The FDA-CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access...
Search Results "Regulatory Constraint"
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Other relevant federal rules and guidance documents
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Alerting to intruders. (Section-by-Section Analysis)
In the original 1991 regulatory text, this phrase was intended to identify service animals that alert individuals who are deaf or hard of hearing to the presence of others....
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1133B.2.3.2
In existing buildings, the provisions of this section shall not apply when legal or physical constraints will not allow compliance with these building standards or equivalent facilitation...
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Alterations to cells. (Section-by-Section Analysis)
The Department has evaluated all of the comments and proposes regulatory language reflecting Option II, which provides an appropriate balance between the needs of prisoners with disabilities...
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1. Movable aisle armrests
The exception for seats on which movable aisle armrests are not feasible was not included in the Foreign Carriers NPRM regulatory text, and a new requirement was proposed that would call...
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6. Conclusion
Preliminary RIA estimates that incremental costs, as assessed and monetized in the assessment, exceed the monetized benefits of the proposed rule, this finding represents only a piece of the regulatory...
- National Institute of Building Sciences (NIBS)
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Section 36.309 Examinations and Courses (Section-by-Section Analysis)
In the NPRM preamble and proposed regulatory amendment and in this final rule, the Department relied on its history of enforcement efforts, research, and body of knowledge of testing and...
- Disability Network Lakeshore - Holland, MI
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Background
Following a lengthy rulemaking process that included a regulatory negotiation involving representatives of the airline industry and disability community, the Department issued a final ACAA...
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6.2 Presentations that Informed the Minimum Height Deliberations
Dual-energy X-ray Absorptiometry (DXA) for Osteoporosis Assessment 01/23/13 Elisabeth George, Vice President of Global Regulations & Standards Chair of Technical and Regulatory...
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1. Rulemaking History Prior to the 2010 ANPRM
The 2008 NPRM did not propose any specific regulatory language with regard to movie captioning or audio description, but asked whether, within a year of the revised regulation’s effective...
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The Advance Notice of Proposed Rulemaking
application of the Access Board's revisions once the Department adopts them as revised standards; and (2) to request background information that would assist the Department in preparing a regulatory...
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Table 3
The impacts of these requirements are analyzed in the regulatory assessment and are discussed below under the relevant requirements in the Section-by-Section Analysis. Question 1....
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382.21 May carriers limit access to transportation on the basis that a passenger has a communicable disease or other medical condition?
The Department has added regulatory language codifying the Department’s guidance on how airlines should determine whether someone’s disease presents a direct threat....
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(A) Staircase replacements are alterations.
The regulatory definition differentiates between “normal maintenance” and more substantial modifications, such as “remodeling, renovation, rehabilitation, [or] reconstruction,” when giving...
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Auxiliary aids and services: captioning and video interpreting services.
The Department is proposing several changes to § 36.303 to update the regulatory language in response to numerous technological advances and breakthroughs in the area of auxiliary aids and...
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Reduced scoping for public accommodations, small facilities, and qualified small businesses. (Section-by-Section Analysis)
Based on comments in the ANPRM and the Department's initial regulatory assessment, the Department has identified ten elements for which the Department believes reduced scoping might be appropriate...
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Q2: What is the Amendments Act?
. § 705(20)(B).5 All persons covered by Section 504 or Title II are protected from discrimination under the general nondiscrimination regulatory provisions implementing these statutes, which...
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Examples of Major Life Activities—Operations of a Major Bodily Function
Examples of Major Life Activities—Operations of a Major Bodily Function In the NPRM, the Department proposed revising the regulatory definitions of disability at §§ 35.108(c)(1)(ii) and...
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Appendix A to Part 37—Standards for Accessible Transportation Facilities
Americans with Disabilities Act (ADA) require the Access Board to adopt accessibility guidelines; sections 204(c) and 306(c) of the ADA require the Department of Transportation to adopt regulatory...
- Assisted Living Directory - Maine Assisted Living Facilities & Senior Care
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Subjects
Four of the 120 subjects enrolled in the study met inclusion criteria for independent transfer but were unable to transfer to/from the station based on space constraints and their method...
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I. Electronic Submission of Comments and Posting of Public Comments
The constraints imposed by the Regulations.gov / FDMS system do not apply to U.S. postal comments, which will be considered as timely filed if they are postmarked before Midnight on the...