Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment, 43199-43200 [E6-12158]
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Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D–0084]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Special Protocol
Assessment
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
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
the information collection in the
guidance for industry on special
protocol assessment.
DATES: Submit written or electronic
comments on the collection of
information by September 29, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Elizabeth Berbakos, Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
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
VerDate Aug<31>2005
17:34 Jul 28, 2006
Jkt 208001
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.
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
1987 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 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
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
43199
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 facsimile 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 until May 31,
2009, under OMB control number 0910–
0014.
FDA suggests that the cover letter to
the request for special protocol
assessment be submitted via facsimile 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
E:\FR\FM\31JYN1.SGM
31JYN1
43200
Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
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 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 requests for
special protocol assessment.
Notification for a Carcinogenicity
Protocol. Based on data collected from
the review divisions and offices within
CDER and CBER, including the number
of notifications for carcinogenicity
protocols and the number of
carcinogenicity protocols submitted in
fiscal years (FY) 2004 and 2005, CDER
estimates that it will receive
approximately 45 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 20
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 data collected
from the review divisions and offices
within CDER and CBER, including the
number of requests for special protocol
assessment submitted in FY 2004 and
FY 2005, CDER estimates that it will
receive approximately 364 requests for
special protocol assessment per year
from approximately 143 sponsors. CBER
estimates that it will receive
approximately 10 requests from
approximately 8 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.
FDA estimates the burden of this
collection as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Notification for Carcinogenicity
Protocols
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
21
2.19
46
8
368
151
Requests for Special Protocol Assessment
2.48
374
15
5,610
Total
5,978
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–12158 Filed 7–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on PROD1PC70 with NOTICES
[Docket No. 2006N–0283]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA Survey of
Physicians’ Perceptions of the Impact
of Early Risk Communication About
Medical Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total Hours
Notice.
VerDate Aug<31>2005
17:34 Jul 28, 2006
Jkt 208001
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 a notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a proposed survey of physicians’
perceptions of the impact of early risk
communication about medical products.
The purpose of the proposed survey is
to improve FDA’s understanding of how
and when physicians get, and would
like to get, information about the risk of
medical products, and what factors
might influence the likelihood of
reporting their patients’ adverse
experiences. Together with other
information, the data from this survey
will be used to assess FDA’s
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
communication efforts concerning early
risk communication about medical
products, and inform any potential
communication-related changes.
DATES: Submit written or electronic
comments on the collection of
information by September 29, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Pages 43199-43200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12158]
[[Page 43199]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D-0084]
Agency Information Collection Activities; Proposed Collection;
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 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 information collection in
the guidance for industry on special protocol assessment.
DATES: Submit written or electronic comments on the collection of
information by September 29, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Elizabeth Berbakos, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
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.
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
1987 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 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 facsimile 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 until May 31, 2009,
under OMB control number 0910-0014.
FDA suggests that the cover letter to the request for special
protocol assessment be submitted via facsimile 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
[[Page 43200]]
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 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 requests for special protocol
assessment.
Notification for a Carcinogenicity Protocol. Based on data
collected from the review divisions and offices within CDER and CBER,
including the number of notifications for carcinogenicity protocols and
the number of carcinogenicity protocols submitted in fiscal years (FY)
2004 and 2005, CDER estimates that it will receive approximately 45
notifications of an intent to request special protocol assessment of a
carcinogenicity protocol per year from approximately 20 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 data collected
from the review divisions and offices within CDER and CBER, including
the number of requests for special protocol assessment submitted in FY
2004 and FY 2005, CDER estimates that it will receive approximately 364
requests for special protocol assessment per year from approximately
143 sponsors. CBER estimates that it will receive approximately 10
requests from approximately 8 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.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses Total Annual Hours per
Respondents per Respondent Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity Protocols 21 2.19 46 8 368
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Special Protocol Assessment 151 2.48 374 15 5,610
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. .................... ................. ................. 5,978
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12158 Filed 7-28-06; 8:45 am]
BILLING CODE 4160-01-S
