Generic Drug User Fee Amendments; Public Meeting; Request for Comments, 38378-38380 [2020-13749]
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38378
Federal Register / Vol. 85, No. 124 / Friday, June 26, 2020 / Notices
TABLE 5— CDER GUIDANCES AND COLLECTIONS—Continued
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
New collection covered by
PHE PRA waiver
Requests for Feedback and
Meetings for Medical Device
Submissions: The Q-Submission Program.
C. CFSAN Guidance
The guidance indicated in the table
below refers to previously approved
collections of information. These
collections of information are subject to
review by OMB under the PRA. The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the table. This guidance also contains a
new collection of information not
approved under a current collection.
This new collection of information has
been granted a PHE waiver from the
PRA by the HHS on March 19, 2020,
under section 319(f) of the PHS Act.
Information concerning the PHE PRA
waiver can be found on the HHS
website at https://aspe.hhs.gov/publichealth-emergency-declaration-prawaivers.
TABLE 6—CFSAN GUIDANCE AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
New collection covered by
PHE PRA waiver
Temporary Policy Regarding
Certain Mandatory Food Labeling Requirements During
the COVID–19 Public Health
Emergency: Minor Formulation Changes and Vending
Machines.
21 CFR part 101; section
403(w) of the FD&C Act.
..................................................
0910–0381, 0910–0782, 0910–
0792.
Recommend that manufacturers post ingredient omissions or substitutions not reflected on the product label.
The guidance entitled ‘‘Returning
Refrigerated Transport Vehicles and
Refrigerated Storage Units to Food Uses
After Using Them to Preserve Human
Remains During the COVID–19
Pandemic’’ contains no collection of
information. Therefore, clearance by
OMB under the PRA is not required.
D. CVM Guidance
This guidance indicated in the table
below refers to previously approved
collections of information. These
collections of information are subject to
review by OMB under the PRA. The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as
indicated in the table. This guidance
also contains a new collection of
information not approved under a
current collection. This new collection
of information has been granted a PHE
waiver from the PRA by HHS on March
19, 2020, under section 319(f) of the
PHS Act. Information concerning the
PHE PRA waiver can be found on the
HHS website at https://aspe.hhs.gov/
public-health-emergency-declarationpra-waivers.
TABLE 7—CVM GUIDANCE AND COLLECTION
CFR cite referenced in
COVID–19 guidance
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
21 CFR 514.1(a)) .....................
..................................................
0910–0032, 0910–0669 ...........
COVID–19 guidance title
GFI# 271, Reporting and Mitigating Animal Drug Shortages during the COVID–19
Public Health Emergency.
jbell on DSKJLSW7X2PROD with NOTICES
IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• The FDA web page entitled
‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders,’’ available at
https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders;
• the FDA web page entitled ‘‘Search
for FDA Guidance Documents’’
available at https://www.fda.gov/
VerDate Sep<11>2014
19:42 Jun 25, 2020
Jkt 250001
regulatory-information/search-fdaguidance-documents; or
• https://www.regulations.gov.
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13829 Filed 6–25–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
New collection covered by
PHE PRA waiver
Reporting and mitigating animal drug shortages.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1459]
Generic Drug User Fee Amendments;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is hosting a virtual public meeting
entitled ‘‘Generic Drug User Fee
SUMMARY:
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Federal Register / Vol. 85, No. 124 / Friday, June 26, 2020 / Notices
Amendments (GDUFA) of 2017.’’ At the
end of September 2022, new legislation
will be required for FDA to continue to
collect generic drug user fees for future
fiscal years. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) requires
that before FDA begins negotiations
with the regulated industry on GDUFA
reauthorization, we publish a notice in
the Federal Register requesting public
input on the reauthorization, hold a
public meeting at which the public may
present its views on the reauthorization,
including specific suggestions for
changes to the goals referred to in the
GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal
Years 2018–2022 (i.e., the GDUFA II
Commitment Letter), provide a period of
30 days after the public meeting to
obtain written comments from the
public, and publish the comments on
FDA’s website. FDA invites public
comment on the GDUFA program and
suggestions regarding the features FDA
should propose for the next GDUFA
program cycle. These comments will be
published and available on FDA’s
website.
The public meeting will be held
on July 21, 2020, from 8:30 a.m. to 3:30
p.m., and will take place virtually and
will be held by webcast only. Submit
either electronic or written comments
on this public meeting by August 20,
2020. 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 August 20, 2020. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of August 20, 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.
DATES:
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
19:42 Jun 25, 2020
Jkt 250001
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–
2020–N–1459 for ‘‘Generic Drug User
Fee Amendments; 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
PO 00000
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38379
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-201509-18/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,
240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Tiana Barnes, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6196,
Silver Spring, MD 20993, 301–796–
2882, Tiana.Barnes@fda.hhs.gov; or Dat
Doan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3334, Silver Spring,
MD 20993, 240–402–8926, Dat.Doan@
fda.hhs.gov;
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
Act, which included GDUFA (Pub. L.
112–144, Title III), was signed into law
by the President. In 2017, the GDUFA
program was reauthorized (GDUFA II)
under the FDA Reauthorization Act of
2017 (Pub. L. 115–52, Title III), which
authorizes FDA to collect fees for
certain generic human drug
applications, drug master files, and
facilities. Designed to speed access to
safe and effective generic drugs to the
public, GDUFA II requires that generic
drug manufacturers and other relevant
entities pay user fees to finance critical
and measurable generic drug program
enhancements. As described in the
GDUFA II Commitment Letter, FDA
committed to achieve certain
performance goals, provide enhanced
communication intended to streamline
abbreviated new drug application
(ANDA) development and assessment,
and take other steps to increase the
efficiency of the assessment process.
E:\FR\FM\26JNN1.SGM
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38380
Federal Register / Vol. 85, No. 124 / Friday, June 26, 2020 / Notices
GDUFA II also includes a pre-ANDA
program to clarify regulatory
expectations for complex generic
product developers early in product
development and during application
review.
Additional information concerning
GDUFA, including the text of the law,
the GDUFA II Commitment Letter, key
Federal Register documents, GDUFArelated guidances, performance reports,
and financial reports may be found on
the FDA website at https://www.fda.gov/
gdufa.
II. Topics for Discussion at the Public
Meeting
FDA is interested in responses to the
following general questions:
• What is your assessment of the
overall performance of the GDUFA
program to date?
• What aspects of GDUFA should be
retained, changed, or discontinued to
further strengthen and improve the
program?
• What new features should FDA
consider adding to the program to
enhance efficiency and effectiveness of
the generic drug review process?
FDA welcomes any other relevant
information the public would like to
share as it relates to the GDUFA
program, including but not limited to
the following topic areas:
• supply chain security and drug
shortages;
• drug quality and advanced
manufacturing; and
• complex products.
In general, the public meeting’s
format will include presentations by
FDA and our stakeholders, which may
include scientific and academic experts,
health care professionals,
representatives of patient and consumer
advocacy groups, the generic drug
industry, and the general public. The
amount of time available for public
testimony will be determined by the
number of persons who register to
present during the virtual public
meeting. A draft agenda and other
background information for the public
meeting will be posted at https://
www.fda.gov/gdufa by July 14, 2020.
jbell on DSKJLSW7X2PROD with NOTICES
III. Participating in the Public Meeting
Registration: FDA is seeking
participation (i.e., oral remote
presentations) during the virtual public
meeting by all interested parties,
including but not limited to scientific
and academic experts, health care
professionals, representatives of patient
and consumer advocacy groups, the
generic drug industry, and the general
public. Persons interested in attending
VerDate Sep<11>2014
19:42 Jun 25, 2020
Jkt 250001
this virtual public meeting should
register online by 11:59 p.m. Eastern
Time on July 7, 2020, at https://
collaboration.fda.gov/e8a35s83so0x/
event/registration.html. Please provide
complete contact information for each
attendee, including name, title,
affiliation, and email.
Requests for Oral Presentations: If you
wish to present during a public
comment session or participate in a
specific session, please submit your
request to GenericDrugPolicy@
fda.hhs.gov by 11:59 p.m. Eastern Time
on July 7, 2020. Your email should
contain which topic(s) you wish to
address and include complete contact
information, including name, title,
affiliation, address, and email address.
We will do our best to accommodate
requests to make public comments and
requests to participate in specific
sessions. Individuals and organizations
with common interests are urged to
consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. Following the
close of registration, we will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
July 8, 2020. All requests to make oral
presentations must be received by the
close of registration on July 7, 2020,
11:59 p.m. Eastern Time. If selected for
presentation, any presentation materials
must be emailed to GenericDrugPolicy@
fda.hhs.gov no later than July 14, 2020.
No commercial or promotional material
will be permitted to be presented or
distributed during the virtual public
meeting.
Streaming Webcast of the Public
Meeting: This virtual public meeting
will be accessible via webcast only. In
order to connect to the webcast, you
must have Adobe Connect. The link for
the webcast will be sent to all registered
attendees in advance of the event.
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 (see ADDRESSES). A link to the
PO 00000
Frm 00025
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Sfmt 4703
transcript will also be available on the
internet at https://www.fda.gov/gdufa.
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13749 Filed 6–25–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Membership Forms for
Organ Procurement and
Transplantation Network OMB No.
0915–0184–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than July 27, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under—Open for Public
Comments’’ or by using the search
function.
DATES:
To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Membership Forms for Organ
Procurement and Transplantation
Network OMB No. 0915–0184–Revision.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\26JNN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38378-38380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13749]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1459]
Generic Drug User Fee Amendments; 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 virtual public meeting entitled ``Generic Drug User Fee
[[Page 38379]]
Amendments (GDUFA) of 2017.'' At the end of September 2022, new
legislation will be required for FDA to continue to collect generic
drug user fees for future fiscal years. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) requires that before FDA begins negotiations
with the regulated industry on GDUFA reauthorization, we publish a
notice in the Federal Register requesting public input on the
reauthorization, hold a public meeting at which the public may present
its views on the reauthorization, including specific suggestions for
changes to the goals referred to in the GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2018-2022
(i.e., the GDUFA II Commitment Letter), provide a period of 30 days
after the public meeting to obtain written comments from the public,
and publish the comments on FDA's website. FDA invites public comment
on the GDUFA program and suggestions regarding the features FDA should
propose for the next GDUFA program cycle. These comments will be
published and available on FDA's website.
DATES: The public meeting will be held on July 21, 2020, from 8:30 a.m.
to 3:30 p.m., and will take place virtually and will be held by webcast
only. Submit either electronic or written comments on this public
meeting by August 20, 2020. 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 August 20, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 20, 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 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-1459 for ``Generic Drug User Fee Amendments; 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Tiana Barnes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6196, Silver Spring, MD 20993, 301-796-
2882, [email protected]; or Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926,
[email protected];
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act, which included GDUFA (Pub. L. 112-144, Title III), was
signed into law by the President. In 2017, the GDUFA program was
reauthorized (GDUFA II) under the FDA Reauthorization Act of 2017 (Pub.
L. 115-52, Title III), which authorizes FDA to collect fees for certain
generic human drug applications, drug master files, and facilities.
Designed to speed access to safe and effective generic drugs to the
public, GDUFA II requires that generic drug manufacturers and other
relevant entities pay user fees to finance critical and measurable
generic drug program enhancements. As described in the GDUFA II
Commitment Letter, FDA committed to achieve certain performance goals,
provide enhanced communication intended to streamline abbreviated new
drug application (ANDA) development and assessment, and take other
steps to increase the efficiency of the assessment process.
[[Page 38380]]
GDUFA II also includes a pre-ANDA program to clarify regulatory
expectations for complex generic product developers early in product
development and during application review.
Additional information concerning GDUFA, including the text of the
law, the GDUFA II Commitment Letter, key Federal Register documents,
GDUFA-related guidances, performance reports, and financial reports may
be found on the FDA website at https://www.fda.gov/gdufa.
II. Topics for Discussion at the Public Meeting
FDA is interested in responses to the following general questions:
What is your assessment of the overall performance of the
GDUFA program to date?
What aspects of GDUFA should be retained, changed, or
discontinued to further strengthen and improve the program?
What new features should FDA consider adding to the
program to enhance efficiency and effectiveness of the generic drug
review process?
FDA welcomes any other relevant information the public would like
to share as it relates to the GDUFA program, including but not limited
to the following topic areas:
supply chain security and drug shortages;
drug quality and advanced manufacturing; and
complex products.
In general, the public meeting's format will include presentations
by FDA and our stakeholders, which may include scientific and academic
experts, health care professionals, representatives of patient and
consumer advocacy groups, the generic drug industry, and the general
public. The amount of time available for public testimony will be
determined by the number of persons who register to present during the
virtual public meeting. A draft agenda and other background information
for the public meeting will be posted at https://www.fda.gov/gdufa by
July 14, 2020.
III. Participating in the Public Meeting
Registration: FDA is seeking participation (i.e., oral remote
presentations) during the virtual public meeting by all interested
parties, including but not limited to scientific and academic experts,
health care professionals, representatives of patient and consumer
advocacy groups, the generic drug industry, and the general public.
Persons interested in attending this virtual public meeting should
register online by 11:59 p.m. Eastern Time on July 7, 2020, at https://collaboration.fda.gov/e8a35s83so0x/event/registration.html. Please
provide complete contact information for each attendee, including name,
title, affiliation, and email.
Requests for Oral Presentations: If you wish to present during a
public comment session or participate in a specific session, please
submit your request to [email protected] by 11:59 p.m.
Eastern Time on July 7, 2020. Your email should contain which topic(s)
you wish to address and include complete contact information, including
name, title, affiliation, address, and email address. We will do our
best to accommodate requests to make public comments and requests to
participate in specific sessions. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate in the focused
sessions. Following the close of registration, we will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants
by July 8, 2020. All requests to make oral presentations must be
received by the close of registration on July 7, 2020, 11:59 p.m.
Eastern Time. If selected for presentation, any presentation materials
must be emailed to [email protected] no later than July 14,
2020. No commercial or promotional material will be permitted to be
presented or distributed during the virtual public meeting.
Streaming Webcast of the Public Meeting: This virtual public
meeting will be accessible via webcast only. In order to connect to the
webcast, you must have Adobe Connect. The link for the webcast will be
sent to all registered attendees in advance of the event.
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
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/gdufa.
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13749 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P
