Federal Register/Vol. 82, No. 8/Thursday, January 12, 2017
Total Page:16
File Type:pdf, Size:1020Kb
3694 Federal Register / Vol. 82, No. 8 / Thursday, January 12, 2017 / Proposed Rules (x) Have disinfecting supplies, gloves, The revision and addition read as Dated: December 9, 2016. masks, and plastic for containing follows: Andrew M. Slavitt, contaminated materials. Acting Administrator, Centers for Medicare (xi) Have a fabrication facility § 424.58 Requirements for DMEPOS & Medicaid Services. accreditation organizations. information system, paper or digital, * * * * * Dated: December 22, 2016. that can track the production, list Sylvia M. Burwell component part number (and serial (c) Additional requirements for accrediting qualified suppliers. To Secretary, Department of Health and Human number if available), quantity, that is Services. accredit qualified suppliers that linked to patient information and be [FR Doc. 2017–00425 Filed 1–11–17; 8:45 am] Health Insurance Portability and fabricate or bill Medicare for prosthetics BILLING CODE 4120–01–P Accountability Act compliant. Such a and custom-fabricated orthotics as system must allow facility staff and specified in § 424.57(c)(22)(ii), an management, including those independent accreditation organization DEPARTMENT OF COMMERCE fabricating, to identify any parts that must be one of the following: could be recalled at a later date. (1) American Board for Certification National Oceanic and Atmospheric (xii) Have parallel bars, a full-length in Orthotics and Prosthetics, Administration mirror, and other appropriate Incorporated (ABC). assessment tools. (2) Board for Orthotist/Prosthetist 50 CFR Part 223 (xiii) Have a process using Certification International, Incorporated precautions to handle used patient (BOC). [Docket No. 160105011–6999–02] devices that are contaminated. (3) An organization that— RIN 0648–XE390 (xiv) Have repair and disinfecting (i) Employs or contracts with an areas clearly labeled. orthotist, prosthetist, occupational 12-Month Finding on a Petition To List (xv) Have the ability to handle all therapist or physical therapist who— Giant and Reef Manta Rays as potentially hazardous materials in (A) Meets the definition of qualified Threatened or Endangered Under the facility properly. practitioner specified in § 424.57(a); and Endangered Species Act (xvi) Have an emergency management (B) Is utilized for the purpose of AGENCY: National Marine Fisheries plan and a safety management plan. surveying the supplier or practitioner Service (NMFS), National Oceanic and (xvii) Have policy for detecting/ for compliance; and Atmospheric Administration (NOAA), reporting counterfeit supplies. (ii) Has the authority granted by CMS Commerce. (xviii) Have the proper tools, to approve or deny the accreditation of ACTION: equipment, and computers commonly Proposed rule; 12-month qualified suppliers as defined in petition finding; request for comments. used in the fabrication of particular § 424.57(a) based on a determination items and typically associated with the that the organization has standards SUMMARY: We, NMFS, announce a 12- particular technical approach (negative equivalent to the ABC or BOC. month finding on a petition to list the impression/positive model, CAD–CAM, * * * * * giant manta ray (Manta birostris) and or direct formed), as applicable: These ■ reef manta ray (Manta alfredi) as tools and equipment would include, but 4. Section § 424.535 is amended as follows: threatened or endangered under the are not limited to the following Endangered Species Act (ESA). We have ■ a. Revising the section heading. (A) Computers with appropriate completed a comprehensive status ■ b. In paragraph (a)(2) introductory text graphics/modeling capacity and review of both species in response to by removing the phrase ‘‘the provider or technology. this petition. Based on the best scientific supplier is—’’ and adding in its place (B) Band saw. and commercial information available, ‘‘the provider or supplier is any of the (C) Disc sander. including the status review report following:’’. (D) Sanding paper. (Miller and Klimovich 2016), and after ■ (E) Flexible shaft sander. c. In paragraph (a)(2)(ii) by removing taking into account efforts being made (F) Lathe. the phrase ‘‘Is debarred, suspended, or’’ to protect these species, we have (G) Drill press. and adding in its place the phrase determined that the giant manta ray (M. (H) Sewing machine. ‘‘Debarred, suspended or’’. birostris) is likely to become an (I) Grinding equipment. ■ d. Adding paragraph (a)(2)(iii). endangered species within the (J) Paint-spraying equipment. The revision and addition reads as foreseeable future throughout a (K) Welding equipment. follows: significant portion of its range. (L) Alignment jig. § 424.535 Revocation of enrollment and Therefore, we propose to list the giant (M) Ovens capable of heating plastics billing privileges in the Medicare program. manta ray as a threatened species under for molding. the ESA. Any protective regulations (a) * * * (N) Computer controlled milling determined to be necessary and machine. (2) * * * advisable for the conservation of the (O) Lockable storage areas for raw (iii) A qualified supplier as defined in proposed threatened giant manta ray materials and finished devices. § 424.57(a) that submitted a claim for under ESA section 4(d) would be (P) Air compressor. payment for a prosthetic or custom- proposed in a subsequent Federal * * * * * fabricated orthotic that was not— Register announcement. Should the ■ 3. Section 424.58 is amended as (A) Furnished by a qualified proposed listing be finalized, we would follows: practitioner; and also designate critical habitat for the ■ a. Revising the section heading. (B) Fabricated by a qualified species, to the maximum extent prudent ■ b. Redesignating paragraphs (c) practitioner or qualified supplier as and determinable. We solicit through (e) as paragraphs (d) through (f) defined in § 424.57(a) at a fabrication information to assist this proposed respectively. facility as defined in § 424.57(a). listing determination, the development ■ c. Adding a new paragraph (c). * * * * * of proposed protective regulations, and VerDate Sep<11>2014 17:58 Jan 11, 2017 Jkt 241001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\12JAP1.SGM 12JAP1 mstockstill on DSK3G9T082PROD with PROPOSALS Federal Register / Vol. 82, No. 8 / Thursday, January 12, 2017 / Proposed Rules 3695 designation of critical habitat in the Caribbean manta ray (M. c.f. birostris) as significant portion of its range.’’ Thus, event the proposed threatened listing for threatened or endangered under the in the context of the ESA, the Services the giant manta ray is finalized. ESA throughout their respective ranges, interpret an ‘‘endangered species’’ to be Additionally, we have determined that or, as an alternative, to list any one that is presently at risk of the reef manta ray (M. alfredi) is not identified distinct population segments extinction. A ‘‘threatened species’’ is currently in danger of extinction (DPSs) as threatened or endangered. The not currently at risk of extinction, but is throughout all or a significant portion of petitioners also requested that critical likely to become so in the foreseeable its range and is not likely to become so habitat be designated concurrently with future. The key statutory difference within the foreseeable future. Therefore, listing under the ESA. On February 23, between a threatened and endangered we find that the reef manta ray does not 2016, we published a positive 90-day species is the timing of when a species warrant listing under the ESA at this finding (81 FR 8874) announcing that may be in danger of extinction, either time. the petition presented substantial now (endangered) or in the foreseeable scientific or commercial information future (threatened). DATES: Comments on the proposed rule indicating that the petitioned action Additionally, as the definition of to list the giant manta ray must be may be warranted for the giant manta ‘‘endangered species’’ and ‘‘threatened received by March 13, 2017. Public ray and reef manta ray, but that the species’’ makes clear, the determination hearing requests must be made by Caribbean manta ray is not a of extinction risk can be based on either February 27, 2017. taxonomically valid species or assessment of the range wide status of ADDRESSES: You may submit comments subspecies for listing, and explained the the species, or the status of the species on this document, identified by NOAA– basis for that finding. We also in a ‘‘significant portion of its range.’’ NMFS–2016–0014, by either of the announced the initiation of a status The Services published a final policy to following methods: • review of the giant manta ray and reef clarify the interpretation of the phrase Electronic Submissions: Submit all manta ray, as required by section ‘‘significant portion of the range’’ in the electronic public comments via the 4(b)(3)(a) of the ESA, and requested ESA definitions of ‘‘threatened species’’ Federal eRulemaking Portal. Go to information to inform the agency’s and ‘‘endangered species’’ (79 FR 37577; www.regulations.gov/ decision on whether these species July 1, 2014) (SPR Policy). The policy #!docketDetail;D=NOAA-NMFS-2016- warrant listing as endangered or consists of the following four 0014. Click the ‘‘Comment Now’’ icon, threatened under the ESA. components: complete the required fields, and enter (1) If a species is found to be or attach your comments. Listing Species Under the Endangered endangered or threatened in only an • Mail: Submit written comments to Species Act SPR, and