[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]


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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.

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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 [email protected]. 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, 
[email protected].

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\
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  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
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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
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\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