Request for Nonsubstantive Change 1 11 13

Request for Non-substantive Change to an OMB Approved Form

CDC/NIOSH (M) 2.8

OMB Approval #0920-0020 – Expiration date 06/30/2014

Justification for non-substantive change:

NIOSH is requesting a non-substantive change to the Roentgenographic Interpretation Form- 2.8 which is included as an attachment in 0920-0020 (National Coal Workers' X-Ray Surveillance Program). The current ICR will expire on 6/30/2014. NIOSH is requesting to add a legend to the back of the form and to change the box at the top of the form which is currently marked “P” (under “Type of Reading”) to F (to reflect the Facility clinical reading). Neither of these changes will have any impact on the burden or the number of respondents.

Form CDC/NIOSH (M) 2.8 is used by physicians who interpret chest radiographs in the NIOSH, Coal Workers’ Health Surveillance Program (CWHSP) for determination of pneumoconiosis among underground coal miners, utilizing a radiographic classification system developed by the International Labour Office (ILO).The CWHSP is a congressionally-mandated medical examination program for monitoring the respiratory health of underground coal miners, established under the Federal Coal Mine Health and Safety Act of 1969, as amended in 1977 and 2006, PL-91-173 (the Act). The Act provides the regulatory authority for the administration of the CWHSP, and the Program operates under the guidelines of 42 CFR Part 37, “Specifications for Medical Examinations of Underground Coal Miners.”

For years, the CWHSP only used film chest radiographs, and physicians providing clinical and ILO interpretation of those radiographs at NIOSH-approved radiographic facilities were required to be NIOSH-certified A or B Readers and use form CDC/NIOSH (M) 2.8. Recently, the 42 CFR Part 37 was revised to accept the use of digital chest radiography, and physicians providing clinical interpretation of digital chest radiographs are no longer required to provide concurrent ILO interpretation and be NIOSH-certified A or B Readers; however the form CDC/NIOSH (M) 2.8 is still to be used. Some of these physicians are not familiar with the “other symbols” present in Section 4B of the form CDC/NIOSH (M) 2.8 while in the past all of the physicians using this form were NIOSH-certified A or B Readers which were trained in the use of the form. We are now requesting permission to add a legend on the back of the form to provide a definition to the “other symbols” present in Section 4B of the form CDC/NIOSH (M) 2.8, with the goal to facilitate documentation of the clinical radiographic interpretation performed at the clinic level. We are also requesting permission to change the box at the top of the form which is currently marked “P” (under “Type of Reading”) to F (to reflect the Facility clinical reading) since P readings are no longer obtained under the revised regulations.

Neither of these changes will result in any additional burden to respondents.