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make. The EPA will generally not Dated: January 30, 2020. Identifier Number (0920–AA68) for this consider comments or comment Dennis Deziel, rulemaking. All relevant comments, contents located outside of the primary Regional Administrator, EPA Region 1. including any personal information submission (i.e. on the web, cloud, or [FR Doc. 2020–02226 Filed 2–13–20; 8:45 am] provided, will be posted without change other file sharing system). For BILLING CODE 6560–50–P to http://www.regulations.gov. For additional submission methods, please detailed instructions on submitting contact the person identified in the FOR public comments, see the ‘‘Public Participation’’ heading of the FURTHER INFORMATION CONTACT section. DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION section of For the full EPA public comment policy, HUMAN SERVICES information about CBI or multimedia this document. submissions, and general guidance on 42 CFR Part 37 FOR FURTHER INFORMATION CONTACT: making effective comments, please visit Rachel Weiss, Program Analyst; 1090 https://www.epa.gov/dockets/ [Docket No. CDC–2019–0088; NIOSH–330] Tusculum Ave., MS: C–48, Cincinnati, OH 45226; telephone (855) 818–1629 commenting-epa-dockets. Publicly RIN 0920–AA68 available docket materials are available (this is a toll-free number); email at https://www.regulations.gov or at the Coal Workers’ Health Surveillance [email protected]. U.S. Environmental Protection Agency, Program: B Reader Decertification and SUPPLEMENTARY INFORMATION: EPA Region 1 Regional Office, Air and Autopsy Payment I. Public Participation Radiation Division, 5 Post Office AGENCY: Centers for Disease Control and Interested parties may participate in Square—Suite 100, Boston, MA. EPA Prevention, HHS. this rulemaking by submitting written requests that if at all possible, you views, opinions, recommendations, and contact the contact listed in the FOR ACTION: Notice of proposed rulemaking. data. Comments received, including FURTHER INFORMATION CONTACT section to SUMMARY: HHS proposes to revise the attachments and other supporting schedule your inspection. The Regional National Institute for Occupational materials, are part of the public record Office’s official hours of business are Safety and Health (NIOSH), Coal and subject to public disclosure. Do not Monday through Friday, 8:30 a.m. to Workers’ Health Surveillance Program include any information in your 4:30 p.m., excluding legal holidays. (Program) regulations by adding a comment or supporting materials that FOR FURTHER INFORMATION CONTACT: Bob provision to allow NIOSH to suspend or you do not wish to be disclosed. You McConnell, Environmental Engineer, revoke B Reader certification. may submit comments on any topic Air and Radiation Division (Mail Code Certification may be revoked for any B related to this notice of proposed 05–2), U.S. Environmental Protection Reader found by NIOSH to have rulemaking. engaged in a pattern of providing Agency, Region 1, 5 Post Office Square, II. Statutory Authority Suite 100, Boston, Massachusetts unreasonably inaccurate chest The Federal Mine Safety and Health 02109–3912; (617) 918–1046. radiograph classifications in practice— Act of 1977 (Pub. L. 91–173, 30 U.S.C. [email protected]. those that are found by the Program to diverge substantially from a competent 801 et seq.) (Mine Act), authorizes the SUPPLEMENTARY INFORMATION: In the interpretation of the radiographs, as HHS Secretary (Secretary) to work with Final Rules Section of this Federal determined by a panel of practicing, coal mine operators to make available to Register, EPA is approving the State’s certified B Readers selected by NIOSH. coal miners the opportunity to have SIP submittal as a direct final rule In addition to the B Reader provisions, regular and routine chest radiographs without prior proposal because the HHS would also amend existing (X-rays) in order to detect coal workers’ Agency views this as a noncontroversial regulatory text to allow compensation (i.e., black lung) and submittal and anticipates no adverse for pathologists who perform autopsies prevent its progression in individual comments. A detailed rationale for the on coal miners at a market rate, on a miners. The Mine Act grants the approval is set forth in the direct final discretionary basis as needed for public Secretary general authority to issue rule. If no adverse comments are health purposes. regulations as is deemed appropriate to carry out provisions of the Act and received in response to this action rule, DATES: Comments must be received by no further activity is contemplated. If specifically directs that medical May 14, 2020. Comments on the examination of coal miners shall be EPA receives adverse comments, the information collection approval request direct final rule will be withdrawn and given in accordance with specifications sought under the Paperwork Reduction prescribed by the Secretary (30 U.S.C. all public comments received will be Act must be received by April 14, 2020. addressed in a subsequent final rule 843(a), 957). The Mine Act also ADDRESSES: Written comments: based on this proposed rule. EPA will authorizes the Secretary to establish Comments may be submitted by any of specifications for the reading of not institute a second comment period. the following methods: Any parties interested in commenting radiographs and to pay for autopsies • Federal eRulemaking Portal: http:// submitted to the Program. on this action should do so at this time. www.regulations.gov. Follow the Please note that if EPA receives adverse instructions for submitting comments to III. Background and Need for comment on an amendment, paragraph, the docket. Rulemaking or section of this rule and if that • Mail: NIOSH Docket Office, Robert All mining work generates fine provision may be severed from the A. Taft Laboratories, MS–C34, 1090 particles of dust in the air. Coal miners remainder of the rule, EPA may adopt Tusculum Avenue, Cincinnati, OH who inhale excessive dust are known to as final those provisions of the rule that 45226. develop a group of diseases of the lungs are not the subject of an adverse Instructions: All submissions received and airways, including dust-induced comment. must include the agency name (Centers fibrotic lung disease (pneumoconiosis) For additional information, see the for Disease Control and Prevention, and chronic obstructive pulmonary direct final rule which is located in the HHS) and docket number (CDC–2019– disease, including chronic bronchitis Rules Section of this Federal Register. 0088; NIOSH–330) or Regulation and emphysema. To address such

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threats to the U.S. coal mining classifications in accordance with ILO has occasionally learned of B Readers workforce, the Mine Act was enacted in standards. The B Reader examination found to provide unreasonably 1969 and amended in 1977, authorizing currently offered by NIOSH consists of inaccurate radiograph classifications in the NIOSH Coal Workers’ Health the classification of 125 chest formal litigation and compensation Surveillance Program, within the radiographs over the course of 6 hours; proceedings relative to the actual Respiratory Health Division, to detect the test addresses proficiency in features of the chest radiographs in pneumoconiosis and prevent its classification of small opacities, large question. ‘‘Unreasonably inaccurate’’ progression in individual miners, while opacities, pleural abnormalities, and classifications are those that diverge at the same time providing information certain other abnormalities that may substantially from a competent for evaluation of temporal and appear in the lung radiographs. In order interpretation of the radiographs and are geographic trends in pneumoconiosis. to maintain B Reader status, B Readers unsupported by the chest radiographs in To inform each miner of his or her must take and pass the B Reader question, as determined by a panel of health status, the Act requires that coal recertification exam every 5 years. practicing, certified B Readers selected mine operators provide each miner who B Readers participate in the NIOSH by NIOSH. For example, one B Reader begins work at a coal mine for the first Coal Workers’ Health Surveillance was accused of ‘‘under-reading’’ chest time a (X-ray) through Program, as well as other national and radiographs, frequently not identifying an approved facility as soon as possible state programs addressing dust-related severe cases of pneumoconiosis that after employment starts. Three years illnesses,2 and are also involved with may have been indicated by the later a miner must be offered a second epidemiologic evaluations, surveillance, radiographs; 4 another was accused of chest radiograph. If this second and worker monitoring programs ‘‘over-reading,’’ frequently identifying examination reveals evidence of involving many types of where the radiographs were pneumoconiosis, the miner is entitled to pneumoconioses. In applying the ILO subsequently found not to support that a third chest radiograph 2 years after the Classification, B Readers compare sets determination.5 The Program second. Further, all miners working in of standard images, which represent regulations in 42 CFR part 37 do not a coal mine must be offered a chest different types of abnormalities and currently provide a mechanism for radiograph approximately every 5 years. levels of disease severity, with images of NIOSH to take remedial action Under NIOSH supervision, chest the individual being evaluated to addressing such B Readers. radiographs are assessed and a summary identify parenchymal abnormalities report based on at least two (small and large opacities), pleural Autopsies independent classifications (readings) of changes, and other features that can The Mine Act also authorizes HHS to each periodic chest radiograph is sent to occur in chest radiographs of provide for coal miner autopsies and to each participating coal miner, who then individuals with pneumoconiosis. In pay for their submission to NIOSH. has the opportunity to take action to the current ILO Classification, the B Autopsies can be used for public health reduce further dust exposure if early Reader is first asked to grade film purposes such as studying the emerging dust-induced lung disease is detected. quality and then to categorize small issue of rapidly progressive and severe The combined results of these opacities according to their presence, pneumoconiosis in coal miners by radiographic examinations of miners shape and size, location, and profusion. assessing its pathology and lung content also enable NIOSH to track rates and Large opacities are classified according of mineral particles relative to what was patterns of pneumoconiosis among the to their presence and size. The B Reader seen in the past. Also, autopsies are participating miners. also assesses the presence, location, sometimes requested after mine disasters. The current regulatory B Readers width, extent, and degree of calcification of pleural abnormalities as language, promulgated over 45 years Pursuant to NIOSH Coal Workers’ well as provides a description of ago, provides for payments to Health Surveillance Program regulations additional features related to dust pathologists up to $200; today, in 42 CFR 37.51 and 37.52, chest exposure and other etiologies visible on autopsies generally cost between $2,000 radiographs taken for the Program are the chest radiograph.3 and $3,000. As a result, very few assessed by qualified licensed physician The classification of chest radiographs autopsies of coal miners are provided to B Readers. B Readers are physicians is semi-quantitative and relies on the B the Coal Workers’ Health Surveillance who have demonstrated proficiency in Reader’s professional judgment, Program and the Autopsy Program is the use of the International Labour comparing case radiographs to the ILO rarely used. Increasing the Office (ILO) Classification of standard classification radiographs. compensation rate would make it Radiographs of Pneumoconioses 1 by Skilled B Readers can disagree about the possible for pathologists to conduct taking and passing a specially-designed presence of disease, particularly in a autopsies of coal miners, thereby proficiency examination offered by radiograph with borderline findings, or allowing the NIOSH Respiratory Health NIOSH, as specified in 42 CFR 37.52. differ somewhat in classifying the Division to better study pneumoconiosis The goal of the NIOSH B Reader severity of disease. However, since the in contemporary coal miners and to Program is to ensure competency in the beginning of the Program in the 1970s, more thoroughly perform public health detection of pneumoconiosis by the NIOSH Respiratory Health Division investigations, especially in the evaluating the ability of readers to aftermath of mine disasters. classify a test set of radiographs, thereby 2 Other examples of national compensation creating and maintaining a pool of programs that use B Readers include the 4 The Center for Public Integrity [2013], Johns qualified readers having the skills and Department of Labor, Office of Workers’ Hopkins Medical Unit Rarely Finds Black Lung, Compensation Programs (OWCP), Division of Coal Helping Coal Industry Defeat Miners’ Claims, ability to provide accurate and precise Mine Workers’ Compensation, Black Lung Program; https://publicintegrity.org/environment/johns- and the Asbestos Medical Surveillance Program, hopkins-medical-unit-rarely-finds-black-lung- 1 International Labour Office [2011], Guidelines administered by the Navy and Marine Corps Public helping-coal-industry-defeat-miners-claims/. for the use of ILO International Classification of Health Center. 5 Fisher D [2012], Law Firm Hit with $429,000 Pneumoconiosis, revised edition 2011, Geneva, 3 NIOSH [2015], Chest Radiograph Classification, Verdict over Faked Asbestos Suits, Forbes, https:// Switzerland: International Labour Office. CDC/NIOSH form (M) 2.8, http://www.cdc.gov/ www.forbes.com/sites/danielfisher/2012/12/21/law- Occupational Safety and Health Series No. 22 (Rev. niosh/topics/surveillance/ords/pdfs/CWHSP- firm-hit-with-429000-verdict-over-faked-asbestos- 2011). ReadingForm-2.8.pdf. suits/#14f1d2f92325.

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IV. Summary of Proposed Rule pattern of providing unreasonably V. Regulatory Assessment To promote administrative efficiency inaccurate chest radiographs in practice, Requirements and ensure program integrity, HHS the B Reader’s certification will be A. Executive Order 12866 (Regulatory proposes to amend 42 CFR part 37 by permanently revoked. Planning and Review) and Executive adding a new paragraph (d) to § 37.52, A new paragraph (d)(3) would Order 13563 (Improving Regulation and to allow NIOSH to take remedial action establish an appeal process for those B Regulatory Review) for any B Reader found by NIOSH to Readers whose certifications have been have engaged in a pattern of providing Executive Orders 12866 and 13563 revoked by the Coal Workers’ Health direct agencies to assess all costs and chest radiograph classifications in Surveillance Program. practice that are found by the Program benefits of available regulatory to be unreasonably inaccurate, as HHS is also considering permitting alternatives and, if regulation is determined by a panel of practicing, the revocation or suspension of B necessary, to select regulatory certified B Readers selected by NIOSH. Reader certifications for demonstrated approaches that maximize net benefits Remedial actions may be taken at patterns of violating the B Reader’s Code (including potential economic, NIOSH’s discretion or in response to a of Ethics. The Code of Ethics is available environmental, public health and safety complaint from any interested party or on the NIOSH website at https:// effects, distributive impacts, and at the discretion of the Coal Workers’ www.cdc.gov/niosh/topics/ equity). E.O. 13563 emphasizes the Health Surveillance Program. To ensure chestradiography/breader-ethics.html, importance of quantifying both costs that NIOSH can identify those B Readers and would be included in part 37 as an and benefits, of reducing costs, of who provide unreasonably inaccurate appendix should this option be adopted. harmonizing rules, and of promoting classifications to compensation HHS encourages comments on this flexibility. programs, a valid complaint from any matter. This proposed rule has been determined not to be a ‘‘significant interested party must provide the chest In addition to the proposed regulatory radiograph(s) and ILO classification(s) regulatory action’’ under section 3(f) of language on remediating inaccurate B E.O. 12866. The revisions proposed in being contested, as well as a letter from Readers, HHS would also amend a medical professional supporting the this notice would allow NIOSH to take existing regulatory text in §§ 37.202 remedial action addressing any B complaint that the classification was through 37.204 to allow NIOSH, on a unreasonable. A new § 37.52(d)(1) Readers who frequently provide chest discretionary basis as needed for public would describe the complaint process. radiograph classifications in practice health purposes, to better compensate Paragraph (d)(1)(i) would define that are determined by the Program to pathologists who perform autopsies on ‘‘unreasonably inaccurate’’ be unreasonably inaccurate. Part 37 classifications as those that a panel of B coal miners. Existing text in § 37.202(a) would also be revised to allow NIOSH Readers would unanimously determine would be revised to clarify that to compensate pathologists at a are substantially divergent from a pathologists must secure prior contemporary rate for autopsies competent interpretation of the authorization from NIOSH and have submitted to the Coal Workers’ Health radiographs and are unsupported by the legal consent to conduct an autopsy on Surveillance Program. radiographs in question. Paragraph a coal miner. New language in The proposed revisions to Part 37 (d)(1)(ii) would describe the elements of § 37.202(a)(2)(i) and (ii) would clarify would not impose significant costs on a valid complaint; paragraph (d)(1)(iii) the types of chest radiographs accepted the public and would benefit coal would describe an invalid complaint. by the Program, and new language in miners and coal mine operators. A new § 37.52(d)(2) would describe § 37.202(b) would specify that Depending on the types of unreasonably the procedures that would be used by pathologists would be compensated in inaccurate classifications they provide, NIOSH to determine whether an accordance with the ordinary, usual, or B Readers can compromise the health of individual B Reader has engaged in a customary fee charged by other and benefits owed to coal miners who pattern of providing unreasonably pathologists for the same services. have pneumoconiosis by under-reading inaccurate chest radiographs in practice. Section 37.203 would be revised to or cause unnecessary emotional distress Complaint investigations would involve update the reference for standard to miners and unnecessary costs for a panel of at least four B Readers who autopsy procedures. Finally, new mine operators by over-reading. would independently review the language in § 37.204(a) would detail the Allowing the NIOSH Respiratory Health information provided in each new requirement that the pathologist Division to take remedial actions complaint. If at least one B Reader on obtain written authorization from the addressing these B Readers through the panel finds that the contested NIOSH Respiratory Health Division suspension or revocation of their B classification is reasonable, no further prior to completion of the autopsy. Reader certifications would ensure that review will be conducted. If the B Existing language specifying how claims these adverse outcomes were minimized Readers on the panel independently and for payment should be submitted to or avoided. Allowing the NIOSH Respiratory Health Division to better unanimously conclude that the NIOSH would be reorganized. classification is not reasonable, the compensate pathologists for autopsies actions described in paragraphs In existing § 37.201(b), the definition submitted to the Program would also (d)(2)(ii)–(v) will be taken. of Miner would be revised to remove the ensure that NIOSH is able to study In accordance with the new word ‘‘underground,’’ to clarify that the pneumoconiosis in coal miners. provisions in § 37.52(d)(2), the autopsy provisions pertain to all coal The costs to the Federal government certification of a B Reader who is under miners. Section 37.201(d) would also be of administering these revisions would investigation will remain in good revised to update the definition of be minor and infrequent. NIOSH standing until the Program issues its ‘‘NIOSH,’’ clarifying that the name of estimates that over a 5-year period, it final decision regarding remedial the NIOSH division responsible for might conduct two evaluations of B actions. If three independent complaint administering the Coal Workers’ Health Readers, costing NIOSH approximately investigations conclude that an Surveillance Program is now the $3,000. Over the same period, NIOSH individual B Reader has engaged in a Respiratory Health Division. estimates it might fund up to 20

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autopsies, costing NIOSH approximately this proposed rule has ‘‘no significant collected; and (d) ways to minimize the $60,000. economic impact upon a substantial burden of the collection of information The only costs potentially imposed on number of small entities’’ within the on respondents. Written comments the public would be borne by B Readers meaning of the Regulatory Flexibility should be received within 60 days of the whose certifications are suspended or Act (5 U.S.C. 601 et seq.). publication of this notice. The addition revoked. NIOSH estimates that over a 5- of additional paperwork requirements D. Paperwork Reduction Act year period it might suspend or revoke resulting from this proposed rule will certifications for one B Reader. The Paperwork Reduction Act (PRA), increase the burden associated with the However, conducting B Reader medical 44 U.S.C. 3501 et seq., requires an following provisions: examinations is generally infrequent agency to invite public comment on, Section 37.52 Proficiency in the use of within a physician’s medical practice, and to obtain Office of Management and systems for classifying the and moreover, other medical procedures Budget (OMB) approval of, any pneumoconioses. This section similarly compensated would likely regulation that requires 10 or more establishes the process for certifying B substitute for conducting B Reader people to report information to the Readers. Of the 167 B Readers currently examinations. It is not possible to agency or to keep certain records. In certified and the approximately reasonably estimate whether such costs accordance with section 3507(d) of the additional 200 who will be certified would arise and, if so, their level and PRA, HHS has determined that the PRA over the next 10 years, HHS anticipates frequency. does apply to information collection that no more than three B Readers may B. Executive Order 13771 (Reducing and recordkeeping requirements be disciplined over time. Of those, HHS Regulation and Controlling Regulatory included in this rule. OMB has already expects two B Readers to challenge or Costs) approved the information collection and appeal the decision to take disciplinary recordkeeping requirements under OMB Executive Order 13771 requires action; if all decisions are challenged Control Number 0920–0020, National executive departments and agencies to and the final decision to revoke Coal Workers’ Health Surveillance eliminate at least two existing certification is appealed, NIOSH would regulations for every new significant Program (CWHSP) (expiration date 9/ receive up to eight letters (for each of regulation that imposes costs. HHS has 30/2021). HHS has determined that the the four final disciplinary decisions). determined that this rulemaking is cost- proposed amendments in this HHS estimates that the challenge or neutral because it does not require any rulemaking would not impact the appeal letter will take no more than 30 new action by stakeholders. The existing collection of data but would minutes to complete, totaling 4 hours rulemaking ensures that coal miners add two new items to the approval: B annually. There will be no form properly receive compensation for their Reader challenge and appeal, and the associated with this collection. occupational illness and that NIOSH pathologist prior authorization request. Section 37.204 Procedure for can more thoroughly study the To request more information or to obtaining payment. This section would development of pneumoconiosis. obtain a copy of the data collection establish that a pathologist who wants Because OMB has determined that this plans and instruments, you may call to submit an autopsy to the Coal rulemaking is not significant, pursuant 404–639–5960; send comments to Workers’ Health Surveillance Program to E.O. 12866, and because it does not Kimberly S. Lane, 1600 Clifton Road, must first obtain written authorization impose costs, OMB has determined that MS–D74, Atlanta, GA 30333; or send an from the NIOSH Respiratory Health this rulemaking is exempt from the email to [email protected]. Division. HHS expects that the number requirements of E.O. 13771. Thus it has Comments are invited on the of requests will vary substantially from not been reviewed by OMB. following: (a) Whether the proposed year-to-year. For example, more requests collection of information is necessary might be granted following a mine C. Regulatory Flexibility Act for the proper performance of the disaster. Over a period of years, HHS The Regulatory Flexibility Act (RFA), functions of the Agency, including expects an average of about four 5 U.S.C. 601 et seq., requires each whether the information shall have requests for prior authorization agency to consider the potential impact practical utility; (b) the accuracy of the annually. HHS estimates that each of its regulations on small entities Agency’s estimate of the burden of the request for prior authorization will take including small businesses, small proposed collection of information; (c) no more than 15 minutes to complete, governmental units, and small not-for- ways to enhance the quality, utility, and averaging about 1 hour annually over a profit organizations. HHS certifies that clarity of the information to be period of years.

Average Number of Responses burden per Total burden Section Title respondents per response (hr) respondent (min)

37.52 ...... Challenge to disciplinary action and appeal of decerti- 2 4 30/60 4 fication decision. 37.204 ...... Autopsy prior authorization ...... 4 1 15/60 1

Total ...... 5

E. Small Business Regulatory seq.), HHS will report the promulgation F. Unfunded Mandates Reform Act of Enforcement Fairness Act of this rule to Congress prior to its 1995 effective date. As required by Congress under the Title II of the Unfunded Mandates Small Business Regulatory Enforcement Reform Act of 1995 (2 U.S.C. 1531 et Fairness Act of 1996 (5 U.S.C. 801 et seq.) directs agencies to assess the

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effects of Federal regulatory actions on consistent with the Federal Plain (iii) A complaint that fails to include State, local, and Tribal governments, Writing Act guidelines. any required element will be considered and the private sector ‘‘other than to the invalid, and the NIOSH Respiratory List of Subjects in 42 CFR Part 37 extent that such regulations incorporate Health Division will notify the requirements specifically set forth in Chronic Obstructive Pulmonary complainant that no further law.’’ For purposes of the Unfunded Disease, Coal Workers’ Pneumoconiosis, investigation will occur. Mandates Reform Act, this proposed Incorporation by reference, Lung (2) Investigations may be initiated at rule does not include any Federal diseases, Mine safety and health, NIOSH’s discretion or in response to a mandate that may result in increased Occupational safety and health, Part 90 valid complaint, pursuant to paragraph annual expenditures in excess of $100 miner, Part 90 transfer rights, (d)(1) of this section, to determine million by State, local, or Tribal Pneumoconiosis, Respiratory and whether a B Reader has provided chest governments in the aggregate, or by the pulmonary diseases, , radiograph classifications in practice private sector. Spirometry, Surface coal mining, that are unreasonably inaccurate. Underground coal mining, X-rays. (i) Investigations will include the G. Executive Order 12988 (Civil Justice following: Reform) Proposed Rule (A) The NIOSH Respiratory Health This proposed rule has been drafted For the reasons discussed in the Division will choose a panel of at least and reviewed in accordance with preamble, the Department of Health and four B Readers who will independently Executive Order 12988 and will not Human Services proposes to amend 42 review the information provided in each unduly burden the Federal court CFR part 37 as follows: valid complaint. system. This rule has been reviewed (B) If one or more of the B Readers on carefully to eliminate drafting errors and PART 37—SPECIFICATIONS FOR the panel independently determines ambiguities. MEDICAL EXAMINATIONS OF COAL that the classification being contested is MINERS reasonable, the NIOSH Respiratory H. Executive Order 13132 (Federalism) Health Division will conclude that the ■ 1. The authority citation for part 37 HHS has reviewed this proposed rule classification being contested is continues to read as follows: in accordance with Executive Order reasonable. The complainant will be 13132 regarding federalism, and has Authority: Sec. 203, 83 Stat. 763, 30 U.S.C. notified of the finding and no further determined that it does not have 843, unless otherwise noted. action will be conducted. ‘‘federalism implications.’’ The rule ■ 2. Revise § 37.52 by adding paragraph (C) If the B Readers on the panel does not ‘‘have substantial direct effects (d) to read as follows: independently and unanimously concur on the States, on the relationship that the classification being contested is between the national government and § 37.52 Proficiency in the use of systems unreasonable, remedial actions will be for classifying the pneumoconioses. the States, or on the distribution of taken by the NIOSH Respiratory Health power and responsibilities among the * * * * * Division pursuant to paragraphs various levels of government.’’ (d) Remedial Actions. (1) Any (d)(2)(ii) through (v) of this section, interested party may make a complaint accordingly. I. Executive Order 13045 (Protection of to the NIOSH Coal Workers’ Health (ii) If, after an investigation, a panel Children From Environmental Health Surveillance Program against any B of B Readers unanimously finds that the Risks and Safety Risks) Reader who routinely provides chest classification contested in a complaint In accordance with Executive Order radiograph classifications in practice is unreasonably inaccurate, the Program 13045, HHS has evaluated the that are believed to be unreasonably will issue an initial report to the B environmental health and safety effects inaccurate. Reader under review. If the B Reader of this proposed rule on children. HHS (i) Inaccurate classifications are those chooses not to challenge the initial has determined that the rule would have that fail to identify small or large report within 30 days, the initial report no environmental health and safety opacities in lung fields, pleural changes, becomes a final determination. If the B effect on children. and other features indicating the Reader chooses to challenge the initial presence of lung disease where they report, the Coal Workers’ Health J. Executive Order 13211 (Actions exist, or those that identify small or Surveillance Program will respond Concerning Regulations That large opacities, pleural changes, and within 90 days; the Program’s decision Significantly Affect Energy Supply, other features where they do not exist. is final. The first final report may be Distribution, or Use) Unreasonably inaccurate classifications considered a warning that further In accordance with Executive Order are those that a panel of B Readers misclassification of small or large 13211, HHS has evaluated the effects of would unanimously determine are opacities or other types of pleural this proposed rule on energy supply, substantially divergent from a abnormalities will result in suspension distribution or use, and has determined competent interpretation of the or revocation of the B Reader’s that the rule will not have a significant radiographs and are unsupported by the certification. adverse effect. chest radiographs in question. (iii) If, after an investigation, a panel (ii) A valid complaint must be of B Readers unanimously finds that the K. Plain Writing Act of 2010 submitted to the NIOSH Coal Workers’ classification contested in a second Under Public Law 111–274 (October Health Surveillance Program, complaint is unreasonably inaccurate, 13, 2010), executive Departments and Respiratory Health Division, and the Program will issue an initial report Agencies are required to use plain include the chest radiographs and ILO to the B Reader under review. If the B language in documents that explain to classifications being contested as well as Reader chooses not to challenge the the public how to comply with a a letter of support from a medical initial report within 30 days, the initial requirement the Federal government professional. A complaint that report becomes a final determination. If administers or enforces. HHS has demonstrates more than a reasonable the B Reader chooses to challenge the attempted to use plain language in difference of opinion will be considered initial report, the Coal Workers’ Health promulgating the proposed rule valid. Surveillance Program will respond

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within 90 days, during which time the any information demonstrating that the authorization from NIOSH pursuant to B Reader’s certification will remain in decertification decision was not § 37.204(a), and with legal consent: good standing; the Program’s decision is reasonable, and/or relevant new (1) Performs an autopsy on a miner in final and may result in the 1-year information not previously considered accordance with this subpart; and suspension of the B Reader’s by the Coal Workers’ Health (2) Submits the findings and other certification with the 1-year period Surveillance Program. materials to NIOSH in accordance with beginning on the date the Program (iii) The appeal request must be sent this subpart within 180 calendar days issues the final decision letter. The to the NIOSH Respiratory Health after having performed the autopsy. suspended B Reader must take and pass Division Director at the address (i) Types of chest radiographic images the certification examination at the specified in the decertification letter. accepted for submission include a conclusion of the suspension period in (iv) The NIOSH Respiratory Health digital chest image (posteroanterior order to be reinstated. Division Director will review the Coal view) provided in an electronic format (iv) If, after an investigation, a panel Workers’ Health Surveillance Program consistent with the DICOM standards of B Readers unanimously finds that the decision and any relevant information described in § 37.42(c)(5), a chest classification contested in a third provided by the B Reader and make a computed tomography provided in an complaint is unreasonably inaccurate, final decision on the appeal. The electronic format consistent with the Program will issue an initial report Director will notify the B Reader of the DICOM standards, or a good-quality to the B Reader under review. If the B following in writing: copy or original of a film chest Reader chooses not to challenge the (A) The Director’s final decision on radiograph (posteroanterior view). initial report within 30 days, the initial the appeal; (ii) More than one type of chest report becomes a final determination. If (B) An explanation of the reason(s) for radiographic image may be submitted. the B Reader chooses to challenge the the Director’s final decision on the (b) Pathologists will be compensated initial report, the Coal Workers’ Health appeal; and in accordance with the ordinary, usual, Surveillance Program will respond (C) Any administrative actions taken or customary fee charged by other within 90 days, during which time the by the Coal Workers’ Health pathologists for the same services, at the B Reader’s certification will remain in Surveillance Program. discretion of NIOSH. NIOSH will good standing; the Program’s decision is ■ 3. Revise § 37.201 to read as follows: additionally compensate a pathologist final, unless the B Reader successfully for the submission of chest radiographic appeals the decision pursuant to § 37.201 Definitions. images made of the subject of the § 37.52(d)(3), and will result in As used in this subpart: autopsy within 5 years prior to his/her permanent revocation of the B Reader’s (a) Secretary means the Secretary of death together with copies of any certification beginning on the date the Health and Human Services. interpretations made. Program issues the final decision letter. (b) Miner means any individual who (c) A pathologist who receives any (v) If the first complaint is found to be during his/her life was employed in any other specific payment, fee, or valid and to demonstrate a pattern of coal mine. reimbursement in connection with the inaccurate chest radiograph (c) Pathologist means autopsy from the miner’s widow/ classifications, the Program will issue (1) A physician certified in anatomic widower, his/her family, his/her estate, an initial report to the B Reader under pathology or pathology by the American or any other Federal agency will not review and immediately apply the Board of Pathology or the American receive compensation from NIOSH. procedures in paragraph (d)(2)(iv) of Osteopathic Board of Pathology, ■ 5. Revise § 37.203 to read as follows: this section. To demonstrate a pattern of (2) A physician who possesses inaccurate classifications, the valid qualifications which are considered § 37.203 Autopsy specifications. complaint must provide radiographs board-eligible by the American Board of (a) Each autopsy for which a claim for from three or more patients conducted Pathology or American Osteopathic payment is submitted pursuant to this within a one-year period that are Board of Pathology, or subpart must be performed in a manner determined by the Program to be (3) An intern, resident, or other consistent with standard autopsy inaccurate. physician in a training program in procedures such as those, for example, (3) A B Reader whose certification is pathology who performs the autopsy set forth in Autopsy Performance & revoked after three final adverse under the supervision of a pathologist as Reporting, third edition (Kim A. Collins, determinations is no longer a certified B defined in paragraph (c) (1) or (2) of this ed., College of American Pathologists, Reader. Such B Reader may appeal the section. 2017). Copies of this document may be Coal Workers’ Health Surveillance (d) NIOSH means the National borrowed from NIOSH. Program’s decision to revoke the B Institute for Occupational Safety and (b) Each autopsy must include: Reader’s certification. Health, located within the Centers for (1) Gross and microscopic (i) An appeal request must be Disease Control and Prevention (CDC). examination of the lungs, pulmonary submitted in writing to the NIOSH Within NIOSH, the Respiratory Health pleura, and tracheobronchial lymph Respiratory Health Division Director, Division (formerly called the Division of nodes; signed and postmarked within 30 Respiratory Disease Studies and the (2) Weights of the heart and each lung calendar days of the date of the letter Appalachian Laboratory for (these and all other measurements notifying the B Reader of the Occupational Safety and Health) is the required under this subparagraph must decertification decision. Electronic organizational unit that has be in the metric system); versions of the signed appeal request programmatic responsibility for the (3) Circumference of each cardiac letter will also be accepted. medical examination and surveillance valve when opened; (ii) The appeal request must state the program. (4) Thickness of right and left reason(s) the B Reader believes the ■ 4. Revise § 37.202 to read as follows: ventricles; these measurements must be decertification decision is incorrect and made perpendicular to the ventricular should be reversed. The appeal request § 37.202 Payment for autopsy. surface and must not include may include scientific or medical (a) NIOSH may, at its discretion, pay trabeculations or pericardial fat. The information correcting factual errors, any pathologist who has received prior right ventricle must be measured at a

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point midway between the tricuspid (3) Report of autopsy: North Capitol Street NW, Washington, valve and the apex, and the left (i) The information, slides, and blocks DC 20573–0001. Phone: (202) 523–5725. ventricle must be measured directly of tissue required by this subpart. Email: [email protected]. above the insertion of the anterior (ii) Clinical abstract of terminal illness • Comments regarding the revised papillary muscle; and other data that the pathologist information collections should be (5) Size, number, consistency, determines is relevant. submitted to the Commission through location, description and other relevant (iii) Final summary, including final one of the preceding methods and a details of all lesions of the lungs; anatomical diagnoses, indicating copy should also be sent to the Office (6) Level of the diaphragm; presence or absence of simple and of Information and Regulatory Affairs, (7) From each type of suspected complicated pneumoconiosis, and Office of Management and Budget, pneumoconiotic lesion, representative correlation with clinical history if Attention: Desk Officer for Federal microscopic slides stained with indicated. Maritime Commission, 725 17th Street hematoxylin eosin or other appropriate Dated: January 10, 2020. NW, Washington, DC 20503; by Fax: stain, and one formalin fixed, paraffin- _ Alex M. Azar II (202) 395–5167; or by email: OIRA impregnated block of tissue; a minimum [email protected]. of three stained slides and three blocks Secretary, Department of Health and Human Instructions: For detailed instructions Services. of tissue must be submitted. When no on submitting comments, including such lesion is recognized, similar [FR Doc. 2020–02705 Filed 2–13–20; 8:45 am] requesting confidential treatment of material must be submitted from three BILLING CODE 4163–218–P comments, and additional information separate areas of the lungs selected at on the rulemaking process, see the random; a minimum of three stained Public Participation heading of the slides and three formalin fixed, paraffin- FEDERAL MARITIME COMMISSION Supplementary Information section of impregnated blocks of tissue must be this document. Note that all comments 46 CFR Part 530 submitted. received will be posted without change (c) Needle biopsy techniques will not [Docket No. 20–02] to the Commission’s website, unless the be accepted. commenter has requested confidential RIN 3072–AC80 ■ 6. Revise § 37.204 to read as follows: treatment. § 37.204 Procedure for obtaining payment. Service Contracts Docket: For access to the docket to read background documents or (a) Prior to performing an autopsy, the AGENCY: Federal Maritime Commission. comments received, go to the pathologist must obtain written Commission’s Electronic Reading Room authorization from NIOSH and ACTION: Notice of proposed rulemaking. at: https://www2.fmc.gov/readingroom/ agreement regarding payment amount SUMMARY: The Federal Maritime proceeding/20-02/, or to the Docket for services specified in § 37.202(a) by Commission (FMC or Commission) Activity Library at 800 North Capitol submitting an Authorization for proposes to amend its rules governing Street NW, Washington, DC 20573, 9:00 Payment of Autopsy (form CDC Service Contracts. The proposed rule is a.m. to 5:00 p.m., Monday through #0.1585). intended to reduce regulatory burden. Friday, except Federal holidays. (1) NIOSH will maintain up-to-date DATES Telephone: (202) 523–5725. information about the availability of : Submit comments on or before: payments on its website. If payments are April 14, 2020. FOR FURTHER INFORMATION CONTACT: For not available, the online Authorization In compliance with the Paperwork questions regarding submitting of Payment for Autopsy form will not be Reduction Act, the Commission is also comments or the treatment of active and available for completion on seeking comment on revisions to one confidential information, contact Rachel the NIOSH website. information collections. See the E. Dickon, Secretary. Phone: (202) 523– (2) After receiving a completed Paperwork Reduction Act section under 5725. Email: [email protected]. For authorization request form, NIOSH will Regulatory Analyses and Notices below. technical questions, contact Florence A. reply in writing with an authorization Please submit all comments relating to Carr, Director, Bureau of Trade determination within 3 working days. the revised information collections to Analysis, Federal Maritime (b) After performance of an autopsy, the Commission and to the Office of Commission, 800 North Capitol Street each claim for payment under this Management and Budget (OMB) at the NW, Washington, DC 20573–0001. subpart must be submitted to NIOSH address listed in the ADDRESSES section Phone: (202) 523–5796. Email: and must include: on or before April 14, 2020. Comments [email protected]. (1) An invoice (in duplicate) on the to OMB are most useful if submitted SUPPLEMENTARY INFORMATION: pathologist’s letterhead or billhead within 30 days of publication. Introduction indicating the date of autopsy, the ADDRESSES: You may submit comments amount of the claim and a signed identified by the Docket No. 20–02 in On September 18, 2018, the Federal statement that the pathologist is not the heading of this document, by the Maritime Commission (FMC or receiving any other specific following methods: Commission) issued a Notice of Filing compensation for the autopsy from the • Email: [email protected]. Include and Request for Comments to obtain miner’s widow/widower, his/her in the subject line: ‘‘Docket No. 20–02, public comments on Petition No. P3–18, surviving next-of-kin, the estate of the Comments on Proposed Service the petition of the World Shipping miner, or any other source. Contract Regulations.’’ Comments Council (WSC), (Petitioner) pursuant to (2) Completed Consent, Release and should be attached to the email as a 46 CFR 502.92 ‘‘. . . for an exemption History Form for Autopsy (CDC/NIOSH Microsoft Word or text-searchable PDF from service contract filing and essential (M)2.6). This form may be completed document. Comments containing terms publication requirements set forth with the assistance of the pathologist, confidential information should not be at 46 U.S.C 40502(b) and (d), attending physician, family physician, submitted by email. respectively . . .’’ Petitioner further or any other responsible person who can • Mail: Rachel E. Dickon, Secretary, petitions the Commission for the provide reliable information. Federal Maritime Commission, 800 initiation of a rulemaking proceeding to

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