Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42821 

Studies.’’ It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Evaluation and Reporting of Age, 

Race, and Ethnicity Data in Medical 

Device Clinical Studies’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500626 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). These collections of information 

in 21 CFR part 812 have been approved 

under OMB control number 0910–0078; 

the collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; the 

collections of information in 21 CFR 

part 822 have been approved under 

OMB control number 0910–0449; and 

the collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. 

V. References 

The following references are on 

display in the Dockets Management 

Staff office (see ADDRESSES) and are 

available for viewing by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. FDA Report: Collection, Analysis, and 

Availability of Demographic Subgroup 

Data for FDA-Approved Medical 

Products, issued August 2013, required 

under FDASIA section 907, available at 

http://www.fda.gov/downloads/ 

RegulatoryInformation/Legislation/ 

SignificantAmendmentstotheFDCAct/ 

FDASIA/UCM365544.pdf. 

2. FDA’s Action Plan to Enhance the 

Collection and Availability of 

Demographic Subgroup Data (August, 

2014), available at https://www.fda.gov/ 

downloads/RegulatoryInformation/ 

Legislation/ 

SignificantAmendmentstotheFDCAct/ 

FDASIA/UCM410474.pdf. 

3. FDA’s guidance entitled ‘‘Evaluation of 

Sex-Specific Data in Medical Device 

Clinical Studies’’ (August 22, 2014), 

available at https://www.fda.gov/ 

downloads/MedicalDevices/Device

RegulationandGuidance/Guidance

Documents/UCM283707.pdf. 

Dated: September 7, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19259 Filed 9–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 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 (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR must be 

received no later than November 13, 

2017. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail to the 

HRSA Information Collection Clearance 

Officer, 14N39, 5600 Fishers Lane, 

Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (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. 

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 


pmangrum on DSK3GDR082PROD with NOTICES1
42822 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 

electronically through the NPDB Web 

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

reporting and querying is performed 

through the secure portal of this Web 

site. 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 

has 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 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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average burden 

per response 

(in hours) 

Total burden 

hours 

(rounded up) 

Accreditation ...................................................................... 10 1 10 .75 8 

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

Criminal Conviction (Guilty Plea or Trial) (manual) ........... 1,140 1 1,140 .75 855 

Criminal Conviction (Guilty Plea or Trial) (automated) ...... 688 1 688 .0003 1 

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

Deferred Conviction or Pre-Trial Diversion ........................ 54 1 54 .75 41 

Exclusion/Debarment (manual) .......................................... 1,624 1 1,624 .75 1,218 

Exclusion/Debarment (automated) .................................... 3,180 1 3,180 .0003 1 

Government Administrative ................................................ 2,062 1 2,062 .75 1,547 

Health Plan Action ............................................................. 335 1 335 .75 252 

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

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

Medical Malpractice Payment (automated) ....................... 242 1 242 .0003 1 

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

Peer Review Organization ................................................. 10 1 10 .75 8 

Professional Society .......................................................... 49 1 49 .75 37 

State Licensure (manual) ................................................... 19,160 1 19,160 .75 14,370 

State Licensure (automated) ............................................. 25,980 1 25,980 .0003 8 

Title IV Clinical Privileges Actions ..................................... 698 1 698 .75 524 

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 

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 

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

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

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 

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

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

Agent Registration (Initial) ................................................. 85 1 85 1 85 

Agent Registration (Renewal & Update) ........................... 278 1 278 .08 23 

Entity Profile ....................................................................... 9,000 1 9,000 .25 2,250 

Licensing Board Attestation ............................................... 301 1 301 1 301 

Licensing Board Data Request .......................................... 146 1 146 10.5 1,533 

Reconciling Missing Actions .............................................. 7,981 1 7,981 0.8 6,385 

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


pmangrum on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42823 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average burden 

per response 

(in hours) 

Total burden 

hours 

(rounded up) 

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

Subject Statement and Dispute ......................................... 3,547 1 3,547 .75 2,661 

Request for Dispute Resolution ......................................... 99 1 99 8 792 

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 

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. 2017–19252 Filed 9–11–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development Initial 

Review Group; Developmental Biology 

Subcommittee. 

Date: October 2, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda Downtown, 

7335 Wisconsin Ave., Bethesda, MD 20814. 

Contact Person: Cathy J. Wedeen, Ph.D., 

Scientific Review Officer, Division of 

Scientific Review, OD, Eunice Kennedy 

Shriver National Institute of Child Health 

and Human Development, NIH, DHHS, 6710 

B Rockledge Drive, Bethesda, Maryland 

20892, 301–435–6878, wedeenc@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 6, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19232 Filed 9–11–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: Government owned 

intellectual property covering imaging 

agents with improved renal clearance 

available for licensing and 

commercialization. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

patent applications listed below may be 

obtained by emailing the indicated 

licensing contact at the National Heart, 

Lung, and Blood, Office of Technology 

Transfer and Development Office of 

Technology Transfer, 31 Center Drive, 

Room 4A29, MSC2479, Bethesda, MD 

20892–2479; telephone: 301–402–5579. 

A signed Confidential Disclosure 

Agreement may be required to receive 

copies of the patent applications. 

SUPPLEMENTARY INFORMATION: The 

inventions listed below are owned by an 

agency of the U.S. Government and are 

available for licensing in the U.S. in 

accordance with 35 U.S.C. 209 and 37 

CFR part 404 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. A description of the 

technology available for licensing 

follows. 

Evans Blue Dye Derivatives for Serum 

Albumin Labeling 

Description of Technology: The 

invention is an imaging agent and 

method of its use for imaging blood 

pools and the lymphatic system. The 

imaging agent binds with high affinity 

to serum albumin, the most abundant 

serum protein, and can be tagged with 

several isotopes making it suitable for 

magnetic resonance imaging or positron 

emission tomographic imaging. To date, 

only very few blood-pool tracers have 

been introduced for positron emission 

tomography. The existing ones have 

short half-lives (20.4 min for 11C and 

2.05 min for 15O) and thus can only be 

used in centers with an in-house 

cyclotron. Compared with these 

radiometals, 18F has the advantages of 

being a pure position emitter with ideal 

half-life. It is the dominant radioisotope 

used for PET imaging for both clinical 

applications and preclinical 

investigations. Evans blue dye has been 

an important tool in many physiological 

and clinical investigations because of its 


pmangrum on DSK3GDR082PROD with NOTICES1