Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Draft Guidance for Industry; Availability, 49244-49246 [2015-20228]
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49244
Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0332]
Endotoxin Testing Recommendations
for Single-Use Intraocular Ophthalmic
Devices; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Endotoxin Testing Recommendations
for Single-Use Intraocular Ophthalmic
Devices.’’ National outbreaks of Toxic
Anterior Segment Syndrome (TASS)
have been associated with single-use
intraocular ophthalmic devices (IODs)
and single-use intraocular ophthalmic
surgical instruments/accessories that are
contaminated with endotoxins. These
devices can become contaminated as
part of the manufacturing, sterilization,
or packaging processes. This guidance
document provides recommendations
for endotoxin limits as well as
endotoxin testing to manufacturers and
other entities involved in submitting
premarket applications (PMAs) or
premarket notification submissions
(510(k)s) for different categories of IODs
to mitigate future outbreaks of TASS.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Endotoxin Testing
Recommendations for Single-Use
Intraocular Ophthalmic Devices’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5431,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:57 Aug 14, 2015
Jkt 235001
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Michelle Tarver, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2504, Silver Spring,
MD 20993–0002, 301–796–5620.
SUPPLEMENTARY INFORMATION:
I. Background
TASS has been increasing in
frequency over the past decade from
approximately 1 in 1,000 to about 2 in
100. Some cases of TASS are severe
enough to require secondary surgical
interventions including glaucoma
surgery and corneal transplantation. The
use of inadequately or improperly
processed ophthalmic surgical
instruments is one of many factors
suggested as a potential cause of TASS.
In many TASS cases, bacterial
endotoxin from medical devices is
believed to cause the inflammation.
This guidance document was
developed to notify manufacturers and
other entities involved in submitting
PMAs or 510(k)s for different categories
of IODs of the recommended endotoxin
limit for the release of IODs and singleuse intraocular ophthalmic surgical
instruments/accessories in an effort to
mitigate future TASS outbreaks.
The draft of this guidance was made
available in the Federal Register on
April 17, 2014 (79 FR 21777), and the
comment period closed July 16, 2014.
Only two sets of comments were
received. The comments were minor,
and FDA made revisions to the
document in response to the comments
where appropriate. FDA also removed
posterior segment devices from the
scope of the guidance document. FDA
may address endotoxin testing
recommendations for this device type in
future guidance documents.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on endotoxin testing
and limits for single-use IODs. 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.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Endotoxin Testing
Recommendations for Single-Use
Intraocular Ophthalmic Devices’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1836 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. 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 814 have been approved
under OMB control number 0910–0231.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20229 Filed 8–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2843]
Qualification of Biomarker—Total
Kidney Volume in Studies for
Treatment of Autosomal Dominant
Polycystic Kidney Disease; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\17AUN1.SGM
Notice.
17AUN1
Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Qualification of Biomarker—Total
Kidney Volume in Studies for
Treatment of Autosomal Dominant
Polycystic Kidney Disease.’’ This draft
guidance provides a qualified context of
use (COU) for total kidney volume
(TKV), measured at baseline, to be used
as a prognostic enrichment biomarker to
select patients with autosomal dominant
polycystic kidney disease (ADPKD) at
high risk for a ‘‘progressive decline’’ in
renal function, defined as a confirmed
30 percent decline in the patient’s
estimated glomerular filtration rate
(eGFR), for inclusion in interventional
clinical trials. This draft guidance also
describes the experimental conditions
and constraints for which this
biomarker is qualified through the
Center for Drug Evaluation and Research
(CDER) Biomarker Qualification
Program. This biomarker can be used by
drug developers for the qualified COU
in submissions of investigational new
drug applications, new drug
applications, and biologics license
applications without the relevant CDER
review group reconsidering and
reconfirming the suitability of the
biomarker.
In the Federal Register of January 7,
2014, FDA announced the availability of
a final guidance for industry entitled
‘‘Qualification Process for Drug
Development Tools’’ that described the
process that would be used to qualify
Drug Development Tools (DDTs) and to
make new DDT qualification
recommendations available on FDA’s
Web site. The qualification
recommendations in this draft guidance
were developed using the process
described in that guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 16,
2015.
ADDRESSES: Submit written requests for
single copies of the draft 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. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:57 Aug 14, 2015
Jkt 235001
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Marianne Noone, Center for Drug
Evaluation and Research (Office of
Translational Sciences, Immediate
Office), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 21,
Rm. 4528, Silver Spring, MD 20993–
0002, 301–796–2600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Qualification of Biomarker—Total
Kidney Volume in Studies for
Treatment of Autosomal Dominant
Polycystic Kidney Disease.’’ This draft
guidance provides qualification
recommendations for the use of TKV,
measured at baseline, as a prognostic
enrichment biomarker to select patients
with ADPKD at high risk for a
‘‘progressive decline’’ in renal function,
defined as a confirmed 30 percent
decline in the patient’s eGFR, for
inclusion in interventional clinical
trials. This biomarker may be used in
combination with the patient’s age and
baseline eGFR as an enrichment factor
in these interventional clinical trials.
Specifically, this draft guidance
provides the COU for which this
biomarker is qualified through the CDER
Biomarker Qualification Program.
Qualification of this biomarker for this
specific COU represents the conclusion
that analytically valid measurements of
the biomarker can be relied on to have
a specific use and interpretable
meaning. This biomarker can be used by
drug developers for the qualified COU
in submission of investigational new
drug applications, new drug
applications, and biologics license
applications without the relevant CDER
review group reconsidering and
reconfirming the suitability of the
biomarker. ‘‘Qualification’’ means that
the use of this biomarker in the specific
COU is not limited to a single, specific
drug development program. Making the
qualification recommendations widely
known and available for use by drug
developers will contribute to drug
innovation, thus supporting public
health.
In the Federal Register of January 7,
2014 (79 FR 831), FDA announced the
availability of a final guidance for
industry entitled ‘‘Qualification Process
for Drug Development Tools’’ that
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
49245
described the process that would be
used to qualify DDTs and to make new
DDT qualification recommendations
available on FDA’s Web site at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. The current draft guidance
is an attachment to that final guidance.
CDER has initiated this formal
qualification process to work with
developers of these biomarker DDTs to
guide them as they refine and evaluate
DDTs for use in the regulatory context.
Once qualified, biomarker DDTs will be
publicly available for use in any drug
development program for the qualified
COU. As described in the January 2014
guidance, biomarker DDTs should be
developed and reviewed using this
process. For more information on FDA’s
DDTs Qualification Programs, refer to
the following Web page: https://
www.fda.gov/Drugs/
DevelopmentApprovalProcess/
DrugDevelopmentTools
QualificationProgram/default.htm.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the use of TKV, measured at
baseline, as a prognostic enrichment
biomarker to select patients with
ADPKD at high risk for a progressive
decline in renal function, defined as a
confirmed 30 percent decline in eGFR,
for inclusion in interventional clinical
trials. This biomarker may be used in
combination with patient age and
baseline eGFR, as an enrichment factor
in these interventional clinical trials. It
does not establish any rights for any
person and not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. The Paperwork Reduction Act of
1995
This guidance contains an
information collection that is 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 information collection has
been approved under the OMB control
numbers 0910–0001 and 0910–0014.
The information requested in this
guidance is currently submitted to FDA
to support medical product
effectiveness (see 21 CFR 312.30, 21
CFR 314.50(d)(5), and 21 CFR
314.126(b)(6)).
E:\FR\FM\17AUN1.SGM
17AUN1
49246
Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20228 Filed 8–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2818]
Rare Diseases: Common Issues in
Drug Development; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Rare
Diseases: Common Issues in Drug
Development.’’ The purpose of this draft
guidance is to advance and facilitate the
development of drugs and biologics to
treat rare diseases. Drug development
for rare diseases has many challenges
related to the nature of these diseases.
This draft guidance is intended to assist
sponsors of drug and biological
products for treating rare diseases in
conducting more efficient and
successful development programs.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:57 Aug 14, 2015
Jkt 235001
on the draft guidance by October 16,
2015.
Submit written requests for
single copies of the draft 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 draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jonathan Goldsmith, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6480,
Silver Spring, MD 20903–0002, 240–
402–9959; 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:
ADDRESSES:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Rare Diseases: Common Issues in Drug
Development.’’ This guidance is
intended to assist sponsors of drug and
biological products for treating rare
diseases in conducting more efficient
and successful development programs
through a discussion of selected issues
commonly encountered in rare disease
drug development. Although these
issues are encountered in other drug
development programs, they are
frequently more difficult to address in
the context of a rare disease than a
common disease for which there is
greater and more widespread medical
experience. These issues are also more
acute with increasing rarity of the
disorder. A rare disease is defined by
the Orphan Drug Act as a disorder or
condition that affects less than 200,000
persons in the United States; however,
most rare diseases affect far fewer
persons.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Most rare disorders are serious
conditions with no approved
treatments, and rare disease patients
have considerable unmet medical needs.
Collectively, rare diseases are highly
diverse. FDA is committed to helping
sponsors of drugs for rare diseases
create successful programs that address
the particular challenges posed by each
disease.
This guidance addresses the following
important components of drug
development:
• Adequate description and
understanding of the disease’s natural
history
• Adequate understanding of the
pathophysiology of the disease and the
drug’s proposed mechanism of action
• Nonclinical pharmacotoxicology
considerations to support the proposed
clinical investigation(s)
• Standard of evidence to establish
safety and effectiveness
• Drug manufacturing considerations
during drug development
Early consideration of these issues
allows sponsors to efficiently and
adequately address them during the
course of drug development, from drug
discovery to confirmatory efficacy and
safety studies, and to have productive
meetings with FDA.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on common issues in drug development
for rare diseases. 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.
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 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.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
E:\FR\FM\17AUN1.SGM
17AUN1
Agencies
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49244-49246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20228]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-2843]
Qualification of Biomarker--Total Kidney Volume in Studies for
Treatment of Autosomal Dominant Polycystic Kidney Disease; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 49245]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Qualification of Biomarker--Total Kidney Volume in Studies for
Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This draft
guidance provides a qualified context of use (COU) for total kidney
volume (TKV), measured at baseline, to be used as a prognostic
enrichment biomarker to select patients with autosomal dominant
polycystic kidney disease (ADPKD) at high risk for a ``progressive
decline'' in renal function, defined as a confirmed 30 percent decline
in the patient's estimated glomerular filtration rate (eGFR), for
inclusion in interventional clinical trials. This draft guidance also
describes the experimental conditions and constraints for which this
biomarker is qualified through the Center for Drug Evaluation and
Research (CDER) Biomarker Qualification Program. This biomarker can be
used by drug developers for the qualified COU in submissions of
investigational new drug applications, new drug applications, and
biologics license applications without the relevant CDER review group
reconsidering and reconfirming the suitability of the biomarker.
In the Federal Register of January 7, 2014, FDA announced the
availability of a final guidance for industry entitled ``Qualification
Process for Drug Development Tools'' that described the process that
would be used to qualify Drug Development Tools (DDTs) and to make new
DDT qualification recommendations available on FDA's Web site. The
qualification recommendations in this draft guidance were developed
using the process described in that guidance.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 16, 2015.
ADDRESSES: Submit written requests for single copies of the draft
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. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Marianne Noone, Center for Drug
Evaluation and Research (Office of Translational Sciences, Immediate
Office), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
21, Rm. 4528, Silver Spring, MD 20993-0002, 301-796-2600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Qualification of Biomarker--Total Kidney Volume in Studies
for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This
draft guidance provides qualification recommendations for the use of
TKV, measured at baseline, as a prognostic enrichment biomarker to
select patients with ADPKD at high risk for a ``progressive decline''
in renal function, defined as a confirmed 30 percent decline in the
patient's eGFR, for inclusion in interventional clinical trials. This
biomarker may be used in combination with the patient's age and
baseline eGFR as an enrichment factor in these interventional clinical
trials. Specifically, this draft guidance provides the COU for which
this biomarker is qualified through the CDER Biomarker Qualification
Program. Qualification of this biomarker for this specific COU
represents the conclusion that analytically valid measurements of the
biomarker can be relied on to have a specific use and interpretable
meaning. This biomarker can be used by drug developers for the
qualified COU in submission of investigational new drug applications,
new drug applications, and biologics license applications without the
relevant CDER review group reconsidering and reconfirming the
suitability of the biomarker. ``Qualification'' means that the use of
this biomarker in the specific COU is not limited to a single, specific
drug development program. Making the qualification recommendations
widely known and available for use by drug developers will contribute
to drug innovation, thus supporting public health.
In the Federal Register of January 7, 2014 (79 FR 831), FDA
announced the availability of a final guidance for industry entitled
``Qualification Process for Drug Development Tools'' that described the
process that would be used to qualify DDTs and to make new DDT
qualification recommendations available on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. The current draft guidance is an attachment to that final
guidance.
CDER has initiated this formal qualification process to work with
developers of these biomarker DDTs to guide them as they refine and
evaluate DDTs for use in the regulatory context. Once qualified,
biomarker DDTs will be publicly available for use in any drug
development program for the qualified COU. As described in the January
2014 guidance, biomarker DDTs should be developed and reviewed using
this process. For more information on FDA's DDTs Qualification
Programs, refer to the following Web page: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the use of
TKV, measured at baseline, as a prognostic enrichment biomarker to
select patients with ADPKD at high risk for a progressive decline in
renal function, defined as a confirmed 30 percent decline in eGFR, for
inclusion in interventional clinical trials. This biomarker may be used
in combination with patient age and baseline eGFR, as an enrichment
factor in these interventional clinical trials. It does not establish
any rights for any person and not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance contains an information collection that is 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 information collection
has been approved under the OMB control numbers 0910-0001 and 0910-
0014. The information requested in this guidance is currently submitted
to FDA to support medical product effectiveness (see 21 CFR 312.30, 21
CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).
[[Page 49246]]
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20228 Filed 8-14-15; 8:45 am]
BILLING CODE 4164-01-P