Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46083 

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. All electronic 

and written submissions submitted to 

the Docket (see ADDRESSES) on or before 

October 17, 2017, will be provided to 

the committees. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 6, 2017. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 10, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require special accommodations 

due to a disability, please contact 

Kalyani Bhatt at least 7 days in advance 

of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21170 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0502] 

Range of Risk Evaluation and 

Mitigation Strategies Platform 

Standards Initiative: Needs 

Assessment; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

seeking public input on the design of 

the REMS Platform Standards Initiative, 

as well as methods and best practices 

for its construction. To facilitate this, 

FDA is making available the ‘‘REMS 

Platform Standards Initiative: Needs 

Assessment’’ (needs assessment), which 

summarizes a range of risk evaluation 

and mitigation strategies (REMS) 

activities that could be standardized and 

integrated into the health care system 

through the use of electronic data 

standards. 

DATES: The comment period will be 

open indefinitely. 

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– 

2013–N–0502 for ‘‘REMS Platform 

Standards Initiative: Needs Assessment; 

Request for Comments.’’ 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 


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46084 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

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: 

Adam Kroetsch, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1168, 

Silver Spring, MD 20993–0002, 301– 

796–3842, REMS_Standardization@

fda.hhs.gov; or Aaron Sherman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6366, 

Silver Spring, MD 20993–0002, 240– 

402–0493, REMS_Standardization@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 5, 2015, FDA launched 

the REMS Platform Standards Initiative 

(previously referred to as the ‘‘Common 

REMS Platform Initiative’’), with the 

goal of developing and leveraging 

electronic health data standards, 

referred to as ‘‘REMS platform 

standards,’’ to further standardize 

certain activities associated with REMS 

with elements to assure safe use 

(ETASU), and integrate them into 

existing health care systems. 

(Information about the initiative can be 

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

downloads/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

UCM507451.pdf). Since then, FDA has 

been working to determine the most 

effective methods for carrying out this 

initiative, including how best to engage 

the public on the project and advance 

the development of REMS platform 

standards. To achieve these ends, FDA 

is publishing the ‘‘REMS Platform 

Standards Initiative: Needs 

Assessment,’’ which seeks to provide 

REMS stakeholders, standards 

developers, and health information 

technology (IT) systems developers with 

specific, detailed information on the 

areas in which standards development 

is needed and the information that the 

data standards would need to 

communicate to effectively carry out 

REMS activities. FDA seeks comment on 

the document as a whole, as well as on 

the specific questions that follow. 

(1) Does this needs assessment cover 

all of the REMS activities for which 

standards development would be 

beneficial? 

(2) Which REMS activities should be 

given highest priority for standards 

development? 

(3) What standards already exist that 

could be used to address the needs and 

facilitate the REMS activities described 

in the needs assessment? 

(4) Where (if at all) do new standards 

need to be developed? 

(5) What other opportunities exist to 

leverage health IT to facilitate the 

completion of REMS activities? 

FDA hopes that the needs assessment 

will help identify areas where standards 

development projects to support REMS 

are already underway, as well as areas 

that are ripe for standards development, 

enabling interested stakeholders to 

engage further in this project. 

What is the REMS Platform Standards 

Initiative? 

The goal of the REMS Platform 

Standards Initiative is to leverage 

electronic health data standards to 

standardize certain activities in REMS 

with ETASU and integrate them into 

health IT systems. Under the initiative, 

FDA seeks to work with third-party 

standards development organizations to 

encourage the development of electronic 

data standards that may be used to 

facilitate communication between 

REMS and their participants. Once the 

standards are developed, FDA would 

maintain a list of REMS platform 

standards, encourage their use in REMS 

with ETASU, and encourage the 

development of tools that use these 

standards to integrate REMS into health 

care providers’ existing systems. 

Why is FDA launching the REMS 

Platform Standards Initiative? 

This initiative was launched for a 

number of reasons. Stakeholders have 

requested a centralized method to enroll 

in and interact with REMS with ETASU 

and more fundamental standardization 

of REMS architecture. There is also a 

need for a comprehensive set of 

standards for REMS to help minimize 

REMS burden on the health care 

delivery system and integrate REMS 

into health IT systems. 

The goal of the REMS Platform 

Standards Initiative is to give all 

stakeholders—including sponsors, data 

vendors, clinical decision support 

system developers (such as those for 

hospitals, private practices, etc.)—a 

‘‘fixed target’’ for standardization and 

integration. If successful, this will 

clarify how sponsors can develop 

standardized REMS that are more easily 

integrated into the health care system 

and what health care providers must do 

to comply with those REMS. Ultimately, 

REMS that are more effectively 

standardized and integrated into the 

health care system should facilitate 

enhanced compliance and safer use of 

drugs that have REMS. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the needs assessment at 

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

ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

UCM565594.pdf. 

Dated: September 19, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21218 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel NICHD Education 

Grants. 

Date: November 6, 2017. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6710 B 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Joanna Kubler-Kielb, 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6100 Executive Boulevard, 

Room 5B01, Bethesda, MD 20892–7510, 301– 

435–6916, kielbj@mail.nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, SPROUTS: 

Development of eating behaviors in early 

childhood. 

Date: November 13, 2017. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 


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