47528 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Mary Jones, 

Reports Clearance Officer. 

[FR Doc. 2017–21960 Filed 10–11–17; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5568] 

Prescription Drug User Fee Act of 

2017; Electronic Submissions and Data 

Standards; Public Meeting; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the following public 

meeting entitled ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ The 

topics to be discussed will include the 

current status of electronic submissions 

and data standards initiatives to 

improve the predictability and 

consistency of the electronic 

submissions process in support of the 

human drug review program. FDA is 

seeking input from a variety of 

stakeholders—industry, academia, 

patient advocates, professional societies 

and other interested parties—as it 

fulfills its commitment under the 

Prescription Drug User Fee Act of 2017 

(PDUFA) to hold annual public 

meetings to seek stakeholder input 

related to enhancing the transparency 

and accountability of the electronic 

submission and data standards 

activities. FDA will use the information 

from the public meeting to inform the 

development of the FDA Information 

Technology (FDA IT) Strategic Plan and 

electronic submissions gateway target 

timeframes. 

DATES: The public meeting will be held 

March 21, 2018, from 9 a.m. to 4 p.m. 

Submit either electronic or written 

comments regarding this public meeting 

prior to the meeting through April 18, 

2018. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503, Section A), Silver Spring, MD 

20993–0002. Entrance for the public 

meeting participants (non-FDA 

employees) is through Building 1, where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/WorkingatFDA

/BuildingsandFacilities/WhiteOak

CampusInformation/default.htm. 

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 April 18, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

April 18, 2018. 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 

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–5568 for ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ 

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 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/2015-233

89.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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47529 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002, 301–796–5333, email: 

cderdatastandards@fda.hhs.gov; 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 

FDA is committed to achieve the longterm goal of improving the 

predictability and consistency of the 

electronic submission process, and 

enhancing transparency and 

accountability of FDA information 

technology related activities. FDA 

agreed in the PDUFA VI commitment 

letter to hold annual public meetings to 

seek stakeholder input related to 

electronic submissions and data 

standards to inform the FDA IT Strategic 

Plan and published targets. The 

commitment letter outlines FDA’s 

performance goals and procedures 

under the PDUFA program for the years 

2018–2022. The commitment letter can 

be found at https://www.fda.gov/for

industry/userfees/prescriptiondrug

userfee/ucm446608.htm. 

II. Topics for Discussion at the Public 

Meeting 

FDA strives to achieve a fully 

automated standards-based IT 

environment that enhances the 

regulatory review processes for human 

drugs and biologics. The purpose of the 

March 21, 2018, public meeting is to 

obtain input from industry and other 

interested stakeholders on enhancing 

the transparency and accountability of 

the electronic submission and data 

standards activities. To help fulfill its 

commitment, FDA is particularly 

interested in receiving input on the 

following topics: 

• Electronic Submissions 

Æ Electronic submission process, 

including key electronic submission 

milestones and associated sponsor 

notifications from the completion of the 

upload of the submission to the 

Electronic Submissions Gateway (ESG) 

through the time the submission is 

made available to the review team. 

Æ Electronic submission system past 

performance, emerging industry needs, 

and technology initiatives. 

Æ Published and future targets for the 

ESG and related electronic submission 

systems. 

Æ Implementation of electronic 

Common Technical Document (eCTD) 

v4.0. 

• Data Standards Initiatives 

Æ International Organization for 

Standards (ISO) Identification of 

Medicinal Products (IDMP): ISO IDMP 

standards implementation will support 

a variety of regulatory activities related 

to development, registration, and life 

cycle management of medicinal 

products, as well as pharmacovigilance 

and risk management. There are five 

standards that describe the substance 

(ISO 11238), dosage form and routes of 

administration (ISO 11239), units of 

measure (ISO 11240), medicinal product 

identifier (ISO 11615), and 

pharmaceutical product identifier (ISO 

11616). 

Æ Individual Case Safety Reports 

(ICSRs): ICSRs provide a consistent 

approach to the creation and review of 

drug and biologics safety information 

and pharmacovigilance activities. 

FDA will consider all comments made 

at this workshop or received through the 

docket (see ADDRESSES). 

III. Participating in the Public Meeting 

Registration: To register to attend 

‘‘Prescription Drug User Fee Act VI; 

Electronic Submissions and Data 

Standards; Public Meeting; Request for 

Comments’’ please send an email to 

cderdatastandards@fda.hhs.gov by 

February 19, 2018. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by February 19, 2018, midnight 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact 

Chenoa Conley, 301–796–0035, email 

Chenoa.Conley@fda.hhs.gov at least 7 

days before the meeting. 

Request for Oral Presentations: During 

online registration you may indicate if 

you wish to present during the public 

comment session and which topic(s) 

you wish to address. FDA will do its 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations. Following the close of 

registration, FDA will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

March 6, 2018. All requests to make oral 

presentations must be received by the 

close of registration on February 19, 

2018, midnight Eastern Time. If selected 

for presentation, any presentation 

materials must be emailed to 

cderdatastandards@fda.hhs.gov no later 

than March 14, 2018. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public meeting. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

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

forindustry/userfees/prescriptiondrug

userfee/ucm446608.htm. 

Dated: October 5, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21981 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0461] 

Format and Content of a Risk 

Evaluation and Mitigation Strategy 

Document; Revised Draft Guidance for 

Industry; 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 a revised 

draft guidance for industry entitled 

‘‘Format and Content of a REMS 

Document.’’ A Risk Evaluation and 

Mitigation Strategy (REMS) document, 

which is part of a REMS that is required 

by FDA, establishes the goals and 

requirements of the REMS. This revised 

draft guidance describes a new 

recommended format for a REMS 

document. The new format was 

developed based on extensive 

stakeholder feedback. This guidance 

revises and supersedes the draft 

guidance entitled ‘‘Format and Content 

of Proposed Risk Evaluation and 

Mitigation Strategies (REMS), REMS 

Assessments, and Proposed REMS 

Modifications,’’ that was published by 

FDA on October 1, 2009. 

DATES: Submit either electronic or 

written comments on the draft guidance 


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