[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]
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