82_FR_4160 82 FR 4151 - Cardiovascular Devices

82 FR 4151 - Cardiovascular Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 9 (January 13, 2017)

Page Range4151-4151
FR Document2017-00796

Federal Register, Volume 82 Issue 9 (Friday, January 13, 2017) 
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Rules and Regulations]
[Page 4151]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870


Cardiovascular Devices

CFR Correction

0
 In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, 
revised as of April 1, 2016, on page 371, Sec.  870.5800 is reinstated 
to read as follows:


Sec.  870.5800   Compressible limb sleeve.

    (a) Identification. A compressible limb sleeve is a device that is 
used to prevent pooling of blood in a limb by inflating periodically a 
sleeve around the limb.
    (b) Classification. Class I (performance standards).

[FR Doc. 2017-00796 Filed 1-12-17; 8:45 am]
 BILLING CODE 1301-00-D

Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations 4151 within 2 miles each side of the 270° bearing DEPARTMENT OF HOUSING AND A. Overview of Public Comments from the airport extending from the 6.4-mile URBAN DEVELOPMENT B. Significant Public Comments and HUD’s radius to 10.2 miles west of the airport. Responses * * * * * 24 CFR Part 35 1. Primary Prevention 2. Resources Available AGL WI E5 Eagle River, WI [Amended] [Docket No. FR–5816–F–02] 3. Tenant Protections Eagle River Union Airport, WI 4. Coordination Between the Involved RIN 2501–AD77 (Lat. 45°55′56″ N., long. 89°16′06″ W.) Parties 5. Technical Concerns That airspace extending upward from 700 Requirements for Notification, 6. Landlord Exemptions feet above the surface within a 6.5-mile Evaluation and Reduction of Lead- 7. Time Available To Complete Work radius of Eagle River Union Airport, and Based Paint Hazards in Federally 8. Penalties for Noncompliance within 2 miles each side of the 225° bearing Owned Residential Property and 9. Future Changes in CDC from the airport extending from the 6.5-mile Housing Receiving Federal Recommendations radius to 9.2 miles southwest of the airport. 10. Timing of Implementation Assistance; Response to Elevated * * * * * Blood Lead Levels 11. Other Issues C. Public Comments in Response to HUD’s AGL WI E5 Hayward, WI [Amended] AGENCY: Office of the Secretary, HUD. Questions Sawyer County Airport, WI ACTION: Final rule. III. Findings and Certifications (Lat. 46°01′31″ N., long. 91°26′39″ W.) A. Regulatory Review—Executive Orders That airspace extending upward from 700 SUMMARY: This final rule amends HUD’s 12866 and 13563 feet above the surface within a 6.6-mile lead-based paint regulations to reduce B. Regulatory Impact Assessment radius of Sawyer County Airport, and within blood lead levels in children under age C. Paperwork Reduction Act Statement 2 miles each side of the 025° bearing from the six (6) who reside in federally-owned or D. Regulatory Flexibility Act airport extending from the 6.6-mile radius to E. Environmental Impact -assisted pre-1978 housing, formally 8.5 miles northeast of the airport. F. Executive Order 13132, Federalism adopting a revised definition of G. Unfunded Mandates Reform Act * * * * * ‘‘elevated blood lead level’’ (EBLL) in AGL WI E5 Wausau, WI [Amended] children under the age of six (6), in I. Background Wausau Downtown Airport, WI accordance with Centers for Disease A. HUD’s Long-Term and Ongoing (Lat. 44°55′35″ N., long. 89°37′37″ W.) Control and Prevention (CDC) guidance. Efforts To Reduce Lead Poisoning in That airspace extending upward from 700 It also establishes more comprehensive Children feet above the surface within a 6.8-mile testing and evaluation procedures for radius of Wausau Downtown Airport. the housing where such children reside. Childhood lead poisoning has long Issued in Fort Worth, Texas, on December This final rule also addresses certain been documented as causing reduced 28, 2016. additional elements of the CDC intelligence, low attention span, and Thomas L. Lattimer, guidance pertaining to assisted housing reading and learning disabilities; it has and makes technical corrections and additionally been linked to juvenile Acting Manager, Operations Support Group, clarifications. This final rule, which delinquency, behavioral problems, and ATO Central Service Center. follows HUD’s September 1, 2016, many other adverse health effects.1 [FR Doc. 2017–00287 Filed 1–12–17; 8:45 am] proposed rule, takes into consideration Despite public health efforts BILLING CODE 4910–13–P public comments submitted in response successfully reducing toxic lead to the proposed rule. exposure in children nationwide, blood DATES: Effective Date: February 13, lead monitoring continues to reveal 2017. children with elevated blood lead levels DEPARTMENT OF HEALTH AND Compliance Date: July 13, 2017. due to exposure in their specific HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: housing environments. The Centers for Food and Drug Administration Warren Friedman, Office of Lead Hazard Disease Control and Prevention (CDC) Control and Healthy Homes, has consistently affirmed its position 21 CFR Part 870 Department of Housing and Urban that lead-based paint and lead- Development, 451 7th Street SW., Room contaminated dust are the most Cardiovascular Devices 8236, Washington, DC 20410; telephone hazardous sources of lead for U.S. number 202–402–7698 (this is not a toll- children.2 Over the past decade, HUD CFR Correction has dramatically reduced housing-based free number). Persons with hearing or speech impairments may access this lead exposure among children through ■ In Title 21 of the Code of Federal lead paint abatement and interim Regulations, Parts 800 to 1299, revised number through TTY by calling the Federal Relay Service, toll-free at 800– controls.3 Nevertheless, a considerable as of April 1, 2016, on page 371, number of children under age six (6) § 870.5800 is reinstated to read as 877–8339. SUPPLEMENTARY INFORMATION: currently reside in HUD-assisted follows: housing units that contain lead-based § 870.5800 Compressible limb sleeve. Table of Contents paint. I. Background (a) Identification. A compressible A. HUD’s Long-Term and Ongoing Efforts 1 See HUD’s proposed rule and the accompanying limb sleeve is a device that is used to asabaliauskas on DSK3SPTVN1PROD with RULES To Reduce Lead Poisoning in Children regulatory impact assessment, available at prevent pooling of blood in a limb by B. Authority for HUD’s Lead-Based Paint www.regulations.gov/document?D=HUD-2016-0096. 2 See CDC, Lead: Prevention Tips, http:// inflating periodically a sleeve around Regulation www.cdc.gov/nceh/lead/tips.htm. the limb. II. Regulatory Approach 3 See, e.g., HUD’s lead hazard control grant (b) Classification. Class I A. Overview programs and the lead hazard control work required B. Changes Made at the Final Rule Stage of landlords under settlements HUD has reached in (performance standards). C. Applicability of Civil Rights Laws enforcing the Lead Disclosure Statute and related [FR Doc. 2017–00796 Filed 1–12–17; 8:45 am] III. Public Comments Submitted on Proposed regulations at 42 U.S.C. 4852d and 24 CFR part 35, BILLING CODE 1301–00–D Rule and HUD’s Responses subpart A. VerDate Sep<11>2014 16:00 Jan 12, 2017 Jkt 241001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\13JAR1.SGM 13JAR1


Document Created: 2017-01-13 02:45:07
Document Modified: 2017-01-13 02:45:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
FR Citation82 FR 4151 
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