Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format, 26766-26768 [2014-10658]
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26766
Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices
free telephone number and email
address, and FDA experience. Each
report is expected to take 0.25 hours to
complete and submit; therefore, total
burden hours for this collection of
information is estimated to be 200 hours
(800 responses × 0.25 hours per
response). The total burden hours for
this collection have decreased by 50
hours (from 250 to 200) because the
number of estimated respondents
decreased from 1,000 to 400, and the
annual responses are expected to drop
from 1,000 to 800. Based on past
submissions to FDA, the number of
estimated annual respondents is
expected to decrease from 1,000 to 400
and each respondent’s number of
submissions is expected to increase
from 1 to 2 annually. Therefore, the
number of responses is expected to
decrease from 1,000 to 800 annually
(400 respondents × 2 responses).
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
title. 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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
Dated: May 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
I. Background
The International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. In January 2012,
the ICH Steering Committee agreed that
the ‘‘E2C(R2) Periodic Benefit-Risk
Evaluation Report’’ draft guidance (the
draft PBRER guidance) should be made
available for public comment. The
PBRER is intended to provide a
common standard for periodic reporting
on approved drugs or biologics among
the ICH regions. The harmonized
PBRER is intended to promote a
consistent approach to periodic
postmarket safety reporting among the
ICH regions and to enhance efficiency
by reducing the number of reports
generated for submission to the
regulatory authorities.
The draft PBRER guidance revises an
earlier version of this guidance issued in
1997 with an addendum issued in 2004.
In the Federal Register of April 11, 2012
(77 FR 21782), FDA announced the
availability of the draft PBRER guidance
for public comment. FDA presented the
comments received as part of the
considerations by the E2C(R2) Expert
Working Group for revisions of the
guidance. A final version of the
guidance was subsequently endorsed by
the ICH on November 15, 2012, and
published as the ICH harmonized
[FR Doc. 2014–10657 Filed 5–8–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1478]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Providing WaiverRelated Materials in Accordance With
Draft Guidance for Industry on
Providing Postmarket Periodic Safety
Reports in the International
Conference on Harmonisation E2C(R2)
Format
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).
DATES: Fax written comments on the
collection of information by June 9,
2014.
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:
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
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Reporting in Accordance With
International Conference on
Harmonisation—Periodic Benefit Risk
Evaluation Report (E2C(R2))
Guidance—(OMB Control Number
0910–NEW)
PO 00000
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tripartite guideline ‘‘Periodic BenefitRisk Evaluation Report (PBRER)
E2C(R2)’’ (the PBRER guidance),
available at https://www.ich.org/
products/guidelines/efficacy/article/
efficacy-guidelines.html. FDA
anticipates issuing final guidance on
this topic that is consistent with the
final ICH document, published
November 2012, and thus is seeking
PRA approval for information
collections consistent with that
document.
II. Voluntary Preparation of Periodic
Safety Reports in Conformance With the
ICH E2C(R2) PBRER Guidance, in Lieu
of PADERs/PAERs Required Under 21
CFR 314.80(c)(2) and 600.80(c)(2)
FDA currently has OMB approval for
the required submission of periodic
adverse drug experience reports
(PADER) for drugs subject to a new drug
application (NDA) or an abbreviated
new drug application (ANDA)
(§ 314.80(c)(2) (21 CFR 314.80(c)(2));
OMB control number 0910–0230), and
for the required submission of periodic
adverse experience reports (PAER) for
drugs subject to a biologics license
application (BLA) (§ 600.80(c)(2) (21
CFR 600.80(c)(2)); OMB control number
0910–0308). Such reports include, for
the reporting interval, reports of serious,
expected adverse experiences and all
non-serious adverse experiences and an
index of these reports, a narrative
summary and analysis of adverse
experiences, an analysis of the 15-day
Alert reports submitted during the
reporting interval, and a history of
actions taken because of adverse
experiences. Applicants must submit
each PADER/PAER to FDA quarterly for
the first 3 years after the product is
approved by FDA and annually
thereafter. As described in the
supporting documentation under OMB
control numbers 0910–0230 and 0910–
0308, FDA currently has OMB approval
for approximately 60 hours for the
preparation and submission of each
PADER under § 314.80(c)(2) and 28
hours for the preparation and
submission of each PAER under
§ 600.80(c)(2).
There is considerable overlap in the
information required under
§§ 314.80(c)(2) and 600.80(c)(2) and the
information requested in a periodic
safety report using the ICH E2C(R2)
PBRER format. As a result, and as
discussed further in this document,
FDA, in the Federal Register of April 8,
2013 (78 FR 20926), announced the
availability of a draft guidance to
indicate its willingness to accept
postmarket periodic safety reports using
the ICH PBRER format in lieu of the
E:\FR\FM\09MYN1.SGM
09MYN1
ehiers on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices
specific reports described in FDA
regulations. (As described further in this
document, the April 2013 draft
guidance also addresses waiver-related
information that should be submitted to
FDA by companies who wish to exercise
this alternative reporting.)
Companies who submit periodic
reports on the same drug to multiple
regulators, including not only the
United States, but, also the European
Union, Japan, and regulators in other
countries who have elected to adopt the
ICH standards, may find it in their
interest to prepare a single PBRER,
rather than preparing multiple types of
reports for multiple regulators.
Companies who choose to submit a
PBRER to FDA would include some
information beyond that required by
FDA regulations, including worldwide
marketing approval status; estimated
exposure and use patterns; information
from clinical trials, non-interventional
studies, non-clinical data, and literature;
benefit evaluation, and benefit-risk
analysis for approved indications, and
should use a particular format described
in the draft PBRER guidance.
FDA is not proposing to require
submission of the PBRER; applicants
subject to periodic safety reporting
requirements under FDA regulations
could choose to continue to submit the
reports as specified in those regulations,
and would be permitted to alternate
between submission of reports in the
PBRER format and submission of reports
as specified in FDA regulations with an
approved waiver. Based on FDA’s
experience with submission of periodic
safety reports under previous ICH
periodic reporting guidance, FDA
believes that applicants would elect to
submit the PBRER to FDA only in cases
where they are also submitting that
report to other regulatory authorities,
some of which have underlying legal
requirements that closely parallel the
elements of the PBRER. For this reason,
FDA believes that the additional burden
associated with preparation of a PBRER
in lieu of existing PADERs/PAERs is not
attributable to the proposed collection
of information by FDA, but rather is a
‘‘usual and customary’’ expenditure of
time, effort, and financial resources that
would be ‘‘incurred by persons in the
normal course of their activities,’’ and
thus is excluded from the calculation of
burden under the PRA (5 CFR
1320.5(b)(2).) Cf. 5 CFR 1320.5(b)(3)
(permitting exclusion from Federal
burden of burden incurred in complying
with an information collection that is
also conducted by a State or local
government if the State or local
requirement would be imposed even in
the absence of a Federal requirement).
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14:53 May 08, 2014
Jkt 232001
We therefore believe that the existing
estimate of burden for submission of
periodic safety reports, approved under
OMB control numbers 0910–0230 and
0910–0308, would be unchanged by this
proposed collection, which would
permit, but not require, the substitution
of a PBRER for the periodic safety report
otherwise required. We request
comment on the assumption that all
PBRERs submitted to FDA would be
prepared in any event to submit to other
jurisdictions, or alternatively, on the
number of PBRERs that applicants will
choose to prepare solely for submission
to FDA, and the estimated burden for
submitting such a report.
III. Materials Related to Waivers
Permitting Submission of a PBRER To
Satisfy the Periodic Safety Reporting
Requirements in §§ 314.80(c)(2) and
600.80(c)(2)
Because FDA regulations in
§§ 314.80(c)(2) and 600.80(c)(2) include
specific requirements for periodic safety
reports, in order for an applicant to
submit an alternative report, such as the
PBRER, for a given product, FDA must
grant a waiver. Existing regulations
permit applicants to request waivers of
any postmarketing safety reporting
requirement, and the information
collections associated with such waiver
requests generally are approved under
existing control numbers. (See
§ 314.90(a), waivers for drugs subject to
NDAs and ANDAs (approved under
OMB control number 0910–0001); and
§ 600.90(a), waivers for products subject
to BLAs (approved under OMB control
number 0910–0308).)
In the Federal Register of April 8,
2013, FDA announced the availability of
a draft guidance entitled ‘‘Providing
Postmarket Periodic Safety Reports in
the ICH E2C(R2) Format’’, which
indicates that FDA will be prepared to
grant waivers to enable submission of
the PBRER in the United States in place
of a PADER required under
§ 314.80(c)(2) or in place of a PAER
required under § 600.80(c)(2). The draft
guidance both explains conditions
under which applicants that have
previously received waivers to submit
reporting information in the format of
the previous ICH guidance would be
permitted to apply those existing
waivers to the submission of PBRERs,
and also advises how applicants that
have not previously obtained a waiver
may submit waiver requests to submit
the PBRER. This Federal Register notice
solicits comment on certain information
collections proposed in the April 8,
2013, draft guidance that are related to
waivers specifically to enable the
submission of PBRERs, and that are not
PO 00000
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26767
already addressed under approved
control numbers covering waiver
submissions and periodic safety reports
generally.
FDA has previously granted waiver
requests, submitted under §§ 314.90(a)
and 600.90(a), that allow applicants to
prepare and submit reports using the
periodic safety update report (PSUR)
format described in the 1997 and 2004
ICH E2C guidance. In accordance with
the recommendations of the April 8,
2013, draft guidance, if an applicant
already has a PSUR waiver in place for
a given approved application, FDA will
consider the existing PSUR waiver to
allow the applicant to submit a PBRER
instead of a PSUR because the PBRER
replaces the PSUR for postmarketing
periodic safety reporting for that
application. The applicant would not
need to submit a new waiver request
unless the applicant wishes to change
the frequency of reporting. FDA will
consider requests to be waived of the
quarterly reporting requirement but will
not waive applicants of the annual
reporting requirement.
If an applicant submits a PBRER in
place of the PSUR and uses a different
data lock point, the applicant should
submit overlapping reports or submit a
one-time PADER/PAER in order to cover
the gap in reporting intervals. The
applicant should submit notification to
the application(s), indicating the change
in data lock point and should include a
description of the measures taken to
ensure that there are no resulting gaps
in reporting.
If an applicant submits a PBRER in
place of the PSUR and uses a different
reporting frequency for the PBRER than
was used for the PSUR, the continued
validity of the waiver will be
conditioned on the submission of a
PADER/PAER as needed to fulfill the
reporting frequency requirement under
FDA regulations. The applicant should
submit a notification to the
application(s), describing this change
and the measures taken to ensure that
the periodicity requirements are being
met.
FDA expects approximately 187
waiver requests and notifications to
include the additional information
described previously in this document
for using a different data lock point and/
or for using a different reporting
frequency when submitting a PBRER.
FDA expects approximately 55
applicants to make these submissions,
and we estimate that the time for
submitting the additional information
described previously would be on
average approximately 1 hour for each
waiver request or notification.
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Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices
If an applicant does not have a PSUR
waiver in place for an approved
application, the applicant may submit a
waiver request under § 314.90(a) or
§ 600.90(a) to submit a PBRER instead of
the PADER/PAER. The applicant should
submit a request to FDA for each
approved application for which a
waiver is requested, and a single waiver
request letter can include multiple
applications. Waiver requests should be
submitted to each of the application(s)
in the request, and may be submitted
electronically or by mail as described in
the April 8, 2013, draft guidance. Each
PBRER waiver request should include
the following information:
1. The product name(s) and
application number(s);
2. A brief description of the
justification for the request;
3. The U.S. approval date for the
product(s) and current reporting interval
used;
4. The reporting interval of the last
PADER/PAER submitted for the
product(s);
5. The data lock point that will be
used for each PBRER. If a data lock
point other than one aligned to the U.S.
approval date is proposed, the applicant
should describe how he/she will ensure
that there are no gaps in reporting
intervals (e.g., by submitting
overlapping reports; submitting a onetime PADER/PAER to cover the gap
period; or, if the gap is less than 2
months, extending the reporting interval
of the final PADER/PAER to close the
gap).
6. The frequency for submitting the
PBRER, as described in section IV.C of
the April 8, 2013, draft guidance.
7. The email address and telephone
number for the individual who can
provide additional information
regarding the waiver request.
As explained earlier, existing
regulations at §§ 314.90(a) or 600.90(a)
permit applicants to request waivers of
any postmarketing safety reporting
requirement, and the information
collections associated with such waiver
requests generally are approved under
OMB control numbers 0910–0001and
0910–0308. FDA believes that the
information submitted under numbers 1
to 4 and number 7 in the list in the
previous paragraph is information that
is typical of any waiver request
regarding postmarketing safety reporting
and is accounted for in the existing
approved collections of information for
waiver requests and reports. Concerning
numbers 5 and 6, FDA expects
approximately 67 waiver requests to
include the additional information for
using a different data lock point and/or
for using a different reporting frequency
when submitting a PBRER. FDA expects
approximately 29 applicants to make
these submissions, and we estimate that
the time for submitting the additional
information described in the previous
paragraph would be on average
approximately 2 hours for each waiver
request.
In the Federal Register of December
10, 2013 (78 FR 74151), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the additional burden
of this collection of information as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Additional information and/or notifications for using
a different data lock point and/or a different
reporting frequency
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Applicants that have a PSUR waiver for an approved application ............................................................................
Applicants that do not have a PSUR waiver for an approved application ............................................................
55
3.4
187
1
187
29
2.3
67
2
134
Total ..............................................................................
........................
........................
........................
........................
321
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
all sessions of the meeting. The meeting
was announced in the Federal Register
on April 22, 2014 (79 FR 22507).
For Further Information Contact:
Patricia Stroup, MBA, MPA, Office of
the Associate Administrator, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 17W43, Rockville,
Maryland 20857; telephone (301) 443–
1127.
[FR Doc. 2014–10658 Filed 5–8–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
ehiers on DSK2VPTVN1PROD with NOTICES
Advisory Committee on Organ
Transplantation; Cancellation of
Meeting
Name: Advisory Committee on Organ
Transplantation.
Dates and Times: May 15, 2014, 10:00
a.m. to 4:00 p.m., Eastern Time.
Status: The meeting of the Advisory
Committee on Organ Transplantation
scheduled for May 15, 2014, is
cancelled. This cancellation applies to
Dated: May 5, 2014.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2014–10739 Filed 5–8–14; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2014–0022]
Privacy Act of 1974; Computer
Matching Program
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: Notice.
AGENCY:
Privacy Act of
1974; Computer Matching Program
between the Department of Homeland
Security, U.S. Citizenship and
Immigration Services and the
Massachusetts Division of
Unemployment Assistance.
SUMMARY: This document provides
notice of the existence of a computer
matching program between the
Department of Homeland Security, U.S.
OVERVIEW INFORMATION:
E:\FR\FM\09MYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Notices]
[Pages 26766-26768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10658]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1478]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Providing Waiver-
Related Materials in Accordance With Draft Guidance for Industry on
Providing Postmarket Periodic Safety Reports in the International
Conference on Harmonisation E2C(R2) Format
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 June 9,
2014.
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 title. 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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Reporting in Accordance With International Conference on
Harmonisation--Periodic Benefit Risk Evaluation Report (E2C(R2))
Guidance--(OMB Control Number 0910-NEW)
I. Background
The International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)
was organized to provide an opportunity for tripartite harmonization
initiatives to be developed with input from both regulatory and
industry representatives. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
among three regions: The European Union, Japan, and the United States.
In January 2012, the ICH Steering Committee agreed that the ``E2C(R2)
Periodic Benefit-Risk Evaluation Report'' draft guidance (the draft
PBRER guidance) should be made available for public comment. The PBRER
is intended to provide a common standard for periodic reporting on
approved drugs or biologics among the ICH regions. The harmonized PBRER
is intended to promote a consistent approach to periodic postmarket
safety reporting among the ICH regions and to enhance efficiency by
reducing the number of reports generated for submission to the
regulatory authorities.
The draft PBRER guidance revises an earlier version of this
guidance issued in 1997 with an addendum issued in 2004. In the Federal
Register of April 11, 2012 (77 FR 21782), FDA announced the
availability of the draft PBRER guidance for public comment. FDA
presented the comments received as part of the considerations by the
E2C(R2) Expert Working Group for revisions of the guidance. A final
version of the guidance was subsequently endorsed by the ICH on
November 15, 2012, and published as the ICH harmonized tripartite
guideline ``Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2)''
(the PBRER guidance), available at https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. FDA anticipates
issuing final guidance on this topic that is consistent with the final
ICH document, published November 2012, and thus is seeking PRA approval
for information collections consistent with that document.
II. Voluntary Preparation of Periodic Safety Reports in Conformance
With the ICH E2C(R2) PBRER Guidance, in Lieu of PADERs/PAERs Required
Under 21 CFR 314.80(c)(2) and 600.80(c)(2)
FDA currently has OMB approval for the required submission of
periodic adverse drug experience reports (PADER) for drugs subject to a
new drug application (NDA) or an abbreviated new drug application
(ANDA) (Sec. 314.80(c)(2) (21 CFR 314.80(c)(2)); OMB control number
0910-0230), and for the required submission of periodic adverse
experience reports (PAER) for drugs subject to a biologics license
application (BLA) (Sec. 600.80(c)(2) (21 CFR 600.80(c)(2)); OMB
control number 0910-0308). Such reports include, for the reporting
interval, reports of serious, expected adverse experiences and all non-
serious adverse experiences and an index of these reports, a narrative
summary and analysis of adverse experiences, an analysis of the 15-day
Alert reports submitted during the reporting interval, and a history of
actions taken because of adverse experiences. Applicants must submit
each PADER/PAER to FDA quarterly for the first 3 years after the
product is approved by FDA and annually thereafter. As described in the
supporting documentation under OMB control numbers 0910-0230 and 0910-
0308, FDA currently has OMB approval for approximately 60 hours for the
preparation and submission of each PADER under Sec. 314.80(c)(2) and
28 hours for the preparation and submission of each PAER under Sec.
600.80(c)(2).
There is considerable overlap in the information required under
Sec. Sec. 314.80(c)(2) and 600.80(c)(2) and the information requested
in a periodic safety report using the ICH E2C(R2) PBRER format. As a
result, and as discussed further in this document, FDA, in the Federal
Register of April 8, 2013 (78 FR 20926), announced the availability of
a draft guidance to indicate its willingness to accept postmarket
periodic safety reports using the ICH PBRER format in lieu of the
[[Page 26767]]
specific reports described in FDA regulations. (As described further in
this document, the April 2013 draft guidance also addresses waiver-
related information that should be submitted to FDA by companies who
wish to exercise this alternative reporting.)
Companies who submit periodic reports on the same drug to multiple
regulators, including not only the United States, but, also the
European Union, Japan, and regulators in other countries who have
elected to adopt the ICH standards, may find it in their interest to
prepare a single PBRER, rather than preparing multiple types of reports
for multiple regulators. Companies who choose to submit a PBRER to FDA
would include some information beyond that required by FDA regulations,
including worldwide marketing approval status; estimated exposure and
use patterns; information from clinical trials, non-interventional
studies, non-clinical data, and literature; benefit evaluation, and
benefit-risk analysis for approved indications, and should use a
particular format described in the draft PBRER guidance.
FDA is not proposing to require submission of the PBRER; applicants
subject to periodic safety reporting requirements under FDA regulations
could choose to continue to submit the reports as specified in those
regulations, and would be permitted to alternate between submission of
reports in the PBRER format and submission of reports as specified in
FDA regulations with an approved waiver. Based on FDA's experience with
submission of periodic safety reports under previous ICH periodic
reporting guidance, FDA believes that applicants would elect to submit
the PBRER to FDA only in cases where they are also submitting that
report to other regulatory authorities, some of which have underlying
legal requirements that closely parallel the elements of the PBRER. For
this reason, FDA believes that the additional burden associated with
preparation of a PBRER in lieu of existing PADERs/PAERs is not
attributable to the proposed collection of information by FDA, but
rather is a ``usual and customary'' expenditure of time, effort, and
financial resources that would be ``incurred by persons in the normal
course of their activities,'' and thus is excluded from the calculation
of burden under the PRA (5 CFR 1320.5(b)(2).) Cf. 5 CFR 1320.5(b)(3)
(permitting exclusion from Federal burden of burden incurred in
complying with an information collection that is also conducted by a
State or local government if the State or local requirement would be
imposed even in the absence of a Federal requirement).
We therefore believe that the existing estimate of burden for
submission of periodic safety reports, approved under OMB control
numbers 0910-0230 and 0910-0308, would be unchanged by this proposed
collection, which would permit, but not require, the substitution of a
PBRER for the periodic safety report otherwise required. We request
comment on the assumption that all PBRERs submitted to FDA would be
prepared in any event to submit to other jurisdictions, or
alternatively, on the number of PBRERs that applicants will choose to
prepare solely for submission to FDA, and the estimated burden for
submitting such a report.
III. Materials Related to Waivers Permitting Submission of a PBRER To
Satisfy the Periodic Safety Reporting Requirements in Sec. Sec.
314.80(c)(2) and 600.80(c)(2)
Because FDA regulations in Sec. Sec. 314.80(c)(2) and 600.80(c)(2)
include specific requirements for periodic safety reports, in order for
an applicant to submit an alternative report, such as the PBRER, for a
given product, FDA must grant a waiver. Existing regulations permit
applicants to request waivers of any postmarketing safety reporting
requirement, and the information collections associated with such
waiver requests generally are approved under existing control numbers.
(See Sec. 314.90(a), waivers for drugs subject to NDAs and ANDAs
(approved under OMB control number 0910-0001); and Sec. 600.90(a),
waivers for products subject to BLAs (approved under OMB control number
0910-0308).)
In the Federal Register of April 8, 2013, FDA announced the
availability of a draft guidance entitled ``Providing Postmarket
Periodic Safety Reports in the ICH E2C(R2) Format'', which indicates
that FDA will be prepared to grant waivers to enable submission of the
PBRER in the United States in place of a PADER required under Sec.
314.80(c)(2) or in place of a PAER required under Sec. 600.80(c)(2).
The draft guidance both explains conditions under which applicants that
have previously received waivers to submit reporting information in the
format of the previous ICH guidance would be permitted to apply those
existing waivers to the submission of PBRERs, and also advises how
applicants that have not previously obtained a waiver may submit waiver
requests to submit the PBRER. This Federal Register notice solicits
comment on certain information collections proposed in the April 8,
2013, draft guidance that are related to waivers specifically to enable
the submission of PBRERs, and that are not already addressed under
approved control numbers covering waiver submissions and periodic
safety reports generally.
FDA has previously granted waiver requests, submitted under
Sec. Sec. 314.90(a) and 600.90(a), that allow applicants to prepare
and submit reports using the periodic safety update report (PSUR)
format described in the 1997 and 2004 ICH E2C guidance. In accordance
with the recommendations of the April 8, 2013, draft guidance, if an
applicant already has a PSUR waiver in place for a given approved
application, FDA will consider the existing PSUR waiver to allow the
applicant to submit a PBRER instead of a PSUR because the PBRER
replaces the PSUR for postmarketing periodic safety reporting for that
application. The applicant would not need to submit a new waiver
request unless the applicant wishes to change the frequency of
reporting. FDA will consider requests to be waived of the quarterly
reporting requirement but will not waive applicants of the annual
reporting requirement.
If an applicant submits a PBRER in place of the PSUR and uses a
different data lock point, the applicant should submit overlapping
reports or submit a one-time PADER/PAER in order to cover the gap in
reporting intervals. The applicant should submit notification to the
application(s), indicating the change in data lock point and should
include a description of the measures taken to ensure that there are no
resulting gaps in reporting.
If an applicant submits a PBRER in place of the PSUR and uses a
different reporting frequency for the PBRER than was used for the PSUR,
the continued validity of the waiver will be conditioned on the
submission of a PADER/PAER as needed to fulfill the reporting frequency
requirement under FDA regulations. The applicant should submit a
notification to the application(s), describing this change and the
measures taken to ensure that the periodicity requirements are being
met.
FDA expects approximately 187 waiver requests and notifications to
include the additional information described previously in this
document for using a different data lock point and/or for using a
different reporting frequency when submitting a PBRER. FDA expects
approximately 55 applicants to make these submissions, and we estimate
that the time for submitting the additional information described
previously would be on average approximately 1 hour for each waiver
request or notification.
[[Page 26768]]
If an applicant does not have a PSUR waiver in place for an
approved application, the applicant may submit a waiver request under
Sec. 314.90(a) or Sec. 600.90(a) to submit a PBRER instead of the
PADER/PAER. The applicant should submit a request to FDA for each
approved application for which a waiver is requested, and a single
waiver request letter can include multiple applications. Waiver
requests should be submitted to each of the application(s) in the
request, and may be submitted electronically or by mail as described in
the April 8, 2013, draft guidance. Each PBRER waiver request should
include the following information:
1. The product name(s) and application number(s);
2. A brief description of the justification for the request;
3. The U.S. approval date for the product(s) and current reporting
interval used;
4. The reporting interval of the last PADER/PAER submitted for the
product(s);
5. The data lock point that will be used for each PBRER. If a data
lock point other than one aligned to the U.S. approval date is
proposed, the applicant should describe how he/she will ensure that
there are no gaps in reporting intervals (e.g., by submitting
overlapping reports; submitting a one-time PADER/PAER to cover the gap
period; or, if the gap is less than 2 months, extending the reporting
interval of the final PADER/PAER to close the gap).
6. The frequency for submitting the PBRER, as described in section
IV.C of the April 8, 2013, draft guidance.
7. The email address and telephone number for the individual who
can provide additional information regarding the waiver request.
As explained earlier, existing regulations at Sec. Sec. 314.90(a)
or 600.90(a) permit applicants to request waivers of any postmarketing
safety reporting requirement, and the information collections
associated with such waiver requests generally are approved under OMB
control numbers 0910-0001and 0910-0308. FDA believes that the
information submitted under numbers 1 to 4 and number 7 in the list in
the previous paragraph is information that is typical of any waiver
request regarding postmarketing safety reporting and is accounted for
in the existing approved collections of information for waiver requests
and reports. Concerning numbers 5 and 6, FDA expects approximately 67
waiver requests to include the additional information for using a
different data lock point and/or for using a different reporting
frequency when submitting a PBRER. FDA expects approximately 29
applicants to make these submissions, and we estimate that the time for
submitting the additional information described in the previous
paragraph would be on average approximately 2 hours for each waiver
request.
In the Federal Register of December 10, 2013 (78 FR 74151), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the additional burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Additional information and/or
notifications for using a Number of Number of Total annual Average
different data lock point and/or respondents responses per responses burden per Total hours
a different reporting frequency respondent response
----------------------------------------------------------------------------------------------------------------
Applicants that have a PSUR 55 3.4 187 1 187
waiver for an approved
application....................
Applicants that do not have a 29 2.3 67 2 134
PSUR waiver for an approved
application....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 321
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10658 Filed 5-8-14; 8:45 am]
BILLING CODE 4160-01-P
