[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13990-13992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06531]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1010]


Food and Drug Administration Prescription Drug User Fee Act VI 
Benefit-Risk Implementation Plan; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft 5-year plan describing the Agency's 
approach to further the implementation of structured benefit-risk 
assessment, including the incorporation of the patient's voice in drug 
development and decision-making, in the human drug review program and 
the opportunity for public comment on the draft plan. This new draft 
plan is an update to the 5-year plan published in February 2013 on 
FDA's website. This new draft plan is

[[Page 13991]]

part of FDA's commitments that were made as part of the sixth 
authorization of the Prescription Drug User Fee Act (PDUFA VI). FDA has 
published the draft plan on its website.

DATES: Submit either electronic or written comments by June 1, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 1, 2018. 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 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 (for written/paper 
submissions): 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-1010 for ``Food and Drug Administration Prescription Drug 
User Fee Act VI Benefit-Risk Implementation Plan; Request for 
Comments.'' 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: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 5-year plan 
describing the Agency's approach to further the implementation of 
structured benefit-risk assessment into human drug and biologics 
review. This draft plan is intended to meet a performance goal included 
in the sixth authorization of PDUFA (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.
    This new draft plan is an update to the 5-year plan published in 
February 2013 on FDA's website: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.
    FDA's commitments to meet certain performance goals under PDUFA VI 
were developed in consultation with patient and consumer advocates, 
health care professionals, and other public stakeholders, as part of 
negotiations with regulated industry. Section J.2 of the commitment 
letter, ``Enhancing Benefit-Risk Assessment in Regulatory Decision-
Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines FDA's commitments in 
this area, including publication of an update to the implementation 
plan published in 2013 entitled ``Structured Approach to Benefit-Risk 
Assessment in Drug Regulatory Decision-Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf). 
The update includes a report on the progress made during PDUFA V and a 
plan for continued implementation during Fiscal Years (FY) 2018-2022. 
The publication and implementation of this plan are intended to fulfill 
the commitments described in Section J of the PDUFA VI Commitment 
Letter.

II. FDA Draft PDUFA VI Benefit-Risk Implementation Plan

    Benefit-risk assessment is the foundation for FDA's regulatory 
review of human drugs and biologics. In PDUFA V, FDA's Center for Drug

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Evaluation and Research and Center for Biologics and Research committed 
to further our efforts to enhance benefit-risk assessment and 
communication in the human drug review process in FY 2013-2017. 
Enhancing and communicating benefit-risk assessment continues to be an 
Agency priority in PDUFA VI. The draft plan describes the progress made 
on PDUFA V in benefit-risk assessment. This progress includes revision 
of FDA's review/decision templates and manuals to incorporate FDA's 
approach to benefit-risk assessment, training review and management of 
staff on the revised templates and manuals, developing an evaluation 
plan to ascertain the impact of FDA's implementation of the Benefit-
Risk Framework in drug review, holding two public workshops on benefit-
risk considerations from the regulator's perspective, and advancing 
FDA's Patient-Focused Drug Development initiative. This draft plan also 
summarizes the third-party evaluation of FDA's implementation of the 
Benefit-Risk Framework into FDA's new drug review.
    The plan also includes an overview of FDA's commitments in PDUFA VI 
for continued implementation of structured benefit-risk assessment 
during FY 2018-2022. These commitments include participating in a 
meeting to gather stakeholder input on key topics, publishing a draft 
guidance on benefit-risk assessment for new drugs and biologics, 
continuing to revise relevant Manuals for Policies and Procedures and 
Standard Operating Practices and Procedures to incorporate benefit-risk 
assessment approaches, and conducting a second evaluation of the 
implementation of the Benefit-Risk Framework beginning in 2021. In 
addition to these commitments, FDA also plans to explore additional 
opportunities to enhance our use and communication of benefit-risk 
assessments.

III. Electronic Access

    FDA has published the draft plan on its website: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm. 
The period for public comment on the draft plan will remain open for 60 
days following the publication of this notice. After consideration of 
public comments, FDA will finalize the plan. Throughout PDUFA VI, the 
Agency will update the plan as necessary and post all updates on FDA's 
website.

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06531 Filed 3-30-18; 8:45 am]
 BILLING CODE 4164-01-P