[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Rules and Regulations]
[Pages 30151-30152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12753]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310, 314, 329, and 600

[Docket No. FDA-2008-N-0334]
RIN 0910-AF96


Postmarketing Safety Reports for Human Drug and Biological 
Products; Electronic Submission Requirements; Delay of Compliance Date; 
Safety Reporting Portal of Electronic Submission of Postmarketing 
Safety Reports for Human Drugs and Nonvaccine Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of compliance date.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is delaying 
the compliance date for the final rule for the electronic submission of 
postmarketing safety reports for human drugs and biological products 
that published in the Federal Register of June 10, 2014. The rule 
amended FDA's postmarketing safety reporting regulations for human 
drugs and biological products to require that persons subject to 
mandatory reporting requirements submit safety reports in an electronic 
format that FDA can process, review, and archive. FDA is also 
announcing the availability of the Safety

[[Page 30152]]

Reporting Portal (SRP), a Web-based electronic submission system, for 
the electronic submission of postmarketing individual case safety 
reports (ICSRs) of adverse events for human drug and nonvaccine 
biological products. The SRP is intended to facilitate the secure 
electronic submission of postmarketing ICSRs and ICSR attachments to 
the FDA Adverse Event Reporting System (FAERS) database. The SRP 
creates a simple and efficient mechanism for electronic reporting of 
ICSRs that does not require an internal database that is compatible 
with the International Conference on Harmonisation-based direct 
submission system. FDA is delaying the compliance date for the final 
rule because FDA understands that not all persons subject to mandatory 
postmarketing reporting requirements who wish to use the newly 
available Safety Reporting Portal (SRP) will have the opportunity to 
register for an account and test the submission process prior to June 
10, 2015, the effective date of the final rule.

DATES: Effective Date: This final rule is effective June 10, 2015. 
Compliance Date: The compliance date for the final rule published at 79 
FR 33072 on June 10, 2014, is delayed until September 8, 2015.

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 20993-0002, 240-402-0498, email: 
[email protected], 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

    FDA published in the Federal Register of June 10, 2014 (79 FR 
33072), a final rule requiring electronic submission of certain 
postmarketing submissions (the final rule) and also published an 
accompanying revised draft guidance for industry ``Providing 
Submissions in Electronic Format--Postmarketing Safety Reports'' (79 FR 
33200) (June 2014 revised draft guidance).\1\ The final rule becomes 
effective June 10, 2015. Under the final rule, persons subject to 
mandatory postmarketing reporting requirements are required to submit 
postmarketing ICSRs to FDA in an electronic format that the Agency can 
process, review, and archive. Postmarketing ICSRs and ICSR attachments 
sent to FDA for human drug and nonvaccine biological products are 
processed into the FAERS database. As discussed in the preamble to the 
final rule, FDA provides two options for electronic submission of ICSRs 
to FAERS to satisfy the requirement in the final rule that persons 
subject to mandatory postmarketing reporting requirements submit 
postmarketing ICSRs to FDA in an electronic format that the Agency can 
process, review, and archive: (1) Direct submission through the 
Electronic Submissions Gateway, and (2) submission through the SRP. 
Persons subject to mandatory postmarketing reporting requirements can 
choose to use these options to meet the requirements of the final rule 
to electronically submit postmarketing ICSRs to FAERS.
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    \1\ The June 2014 revised draft guidance is available on the 
Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and on 
the FAERS Electronic Submissions Web page at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm115894.htm.
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    At this time, FDA is announcing the availability of the SRP, a Web-
based electronic submission system, for the electronic submission of 
postmarketing ICSRs of adverse events for human drug and nonvaccine 
biological products.
    To use the SRP, the ICSR information is entered manually into a 
Web-based form and then submitted to FDA to be uploaded into the FAERS 
database. The SRP may be used by any persons subject to mandatory 
postmarketing safety reporting requirements, including manufacturers, 
packers, and distributors, and applicants with approved new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), and 
biologics license applications (BLAs), those that market prescription 
drugs for human use without an approved application including entities 
that are registered with FDA as outsourcing facilities under section 
503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 353b), and those subject to the reporting requirements in 
section 760 of the FD&C Act (21 U.S.C. 379aa).

II. Discussion of Rationale for Delay

    The Agency believes that the SRP may be particularly useful for 
those entities that submit a small volume of ICSRs because the SRP does 
not require an internal database that is compatible with the ICH-based 
direct transmission system. FDA understands that not all persons 
subject to mandatory postmarketing reporting requirements who wish to 
use the SRP will have the opportunity to register for an account and 
test the submission process prior to June 10, 2015, the effective date 
of the final rule. Therefore, while persons subject to mandatory 
postmarketing reporting requirements are going through the registration 
process, FDA is delaying the compliance date of the final rule until 
September 8, 2015. FDA will continue to accept postmarketing ICSRs 
submitted on paper Forms FDA 3500A for 90 calendar days from the June 
10, 2015, effective date of the final rule. FDA expects full compliance 
with the final rule by Tuesday, September 8, 2015. FDA is delaying the 
compliance date for this rule directly, without issuing notice of 
proposed rulemaking or taking comments on this action, for good cause. 
Because not all persons who want to use the SRP will be able to do so 
prior to the June 10, 2015, effective date for this rule, and because 
this effective date is now imminent, we find that issuing notice and 
taking comments are impracticable, unnecessary, and contrary to the 
public interest with respect to this action.

III. Overview of the SRP

    The SRP originated as a collaborative initiative developed by a 
multi-agency Federal Adverse Event Task Force, which included FDA as 
part of the Agency's MedWatch Plus strategic effort, starting in 2004. 
Submission of safety reports through the SRP is described on the FDA 
SRP Web page (the SRP is available on the SRP Web page at https://www.safetyreporting.hhs.gov/fpsr/WorkflowLoginIO.aspx?metinstance=0AA0751AD2587A59D28B14D5C764AC7CA68678FE). The SRP is intended to create greater harmonization among Federal 
Agencies for adverse event and product problem reporting by 
streamlining and coordinating the currently diverse Federal 
requirements for the reporting and the review of adverse events.\2\ 
Further information on submitting ICSRs through the SRP is included in 
FDA's June 2014 revised draft guidance.
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    \2\ The origins and purpose of the SRP are discussed on the SRP 
Web page at https://www.safetyreporting.hhs.gov/fpsr/About.aspx.

    Dated: May 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12753 Filed 5-26-15; 8:45 am]
 BILLING CODE 4164-01-P