41416 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Total number 

of responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Public Agencies .............................................. Retrieving and refile records .......................... 56 1,223 30/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–18512 Filed 8–30–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4565] 

Electronic Study Data Submission; 

Data Standards; Support for Version 

Update of the Medical Dictionary for 

Regulatory Activities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing support for the most current 

version of Medical Dictionary for 

Regulatory Activities (MedDRA), end of 

support for earlier versions of MedDRA, 

and an update to the FDA Data 

Standards Catalog (Catalog) for study 

data provided in new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), and investigational 

new drug applications (INDs) to the 

Center for Biologics Evaluation and 

Research (CBER) and the Center for 

Drug Evaluation and Research (CDER). 

DATES: Submit either electronic or 

written comments on this document at 

any time. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submission 

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 

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–4565 for ‘‘Electronic Study 

Data Submission; Data Standards; 

Support for Version Update of the 

Medical Dictionary for Regulatory 

Activities.’’ 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. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, 

cderdatastandards@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7268, 

Silver Spring, MD 20993–0002, 240– 

402–7911, stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

December 17, 2014, FDA published final 

guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Standardized Study Data’’ 

(eStudy Data) posted on FDA’s Study 

Data Standards Resources Web page at 

https://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The eStudy Data guidance 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41417 

implements the electronic submission 

requirements of section 745A(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379k–1(a)) for study data 

contained in NDAs, ANDAs, BLAs, and 

INDs to CBER or CDER by specifying the 

format for electronic submissions. This 

provision required that the electronic 

format for submission of applications be 

specified in guidance and effective no 

sooner than 24 months after issuance of 

the final guidance. The initial timetable 

for the implementation of electronic 

submission requirements for study data 

is December 17, 2016 (24 months after 

issuance of final guidance for NDAs, 

BLAs, ANDAs, and 36 months for INDs). 

The eStudy Data guidance states that a 

Federal Register notice will specify the 

transition date for all version updates 

(with the month and day for the 

transition date corresponding to March 

15). 

FDA currently supports and requires 

MedDRA for the coding of adverse 

events in studies submitted to FDA’s 

CBER or CDER in NDAs, ANDAs, BLAs, 

and INDs in the electronic common 

technical document (eCTD) format. 

However, the requirement to code 

adverse events using MedDRA in the 

most current version (available at 

https://www.meddra.org) does not apply 

to postmarketing studies that are 

submitted in eCTD sections 5.3.5.4 and 

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

Drugs/DevelopmentApprovalProcess/ 

FormsSubmissionRequirements/ 

ElectronicSubmissions/ 

UCM163175.pdf). 

Generally, the studies included in a 

submission are conducted over many 

years and may have used different 

MedDRA versions to code adverse 

events. The expectation is that sponsors 

or applicants will use the most current 

version of MedDRA at the time of study 

start. However, there is no requirement 

to recode earlier studies. The transition 

date for support and requirement to use 

the most current version of MedDRA is 

March 15, 2018. Although the use of the 

most current version is supported as of 

this Federal Register notice and 

sponsors or applicants are encouraged 

to begin using it, the use of the most 

current version will only be required in 

submissions for studies that start after 

March 15, 2019. The Catalog will list 

March 15, 2019, as the ‘‘date 

requirement begins.’’ The Study Data 

Technical Conformance Guide provides 

additional information and 

recommendations on the coding of 

adverse events (https://www.fda.gov/ 

downloads/forindustry/datastandards/ 

studydatastandards/ucm384744.pdf). 

FDA will no longer support version 8 

or earlier of MedDRA. FDA support for 

earlier versions of MedDRA will end for 

studies that start after March 15, 2019. 

The FDA Data Standards Catalog will be 

updated to list March 15, 2019, as the 

‘‘date support ends.’’ Studies that start 

after March 15, 2019, will be required to 

use the most current version of 

MedDRA. 

Dated: August 28, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18471 Filed 8–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–4764] 

Policy Clarification and Premarket 

Notification (510(k)) Submissions for 

Ultrasonic Diathermy Devices; Draft 

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 draft 

guidance entitled ‘‘Policy Clarification 

and Premarket Notification [510(k)] 

Submissions for Ultrasonic Diathermy 

Devices—Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ When final, this draft guidance 

will clarify FDA’s policy related to 

compliance with applicable 

performance standards and 

conformance to International 

Electrotechnical Commission (IEC) 

consensus standards for ultrasonic 

diathermy devices. This draft guidance 

will also provide recommendations for 

information to provide in 510(k) 

submissions for ultrasonic diathermy 

devices. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by October 30, 

2017. 

ADDRESSES: You may submit comments 

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 

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–D–4764 for ‘‘Policy Clarification 

and Premarket Notification [510(k)] 

Submissions for Ultrasonic Diathermy 

Devices—Draft Guidance for Industry 

and Food and Drug Administration.’’ 

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 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 


sradovich on DSK3GMQ082PROD with NOTICES