Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal; Correction, 1599-1600 [2023-00390]
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Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Notices
The goal of the early meeting
discussions granted under this program
is to provide advice on how specific,
proposed MIDD approaches can be used
in a particular drug development
program. FDA has committed to
accepting one to two appropriate
meeting requests quarterly each fiscal
year. The meetings granted will include
an initial and followup meeting on the
same drug development issues. The
second meeting will occur within
approximately 60 days of receiving the
briefing package.
II. Eligibility and Selection for
Participation in the MIDD Program
The sponsor should be a drug/
biologics development company
(interested consortia or software/device
developer should come in partnership
with a drug development company) and
have an investigational new drug
application (IND) or pre-IND (PIND)
number for the relevant program. FDA
welcomes submissions related to any
relevant MIDD topics, such as:
• Dose selection or estimation (e.g.,
for dose/dosing regimen selection or
refinement)
• Clinical trial simulation (e.g., based
on drug-trial-disease models to inform
the duration of a trial, select appropriate
response measures, predict outcomes,
etc.)
• Predictive or mechanistic safety
evaluation (e.g., use of systems
pharmacology/mechanistic models for
predicting safety or identifying critical
biomarkers of interest)
III. Procedures and Submission
Information
A. General Information
The MIDD program will be jointly
administered by CDER’s Office of
Clinical Pharmacology, in the Office of
Translational Sciences, which is the
point of contact for all communications
for CDER products, and CBER’s Office of
Biostatistics and Pharmacovigilance,
which is the point of contact for all
communications for CBER products.
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B. How To Submit a Meeting Request
and Meeting Package
Meeting requests should be submitted
electronically to the relevant application
(i.e., PIND, IND) with ‘‘MIDD Program
Meeting Request for CDER’’ (CDER
applications) or ‘‘MIDD Program
Meeting Request for CBER’’ (CBER
applications) in the subject line.
Information about providing regulatory
submissions in electronic format is
available at: https://www.fda.gov/drugs/
development-approval-process-drugs/
forms-submission-requirements.
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C. Content and Format of the Meeting
Request
Include the following information in
the meeting request (no more than three
to four pages):
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indication(s) or context of
product development.
5. A brief statement of the purpose
and objectives of the meeting. The
statement should include a brief
background of the MIDD issues
underlying the agenda.
6. MIDD approach(es) considered for
the product under development and
how MIDD can assess uncertainties
about issues (e.g., dosing, duration,
patient selection) in a way that can
inform regulatory decision-making.
7. A list of issues for discussion with
the Agency about the specific MIDD
proposed approach for the applicable
drug development program.
D. Content and Format of the Meeting
Information Package
Sponsors whose meeting requests are
granted as part of the program should
submit a meeting information package
electronically with ‘‘MIDD Program
Meeting Package for CDER’’ (CDER
applications) or ‘‘MIDD Program
Meeting Package for CBER’’ (CBER
applications) in the subject line no later
than 47 days before the initial meeting
and 60 days before the follow-up
meeting. This meeting package should
include the following information:
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indications or context of
product development.
5. Background section that includes a
brief history of the development
program and the events leading up to
the meeting as well as the status of
product development.
6. Proposed agenda, including
estimated times needed for discussion
of each agenda item.
7. List of questions for discussion
along with a brief summary explaining
the question of interest and the context
of use for each question. State whether
the model will be used to inform future
trials, to provide mechanistic insight, or
in lieu of a clinical trial.
8. The drug development issue (e.g.,
dosing, clinical trial design, safety
prediction, etc.), the proposed MIDD
approach to the solution, information to
support discussion (e.g., a description of
the data utilized for developing the
models, model development, simulation
plan, results), assessment of model risk,
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1599
and how the Agency can help guide any
next steps relative to the regulatory
decision-making process should be
summarized and clearly articulated with
any supporting data imperative to the
discussion.
E. Meeting Summaries
A meeting summary will be sent to
the requester within 30 days of each
meeting.
IV. Paperwork Reduction Act of 1995
While this notice contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this notice. The
previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information pertaining to Prescription
Drug User Fee Program have been
approved under OMB control number
0910–0297. The collections of
information for requesting meetings
with FDA about drug development
programs have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
part 312 for INDs and clinical trials have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 601 for
biologics license applications have been
approved under OMB control number
0910–0338.
Dated: January 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00389 Filed 1–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3091]
Advisory Committee; Cardiovascular
and Renal Drugs Advisory Committee;
Renewal; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Advisory Committee;
Cardiovascular and Renal Drugs
Advisory Committee; Renewal’’ that
appeared in the Federal Register of
December 13, 2022. The document
announced the renewal of the
SUMMARY:
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1600
Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Notices
Cardiovascular and Renal Drugs
Advisory Committee. The document
was published with the incorrect docket
number. This document corrects that
error.
Lisa
Granger, Office of Policy, Planning,
Legislation and International Affairs,
Food and Drug Administration, 301–
796–9115, Lisa.Granger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, December
13, 2022 (87 FR 76197), in FR Doc.
2022–27014, on page 76197 the
following correction is made:
1. On page 76197, in the first column
of the header of the document, ‘‘Docket
No. FDA–2022–N–3091’’ is corrected to
read ‘‘Docket No. FDA–2018–N–3091’’.
FOR FURTHER INFORMATION CONTACT:
Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00390 Filed 1–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The National
Health Service Corps and Nurse Corps
Interest Capture Form—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
SUMMARY:
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 13, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at 301–594–4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The National Health Service Corps
(NHSC) and Nurse Corps Interest
Capture Form OMB No. 0915–0337—
Revision.
Abstract: The NHSC and the Nurse
Corps Scholarship and Loan Repayment
Programs of HRSA are both committed
to improving the health of the nation’s
underserved by uniting communities in
need with caring health professionals
and by supporting communities’ efforts
to build better systems of care. The
NHSC and Nurse Corps Interest Capture
Form, which can be accessed on the
HRSA website at https://bhw.hrsa.gov/
about-us/ask-question, is an optional
form that a health profession student,
licensed clinician, faculty member,
clinical site administrator, or other
interested individual can complete and
submit to HRSA online. The purpose of
the form is to enable individuals and
clinical sites to ask questions about the
NHSC and/or Nurse Corps Scholarship
and Loan Repayment Programs, and to
provide their contact information so that
HRSA may provide them with periodic
program updates and other general
information via email. Completed forms
will contain information such as the
names and roles of the individual(s),
their phone number(s) and email
address(es), and the HRSA program(s) in
which they are interested or about
which they have questions.
The revisions in this ICR are as
follows:
a. The discontinuation of the print
version of the NHSC and Nurse Corps
Interest Capture Form, previously used
by HRSA staff for sharing program
information with health profession
students and providers at national and
regional conferences and campus
recruiting events.
b. The addition of an online version
of the NHSC and Nurse Corps Interest
Capture Form, located on the HRSA
website at https://bhw.hrsa.gov/aboutus/ask-question.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to share
resources and information regarding the
NHSC and Nurse Corps Scholarship and
Loan Repayment Programs with
interested HRSA website (hrsa.gov)
visitors.
Likely Respondents: Individuals and
potential service sites interested in the
NHSC or Nurse Corps Scholarship and
Loan Repayment Programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NHSC and Nurse Corps Interest Capture Form .................
16,144
1
16,144
.025
404
Total ..............................................................................
16,144
........................
16,144
........................
404
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]]>Agencies
[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Notices]
[Pages 1599-1600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00390]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3091]
Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee; Renewal; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee; Renewal'' that appeared in the Federal Register of December
13, 2022. The document announced the renewal of the
[[Page 1600]]
Cardiovascular and Renal Drugs Advisory Committee. The document was
published with the incorrect docket number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Planning, Legislation and International Affairs, Food and Drug
Administration, 301-796-9115, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, December
13, 2022 (87 FR 76197), in FR Doc. 2022-27014, on page 76197 the
following correction is made:
1. On page 76197, in the first column of the header of the
document, ``Docket No. FDA-2022-N-3091'' is corrected to read ``Docket
No. FDA-2018-N-3091''.
Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00390 Filed 1-10-23; 8:45 am]
BILLING CODE 4164-01-P
