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, 59801-59803 [2020-20960]
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Federal Register / Vol. 85, No. 185 / Wednesday, September 23, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–7012]
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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with FDA
recognition of public human genetic
variant databases to support clinical
validity for genetic and genomic-based
in vitro diagnostics.
DATES: Submit either electronic or
written comments on the collection of
information by November 23, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 23,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 23, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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
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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–
2017–N–7012 for ‘‘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.’’ 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
PO 00000
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59801
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
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: 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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
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Federal Register / Vol. 85, No. 185 / Wednesday, September 23, 2020 / Notices
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 January 17,
2018 (83 FR 2451), FDA announced the
availability of a guidance for industry
entitled ‘‘Use of Public Human Genetic
Variant Databases To Support Clinical
Validity for Next Generation
Sequencing-Based In Vitro Diagnostics.’’
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 NGSbased 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 1 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.
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.
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.
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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.
1 FDA acknowledges that many databases may not
use the term ‘‘administrator’’ or may have a
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committee of individuals that oversee the database.
Therefore, for the purpose of this guidance, a
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genetic variant database administrator is the entity
or entities that oversee database operations.
E:\FR\FM\23SEN1.SGM
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Federal Register / Vol. 85, No. 185 / Wednesday, September 23, 2020 / Notices
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: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–20960 Filed 9–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1879]
Determination That PREXXARTAN
(Valsartan) Oral Solution, 20
Milligrams/5 Milliliters and 80
Milligrams/20 Milliliters, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PREXXARTAN
(valsartan) oral solution, 20 milligrams
(mg)/5 milliliters (mL) and 80 mg/20
mL, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for valsartan oral
solution, 20 mg/5 mL and 80 mg/20 mL,
if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Robin Fastenau, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 240–
402–4510, robin.fastenau@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
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SUMMARY:
VerDate Sep<11>2014
18:02 Sep 22, 2020
Jkt 250001
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
PREXXARTAN (valsartan) oral
solution, 20 mg/5 mL and 80 mg/20 mL,
is the subject of NDA 209139, held by
Carmel Biosciences, Inc., and initially
approved on December 19, 2017.
PREXXARTAN is indicated for
hypertension in adults and children 6
years and older, to lower blood
pressure; for heart failure by
significantly reducing hospitalization
for patients who are unable to swallow
valsartan tablets; and for stable left
ventricular failure or left ventricular
dysfunction following myocardial
infarction.
PREXXARTAN (valsartan) oral
solution, 20 mg/5 mL and 80 mg/20 mL,
is currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. Additionally, Carmel Biosciences
has never marketed PREXXARTAN
(valsartan) oral solution, 20 mg/5 mL
and 80 mg/20 mL. In previous instances
(see, e.g., 72 FR 9763, March 5, 2007; 61
FR 25497, May 21, 1996), the Agency
has determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Novitium Pharma LLC submitted a
citizen petition dated January 30, 2020
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
59803
(Docket No. FDA–2020–P–0511), under
21 CFR 10.30, requesting that the
Agency determine whether
PREXXARTAN (valsartan) oral solution,
20 mg/5 mL, was withdrawn from sale
for reasons of safety or effectiveness.
Although the citizen petition did not
address the 80 mg/20 mL strength, that
strength has also been discontinued. On
our own initiative, we have also
determined whether that strength was
withdrawn for safety or effectiveness
reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PREXXARTAN
(valsartan) oral solution, 20 mg/5 mL
and 80 mg/20 mL, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that this
drug product was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
PREXXARTAN (valsartan) oral solution,
20 mg/5 mL and 80 mg/20 mL, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list PREXXARTAN
(valsartan) oral solution, 20 mg/5 mL
and 80 mg/20 mL, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to PREXXARTAN
(valsartan) oral solution, 20 mg/5 mL
and 80 mg/20 mL, may be approved by
the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: September 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–20965 Filed 9–22–20; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Pages 59801-59803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20960]
[[Page 59801]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-7012]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with FDA
recognition of public human genetic variant databases to support
clinical validity for genetic and genomic-based in vitro diagnostics.
DATES: Submit either electronic or written comments on the collection
of information by November 23, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 23, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-7012 for ``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.'' 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: 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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
[[Page 59802]]
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 January 17, 2018 (83 FR 2451), FDA
announced the availability of a guidance for industry entitled ``Use of
Public Human Genetic Variant Databases To Support Clinical Validity for
Next Generation Sequencing-Based In Vitro Diagnostics.'' 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 NGS-based test. The
guidance further outlines the process by which administrators \1\ 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.
---------------------------------------------------------------------------
\1\ 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.
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..........................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 59803]]
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: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20960 Filed 9-22-20; 8:45 am]
BILLING CODE 4164-01-P
