Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses, 34190-34191 [2019-15160]
Download as PDF
<![CDATA[
34190
Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health and FDA’s Center for Biologics
Evaluation and Research to initiate the
administrative screening of new medical
device applications and supplemental
applications.
The total number of annual responses
is based on the average number of cover
sheet submissions received by FDA in
recent years. The number of received
annual responses includes cover sheets
for applications that were qualified for
small businesses and fee waivers or
reductions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions, and range from 5 to 30
minutes. The hours per response are
based on the average of these estimates
(18 minutes).
In the Federal Register of December
28, 2018 (83 FR 67287), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was
received.
The comment was generally
supportive of the user fee cover sheet for
medical devices. However, the comment
also noted that there are costs associated
with the preparation of the cover sheet.
The comment did not suggest specific
changes to our cost or hour burden
estimates provided in this information
collection request. We have not changed
our estimates as a result of the
comment.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA Form No.
3601 .............................................................
1 There
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15161 Filed 7–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
6,379
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
Food and Drug Administration,
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.
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
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:
HHS.
SUMMARY:
Fax written comments on the
collection of information by August 16,
2019.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0584. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
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.
[Docket No. FDA–2015–N–3662]
jbell on DSK3GLQ082PROD with NOTICES
1
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
ACTION:
6,379
Average
burden per
response
Total annual
responses
0.30 (18 minutes) ...........
Total hours
1,914
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 350 hours and a
corresponding increase of 1,165
responses/records. We attribute this
adjustment to an increase in the number
of submissions we received over the last
few years.
AGENCY:
Number of
responses per
respondent
Guidance on Reagents for Detection of
Specific Novel Influenza A Viruses—21
CFR Part 866
OMB Control Number 0910–0584—
Extension
In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360c), FDA
evaluated an application for an in vitro
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
diagnostic device for detection of
influenza subtype H5 (Asian lineage),
commonly known as avian flu. FDA
concluded that this device is properly
classified into class II in accordance
with section 513(a)(1)(B) of the FD&C
Act, because it is a device for which the
general controls by themselves are
insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, but there is sufficient
information to establish special controls
to provide such assurance. The statute
permits FDA to establish as special
controls many different things,
including postmarket surveillance,
development and dissemination of
guidance recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (section 513(a)(1)(B)
of the FD&C Act). This information
collection is a measure that FDA
determined to be necessary to provide
reasonable assurance of safety and
effectiveness of reagents for detection of
specific novel influenza A viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on March 22, 2006 (71 FR
14377), establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification was
codified in 21 CFR 866.3332, a
regulation that describes the new
classification for reagents for detection
of specific novel influenza A viruses
and sets forth the special controls that
E:\FR\FM\17JYN1.SGM
17JYN1
34191
Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation refers to the document
entitled ‘‘Class II Special Controls
Guidance Document: Reagents for
Detection of Specific Novel Influenza A
Viruses,’’ which provides
recommendations for measures to help
provide a reasonable assurance of safety
and effectiveness for these reagents. The
guidance recommends that sponsors
obtain and analyze postmarket data to
ensure the continued reliability of their
device in detecting the specific novel
influenza A virus that it is intended to
detect, particularly given the propensity
for influenza viruses to mutate and the
potential for changes in disease
prevalence over time. As updated
sequences for novel influenza A viruses
become available from the World Health
Organization, National Institutes of
Health, and other public health entities,
sponsors of reagents for detection of
specific novel influenza A viruses will
collect this information, compare them
with the primer/probe sequences in
their devices, and incorporate the result
of these analyses into their quality
management system, as required by 21
CFR 820.100(a)(1). These analyses will
be evaluated against the device design
validation and risk analysis required by
21 CFR 820.30(g) to determine if any
design changes may be necessary.
FDA estimates that one respondent
will be affected annually. The
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 30
hours.
The guidance also refers to previously
approved information collections found
in FDA regulations. The collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; 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 820 have been approved under
OMB control number 0910–0073.
In the Federal Register of March 5,
2019 (84 FR 7904), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping regarding reagents for detection of
specific novel influenza A viruses ..........................
1
2
2
15
30
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Manufactures are increasingly
adopting in silico methods
(computational analysis) for the
detection of specific novel Influenza A
viruses over traditional laboratory
techniques. Therefore, few
manufactures are using reagents for
detection of specific novel influenza A
viruses. Based on these industry trends,
we estimate a decrease in the number of
total annual records and a
corresponding decrease of 270 hours in
the total burden since our last OMB
approval.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
HHS.
[FR Doc. 2019–15160 Filed 7–16–19; 8:45 am]
jbell on DSK3GLQ082PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
Food and Drug Administration
[Docket No. FDA–2013–N–0297]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prevention of
Salmonella Enteritidis in Shell Eggs
During Production; Recordkeeping and
Registration Provisions
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
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: Fax written comments on the
collection of information by August 16,
2019.
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 oira_
SUMMARY:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0660. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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:
Prevention of Salmonella Enteritidis
in Shell Eggs During Production—
Recordkeeping and Registration
Provisions—21 CFR 118.10 and 118.11
OMB Control Number 0910–0660—
Extension
Shell eggs contaminated with
Salmonella Enteritidis (SE) are
responsible for more than 140,000
illnesses per year. The Public Health
Service Act (PHS Act) (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services to make and enforce
such regulations as ‘‘are necessary to
prevent the introduction, transmission,
E:\FR\FM\17JYN1.SGM
17JYN1
]]>Agencies
[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34190-34191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15160]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3662]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Reagents
for Detection of Specific Novel Influenza A Viruses
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 August
16, 2019.
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 0910-0584.
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.
Guidance on Reagents for Detection of Specific Novel Influenza A
Viruses--21 CFR Part 866
OMB Control Number 0910-0584--Extension
In accordance with section 513 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c), FDA evaluated an application
for an in vitro diagnostic device for detection of influenza subtype H5
(Asian lineage), commonly known as avian flu. FDA concluded that this
device is properly classified into class II in accordance with section
513(a)(1)(B) of the FD&C Act, because it is a device for which the
general controls by themselves are insufficient to provide reasonable
assurance of the safety and effectiveness of the device, but there is
sufficient information to establish special controls to provide such
assurance. The statute permits FDA to establish as special controls
many different things, including postmarket surveillance, development
and dissemination of guidance recommendations, and ``other appropriate
actions as the Secretary deems necessary'' (section 513(a)(1)(B) of the
FD&C Act). This information collection is a measure that FDA determined
to be necessary to provide reasonable assurance of safety and
effectiveness of reagents for detection of specific novel influenza A
viruses.
FDA issued an order classifying the H5 (Asian lineage) diagnostic
device into class II on March 22, 2006 (71 FR 14377), establishing the
special controls necessary to provide reasonable assurance of the
safety and effectiveness of that device and similar future devices. The
new classification was codified in 21 CFR 866.3332, a regulation that
describes the new classification for reagents for detection of specific
novel influenza A viruses and sets forth the special controls that
[[Page 34191]]
help to provide a reasonable assurance of the safety and effectiveness
of devices classified under that regulation. The regulation refers to
the document entitled ``Class II Special Controls Guidance Document:
Reagents for Detection of Specific Novel Influenza A Viruses,'' which
provides recommendations for measures to help provide a reasonable
assurance of safety and effectiveness for these reagents. The guidance
recommends that sponsors obtain and analyze postmarket data to ensure
the continued reliability of their device in detecting the specific
novel influenza A virus that it is intended to detect, particularly
given the propensity for influenza viruses to mutate and the potential
for changes in disease prevalence over time. As updated sequences for
novel influenza A viruses become available from the World Health
Organization, National Institutes of Health, and other public health
entities, sponsors of reagents for detection of specific novel
influenza A viruses will collect this information, compare them with
the primer/probe sequences in their devices, and incorporate the result
of these analyses into their quality management system, as required by
21 CFR 820.100(a)(1). These analyses will be evaluated against the
device design validation and risk analysis required by 21 CFR 820.30(g)
to determine if any design changes may be necessary.
FDA estimates that one respondent will be affected annually. The
respondent will collect this information twice per year; each response
is estimated to take 15 hours. This results in a total data collection
burden of 30 hours.
The guidance also refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 801 have been approved under OMB control number 0910-0485;
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 820 have been approved under OMB control
number 0910-0073.
In the Federal Register of March 5, 2019 (84 FR 7904), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding reagents for detection of specific 1 2 2 15 30
novel influenza A viruses....................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Manufactures are increasingly adopting in silico methods
(computational analysis) for the detection of specific novel Influenza
A viruses over traditional laboratory techniques. Therefore, few
manufactures are using reagents for detection of specific novel
influenza A viruses. Based on these industry trends, we estimate a
decrease in the number of total annual records and a corresponding
decrease of 270 hours in the total burden since our last OMB approval.
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15160 Filed 7-16-19; 8:45 am]
BILLING CODE 4164-01-P
