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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47530 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

by December 11, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 

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– 

2009–D–0461 for ‘‘Format and Content 

of a REMS Document.’’ 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or to 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 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Gita 

Toyserkani, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2422, Silver Spring, 

MD 20993, 301–796–1783, 

Gita.Toyserkani@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 announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Format and Content of a REMS 

Document.’’ The Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85) created section 

505–1 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

355–1), which authorizes FDA to 

require a REMS for certain drugs if FDA 

determines that a REMS is necessary to 

ensure that the benefits of the drug 

outweigh its risks (see section 505–1(a) 

of the FD&C Act). A REMS is a required 

risk management strategy that can 

include one or more elements to ensure 

that the benefits of a drug outweigh its 

risks (see section 505–1(e) of the FD&C 

Act). The REMS document includes 

concise information about the goals and 

requirements of the REMS as they relate 

to the elements described under the 

FD&C Act. 

In the Federal Register of October 1, 

2009 (74 FR 50801), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Format and Content 

of Proposed Risk Evaluation and 

Mitigation Strategies (REMS), REMS 

Assessments, and Proposed REMS 

Modifications.’’ The 2009 draft guidance 

described the recommended format and 

content for submission of proposed 

REMS. It also included information and 

recommendations on the content of 

assessments and proposed 

modifications of approved REMS. 

Over the last 6 years, under the REMS 

Integration Initiative, FDA’s 

implementation of the REMS authorities 

has evolved. The goals of the REMS 

Integration Initiative included 

developing guidance, improving 

standardization and assessment of 

REMS, and improving integration of 

REMS into the health care system. 

(More information on the REMS 

Integration Initiative can be found at: 

https://www.fda.gov/ForIndustry/

UserFees/PrescriptionDrugUserFee/

ucm350852.htm). 

Through the REMS Integration 

Initiative and other outreach, FDA has 

received feedback that specific activities 

and requirements for various 

stakeholders (e.g., prescribers, 


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Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47531 

pharmacists) are not clearly 

communicated in REMS documents. 

Stakeholders have reported spending 

excessive time trying to locate, 

understand, and comply with REMS 

requirements. 

To address the stakeholders’ feedback, 

FDA is revising the 2009 draft guidance 

on the format and content of a REMS to 

include information to assist applicants 

in drafting clear, informative, and 

standardized REMS documents. This 

revised draft guidance provides updated 

recommendations on the format and 

content of a REMS document and 

supersedes the 2009 draft guidance. 

Additional and more detailed 

information is provided in the template 

appended to this guidance. 

The new format of the REMS 

document, as described in this revised 

draft guidance and appended template, 

contains substantially the same content 

as described in the 2009 draft guidance; 

however, the information has been 

reorganized. In the old format, the 

REMS requirements were organized by 

the elements described in the statute. In 

the new format, requirements are 

organized to describe who is responsible 

for implementing the requirement, 

when the requirement is to be 

implemented, what the required action 

is, and with what REMS material(s). 

Additionally, the new format supports 

submission of REMS documents in 

Structured Product Labeling (SPL) 

format. 

Certain information included in the 

2009 draft guidance has been revised 

and included in other guidances 

subsequently published and therefore 

has been omitted from this revised draft 

guidance. For example: 

• Information on how FDA 

determines when a REMS is necessary 

to ensure that the benefits of a drug 

outweigh its risks can be found in the 

draft guidance for industry, ‘‘FDA’s 

Application of Statutory Factors in 

Determining When a REMS Is 

Necessary’’ (at: https://www.fda.gov/

ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/

ucm521504.pdf). 

• Information on REMS modifications 

can be found in the guidance for 

industry, ‘‘Risk Evaluation and 

Mitigation Strategies: Modifications and 

Revisions’’ (at: https://www.fda.gov/

downloads/drugs/guidancecompliance

regulatoryinformation/guidances/

ucm441226.pdf). 

This revised guidance and appended 

template are being reissued in draft form 

to enable the public to review and 

comment before finalization. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The revised draft guidance, 

when finalized, will represent the 

current thinking of FDA on the format 

and content of a REMS document. 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. 

II. The Paperwork Reduction Act of 

1995 

This revised draft guidance contains 

information collection provisions that 

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 collection of 

information in the guidance was 

approved under OMB control numbers 

0910–0001 and 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: October 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22050 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–2017–D–5868] 

Requests for Reconsideration at the 

Division Level Under the Generic Drug 

User Fee Act; 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 draft 

guidance for industry entitled ‘‘Requests 

for Reconsideration at the Division 

Level Under GDUFA.’’ This guidance 

provides recommendations for industry 

on the procedures for resolving 

scientific and/or regulatory issues or 

matters between FDA and applicants of 

abbreviated new drug applications 

(ANDAs) that wish to pursue a request 

for reconsideration within the review 

discipline at the division level or 

original signatory authority. This 

guidance also provides information for 

applicants to consider before pursuing a 

request for reconsideration, procedures 

for submitting a request for 

reconsideration, and the Agency’s 

process for responding to those requests. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 11, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 

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– 


asabaliauskas on DSKBBXCHB2PROD with NOTICES