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Quality Assurance (QA) Module

 

June 2003
NIOSH Docket Number 001

Public meetings were hosted by NIOSH/NPPTL at the Quality Hotel and Suites in Arlington, VA on August 8, 2000; at the Embassy Suites, Burlingame, CA on August 16, 2000; at the Hilton Garden Inn Pittsburgh/Southpointe in Canonsburg, PA on June 25, 2003 and at the Radisson Hotel at Waterfront Place in Morgantown, WV on October 16, 2003. These meetings provided a forum for NIOSH to provide a general overview of the history/background of our work relating to modifications to 42 CFR Part 84 and to present our proposed concepts and to gain shareholders input on the Quality Assurance module and other subjects. Public responses to the meetings as well as pre-meeting correspondence, the agenda, meeting transcripts and more, as they pertain to Quality Assurance and Administrative changes are available below in PDF format.

Meeting held at the Quality Inn and Suites in Arlington, VA on August 8, 2000 and at the Embassy Suites, Burlingame, CA on August 16, 2000

Pre-Meeting Information

Notice; 65 FR 41472 – 7/5/00 [PDF – 380 KB]

Letter to all interested parties from Richard Metzler (NIOSH/NPPTL) regarding announcement of two meetings – 6/26/00 [PDF – 1,780 KB]

Meeting held in Morgantown, WV on July 25-26, 2000

Pre-Meeting Information

Letter to Testing Laboratories and accredited registrar accreditation Board Auditors from Richard Metzler (NIOSH/NPPTL) – 6/30/00 [PDF – 2,020 KB]

Meeting Information / Handouts / Discussion documents

Notice; 64 FR 59691 – NIST proposed guidance on Federal conformance assessment activities – 11/3/99 [PDF – 2,980 KB]

Notice; 64 FR 59616 – NIST national voluntary laboratory accreditation program: amendment to regulations – 11/3/99 [PDF – 1,420 KB]

NIST/NACLA Letter of Agreement – 7/13/00 [PDF – 1,000 KB]

Summary of answers to questions at meeting and miscellaneous notes – 7/25/00 [PDF – 4,790 KB]

List of attendees – 7/25/00 [PDF – 293 KB]

Meeting held at the Hilton Garden Inn Pittsburgh/Southpointe in Canonsburg, PA on June 25, 2003

Pre-Meeting Information

Notice: 68 FR 33494 – 6/4/03 [PDF – 313 KB]

Letter to all interested parties from Boord (NIOSH) – 6/4/03 [PDF – 3,470 KB]

Respirator fact sheet – 4/14/03 [PDF – 5,310 KB]

Draft for discussion “Concept for CBRN escape respirator standard” – 6/15/03 [PDF – 9,290 KB]

Draft paper for discussion “Concept for CBRN escape respirator standard” – 5/15/03 [PDF – 9,890 KB]

Letter to all manufacturers from BerryAnn (NIOSH) on upgrade or previously-deployed SCBA configuration approval – 3/11/03 [PDF – 2,820 KB]

Letter to all manufacturers from BerryAnn (NIOSH) on NIOSH/NPPTL CBRN respirator research and development (R&D) test program – 3/11/03 [PDF – 1,760 KB]

Meeting Information

Agenda for meeting – 6/25/03 [PDF – 135 KB]

Welcome and introduction presentation by Metzler (NIOSH) – 6/25/03 [PDF – 4,880 KB]

Presentation by Palya (NIOSH) entitled “Test sequence and required quantity for CBRN air-purifying escape respirator” – 6/25/03 [PDF – 1,570 KB]

Presentation entitled “Summary 42 CFR 84: Quality assurance improvement concepts” – 6/25/03 [PDF – 1,930 KB]

Presentation entitled “CBRN Escape Respirator: Breathing Gas Control” – 6/25/03

Presentation entitled “CBRN Escape Respirator: Laboratory Respirator Protection Level (LRPL Concept)” – 6/25/03

Presentation entitled “CBRN Escape Respirator: CBRN Self Contained Escape CWA Concept” – 6/25/03

Presentation entitled “CBRN Escape Respirator Concept: Docket and Meeting Comments” – 6/25/03

Presentation entitled “CBRN Escape Respirator Overview” – 6/25/03

Presentation entitled “CBRN Standards Development” – 6/25/03

List of attendees – 6/25/03 [PDF – 1,810 KB]

Transcript of NIOSH public meeting – 6/25/03 [PDF – 4,600 KB]

Meeting held at the Radisson Hotel at Waterfront Place in Morgantown, WV on October 16, 2003

Pre-Meeting Information

Notice; 68 FR 54458 – 9/17/03 [PDF – 336 KB]

Letter to all interested parties from BerryAnn (NPPTL/NIOSH) regarding announcement of two meetings – 9/24/03 [PDF – 1,400 KB]

Draft for discussion “CBRN PAPR concept paper” – 9/15/03 [PDF – 708 KB]

Updated draft for discussion “QA module concepts” – 7/14/03 [PDF – 685 KB]

Meeting Information

Agenda for meeting – 10/16/03 [PDF – 234 KB]

Presentation by Stein (NIOSH) on “QA module concepts” – 10/16/03 [PDF – 9,920 KB]

List of attendees – 10/16/03 [PDF – 804 KB]

Transcript of NIOSH public meeting held in Morgantown, WV – 10/16/03 [PDF – 1,730 KB]

Submissions to Docket in order of receipt

Submission to Matt Bowyer (NIOSH) from Gladhill (NIST) – 8/1/00 [PDF – 613 KB]

Submission to the docket from Parker (Bullard) – 9/14/00 [PDF – 23 KB]

Submission to the docket from Bradley (ISEA) – 10/27/00 [PDF – 1,570 KB]

Submission to the docket from Gutshall (MSA) – 12/8/00 [PDF – 253 KB]

Submission to Les Boord (NIOSH) from Bradley (ISEA) – 8/29/03 [PDF – 973 KB]

Submission to the docket from Sell (Draeger) – 8/27/03 [PDF – 230 KB]

Submission to the docket from Heins (Draeger) – 11/21/03 [PDF – 2,790 KB]

Submission to the docket from Shipp (ISEA) – 4/13/04 [PDF – 289 KB]