41968 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18693 Filed 9–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–E–4282] 

Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling; Draft Guidance for Industry; 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 

‘‘Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling.’’ This draft guidance is being 

issued in accordance with the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA), which 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to require 

that certain submissions under the 

FD&C Act and the Public Health Service 

Act (PHS Act) be submitted in 

electronic format, beginning no earlier 

than 24 months after issuance of final 

guidance on electronic format for 

submissions. The draft guidance 

describes how FDA plans to implement 

the requirements for the electronic 

submission of Risk Evaluation and 

Mitigation Strategies (REMS) documents 

in certain submissions under new drug 

applications, abbreviated new drug 

applications, and biologics license 

applications, beginning no earlier than 

24 months after issuance of the final 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 5, 2018 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draft guidance before it begins work on 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– 

2017–E–4282] for ’’ Providing 

Regulatory Submissions in Electronic 

Format—Content of the Risk Evaluation 

and Mitigation Strategies Document 

Using Structured Product Labeling; 

Draft Guidance for Industry; 

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 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. 

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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Adam Kroetsch, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, Rm. 

1168, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3842; or Aaron Sherman, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, Bldg. 51, Rm. 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41969 

6366, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 240– 

402–0493; 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 draft guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Content of the Risk 

Evaluation and Mitigation Strategies 

Document Using Structured Product 

Labeling; Draft Guidance for Industry.’’ 

FDASIA (Pub. L. 112–144), amended 

the FD&C Act to add section 745A (21 

U.S.C. 379k–1), entitled ‘‘Electronic 

Format for Submissions.’’ Section 

745A(a)(1) of the FD&C Act requires that 

submissions under section 505(b), (i), or 

(j) of the FD&C Act (21 U.S.C. 355(b), (i), 

or (j)) and submissions under section 

351(a) or (k) of the PHS Act (42 U.S.C. 

262(a) or (k)) be submitted to FDA in 

electronic format no earlier than 24 

months after FDA issues final guidance 

on electronic format for submissions. In 

accordance with section 745A(a)(1) of 

the FD&C Act, FDA is issuing this draft 

guidance, announcing its determination 

that submission types identified in the 

guidance must be submitted 

electronically in the format specified in 

the guidance beginning 24 months after 

the issuance of the final guidance. 

This draft guidance (and the technical 

specification documents it references) 

describes how certain REMS documents 

will be required to be submitted in 

electronic format using Structured 

Product Labeling (SPL) as outlined in 

the FDA ‘‘Structured Product Labeling 

(SPL) Implementation Guide with 

Validation Procedures’’ (available at 

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

ForIndustry/DataStandards/ 

StructuredProductLabeling/ 

UCM321876.pdf). (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.) SPL is a Health Level 

7 data standard used by FDA since 

2005. For more information on how 

FDA interprets section 745A(a) of the 

FD&C Act, see the guidance for industry 

‘‘Providing Regulatory Submissions in 

Electronic Format—Submissions Under 

Section745A(a) of the Federal Food, 

Drug, and Cosmetic Act’’ (available at 

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

GuidanceComplianceRegulatory

Information/Guidances/

UCM384686.pdf). 

Development of this guidance was 

facilitated by completion of the 

‘‘Pharmacy Systems Under REMS 

Project: Standardizing REMS 

Information for Inclusion Into Pharmacy 

Systems Using Structured Product 

Labeling (SPL).’’ More information on 

this project—one of four predefined 

priority projects that are a part of the 

larger REMS Integration Initiative—can 

be found in the report ‘‘Standardizing 

and Evaluating Risk Evaluation and 

Mitigation Strategies (REMS)’’ (available 

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

ForIndustry/UserFees/Prescription

DrugUserFee/UCM415751.pdf). 

II. 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 314 have been approved 

under OMB control number 0910–0001. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: August 23, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18506 Filed 9–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4866] 

Pediatric Post-Marketing 

Pharmacovigilance and Drug 

Utilization Reviews; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice, establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing a 

public docket to collect comments 

related to the pediatric post-marketing 

pharmacovigilance and drug utilization 

reviews of products posted between 

March 11, 2017, and September 12, 

2017, on FDA’s Web site but not 

presented at the September 12, 2017, 

Pediatric Advisory Committee (PAC) 

meeting. These reviews are intended to 

be available for review and comment by 

members of the PAC, interested parties 

(such as academic researchers, regulated 

industries, consortia, and patient 

groups), and the general public. 

DATES: Submit either electronic or 

written comments by October 20, 2017. 

ADDRESSES: You may submit your 

comments as follows. Please note that 

late, untimely filed comments will not 

be considered. Electronic comments 

must be submitted on or before October 

20, 2017. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

October 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 

third party may not wish to be posted, 

such as medical information, you 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 submission 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. 

mstockstill on DSK30JT082PROD with NOTICES