Document ID: FDA-2017-N-7012-0003
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2020-09-23T04:00Z

[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.

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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, 
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

[[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.
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    \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.
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    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\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total  hours
                                                                       respondents       respondent       responses       per response
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Application for recognition of genetic database....................               5                1                5               80              400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Maintenance of recognition activities..............................               5                1                5               20              100
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\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\
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                                                                                         Number of
                              Activity                                  Number of     disclosures per   Total  annual   Average  burden    Total  hours
                                                                       respondents       respondent      disclosures    per  disclosure
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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