26482 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

Pharmaceutical informed FDA that it 

did not want approval of the ANDA 

withdrawn. Because Sun 

Pharmaceutical timely requested that 

approval of this ANDA not be 

withdrawn, the approval of ANDA 

077483 is still in effect. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Friday, February 23, 

2018 (83 FR 8089), appearing on page 

8089 in FR Doc. 2018–03700, the 

following correction is made: 

1. On page 8090, the entry for ANDA 

077483 in the table is removed. 

Dated: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12220 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–D–1774] 

Requests for Feedback and Meetings 

for Medical Device Submissions: The 

Q-Submission Program; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; 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 

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Program; Draft Guidance for Industry 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.’’ This draft guidance document 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 investigational device exemption 

(IDE) applications, premarket approval 

(PMA) applications, humanitarian 

device exemption (HDE) applications, 

evaluation of automatic class III 

designations (de novo requests), 

premarket notification (510(k)) 

submissions, Clinical Laboratory 

Improvement Amendments (CLIA) 

Waiver by Application, Accessory 

Classification Requests, and certain 

investigational new drug (IND) 

applications and biologics license 

applications (BLAs). This draft 

guidance, when finalized, is intended to 

supersede the document entitled 

‘‘Requests for Feedback on Medical 

Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

issued on September 29, 2017. This 

draft guidance is not final nor is it in 

effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 6, 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– 

2018–D–1774 for ‘‘Requests for 

Feedback and Meetings for Medical 

Device Submissions: The Q-Submission 

Program; Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ 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 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 


sradovich on DSK3GMQ082PROD with NOTICES
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