80 FR 38694 - 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in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 129 (July 7, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 129 (July 7, 2015)
| Page Range | 38694-38695 | |
| FR Document | 2015-16563 |
[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)] [Notices] [Pages 38694-38695] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16563] ----------------------------------------------------------------------- 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in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualification of Biomarker--Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic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 This draft guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at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 This draft guidance also describes the experimental conditions [[Page 38695]] and constraints for which this biomarker is qualified through the Center for Drug Evaluation and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] BILLING CODE 4164-01-P
![38694 Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Notices
Assistance Programs (SHIPs), Area patterned after the statutory formula Programs, is not applicable to these
Agencies on Aging (AAAs), and Aging used for SHIPs and AAAs. grant applications.
and Disability Resource Center
2. Anticipated Total Priority Area IV. Submission Information
programs (ADRCs), to inform Medicare
Funding per Budget Period
beneficiaries about available Federal 1. Application Kits
and State benefits. ACL seeks plans ACL intends to make available, under
this program announcement, grant Application kits/Program Instructions
from states that will describe how the are available at www.grantsolutions.gov.
MIPPA funds will be used for awards for the three MIPPA priority
areas. Funding will be distributed Instructions for completing the
beneficiary outreach and education over application kit will be available on the
the next two years. through a formula as identified in
statute. The amounts allocated are based site.
ACL requests that states submit a two
year state plan with specific project upon factors defined in statute and will 2. Submission Dates and Times
be distributed to each priority area
strategies to expand, extend, or enhance To receive consideration, applications
based on the formula. ACL will fund
the outreach efforts to beneficiaries on must be submitted by 11:59 p.m. Eastern
total project periods of up to two (2)
Medicare Part D and for those with time on August 31, 2015, through
years contingent upon availability of
limited incomes. States should describe www.GrantSolutions.gov.
federal funds.
how the SHIP, AAA, and ADRC efforts Priority Area 1—SHIP: $7.5 million in
will be coordinated to provide outreach VII. Agency Contacts
FY 15 and potentially $13 million in FY
to beneficiaries with limited incomes 16 for state agencies that administer the Direct inquiries regarding
statewide, for general Medicare Part D SHIP Program. programmatic issues to U.S. Department
outreach and assistance to beneficiaries Priority Area 2—AAA: $7.5 million in of Health and Human Services,
in rural areas, and for outreach activities FY 15 and potentially $7.5 million in Administration on Aging, Office of
aimed at Medicare prevention and FY 16 for SUAs for Area Agencies on Healthcare Information and Counseling,
wellness benefits as well as the Aging and for Native American Washington, DC 20201, attention:
improvements in the Part D program programs. Funding for Native American Katherine Glendening or by calling 202–
under the Affordable Care Act as Programs ($264,000) is deducted from 357–3859, or by email
mandated by Section 3306 of the Act. Priority 2 and is being allocated through Katherine.Glendening@acl.hhs.gov.
States that are eligible to apply are a separate process. Dated: June 29, 2015.
asked to review previous MIPPA plans Priority Area 3—ADRC: $5 million in Kathy Greenlee,
and update these plans to reflect FY 2015 and potentially $5 million in Administrator and Administration on Aging.
successes achieved to date and direct FY 16 for state agencies that administer [FR Doc. 2015–16509 Filed 7–6–15; 8:45 am]
their efforts to enhance and expand ADRC programs that were established
BILLING CODE 4154–01–P
their MIPPA outreach activities. State prior to March 2014.
agencies may prepare either one
statewide plan or separate plans for III. Eligibility Criteria and Other
Requirements DEPARTMENT OF HEALTH AND
each eligible State agency.
HUMAN SERVICES
II. Award Information 1. Eligible Applicants MIPPA Priority
Areas 1, 2 and 3 Food and Drug Administration
1. Funding Instrument Type Awards made under this [Docket No. FDA–2015–D–2244
These awards will be made in the announcement, by statute, will be made
form of grants to State Agencies for each only to agencies of State Governments. Qualification of Biomarker—Plasma
MIPPA Priority Area. Priority Area 1: Only existing SHIP Fibrinogen in Studies Examining
Priority Area 1—Grants to State grant recipients are eligible to apply. Exacerbations and/or All-Cause
Priority Area 2: Only State Units on Mortality for Patients With Chronic
Agencies (the State Unit on Aging or the
Aging are eligible to apply. Obstructive Pulmonary Disease; Draft
State Department of Insurance) that Priority Area 3: Only State Agencies
administer the State Health Insurance Guidance for Industry; Availability
that received an ACL and CMS Aging
Assistance Programs to provide and Disability Resource Center (ADRC) AGENCY: Food and Drug Administration,
enhanced outreach to eligible Medicare grant where the ADRC was established HHS.
beneficiaries regarding their benefits by March, 2015 are eligible in FY 2015.
and enhanced outreach to individuals ACTION: Notice.
Eligibility may change if future
who may be eligible for the LIS or for funding is available. SUMMARY: The Food and Drug
the MSP. Administration (FDA or Agency) is
Priority Area 2—Grants to State Units 2. Cost Sharing or Matching Is Not
announcing the availability of a draft
on Aging for AAAs to provide enhanced Required.
guidance for industry entitled
outreach to eligible Medicare 3. DUNS Number ‘‘Qualification of Biomarker—Plasma
beneficiaries regarding their benefits All grant applicants must obtain and Fibrinogen in Studies Examining
and enhanced outreach to individuals keep current a D–U–N–S number from Exacerbations and/or All-Cause
who may be eligible for the LIS, MSP, Dun and Bradstreet. It is a nine-digit Mortality in Patients With Chronic
Medicare Part D and Part D in rural identification number, which provides Obstructive Pulmonary Disease.’’ This
areas. unique identifiers of single business draft guidance provides a qualified
tkelley on DSK3SPTVN1PROD with NOTICES
Priority Area 3—Grants to State Units entities. The D–U–N–S number can be context of use (COU) for plasma
on Aging that administer the Aging and obtained from: https://iupdate.dnb.com/ fibrinogen in interventional clinical
Disability Resource Centers to provide iUpdate/viewiUpdateHome.htm. trials of chronic obstructive pulmonary
outreach to individuals regarding the disease (COPD) subjects at high risk for
benefits available under Medicare Part D 4. Intergovernmental Review exacerbations and/or all-cause
and under the MSP. Funds will be Executive Order 12372, mortality. This draft guidance also
allocated to ADRCs via a formula Intergovernmental Review of Federal describes the experimental conditions
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![Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Notices 38695
and constraints for which this Exacerbations and/or All-Cause www.fda.gov/Drugs/Development
biomarker is qualified through the Mortality for Chronic Obstructive ApprovalProcess/
Center for Drug Evaluation and Research Pulmonary Disease.’’ This draft DrugDevelopmentToolsQualification
(CDER) Biomarker Qualification guidance provides qualification Program/default.htm.
Program. This biomarker can be used by recommendations for the use of plasma
This draft guidance is being issued
drug developers for the qualified COU fibrinogen, measured at baseline, as a
consistent with FDA’s good guidance
in submissions of investigational new prognostic biomarker to enrich clinical
trial populations of COPD subjects at practices regulation (21 CFR 10.115).
drug applications (INDs), new drug
applications (NDAs), and biologics high risk for exacerbations and/or all- The draft guidance, when finalized, will
license applications (BLAs) without the cause mortality for inclusion in represent the Agency’s current thinking
relevant CDER review group interventional clinical trials. This on the use of plasma fibrinogen as an
reconsidering and reconfirming the biomarker should be considered with enrichment biomarker in interventional
suitability of the biomarker. other subject demographic and clinical clinical trials of COPD patients. It does
In the Federal Register of January 7, characteristics, including a prior history not establish any rights for any person
2014, FDA announced the availability of of COPD exacerbations, as an and is not binding on FDA or the public.
a final guidance for industry entitled enrichment factor in these trials. You can use an alternative approach if
‘‘Qualification Process for Drug Specifically, this draft guidance it satisfies the requirements of the
Development Tools’’ that described the provides the COU for which this applicable statutes and regulations.
process that would be used to qualify biomarker is qualified through the CDER
drug development tools (DDTs) and to Biomarker Qualification Program. II. The Paperwork Reduction Act of
make new DDT qualification Qualification of this biomarker for this 1995
recommendations available on FDA’s specific COU represents the conclusion
This guidance contains an
Web site. The qualification that analytically valid measurements of
the biomarker can be relied on to have information collection that is subject to
recommendations in this draft guidance review by the Office of Management and
were developed using the process a specific use and interpretable
meaning. This biomarker can be used by Budget (OMB) under the Paperwork
described in that guidance.
drug developers for the qualified COU Reduction Act of 1995 (44 U.S.C. 3501–
DATES: Although you can comment on
in submission of IND applications, 3520). The information collection has
any guidance at any time (see 21 CFR been approved under the OMB control
10.115(g)(5)), to ensure that the Agency NDAs, and BLAs without the relevant
CDER review group reconsidering and numbers 0910–0001 and 0910–0014.
considers your comment on this draft
reconfirming the suitability of the The information requested in this
guidance before it begins work on the
final version of the guidance, submit biomarker. ‘‘Qualification’’ means that guidance is currently submitted to FDA
either electronic or written comments the use of this biomarker in the specific to support medical product
on the draft guidance by September 8, COU is not limited to a single, specific effectiveness (see 21 CFR 312.30, 21
drug development program. Making the CFR 314.50(d)(5), and 21 CFR
2015.
qualification recommendations widely 314.126(b)(6)).
ADDRESSES: Submit written requests for
known and available for use by drug
single copies of the draft guidance to the developers will contribute to drug III. Comments
Division of Drug Information, Center for innovation, thus supporting public
Drug Evaluation and Research, Food Interested persons may submit either
health.
and Drug Administration, 10001 New As stated previously, in the Federal electronic comments regarding this
Hampshire Ave., Hillandale Building, Register of January 7, 2014 (79 FR 831), document to http://www.regulations.gov
4th Floor, Silver Spring, MD 20993– FDA announced the availability of a or written comments to the Division of
0002. Send one self-addressed adhesive final guidance for industry entitled Dockets Management (see ADDRESSES).
label to assist that office in processing ‘‘Qualification Process for Drug It is only necessary to send one set of
your requests. See the SUPPLEMENTARY Development Tools’’ that described the comments. Identify comments with the
INFORMATION section for electronic process that would be used to qualify docket number found in brackets in the
access to the draft guidance document. DDTs and to make new DDT heading of this document. Received
Submit electronic comments on the qualification recommendations comments may be seen in the Division
draft guidance to http:// available on FDA’s Web site at http:// of Dockets Management between 9 a.m.
www.regulations.gov. Submit written www.fda.gov/Drugs/ and 4 p.m., Monday through Friday, and
comments to the Division of Dockets GuidanceCompliance will be posted to the docket at http://
Management (HFA–305), Food and Drug RegulatoryInformation/Guidances/ www.regulations.gov.
Administration, 5630 Fishers Lane, Rm. default.htm. The current draft guidance
1061, Rockville, MD 20852. is an attachment to that final guidance. IV. Electronic Access
FOR FURTHER INFORMATION CONTACT: CDER has initiated this formal
Marianne Noone, Center for Drug qualification process to work with Persons with access to the Internet
Evaluation and Research, Food and developers of these biomarker DDTs to may obtain the document at either
Drug Administration, 10903 New guide them as they refine and evaluate http://www.fda.gov/Drugs/
Hampshire Ave., Bldg. 21, Rm. 4528, DDTs for use in the regulatory context. GuidanceComplianceRegulatory
Silver Spring, MD 20993–0002, 301– Once qualified, DDTs will be publicly Information/Guidances/default.htm or
796–2600. available for use in any drug http://www.regulations.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: development program for the qualified Dated: June 30, 2015.
COU. As described in the January 2014
I. Background Leslie Kux,
guidance, biomarker DDTs should be
FDA is announcing the availability of developed and reviewed using this Associate Commissioner for Policy.
a draft guidance for industry entitled process. For more information on FDA’s [FR Doc. 2015–16563 Filed 7–6–15; 8:45 am]
‘‘Qualification of Biomarker—Plasma DDTs Qualification Programs, refer to BILLING CODE 4164–01–P
Fibrinogen in Studies Examining the following Web site: http://
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Document Created: 2015-12-15 13:27:49
Document Modified: 2015-12-15 13:27:49
| 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. | |
| 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. | |
| 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 | 80 FR 38694 |
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