[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Rules and Regulations]
[Pages 37038-37039]
[FR Doc No: 2021-14326]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2020-0004]
RIN 1218-AD36

Occupational Exposure to COVID-19; Emergency Temporary Standard

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

ACTION: Interim final rule; correction.

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SUMMARY: OSHA is fixing minor errors in the interim final rule
published on June 21, 2021, titled Occupational Exposure to COVID-19;
Emergency Temporary Standard, including correcting the docket number
for submission of comments related to OSHA's information collection
estimates under the Paperwork Reduction Act.

DATES: Effective July 14, 2021.

FOR FURTHER INFORMATION CONTACT:
    Press inquiries: Frank Meilinger, Director, OSHA Office of
Communications; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    For technical inquiries: Maureen Ruskin, OSHA Directorate of
Standards and Guidance; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Summary and Explanation

    On June 21, 2021, OSHA published an interim final rule establishing
an emergency temporary standard (ETS) to protect healthcare and
healthcare support service workers from occupational exposure to COVID-
19 in settings where people with COVID-19 are reasonably expected to be
present (86 FR 32376). In the Dates section of the preamble, the agency
inadvertently included an incorrect docket number for submitting
comments related to the information collection estimates under the
Paperwork Reduction Act. The agency is submitting this document to
correct this error.
    In addition, in Section VI.B Economic Feasibility, several table
references were incorrect or missing, some tables were incorrectly
numbered, and one subsection heading was labeled incorrectly. Those
changes are shown in the table below, titled ``Table of Non-substantive
Corrections.''

II. Exemption From Notice-and-Comment Procedures

    OSHA has determined that these corrections are not subject to the
procedures for public notice and comment specified in the
Administrative Procedure Act (5 U.S.C. 553) or Section 6(b) of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)). This
rulemaking only corrects minor errors in the published rule and does
not affect or change any existing rights or obligations. No stakeholder
is likely to object to these corrections. Therefore, the agency finds
good cause that public notice and comment are unnecessary under 5
U.S.C. 553(b)(3)(B), 29 U.S.C. 655(b), and 29 CFR 1911.5.

III. Correction of Publication

    In FR Doc. 2021-12428 appearing in the Federal Register of June 21,
2021 (86 FR 32376), make the following corrections in the Dates section
of the preamble.
    On page 32376, in the second column, the second full paragraph is
corrected to read as follows:
    Comments due: Written comments, including comments on any aspect of
this ETS and whether this ETS should become a final rule, must be
submitted by July 21, 2021 in Docket No. OSHA-2020-0004. Comments on
the information collection determination described in Section VII.K of
the preamble (OMB Review under the Paperwork Reduction Act of 1995) may
be submitted by August 20, 2021 in Docket Number OSHA-2021-0003.
    In addition, the agency provides the following table, which
contains a list of corrections of minor, non-substantive errors into
section VI.B. These changes are to five table references within the
text, six table numbers, and one subsection heading.

                  Table of Non-Substantive Corrections
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        Page No.              Original text           Corrected text
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Page 32519.............  below shows the          Table VI.B.36 below
                          entities and employees.  shows the entities
                                                   and employees.
Page 32537.............  Table VI.B.4142........  Table VI.B.41.
Page 32539.............  Table VI.B.4344........  Table VI.B.43.
Page 32540.............  Table VI.B.01..........  Table VI.B.44.
Page 32541.............  Table VI.B.12..........  Table VI.B.45.
Page 32542.............  Table VI.B.2...........  Table VI.B.46.
Page 32544.............  (raw data from Table     (raw data from Table
                          VI.B.4546, Row K).       VI.B.45, Row K).
Page 32544.............  (Table VI.B.4546, Row    (Table VI.B.45, Row
                          M).                      M).
Page 32544.............  summarized in Row L of   summarized in Row L of
                          in Need for Specific     Table VI.B.44. In
                          Provisions.              Need for Specific
                                                   Provisions.
Page 32544.............  (see Table VI.B.4142...  (see Table VI.B.41.
Page 32546.............  d. Low-Case Sensitivity  Low-Case Sensitivity
                          Analysis.                Analysis.
Page 32548.............  Error! Reference source  Table VI.B.A.1.
                          not found.
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List of Subjects for 29 CFR part 1910

    COVID-19, Disease, Health facilities, Health, Healthcare,
Incorporation by reference, Occupational health and safety, Public
health, Quarantine, Reporting and recordkeeping requirements,
Respirators, SARS-CoV- 2, Telework, Vaccines, Viruses.

Authority and Signature

    James S. Frederick, Acting Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Avenue NW, Washington, DC 20210, authorized the
preparation of this document pursuant to the following authorities:
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor's Order 8-2020 (85 FR
58393 (Sept. 18, 2020)); 29 CFR part 1911; and 5 U.S.C. 553.

James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-14326 Filed 7-13-21; 8:45 am]
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Comment Info: =================

General Comment:“A 75 day period time to review the
proposed regulations is insufficient.
We are requesting that the review period
be extended to 180 days.”


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Proposed Rules]
[Pages 8577-8578]
[FR Doc No: 2015-03211]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. FDA-2013-N-0500]

Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products; Public Meeting; Request for Comments;
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments; reopening of
the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day
public meeting entitled ``Supplemental Applications Proposing Labeling
Changes for Approved Drugs and Biological Products.'' The purpose of
the meeting is to provide a public forum for FDA to listen to comments
on the proposed rule on ``changes being effected'' supplements that was
published in the Federal Register of November 13, 2013, and
alternatives offered to this proposed rule. FDA is also reopening the
comment period for the proposed rule to receive submissions of
additional written comments on the proposed rule as well as alternative
proposals presented during the public meeting.

DATES: Meeting. The public meeting will be held on March 27, 2015, from
8 a.m. to 5 p.m. Registration to attend the meeting must be received by
March 20, 2015. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting.
    Comments. The comment period for the proposed rule publilshed
November 13, 2013 (78 FR 67985), is reopened. Submit either electronic
or written comments regarding proposed alternatives to the proposed
rule by April 27, 2015.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave, Building 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0500 for the proposed rule. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ellen Molinaro, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm.
6218, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3601, FAX:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 13, 2013 (78 FR 67985), FDA
proposed regulations to revise and clarify procedures for application
holders of an approved drug or biological product to change the product
labeling to reflect certain types of newly acquired safety-related
information in advance of FDA's review of the change by submitting a
changes being effected (CBE-0) supplement to FDA. The need to promptly
communicate certain safety-related labeling changes based on newly
acquired information is the basis for the ``changes being effected''
exception to the general requirement for FDA approval of revised
labeling prior to distribution. The proposed rule, if finalized, would
enable abbreviated new drug application (ANDA) holders for generic
drugs to update product labeling promptly to reflect certain types of
newly acquired safety-related information, irrespective of whether the
revised labeling differs from that of the corresponding reference
listed drug (RLD or brand drug) upon submission of a CBE-0 supplement
to FDA. FDA's proposed revisions to its regulations to allow generic
drug manufacturers to update product labeling through CBE-0 supplements
in the same manner as brand drug manufacturers are intended to improve
communication of important, newly acquired drug safety information to
health care professionals and the public. For further information about
this and other proposed regulatory changes described in the proposed
rule, see 78 FR 67985.
    FDA received numerous comments on the proposed rule from a diverse
group of stakeholders, including comments proposing alternative
approaches to communicating newly acquired safety-related information
in a multisource environment. In November 2014, FDA received a request
from two trade associations for a listening meeting with FDA to present
an alternative to the proposed regulatory changes described in the
proposed rule that they described as intended to meet shared public
health goals regarding multisource drugs (see Ref. 1). In December
2014, an explanatory statement accompanying the Consolidated and
Further Continuing Appropriations Act, 2015

(Pub. L. 113-235), supported a listening meeting between FDA and the
regulated industries to consider alternative solutions to the proposed
rule on safety labeling that will meet all public health goals relating
to multisource drugs (see https://www.congress.gov/congressional-record/2014/12/11/house-section/article/H9307-1) (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register).
    In view of these requests and to promote transparency, FDA will
hold a public meeting at which any stakeholders may present or comment
on the proposed rule or any alternative proposals intended to improve
communication of important newly acquired drug safety information to
health care professionals and the public.
    In addition, FDA is reopening the comment period for the proposed
rule (78 FR 67985) until April 27, 2015, to receive submissions of
additional written comments on the proposed rule as well as alternative
proposals presented during the public meeting.

II. Registration and Requests for Oral Presentations

    If you would like to attend the public meeting, please register for
the meeting by email to<EMAIL_ADDRESS>by
March 20, 2015. The email should contain complete contact information
for each attendee (including name, title, firm name or affiliation,
address, email, telephone and fax numbers). Those without email access
can register by contacting Ellen Molinaro (see FOR FURTHER INFORMATION
CONTACT) by March 20, 2015. There is no fee to register for the
meeting, and registration will be on a first-come, first-served basis.
Early registration is recommended because seating is limited. Onsite
registration on the day of the meeting also will be permitted on a
space-available basis beginning at 7:30 a.m.
    Individuals who wish to present at the public meeting must register
on or before March 16, 2015, and provide complete contact information,
including name, title, firm name or affiliation, address, email,
telephone and fax numbers. You should provide a brief description of
your presentation, and indicate the approximate desired length of your
presentation, so that FDA can consider these in organizing the
presentations. FDA will do its best to accommodate requests to speak
and will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
After reviewing the presentation requests, FDA will notify each
participant before the meeting of the amount of time available and the
approximate time their presentation is scheduled to begin. If time
permits, individuals or organizations that did not register in advance
may be granted the opportunity to make a presentation. An agenda will
be posted on the FDA Web site at http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm prior to the meeting. Presenters are encouraged to submit
a copy of their presentation and related written material to the docket
(see ``Comments'') in advance of the public meeting.
    If you need special accommodations because of a disability, please
contact Ellen Molinaro (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.

III. Streaming Webcast of the Public Meeting

    This public meeting will also be Webcast. Information about how to
view the live Webcast of this meeting will be posted on the FDA Web
site at http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm prior to the
meeting.

IV. Comments

    Interested persons may submit either electronic comments regarding
proposed alternatives to the proposed rule to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Electronic or written comments will be accepted after the public
meeting until April 27, 2015.

V. Transcripts

    Please be advised that as soon as possible after a transcript of
the public meeting is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to the Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

VI. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter dated November 14, 2014, from Mr. Neas (GPhA) and Mr.
Castellani (PhRMA) to Dr. Hamburg (FDA) regarding request for listening
meeting on Expedited Agency Review proposal.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03211 Filed 2-17-15; 8:45 am]
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