Emergency Request Memo - Extension 08SEP2021

D EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

_______________________________________________________________________________________

Centers for Disease Control

and Prevention (CDC)

Atlanta GA 30341-3724

September 7, 2021

Dominic Mancini

Deputy Director

Office of Information and Regulatory Affairs

Office of Management and Budget

Washington, DC

Subject: Request for Emergency Review and Clearance

Dear Mr. Mancini:

Pursuant to Office of Management and Budget (OMB) procedures established at 5 CFR Part 1320, Controlling Paperwork Burdens on the Public, I request that the proposed information collection project, National Coal Workers’ Health Surveillance Program (CWHSP) be processed in accordance with section 1320.13, Emergency Processing.

I have determined that this information must be collected prior to the expiration of time periods established under Part 1320, and that this information is essential in the continued and uninterrupted operation of the CWHSP. The CWHSP is a Congressionally mandated program, and in order to keep in compliance with the statute, the information collection request (ICR) needs to go forward as an Emergency to avoid a lapse in collection activities.

This ICR is a revision of the existing OMB #0920-0020 approval from the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention. This request includes an addition of a new data collection instrument. The revision and additional tool have become necessary due to proposed revisions to the code of federal regulations that the CWHSP operates in accordance with (42 CFR Part 37). Approval is requested for three years as the current ICR will expire on September 30, 2021.

Coal miners who inhale excessive dust are known to develop a group of diseases of the lungs and airways, including chronic bronchitis, emphysema, chronic obstructive pulmonary disease, silicosis, and coal workers’ pneumoconiosis. Section 203, “Medical Examinations,” of the Act, is intended to protect the health and safety of coal miners. This Act provides the basis for all forms being utilized in conjunction with this data collection. Through delegation of authority, the Act directs NIOSH to study the causes and consequences of coal-related respiratory disease, and, in cooperation with the Mine Safety and Health Administration (MSHA), to carry out a program for early detection and prevention of coal workers' pneumoconiosis and to provide the opportunity for an autopsy after the death of any active or inactive miner. These activities are administered through the CWHSP, as specified in the Code of Federal Regulations, 42 CFR 37, “Specifications for Medical Examinations of Coal Miners”.

The CWHSP administers all aspects of the following activities related to the conduct of periodic medical examinations for coal miners: 1) testing and certification of A and B Readers (physicians qualified to interpret and classify radiographs for the pneumoconioses); 2) evaluation and approval of radiograph and spirometry facilities where testing may be offered; 3) evaluation and approval of coal mine operator plans for providing medical examinations; 4) arranging and paying for B Reader classifications of chest radiographs; 5) contracting with approved facilities to take radiographs and provide initial classifications for mines that are out of compliance and are not covered by approved coal mine operator plans; 6) arranging locally available testing, including spirometry, chest radiograph, and blood pressure monitoring for former and actively working surface and underground miners through the NIOSH Mobile Health Surveillance Units; 7) generation and dissemination of letters that notify participating miners of the results of their medical examinations; and, 8) maintenance of databases of information related to all aspects of the Program for purposes of assessing effectiveness, identifying disease trends, and storage allowing rapid retrieval of information relative to the taking, interpreting, and notification of results.

The Act also authorizes NIOSH to make necessary arrangements with the next-of-kin for providing a post-mortem examination to be performed after the death of any active or inactive miner, and specifies that the autopsy shall be paid for (through delegation) by NIOSH through the CWHSP. Results of these autopsies are used for research purposes (both epidemiological and clinical) and may also be used by the next-of-kin in support of compensation claims.

CDC cannot reasonably comply with the normal clearance given the fact that this is a mandated/required program, normal clearance processing time will prevent the program from being in compliance with the statue. Therefore, the ICR needs to be go forward as an emergency to prevent a lapse in collection activities.

Please provide an approval/disapproval determination of this request to collect information under an emergency clearance by close of business 9/30/2021.

Respectfully,

________________________________________

David Weissman, MD

Director, Respiratory Health Division (RHD)

National Institute for Occupational Safety and Health (NIOSH)

Centers for Disease Control and Prevention (CDC)