Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date
| Published date | 04 March 2022 |
| Citation | 87 FR 12399 |
| Record Number | 2022-04524 |
| Section | Rules and Regulations |
| Court | Centers For Medicare And Medicaid Services,Children And Families Administration,Public Health Service,The Inspector General Office |
12399
Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations
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[FR Doc. 2022–04497 Filed 3–3–22; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 6
Public Health Service
42 CFR Part 1
Centers for Medicare and Medicaid
Services
42 CFR Part 404
Office of the Inspector General
42 CFR Part 1000
Office of the Secretary
45 CFR Part 8
Administration for Children and
Families
45 CFR Parts 200, 300, 403, 1010, and
1300
[Docket No. HHS–OS–2020–0012]
RIN 0991–AC24
Securing Updated and Necessary
Statutory Evaluations Timely;
Administrative Delay of Effective Date
AGENCY
: Department of Health and
Human Services (HHS).
ACTION
: Final rule; delay of effective
date.
SUMMARY
: The Department of Health and
Human Services (HHS or Department) is
postponing, pending judicial review, the
effective date of a final rule entitled
‘‘Securing Updated and Necessary
Statutory Evaluations Timely’’ (SUNSET
final rule) and published in the Federal
Register of January 19, 2021, and a final
rule correction published in the Federal
Register of March 23, 2021.
DATES
: As of March 4, 2022, the
effective date of the SUNSET final rule
published January 19, 2021 (86 FR
5694), which was delayed until March
22, 2022, by an order that took effect as
of March 19, 2021 (86 FR 15404, March
23, 2021), is further delayed pursuant to
5 U.S.C. 705 for six months until
September 22, 2022.
As of March 4, 2022, the effective date
of the correction published March 23,
2021 (86 FR 15404), is delayed until
September 22, 2022.
FOR FURTHER INFORMATION CONTACT
:
Daniel J. Barry, Acting General Counsel,
200 Independence Avenue SW,
Washington, DC 20201; or by email at
reviewnprm@hhs.gov; or by telephone at
1–877–696–6775.
SUPPLEMENTARY INFORMATION
:
I. Overview
The SUNSET final rule, if
implemented, would establish a new
process for regulatory review of HHS
regulations, which includes the
automatic expiration of regulations
under certain circumstances. It was
scheduled to take effect on March 22,
2021. After a lawsuit was filed on March
9, 2021, seeking to overturn the
SUNSET final rule, HHS issued an
Administrative Delay of Effective Date
(First Administrative Delay), which took
effect as of March 19, 2021, which
postponed the effective date of the
SUNSET final rule, pending judicial
review, until March 22, 2022. 86 FR
15404 (Mar. 23, 2021).
After conducting a thorough review of
the SUNSET final rule including the
oral and written comments on its
proposal and the allegations in the
lawsuit, HHS published a notice of
proposed rulemaking to withdraw or
repeal the SUNSET final rule
(Withdrawal NPRM). 86 FR 59906 (Oct.
29, 2021). The comment period on the
Withdrawal NPRM closed on December
28, 2021. HHS received approximately
80 comments. Some comments were
submitted by Plaintiffs in the lawsuit
seeking to overturn the SUNSET final
rule, and their comments incorporated
by reference the Complaint they had
filed.
HHS is currently in the process of
reviewing the comments and developing
a final rule. For the reasons described
below, HHS finds that the interests of
justice require that the SUNSET final
rule’s effective date be postponed
pending judicial review because: (1) A
postponement will permit HHS to
continue and complete its review of the
SUNSET final rule in light of the claims
raised in the litigation; (2) the resolution
of the rulemaking will inform the
government’s position in this lawsuit;
and (3) based on HHS’s review of the
Complaint, HHS believes that the Court
may find that: (a) Some of Plaintiffs’
claims have merit; (b) Plaintiffs’
allegations of harm are credible; and (c)
the balance of equities and the public
interest warrant postponement of the
effective date to preserve the status quo
while the Court considers the challenge
to the SUNSET final rule.
II. Background
A. The SUNSET Proposed and Final
Rules
On November 4, 2020, HHS published
a notice of proposed rulemaking entitled
‘‘Securing Updated and Necessary
Statutory Evaluations Timely’’ (SUNSET
proposed rule). 85 FR 70096. The
SUNSET proposed rule provided that
comments could be submitted until
December 4, 2020, except for comments
on the portion of the rule amending 42
CFR parts 400–429 and parts 475–499,
which were due by January 4, 2021.
HHS received 532 comments total
throughout the 60-day comment period,
and the commenters ‘‘generally opposed
the proposed rule, although some
commenters supported it.’’ 86 FR 5704.
HHS also held a public hearing on
November 23, 2020, to receive
information and views on the proposed
rule (Public Hearing). Over twenty
interested parties provided oral
comments at the Public Hearing. See
Transcript, Public Hearing on the
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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations
Securing Updated and Necessary
Statutory Evaluations Timely Notice of
Proposed Rulemaking (Nov. 23, 2020)
(available at https://
www.regulations.gov/document/
HHSOS-2020-0012-0501) (Public
Hearing Transcript).
HHS issued the SUNSET final rule on
January 19, 2021. 86 FR 5694. The
substance of the SUNSET proposed and
final rules are more fully described in
the First Administrative Delay, and that
description is adopted by reference into
this preamble. See 86 FR 15405.
B. The Santa Clara Complaint
On March 9, 2021, the County of
Santa Clara, California Tribal Families
Coalition, National Association of
Pediatric Nurse Practitioners, American
Lung Association, Center for Science in
the Public Interest, and Natural
Resources Defense Council sued the
Department seeking to overturn the
SUNSET final rule under the
Administrative Procedure Act (APA).
Complaint, County of Santa Clara v.
HHS, Case No. 5:21–cv–01655–BLF
(N.D. Cal.). The substance of the
Complaint is more fully described in the
First Administrative Delay, and that
description is adopted by reference into
this preamble. See 86 FR 15405.
C. The Administrative Delay of Effective
Date and Stay of Litigation.
On March 9, 2021, HHS issued the
First Administrative Delay, which took
effect as of March 19, 2021, which
postponed the effective date of the
SUNSET final rule, pending judicial
review, until March 22, 2022. HHS
explained that it believed that the Court
may find: (a) That some of Plaintiffs’
claims have merit; (b) that Plaintiffs’
allegations of harm are credible; and (c)
that the balance of equities and the
public interest warrant postponement of
the effective date pending judicial
review. Accordingly, the Department
found that the interests of justice
required a postponement in order to
preserve the status quo, because, if the
rule took effect while HHS was
evaluating the rule in light of the claims
raised in litigation, it could create
significant obligations for HHS, cause
confusion for the public, including
Plaintiffs, and may lead to compliance
costs as entities, including Plaintiffs,
plan steps necessary to deal with the
rule’s implementation. HHS also
observed that it was unaware of any
benefits from the implementation of the
SUNSET final rule that would be
significantly curtailed from a stay of its
effective date. See 86 FR 15404–08.
With respect to the Santa Clara
litigation, the parties requested that the
court stay the case on the ground that
HHS was reviewing the SUNSET final
rule in light of Plaintiffs’ claims raised
in this litigation and needed additional
time to evaluate the claims and its
position before taking further steps in
the litigation. The court granted the
stay. Order, County of Santa Clara v.
HHS, Case No. 5:21–cv–01655–BLF
(N.D. Cal.) (Apr. 22, 2021). Since that
time, the parties have periodically
submitted joint status reports to the
court and requested that the litigation
stay be extended, and those requests
have thus far, as of February 1, 2022,
been granted.
D. The Withdrawal NPRM
HHS published the Withdrawal
NPRM on October 29, 2021, in which it
proposed to withdraw or repeal the
SUNSET final rule in its entirety. 86 FR
59906. In the Withdrawal NPRM, the
Department explained that, in issuing
the SUNSET rule, it should have
engaged in a more robust consideration
of the comments and should have given
greater weight to the potential harms to
stakeholders and the public health.
Therefore, before issuing the
Withdrawal NPRM, the Department
reexamined the SUNSET final rule in
light of the allegations in the Santa
Clara complaint, the many comments
submitted to the SUNSET proposed rule
docket and raised at the Public Hearing,
and the current Administration’s
policies. That review considered the
processes followed in issuing the
SUNSET final rule, its policy goals and
objectives, the projected effects and
analysis of impacts in its
implementation, and the legal
evaluation of and support for its
provisions, including whether the rule
is consistent with all HHS statutory
obligations and its mission to promote
and protect the public health.
The comment period on the
Withdrawal NPRM closed on December
28, 2021, and HHS received
approximately 80 comments. HHS is
actively engaged in considering the
comments and developing a final rule.
III. Discussion
Under 5 U.S.C. 705 of the APA, an
agency ‘‘may postpone the effective date
of action taken by it, pending judicial
review,’’ when the ‘‘agency finds that
justice so requires.’’ On March 9, 2021,
HHS issued the First Administrative
Delay after concluding that the interests
of justice required that the SUNSET
final rule be stayed pending judicial
review. For the reasons described in the
First Administrative Delay and as
further discussed in this document, the
Department has concluded that the
considerations supporting the First
Administrative Delay remain true today,
and the interests of justice require that
the effective date of the SUNSET final
rule should be further stayed until
September 22, 2022.
In the First Administrative Delay, the
Department explained that it was taking
a fresh and critical look at the SUNSET
final rule in light of the allegations in
the Complaint. The Complaint alleged
serious legal vulnerabilities of the rule,
and, while HHS did not concede any of
these claims at that time, HHS required
additional time to complete its
evaluation of the SUNSET final rule
given the pending litigation. In addition,
the Complaint raised the question as to
whether the SUNSET final rule, issued
in the final days of the last
Administration, is consistent with the
policies and goals of the current
Administration, both in terms of the
appropriate role of regulatory oversight
of the health care industry and
necessary engagement with the public,
including tribal organizations.
After further review of the SUNSET
final rule, the allegations in the
Complaint, and the comments on the
SUNSET proposed rule, we issued the
Withdrawal NPRM in October 2021, in
which we discussed our tentative
conclusions for further public comment.
Our discussion included concerns
regarding the procedural shortcomings
of the SUNSET rulemaking process, the
fundamental errors in its Regulatory
Impact Analysis, and the attendant legal
vulnerabilities of the SUNSET final rule.
Our reanalysis of the regulatory impact
of this rule, as set forth in the
Withdrawal NPRM, has underscored our
belief that the Santa Clara court could
find merit in at least some of Plaintiffs’
claims.
Our review of the approximately 80
comments submitted on the Withdrawal
NPRM is ongoing. A few substantive
comments support the SUNSET final
rule while many other substantive
comments favor withdrawal or repeal.
As noted, Plaintiffs in the Santa Clara
litigation submitted comments on the
Withdrawal NPRM that attached copies
of the Complaint. Accordingly, HHS’s
consideration of the Complaint’s
critique of the SUNSET final rule are
part of its ongoing review.
The Complaint also alleges that
Plaintiffs and others would be
immediately harmed by the SUNSET
final rule, if implemented. The
Complaint alleges that the uncertainty
resulting from its implementation
impacts the entire healthcare sector,
which accounts for nearly one-fifth of
the U.S. economy and secures
individual and community health for
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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations
hundreds of millions of Americans, and
that participants in every single
industry the Department regulates,
including Plaintiffs, must plan their
futures and operations without knowing
what regulations will govern their
businesses in these notoriously complex
regulatory arenas. See Complaint, ¶¶ 2,
95–122. While HHS does not concede
that Plaintiffs would establish
irreparable harm in litigation, HHS
agrees that it is appropriate to postpone
the effective date of the SUNSET final
rule to preserve the status quo and to
ensure that HHS has time to evaluate
the rule before it takes effect to avoid
the possibility of confusion among the
regulated community. All of these
potential consequences would be
detrimental to the public health,
underscoring that justice requires a
postponement of the SUNSET final
rule’s effective date pursuant to 5 U.S.C.
705.
We further conclude that extending
the effective date of the SUNSET final
rule will create no countervailing harms
because this delay merely continues the
status quo. And because
implementation of the regulatory review
framework provided under the SUNSET
final rule would be a complex and
lengthy process, any purported benefits
from the retirement of regulations under
the new process would not accrue for
several years. Accordingly, given the
public health concerns and the harms
from the implementation of the
SUNSET final rule alleged by the
Plaintiffs and echoed in the comments
to the SUNSET proposed rule and the
Withdrawal NPRM, and the dearth of
countervailing harms from extending
the effective date, the balance of equities
and the public interest favor the
extension of the stay of the effective
date of the SUNSET final rule to
preserve the status quo and allow for
judicial review of its legality before any
implementation.
Accordingly, HHS is issuing this
further stay of the effective date of this
final rule pending judicial review. This
postponement applies to all of the
regulations established under the
SUNSET final rule. As noted above, the
Complaint alleges that the SUNSET
final rule suffers from a variety of
defects, including procedural defects
related to its promulgation. The
Department believes it is appropriate to
review the entire rule in light of the
claims raised in the litigation, which it
continues to actively evaluate in
conjunction with its consideration of
the comments to the Withdrawal NPRM
and its efforts to develop a final rule.
Thus, this postponement reaches the
full rule, consistent with the
Complaint’s prayer for relief.
Xavier Becerra,
Secretary.
[FR Doc. 2022–04524 Filed 3–3–22; 8:45 am]
BILLING CODE 4150–26–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 7
[Docket No. FDA–2018–D–2074]
Initiation of Voluntary Recalls;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY
: Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION
: Notification of availability.
SUMMARY
: The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry and FDA staff
entitled ‘‘Initiation of Voluntary Recalls
Under 21 CFR part 7, subpart C.’’ The
guidance for industry and FDA staff
provides guidance on timely initiation
of voluntary recalls of FDA-regulated
products. It also discusses preparations
that firms in a distribution chain should
consider making to ensure timely
responses to a recall communication. In
addition, the guidance discusses how
FDA assists firms with carrying out their
recall responsibilities to protect the
public health from distributed products
in violation of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and other
laws administered by FDA. This
guidance finalizes the draft guidance of
the same title issued on April 24, 2019.
DATES
: The announcement of the
guidance is published in the Federal
Register on March 4, 2022.
ADDRESSES
: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
•Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
•If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
•Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
•For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–2074 for ‘‘Initiation of
Voluntary Recalls Under 21 CFR part 7,
subpart C.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
•Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
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