[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Notices]
[Pages 44573-44574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0755]


Guidance for Industry on Providing Submissions in Electronic 
Format--Postmarket Non-Expedited Individual Case Safety Reports; 
Technical Questions and Answers; 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 guidance to industry entitled ``Providing Submissions 
in Electronic Format--Postmarket Non-Expedited ICSRs; Technical 
Questions and Answers.'' The guidance provides firms with information 
on the appropriate electronic file format to use when electronically 
submitting to FDA postmarket non-expedited individual case safety 
reports (ICSRs) on adverse drug experiences.\1\ The guidance explains 
that firms that had previously submitted non-expedited ICSRs in an 
electronic format that is not supported by FDA should contact the 
Center for Drug Evaluation and Research (CDER) or Center for Biologics 
and Evaluation and Research (CBER) and resubmit their non-expedited 
ICSRs in a compatible electronic format.
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    \1\ For purposes of this guidance, adverse drug experience 
includes an adverse experience associated with use of a drug or 
biological product, including a therapeutic vaccine.

DATES: Submit either electronic or written comments on Agency guidances 
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at any time.

ADDRESSES: 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, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002, or Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448. 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFD-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jeffrey Trunzo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4447, Silver Spring, MD 20993-0002, 301-
796-2029, email: [email protected]; 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 guidance entitled 
``Providing Submissions in Electronic Format--Postmarket Non-Expedited 
ICSRs; Technical Questions and Answers.'' The guidance provides firms 
with information on the appropriate electronic file format to use when 
electronically submitting to FDA postmarket non-expedited ICSRs for 
adverse drug experiences. The guidance explains that firms that had 
previously submitted non-expedited ICSRs in an electronic format that 
is not supported by FDA should contact CDER or CBER and resubmit their 
non-expedited ICSRs in a compatible electronic format.
    FDA regulations at Sec. Sec.  314.80(c)(2) and 600.80(c)(2) (21 CFR 
314.80(c)(2) and 600.80(c)(2)) require applicants to submit postmarket 
periodic safety reports at prescribed intervals. Each periodic safety 
report must contain a descriptive portion and the non-expedited ICSRs 
\2\ for the reporting interval. The descriptive portion can be 
submitted as a periodic adverse drug experience report \3\; a periodic 
adverse experience report \4\; a periodic safety

[[Page 44574]]

update report \5\; or a periodic benefit-risk evaluation report.\6\
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    \2\ As described in Sec. Sec.  314.80(c)(2)(ii)(b) and 
600.80(c)(2)(ii)(B). Non-expedited ICSRs were previously referred to 
as periodic ICSRs.
    \3\ As described in Sec.  314.80.
    \4\ As described in Sec.  600.80.
    \5\ FDA allows firms with approved waivers (under 21 CFR 314.90 
and 600.90) to use the ICH E2C Periodic Safety Update Report format 
when submitting the descriptive portion of periodic safety reports.
    \6\ FDA allows firms with approved waivers (under 21 CFR 314.90 
and 600.90) to use the ICH E2C(R2) Periodic Benefit-Risk Evaluation 
Report format when submitting the descriptive portion of periodic 
safety reports.
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    Non-expedited ICSRs can be submitted on paper or electronically. 
When submitted electronically, the non-expedited ICSRs should be 
submitted in XML format. This is because FDA is currently able to 
process electronic submissions of non-expedited ICSRs only in XML, 
prepared according to International Conference on Harmonisation (ICH) 
standards for database-to-database transmission of information.\7\ When 
submitted in this compatible electronic format, non-expedited ICSRs can 
be downloaded into the FDA Adverse Event Reporting System (FAERS) 
database through the Electronic Submission Gateway.
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    \7\ See FAERS Electronic Submissions at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm.
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    We have become aware that some firms have submitted non-expedited 
ICSRs to the electronic Common Technical Document (eCTD) in a portable 
document file (pdf) format together with the descriptive portion of the 
periodic safety report.
    FDA does not have a systematic method to identify non-expedited 
ICSRs that are submitted to the eCTD in pdf format together with the 
descriptive portion of the periodic safety report. In addition, non-
expedited ICSRs submitted to the eCTD in pdf format cannot be 
downloaded into the FAERS database. Lack of access to non-expedited 
ICSRs in FAERS hinders FDA's ability to monitor product safety and 
public health. Furthermore, submission in pdf format prevents public 
access to the non-expedited ICSRs through FAERS.\8\
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    \8\ FAERS data are available to the public as quarterly data 
files or by written Freedom of Information request to FDA. See 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm.
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    FDA is issuing this guidance as level 2 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The guidance 
represents the Agency's current thinking on the submission of non-
expedited ICSRs in an electronic format supported by FDA. 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501-3520). The collections of information in Sec.  
314.80 have been approved under OMB control number 0910-0230. The 
collections of information in Sec.  600.80 have been approved under OMB 
control number 0910-0308.

IV. Electronic Access

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

    Dated: July 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17747 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P