83 FR 54593 - 21st Century Cures: Announcing the Establishment of a Surrogate Endpoint Table; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 210 (October 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 210 (October 30, 2018)
| Page Range | 54593-54594 | |
| FR Document | 2018-23641 |
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)] [Notices] [Pages 54593-54594] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23641] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.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: 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
![Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices 54593
++ AAAASF’s capacity to provide DEPARTMENT OF HEALTH AND comment does not include any
CMS with electronic data and reports HUMAN SERVICES confidential information that you or a
necessary for effective validation and third party may not wish to be posted,
assessment of the organization’s survey Food and Drug Administration such as medical information, your or
process. [Docket No. FDA–2018–N–3689] anyone else’s Social Security number, or
confidential business information, such
++ The adequacy of AAAASF’s staff
21st Century Cures: Announcing the as a manufacturing process. Please note
and other resources, and its financial that if you include your name, contact
Establishment of a Surrogate Endpoint
viability. information, or other information that
Table; Establishment of a Public
++ AAAASF’s capacity to adequately Docket; Request for Comments identifies you in the body of your
fund required surveys. comments, that information will be
AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
++ AAAASF’s policies with respect HHS. • If you want to submit a comment
to whether surveys are announced or ACTION: Notice; establishment of docket; with confidential information that you
unannounced, to assure that surveys are request for comments. do not wish to be made available to the
unannounced. public, submit the comment as a
++ AAAASF’s agreement to provide SUMMARY: The Food and Drug
written/paper submission and in the
CMS with a copy of the most current Administration (FDA or Agency) is
manner detailed (see ‘‘Written/Paper
announcing the establishment of a
accreditation survey together with any Submissions’’ and ‘‘Instructions’’).
public docket to receive suggestions and
other information related to the survey Written/Paper Submissions
comments from interested parties
as CMS may require (including (including academic institutions,
corrective action plans). Submit written/paper submissions as
regulated industry, and patient groups) follows:
IV. Collection of Information on the Agency’s publication of the • Mail/Hand delivery/Courier (for
Requirements surrogate endpoint table (SE table). FDA written/paper submissions): Dockets
has developed a web page, available at Management Staff (HFA–305), Food and
This document does not impose https://www.fda.gov/Drugs/ Drug Administration, 5630 Fishers
information collection requirements, DevelopmentApprovalProcess/ Lane, Rm. 1061, Rockville, MD 20852.
that is, reporting, recordkeeping or DevelopmentResources/ucm613636.htm • For written/paper comments
third-party disclosure requirements. that displays the SE table, describes the submitted to the Dockets Management
Consequently, there is no need for purpose of the table, and provides Staff, FDA will post your comment, as
review by the Office of Management and additional background information. well as any attachments, except for
Budget under the authority of the Comments received on the SE table will information submitted, marked and
Paperwork Reduction Act of 1995 (44 help FDA determine its utility and may identified, as confidential, if submitted
U.S.C. 3501 et seq.). assist FDA in developing future as detailed in ‘‘Instructions.’’
iterations of the SE table and identifying Instructions: All submissions received
V. Response to Public Comments best methods for conveying information must include the Docket No. FDA–
about SEs on the FDA’s website. 2018–N–3689 for ‘‘21st Century Cures:
Because of the large number of public Announcing the Establishment of a
DATES: Submit either electronic or
comments we normally receive on Surrogate Endpoint Table.’’ Received
written comments on this notice by
Federal Register documents, we are not December 31, 2018. comments, those filed in a timely
able to acknowledge or respond to them manner (see ADDRESSES), will be placed
ADDRESSES: You may submit comments
individually. We will consider all in the docket and, except for those
as follows. Please note that late,
comments we receive by the date and untimely filed comments will not be submitted as ‘‘Confidential
time specified in the DATES section of considered. Electronic comments must Submissions,’’ publicly viewable at
this preamble, and, when we proceed be submitted on or before December 31, https://www.regulations.gov or at the
with a subsequent document, we will 2018. The https://www.regulations.gov Dockets Management Staff between 9
respond to the comments in the electronic filing system will accept a.m. and 4 p.m., Monday through
preamble to that document. comments until 11:59 p.m. Eastern Time Friday.
Upon completion of our evaluation, at the end of December 31, 2018. • Confidential Submissions—To
including evaluation of comments Comments received by mail/hand submit a comment with confidential
received as a result of this proposed delivery/courier (for written/paper information that you do not wish to be
submissions) will be considered timely made publicly available, submit your
notice, we will publish a final notice in
if they are postmarked or the delivery comments only as a written/paper
the Federal Register announcing the
service acceptance receipt is on or submission. You should submit two
result of our evaluation. copies total. One copy will include the
before that date.
Dated: October 19, 2018. information you claim to be confidential
Seema Verma, Electronic Submissions with a heading or cover note that states
Administrator, Centers for Medicare & Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Medicaid Services. following way: CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2018–23611 Filed 10–29–18; 8:45 am] • Federal eRulemaking Portal: Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
khammond on DSK30JT082PROD with NOTICES
BILLING CODE 4120–01–P
instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/83_FR_54803/page/1.svg)
![54594 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Staff. If you do not wish your name and physical sign, or other measure, that DEPARTMENT OF HEALTH AND
contact information to be made publicly does not directly measure clinical HUMAN SERVICES
available, you can provide this benefit but (1) is known to predict
information on the cover sheet and not clinical benefit and can potentially be Food and Drug Administration
in the body of your comments and you used to support traditional approval of [Docket No. FDA–2018–N–3809]
must identify this information as a drug or biological product or (2) is
‘‘confidential.’’ Any information marked reasonably likely to predict clinical Sesame as an Allergen in Foods
as ‘‘confidential’’ will not be disclosed benefit and could be used to support
except in accordance with 21 CFR 10.20 AGENCY: Food and Drug Administration,
accelerated approval in accordance with HHS.
and other applicable disclosure law. For section 506(c) of the FD&C Act (21
more information about FDA’s posting ACTION: Notice; request for comments.
U.S.C. 356(c)).
of comments to public dockets, see 80 SUMMARY: The Food and Drug
FR 56469, September 18, 2015, or access This SE table includes SEs that
sponsors have used as primary efficacy Administration (FDA or we) invites data
the information at: https://www.gpo.gov/ and other information on the prevalence
fdsys/pkg/FR-2015-09-18/pdf/2015- clinical trial endpoints for approval of
and severity of sesame allergies in the
23389.pdf. new drug applications (NDAs) or
United States and the prevalence of
Docket: For access to the docket to biologics license applications (BLAs). sesame-containing foods sold in the
read background documents or the The table also includes SEs that may be United States that are not required to
electronic and written/paper comments appropriate for use as a primary efficacy disclose sesame as an ingredient. We are
received, go to https:// clinical trial endpoint for drug or taking this action to inform possible
www.regulations.gov and insert the biologic approval, although the SEs regulatory action on sesame to protect
docket number, found in brackets in the have not necessarily been used to and promote the public health.
heading of this document, into the support an approved NDA or BLA. FDA DATES: Submit either electronic or
‘‘Search’’ box and follow the prompts believes that this table should facilitate written comments on this document by
and/or go to the Dockets Management discussions of potential SEs by sponsors December 31, 2018.
Staff, 5630 Fishers Lane, Rm. 1061, when developers are designing their ADDRESSES: You may submit comments
Rockville, MD 20852. drug development programs. as follows. Electronic comments must
FOR FURTHER INFORMATION CONTACT:
II. Additional Issues for Consideration be submitted on or before December 31,
Christopher Leptak, Center for Drug 2018. The https://www.regulations.gov
Evaluation and Research, Food and To help FDA determine the utility of electronic filing system will accept
Drug Administration, 10903 New comments until 11:59 p.m. Eastern Time
the SE table, develop future iterations of
Hampshire Ave., Bldg. 22, Rm. 6461, at the end of December 31, 2018.
the SE table, and identify best methods
Silver Spring, MD 20993–0002, 301– Comments received by mail/hand
for conveying this information on FDA’s
796–0017, Christopher.Leptak@ delivery/courier (for written/paper
fda.hhs.gov; or Stephen Ripley, Center website, FDA is soliciting public
suggestions and comments on the SE submissions) will be considered timely
for Biologics Evaluation and Research, if they are postmarked or the delivery
Food and Drug Administration, 10903 table listed on the following web page:
https://www.fda.gov/Drugs/ service acceptance receipt is on or
New Hampshire Ave., Bldg. 71, Rm. before that date.
7301, Silver Spring, MD 20993–0002, DevelopmentApprovalProcess/
240–402–7911. DevelopmentResources/ucm60 Electronic Submissions
SUPPLEMENTARY INFORMATION: 6684.htm. Submit electronic comments in the
Specifically, FDA welcomes following way:
I. Background • Federal eRulemaking Portal:
comments concerning: (1) The utility of
Section 3011 of the 21st Century the SE table; (2) suggestions on SEs that https://www.regulations.gov. Follow the
Cures Act established section 507 of the may not be reflected on the current SE instructions for submitting comments.
Federal Food, Drug, and Cosmetic Act table but that have been used for drug Comments submitted electronically,
(FD&C Act) (21 U.S.C. 357), which or biologic approvals; (3) the best including attachments, to https://
mandates that FDA publish a list of approach for developing future www.regulations.gov will be posted to
surrogate endpoints used as a basis to iterations of the table, and (4) SE table the docket unchanged. Because your
approve or license a drug or biological questions you would like FDA to comment will be made public, you are
product under both accelerated and address in future communications. As solely responsible for ensuring that your
traditional approval provisions. The SE comment does not include any
required by section 507(c)(1) of the
table fulfills this legislative requirement confidential information that you or a
FD&C Act, FDA will update this table
and is intended to provide valuable third party may not wish to be posted,
information for drug developers on on the website every 6 months. The
such as medical information, your or
endpoints that may be considered and Agency will consider comments
anyone else’s Social Security number, or
discussed with FDA for individual submitted to the docket as it revises the confidential business information, such
development programs. FDA refers the SE table. as a manufacturing process. Please note
public to the following web page for Dated: October 25, 2018. that if you include your name, contact
additional background information as Leslie Kux, information, or other information that
well as the SE table: https://
khammond on DSK30JT082PROD with NOTICES
Associate Commissioner for Policy. identifies you in the body of your
www.fda.gov/Drugs/Development comments, that information will be
[FR Doc. 2018–23641 Filed 10–29–18; 8:45 am]
ApprovalProcess/Development posted on https://www.regulations.gov.
Resources/ucm606684.htm. BILLING CODE 4164–01–P • If you want to submit a comment
Section 507(e)(9) of the FD&C Act with confidential information that you
defines the term ‘‘surrogate endpoint’’ to do not wish to be made available to the
mean a marker, e.g., a laboratory public, submit the comment as a
measurement, radiographic image, written/paper submission and in the
VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/83_FR_54803/page/2.svg)
Document Created: 2018-10-30 00:43:19
Document Modified: 2018-10-30 00:43:19
| 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; establishment of docket; request for comments. | |
| Dates | Submit either electronic or written comments on this notice by December 31, 2018. | |
| 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. | |
| FR Citation | 83 FR 54593 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR