Health Resources and Services Administration (HRSA), Department of Health and Human Services.
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Comments on this ICR should be received no later than February 18, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
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FOR FURTHER INFORMATION CONTACT:
To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at firstname.lastname@example.org or call (301) 443-1984.
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Start Supplemental Information
Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR Part 60 Regulations and Forms, OMB No. 0915-0126—Revision.
Abstract: This is a request for OMB's approval for a revision to the information collection contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Administrative forms are also included to aid in monitoring compliance with federal reporting and querying requirements. Responsibility for NPDB implementation and operation resides in HRSA's Bureau of Health Workforce.
The intent of the NPDB is to improve the quality of health care by encouraging entities such as hospitals, State licensing boards, professional societies, and other eligible entities 
providing health care services to identify and discipline those who engage in unprofessional behavior, and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from state to state without disclosure or discovery of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, federal agencies, and state agencies. Users of the NPDB include reporters (entities that are required to Start Printed Page 5221submit reports) and queriers (entities and individuals that are authorized to request for information).
The reporting forms, request for information forms (query forms), and administrative forms (used to monitor compliance) are accessed, completed, and submitted to the NPDB electronically through the NPDB website at https://www.npdb.hrsa.gov/. All reporting and querying is performed through the secure portal of this website.
This revision proposes changes to improve overall data integrity. In addition, this revision contains the five NPDB forms that were originally approved in: “NPDB Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Certain Other Health Care Entities, OMB No. 0906-0028” which will be discontinued upon approval of this ICR.
A 60-day notice published in the Federal Register on October 16, 2020, vol. 85, No. 201; pp. 65834-65837. There were two public comments that addressed ways to enhance the quality, utility, and clarity of the information to be collected by the NPDB.
Need and Proposed Use of the Information: The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information is collected from, and disseminated to, eligible entities (entities that are entitled to query and/or report to the NPDB as authorized in Title 45 CFR part 60 of the Code of Federal Regulations) on the following: (1) Medical malpractice payments, (2) licensure actions taken by Boards of Medical Examiners, (3) State licensure and certification actions, (4) Federal licensure and certification actions, (5) negative actions or findings taken by peer review organizations or private accreditation entities, (6) adverse actions taken against clinical privileges, (7) federal or state criminal convictions related to the delivery of a health care item or service, (8) civil judgments related to the delivery of a health care item or service, (9) exclusions from participation in Federal or State health care programs, and (10) other adjudicated actions or decisions. It is intended that NPDB information should be considered with other relevant information in evaluating credentials of health care practitioners, providers, and suppliers.
Likely Respondents: Eligible entities or individuals that are entitled to query and/or report to the NPDB as authorized in regulations found at 45 CFR part 60.
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
Total Estimated Annualized Burden—Hours
|Regulation citation||Form name||Number of respondents||Number of responses per
respondent||Total responses||Average burden per
(in hours)||Total burden hours
|§ 60.6: Reporting errors, omissions, revisions or whether an action is on appeal||Correction, Revision-to-Action, Void, Notice of Appeal (manual)||11,918||1||11,918||.25||2,980|
| ||Correction, Revision-to-Action, Void, Notice of Appeal (automated)||18,301||1||18,301||.0003||5|
|§ 60.7: Reporting medical malpractice payments||Medical Malpractice Payment (manual)||11,481||1||11,481||.75||8,611|
| ||Medical Malpractice Payment (automated)||296||1||296||.0003||1|
|§ 60.8: Reporting licensure actions taken by Boards of Medical Examiners||State Licensure or Certification (manual)||19,749||1||19,749||.75||14,812|
|§ 60.9: Reporting licensure and certification actions taken by States||State Licensure or Certification (automated)||17,189||1||17,189||.0003||5|
|§ 60.10: Reporting Federal licensure and certification actions||DEA/Federal Licensure||600||1||600||.75||450|
|§ 60.11: Reporting negative actions or findings taken by peer review organizations or private accreditation entities||Peer Review Organization||10||1||10||.75||8|
|§ 60.12: Reporting adverse actions taken against clinical privileges||Title IV Clinical Privileges Actions||978||1||978||.75||734|
| ||Professional Society||41||1||41||.75||31|
|§ 60.13: Reporting Federal or State criminal convictions related to the delivery of a health care item or service||Criminal Conviction (Guilty Plea or Trial) (manual)||1,174||1||1,174||.75||881|
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| ||Criminal Conviction (Guilty Plea or Trial) (automated)||683||1||683||.0003||1|
| ||Deferred Conviction or Pre-Trial Diversion||70||1||70||.75||53|
| ||Nolo Contendere (no contest plea)||127||1||127||.75||95|
|§ 60.14: Reporting civil judgments related to the delivery of a health care item or service||Civil Judgment||9||1||9||.75||7|
|§ 60.15: Reporting exclusions from participation in Federal or State health care programs||Exclusion or Debarment (manual)||1,707||1||1,707||.75||1,280|
| ||Exclusion or Debarment (automated)||2,506||1||2,506||.0003||1|
|§ 60.16: Reporting other adjudicated actions or decisions||Government Administrative (manual)||1,750||1||1,750||.75||1,313|
| ||Government Administrative (automated)||39||1||39||.0003||1|
| ||Health Plan Action||488||1||488||.75||366|
|§ 60.17 Information which hospitals must request from the National Practitioner Data Bank||One-Time Query for an Individual (manual)||1,958,176||1||1,958,176||.08||156,654|
| ||One-Time Query for an Individual (automated)||3,349,778||1||3,349,778||.0003||1,005|
| ||One-Time Query for an Organization (manual)||50,681||1||50,681||.08||4,054|
| ||One-Time Query for an Organization (automated)||25,610||1||25,610||.0003||8|
|§ 60.18 Requesting Information from the NPDB||Self-Query on an Individual||168,557||1||168,557||.42||70,794|
| ||Self-Query on an Organization||1,059||1||1,059||.42||445|
| ||Continuous Query (manual)||806,971||1||806,971||.08||64,558|
| ||Continuous Query (automated)||619,001||1||619,001||.0003||186|
|§ 60.21: How to dispute the accuracy of NPDB information||Subject Statement and Dispute||3,264||1||3,264||.75||2,448|
| ||Request for Dispute Resolution||74||1||74||8||592|
|Administrative||Entity Registration (Initial)||3,484||1||3,484||1||3,484|
| ||Entity Registration (Renewal & Update)||13,245||1||13,245||.25||3,311|
| ||State Licensing Board Data Request||60||1||60||10.5||630|
| ||State Licensing Board Attestation||325||1||325||1||325|
| ||Authorized Agent Attestation||350||1||350||1||350|
| ||Health Center Attestation||722||1||722||1||722|
| ||Hospital Attestation||3,416||1||3,416||1||3,416|
| ||Medical Malpractice Payer, Peer Review Organization, or Private Accreditation Organization Attestation||274||1||274||1||274|
| ||Other Eligible Entity Attestation||1,884||1||1,884||1||1,884|
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| ||Corrective Action Plan (Entity)||10||1||10||.08||1|
| ||Reconciling Missing Actions||1,491||1||1,491||.08||119|
| ||Agent Registration (Initial)||44||1||44||1||44|
| ||Agent Registration (Renewal & Update)||304||1||304||.08||24|
| ||Electronic Funds Transfer (EFT) Authorization||644||1||644||.08||52|
| ||Authorized Agent Designation||183||1||183||.25||46|
| ||Account Discrepancy||85||1||85||.25||21|
| ||New Administrator Request||600||1||600||.08||48|
| ||Purchase Query Credits||1,786||1||1786||.08||143|
| ||Education Request||40||1||40||.08||3|
| ||Account Balance Transfer||10||1||10||.08||1|
| ||Missing Report From Query Form||10||1||10||.08||1|
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-00989 Filed 1-15-21; 8:45 am]
BILLING CODE 4165-15-P