[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54593-54594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3689]


21st Century Cures: Announcing the Establishment of a Surrogate 
Endpoint Table; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of a public docket to receive suggestions and 
comments from interested parties (including academic institutions, 
regulated industry, and patient groups) on the Agency's publication of 
the surrogate endpoint table (SE table). FDA has developed a web page, 
available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm613636.htm that displays the SE table, 
describes the purpose of the table, and provides additional background 
information. Comments received on the SE table will help FDA determine 
its utility and may assist FDA in developing future iterations of the 
SE table and identifying best methods for conveying information about 
SEs on the FDA's website.

DATES: Submit either electronic or written comments on this notice by 
December 31, 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 December 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 31, 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-3689 for ``21st Century Cures: Announcing the Establishment 
of a Surrogate Endpoint Table.'' 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

[[Page 54594]]

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: Christopher Leptak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017, [email protected]; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 3011 of the 21st Century Cures Act established section 507 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 357), 
which mandates that FDA publish a list of surrogate endpoints used as a 
basis to approve or license a drug or biological product under both 
accelerated and traditional approval provisions. The SE table fulfills 
this legislative requirement and is intended to provide valuable 
information for drug developers on endpoints that may be considered and 
discussed with FDA for individual development programs. FDA refers the 
public to the following web page for additional background information 
as well as the SE table: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm606684.htm.
    Section 507(e)(9) of the FD&C Act defines the term ``surrogate 
endpoint'' to mean a marker, e.g., a laboratory measurement, 
radiographic image, physical sign, or other measure, that does not 
directly measure clinical benefit but (1) is known to predict clinical 
benefit and can potentially be used to support traditional approval of 
a drug or biological product or (2) is reasonably likely to predict 
clinical benefit and could be used to support accelerated approval in 
accordance with section 506(c) of the FD&C Act (21 U.S.C. 356(c)).
    This SE table includes SEs that sponsors have used as primary 
efficacy clinical trial endpoints for approval of new drug applications 
(NDAs) or biologics license applications (BLAs). The table also 
includes SEs that may be appropriate for use as a primary efficacy 
clinical trial endpoint for drug or biologic approval, although the SEs 
have not necessarily been used to support an approved NDA or BLA. FDA 
believes that this table should facilitate discussions of potential SEs 
by sponsors when developers are designing their drug development 
programs.

II. Additional Issues for Consideration

    To help FDA determine the utility of the SE table, develop future 
iterations of the SE table, and identify best methods for conveying 
this information on FDA's website, FDA is soliciting public suggestions 
and comments on the SE table listed on the following web page: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm606684.htm.
    Specifically, FDA welcomes comments concerning: (1) The utility of 
the SE table; (2) suggestions on SEs that may not be reflected on the 
current SE table but that have been used for drug or biologic 
approvals; (3) the best approach for developing future iterations of 
the table, and (4) SE table questions you would like FDA to address in 
future communications. As required by section 507(c)(1) of the FD&C 
Act, FDA will update this table on the website every 6 months. The 
Agency will consider comments submitted to the docket as it revises the 
SE table.

    Dated: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23641 Filed 10-29-18; 8:45 am]
 BILLING CODE 4164-01-P


