[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85976-85977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0349]


Providing Postmarketing Periodic Safety Reports in the 
International Council for Harmonisation E2C(R2) Format (Periodic 
Benefit-Risk Evaluation Report); Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Providing 
Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format 
(Periodic Benefit-Risk Evaluation Report).'' This guidance is intended 
to inform applicants of the conditions under which FDA will exercise 
its waiver authority to permit applicants to submit an International 
Council for Harmonisation (ICH) (formerly International Conference on 
Harmonisation) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) 
in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. 
Periodic adverse drug experience report (PADER), or U.S. Periodic 
adverse experience report (PAER), to satisfy the periodic safety 
reporting requirements in FDA regulations. The guidance describes the 
steps applicants can take to submit the PBRER, and discusses the 
format, content, submission deadline, and frequency of reporting for 
the PBRER.

DATES: Submit either electronic or written comments on the guidance 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'').

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 Postmarketing Periodic Safety Reports 
in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' 
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: http://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 this guidance 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 guidance 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 document.

FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 4466, Silver Spring, MD 20993-0002, 301-796-2380; or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration,10903 New Hampshire Ave., Bldg. 71, Rm. 3128,

[[Page 85977]]

Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Providing Postmarketing Periodic Safety Reports in the ICH 
E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' We are 
issuing the guidance to describe the conditions under which FDA will 
exercise its waiver authority to permit the holders of approved new 
drug applications, abbreviated new drug applications, and biologics 
license applications (applicants) to use the reporting format of the 
PBRER to submit periodic safety reports for their marketed products. 
The harmonized PBRER is intended to promote a consistent approach to 
periodic postmarketing safety reporting among the ICH regions and to 
enhance efficiency by reducing the number of reports generated for 
submissions to the regulatory authorities.
    FDA's postmarketing safety reporting regulations require applicants 
to submit periodic safety reports in the form of a Periodic adverse 
drug experience report (PADER) (for drugs) or a Periodic adverse 
experience report (PAER) (for biologics) (21 CFR 314.80(c)(2) and 
600.80(c)(2), respectively). FDA has routinely granted waivers under 21 
CFR 314.90(b) and 600.90(b) permitting applicants to submit an 
internationally harmonized Periodic Safety Update Report (PSUR) 
prepared in accordance with ICH E2C (see 62 FR 27470, May 19, 1997) and 
69 FR 5551, February 5, 2004)) instead of a PADER/PAER under conditions 
stated in the waiver. On November 15, 2012, the ICH Steering Committee 
signed off on the ICH harmonized guideline ``Periodic Benefit-Risk 
Evaluation Report (PBRER) E2C(R2)'' and recommended that the PBRER 
format be adopted by the ICH regulatory bodies of the three regions. 
Therefore, the new and more comprehensive report format, the PBRER, has 
superseded the PSUR report format.
    This guidance provides information on the steps applicants can take 
to submit a PBRER to the FDA in place of a PSUR, PADER, or PAER. The 
guidance discusses: (1) Applicants who have a waiver for their approved 
product to submit a PSUR instead of a PADER/PAER and (2) applicants who 
have not obtained a waiver and are currently submitting PADERs/PAERs as 
required under FDA regulations. Because the PBRER has replaced the PSUR 
as the ICH E2C harmonized postmarketing safety report format, FDA is 
permitting applicants with an existing PSUR waiver to substitute the 
PBRER for the PSUR without submitting a new waiver request. This 
guidance describes the steps an applicant should take to submit the 
PBRER instead of the PSUR. For applicants who do not have a PSUR waiver 
for their approved application but would like to submit the PBRER 
instead of the PADER/PAER, this guidance provides information on how to 
submit a waiver request if they wish to do so.
    This guidance describes the content, format, and submission 
deadlines applicants should follow when submitting the PBRER, as well 
as U.S.-specific appendices that should be submitted with the PBRER. It 
also explains how applicants can fulfill FDA's annual reporting 
requirement while submitting a harmonized PBRER that covers a longer 
reporting interval. In addition, FDA will consider requests to waive 
the quarterly reporting requirement.
    This guidance finalizes the draft guidance for industry entitled 
``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) 
Format (Periodic Benefit-Risk Evaluation Report),'' which was announced 
in the Federal Register of April 8, 2013 (78 FR 20926). We reviewed the 
comments received on the draft guidance and revised several sections of 
the guidance in response to comments and questions on topics such as 
the submission of the nonexpedited individual case safety reports, 
waivers of the quarterly reporting requirement, the supplemental 
information to be provided with the PSUR/PBRER, handling gaps in 
reporting with changes to the date of the data lock point for the 
reporting interval, and accepted formats for the periodic safety 
report. In response to comments, we also clarified the text in the 
examples that were given in the draft guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on providing postmarketing periodic safety 
reports in the ICH E2C(R2) PBRER format. It does not establish any 
rights for any person and is 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.regulations.gov/, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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 collections of information related to submission of 
waiver requests under Sec. Sec.  314.90(a) and 600.90 have been 
approved under OMB control numbers 0910-0001 and 0910-0308. The 
guidance also refers to collections of information that have been 
approved under OMB control number 0910-0771 related to providing 
waiver-related materials in accordance with the guidance.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28606 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P