[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Proposed Rules]
[Pages 49956-49968]
[FR Doc No: 2015-19226]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1902, 1903, 1904, 1952, 1953, 1954, 1955, and 1956

[Docket No. OSHA-2014-0009]
RIN 1218-AC76

Streamlining of Provisions on State Plans for Occupational Safety
and Health

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

ACTION: Notice of proposed rulemaking.

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SUMMARY: This document primarily proposes to amend OSHA regulations to
remove the detailed descriptions of State plan coverage, purely
historical data, and other unnecessarily codified information. In
addition, this document proposes to move most of the general provisions
of subpart A of part 1952 into part 1902, where the general regulations
on State plan criteria are found. It also proposes to amend several
other OSHA regulations to delete references to part 1952, which would
no longer apply. The purpose of these proposed revisions is to
eliminate the unnecessary codification of material in the Code of
Federal Regulations and save the time and funds currently expended in
publicizing State plan revisions. The proposed streamlining of OSHA
State plan regulations would not change the areas of coverage or any
other substantive components of any State plan. It also does not affect
the rights and responsibilities of the State plans, or any employers or
employees, except to eliminate the burden on State plan designees to
keep paper copies of approved State plans and plan supplements in an
office, and to submit multiple copies of proposed State plan documents
to OSHA. This document also contains a request for comments for an
Information Collection Request (ICR) under the Paperwork Reduction Act
of 1995 (PRA), which covers all collection of information requirements
in OSHA State plan regulations.

DATES: Comments and additional materials (including comments on the
information-collection (paperwork) determination described under the
section titled SUPPLEMENTARY INFORMATION of this document) must be
submitted (post-marked, sent or received) by September 17, 2015.

ADDRESSES: You may submit comments, identified by docket number OSHA-
2014-0009, or regulatory information number (RIN) 1218-AC76 by any of
the following methods:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions on-line for making
electronic submissions; or
    Fax: If your submission, including attachments, does not exceed 10
pages, you may fax them to the OSHA Docket Office at<PHONE_NUMBER>; or
    U.S. mail, hand delivery, express mail, messenger or courier
service: You must submit your comments and attachments to the OSHA
Docket Office, Docket No. OSHA-2014-0009, U.S. Department of Labor,
Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210;
telephone<PHONE_NUMBER> (OSHA's TTY number is<PHONE_NUMBER>).
Deliveries (hand, express mail, messenger and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m.-4:45 p.m., EST.
    Instructions for submitting comments: All submissions must include
the Docket Number (Docket No. OSHA-2014-0009) or the RIN number (RIN
1218-AC76) for this rulemaking. Because of security-related procedures,
submission by regular mail may result in significant delay. Please
contact the OSHA Docket Office for information about security
procedures for making submissions by hand delivery, express delivery
and messenger or courier service.
    All comments, including any personal information you provide, are
placed in the public docket without change and may be made available
online at http://www.regulations.gov. Therefore, caution should be
taken in submitting personal information, such as Social Security
numbers and birth dates.
    Docket: To read or download submissions in response to this Federal
Register document, go to docket number OSHA-2014-0009, at http://www.regulations.gov. All submissions are listed in the http://www.regulations.gov index: However, some information (e.g., copyrighted
material) is not publicly available to read or download through that
Web page. All submissions, including copyrighted material, are
available for inspection at the OSHA Docket Office.
    Electronic copies of this Federal Register document are available
at http://www.regulations.gov. This document, as well as news releases
and other relevant information, is available at OSHA's Web page at
http://www.osha.gov. A copy of the documents referenced in this
document may be obtained from: Office of State Programs, Directorate of
Cooperative and State Programs, Occupational Safety and Health
Administration, Room N3700, 200 Constitution Avenue NW., Washington, DC
20210,<PHONE_NUMBER>, fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Francis
Meilinger, OSHA Office of Communications, Room N-3647, U.S. Department
of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone
(202) 693-1999; email<EMAIL_ADDRESS>    For general and technical information: Douglas J. Kalinowski,
Director, OSHA Directorate of Cooperative and State Programs, Room N-
3700, U.S. Department of Labor, 200 Constitution Avenue NW, Washington
DC 20210; telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    Section 18 of the Occupational Safety and Health Act of 1970 (the
Act), 29 U.S.C. 667, provides that States that desire to assume
responsibility for the development and enforcement of occupational
safety and health standards may do so by submitting, and obtaining
federal approval of, a State plan. States may obtain approval for plans
that cover private-sector employers and State and local government
employers (comprehensive plans) or for plans that only cover State and
local government employers.
    From time to time changes are made to these State plans,
particularly with respect to the issues which they cover. Procedures
for approval of and changes to comprehensive State plans are set forth
in the regulations at 29 CFR part 1902 and 29 CFR part 1953. A
description of each comprehensive State plan has previously been set
forth in 29 CFR part 1952, subparts C-FF. These descriptions have
contained the following sections: Description of the plan,
Developmental schedule, Completion of developmental steps and
certifications, Staffing benchmarks, Final approval determination (if
applicable), Level of Federal enforcement, Location where the State
plan may be physically inspected, and Changes to approved plan.
    Procedures for approval of a State plan covering State and local
government employees only are set forth in the regulations at 29 CFR
part 1956, subparts A-C. Pursuant to 29 CFR 1956.21, procedures for
changes to these State plans are also governed by 29 CFR part 1953. A
description of each State

plan for State and local government employees only has previously been
set forth in 29 CFR part 1956, subparts E-I. These subparts have
contained the following sections: Description of the plan as certified
(or as initially approved), Developmental schedule, Completed
developmental steps and certification (if applicable), and Location of
basic State plan documentation.
    The area of coverage of each State plan has previously been
codified at 29 CFR part 1952 under each State's subpart within the
sections entitled ``Final approval determination'' and ``Level of
Federal enforcement,'' and in 29 CFR part 1956 within the section on
the description of the plan. Therefore, any change to a State plan's
coverage or other part of the State plan description contained in 29
CFR part 1952 or 29 CFR part 1956 has thus far necessitated an
amendment to the language of the CFR, which has required the
expenditure of additional time and resources, such as those needed for
printing. Furthermore, reprinting parts 1952 and 1956 in the annual CFR
publication has necessitated the expenditure of additional time and
resources. The individual descriptions of the State plans consisted of
103 pages in the July 1, 2013 revision of title 29, part 1927 to end,
of the CFR. For these reasons, OSHA proposes to streamline parts 1952
and 1956 to delete the detailed descriptions of State plan coverage,
purely historical data, and other unnecessarily codified information,
thus saving time and funds currently expended in publishing changes to
these parts of the CFR.
    There is no legal statutory requirement that individual State plans
be described in the CFR. The CFR is a codification of the documents of
each agency of the Government having general applicability and legal
effect, issued or promulgated by the agency in the Federal Register. 44
U.S.C. 1510(a) and (b). The description of a State plan is not a
document of general applicability; it only applies to a particular
State. Nevertheless, in this document, OSHA sets forth brief
descriptions of each State plan that will be retained in the CFR in
part 1952 in order to make this information readily available to those
conducting legal research and relying on the CFR. Brief descriptions of
comprehensive plans are included in subpart A of part 1952 and brief
descriptions of State plans covering State and local government
employees only are included in subpart B of part 1952. Any significant
changes that would make these descriptions outdated, such as a
withdrawal or grant of final approval, will continue to be codified in
the CFR.
    The proposed partial deletions of the State plan descriptions from
the CFR will not decrease transparency. Each section of part 1952 would
continue to note each State plan, the date of its initial approval,
and, where applicable, the date of final approval, the existence of an
operational status agreement, and the approval of staffing requirements
(``benchmarks''). Each section would have a general statement of
coverage indicating whether the plan covers all private-sector and
State and local government employers, with some exceptions, or State
and local government employers only. Each section would also note that
current information about these coverage exceptions and additional
details about the State plan could be obtained from the Web page on the
OSHA public Web site describing the particular State plan (a link would
be referenced). The OSHA Web page for each State plan would also be
updated to include the latest information on coverage and other
important changes. Furthermore, the other information about the State
plan that is currently in the CFR would still be available in the
Federal Register, and could be searched electronically at https://www.federalregister.gov and would also be available in printed form.
The Federal Register could also be searched electronically on
commercially available legal databases. When changes are made to State
plan coverage, all of the information on coverage would be reprinted in
the Federal Register along with the change, so that readers would not
have to search through many Federal Register notices to obtain a
comprehensive description of coverage.
    In addition to changing the individual descriptions of all State
plans within part 1952, OSHA proposes to make several other
housekeeping changes. First, OSHA proposes to move the provisions of
subpart A of part 1952 that pertain to the required criteria for State
plans, to part 1902. (The following provisions would be moved to part
1902: 29 CFR 1952.4, Injury and illness recording and reporting
requirements; 29 CFR 1952.6, Partial approval of State plans; 29 CFR
1952.8, Variations, tolerances, and exemptions affecting the national
defense; 29 CFR1952.9, Variances affecting multi-state employers; 29
CFR 1952.10, Requirements for approval of State posters; and 29 CFR
1952.11, State and local government employee programs.) As a result,
the complete criteria for State plans would be located within part
1902.
    OSHA proposes to delete 29 CFR 1952.1 (Purpose and scope) and 29
CFR 1952.2 (Definitions) because the changes described above and the
restructuring of part 1952 would make these provisions unnecessary.
OSHA proposes to delete 29 CFR 1952.3 (Developmental plans) because
that material is covered by 29 CFR 1902.2(b). The text of 29 CFR 1952.5
(Availability of State plans) requires complete copies of each State
plan, including supplements thereto, to be kept at OSHA's National
Office, the office of the nearest OSHA Regional Administrator, and the
office of the State plan agency listed in part 1952. OSHA proposes to
delete 29 CFR 1952.5 because with the widespread use of electronic
document storage and the Internet, it is no longer necessary to
physically store such information in order to make it available to the
public. Information about State plans can now be found on each State's
Web site, as well as on OSHA's Web site. For the same reasons, OSHA
proposes to delete the language in 29 CFR 1953.3(c) (Plan supplement
availability) which discusses making State plan documents available for
public inspection and photocopying in designated offices. OSHA proposes
to delete the text of 29 CFR 1952.7(a), which deals with product
standards, because the explanation of section 18(c)(2) of the Act, 29
U.S.C. 667(c)(2), on product standards is already covered by 29 CFR
1902.3(c)(2). However, OSHA proposes to move Sec.  1952.7(b) to the end
of Sec.  1902.3(c)(2) because that material was not previously
included. In addition, OSHA proposes to delete references to part 1952
from several other parts of the regulations, such as parts 1903, 1904,
1953, 1954 and 1955, because these references would no longer be
accurate due to the proposed changes. Where appropriate, OSHA proposes
to insert references to the newly numbered part 1902.
    Finally, OSHA proposes to make some further minor changes to part
1902. The text of 29 CFR 1902.3(j), which briefly describes State plans
covering State and local government employees, would be deleted because
a more detailed description of State plan coverage of State and local
government employees, formerly set forth in 29 CFR 1952.11, would be
incorporated into 29 CFR part 1902 as Sec.  1902.4(d). This change
would necessitate the re-designation of paragraphs in Sec.  1902.3.
Also, OSHA proposes to change 29 CFR 1902.10(a) to reduce the number of
copies a State agency must submit in order to obtain approval of a
State plan. With the advent of computer

technology, the submission of extra paper copies is not necessary. OSHA
also proposes to delete outdated references to an address in 29 CFR
1902.11(c) and (d).

Administrative Procedure Act and Direct Final Rulemaking

    The notice and comment rulemaking procedures of section 553 of the
Administrative Procedure Act (APA) do not apply ``to interpretive
rules, general statements of policy or, rules of agency organization,
procedure, or practice'' or when the agency for good cause finds that
``notice and public procedure thereon are impracticable, unnecessary,
or contrary to the public interest.'' 5 U.S.C. 553(b)(A), (B). The
proposed revisions set forth in this document would not implement any
substantive change in the development, operation or monitoring of State
plans. Nor would these revisions change the coverage or other
enforcement responsibilities of the State plans or federal OSHA. The
compliance obligations of employers and the rights of employees remain
unaffected. Therefore, OSHA for good cause finds that notice and
comment is unnecessary. In addition, the proposed elimination of the
requirement to make paper copies of State plan documents available in
certain federal and State offices and the reduction of the number of
copies of a proposed State plan which a State agency must submit would
be purely procedural changes. Future alterations to State plan coverage
would only require a simple, easily searchable notice to be published
in the Federal Register and an update to OSHA's State plan Web page.
    Although neither the Act nor the APA requires notice and comment
rulemaking here, OSHA, as a matter of policy, is providing interested
persons 30 days to submit comments. OSHA believes a 30-day timeframe
for submitting comments is appropriate because the proposal is
primarily a set of non-substantive technical changes.
    OSHA is publishing a companion direct final rule along with this
proposed rule in the ``Final Rules'' section of this Federal Register.
An agency uses direct final rulemaking when it anticipates that a rule
will not be controversial. OSHA does not consider this proposed rule to
be such because it primarily consists of changes in the organization of
State plan information housed within the CFR, and the resultant re-
numbering and updates to cross-references throughout the CFR.
    In direct final rulemaking, an agency publishes a direct final rule
in the Federal Register with a statement that the rule will become
effective unless the agency receives significant adverse comment within
a specified period. The agency may publish an identical proposed rule
at the same time. If the agency receives no significant adverse comment
in response to the direct final rule, the agency typically confirms the
effective date of a direct final rule through a separate Federal
Register document. If the agency receives a significant adverse
comment, the agency withdraws the direct final rule and treats such
comment as a response to the proposed rule. For purposes of this
proposed rule and the companion direct final rule, a significant
adverse comment is one that explains why the rule would be
inappropriate.
    The comment period for the direct final rule runs concurrently with
that of this proposed rule. OSHA will treat comments received on the
companion direct final rule as comments regarding the proposed rule.
OSHA also will consider significant adverse comment submitted to this
proposed rule as comment to the companion direct final rule. If OSHA
receives no significant adverse comment to either this proposal or the
companion direct final rule, OSHA will publish a Federal Register
document confirming the effective date of the direct final rule and
withdrawing this companion proposed rule. Such confirmation may include
minor stylistic or technical changes to the document. If OSHA receives
a significant adverse comment on either the direct final rule or this
proposed rule, it will publish a timely withdrawal of the companion
direct final rule and proceed with this proposed rule. In the event
that OSHA withdraws the direct final rule because of significant
adverse comment, OSHA will consider all timely comments received in
response to the direct final rule when it continues with the proposed
rule. After carefully considering all comments to the direct final rule
and the proposal, OSHA will decide whether to publish a new final rule.

OMB Review Under the Paperwork Reduction Act of 1995

    This proposed rule revises ``collection of information''
(paperwork) requirements that are subject to review by the Office of
Management and Budget (``OMB'') under the Paperwork Reduction Act of
1995 (``PRA-95''), 44 U.S.C. 3501 et seq., and OMB's regulations at 5
CFR part 1320. The Paperwork Reduction Act defines a ``collection of
information'' as ``the obtaining, causing to be obtained, soliciting,
or requiring the disclosure to third parties or the public of facts or
opinions by or for an agency regardless of form or format'' (44 U.S.C.
3502(3)(A)). OMB approved the collection of information requirements
currently contained in the regulations associated with OSHA-approved
State Plans (29 CFR parts 1902, 1952, 1953, 1954, and 1956) under OMB
Control Number 1218-0247.
    Through emergency processing procedures, OSHA submitted a request
that OMB revise the collection of information requirements contained in
these regulations within 45 days of publication. The proposed rule
would not impose new collection of information requirements for
purposes of PRA-95; therefore, the Agency does not believe that this
rule will impact burden hours or costs. The proposed rule would move
the current collection of information requirement provisions of subpart
A of part 1952, pertaining to required criteria for State plans, to
part 1902. The proposed rule would delete the text of current 29 CFR
1952.5 (Availability of State plans) requiring complete copies of each
State plan, including supplements thereto, to be kept at OSHA's
National Office, the nearest OSHA Regional Office, and the office of
the State plan agency. The rule would also delete the language in
current 29 CFR 1953.3(c) (Plan supplement availability) which discusses
making State plan documents available for public inspection and
photocopying in designated offices. The rule would also reduce from ten
to one the number of copies of the State Plan which a State agency must
submit under 29 CFR 1902.10(a) in order to obtain approval of the State
plan. Finally, the proposed rule would revise regulations containing
current collection of information requirements at 29 CFR parts 1902,
1952, 1953, 1954, and 1956 to delete or update cross-references, remove
duplicative provisions, and re-designate paragraphs.
    OSHA has submitted an ICR addressing the collection of information
requirements identified in this rule to OMB for review (44 U.S.C.
3507(d)). OSHA solicits comments on the proposed extension and revision
of the collection of information requirements and the estimated burden
hours associated with the regulations associated with OSHA-approved
State Plans, including comments on the following:
    Whether the proposed collection of information requirements are
necessary for the proper performance of the Agency's functions,
including whether the information is useful;
    The accuracy of OSHA's estimate of the burden (time and cost) of
the information collection requirements,

including the validity of the methodology and assumptions used;
    Enhancing the quality, utility, and clarity of the information
collected; and
    Minimizing the burden on employers who must comply, for example, by
using automated or other technological techniques for collecting and
transmitting information.
    Pursuant to 5 CFR 1320.5(a)(1)(iv), OSHA provides the following
summary of the Occupational Safety and Health State Plans Information
Collection Request (ICR):
    1. Type of Review: Revision of a currently approved collection.
    2. Title: Occupational Safety and Health State Plans
    3. OMB Control Number: 1218-0247.
    4. Description of Collection of Information Requirements: The
proposed collection of information requirements, contained in the
regulations associated with this rule are set forth below. The
citations reflect the changes in this notice of proposed rulemaking and
the accompanying direct final rule.

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                                              Collection of Information
                   Part                             Requirements
------------------------------------------------------------------------
29 CFR 1902...............................  1902.2(a), 1902.2(b),
                                             1902.2(c)(2), 1902.2(c)(3),
                                             1902.3(a), 1902.3(b)(1)-
                                             (b)(3), 1902.3(c)(1),
                                             1902.3(d)(1), 1902.3(d)(2),
                                             1902.3(e), 1902.3(f),
                                             1902.3(g), 1902.3(h),
                                             1902.3(i), 1902.3(j),
                                             1902.3(k), 1902.4(a),
                                             1902.4(a)(1), 1902.4(a)(2),
                                             1902.4(b)(1), 1902.4(b)(2),
                                             1902.4(b)(2)(i)-(b)(2)(vii)
                                             , 1902.4(c)(1),
                                             1902.4(c)(2),
                                             1902.4(c)(2)(i)-(c)(2)(xiii
                                             ), 1902.4(d)(1),
                                             1902.4(d)(2),
                                             1902.4(d)(2)(i)-(d)(2)(iii)
                                             (k), 1902.4(e), 1902.7(a),
                                             1902.7(d), 1902.9(a)(1),
                                             1902.9(a)(5),
                                             1902.9(a)(5)(i)-(a)(5)(xii)
                                             , 1902.10, 1902.10(a),
                                             1902.10(b), 1902.31,
                                             1902.32(e), 1902.33,
                                             1902.38(b), 1902.39(a),
                                             1902.39(b), 1902.44(a),
                                             1902.46(d), 1902.46(d)(1).
29 CFR 1952.
29 CFR 1953...............................  1953.1(a), 1953.1(b),
                                             1953.1(c), 1953.2(c)-
                                             1953.2(j), 1953.3(a)-(e),
                                             1953.4(a)(1)-1953.4(a)(5),
                                             1953.4(b)(1)-1953.4(b)(7),
                                             1953.4(c)(1)-1953.4(c)(5),
                                             1953.4(d)(1), 1953.4(d)(2),
                                             1953.5(a)(1)-1953.5(a)(3),
                                             1953.5(b)(1)-(b)(3),
                                             1953.6(a), 1953.6(e).
29 CFR 1954...............................  1954.2(a), 1954.2(b),
                                             1954.2(b)(1)-1954.2(b)(3),
                                             1954.2(c), 1954.2(d),
                                             1954.2(e), 1954.2(e)(1)-
                                             (e)(4), 1954.3(f)(1),
                                             1954.3(f)(1)(i)-1954.3(f)(1
                                             )(v), 1954.10(a),
                                             1954.10(b), 1954.10(c),
                                             1954.11, 1954.20(a),
                                             1954.20(b), 1954.20(c)(1),
                                             1954.20(c)(2),
                                             1954.20(c)(2)(i)-1954.20(c)
                                             (2)(iv), 1954.21(a),
                                             1954.21(b), 1954.21(c),
                                             1954.21(d), 1954.22(a)(1),
                                             1954.22(a)(2).
29 CFR 1955.
29 CFR 1956...............................  1956.2(b)(1),
                                             1956.2(b)(1)(i)-(ii),
                                             1956.2(b)(2), 1956.2(b)(3),
                                             1956.2(c)(1), 1956.2(c)(2),
                                             1956.10(a), 1956.10(b)(1),
                                             1956.10(b)(2),
                                             1956.10(b)(3), 1956.10(c),
                                             1956.10(d)(1),
                                             1956.10(d)(2), 1956.10(e),
                                             1956.10(f), 1956.10(g),
                                             1956.10(h), 1956.10(i),
                                             1956.10(j), 1956.11(a),
                                             1956.11(a)(1),
                                             1956.11(a)(2), 1956.11(d),
                                             1956.20, 1956.21, 1956.22,
                                             1956.23.
------------------------------------------------------------------------

    5. Affected Public: Designated state government agencies that are
seeking or have submitted and obtained approval for State Plans for the
development and enforcement of occupational safety and health
standards.
    6. Number of Respondents: 28.
    7. Frequency: On occasion; quarterly; annually.
    8. Average Time per Response: Varies from 30 minutes (.5 hour) to
respond to an information inquiry to 80 hours to document state annual
performance goals.
    9. Estimated Total Burden Hours: The Agency does not believe that
this rule will impact burden hours or costs. However, based on updated
data and estimates, the Agency is requesting an adjustment increase of
173 burden hours, from 11,196 to 11,369 burden hours. This burden hour
increase is the result of the anticipated increase in the submission of
state plan changes associated with one state (Maine) actively
implementing a new State Plan. The burden hour increase was partially
offset by the decrease in the estimated number of state-initiated state
plan changes.
    10. Estimated Costs (Operation and Maintenance): There are no
capital costs for this collection of information.
    Submitting comments. In addition to having an opportunity to file
comments with the Department, the PRA provides that an interested party
may file comments on the collection of information requirements
contained in the rule directly with the Office of Management and
Budget, at the Office of Information and Regulatory Affairs, Attn: OMB
Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235,
725 17th Street NW., Washington, DC 20503; by Fax:<PHONE_NUMBER> (this
is not a toll-free number); or by email<EMAIL_ADDRESS>
Commenters are encouraged, but not required, to send a courtesy copy of
any comments to the Department. See ADDRESSES section of this preamble.
The OMB will consider all written comments that the agency receives
within forty-five (45) days of publication of this NPRM in the Federal
Register. In order to help ensure appropriate consideration, comments
should mention OMB control number 1218-0247. Comments submitted in
response to this document are public records; therefore, OSHA cautions
commenters about submitting personal information such as Social
Security numbers and date of birth.
    Docket and inquiries. To access the docket to read or download
comments and other materials related to this paperwork determination,
including the complete Information Collection Request (ICR) (containing
the Supporting Statement with attachments describing the paperwork
determinations in detail), use the procedures described under the
section of this document titled ADDRESSES. You also may obtain an
electronic copy of the complete ICR by visiting the Web page, http://www.reginfo.gov/public/do/PRAMain, select ``Department of Labor'' under
``Currently Under Review'' to view all of DOL's ICRs, including the ICR
related to this rulemaking. To make inquiries, or to request other
information, contact Mr. Todd Owen, Directorate of Standards and
Guidance, OSHA, Room N-3609, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER>.
    OSHA notes that a Federal agency cannot conduct or sponsor a
collection of information unless it is approved by OMB under the PRA
and displays a currently valid OMB control number, and the public is
not required to respond to a collection of information unless it
displays a currently valid OMB control number. Also, notwithstanding
any other provisions of law, no person shall be subject to penalty for
failing to comply with a collection of information if the collection of
information does not display a currently valid OMB control number.

Regulatory Flexibility Analysis, Unfunded Mandates, and Executive
Orders on the Review of Regulations

    In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et
seq. (as amended), OSHA examined the provisions of the proposal to
determine whether it would have a significant economic impact on a
substantial number of small entities. Since no employer of any size
would have any new compliance obligations, the Agency certifies that
the proposal would not have a significant economic impact on a
substantial number of small entities. OSHA also reviewed this proposal
in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA; 2
U.S.C. 1501 et seq.) and Executive Orders 12866 (58 FR 51735, September
30, 1993) and 13563 (76 FR 3821, January 21, 2011). Because this
proposal would impose no new compliance obligations, it would require
no additional expenditures by either private employers or State, local,
or tribal governments.
    Executive Order 13132, ``Federalism,'' (64 FR 43255, August 10,
1999) emphasizes consultation between Federal agencies and the States
on policies not required by statute which have federalism implications,
i.e., policies, such as regulations, which 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, or which
impose substantial direct compliance costs on State and local
governments. This proposal has no federalism implications and would not
impose substantial direct compliance costs on State or local
governments.
    OSHA has reviewed this proposal in accordance with Executive Order
13175, ``Consultation and Coordination with Indian Tribal
Governments,'' (65 FR 67249, November 6, 2000) and determined that the
proposal would 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.

List of Subjects in 29 CFR Parts 1902, 1903, 1904, 1952, 1953,
1954, 1955, and 1956

    Intergovernmental relations, Law enforcement, Occupational safety
and health.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave. NW., Washington, DC, authorized the preparation of
this proposal. OSHA is issuing this proposal under the authority
specified by Sections 8(c)(1), 8(c)(2), and 8(g)(2) and 18 of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 657(c)(1),
(c)(2), and (g)(2) and 667) and Secretary of Labor's Order No. 1-2012
(76 FR 3912).

    Signed at Washington, DC, on July 28, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

Amendments to Regulations

    For the reasons set forth in the preamble of this proposal, OSHA
proposes to amend 29 CFR parts 1902, 1903, 1904, 1952, 1953, 1954,
1955, and 1956 as follows:

PART 1902--STATE PLANS FOR THE DEVELOPMENT AND ENFORCEMENT OF STATE
STANDARDS

0
1. The authority citation for part 1902 is revised to read as follows:

    Authority: Secs. 8 and 18, 84 Stat. 1608 (29 U.S.C. 657, 667);
Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

Subpart B--Criteria for State Plans

0
2. Amend Sec.  1902.3 as follows:
0
a. Revise paragraph (c)(2);
0
b. Remove paragraph (j);
0
c. Redesignate paragraphs (k) and (l) as (j) and (k), respectively.
    The revision reads as follows:

Sec.  1902.3  Specific criteria.

* * * * *
    (c) * * *
    (2) The State plan shall not include standards for products
distributed or used in interstate commerce which are different from
Federal standards for such products unless such standards are required
by compelling local conditions and do not unduly burden interstate
commerce. This provision, reflecting section 18(c)(2) of the Act, is
interpreted as not being applicable to customized products or parts not
normally available on the open market, or to the optional parts or
additions to products which are ordinarily available with such optional
parts or additions. In situations where section 18(c)(2) is considered
applicable, and provision is made for the adoption of product
standards, the requirements of section 18(c)(2), as they relate to
undue burden on interstate commerce, shall be treated as a condition
subsequent in light of the facts and circumstances which may be
involved.
* * * * *
0
3. Amend Sec.  1902.4 by revising paragraph (d) and adding paragraph
(e) to read as follows:

Sec.  1902.4  Indices of effectiveness.

* * * * *
    (d) State and local government employee programs. (1) Each approved
State plan must contain satisfactory assurances that the State will, to
the extent permitted by its law, establish and maintain an effective
and comprehensive occupational safety and health program applicable to
all employees of public agencies of the State and its political
subdivisions which program is as effective as the standards contained
in an approved plan.
    (2) This criterion for approved State plans is interpreted to
require the following elements with regard to coverage, standards, and
enforcement:
    (i) Coverage. The program must cover all public employees over
which the State has legislative authority under its constitution. The
language in section 18(c)(6) which only requires such coverage to the
extent permitted by the State's law specifically recognizes the
situation where local governments exclusively control their own
employees, such as under certain home rule charters.
    (ii) Standards. The program must be as effective as the standards
contained in the approved plan applicable to private employers. Thus,
the same criteria and indices of standards effectiveness contained in
Sec. Sec.  1902.3(c) and 1902.4(a) and (b) would apply to the public
employee program. Where hazards are unique to public employment, all
appropriate indices of effectiveness, such as those dealing with
temporary emergency standards, development of standards, employee
information, variances, and protective equipment, would be applicable
to standards for such hazards.
    (iii) Enforcement. Although section 18(c)(6) of the Act requires
State public employee programs to be as effective as standards
contained in the State plan, minimum enforcement elements are required
to ensure an effective and comprehensive public employee program as
follows:
    (A) Regular inspections of workplaces, including inspections in
response to valid employee complaints;
    (B) A means for employees to bring possible violations to the
attention of inspectors;
    (C) Notification to employees, or their representatives, of
decisions that no

violations are found as a result of complaints by such employees or
their representatives, and informal review of such decisions;
    (D) A means of informing employees of their protections and
obligations under the Act;
    (E) Protection for employees against discharge of discrimination
because of the exercise of rights under the Act;
    (F) Employee access to information on their exposure to toxic
materials or harmful physical agents and prompt notification to
employees when they have been or are being exposed to such materials or
agents at concentrations or levels above those specified by the
applicable standards;
    (G) Procedures for the prompt restraint or elimination of imminent
danger situations;
    (H) A means of promptly notifying employers and employees when an
alleged violation has occurred, including the proposed abatement
requirements;
    (I) A means of establishing timetables for the correction of
violations;
    (J) A program for encouraging voluntary compliance; and
    (K) Such other additional enforcement provisions under State law as
may have been included in the State plan.
    (3) In accordance with Sec.  1902.3(b)(3), the State agency or
agencies designated to administer the plan throughout the State must
retain overall responsibility for the entire plan. Political
subdivisions may have the responsibility and authority for the
development and enforcement of standards: Provided, that the designated
State agency or agencies have adequate authority by statute,
regulation, or agreement to insure that the commitments of the State
under the plan will be fulfilled.
    (e) Additional indices. Upon his own motion or after consideration
of data, views and arguments received in any proceeding held under
subpart C of this part, the Assistant Secretary may prescribe
additional indices for any State plan which shall be in furtherance of
the purpose of this part, as expressed in Sec.  1902.1.
0
4. Add Sec. Sec.  1902.7 through 1902.09 to read as follows:
Sec.
* * * * *
1902.7 Injury and illness recording and reporting requirements.
1902.8 Variations and variances.
1902.9 Requirements for approval of State posters.
* * * * *

Sec.  1902.7  Injury and illness recording and reporting requirements.

    (a) Injury and illness recording and reporting requirements
promulgated by State-Plan States must be substantially identical to
those in 29 CFR part 1904 on recording and reporting occupational
injuries and illnesses. State-Plan States must promulgate recording and
reporting requirements that are the same as the Federal requirements
for determining which injuries and illnesses will be entered into the
records and how they are entered. All other injury and illness
recording and reporting requirements that are promulgated by State-Plan
States may be more stringent than, or supplemental to, the Federal
requirements, but, because of the unique nature of the national
recordkeeping program, States must consult with OSHA and obtain
approval of such additional or more stringent reporting and recording
requirements to ensure that they will not interfere with uniform
reporting objectives. State-Plan States must extend the scope of their
regulation to State and local government employers.
    (b) A State may not grant a variance to the injury and illness
recording and reporting requirements for private sector employers. Such
variances may only be granted by Federal OSHA to assure nationally
consistent workplace injury and illness statistics. A State may only
grant a variance to the injury and illness recording and reporting
requirements for State or local government entities in that State after
obtaining approval from Federal OSHA.
    (c) A State must recognize any variance issued by Federal OSHA.
    (d) A State may, but is not required, to participate in the Annual
OSHA Injury/Illness Survey as authorized by 29 CFR 1904.41. A
participating State may either adopt requirements identical to Sec.
1904.41 in its recording and reporting regulation as an enforceable
State requirement, or may defer to the Federal regulation for
enforcement. Nothing in any State plan shall affect the duties of
employers to comply with Sec.  1904.41, when surveyed, as provided by
section 18(c)(7) of the Act.

Sec.  1902.8  Variations and variances.

    (a) The power of the Secretary of Labor under section 16 of the Act
to provide reasonable limitations and variations, tolerances, and
exemptions to and from any or all provisions of the Act as he may find
necessary and proper to avoid serious impairment of the national
defense is reserved.
    (b) No action by a State under a plan shall be inconsistent with
action by the Secretary under this section of the Act.
    (c) Where a State standard is identical to a Federal standard
addressed to the same hazard, an employer or group of employers seeking
a temporary or permanent variance from such standard, or portion
thereof, to be applicable to employment or places of employment in more
than one State, including at least one State with an approved plan, may
elect to apply to the Assistant Secretary for such variance under the
provisions of 29 CFR part 1905.
    (d) Actions taken by the Assistant Secretary with respect to such
application for a variance, such as interim orders, with respect
thereto, the granting, denying, or issuing any modification or
extension thereof, will be deemed prospectively an authoritative
interpretation of the employer or employers' compliance obligations
with regard to the State standard, or portion thereof, identical to the
Federal standard, or portion thereof, affected by the action in the
employment or places of employment covered by the application.
    (e) Nothing herein shall affect the option of an employer or
employers seeking a temporary or permanent variance with applicability
to employment or places of employment in more than one State to apply
for such variance either to the Assistant Secretary or the individual
State agencies involved. However, the filing with, as well as granting,
denial, modification, or revocation of a variance request or interim
order by, either authority (Federal or State) shall preclude any
further substantive consideration of such application on the same
material facts for the same employment or place of employment by the
other authority.
    (f) Nothing herein shall affect either Federal or State authority
and obligations to cite for noncompliance with standards in employment
or places of employment where no interim order, variance, or
modification or extension thereof, granted under State or Federal law
applies, or to cite for noncompliance with such Federal or State
variance action.

Sec.  1902.9  Requirements for approval of State posters.

    (a)(1) In order to inform employees of their protections and
obligations under applicable State law, of the issues not covered by
State law, and of the continuing availability of Federal monitoring
under section 18(f) of the Act, States with approved plans shall
develop and require employers to post a State poster meeting the
requirements set out in paragraph (a)(5) of this section.

    (2) Such poster shall be substituted for the Federal poster under
section 8(c)(1) of the Act and Sec.  1903.2 of this chapter where the
State attains operational status for the enforcement of State standards
as defined in Sec.  1954.3(b) of this chapter.
    (3) Where a State has distributed its poster and has enabling
legislation as defined in Sec.  1954.3(b)(1) of this chapter but
becomes nonoperational under the provisions of Sec.  1954.3(f)(1) of
this chapter because of failure to be at least as effective as the
Federal program, the approved State poster may, at the discretion of
the Assistant Secretary, continue to be substituted for the Federal
poster in accordance with paragraph (a)(2) of this section.
    (4) A State may, for good cause shown, request, under 29 CFR part
1953, approval of an alternative to a State poster for informing
employees of their protections and obligations under the State plans,
provided such alternative is consistent with the Act, Sec.
1902.4(c)(2)(iv) and applicable State law. In order to qualify as a
substitute for the Federal poster under this paragraph (a), such
alternative must be shown to be at least as effective as the Federal
poster requirements in informing employees of their protections and
obligations and address the items listed in paragraph (a)(5) of this
section.
    (5) In developing the poster, the State shall address but not be
limited to the following items:
    (i) Responsibilities of the State, employers and employees;
    (ii) The right of employees or their representatives to request
workplace inspections;
    (iii) The right of employees making such requests to remain
anonymous;
    (iv) The right of employees to participate in inspections;
    (v) Provisions for prompt notice to employers and employees when
alleged violations occur;
    (vi) Protection for employees against discharge or discrimination
for the exercise of their rights under Federal and State law;
    (vii) Sanctions;
    (viii) A means of obtaining further information on State law and
standards and the address of the State agency;
    (ix) The right to file complaints with the Occupational Safety and
Health Administration about State program administration;
    (x) A list of the issues as defined in Sec.  1902.2(c) which will
not be covered by State plan;
    (xi) The address of the Regional Office of the Occupational Safety
and Health Administration; and
    (xii) Such additional employee protection provisions and
obligations under State law as may have been included in the approved
State plan.
    (b) Posting of the State poster shall be recognized as compliance
with the posting requirements in section 8(c)(1) of the Act and Sec.
1903.2 of this chapter, provided that the poster has been approved in
accordance with subpart B of part 1953 of this chapter. Continued
Federal recognition of the State poster is also subject to pertinent
findings of effectiveness with regard to the State program under 29 CFR
part 1954.

Subpart C--Procedures for Submission, Approval and Rejection of
State Plans

0
5. In Sec.  1902.10, revise paragraph (a) to read as follows:

Sec.  1902.10  Submission.

    (a) An authorized representative of the State agency or agencies
responsible for administering the plan shall submit one copy of the
plan to the appropriate Assistant Regional Director of the Occupational
Safety and Health Administration, U.S. Department of Labor. The State
plan shall include supporting papers conforming to the requirements
specified in the subpart B of this part, and the State occupational
safety and health standards to be included in the plan, including a
copy of any specific or enabling State laws and regulations relating to
such standards. If any of the representations concerning the
requirements of subpart B of this part are dependent upon any judicial
or administrative interpretations of the State standards or enforcement
provisions, the State shall furnish citations to any pertinent judicial
decisions and the text of any pertinent administrative decisions.
* * * * *
0
6. In Sec.  1902.11, revise paragraphs (c) and (d) to read as follows:

Sec.  1902.11  General notice.

* * * * *
    (c) The notice shall provide that the plan, or copies thereof,
shall be available for inspection and copying at the office of the
Director, Office of State Programs, Occupational Safety and Health
Administration, office of the Assistant Regional Director in whose
region the State is located, and an office of the State which shall be
designated by the State for this purpose.
    (d) The notice shall afford interested persons an opportunity to
submit in writing, data, views, and arguments on the proposal,
subjects, or issues involved within 30 days after publication of the
notice in the Federal Register. Thereafter the written comments
received or copies thereof shall be available for public inspection and
copying at the office of the Director, Office of State Programs,
Occupational Safety and Health Administration, office of the Assistant
Regional Director in whose region the State is located, and an office
of the State which shall be designated by the State for this purpose.
* * * * *
0
7. Add Sec.  1902.16 immediately following Sec.  1902.15 to read as
follows:

Sec.  1902.16  Partial approval of State plans.

    (a) The Assistant Secretary may partially approve a plan under this
part whenever:
    (1) The portion to be approved meets the requirements of this part;
    (2) The plan covers more than one occupational safety and health
issue; and
    (3) Portions of the plan to be approved are reasonably separable
from the remainder of the plan.
    (b) Whenever the Assistant Secretary approves only a portion of a
State lan, he may give notice to the State of an opportunity to show
cause why a proceeding should not be commenced for disapproval of the
remainder of the plan under subpart C of this part before commencing
such a proceeding.

Subpart D--Procedures for Determinations Under Section 18(e) of the
Act

0
8. In Sec.  1902.31, revise the definition of ``Development step'' to
read as follows:

Sec.  1902.31  Definitions.

* * * * *
    Development step includes, but is not limited to, those items
listed in the published developmental schedule, or any revisions
thereof, for each plan. A developmental step also includes those items
specified in the plan as approved under section 18(c) of the Act for
completion by the State, as well as those items which under the
approval decision were subject to evaluations and changes deemed
necessary as a result thereof to make the State program at least as
effective as the Federal program within the 3 years developmental
period. (See 29 CFR 1953.4(a)).
* * * * *
0
9. Revise Sec.  1902.33 to read as follows:

Sec.  1902.33  Developmental period.

    Upon the commencement of plan operations after the initial approval
of a State's plan by the Assistant Secretary, a State has three years
in which to complete all of the developmental steps

specified in the plan as approved. Section 1953.4 of this chapter sets
forth the procedures for the submission and consideration of
developmental changes by OSHA. Generally, whenever a State completes a
developmental step, it must submit the resulting plan change as a
supplement to its plan to OSHA for approval. OSHA's approval of such
changes is then published in the Federal Register.
0
10. In Sec.  1902.34, revise paragraph (c) to read as follows:

Sec.  1902.34  Certification of completion of developmental steps.

* * * * *
    (c) After a review of the certification and the State's plan, if
the Assistant Secretary finds that the State has completed all the
developmental steps specified in the plan, he shall publish the
certification in the Federal Register.

Sec.  1902.41  [Amended]

0
11. In Sec.  1902.41, remove paragraph (c) and redesignate paragraph
(d) as (c).
0
12. In Sec.  1902.43, revise paragraph (a)(3) to read as follows:

Sec.  1902.43  Affirmative 18(e) decision.

    (a) * * *
    (3) An amendment to the appropriate section of part 1952 of this
chapter;
* * * * *

PART 1903--INSPECTIONS, CITATIONS AND PROPOSED PENALTIES

0
13. The authority citation for part 1903 is revised to read as follows:

    Authority:  Secs. 8 and 9 (29 U.S.C. 657, 658); 5 U.S.C. 553;
Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

0
14. In Sec.  1903.2, revise paragraph (a)(2) to read as follows:

Sec.  1903.2  Posting of notice; availability of the Act, regulations
and applicable standard.

    (a) * * *
    (2) Where a State has an approved poster informing employees of
their protections and obligations as defined in Sec.  1902.9 of this
chapter, such poster, when posted by employers covered by the State
plan, shall constitute compliance with the posting requirements of
section 8(c)(1) of the Act. Employers whose operations are not within
the issues covered by the State plan must comply with paragraph (a)(1)
of this section.
* * * * *

PART 1904--RECORDING AND REPORTING OCCUPATIONAL INJURIES AND
ILLNESSES

0
15. The authority citation for part 1904 is revised to read as follows:

    Authority: 29 U.S.C. 657, 658, 660, 666, 669, 673, Secretary of
Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

Subpart D--Other OSHA Injury and Illness Recordkeeping Requirements

0
16. In Sec.  1904.37, revise paragraph (a) to read as follows:

Sec.  1904.37  State recordkeeping requirements.

    (a) Basic requirement. Some States operate their own OSHA programs,
under the authority of a State plan as approved by OSHA. States
operating OSHA-approved State plans must have occupational injury and
illness recording and reporting requirements that are substantially
identical to the requirements in this part (see 29 CFR 1902.3(j), 29
CFR 1902.7, and 29 CFR 1956.10(i)).
* * * * *

PART 1952--APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS

0
17. The authority citation for part 1952 is revised to read as follows:

    Authority:  Sec. 18, 84 Stat. 1608 (29 U.S.C. 667); 29 CFR part
1902; Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012).

0
18. Revise subpart A to read as follows:
Subpart A--List of Approved State Plans for Private-Sector and State
and Local Government Employees
Sec.
1952.1 South Carolina.
1952.2 Oregon.
1952.3 Utah.
1952.4 Washington.
1952.5 North Carolina.
1952.6 Iowa.
1952.7 California.
1952.8 Minnesota.
1952.9 Maryland.
1952.10 Tennessee.
1952.11 Kentucky.
1952.12 Alaska.
1952.13 Michigan.
1952.14 Vermont.
1952.15 Nevada.
1952.16 Hawaii.
1952.17 Indiana.
1952.18 Wyoming.
1952.19 Arizona.
1952.20 New Mexico.
1952.21 Virginia.
1952.22 Puerto Rico.

Subpart A--List of Approved State Plans for Private-Sector and
State and Local Government Employees

Sec.  1952.1  South Carolina.

    (a) The South Carolina State plan received initial approval on
December 6, 1972.
    (b) The South Carolina State plan received final approval on
December 18, 1987.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance officer staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984, South
Carolina, in conjunction with OSHA, completed a reassessment of the
staffing levels initially established in 1980 and proposed revised
compliance staffing benchmarks of 17 safety and 12 health compliance
officers. After opportunity for public comment and service on the AFL-
CIO, the Assistant Secretary approved these revised staffing
requirements on January 17, 1986.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/south_carolina.html.

Sec.  1952.2  Oregon.

    (a) The Oregon State plan received initial approval on December 28,
1972.
    (b) The Oregon State plan received final approval on May 12, 2005.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (``benchmarks'') necessary for a ``fully
effective'' enforcement program were required for each State operating
an approved State plan. In October 1992, Oregon completed, in
conjunction with OSHA, a reassessment of the health staffing level
initially established in 1980 and proposed a revised health benchmark
of 28 health compliance officers. Oregon elected to retain the safety
benchmark level established in the 1980 Report to the Court of the U.S.
District Court for the District of Columbia in 1980 of 47 safety
compliance officers. After opportunity for public comment and service
on the AFL-CIO, the Assistant Secretary approved these revised staffing
requirements on August 11, 1994.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and

local government employers and employees, within the State. For current
information on these exceptions and for additional details about the
plan, please visit http://www.osha.gov/dcsp/osp/stateprogs/oregon.html.

Sec.  1952.3  Utah.

    (a) The Utah State plan received initial approval on January 10,
1973.
    (b) The Utah State plan received final approval on July 16, 1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984, Utah,
in conjunction with OSHA, completed a reassessment of the levels
initially established in 1980 and proposed revised compliance staffing
benchmarks of 10 safety and 9 health compliance officers. After
opportunity for public comments and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements
effective July 16, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/utah.html.

Sec.  1952.4  Washington.

    (a) The Washington State plan received initial approval on January
26, 1973.
    (b) OSHA entered into an operational status agreement with
Washington.
    (c) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/washington.html.

Sec.  1952.5  North Carolina.

    (a) The North Carolina State plan received initial approval on
February 1, 1973.
    (b) The North Carolina State plan received final approval on
December 18, 1996.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (``benchmarks'') necessary for a ``fully
effective'' enforcement program were required for each State operating
an approved State plan. In September 1984, North Carolina, in
conjunction with OSHA, completed a reassessment of the levels initially
established in 1980 and proposed revised benchmarks of 50 safety and 27
health compliance officers. After opportunity for public comment and
service on the AFL-CIO, the Assistant Secretary approved these revised
staffing requirements on January 17, 1986. In June 1990, North Carolina
reconsidered the information utilized in the initial revision of its
1980 benchmarks and determined that changes in local conditions and
improved inspection data warranted further revision of its benchmarks
to 64 safety inspectors and 50 industrial hygienists. After opportunity
for public comment and service on the AFL-CIO, the Assistant Secretary
approved these revised staffing requirements on June 4, 1996.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/north_carolina.html.

Sec.  1952.6  Iowa.

    (a) The Iowa State plan received initial approval on July 20, 1973.
    (b) The Iowa State plan received final approval on July 2, 1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984, Iowa,
in conjunction with OSHA, completed a reassessment of the levels
initially established in 1980 and proposed revised compliance staffing
benchmarks of 16 safety and 13 health compliance officers. After
opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements
effective July 2, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/iowa.html.

Sec.  1952.7  California.

    (a) The California State plan received initial approval on May 1,
1973.
    (b) OSHA entered into an operational status agreement with
California.
    (c) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/california.html.

Sec.  1952.8  Minnesota.

    (a) The Minnesota State plan received initial approval on June 8,
1973.
    (b) The Minnesota State plan received final approval on July 30,
1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984
Minnesota, in conjunction with OSHA, completed a reassessment of the
levels initially established in 1980 and proposed revised compliance
staffing benchmarks of 31 safety and 12 health compliance officers.
After opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
July 30, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/minnesota.html.

Sec.  1952.9  Maryland.

    (a) The Maryland State plan received initial approval on July 5,
1973.
    (b) The Maryland State plan received final approval on July 18,
1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984
Maryland, in conjunction with OSHA, completed a reassessment of the
levels initially established in 1980 and proposed revised compliance
staffing benchmarks of 36 safety and 18 health compliance officers.
After opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
July 18, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current

information on these exceptions and for additional details about the
plan, please visit http://www.osha.gov/dcsp/osp/stateprogs/maryland.html.

Sec.  1952.10  Tennessee.

    (a) The Tennessee State plan received initial approval on July 5,
1973.
    (b) The Tennessee State plan received final approval on July 22,
1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984
Tennessee, in conjunction with OSHA, completed a reassessment of the
levels initially established in 1980 and proposed revised compliance
staffing benchmarks of 22 safety and 14 health compliance officers.
After opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
July 22, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/tennessee.html.

Sec.  1952.11  Kentucky.

    (a) The Kentucky State plan received initial approval on July 31,
1973.
    (b) The Kentucky State plan received final approval on June 13,
1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984
Kentucky, in conjunction with OSHA, completed a reassessment of the
levels initially established in 1980 and proposed revised compliance
staffing benchmarks of 23 safety and 14 health compliance officers.
After opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
June 13, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/kentucky.html.

Sec.  1952.12  Alaska.

    (a) The Alaska State plan received initial approval on August 10,
1973.
    (b) The Alaska State plan received final approval on September 28,
1984.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. Alaska's compliance
staffing benchmarks are 4 safety and 5 health compliance officers.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/alaska.html.

Sec.  1952.13  Michigan.

    (a) The Michigan State plan received initial approval on October 3,
1973.
    (b) OSHA entered into an operational status agreement with
Michigan.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (``benchmarks'') necessary for a ``fully
effective'' enforcement program were required for each State operating
an approved State plan. In 1992, Michigan completed, in conjunction
with OSHA, a reassessment of the levels initially established in 1980
and proposed revised benchmarks of 56 safety and 45 health compliance
officers. After opportunity for public comment and service on the AFL-
CIO, the Assistant Secretary approved these revised staffing
requirements on April 20, 1995.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit https://www.osha.gov/dcsp/osp/stateprogs/michigan.html.

Sec.  1952.14  Vermont.

    (a) The Vermont State plan received initial approval on October 16,
1973.
    (b) OSHA entered into an operational status agreement with Vermont.
    (c) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/vermont.html.

Sec.  1952.15  Nevada.

    (a) The Nevada State plan received initial approval on January 4,
1974.
    (b) The Nevada State plan received final approval on April 18,
2000.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In July 1986 Nevada, in
conjunction with OSHA, completed a reassessment of the levels initially
established in 1980 and proposed revised compliance staffing benchmarks
of 11 safety and 5 health compliance officers. After opportunity for
public comment and service on the AFL-CIO, the Assistant Secretary
approved these revised staffing requirements on September 2, 1987.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/nevada.html.

Sec.  1952.16  Hawaii.

    (a) The Hawaii State plan received initial approval on January 4,
1974.
    (b) The Hawaii State plan received final approval on May 4, 1984.
    (c) On September 21, 2012 OSHA modified the State Plan's approval
status from final approval to initial approval, and reinstated
concurrent federal enforcement authority pending the necessary
corrective action by the State Plan in order to once again meet the
criteria for a final approval determination. OSHA and Hawaii entered
into an operational status agreement to provide a workable division of
enforcement responsibilities.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/hawaii.html.

Sec.  1952.17  Indiana.

    (a) The Indiana State plan received initial approval on March 6,
1974.
    (b) The Indiana State plan received final approval on September 26,
1986.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to

be established for each State operating an approved State plan. In
September 1984 Indiana, in conjunction with OSHA, completed a
reassessment of the levels initially established in 1980 and proposed
revised compliance staffing benchmarks of 47 safety and 23 health
compliance officers. After opportunity for public comment and service
on the AFL-CIO, the Assistant Secretary approved these revised staffing
requirements on January 17, 1986.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/indiana.html.

Sec.  1952.18  Wyoming.

    (a) The Wyoming State plan received initial approval on May 3,
1974.
    (b) The Wyoming State plan received final approval on June 27,
1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984 Wyoming,
in conjunction with OSHA, completed a reassessment of the levels
initially established in 1980 and proposed revised compliance staffing
benchmarks of 6 safety and 2 health compliance officers. After
opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
June 27, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/wyoming.html.

Sec.  1952.19  Arizona.

    (a) The Arizona State plan received initial approval on November 5,
1974.
    (b) The Arizona State plan received final approval on June 20,
1985.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984, Arizona
in conjunction with OSHA, completed a reassessment of the levels
initially established in 1980 and proposed revised compliance staffing
benchmarks of 9 safety and 6 health compliance officers. After
opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
June 20, 1985.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/arizona.html.

Sec.  1952.20  New Mexico.

    (a) The New Mexico State plan received initial approval on December
10, 1975.
    (b) OSHA entered into an operational status agreement with New
Mexico.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (``benchmarks'') necessary for a ``fully
effective'' enforcement program were required for each State operating
an approved State plan. In May 1992, New Mexico completed, in
conjunction with OSHA, a reassessment of the staffing levels initially
established in 1980 and proposed revised benchmarks of 7 safety and 3
health compliance officers. After opportunity for public comment and
service on the AFL-CIO, the Assistant Secretary approved these revised
staffing requirements on August 11, 1994.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/new_mexico.html.

Sec.  1952.21  Virginia.

    (a) The Virginia State plan received initial approval on September
28, 1976.
    (b) The Virginia State plan received final approval on November 30,
1988.
    (c) Under the terms of the 1978 Court Order in AFL-CIO v. Marshall,
compliance staffing levels (benchmarks) necessary for a ``fully
effective'' enforcement program were required to be established for
each State operating an approved State plan. In September 1984
Virginia, in conjunction with OSHA, completed a reassessment of the
levels initially established in 1980 and proposed revised compliance
staffing benchmarks of 38 safety and 21 health compliance officers.
After opportunity for public comment and service on the AFL-CIO, the
Assistant Secretary approved these revised staffing requirements on
January 17, 1986.
    (d) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/virginia.html.

Sec.  1952.22  Puerto Rico.

    (a) The Puerto Rico State plan received initial approval on August
30, 1977.
    (b) OSHA entered into an operational status agreement with Puerto
Rico.
    (c) The plan covers all private-sector employers and employees,
with several notable exceptions, as well as State and local government
employers and employees, within the State. For current information on
these exceptions and for additional details about the plan, please
visit http://www.osha.gov/dcsp/osp/stateprogs/puerto_rico.html.
0
19. Add subpart B to read as follows:
Subpart B--List of Approved State Plans for State and Local Government
Employees
Sec.
1952.23 Connecticut.
1952.24 New York.
1952.25 New Jersey.
1952.26 The Virgin Islands.
1952.27 Illinois.

Subpart B--List of Approved State Plans for State and Local
Government Employees

Sec.  1952.23  Connecticut.

    (a) The Connecticut State plan for State and local government
employees received initial approval from the Assistant Secretary on
November 3, 1978.
    (b) In accordance with 29 CFR 1956.10(g), a State is required to
have a sufficient number of adequately trained and competent personnel
to discharge its responsibilities under the plan. The Connecticut
Public Employee Only State plan provides for three (3) safety
compliance officers and one (1) health compliance officer as set forth
in the Connecticut Fiscal Year 1986 grant. This staffing level meets
the ``fully effective'' benchmarks established for Connecticut for both
safety and health.
    (c) The plan only covers State and local government employers and
employees within the State. For additional details about the plan,
please visit http://www.osha.gov/dcsp/osp/stateprogs/connecticut.html.

Sec.  1952.24  New York.

    (a) The New York State plan for State and local government
employees received initial approval from the Assistant Secretary on
June 1, 1984.
    (b) The plan, as revised on April 28, 2006, provides assurances of
a fully trained, adequate staff, including 29 safety and 21 health
compliance officers for enforcement inspections and 11 safety and 9
health consultants to perform consultation services in the public
sector. The State has also given satisfactory assurances of continued
adequate funding to support the plan.
    (c) The plan only covers State and local government employers and
employees within the State. For additional details about the plan,
please visit http://www.osha.gov/dcsp/osp/stateprogs/new_york.html.

Sec.  1952.25  New Jersey.

    (a) The New Jersey State plan for State and local government
employees received initial approval from the Assistant Secretary on
January 11, 2001.
    (b) The plan further provides assurances of a fully trained,
adequate staff, including 20 safety and 7 health compliance officers
for enforcement inspections, and 4 safety and 3 health consultants to
perform consultation services in the public sector, and 2 safety and 3
health training and education staff. The State has assured that it will
continue to provide a sufficient number of adequately trained and
qualified personnel necessary for the enforcement of standards as
required by 29 CFR 1956.10. The State has also given satisfactory
assurance of adequate funding to support the plan.
    (c) The plan only covers State and local government employers and
employees within the State. For additional details about the plan,
please visit http://www.osha.gov/dcsp/osp/stateprogs/new_jersey.html.

Sec.  1952.26  The Virgin Islands.

    (a) The Virgin Islands State plan for Public Employees Only was
approved on July 23, 2003.
    (b) The plan only covers State and local government employers and
employees within the State. For additional details about the plan,
please visit http://www.osha.gov/dcsp/osp/stateprogs/virgin_islands.html.

Sec.  1952.27  Illinois.

    (a) The Illinois State plan for state and local government
employees received initial approval from the Assistant Secretary on
September 1, 2009.
    (b) The Plan further provides assurances of a fully trained,
adequate staff within three years of plan approval, including 11 safety
and 3 health compliance officers for enforcement inspections, and 3
safety and 2 health consultants to perform consultation services in the
public sector. The state has assured that it will continue to provide a
sufficient number of adequately trained and qualified personnel
necessary for the enforcement of standards as required by 29 CFR
1956.10. The state has also given satisfactory assurance of adequate
funding to support the Plan.
    (c) The plan only covers State and local government employers and
employees within the state. For additional details about the plan,
please visit http://www.osha.gov/dcsp/osp/stateprogs/illinois.html.

Subparts C through FF [Removed]

0
20. Remove subparts C through FF.

PART 1953--CHANGES TO STATE PLANS

0
21. The authority citation for part 1953 is revised to read as follows:

    Authority:  Sec. 18, 84 Stat. 1608 (29 U.S.C. 667); Secretary of
Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

0
22. In Sec.  1953.3, revise paragraph (c) to read as follows:

Sec.  1953.3  General policies and procedures.

* * * * *
    (c) Plan supplement availability. The underlying documentation for
identical plan changes shall be maintained by the State. Annually,
States shall submit updated copies of the principal documents
comprising the plan, or appropriate page changes, to the extent that
these documents have been revised. To the extent possible, plan
documents will be maintained and submitted by the State in electronic
format and also made available in such manner.
* * * * *

PART 1954--PROCEDURES FOR THE EVALUATION AND MONITORING OF APPROVED
STATE PLANS

0
23. The authority citation for part 1954 is revised to read as follows:

    Authority:  Sec. 18, 84 Stat. 1608 (29 U.S.C. 667); Secretary of
Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

Subpart A--General

0
24. In Sec.  1954.3, revise paragraphs (d)(1)(ii) and (iii) to read as
follows:

Sec.  1954.3  Exercise of Federal discretionary authority.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Subject to pertinent findings of effectiveness under this
part, and approval under part 1953 of this chapter, Federal enforcement
proceedings will not be initiated where an employer has posted the
approved State poster in accordance with the applicable provisions of
an approved State plan and Sec.  1902.9 of this chapter.
    (iii) Subject to pertinent findings of effectiveness under this
part, and approval under part 1953 of this chapter, Federal enforcement
proceedings will not be initiated where an employer is in compliance
with the recordkeeping and reporting requirements of an approved State
plan as provided in Sec.  1902.7 of this chapter.
* * * * *

PART 1955--PROCEDURES FOR WITHDRAWAL OF APPROVAL OF STATE PLANS

0
25. The authority citation for part 1955 is revised to read as follows:

     Authority:  Secs. 8 and 18, 84 Stat. 1608 (29 U.S.C. 657, 667);
Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

Subpart A--General

0
26. In Sec.  1955.2, revise paragraph (a)(4) to read as follows:

Sec.  1955.2  Definitions.

    (a) * * *
    (4) Developmental step includes, but is not limited to, those items
listed in the published developmental schedule, or any revisions
thereto, for each plan. A developmental step also includes those items
in the plan as approved under section 18(c) of the Act, as well as
those items in the approval decision which are subject to evaluations
(see e.g., approval of Michigan plan), which were deemed necessary to
make the State program at least as effective as the Federal program
within the 3 year developmental period. (See part 1953 of this
chapter.)
* * * * *

PART 1956--STATE PLANS FOR THE DEVELOPMENT AND ENFORCEMENT OF STATE
STANDARDS APPLICABLE TO STATE AND LOCAL GOVERNMENT EMPLOYEES IN
STATES WITHOUT APPROVED PRIVATE EMPLOYEE PLANS

0
27. The authority citation for part 1956 is revised to read as follows:

    Authority:  Section 18 (29 U.S.C. 667), 29 CFR parts 1902 and
1955, and Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan.
25, 2012).

Subparts E through I [Removed]

0
28. Remove subparts E through I.

[FR Doc. 2015-19226 Filed 8-17-15; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8872-8873]
[FR Doc No: 2023-02809]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1136]

Temporary Policy on Repackaging or Combining Propofol Drug
Products During the COVID-19 Public Health Emergency; Withdrawal of
Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of the guidance for industry entitled ``Temporary Policy
on Repackaging or Combining Propofol Drug Products During the COVID-19
Public Health Emergency,'' which was issued in April 2020 to
communicate a temporary policy regarding the repackaging or combining
of propofol drug products. FDA is withdrawing this guidance document
because the conditions that created the need for this policy described
in the document have evolved and the policy is no longer needed.

DATES: The withdrawal date is March 13, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Office of Regulatory
Policy, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-2357.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support
response efforts to the Coronavirus Disease 2019 (COVID-19) \1\
pandemic, in April 2020, the Agency published the guidance for industry
entitled ``Temporary Policy on Repackaging or Combining Propofol Drug
Products During the COVID-19 Public Health Emergency.'' This guidance
communicated the Agency's temporary policy regarding the repackaging or
combining of propofol drug products by licensed pharmacists in State
licensed pharmacies, Federal facilities, and outsourcing facilities
registered pursuant to section 503B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353b).\2\ FDA had received reports
from some hospitals that they were having difficulty obtaining adequate
supplies of FDA-approved propofol injectable emulsion (propofol)
products, 10 milligrams (mg) per milliliter (mL), in the presentations
used to support COVID-19 patients who had been sedated and intubated,
or for other procedures involved in the care of such patients. At the
time the guidance was published, propofol was on FDA's drug shortage
list, with several presentations on backorder or on allocation. FDA
recognized that pharmacies and outsourcing facilities that had access
to certain presentations of propofol drug products wanted to repackage
or combine units of a finished, FDA-approved drug product to provide
hospitals with presentations needed for patients with COVID-19. The
guidance stated that as a temporary measure during the public health
emergency related to COVID-19, or for such shorter time as FDA may
announce by updating or withdrawing the guidance based on evolving
needs and circumstances, FDA intended to extend, under certain
circumstances described in the guidance, its existing enforcement
discretion policy described in the

guidance for industry entitled ``Repackaging of Certain Human Drug
Products by Pharmacies and Outsourcing Facilities,'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/repackaging-certain-human-drug-products-pharmacies-and-outsourcing-facilities), when a State-licensed pharmacy, Federal facility, or
outsourcing facility repackaged an FDA-approved propofol injectable
emulsion, 10 mg/mL product, or combined different FDA-approved propofol
injectable emulsion, 10 mg/mL products in the same container.
---------------------------------------------------------------------------

    \1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
    \2\ As explained in the guidance, provided that circumstances
described in the guidance were present, FDA did not intend to take
action for violations of section 505 (concerning new drug
applications), section 502(f)(1) (concerning labeling with adequate
directions for use), and section 582 (concerning drug supply chain
security) of the FD&C Act (21 U.S.C. 355, 352(f)(1), and 360eee-1)
if a State-licensed pharmacy, a Federal facility, or an outsourcing
facility prepared drug products as described in this guidance and
met other applicable requirements. Applicable requirements included,
for example, the requirement that manufacturers not adulterate a
drug product by preparing, packing, or holding the drug product
under insanitary conditions. See section 501(a)(2)(A) of the FD&C
Act (21 U.S.C. 351(a)(2)(A)). In addition, FDA did not intend to
take action for violations of section 501(a)(2)(B) of the FD&C Act
if the drug product was repackaged by a State-licensed pharmacy or a
Federal facility in accordance with the conditions described in the
guidance, and any applicable requirements. Finally, with respect to
entities that did not qualify for the exemptions from registration
under section 510 of the FD&C Act (21 U.S.C. 360), FDA did not
intend to take action for violations of section 502(o) of the FD&C
Act.
---------------------------------------------------------------------------

    As stated above, propofol had been on FDA's drug shortage list when
FDA issued the guidance document. Based on our review of currently
available data, we have determined that the shortage of propofol drug
products has been resolved, with manufacturers reporting having an
adequate supply of the drug products. Further, hospitals have not been
reporting to FDA that they are having difficulty obtaining adequate
supplies of propofol drug products. Accordingly, we have determined
that the circumstances related to this temporary policy have evolved
such that the temporary policy is no longer needed, and the guidance
document should be withdrawn.

II. Withdrawal Date

    The withdrawal date for the guidance document discussed in this
document is March 13, 2023. The COVID-19 pandemic is a constantly
evolving situation. FDA continues to assess these circumstances and
should the current data change to indicate that the demand of propofol
drug product has again outstripped supply before March 13, 2023, FDA
may revise this date.

    Dated: February 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02809 Filed 2-9-23; 8:45 am]
BILLING CODE 4164-01-P