[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4553-4554]
[FR Doc No: 2019-02392]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85096; File No. SR-NYSE-2018-34]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To Amend NYSE Rule 104 Governing Transactions by Designated
Market Makers

February 11, 2019.
    On July 31, 2018, New York Stock Exchange LLC (``NYSE'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to amend NYSE Rule
104 governing transactions by Designated Market Makers (``DMMs''). The
proposed rule change was published for comment in the Federal Register
on August 16, 2018.\3\ On September 24, 2018, pursuant to Section
19(b)(2) of the Act,\4\ the Commission extended to November 14, 2018
the time period in which to approve, disapprove, or institute
proceedings to determine whether to approve or disapprove, the proposed
rule change.\5\ On November 1, 2018, the Commission issued an order
instituting proceedings, pursuant to Section 19(b)(2)(B) of the Act,\6\
to determine whether to approve or disapprove the proposed rule
change.\7\ The Commission has received one comment letter on the
proposal.\8\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 83821 (Aug. 10,
2018), 83 FR 40808 (Aug. 16, 2018).
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 84276 (Sep. 24,
2018), 83 FR 49143 (Sep. 28, 2018).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 84515, (Nov. 1,
2018), 83 FR 55763 (Nov. 7, 2018).
    \8\ See Letter from Stephen John Berger, Managing Director,
Government and Regulatory Policy, Citadel Securities, to Assistant
Secretary, Commission, dated Nov. 28, 2018.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \9\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on August 16, 2018. February 12, 2019 is 180 days from
that date, and April 13, 2019 is 240 days from that date.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change. Accordingly, the Commission, pursuant to Section 19(b)(2)
of the Act,\10\ designates April

13, 2019, as the date by which the Commission shall either approve or
disapprove the proposed rule change (File No. SR-NYSE-2018-34).
---------------------------------------------------------------------------

    \10\ Id.
    \11\ 17 CFR 200.30-3(a)(57).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02392 Filed 2-14-19; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life.I had smoked over 40 years. I have tried all NRTs available as  well as prescription medications with NO RESULT. I have been smoke free 3 years due to electronic cigarettes with the arrest of pulmonary and coronary disease  and wish to provide you with my personal story as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


MEMORANDUM

DATE:   September 1, 2011

FROM:  Becky Mitschele, EPA/OW/OWM/WPD/RB

TO: Docket EPA-HQ-OW-2011-0188, proposed National Pollutant Discharge Elimination System (NPDES) Concentrated Animal Feeding Operation (CAFO) Reporting Rule

SUBJECT:   Incorporation by reference of Docket EPA-HQ-OW-2005-0037, Revised National Pollutant Discharge Elimination System Permit Regulation and Effluent Limit Guidelines for Concentrated Animal Feeding Operations in Response to the Waterkeeper Decision.

Docket EPA-HQ-OW-2005-0037contains information that is relevant to the proposed NPDES CAFO Reporting Rule, and Docket EPA-HQ-OW-2005-0037 is incorporated by reference into this docket EPA-HQ-OW-2011-0188.


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56066-56070]
[FR Doc No: 2022-19713]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2065]

Alternative or Streamlined Mechanisms for Complying With the
Current Good Manufacturing Practice Requirements for Combination
Products; List Under the 21st Century Cures Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: As required by the 21st Century Cures Act (Cures Act), the
Food and Drug Administration (FDA, Agency, or we) is finalizing a list
of alternative or streamlined mechanisms for complying with the current
good manufacturing practice (CGMP) requirements for combination
products. A combination product is a product composed of any
combination of a drug, a device, and/or a biological product.

DATES: This notice is published in the Federal Register on September
13, 2022.

ADDRESSES: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected] or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On January 22, 2013, FDA issued a final rule on CGMP requirements
for combination products (see 78 FR 4307 and part 4, subpart A (21 CFR
part 4, subpart A)) (CGMP Rule). The drugs, devices, and biological
products included in combination products are referred to as
``constituent parts'' of the combination product. Combination products
include ``single-entity'' combination products, the constituent parts
of which are physically, chemically, or otherwise combined or mixed and
produced as a single entity (see Sec.  3.2(e)(1) (21 CFR 3.2(e)(1)))
(e.g., prefilled syringes and drug-eluting stents), and ``co-packaged''
combination products where the constituent parts are packaged together
in a single package or as a unit (see Sec.  3.2(e)(2)) (e.g., a
surgical or first-aid kit).\1\ Section 4.4 (21 CFR 4.4) outlines how
manufacturers of single-entity and co-packaged combination products
(hereafter ``CP manufacturers'') can demonstrate compliance with
applicable CGMP requirements, including through implementation of a
streamlined approach to meet the requirements of both the drug CGMP and
the device quality system (QS) regulations.
---------------------------------------------------------------------------

    \1\ There are also ``cross-labeled'' combination products (Sec.
3.2(e)(3) and (4)). See Ref. 1 for additional information regarding
CGMP requirements for them, as well as use of the ``streamlined
approach'' if a device and drug or biological product constituent
part of a cross-labeled combination product are manufactured at the
same facility.
---------------------------------------------------------------------------

    In December 2016, the Cures Act (Pub. L. 114-255) was signed into
law. Section 3038(c) of the Cures Act mandated that FDA publish in the
Federal Register a list identifying types of combination products and
manufacturing processes for which ``good manufacturing processes'' may
be adopted that vary from the requirements set forth in Sec.  4.4, or
that FDA proposes can satisfy the requirements in Sec.  4.4 through
``alternative or streamlined mechanisms,'' and to review this list
periodically. In accordance with this statutory mandate, FDA published
a proposed list on June 13, 2018 (83 FR 27609).
    FDA received six comments on this proposed list, has considered
them, and is now publishing a list after such consideration (see
section II of this document). In response to the comments, FDA added
and refined examples and provided additional clarity regarding FDA's
expectations for CP manufacturers when applying mechanisms presented in
this list. FDA also added reference to a guidance on how to request FDA
feedback on combination products, which provides additional detail on
interacting with

FDA, including with respect to CGMP issues addressed in this list.
    While FDA has provided examples in this notice of the types of
mechanisms that may be appropriate, CP manufacturers should consider
the suitability of an approach in the context of their product and
manufacturing process. For these examples, we have recommended engaging
the Agency before adoption of some, whereas others may be evaluated on
inspection as appropriate. Additional approaches may be permissible as
well for evaluation on a case-by-case basis for a particular product
and CP manufacturer. FDA continues to apply a risk-based approach to
evaluating alternative or streamlined mechanisms for ensuring the
quality of combination products, and as FDA and CP manufacturers
develop additional data and rationales, this list may be expanded,
including to provide additional examples or to identify types of
combination products for which alternative or streamlined mechanisms
may be applicable.

II. List of Mechanisms for Complying With Sec.  4.4 CGMP Requirements
for Combination Products

A. Introduction

    Sections II.B and II.C present mechanisms for demonstrating
compliance with relevant combination product CGMP requirements. Where
applicable, reference is made to sections of the ``Guidance for
Industry and FDA Staff: Current Good Manufacturing Practice
Requirements for Combination Products'' for additional information
(Ref. 1). FDA will continue to evaluate this list in light of Agency
experience and stakeholder input. CP manufacturers are welcome to
propose other approaches not described, including approaches to other
requirements set forth in Sec.  4.4 for which FDA is not currently
describing mechanisms for demonstrating compliance in the sections
below.
    For each mechanism described below, CP manufacturers should
consider what documentation would be sufficient to support that the
mechanism, including the specific approach for implementing it, assures
appropriate control of the manufacture of the combination product to
ensure safety and effectiveness of the product. Appropriate evidence
and an explanation of the rationale to support the approach should be
accessible at the manufacturing facility for review during facility
inspections regardless of whether the approach has been discussed with
FDA.
    In some cases, CP manufacturers may need to interact with FDA to
gain approval or otherwise notify FDA of a manufacturing change (see
section III.A). For example, if a CP manufacturer utilizes a
bracketing/matrixing design for stability studies, this approach should
be submitted to FDA either as a proposal at the time of premarket
review or as a postmarket change.
    For additional discussion on how to interact with FDA regarding the
mechanisms described below, see section III.

B. Mechanisms for Complying With Drug CGMP Requirements (Part 211)
Specified in Sec.  4.4 2
---------------------------------------------------------------------------

    \2\ Several drug CGMP mechanisms included in this list depend
upon use of a more broadly defined batch. FDA notes that approaches
that depend upon broadly defined batches may increase the number of
distributed products implicated when corrective actions are
necessary to address postmarket issues.
---------------------------------------------------------------------------

    FDA interprets the mechanisms identified in the sections below as
means to demonstrate compliance with the following part 211 (21 CFR
part 211) requirements specified in Sec.  4.4:
1. Section 211.165 Testing and Release for Distribution
    Use of samples that are not finished combination products, but that
are representative of the finished combination product with respect to
the characteristics and attributes being tested, when performing
testing required by Sec.  211.165 (21 CFR 211.165) to determine whether
the drug constituent part, and thus the combination product, meets
relevant final specifications. To meet the requirements of Sec.
211.165, the CP manufacturer using this mechanism would need to
establish, including where appropriate through bridging studies and
other quantitative means, that any differences in the manufacturing
process for the representative samples as compared to the finished
combination product do not affect the drug constituent part (i.e., to
establish that there is no difference in the quality attributes related
to the drug constituent part in the representative sample as compared
to the attributes related to the drug constituent part in the finished
combination product). For example, as part of product release testing,
drug-eluting lead CP manufacturers could perform release testing for
identity, potency, or other quality attributes on a representative lead
tip assembly that contains the drug constituent part, rather than on
the finished combination product containing the full electronic and
mechanical assembly, so long as they can establish that the
representative lead tip assemblies meet the relevant acceptance
criteria and there are no statistically significant differences in the
test results for the representative lead tip assemblies compared to the
finished combination product.
    (See also section IV.B.5 of Ref. 1 for additional information on
testing and release for combination products.)
2. Section 211.166 Stability Testing
    Use of bracketing and matrixing approaches to stability studies for
combination products. Principles for bracketing and matrixing
approaches to meet the requirements of Sec.  211.166 (21 CFR 211.166)
have already been addressed by the Agency, including in The
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) guidelines with regard to drug
products (Refs. 2 and 3), and such principles can also be applied to
combination products. CP manufacturers could utilize a bracketing/
matrixing design, if appropriate, for stability studies. For example,
when assessing stability for a prefilled syringe that is marketed in
various fill volumes, one of the approaches that a CP manufacturer
could utilize, if appropriate, is bracketing based on the smallest and
the largest fill volume of product configurations. In determining the
extremes for a bracketing approach and/or when justifying the use of a
matrix design for single-entity combination products, it is important
that the drug-device interactions and variations in the manufacturing
processes are considered. For co-packaged combination products, such
approaches can only be applied to the drug constituent part of the
product.
    Leveraging stability data for an already marketed combination
product. Mechanisms that use prior stability knowledge, data, or
information for an existing product to support stability assessment for
a modification to that product may be appropriate when a new
combination product is a modification of an already marketed product
and the modification does not have the potential to impact the
stability of the drug constituent part. For example, when developing
new lengths of a drug-coated catheter product for which the catheter
materials, drug coating, manufacturing process, and packaging
configurations are largely unchanged from existing marketed sizes, the
CP manufacturer would generally be able to leverage existing stability
data to establish initial product shelf life or to support reduced
stability data requirements, so long as characteristics of the product
that could impact stability (e.g., materials, packaging configuration)
remain the same. However, if the device constituent

part of a drug-coated catheter includes a new material that is in
contact with the drug coating or is a new design with a different drug-
coated area or geometry, for example, new stability studies would
generally be needed under Sec.  211.166.
    (See also section IV.B.6 of Ref. 1 for additional information on
stability requirements for combination products.)
3. Section 211.167 Special Testing Requirements
    Defining ``batch'' based on the drug constituent part rather than
the finished combination product for purposes of special testing
requirements for pyrogens and endotoxins. For example, a CP
manufacturer of a combination product consisting of a device that is
coated with a drug, where a larger batch of coating is used to
manufacture several ``batches'' or ``lots'' of the overall combination
product, may be able to define a batch for purposes of pyrogen and
endotoxin testing as a set of combination products that were all
manufactured using the same coating batch for purposes of meeting the
requirements of Sec.  211.167 (21 CFR 211.167). As with the other
mechanisms described in this list, this mechanism would only
potentially be available if there would be no impact on the endotoxin
or pyrogen levels for the finished combination product from subsequent
manufacturing processes, including when the constituent parts are
combined to produce the final combination product (e.g., there are no
statistically significant differences in pyrogen or endotoxin test
results for the combination product immediately following the coating
process step as compared to the finished combination product). When
defining the batch, CP manufacturers should consider whether such risks
may be introduced later in the production process.
    (See also section IV.B.7 of Ref. 1 for additional information on
special testing requirements for combination products.)
4. Section 211.170 Reserve Samples
    Keeping reserve samples that are representative of the finished
combination product. CP manufacturers may use validated surrogates as
representative samples to meet the requirements of Sec.  211.170 (21
CFR 211.170), provided the surrogate is appropriate, both in terms of
the manufacturing process and the characteristics of the container
closure. For example, it may be permissible to maintain as a reserve
sample only the drug-containing subassembly of a single-entity
combination product, such as only the distal tip subassembly (with
drug-containing collar) of a pacemaker lead without the associated
internal electronic components, or the drug constituent part of a co-
packaged combination product, such as the prefilled cartridge of a
combination product that is distributed as a prefilled cartridge with
an injector system. Such approaches would generally be permissible
under the regulation when: (1) all subsequent manufacturing process
steps to produce the final combination product are shown not to affect
the drug constituent part, (2) the immediate container closure has
essentially the same characteristics as that for the drug constituent
part as packaged in the combination product for distribution, and (3)
the representative samples are suitable for all required testing of the
drug constituent part for which the reserve samples are being kept.
    Using samples from representative lots of a larger batch for
retention of reserve samples. To meet the requirements of Sec.
211.170, CP manufacturers may be able to use bracketing and matrixing
approaches to retain reserve samples from certain lots to adequately
represent the broadly defined batch of the combination product. For
example, where relevant lot-release tests, analytical procedures, and
acceptance criteria are the same for the product matrix and the
relevant aspects of the manufacturing process are the same, CP
manufacturers might be able to retain reserve samples of appropriately
varied sizes of a drug-coated combination product from across that
matrix.
    (See also section IV.B.8 of Ref. 1 for additional information on
reserve sample requirements for combination products.)

C. Mechanisms for Complying With Device Quality System Requirements
(Part 820) Specified in Sec.  4.4

    FDA interprets the mechanisms identified in the sections below as
means to demonstrate compliance with the following part 820 (21 CFR
part 820) requirements specified in Sec.  4.4:
1. Section 820.30 Design Controls
    Using existing pharmaceutical development practices and
documentation that align with the design control principles and
requirements of Sec.  820.30 (21 CFR 820.30). Robust pharmaceutical
development practices would address many design control requirements to
assure compliance with Sec.  820.30 where applicable (Ref. 4). CP
manufacturers need to demonstrate how development processes,
procedures, and terminology align with design control principles and
requirements in Sec.  820.30, when applicable, including developing
additional design control elements, if necessary. When evaluating the
adequacy of existing pharmaceutical development processes and related
documentation, particular attention should be given to postmarket
management of design changes to the combination product and the
alignment of change control practices with the principles and
requirements of Sec.  820.30, as applicable.
    (See also section IV.A.2 of Ref. 1 for additional information on
the requirements of Sec.  820.30 as they apply to combination
products.)
2. Exemption of Combination Products From Device QS Regulation
    Exemption of the combination product from provisions of the device
QS regulation (part 820) if the device constituent part of the
combination product is itself exempt from the device QS requirements
specified in Sec.  4.4(b)(1) (i.e., the intended use of the device as a
constituent part falls within the scope of the relevant exemption).
Some devices are exempt from certain provisions of the device QS
regulation (see, for example, liquid medication dispensers such as cups
and droppers that fall within the scope of Sec.  880.6430 (21 CFR
880.6430); see also, for example, limitations to device exemptions
under 21 CFR 880.9). Accordingly, a combination product is exempt from
the associated provisions of the device QS regulation specified in
Sec.  4.4(b)(1) if the device constituent part falls within the scope
of the relevant exemption; i.e., if the intended use of the device in
the combination product is not a new intended use and does not
otherwise raise different safety and effectiveness questions for the
device. This circumstance will most frequently apply to co-packaged
combination products. For example, an oral dosing syringe (a liquid
medication dispenser under Sec.  880.6430) that is co-packaged with a
drug may be exempt from all provisions of the device QS regulation
except for 21 CFR 820.180 (general requirements concerning records) and
21 CFR 820.198 (requirements concerning complaint files) when marketed
as a stand-alone device (and hence the combination product may also be
exempt from such provisions). Accordingly, if the CP manufacturer for
the co-packaged combination product is using a streamlined approach
based on drug CGMP requirements (see Sec.  4.4(b)(1)), the CP
manufacturer does not need to demonstrate compliance

with the device QS requirements because the product is exempt from all
device QS requirements specified in Sec.  4.4(b)(1) and, therefore,
must only be compliant with the drug CGMP requirements. However,
incorporating such a dispenser into a primary container closure system
or co-packaging of such a dispenser with a drug with a narrow
therapeutic index, for example, each may constitute a new intended use
for the dispenser or raise different safety and effectiveness questions
related to performance of the dispenser, such that the relevant
exemption would not apply.
    (See also section III.C.3 of Ref. 1 for additional information on
the exemption from provisions of the device QS regulation for
combination products.)

III. Interacting With FDA on Mechanisms for Complying With CGMP for
Combination Products

A. Process for Interacting With FDA

    In some cases, CP manufacturers may need to interact with FDA to
gain approval or otherwise notify FDA of a manufacturing change. In
other cases, although a submission or notification is not required, CP
manufacturers may want to discuss potential use of CGMP mechanisms with
FDA. CP manufacturers are encouraged to interact early with FDA on any
such contemplated use of alternative or streamlined CGMP mechanisms for
combination products (see also Ref. 5 regarding interactions with FDA
on combination products).
     Pre-Submissions and Meeting Requests. CP manufacturers who
want to obtain FDA feedback prior to making a premarket submission or
submitting a postmarket supplement or who otherwise want to obtain
feedback on their CGMP approach, may interact with FDA via the
processes available for such questions at the lead Center \3\ for the
combination product (see Ref. 5). For combination products reviewed
under a new drug application (NDA) or a biologics license application
(BLA), such interactions will generally be through Type C meetings
(Ref. 6). For combination products reviewed under an abbreviated new
drug application (ANDA), such interactions will generally be through
the pre-ANDA program or controlled correspondence for a premarket
application (Refs. 7 and 8). For combination products reviewed under a
device premarket submission (e.g., a premarket approval application
(PMA), de novo classification, or premarket notification (510(k)),
these interactions will generally be via the pre-submission process
(Ref. 9). Regardless of the type of submission or meeting, such
interactions should be focused on a general discussion of the CGMP
approach the CP manufacturer wishes to pursue and associated
justification to support the approach.\4\ Only representative data is
typically appropriate in these interactions; complete data should be
included in the subsequent premarket submission or postmarket
supplement and/or be maintained at the manufacturing facility, as
appropriate.
---------------------------------------------------------------------------

    \3\ A combination product is assigned to an Agency center
(Center for Biologics Evaluation and Research, Center for Drug
Evaluation and Research, or Center for Devices and Radiological
Health) that will have primary jurisdiction (i.e., be the ``lead
Center'') for that combination product's review and regulation.
Assignment of a combination product to a lead Center is based on a
determination of which constituent part provides the primary mode of
action of the combination product (21 U.S.C. 353(g)). Manufacturers
who are unsure of the lead Center for their combination product or
of whether their product is a combination product, should contact
the Office of Combination Products.
    \4\ Note that to discuss a mechanism for complying with CGMP
requirements for which the CP manufacturer is referencing
information in a master file, the CP manufacturer must have the
appropriate authorization from the master file holder (see, e.g., 21
CFR 314.420 and 814.20(c)). The authorization should clearly
identify the specific information within the master file that is
being made available to reference. For more information on
biologics, device, and drug master files, see CBER's master files
for CBER-Regulated Products web page (available at https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/master-files-cber-regulated-products), CDRH's master files web
page (available at https://www.fda.gov/medical-devices/premarket-approval-pma/master-files), and CDER's drug master files web page
(available at https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs), respectively.
---------------------------------------------------------------------------

     Premarket Review. CP manufacturers should include in their
original submission for NDAs, BLAs, ANDAs, and PMAs information on any
alternative or streamlined mechanisms for complying with combination
product CGMP requirements. For PMAs, this information should be
included in the manufacturing section of the PMA. For information
regarding where to place information in NDAs, BLAs, or ANDAs, refer to
``eCTD Technical Conformance Guide'' (Ref. 10).
     Postmarket Supplements or Notifications to FDA. Postmarket
changes to implement a combination product CGMP mechanism for NDAs,
ANDAs, BLAs, and PMAs may require submission of a supplement or
notification to FDA.\5\ CP manufacturers should consult related
guidances relevant to the type of constituent part(s) included in the
combination product (e.g., Refs. 11 to 13, as appropriate). If a CP
manufacturer has questions on the appropriate submission type or the
need for a submission, they can contact the lead Center for assistance.
---------------------------------------------------------------------------

    \5\ Requirements for postmarket supplements are contained, for
example, in 21 CFR 314.70 and 314.97 (NDAs and ANDAs), 21 CFR 601.12
(BLAs), and 21 CFR 814.39 (PMAs). Any questions on whether FDA
review is required for a postmarket CGMP mechanism should generally
be directed to the lead Center.
---------------------------------------------------------------------------

B. Submission Content

    When submitting information on a CGMP mechanism, CP manufacturers
should refer to applicable guidance (see section V below) as the
primary reference regarding what information to provide. Along with
other information indicated in relevant guidance (see section V), the
following content should be included:
     Applicable CGMP Regulation. Identify the applicable CGMP
regulation to which the described mechanism relates. For example, if a
submission includes a mechanism related to stability testing, indicate
that Sec.  211.166 is the applicable CGMP requirement.
     Applicable Products. If the mechanism is to be applied to
multiple products and/or product configurations, list all related
sizes, strengths, etc., as well as all related application numbers.
     Prior, Related Interactions with FDA. If the CP
manufacturer has had previous interactions with FDA relevant to the
proposed mechanism, either for the product addressed in the submission
or for related products, the CP manufacturer should provide reference
to those interactions. Where applicable, the CP manufacturer may cross-
reference previously submitted information.
     Justification and Scientific Data. Include a justification
to support that the proposed mechanism assures adequate manufacturing
control to ensure product safety and effectiveness. When describing a
CGMP alternative or streamlined mechanism in a premarket or postmarket
submission, the description should be accompanied by such data as may
be necessary to support the approach. When proposing a change from a
CGMP approach that was reviewed previously by FDA, such justification
should include analysis of how the proposed approach compares to the
previously reviewed approach as an effective manufacturing control,
including representative data, as appropriate, to substantiate the
analysis.
     Exemption from Part 820. For interactions with FDA
regarding whether a combination product is exempt from the provisions
of part 820 specified in Sec.  4.4(b)(1), the submission should include
a description of the device constituent part and justification

that: (1) the intended use of the device in the combination product is
consistent with the intended use of a separately marketed device that
has been exempted from the requirements of part 820 specified in Sec.
4.4(b)(1), and (2) the use of the device constituent part in the
combination product does not raise any different device performance-
related safety and effectiveness questions as compared to a separately
marketed device.

C. FDA Engagement

    CP manufacturers are encouraged to discuss combination product CGMP
mechanisms with FDA. In some cases, CP manufacturers may need to
interact with FDA to gain approval or otherwise notify FDA of a
manufacturing change (see III.A above). Any questions on how to engage
FDA in such discussions should generally be directed to the lead Center
for the product (see Ref. 5). The lead Center will engage appropriate
expertise from within the lead Center and from other FDA Centers and
the Office of Combination Products, as needed, to support review (see
Ref. 14), and FDA will provide appropriate feedback (see section III.D
below).

D. FDA Review

    FDA may review information from a CP manufacturer related to
alternative or streamlined mechanisms in pre-submissions and meetings,
premarket applications, postmarket supplements or notifications, and
during facility inspections. FDA may determine whether the data and
rationale presented by a CP manufacturer for a particular mechanism are
sufficient to demonstrate that the mechanism, as proposed or
implemented, is acceptable. In such cases, FDA generally will notify
the CP manufacturer and/or applicant regarding acceptability of the
mechanism, consistent with existing policies and practices for the
submission type and, if the Agency finds the approach insufficient, FDA
intends to provide the scientific and/or regulatory basis for this
determination.

IV. Paperwork Reduction Act

    This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). We
note that the information collected under the underlying CGMP
regulations for drugs, devices, and biological products, including
current good tissue practices for human cells, tissues, and cellular
and tissue-based products, found in parts 211, 820, 600 through 680,
and 1271 (21 CFR parts 211, 820, 600 through 680, and 1271), have
already been approved and are in effect. The provisions of part 211 are
approved under the OMB control number 0910-0139. The provisions of part
820 are approved under OMB control number 0910-0073. The provisions of
parts 606 and 640 are approved under OMB control number 0910-0116. The
provisions of part 610 are approved under OMB control number 0910-0116
and OMB control number 0910-0338 (also for part 680). The provisions of
part 1271, subparts C and D, are approved under OMB control number
0910-0543.
    We note that the information collected under the related submission
types have already been approved and are in effect. The collections of
information regarding formal meetings with sponsors and applicants are
approved under OMB control number 0910-0429. The collections of
information regarding NDA and ANDA are approved under OMB control
number 0910-0001. The collections of information regarding the pre-ANDA
program and controlled correspondence are approved under OMB control
number 0910-0797. The collections of information regarding pre-
submissions are approved under OMB control number 0910-0756. The
collections of information regarding PMAs are approved under OMB
control number 0910-0231. The collections of information for premarket
notification (510(k)) are approved under OMB control number 0910-0120.
The collections of information for the de novo classification process
are approved under OMB control number 0910-0844. The collections of
information regarding BLAs are approved under OMB control number 0910-
0338. The collections of information regarding combination product
agreement meetings are approved under OMB control number 0910-0523.

V. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. ``Guidance for Industry and FDA Staff: Current Good Manufacturing
Practice Requirements for Combination Products,'' January 2017.
https://www.fda.gov/media/90425/download.
2. ``Guidance for Industry Q1D Bracketing and Matrixing Designs for
Stability Testing of New Drug Substances and Products,'' January
2003. https://www.fda.gov/media/71720/download.
3. ``Guidance for Industry Quality of Biotechnological Products:
Stability Testing of Biotechnological/Biological Products'' Q5C,
July 1996. https://www.fda.gov/media/71441/download.
4. ``Guidance for Industry Q8(R2) Pharmaceutical Development,''
November 2009. https://www.fda.gov/media/71535/download.
5. ``Guidance for Industry and FDA Staff: Requesting FDA Feedback on
Combination Products,'' December 2020. https://www.fda.gov/media/133768/download.
6. ``Draft Guidance for Industry Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products,'' December 2017. https://www.fda.gov/media/109951/download.
7. ``Guidance for Industry Formal Meetings Between FDA and ANDA
Applicants of Complex Products Under GDUFA,'' November 2020. https://www.fda.gov/media/107626/download.
8. ``Guidance for Industry Controlled Correspondence Related to
Generic Drug Development,'' December 2020. https://www.fda.gov/media/109232/download.
9. ``Guidance for Industry and FDA Staff Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program,''
January 2021. https://www.fda.gov/media/114034/download.
10. ``eCTD Technical Conformance Guide,'' March 2022. https://www.fda.gov/media/93818/download.
11. ``Guidance for Industry Changes to an Approved NDA or ANDA,''
April 2004. https://www.fda.gov/media/71846/download.
12. ``Guidance for Industry Chemistry, Manufacturing, and Controls
Changes to an Approved Application: Certain Biological Products,''
June 2021. https://www.fda.gov/media/109615/download.
13. ``Guidance for Industry and FDA Staff: 30-Day Notices, 135-Day
Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device
Exemption (HDE) Supplements for Manufacturing Method or Process
Changes,'' December 2019. https://www.fda.gov/media/72663/download.
14. FDA Staff Manual Guide SMG 4101 ``Inter-Center Consult Request
Process,'' June 2018. https://www.fda.gov/media/81927/download.

    Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19713 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16426-16431]
[FR Doc No: 2022-06080]

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

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 in Healthcare Settings

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

ACTION: Notice of limited reopening of comment period; notice of
informal hearing.

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

SUMMARY: OSHA is partially reopening the comment period to allow for
additional public comment on specific topics and is scheduling an
informal public hearing on its interim final rule establishing an
Emergency Temporary Standard (ETS), ``Occupational Exposure to COVID-
19.'' The public hearing will begin on April 27, 2022.

DATES: Comments: Written comments in response to OSHA's limited
reopening of the comment period must be submitted in Docket No. OSHA-
2020-0004 on or before April 22, 2022.
    Informal public hearing: The hearing will begin on April 27, 2022,
and will be held virtually. If necessary, the hearing will continue on
subsequent days. Additional information on how to access the informal
hearing will be posted when available at https://www.osha.gov/coronavirus/healthcare/rulemaking. To testify at the hearing,
interested persons must electronically submit their Notice of Intention
to Appear (NOITA) by April 6, 2022.

ADDRESSES:
    Notices of Intention to Appear: Notices of intention to appear at
the hearing (NOITA) must be submitted electronically at https://www.osha.gov/coronavirus/healthcare/rulemaking. Follow the instructions
online for making electronic submissions. See ``Notices of Intention to
Appear'' in the SUPPLEMENTARY INFORMATION section of this document for
additional requirements for NOITAs.
    Written comments: You may submit comments and attachments,
identified by Docket No. OSHA-2020-0004, electronically at
www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the instructions online for making electronic submissions. After
accessing ``all documents and comments'' in the docket (Docket No.
OSHA-2020-0004), check the ``proposed rule'' box in the column headed
``Document Type,'' find the document posted on the date of publication
of this hearing notice, and click the ``Comment Now'' link. When
uploading multiple attachments to www.regulations.gov, please number
all of your attachments because www.regulations.gov will not
automatically number the attachments. This will be very useful in
identifying all attachments in the preamble. For example, Attachment
1_title of your document, Attachment 2_title of your document,
Attachment 3_title of your document. For assistance with commenting
and uploading documents, please see the Frequently Asked Questions on
www.regulations.gov.
    Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2020-0004). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public,
or submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
    Docket: To read or download comments and other materials submitted
in the docket, or to view the hearing schedule and procedures when
available, go to Docket No. OSHA-2020-0004 at www.regulations.gov. All
comments and submissions are listed in the www.regulations.gov index;
however, some information (e.g., copyrighted material) may not be
publicly available to read or download through that website. All
documents submitted to www.regulations.gov, including copyrighted
material, are available for inspection through the OSHA Docket Office.
Documents submitted to the docket by OSHA or stakeholders are assigned
document identification numbers (Document ID) for easy identification
and retrieval. The full Document ID is the docket number plus a unique
four-digit code. OSHA is identifying supporting information in this
rulemaking by author name and

publication year, when appropriate. This information can be used to
search for a supporting document in the docket at www.regulations.gov.
Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY number: (877)
889-5627) for assistance in locating docket submissions. Please note
that NOITAs will be gathered outside the docket and OSHA will add a
list of individuals who have submitted NOITAs to the docket after the
submission deadline has passed.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Contact Frank Meilinger, Director, Office of
Communications, Occupational Safety and Health Administration, U.S.
Department of Labor; telephone:<PHONE_NUMBER>; email:
[email protected].
    For general information and technical inquiries: Contact Andrew
Levinson, Acting Director, Directorate of Standards and Guidance,
Occupational Safety and Health Administration, U.S. Department of
Labor; telephone:<PHONE_NUMBER>; email: [email protected].
    For Hearing Inquiries: Contact Amy Tryon, Division of Occupational
Safety and Health, Office of the Solicitor, U.S. Department of Labor;
telephone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION: On June 21, 2021, OSHA published an 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). Although the
ETS took effect immediately, OSHA also requested comment on whether it
should become permanent, as well as on all other aspects of the ETS.
OSHA received 481 comments concerning the ETS during the comment
period, which was to end on July 21, 2021, but was extended to August
20, 2021, in response to requests from the public (86 FR 38232). To
read or download comments and other materials submitted in the docket,
go to Docket No. OSHA-2020-0004 at www.regulations.gov. In accordance
with 29 U.S.C. 655(c)(3), the agency is now preparing to promulgate a
final standard.

I. Additional Information and Request for Comment

    OSHA is seeking public comment on certain specific topics and
questions for the development of a final standard. Accordingly, the
agency is partially reopening the comment period for the ETS to allow
for additional comment on the topics identified below. OSHA encourages
commenters to explain why they prefer or disfavor particular policy
choices, and include any relevant studies, experiences, anecdotes, or
other information that may help support the comment. OSHA seeks
comments on the following topics:

A. Potential Changes From the ETS

    The following is a list of potential rulemaking outcomes that would
depart from the provisions of the ETS such that OSHA has decided to
provide this additional notice and an opportunity to comment. OSHA has
not made any decisions about these potential provisions or approaches,
nor is this intended to list all of the potential changes from the ETS.
Other changes may result after due consideration of all comments and
hearing testimony.
    A.1--Alignment with CDC Recommendations for Healthcare Infection
Control Practices: Evolving CDC recommendations have resulted in
inconsistencies between those recommendations and some of the
Healthcare ETS provisions (e.g., isolation and return-to-work
guidance). A number of commenters requested that OSHA align its ETS
more closely with various CDC recommendations. OSHA is considering
doing so, but notes that, in some cases, CDC recommendations have
continued to evolve even after the close of the comment period. OSHA is
considering whether it is appropriate to align its final rule with some
or all of the CDC recommendations that have changed between the close
of the original comment period for this rule and the close of this
comment period. OSHA seeks comment on this approach.
    A.2--Additional Flexibility for Employers: Some employers expressed
concern that the provisions of the Healthcare ETS were overly
prescriptive. The ETS, while rooted in a programmatic approach (e.g.,
COVID-19 plan, hazard assessment, policies and procedures to minimize
the risk of transmission of COVID-19), also specified how employers
were required to implement particular policies and procedures (e.g.,
criteria for medical removal and return to work, cleaning, ventilation,
barriers, aerosol-generating procedures). OSHA is considering restating
various provisions as broader requirements without the level of detail
included in the Healthcare ETS and providing a ``safe harbor''
enforcement policy for employers who are in compliance with CDC
guidance applicable during the period at issue. OSHA seeks comment on
this approach.
    A.3--Removal of Scope Exemptions (e.g., ambulatory care facilities
where COVID-19 patients are screened out; home healthcare): A final
standard will be adopted under Section 6(b) of the OSH Act, which
requires a finding of significant risk from exposure to COVID-19,
rather than the finding of grave danger OSHA made in issuing the
Healthcare ETS under Section 6(c) of the OSH Act. Section 6(b) requires
that the standard substantially reduce or eliminate significant risk of
material impairment of health to the extent feasible. In view of this
different risk finding, OSHA is considering whether the scope of the
final standard should cover employers regardless of screening
procedures for non-employees and/or vaccination status of employees to
ensure that all workers are protected to the extent there is a
significant risk. OSHA seeks comment on this approach.
    A.4--Tailoring Controls to Address Interactions with People with
Suspected or Confirmed COVID-19: OSHA is considering the need for
COVID-19-specific infection control measures in areas where healthcare
employees are not reasonably expected to encounter people with
suspected or confirmed COVID-19. This could include eliminating certain
requirements that were included in the Healthcare ETS and that applied
to all areas of covered healthcare settings. For example, OSHA could
consider imposing cleaning requirements or medical removal provisions
only with respect to staff exposed to COVID-19 patients or eliminating
facemask requirements for staff not exposed to COVID-19 patients. If
OSHA did restrict infection control requirements to particular areas of
a facility or particular staff, it could consider balancing that
narrower scope with a new ``outbreak provision'' to ensure that
healthcare employers would still have a duty to address an outbreak
quickly if an outbreak occurs among staff in the areas normally subject
to fewer requirements. For example, an outbreak could trigger a broad
performance requirement for the employer to implement additional
infection control measures to stop the outbreak, or it could trigger
more specific requirements, such as employer-provided testing and/or
medical removal of staff with COVID-19 even if they do not interact
with COVID-19 patients. OSHA seeks comment on these approaches,
including comment on how OSHA should define an ``outbreak'' if it were
to implement that approach (the CDC discusses ``outbreaks'' at https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracing-plan/outbreaks.html).

A.5--Vaccination
    A.5.1--Booster Doses: In the ETS, certain requirements take account
of whether individuals are ``fully vaccinated,'' which is defined in
paragraph (b) of the ETS as meaning ``2 weeks or more following the
final dose of a COVID-19 vaccine.'' Subsequent to the publication of
the ETS, the Advisory Committee on Immunization Practices (ACIP) has
recommended additional doses and booster doses. CDC has also adopted
the concept of ``up to date'' to describe vaccination recommendations
beyond the primary vaccination series. OSHA is considering how these
ACIP and CDC recommendations might impact the requirements in the ETS
that take account of individuals' vaccination status (e.g., fully
vaccinated, up to date) and seeks comment on this issue.
    A.5.2--Employer Support of Employee Vaccination: OSHA is not
considering at this time requiring mandatory vaccination for employees
covered by this standard.
    [cir] The Healthcare ETS included a provision requiring employers
to inform employees about the safety, efficacy, and benefits of
vaccination and provide reasonable time and paid leave to each employee
for vaccination and side effects experienced following vaccination.
OSHA is considering an adjustment to the requirement that would include
paid time up to 4 hours, including travel time, for employees to
receive a vaccine and paid sick leave to recover from side effects and
seeks comment on the approach.
    [cir] OSHA is considering requiring employer support for employees
who wish to stay up to date on vaccination and boosters in accordance
with ACIP and CDC recommendations. OSHA seeks comment on the approach.
    [cir] OSHA is considering whether to limit the provisions that
provide support for vaccination to employees not covered by the Centers
for Medicare & Medicaid Services (CMS) vaccination rule (86 FR 61555)
and seeks comment on this approach. The CMS vaccination rule requires
healthcare staff in facilities regulated by CMS to be vaccinated. The
majority of healthcare employees covered by this final rule work in
facilities covered by the CMS vaccination rule and are subject to the
CMS requirements.
    A.5.3--Requirements for Vaccinated Workers: During the initial
comment period, stakeholders raised questions about whether the
Healthcare ETS requirements should be relaxed or eliminated based on
the vaccination status of the individual worker involved, the general
vaccination rate of the entire staff, and/or the general vaccination
rate of the community. OSHA is considering suggestions that
requirements be relaxed:

[cir] For masking, barriers, or physical distancing for vaccinated
workers in all areas of healthcare settings, not just where there is no
reasonable expectation that someone with suspected or confirmed COVID-
19 will be present
[cir] in healthcare settings where a high percentage of staff is
vaccinated (OSHA also is accepting comment on what that percentage
should be)
[cir] for exposure notification for vaccinated employees

    OSHA seeks comment on these approaches.
    A.6--Limited Coverage of Construction Activities in Healthcare
Settings: OSHA did not expressly include employers that engage in
construction work in hospitals, long-term care facilities and other
settings that are covered by the ETS. The construction industry was not
included in OSHA's industrial profile for the rule. OSHA is considering
clarifying this coverage and seeks comment on this approach. For
example, OSHA is considering the same coverage for workers engaged in
construction work inside a hospital (e.g., installing new ventilation
or new equipment or adding a new wall) as for workers engaged in
maintenance work or custodial tasks in the same facility. OSHA could
consider exceptions for construction work in isolated wings or other
spaces where construction employees would not be exposed to patients or
other staff.
    A.7--Recordkeeping and Reporting: New Cap for COVID-19 Log
Retention Period: The COVID-19 log and reporting provisions, 29 CFR
1910.502(q)(2)(ii), (q)(3)(ii)-(iv), and (r), have remained in effect
because OSHA found good cause to forgo notice and comment in light of
the grave danger presented by the pandemic. See 86 FR 32559. Now that
OSHA is re-opening the comment period for the final rule, the agency
also seeks additional comment on 1910.502(q) and (r). In general, OSHA
is focused on whether any adjustments to those paragraphs should be
made in light of experiences involving the Delta or Omicron variants.
In addition, the agency proposes to cap the record retention period for
the COVID-19 log at one year from the date of the last entry in the
log, rather than the current approach in which that retention period is
tied to the duration of the standard (see 29 CFR
1910.502(q)(2)(ii)(C)).
    A.8--Triggering Requirements Based on the Level of Community
Transmission: When employees are treating people with suspected or
confirmed COVID-19, the ETS requires certain control strategies (e.g.,
PPE) regardless of community transmission levels. Under the CDC's
current guidance for healthcare workers,\1\ many requirements for those
workers are triggered based on the level of community transmission of
COVID-19 (e.g., controls needed in areas of substantial or high
transmission, controls not needed in areas of low or moderate
transmission). OSHA is considering linking regulatory requirements to
measures of local risk, such as CDC's community transmission used in
CDC's guidance for healthcare settings or the CDC's COVID-19 Community
Levels used in CDC's guidance for prevention measures in community
settings.\2\ OSHA is seeking comment on that approach, including
impacts of such an approach on compliance and enforcement.
---------------------------------------------------------------------------

    \1\ Centers for Disease Control and Prevention (CDC). (2022,
February 2). Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus
Disease 2019 (COVID-19) Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.
    \2\ See Centers for Disease Control and Prevention (CDC). (2022,
February 2); see also Centers for Disease Control and Prevention
(CDC). (2022, March 4). COVID-19 Community Levels. https://www.cdc.gov/coronavirus/2019-ncov/science/community-levels.html.
---------------------------------------------------------------------------

    A.9--Evolution of SARS-CoV-2 into a Second Novel Strain: It is
possible that a future variant of SARS-CoV-2 will have sufficient
genetic drift to be designated another novel coronavirus strain but
still results in a disease that is similar to the current illness
(e.g., a hypothetical ``COVID-22''). OSHA is considering specifying
that this final standard would apply not only to COVID-19, but also to
subsequent related strains of the virus that are transmitted through
aerosols and pose similar risks and health effects. OSHA seeks comment
on this approach and alternatives to addressing the potential for new
strains related to SARS-CoV-2.

B. Additional Information/Data Requested

    OSHA recognizes that the majority of the comment period occurred
prior to when the Delta and Omicron variants became prevalent in the
United States. OSHA requests new studies or data related to the Delta
and Omicron variants since the close of the initial comment period in
August 2021, particularly with respect to:

B.1: The average number of days healthcare workers have taken away from
work resulting from a COVID-

19 infection or quarantine and the percentage of healthcare workers who
have taken days away from work due to a COVID-19 infection or
quarantine
B.2: The health effects for fully vaccinated employees, and fully
vaccinated and boosted employees, who test positive for COVID-19,
including data on days away from work, hospitalizations, long COVID,
and fatalities
B.3: The percentage of healthcare workers who are at elevated risk of
severe COVID-19 infections (e.g., resulting in hospitalization or
extended days away from work), including for age-related or
immunocompromised reasons (not based solely on vaccination status)
B.4: The rate of infection, long COVID, hospitalization, and death
among healthcare workers compared to those rates among the general
adult population
B.5: The health effects and transmission rate of new and emerging
variants and sub-lineages of variants, including Omicron BA.2

    Additionally, OSHA requests data and information on:

B.6: The vaccination rate among healthcare workers, including the rate
of healthcare workers who are fully vaccinated and boosted
B.7: The clinical indicators that will reliably predict the degree of
protection afforded by prior infection (i.e., infection-acquired
immunity), and how long such protection lasts
B.8: Vaccine efficacy and how such efficacy decreases over time
B.9: The appropriate periodicity of additional vaccine doses and
booster doses
B.10: Unintended consequences, such as decreases in staffing retention,
or other impacts, such as increases in staffing retention, due to the
potential alternatives raised in this notice

C. Information for Economic Analysis

    C.1 Industry Profile: For the Healthcare ETS Industry Profile, OSHA
based the number of Affected Employees for Affected Industries on
whether employees performed healthcare services or healthcare support
services under the ETS. If employees did not perform healthcare
services or healthcare support services, OSHA did not consider them
Affected Employees. See 86 FR 32485. While this approach covered the
appropriate North American Industry Classification System (NAICS), the
approach may have resulted in an underestimate of Affected Employees.
As stated in 29 CFR 1910.502(a), ``this section applies to all settings
where any employee provides healthcare services or healthcare support
services.'' To address this potential underestimate for the final rule,
OSHA is considering revising its approach to base the number of
Affected Employees on setting, rather than occupation. OSHA seeks
comment on this potential approach.
C.1.1--Covered Industries
    C.1.1A: OSHA acknowledged in the Healthcare ETS that it did not
``determine[ ] how many non-hospital ambulatory care providers will
screen patients for COVID-19 infections and symptoms, and therefore
might be fully exempt from the standard under paragraph (a)(2)(iii)''
of the ETS (86 FR at 32485). While OSHA included in the Healthcare ETS
Industry Profile several NAICS outside of healthcare where embedded
clinics are prevalent, such as schools, OSHA did not include a number
of industries that may have settings with embedded clinics (e.g.,
embedded clinics in manufacturing facilities) in the industry profile.
The Healthcare ETS applies to these embedded clinics, as OSHA made
clear both in the regulatory text and the Summary and Explanation for
the ETS. See 29 CFR 1910.502(a)(3)(i); 86 FR at 32563. To address this,
OSHA is considering including these industries in the final rule's
industry profile. OSHA notes that compliance with the final rule for
these industries would most likely result in minimal costs or no costs
because, under the Healthcare ETS, OSHA anticipated that many embedded
clinics will be fully exempt under the non-hospital ambulatory care
exception; and, if the rule applies, it will apply only with respect to
embedded clinics and not the entire facility. OSHA seeks comment on
this potential approach.
    C.1.1B: As discussed above, OSHA noted in the Healthcare ETS that
it did not determine ``how many non-hospital ambulatory care providers
will screen patients for COVID-19 infections and symptoms, and
therefore be fully exempt from this rule under paragraph (a)(2)(iii)''
(86 FR at 32485). OSHA also noted that ``[t]o the extent that providers
meet these exemption criteria, they will incur no costs for compliance
with respect to these settings,'' and that ``[t]herefore, for this
subset of establishments, the costs presented in OSHA's analysis will
be dramatic overestimates (i.e., OSHA assumes full costs where costs
should be zero).'' (Id.) For the final rule, OSHA is considering
estimating the number of employers subject to this exemption, if it
remains in the standard, but seeks information and data to support such
an estimate.
    C.1.2 Telework Employees: In the Healthcare ETS, OSHA accounted for
reduced employee exposure due to telework for benefits, but did not
explicitly account for telework in the number of employees affected by
the final rule in the Industry Profile. This may have resulted in an
overestimate of several employee-based costs, like the costs of
respirators and personal protective equipment, because OSHA may have
overestimated the number of employees affected by the final rule. In
the Vaccination and Testing ETS, OSHA adjusted its telework estimates
to reflect then-current teleworking conditions (see 86 FR 61462-61467).
OSHA is considering making similar adjustments to the final Healthcare
rule to estimate the current number of employees who telework. OSHA
seeks comment on this potential approach.
C.2 Costs
    C.2.1--One-time costs: OSHA requests comments on the extent to
which some costs (e.g., costs associated with initial training,
upgrading ventilation, rule familiarization, COVID-19 Plan development,
respiratory protection program development) have already been incurred
to comply with the ETS. OSHA further requests comments on the extent to
which employers and other entities will bear ongoing costs (e.g.,
ongoing costs associated with training, PPE, respirators and the
respiratory protection program, medical removal protection, COVID-19
plan monitoring and modification, and ventilation maintenance) under a
final rule.
C.2.2--Age Group 65-74
    C.2.2A: OSHA had not included employees in the age group 65-74 in
the economic analysis of the Healthcare ETS out of concern that the
population-wide average of workers in this age bracket would overcount
the number of such workers in this sector. See 86 FR at 61470 n. 32.
OSHA is rethinking this approach for the Healthcare final rule and
seeks comment on including this age group in the analysis of both costs
and benefits.
    C.2.2B: OSHA will likely update its estimates to reflect the
current baseline of vaccinated employees (for example, to incorporate
the effects of the CMS vaccine-mandate rule on vaccination rates). OSHA
will likely rely on the most recent CDC COVID-19 data tracker, as it
did for the Healthcare ETS and the Vaccination and Testing ETS,

and may also rely on estimates or data from CMS or other credible
sources, to update its estimates. OSHA seeks comment on whether there
is other data OSHA should rely on.
C.2.3--Ancillary Costs
    C.2.3A: In the Healthcare ETS, OSHA offset the cost to employers
associated with medical removal and vaccination support with tax
credits employers would receive. OSHA is considering how to adjust its
methodology in the final rule given the expiration of these tax credits
and seeks data and information on this issue. OSHA notes that it could
take an approach similar to the one it took in the Vaccination and
Testing ETS, i.e., by estimating the number of employers that would
(and would not) incur costs because employees could be required to use
accrued sick leave benefits for medical removal and vaccination support
(Compare 86 FR 32512 (including footnote 61) with 86 FR 61480).
    C.2.3B: OSHA is considering updating the manner in which it
estimates side effects associated with vaccine doses using CDC
estimates (86 FR 32513 & n.63). OSHA is considering following an
approach similar to the one it followed in the Vaccination and Testing
ETS (86 FR 61480) where OSHA calculated the estimated time off using a
more recent study that surveyed workers at a state-wide healthcare
system who had been vaccinated.\3\ OSHA seeks data and information on
this issue.
---------------------------------------------------------------------------

    \3\ Levi ML et al. (2021, September 25). COVID-19 mRNA
vaccination, reactogenicity, work-related absences and the impact on
operating room staffing: A cross-sectional study. Perioperative Care
and Operating Room Management preprint. https://doi.org/10.1016/j.pcorm.2021.100220.
---------------------------------------------------------------------------

    C.3 Benefits Data Sources: For the final rule, OSHA is considering
using CDC COVID-19 case and fatality data which was unavailable when
the Healthcare ETS was initially issued, and seeks comment on this
issue. OSHA based the Vaccination and Testing ETS impact analysis on
the CDC data which tabulates the respective number of cases and
fatalities for the unvaccinated and vaccinated populations.
    OSHA also seeks information and data on cases, illnesses,
hospitalizations, and fatalities that are specific to employees that
would be subject to the final rule (i.e., those in the healthcare
field). OSHA notes that it is aware of one potential source that
measured deaths in healthcare occupations during the first year of the
pandemic.\4\
---------------------------------------------------------------------------

    \4\ Kaiser Health News and the Guardian. (2021, April). Lost on
the Frontline. The Guardian. https://www.theguardian.com/us-news/ng-interactive/2020/aug/11/lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database.
---------------------------------------------------------------------------

    OSHA is considering using all sources of data on which it relied in
the Healthcare ETS and the Vaccination and Testing ETS, as well some
new data sources it did not rely on, including, for example:
     CDC Daily Tracker: Daily Tracker Home,\5\
---------------------------------------------------------------------------

    \5\ CDC Daily Tracker: Daily Tracker Home: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
---------------------------------------------------------------------------

     Demographic Trends of COVID-19 cases and deaths in the US
reported to CDC,6 7 8
---------------------------------------------------------------------------

    \6\ COVID-19 Weekly Cases and Deaths per 100,000 Population by
Age, Race/Ethnicity, and Sex: https://covid.cdc.gov/covid-data-tracker/#demographicsovertime.
    \7\ Demographic Trends of COVID-19 cases and deaths in the U.S.
reported to CDC: https://covid.cdc.gov/covid-data-tracker/#demographics.
    \8\ Trends in COVID-19 Cases and Deaths in the United States, by
County-level Population Factors
    Maps, charts, and data provided by CDC: https://covid.cdc.gov/covid-data-tracker/#pop-factors_7daynewcases.
---------------------------------------------------------------------------

     Rates of COVID-19 Cases and Deaths by Vaccination
Status,\9\
---------------------------------------------------------------------------

    \9\ Rates of COVID-19 Cases and Deaths by Vaccination Status:
https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status.
---------------------------------------------------------------------------

     Rates of laboratory-confirmed COVID-19 hospitalizations by
vaccination status,\10\
---------------------------------------------------------------------------

    \10\ https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination.
---------------------------------------------------------------------------

     United States COVID-19 Cases, Deaths, and Laboratory
Testing (NAATs) by State, Territory, and Jurisdiction,\11\
---------------------------------------------------------------------------

    \11\ https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days.
---------------------------------------------------------------------------

     Nationwide COVID-19 Infection-Induced Antibody
Seroprevalence,12 13
---------------------------------------------------------------------------

    \12\ Nationwide COVID-19 Infection-Induced Antibody
Seroprevalence (Commercial laboratories): https://covid.cdc.gov/covid-data-tracker/#national-lab.
    \13\ Nationwide COVID-19 Infection- and Vaccination-Induced
Antibody Seroprevalence (Blood donations): https://covid.cdc.gov/covid-data-tracker/#nationwide-blood-donor-seroprevalence.
---------------------------------------------------------------------------

     Kaiser Health News/UK Guardian,\14\
---------------------------------------------------------------------------

    \14\ Kaiser Health News and the Guardian. (2021, April). Lost on
the Frontline. The Guardian. https://www.theguardian.com/us-news/ng-interactive/2020/aug/11/lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database.
---------------------------------------------------------------------------

     US Census: Current Population Statistics,\15\
---------------------------------------------------------------------------

    \15\ https://www.census.gov/programs-surveys/cps/data.html.
---------------------------------------------------------------------------

     The National Panel Study of COVID-19
(NPSC19),16 17
---------------------------------------------------------------------------

    \16\ https://www.brookings.edu/blog/up-front/2020/08/13/the-covid-19-public-health-and-economic-crises-leave-vulnerable-populations-exposed/.
    \17\ https://static1.squarespace.com/static/57c9d7602994ca1ac7d06b71/t/60243c4a2c291024fa12e979/1612987471528/UW_IRP_Grooms_Feb_2021.pdf.
---------------------------------------------------------------------------

     Census Bureau Household Pulse Survey,\18\
---------------------------------------------------------------------------

    \18\ Household Pulse Survey: Measuring Social and Economic
Impacts during the Coronavirus Pandemic: https://www.census.gov/programs-surveys/household-pulse-survey.html.
---------------------------------------------------------------------------

     National Center for Health Statistics,\19\
---------------------------------------------------------------------------

    \19\ https://www.cdc.gov/nchs/data_access/ftp_data.htm.
---------------------------------------------------------------------------

     American Community Survey,\20\ and
---------------------------------------------------------------------------

    \20\ https://www.census.gov/programs-surveys/acs/data.html.
---------------------------------------------------------------------------

     Optum Clinformatics Data Mart.\21\
---------------------------------------------------------------------------

    \21\ https://web.uri.edu/optum/.
---------------------------------------------------------------------------

    C.4 Small Business: In developing the Final Regulatory Flexibility
Analysis (FRFA), OSHA is seeking comments on whether there are specific
issues regarding small covered healthcare entities (i.e., small
businesses, small non-profits, and small government jurisdictions) that
OSHA should consider, particularly with respect to the technical or
economic feasibility of complying with a possible revised rule.
C.5--Assumptions
    C.5.1 Vaccine Efficacy: For the Healthcare ETS, OSHA accounted for
vaccine efficacy in its benefits analysis. For the final rule, OSHA is
considering accounting for booster efficacy using the CDC Data Tracker,
which was the same source for determining vaccine efficacy. OSHA seeks
comment on this potential approach and data on which to update its
estimates.
    C.5.2 Frequency, Severity, and Distribution of Infections: There
was ``still some uncertainty surrounding the frequency and severity of
COVID-19 infections and their distribution'' when the Healthcare ETS
was issued (86 FR 32545), so OSHA focused that economic analysis on
hospitalizations and fatalities. More time and data have brought more
certainty regarding other outcomes, so for the final rule OSHA is
considering also accounting in its economic analysis for COVID-19-
related long-term effects (i.e., long COVID), hospitalization, and
shorter illness (due to variants, increased vaccinations, and improved
treatments). Additionally, OSHA is considering using an approach
similar to that in the Vaccination and Testing ETS, where OSHA took
account of breakthrough cases and fatalities in vaccinated employees
when it assessed the health impacts. OSHA seeks comment and data on
these potential modifications.

II. Informal Public Hearing--Purpose, Rules, and Procedures

    One commenter requested that OSHA hold a public hearing on the

rulemaking. See OSHA-2020-0004-1034, Attachment 1. OSHA has agreed to
do so. OSHA invites interested persons to participate in this
rulemaking by providing oral testimony and documentary evidence at the
informal public hearing to provide the agency with the best available
evidence to use in developing the final rule.
    Pursuant to 29 CFR 1911.15(a) and 5 U.S.C. 553(c), members of the
public have an opportunity at the informal public hearing to provide
oral testimony and evidence on issues raised by the proposal. An
administrative law judge (ALJ) presides over each OSHA hearing and will
resolve any procedural matters relating to the hearing.
    OSHA's regulation governing public hearings (29 CFR 1911.15)
establishes the purpose and procedures of informal public hearings.
Although the presiding officer of the hearing is an ALJ and questioning
of witnesses may be allowed on crucial issues, the proceeding is
largely informal and essentially legislative in purpose. Therefore, the
hearing provides interested persons with an opportunity to make oral
presentations in the absence of rigid procedures that could impede or
protract the rulemaking process. The hearing is not an adjudicative
proceeding subject to the Federal Rules of Evidence. Instead, it is an
informal administrative proceeding convened for the purpose of
gathering and clarifying information. Accordingly, questions of
relevance, procedure, and participation generally will be resolved in
favor of developing a clear, accurate, and complete record within the
available time frame.
    The available time frame for this rulemaking is short as the agency
hopes to complete the rulemaking as quickly as possible. OSHA remains
aware of the dangers to healthcare workers exposed to COVID-19, as well
as the potential for new variants and the surges of patients with
COVID-19 that could follow in healthcare. Pursuant to 29 CFR 1911.4,
the Assistant Secretary may, on reasonable notice, issue additional or
alternative procedures to expedite the proceedings.
    Although the ALJ presiding over the hearing makes no decision or
recommendation on the merits of the proposal, the ALJ has the
responsibility and authority necessary to ensure that the hearing
progresses at a reasonable pace and in an orderly manner. To ensure a
full and fair hearing, the ALJ has the power to regulate the course of
the proceedings; dispose of procedural requests, objections, and
comparable matters; confine presentations to matters pertinent to the
issues the proposed rule raises; use appropriate means to regulate the
conduct of persons present at the hearing; question witnesses and
permit others to do so; limit such questioning; and leave the record
open for a reasonable time after the hearing for the submission of
additional data, evidence, comments, and arguments from those who
participated in the hearing (29 CFR 1911.16).
    At the close of the hearing, there will be a post-hearing comment
period during which stakeholders may submit final briefs, arguments,
summations, and additional data and information to OSHA.

III. Notice of Intention To Appear at the Hearing

    Interested persons who intend to provide oral testimony or
documentary evidence at the hearing must file a written NOITA prior to
the hearing and in accordance with the instructions in the ADDRESSES
section earlier in this document. To testify at the hearing, interested
persons must electronically submit their NOITA on or before April 6,
2022. The NOITA must provide the following information:
    (1) Name, address, email address, and telephone number of each
individual who will give oral testimony;
    (2) Name of the establishment or organization each individual
represents, if any;
    (3) Occupational title and position of each individual testifying;
and
    (4) A brief statement of the position each individual will take
with respect to the issues raised by the ETS (e.g., ``I generally
support/oppose the whole standard,'' ``the requirement for [specific
provision] should be removed,'' ``the scope of the rule should be
changed to include/exclude . . .'').
    The agency will consider the information in each submission when
setting the hearing schedule. Before the hearing, OSHA will make the
hearing procedures and hearing schedule available at https://www.osha.gov/coronavirus/healthcare/rulemaking and in the docket. OSHA
emphasizes that the hearing is open to the public; however, only
individuals who file a NOITA may testify at the hearing.

IV. Certification of the Hearing Record and Agency Final Determination

    Following the close of the hearing and the post-hearing comment
period, the ALJ will certify the record to the Assistant Secretary of
Labor for Occupational Safety and Health. The record will consist of
all of the written comments, oral testimony, and documentary evidence
received during the proceeding. The ALJ, however, will not make or
recommend any decisions as to the content of the final standard.
Following certification of the record, OSHA will review all the
evidence received into the record and will issue the final rule based
on the record as a whole.

Authority and Signature

    This document was prepared under the direction of Douglas L.
Parker, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, 200 Constitution Avenue NW,
Washington, DC 20210. It is issued under the authority of 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 No. 8-2020 (85 FR 58393
(Sept. 18, 2020)); 29 CFR part 1911; and 5 U.S.C. 553.

Douglas L. Parker,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-06080 Filed 3-22-22; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 77, Number 1 (Tuesday, January 3, 2012)]
[Notices]
[Page 144]
[FR Doc No: 2011-33775]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission Advisory Committee on Small and Emerging
Companies will hold a public telephone meeting on Friday, January 6,
2012, beginning at 1 p.m. Eastern Standard Time. The meeting will be
audio webcast on the Commission's Web site at http://www.sec.gov.
    On December 15, 2011, the Commission published notice of the
Committee meeting (Release No. 33-9285), indicating that the meeting is
open to the public and inviting the public to submit written comments
to the Committee. This Sunshine Act notice is being issued because a
majority of the Commission may attend the meeting.
    The agenda for the meeting includes consideration of a
recommendation to the Commission on relaxing current restrictions on
general solicitation and advertising in exempt offerings of securities.
    For further information, please contact the Office of the Secretary
at<PHONE_NUMBER>.

    Dated: December 29, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-33775 Filed 12-29-11; 4:15 pm]
BILLING CODE 8011-01-P