Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic, 15153-15154 [2018-07154]
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15153
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB
Control No.
Title of collection
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion ...................................................................................................................................................................
Data to Support Drug Product Communications .....................................................................................................
Applications for FDA Approval to Market a New Drug ...........................................................................................
Animal Drug Adverse Event Reporting and Recordkeeping ...................................................................................
Extralabel Drug Use in Animals ..............................................................................................................................
Application for Participation in FDA Fellowship Programs ......................................................................................
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
[FR Doc. 2018–07146 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0610]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Medical Products
and Dietary Supplements During an
Influenza Pandemic
AGENCY:
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 May 9,
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0701. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:06 Apr 06, 2018
Jkt 244001
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic
OMB Control Number 0910–0701—
Extension
This information collection supports
the above captioned Agency guidance.
The guidance includes
recommendations for planning,
notification, and documentation for
firms that report postmarketing adverse
events. The guidance recommends that
each firm’s pandemic influenza
continuity of operations plan (COOP)
include instructions for reporting
adverse events, including a plan for the
submission of stored reports that were
not submitted within regulatory
timeframes. The guidance explains that
firms that are unable to fulfill normal
adverse event reporting requirements
during an influenza pandemic should:
(1) Maintain documentation of the
conditions that prevent them from
meeting normal reporting requirements;
(2) notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist and when the
reporting process is restored; and (3)
maintain records to identify what
reports have been stored.
Based on the number of
manufacturers that would be covered by
the guidance, we estimate that
approximately 5,000 firms will add the
following to their COOP: (1) Instructions
for reporting adverse events and (2) a
PO 00000
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Fmt 4703
Sfmt 4703
0910–0849
0910–0695
0910–0001
0910–0284
0910–0325
0910–0780
Date
approval
expires
1/31/2021
2/28/2021
3/31/2021
3/31/2021
3/31/2021
3/31/2021
plan for submitting stored reports that
were not submitted within regulatory
timeframes. We estimate that each firm
will take approximately 50 hours to
prepare the adverse event reporting plan
for its COOP.
We estimate that approximately 500
firms will be unable to fulfill normal
adverse event reporting requirements
because of conditions caused by an
influenza pandemic and that these firms
will notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist. Although we
do not anticipate such pandemic
influenza conditions to occur every
year, for purposes of the PRA, we
estimate that each of these firms will
notify FDA approximately once each
year and that each notification will take
approximately 8 hours to prepare and
submit.
Concerning the recommendation in
the guidance that firms unable to fulfill
normal adverse event reporting
requirements maintain documentation
of the conditions that prevent them from
meeting these requirements and also
maintain records to identify what
adverse event reports have been stored
and when the reporting process is
restored, we estimate that
approximately 500 firms will each need
approximately 8 hours to maintain the
documentation and that approximately
500 firms will each need approximately
8 hours to maintain the records.
In the Federal Register of October 31,
2017 (82 FR 50431) we published a
notice inviting public comment of the
proposed collection of information.
Although one comment was received, it
did not respond to any of the four
information collection topics solicited
in the notice under the PRA. We
therefore made no changes to our
estimate of the burden for the
information collection, which remains
as follows:
E:\FR\FM\09APN1.SGM
09APN1
15154
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of reporting
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notify FDA when normal reporting is not feasible ...............
500
1
500
8
4,000
Hours per
record
Total hours
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
recordkeepers
Type of recordkeeping
Number of
records per
recordkeeper
Total annual
records
Add adverse event reporting plan to COOP .....................
Maintain documentation of influenza pandemic conditions
and resultant high absenteeism .....................................
Maintain records to identify what reports have been
stored and when the reporting process was restored ...
5,000
1
5,000
50
250,000
500
1
500
8
4,000
500
1
500
8
4,000
Total ............................................................................
..........................
........................
........................
........................
258,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
comments should be identified with the
OMB control number 0910–0577. 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, 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.
[FR Doc. 2018–07154 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices
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 May 9,
2018.
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
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
18:06 Apr 06, 2018
Jkt 244001
OMB Control Number 0910–0577—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
352), among other things, establishes
requirements that the label or labeling of
a medical device must meet so that it is
not misbranded and subject to
regulatory action. Section 301 of the
Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250) amended section 502 of the FD&C
Act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Section 2(c) of the Medical Device
User Fee Stabilization Act of 2005 (Pub.
L. 109–43) amends section 502(u) of the
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
FD&C Act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Under the amended provision, if
the original SUD or an attachment to it
prominently and conspicuously bears
the name of the manufacturer, then the
reprocessor of the SUD is required to
identify itself by name, abbreviation, or
symbol in a prominent and conspicuous
manner on the device or attachment to
the device. If the original SUD does not
prominently and conspicuously bear the
name of the manufacturer, the
manufacturer who reprocesses the SUD
for reuse may identify itself using a
detachable label that is intended to be
affixed to the patient record.
The requirements of section 502(u) of
the FD&C Act impose a minimal burden
on industry. This section of the FD&C
Act only requires the manufacturer,
packer, or distributor of a device to
include their name and address on the
labeling of a device. This information is
readily available to the establishment
and easily supplied. From its
registration and premarket submission
database, FDA estimates that there are
67 establishments that distribute
approximately 427 reprocessed SUDs.
Each response is anticipated to take 0.1
hours (6 minutes) resulting in a total
burden to industry of 43 hours.
In the Federal Register of December
19, 2017 (82 FR 60207), 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:
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15153-15154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07154]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0610]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Postmarketing Adverse Event Reporting for Medical Products and
Dietary Supplements During an Influenza Pandemic
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 May 9,
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 0910-0701.
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,
[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 for Industry on Postmarketing Adverse Event Reporting for
Medical Products and Dietary Supplements During an Influenza Pandemic
OMB Control Number 0910-0701--Extension
This information collection supports the above captioned Agency
guidance. The guidance includes recommendations for planning,
notification, and documentation for firms that report postmarketing
adverse events. The guidance recommends that each firm's pandemic
influenza continuity of operations plan (COOP) include instructions for
reporting adverse events, including a plan for the submission of stored
reports that were not submitted within regulatory timeframes. The
guidance explains that firms that are unable to fulfill normal adverse
event reporting requirements during an influenza pandemic should: (1)
Maintain documentation of the conditions that prevent them from meeting
normal reporting requirements; (2) notify the appropriate FDA
organizational unit responsible for adverse event reporting compliance
when the conditions exist and when the reporting process is restored;
and (3) maintain records to identify what reports have been stored.
Based on the number of manufacturers that would be covered by the
guidance, we estimate that approximately 5,000 firms will add the
following to their COOP: (1) Instructions for reporting adverse events
and (2) a plan for submitting stored reports that were not submitted
within regulatory timeframes. We estimate that each firm will take
approximately 50 hours to prepare the adverse event reporting plan for
its COOP.
We estimate that approximately 500 firms will be unable to fulfill
normal adverse event reporting requirements because of conditions
caused by an influenza pandemic and that these firms will notify the
appropriate FDA organizational unit responsible for adverse event
reporting compliance when the conditions exist. Although we do not
anticipate such pandemic influenza conditions to occur every year, for
purposes of the PRA, we estimate that each of these firms will notify
FDA approximately once each year and that each notification will take
approximately 8 hours to prepare and submit.
Concerning the recommendation in the guidance that firms unable to
fulfill normal adverse event reporting requirements maintain
documentation of the conditions that prevent them from meeting these
requirements and also maintain records to identify what adverse event
reports have been stored and when the reporting process is restored, we
estimate that approximately 500 firms will each need approximately 8
hours to maintain the documentation and that approximately 500 firms
will each need approximately 8 hours to maintain the records.
In the Federal Register of October 31, 2017 (82 FR 50431) we
published a notice inviting public comment of the proposed collection
of information. Although one comment was received, it did not respond
to any of the four information collection topics solicited in the
notice under the PRA. We therefore made no changes to our estimate of
the burden for the information collection, which remains as follows:
[[Page 15154]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notify FDA when normal reporting is not feasible................... 500 1 500 8 4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
Type of recordkeeping Number of records per Total annual Hours per Total hours
recordkeepers recordkeeper records record
----------------------------------------------------------------------------------------------------------------
Add adverse event reporting 5,000 1 5,000 50 250,000
plan to COOP..................
Maintain documentation of 500 1 500 8 4,000
influenza pandemic conditions
and resultant high absenteeism
Maintain records to identify 500 1 500 8 4,000
what reports have been stored
and when the reporting process
was restored..................
--------------------------------------------------------------------------------
Total...................... ............... .............. .............. .............. 258,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07154 Filed 4-6-18; 8:45 am]
BILLING CODE 4164-01-P
