[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Rules and Regulations]
[Pages 30081-30082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 130

RIN 0906-AB13


Removing Outmoded Regulations Regarding the Ricky Ray Hemophilia 
Relief Fund Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final rule.

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SUMMARY: This action removes the outmoded regulations for the Ricky Ray 
Hemophilia Relief Fund Program. The program and its implementing 
regulation have been rendered obsolete by the statutory language in the 
authorizing legislation stating that the Fund should terminate on the 
expiration of the 5-year period beginning on the date of the enactment 
of the Act. The statute was enacted on November 12, 1998; thus, the 
fund expired on November 12, 2003.

DATES: This action is effective July 27, 2018.

FOR FURTHER INFORMATION CONTACT: Sweta Maheshwari J.D., Legislative 
Analyst, Division of Policy and Shortage Designation, Bureau of Health 
Workforce, HRSA, 5600 Fishers Lane, Room 11W21A, Rockville, MD 20857, 
by phone at (301) 945-3527, or by email at [email protected].

SUPPLEMENTARY INFORMATION: In response to Executive Order 13563, Sec. 
6(a), which urges agencies to repeal existing regulations that are 
outmoded from the Code of Federal Regulations (CFR), HHS is removing 42 
CFR part 130. HHS believes that there is good cause to bypass notice 
and comment and proceed to a final rule, pursuant to 5 U.S.C. 
553(b)(3)(B). The action is non-controversial, as it merely removes a 
provision from the CFR that is obsolete. This rule poses no new 
substantive requirements on the public.

Background

    The Ricky Ray Hemophilia Relief Fund Act of 1998 (Pub. L. 105-369) 
established the Ricky Ray Hemophilia Relief Fund Program designed to 
provide payments to individuals with blood-clotting disorders, such as 
hemophilia, who contracted HIV through the use of antihemophilic factor 
administered between July 1, 1982, and December 31, 1987. The Act also 
provided for payments to certain persons who contracted HIV from an 
individual as described above and certain specified survivors.
    HHS promulgated 42 CFR part 130 to establish the proper regulatory 
framework for program implementation. The regulation can be 
conceptualized as four parts: The process for payment, the 
documentation required to prove eligibility, the petition process, and 
the reconsideration process. The Ricky Ray Hemophilia Relief Fund was 
authorized with a directive to pay $100,000 in compensation to eligible 
individuals. At that time, however, no funds were appropriated to 
implement this statute. In FY 2000, Congress appropriated $75 million 
and, in FY 2001, Congress appropriated $580 million, for a total of 
$655 million. The appropriated amounts provided sufficient funding to 
make compassionate payments on all eligible petitions received by the 
program. The program received over 6,000 petitions resulting in 
approved payments over $550 million.
    The statutory language in the authorizing legislation stated that 
the ``Fund shall terminate upon the expiration of the 5-year period 
beginning on the date of the enactment of this Act.'' The statute was 
enacted on November 12, 1998; thus, the fund expired on November 12, 
2003. The program is no longer in effect or funded. The repeal of this 
regulation should not create any challenges for other programs, as the 
regulation was strictly for the implementation of the Ricky Ray 
Hemophilia Relief Fund program, which has not been in operation for 
almost 14 years.

Executive Orders 12866, 13563, 13771, and 13777

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13771 directs agencies to categorize all impacts which generate 
or alleviate costs associated with regulatory burden and to determine 
the actions net incremnatal effect.

[[Page 30082]]

    Section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) Having an annual effect on the economy of $100 million or more in 
any 1 year, or adversely and materially affecting a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local or Tribal governments or communities 
(also referred to as ``economically significant''); (2) creating a 
serious inconsistency or otherwise interfering with an action taken or 
planned by another agency; (3) materially altering the budgetary 
impacts of entitlement grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raising novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). HHS submits that this final rule is not ``economically 
significant'' as measured by the $100 million threshold, and hence not 
a major rule under the Congressional Review Act. This rule has not been 
designated as a ``significant regulatory action'' under Executive Order 
12866. Accordingly, this rule has not been reviewed by the Office of 
Management and Budget (OMB).
    Executive Order 13771, titled ``Reducing Regulation and Controlling 
Regulatory Costs,'' was issued on January 30, 2017. HHS identifies this 
final rule as a deregulatory action (removing an obsolete rule from the 
Code of Federal Regulations). For the purposes of Executive Order 
13771, this final rule is not a substantive rule; rather it is 
administrative in nature and provides no cost savings.
    Executive Order 13777, titled ``Enforcing the Regulatory Reform 
Agenda,'' was issued on February 24, 2017. As required by Section 3 of 
this Executive Order, HHS established a Regulatory Reform Task Force 
(HHS Task Force). Pursuant to Section 3(d)(ii), the HHS Task Force 
evaluated this rulemaking and determined that these regulations are 
``outdated, unnecessary, or ineffective.'' Following this finding, the 
HHS Task Force advised the HRSA Administrator to initiate this 
rulemaking to remove the obsolete regulations from the Code of Federal 
Regulations.

Regulatory Flexibility Act

    This action will not have a significant economic impact on a 
substantial number of small entities. Therefore, the regulatory 
flexibility analysis provided for under the Regulatory Flexibility Act 
is not required.

Paperwork Reduction Act

    This action does not affect any information collections.

    Dated: June 4, 2018.
George Sigounas,
Administrator, Health Resources and Services Administration.
    Approved: June 21, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

List of Subjects in 42 CFR Part 130

    Health care, Hemophilia, HIV/AIDS.

PART 130--[REMOVED]

0
For reasons set out in the preamble, and under the authority at 5 
U.S.C. 301, HHS amends 42 CFR chapter I by removing part 130.

[FR Doc. 2018-13836 Filed 6-26-18; 8:45 am]
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