[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]


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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.

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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

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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

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[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


