Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers; Availability, 44573-44574 [2013-17747]

Download as PDF 44573 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Notices for submitting the information described above to ORA/DIO. FDA requests comments on this information collection: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 50 3.68 184 16 2,944 PLAIR ................................................................................... 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any additional information collections recommended in this guidance that are new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances. III. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. [FR Doc. 2013–17768 Filed 7–23–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sroberts on DSK5SPTVN1PROD with NOTICES [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 Food and Drug Administration, HHS. ACTION: Notice. VerDate Mar<15>2010 16:35 Jul 23, 2013 Jkt 229001 Submit either electronic or written comments on Agency guidances at any time. DATES: 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 selfaddressed 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 https://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. ADDRESSES: Dated: July 19, 2013. Leslie Kux, Assistant Commissioner for Policy. AGENCY: The Food and Drug Administration (FDA) is announcing the availability of a guidance to industry entitled ‘‘Providing Submissions in Electronic Format—Postmarket NonExpedited 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. SUMMARY: 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. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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: jeffrey.trunzo@fda.hhs.gov; 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 §§ 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 nonexpedited 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 2 As described in §§ 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 § 314.80. 4 As described in § 600.80. E:\FR\FM\24JYN1.SGM 24JYN1 44574 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES update report 5; or a periodic benefit– risk evaluation report.6 Non-expedited ICSRs can be submitted on paper or electronically. When submitted electronically, the nonexpedited 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, nonexpedited ICSRs can be downloaded into the FDA Adverse Event Reporting System (FAERS) database through the Electronic Submission Gateway. 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 nonexpedited 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 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 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. 7 See FAERS Electronic Submissions at https:// www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrug Effects/ucm115894.htm. 8 FAERS data are available to the public as quarterly data files or by written Freedom of Information request to FDA. See https:// www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/ Surveillance/AdverseDrugEffects/ucm082193.htm. VerDate Mar<15>2010 16:35 Jul 23, 2013 Jkt 229001 alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. Dated: July 18, 2013. Leslie Kux, Assistant Commissioner for Policy. representatives of Health Professional Organizations. Topics on the agenda include FDA Updates, an overview of FDA’s Network of Experts (public/ private partnerships), and a FDA Town Hall. The FDA Town Hall will feature FDA senior executives including Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health; Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs of the Center for Drug Evaluation and Research; and Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine. Date and Time: The conference will be held on October 24, 2013, from 8 a.m. to 12 noon. Location: The conference will be held at the White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Contact: Brenda Rose, Office of Special Health Issues, 10903 New Hampshire Ave., Silver Spring, MD 20993, Brenda.Rose@fda.hhs.gov, 301– 796–8460. Registration: Register at https:// www.cvent.com/d/hcqym9/1Q. Please include the name and title of the person attending, the name of the organization, and email address. There is no registration fee for this conference. Early registration is suggested because space is limited. [FR Doc. 2013–17747 Filed 7–23–13; 8:45 am] SUPPLEMENTARY INFORMATION: II. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// 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 § 314.80 have been approved under OMB control number 0910–0230. The collections of information in § 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or https://www.regulations.gov. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Third Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conference. The Food and Drug Administration (FDA) is announcing a conference for PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff. The Office of Health and Constituent Affairs serves as a liaison between the FDA Centers and the public on matters that involve medical product safety. Please indicate during your registration a question of greatest interest to you for the FDA Town Hall. If you need special accommodations due to a disability, please contact Brenda Rose at Brenda.Rose@fda.hhs.gov at least 7 days in advance of the conference. E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Notices]
[Pages 44573-44574]
From the Federal Register Online via the Government Printing 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.

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

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.
---------------------------------------------------------------------------

\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
---------------------------------------------------------------------------
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 https://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: jeffrey.trunzo@fda.hhs.gov; 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\
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

\7\ See FAERS Electronic Submissions at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

\8\ FAERS data are available to the public as quarterly data
files or by written Freedom of Information request to FDA. See
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm.
---------------------------------------------------------------------------

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 https://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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://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

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