2022-09784. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

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 comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Formative Respirator and Personal Protective Clothing Laboratory Testing. NIOSH proposes using questionnaires, physiological monitoring/measurements, anthropometric measurements, respirator fit measurements, self-perception data, and biomechanical measurements to assess gaps in respirator and personal protective clothing use among the Unites States working population.

DATES:

CDC must receive written comments on or before July 5, 2022.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2022-0057 by either of the following methods:

• Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.

• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (www.regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

Formative Respirator and Protective Clothing Laboratory Testing—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), is requesting approval of a new generic information collection for a period of three years under the project titled Formative Respirator and Personal Protective Clothing Laboratory Testing.

The National Personal Protective Technology Laboratory (NPPTL) is a division of NIOSH, which operates within the CDC. NIOSH is the federal institute specifically dedicated to generating new knowledge in the field of occupational safety and health and is responsible for transferring that knowledge into practice for the betterment of workers.

NPPTL was established in 2001, at the request of Congress, with the mission of preventing disease, injury, and death for the millions of working men and women relying on personal protective technology (PPT). PPT plays an important role in keeping many workers within various industries safe while performing their professional duties. To achieve their mission, NPPTL conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to requests for workplace health hazard evaluations. The development of NPPTL filled a need for improved PPT and focused research into PPT.

Respiratory protection is the cornerstone of NPPTL's efforts. One of the primary responsibilities of NPPTL is to test and approve respirators used in U.S. occupational settings. This function ensures a standard level of quality and filtration efficiency for all respirators used within a U.S. workplace setting. The NPPTL Respirator Approval Program exists to increase the level of worker protection from airborne particulates, chemicals, and vapors.

In addition to respirators, NPPTL conducts research on other types of PPT, including chemical-resistant clothing, hearing protection, gloves, eye and face protective devices, hard hats, sensors to detect hazardous substances, and communication devices used for safe deployment of emergency workers. The NPPTL's PPT research examines exposure to inhalation hazards, dermal hazards, and any other hazardous environmental threats within an occupational setting.

PPT performance requirements and test methods are specified within: (1) Federal regulations by NIOSH, the Food and Drug Administration (FDA), and the Mine Safety and Health Administration (MSHA); and (2) voluntary consensus standards published by organizations such as the American National Standards Institute (ANSI), American Society for Testing and Materials (ASTM) International, and International Organization for Standardization (ISO). Thus, the information collected from human subjects in a laboratory setting is generally consistent across NPPTL studies with only the boundary conditions changing ( e.g., environmental conditions such as heat or humidity, human subject activity such as simulated surgery or climbing a ladder, and distance between two subjects communicating by spoken word). Additionally, novel PPT designs may be examined or compared to commercially available products under similar boundary conditions to examine adherence to regulations and/or standards. NPPTL requests a new Generic information collection package for laboratory-collected information for testing respirators and personal protective clothing.

NIOSH estimates that up to 1,500 individuals could be burdened per year. Recruitment for all laboratory studies includes individuals from the general population rather than specific industries or working status. These individuals are all adults between the ages of 18 and 65 years. CDC requests OMB approval for an estimated 11,903 annual burden hours. There is no cost to respondents other than their time to participate.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Members of the general public	Informed Consent	470	1	30/60	235
	Health Screening Questionnaire	470	6	1	2820
	Demographics Questionnaire	470	1	30/60	235
	Job-related Data: Occupational Tasks, postures used, duration of exposure	470	1	15/60	118
	Physiological Measurements: Chest-worn heart rate monitor strap, COSMED Kb5, SQ2020-1F8 temperature logger, TOSCA 500 pulse oximeter, koken breathing waveform recording mask	200	6	1.5	1800
	Biological Measurements: Cortisol (stress) levels, pregnancy tests, hydration status, lipids, inflammatory markers, heat shock proteins	100	6	15/60	150
	Anthropometric Measurements: Calipers/digital measuring of facial and body dimensions	500	1	15/60	125
	Respirator Fit Measurements: Filter cassettes with air pumps, fit-testing equipment, QLFT/sodium saccharin solution	225	100	15/60	5,625
	Self-Perception Data: Level of exertion, perceived comfort level, heat sensation, fatigue	500	6	15/60	750
	Biomechanics Measurements: Force plate, stopwatch, accelerometers	30	3	30/60	45
Total					11,903

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.