Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26485 

approximate time requested to make 

their presentation on or before July 2, 

2018. 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 July 3, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

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 accommodations due to a 

disability, please contact Jennifer 

Shepherd (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website 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: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12226 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Facilitation of Public-Private Dialogue 

to Increase Innovation and Investment 

in the Healthcare Sector 

AGENCY: Immediate Office of the 

Secretary, HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

solicits public comment on a planned 

initiative of the Office of the Deputy 

Secretary of HHS to develop a 

workgroup to facilitate constructive, 

high-level dialogue between HHS 

leadership and those focused on 

innovating and investing in the 

healthcare industry. HHS seeks 

comment on how to structure a 

workgroup, or other form of interaction 

between the Department and such 

participants in the healthcare industry, 

in order to best support communication 

and understanding between these 

parties that will spur investment, 

increase competition, accelerate 

innovation, and allow capital 

investment in the healthcare sector to 

have a more significant impact on the 

health and wellbeing of Americans. 

HHS also seeks comment more broadly 

on opportunities for increased 

engagement and dialogue between HHS 

and those focused on innovating and 

investing in the healthcare industry. 

DATES: Comments must be submitted 

within 30 days after the date of 

publication in the Federal Register. 

ADDRESSES: You may submit comments 

in one of three ways (please choose only 

one of the ways listed): 

1. Electronically. You may submit 

electronic comments through http://

www.regulations.gov. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Immediate Office of the 

Secretary, Office of the Deputy 

Secretary, U.S. Department of Health 

and Human Services, Attention: RFI 

Regarding Healthcare Sector Innovation 

and Investment Workgroup, 200 

Independence Avenue SW, Washington, 

DC 20201. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may mail written comments to the 

following address ONLY: Immediate 

Office of the Secretary, Office of the 

Deputy Secretary, U.S. Department of 

Health and Human Services, Attention: 

RFI Regarding Healthcare Sector 

Innovation and Investment Workgroup, 

200 Independence Avenue SW, 

Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

William Brady, (202) 690–6133. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The healthcare industry is a complex 

and highly regulated industry, and 

although significant investment occurs 

within the industry, innovation and 

investment in the healthcare industry 

must increase to produce more 

significant impact on the health and 

wellbeing of the American people. 

Through this effort, the Department 

intends to provide a forum for HHS 

leadership to engage in a dialogue with 

those focused on innovating and 

investing in the healthcare industry, 

such as healthcare innovation-focused 

companies, healthcare startup 

incubators and accelerators, healthcare 

investment professionals, healthcarefocused private equity firms, healthcarefocused venture capital firms, and 

lenders to healthcare investors and 

innovators. While HHS seeks comment 

on the structure and focus of the 

workgroup, as well as other 

opportunities for engagement, the 

Department envisions the workgroup as 

a forum to hear the individual 

perspectives of attendees and foster new 

and innovative approaches to tackle the 

complicated challenges facing the 

healthcare industry. The Department 

intends for non-HHS attendees to be 

diverse across the subsectors of the 

healthcare industry and the investment 

and innovation lifecycles, and for HHS 

attendees to be diverse across the 

Department in senior leadership 

positions. Workgroup members will not 

be asked to provide any reports or 

collaborative work product. No travel 

expenses, per diem, or compensation of 

any type will be provided to attendees. 

II. Solicitation of Comments 

HHS seeks comment on how to 

structure the workgroup in order to best 

support communication and 

understanding between these parties 

that will spur investment in the 

healthcare industry, increase 

competition, improve innovation, and 

allow capital investment in the 

healthcare sector to have a more 

significant impact on the health and 

wellbeing of Americans. HHS also seeks 

comment more broadly on opportunities 

for increased engagement and dialogue 

between HHS and those focused on 

innovating and investing in the 

healthcare industry. Specifically, HHS 

seeks comments addressing the 

following topics: 

1. Specific areas of inquiry or focus 

for the workgroup. Should the 

workgroup review recent developments 

in health innovation and investing? 

Should the workgroup examine 

perceived barriers to innovation and 

competition in the healthcare industry? 

Should the workgroup encourage 

outside parties to provide HHS with 

information about how they are affected 

by HHS programs or regulatory 

requirements? Should the workgroup 

provide a forum for attendees to share 

their perspectives as to how the 

Department may improve relevant 

regulations, guidance, or other 

documents? Should the workgroup 

examine ways to encourage private 

sector investment to help combat health 

crises? What other areas of focus would 

best help the Department engage with 

diverse subsectors of the healthcare 


sradovich on DSK3GMQ082PROD with NOTICES
26486 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

industry and investment industry in 

order to increase innovation and 

investment in the healthcare sector? 

2. How the workgroup should be 

convened and structured, including 

what subsectors of the healthcare 

economy should be invited to 

participate, and the most effective size. 

How should the agency structure 

meetings or other engagements in order 

to best facilitate the exchange of 

information and the presentation of 

attendees’ individual perspectives? The 

Department seeks comment on how 

suitable attendees should be identified 

and selected to attend and engage in an 

exchange of ideas about the 

Department’s goals of increasing 

innovation and investment in the 

healthcare sector. 

3. HHS also seeks comment more 

broadly on opportunities for increased 

engagement and dialogue between HHS 

and those focused on innovating and 

investing in the healthcare industry, 

including alternatives to the workgroup 

structure discussed in this request for 

information. The Department is 

interested in comments that propose 

alternatives for developing a durable 

and consistent approach to increase 

innovation and investment in the 

healthcare sector to improve the public 

health and wellbeing of Americans. 

This is a request for information only. 

Respondents are encouraged to provide 

complete but concise responses to any 

or all of the questions outlined above. 

This request for information is issued 

solely for information and planning 

purposes; it does not constitute a notice 

of proposed rulemaking or request for 

proposals, applications, proposal 

abstracts, or quotations, nor does it 

suggest that the Department will 

undertake any particular action in 

response to comments. This request for 

information does not commit the United 

States Government (‘‘Government’’) to 

contract for any supplies or services or 

make a grant award. Further, HHS is not 

seeking proposals through this request 

for information and will not accept 

unsolicited proposals. Respondents are 

advised that the Government will not 

pay for any information or 

administrative costs incurred in 

response to this request for information; 

all costs associated with responding to 

this request for information will be 

solely at the interested party’s expense. 

Not responding to this request for 

information does not preclude 

participation in any future rulemaking 

or procurement, if conducted. It is the 

responsibility of the potential 

responders to monitor this request for 

information announcement for 

additional information pertaining to this 

request. We also note that HHS will not 

respond to questions about the policy 

issues raised in this request for 

information. HHS may or may not 

choose to contact individual responders. 

Such communications would only serve 

to further clarify written responses. 

Contractor support personnel may be 

used to review the responses submitted 

under this request for information. 

Responses to this notice are not offers 

and cannot be accepted by the 

Government to form a binding contract 

or issue a grant. Information obtained in 

response to this request for information 

may be used by the Government for 

program planning on a non-attribution 

basis. Respondents should not include 

any information that might be 

considered proprietary or confidential. 

This request for information should not 

be construed as a commitment or 

authorization to incur cost for which 

reimbursement would be required or 

sought. All submissions become 

Government property and will not be 

returned. HHS may publicly post the 

comments received, or a summary 

thereof. While responses to this request 

for information do not bind HHS to any 

further actions related to the response, 

all comments may be posted online on 

http://www.regulations.gov. 

III. Collection of Information 

This document does not impose 

information collection requirements; 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

This request for information constitutes 

a general solicitation of comments. In 

accordance with the implementing 

regulations of the Paperwork Reduction 

Act of 1995 (PRA) at 5 CFR 1320.3(h)(4), 

information subject to the PRA does not 

generally include ‘‘facts or opinions 

submitted in response to general 

solicitations of comments from the 

public, published in the Federal 

Register or other publications, 

regardless of the form or format thereof, 

provided that no person is required to 

supply specific information pertaining 

to the commenter, other than that 

necessary for self-identification, as a 

condition of the agency’s full 

consideration of the comment.’’ 

Consequently, this document need not 

be reviewed by the Office of 

Management and Budget under the 

authority of the PRA (44 U.S.C. 3501 et 

seq.). 

Authority: 42 U.S.C. 3501. 

Dated: June 1, 2018. 

Eric D. Hargan, 

Deputy Secretary, Department of Health and 

Human Services. 

[FR Doc. 2018–12234 Filed 6–6–18; 8:45 am] 

BILLING CODE 4150–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

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: Arthritis and 

Musculoskeletal and Skin Diseases Initial 

Review Group; Arthritis and Musculoskeletal 

and Skin Diseases Special Grants Review 

Committee. 

Date: June 13–14, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites, Chevy Chase 

Pavilion, 4300 Military Rd. NW, Washington, 

DC 20015. 

Contact Person: Helen Lin, Ph.D., 

Scientific Review Officer, NIH/NIAMS/RB, 

6701 Democracy Blvd., Suite 800, Plaza One, 

Bethesda, MD 20817, 301–594–4952, linh1@

mail.nih.gov. 

Name of Committee: Arthritis and 

Musculoskeletal and Skin Diseases Initial 

Review Group; Arthritis and Musculoskeletal 

and Skin Diseases Clinical Trials Review 

Committee. 

Date: June 19, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, 1 Bethesda 

Metro Center, Bethesda, MD 20814. 

Contact Person: Nakia C Brown, Ph.D., 

Scientific Review Officer, 6701 Democracy 

Blvd., RM 816, Bethesda, MD 20892, 301– 

827–4905, brownnac@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 


sradovich on DSK3GMQ082PROD with NOTICES