82 FR 18002 - Closed-Circuit Escape Respirators; Final Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 71 (April 14, 2017)
Federal Register Volume 82, Issue 71 (April 14, 2017)
| Page Range | 18002-18004 | |
| FR Document | 2017-07587 |
[Federal Register Volume 82, Number 71 (Friday, April 14, 2017)] [Notices] [Pages 18002-18004] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07587] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket Number CDC-2016-0121; NIOSH-285] Closed-Circuit Escape Respirators; Final Guidance for Industry; Availability AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: On December 28, 2016, the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention, Department of Health and Human Services, published a notice in the Federal Register announcing the availability of an interim guidance document addressing the availability of closed-circuit escape respirators (CCERs) for purchase, and the readiness of respirator manufacturers to comply with the regulatory provisions [[Page 18003]] addressing these respirators. After consideration of public comments, NIOSH has revised the guidance and now announces that NIOSH does not intend to revoke any certificate of approval for any escape respirator approved for use in mining in accordance with NIOSH regulations, that are manufactured, labeled, or sold prior to June 1, 2019, provided that th.ere is no cause for revocation under existing NIOSH regulation. DATES: The final guidance announced in this Federal Register notice is effective on April 14, 2017. FOR FURTHER INFORMATION CONTACT: Maryann D'Alessandro, NIOSH National Personal Protective Technology Laboratory, 626 Cochrans Mill Road, Pittsburgh, PA 15236; 1-888-654-2294 (this is a toll-free phone number); [email protected]. SUPPLEMENTARY INFORMATION: The final guidance announced in this notice addresses the availability of closed-circuit escape respirators (CCERs) for purchase and the readiness of respirator manufacturers to comply with the provisions in Part 84, Subpart O, of Title 42 of the Code of Federal Regulations (CFR). Pursuant to a Federal Register notice published on February 10, 2016, beginning on January 4, 2017, manufacturers were no longer authorized to manufacture, label, and sell 1-hour escape respirators, known in the mining community as self- contained self-rescuers (SCSRs), approved in accordance with the certification testing standards in Part 84, Subpart H.\1\ Beginning on May 14, 2016, manufacturers were no longer authorized to manufacture, label, or sell 10-minute escape respirators for use in mining approved pursuant to Subpart H.\2\ --------------------------------------------------------------------------- \1\ 81 FR 7121. \2\ See NIOSH final rule, Closed-Circuit Escape Respirators; Extension of Transition Period, 80 FR 48268 (August 12, 2015). --------------------------------------------------------------------------- In an interim guidance document published on December 28, 2016,\3\ NIOSH announced its intention not to revoke any certificate of approval for 1-hour escape respirators approved in accordance with 42 CFR part 84, Subpart H, that are manufactured, labeled, or sold prior to January 4, 2018, provided that there is no cause for revocation under 42 CFR 84.34 or 84.43(c). Upon consideration of public comments submitted to the docket for this action, NIOSH has reconsidered the scope of the guidance as well as the compliance deadline.\4\ The final guidance is summarized below. The full final guidance, entitled ``Closed-Circuit Escape Respirators Approved for Use in Mining, 42 CFR part 84, Subpart O Compliance; Guidance for Industry; Final'' is available on the NIOSH National Personal Protective Technology Web site at www.cdc.gov/niosh/npptl. --------------------------------------------------------------------------- \3\ The December 2016 guidance was announced in a Federal Register notice published on December 28, 2016 (81 FR 95623). \4\ One public commenter asked that we extend the comment period for this action. Although we are closing the comment period for this final guidance, we are considering additional steps, such as a public meeting, to continue a dialog with stakeholders concerning the implementation of the CCER standards in 42 CFR part 84, Subpart O. --------------------------------------------------------------------------- Standards for the approval of CCERs were updated in a final rule published March 8, 2012, in which HHS codified the new Subpart O and removed only those technical requirements in 42 CFR part 84, Subpart H that were uniquely applicable to CCERs.\5\ All other applicable requirements of 42 CFR part 84 were unchanged. The purpose of these updated requirements is to enable NIOSH and the Mine Safety and Health Administration (MSHA), which co-approves respirators used in underground coal mining, respirator manufacturers, and ultimately, respirator users, to more effectively ensure the performance, reliability, and safety of CCERs used in all workplace applications.\6\ The March 2012 final rule established a sunset provision for the Subpart H standards on April 9, 2015, three years after the final rule's effective date; the three-year period was intended to provide sufficient time for manufacturers to obtain certificates of approval for CCER designs developed under the Subpart O standards. Since April 10, 2012, no new applications for approval of Subpart H SCSRs have been accepted. --------------------------------------------------------------------------- \5\ 77 FR 14168. \6\ See 77 FR 14168 at 14169-14182 to read the background for this rulemaking; additional background materials as well as public comments are available in NIOSH Docket 005. --------------------------------------------------------------------------- However, manufacturers did not develop small capacity CCERs approved for use in mining or large capacity CCERs approved for use in non-mining and mining in time to meet the April 2015 transition deadline and, as a result, NIOSH ultimately extended the deadline to one year after the date that the first approval was granted to those CCER models.\7\ Under this deadline extension formula, manufacturers were authorized to continue the manufacturing, labeling, and sale of 10-minute Subpart H escape respirators approved for use in mining until May 13, 2016 and 1-hour Subpart H escape respirators for use in mining until January 4, 2017. --------------------------------------------------------------------------- \7\ 80 FR 4801 (January 29, 2015). --------------------------------------------------------------------------- The deadline extensions have contributed to the availability of new escape respirator designs which conform to the Subpart O requirements, and have addressed the needs of certain broad segments of the market for such devices; \8\ however, MSHA has recently expressed concern that a market gap is imminent in the underground coal mining industry.\9\ Further communications with stakeholders, including the underground coal mine industry and respirator manufacturers, some of whom submitted comments to the docket for this action, have indicated that the supply of Subpart O CCERs approved for use in mining are insufficient to meet the current needs of the mining industry. --------------------------------------------------------------------------- \8\ The maritime market, which includes the U.S. Navy, have been quick adopters of newly-approved small capacity (Cap 1) CCERs (often referred to in that market as emergency escape breathing devices or EEBDs). Cap 1 CCERs which were available to replace Subpart H, 10- minute approved apparatus are being deployed in that market segment in great numbers. \9\ Joe Main, Assistant Secretary of Labor, MSHA, letter to John Howard, Director, NIOSH, December 14, 2016. This letter is available in the docket for this guidance and corresponding Federal Register notice. --------------------------------------------------------------------------- In order to allow mine operators access to all of the tools necessary to protect miners, to give respirator manufacturers time to develop a solution to the mine industry's desire for person-wearable Subpart O CCERs, and to ensure a smooth transition from the Subpart H to Subpart O approval standards, NIOSH does not intend to revoke any certificate of approval for escape respirators approved for use in mining in accordance with 42 CFR part 84, Subpart H, that are manufactured, labeled, or sold prior to June 1, 2019, provided that there is no cause for revocation under 42 CFR 84.34 or 84.43(c), including misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the applicable quality control requirements. The final guidance, available on the NIOSH National Personal Protective Technology Web site, does not create any new deadlines or waive any existing deadlines. The final guidance is not an interpretation of 42 CFR 84.301(a), it is a policy statement regarding NIOSH's intent to not revoke, except for cause, any certificate of approval for escape respirators approved for use in mining in accordance with 42 CFR part 84, [[Page 18004]] Subpart H, that are manufactured, labeled, or sold prior to June 1, 2019. Thomas E. Price, Secretary, Department of Health and Human Services. [FR Doc. 2017-07587 Filed 4-13-17; 8:45 am] BILLING CODE 4163-19-P
![18002 Federal Register / Vol. 82, No. 71 / Friday, April 14, 2017 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent * (in hours)
Heart Recipient Registration ................................................ 137 20.5 2.805 1.2 3,366.0
Heart Follow-Up (6 Months) ................................................ 137 16.5 2,261 0.4 904.4
Heart Follow-Up (1–5 Years) ............................................... 137 77.3 10,595 0.9 9,535.5
Heart Follow-Up (Post 5 Years) .......................................... 137 117.4 16,085 0.5 8,042.5
Heart Post-Transplant Malignancy ...................................... 137 11.8 1,623 0.9 1,460.7
Lung Candidate Registration ............................................... 70 37.0 2,592 0.9 2,332.8
Lung Recipient Registration ................................................. 70 29.4 2,058 1.2 2,469.6
Lung Follow-Up (6 Months) ................................................. 70 25.8 1,809 0.5 904.5
Lung Follow-Up (1–5 Years) ................................................ 70 99.1 6,939 1.1 7,632.9
Lung Follow-Up (Post 5 Years) ........................................... 70 70.0 4,898 0.6 2,938.8
Lung Post-Transplant Malignancy ....................................... 70 15.8 1,106 0.4 442.4
Heart/Lung Candidate Registration ..................................... 68 0.7 46 1.1 50.6
Heart/Lung Recipient Registration ....................................... 68 0.2 14 1.3 18.2
Heart/Lung Follow-Up (6 Months) ....................................... 68 0.2 13 0.8 10.4
Heart/Lung Follow-Up (1–5 Years) ...................................... 68 1.4 94 1.1 103.4
Heart/Lung Follow-Up (Post 5 Years) ................................. 68 2.9 199 0.6 119.4
Heart/Lung Post-Transplant Malignancy ............................. 68 0.3 21 0.4 8.4
Liver Candidate Registration ............................................... 140 85.9 12,026 0.8 9,620.8
Liver Recipient Registration ................................................. 140 50.9 7,125 1.2 8,550.0
Liver Follow-Up (6 Months–5 Years) ................................... 140 235.6 32,985 1 32,985.0
Liver Follow-Up (Post 5 Years) ........................................... 140 279.3 39,108 0.5 19,554.0
Liver Recipient Explant Pathology ....................................... 140 12.9 1,812 0.6 1,087.2
Liver Post-Transplant Malignancy ....................................... 140 14.2 1,985 0.8 1,588.0
Intestine Candidate Registration .......................................... 40 5.0 200 1.3 260.0
Intestine Recipient Registration ........................................... 40 3.5 141 1.8 253.8
Intestine Follow-Up (6 Months–5 Years) ............................. 40 13.3 530 1.5 795.0
Intestine Follow-Up (Post 5 Years) ...................................... 40 16.4 655 0.4 262.0
Intestine Post-Transplant Malignancy .................................. 40 0.6 24 1 24.0
Kidney Candidate Registration ............................................ 238 151.6 36,076 0.8 28,860.8
Kidney Recipient Registration .............................................. 238 75.2 17,899 1.2 21,478.8
Kidney Follow-Up (6 Months–5 Years) ................................ 238 383.3 91,234 0.9 82,110.6
Kidney Follow-Up (Post 5 Years) ........................................ 238 375.9 89,453 0.5 44,726.5
Kidney Post-Transplant Malignancy .................................... 238 22.4 5,327 0.8 4,261.6
Pancreas Candidate Registration ........................................ 133 2.9 389 0.6 233.4
Pancreas Recipient Registration ......................................... 133 1.8 233 1.2 279.6
Pancreas Follow-Up (6 Months–5 Years) ........................... 133 9.4 1,252 0.5 626.0
Pancreas Follow-Up (Post 5 Years) .................................... 133 14.7 1,953 0.5 976.5
Pancreas Post-Transplant Malignancy ................................ 133 0.9 120 0.6 72.0
Kidney/Pancreas Candidate Registration ............................ 133 9.5 1,265 0.6 759.0
Kidney/Pancreas Recipient Registration ............................. 133 5.4 718 1.2 861.6
Kidney/Pancreas Follow-Up (6 Months–5 Years) ............... 133 32.0 4,262 0.5 2,131.0
Kidney/Pancreas Follow-Up (Post 5 Years) ........................ 133 51.7 6,876 0.6 4,125.6
Kidney/Pancreas Post-Transplant Malignancy Form .......... 133 2.1 283 0.4 113.2
VCA Candidate Registration ................................................ 28 1.8 49 0.4 19.6
VCA Recipient Registration ................................................. 28 1.8 49 1.3 63.7
VCA Recipient Follow-Up .................................................... 28 1.8 49 1 49.0
Total .............................................................................. ** 463 ........................ 488,980 ........................ 370,274.9
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to
the nearest tenth.
** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate or recipient forms based on
the organ-specific programs associated with each form.
Amy McNulty, DEPARTMENT OF HEALTH AND SUMMARY: On December 28, 2016, the
Deputy Director, Division of the Executive HUMAN SERVICES National Institute for Occupational
Secretariat. Safety and Health (NIOSH), within the
[FR Doc. 2017–07526 Filed 4–13–17; 8:45 am] [Docket Number CDC–2016–0121; NIOSH– Centers for Disease Control and
BILLING CODE 4165–15–P 285] Prevention, Department of Health and
Human Services, published a notice in
sradovich on DSK3GMQ082PROD with NOTICES
Closed-Circuit Escape Respirators; the Federal Register announcing the
Final Guidance for Industry; availability of an interim guidance
Availability document addressing the availability of
AGENCY: Centers for Disease Control and closed-circuit escape respirators
Prevention, HHS. (CCERs) for purchase, and the readiness
of respirator manufacturers to comply
ACTION: Notice of availability.
with the regulatory provisions
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![18004 Federal Register / Vol. 82, No. 71 / Friday, April 14, 2017 / Notices
Subpart H, that are manufactured, ACTION: Notice of accreditation of King Customs and Border Protection, 1300
labeled, or sold prior to June 1, 2019. Laboratories, Inc., as a commercial Pennsylvania Avenue NW., Suite
laboratory. 1500N, Washington, DC 20229, tel. 202–
Thomas E. Price,
344–1060.
Secretary, Department of Health and Human SUMMARY: Notice is hereby given,
Services. SUPPLEMENTARY INFORMATION: Notice is
pursuant to CBP regulations, that King
hereby given pursuant to 19 CFR 151.12,
[FR Doc. 2017–07587 Filed 4–13–17; 8:45 am] Laboratories, Inc., has been accredited
that King Laboratories, Inc., 1300 E.
BILLING CODE 4163–19–P to test petroleum and certain petroleum
223rd St., #401, Carson, CA 90745, has
products for customs purposes as of
been accredited to test petroleum and
February 15, 2017.
certain petroleum products for customs
DEPARTMENT OF HOMELAND DATES: Effective: The accreditation of purposes, in accordance with the
SECURITY King Laboratories, Inc., as commercial provisions of 19 CFR 151.12.
laboratory became effective on February King Laboratories, Inc., is accredited
U.S. Customs and Border Protection 15, 2017. The next triennial inspection for the following laboratory analysis
date will be scheduled for September procedures and methods for petroleum
Accreditation of King Laboratories, 2018.
Inc., as a Commercial Laboratory and certain petroleum products set forth
FOR FURTHER INFORMATION CONTACT: by the U.S. Customs and Border
AGENCY: U.S. Customs and Border Approved Gauger and Accredited Protection Laboratory Methods (CBPL)
Protection, Department of Homeland Laboratories Manager, Laboratories and and American Society for Testing and
Security. Scientific Services Directorate, U.S. Materials (ASTM):
CBPL No. ASTM Title
ASTM D7153 Standard Test Method for Freezing Point of Aviation Fuels (Automatic Laser Method).
Anyone wishing to employ this entity DEPARTMENT OF HOMELAND response time should be directed to the
to conduct laboratory analyses and SECURITY Office of Information and Regulatory
gauger services should request and Affairs, Office of Management and
receive written assurances from the U.S. Immigration and Customs Budget. Comments should be addressed
entity that it is accredited or approved Enforcement to the OMB Desk Officer for U.S.
by the U.S. Customs and Border Immigration and Customs Enforcement,
Agency Information Collection
Protection to conduct the specific test or Department of Homeland Security, and
Activities: Extension, Without Change,
gauger service requested. Alternatively, of an Existing Information Collection; sent via electronic mail to oira_
inquiries regarding the specific test or Comment Request; OMB Control No. submission@omb.eop.gov or faxed to
gauger service this entity is accredited 1653–0051 (202) 395–5806.
or approved to perform may be directed Written comments and suggestions
to the U.S. Customs and Border AGENCY: U.S. Immigration and Customs
from the public and affected agencies
Protection by calling (202) 344–1060. Enforcement, Department of Homeland
concerning the proposed collection of
The inquiry may also be sent to Security.
information should address one or more
CBPGaugersLabs@cbp.dhs.gov. Please ACTION: 30-Day Notice of Information
of the following four points:
reference the Web site listed below for collection for review; Standards to
Prevent, Detect, and Respond to Sexual (1) Evaluate whether the proposed
a complete listing of CBP approved
Abuse and Assault in Confinement collection of information is necessary
gaugers and accredited laboratories.
Facilities; OMB Control No. 1653–0051. for the proper performance of the
http://www.cbp.gov/about/labs-
functions of the agency, including
scientific/commercial-gaugers-and- The Department of Homeland whether the information will have
laboratories. Security, U.S. Immigration and Customs practical utility;
Dated: April 7, 2017. Enforcement (USICE) is submitting the
following information collection request (2) Evaluate the accuracy of the
Ira S. Reese, agencies estimate of the burden of the
for review and clearance in accordance
Executive Director, Laboratories and proposed collection of information,
with the Paperwork Reduction Act of
Scientific Services Directorate. including the validity of the
1995. The information collection is
[FR Doc. 2017–07559 Filed 4–13–17; 8:45 am] methodology and assumptions used;
published in the Federal Register to
BILLING CODE 9111–14–P obtain comments from the public and (3) Enhance the quality, utility, and
affected agencies. This information clarity of the information to be
collection was previously published in collected; and
the Federal Register on February 8,
(4) Minimize the burden of the
2017, Vol. 82 No. 9752 allowing for a 60
day comment period. No comments collection of information on those who
are to respond, including through the
sradovich on DSK3GMQ082PROD with NOTICES
were received on this information
collection. The purpose of this notice is use of appropriate automated,
to allow an additional 30 days for public electronic, mechanical, or other
comments. technological collection techniques or
Written comments and suggestions other forms of information technology,
regarding items contained in this notice e.g., permitting electronic submission of
and especially with regard to the responses.
estimated public burden and associated
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Document Created: 2017-04-14 00:56:35
Document Modified: 2017-04-14 00:56:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The final guidance announced in this Federal Register notice is effective on April 14, 2017. | |
| Contact | Maryann D'Alessandro, NIOSH National Personal Protective Technology Laboratory, 626 Cochrans Mill Road, Pittsburgh, PA 15236; 1-888-654-2294 (this is a toll-free phone number); [email protected] | |
| FR Citation | 82 FR 18002 |
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