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, 2451-2452 [2018-00685]
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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00678 Filed 1–16–18; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
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:
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 oira_
submission@omb.eop.gov. 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.
ADDRESSES:
Notice.
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.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
2451
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 NGSbased 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.
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
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
ethrower on DSK3G9T082PROD with NOTICES
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.
1 FDA acknowledges that many databases may not
use the term ‘‘administrator’’ or may have a
VerDate Sep<11>2014
17:14 Jan 16, 2018
Jkt 244001
committee of individuals that oversee the database.
Therefore, for the purpose of this guidance, a
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
genetic variant database administrator is the entity
or entities that oversee database operations.
E:\FR\FM\17JAN1.SGM
17JAN1
2452
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2227]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SYNERGY EVEROLIMUS–
ELUTING PLATINUM CHROMIUM
CORONARY STENT SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SYNERGY EVEROLIMUS–ELUTING
PLATINUM CHROMIUM CORONARY
STENT SYSTEM and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
ethrower on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:14 Jan 16, 2018
Jkt 244001
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by March 19, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
July 16, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 March 19,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of March 19, 2018. 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
PO 00000
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Fmt 4703
Sfmt 4703
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–
2016–E–2227 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; SYNERGY
EVEROLIMUS–ELUTING PLATINUM
CHROMIUM CORONARY STENT
SYSTEM.’’ 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.
• 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
E:\FR\FM\17JAN1.SGM
17JAN1
]]>Agencies
[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
