[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, 
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.

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


