Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability, 46839-46840 [2014-18944]
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Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
46839
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Form FDA
2830
607.20(a), 607.21, 607.22, 607.25, and
607.40.
607.21, 607.22, 607.25, 607.26, 607.31,
and 607.40.
607.21, 607.25, 607.30(a), 607.31, and
607.40.
Initial Registration.
Re-registration.
Product Updating List.
Total ....................................................
1 There
......................
Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18945 Filed 8–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1081]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Medical Products
and Dietary Supplements During an
Influenza Pandemic; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the guidance which discusses FDA’s
approach to enforcement of adverse
event reporting requirements during an
influenza pandemic.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
Total annual
responses
68
1
68
2,615
1
2,615
166
1
166
........................
........................
........................
Average
burden per
response
Total hours
1 ....................
68
0.5 (30 minutes).
0.25 (15 minutes).
1,308
.......................
1,418
42
are no capital costs of operating and maintenance costs associated with this collection of information.
FDA estimates the burden of this
collection of information based upon
information obtained from FDA’s Center
for Biologics Evaluation and Research’s
database and FDA experience with the
blood establishment registration and
product listing requirements.
AGENCY:
Number of
respondents
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
Submit either electronic or
written comments on the collection of
information by October 10, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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.
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
(OMB Control Number 0910–0701)—
Extension
DATES:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic; Availability
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.
E:\FR\FM\11AUN1.SGM
11AUN1
46840
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
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.
Therefore, the total recordkeeping
burden that would result from the
guidance would be 258,000 hours.
The guidance also refers to previously
approved collections of information
found in FDA’s adverse event reporting
requirements in 21 CFR 310.305, 314.80,
314.98, 600.80, 606.170, 640.73,
1271.350, and part 803. These
regulations contain collections of
information that are subject to review by
OMB under the PRA (44 U.S.C. 3501–
3520) and are approved under OMB
control numbers 0910–0116, 0910–0291,
0910–0230, 0910–0308, 0910–0437, and
0910–0543. In addition, the guidance
also refers to adverse event reports for
nonprescription human drug products
marketed without an approved
application and dietary supplements
required under sections 760 and 761 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379aa and 379aa–1),
which include collections of
information approved under OMB
control numbers 0910–0636 and 0910–
0635.
FDA estimates the burden of this
collection of information as follows:
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
Average
burden per
recordkeeper
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
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 ................
Number of
records per
recordkeeper
Total annual
records
[FR Doc. 2014–18944 Filed 8–8–14; 8:45 am]
BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
HHS.
ACTION:
5,000
50
250,000
500
1
500
8
4,000
500
1
500
8
4,000
........................
........................
........................
258,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
1
........................
1 There
5,000
Notice.
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Web Application for Managing the
Request Process for Order Set
Development Within an Electronic
Health Record
Description of Technology:
Technology to empower clinical staff in
requesting and designing order sets can
be transformative for hospitals and other
health care organizations. This software
is proving itself vital in building greater
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46839-46840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18944]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1081]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the guidance which discusses
FDA's approach to enforcement of adverse event reporting requirements
during an influenza pandemic.
DATES: Submit either electronic or written comments on the collection
of information by October 10, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry on Postmarketing Adverse Event Reporting for
Medical Products and Dietary Supplements During an Influenza Pandemic;
Availability
(OMB Control Number 0910-0701)--Extension
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.
[[Page 46840]]
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.
Therefore, the total recordkeeping burden that would result from the
guidance would be 258,000 hours.
The guidance also refers to previously approved collections of
information found in FDA's adverse event reporting requirements in 21
CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and
part 803. These regulations contain collections of information that are
subject to review by OMB under the PRA (44 U.S.C. 3501-3520) and are
approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230,
0910-0308, 0910-0437, and 0910-0543. In addition, the guidance also
refers to adverse event reports for nonprescription human drug products
marketed without an approved application and dietary supplements
required under sections 760 and 761 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379aa and 379aa-1), which include collections
of information approved under OMB control numbers 0910-0636 and 0910-
0635.
FDA estimates the burden of this collection of information as
follows:
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 Average burden
Type of recordkeeping Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeper
----------------------------------------------------------------------------------------------------------------
Add adverse event reporting plan 5,000 1 5,000 50 250,000
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...................
-------------------------------------------------------------------------------
.............. .............. .............. .............. 258,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18944 Filed 8-8-14; 8:45 am]
BILLING CODE 4164-01-P
