83 FR 2799 - 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-OMB No. 0915-0126-Revision

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 13 (January 19, 2018)

Page Range		2799-2802
FR Document		2018-00825

In compliance with the Paperwork Reduction Act of 1995, 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.

Federal Register, Volume 83 Issue 13 (Friday, January 19, 2018)

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2799-2802]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00825]


-----------------------------------------------------------------------

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--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 
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 February 
20, 2018.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] 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 Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer, at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference, in compliance with Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995.
    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.

[[Page 2800]]

    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 HRSA's Bureau of Health Workforce.
    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 
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 eliminate redundant and unnecessary forms, improve 
user error recovery, and improve overall data integrity. There is no 
change to the average burden per response. The total estimated number 
of respondents has increased from 5 million in 2015 to over 6 million 
in 2017, primarily attributable to increases in use of the ``One-Time 
Query for an Individual'' and ``Continuous Query'' forms. The increase 
in total respondents resulted in an estimated increase of approximately 
47,000 total burden hours.
    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) 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                          Average burden
            Regulation citation                       Form name              Number of     Responses per       Total       per response    Total burden
                                                                            respondents     respondent       responses      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   60.6: Reporting errors, omissions,   Correction, Revision to               11,114               1          11,114             .25           2,779
 revisions or whether an action is on        Action, Correction of
 appeal.                                     Revision to Action, Void,
                                             Notice of Appeal (manual).
                                            Correction, Revision to               17,966               1          17,966           .0003               6
                                             Action, Correction of
                                             Revision to Action, Void,
                                             Notice of Appeal
                                             (automated).
Sec.   60.7: Reporting medical malpractice  Medical Malpractice Payment           11,993               1          11,993             .75           8,995
 payments.                                   (manual).
                                            Medical Malpractice Payment              242               1             242           .0003               1
                                             (automated).
Sec.   60.8: Reporting licensure actions    State Licensure (manual)....          19,160               1          19,160             .75          14,370
 taken by Boards of Medical Examiners.      State Licensure (automated).          25,980               1          25,980           .0003               8
&.........................................
Sec.   60.9: Reporting licensure and
 certification actions taken by States..
Sec.   60.10: Reporting Federal licensure   DEA/Federal Licensure.......             698               1             698             .75             524
 and certification actions.

[[Page 2801]]

 
Sec.   60.11: Reporting negative actions    Peer Review Organization....              10               1              10             .75               8
 or findings taken by peer review           Accreditation...............              10               1              10             .75               8
 organizations or private accreditation
 entities.
Sec.   60.12: Reporting adverse actions     Title IV Clinical Privileges             698               1             698             .75             524
 taken against clinical privileges.          Actions.                                 49               1              49  ..............              37
                                            Professional Society........
Sec.   60.13: Reporting Federal or State    Criminal Conviction (Guilty            1,140               1           1,140             .75             855
 criminal convictions related to the         Plea or Trial) (manual).                688               1             688           .0003               1
 delivery of a health care item or service. Criminal Conviction (Guilty               54               1              54             .75              41
                                             Plea or Trial) (automated).
                                            Deferred Conviction or Pre-
                                             Trial Diversion.
                                            Nolo Contendere (No Contest)              85               1              85             .75              64
                                             Plea.
                                            Injunction..................              10               1              10             .75               8
Sec.   60.14: Reporting civil judgments     Civil Judgment..............              10               1              10             .75               8
 related to the delivery of a health care
 item or service.
Sec.   60.15: Reporting exclusions from     Exclusion/Debarment (manual)           1,624               1           1,624             .75           1,218
 participation in Federal or State health   Exclusion/Debarment                    3,180               1           3,180           .0003               1
 care programs.                              (automated).
Sec.   60.16: Reporting other adjudicated   Government Administrative...           2,062               1           2,062             .75           1,547
 actions or decisions.                      Health Plan Action..........             335               1             335             .75             252
Sec.   60.18 Requesting Information from    One-Time Query for an              2,054,381               1       2,054,381             .08         164,351
 the NPDB.                                   Individual (manual).
                                            One-Time Query for an              2,813,341               1       2,813,341           .0003             844
                                             Individual (automated).
                                            One-Time Query for an                 39,695               1          39,695             .08           3,176
                                             Organization (manual).
                                            One-Time Query for an                 10,201               1          10,201           .0003               4
                                             Organization (automated).
                                            Self-Query on an Individual.         131,481               1         131,481             .42          55,223
                                            Self-Query on an                       1,545               1           1,545             .42             649
                                             Organization.
                                            Continuous Query (manual)...         643,860               1         643,860             .08          51,509
                                            Continuous Query (automated)         226,838               1         226,838           .0003              69
Sec.   60.21: How to dispute the accuracy   Subject Statement and                  3,547               1           3,547             .75           2,661
 of NPDB information.                        Dispute.                                 99               1              99               8             792
                                            Request for Dispute
                                             Resolution.
Administrative............................  Entity Registration                    1,073               1           1,073               1           1,073
                                             (Initial).
                                            Entity Registration (Renewal          14,060               1          14,060             .25           3,515
                                             & Update).
                                            Entity Profile..............           9,000               1           9,000             .25           2,250
                                            Licensing Board Data Request             146               1             146            10.5           1,533
                                            Licensing Board Attestation.             301               1             301               1             301
                                            Corrective Action Plan......              10               1              10             .08               1
                                            Reconciling Missing Actions.           7,981               1           7,981             0.8           6,385
                                            Agent Registration (Initial)              85               1              85               1              85
                                            Agent Registration (Renewal)             278               1             278             .08              23
                                            Electronic Transfer of Funds             654               1             654             .08              53
                                             (EFT) Authorization.
                                            Authorized Agent Designation             213               1             213             .25              54
                                            Account Discrepancy.........              10               1              10             .25               3
                                            New Administrator Request...           3,016               1           3,016             .08             242
                                            Query Credit Purchase.......             789               1             789             .08              64
                                            Educational Request.........              10               1              10             .08               1
                                            Account Balance Transfer....              10               1              10             .08               1

[[Page 2802]]

 
                                            Missing Report Form.........              29               1              29             .08               3
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................       6,059,761  ..............       6,059,761  ..............         326,120
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-00825 Filed 1-18-18; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2799

agencies to provide a 60-day notice in information collected on the least 90 days before use. We estimate
the Federal Register for each proposed respondents, including through the use that we will receive annually
collection of information before of automated collection techniques, approximately 2 notifications of intent
submitting the collection to OMB for when appropriate, and other forms of to use a voucher from 2 sponsors, and
approval. To comply with this information technology. that each notification will take
requirement, FDA is publishing this Under the draft guidance, sponsors of approximately 8 hours to prepare and
notice of the proposed collection of certain medical countermeasure product submit to FDA. The draft guidance also
information set forth in this document. applications submitted under section permits the transfer of a priority review
With respect to the collection of 505(b)(1) of the FD&C Act and section voucher from one sponsor to another,
information associated with this draft 351 of the PHS Act may request a and states that each transfer should be
guidance, FDA invites comment on the priority review voucher. Based on documented with a letter of transfer. We
following topics: (1) Whether the inquiries FDA has received on section estimate that we will receive
proposed information collected is 565A and related discussions with approximately 1 letter indicating the
necessary for the proper performance of sponsors, we estimate that we will transfer of a voucher from 1.5
FDA’s functions, including whether the receive annually approximately 2 application holders, and 1 letter
information will have practical utility; requests from 2 sponsors, and that each acknowledging the receipt of a
(2) the accuracy of FDA’s estimated request will take approximately 8 hours transferred voucher from 1.5 new
burden of the proposed information to prepare and submit to FDA. voucher owners acknowledging the
collected, including the validity of the The draft guidance also states that transfer, and that it will take
methodology and assumptions used; (3) sponsors should notify FDA of their approximately 8 hours to prepare and
ways to enhance the quality, utility, and intent to use a priority review voucher, submit each letter to FDA.
clarity of the information collected; and including the date on which the sponsor FDA estimates the burden of this
(4) ways to minimize the burden of intends to submit the application, at collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of re- Total Hours per Total
Reporting under Section 3086 of the Cures Act responses per
spondents responses response hours
respondent

Priority review voucher request ........................................... 2 1 2 8 16
Notifications of intent to use a voucher ............................... 2 1 2 8 16
Letters indicating the transfer of a voucher ......................... 1.5 1 1.5 8 12
Letters acknowledging the receipt of a transferred voucher 1.5 1 1.5 8 12

Total .............................................................................. ........................ ........................ ........................ ........................ 56
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access DEPARTMENT OF HEALTH AND the public during the review and
HUMAN SERVICES approval period.
Persons with access to the internet DATES: Comments on this ICR should be
may obtain the draft guidance at https:// Health Resources and Services received no later than February 20,
www.fda.gov/RegulatoryInformation/ Administration 2018.
Guidances/default.htm, https://
ADDRESSES: Submit your comments,
www.regulations.gov, or https:// Agency Information Collection
including the ICR Title, to the desk
www.fda.gov/medicalcountermeasures. Activities: Submission to OMB for
officer for HRSA, either by email to
Dated: January 11, 2018.
Review and Approval; Public Comment
OIRA_submission@omb.eop.gov or by
Request; Information Collection
Leslie Kux, fax to 202–395–5806.
Request Title: National Practitioner
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: To
Data Bank for Adverse Information on
[FR Doc. 2018–00900 Filed 1–17–18; 8:45 am] request a copy of the clearance requests
Physicians and Other Health Care
submitted to OMB for review, email Lisa
BILLING CODE 4164–01–P Practitioners—OMB No. 0915–0126—
Wright-Solomon, the HRSA Information
Revision
Collection Clearance Officer, at
AGENCY: Health Resources and Services paperwork@hrsa.gov or call (301) 443–
Administration (HRSA), Department of 1984.
Health and Human Services. SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
ACTION: Notice. information, please include the
information request collection title for
SUMMARY: In compliance with the reference, in compliance with Section
Paperwork Reduction Act of 1995, 3506(c)(2)(A) of the Paperwork
daltland on DSKBBV9HB2PROD with NOTICES

HRSA has submitted an Information Reduction Act of 1995.
Collection Request (ICR) to the Office of Information Collection Request Title:
Management and Budget (OMB) for National Practitioner Data Bank for
review and approval. Comments Adverse Information on Physicians and
submitted during the first public review Other Health Care Practitioners—45
of this ICR will be provided to OMB. CFR part 60 Regulations and Forms,
OMB will accept further comments from OMB No. 0915–0126—Revision.

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2802 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Average
Responses
Number of Total burden per Total burden
Regulation citation Form name per
respondents responses response hours
respondent (in hours)

Missing Report Form .......... 29 1 29 .08 3

Total ............................. ............................................. 6,059,761 ........................ 6,059,761 ........................ 326,120

HRSA specifically requests comments contact CDR Holly Berilla, Senior Public regarding the National Ryan White HIV/
on (1) the necessity and utility of the Health Analyst, Division of Policy and AIDS Program Conference, and
proposed information collection for the Data (DPD), HIV/AIDS Bureau (HAB), Committee business-related items.
proper performance of the agency’s HRSA, in one of three ways: (1) Mail a Agenda items are subject to change as
functions, (2) the accuracy of the request to CDR Holly Berilla, Senior priorities dictate.
estimated burden, (3) ways to enhance Public Health Analyst, HRSA/HAB/ Due to the nature and time limitations
the quality, utility, and clarity of the DPD, 5600 Fishers Lane, 09N156, of the meeting, members of the public
information to be collected, and (4) the Rockville, Maryland 20857; (2) call 301– will not have an opportunity to provide
use of automated collection techniques 443–9965; or (3) send an email to oral comments, although written
or other forms of information hberilla@hrsa.gov. comments may be submitted to CDR
technology to minimize the information SUPPLEMENTARY INFORMATION: The CDC/ Holly Berilla at the contact information
collection burden. HRSA Advisory Committee on HIV, listed above at least 10 days prior to the
Viral Hepatitis and STD Prevention and meeting. Individuals who need special
Amy McNulty,
Treatment was established under assistance should notify CDR Holly
Acting Director, Division of the Executive Berilla at the contact information listed
Secretariat. Section 222 of the Public Health Service
(PHS) Act, [42 U.S.C. Section 217a], as above at least 10 days prior to the
[FR Doc. 2018–00825 Filed 1–18–18; 8:45 am] meeting.
amended.
BILLING CODE 4165–15–P
The purpose of the CDC/HRSA Amy McNulty,
Advisory Committee on HIV, Viral Acting Director, Division of the Executive
DEPARTMENT OF HEALTH AND Hepatitis and STD Prevention and Secretariat.
HUMAN SERVICES Treatment is to advise the Secretary, [FR Doc. 2018–00824 Filed 1–18–18; 8:45 am]
HHS; the Director, CDC; and the
BILLING CODE 4165–15–P
Health Resources and Services Administrator, HRSA regarding
Administration objectives, strategies, policies, and
priorities for HIV, viral hepatitis, and DEPARTMENT OF HEALTH AND
CDC/HRSA Advisory Committee on other STDs; prevention and treatment HUMAN SERVICES
HIV, Viral Hepatitis and STD Prevention efforts including surveillance of HIV
and Treatment infection, AIDS, viral hepatitis, and Office of the Secretary
other STDs, and related behaviors;
AGENCY: Health Resources and Service epidemiologic, behavioral, health Statement of Organization, Functions,
Administration (HRSA), Department of services, and laboratory research on and Delegations of Authority
Health and Human Services (HHS). HIV, viral hepatitis, and other STDs;
ACTION: Notice of meeting. AGENCY: Office for Civil Rights, Office of
identification of policy issues related to the Secretary, HHS.
HIV/viral hepatitis/STD professional
SUMMARY: In accordance with the SUMMARY: This notice establishes the
eduction, patient healthcare delivery,
Federal Advisory Committee Act, this Conscience and Religious Freedom
and prevention services; Agency
notice announces that the Centers for Division in the Office for Civil Rights of
policies about prevention of HIV, viral
Disease Control and Prevention (CDC)/ the Department of Health and Human
hepatitis and other STDs; treatment,
Health Resources and Services Services.
healthcare delivery, and research and
Administration (HRSA) Advisory SUPPLEMENTARY INFORMATION: In
training; strategic issues influencing the
Committee on HIV, Viral Hepatitis and accordance with Executive Order 13798
ability of CDC and HRSA to fulfill their
STD Prevention and Treatment will Promoting Free Speech and Religious
missions of providing prevention and
hold a public meeting. Liberty (May 4, 2017), 82 FR 21675, and
treatment services; programmatic efforts
DATES: February 22, 2018, 2:00 p.m. to the Attorney General’s Guidance on
to prevent and treat HIV, viral hepatitis,
4:00 p.m. ET. and other STDs; and support to the Federal Law Protections for Religious
ADDRESSES: This teleconference meeting Agencies in their developoment of Liberty (October 6, 2017), Part A, Office
will accommodate up to 100 attendees. responses to emerging health needs of the Secretary, Statement of
Parties may access the teleconference by related to HIV, viral hepatitis, and other Organization, Functions, and
dialing 888–989–6421 and using STDs. Information about the Committee Delegations of Authority for the
participant code 9874492. Participants and the meeting agenda is available by Department of Health and Human
daltland on DSKBBV9HB2PROD with NOTICES

should call and connect 15-minutes contacting CDR Holly Berilla at the Services (HHS), as last amended at 81
prior to the start of the meeting. contact information above. FR 95622 (December 28, 2016), is being
FOR FURTHER INFORMATION CONTACT: During the meeting, the CDC/HRSA amended at Chapter AT, Office for Civil
Anyone requesting information Advisory Committee on HIV, Viral Rights (OCR) to reflect the restructuring
regarding the CDC/HRSA Advisory Hepatitis and STD Prevention and of OCR as follows:
Committee on HIV, Viral Hepatitis and Treatment will discuss workgroup I. Under Chapter AT, Office for Civil
STD Prevention and Treatment should reports and updates, information Rights (OCR), in the outline section

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Document Created: 2018-01-19 02:42:33
Document Modified: 2018-01-19 02:42:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on this ICR should be received no later than February 20, 2018.
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 [email protected] or call (301) 443-1984.
FR Citation		83 FR 2799

83 FR 2799 - 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-OMB No. 0915-0126-Revision

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 83, Issue 13 (January 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration