E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report-Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability, 46938-46940 [2016-17009]
Download as PDF
<![CDATA[
46938
Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
56.109(d) Written statement about minimal risk research
when documentation of informed consent is waived .......
Average
burden per
response
Total annual
responses
Total hours
2,520
2
5,040
0.5
(30 minutes)
2,520
2,520
40
100,800
1
100,800
56.109(e) IRB written notification to approve or disapprove
research; 56.109(f) Continuing review; 50.25 Elements
of informed consent; and 50.27 Documentation of informed consent .................................................................
50.24 Exception from informed consent requirements for
emergency research .........................................................
56.113 Suspension or termination of IRB approval of research ...............................................................................
8
3
24
1
24
2,520
1
2,520
0.5
(30 minutes)
1,260
56.120(a) IRB response to lesser administrative actions
for noncompliance ............................................................
56.123 Reinstatement of an IRB or an institution ...............
7
1
1
1
7
1
10
5
70
5
Total ..............................................................................
........................
........................
........................
........................
104,679
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
56.109(g) IRB written statement about public disclosures
to sponsor of emergency research under 50.24 ..............
8
2
16
1
16
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17016 Filed 7–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0315]
E2C(R2) Periodic Benefit-Risk
Evaluation Report and E2C(R2)
Periodic Benefit-Risk Evaluation
Report—Questions and Answers;
International Council for
Harmonisation; Guidances for
Industry; Availability
AGENCY:
Food and Drug Administration,
mstockstill on DSK3G9T082PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of guidances
for industry entitled ‘‘E2C(R2) Periodic
Benefit-Risk Evaluation’’ (E2C(R2)
guidance) and ‘‘E2C(R2) Periodic
Benefit-Risk Evaluation Report—
SUMMARY:
VerDate Sep<11>2014
19:39 Jul 18, 2016
Jkt 238001
Questions and Answers’’ (E2C(R2) Q&A
guidance). These guidances were
prepared under the auspices of the
International Council for Harmonisation
(ICH), formerly the International
Conference on Harmonisation. The
E2C(R2) draft guidance, issued April 11,
2012, updated and combined two ICH
guidances, ‘‘E2C Clinical Safety Data
Management: Periodic Safety Update
Reports for Marketed Drugs’’ (E2C
guidance) and ‘‘Addendum to E2C
Clinical Safety Data Management:
Periodic Safety Update Reports for
Marketed Drugs’’ (addendum to the E2C
guidance). The E2C(R2) guidance is
intended to describe the format, content,
and timing of a Periodic Benefit-Risk
Evaluation Report (PBRER) for an
approved drug or biologic, and it
finalizes the draft guidance. The
E2C(R2) Q&A guidance is a
supplementary guidance that is
intended to clarify key issues in the
E2C(R2) guidance.
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
ADDRESSES:
You may submit comments
as follows:
PO 00000
Frm 00053
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
E:\FR\FM\19JYN1.SGM
19JYN1
Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked, and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0315 for ‘‘E2C(R2) Periodic
Benefit-Risk Evaluation Report and
E2C(R2) Periodic Benefit-Risk
Evaluation Report—Questions and
Answers; International Council for
Harmonisation; Guidances for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
VerDate Sep<11>2014
19:39 Jul 18, 2016
Jkt 238001
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of these guidances to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The guidances may also
be obtained by mail by calling CBER at
1–800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
documents.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Maureen
Melvin, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4480, Silver Spring,
MD 20993–0002, 301–796–5366; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
Regarding the ICH: Amanda Roache,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1128, Silver Spring,
MD 20993–0002, 301–796–4548.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
46939
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products for human use
among regulators around the world. The
six founding members of the ICH are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and
the Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
Swissmedic. Any party eligible as a
Member in accordance with the ICH
Articles of Association can apply for
membership in writing to the ICH
Secretariat. The ICH Secretariat, which
coordinates the preparation of
documentation, operates as an
international nonprofit organization and
is funded by the Members of the ICH
Association.
The ICH Assembly is the overarching
body of the Association and includes
representatives from each of the ICH
members and observers.
In the Federal Register of April 11,
2012 (77 FR 21782), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘E2C(R2)
Periodic Benefit-Risk Evaluation
Report.’’ The draft E2C(R2) guidance
updated and combined the E2C
guidance and the addendum to the E2C
guidance. The notice gave interested
persons an opportunity to submit
comments by May 11, 2012.
After consideration of the comments
received and revisions to the guidance,
a final draft of the guidance was
submitted to the ICH Steering
Committee and endorsed by the
regulatory agencies in November 2012.
The E2C(R2) guidance provides
guidance on the format, content, and
timing of a PBRER for an approved drug
or biologic, and it finalizes the draft
guidance. The PBRER will serve as 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
E:\FR\FM\19JYN1.SGM
19JYN1
46940
Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
generated for submission to the
regulatory authorities.
Since the E2C(R2) draft guidance was
made available in 2012, ICH has
identified questions linked to the
interpretation and application of the
E2C(R2) guidance. The E2C(R2) Q&A
guidance is intended to clarify questions
relating to implementation of the
E2C(R2) guidance.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidances represent the current
thinking of FDA on the E2C(R2) PBRER.
They do not establish any rights for any
person and are not binding on FDA or
the public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
II. The Paperwork Reduction Act of
1995
SUMMARY:
These guidances refer to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3520). The collection of
information in the ‘‘Guidance on
Reporting in Accordance with
International Council for
Harmonisation—Periodic Benefit-Risk
Evaluation Report (E2C(R2)) and
Providing Waiver-Related Materials’’
has been approved under OMB control
number 0910–0771. The guidances also
reference other collections of
information. The collection of
information in 21 CFR 314.80 has been
approved under OMB control number
0910–0230, and the collection of
information in 21 CFR 600.80 has been
approved under OMB control number
0910–0308.
mstockstill on DSK3G9T082PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
VerDate Sep<11>2014
19:39 Jul 18, 2016
Jkt 238001
[FR Doc. 2016–17009 Filed 7–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0873]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Bar Code Label
Requirement for Human Drug and
Biological Products
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 August 18,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0537. 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, Three White
Flint North 10A–12M, 11601
Landsdown Street, North Bethesda, MD
20852, 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.
Bar Code Label Requirement for
Human Drug Products and Blood; OMB
Control No. 0910–0537—Extension
In the Federal Register of February
26, 2004 (69 FR 9120), FDA issued a
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
final rule that requires human drug
product and biological product labels to
have bar codes. Specifically, the rule
requires bar codes on most human
prescription drug products and on overthe-counter (OTC) drug products that
are dispensed under an order and
commonly used in health care facilities.
The rule also requires machine-readable
information on blood and blood
components. For human prescription
drug products and OTC drug products
that are dispensed under an order and
commonly used in health care facilities,
the bar code must contain the NDC
number for the product. For blood and
blood components, the rule specifies the
minimum contents of the label in a
format that is machine-readable and
approved for use by the Director, Center
for Biologics Evaluation and Research.
We believe the rule helps to reduce the
number of medication errors in
hospitals and other health care settings
by allowing health care professionals to
use bar code scanning equipment to
verify that the right drug (in the right
dose and right route of administration)
is being given to the right patient at the
right time.
While most of the information
collection burdens created by the final
rule have now been incorporated into
currently approved information
collections supporting the applicable
regulations, respondents to the
collection may continue to seek an
exemption from the bar code label
requirement under § 201.25(d) (21 CFR
201.25(d)). Section 201.25(d) requires
submission of a written request for an
exemption and describes the
information that must be included in
such a request. Based on the number of
exemption requests we have received
previously, we estimate that
approximately 2 exemption requests
will be submitted annually and that
each exemption request will require 24
hours to complete. This results in an
annual reporting burden of 48 hours, as
reflected below in Table 1.
In the Federal Register of December
15, 2015 (80 FR 77637) FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46938-46940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17009]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0315]
E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2)
Periodic Benefit-Risk Evaluation Report--Questions and Answers;
International Council for Harmonisation; Guidances for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of guidances for industry entitled ``E2C(R2) Periodic
Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic
Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A
guidance). These guidances were prepared under the auspices of the
International Council for Harmonisation (ICH), formerly the
International Conference on Harmonisation. The E2C(R2) draft guidance,
issued April 11, 2012, updated and combined two ICH guidances, ``E2C
Clinical Safety Data Management: Periodic Safety Update Reports for
Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety
Data Management: Periodic Safety Update Reports for Marketed Drugs''
(addendum to the E2C guidance). The E2C(R2) guidance is intended to
describe the format, content, and timing of a Periodic Benefit-Risk
Evaluation Report (PBRER) for an approved drug or biologic, and it
finalizes the draft guidance. The E2C(R2) Q&A guidance is a
supplementary guidance that is intended to clarify key issues in the
E2C(R2) guidance.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
[[Page 46939]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-D-0315 for ``E2C(R2) Periodic Benefit-Risk Evaluation Report
and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and
Answers; International Council for Harmonisation; Guidances for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of these guidances to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidances may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance documents.
FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Maureen
Melvin, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4480, Silver
Spring, MD 20993-0002, 301-796-5366; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
Regarding the ICH: Amanda Roache, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 1128, Silver Spring, MD 20993-0002, 301-796-4548.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
In the Federal Register of April 11, 2012 (77 FR 21782), FDA
published a notice announcing the availability of a draft guidance
entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report.'' The draft
E2C(R2) guidance updated and combined the E2C guidance and the addendum
to the E2C guidance. The notice gave interested persons an opportunity
to submit comments by May 11, 2012.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the regulatory agencies in November
2012.
The E2C(R2) guidance provides guidance on the format, content, and
timing of a PBRER for an approved drug or biologic, and it finalizes
the draft guidance. The PBRER will serve as 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
[[Page 46940]]
generated for submission to the regulatory authorities.
Since the E2C(R2) draft guidance was made available in 2012, ICH
has identified questions linked to the interpretation and application
of the E2C(R2) guidance. The E2C(R2) Q&A guidance is intended to
clarify questions relating to implementation of the E2C(R2) guidance.
These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the current thinking of FDA on the E2C(R2) PBRER. They do not establish
any rights for any person and are not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
These guidances refer to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collection of information in the ``Guidance on Reporting in
Accordance with International Council for Harmonisation--Periodic
Benefit-Risk Evaluation Report (E2C(R2)) and Providing Waiver-Related
Materials'' has been approved under OMB control number 0910-0771. The
guidances also reference other collections of information. The
collection of information in 21 CFR 314.80 has been approved under OMB
control number 0910-0230, and the collection of information in 21 CFR
600.80 has been approved under OMB control number 0910-0308.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17009 Filed 7-18-16; 8:45 am]
BILLING CODE 4164-01-P
