Agency Information Collection Activities; Proposed Collection; Comment Request; Special Protocol Assessment; Guidance for Industry, 65779-65781 [2022-23727]
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Federal Register / Vol. 87, No. 210 / Tuesday, November 1, 2022 / Notices
Our estimated burden for the
information collection reflects an
overall increase of 467,907 hours and a
corresponding increase in responses.
We attribute part of this adjustment in
the total hours to an increase in the
number of submissions that we have
received under 601.12(b)(1) and (3), (e),
and (f)(4), and 601.45 over the last few
years, which accounts for an increase of
467,549 hours. An additional increase of
358 hours is associated with
certifications on Form FDA 3674.
Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23728 Filed 10–31–22; 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; Proposed Collection;
Comment Request; Special Protocol
Assessment; Guidance for Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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
entitled ‘‘Special Protocol Assessment’’
(Revision 1).
DATES: Either electronic or written
comments on the collection of
information must be submitted by
January 3, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 3, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
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SUMMARY:
VerDate Sep<11>2014
17:11 Oct 31, 2022
Jkt 259001
timely if they are received on or before
that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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. 2016–N–
3535 for ‘‘Special Protocol Assessment’’
(Revision 1). Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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
PO 00000
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65779
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
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65780
Federal Register / Vol. 87, No. 210 / Tuesday, November 1, 2022 / Notices
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.
Special Protocol Assessment
OMB Control Number 0910–0470—
Extension
This information collection request
supports Agency guidance entitled
‘‘Special Protocol Assessment’’
(Revision 1) (2018) that describes
Agency procedures to evaluate issues
related to the adequacy (e.g., design,
conduct, analysis) of certain proposed
studies. The guidance (available at
https://www.fda.gov/media/97618/
download) describes procedures for
sponsors to request special protocol
assessment and for FDA to act on such
requests. The guidance provides
information on how FDA interprets and
applies provisions of the Food and Drug
Administration Modernization Act and
specific Prescription Drug User Fee Act
(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 an FDA
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 FDA may review reference
material related to carcinogenicity
protocol design before 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 FDA in triplicate
along with Form FDA 1571.1 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. FDA regulations (21 CFR
312.23(d)) state that information
provided to us 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 FDA staff to prepare for the
arrival of the protocol for assessment.
FDA 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 FDA’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 CBER or
CDER division with each request for
special protocol assessment so that the
division may quickly and efficiently
respond to the request:
• Questions to FDA concerning
specific issues regarding the protocol.
• 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 that FDA
regulates under the Federal Food, Drug,
and Cosmetic Act or section 351 of the
Public Health Service Act (42 U.S.C.
262) requesting special protocol
assessment.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
lotter on DSK11XQN23PROD with NOTICES1
Information collection activity; guidance document section
Number of
respondents
Notification for Carcinogenicity Protocols; Sections III. and
V .......................................................................................
Requests for Special Protocol Assessment Reports; Sections IV. and VI .................................................................
Number of
responses per
respondent
Total annual
responses
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PO 00000
Frm 00049
Fmt 4703
Total hours
99
0.94
93
8
744
100
1.54
154
15
2,310
1 Form FDA 1571 is available at https://
www.fda.gov/media/116608/download.
VerDate Sep<11>2014
Average
burden per
response
Sfmt 4703
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Federal Register / Vol. 87, No. 210 / Tuesday, November 1, 2022 / Notices
65781
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Number of
responses per
respondent
........................
........................
Information collection activity; guidance document section
Total ..............................................................................
lotter on DSK11XQN23PROD with NOTICES1
1 There
Total annual
responses
247
Average
burden per
response
........................
Total hours
3,054
are no capital costs or operating and maintenance costs associated with this collection of information.
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 92 notifications of an
intent to request special protocol
assessment of a carcinogenicity protocol
per year from approximately 98
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 152 requests for special
protocol assessment per year from
approximately 98 sponsors. CBER
estimates that it will receive
approximately two requests from
approximately two 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 our experience with these
submissions, we estimate approximately
15 hours on average would be needed
per response.
The information collection reflects an
adjustment decrease in burden by 196
hours. We attribute this adjustment to a
decrease in the number of notifications
for carcinogenicity protocols and an
increase in the number of requests for
VerDate Sep<11>2014
17:11 Oct 31, 2022
Jkt 259001
special protocol assessment reports we
received over the last few years.
Dated: October 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23727 Filed 10–31–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0760]
Measuring Growth and Evaluating
Pubertal Development in Pediatric
Clinical Trials; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Measuring Growth and Evaluating
Pubertal Development in Pediatric
Clinical Trials.’’ The purpose of this
draft guidance is to outline the most
appropriate methods for measuring and
recording growth and evaluating
pubertal development for drugs or
biological products in development for
pediatric use when such an assessment
is necessary to support safety. This draft
guidance is intended to encourage a
consistent approach to collecting
interpretable and accurate growth and
pubertal development data. This draft
guidance does not address use of growth
or pubertal development data to support
primary evidence of efficacy in growth
disorders and does not address
evaluation of nutritional status.
DATES: Submit either electronic or
written comments on the draft guidance
by January 3, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2022–D–0760 for ‘‘Measuring Growth
and Evaluating Pubertal Development in
Pediatric Clinical Trials.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
E:\FR\FM\01NON1.SGM
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Agencies
[Federal Register Volume 87, Number 210 (Tuesday, November 1, 2022)]
[Notices]
[Pages 65779-65781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23727]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3535]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Special Protocol Assessment; Guidance for Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 entitled ``Special Protocol Assessment'' (Revision 1).
DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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.
2016-N-3535 for ``Special Protocol Assessment'' (Revision 1). Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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
[[Page 65780]]
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.
Special Protocol Assessment
OMB Control Number 0910-0470--Extension
This information collection request supports Agency guidance
entitled ``Special Protocol Assessment'' (Revision 1) (2018) that
describes Agency procedures to evaluate issues related to the adequacy
(e.g., design, conduct, analysis) of certain proposed studies. The
guidance (available at https://www.fda.gov/media/97618/download)
describes procedures for sponsors to request special protocol
assessment and for FDA to act on such requests. The guidance provides
information on how FDA interprets and applies provisions of the Food
and Drug Administration Modernization Act and specific Prescription
Drug User Fee Act (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 an FDA
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 FDA may review reference
material related to carcinogenicity protocol design before 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 FDA in
triplicate along with Form FDA 1571.\1\ 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. FDA
regulations (21 CFR 312.23(d)) state that information provided to us 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.
---------------------------------------------------------------------------
\1\ Form FDA 1571 is available at https://www.fda.gov/media/116608/download.
---------------------------------------------------------------------------
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 FDA staff to prepare for the arrival of the
protocol for assessment. FDA 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 FDA'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 CBER or CDER division with each request
for special protocol assessment so that the division may quickly and
efficiently respond to the request:
Questions to FDA concerning specific issues regarding the
protocol.
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 that FDA regulates under the Federal
Food, Drug, and Cosmetic Act or section 351 of the Public Health
Service Act (42 U.S.C. 262) requesting special protocol assessment.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Information collection activity; Number of responses per Total annual burden per Total hours
guidance document section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity 99 0.94 93 8 744
Protocols; Sections III. and V.
Requests for Special Protocol 100 1.54 154 15 2,310
Assessment Reports; Sections
IV. and VI.....................
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[[Page 65781]]
Total....................... .............. .............. 247 .............. 3,054
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 92 notifications of an
intent to request special protocol assessment of a carcinogenicity
protocol per year from approximately 98 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 152
requests for special protocol assessment per year from approximately 98
sponsors. CBER estimates that it will receive approximately two
requests from approximately two 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 our experience with these submissions, we estimate
approximately 15 hours on average would be needed per response.
The information collection reflects an adjustment decrease in
burden by 196 hours. We attribute this adjustment to a decrease in the
number of notifications for carcinogenicity protocols and an increase
in the number of requests for special protocol assessment reports we
received over the last few years.
Dated: October 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23727 Filed 10-31-22; 8:45 am]
BILLING CODE 4164-01-P