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, 64177-64178 [2016-22470]

Download as PDF Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary. (The product identifier is a standardized graphic that includes, in both human- and machine-readable forms, the National Drug Code, serial number, lot number, and expiration date of the product.) Under section 582(b)(2) and (e)(2) of the FD&C Act, manufacturers and repackagers must affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce, by November 2017 and November 2018, respectively. Other topics of interest to FDA that may be presented at the public meeting include, but are not limited to: • An assessment of the steps taken by supply chain members to build capacity for a unit-level system for electronic product tracing, including the impact on (1) the ability of the health care system to maintain patient access to medicines; (2) the scalability of such requirements, including as it relates to product lines; and (3) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier; and • information related to the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain. FDA will post the agenda of the meeting at https://www.fda.gov/Drugs/ NewsEvents/ucm519587.htm. III. Registration Registration to attend is free and will be on a first-come, first-served basis. To register for the meeting either: (1) Email your registration information to CDERODSIRPublicMeetings@ fda.hhs.gov, or (2) mail your registration information to the contact person (see FOR FURTHER INFORMATION CONTACT). Registration information should include: • ‘‘Registration for October 14, 2016, DSCSA meeting’’ in the subject line, and • Registrant name, company or organization, address, phone number, and email address in the body of your email or mailing. Registration requests should be received by October 6, 2016. Onsite registration on the day of the meeting, starting at 8 a.m., will be based on space availability. Seating will be limited; therefore, if registration meets the maximum capacity, FDA will post a notice closing meeting registration for the meeting on FDA’s Web site at: https://www.fda.gov/Drugs/NewsEvents/ ucm519587.htm. VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 If you need special accommodations due to a disability, please contact Daniel Bellingham (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the public meeting. IV. Requests for Oral Presentations Any person interested in presenting at the public meeting should include a request to present in a single email with a registration request (see section III. Registration). The request should specify the topic(s) that will be addressed in the presentation. FDA will do its best to accommodate requests for oral presentations. Individuals and organizations with common interests are encouraged to consolidate or coordinate their presentations and can submit a single request to present. All requests to make oral presentations must be received by October 5, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled public comment session, FDA may conduct a lottery to determine the speakers for the public comment session. The contact person will notify interested persons regarding their request to speak by October 7, 2016. Presenters must email their presentation materials, if any, to CDERODSIRPublicMeetings@ fda.hhs.gov no later than October 12, 2016. This meeting is not intended to be a venue for circulation of productspecific promotional material, but rather an opportunity to gather information related to stakeholder progress towards implementing the product identification requirements of the DSCSA. V. Webcasting of the Public Meeting Portions of this public meeting will be recorded and Webcast on the day of the meeting. Information for how to access the Webcast will be available at https:// www.fda.gov/Drugs/NewsEvents/ ucm519587.htm by October 14, 2016. The Webcast will be conducted in listening mode only. Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–22441 Filed 9–16–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 64177 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 FDAApproved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for comments. ACTION: 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. SUMMARY: ADDRESSES: You may submit comments 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 E:\FR\FM\19SEN1.SGM 19SEN1 64178 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES 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 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 VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 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. • 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. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration 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. [Docket No. FDA–2016–D–2569] SUPPLEMENTARY INFORMATION: 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES S9 Nonclinical Evaluation for Anticancer Pharmaceuticals— Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability I. Background AGENCY: 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 FDAApproved Therapeutics (October 2007 to December 2015). ACTION: 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. PO 00000 Frm 00053 Fmt 4703 Food and Drug Administration, HHS. Sfmt 4703 Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ‘‘S9 Nonclinical Evaluation for Anticancer Pharmaceuticals—Questions and Answers.’’ The draft questions and answers (Q&As) guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft Q&As guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnologyderived products, intended to treat patients with cancer. The Q&As are intended to provide additional clarity for topics discussed in the ICH guidance entitled ‘‘S9 Nonclinical Evaluation for Anticancer Pharmaceuticals’’ (S9 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 November 18, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64177-64178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22470]


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

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.

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

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: 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

[[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 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, 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
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