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

Forms and Documents

Document Name	Status
Form 37 ReconcilingMissingActionForm Form and Instruction	Unchanged
Form 36 Corrective Action Plan (Entity) Form and Instruction	Unchanged
Form 35 LicensingBoardAttestation Form and Instruction	Unchanged
Form 34 ReportingDiscrepancyLetter Form and Instruction	Unchanged
Form 33 LicensingBoardDataRequest Form and Instruction	Unchanged
Form 32 HospitalRegistrationRenewal Form and Instruction	Unchanged
Form 31 HospitalRegistrationInitial Form and Instruction	Unchanged
Form 30 Account Discrepancy Form and Instruction	Unchanged
Form 29 Authorized Agent Designation Form and Instruction	Unchanged
Form 28 Electronic Transfer of Funds (ETF) Authorization Form and Instruction	Unchanged
Form 27 Agent Registration (Renewal & Update) Form and Instruction	Unchanged
Form 26 Agent Registration (Initial) Form and Instruction	Unchanged
Form 25 Entity Registration (Renewal & Update) Form and Instruction	Unchanged
Form 24 Entity Registration (Initial) Form and Instruction	Unchanged
Form 23 Request for Secretarial Review Form and Instruction	Unchanged
Form 22 Subject Statement and Dispute Form and Instruction	Unchanged
Form 21 Continuous Query Form and Instruction	Unchanged
Form 20 Self-Query on an Organization Form and Instruction	Unchanged
Form 19 Self-Query on an Individual Form and Instruction	Unchanged
Form 18 One Time Query for an Organization Form and Instruction	Unchanged
Form 17 One Time Query for an Individual Form and Instruction	Unchanged
Form 16 Health Plan Action Form and Instruction	Unchanged
Form 15 Government Administrative Form and Instruction	Unchanged
Form 14 Exclusion/Debarment Form and Instruction	Unchanged
Form 13 Civil Judgment Form and Instruction	Unchanged
Form 12 Injunction Form and Instruction	Unchanged
Form 11 Nolo Contendere (no contest) plea Form and Instruction	Unchanged
Form 10 Deferred Conviction or Pre-Trial Diversion Form and Instruction	Unchanged
Form 9 Criminal Conviction (Guilty Plea or Trial) Form and Instruction	Unchanged
Form 8 Professional Society Form and Instruction	Unchanged
Form 7 Title IV Clinical Privileges Actions Form and Instruction	Unchanged
Form 6 Accreditation Form and Instruction	Unchanged
Form 5 Peer Review Organization Form and Instruction	Unchanged
Form 4 DEA/Federal Licensure Form and Instruction	Unchanged
Form 3 State Licensure Form and Instruction	Unchanged
Form 2 Medical Malpractice Payment Form and Instruction	Unchanged
Form 1 Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal Form and Instruction	Unchanged
NPDB 0915-0126 Change Memo11-16.docx Justification for No Material/Nonsubstantive Change	2016-11-07
SSA 0126.docx Supporting Statement A	2015-03-30

IC Document Collections

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

ICR Details

OMB Control No: 0915-0126	ICR Reference No: 201611-0915-002
Status: Historical Active	Previous ICR Reference No: 201502-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No: 19186
Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Regulations and Forms
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/30/2016
	Date Received in OIRA: 11/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	03/31/2018	03/31/2018
Responses	5,012,335	0	5,012,335
Time Burden (Hours)	278,753	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 condcut 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
   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
   PL: Pub.L. 111 - 148 6403 Name of Law: Patient Protection and Affordable Care Act of 2010
  

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:
	79 FR 72690	12/08/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 7481	02/10/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 37

IC Title	Form No.	Form Name
Continuous Query	21	Continuous Query
Subject Statement and Dispute	22	Subject Statement and Dispute
Request for Secretarial Review	23	Request for Secretarial Review
Entity Registration (Initial)	24	Entity Registration (Initial)
Entity Registration (Renewal & Update)	25	Entity Registration (Renewal & Update)
Agent Registration (Initial)	26	Agent Registration (Initial)
Agent Registration (Renewal & Update)	27	Agent Registration (Renewal & Update)
Electronic Transfer of Funds (ETF) Authorization	28	Electronic Transfer of Funds (ETF) Authorization
Authorized Agent Designation	29	Authorized Agent Designation
Account Discrepancy	30	Account Discrepancy
HospitalRegistrationInitial	31	31 HospitalRegistrationInitial
One Time Query for an Individual	17	One Time Query for an Individual
HospitalRegistrationRenewal	32	HospitalRegistrationRenewal
LicensingBoardDataRequest	33	LicensingBoardDataRequest
ReportingDiscrepancyLetter	34	ReportingDiscrepancyLetter
LicensingBoardAttestation	35	LicensingBoardAttestation
Corrective Action Plan (Entity)	36	Corrective Action Plan (Entity)
ReconcilingMissingActionForm	37	ReconcilingMissingActionForm
Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal	1	Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal
Medical Malpractice Payment	2	Medical Malpractice Payment
State Licensure	3	State Licensure
DEA/Federal Licensure	4	DEA/Federal Licensure
Peer Review Organization	5	Peer Review Organization
Accreditation	6	Accreditation
Title IV Clinical Privileges Actions	7	Title IV Clinical Privileges Actions
Professional Society	8	Professional Society
Criminal Conviction (Guilty Plea or Trial)	9	Criminal Conviction (Guilty Plea or Trial)
Deferred Conviction or Pre-Trial Diversion	10	Deferred Conviction or Pre-Trial Diversion
Government Administrative	15	Government Administrative
Nolo Contendere (no contest) plea	11	Nolo Contendere (no contest) plea
Self-Query on an Organization	20	Self-Query on an Organization
Injunction	12	Injunction
Civil Judgment	13	Civil Judgment
Exclusion/Debarment	14	Exclusion/Debarment
Health Plan Action	16	Health Plan Action
One Time Query for an Organization	18	One Time Query for an Organization
Self-Query on an Individual	19	Self-Query on an Individual

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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	5,012,335	5,012,335	0	0	0	0
Annual Time Burden (Hours)	278,753	278,753	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The total burden hours increased by approximately 9,700 hours and the total number of respondents increased by approximately 3.3 million respondents since our last approved burden. In the previous submission, we only counted individual transactions that were manually processed through the IQRS system. We did not account for batch transactions that were processed through an automated system called QRXS because there is no direct user burden. This time, we decided to include the number of batch queries and reports due to the large volume of automated transactions. For this reason, the burden table provides a more complete picture of our respondent numbers because it reflects manual (IQRS) and automatic (QRXS) transactions.

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Annual Cost to Federal Government: $20,500,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 11/08/2016

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