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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
described in paragraph a1 of this section.
b End of the period. The MCIT
pathway for a breakthrough device ends as follows:
1 No later than 4 years from the date the breakthrough device received FDA
market authorization.
2 Prior to 4 years if a manufacturer withdraws the breakthrough device from the MCIT pathway.
3 Prior to 4 years if the breakthrough device becomes the subject of a national coverage determination or otherwise becomes noncovered through law, regulation, or at the discretion of the Secretary subsequent to an FDA medical device safety communication or Warning Letter.
4 Prior to 4 years if the FDA removes authorization of a device, the breakthrough device is removed from the MCIT pathway.
Dated: December 31, 2020.
Seema Verma, Administrator, Centers for Medicare &
Medicaid Services.
Dated: January 5, 2021.
Alex M. Azar II, Secretary, Department of Health and Human Services.
FR Doc. 202100707 Filed 11221; 4:15 pm BILLING CODE 412001P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 1
HHSOS20210001
RIN 0991AC18

Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions Office of the Secretary, Department of Health and Human Services.
ACTION: Final rule.
AGENCY:

The Department of Health and Human Services is issuing regulations promoting transparency and fairness in civil enforcement actions. These regulations will help to ensure that regulated parties receive fair notice of laws and regulations they are subject to, and have an opportunity to contest an agency determination prior to the agency taking an action that has a legal consequence.
DATES: Effective January 12, 2021.
FOR FURTHER INFORMATION CONTACT:
Brenna Jenny, Department of Health and Human Services, 200 Independence
khammond on DSKJM1Z7X2PROD with RULES

SUMMARY:

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Avenue SW, Room 713F, Washington, DC 20201. Email: Good.Guidance@
hhs.gov. Telephone: 202 6907741.
I. Statutory and Regulatory Background The primary legal authority supporting this rulemaking is 5 U.S.C.
301. That provision provides that the head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This statute authorizes an agency to regulate its own affairs, and issue rules, such as this one, that are rules of agency organization, procedure or practice.
Chrysler Corp. v. Brown, 441 U.S. 281, 30910 1979. Similarly, 42 U.S.C. 1302
provides that the Secretary shall make and publish such rules and regulations, not inconsistent with this chapter, as may be necessary to the efficient administration of the functions with which he is charged under Chapter 7
of the Social Security Act. Chapter 7
contains, among other things, statutory provisions governing Medicare, Medicaid, and the Health Insurance Portability and Accountability Act HIPAA.
The Administrative Procedure Act APA, 5 U.S.C. 551 et seq., specifies the process by which such regulations are promulgated. Department heads generally must prescribe regulations through notice-and-comment rulemaking, but there is an exception for rules of agency organization, procedure, or practice. The requirements for notice and comment prior to finalization also do not apply to regulations that involve a matter relating to agency management or personnel. 5 U.S.C. 553a2.
Because this final rule only specifies procedures that agency personnel must follow or that will govern civil enforcement actions, it is exempt from the requirement for notice and comment prior to finalization. In determining whether notice-and-comment rulemaking is required, the critical feature is that the rule covers agency actions that do not themselves alter the rights or interests of the parties, although it may alter the manner in which the parties present themselves or their viewpoints to the agency. Natl Sec. Counselors v. CIA, 931 F. Supp. 2d 77, 10607 D.D.C. 2013 quoting Batterton v. Marshall, 648 F.2d 694, 707
D.C. Cir. 1980. This rule is exempt from notice and comment because it does not put a stamp of approval or disapproval on a given type of
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behavior. Am. Hosp. Assoc. v. Bowen, 834 F.2d 1037, 1047 D.C. Cir. 1987.
What had been a regulatory violation prior to finalization of this rule still is;
the Department of Health and Human Services HHS or the Department is only modifying the procedures governing civil enforcement actions and the Departments civil enforcement action practices. To be sure, these procedural modifications, like most rules of agency procedure or personnel, might have some impact on the public.
But agency rules that impose derivative, incidental, or mechanical burdens upon regulated individuals are considered procedural, rather than substantive, and are therefore exempt from the notice-andcomment requirement. Id. at 1051.
Moreover, to the extent this rule has effects on the public, it only provides additional protections to the public, rather than depriving the public of any rights or interests it previously had.
The APA requires that administrative policies affecting individual rights and obligations be promulgated pursuant to certain stated procedures so as to avoid the inherently arbitrary nature of unpublished ad hoc determinations. Morton v. Ruiz, 415
U.S. 199, 232 1974. The Freedom of Information Act amended the APA to advance this goal, and generally requires that agencies publish in the Federal Register their substantive rules of general applicability, statements of general policy, and interpretations of law that are generally applicable. 5
U.S.C. 552a1D. Unless a party has actual and timely notice of the terms of a rule or policy, the Freedom of Information Act generally provides that a party may not be adversely affected by a rule or policy required to be published in the Federal Register that is not so published. 5 U.S.C. 552a1flush language. This rule of agency procedure ensures that HHS actions comport with these requirements.
II. Summary of Transparency and Fairness Regulations To provide regulated parties with greater transparency and fairness in administrative actions, and consistent with the requirements of Executive Order 13892 of October 9, 2019, Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication, 84 FR 55239 Oct. 15, 2019, HHS is setting forth policies that promote transparency and fairness in civil enforcement actions that will apply to all divisions of HHS. The requirements in this rule amend 45 CFR
part 1.

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