
[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 oira_submission@omb.eop.gov. 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]
 BILLING CODE 4164-01-P


