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

agencies to provide a 60-day notice in 

the Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comment on the 

following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Under the draft guidance, sponsors of 

certain medical countermeasure product 

applications submitted under section 

505(b)(1) of the FD&C Act and section 

351 of the PHS Act may request a 

priority review voucher. Based on 

inquiries FDA has received on section 

565A and related discussions with 

sponsors, we estimate that we will 

receive annually approximately 2 

requests from 2 sponsors, and that each 

request will take approximately 8 hours 

to prepare and submit to FDA. 

The draft guidance also states that 

sponsors should notify FDA of their 

intent to use a priority review voucher, 

including the date on which the sponsor 

intends to submit the application, at 

least 90 days before use. We estimate 

that we will receive annually 

approximately 2 notifications of intent 

to use a voucher from 2 sponsors, and 

that each notification will take 

approximately 8 hours to prepare and 

submit to FDA. The draft guidance also 

permits the transfer of a priority review 

voucher from one sponsor to another, 

and states that each transfer should be 

documented with a letter of transfer. We 

estimate that we will receive 

approximately 1 letter indicating the 

transfer of a voucher from 1.5 

application holders, and 1 letter 

acknowledging the receipt of a 

transferred voucher from 1.5 new 

voucher owners acknowledging the 

transfer, and that it will take 

approximately 8 hours to prepare and 

submit each letter to FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting under Section 3086 of the Cures Act Number of respondents 

Number of 

responses per 

respondent 

Total 

responses 

Hours per 

response 

Total 

hours 

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 

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

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/RegulatoryInformation/ 

Guidances/default.htm, https://

www.regulations.gov, or https://

www.fda.gov/medicalcountermeasures. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00900 Filed 1–17–18; 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—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 

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 Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov 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. 


daltland on DSKBBV9HB2PROD with NOTICES
2800 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

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

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).11,114 1 11,114 .25 2,779 

Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (automated).17,966 1 17,966 .0003 6 

§ 60.7: Reporting medical 

malpractice payments.

Medical Malpractice Payment (manual).11,993 1 11,993 .75 8,995 

Medical Malpractice Payment (automated).242 1 242 .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) ...

State Licensure (automated).

19,160 

25,980 

1 

1 

19,160 

25,980 

.75 

.0003 

14,370 

8 

§ 60.10: Reporting Federal 

licensure and certification 

actions.

DEA/Federal Licensure ...... 698 1 698 .75 524 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2801 

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 

§ 60.11: Reporting negative 

actions or findings taken 

by peer review organizations or private accreditation entities.

Peer Review Organization

Accreditation .......................

10 

10 

1 

1 

10 

10 

.75 

.75 

8 

8 

§ 60.12: Reporting adverse 

actions taken against clinical privileges.

Title IV Clinical Privileges 

Actions.

Professional Society ...........

698 

49 

1 

1 

698 

49 

.75 

........................

524 

37 

§ 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).

Criminal Conviction (Guilty 

Plea or Trial) (automated).

Deferred Conviction or PreTrial Diversion.

1,140 

688 

54 

1 

1 

1 

1,140 

688 

54 

.75 

.0003 

.75 

855 

1 

41 

Nolo Contendere (No Contest) Plea.85 1 85 .75 64 

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

§ 60.14: Reporting civil judgments related to the delivery of a health care item 

or service.

Civil Judgment .................... 10 1 10 .75 8 

§ 60.15: Reporting exclusions from participation in 

Federal or State health 

care programs.

Exclusion/Debarment (manual).

Exclusion/Debarment (automated).

1,624 

3,180 

1 

1 

1,624 

3,180 

.75 

.0003 

1,218 

1 

§ 60.16: Reporting other adjudicated actions or decisions.Government Administrative 

Health Plan Action .............

2,062 

335 

1 

1 

2,062 

335 

.75 

.75 

1,547 

252 

§ 60.18 Requesting Information from the NPDB.One-Time Query for an Individual (manual).2,054,381 1 2,054,381 .08 164,351 

One-Time Query for an Individual (automated).2,813,341 1 2,813,341 .0003 844 

One-Time Query for an Organization (manual).39,695 1 39,695 .08 3,176 

One-Time Query for an Organization (automated).10,201 1 10,201 .0003 4 

Self-Query on an Individual 131,481 1 131,481 .42 55,223 

Self-Query on an Organization.1,545 1 1,545 .42 649 

Continuous Query (manual) 643,860 1 643,860 .08 51,509 

Continuous Query (automated).226,838 1 226,838 .0003 69 

§ 60.21: How to dispute the 

accuracy of NPDB information.

Subject Statement and Dispute.

Request for Dispute Resolution.

3,547 

99 

1 

1 

3,547 

99 

.75 

8 

2,661 

792 

Administrative ...................... Entity Registration (Initial) .. 1,073 1 1,073 1 1,073 

Entity Registration (Renewal & Update).14,060 1 14,060 .25 3,515 

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 (EFT) Authorization.

654 1 654 .08 53 

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 


daltland on DSKBBV9HB2PROD with NOTICES
2802 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

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 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

CDC/HRSA Advisory Committee on 

HIV, Viral Hepatitis and STD Prevention 

and Treatment 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Centers for 

Disease Control and Prevention (CDC)/ 

Health Resources and Services 

Administration (HRSA) Advisory 

Committee on HIV, Viral Hepatitis and 

STD Prevention and Treatment will 

hold a public meeting. 

DATES: February 22, 2018, 2:00 p.m. to 

4:00 p.m. ET. 

ADDRESSES: This teleconference meeting 

will accommodate up to 100 attendees. 

Parties may access the teleconference by 

dialing 888–989–6421 and using 

participant code 9874492. Participants 

should call and connect 15-minutes 

prior to the start of the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requesting information 

regarding the CDC/HRSA Advisory 

Committee on HIV, Viral Hepatitis and 

STD Prevention and Treatment should 

contact CDR Holly Berilla, Senior Public 

Health Analyst, Division of Policy and 

Data (DPD), HIV/AIDS Bureau (HAB), 

HRSA, in one of three ways: (1) Mail a 

request to CDR Holly Berilla, Senior 

Public Health Analyst, HRSA/HAB/ 

DPD, 5600 Fishers Lane, 09N156, 

Rockville, Maryland 20857; (2) call 301– 

443–9965; or (3) send an email to 

hberilla@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The CDC/ 

HRSA Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment was established under 

Section 222 of the Public Health Service 

(PHS) Act, [42 U.S.C. Section 217a], as 

amended. 

The purpose of the CDC/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment is to advise the Secretary, 

HHS; the Director, CDC; and the 

Administrator, HRSA regarding 

objectives, strategies, policies, and 

priorities for HIV, viral hepatitis, and 

other STDs; prevention and treatment 

efforts including surveillance of HIV 

infection, AIDS, viral hepatitis, and 

other STDs, and related behaviors; 

epidemiologic, behavioral, health 

services, and laboratory research on 

HIV, viral hepatitis, and other STDs; 

identification of policy issues related to 

HIV/viral hepatitis/STD professional 

eduction, patient healthcare delivery, 

and prevention services; Agency 

policies about prevention of HIV, viral 

hepatitis and other STDs; treatment, 

healthcare delivery, and research and 

training; strategic issues influencing the 

ability of CDC and HRSA to fulfill their 

missions of providing prevention and 

treatment services; programmatic efforts 

to prevent and treat HIV, viral hepatitis, 

and other STDs; and support to the 

Agencies in their developoment of 

responses to emerging health needs 

related to HIV, viral hepatitis, and other 

STDs. Information about the Committee 

and the meeting agenda is available by 

contacting CDR Holly Berilla at the 

contact information above. 

During the meeting, the CDC/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment will discuss workgroup 

reports and updates, information 

regarding the National Ryan White HIV/ 

AIDS Program Conference, and 

Committee business-related items. 

Agenda items are subject to change as 

priorities dictate. 

Due to the nature and time limitations 

of the meeting, members of the public 

will not have an opportunity to provide 

oral comments, although written 

comments may be submitted to CDR 

Holly Berilla at the contact information 

listed above at least 10 days prior to the 

meeting. Individuals who need special 

assistance should notify CDR Holly 

Berilla at the contact information listed 

above at least 10 days prior to the 

meeting. 

Amy McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–00824 Filed 1–18–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Office for Civil Rights, Office of 

the Secretary, HHS. 

SUMMARY: This notice establishes the 

Conscience and Religious Freedom 

Division in the Office for Civil Rights of 

the Department of Health and Human 

Services. 

SUPPLEMENTARY INFORMATION: In 

accordance with Executive Order 13798 

Promoting Free Speech and Religious 

Liberty (May 4, 2017), 82 FR 21675, and 

the Attorney General’s Guidance on 

Federal Law Protections for Religious 

Liberty (October 6, 2017), Part A, Office 

of the Secretary, Statement of 

Organization, Functions, and 

Delegations of Authority for the 

Department of Health and Human 

Services (HHS), as last amended at 81 

FR 95622 (December 28, 2016), is being 

amended at Chapter AT, Office for Civil 

Rights (OCR) to reflect the restructuring 

of OCR as follows: 

I. Under Chapter AT, Office for Civil 

Rights (OCR), in the outline section 


daltland on DSKBBV9HB2PROD with NOTICES