[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]
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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.
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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