Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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, 37098-37100 [2017-16647]
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37098
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
(4) Youth discussions topic guide: We
will hold discussions with youth from
target populations about their
perceptions of PREP-related
programming.
Respondents: Grantees and their
independent evaluators; and youth from
target populations.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
(1)
(2)
(3)
(4)
Abstract template ...........................................................
CONSORT diagram template ........................................
Baseline equivalence template ......................................
Youth discussions topic guide ........................................
Annual
number of
respondents
29
29
16
64
Number of
responses per
respondent
(annually)
29
29
16
21
1
2
2
*1
Average
burden hours
per response
Annual
burden hours
3
1
2
1.5
87
58
64
32
* Total.
Estimated Total Annual Burden
Hours: 241.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017–16671 Filed 8–7–17; 8:45 am]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4184–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0349]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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 September
7, 2017.
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 0910–0771. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
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.
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21:16 Aug 07, 2017
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PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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,
to enhance efficiency and reduce
burden 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).
E:\FR\FM\08AUN1.SGM
08AUN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
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,
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
VerDate Sep<11>2014
21:16 Aug 07, 2017
Jkt 241001
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
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.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
37099
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 paper 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 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
E:\FR\FM\08AUN1.SGM
08AUN1
37100
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
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 May 23,
2017 (82 FR 23578), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
We therefore estimate the 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 or operating and maintenance costs associated with the information collection.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 0910–0599. Also
include the FDA docket number found
in brackets in the heading of this
document.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2017–16647 Filed 8–7–17; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2017–N–1848]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) 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 (PRA).
DATES: Fax written comments on the
collection of information by September
7, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, 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.
Cosmetic Labeling Regulations—21 CFR
Part 701
OMB Control Number 0910–0599—
Extension
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and the Fair
Packaging and Labeling Act (the FPLA)
require that cosmetic manufacturers,
packers, and distributors disclose
information about themselves or their
products on the labels or labeling of
their products. Sections 201, 301, 502,
601, 602, 603, 701, and 704 of the FD&C
Act (21 U.S.C. 321, 352, 361, 362, 363,
371, and 374) and sections 4 and 5 of
the FPLA (15 U.S.C. 1453 and 1454)
provide authority to FDA to regulate the
labeling of cosmetic products. Failure to
comply with the requirements for
cosmetic labeling may render a cosmetic
adulterated under section 601 of the
FD&C Act or misbranded under section
602 of the FD&C Act.
FDA’s cosmetic labeling regulations
are published in part 701 (21 CFR part
701). Four of the cosmetic labeling
regulations have information collection
provisions. Section 701.3 requires the
label of a cosmetic product to bear a
declaration of the ingredients in
descending order of predominance.
Section 701.11 requires the principal
display panel of a cosmetic product to
bear a statement of the identity of the
product. Section 701.12 requires the
label of a cosmetic product to specify
the name and place of business of the
manufacturer, packer, or distributor.
Section 701.13 requires the label of a
cosmetic product to declare the net
quantity of contents of the product.
In the Federal Register of May 23,
2017 (82 FR 23576), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
which described ingredients used in the
creation of cosmetics but was not PRArelated and will not be addressed here.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section/activity
701.3—Ingredients in order of predominance .....................
701.11—Statement of identity .............................................
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21:16 Aug 07, 2017
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Frm 00061
Number of
disclosures
per
respondent
1,518
1,518
Fmt 4703
Sfmt 4703
21
24
Total annual
disclosures
31,878
36,432
E:\FR\FM\08AUN1.SGM
08AUN1
Average
burden per
disclosure
Total hours
1
1
31,878
36,432
]]>Agencies
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37098-37100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16647]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0349]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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
September 7, 2017.
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 0910-0771.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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, to enhance efficiency and
reduce burden 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).
[[Page 37099]]
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, 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 paper 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
[[Page 37100]]
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 May 23, 2017 (82 FR 23578), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. No comments were received.
We therefore estimate the 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 burden
different data lock point and/or respondents responses per responses per response Total hours
a different reporting frequency respondent
----------------------------------------------------------------------------------------------------------------
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....................
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Total....................... .............. .............. .............. .............. 321
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16647 Filed 8-7-17; 8:45 am]
BILLING CODE 4164-01-P
