National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: 45 CFR Part 60 Regulations and Forms

Forms and Documents

Document Name	Status
Form 40 Missing Report Form Form and Instruction	New
Form 39 Account Balance Transfer Form and Instruction	New
Form 38 Educational Request Form and Instruction	New
Form 37 Query Credit Purchase Form and Instruction	Modified
Form 36 New Administrator Request Form and Instruction	Modified
Form 35 Account Discrepancy Form and Instruction	Modified
Form 34 Authorized Agent Designation Form and Instruction	Modified
Form 33 Electronic Transfer of Funds (EFT) Authorization Form and Instruction	Modified
Form 32 Agent Registration (Renewal) Form and Instruction	Modified
Form 31 Agent Registration (Initial) Form and Instruction	Modified
Form 30 Reconciling Missing Actions Form and Instruction	Modified
Form 29 Corrective Action Plan Form and Instruction	Modified
Form 28 Licensing Board Attestation Form and Instruction	Modified
Form 27 Licensing Board Data Request Form and Instruction	Modified
Form 26 Entity Profile Form and Instruction	Modified
Form 25 Entity Registration (Renewal & Update) Form and Instruction	Modified
Form 24 Entity Registration (Initial) Form and Instruction	Modified
Form 23 Request for Dispute Resolution Form and Instruction	Modified
Form 22 Subject Statement and Dispute Form and Instruction	Modified
Form 21 Continuous Query Form and Instruction	Modified
Form 20 Self-Query on an Organization Form and Instruction	Modified
Form 19 Self-Query on an Individual Form and Instruction	Modified
Form 18 One Time Query for an Organization Form and Instruction	Modified
Form 17 One Time Query for an Individual Form and Instruction	Modified
Form 16 Health Plan Action Form and Instruction	Modified
Form 15 Government Administrative Form and Instruction	Modified
Form 14 Exclusion/Debarment Form and Instruction	Modified
Form 13 Civil Judgment Form and Instruction	Modified
Form 12 Injunction Form and Instruction	Modified
Form 11 Nolo Contendere (no contest) plea Form and Instruction	Modified
Form 10 Deferred Conviction or Pre-Trial Diversion Form and Instruction	Modified
Form 9 Criminal Conviction (Guilty Plea or Trial) Form and Instruction	Modified
Form 8 Professional Society Form and Instruction	Modified
Form 7 Title IV Clinical Privileges Actions Form and Instruction	Modified
Form 6 Accreditation Form and Instruction	Modified
Form 5 Peer Review Organization Form and Instruction	Modified
Form 4 DEA/Federal Licensure Form and Instruction	Modified
Form 3 State Licensure Form and Instruction	Modified
Form 2 Medical Malpractice Payment Form and Instruction	Modified
Form 1 Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal Form and Instruction	Modified
FINALLicensing Board Attestation.pdf Supplementary Document	2018-01-31
Academy Comments re NPDB 11132017.pdf Supplementary Document	2018-01-31
FINALNPDB Summary Statement_response to OPAE comments.docx Supporting Statement A	2018-01-31
NPDB 0915-0126 Change Memo11-16.docx Justification for No Material/Nonsubstantive Change	2016-11-07

IC Document Collections

IC ID	Document Title	Status
229942	Missing Report Form Form and Instruction	New
229941	Account Balance Transfer Form and Instruction	New
229939	Educational Request Form and Instruction	New
214939	Query Credit Purchase Form and Instruction	Modified
214938	New Administrator Request Form and Instruction	Modified
214937	Account Discrepancy Form and Instruction	Modified
214936	Authorized Agent Designation Form and Instruction	Modified
214935	Electronic Transfer of Funds (EFT) Authorization Form and Instruction	Modified
214934	Agent Registration (Renewal) Form and Instruction	Modified
214933	Agent Registration (Initial) Form and Instruction	Modified
206509	Reconciling Missing Actions Form and Instruction	Modified
206508	Corrective Action Plan Form and Instruction	Modified
206507	Licensing Board Attestation Form and Instruction	Modified
206506	Licensing Board Data Request Form and Instruction	Modified
206505	Entity Profile Form and Instruction	Modified
206504	Entity Registration (Renewal & Update) Form and Instruction	Modified
206503	Entity Registration (Initial) Form and Instruction	Modified
206502	Request for Dispute Resolution Form and Instruction	Modified
206501	Subject Statement and Dispute Form and Instruction	Modified
206500	Continuous Query Form and Instruction	Modified
206499	Self-Query on an Organization Form and Instruction	Modified
206498	Self-Query on an Individual Form and Instruction	Modified
206497	One Time Query for an Organization Form and Instruction	Modified
206496	One Time Query for an Individual Form and Instruction	Modified
206495	Health Plan Action Form and Instruction	Modified
206494	Government Administrative Form and Instruction	Modified
206493	Exclusion/Debarment Form and Instruction	Modified
206492	Civil Judgment Form and Instruction	Modified
206491	Injunction Form and Instruction	Modified
206490	Nolo Contendere (no contest) plea Form and Instruction	Modified
206489	Deferred Conviction or Pre-Trial Diversion Form and Instruction	Modified
206488	Criminal Conviction (Guilty Plea or Trial) Form and Instruction	Modified
206487	Professional Society Form and Instruction	Modified
206486	Title IV Clinical Privileges Actions Form and Instruction	Modified
206485	Accreditation Form and Instruction	Modified
206484	Peer Review Organization Form and Instruction	Modified
206483	DEA/Federal Licensure Form and Instruction	Modified
206482	State Licensure Form and Instruction	Modified
206481	Medical Malpractice Payment Form and Instruction	Modified
206480	Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal Form and Instruction	Modified

ICR Details

OMB Control No: 0915-0126	ICR Reference No: 201801-0915-001
Status: Active	Previous ICR Reference No: 201611-0915-002
Agency/Subagency: HHS/HSA	Agency Tracking No: 19186
Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: 45 CFR Part 60 Regulations and Forms
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/05/2018
	Date Received in OIRA: 02/02/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved	03/31/2018
Responses	6,059,761	0	5,012,335
Time Burden (Hours)	326,120	0	278,753
Cost Burden (Dollars)	0	0	0

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Abstract: The National Practitioner Data Bank (NPDB) is required to receive and release under 45 CFR Part 60 certain adverse data regarding physicians, dentists, and other licensed health care practitioners. Data collected on adverse actions and information relating to the professional competence and conduct of physicians and other health care practitioners will be shared with hospitals, licensing boards, professional societies, and selected health providers. These data will be used to maintain and improve health care and will be obtained from insurers, licensure boards, hospitals, and other providers.

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Authorizing Statute(s): PL: Pub.L. 104 - 101 221 Name of Law: Establishment of the Health Care Fraud and Abuse Data Collection Program
   PL: Pub.L. 99 - 660 402 Name of Law: Health Care Quality Improvement Act of 1986
   US Code: 42 USC 11101 Name of Law: Health Care Quality Improvement Act of 1986
   PL: Pub.L. 111 - 148 6403 Name of Law: Patient Protection and Affordable Care Act of 2010
   US Code: 42 USC 1301 Name of Law: Health Care and Abuse Data Collection Program
   US Code: 42 USC 136r-2 Name of Law: 2. Section 1921 of the Social Security Act
   US Code: 42 USC 1320a-7e Name of Law: 3. Section 1128E of the Social Security Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 42821	09/12/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 2799	01/19/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 40

IC Title	Form No.	Form Name
Government Administrative	15	Government Administrative.pdf
Nolo Contendere (no contest) plea	11	Nolo Contendere (no contest) plea.pdf
Injunction	12	Injunction.pdf
Civil Judgment	13	Civil Judgment.pdf
Exclusion/Debarment	14	Exclusion_Debarment.pdf
Health Plan Action	16	Health Plan Action.pdf
One Time Query for an Organization	18	One Time Query for an Organization.pdf
Self-Query on an Individual	19	Self-Query on an Individual.pdf
Continuous Query	21	Continuous Query.pdf
Subject Statement and Dispute	22	Subject Statement and Dispute.pdf
Request for Dispute Resolution	23	Request for Dispute Resolution.pdf
Entity Registration (Initial)	24	Entity Registration (Initial).pdf
Self-Query on an Organization	20	Self-Query on an Organization.pdf
Entity Registration (Renewal & Update)	25	Entity Registration (Renewal & Update).pdf
Entity Profile	26	Entity Profile.pdf
Licensing Board Data Request	27	LicensingBoardDataRequest.pdf
Licensing Board Attestation	28	FINALLicensing Board Attestation.pdf
Corrective Action Plan	29	Corrective Action Plan (Entity).pdf
Reconciling Missing Actions	30	ReconcilingMissionActionForm.pdf
Agent Registration (Initial)	31	Agent Registration (Initial).pdf
One Time Query for an Individual	17	One Time Query for an Individual.pdf
Agent Registration (Renewal)	32	Agent Registration (Renewal & Update).pdf
Electronic Transfer of Funds (EFT) Authorization	33	Electronic Transfer of Funds (EFT) Authorization.pdf
Authorized Agent Designation	34	Authorized Agent Designation.pdf
Account Discrepancy	35	Account Discrepancy.pdf
New Administrator Request	36	NewAdmin.pdf
Query Credit Purchase	37	Query_Credits.pdf
Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal	1	Correction, Revision to Action, Void, Notice of Appeal.pdf
Medical Malpractice Payment	2	Medical Malpractice Payment Report.pdf
State Licensure	3	State Licensure.pdf
DEA/Federal Licensure	4	DEA_Federal Licensure.pdf
Peer Review Organization	5	Peer Review Organization.pdf
Accreditation	6	Accreditation.pdf
Title IV Clinical Privileges Actions	7	Title IV Clinical Privileges Actions.pdf
Professional Society	8	Professional Society.pdf
Educational Request	38	Education Request.pdf
Account Balance Transfer	39	Account Balance Transfer.pdf
Missing Report Form	40	Missing Report from Query.pdf
Criminal Conviction (Guilty Plea or Trial)	9	Criminal Conviction (Guilty Plea or Trial).pdf
Deferred Conviction or Pre-Trial Diversion	10	Deferred Conviction or Pre-Trial Diversion .pdf

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	6,059,761	5,012,335	0	1,047,426	0	0
Annual Time Burden (Hours)	326,120	278,753	0	47,367	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The NPDB has system of record notice number 09-15-0054 (https://www.hrsa.gov/about/privacy-act/09-15-0054.html). Burden Increase due to increase in amount of foms, this increase in Burden. Burden decrease due to the increased use of information technology.

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Annual Cost to Federal Government: $19,500,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/02/2018

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