[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21782-21783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0315]


International Conference on Harmonisation; Draft Guidance for 
Industry on E2C(R2) 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availability of a draft guidance for industry entitled ``E2C(R2) 
Periodic Benefit-Risk Evaluation Report.'' The draft guidance was 
prepared under the auspices of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH). The draft guidance updates and 
combines two ICH guidances, ``E2C Clinical Safety Data Management: 
Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and 
``Addendum to E2C Clinical Safety Data Management: Periodic Safety 
Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The 
draft guidance describes the format, content, and timing of a periodic 
benefit-risk evaluation report (PBRER) for an approved drug or 
biologic. The harmonized PBRER is intended to promote a consistent 
approach to periodic postmarket safety reporting among the ICH regions 
and to enhance efficiency by reducing the number of reports generated 
for submission to the regulatory authorities.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 11, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 draft guidance may also be obtained by mail 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: Regarding the draft guidance: Andrea 
Feight, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4494, Silver 
Spring, MD 20993-0002, 301-796-0152; 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. Regarding the ICH: Michelle Limoli, Office of 
International Programs, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 3506, Silver Spring, MD 20993-0002, 301-
796-8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory Agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug

[[Page 21783]]

Evaluation and Research and Biologics Evaluation and Research, FDA; and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of May 19, 1997 (62 FR 27470), FDA 
published a notice announcing the availability of the E2C guidance. In 
the Federal Register of February 5, 2004 (69 FR 5551), FDA also 
published the addendum to the E2C guidance to provide needed 
clarification and additional guidance. Since that time, the 
pharmacovigilance environment has evolved, prompting reassessment of 
the role of the periodic safety update report in the spectrum of safety 
documents submitted to regulatory authorities. This reassessment 
highlighted several factors that led to consensus for revising the E2C 
guidance and the addendum to the E2C guidance to enhance their 
usefulness in light of advances in the field. There has been 
significant progress in the technology and science of 
pharmacovigilance, including electronic submission of individual case 
safety reports to regulatory authorities, automated data mining 
techniques, more attention to benefit-risk evaluation, greater emphasis 
on proactive and documented risk management planning, and increasing 
recognition that meaningful evaluation of important new risk 
information should be undertaken in the context of a medicinal 
product's benefits.
    In January 2012, the ICH Steering Committee agreed that a draft 
guidance entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report'' 
should be made available for public comment. The draft guidance is the 
product of the E2C(R2) Expert Working Group of the ICH. Comments about 
this draft will be considered by FDA and the E2C(R2) Expert Working 
Group.
    The draft guidance describes the format, content, and timing of a 
PBRER for an approved drug or biologic. The PBRER will serve as a 
common standard for periodic reporting on approved drugs or biologics 
among the ICH regions. Once this guidance is finalized, applicants can 
submit a waiver request for submission of the PBRER in the United 
States in place of a periodic adverse drug experience report for a new 
drug application, for an abbreviated new drug application, or for a 
biologics license application. The harmonized PBRER is intended to 
promote a consistent approach to periodic postmarket safety reporting 
among the ICH regions and to enhance efficiency by reducing the number 
of reports generated for submission to the regulatory authorities.
    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 this topic. 
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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

III. The Paperwork Reduction Act of 1995

    This draft guidance includes 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). 
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.

IV. Electronic Access

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

    Dated: April 6, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-8697 Filed 4-10-12; 8:45 am]
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