[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]
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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.
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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]
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