Standards for Accessible Medical Diagnostic Equipment, 6037-6038 [2022-02133]

Agencies

• Architectural and Transportation Barriers Compliance Board

[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Rules and Regulations]
[Pages 6037-6038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02133]



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ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD

36 CFR Part 1195

[Docket No. ATBCB-2021-0002]
RIN 3014-AA45


Standards for Accessible Medical Diagnostic Equipment

AGENCY: Architectural and Transportation Barriers Compliance Board.

ACTION: Direct final rule.

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SUMMARY: We, the Architectural and Transportation Barriers Compliance 
Board (hereafter, ``Access Board'' or ``Board''), are issuing this 
direct final rule to extend, for three years, the sunset provisions in 
the Board's existing accessibility standards for medical diagnostic 
equipment related to the low-height specifications for transfer 
surfaces to provide additional time for research necessary to determine 
the appropriate, final specification for the low transfer height 
position. The Access Board is issuing these amendments directly as a 
final rule because we believe they are noncontroversial, unlikely to 
receive adverse comment, and will serve the public interest.

DATES: This direct final rule is effective February 3, 2022, without 
further action, unless adverse comment is received by March 7, 2022. If 
timely adverse comment is received, the Access Board will publish a 
notification of withdrawal in the Federal Register. Such notification 
may withdraw the direct final rule in whole or in part.

ADDRESSES: You may submit comments by any one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Email: board.gov">[email protected]board.gov. Include docket number 
ATBCB-2021-0002 in the subject line of the message.
     Mail: Office of General Counsel, U.S. Access Board, 1331 F 
Street NW, Suite 1000, Washington, DC 20004-1111.
    Instructions: All submissions must include the docket number 
(ATBCB-2021-0002) for this regulatory action. All comments received 
will be posted without change to https://www.regulations.gov, including 
any personal information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov/docket/ATBCB-2022-0002.

FOR FURTHER INFORMATION CONTACT: Attorney Advisor Wendy Marshall, (202) 
272-0043, board.gov">[email protected]board.gov.

SUPPLEMENTARY INFORMATION:

Legal Authority

    Section 510 of the Rehabilitation Act charges the Access Board with 
developing and maintaining minimum technical criteria to ensure that 
``medical diagnostic equipment used in or in conjunction with 
physician's offices, clinics, emergency rooms, hospitals, and other 
medical settings, is accessible to, and usable by, individuals with 
accessibility needs, and shall allow independent entry to, use of, and 
exit from the equipment by such individuals to the maximum extent 
possible.'' 29 U.S.C. 794f. The Access Board's minimum technical 
criteria do not impose any mandatory requirements on health care 
providers or medical device manufacturers. Adopting agencies or 
entities may, however, issue regulations or adopt policies requiring 
health care providers to acquire accessible medical diagnostic 
equipment that complies with the minimum technical criteria set forth 
by the Access Board.

Purpose of Direct Final Rule

    In January 2017, the Board issued a final rule establishing 
accessibility standards for medical diagnostic equipment (MDE 
Standards). 82 FR 2810 (codified at 36 CFR part 1195). The MDE 
Standards set forth minimum technical criteria to ensure that medical 
diagnostic equipment used by health care providers (such as examination 
tables, weight scales, and imaging equipment) is accessible to, and 
usable by, individuals with disabilities. One of the areas covered by 
these Standards is the adjustability of transfer surfaces for certain 
types of medical diagnostic equipment. Specifically, for diagnostic 
equipment used by patients in a supine, prone, side-lying, or seated 
position, the MDE Standards specify the following adjustability 
requirements for transfer-height positions: A high height of 25 inches, 
a low height of 17-19 inches, and four unspecified intermediate heights 
between the high and low transfer height, which are separated by a 
minimum of one inch. 36 CFR part 1195, appendix, sections M301.2.1 & 
M302.2.2.
    Unlike the other transfer height specifications, the low transfer 
height was set as a temporary range with five-year sunset provisions. 
Id. As explained in the preamble to the final rule, the Board took this 
approach because ``there was insufficient information to designate a 
single minimum low height requirement at this time. Specifically, there 
[was] insufficient data on the extent to which and how many individuals 
would benefit from a transfer height lower than 19 inches.'' 82 FR at 
2816. The Board thus specified a five-year sunset period to afford time 
for needed research and subsequent promulgation of a final 
specification for the low transfer height position. Id.
    The Access Board is currently conducting research on low transfer 
heights; however, this research will not be completed in time for the 
Board to finalize a low transfer height specification prior to the 
expiration of the sunset period. By this rule, the Board thus extends 
the sunset provisions by an additional three years (i.e., January 2025) 
so that there is no lapse in specifications for the low transfer height 
provisions while the Board completes both its research and the required 
rulemaking processes to establish final specifications.

Regulatory Process Matters

A. Administrative Procedures Act and Good Cause Findings

    The Access Board is extending the sunset provisions in the MDE 
Standards without prior notice and opportunity for public comment 
because it has determined that such procedures are unnecessary and 
contrary to the public interest. See 5 U.S.C. 553(b)(B) (permitting 
agencies to bypass notice-and-comment procedures when, for good cause, 
they find prior notice ``impracticable, unnecessary, or contrary to the 
public interest''). Extending the sunset provisions for the low 
transfer height provisions represents a minor, technical change that 
merely maintains the status quo for an additional three years. We thus 
believe the changes effected by this direct final rule will be 
noncontroversial and unlikely to draw adverse comment. Additionally, 
because the MDE Standards were promulgated through full notice-and-
comment rulemaking, the public interest is best served by ensuring 
there is no lapse in low transfer height requirements. The Board thus 
finds good cause for waiver of prior notice and comment.
    In addition, the Access Board finds good cause under 5 U.S.C. 
553(d)(3) to

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waive the 30-day delay in effectiveness of this rule. This finding is 
based upon the reasons provided above for waiver of prior notice and 
opportunity for public comment.

B. Regulatory Planning and Review (Executive Orders 12866 and 13563)

    The Access Board has examined the impact of this direct final rule 
under Executive Orders 12866 and 13563. These executive orders direct 
agencies to assess the 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). This rule does not impose any incremental costs or 
benefits because it simply extends the sunset period for the low 
transfer height requirement for an additional three years; it imposes 
no new or revised substantive obligations. As such, this direct final 
rule is not a significant regulatory action for purposes of section 
3(f) of Executive Order 12866.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires federal agencies to 
analyze the impact of regulatory actions on small entities, unless an 
agency certifies that the rule will not have a significant impact on a 
substantial number of small entities. 5 U.S.C. 604, 605 (b). Because 
this direct final rule merely extends the existing sunset period for an 
additional three years to permit the Access Board to complete both its 
research and the required rulemaking processes to establish a permanent 
specification for the low transfer height position, the Access Board 
certifies that the rule will not have a significant economic impact on 
a substantial number of small entities.

D. Federalism (Executive Order 13132)

    The Access Board has evaluated this direct final rule in accordance 
with the principles and criteria set forth in Executive Order 13132. We 
have determined that this action will not have a substantial direct 
effect on the States, the relationship between the Federal Government 
and the States, or on the distribution of power and responsibilities 
among the various levels of government, and, therefore, does not have 
Federalism implications.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (codified at 2 U.S.C. 1531 
et seq.) (``UMRA'') generally requires that Federal agencies assess the 
effects of their discretionary regulatory actions that may result in 
the expenditure of $100 million (adjusted for inflation) or more in any 
one year by the private sector, or by state, local, and tribal 
governments in the aggregate. Because this direct final rule is being 
issued under the APA's good cause exception, UMRA's analytical 
requirements are inapplicable. See 2 U.S.C. 1532(a).

F. Paperwork Reduction Act

    Under the Paperwork Reduction Act (PRA), federal agencies are 
generally prohibited from conducting or sponsoring a ``collection of 
information: As defined by the PRA, absent OMB approval. See 44 U.S.C. 
3507 et seq. The MDE Standards do not impose any new or revised 
collections of information within the meaning of the PRA.

G. Congressional Review Act

    This direct final rule is not a major rule within the meaning of 
the Congressional Review Act (5 U.S.C. 801 et seq.)

List of Subjects in 36 CFR Part 1195

    Health care, Individuals with disabilities, Medical devices.

    For the reasons stated in the preamble, and under the authority of 
29 U.S.C. 794f, the Board amends 36 CFR part 1195 as follows:

PART 1195--STANDARDS FOR ACCESSIBLE MEDICAL DIAGNOSTIC EQUIPMENT

0
1. The authority citation for part 1195 continues to read as follows:

    Authority: 29 U.S.C. 794f.

Appendix to Part 1195--[Amended]

0
2. In the appendix to part 1195:
0
a. In M301.2.2, remove the words ``January 10, 2022'' and add, in their 
place, the words ``January 10, 2025''.
0
b. In M302.2.2, remove the words ``January 10, 2022'' and add, in their 
place, the words ``January 10, 2025''.

    Approved by notational vote of the Access Board on December 10, 
2021.
Sachin Pavithran,
Executive Director.
[FR Doc. 2022-02133 Filed 2-2-22; 8:45 am]
BILLING CODE 8150-01-P