LegiStorm

Summary:
Highlights

GAO reviewed the Centers for Disease Control and Prevention (CDC) new rule entitled "Control of Communicable Diseases; Foreign Quarantine: Suspension of Introduction of Persons Into United States From Designated Foreign Countries or Places for Public Health Purposes." GAO found that the final rule provides a procedure for CDC to suspend the introduction of persons from designated countries or places, if required, in the interest of public health.







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B-333045

March 10, 2021

The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Frank Pallone, Jr.
Chairman
The Honorable Cathy
McMorris Rodgers
Ranking Member
Committee on Energy and Commerce
House of Representatives


Subject: Department of Health and Human Services: Control of Communicable Diseases;
Foreign Quarantine: Suspension of Introduction of Persons Into United States From
Designated Foreign Countries or Places for Public Health Purposes 
Pursuant to section 801(a)(2)(A) of title 5, United States Code, this
is our report on a major rule promulgated by the Centers for Disease Control and Prevention
(CDC) within the U.S. Department of Health and Human Services (HHS) entitled ?Control of
Communicable Diseases; Foreign Quarantine: Suspension of Introduction of Persons Into
United States From Designated Foreign Countries or Places for Public Health Purposes?
(RIN:  0920-AA76).  We received the rule on May 8, 2020.[1]  It was published in the
Federal Register as an interim final rule with request for comments on March 24,
2020.  85 Fed. Reg.16559.  The effective date of this interim final rule was
March 20, 2020.

According to HHS, CDC is issuing this interim final rule with request
for comments to amend its Foreign Quarantine Regulations.  HHS stated that this
interim final rule provides a procedure for CDC to suspend the introduction of persons from
designated countries or places, if required, in the interest of public health.

The Congressional Review Act (CRA) requires a 60-day delay in the
effective date of a major rule from the date of publication in the Federal Register
or receipt of the rule by Congress, whichever is later.  5 U.S.C. §
801(a)(3)(A).  The 60-day delay in effective date can be waived, however, if the
agency finds for good cause that delay is impracticable, unnecessary, or contrary to the
public interest, and the agency incorporates a statement of the findings and its reasons in
the rule issued.  5 U.S.C. §§ 553(b)(3)(B), 808(2).  Here, although HHS did not
specifically mention CRA?s 60-day delay in effective date requirement, HHS stated that
notice and comment procedures were unnecessary for this interim final rule because it found
good cause to waive such procedures under section 553(b)(3)(B) of the Administrative
Procedure Act (APA).  HHS also stated that given the national emergency caused by the
Coronavirus Disease 2019, it would be impracticable and contrary to the public health?and,
by extension, the public interest?to delay these implementing regulations until a full
public notice-and-comment process is completed.  HHS stated further, for the same
reasons, it has determined, consistent with section 553(d) of APA, that there is good cause
to make this interim final rule effective immediately.

Enclosed is our assessment of HHS?s and CDC?s compliance with the
procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect
to the rule.  If you have any questions about this report or wish to contact GAO
officials responsible for the evaluation work relating to the subject matter of the rule,
please contact Shari Brewster, Assistant General Counsel, at (202) 512-6398.


Shirley A. Jones
Managing Associate General Counsel

Enclosure

cc:  Vanessa Jones
  Regulations
  Department of Health and Human
Services
ENCLOSURE

REPORT UNDER 5 U.S.C. §
801(a)(2)(A) ON A MAJOR RULE
ISSUED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
ENTITLED
?CONTROL OF COMMUNICABLE
DISEASES; FOREIGN QUARANTINE:
SUSPENSION OF INTRODUCTION OF PERSONS INTO UNITED STATES
FROM DESIGNATED FOREIGN COUNTRIES OR PLACES
FOR PUBLIC HEALTH PURPOSES?
(RIN:  0920-AA76)


(i) Cost-benefit analysis

In its submission to us, the Department of Health and Human Services
(HHS) on behalf of the Centers for Disease Control and Prevention (CDC) indicated that it
did not prepare an analysis of the costs and benefits of this interim final rule (IFR).

(ii) Agency actions relevant to the Regulatory Flexibility Act
(RFA), 5 U.S.C. §§ 603-605, 607, and 609

In its submission to us, HHS indicated that a regulatory flexibility
analysis was not prepared for this IFR.  However, according HHS, when a rule is
promulgated in response to an emergency that makes timely compliance impracticable, the
agency must publish a regulatory flexibility analysis within 180 days of publication of the
final rule.  5 U.S.C. § 608(b).  HHS stated that for the reasons set forth in
this IFR pertaining to the Coronavirus Disease 2019 (COVID-19) outbreak, the Secretary
found that this IFR was being promulgated in response to an emergency that made timely
compliance with the provisions of section 604 impracticable.  HHS also stated that it
will assess the potential impacts?including economic effects?of this action on all small
entities.  HHS stated further, based on that assessment, the Secretary will either
certify that the rule will not have a significant economic impact on a substantial number
of small entities or publish a final regulatory flexibility analysis.

(iii) Agency actions relevant to sections 202-205 of the Unfunded
Mandates Reform Act of 1995, 2 U.S.C. §§ 1532-1535

HHS determined that this IFR is not expected to result in expenditures
by state, local, and tribal governments, or by the private sector, of $154 million ($100
million, adjusted for inflation) or more in any one year, because it only establishes a
regulatory mechanism for the exercise of the Public Health Service Act?s section 362
suspension authority, which applies against persons and not state, local, or tribal
governments, or the private sector.  42 U.S.C. § 265. 

(iv) Other relevant information or requirements under acts and
executive orders

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.

HHS stated that notice and comment procedures were unnecessary for
this IFR, and it found good cause to waive such procedures under section 553(b)(3)(B) of
the Administrative Procedure Act (APA).  HHS also stated that given the national
emergency caused by COVID-19, it would be impracticable and contrary to the public health?and, by extension,
the public interest?to delay these implementing regulations until a full public
notice-and-comment process was completed. 

Paperwork Reduction Act (PRA), 44 U.S.C. §§ 3501-3520

HHS determined that this IFR has no new collections of information for
purposes of PRA.

Statutory authorization for the rule

HHS, on behalf of CDC, promulgated this IFR pursuant to sections 216,
243, and 264?272 of title 42, United States Code.

Executive Order No. 12866 (Regulatory Planning and Review)

HHS determined that this IFR is economically significant under the
Order.  HHS stated that it is proceeding under the emergency provision of the Order at
section 6(a)(3)(D) based on the need to move expeditiously during the current public health
emergency to limit the number of new cases of COVID-19.

Executive Order No. 13132 (Federalism)

According to HHS, this IFR does not alter the relationship between the
federal government and state/local governments as set forth in 42 U.S.C. § 264(e), which
provides that federal public health regulations do not preempt state or local public health
regulations, except in the event of a conflict with the exercise of federal
authority.  HHS stated that the longstanding provision on preemption in the event of a
conflict with federal authority, 42 C.F.R. § 70.2, is left unchanged by this
rulemaking.  HHS stated further that there are no provisions in this IFR that impose
direct compliance costs on state and local governments.





[1] This major rule report was due on June 30, 2020.  Due to a
processing error on our part, we are delayed in our issuance of this report.





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