81 FR 62908 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 177 (September 13, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 177 (September 13, 2016)
| Page Range | 62908-62909 | |
| FR Document | 2016-21964 |
[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)] [Notices] [Pages 62908-62909] From the Federal Register Online [www.thefederalregister.org] [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
![62908 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Individuals Responding to Initial Phone Call Screening Interview Guide ............................. 1,250 1 1/60
Who Refuse to be Screened.
Individuals Responding to Initial Phone Call Screening Interview Guide ............................. 750 1 5/60
Responding to Screening Questions.
Study Participants ........................................... Baseline Interview Guide ............................... 500 1 10/60
Study Participants ........................................... MPT ................................................................ 250 1 30/60
Study Participants ........................................... Follow-up Interview Guide ............................. 450 1 10/60
Leroy A. Richardson, review group reconsidering and except for information submitted,
Chief, Information Collection Review Office, reconfirming the suitability of the marked and identified, as confidential,
Office of Scientific Integrity, Office of the biomarker. if submitted as detailed in
Associate Director for Science, Office of the ‘‘Instructions.’’
Director, Centers for Disease Control and DATES: Submit either electronic or
Instructions: All submissions received
Prevention. written comments on Agency guidances
must include the Docket No. FDA–
[FR Doc. 2016–21922 Filed 9–12–16; 8:45 am] at any time.
2015–D–2244 for ‘‘Qualification for the
BILLING CODE 4163–18–P ADDRESSES: You may submit comment Use of Plasma Fibrinogen in Studies
as follows: Examining Exacerbations and/or All-
Electronic Submissions Cause Mortality for Patients with
DEPARTMENT OF HEALTH AND Chronic Obstructive Pulmonary Disease;
HUMAN SERVICES Submit electronic comments in the Availability.’’ Received comments will
following way: be placed in the docket and, except for
Food and Drug Administration • Federal eRulemaking Portal: http:// those submitted as ‘‘Confidential
www.regulations.gov. Follow the Submissions,’’ publicly viewable at
[Docket No. FDA–2015–D–2244]
instructions for submitting comments. http://www.regulations.gov or at the
Qualification of Biomarker—Plasma Comments submitted electronically, Division of Dockets Management
Fibrinogen in Studies Examining including attachments, to http:// between 9 a.m. and 4 p.m., Monday
Exacerbations and/or All-Cause www.regulations.gov will be posted to through Friday.
Mortality for Patients With Chronic the docket unchanged. Because your • Confidential Submissions—To
Obstructive Pulmonary Disease; comment will be made public, you are submit a comment with confidential
Guidance for Industry; Availability solely responsible for ensuring that your information that you do not wish to be
comment does not include any made publicly available submit your
AGENCY: Food and Drug Administration, confidential information that you or a comments only as a written/paper
HHS. third party may not wish to be posted, submission. You should submit two
ACTION: Notice of availability. such as medical information, your or copies total. One copy will include the
anyone else’s Social Security number, or information you claim to be confidential
SUMMARY: The Food and Drug confidential business information, such with a heading or cover note that states
Administration (FDA or Agency) is as a manufacturing process. Please note ‘‘THIS DOCUMENT CONTAINS
announcing the availability of a that if you include your name, contact CONFIDENTIAL INFORMATION.’’ The
guidance for industry entitled information, or other information that Agency will review this copy, including
‘‘Qualification of Biomarker—Plasma identifies you in the body of your the claimed confidential information, in
Fibrinogen in Studies Examining comments, that information will be its consideration of comments. The
Exacerbations and/or All-Cause posted on http://www.regulations.gov. second copy, which will have the
Mortality for Patients With Chronic • If you want to submit a comment claimed confidential information
Obstructive Pulmonary Disease.’’ This with confidential information that you redacted/blacked out, will be available
guidance provides a qualified context of do not wish to be made available to the for public viewing and posted on http://
use (COU) for plasma fibrinogen in public submit the comment as a written/ www.regulations.gov. Submit both
interventional clinical trials of chronic paper submission and in the manner copies to the Division of Dockets
obstructive pulmonary disease (COPD) detailed (see ‘‘Written/Paper Management. If you do not wish your
subjects at high risk for exacerbations Submissions’’ and ‘‘Instructions’’). name and contact information to be
and/or all-cause mortality. This made publicly available, you can
guidance also describes the Written/Paper Submissions
provide this information on the cover
experimental conditions and constraints Submit written/paper submissions as sheet and not in the body of your
for which this biomarker is qualified follows: comments and you must identify this
through the Center for Drug Evaluation • Mail/Hand delivery/Courier (for information as ‘‘confidential.’’ Any
and Research (CDER) Biomarker written/paper submissions): Division of information marked as ‘‘confidential’’
Lhorne on DSK30JT082PROD with NOTICES
Qualification Program. This biomarker Dockets Management (HFA–305), Food will not be disclosed except in
can be used by drug developers for the and Drug Administration, 5630 Fishers accordance with 21 CFR 10.20 and other
qualified COU in submissions of Lane, Rm. 1061, Rockville, MD 20852. applicable disclosure law. For more
investigational new drug applications • For written/paper comments information about FDA’s posting of
(INDs), new drug applications (NDAs), submitted to the Division of Dockets comments to public dockets, see 80 FR
and biologics license applications Management, FDA will post your 56469, September 18, 2015, or access
(BLAs) without the relevant CDER comment, as well as any attachments, the information at: http://www.fda.gov/
VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/81_FR_63085/page/1.svg)
![Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices 62909
regulatoryinformation/dockets/ Disease.’’ The Agency did not receive development program for the qualified
default.htm. any comments on that draft guidance COU. As described in the January 2014
Docket: For access to the docket to during the public comment period. The guidance, biomarker DDTs should be
read background documents or the current guidance finalizes that draft developed and reviewed using this
electronic and written/paper comments guidance. process.
received, go to http:// This guidance provides
recommendations for the use of plasma This guidance is being issued
www.regulations.gov and insert the
fibrinogen, measured at baseline, as a consistent with FDA’s good guidance
docket number, found in brackets in the
heading of this document, into the prognostic biomarker to enrich clinical practices regulation (21 CFR 10.115).
‘‘Search’’ box and follow the prompts trial populations of COPD subjects at The guidance represents the current
and/or go to the Division of Dockets high risk for exacerbations and/or all- thinking of FDA on the use of plasma
Management, 5630 Fishers Lane, Rm. cause mortality for inclusion in fibrinogen, measured at baseline, as a
1061, Rockville, MD 20852. interventional clinical trials. This prognostic biomarker to enrich clinical
Submit written requests for single biomarker should be considered with trial populations of COPD subjects at
copies of this guidance to the Division other subject demographic and clinical high risk for exacerbations and/or all-
of Drug Information, Center for Drug characteristics, including a prior history cause mortality for inclusion in
Evaluation and Research, Food and of COPD exacerbations, as an interventional clinical trials. This
Drug Administration, 10001 New enrichment factor in these trials. guidance does not establish any rights
Hampshire Ave., Hillandale Building, Specifically, this guidance provides the for any person and is not binding on
4th Floor, Silver Spring, MD 20993– COU for which this biomarker is FDA or the public. You can use an
0002. Send one self-addressed adhesive qualified through the CDER Biomarker alternative approach if it satisfies the
label to assist that office in processing Qualification Program. ‘‘Biomarker requirements of the applicable statutes
your requests. See the SUPPLEMENTARY qualification’’ is a conclusion that and regulations.
INFORMATION section for electronic within the stated COU, the biomarker
access to the guidance document. can be relied upon to have a specific II. The Paperwork Reduction Act of
interpretation and application in drug 1995
FOR FURTHER INFORMATION CONTACT:
development and regulatory review.
Marianne Noone, Center for Drug This guidance contains an
Qualification of this biomarker for this
Evaluation and Research, Food and information collection that is subject to
specific COU represents the conclusion
Drug Administration, 10903 New review by the Office of Management and
that analytically valid measurements of
Hampshire Ave., Bldg. 21, Rm. 4528, Budget (OMB) under the Paperwork
the biomarker can be relied on to have
Silver Spring, MD 20993–0002, 301–
a specific use and interpretable Reduction Act of 1995 (44 U.S.C. 3501–
796–2600.
meaning. This biomarker can be used by 3520). The information collection has
SUPPLEMENTARY INFORMATION: drug developers for the qualified been approved under the OMB control
I. Background context in submission of INDs, NDAs, numbers 0910–0001 and 0910–0014.
and BLAs without the relevant CDER The information requested in this
FDA is announcing the availability of review group reconsidering and
a guidance for industry entitled guidance is currently submitted to FDA
reconfirming the suitability of the to support medical product
‘‘Qualification of Biomarker—Plasma biomarker. After a biomarker is
Fibrinogen in Studies Examining effectiveness (see 21 CFR 312.30, 21
qualified for the specific COU, its CFR 314.50(d)(5), and 21 CFR
Exacerbations and/or All-Cause qualification is not limited to a single,
Mortality for Patients With Chronic 314.126(b)(6)).
specific drug development program.
Obstructive Pulmonary Disease.’’ In the Making the qualification III. Electronic Access
Federal Register of January 7, 2014 (79 recommendations widely known and
FR 831), FDA announced the available for use by drug developers will Persons with access to the Internet
availability of a guidance for industry contribute to drug innovation, thus may obtain the document at either
entitled ‘‘Qualification Process for Drug supporting public health. http://www.fda.gov/Drugs/
Development Tools’’ that described the Innovative and improved DDTs can GuidanceCompliance
process that would be used to qualify help streamline the drug development RegulatoryInformation/Guidances/
Drug Development Tools (DDTs) and to process, improve the chances for default.htm or http://
make new DDT qualification clinical trial success, and yield more www.regulations.gov.
recommendations available on FDA’s information about a treatment and/or
Web site at http://www.fda.gov/Drugs/ Dated: September 8, 2016.
disease. DDTs include, but are not
GuidanceCompliance limited to, biomarkers, clinical outcome Leslie Kux,
RegulatoryInformation/Guidances/ assessments, and animal models under Associate Commissioner for Policy.
default.htm. The qualification the animal rule. Refer to DDTs [FR Doc. 2016–21964 Filed 9–12–16; 8:45 am]
recommendations in the current Qualification Programs at http:// BILLING CODE 4164–01–P
guidance were developed using the www.fda.gov/Drugs/
process described in that 2014 guidance, DevelopmentApprovalProcess/
and the current guidance is an DrugDevelopmentTools
attachment to that 2014 guidance. QualificationProgram/default.htm for
Later, in the Federal Register of July additional information.
Lhorne on DSK30JT082PROD with NOTICES
7, 2015 (80 FR 38694), FDA announced CDER has initiated this formal
the availability of a draft guidance qualification process to work with
entitled ‘‘Qualification of Biomarker— developers of these biomarker DDTs to
Plasma Fibrinogen in Studies guide them as they refine and evaluate
Examining Exacerbations and/or All- DDTs for use in the regulatory context.
Cause Mortality for Patients With Once qualified, biomarker DDTs will be
Chronic Obstructive Pulmonary publicly available for use in any drug
VerDate Sep<11>2014 15:27 Sep 12, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 E:\FR\FM\13SEN1.SGM 13SEN1](https://thefederalregister.org/doc/81_FR_63085/page/2.svg)
Document Created: 2018-02-09 13:16:29
Document Modified: 2018-02-09 13:16:29
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 62908 |
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