Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format, 23578-23581 [2017-10537]
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Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per respondent
Number of
respondents
21 CFR section/activity
Average
burden per
disclosure
Total annual
disclosures
Total hours
701.3—Ingredients in order of predominance ...................
701.11—Statement of identity ...........................................
701.12—Name and place of business ..............................
701.13—Net quantity of contents ......................................
1,518
1,518
1,518
1,518
21
24
24
24
31,878
36,432
36,432
36,432
1
1
1
1
31,878
36,432
36,432
36,432
Total ............................................................................
........................
..........................
........................
........................
141,174
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The hour burden is the additional or
incremental time that establishments
need to design and print labeling that
includes the following required
elements: A declaration of ingredients
in decreasing order of predominance, a
statement of the identity of the product,
a specification of the name and place of
business of the establishment, and a
declaration of the net quantity of
contents. These requirements increase
the time establishments need to design
labels because they increase the number
of label elements that establishments
must take into account when designing
labels. These requirements do not
generate any recurring burden per label
because establishments must already
print and affix labels to cosmetic
products as part of normal business
practices.
The estimated annual third party
disclosure is based on data available to
the Agency, our knowledge of and
experience with cosmetic labeling, and
our communications with industry. We
estimate there are 1,518 cosmetic
product establishments in the United
States. We calculate label design costs
based on stock keeping units (SKUs)
because each SKU has a unique product
label. Based on data available to the
Agency and on communications with
industry, we estimate that cosmetic
establishments will offer 94,800 SKUs
for retail sale in 2017. This corresponds
to an average of 62 SKUs per
establishment.
One of the four provisions that we
discuss in this information collection,
§ 701.3, applies only to cosmetic
products offered for retail sale.
However, the other three provisions,
§§ 701.11, 701.12, and 701.13, apply to
all cosmetic products, including nonretail professional-use-only products.
We estimate that including professionaluse-only cosmetic products increases
the total number of SKUs by 15 percent
to 109,020. This corresponds to an
average of 72 SKUs per establishment.
Finally, based on the Agency’s
experience with other products, we
estimate that cosmetic establishments
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Jkt 241001
may redesign up to one-third of SKUs
per year. Therefore, we estimate that the
number of disclosures per respondent
will be 21 (31,878 SKUs) for § 701.3 and
24 each (36,432 SKUs) for §§ 701.11,
701.12, and 701.13.
We estimate that each of the required
label elements may add approximately 1
hour to the label design process. We
base this estimate on the hour burdens
the Agency has previously estimated for
food, drug, and medical device labeling
and on the Agency’s knowledge of
cosmetic labeling. Therefore, we
estimate that the total hour burden on
members of the public for this
information collection is 141,174 hours
per year.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–10532 Filed 5–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0349]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Providing WaiverRelated Materials in Accordance With
the Guidance for Industry on Providing
Post-Market 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 an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
SUMMARY:
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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 collection of information associated
with the Guidance ‘‘Providing Postmarket Periodic Safety Reports in the
ICH E2C(R2) Format (Periodic BenefitRisk Evaluation Report).’’
DATES: Submit either electronic or
written comments on the collection of
information by July 24, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 24, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 24, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
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Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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’’).
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–
2013–D–0349 for ‘‘Providing WaiverRelated Materials in Accordance With
the Guidance for Industry on Providing
Post-market Periodic Safety Reports in
the International Conference on
Harmonisation E2C(R2) Format.’’
Received comments, those filed in a
timely manner (see DATES), 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
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21:15 May 22, 2017
Jkt 241001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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,
SUPPLEMENTARY INFORMATION:
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23579
when appropriate, and other forms of
information technology.
Providing Waiver-Related Materials in
Accordance With the Guidance for
Industry on Providing Post-Market
Periodic Safety Reports in the
International Conference on
Harmonisation E2C(R2) Format
(Periodic Benefit-Risk Evaluation
Report), OMB Control Number 0910–
0771—Extension
The International Conference on
Harmonisation (ICH) of Technical
Requirements for Registration of
Pharmaceuticals for Human Use issued,
on November 15, 2012, the ICH
harmonized tripartite guideline entitled
‘‘Periodic Benefit-Risk Evaluation
Report (PBRER) E2C(R2)’’ (the PBRER
guideline) (available at https://
www.ich.org/products/guidelines/
efficacy/article/efficacyguidelines.html). The PBRER guideline
is intended to promote a consistent
approach to periodic post-marketing
safety reporting among the ICH regions
and to enhance efficiency by reducing
the number of reports generated for
submission to the regulatory authorities.
The PBRER is intended to provide a
common standard for periodic reporting
on approved drugs or biologics among
the ICH regions.
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).
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. 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 submit reports in
the PBRER format and submit reports as
specified in FDA regulations with an
approved waiver. 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,
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sradovich on DSK3GMQ082PROD with NOTICES
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Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
rather than preparing multiple types of
reports for multiple regulators. As a
result, FDA, in the Federal Register of
November 29, 2016 (81 FR 85976),
announced the availability of the
guidance for industry entitled
‘‘Providing Post-marketing Periodic
Safety Reports in the ICH E2C(R2)
Format (Periodic Benefit-Risk
Evaluation Report)’’ to indicate its
willingness to accept post-market
periodic safety reports using the ICH
PBRER format in lieu of the specific
reports described in FDA regulations.
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 post-marketing 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.) The November 29,
2016, 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.
There are information collections
proposed in the November 29, 2016,
guidance that are related to waivers
specifically to enable the submission of
PBRERs, and these information
collections are not already addressed
under the 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 FDA’s 1996 and
2004 ICH E2C guidance. In accordance
with the recommendations of the
November 29, 2016, 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
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21:15 May 22, 2017
Jkt 241001
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.
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 November 29, 2016, guidance. Each
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PBRER waiver request should include
the following information:
• The product name(s) and
application number(s);
• a brief description of the
justification for the request;
• the U.S. approval date for the
product(s) and current reporting interval
used;
• the reporting interval of the last
PADER/PAER submitted for the
product(s); and
• 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).
• The frequency for submitting the
PBRER, as described in section IV.C of
the April 8, 2013, draft guidance.
• 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 post-marketing safety reporting
requirement, and the information
collections associated with such waiver
requests generally are approved under
OMB control numbers 0910–0001 and
0910–0308. FDA believes that the
information submitted under numbers
1–4 and number 7 in the list in the
previous paragraph is information that
is typical of any waiver request
regarding post-marketing 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.
FDA estimates the additional burden
of this collection of information as
follows:
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Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
TABLE 1—ESTIMATED 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 or operating and maintenance costs associated with the information collection.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–10537 Filed 5–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0222]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry—User Fee Waivers,
Reductions, and Refunds for Drug and
Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 recommendations
to applicants considering whether to
request a waiver or reduction in user
fees.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by July 24, 2017.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov/. Follow
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
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’’).
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–
2014–N–0222 for ‘‘User Fee Waivers,
Reductions, and Refunds for Drug and
Biological Products.’’ 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
PO 00000
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
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]]>Agencies
[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23578-23581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10537]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0349]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Providing Waiver-Related Materials in Accordance With
the Guidance for Industry on Providing Post-Market 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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 collection of information associated
with the Guidance ``Providing Post-market Periodic Safety Reports in
the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).''
DATES: Submit either electronic or written comments on the collection
of information by July 24, 2017. Late, untimely filed comments will not
be considered. Electronic comments must be submitted on or before July
24, 2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of July 24,
2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
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
[[Page 23579]]
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'').
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-2013-D-0349 for ``Providing Waiver-Related Materials in Accordance
With the Guidance for Industry on Providing Post-market Periodic Safety
Reports in the International Conference on Harmonisation E2C(R2)
Format.'' Received comments, those filed in a timely manner (see
DATES), 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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.
Providing Waiver-Related Materials in Accordance With the Guidance for
Industry on Providing Post-Market Periodic Safety Reports in the
International Conference on Harmonisation E2C(R2) Format (Periodic
Benefit-Risk Evaluation Report), OMB Control Number 0910-0771--
Extension
The International Conference on Harmonisation (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use issued,
on November 15, 2012, the ICH harmonized tripartite guideline entitled
``Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2)'' (the PBRER
guideline) (available at https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html). The PBRER guideline is
intended to promote a consistent approach to periodic post-marketing
safety reporting among the ICH regions and to enhance efficiency by
reducing the number of reports generated for submission to the
regulatory authorities. The PBRER is intended to provide a common
standard for periodic reporting on approved drugs or biologics among
the ICH regions.
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. [thinsp]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. [thinsp]600.80(c)(2) (21 CFR 600.80(c)(2))
(OMB control number 0910-0308).
There is considerable overlap in the information required under
Sec. Sec. [thinsp]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. 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 submit
reports in the PBRER format and submit reports as specified in FDA
regulations with an approved waiver. 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,
[[Page 23580]]
rather than preparing multiple types of reports for multiple
regulators. As a result, FDA, in the Federal Register of November 29,
2016 (81 FR 85976), announced the availability of the guidance for
industry entitled ``Providing Post-marketing Periodic Safety Reports in
the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)'' to
indicate its willingness to accept post-market periodic safety reports
using the ICH PBRER format in lieu of the specific reports described in
FDA regulations.
Because FDA regulations in Sec. Sec. [thinsp]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 post-marketing
safety reporting requirement, and the information collections
associated with such waiver requests generally are approved under
existing control numbers. (See Sec. [thinsp]314.90(a), waivers for
drugs subject to NDAs and ANDAs, approved under OMB control number
0910-0001, and Sec. [thinsp]600.90(a), waivers for products subject to
BLAs, approved under OMB control number 0910-0308.) The November 29,
2016, 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.
There are information collections proposed in the November 29,
2016, guidance that are related to waivers specifically to enable the
submission of PBRERs, and these information collections are not already
addressed under the approved control numbers covering waiver
submissions and periodic safety reports generally. FDA has previously
granted waiver requests, submitted under Sec. Sec. [thinsp]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
FDA's 1996 and 2004 ICH E2C guidance. In accordance with the
recommendations of the November 29, 2016, 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 post-marketing 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.
If an applicant does not have a PSUR waiver in place for an
approved application, the applicant may submit a waiver request under
Sec. [thinsp]314.90(a) or Sec. [thinsp]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 November 29, 2016, guidance. Each PBRER waiver request should
include the following information:
The product name(s) and application number(s);
a brief description of the justification for the request;
the U.S. approval date for the product(s) and current
reporting interval used;
the reporting interval of the last PADER/PAER submitted
for the product(s); and
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).
The frequency for submitting the PBRER, as described in
section IV.C of the April 8, 2013, draft guidance.
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. 314.90(a) or
600.90(a) permit applicants to request waivers of any post-marketing
safety reporting requirement, and the information collections
associated with such waiver requests generally are approved under OMB
control numbers 0910-0001 and 0910-0308. FDA believes that the
information submitted under numbers 1-4 and number 7 in the list in the
previous paragraph is information that is typical of any waiver request
regarding post-marketing 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.
FDA estimates the additional burden of this collection of
information as follows:
[[Page 23581]]
Table 1--Estimated 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 or operating and maintenance costs associated with the information collection.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10537 Filed 5-22-17; 8:45 am]
BILLING CODE 4164-01-P
