Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42819 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–4515 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; 

Ocfentanil, Carfentanil, Pregabalin, 

Tramadol, Cannabidiol, Ketamine, and 

Eleven Other Substances; Extension of 

Comment Period.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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

Monday through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5150, Silver Spring, 

MD 20993–0002, 301–796–3156, email: 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 14, 2017, 

FDA published a notice with a 30-day 

comment period to request comments 

on abuse potential, actual abuse, 

medical usefulness, trafficking, and 

impact of scheduling changes on 

availability for medical use of 17 drug 

substances. 

The Agency has received requests for 

an extension of the comment period for 

the notice. Each request conveyed 

concern that the current 30-day 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the notice. 

FDA has considered the requests and 

is extending the comment period for the 

notice until September 20, 2017. The 

Agency believes this extension allows 

adequate time for interested persons to 

submit comments. 

Dated: September 7, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19261 Filed 9–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0734] 

Evaluation and Reporting of Age, 

Race, and Ethnicity Data in Medical 

Device Clinical Studies; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

guidance entitled ‘‘Evaluation and 

Reporting of Age, Race, and Ethnicity 

Data in Medical Device Clinical 

Studies.’’ The purpose of this document 

is to outline FDA’s recommendations 

and expectations for the evaluation and 

reporting of age, race, and ethnicity data 

in medical device clinical studies. The 

primary intent of these 

recommendations is to improve the 

quality, consistency, and transparency 

of data regarding the performance of 

medical devices within specific age, 

race, and ethnic groups. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 12, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 


pmangrum on DSK3GDR082PROD with NOTICES1
42820 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–0734 for ‘‘Evaluation and 

Reporting of Age, Race, and Ethnicity 

Data in Medical Device Clinical Studies; 

Guidance for Industry and Food and 

Drug Administration Staff; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Evaluation and 

Reporting of Age, Race, and Ethnicity 

Data in Medical Device Clinical 

Studies’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or the Office of 

Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Katheryn O’Callaghan, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5418, 

Silver Spring, MD 20993–0002, 301– 

796–6349; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 907 of the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144) (FDASIA) 

directed the Agency to publish and 

provide to Congress a report describing 

the extent to which clinical trial 

participation and safety and 

effectiveness data by demographic 

subgroups, including sex, age, race, and 

ethnicity, is included in applications 

submitted to FDA (Ref. 1). Section 907 

also directed FDA to publish and 

provide to Congress an action plan 

outlining recommendations to improve 

the completeness and quality of 

analyses of data on demographic 

subgroups in summaries of product 

safety and effectiveness data and in 

labeling; on the inclusion of such data, 

or the lack of availability of such data, 

in labeling, and to improve the public 

availability of such data to patients 

health care providers and researchers, 

and to indicate the applicability of these 

recommendations to the types of 

medical products addressed in section 

907. In the Action Plan, FDA committed 

to developing this guidance as part of 

the strategy to fulfill FDASIA 

requirements (Ref. 2). 

This guidance outlines FDA’s 

recommendations and expectations for 

patient enrollment, data analysis, and 

reporting of age, race, and ethnicity data 

in medical device clinical studies. 

Specific objectives of this guidance are 

to (1) encourage the collection and 

consideration of age, race, ethnicity, and 

associated covariates (e.g., body size, 

biomarkers, bone density) during the 

study design stage; (2) outline 

recommended analyses of study 

subgroup data with a framework for 

considering demographic data when 

interpreting overall study outcomes; and 

(3) specify FDA’s recommendations for 

reporting age, race, and ethnicityspecific information in summaries and 

labeling for approved or cleared medical 

devices. FDA believes these 

recommendations will help improve the 

quality, consistency, and transparency 

of data regarding the performance of 

medical devices within specific age, 

race, and ethnic groups as well as 

encourage appropriate enrollment of 

diverse populations including relevant 

age, race, and ethnic groups. Proper 

evaluation and reporting of these data 

can benefit patients, clinicians, 

researchers, regulators, and other 

stakeholders. 

FDA considered comments received 

on the draft guidance that appeared in 

the Federal Register of June 20, 2016 

(81 FR 39927). FDA revised the 

guidance as appropriate in response to 

the comments. This document extends 

the policy established in FDA’s 

guidance entitled ‘‘Evaluation of SexSpecific Data in Medical Device Clinical 

Studies’’ to additional demographic 

subgroups of age, race, and ethnicity 

(Ref. 3). 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Evaluation and 

Reporting of Age, Race, and Ethnicity 

data in Medical Device Clinical 


pmangrum on DSK3GDR082PROD with NOTICES1
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