Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments, 65631-65633 [2024-17924]
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65631
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
Profile Form is based upon an estimate
of 74 respondents per year and an
estimated three hours per response.
6. PSO Change of Listing Information
Form: The average annual burden for
the collection of information requested
by the PSO Change of Listing
Information Form is based upon an
estimate of 51 respondents per year and
an estimated time of five minutes per
response.
7. PSO Voluntary Relinquishment
Form: The average annual burden for
the collection of information requested
by the PSO Voluntary Relinquishment
Form is based upon a total average
estimate of four respondents per year
and an estimated time of thirty minutes
per response.
8. OCR Patient Safety Confidentiality
Complaint Form: The overall annual
burden estimate of one hour for the
collection of information requested by
the form is based on an estimate of one
respondent per year and an estimated
twenty minutes per response.
9. Common Formats: AHRQ estimates
that 5% FTE of a patient safety manager
at a facility will be spent to administer
the Common Formats, which is
approximately 100 hours a year.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form
1.
2.
3.
4.
5.
6.
7.
8.
9.
Number of
responses per
respondent
Hours per
response
Total burden
hours
PSO Certification for Initial Listing Form .....................................................
PSO Certification for Continued Listing Form .............................................
PSO Two Bona Fide Contracts Requirement Form ....................................
PSO Disclosure Statement Form ................................................................
PSO Profile Form ........................................................................................
PSO Change of Listing Information .............................................................
PSO Voluntary Relinquishment Form .........................................................
OCR Patient Safety Confidentiality Complaint Form ..................................
Common Formats ........................................................................................
11
40
56
3
74
51
4
1
1,000
1
1
1
1
1
1
1
1
1
18
8
1
3
3
05/60
30/60
20/60
100
198
320
56
9
222
4.25
2
.33
100,000
Total ..........................................................................................................
........................
NA
NA
100,811.58
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Total burden
hours
Form
1.
2.
3.
4.
5.
6.
7.
8.
9.
Average
hourly wage
rate *
Total cost
PSO Certification for Initial Listing Form .................................................................................
PSO Certification for Continued Listing Form .........................................................................
PSO Two Bona Fide Contracts Requirement Form ...............................................................
PSO Disclosure Statement Form ............................................................................................
PSO Profile Form ....................................................................................................................
PSO Change of Listing Form ..................................................................................................
PSO Voluntary Relinquishment Form .....................................................................................
OCR Patient Safety Confidentiality Complaint Form ..............................................................
Common Formats ....................................................................................................................
198
320
56
9
222
4.25
2
.33
100,000
$49.07
49.07
49.07
49.07
49.07
49.07
49.07
49.07
49.07
$9,715.86
15,702.40
2,747.92
441.63
10,893.54
208.55
98.14
15.35
4,907,000
Total ......................................................................................................................................
........................
........................
4,946,824.23
* Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29–0000, National Compensation
Survey, May 2023, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ https://www.bls.gov/oes/current/oes290000.htm.
khammond on DSKJM1Z7X2PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
VerDate Sep<11>2014
17:30 Aug 09, 2024
Jkt 262001
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3528]
Advancing Rare Disease Therapies
Through a Food and Drug
Administration Rare Disease
Innovation Hub; Public Meeting;
Request for Comments
Mamatha Pancholi,
Deputy Director.
AGENCY:
[FR Doc. 2024–17813 Filed 8–9–24; 8:45 am]
ACTION:
BILLING CODE 4160–90–P
PO 00000
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting, entitled ‘‘Advancing Rare
SUMMARY:
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65632
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Disease Therapies Through an FDA Rare
Disease Innovation Hub.’’ The purpose
of the public meeting is to discuss the
establishment of a Rare Disease
Innovation Hub, which will enhance
collaboration and cooperation across the
Center for Biologics Evaluation and
Research (CBER) and the Center for
Drug Evaluation and Research (CDER),
as well as other centers and offices
across FDA, to advance rare disease
therapies. In particular, this meeting
will be an opportunity for those in the
rare disease community, including
patients and caregiver groups, industry
organizations, and scientific/academic
organizations, to provide input on the
priorities of the Rare Disease Innovation
Hub and how the Hub can best engage
with members of the rare disease
community. The public meeting will be
facilitated by the Reagan-Udall
Foundation for the FDA.
DATES: The public meeting will be held
on October 16, 2024, from 10 a.m. to 1
p.m. Eastern Time. Either electronic or
written comments on this public
meeting must be submitted by 11:59
p.m. Eastern Time on October 31, 2024.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (Great Room), Silver Spring,
MD 20993–0002. Entrance for the public
meeting participants (non-FDA
employees) is through Bldg. 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/visitorinformation.
You may submit written comments as
follows. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 31, 2024.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received 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
VerDate Sep<11>2014
17:30 Aug 09, 2024
Jkt 262001
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–
2024–N–3528 for ‘‘Advancing Rare
Disease Therapies Through an FDA Rare
Disease Innovation Hub; 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
PO 00000
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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-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.
FOR FURTHER INFORMATION CONTACT:
Janet Goldberg, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911; or Cynthia Rothblum-Oviatt,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5390, Silver Spring,
MD 20993–0002, 301–796–0957.
SUPPLEMENTARY INFORMATION:
I. Background
CBER and CDER are launching a
CBER–CDER Rare Disease Innovation
Hub (the Hub) to advance rare disease
therapy development through greater
communication, collaboration, and
coordination across CBER and CDER, in
coordination with other centers and
offices across FDA. Helmed by senior
leadership from CBER and CDER, the
Hub will work to develop and
implement a rare disease
comprehensive cross-center strategic
agenda that takes full advantage of our
current clinical and scientific expertise
across both centers and is based on a
shared vision and comprehensive
approach to (1) align review efforts; (2)
identify and enable innovative
approaches in the areas of novel
endpoints, biomarker development, and
innovative trial designs; and (3)
streamline communications with the
rare disease community.
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Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
The Directors of CBER and CDER
(Directors) will lead the Hub, cochairing the Rare Disease Innovation
Hub Steering Committee, which will
include senior leaders from CBER’s
Office of Therapeutic Products, CDER’s
Office of New Drugs, and across FDA,
such as the Center for Devices and
Radiological Health, Oncology Center of
Excellence, Office of Orphan Products
Development, and Office of
Combination Products. The Rare Disease
Innovation Hub will leverage the
activities of the CDER Accelerating Rare
disease Cures program and CBER Rare
Disease Program and enhance existing
cross-center collaborations. In addition,
the Hub will be anchored by the new
Director for Strategic Coalitions for the
Hub (Associate Director for Rare Disease
Strategy), who will serve as a single
point of connection and engagement
with stakeholders on behalf of the Hub,
including patient and caregiver groups,
trade organizations, and scientific/
academic organizations, on cross-cutting
rare disease-related issues. The
Directors will develop approaches to
ensure appropriate FDA staff
involvement or appropriate settings for
further external engagement and will
seek input from the community to
inform the priorities of the Hub.
The Reagan-Udall Foundation for the
FDA will facilitate the public meeting.
The Reagan-Udall Foundation for the
FDA is an independent 501(c)(3) notfor-profit organization created by
Congress to advance the mission of FDA
to modernize medical, veterinary, food,
food ingredient, and cosmetic product
development; accelerate innovation; and
enhance product safety. With the
ultimate goal of improving public
health, the Foundation provides a
unique opportunity for different sectors
(FDA, patient groups, academia, other
government entities, and industry) to
work together in a transparent way to
create exciting new research and
engagement projects to advance
regulatory science.
II. Topics for Discussion at the Public
Meeting
This public meeting is being
convened for FDA to provide
information on the Rare Disease
Innovation Hub, including its proposed
priorities and initiatives, and to serve as
an opportunity for those in the rare
disease community, including patients
and caregiver groups, industry
organizations, and scientific/academic
organizations, to provide input on the
priorities of the Rare Disease Innovation
Hub and how the Hub can best engage
with members of the rare disease
community. In particular, FDA is
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interested in receiving comments on the
following:
1. What specific rare disease-related
scientific, regulatory, or policy issues
should be prioritized for consideration
by the Rare Disease Innovation Hub?
2. To the extent the issues identified
in response to Question 1 are related to
specific types of rare diseases or
conditions, please explain.
3. What specific types of rare diseaserelated activities do you believe would
benefit from enhanced collaboration,
focused attention, or increased
transparency (to the extent legally
permissible) under the Rare Disease
Innovation Hub? Please identify in your
comments rare disease-related activities
or initiatives currently being undertaken
by CDER or CBER that you believe
would benefit from being undertaken by
the Rare Disease Innovation Hub as a
joint endeavor.
4. Please comment on approaches that
the Rare Disease Innovation Hub should
follow for engagement with patients and
caregiver groups, industry
organizations, and scientific/academic
organizations (including different
approaches for different types of
engagement, as appropriate).
Comments will be accepted until
11:59 p.m. Eastern Time on October 31,
2024.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website to register: https://
reaganudall.org/news-and-events/
events/advancing-rare-diseasetherapies-through-an-fda-rare-diseaseinnovation-hub. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone number.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register online by October 15, 2024, at
5 p.m. Eastern Time. Early registration
is recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization.
If you need special accommodations
due to a disability, please contact Lea
Ann Browning-McNee, Director of
Communication and Stakeholder
Engagement, Reagan-Udall Foundation
for FDA, 202–849–2075, Lmcnee@
reaganudall.org, no later than October 9,
2024, at 5 p.m. Eastern Time.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session and which
PO 00000
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65633
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. 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. 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 October 4, 2024. All requests to make
oral presentations must be received by
11:59 p.m. on September 25, 2024. If
selected for a presentation, you will be
contacted by Lea Ann Browning-McNee,
Director of Communication and
Stakeholder Engagement, Reagan-Udall
Foundation for FDA regarding
submission of a single slide in
PowerPoint format. No commercial or
promotional material will be permitted
to be presented or distributed at the
public meeting.
(Notice of this meeting is given pursuant to
21 CFR 10.65.)
Dated: August 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17924 Filed 8–9–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3609]
Development of an Enhanced
Systematic Process for the Food and
Drug Administration’s Post-Market
Assessment of Chemicals in Food;
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 or we) is
announcing the following public
meeting entitled ‘‘Development of an
Enhanced Systematic Process for FDA’s
Post-Market Assessment of Chemicals in
Food.’’ This public meeting will assist
in developing the post-market chemicals
assessment program we will establish
under the new FDA Human Foods
Program. The purpose of the public
meeting is to hear from interested
parties about approaches to systematic
post-market assessment of chemicals in
food.
SUMMARY:
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65631-65633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3528]
Advancing Rare Disease Therapies Through a Food and Drug
Administration Rare Disease Innovation Hub; 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
announcing the following public meeting, entitled ``Advancing Rare
[[Page 65632]]
Disease Therapies Through an FDA Rare Disease Innovation Hub.'' The
purpose of the public meeting is to discuss the establishment of a Rare
Disease Innovation Hub, which will enhance collaboration and
cooperation across the Center for Biologics Evaluation and Research
(CBER) and the Center for Drug Evaluation and Research (CDER), as well
as other centers and offices across FDA, to advance rare disease
therapies. In particular, this meeting will be an opportunity for those
in the rare disease community, including patients and caregiver groups,
industry organizations, and scientific/academic organizations, to
provide input on the priorities of the Rare Disease Innovation Hub and
how the Hub can best engage with members of the rare disease community.
The public meeting will be facilitated by the Reagan-Udall Foundation
for the FDA.
DATES: The public meeting will be held on October 16, 2024, from 10
a.m. to 1 p.m. Eastern Time. Either electronic or written comments on
this public meeting must be submitted by 11:59 p.m. Eastern Time on
October 31, 2024. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (Great Room), Silver
Spring, MD 20993-0002. Entrance for the public meeting participants
(non-FDA employees) is through Bldg. 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/about-fda/visitor-information.
You may submit written comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 31, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2024-N-3528 for ``Advancing Rare Disease Therapies Through an FDA
Rare Disease Innovation Hub; 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: Janet Goldberg, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; or Cynthia Rothblum-Oviatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 5390, Silver Spring, MD 20993-0002, 301-796-0957.
SUPPLEMENTARY INFORMATION:
I. Background
CBER and CDER are launching a CBER-CDER Rare Disease Innovation Hub
(the Hub) to advance rare disease therapy development through greater
communication, collaboration, and coordination across CBER and CDER, in
coordination with other centers and offices across FDA. Helmed by
senior leadership from CBER and CDER, the Hub will work to develop and
implement a rare disease comprehensive cross-center strategic agenda
that takes full advantage of our current clinical and scientific
expertise across both centers and is based on a shared vision and
comprehensive approach to (1) align review efforts; (2) identify and
enable innovative approaches in the areas of novel endpoints, biomarker
development, and innovative trial designs; and (3) streamline
communications with the rare disease community.
[[Page 65633]]
The Directors of CBER and CDER (Directors) will lead the Hub, co-
chairing the Rare Disease Innovation Hub Steering Committee, which will
include senior leaders from CBER's Office of Therapeutic Products,
CDER's Office of New Drugs, and across FDA, such as the Center for
Devices and Radiological Health, Oncology Center of Excellence, Office
of Orphan Products Development, and Office of Combination Products. The
Rare Disease Innovation Hub will leverage the activities of the CDER
Accelerating Rare disease Cures program and CBER Rare Disease Program
and enhance existing cross-center collaborations. In addition, the Hub
will be anchored by the new Director for Strategic Coalitions for the
Hub (Associate Director for Rare Disease Strategy), who will serve as a
single point of connection and engagement with stakeholders on behalf
of the Hub, including patient and caregiver groups, trade
organizations, and scientific/academic organizations, on cross-cutting
rare disease-related issues. The Directors will develop approaches to
ensure appropriate FDA staff involvement or appropriate settings for
further external engagement and will seek input from the community to
inform the priorities of the Hub.
The Reagan-Udall Foundation for the FDA will facilitate the public
meeting. The Reagan-Udall Foundation for the FDA is an independent
501(c)(3) not-for-profit organization created by Congress to advance
the mission of FDA to modernize medical, veterinary, food, food
ingredient, and cosmetic product development; accelerate innovation;
and enhance product safety. With the ultimate goal of improving public
health, the Foundation provides a unique opportunity for different
sectors (FDA, patient groups, academia, other government entities, and
industry) to work together in a transparent way to create exciting new
research and engagement projects to advance regulatory science.
II. Topics for Discussion at the Public Meeting
This public meeting is being convened for FDA to provide
information on the Rare Disease Innovation Hub, including its proposed
priorities and initiatives, and to serve as an opportunity for those in
the rare disease community, including patients and caregiver groups,
industry organizations, and scientific/academic organizations, to
provide input on the priorities of the Rare Disease Innovation Hub and
how the Hub can best engage with members of the rare disease community.
In particular, FDA is interested in receiving comments on the
following:
1. What specific rare disease-related scientific, regulatory, or
policy issues should be prioritized for consideration by the Rare
Disease Innovation Hub?
2. To the extent the issues identified in response to Question 1
are related to specific types of rare diseases or conditions, please
explain.
3. What specific types of rare disease-related activities do you
believe would benefit from enhanced collaboration, focused attention,
or increased transparency (to the extent legally permissible) under the
Rare Disease Innovation Hub? Please identify in your comments rare
disease-related activities or initiatives currently being undertaken by
CDER or CBER that you believe would benefit from being undertaken by
the Rare Disease Innovation Hub as a joint endeavor.
4. Please comment on approaches that the Rare Disease Innovation
Hub should follow for engagement with patients and caregiver groups,
industry organizations, and scientific/academic organizations
(including different approaches for different types of engagement, as
appropriate).
Comments will be accepted until 11:59 p.m. Eastern Time on October
31, 2024.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website to register: https://reaganudall.org/news-and-events/events/advancing-rare-disease-therapies-through-an-fda-rare-disease-innovation-hub. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone number.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register online by October 15, 2024, at 5 p.m. Eastern
Time. Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization.
If you need special accommodations due to a disability, please
contact Lea Ann Browning-McNee, Director of Communication and
Stakeholder Engagement, Reagan-Udall Foundation for FDA, 202-849-2075,
[email protected], no later than October 9, 2024, at 5 p.m.
Eastern Time.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. 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. 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 October 4, 2024. All
requests to make oral presentations must be received by 11:59 p.m. on
September 25, 2024. If selected for a presentation, you will be
contacted by Lea Ann Browning-McNee, Director of Communication and
Stakeholder Engagement, Reagan-Udall Foundation for FDA regarding
submission of a single slide in PowerPoint format. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting.
(Notice of this meeting is given pursuant to 21 CFR 10.65.)
Dated: August 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17924 Filed 8-9-24; 8:45 am]
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