[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33200-33201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-D-0067 (Formerly Docket No. 2001D-0185)]


Draft Guidance for Industry on Providing Submissions in 
Electronic Format--Postmarketing Safety Reports; 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availability of a draft guidance for industry entitled ``Providing 
Submissions in Electronic Format--Postmarketing Safety Reports.'' This 
draft guidance provides general information pertaining to electronic 
submission of postmarketing safety reports (individual case safety 
reports (ICSRs), attachments to ICSRs (ICSR attachments), and other 
postmarketing safety reports) for certain human drug and biological 
products. We are issuing the draft guidance to help persons required to 
submit postmarketing safety reports comply with the final rule.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 11, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the

[[Page 33201]]

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 to the Office of Communication, 
Outreach and Development, Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 3128, Silver Spring, MD 20993. The draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. 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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 
    For information concerning human drug products: 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, 
301-796-1874.
    For information concerning human biological products: Stephen 
Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, 
Silver Spring, MD, 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Submissions in Electronic Format--Postmarketing 
Safety Reports.'' This draft guidance provides general information 
pertaining to electronic submission of postmarketing safety reports 
(ICSRs, ICSR attachments, and other postmarketing safety reports) for 
the following products:
     Drug products marketed for human use with approved new 
drug applications (NDAs) and abbreviated new drug applications (ANDAs);
     Prescription drug products marketed for human use without 
an approved NDA or ANDA;
     Biological products, other than vaccines, marketed for 
human use with approved biologic license applications (or BLAs);
     Nonprescription (over-the-counter or OTC) human drug 
products marketed without an approved application.
    This draft guidance does not apply to vaccines, human cells, 
tissues, and cellular and tissue-based products regulated under section 
361 of the Public Health Service Act, whole blood, components of whole 
blood, or lot distribution reports.
    This draft guidance revises and replaces the draft guidance for 
industry entitled ``Providing Regulatory Submissions in Electronic 
Format--Postmarketing Individual Case Safety Reports,'' issued on June 
12, 2008 (73 FR 33436). Elsewhere in this issue of the Federal 
Register, we are publishing a final rule to require that mandatory 
postmarketing safety reports for human drug and biological products be 
submitted to FDA in an electronic format that the Agency can process, 
review, and archive. The revised draft guidance is intended to help 
persons subject to mandatory postmarketing safety reporting 
requirements comply with the final rule. Along with other information, 
the revised draft guidance provides updated information about the 
following: (1) Options for submitting postmarketing safety reports to 
FDA in electronic format, (2) the notification that submitters will 
receive when FDA has received the electronic postmarketing safety 
report, and (3) procedures for requesting temporary waivers from the 
electronic submission requirement.
    The 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 submission 
of postmarketing safety reports in electronic 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 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. Paperwork Reduction Act of 1995

    The information collection resulting from this draft guidance is 
covered by the information collection provisions of the final rule 
entitled ``Postmarketing Safety Reports for Human Drug and Biological 
Products; Electronic Submission Requirements,'' which is published 
elsewhere in this issue of the Federal Register. The information 
collection provisions of the final rule have been submitted to the 
Office of Management and Budget (OMB) for review, as required under 
section 3507(d) of the Paperwork Reduction Act. Prior to the effective 
date of the final rule, FDA will publish a notice in the Federal 
Register announcing OMB's decision to approve, modify, or disapprove 
the information collection provisions in the final rule. An Agency may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

IV. 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/default.htm, or http://www.regulations.gov.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13479 Filed 6-9-14; 8:45 am]
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