Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics, 11300-11301 [2021-03729]
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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
Our estimated burden for the
information collection reflects an
increase of 52 hours. We attribute this
adjustment to an increase in the number
of establishments and reprocessed
SUDs.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03748 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–7012]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Use of Public
Human Genetic Variant Databases To
Support Clinical Validity for Genetic
and Genomic-Based In Vitro
Diagnostics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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://
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 0910–0850. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:21 Feb 23, 2021
Jkt 253001
has submitted the following proposed
collection of information to OMB for
review and clearance.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Use of Public
Human Genetic Variant Databases To
Support Clinical Validity for Genetic
and Genomic-Based In Vitro
Diagnostics
OMB Control Number 0910–0850—
Extension
Section 2011 of the 21st Century
Cures Act of 2016 (Pub. L. 114–255)
encourages the FDA to develop new
approaches for addressing regulatory
science issues as part of the Precision
Medicine Initiative (PMI).
In the Federal Register of April 13,
2018 (83 FR 16110), FDA announced the
availability of a guidance for industry
entitled ‘‘Use of Public Human Genetic
Variant Databases to Support Clinical
Validity for Genetic and Genomic-Based
In Vitro Diagnostics; Guidance for
Stakeholders and Food and Drug
Administration Staff.’’ 1 The guidance
describes one part of FDA’s PMI effort
to create a flexible and adaptive
regulatory approach to the oversight of
next generation sequencing (NGS)-based
tests. The goal of this effort is to help
ensure patients receive accurate and
meaningful test results, while promoting
innovation in test development. The
guidance describes how publicly
accessible databases of human genetic
variants can serve as sources of valid
scientific evidence to support the
clinical validity of genotype-phenotype
relationships in FDA’s regulatory review
of both NGS-based tests and genetic and
genomic tests based on other
technologies. Publicly accessible genetic
databases may be useful to support the
clinical validity of NGS tests as well as
single gene or panel tests that use other
technology.
The guidance describes FDA’s
considerations in determining whether a
genetic variant database is a source of
valid scientific evidence that could
support the clinical validity of an NGSbased test. The guidance further
outlines the process by which
administrators 2 of genetic variant
databases could voluntarily apply to
FDA for recognition, and how FDA
1 Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/usepublic-human-genetic-variant-databases-supportclinical-validity-genetic-and-genomic-based-vitro.
2 FDA acknowledges that many databases may not
use the term ‘‘administrator’’ or may have a
committee of individuals that oversee the database.
Therefore, for the purpose of this guidance, a
genetic variant database administrator is the entity
or entities that oversee database operations.
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
would review such applications and
periodically reevaluate recognized
databases. The guidance also
recommends that, at the time of
recognition, the database administrator
make information regarding policies,
procedures, and conflicts of interest
publicly available and accessible on the
genetic variant database’s website.
Respondents are administrators of
genetic databases. Our estimate of five
respondents per year is based on the
current number of databases that may
meet FDA recommendations for
recognition and seek such recognition.
Based on our experience and the
nature of the information, we estimate
that it will take an average of 80 hours
to complete and submit an application
for recognition. We estimate that
maintenance of recognition activities
will take approximately one-fourth of
that time (20 hours) annually. We
estimate that it will take approximately
1 hour to post the information on the
website.
In the Federal Register of September
23, 2020 (85 FR 59801), we published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments. One comment was not
relevant to the topic or information
collection. A summary of the other
comment and our response are as
follows:
(Comment) One comment expressed
concerns and suggestions regarding the
collection, storage, and security of
personally identifiable information (PII)
and protected health information (PHI).
(Response) The guidance document
‘‘Use of Public Human Genetic Variant
Databases to Support Clinical Validity
for Genetic and Genomic-Based In Vitro
Diagnostics’’ describes, among other
things, FDA’s considerations in
determining whether a publicly
accessible genetic variant database is a
source of valid scientific evidence that
could support the clinical validity of
genetic and genomic-based tests in a
premarket submission and outlines the
process by which administrators of
publicly accessible genetic variant
databases could voluntarily apply to
FDA for recognition, and how FDA
would assess such applications and
periodically reevaluate recognized
databases. FDA recommends that
genetic database administrators should
identify the applicable laws and
regulations to assure that any
requirements are addressed and
transparently documented. Genetic
variant database administrators should
also put in place adequate security
measures to ensure the protection and
privacy of PII and PHI and provide
E:\FR\FM\24FEN1.SGM
24FEN1
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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17:21 Feb 23, 2021
Jkt 253001
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
(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
24FEN1
]]>Agencies
[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11300-11301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-7012]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Use of Public Human
Genetic Variant Databases To Support Clinical Validity for Genetic and
Genomic-Based In Vitro Diagnostics
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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://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 0910-0850. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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.
Agency Information Collection Activities; Proposed Collection; Comment
Request; Use of Public Human Genetic Variant Databases To Support
Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics
OMB Control Number 0910-0850--Extension
Section 2011 of the 21st Century Cures Act of 2016 (Pub. L. 114-
255) encourages the FDA to develop new approaches for addressing
regulatory science issues as part of the Precision Medicine Initiative
(PMI).
In the Federal Register of April 13, 2018 (83 FR 16110), FDA
announced the availability of a guidance for industry entitled ``Use of
Public Human Genetic Variant Databases to Support Clinical Validity for
Genetic and Genomic-Based In Vitro Diagnostics; Guidance for
Stakeholders and Food and Drug Administration Staff.'' \1\ The guidance
describes one part of FDA's PMI effort to create a flexible and
adaptive regulatory approach to the oversight of next generation
sequencing (NGS)-based tests. The goal of this effort is to help ensure
patients receive accurate and meaningful test results, while promoting
innovation in test development. The guidance describes how publicly
accessible databases of human genetic variants can serve as sources of
valid scientific evidence to support the clinical validity of genotype-
phenotype relationships in FDA's regulatory review of both NGS-based
tests and genetic and genomic tests based on other technologies.
Publicly accessible genetic databases may be useful to support the
clinical validity of NGS tests as well as single gene or panel tests
that use other technology.
---------------------------------------------------------------------------
\1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-public-human-genetic-variant-databases-support-clinical-validity-genetic-and-genomic-based-vitro.
---------------------------------------------------------------------------
The guidance describes FDA's considerations in determining whether
a genetic variant database is a source of valid scientific evidence
that could support the clinical validity of an NGS-based test. The
guidance further outlines the process by which administrators \2\ of
genetic variant databases could voluntarily apply to FDA for
recognition, and how FDA would review such applications and
periodically reevaluate recognized databases. The guidance also
recommends that, at the time of recognition, the database administrator
make information regarding policies, procedures, and conflicts of
interest publicly available and accessible on the genetic variant
database's website.
---------------------------------------------------------------------------
\2\ FDA acknowledges that many databases may not use the term
``administrator'' or may have a committee of individuals that
oversee the database. Therefore, for the purpose of this guidance, a
genetic variant database administrator is the entity or entities
that oversee database operations.
---------------------------------------------------------------------------
Respondents are administrators of genetic databases. Our estimate
of five respondents per year is based on the current number of
databases that may meet FDA recommendations for recognition and seek
such recognition.
Based on our experience and the nature of the information, we
estimate that it will take an average of 80 hours to complete and
submit an application for recognition. We estimate that maintenance of
recognition activities will take approximately one-fourth of that time
(20 hours) annually. We estimate that it will take approximately 1 hour
to post the information on the website.
In the Federal Register of September 23, 2020 (85 FR 59801), we
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments. One comment was
not relevant to the topic or information collection. A summary of the
other comment and our response are as follows:
(Comment) One comment expressed concerns and suggestions regarding
the collection, storage, and security of personally identifiable
information (PII) and protected health information (PHI).
(Response) The guidance document ``Use of Public Human Genetic
Variant Databases to Support Clinical Validity for Genetic and Genomic-
Based In Vitro Diagnostics'' describes, among other things, FDA's
considerations in determining whether a publicly accessible genetic
variant database is a source of valid scientific evidence that could
support the clinical validity of genetic and genomic-based tests in a
premarket submission and outlines the process by which administrators
of publicly accessible genetic variant databases could voluntarily
apply to FDA for recognition, and how FDA would assess such
applications and periodically reevaluate recognized databases. FDA
recommends that genetic database administrators should identify the
applicable laws and regulations to assure that any requirements are
addressed and transparently documented. Genetic variant database
administrators should also put in place adequate security measures to
ensure the protection and privacy of PII and PHI and provide
[[Page 11301]]
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 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public disclosure of policies, procedures, and conflicts of 5 1 5 1 5
interest..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03729 Filed 2-23-21; 8:45 am]
BILLING CODE 4164-01-P
