[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]
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