[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Pages 73115-73116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25606]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0663]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational New
Drug Safety Reporting Requirements for Human Drug and Biological
Products and Safety Reporting Requirements for Bioavailability and
Bioequivalence Studies in Humans
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by
November 23, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0672.
Also include the FDA docket number found in brackets in the heading of
this document.
Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans; OMB Control
Number 0910-0672--Extension
In the Federal Register of October 31, 2013 (78 FR 65338), FDA
published a document entitled ``Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans.'' The document clarified the Agency's expectations
for timely review, evaluation, and submission of relevant and useful
safety information and implemented internationally harmonized
definitions and reporting standards for IND safety reports. The
document also required safety reporting for bioavailability and
bioequivalence studies. The document was intended to improve the
utility of Investigational New Drug (IND) safety reports, expedite
FDA's review of critical safety information, better protect human
subjects enrolled in clinical trials, and harmonize safety reporting
requirements internationally.
The rulemaking included the following information collection under
the PRA that was not already included in 21 CFR 312.32 and approved
under OMB control number 0910-0014.
Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA,
in an IND safety report, of potential serious risks from clinical
trials within 15 calendar days for findings from epidemiological
studies, pooled analyses of multiple studies, or other clinical studies
that suggest a significant risk in humans exposed to the drug.
Section 312.32(c)(1)(iii) specifies the requirements for reporting
to FDA in an IND safety report potential serious risks from clinical
trials within 15 calendar days for findings from in vitro testing that
suggest a significant risk to humans.
Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety
report within 15 calendar days of any clinically important increase in
the rate of occurrence of serious suspected adverse reactions over that
listed in the protocol or investigator brochure.
The rulemaking also included new information collection under the
PRA by requiring safety reporting for bioavailability and
bioequivalence studies (21 CFR 320.31(d)).
In tables 1 and 2 of this document, the estimates for ``No. of
Respondents,'' ``No. of Responses per Respondent,'' and ``Total Annual
Responses'' were obtained from the Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER) reports and data management systems for submissions received in
2013, 2014, and 2015, and from other sources familiar with the number
of submissions received under the noted 21 CFR section. The estimates
the ``Hours per Response'' are unchanged based on information from CDER
and CBER individuals familiar with the burden associated with these
reports and from prior estimates received from the pharmaceutical
industry.
In the Federal Register of March 18, 2016 (81 FR 14860), we
published a 60-day notice requesting public comment on the proposed
extension of this
[[Page 73116]]
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
[CDER] \1\
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Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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320.31(d) Bioavailability and 13 15 195 14 2,730
Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii) 100 6 600 12 7,200
IND Safety Reports.............
312.32(c)(1)(iv) IND Safety 10 1 10 12 120
Reports........................
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Total (CDER)................ .............. .............. .............. .............. 10,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden
[CBER] \1\
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Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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320.31(d) Bioavailability and 1 1 1 14 14
Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii) 137 4 548 12 6,576
IND Safety Reports.............
312.32(c)(1)(iv) IND Safety 5 1.4 7 12 84
Reports........................
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Total (CBER)................ .............. .............. .............. .............. 6,674
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25606 Filed 10-21-16; 8:45 am]
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