Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 7481 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 24, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Stephanie L. 

Begansky at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 5, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–02670 Filed 2–9–15; 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 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has 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. 

DATES: Comments on this ICR should be 

received no later than March 12, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 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 a 

revision of OMB approval of 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 the Bureau of Health Workforce, 

Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

The intent of the NPDB is to improve 

the quality of health care by 

encouraging hospitals, state licensing 

boards, professional societies, and other 

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 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. 

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 Web 

site at http://www.npdb.hrsa.gov/. All 

reporting and querying is performed 

through this secure Web site. 

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 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 

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. 


rljohnson on DSK3VPTVN1PROD with NOTICES
7482 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Regulation citation Form name Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average burden 

per response 

(in hours) 

Total burden 

hours 

§ 60.6: Reporting errors, 

omissions, revisions, or 

whether an action is on 

appeal.

Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (manual).20,482 1 20,482 .25 5,121 

Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (automated).17,185 1 17,185 .0003 5 

§ 60.7: Reporting medical 

malpractice payments.

Medical Malpractice Payment (manual).12,613 1 12,613 .75 9,460 

Medical Malpractice Payment (automated).250 1 250 .0003 .1 

§ 60.8: Reporting licensure 

actions taken by Boards 

of Medical Examiners & 

§ 60.9: Reporting licensure and certification actions taken by States.

State Licensure (manual) 16,770 1 16,770 .75 12,578 

State Licensure (automated).17,422 1 17,422 .0003 5 

§ 60.10: Reporting Federal 

licensure and certification actions.

DEA/Federal Licensure .... 114 1 114 .75 86 

§ 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 ..................... 12 1 12 .75 9 

§ 60.12: Reporting adverse 

actions taken against 

clinical privileges.

Title IV Clinical Privileges 

Actions.

671 1 671 .75 503 

Professional Society ......... 50 1 50 .75 38 

§ 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).

1,308 1 1,308 .75 981 

Criminal Conviction (Guilty 

Plea or Trial) (automated).

937 1 937 .0003 .3 

Deferred Conviction or 

Pre-Trial Diversion.

50 1 50 .75 38 

Nolo Contendere (No Contest) Plea.80 1 80 .75 60 

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

§ 60.14: Reporting civil 

judgments related to the 

delivery of a health care 

item or service.

Civil Judgment .................. 14 1 14 .75 11 

§ 60.15: Reporting exclusions from participation 

in Federal or State 

health care programs.

Exclusion/Debarment 

(manual).

1,185 1 1,185 .75 889 

Exclusion/Debarment 

(automated).

5,094 1 5,094 .0003 2 

Health Plan Action ............ 524 1 524 .75 393 

§ 60.18 Requesting Information from the NPDB.One Time Query for an Individual (manual).1,980,825 1 1,980,825 .08 158,466 

One Time Query for an Individual (automated).2,163,208 1 2,163,208 .0003 649 

One Time Query for an 

Organization (manual).

39,920 1 39,920 .08 3,194 

One Time Query for an 

Organization (automated).

2,266 1 2,266 .0003 1 

Self-Query on an Individual.77,318 1 77,318 .42 30,201 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 7483 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued 

Regulation citation Form name Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average burden 

per response 

(in hours) 

Total burden 

hours 

Self-Query on an Organization.427 1 427 1 427 

Continuous Query (manual).508,203 1 508,203 .08 40,656 

Continuous Query (automated).121,718 1 121,718 .0003 37 

§ 60.21: How to dispute 

the accuracy of NPDB 

information.

Subject Statement and 

Dispute.

3,501 1 3,501 .75 2,626 

Request for Dispute Resolution.94 1 94 8 752 

Administrative ................... Non-Hospital Entity Registration (Initial).524 1 524 1 524 

Non-Hospital Entity Registration (Renewal).6,383 1 6,383 .25 1,596 

Hospital Registration (Initial).37 1 37 1 37 

Hospital Registration (Renewal).3,198 1 3,198 .25 800 

Licensing Board Data Request.140 1 140 10 .5 1,470 

Reporting Entity Discrepancy Letter.389 1 389 4 1556 

Licensing Board Attestation.354 1 354 1 354 

Corrective Action Plan ...... 10 1 10 .08 1 

Reconciling Missing Actions.2,176 1 2,176 0 .8 174 

Agent Registration (Initial) 30 1 30 1 30 

Agent Registration (Renewal).194 1 194 .08 16 

Electronic Transfer of 

Funds (EFT) Authorization.

566 1 566 .08 45 

Authorized Agent Designation.788 1 788 .25 197 

Account Discrepancy ........ 41 1 41 .25 10 

Total ........................... ........................................... 5,009,324 ........................ 5,009,324 .......................... 275,689 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–02658 Filed 2–9–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Food and Drug 

Administration (FDA) and the National 

Cancer Institute (NCI) Health 

Communication Survey (FDA–NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on December 4, 

2014 (Vol. 79, No. 233, pages 72003–4) 

and allowed 60 days for public 

comment. A total of five public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Cancer Institute (NCI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Bradford W. Hesse, Ph.D., 

Health Communication and Informatics 

Research Branch, 9609 Medical Center 

Drive, MSC 9761, Room 3E610, 

Rockville, MD 20850 or call non-toll 

free number 240–276–6721 or Email 

your request, including your address, to 

hesseb@mail.nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

Proposed Collection: Health 

Information National Trends Survey 

(HINTS) 0925–0538, Reinstatement with 

Change, National Cancer Institute (NCI), 

National Institutes of Health (NIH). 


rljohnson on DSK3VPTVN1PROD with NOTICES