Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments, 56347-56349 [2018-24656]

Download as PDF Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices ACTION: [FR Doc. 2018–24673 Filed 11–9–18; 8:45 am] BILLING CODE 4120–01–C The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2017–N–0558; FDA– 2017–N–1315; FDA–2011–N–0776; FDA– 2018–N–3038; FDA–2018–N–0405; FDA– 2014–N–1048; FDA–2011–N–0908; FDA– 2011–N–0920; and FDA–2018–N–1857] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Notice. Food and Drug Administration, HHS. 56347 Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. 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. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Disclosures in Professional and Consumer Prescription Drug Promotion .............................................................. Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads .......................... Reclassification Petitions for Medical Devices ........................................................................................................ Request for Samples and Protocols ........................................................................................................................ Medical Device Recall Authority .............................................................................................................................. Food Safety, Health, and Diet Survey ..................................................................................................................... Medical Device Labeling Regulations ..................................................................................................................... GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food ..................................................................................................................................................................... Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals ................................................................................................................................................................. Dated: November 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24609 Filed 11–9–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4100] Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. amozie on DSK3GDR082PROD with NOTICES1 ACTION: VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 The public meeting will be held on December 11, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by January 31, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information. DATES: The public meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security ADDRESSES: The Food and Drug Administration (FDA or the Agency) is announcing a public meeting entitled ‘‘Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.’’ This public meeting is intended to fulfill commitments made by FDA under the sixth authorization of the SUMMARY: Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Date approval expires 0910–0860 0910–0861 0910–0138 0910–0206 0910–0432 0910–0345 0910–0485 0910–0581 9/30/2020 9/30/2020 9/30/2021 9/30/2021 9/30/2021 10/31/2020 10/30/2021 10/31/2021 0910–0751 10/31/2021 0910–0789 10/31/2021 information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241 740.htm. You may submit comments as follows. Please note that late, untimely filed comments may not be considered. For timely consideration we request that electronic comments be submitted on or before January 31, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on January 31, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 E:\FR\FM\13NON1.SGM 13NON1 56348 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 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: Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2018–N–4100 for ‘‘Drug Development Tools Qualification under the 21st Century Cures Act and PDUFA VI.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Valerie Jimenez, Center for Drug Evaluation and Research, Food and Drug Administration, Hillandale Bldg., Rm. 2156, Silver Spring, MD 20993; 301–796–1345, QualificationPublicMeeting@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The Drug Development Tool (DDT) provisions in section 507 of the FD&C Act (21 U.S.C. 357) were added in December 2016 by section 3011 of the Cures Act (Pub. L. 114–255). FDA’s DDT programs include the Animal Model Qualification Program, the Biomarker Qualification Program, and the Clinical Outcome Assessment Qualification Program. These programs are designed to facilitate drug and biological product development by allowing FDA to qualify DDTs based on certain foundational scientific information, thereby minimizing duplication of research and development efforts. FDA committed to meet certain performance goals under PDUFA VI. This reauthorization, part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017, includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter, which is available at https:// www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/ UCM511438.pdf. These goal PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 commitments were developed in consultation with patient and consumer advocates, healthcare professionals, and other public stakeholders, as part of negotiations with regulated industry. Section I.J.6.b. of the commitment letter, ‘‘Enhancing Drug Development Tools Qualification Pathway for Biomarkers,’’ states that FDA will convene a public meeting to discuss taxonomy for biomarkers used in drug development and a framework with appropriate standards and scientific approaches to support biomarkers under the taxonomy, including scientific criteria to determine acceptance of a biomarker qualification submission and essential elements of a formal biomarker qualification plan. Since there are overlapping deliverables between the Cures Act and PDUFA VI, this public meeting will address and fulfill those deliverables. II. Topics for Discussion at the Public Meeting FDA is convening a public meeting to discuss and seek public input regarding the DDT qualification pathway for animal models, biomarkers, and clinical outcome assessments. This public meeting will describe the qualification process under section 507 of the FD&C Act and will discuss taxonomy used in drug development, which will include the scientific criteria to determine the acceptance of a qualification submission and essential elements of a full qualification plan. In addition, we will discuss ongoing activities to develop general evidentiary standards to support qualification by the three qualification programs. III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following website: https://www.eventbrite.com/e/ drug-development-tool-process-underthe-21st-century-cures-legislationtickets-50528044742. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by 11:59 p.m. Eastern Time on Friday, November 30, 2018. Registrants will receive confirmation when they have been accepted. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If you need special accommodations due to a disability, please contact E:\FR\FM\13NON1.SGM 13NON1 Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices QualificationPublicMeeting@ fda.hhs.gov no later than Friday, November 30, 2018, by 11:59 p.m. Eastern Time. Requests for Oral Presentations: There will be time allotted during the public meeting for open public comment. Signup for this session will be on a firstcome, first-served basis; there will be a time limit on the day of the workshop. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Webcast Information: FDA plans to provide a free, live webcast of this public meeting. The link to the public meeting is https://collaboration.fda.gov/ r7zu2p7t3ab, which will not be accessible until 45 minutes prior to the meeting. FDA plans to post archived webcasts after the meeting; archived webcasts will be available. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). Dated: November 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24656 Filed 11–9–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–2970] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Surveys and Interviews With Investigational New Drug Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. SUMMARY: Fax written comments on the collection of information by December 13, 2018. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ‘‘Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act.’’ Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. amozie on DSK3GDR082PROD with NOTICES1 FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:34 Nov 09, 2018 Jkt 247001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 56349 Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI) OMB Control Number 0910–NEW In Fiscal Year 2017, FDA published guidance on communications between FDA review staff and drug sponsors during the IND phase of drug development. As part of PDUFA VI, FDA committed to a third-party assessment of current IND-phase communication practices, which should reflect this guidance. The contractor for the assessment of IND communication practices is Eastern Research Group, Inc. (ERG). Therefore, in accordance with the PDUFA VI Commitment Letter, FDA proposes to have ERG conduct surveys and interviews with sponsors of up to 150 active commercial INDs as follows: • For each formal meeting between FDA review staff and active commercial IND sponsors during the assessment period, send a survey to the sponsor to solicit specific feedback about communication practices employed for that meeting. For the purpose of this assessment, formal meetings are Type A, B, B (End of Phase), and C meetings during the IND phase of drug development. • For each active commercial IND in the assessment, conduct an interview with the sponsor to obtain broader feedback about all communications with FDA review staff during the study period, including telephone and email interactions in addition to meetings. The purpose of this information collection is to understand active commercial IND sponsor perspectives on communication during drug development with a focus on what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement. The contractor will develop anonymized aggregated summaries of survey and interview responses, analyze this information to identify common themes, consider these results along with IND data and feedback from FDA review staff to develop a set of findings and recommendations, and prepare a report to be published on FDA’s website. The contractor will keep information collected private; ERG will not disclose personally identifying information to FDA or any other party. In the Federal Register of August 16, 2018 (83 FR 40771), FDA published a 60-day notice requesting public E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56347-56349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24656]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4100]


Drug Development Tool Process Under the 21st Century Cures Act 
and Prescription Drug User Fee Act VI; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing a public meeting entitled ``Drug Development Tool Process 
under the 21st Century Cures Act and PDUFA VI.'' This public meeting is 
intended to fulfill commitments made by FDA under the sixth 
authorization of the Prescription Drug User Fee Act (PDUFA VI) and the 
21st Century Cures Act (Cures Act) by soliciting comments on Drug 
Development Tool Qualification at FDA related to the qualification 
process under section 507 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act); discussing taxonomy for biomarkers and related concepts 
used in drug development; and planning activities to define a framework 
with appropriate standards and scientific approaches to support 
qualification for a specified context of use.

DATES: The public meeting will be held on December 11, 2018, from 9 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public meeting by January 31, 2019. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver 
Spring, MD 20993. Entrance for the public meeting participants (non-FDA 
employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments may not be considered. For timely consideration we 
request that electronic comments be submitted on or before January 31, 
2019. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time on January 31, 2019. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

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

[[Page 56348]]

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: Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-4100 for ``Drug Development Tools Qualification under the 
21st Century Cures Act and PDUFA VI.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie Jimenez, Center for Drug 
Evaluation and Research, Food and Drug Administration, Hillandale 
Bldg., Rm. 2156, Silver Spring, MD 20993; 301-796-1345, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Development Tool (DDT) provisions in section 507 of the 
FD&C Act (21 U.S.C. 357) were added in December 2016 by section 3011 of 
the Cures Act (Pub. L. 114-255). FDA's DDT programs include the Animal 
Model Qualification Program, the Biomarker Qualification Program, and 
the Clinical Outcome Assessment Qualification Program. These programs 
are designed to facilitate drug and biological product development by 
allowing FDA to qualify DDTs based on certain foundational scientific 
information, thereby minimizing duplication of research and development 
efforts. FDA committed to meet certain performance goals under PDUFA 
VI. This reauthorization, part of the FDA Reauthorization Act of 2017 
signed by the President on August 18, 2017, includes a number of 
performance goals and procedures that are documented in the PDUFA VI 
Commitment Letter, which is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. These goal 
commitments were developed in consultation with patient and consumer 
advocates, healthcare professionals, and other public stakeholders, as 
part of negotiations with regulated industry. Section I.J.6.b. of the 
commitment letter, ``Enhancing Drug Development Tools Qualification 
Pathway for Biomarkers,'' states that FDA will convene a public meeting 
to discuss taxonomy for biomarkers used in drug development and a 
framework with appropriate standards and scientific approaches to 
support biomarkers under the taxonomy, including scientific criteria to 
determine acceptance of a biomarker qualification submission and 
essential elements of a formal biomarker qualification plan. Since 
there are overlapping deliverables between the Cures Act and PDUFA VI, 
this public meeting will address and fulfill those deliverables.

II. Topics for Discussion at the Public Meeting

    FDA is convening a public meeting to discuss and seek public input 
regarding the DDT qualification pathway for animal models, biomarkers, 
and clinical outcome assessments. This public meeting will describe the 
qualification process under section 507 of the FD&C Act and will 
discuss taxonomy used in drug development, which will include the 
scientific criteria to determine the acceptance of a qualification 
submission and essential elements of a full qualification plan. In 
addition, we will discuss ongoing activities to develop general 
evidentiary standards to support qualification by the three 
qualification programs.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://www.eventbrite.com/e/drug-development-tool-process-under-the-21st-century-cures-legislation-tickets-50528044742. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by 11:59 p.m. Eastern Time on Friday, November 
30, 2018. Registrants will receive confirmation when they have been 
accepted. Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization.
    If you need special accommodations due to a disability, please 
contact

[[Page 56349]]

[email protected] no later than Friday, November 
30, 2018, by 11:59 p.m. Eastern Time.
    Requests for Oral Presentations: There will be time allotted during 
the public meeting for open public comment. Signup for this session 
will be on a first-come, first-served basis; there will be a time limit 
on the day of the workshop. Individuals and organizations with common 
interests are urged to consolidate or coordinate their presentations 
and request time for a joint presentation. No commercial or promotional 
material will be permitted to be presented or distributed at the public 
meeting.
    Webcast Information: FDA plans to provide a free, live webcast of 
this public meeting. The link to the public meeting is https://collaboration.fda.gov/r7zu2p7t3ab, which will not be accessible until 
45 minutes prior to the meeting.
    FDA plans to post archived webcasts after the meeting; archived 
webcasts will be available.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES).

    Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24656 Filed 11-9-18; 8:45 am]
BILLING CODE 4164-01-P

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