[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]
BILLING CODE 4164-01-P