Document ID: FDA-2015-D-2244-0003
Agency: fda
Document Type: Notice
Title: Qualification of Biomarker—Plasma Fibrinogen in Studies Examining
Exacerbations and/or All-Cause Mortality for Patients With Chronic
Obstructive Pulmonary Disease; Guidance for Industry; Availability
Posted Date: 2016-09-13T04:00Z

[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62908-62909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21964]

-----------------------------------------------------------------------

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; 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 ``Qualification of 
Biomarker--Plasma Fibrinogen in Studies Examining Exacerbations and/or 
All-Cause Mortality for Patients With Chronic Obstructive Pulmonary 
Disease.'' This 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 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 (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: Submit either electronic or written comments on Agency guidances 
at any time.

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-2015-D-2244 for ``Qualification for the Use of Plasma Fibrinogen in 
Studies Examining Exacerbations and/or All-Cause Mortality for Patients 
with Chronic Obstructive Pulmonary Disease; Availability.'' 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/

[[Page 62909]]

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.
    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. 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: 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 guidance for industry 
entitled ``Qualification of Biomarker--Plasma Fibrinogen in Studies 
Examining Exacerbations and/or All-Cause Mortality for Patients With 
Chronic Obstructive Pulmonary Disease.'' In the Federal Register of 
January 7, 2014 (79 FR 831), FDA announced the availability of a 
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 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
The qualification recommendations in the current guidance were 
developed using the process described in that 2014 guidance, and the 
current guidance is an attachment to that 2014 guidance.
    Later, in the Federal Register of July 7, 2015 (80 FR 38694), FDA 
announced the availability of a draft guidance entitled ``Qualification 
of Biomarker--Plasma Fibrinogen in Studies Examining Exacerbations and/
or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary 
Disease.'' The Agency did not receive any comments on that draft 
guidance during the public comment period. The current guidance 
finalizes that draft guidance.
    This guidance provides 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 guidance provides the COU for which this 
biomarker is qualified through the CDER Biomarker Qualification 
Program. ``Biomarker qualification'' is a conclusion that within the 
stated COU, the biomarker can be relied upon to have a specific 
interpretation and application in drug development and regulatory 
review. 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 context in submission of INDs, NDAs, and BLAs without the 
relevant CDER review group reconsidering and reconfirming the 
suitability of the biomarker. After a biomarker is qualified for the 
specific COU, its qualification 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 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 under the animal rule. Refer to DDTs 
Qualification Programs at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm for additional information.
    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.
    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 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 
guidance 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. 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: September 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21964 Filed 9-12-16; 8:45 am]
BILLING CODE 4164-01-P