Source: https://www.federalregister.gov/documents/2017/10/20/2017-22774/proposed-data-collection-submitted-for-public-comment-and-recommendations
Timestamp: 2020-08-04 17:27:10
Document Index: 656056396

Matched Legal Cases: ['art 11', 'art 84', 'art 84', 'art 84', 'arts 84', 'art 84', 'art 84', 'art 84']

A Notice by the Centers for Disease Control and Prevention on 10/20/2017
CDC must receive written comments on or before December 19, 2017.
82 FR 48812
48812-48814 (3 pages)
60Day-FY-0109
Docket No. CDC-2017-0074
https://www.federalregister.gov/d/2017-22774
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to provide comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Respiratory Protective Devices information collection project.
You may submit comments, identified by Docket No. CDC-2017-0074 by any of the following methods:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including Start Printed Page 48813whether the information will have practical utility;
The regulatory authority for the National Institute for Occupational Safety and Health (NIOSH) certification program for respiratory protective devices is found in the Mine Safety and Health Amendments Act of 1977 (30 U.S.C. 577a, 651 et seq., and 657(g)) and the Occupational Safety and Health Act of 1970 (30 U.S.C. 3, 5, 7, 811, 842(h), 844). These regulations have, as their basis, the performance tests and criteria for approval of respirators used by millions of American construction workers, miners, painters, asbestos removal workers, fabric mill workers, and fire fighters.
Regulations of the Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC) also require the use of NIOSH-approved respirators. These regulations also establish methods for respirator manufacturers to submit respirators for testing under the regulation and have them certified as NIOSH-approved if they meet the criteria given in the above regulation. This data collection was formerly named Respiratory Protective Devices 30 CFR part 11, but in 1995, the respirator standard was moved to 42 CFR part 84.
In accordance with 42 CFR part 84, NIOSH performs the following activities: (1) Issues certificates of approval for respirators which have met specified construction, performance, and protection requirements; (2) establishes procedures and requirements to be met in filing applications for approval; (3) specifies minimum requirements and methods to be employed by NIOSH and by applicants in conducting inspections, examinations, and tests to determine effectiveness of respirators; (4) establishes a schedule of fees to be charged applicants for testing and certification, and (5) establishes approval labeling requirements. To establish the scope and intent of request, NIOSH collects information from those who request services under 42 CFR part 84.
The main instrument for data collection for respirator approval functions is the Standard Application for the Approval of Respirators (SAF), currently Version 9.
Respirator manufacturers are the respondents (estimated to average 73 each year over the years 2017-2020). Upon submission of the SAF, NIOSH evaluates their applications for approval. Respirator manufacturers submit applications according to their business needs, which depends upon market conditions, technical advances, and other factors that are not easy to forecast. The best estimate for the annual number of respondents is the number from the most recent year for which data exists, 73 in 2016, an increase from 63 in 2014. Those 73 applicants submitted 542 applications in 2016, providing the current best estimate. A $200 fee is required for each application. Respondents requesting respirator approval or certain extensions of approval are required to submit additional fees for necessary testing and evaluation as specified in 42 CFR parts 84.20-22, 84.66, 84.258 and 84.1102. In 2016, $2,662,329.00 was accepted.
Also, 42 CFR part 84 approvals offer corroboration that approved respirators are produced to certain quality standards. Although 42 CFR part 84 Subpart E prescribes certain quality standards, it is not expected that requiring approved quality standards will impose an additional cost burden over similarly effective quality standards that are not approved under 42 CFR part 84.
Manufacturers with current approvals are subject to site audits by the Institute or its agents. Audits may occur periodically, typically every second year, or because of a reported issue. NIOSH scheduled Sixty-three site audits from 92 respirator approval holders for the 2016 fiscal year.
There is an average fee of $8,833 for each audit to align with fee collection provisions of the Independent Offices Appropriations Act of 1952 (31 U.S.C. 9701), and OMB Circular A-25 Revised.
Business or other for-profit Standard Application for the Approval of Respirators 73 7 229 117,019
Business or other for-profit Audit 63 1 24 1,512
Total 118,531
[FR Doc. 2017-22774 Filed 10-19-17; 8:45 am]