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; Availability, 508-509 [2014-30907]
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508
Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices
Statutory Authority: Section 5(a) of the
‘‘Torture Victims Relief Act of 1998,’’ Public
Law 105–320 (22 U.S.C. 2152 note).
Melody Wayland,
Senior Grants Policy Specialist, Office of
Administration.
[FR Doc. 2014–30906 Filed 1–5–15; 8:45 am]
BILLING CODE 4184–46–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1081]
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; Availability
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
(the PRA).
SUMMARY:
Fax written comments on the
collection of information by February 5,
2015.
DATES:
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.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
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:
VerDate Sep<11>2014
19:38 Jan 05, 2015
Jkt 235001
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.
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,
maintaining records to identify what
adverse event reports have been stored,
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
and when the reporting process is
restored. We estimate that
approximately 500 firms will each need
approximately 8 hours to maintain the
documentation and 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.
In the Federal Register of August 11,
2014 (79 FR 46839), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment.
The comment said that during an
influenza pandemic, FDA should not
put forth a policy of reduced reporting,
especially for newly approved drugs
and vaccines. The comment
recommended that FDA ask companies
to modify their contingency plans by
either leveraging the company’s remote
call center locations not affected by the
pandemic or by outsourcing their safety
reporting to such locations. The
comment stated that at minimum, FDA
should require weekly reporting or
establish a threshold number of reports
that a company must report to FDA. The
comment added that FDA should
specifically require reporting on newly
approved drugs or vaccines for which
there is little safety information.
FDA response: The Guidance for
Industry on Postmarketing Adverse
Event Reporting for Medical Products
and Dietary Supplements During an
Influenza Pandemic does not describe
an approach of reduced reporting during
an influenza pandemic. Rather, the
guidance states that ‘‘normal adverse
event reporting processes should be
maintained to the maximum extent
possible’’ (see section III.C.1, page 3).
E:\FR\FM\06JAN1.SGM
06JAN1
509
Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices
FDA also provides recommendations on
how to prioritize reporting when
regulatory timelines cannot be met due
to limited resources during a pandemic,
so that FDA continues to receive critical
safety information in a timely manner.
For example, table 1 of the guidance
outlines how companies should
prioritize their submission of
postmarketing safety reports during an
influenza pandemic if normal processes
of mandatory adverse event reporting
are not feasible because of high
employee absenteeism: Reports for
pandemic influenza vaccines, drugs and
biological products labeled for the
treatment of influenza, drugs and
biologics approved for less than three
years, and products with special
concerns as specified by FDA. The list
includes reporting on newly approved
products as the comment recommended.
The guidance provides resources for
companies establishing a COOP plan,
but specifying the content of the COOP
plans as suggested by the comment is
beyond the scope of the guidance.
Instead, the guidance provides the more
general recommendation that ‘‘each
firm’s pandemic influenza COOP plan
should include instructions for
reporting adverse events and the
submission of any stored reports not
submitted in the regulatory timeframes’’
(see section III.B, page 2).
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
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: December 30, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30907 Filed 1–5–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–P–0980]
Determination That REYATAZ
(Atazanavir Sulfate) Capsules, 100
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that REYATAZ (atazanavir
sulfate) capsules, 100 milligrams (mg),
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
SUMMARY:
VerDate Sep<11>2014
19:38 Jan 05, 2015
Jkt 235001
applications (ANDAs) for atazanavir
sulfate, 100 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Na’Im R. Moses, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 240–
402–3990.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
REYATAZ (atazanavir sulfate)
capsules, 100 mg, is the subject of NDA
21–567, held by Bristol-Myers Squibb,
and initially approved on June 20, 2003.
E:\FR\FM\06JAN1.SGM
06JAN1
]]>Agencies
[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 508-509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1081]
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; Availability
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 (the PRA).
DATES: Fax written comments on the collection of information by
February 5, 2015.
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: 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 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.
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, maintaining 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 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.
In the Federal Register of August 11, 2014 (79 FR 46839), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment. The comment said
that during an influenza pandemic, FDA should not put forth a policy of
reduced reporting, especially for newly approved drugs and vaccines.
The comment recommended that FDA ask companies to modify their
contingency plans by either leveraging the company's remote call center
locations not affected by the pandemic or by outsourcing their safety
reporting to such locations. The comment stated that at minimum, FDA
should require weekly reporting or establish a threshold number of
reports that a company must report to FDA. The comment added that FDA
should specifically require reporting on newly approved drugs or
vaccines for which there is little safety information.
FDA response: The Guidance for Industry on Postmarketing Adverse
Event Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic does not describe an approach of reduced reporting
during an influenza pandemic. Rather, the guidance states that ``normal
adverse event reporting processes should be maintained to the maximum
extent possible'' (see section III.C.1, page 3).
[[Page 509]]
FDA also provides recommendations on how to prioritize reporting when
regulatory timelines cannot be met due to limited resources during a
pandemic, so that FDA continues to receive critical safety information
in a timely manner. For example, table 1 of the guidance outlines how
companies should prioritize their submission of postmarketing safety
reports during an influenza pandemic if normal processes of mandatory
adverse event reporting are not feasible because of high employee
absenteeism: Reports for pandemic influenza vaccines, drugs and
biological products labeled for the treatment of influenza, drugs and
biologics approved for less than three years, and products with special
concerns as specified by FDA. The list includes reporting on newly
approved products as the comment recommended. The guidance provides
resources for companies establishing a COOP plan, but specifying the
content of the COOP plans as suggested by the comment is beyond the
scope of the guidance. Instead, the guidance provides the more general
recommendation that ``each firm's pandemic influenza COOP plan should
include instructions for reporting adverse events and the submission of
any stored reports not submitted in the regulatory timeframes'' (see
section III.B, page 2).
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...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 258,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 30, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30907 Filed 1-5-15; 8:45 am]
BILLING CODE 4164-01-P
