
[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)]
[Notices]
[Pages 40890-40891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14845]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1280]


International Conference on Harmonisation; Electronic 
Transmission of Postmarket Individual Case Safety Reports for Drugs and 
Biologics, Excluding Vaccines; Availability of Food and Drug 
Administration Regional Implementation Specifications for ICH E2B(R3) 
Reporting to the Food and Drug Administration Adverse Event Reporting 
System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of its FDA Adverse Event Reporting System (FAERS) Regional 
Implementation Specifications for the International Conference on 
Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical 
specifications document available to assist interested parties in 
electronically submitting individual case safety reports (ICSRs) (and 
ICSR attachments) to the Center for Drug Evaluation and Research (CDER) 
and the Center for Biologics Evaluation and Research (CBER). This 
document, entitled ``FDA Regional Implementation Specifications for ICH 
E2B(R3) Implementation: Postmarket Submission of Individual Case Safety 
Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines'' 
supplements the ``E2B(R3) Electronic Transmission of Individual Case 
Safety Reports (ICSRs) Implementation Guide--Data Elements and Message 
Specification'' final guidance for industry and describes FDA's 
technical approach for receiving ICSRs, for incorporating regionally 
controlled terminology, and for adding region-specific data elements 
when reporting to FAERS.

DATES: Submit either electronic or written comments on the Regional 
Implementation Specifications document at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2016-D-1280 for ``FDA Regional Implementation Specifications for 
ICH E2B(R3) Implementation: Postmarket Submission of Individual Case 
Safety Reports for Drugs and Biologics, Excluding Vaccines.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://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 http://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 http://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,

[[Page 40891]]

4th Floor, Silver Spring, MD 20993-0002; or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Suranjan De, Office of Surveillance 
and Epidemiology, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4307, 
Silver Spring, MD 20993, 240-402-0498, or FAERSESUB@fda.hhs.gov; or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    On February 21, 2014, FDA issued a Federal Register notice (79 FR 
9908) announcing the availability of a final guidance for industry 
entitled ``E2B (R3) Electronic Transmission of Individual Case Safety 
Reports (ICSRs) Implementation Guide--Data Elements and Message 
Specification'' (ICH E2B(R3) guidance) and an appendix to the guidance 
entitled ``ICSRs: Appendix to the Implementation Guide--Backwards and 
Forward Compatibility'' (BFC appendix). The ICH E2B(R3) guidance and 
BFC appendix were issued as a package that included schema files and 
additional technical information to be used for creating compatible 
ICSR files. The preface to the ICH E2B(R3) implementation guidance 
makes clear that any future ``technical specifications document 
associated with that guidance would be provided as a stand-alone 
document'' but incorporated by reference into that guidance. 
Accordingly, in this notice, we are announcing the availability of a 
technical specifications document that will be incorporated into that 
final guidance.
    This technical specifications document, which is available on the 
FDA Guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm, is to 
assist interested parties in electronically submitting individual case 
safety reports (ICSRs) (and any ICSR attachments) to CDER and CBER. 
This document describes FDA's technical approach for submitting ICSRs, 
for incorporating its regionally controlled terminology, and for adding 
its regional data elements that are not addressed in the ICH E2B (R3) 
guidance for the following FDA-regulated products: Drug products 
marketed for human use with approved new drug applications and 
abbreviated new drug applications; prescription drug products marketed 
for human use without an approved application; nonprescription (over-
the-counter) human drug products marketed without an approved 
application; and biological products marketed for human use with 
approved biologic license applications.

II. Electronic Access

    Persons with access to the Internet may obtain a copy of the FDA 
Regional Implementation Specifications for ICH E2B(R3) at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm115894.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: June 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14845 Filed 6-22-16; 8:45 am]
 BILLING CODE 4164-01-P


