[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Pages 44098-44099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15729]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1529]


Independent Third-Party Assessment of Investigational New Drug 
Food and Drug Administration-Sponsor Communication Practices in 
Prescription Drug User Fee Act VI; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
hosting a public meeting entitled ``Independent Third-Party Assessment 
of IND FDA-Sponsor Communication Practices in PDUFA VI,'' and an 
opportunity for public comment. The meeting will include a presentation 
from an independent third-party contractor about its assessment of FDA-
sponsor communications during the investigational new drug (IND) stage 
of drug/biologic development in the Prescription Drug User Fee Act 
(PDUFA) VI; a series of presentations by and a panel discussion with 
invited regulatory and industry representatives, and an open public 
comment period. This meeting is intended to satisfy FDA's commitment to 
host a public meeting about the assessment no later than March 2021.

DATES: The public meeting will be held on August 11, 2020, from 9:30 
a.m. to 12:30 p.m. and will take place virtually by webcast only. 
Registration to attend the meeting and other information can be found 
at https://indassessmentmeeting.eventbrite.com. See the SUPPLEMENTARY 
INFORMATION section for registration date and information.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before September 11, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 11, 2020. 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.

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

[[Page 44099]]

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-2020-N-1529 for ``Independent Third-Party Assessment of IND FDA-
Sponsor Communication Practices in PDUFA VI; Public Meeting; Request 
for Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Kimberly Taylor, 240-402-5193, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    This public meeting is intended to meet performance commitments 
included in PDUFA VI. This user fee program was reauthorized as part of 
the FDA Reauthorization Act of 2017 (FDARA), signed by the President on 
August 18, 2017. The complete set of performance goals for PDUFA is 
available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.
    Section I.I of the PDUFA VI goals (``PDUFA Reauthorization 
Performance Goals and Procedures Fiscal Years 2018 Through 2022'' (p. 
21)), entitled ``Enhancing Regulatory Science and Expediting Drug 
Development,'' details FDA's commitments to promote innovation through 
enhanced communication between FDA and sponsors during drug 
development; it also describes FDA's commitment to contract with an 
independent third party to assess FDA-sponsor communication practices 
during the IND stage of drug/biologic development in PDUFA VI and 
identify best practices and areas for improvement. An independent 
third-party contractor, Eastern Research Group, Inc., has completed the 
assessment of FDA-sponsor communication practices during the IND stage 
of drug/biologic development in PDUFA VI. FDA has published the report 
to its website at https://www.fda.gov/media/138379/download.

II. Topics for Discussion at the Public Meeting

    This meeting will provide FDA with the opportunity to share the 
independent third-party assessment of FDA-sponsor communications during 
the IND stage of drug/biologic development in PDUFA VI. This meeting 
will also be an opportunity to share any challenges and lessons learned 
relating to communications between FDA and IND sponsors. The format of 
the meeting will consist of a presentation of assessment results, 
followed by a series of presentations by and a panel discussion with 
invited regulatory and industry representatives regarding their 
experiences with and approaches to communications during the IND stage 
of drug development. The meeting will conclude with an open public 
comment period.

III. Attending the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://indassessmentmeeting.eventbrite.com. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Persons interested in attending this public meeting must register 
by August 10, 2020, at 11:59 p.m. Eastern Time. Registrants will 
receive confirmation once they have been accepted.
    Streaming Webcast of the Public Meeting: The webcast for this 
meeting will be available to registrants. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this 
document, as of the date this document publishes in the Federal 
Register, but websites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff, 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500.

    Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15729 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P