Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment, 7676-7677 [2014-02754]
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Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Notices
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.
Estimated Total Annual Burden
Hours: 20,552.
Dated: February 4, 2014.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2014–02839 Filed 2–7–14; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1394]
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) 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 March 12,
2014.
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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,
VerDate Mar<15>2010
19:25 Feb 07, 2014
Jkt 232001
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.
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
PO 00000
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Fmt 4703
Sfmt 4703
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 of this
document 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
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10FEN1
7677
Federal Register / Vol. 79, No. 27 / Monday, February 10, 2014 / Notices
estimates that it will receive
approximately 50 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 23
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.
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, 2013 (78 FR 69093), 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 as follows:
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 300 requests for special
protocol assessment per year from
approximately 145 sponsors. CBER
estimates that it will receive
approximately 14 requests from
approximately 11 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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notification for carcinogenicity protocols .............................
Requests for special protocol assessment ..........................
24
156
2.1
2
51
314
8
15
408
4,710
Total ..............................................................................
........................
........................
........................
........................
5,118
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02754 Filed 2–7–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Safety Communication
Readership Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
the FDA Safety Communication
Readership Survey.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:25 Feb 07, 2014
Jkt 232001
Submit either electronic or
written comments on the collection of
information by April 11, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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,
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
DATES:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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.
FDA Safety Communication (Formerly
Known as Public Health Notification)
Readership Survey—(OMB Control
Number 0910–0341)—Extension
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
375(b)) gives FDA authority to
disseminate information concerning
suspected or imminent danger to public
health by any regulated product. Section
1701(a)(4) of the Public Health Service
Act (42 U.S.C. 300u(a)(4)) also
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7676-7677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02754]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1394]
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) 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 March
12, 2014.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
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.
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 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 of this document 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
[[Page 7677]]
estimates that it will receive approximately 50 notifications of an
intent to request special protocol assessment of a carcinogenicity
protocol per year from approximately 23 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 300
requests for special protocol assessment per year from approximately
145 sponsors. CBER estimates that it will receive approximately 14
requests from approximately 11 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, 2013 (78 FR 69093), 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 as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Notification for carcinogenicity 24 2.1 51 8 408
protocols......................
Requests for special protocol 156 2 314 15 4,710
assessment.....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,118
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02754 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P
