Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26483 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Requests for 

Feedback and Meetings for Medical 

Device Submissions: The Q-Submission 

Program; Draft Guidance for Industry 

and Food and Drug Administration 

Staff’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or 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 

request. 

FOR FURTHER INFORMATION CONTACT: J. 

Allen Hill, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5627, Silver Spring, 

MD 20993–0002, 301–796–7086; 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, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The pre-IDE program was established 

in 1995, to provide applicants a 

mechanism to obtain FDA feedback on 

future IDE applications prior to their 

submission. Over time, the pre-IDE 

program evolved to include feedback on 

PMA applications, HDE applications, de 

novo requests, and 510(k) submissions, 

as well as to address whether a clinical 

study requires submission of an IDE. 

To capture this evolution, the 

Secretary of Health and Human 

Services’ 2012 Commitment Letter to 

Congress regarding the Medical Device 

User Fee Amendments of 2012 (MDUFA 

III) included FDA’s commitment to 

institute a structured process for 

managing these interactions, referring to 

them as ‘‘Pre-Submissions.’’ The PreSubmission Guidance, published 

February 18, 2014, implemented the 

broader Q-Submission (Q-Sub) Program, 

which includes Pre-Submissions (PreSubs), as well as additional 

opportunities to engage with FDA. 

As part of the Medical Device User 

Fee Amendments of 2017 (MDUFA IV), 

industry and the Agency agreed to 

refine the Q-Sub Program with changes 

related to the scheduling of Pre-Sub 

meetings and a new performance goal 

on the timing of FDA feedback on PreSubs. This guidance reflects those 

changes and clarifies other elements of 

the Q-Sub program. 

This draft guidance document 

provides an overview of the 

mechanisms available to applicants 

through which they can request 

feedback from or a meeting with FDA 

regarding potential or planned medical 

device IDE applications, PMA 

applications, HDE applications, de novo 

requests, 510(k) Submissions, CLIA 

Waiver by Application, Accessory 

Classification Requests, and certain 

INDs and BLAs. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Requests for Feedback and Meetings 

for Medical Device Submissions: The QSubmission Program; Draft Guidance for 

Industry and Food and Drug 

Administration Staff.’’ 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. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

draft guidance is also available at 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Requests for Feedback and Meetings 

for Medical Device Submissions: The QSubmission Program; Draft Guidance for 

Industry and Food and Drug 

Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1677 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance also refers to 

previously approved information 

collections 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 803 are 

approved under OMB control number 

0910–0437; the collections of 

information in 21 CFR part 807, subpart 

E are approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR part 812 are 

approved under OMB control number 

0910–0078; the collections of 

information in 21 CFR part 814 are 

approved under OMB control number 

0910–0231; and the collections of 

information for ‘‘Request for Feedback 

on Medical Device Submissions’’ are 

approved under OMB control number 

0910–0756. 

Dated: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12223 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1823] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting; 

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) announces a 

forthcoming public advisory committee 

meeting of the Pulmonary-Allergy Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on July 

25, 2018, from 8 a.m. to 4 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 


sradovich on DSK3GMQ082PROD with NOTICES
26484 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–1823. 

The docket will close on July 24, 2018. 

Submit either electronic or written 

comments on this public meeting by 

July 24, 2018. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before July 24, 2018. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of July 24, 2018. 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. 

Comments received on or before July 

11, 2018, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. 

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– 

2018–N–1823, for ‘‘Pulmonary-Allergy 

Drugs Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSSES), 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.’’ FDA 

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 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 the 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. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Shepherd, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

PADAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

supplemental biologics license 

application (sBLA) 125526 for 

mepolizumab for injection, submitted 

by GlaxoSmithKline for add-on 

treatment to inhaled corticosteroidbased maintenance treatment for the 

reduction of exacerbations in patients 

with chronic obstructive pulmonary 

disease (COPD) guided by blood 

eosinophil counts. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

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 committee. Written 

submissions may be made to the contact 

person on or before July 11, 2018. 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 


sradovich on DSK3GMQ082PROD with NOTICES
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