80 FR 70235 - Guidance on Qualification of Biomarker-Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 219 (November 13, 2015)

Page Range		70235-70236
FR Document		2015-28804

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance on Qualification of Biomarker--Galactomannan in Studies of Treatments of Invasive Aspergillosis.'' This guidance provides a qualified context of use (COU) for Galactomannan detection in serum and/or bronchoalveolar lavage (BAL) fluid as the sole microbiological criterion to classify patients as having probable invasive Aspergillosis (IA) for enrollment in clinical trials. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the CDER Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.

Federal Register, Volume 80 Issue 219 (Friday, November 13, 2015)

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70235-70236]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-28804]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1630]

Guidance on Qualification of Biomarker--Galactomannan in Studies
of Treatments of Invasive Aspergillosis; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Guidance on
Qualification of Biomarker--Galactomannan in Studies of Treatments of
Invasive Aspergillosis.'' This guidance provides a qualified context of
use (COU) for Galactomannan detection in serum and/or bronchoalveolar
lavage (BAL) fluid as the sole microbiological criterion to classify
patients as having probable invasive Aspergillosis (IA) for enrollment
in clinical trials. This guidance also describes the experimental
conditions and constraints for which this biomarker is qualified
through the CDER Biomarker Qualification Program. This biomarker can be
used by drug developers for the qualified COU in submissions of
investigational new drug applications (INDs), new drug applications
(NDAs), and biologics license applications (BLAs) without the relevant
CDER review group reconsidering and reconfirming the suitability of the
biomarker.

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
guidance before it begins work on the final version of the guidance,
submit either electronic or written comments on the guidance by January
12, 2016

ADDRESSES: You may submit comment as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2013-D-1630 for ``Guidance on Qualification of Biomarker--
Galactomannan in Studies of Treatments of Invasive Aspergillosis.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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 guidance for industry
entitled ``Guidance on Qualification of Biomarker--Galactomannan in
Studies of Treatments of Invasive Aspergillosis.'' In the Federal
Register of October 27, 2014 (79 FR 63921), FDA

[[Page 70236]]

announced the availability of a draft guidance entitled ``Draft
Guidance on Qualification of Biomarker--Galactomannan in studies of
Treatments of Invasive Aspergillosis.'' The Agency received one comment
during the public comment period which was supportive of the
qualification of this biomarker. This guidance finalizes the draft
guidance issued in October 2014.
This guidance provides qualification recommendations for the use of
Galactomannan detection in serum and/or BAL fluid as the sole
microbiological criterion to classify patients with hematologic
malignancies and recipients of allogeneic hematopoietic stem cell
transplants and who also have radiologic evidence suggestive of
invasive fungal infection (Ref. 1) as having probable IA for enrollment
in clinical trials.
Specifically, this 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 INDs, NDAs, and BLAs 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.
Innovative and improved Drug Development Tools (DDTs) can help
streamline the drug development process, improve the chances for
clinical trial success, and yield more information about a treatment
and/or disease. DDTs include, but are not limited to, biomarkers,
clinical outcome assessments, and animal models. Refer to DDTs
Qualification Programs at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm for additional information.
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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. The current 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: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking for the use of Galactomannan detection in
serum and/or BAL fluid as the sole microbiological criterion to
classify patients as having probable IA for enrollment in clinical
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.

II. The 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 312.30, 21 CFR 314.50(d)(5), and
21 CFR 314.126(b)(6) have been approved under OMB control numbers 0910-
0001 and 0910-0014.

III. Electronic Access

Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

IV. Reference

The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov.

1. De Pauw, B., T. J. Walsh, J. P. Donnelly, et al., ``Revised
Definitions of Invasive Fungal Disease from European Organization
for Research and Treatment of Cancer/Invasive Fungal Infections
Cooperative Group and the National Institute of Allergy and
Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus
Group,'' Clinical Infectious Diseases, 46:12, pp. 1813-1821, 2008.

Dated: November 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28804 Filed 11-12-15; 8:45 am]
BILLING CODE 4164-01-P

70236 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices

announced the availability of a draft www.fda.gov/Drugs/Guidance 1. De Pauw, B., T. J. Walsh, J. P. Donnelly,
guidance entitled ‘‘Draft Guidance on ComplianceRegulatoryInformation/ et al., ‘‘Revised Definitions of Invasive
Qualification of Biomarker— Guidances/default.htm. The current Fungal Disease from European Organization
guidance is an attachment to that final for Research and Treatment of Cancer/
Galactomannan in studies of Treatments
Invasive Fungal Infections Cooperative
of Invasive Aspergillosis.’’ The Agency guidance. Group and the National Institute of Allergy
received one comment during the public CDER has initiated this formal and Infectious Diseases Mycoses Study
comment period which was supportive qualification process to work with Group (EORTC/MSG) Consensus Group,’’
of the qualification of this biomarker. developers of these biomarker DDTs to Clinical Infectious Diseases, 46:12, pp. 1813–
This guidance finalizes the draft guide them as they refine and evaluate 1821, 2008.
guidance issued in October 2014. DDTs for use in the regulatory context. Dated: November 4, 2015.
This guidance provides qualification Once qualified, biomarker DDTs will be Leslie Kux,
recommendations for the use of publicly available for use in any drug
Associate Commissioner for Policy.
Galactomannan detection in serum and/ development program for the qualified
or BAL fluid as the sole microbiological [FR Doc. 2015–28804 Filed 11–12–15; 8:45 am]
COU. As described in the January 2014
criterion to classify patients with guidance, biomarker DDTs should be BILLING CODE 4164–01–P
hematologic malignancies and developed and reviewed using this
recipients of allogeneic hematopoietic process. For more information on FDA’s
stem cell transplants and who also have DDTs Qualification Programs, refer to DEPARTMENT OF HEALTH AND
radiologic evidence suggestive of the following Web page: http:// HUMAN SERVICES
invasive fungal infection (Ref. 1) as www.fda.gov/Drugs/Development Food and Drug Administration
having probable IA for enrollment in ApprovalProcess/DrugDevelopment
clinical trials. ToolsQualificationProgram/default.htm. [Docket No. FDA–2011–N–0922]
Specifically, this guidance provides This guidance is being issued
the COU for which this biomarker is consistent with FDA’s good guidance Agency Information Collection
qualified through the CDER Biomarker practices regulation (21 CFR 10.115). Activities; Announcement of Office of
Qualification Program. Qualification of The guidance represents the Agency’s Management and Budget Approval;
this biomarker for this specific COU current thinking for the use of Current Good Manufacturing Practice,
represents the conclusion that Galactomannan detection in serum and/ Hazard Analysis, and Risk-Based
analytically valid measurements of the or BAL fluid as the sole microbiological Preventive Controls for Food for
biomarker can be relied on to have a criterion to classify patients as having Animals
specific use and interpretable meaning. probable IA for enrollment in clinical AGENCY: Food and Drug Administration,
This biomarker can be used by drug trials. It does not establish any rights for HHS.
developers for the qualified COU in any person and is not binding on FDA
submission of INDs, NDAs, and BLAs ACTION: Notice.
or the public. You can use an alternative
without the relevant CDER review group approach if it satisfies the requirements SUMMARY: The Food and Drug
reconsidering and reconfirming the of the applicable statutes and Administration (FDA) is announcing
suitability of the biomarker. regulations. that a collection of information entitled
‘‘Qualification’’ means that the use of ‘‘Current Good Manufacturing Practice,
this biomarker in the specific COU is II. The Paperwork Reduction Act of
Hazard Analysis, and Risk-Based
not limited to a single, specific drug 1995
Preventive Controls for Food for
development program. Making the This guidance refers to previously Animals’’ has been approved by the
qualification recommendations widely approved collections of information Office of Management and Budget
known and available for use by drug found in FDA regulations. These (OMB) under the Paperwork Reduction
developers will contribute to drug collections of information are subject to Act of 1995.
innovation, thus supporting public review by the Office of Management and FOR FURTHER INFORMATION CONTACT: FDA
health. Budget (OMB) under the Paperwork
Innovative and improved Drug PRA Staff, Office of Operations, Food
Reduction Act of 1995 (44 U.S.C. 3501– and Drug Administration, 8455
Development Tools (DDTs) can help 3520). The collections of information in
streamline the drug development Colesville Rd., COLE–14526, Silver
21 CFR 312.30, 21 CFR 314.50(d)(5), and Spring, MD 20993–0002, PRAStaff@
process, improve the chances for 21 CFR 314.126(b)(6) have been
clinical trial success, and yield more fda.hhs.gov.
approved under OMB control numbers
information about a treatment and/or SUPPLEMENTARY INFORMATION: On
0910–0001 and 0910–0014.
disease. DDTs include, but are not September 17, 2015, the Agency
limited to, biomarkers, clinical outcome III. Electronic Access submitted a proposed collection of
assessments, and animal models. Refer Persons with access to the Internet information entitled ‘‘Current Good
to DDTs Qualification Programs at may obtain the document at either Manufacturing Practice, Hazard
http://www.fda.gov/Drugs/Development http://www.fda.gov/Drugs/Guidance Analysis, and Risk-Based Preventive
ApprovalProcess/DrugDevelopment ComplianceRegulatoryInformation/ Controls for Food for Animals’’ to OMB
ToolsQualificationProgram/default.htm Guidances/default.htm or http:// for review and clearance under 44
for additional information. www.regulations.gov. U.S.C. 3507. An Agency may not
In the Federal Register of January 7, conduct or sponsor, and a person is not
2014 (79 FR 831), FDA announced the IV. Reference required to respond to, a collection of
jstallworth on DSK7TPTVN1PROD with NOTICES

availability of a final guidance for The following reference is on display information unless it displays a
industry entitled ‘‘Qualification Process in the Division of Dockets Management currently valid OMB control number.
for Drug Development Tools’’ that (see ADDRESSES) and is available for OMB has now approved the information
described the process that would be viewing by interested persons between collection and has assigned OMB
used to qualify DDTs and to make new 9 a.m. and 4 p.m., Monday through control number 0910–0789. The
DDT qualification recommendations Friday; it is also available electronically approval expires on October 31, 2018. A
available on FDA’s Web site at http:// at http://www.regulations.gov. copy of the supporting statement for this

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Document Created: 2018-03-01 11:22:29
Document Modified: 2018-03-01 11:22:29

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the guidance by January 12, 2016
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.
FR Citation		80 FR 70235

80 FR 70235 - Guidance on Qualification of Biomarker-Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 219 (November 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration