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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Rules and Regulations
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6. Adequacy of Rulemaking Process Lastly, OMB Memorandum M2114
requires agencies to consider, among other things, whether the rulemaking process was procedurally adequate and whether interested parties had a fair opportunity to present contrary facts and arguments. We are soliciting comment on the following:
Whether there are any other procedural issues pertaining to the January 2021 MCIT rulemaking process.
If there are other procedural issues, what are those issues and what should CMS do to remedy those issues?
Should the January 2021 MCIT final rule be amended, rescinded, or further delayed pending review by the CMS or allowed to go into effect?
III. Waiver of Proposed Rulemaking and the 60-Day Public Comment Periods We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment prior to a rule taking effect in accordance with section 1871 of the Act and section 553b of the Administrative Procedure Act APA. Unless there is a statutory exception, section 1871b1
of the Act generally requires the Secretary of the Department of Health and Human Services the Secretary to provide for notice of a proposed rule in the Federal Register and provide a period of not less than 60 days for public comment before establishing or changing a substantive legal standard regarding the matters enumerated by the statute. Similarly, under 5 U.S.C. 553b of the APA, the agency is required to publish a notice of proposed rulemaking in the Federal Register before a substantive rule takes effect. Section 553d of the APA and section 1871e1Bi of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. Sections 553bB
and 553d3 of the APA provide for exceptions from the advance notice and comment requirement and the delay in effective date requirements. Sections 1871b2C and 1871e1Bii of the Act also provide exceptions from the notice and 60-day comment period and the 30-day delay in effective date.
Section 553bB of the APA and section 1871b2C of the Act expressly authorize an agency to dispense with notice and comment rulemaking for good cause if the agency makes a finding that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest.
We find that notice and comment rulemaking is impracticable,
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unnecessary, and contrary to the public interest with respect to the relatively short delay in the effective date of the final MCIT rule announced by this action. The final rule was published in the Federal Register on January 14, 2021. Even if the MCIT final rule were to go into effect on March 15, 2021, CMS would be unable to operationalize the program by that date. Because the agency is required to make other decisions, such as benefit category determinations, whether there is an existing payment methodology and whether there is an existing code or establishing code for the MCIT eligible breakthrough device, it would be impracticable to operationalize the MCIT rule on the March 15, 2021
effective date. These operational practicalities leave CMS incapable of implementing the MCIT program on March 15, 2021. Additionally, the higher than anticipated volume of devices receiving FDA breakthrough device designation exponentially complicates the operational concerns that we have identified. Further, public comments highlighted the importance of the agency having the ability to not only cover an FDA-designated breakthrough device expeditiously, but also to be able to have coding and payment levels established at the same time.
It would be impracticable to provide the normal 60-day comment period for such a brief delay in the effective date because the rule would be effective before the public comments could be meaningfully considered. Given the March 15, 2021 effective date for the MCIT final rule, there is not sufficient time to adequately consider advance public comment on this delay and it would interfere with the publics interest in the orderly promulgation and implementation of regulations. We find good cause for dispensing with advance public comment because it is impracticable to provide a meaningful opportunity to comment before extending the effective date of the MCIT
rule.
The White House memorandum also recommends that, for rules postponed for further review, agencies consider opening a 30-day comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by those rules, and consider any requests for reconsideration involving such rules.
Consistent with this guidance, we are requesting public comments on these topics, as well as the specific questions posed previously. After reviewing comments received in response to this notice, we may determine there is a need to postpone the effective date
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further to allow additional time to consider issues of fact, law, and policy or to reconsider the January 2021 MCIT
final rule.
IV. Summary This rule delays the effective date of January 2021 MCIT final rule to May 15, 2021 for further review of the of fact, law, and policy raised by the rule. This rule also invites 30 days of public comment and requests interested parties to provide comments about issues of fact, law, and policy raised by the January 14, 2021 final rule so that CMS
can consider any requests for reconsideration involving the rule. We also invite additional public comments on whether the rule should be amended, rescinded, delayed pending further review, or allowed to go into effect.
For the reasons stated previously, we find that there is good cause under 5
U.S.C. 553bB and d3 to publish this action without prior notice and comment, and for this action to become effective immediately upon publication in the Federal Register.
V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually.
Norris Cochran, Acting Secretary, Department of Health and Human Services.
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management Agency 44 CFR Part 64
Docket ID FEMA20210003; Internal Agency Docket No. FEMA8671

Suspension of Community Eligibility Federal Emergency Management Agency, DHS.
ACTION: Final rule.
AGENCY:

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program NFIP that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency
SUMMARY:

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