Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment, 13820-13821 [2017-05098]
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In the
Federal Register of January 18, 2017 (82
FR 5579), FDA published a notice with
a 60-day comment period to request
comments on ‘‘Considerations in
Demonstrating Interchangeability With a
Reference Product.’’
The Agency has received several
requests for a 60-day extension of the
comment period for the notice. The
requests conveyed concern that the
current 60-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the notice.
FDA has considered the requests and
is extending the comment period for the
notice for 60 days, until May 19, 2017.
The Agency believes that a 60-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying
rulemaking on these important issues.
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
SUPPLEMENTARY INFORMATION:
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18:19 Mar 14, 2017
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Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05102 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3535]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Special Protocol
Assessment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, 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 April 14,
2017.
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 0910–0470. 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, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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.
SUMMARY:
Guidance for Industry on Special
Protocol Assessment OMB Control
Number 0910–0470—Extension
The ‘‘Guidance for Industry on
Special Protocol Assessment’’ describes
Agency procedures to evaluate issues
related to the adequacy (e.g., design,
conduct, analysis) of certain proposed
PO 00000
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studies. The guidance describes
procedures for sponsors to request
special protocol assessment and for the
Agency to act on such requests. The
guidance provides information on how
the Agency interprets and applies
provisions of the Food and Drug
Administration Modernization Act of
1997 and the specific Prescription Drug
User Fee Act of 1992 (PDUFA) goals for
special protocol assessment associated
with the development and review of
PDUFA products. The guidance
describes the following two collections
of information: (1) The submission of a
notice of intent to request special
protocol assessment of a carcinogenicity
protocol and (2) the submission of a
request for special protocol assessment.
I. Notification for a Carcinogenicity
Protocol
As described in the guidance, a
sponsor interested in Agency
assessment of a carcinogenicity protocol
should notify the appropriate division
in FDA’s Center for Drug Evaluation and
Research (CDER) or the Center for
Biologics Evaluation and Research
(CBER) of an intent to request special
protocol assessment at least 30 days
prior to submitting the request. With
such notification, the sponsor should
submit relevant background information
so that the Agency may review reference
material related to carcinogenicity
protocol design prior to receiving the
carcinogenicity protocol.
II. Request for Special Protocol
Assessment
The guidance asks that a request for
special protocol assessment be
submitted as an amendment to the
investigational new drug application
(IND) for the underlying product and
that it be submitted to the Agency in
triplicate with Form FDA 1571 attached.
The guidance also suggests that the
sponsor submit the cover letter to a
request for special protocol assessment
via fax to the appropriate division in
CDER or CBER. Agency regulations (21
CFR 312.23(d)) state that information
provided to the Agency as part of an
IND is to be submitted in triplicate and
with the appropriate cover form, Form
FDA 1571. An IND is submitted to FDA
under existing regulations in part 312
(21 CFR part 312), which specifies the
information that manufacturers must
submit so that FDA may properly
evaluate the safety and effectiveness of
investigational drugs and biological
products. The information collection
requirements resulting from the
preparation and submission of an IND
under part 312 have been estimated by
FDA and the reporting and
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Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
recordkeeping burden has been
approved by OMB under OMB control
number 0910–0014.
FDA suggests that the cover letter to
the request for special protocol
assessment be submitted via fax to the
appropriate division in CDER or CBER
to enable Agency staff to prepare for the
arrival of the protocol for assessment.
The Agency recommends that a request
for special protocol assessment be
submitted as an amendment to an IND
for two reasons: (1) To ensure that each
request is kept in the administrative file
with the entire IND and (2) to ensure
that pertinent information about the
request is entered into the appropriate
tracking databases. Use of the
information in the Agency’s tracking
databases enables the appropriate
Agency official to monitor progress on
the evaluation of the protocol and to
ensure that appropriate steps will be
taken in a timely manner.
The guidance recommends that the
following information should be
submitted to the appropriate Center
with each request for special protocol
assessment so that the Center may
quickly and efficiently respond to the
request:
• Questions to the Agency concerning
specific issues regarding the protocol;
and
• All data, assumptions, and
information needed to permit an
adequate evaluation of the protocol,
including: (1) The role of the study in
the overall development of the drug; (2)
information supporting the proposed
sponsor would spend preparing the
notification and background
information to be submitted in
accordance with the guidance, is
estimated to be approximately 8 hours.
Requests for Special Protocol
Assessment: Based on the number of
requests for special protocol assessment
currently submitted to CDER and CBER,
CDER estimates that it will receive
approximately 211 requests for special
protocol assessment per year from
approximately 112 sponsors. CBER
estimates that it will receive
approximately nine requests from
approximately seven sponsors. The
hours per response is the estimated
number of hours that a respondent
would spend preparing the information
to be submitted with a request for
special protocol assessment, including
the time it takes to gather and copy
questions to be posed to the Agency
regarding the protocol and data,
assumptions, and information needed to
permit an adequate evaluation of the
protocol. Based on the Agency’s
experience with these submissions, FDA
estimates approximately 15 hours on
average would be needed per response.
In the Federal Register of November
18, 2016 (81 FR 81776), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. No
comments were received in response to
the notice.
FDA estimates the burden of this
collection as follows:
trial, including power calculations, the
choice of study endpoints, and other
critical design features; (3) regulatory
outcomes that could be supported by
the results of the study; (4) final labeling
that could be supported by the results
of the study; and (5) for a stability
protocol, product characterization and
relevant manufacturing data.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biologic product regulated by
the Agency under the Federal Food,
Drug, and Cosmetic Act or section 351
of the Public Health Service Act (42
U.S.C. 262) who requests special
protocol assessment.
Burden Estimate: Table 1 provides an
estimate of the annual reporting burden
for notifications for a carcinogenicity
protocol and requests for a special
protocol assessment.
Notification for a Carcinogenicity
Protocol: Based on the number of
notifications for carcinogenicity
protocols and the number of
carcinogenicity protocols currently
submitted to CDER and CBER, CDER
estimates that it will receive
approximately 52 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 28
sponsors. CBER estimates that it will
receive approximately one notification
of an intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately one
sponsor. The hours per response, which
is the estimated number of hours that a
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Number of
responses per
respondent
Total annual
responses
Hours per
response
Total hours
Notification for Carcinogenicity Protocols ............................
Requests for Special Protocol Assessment ........................
29
119
1.8
1.8
53
220
8
15
424
3,300
Total ..............................................................................
........................
........................
........................
........................
3,724
1 There
are no capital costs or operating and maintenance costs associated with this collection.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05098 Filed 3–14–17; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
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Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13820-13821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3535]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Special Protocol Assessment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, 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 April
14, 2017.
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 0910-0470.
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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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.
Guidance for Industry on Special Protocol Assessment OMB Control Number
0910-0470--Extension
The ``Guidance for Industry on Special Protocol Assessment''
describes Agency procedures to evaluate issues related to the adequacy
(e.g., design, conduct, analysis) of certain proposed studies. The
guidance describes procedures for sponsors to request special protocol
assessment and for the Agency to act on such requests. The guidance
provides information on how the Agency interprets and applies
provisions of the Food and Drug Administration Modernization Act of
1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA)
goals for special protocol assessment associated with the development
and review of PDUFA products. The guidance describes the following two
collections of information: (1) The submission of a notice of intent to
request special protocol assessment of a carcinogenicity protocol and
(2) the submission of a request for special protocol assessment.
I. Notification for a Carcinogenicity Protocol
As described in the guidance, a sponsor interested in Agency
assessment of a carcinogenicity protocol should notify the appropriate
division in FDA's Center for Drug Evaluation and Research (CDER) or the
Center for Biologics Evaluation and Research (CBER) of an intent to
request special protocol assessment at least 30 days prior to
submitting the request. With such notification, the sponsor should
submit relevant background information so that the Agency may review
reference material related to carcinogenicity protocol design prior to
receiving the carcinogenicity protocol.
II. Request for Special Protocol Assessment
The guidance asks that a request for special protocol assessment be
submitted as an amendment to the investigational new drug application
(IND) for the underlying product and that it be submitted to the Agency
in triplicate with Form FDA 1571 attached. The guidance also suggests
that the sponsor submit the cover letter to a request for special
protocol assessment via fax to the appropriate division in CDER or
CBER. Agency regulations (21 CFR 312.23(d)) state that information
provided to the Agency as part of an IND is to be submitted in
triplicate and with the appropriate cover form, Form FDA 1571. An IND
is submitted to FDA under existing regulations in part 312 (21 CFR part
312), which specifies the information that manufacturers must submit so
that FDA may properly evaluate the safety and effectiveness of
investigational drugs and biological products. The information
collection requirements resulting from the preparation and submission
of an IND under part 312 have been estimated by FDA and the reporting
and
[[Page 13821]]
recordkeeping burden has been approved by OMB under OMB control number
0910-0014.
FDA suggests that the cover letter to the request for special
protocol assessment be submitted via fax to the appropriate division in
CDER or CBER to enable Agency staff to prepare for the arrival of the
protocol for assessment. The Agency recommends that a request for
special protocol assessment be submitted as an amendment to an IND for
two reasons: (1) To ensure that each request is kept in the
administrative file with the entire IND and (2) to ensure that
pertinent information about the request is entered into the appropriate
tracking databases. Use of the information in the Agency's tracking
databases enables the appropriate Agency official to monitor progress
on the evaluation of the protocol and to ensure that appropriate steps
will be taken in a timely manner.
The guidance recommends that the following information should be
submitted to the appropriate Center with each request for special
protocol assessment so that the Center may quickly and efficiently
respond to the request:
Questions to the Agency concerning specific issues
regarding the protocol; and
All data, assumptions, and information needed to permit an
adequate evaluation of the protocol, including: (1) The role of the
study in the overall development of the drug; (2) information
supporting the proposed trial, including power calculations, the choice
of study endpoints, and other critical design features; (3) regulatory
outcomes that could be supported by the results of the study; (4) final
labeling that could be supported by the results of the study; and (5)
for a stability protocol, product characterization and relevant
manufacturing data.
Description of Respondents: A sponsor, applicant, or manufacturer
of a drug or biologic product regulated by the Agency under the Federal
Food, Drug, and Cosmetic Act or section 351 of the Public Health
Service Act (42 U.S.C. 262) who requests special protocol assessment.
Burden Estimate: Table 1 provides an estimate of the annual
reporting burden for notifications for a carcinogenicity protocol and
requests for a special protocol assessment.
Notification for a Carcinogenicity Protocol: Based on the number of
notifications for carcinogenicity protocols and the number of
carcinogenicity protocols currently submitted to CDER and CBER, CDER
estimates that it will receive approximately 52 notifications of an
intent to request special protocol assessment of a carcinogenicity
protocol per year from approximately 28 sponsors. CBER estimates that
it will receive approximately one notification of an intent to request
special protocol assessment of a carcinogenicity protocol per year from
approximately one sponsor. The hours per response, which is the
estimated number of hours that a sponsor would spend preparing the
notification and background information to be submitted in accordance
with the guidance, is estimated to be approximately 8 hours.
Requests for Special Protocol Assessment: Based on the number of
requests for special protocol assessment currently submitted to CDER
and CBER, CDER estimates that it will receive approximately 211
requests for special protocol assessment per year from approximately
112 sponsors. CBER estimates that it will receive approximately nine
requests from approximately seven sponsors. The hours per response is
the estimated number of hours that a respondent would spend preparing
the information to be submitted with a request for special protocol
assessment, including the time it takes to gather and copy questions to
be posed to the Agency regarding the protocol and data, assumptions,
and information needed to permit an adequate evaluation of the
protocol. Based on the Agency's experience with these submissions, FDA
estimates approximately 15 hours on average would be needed per
response.
In the Federal Register of November 18, 2016 (81 FR 81776), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
FDA estimates the burden of this collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity 29 1.8 53 8 424
Protocols......................
Requests for Special Protocol 119 1.8 220 15 3,300
Assessment.....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,724
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05098 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P