[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42022-42023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0903]


Draft Guidance for Industry: Providing Submissions in Electronic 
Format--Postmarketing Safety Reports for Vaccines; 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 document entitled ``Guidance for Industry: 
Providing Submissions in Electronic Format--Postmarketing Safety 
Reports for Vaccines'' dated July 2014. The draft guidance document 
provides information and recommendations pertaining to the electronic 
submission of postmarketing safety reports involving vaccine products 
marketed for human use with approved biologics license applications 
(BLAs), including individual case safety reports (ICSRs) and 
attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event 
Reporting System (VAERS). FDA recently published in the Federal 
Register a final rule requiring that certain postmarketing safety 
reports for human drug and biological products, including vaccines, be 
submitted to FDA in an electronic format that the Agency can process, 
review, and archive. The draft guidance, when finalized, is intended to 
help applicants required to submit postmarketing safety reports comply 
with the final rule. The draft guidance, when finalized, also will 
supersede the document entitled ``Guidance for Industry: How to 
Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated 
September 1998.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 16, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 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 20993-0002. 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 240-402-7800. 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: John Reilly, 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

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Providing Submissions in Electronic Format--
Postmarketing Safety Reports for Vaccines'' dated July 2014. The draft 
guidance provides information and recommendations pertaining to the 
electronic submission of postmarketing safety reports involving vaccine 
products, including ICSRs and ICSR attachments, into VAERS. The 
guidance is applicable to vaccine products marketed for human use with 
approved BLAs for which CBER has regulatory responsibility. This 
guidance does not apply to any other biologic product.
    In the Federal Register of June 10, 2014 (79 FR 33072), FDA 
published a final rule requiring that certain postmarketing safety 
reports for human drug and biological products, including vaccines, be 
submitted to FDA in an electronic format that the Agency can process, 
review, and archive. The draft guidance, when finalized, is intended to 
help applicants subject to postmarketing safety reporting requirements 
comply with the final rule. Along with other information, the draft 
guidance provides updated information about the following: (1) Options 
for submitting ICSRs and ICSR attachments, as well as other 
postmarketing safety reports to FDA in electronic format, (2) the 
notification sent to submitters when FDA has received the electronic 
postmarketing safety report, and (3) procedures for requesting 
temporary waivers from the electronic submission requirement. The draft 
guidance, when finalized, also will supersede the document entitled 
``Guidance for Industry: How to Complete the Vaccine Adverse Event 
Reporting System Form (VAERS-1)'' dated September 1998.
    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 FDA'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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The information collection resulting from this draft guidance is 
covered by the information collection provisions of the June 10, 2014, 
final rule entitled ``Postmarketing Safety Reports for Human Drug and 
Biological Products; Electronic Submission Requirements.'' 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.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. 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.

[[Page 42023]]

IV. Electronic Access

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

    Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16931 Filed 7-17-14; 8:45 am]
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