Guidance on Qualification of Biomarker-Galactomannan in Studies of Treatments of Invasive Aspergillosis; Guidance for Industry; Availability, 70235-70236 [2015-28804]

Download as PDF Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices burden for this section to be 2,932 hours. The annual burden reflects our estimate to test the tobacco products (i.e., carry out laboratory work). The burden estimate assumes that manufacturers report HPHC quantities in cigarette mainstream smoke according to the two smoking regimens described in the table. The estimated total annual burden for the reporting of HPHC under section 904(c)(1) of the FD&C Act is 3,847 hours. We do not believe there are any capital costs associated with this collection. Dated: November 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–28787 Filed 11–12–15; 8:45 am] BILLING CODE 4164–01–P 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. 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 jstallworth on DSK7TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 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: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 https://www.regulations.gov or at the Division of Dockets Management PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 70235 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 https://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: https://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 https:// 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 E:\FR\FM\13NON1.SGM 13NON1 jstallworth on DSK7TPTVN1PROD with NOTICES 70236 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 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 https://www.fda.gov/Drugs/Development ApprovalProcess/DrugDevelopment ToolsQualificationProgram/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 https:// VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ 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: https:// www.fda.gov/Drugs/Development ApprovalProcess/DrugDevelopment ToolsQualificationProgram/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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 https://www.regulations.gov. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0922] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On September 17, 2015, the Agency submitted a proposed collection of information entitled ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0789. The approval expires on October 31, 2018. A copy of the supporting statement for this SUMMARY: E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70235-70236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28804]


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

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.

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

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://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 https://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: https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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 https://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
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