83 FR 56347 - Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 219 (November 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 219 (November 13, 2018)
| Page Range | 56347-56349 | |
| FR Document | 2018-24656 |
[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)] [Notices] [Pages 56347-56349] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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, 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 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]] 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 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
![Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices 56347
[FR Doc. 2018–24673 Filed 11–9–18; 8:45 am] ACTION: Notice. Reduction Act of 1995 (44 U.S.C. 3507).
BILLING CODE 4120–01–C The OMB control number and
SUMMARY: The Food and Drug
expiration date of OMB approval for
Administration (FDA) is publishing a
each information collection are shown
DEPARTMENT OF HEALTH AND list of information collections that have
been approved by the Office of in table 1. Copies of the supporting
HUMAN SERVICES statements for the information
Management and Budget (OMB) under
Food and Drug Administration the Paperwork Reduction Act of 1995. collections are available on the internet
FOR FURTHER INFORMATION CONTACT: Ila
at http://www.reginfo.gov/public/do/
[Docket Nos. FDA–2017–N–0558; FDA– PRAMain. An Agency may not conduct
2017–N–1315; FDA–2011–N–0776; FDA– S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White or sponsor, and a person is not required
2018–N–3038; FDA–2018–N–0405; FDA–
2014–N–1048; FDA–2011–N–0908; FDA– Flint North, 10A–12M, 11601 to respond to, a collection of
2011–N–0920; and FDA–2018–N–1857] Landsdown St., North Bethesda, MD information unless it displays a
20852, 301–796–7726, PRAStaff@ currently valid OMB control number.
Agency Information Collection fda.hhs.gov.
Activities; Announcement of Office of
SUPPLEMENTARY INFORMATION: The
Management and Budget Approvals
following is a list of FDA information
AGENCY: Food and Drug Administration, collections recently approved by OMB
HHS. under section 3507 of the Paperwork
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Disclosures in Professional and Consumer Prescription Drug Promotion .............................................................. 0910–0860 9/30/2020
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads .......................... 0910–0861 9/30/2020
Reclassification Petitions for Medical Devices ........................................................................................................ 0910–0138 9/30/2021
Request for Samples and Protocols ........................................................................................................................ 0910–0206 9/30/2021
Medical Device Recall Authority .............................................................................................................................. 0910–0432 9/30/2021
Food Safety, Health, and Diet Survey ..................................................................................................................... 0910–0345 10/31/2020
Medical Device Labeling Regulations ..................................................................................................................... 0910–0485 10/30/2021
GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees 0910–0581 10/31/2021
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human
Food ..................................................................................................................................................................... 0910–0751 10/31/2021
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals ................................................................................................................................................................. 0910–0789 10/31/2021
Dated: November 5, 2018. Prescription Drug User Fee Act (PDUFA information, please refer to https://
Leslie Kux, VI) and the 21st Century Cures Act www.fda.gov/AboutFDA/
Associate Commissioner for Policy. (Cures Act) by soliciting comments on WorkingatFDA/BuildingsandFacilities/
[FR Doc. 2018–24609 Filed 11–9–18; 8:45 am] Drug Development Tool Qualification at WhiteOakCampusInformation/ucm241
BILLING CODE 4164–01–P
FDA related to the qualification process 740.htm.
under section 507 of the Federal Food, You may submit comments as
Drug, and Cosmetic Act (FD&C Act); follows. Please note that late, untimely
DEPARTMENT OF HEALTH AND discussing taxonomy for biomarkers and filed comments may not be considered.
HUMAN SERVICES related concepts used in drug For timely consideration we request that
development; and planning activities to electronic comments be submitted on or
Food and Drug Administration define a framework with appropriate before January 31, 2019. The https://
standards and scientific approaches to www.regulations.gov electronic filing
[Docket No. FDA–2018–N–4100]
support qualification for a specified system will accept comments until
Drug Development Tool Process Under context of use. 11:59 p.m. Eastern Time on January 31,
the 21st Century Cures Act and 2019. Comments received by mail/hand
DATES: The public meeting will be held
Prescription Drug User Fee Act VI; delivery/courier (for written/paper
on December 11, 2018, from 9 a.m. to 5
Public Meeting; Request for Comments submissions) will be considered timely
p.m. Submit either electronic or written
if they are postmarked or the delivery
comments on this public meeting by
AGENCY: Food and Drug Administration, service acceptance receipt is on or
January 31, 2019. See the
HHS. before that date.
SUPPLEMENTARY INFORMATION section for
ACTION: Notice of public meeting; registration date and information. Electronic Submissions
request for comments.
ADDRESSES: The public meeting will be Submit electronic comments in the
SUMMARY: The Food and Drug held at FDA White Oak Campus, 10903 following way:
amozie on DSK3GDR082PROD with NOTICES1
Administration (FDA or the Agency) is New Hampshire Ave., Bldg. 31, Rm. • Federal eRulemaking Portal:
announcing a public meeting entitled 1503A (the Great Room), Silver Spring, https://www.regulations.gov. Follow the
‘‘Drug Development Tool Process under MD 20993. Entrance for the public instructions for submitting comments.
the 21st Century Cures Act and PDUFA meeting participants (non-FDA Comments submitted electronically,
VI.’’ This public meeting is intended to employees) is through Building 1 where including attachments, to https://
fulfill commitments made by FDA routine security check procedures will www.regulations.gov will be posted to
under the sixth authorization of the be performed. For parking and security the docket unchanged. Because your
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QualificationPublicMeeting@ DEPARTMENT OF HEALTH AND Surveys and Interviews With
fda.hhs.gov no later than Friday, HUMAN SERVICES Investigational New Drug (IND)
November 30, 2018, by 11:59 p.m. Sponsors To Assess Current
Eastern Time. Food and Drug Administration Communication Practices With Food
and Drug Administration Review Staff
Requests for Oral Presentations: There
[Docket No. FDA–2018–N–2970] Under the Sixth Authorization of the
will be time allotted during the public
Prescription Drug User Fee Act (PDUFA
meeting for open public comment. VI)
Signup for this session will be on a first- Agency Information Collection
come, first-served basis; there will be a Activities; Submission for Office of OMB Control Number 0910–NEW
time limit on the day of the workshop. Management and Budget Review;
In Fiscal Year 2017, FDA published
Individuals and organizations with Comment Request; Surveys and
guidance on communications between
common interests are urged to Interviews With Investigational New FDA review staff and drug sponsors
consolidate or coordinate their Drug Sponsors To Assess Current during the IND phase of drug
presentations and request time for a Communication Practices With Food development. As part of PDUFA VI,
joint presentation. No commercial or and Drug Administration Review Staff FDA committed to a third-party
promotional material will be permitted Under the Sixth Authorization of the assessment of current IND-phase
to be presented or distributed at the Prescription Drug User Fee Act communication practices, which should
public meeting. reflect this guidance. The contractor for
AGENCY: Food and Drug Administration, the assessment of IND communication
Webcast Information: FDA plans to HHS. practices is Eastern Research Group, Inc.
provide a free, live webcast of this (ERG).
public meeting. The link to the public ACTION: Notice.
Therefore, in accordance with the
meeting is https://collaboration.fda.gov/ PDUFA VI Commitment Letter, FDA
r7zu2p7t3ab, which will not be SUMMARY: The Food and Drug proposes to have ERG conduct surveys
accessible until 45 minutes prior to the Administration (FDA) is announcing and interviews with sponsors of up to
meeting. that a proposed collection of 150 active commercial INDs as follows:
FDA plans to post archived webcasts
information has been submitted to the • For each formal meeting between
Office of Management and Budget FDA review staff and active commercial
after the meeting; archived webcasts (OMB) for review and clearance under IND sponsors during the assessment
will be available. the Paperwork Reduction Act of 1995. period, send a survey to the sponsor to
If you have never attended a Connect solicit specific feedback about
Pro event before, test your connection at DATES: Fax written comments on the
communication practices employed for
https://collaboration.fda.gov/common/ collection of information by December
that meeting. For the purpose of this
help/en/support/meeting_test.htm. To 13, 2018.
assessment, formal meetings are Type
get a quick overview of the Connect Pro ADDRESSES: To ensure that comments on A, B, B (End of Phase), and C meetings
program, visit https://www.adobe.com/ the information collection are received, during the IND phase of drug
go/connectpro_overview. FDA has OMB recommends that written development.
verified the website addresses in this comments be faxed to the Office of • For each active commercial IND in
document, as of the date this document Information and Regulatory Affairs, the assessment, conduct an interview
publishes in the Federal Register, but OMB, Attn: FDA Desk Officer, Fax: 202– with the sponsor to obtain broader
websites are subject to change over time. 395–7285, or emailed to oira_ feedback about all communications with
submission@omb.eop.gov. All FDA review staff during the study
Transcripts: Please be advised that as period, including telephone and email
soon as a transcript of the public comments should be identified with the
interactions in addition to meetings.
meeting is available, it will be accessible OMB control number 0910–NEW and The purpose of this information
at https://www.regulations.gov. It may title ‘‘Surveys and Interviews with collection is to understand active
be viewed at the Dockets Management Investigational New Drug Sponsors to commercial IND sponsor perspectives
Staff (see ADDRESSES). Assess Current Communication on communication during drug
Practices with Food and Drug development with a focus on what is
Dated: November 6, 2018.
Administration Review Staff Under the working well, ongoing challenges and
Leslie Kux, Sixth Authorization of the Prescription pain points, lessons learned, and
Associate Commissioner for Policy. Drug User Fee Act.’’ Also include the opportunities for improvement. The
[FR Doc. 2018–24656 Filed 11–9–18; 8:45 am] FDA docket number found in brackets contractor will develop anonymized
BILLING CODE 4164–01–P in the heading of this document. aggregated summaries of survey and
FOR FURTHER INFORMATION CONTACT: Ila interview responses, analyze this
information to identify common themes,
S. Mizrachi, Office of Operations, Food
consider these results along with IND
and Drug Administration, Three White
data and feedback from FDA review
Flint North, 10A–12M, 11601 staff to develop a set of findings and
Landsdown St., North Bethesda, MD recommendations, and prepare a report
20852, 301–796–7726, PRAStaff@ to be published on FDA’s website. The
amozie on DSK3GDR082PROD with NOTICES1
fda.hhs.gov. contractor will keep information
SUPPLEMENTARY INFORMATION: In collected private; ERG will not disclose
compliance with 44 U.S.C. 3507, FDA personally identifying information to
FDA or any other party.
has submitted the following proposed In the Federal Register of August 16,
collection of information to OMB for 2018 (83 FR 40771), FDA published a
review and clearance. 60-day notice requesting public
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Document Created: 2018-11-10 03:18:20
Document Modified: 2018-11-10 03:18:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 56347 |
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