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, 15727-15728 [2016-06710]
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15727
Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in Hours)
Number of
responses per
respondent
Total burden
(in hours)
Type of respondent
Form name
Providers ...........................................
K–BAP Provider Baseline Screener
and Survey.
K–BAP Provider Follow-Up Screener and Survey.
1,827
1
29/60
883
914
1
19/60
289
...........................................................
........................
........................
........................
1,172
Providers ...........................................
Total ...........................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–06707 Filed 3–23–16; 8:45 am]
BILLING CODE 4163–18–P
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
Food and Drug Administration,
HHS.
ACTION:
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 April 25,
2016.
SUMMARY:
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
17:44 Mar 23, 2016
Jkt 238001
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:
Guidance on Reagents for Detection of
Specific Novel Influenza A Viruses—21
CFR Part 866 OMB Control Number
0910–0584—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(the 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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
and sets forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation refers to the special controls
guidance 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 document 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 10 respondents
will be affected annually. Each
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 300
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
E:\FR\FM\24MRN1.SGM
24MRN1
15728
Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
part 820 have been approved under
OMB control number 0910–0073.
In the Federal Register of October 19,
2015 (80 FR 63230), 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
FD&C Act section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
513(g) ...................................................................................
10
2
20
15
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06710 Filed 3–23–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–0159]
Medical Devices; Exemption From
Premarket Notification: Method,
Metallic Reduction, Glucose (Urinary,
Non-Quantitative) Test System in a
Reagent Tablet Format
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that it has received a petition requesting
exemption from the premarket
notification requirements for a method,
metallic reduction, glucose (urinary,
non-quantitative) test system in a
reagent tablet format that is intended to
measure glucosuria (glucose in urine).
Method, metallic reduction, glucose
(urinary, non-quantitative) test systems
in a reagent tablet format are used in the
diagnosis and treatment of carbohydrate
metabolism disorders including diabetes
mellitus, hypoglycemia, and
hyperglycemia. FDA is publishing this
notice to obtain comments in
accordance with procedures established
by the Food and Drug Administration
Modernization Act of 1997 (FDAMA).
DATES: Submit either electronic or
written comments by April 25, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
17:44 Mar 23, 2016
Jkt 238001
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–P–0159 for ‘‘Medical Devices;
Exemption From Premarket
Notification: Method, Metallic
Reduction, Glucose (Urinary, NonQuantitative) Test System in a Reagent
Tablet Format.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Division of Dockets Management
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
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ana
Loloei Marsal, Center for Devices and
Radiological Health (CDRH), Food and
E:\FR\FM\24MRN1.SGM
24MRN1
Agencies
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15727-15728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06710]
-----------------------------------------------------------------------
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 April
25, 2016.
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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
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 (the 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 help
to provide a reasonable assurance of the safety and effectiveness of
devices classified under that regulation. The regulation refers to the
special controls guidance 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 document 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 10 respondents will be affected annually. Each
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 300 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
[[Page 15728]]
part 820 have been approved under OMB control number 0910-0073.
In the Federal Register of October 19, 2015 (80 FR 63230), 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
FD&C Act section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
513(g)............................................................. 10 2 20 15 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06710 Filed 3-23-16; 8:45 am]
BILLING CODE 4164-01-P