[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Pages 38694-38695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16563]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2244


Qualification of Biomarker--Plasma Fibrinogen in Studies 
Examining Exacerbations and/or All-Cause Mortality for Patients With 
Chronic Obstructive Pulmonary Disease; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Qualification of Biomarker--Plasma Fibrinogen in Studies Examining 
Exacerbations and/or All-Cause Mortality in Patients With Chronic 
Obstructive Pulmonary Disease.'' This draft guidance provides a 
qualified context of use (COU) for plasma fibrinogen in interventional 
clinical trials of chronic obstructive pulmonary disease (COPD) 
subjects at high risk for exacerbations and/or all-cause mortality. 
This draft guidance also describes the experimental conditions

[[Page 38695]]

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 
(INDs), new drug applications (NDAs), and biologics license 
applications (BLAs) 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qualification recommendations in this draft guidance were developed 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draft guidance before it begins work on the final version of the 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 September 8, 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 http://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, 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--Plasma Fibrinogen in Studies 
Examining Exacerbations and/or All-Cause Mortality for Chronic 
Obstructive Pulmonary Disease.'' This draft guidance provides 
qualification recommendations for the use of plasma fibrinogen, 
measured at baseline, as a prognostic biomarker to enrich clinical 
trial populations of COPD subjects at high risk for exacerbations and/
or all-cause mortality for inclusion in interventional clinical trials. 
This biomarker should be considered with other subject demographic and 
clinical characteristics, including a prior history of COPD 
exacerbations, as an enrichment factor in these 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 IND applications, 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.
    As stated previously, 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 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, 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 site: http://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 
plasma fibrinogen as an enrichment biomarker in interventional clinical 
trials of COPD patients. 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 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)).

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

IV. 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.

    Dated: June 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16563 Filed 7-6-15; 8:45 am]
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