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, 73115-73116 [2016-25606]
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Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
B. Candidate Prioritization
The Agencies intend to review
Parallel Review requests and respond
within 30 days after receipt of the email.
The Agencies intend to prioritize
innovative medical devices that will
benefit from the efficiencies of the
Parallel Review. Priority will also be
given to medical devices expected to
have the most impact on the Medicare
population. An FDA marketing approval
does not guarantee a favorable coverage
decision.
III. Paperwork Reduction Act of 1995
As stated in previous Federal Register
notices related to the Parallel Review
pilot, due to FDA and CMS resource
issues, the permanent program will
follow the same capacity limit by
accepting no more than five candidates
per year. As such, like the pilot
program, this collection of information
does not meet the definition of an
information collection, as defined under
44 U.S.C. 3501–3520.
IV. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
sradovich on DSK3GMQ082PROD with NOTICES
1. FDA Guidance, ‘‘Requests for Feedback
on Medical Device Submissions: The PreSubmission Program and Meetings with Food
and Drug Administration Staff.’’ Available at
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM311176.pdf.
Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and
Drug Administration.
Dated: October 5, 2016.
Andy Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–25659 Filed 10–21–16; 8:45 am]
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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.
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.
SUMMARY:
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
73115
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 60day notice requesting public comment
on the proposed extension of this
E:\FR\FM\24OCN1.SGM
24OCN1
73116
Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
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
Number of
respondents
21 CFR section
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
320.31(d) Bioavailability and Bioequivalence Safety Reports ..................................................................................
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ...............
312.32(c)(1)(iv) IND Safety Reports ....................................
13
100
10
15
6
1
195
600
10
14
12
12
2,730
7,200
120
Total (CDER) ................................................................
........................
........................
........................
........................
10,050
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
Number of
respondents
21 CFR section
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
320.31(d) Bioavailability and Bioequivalence Safety Reports ..................................................................................
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ...............
312.32(c)(1)(iv) IND Safety Reports ....................................
1
137
5
1
4
1.4
1
548
7
14
12
12
14
6,576
84
Total (CBER) ................................................................
........................
........................
........................
........................
6,674
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0882]
Generic Drug User Fees; Notice of
Public Meeting; Request for
Comments; Extension of Comment
Period; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice; extension of comment
period; correction.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
extension of the comment period and
correcting a notice that appeared in the
Federal Register of Monday, September
26, 2016 (81 FR 66035). The document
announced a public meeting entitled
‘‘Generic Drug User Fees; Public
Meeting; Request for Comments.’’ In
that Federal Register notice, FDA
requested comments on the draft
recommendations related to the
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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17:42 Oct 21, 2016
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reauthorization of the Generic Drug User
Fee Amendments of 2012 (GDUFA). The
Agency is taking this action to allow
interested persons the statutorily
required 30 days to submit comments.
Also, the document was published with
an error in the SUPPLEMENTARY
INFORMATION section. This document
corrects that error.
DATES: FDA is extending the comment
period on the Generic Drug User Fee
recommendations published September
26, 2016 (81 FR 66035). Submit either
electronic or written comments by
November 16, 2016.
FOR FURTHER INFORMATION CONTACT:
Derek Griffing, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673,
Silver Spring, MD 20993, 240–402–
6980, email: GenericDrugPolicy@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 26, 2016,
FDA published a request for comments
on GDUFA reauthorization draft
recommendations. The comment period
ends on November 7, 2016.
Because the Agency posted the draft
recommendations on October 14, 2016,
and the statute requires a period of 30
days be provided for the public to
provide comments on the draft
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recommendations, FDA is extending the
comment period for the GDUFA
reauthorization draft recommendations
until November 16, 2016.
In addition, in FR Doc. 2016–23111,
appearing on page 66035 in the Federal
Register of Monday, September 26,
2016, the following correction is made:
On page 66038, in the final paragraph
of the first column, the second sentence
is corrected to read: ‘‘Specifically, FDA
would issue product-specific guidance
identifying the methodology for
developing drugs and generating
evidence needed to support ANDA
approval, for 90 percent of new
chemical entity new drug applications
that are approved on or after October 1,
2017, at least 2 years prior to the earliest
lawful filing date.’’
Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25603 Filed 10–21–16; 8:45 am]
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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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