[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2451-2452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00685]


-----------------------------------------------------------------------

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) 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: Fax written comments on the collection of information by 
February 16, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Use of Public Human Genetic Variant Databases to Support 
Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics.'' 
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, 
[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.

Use of Public Human Genetic Variant Databases To Support Clinical 
Validity for Genetic and Genomic-Based In Vitro Diagnostics--OMB 
Control Number 0910--NEW

    This information collection supports the above captioned Agency 
guidance document. In the Federal Register of July 8, 2016 (81 FR 
44611), FDA announced the availability of a draft guidance for industry 
entitled ``Use of Public Human Genetic Variant Databases To Support 
Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro 
Diagnostics,'' and included an analysis of the associated information 
collection.
    The draft guidance described 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. 
This draft 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 draft 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.
---------------------------------------------------------------------------

    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.
    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.
    FDA received 36 comments on the draft guidance, none of which 
pertained to the information collection burden estimate.
    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.


[[Page 2452]]


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of       disclosures      Total annual   Average  burden    Total hours
                                                                       respondents    per  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.

    The draft guidance also refers to previously approved collections 
of information. These collections of information are subject to review 
by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in the guidance document 
``Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration 
Staff'' have been approved under OMB control number 0910-0756. The 
collections of information regarding premarket submissions have been 
approved as follows: The collections of information in 21 CFR part 807, 
subpart E, have been approved under OMB control number 0910-0120 and 
the collections of information in 21 CFR part 814, subparts A through 
E, have been approved under OMB control number 0910-0231.

    Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00685 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P


