
[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14860-14862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0663]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on Investigational New Drug 
Safety Reporting Requirements for Human Drug and Biological Products 
and Safety Reporting Requirements for Bioavailability and 
Bioequivalence Studies in Humans.

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0663 for ``Investigational New Drug Safety Reporting 
Requirements for Human Drug and Biological Products and Safety 
Reporting Requirements for Bioavailability and Bioequivalence Studies 
in Humans.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be

[[Page 14861]]

made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 
for ``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. 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
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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........................
                                                                                                 ---------------
    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.


[[Page 14862]]


                             Table 2--Estimated Annual Reporting Burden--(CBER) \1\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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........................
                                                                                                 ---------------
    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: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06128 Filed 3-17-16; 8:45 am]
BILLING CODE 4164-01-P


