42818 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 

of QSIT, and informed by the PMA CtQ 

information developed jointly by FDA 

and the PMA applicant. 

7. Following completion of the 

inspection, participating FDA Offices 

and applicants provide the information/ 

data needed to assess the voluntary 

PMA CtQ pilot program’s impact on 

resource utilization and quality focus, 

utilizing the evaluation forms provided 

in Appendices A and B (Ref. 11). 

During this voluntary PMA CtQ pilot 

program, CDRH staff intends to be 

available to answer questions or 

concerns that may arise. The voluntary 

PMA CtQ pilot program participants 

will be asked to comment on and 

discuss their experiences with the PMA 

CtQ pilot submission process. 

Comments and discussions may assist 

FDA in determining whether the goals 

of this voluntary PMA CtQ pilot 

program goal are clearly communicated 

and attainable. 

II. Duration of the Premarket Approval 

Application Critical to Quality Pilot 

Program 

FDA intends to accept requests for 

participation in the voluntary PMA CtQ 

pilot program from September 29, 2017, 

to December 31, 2018, or until such time 

as when a total of nine PMAs have been 

enrolled. 

III. Paperwork Reduction Act of 1995 

This notice 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). 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 820 have 

been approved under OMB control 

number 0910–0073; and the collections 

of information in ‘‘Requests for 

Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ have been 

approved under OMB control number 

0910–0756. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

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

through Friday, and are available 

electronically at https://

www.regulations.gov. (FDA has verified 

the Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Implantable Devices that Contain Batteries 

Critical to Quality Inspection Pilot. 

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

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

MedicalDeviceQualityandCompliance/ 

UCM469128.pdf. 

2. FDA’s Case for Quality, available at http:// 

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

MedicalDeviceQualityandCompliance/ 

ucm378185.htm. 

3. FDA’s Guide to Inspections of Quality 

Systems, Quality System Inspection 

Technique, available at http://

www.fda.gov/ICECI/Inspections/ 

InspectionGuides/ucm074883.htm. 

4. FDA Guidance for Industry and FDA Staff 

‘‘Requests for Feedback on Medical 

Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

dated February 18, 2014. Available at 

https://www.fda.gov/ucm/groups/fdagovpublic/@fdagov-meddev-gen/documents/ 

document/ucm311176.pdf. 

5. FDA’s Guidance for Industry and FDA 

Staff: Acceptance and Filing Reviews for 

Premarket Approval Applications 

(PMAs) at https://www.fda.gov/ucm/ 

groups/fdagov-public/@fdagov-meddevgen/documents/document/ 

ucm313368.pdf. 

6. FDA’s Guidance for Industry and FDA 

Staff: Quality System Information for 

Certain Premarket Application Reviews, 

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

medicaldevices/ 

deviceregulationandguidance/ 

guidancedocuments/ucm070897.htm. 

7. FDA’s Official Action Indicated, available 

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

AboutFDA/Transparency/ 

PublicDisclosure/ 

GlossaryofAcronymsandAbbreviations/ 

UCM212061.pdf. 

8. 2017 FDA Investigations Operations 

Manual (IOM) Chapter 5 at https://

www.fda.gov/ucm/groups/fdagov-public/ 

@fdagov-afda-ice/documents/document/ 

ucm123522.pdf. 

9. FDA Compliance Program 7383.001 at 

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

MedicalDevices/ 

DeviceRegulationandGuidance/ 

MedicalDeviceQualityandCompliance/ 

UCM295570.pdf. 

10. FDA Compliance Program 7382.845 at 

https://www.fda.gov/downloads/ 

MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM244277.pdf. 

11. Appendices A and B. 

Dated: September 5, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19258 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–2017–N–4515] 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice that appeared in the Federal 

Register of August 14, 2017. In the 

notice, FDA requested comments 

concerning abuse potential, actual 

abuse, medical usefulness, trafficking, 

and impact of scheduling changes on 

availability for medical use of 17 drug 

substances. The Agency is taking this 

action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the notice published August 

14, 2017 (82 FR 37866). Submit either 

electronic or written comments by 

September 20, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 20, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 20, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 


pmangrum on DSK3GDR082PROD with NOTICES1
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