81_FR_64358 81 FR 64177 - A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket

81 FR 64177 - A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 181 (September 19, 2016)

Page Range64177-64178
FR Document2016-22470

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. Comments received on this list will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future.

Federal Register, Volume 81 Issue 181 (Monday, September 19, 2016) 
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64177-64178]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2610]


A List of Biomarkers Used as Outcomes in Development of FDA-
Approved New Molecular Entities and New Biological Therapeutics 
(October 2007 to December 2015); Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of a docket to receive suggestions, recommendations, 
and comments from interested parties (such as academic researchers, 
regulated industries, consortia, and patient groups) on a list of 
biomarkers that were used as outcomes to develop FDA-approved new 
molecular entities (NMEs) and New Biological Therapeutics from October 
2007 to December 2015. Comments received on this list will help FDA 
determine the utility of the list and may assist FDA in developing 
databases on biomarkers for drug development in the future.

DATES: Submit either electronic or written comments by November 18, 
2016.

ADDRESSES: You may submit comments 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

[[Page 64178]]

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-2016-N-2610 for ``A List of Biomarkers Used as Outcomes in 
Development of FDA-Approved New Molecular Entities and New Biological 
Therapeutics (October 2007 to December 2015); Establishment of Public 
Docket.'' 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/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.

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 committed to support more efficient drug development by 
providing scientific, technical, and regulatory advice to stakeholders 
(such as to pharmaceutical industries, academia, patient advocacy 
groups, and consortia). As part of this commitment, FDA is providing a 
list of biomarkers that were used as outcomes in the development of 
FDA-approved NMEs and New Biological Therapeutics in different disease 
areas from October 2007 to December 2015. This list is intended to 
provide examples of biomarkers that were accepted and used as endpoints 
in clinical trials for drug and biologic approvals from October 2007 to 
December 2015. This list, along with brief background information, is 
accessible at Biomarkers Used as Outcomes in Development of FDA-
Approved Therapeutics (October 2007 to December 2015).

II. Establishment of a Public Docket and Request for Comments

    FDA is soliciting suggestions and comments from stakeholders to 
determine the utility of the biomarker outcomes list and to identify 
any areas of improvement for disseminating information on biomarkers 
that have been used to support the approval of drugs or biologics. 
Specifically, FDA welcomes comments regarding the following two areas:
     Areas of improvement for communicating and disseminating 
information about biomarkers and their utility as drug development 
tools.
     The best approach for updating the biomarkers outcomes 
list, including any modifications of the list, in the future.
    FDA will consider all comments submitted but will generally not 
respond directly to the person or organization submitting the comment.

    Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22470 Filed 9-16-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices 64177 enhance tracing of product at the If you need special accommodations DEPARTMENT OF HEALTH AND package level, including allowing for due to a disability, please contact Daniel HUMAN SERVICES verification, aggregation, and inference, Bellingham (see FOR FURTHER as necessary. (The product identifier is INFORMATION CONTACT) at least 7 days in Food and Drug Administration a standardized graphic that includes, in advance of the public meeting. [Docket No. FDA–2016–N–2610] both human- and machine-readable forms, the National Drug Code, serial IV. Requests for Oral Presentations A List of Biomarkers Used as number, lot number, and expiration date Outcomes in Development of FDA- Any person interested in presenting at of the product.) Under section 582(b)(2) Approved New Molecular Entities and the public meeting should include a and (e)(2) of the FD&C Act, New Biological Therapeutics (October manufacturers and repackagers must request to present in a single email with a registration request (see section III. 2007 to December 2015); affix or imprint a product identifier to Establishment of a Public Docket each package and homogenous case of a Registration). The request should product intended to be introduced in a specify the topic(s) that will be AGENCY: Food and Drug Administration, transaction into commerce, by addressed in the presentation. FDA will HHS. November 2017 and November 2018, do its best to accommodate requests for ACTION: Notice; establishment of docket; respectively. oral presentations. Individuals and request for comments. Other topics of interest to FDA that organizations with common interests are may be presented at the public meeting encouraged to consolidate or coordinate SUMMARY: The Food and Drug include, but are not limited to: their presentations and can submit a Administration (FDA or Agency) is • An assessment of the steps taken by single request to present. announcing the establishment of a supply chain members to build capacity docket to receive suggestions, All requests to make oral recommendations, and comments from for a unit-level system for electronic presentations must be received by interested parties (such as academic product tracing, including the impact on October 5, 2016. Time allotted for each researchers, regulated industries, (1) the ability of the health care system to maintain patient access to medicines; presentation may be limited. If the consortia, and patient groups) on a list (2) the scalability of such requirements, number of registrants requesting to of biomarkers that were used as including as it relates to product lines; speak is greater than can be reasonably outcomes to develop FDA-approved and (3) the capability of different sectors accommodated during the scheduled new molecular entities (NMEs) and New and subsectors, including both large and public comment session, FDA may Biological Therapeutics from October small businesses, to affix and utilize the conduct a lottery to determine the 2007 to December 2015. Comments product identifier; and speakers for the public comment received on this list will help FDA • information related to the secure, session. The contact person will notify determine the utility of the list and may interoperable electronic data exchange interested persons regarding their assist FDA in developing databases on among sectors within the request to speak by October 7, 2016. biomarkers for drug development in the pharmaceutical distribution supply Presenters must email their presentation future. chain. materials, if any, to DATES: Submit either electronic or FDA will post the agenda of the CDERODSIRPublicMeetings@ written comments by November 18, meeting at http://www.fda.gov/Drugs/ fda.hhs.gov no later than October 12, 2016. NewsEvents/ucm519587.htm. 2016. This meeting is not intended to be ADDRESSES: You may submit comments III. Registration a venue for circulation of product- as follows: Registration to attend is free and will specific promotional material, but rather an opportunity to gather information Electronic Submissions be on a first-come, first-served basis. To register for the meeting either: (1) Email related to stakeholder progress towards Submit electronic comments in the your registration information to implementing the product identification following way: CDERODSIRPublicMeetings@ requirements of the DSCSA. • Federal eRulemaking Portal: http:// fda.hhs.gov, or (2) mail your registration www.regulations.gov. Follow the V. Webcasting of the Public Meeting instructions for submitting comments. information to the contact person (see FOR FURTHER INFORMATION CONTACT). Portions of this public meeting will be Comments submitted electronically, Registration information should recorded and Webcast on the day of the including attachments, to http:// include: meeting. Information for how to access www.regulations.gov will be posted to • ‘‘Registration for October 14, 2016, the Webcast will be available at http:// the docket unchanged. Because your DSCSA meeting’’ in the subject line, and www.fda.gov/Drugs/NewsEvents/ comment will be made public, you are • Registrant name, company or ucm519587.htm by October 14, 2016. solely responsible for ensuring that your organization, address, phone number, comment does not include any The Webcast will be conducted in and email address in the body of your confidential information that you or a listening mode only. third party may not wish to be posted, email or mailing. Registration requests should be Dated: September 13, 2016. such as medical information, your or received by October 6, 2016. Onsite Leslie Kux, anyone else’s Social Security number, or registration on the day of the meeting, Associate Commissioner for Policy. confidential business information, such starting at 8 a.m., will be based on space as a manufacturing process. Please note mstockstill on DSK3G9T082PROD with NOTICES [FR Doc. 2016–22441 Filed 9–16–16; 8:45 am] availability. Seating will be limited; that if you include your name, contact BILLING CODE 4164–01–P therefore, if registration meets the information, or other information that maximum capacity, FDA will post a identifies you in the body of your notice closing meeting registration for comments, that information will be the meeting on FDA’s Web site at: posted on http://www.regulations.gov. http://www.fda.gov/Drugs/NewsEvents/ • If you want to submit a comment ucm519587.htm. with confidential information that you VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1

64178 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices do not wish to be made available to the information about FDA’s posting of • The best approach for updating the public submit the comment as a written/ comments to public dockets, see 80 FR biomarkers outcomes list, including any paper submission and in the manner 56469, September 18, 2015, or access modifications of the list, in the future. detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/ FDA will consider all comments Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/ submitted but will generally not default.htm. respond directly to the person or Written/Paper Submissions Docket: For access to the docket to organization submitting the comment. Submit written/paper submissions as read background documents or the Dated: September 14, 2016. follows: electronic and written/paper comments • Mail/Hand delivery/Courier (for Leslie Kux, received, go to http:// Associate Commissioner for Policy. written/paper submissions): Division of www.regulations.gov and insert the Dockets Management (HFA–305), Food [FR Doc. 2016–22470 Filed 9–16–16; 8:45 am] docket number, found in brackets in the and Drug Administration, 5630 Fishers BILLING CODE 4164–01–P heading of this document, into the Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments ‘‘Search’’ box and follow the prompts submitted to the Division of Dockets and/or go to the Division of Dockets DEPARTMENT OF HEALTH AND Management, FDA will post your Management, 5630 Fishers Lane, Rm. HUMAN SERVICES comment, as well as any attachments, 1061, Rockville, MD 20852. except for information submitted, FOR FURTHER INFORMATION CONTACT: Food and Drug Administration marked and identified, as confidential, Marianne Noone, Center for Drug [Docket No. FDA–2016–D–2569] if submitted as detailed in Evaluation and Research, Food and ‘‘Instructions.’’ Drug Administration, 10903 New S9 Nonclinical Evaluation for Instructions: All submissions received Hampshire Ave., Bldg. 21, Rm. 4528, Anticancer Pharmaceuticals— must include the Docket No. FDA– Silver Spring, MD 20993–0002, 301– Questions and Answers; International 2016–N–2610 for ‘‘A List of Biomarkers 796–2600. Council for Harmonisation; Draft Used as Outcomes in Development of Guidance for Industry; Availability SUPPLEMENTARY INFORMATION: FDA-Approved New Molecular Entities and New Biological Therapeutics I. Background AGENCY: Food and Drug Administration, (October 2007 to December 2015); HHS. Establishment of Public Docket.’’ FDA is committed to support more ACTION: Notice of availability. Received comments will be placed in efficient drug development by providing the docket and, except for those scientific, technical, and regulatory SUMMARY: The Food and Drug submitted as ‘‘Confidential advice to stakeholders (such as to Administration (FDA or Agency) is Submissions,’’ publicly viewable at pharmaceutical industries, academia, announcing the availability of a draft http://www.regulations.gov or at the patient advocacy groups, and consortia). guidance entitled ‘‘S9 Nonclinical Division of Dockets Management As part of this commitment, FDA is Evaluation for Anticancer between 9 a.m. and 4 p.m., Monday providing a list of biomarkers that were Pharmaceuticals—Questions and through Friday. used as outcomes in the development of Answers.’’ The draft questions and • Confidential Submissions—To FDA-approved NMEs and New answers (Q&As) guidance was prepared submit a comment with confidential Biological Therapeutics in different under the auspices of the International information that you do not wish to be disease areas from October 2007 to Council for Harmonisation (ICH), made publicly available submit your December 2015. This list is intended to formerly the International Conference comments only as a written/paper provide examples of biomarkers that on Harmonisation. The draft Q&As submission. You should submit two were accepted and used as endpoints in guidance provides recommendations for copies total. One copy will include the clinical trials for drug and biologic nonclinical studies for the development information you claim to be confidential approvals from October 2007 to of pharmaceuticals, including both with a heading or cover note that states December 2015. This list, along with small molecule and biotechnology- ‘‘THIS DOCUMENT CONTAINS brief background information, is derived products, intended to treat CONFIDENTIAL INFORMATION.’’ The accessible at Biomarkers Used as patients with cancer. The Q&As are Agency will review this copy, including Outcomes in Development of FDA- intended to provide additional clarity the claimed confidential information, in Approved Therapeutics (October 2007 for topics discussed in the ICH guidance its consideration of comments. The to December 2015). entitled ‘‘S9 Nonclinical Evaluation for second copy, which will have the Anticancer Pharmaceuticals’’ (S9 II. Establishment of a Public Docket and guidance). claimed confidential information Request for Comments redacted/blacked out, will be available DATES: Although you can comment on for public viewing and posted on http:// FDA is soliciting suggestions and any guidance at any time (see 21 CFR www.regulations.gov. Submit both comments from stakeholders to 10.115(g)(5)), to ensure that the Agency copies to the Division of Dockets determine the utility of the biomarker considers your comment on this draft Management. If you do not wish your outcomes list and to identify any areas guidance before it begins work on the name and contact information to be of improvement for disseminating final version of the guidance, submit made publicly available, you can information on biomarkers that have either electronic or written comments provide this information on the cover been used to support the approval of on the draft guidance by November 18, mstockstill on DSK3G9T082PROD with NOTICES sheet and not in the body of your drugs or biologics. Specifically, FDA 2016. comments and you must identify this welcomes comments regarding the ADDRESSES: You may submit comments information as ‘‘confidential.’’ Any following two areas: as follows: information marked as ‘‘confidential’’ • Areas of improvement for will not be disclosed except in communicating and disseminating Electronic Submissions accordance with 21 CFR 10.20 and other information about biomarkers and their Submit electronic comments in the applicable disclosure law. For more utility as drug development tools. following way: VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1


Document Created: 2016-09-17 02:30:40
Document Modified: 2016-09-17 02:30:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of docket; request for comments.
DatesSubmit either electronic or written comments by November 18, 2016.
ContactMarianne 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 Citation81 FR 64177 
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