21st Century Cures: Announcing the Establishment of the BEST Resource Taxonomy; Establishment of a Public Docket; Request for Comments, 35868-35869 [2019-15827]
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35868
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–15818 Filed 7–24–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2769]
21st Century Cures: Announcing the
Establishment of the BEST Resource
Taxonomy; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the establishment of a
public docket to receive comments from
interested parties (including academic
institutions, regulated industry, and
patient groups) on the Agency’s
publication of a glossary of terms which
is part of the BEST (Biomarkers,
EndpointS, and other Tools) Resource
Taxonomy. FDA has developed a web
page that describes the BEST Resource
Taxonomy and links out to the official
National Library of Medicine web page
for the BEST glossary of terms.
Comments on the BEST Resource
Taxonomy will help FDA enhance its
utility and may assist FDA in
developing future versions of this
resource and identifying best methods
for conveying information about
biomarkers, endpoints, and other drug
development tools to the general public.
DATES: Submit either electronic or
written comments on this notice by
September 23, 2019.
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 September 23,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 23, 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.
jspears on DSK30JT082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:54 Jul 24, 2019
Jkt 247001
• 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–
2019–N–2769 for ‘‘21st Century Cures:
Announcing the Establishment of the
BEST Resource Taxonomy.’’ 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
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
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/201523389.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, Christopher.Leptak@
fda.hhs.gov; 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 (Pub. L. 114–255) added a
new section 507 to the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 357).
Section 3011(b)(3)(A) requires FDA to
collaborate with biomedical research
consortia and other interested parties to
‘‘establish a taxonomy for the
classification of biomarkers (and related
scientific concepts) for use in drug
development.’’ FDA is meeting this
legislative requirement through updates
to the BEST Resource on the National
Library of Medicine website, available at
https://www.ncbi.nlm.nih.gov/books/
NBK326791/, is FDA’s response to this
E:\FR\FM\25JYN1.SGM
25JYN1
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
jspears on DSK30JT082PROD with NOTICES
legislative requirement. In Spring 2015,
the FDA–NIH (National Institutes of
Health) Joint Leadership Council
identified the harmonization of terms
used in translational science and
medical product development as a
priority need, with a focus on terms
related to study endpoints and
biomarkers (see https://www.fda.gov/
Drugs/DevelopmentApprovalProcess/
DevelopmentResources/
ucm614359.htm). Working together with
the goals of improving communication,
aligning expectations, and improving
scientific understanding, the two
agencies developed the BEST Resource.
The current phase of BEST comprises a
glossary that clarifies use of important
terms in the context of biomarkers and
related scientific concepts and describes
some of the hierarchical relationships,
connections, and dependencies among
the terms it contains. For example, the
BEST glossary aims to capture
distinctions between biomarkers and
clinical assessments and to describe
their distinct roles in biomedical
research, clinical practice, and medical
product development. FDA refers the
public to the following web page for
additional background information as
well as a link to the BEST glossary of
terms: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
DevelopmentResources/
ucm614359.htm. FDA has previously
discussed taxonomy for biomarkers
used in drug development at its public
meeting on Drug Development Tool
Process on December 11, 2018, and
invited comment on the BEST taxonomy
in guidance published on December 12,
2018, on the evidentiary framework for
biomarker qualification.
II. Establishment of a Docket and Issues
for Consideration
To help FDA determine the utility of
the BEST glossary of terms, develop
future iterations, and identify best
methods for conveying this information,
FDA is soliciting public comments on
the BEST glossary that can be found on
the following web page: https://
www.ncbi.nlm.nih.gov/books/
NBK338448/?report=reader. The BEST
glossary is meant to be a resource that
will be periodically updated with
additional terms and clarifying
information. Specifically, FDA
welcomes comments concerning: (1)
The utility of the BEST glossary; (2)
specific proposed edits, including
additions and removal of terms, with a
rationale supporting these proposed
edits; (3) the best approach for
developing future iterations of the
glossary; and (4) questions pertaining to
the BEST glossary that you would like
VerDate Sep<11>2014
17:54 Jul 24, 2019
Jkt 247001
FDA to address in future
communications. As the glossary is
refined, the goal is to elaborate on these
terms, so they will remain relevant, thus
fostering consistent usage. Ultimately,
FDA hopes that the BEST glossary will
help to accelerate development and
refinement of medical products, which
will lead to improvements in health
outcomes. The Agency will consider
comments submitted to the docket as it
revises the BEST glossary of terms.
Dated: July 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15827 Filed 7–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0994]
Modified Risk Tobacco Product
Applications for VLNTM King and
VLNTM Menthol King, Combusted,
Filtered Cigarettes, Submitted by 22nd
Century Group, Inc.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of
modified risk tobacco product
applications (MRTPAs) for VLNTM King
and VLNTM Menthol King, combusted,
filtered cigarettes, submitted by 22nd
Century Group, Inc.
DATES: Electronic or written comments
on the application may be submitted
beginning July 25, 2019. FDA will
establish a closing date for the comment
period as described in section I.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
35869
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–
2019–N–0994 for ‘‘Modified Risk
Tobacco Product Applications for
VLNTM King and VLNTM Menthol King,
Combusted, Filtered Cigarettes
Submitted by 22nd Century Group Inc.’’
Received comments 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
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35868-35869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2769]
21st Century Cures: Announcing the Establishment of the BEST
Resource Taxonomy; 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 comments from
interested parties (including academic institutions, regulated
industry, and patient groups) on the Agency's publication of a glossary
of terms which is part of the BEST (Biomarkers, EndpointS, and other
Tools) Resource Taxonomy. FDA has developed a web page that describes
the BEST Resource Taxonomy and links out to the official National
Library of Medicine web page for the BEST glossary of terms. Comments
on the BEST Resource Taxonomy will help FDA enhance its utility and may
assist FDA in developing future versions of this resource and
identifying best methods for conveying information about biomarkers,
endpoints, and other drug development tools to the general public.
DATES: Submit either electronic or written comments on this notice by
September 23, 2019.
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 September 23, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 23, 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 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-2019-N-2769 for ``21st Century Cures: Announcing the Establishment
of the BEST Resource Taxonomy.'' 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: 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 (Pub. L. 114-255) added
a new section 507 to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 357). Section 3011(b)(3)(A) requires FDA to collaborate with
biomedical research consortia and other interested parties to
``establish a taxonomy for the classification of biomarkers (and
related scientific concepts) for use in drug development.'' FDA is
meeting this legislative requirement through updates to the BEST
Resource on the National Library of Medicine website, available at
https://www.ncbi.nlm.nih.gov/books/NBK326791/, is FDA's response to
this
[[Page 35869]]
legislative requirement. In Spring 2015, the FDA-NIH (National
Institutes of Health) Joint Leadership Council identified the
harmonization of terms used in translational science and medical
product development as a priority need, with a focus on terms related
to study endpoints and biomarkers (see https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm614359.htm). Working
together with the goals of improving communication, aligning
expectations, and improving scientific understanding, the two agencies
developed the BEST Resource. The current phase of BEST comprises a
glossary that clarifies use of important terms in the context of
biomarkers and related scientific concepts and describes some of the
hierarchical relationships, connections, and dependencies among the
terms it contains. For example, the BEST glossary aims to capture
distinctions between biomarkers and clinical assessments and to
describe their distinct roles in biomedical research, clinical
practice, and medical product development. FDA refers the public to the
following web page for additional background information as well as a
link to the BEST glossary of terms: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm614359.htm. FDA has
previously discussed taxonomy for biomarkers used in drug development
at its public meeting on Drug Development Tool Process on December 11,
2018, and invited comment on the BEST taxonomy in guidance published on
December 12, 2018, on the evidentiary framework for biomarker
qualification.
II. Establishment of a Docket and Issues for Consideration
To help FDA determine the utility of the BEST glossary of terms,
develop future iterations, and identify best methods for conveying this
information, FDA is soliciting public comments on the BEST glossary
that can be found on the following web page: https://www.ncbi.nlm.nih.gov/books/NBK338448/?report=reader. The BEST glossary
is meant to be a resource that will be periodically updated with
additional terms and clarifying information. Specifically, FDA welcomes
comments concerning: (1) The utility of the BEST glossary; (2) specific
proposed edits, including additions and removal of terms, with a
rationale supporting these proposed edits; (3) the best approach for
developing future iterations of the glossary; and (4) questions
pertaining to the BEST glossary that you would like FDA to address in
future communications. As the glossary is refined, the goal is to
elaborate on these terms, so they will remain relevant, thus fostering
consistent usage. Ultimately, FDA hopes that the BEST glossary will
help to accelerate development and refinement of medical products,
which will lead to improvements in health outcomes. The Agency will
consider comments submitted to the docket as it revises the BEST
glossary of terms.
Dated: July 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15827 Filed 7-24-19; 8:45 am]
BILLING CODE 4164-01-P
