Special Protocol Assessment; Guidance for Industry; Availability, 16367-16369 [2018-07871]
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Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Investigational In Vitro Diagnostics in
Oncology Trials: Streamlined
Submission Process for Study Risk
Determination.’’ This guidance,
developed by the Oncology Center of
Excellence, CDER, CBER, and CDRH at
FDA, describes an optional streamlined
submission process to determine
whether an investigational in vitro
diagnostic in an oncology clinical trial
under an IND (an oncology codevelopment program) is significant
risk. In the traditional submission
process, many sponsors submitted a
study risk determination Q-submission
to CDRH and an IND to the appropriate
center (CBER or CDER). In the
streamlined process, all information
regarding the oncology co-development
program (including investigational in
vitro diagnostic information) is initially
submitted to the IND. CBER or CDER
works with CDRH to determine whether
the in vitro diagnostic is significant risk.
Initially, FDA plans to implement the
streamlined submission process for
oncology-related products, because FDA
has received the greatest number of codevelopment submissions in this
disease area and has the most
experience evaluating whether the in
vitro diagnostic is significant risk.
However, FDA is interested in receiving
comments on whether the streamlined
submission process should be extended
to other disease areas in the future.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This draft guidance is not final nor is it
in effect at this time. The draft guidance,
when finalized, will represent the
current thinking of FDA on a
streamlined submission process for
study risk determination for in vitro
diagnostics in oncology trials. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
srobinson on DSK3G9T082PROD with NOTICES
This guidance refers to currently
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 809 have
been approved under OMB control
19:42 Apr 13, 2018
Jkt 244001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Special
Protocol Assessment.’’ This guidance
provides information about the
procedures and general policies adopted
by the Center for Drug Evaluation and
Research and the Center for Biologics
Evaluation and Research for special
protocol assessment (SPA). This
guidance is intended to improve the
quality of requests for SPAs and
accompanying submission materials,
and the quality of the resulting
interactions between sponsors and FDA.
This guidance finalizes the draft
guidance of the same name issued May
4, 2016, and replaces the guidance of
the same name issued May 17, 2002.
DATES: The announcement of the
guidance is published in the Federal
Register on April 16, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Food and Drug Administration
II. The Paperwork Reduction Act of
1995
VerDate Sep<11>2014
number 0910–0485; the collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0755; the collections of
information in 21 CFR 56.115 have been
approved under OMB control number
0910–0130; the collections of
information in 21 CFR 50.23 have been
approved under OMB control number
0910–0586; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; and the collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in the guidance document
titled ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
(available at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/documents/document/
ucm311176.pdf) have been approved
under OMB control number 0910–0756.
16367
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’’).
[Docket No. FDA–2016–D–1174]
Written/Paper Submissions
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07812 Filed 4–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Special Protocol Assessment;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of availability.
Frm 00083
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\16APN1.SGM
16APN1
srobinson on DSK3G9T082PROD with NOTICES
16368
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
• 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–
2016–D–1174 for ‘‘Special Protocol
Assessment; Guidance for Industry.’’
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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Amalia Himaya, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6439,
Silver Spring, MD 20993–0002, 301–
796–0700; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Special Protocol Assessment.’’ SPA is
a process by which sponsors may
request to meet with FDA to reach
agreement on the design and size of
certain trials, clinical studies, or animal
studies to determine if they adequately
address scientific and regulatory
requirements for a study that could
support marketing approval. After
completing the SPA review, FDA issues
a letter including comments from the
review team, agreement or
nonagreement with the proposed
protocol, and answers to the sponsor’s
relevant questions. Section 119 of the
Food and Drug Administration
Modernization Act of 1997 (FDAMA)
amended section 505(b) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(b)) and directed
FDA to meet with sponsors who request
to meet, provided certain conditions are
met, to reach agreement on the design
and size of the well-controlled clinical
trials intended to form the primary basis
for a demonstration of effectiveness in a
marketing application submitted under
section 505(b) of the FD&C Act or
section 351 of the Public Health Service
Act (PHS Act) (42 U.S.C. 262). These
provisions subsequently were amended
in section 7002(d)(1) of the Biologics
Price Competition and Innovation Act of
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
2009 to include any necessary clinical
study or studies for biosimilar biological
product applications under section
351(k) of the PHS Act. In 2013, the
Pandemic and All Hazards Preparedness
Reauthorization Act of 2013 further
amended the SPA provisions to provide
for SPA agreements regarding animal
and associated clinical trials conducted
in support of applications for products
developed under 21 CFR part 314,
subpart I, and 21 CFR part 601, subpart
H (the animal rule). Such marketing
applications include new drug
applications (NDAs), biologics license
applications (BLAs), and efficacy
supplements to approved NDAs and
BLAs.
In conjunction with the
reauthorization of the prescription drug
user fee program in FDAMA
(Prescription Drug User Fee Act
(PDUFA) II),1 and with the Biosimilar
User Fee Act of 2012 (BsUFA), enacted
as part of the Food and Drug
Administration Safety and Innovation
Act, FDA agreed to specific performance
goals (PDUFA goals and BsUFA goals,2
respectively) for SPA. Per section
505(b)(5)(B) of the FD&C Act, the
PDUFA goals, and the BsUFA goals, the
following protocols are eligible for SPA:
(1) Animal carcinogenicity protocols; (2)
drug substance and drug product
stability protocols; (3) animal efficacy
protocols for studies intended to
provide primary evidence of
effectiveness required for approval or
for licensure for products developed
under the animal rule; (4) protocols for
trials intended to form the primary basis
of an efficacy claim; and (5) clinical
studies necessary to prove biosimilarity
and/or interchangeability.
This guidance finalizes the draft
guidance of the same name issued May
4, 2016, and replaces the guidance of
the same name issued May 17, 2002.
Changes were made from the 2016 draft
guidance to improve clarity and
readability.
This guidance is being issued
consistent with FDA’s good guidance
1 FDA first agreed to specific PDUFA goals for
SPA in November 1997 in conjunction with PDUFA
II, the reauthorization of the Prescription Drug User
Fee Act of 1992. The PDUFA II goals are described
in ‘‘PDUFA Reauthorization Performance Goals and
Procedures,’’ an enclosure to a letter dated
November 12, 1997, from the Secretary of Health
and Human Services, Donna E. Shalala, to Senator
James M. Jeffords (https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm143135.htm). The program has been
reauthorized every 5 years; the most recent goals
letter is available on the FDA website at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/ucm149212.htm.
2 The BsUFA goals were later updated, in
conjunction with the Biosimilar User Fee
Amendments of 2017.
E:\FR\FM\16APN1.SGM
16APN1
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on SPA. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information referred to in the
guidance entitled ‘‘Special Protocol
Assessment’’ have been approved under
OMB control number 0910–0470. The
collections of information for Form FDA
1571 have been approved under OMB
control number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
Dated: April 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07871 Filed 4–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1189]
Highly Concentrated Caffeine in
Dietary Supplements; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry, ‘‘Highly
Concentrated Caffeine in Dietary
Supplements.’’ FDA considers some
dietary supplements that consist of only
or primarily pure or highly concentrated
caffeine to be adulterated. FDA is
issuing this document to provide
srobinson on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
guidance to firms that manufacture,
market, or distribute dietary supplement
products that contain pure or highly
concentrated caffeine, or are considering
doing so. This guidance should help
such parties determine whether their
products are or would be adulterated
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and to help
them understand how to reduce the
likelihood that their products will be
considered adulterated.
DATES: The announcement of the
guidance is published in the Federal
Register on April 16, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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. FDA–
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
16369
2018–D–1189 for ‘‘Highly Concentrated
Caffeine in Dietary Supplements;
Guidance for Industry; Availability.’’
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.
• 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.’’ We
will review this copy, including the
claimed confidential information, in our
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to Office of
Dietary Supplement Programs, Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16367-16369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1174]
Special Protocol Assessment; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Special Protocol
Assessment.'' This guidance provides information about the procedures
and general policies adopted by the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research for
special protocol assessment (SPA). This guidance is intended to improve
the quality of requests for SPAs and accompanying submission materials,
and the quality of the resulting interactions between sponsors and FDA.
This guidance finalizes the draft guidance of the same name issued May
4, 2016, and replaces the guidance of the same name issued May 17,
2002.
DATES: The announcement of the guidance is published in the Federal
Register on April 16, 2018.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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.
[[Page 16368]]
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-2016-D-1174 for ``Special Protocol Assessment; Guidance for
Industry.'' 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.
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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Amalia Himaya, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Special Protocol Assessment.'' SPA is a process by which
sponsors may request to meet with FDA to reach agreement on the design
and size of certain trials, clinical studies, or animal studies to
determine if they adequately address scientific and regulatory
requirements for a study that could support marketing approval. After
completing the SPA review, FDA issues a letter including comments from
the review team, agreement or nonagreement with the proposed protocol,
and answers to the sponsor's relevant questions. Section 119 of the
Food and Drug Administration Modernization Act of 1997 (FDAMA) amended
section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355(b)) and directed FDA to meet with sponsors who request
to meet, provided certain conditions are met, to reach agreement on the
design and size of the well-controlled clinical trials intended to form
the primary basis for a demonstration of effectiveness in a marketing
application submitted under section 505(b) of the FD&C Act or section
351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). These
provisions subsequently were amended in section 7002(d)(1) of the
Biologics Price Competition and Innovation Act of 2009 to include any
necessary clinical study or studies for biosimilar biological product
applications under section 351(k) of the PHS Act. In 2013, the Pandemic
and All Hazards Preparedness Reauthorization Act of 2013 further
amended the SPA provisions to provide for SPA agreements regarding
animal and associated clinical trials conducted in support of
applications for products developed under 21 CFR part 314, subpart I,
and 21 CFR part 601, subpart H (the animal rule). Such marketing
applications include new drug applications (NDAs), biologics license
applications (BLAs), and efficacy supplements to approved NDAs and
BLAs.
In conjunction with the reauthorization of the prescription drug
user fee program in FDAMA (Prescription Drug User Fee Act (PDUFA)
II),\1\ and with the Biosimilar User Fee Act of 2012 (BsUFA), enacted
as part of the Food and Drug Administration Safety and Innovation Act,
FDA agreed to specific performance goals (PDUFA goals and BsUFA
goals,\2\ respectively) for SPA. Per section 505(b)(5)(B) of the FD&C
Act, the PDUFA goals, and the BsUFA goals, the following protocols are
eligible for SPA: (1) Animal carcinogenicity protocols; (2) drug
substance and drug product stability protocols; (3) animal efficacy
protocols for studies intended to provide primary evidence of
effectiveness required for approval or for licensure for products
developed under the animal rule; (4) protocols for trials intended to
form the primary basis of an efficacy claim; and (5) clinical studies
necessary to prove biosimilarity and/or interchangeability.
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\1\ FDA first agreed to specific PDUFA goals for SPA in November
1997 in conjunction with PDUFA II, the reauthorization of the
Prescription Drug User Fee Act of 1992. The PDUFA II goals are
described in ``PDUFA Reauthorization Performance Goals and
Procedures,'' an enclosure to a letter dated November 12, 1997, from
the Secretary of Health and Human Services, Donna E. Shalala, to
Senator James M. Jeffords (https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm143135.htm). The program has been
reauthorized every 5 years; the most recent goals letter is
available on the FDA website at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm.
\2\ The BsUFA goals were later updated, in conjunction with the
Biosimilar User Fee Amendments of 2017.
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This guidance finalizes the draft guidance of the same name issued
May 4, 2016, and replaces the guidance of the same name issued May 17,
2002. Changes were made from the 2016 draft guidance to improve clarity
and readability.
This guidance is being issued consistent with FDA's good guidance
[[Page 16369]]
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on SPA. It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information referred to in the guidance
entitled ``Special Protocol Assessment'' have been approved under OMB
control number 0910-0470. The collections of information for Form FDA
1571 have been approved under OMB control number 0910-0014.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: April 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07871 Filed 4-13-18; 8:45 am]
BILLING CODE 4164-01-P
