Best Practices for Development and Application of Disease Progression Models; Public Workshop; Establishment of a Public Docket; Request for Comments, 11301-11303 [2021-03727]
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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
training for database staff on security
and privacy protection. The guidance
recommends that, among other
considerations, such a genetic variant
database would collect, store, and report
data and conclusions in compliance
with all applicable requirements
regarding protected health information,
patient privacy, research subject
protections, and data security. In section
V.A of the guidance, FDA discusses
security and privacy of such data,
stating that ‘‘[g]enetic variant database
operations must be in compliance with
all applicable federal laws and
regulations (e.g., the Health Insurance
Portability and Accountability Act, the
Genetic Information Nondiscrimination
Act, the Privacy Act, the Federal Policy
for the Protection of Human Subjects
(‘‘Common Rule’’), etc.) regarding
protected health information, patient
privacy, research involving human
subjects, and data security, as
applicable.’’
However, we believe the comment
may misunderstand the subject of the
information collection request. We are
requesting extension of the OMB
approval of the information collection
associated with the guidance document,
i.e., the application for recognition of a
publicly accessible genetic variant
database as a source of valid scientific
evidence that could support the clinical
validity of genetic and genomic-based
tests in a premarket submission, as well
as record maintenance and public
disclosure related to such recognition.
The application for recognition does not
11301
include submission of PII or PHI that
may be contained in a genetic variant
database. Rather, the application
includes standard operating procedures
and other documents related to the
database’s handling of PII and PHI
confidentiality and privacy, among
other considerations. The information
collected in the application for
recognition is used to evaluate the
database’s oversight and governance
procedures to determine that, among
other things, they are designed to ensure
the protection of PII and PHI and
provide appropriate training for
database staff.
We have not revised the information
collection based on the comment.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Application for recognition of genetic database ..................
5
1
5
80
400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Maintenance of recognition activities ...................................
5
1
5
20
100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Public disclosure of policies, procedures, and conflicts of
interest ..............................................................................
5
1
5
1
5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[Docket No. FDA–2021–N–0031]
khammond on DSKJM1Z7X2PROD with NOTICES
[FR Doc. 2021–03729 Filed 2–23–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Best Practices for Development and
Application of Disease Progression
Models; Public Workshop;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
One of the goals of the
Prescription Drug User Fee Act of 2017
SUMMARY:
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(PDUFA VI), part of the FDA
Reauthorization Act of 2017 (FDARA),
is advancing model-informed drug
development (MIDD). The ‘‘Best
Practices for Development and
Application of Disease Progression
Models’’ workshop fulfills FDA’s
performance commitment under PDUFA
VI to hold a workshop. The Food and
Drug Administration (FDA or Agency) is
opening a docket to solicit public input
on topics areas for an upcoming disease
progression modeling workshop. The
purpose of this public workshop is to
discuss the best practices for developing
disease progression models and their
application to support drug
development decisions; share
E:\FR\FM\24FEN1.SGM
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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
experiences and case studies that
highlight the opportunities and
limitations in the development and
application of disease progression
models including models for natural
history of disease and clinical trial
simulations; and discuss the knowledge
gaps and research needed to advance
the development and use of disease
progression models.
DATES: To ensure that the Agency
considers your input, submit either
electronic or written comments by
March 26, 2021.
ADDRESSES: FDA is establishing a docket
for public comment on this workshop.
The docket number is FDA–2021–N–
0031. The docket will close on March
26, 2021. Submit either electronic or
written comments on this public
workshop by March 26, 2021. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before March 26, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 26, 2021. 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.
You may submit comments as
follows:
khammond on DSKJM1Z7X2PROD 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
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’’).
VerDate Sep<11>2014
17:21 Feb 23, 2021
Jkt 253001
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–
2021–N–0031 for ‘‘Best Practices for
Development and Application of
Disease Progression Models; Public
Workshop; 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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
PO 00000
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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:
Maryanne Dingman, Office of Clinical
Pharmacology, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–8777, or Stephen
Ripley, 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.
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA, FDA agreed, in
accordance with section I of the PDUFA
VI Performance Goals, ‘‘Ensuring the
Effectiveness of the Human Drug
Review, part J, Enhancing Regulatory
Decision Tools to Support Drug
Development and Review,’’ to hold
several workshops to identify best
practices for MIDD. The workshop
entitled ‘‘Best Practices for Development
and Application of Disease Progression
Models,’’ to be held in 2021, fulfills
FDA’s performance commitment under
PDUFA VI. FDA is requesting comments
from the public to help identify areas of
interest to be discussed during the
workshop given the wide range of
approaches to data collection,
aggregation modeling, model
development, verification and
validation, and potential applications in
drug development and regulatory
review. The outcome will help the
Agency inform the public on current
experience, emerging techniques, and
limitations to streamline the drug model
development and facilitate the decisionmaking process.
II. Request for Information and
Comments
Interested persons are invited to
provide detailed information and
comments on areas of interest to discuss
during the upcoming ‘‘Best Practices for
Development and Application of
Disease Progression Models ’’ workshop.
FDA is interested in responses about
best practice considerations including,
but not limited to, the following:
1. The development and application
of different types of disease progression
models (e.g., empirical, semimechanistic, and fully mechanistic or
systems modeling).
E:\FR\FM\24FEN1.SGM
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11303
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
2. Modeling natural history of disease,
specifically methodological
considerations and challenges in
characterizing the natural relationship
between pharmacodynamic markers and
clinical outcomes.
3. Clinical trial simulations based on
disease progression/natural history
models to support drug development
and regulatory decisions.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03727 Filed 2–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4951]
Medical Devices; Humanitarian Use
Devices—21 CFR Part 814
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by March 26,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
SUMMARY:
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0332. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–0332—
Extension
This collection of information
implements the humanitarian use
devices (HUDs) provision of section
520(m) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360j(m)) and part 814, subpart H (21
CFR part 814, subpart H). Under section
520(m) of the FD&C Act, FDA is
authorized to exempt an HUD from the
effectiveness requirements of sections
514 and 515 of the FD&C Act (21 U.S.C.
360d and 360e) provided that the
device: (1) Is designed to treat or
diagnose a disease or condition that
affects no more than 8,000 individuals
in the United States; (2) would not be
available to a person with a disease or
condition unless an exemption is
granted and there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose such
disease or condition; and (3) will not
expose patients to an unreasonable or
significant risk of illness or injury and
the probable benefit to health from the
use of the device outweighs the risk of
injury or illness from its use, taking into
account the probable risks and benefits
of currently available devices or
alternative forms of treatment.
Respondents may submit a
humanitarian device exemption (HDE)
application seeking exemption from the
effectiveness requirements of sections
514 and 515 of the FD&C Act as
authorized by section 520(m)(2) of the
FD&C Act. The information collected
will assist FDA in making
determinations on the following: (1)
Whether to grant HUD designation of a
medical device; (2) whether to exempt
an HUD from the effectiveness
requirements under sections 514 and
515 of the FD&C Act, provided that the
device meets requirements set forth
under section 520(m) of the FD&C Act;
and (3) whether to grant marketing
approval(s) for the HUD. Failure to
collect this information would prevent
FDA from making a determination on
the factors listed previously in this
document. Further, the collected
information would also enable FDA to
determine whether the holder of an
HUD is in compliance with the HUD
provisions under section 520(m) of the
FD&C Act.
In the Federal Register of August 13,
2020 (85 FR 49379), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although two comments
were received, they were not responsive
to the four collection of information
topics solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for HUD designation—814.102 .............................
HDE Application—814.104 ..................................................
HDE Amendments and resubmitted HDEs—814.106 .........
HDE Supplements—814.108 ...............................................
Notification of withdrawal of an HDE—814.116(e)(3) .........
Notification of withdrawal of institutional review board approval—814.124(b) ...........................................................
Periodic reports—814.126(b)(1) ..........................................
20
4
20
116
2
1
1
5
1
1
20
4
100
116
2
40
328
50
80
1
800
1,312
5,000
9,280
2
1
50
1
1
1
50
2
120
2
6,000
Total ..............................................................................
........................
........................
........................
........................
22,396
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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24FEN1
]]>Agencies
[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11301-11303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03727]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0031]
Best Practices for Development and Application of Disease
Progression Models; Public Workshop; Establishment of a Public Docket;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: One of the goals of the Prescription Drug User Fee Act of 2017
(PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), is
advancing model-informed drug development (MIDD). The ``Best Practices
for Development and Application of Disease Progression Models''
workshop fulfills FDA's performance commitment under PDUFA VI to hold a
workshop. The Food and Drug Administration (FDA or Agency) is opening a
docket to solicit public input on topics areas for an upcoming disease
progression modeling workshop. The purpose of this public workshop is
to discuss the best practices for developing disease progression models
and their application to support drug development decisions; share
[[Page 11302]]
experiences and case studies that highlight the opportunities and
limitations in the development and application of disease progression
models including models for natural history of disease and clinical
trial simulations; and discuss the knowledge gaps and research needed
to advance the development and use of disease progression models.
DATES: To ensure that the Agency considers your input, submit either
electronic or written comments by March 26, 2021.
ADDRESSES: FDA is establishing a docket for public comment on this
workshop. The docket number is FDA-2021-N-0031. The docket will close
on March 26, 2021. Submit either electronic or written comments on this
public workshop by March 26, 2021. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before March 26, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of March 26, 2021. 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.
You may submit comments as follows:
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-2021-N-0031 for ``Best Practices for Development and Application of
Disease Progression Models; Public Workshop; 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: Maryanne Dingman, Office of Clinical
Pharmacology, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-8777, or Stephen Ripley, 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.
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA, FDA agreed, in accordance with section I of the PDUFA
VI Performance Goals, ``Ensuring the Effectiveness of the Human Drug
Review, part J, Enhancing Regulatory Decision Tools to Support Drug
Development and Review,'' to hold several workshops to identify best
practices for MIDD. The workshop entitled ``Best Practices for
Development and Application of Disease Progression Models,'' to be held
in 2021, fulfills FDA's performance commitment under PDUFA VI. FDA is
requesting comments from the public to help identify areas of interest
to be discussed during the workshop given the wide range of approaches
to data collection, aggregation modeling, model development,
verification and validation, and potential applications in drug
development and regulatory review. The outcome will help the Agency
inform the public on current experience, emerging techniques, and
limitations to streamline the drug model development and facilitate the
decision-making process.
II. Request for Information and Comments
Interested persons are invited to provide detailed information and
comments on areas of interest to discuss during the upcoming ``Best
Practices for Development and Application of Disease Progression Models
'' workshop. FDA is interested in responses about best practice
considerations including, but not limited to, the following:
1. The development and application of different types of disease
progression models (e.g., empirical, semi-mechanistic, and fully
mechanistic or systems modeling).
[[Page 11303]]
2. Modeling natural history of disease, specifically methodological
considerations and challenges in characterizing the natural
relationship between pharmacodynamic markers and clinical outcomes.
3. Clinical trial simulations based on disease progression/natural
history models to support drug development and regulatory decisions.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03727 Filed 2-23-21; 8:45 am]
BILLING CODE 4164-01-P
