[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65338-65339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25959]


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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) 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.

DATES: Fax written comments on the collection of information by 
December 2, 2013.

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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 September 29, 2010 (75 FR 59935), 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 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. FDA estimates that approximately 
100 sponsors spend a total of approximately 12 hours per report to 
prepare and submit approximately 600 reports annually.
    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. FDA estimates that 
approximately 10 sponsors spend a total of approximately 12 hours per 
report to prepare and submit approximately 10 reports annually.
    The rulemaking also included new information collection under the 
PRA by requiring safety reporting for bioavailability and 
bioequivalence studies (21 CFR 320.31(d)). FDA estimates that 
approximately 10 sponsors spend a total of approximately 14 hours per 
report to prepare and submit approximately 200 reports annually.
    In the Federal Register of June 12, 2013 (78 FR 35283), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 65339]]



                                   Table 1--Estimated Annual Reporting Burden
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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                 10              20             200              14           2,800
 Bioequivalence Safety Reports..
312.32(c)(1)(ii) and                         100               6             600              12           7,200
 (c)(1)(iii)--IND Safety Reports
 \2\............................
312.32(c)(1)(iv)--IND Safety                  10               1              10              12             120
 Reports \3\....................
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    Total.......................  ..............  ..............  ..............  ..............          10,120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information. The estimates are for the additional burdens beyond those already approved for current Sec.  Sec.
    312.32 and 312.64.
\2\ Includes reports based on findings suggesting a significant risk in humans from epidemiological studies,
  pooled analysis of multiple studies, other clinical studies, or in vitro testing. Reports from animal testing
  are not included.
\3\ Includes reports of clinically important increases in the rate of occurrence of serious, expected suspected
  adverse reactions.


    Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25959 Filed 10-30-13; 8:45 am]
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