5220 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 

1 ‘‘Other eligible entities’’ that participate in the 

NPDB are defined in the provisions of Title IV, 

Section 1921, Section 1128E, and implementing 

regulations. In addition, a few federal agencies also 

participate with the NPDB through federal 

memorandums of understanding. Eligible entities 

are responsible for complying with all reporting 

and/or querying requirements that apply; some 

entities may qualify as more than one type of 

eligible entity. Each eligible entity must certify its 

eligibility in order to report to the NPDB, query the 

NPDB, or both. Information from the NPDB is 

available only to those entities specified as eligible 

in the statutes and regulations. Not all entities have 

the same reporting requirements or level of query 

access. 

communication campaigns and (2) to 

assess the potential effectiveness of 

messages and materials in reaching and 

successfully communicating with their 

intended audiences. We will use these 

methods to test and refine our ideas and 

to help develop messages and other 

communications but will generally 

conduct further research before making 

important decisions, such as adopting 

new policies and allocating or 

redirecting significant resources to 

support these policies. We will use this 

mechanism to test messages about 

regulated drug products on a variety of 

subjects related to consumer, patient, or 

healthcare professional perceptions and 

about use of drug products and related 

materials, including but not limited to, 

direct-to-consumer prescription drug 

promotion, physician labeling of 

prescription drugs, medication guides, 

over-the-counter drug labeling, 

emerging risk communications, patient 

labeling, online sale of medical 

products, and consumer and 

professional education. 

Annually, we project about 45 

communication studies using the 

variety of test methods listed in this 

document. We are requesting an 

extension of these burden hours so as 

not to restrict our ability to gather 

information on public sentiment for 

FDA’s proposals in its regulatory and 

communications programs. 

In the Federal Register of June 17, 

2020 (85 FR 36591), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Interviews/Surveys ............................ 43,875 1 43,875 0.21925 (12 minutes) ....................... 9,620 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–01030 Filed 1–15–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; 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 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: 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. 

DATES: Comments on this ICR should be 

received no later than February 18, 

2021. 

ADDRESSES: 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. 

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 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY 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 1

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 5221 

submit 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 

response 

(in hours) 

Total burden 

hours 

(rounded up) 

§ 60.6: Reporting errors, omissions, revisions or whether an 

action is on appeal.

Correction, Revision-toAction, Void, Notice 

of Appeal (manual).

11,918 1 11,918 .25 2,980 

Correction, Revision-toAction, 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 

Accreditation ................ 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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5222 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued 

Regulation citation Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

(rounded up) 

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 

Injunction ...................... 10 1 10 .75 8 

§ 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 5223 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued 

Regulation citation Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

(rounded up) 

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 

Total .................................... ...................................... 7,101,274 ........................ 7,101,274 ........................ 347,294 

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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–00989 Filed 1–15–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–new] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before February 18, 2021. 

ADDRESSES: 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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–New–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

Title of the Collection: Incident Report 

Form. 

Type of Collection: New. 

OMB No. 0990–NEW—Office of the 

Assistant Secretary for Health, Office for 

Human Research Protections. 

Abstract: The Office of the Assistant 

Secretary for Health, Office for Human 

Research Protections is requesting 

approval for three years of a new 

information collection on the OHRP 

Incident Report Form. This form will 

facilitate prompt reporting of specific 

human subject protection incidents to 

OHRP by organizations and institutions 

conducting or reviewing human subjects 

research, and will provide a simplified 

standardized format for the reports. The 

information collected on the form will 

help OHRP to ensure the safety of 

human research subjects involved in 

non-exempt HHS-conducted or 

-supported research and to ensure that 

the research is conducted in accordance 

with the HHS Protection of Human 

Subjects regulations at 45 CFR part 46. 

Likely Respondents: Institutions or 

organizations conducting non-exempt 

HHS-conducted or -supported human 

subjects research. 


khammond on DSKJM1Z7X2PROD with NOTICES