through the Exchange and executed at NASDAQ BX through the TRIM
routing strategy, the proposed fee change is designed to equal the
rebate that a Member would have received if such routed orders would
have been executed directly by a Member at NASDAQ BX.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and paragraph (f) of Rule 19b-4
thereunder.\11\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2013-049 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-BATS-2013-049. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such

filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-BATS-2013-049 and should be submitted on or before
October 7, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-22400 Filed 9-13-13; 8:45 am]
BILLING CODE 8011-01-P