[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20926-20927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Providing Postmarket Periodic 
Safety Reports in the International Conference on Harmonisation E2C(R2) 
Format (Periodic Benefit-Risk Evaluation Report); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Providing 
Postmarket 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 Conference on 
Harmonisation (ICH) 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 8, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by calling 
CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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 (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Postmarket Periodic Safety Reports in the ICH 
E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' We are 
issuing the draft 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 postmarket safety reporting among the ICH regions (the 
European Union, Japan, and the United States) and to enhance efficiency 
by reducing the number of reports generated for submissions to the 
regulatory authorities.
    FDA's postmarket safety reporting regulations require applicants to 
submit periodic safety reports in the form of a

[[Page 20927]]

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 (Feb. 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 in place 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 postmarket 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 in place of the PSUR. For applicants who do not have a 
PSUR waiver in place for their approved application but would like to 
submit the PBRER in place 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, the guidance notifies applicants that 
they may submit requests to be waived of the quarterly reporting 
requirement and instead, to submit PBRERs on a 6-month basis.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on providing 
postmarket periodic safety reports in the ICH E2C(R2) PBRER format. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

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

IV. The Paperwork Reduction Act of 1995

    This draft guidance addresses information collection provisions 
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. In accordance with the PRA, 
before publication of the final guidance document, FDA intends to 
solicit public comment and obtain OMB approval for any information 
collections recommended in this guidance that are new or that would 
represent material modifications to previously approved collections of 
information found in FDA regulations.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08014 Filed 4-5-13; 8:45 am]
BILLING CODE 4160-01-P