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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46085 

Place: National Institutes of Health, 6710 B 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

Ph.D., Scientific Review Administrator 

Division of Scientific Review National 

Institute of Child Health and Human D, 6100 

Executive Boulevard, Room 5B01, Bethesda, 

MD 20892–9304, (301) 435–6680, skandasa@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 27, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21139 Filed 10–2–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following NHLBI Mentored Clinical and 

Basic Science Review Committee 

meeting. 

The meeting 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: Heart, Lung, and 

Blood Initial Review Group; NHLBI 

Mentored Clinical and Basic Science Review 

Committee. 

Date: October 26–27, 2017. 

Time: 10:30 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza National Airport, 1480 

Crystal Drive, Arlington, VA 22202. 

Contact Person: Keith A. Mintzer, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7186, Bethesda, MD 20892–7924, 301–827– 

7949, mintzerk@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 27, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21136 Filed 10–2–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel NIAID Peer Review Meeting. 

Date: October 26–27, 2017. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892, 

(Telephone Conference Call). 

Contact Person: Susana Mendez, DVM, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, Room 3G53B, National Institutes 

of Health, NIAID, 5601 Fishers Lane Dr., 

MSC 9823, Bethesda, MD 20892–9823, (240) 

669–5077, mendezs@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 27, 2017. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21138 Filed 10–2–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Diseases and Pathophysiology of the 

Visual System Study Section. 

Date: October 26–27, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Nataliya Gordiyenko, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5202, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1265, gordiyenkon@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; 

Cancer Etiology Study Section. 

Date: October 26–27, 2017. 

Time: 8:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Marines’ Memorial Club & Hotel, 

609 Sutter Street, San Francisco, CA 94102. 

Contact Person: Ola Mae Zack Howard, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Dr., Room 4192, MSC 

7806, Bethesda, MD 20892, 301–451–4467, 

howardz@mail.nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Neurotoxicology 

and Alcohol Study Section. 

Date: October 26–27, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Washington, DC 

Downtown, 1199 Vermont Avenue NW., 

Washington, DC 20005. 

Contact Person: Jana Drgonova, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

Bethesda, MD 20892, 301–827–2549, 

jdrgonova@mail.nih.gov. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES