[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75334-75336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]


Qualification Process for Drug Development Tools; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation 
and Research (CBER) are announcing the availability of a final guidance 
for industry and FDA staff entitled ``Qualification Process for Drug 
Development Tools.'' Under the 21st Century Cures Act (Cures Act), 
enacted on December 13, 2016, a new section was added to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage 
qualification process for drug development tools (DDTs). This guidance 
meets the Cures

[[Page 75335]]

Act's requirement to issue guidance on this qualification process. It 
elaborates on the new qualification process and transparency 
requirements and discusses the taxonomy for biomarkers and other DDTs. 
This guidance finalizes the draft guidance of the same title issued on 
December 16, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on November 25, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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-2010-D-0529 for ``Qualification Process for Drug Development 
Tools.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Chris 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; or Stephen Ripley, Center for Biologics Evaluation and 
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, 
MD 20993-0002; 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    CDER and CBER are announcing the availability of a final guidance 
for industry and FDA staff entitled ``Qualification Process for Drug 
Development Tools.'' Signed into law on December 13, 2016, the Cures 
Act codified, in new section 507 of the FD&C Act (21 U.S.C. 357), a new 
statutory process for DDT qualification and added transparency 
provisions for information related to qualification submissions through 
which there is enhanced ability to share knowledge. In addition, 
Congress directed the establishment of a taxonomy for the 
classification of biomarkers (and related scientific concepts) for use 
in drug (including biological product) development. CDER and CBER 
convened a public meeting on December 11, 2018, to solicit public input 
about implementing the new qualification process under section 507 of 
the FD&C Act and about identifying the Biomarkers, EndpointS, and other 
Tools (BEST) glossary as the taxonomy for classifying types of DDTs, 
including biomarkers. CDER and CBER are issuing this final guidance to 
meet the Cures Act requirement that the Agency issue final guidance on 
the section 507 qualification process.
    DDTs are methods, materials, or measures that can aid drug 
development and regulatory review. Qualification means that a DDT and 
its proposed context of use can be relied upon to have a specific 
interpretation and application in drug development and regulatory 
review. Qualified DDTs can accelerate the integration of innovation, 
clinical knowledge, and scientific advances, thereby expediting drug 
development and aiding the regulatory review of applications.
    Although the DDT qualification process is voluntary, requestors who 
seek qualification under section 507 of the FD&C Act must follow the 
three-

[[Page 75336]]

stage process described in the Cures Act. This consists of the 
following stages: The Letter of Intent, the Qualification Plan, and the 
Full Qualification Package. These stages are discussed in detail in 
section III of the final guidance.
    The Cures Act includes transparency provisions that require the 
Agency to make information with respect to qualification submissions 
publicly available. A description of information that is made public on 
the Agency's website is provided in section II of the final guidance.
    CDER and CBER have considered public comments made during the 
December 11, 2018, public meeting and submitted to the docket in 
developing the draft guidance of the same title published on December 
16, 2019 (84 FR 68460). The Agency received various comments to the 
docket in response to the publication of the draft guidance and has 
considered those comments in developing this final guidance. Changes 
made in the final guidance in response to comments include requests for 
additional clarity on the qualification process, support for the 
proposed time frames, and requests to reference specific programs' 
content element outlines in the guidance. This final guidance meets the 
Cures Act's requirement to finalize guidance on the section 507 
qualification process and affirms the BEST glossary as the taxonomy for 
classifying types of DDTs. This guidance does not address evidentiary 
standards for purposes of DDT qualification. It also does not address 
the qualification of medical device development tools or other programs 
under the Center for Devices and Radiological Health oversight, which 
are not addressed in section 507 of the FD&C Act.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the ``Qualification Process for Drug 
Development Tools.'' It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The previously 
approved collections of information are subject to review by OMB under 
the PRA. The collections of information pertaining to submissions of 
investigational new drug applications have been approved under OMB 
control number 0910-0014; the collections of information pertaining to 
submissions of new drug applications and abbreviated new drug 
applications have been approved under OMB control number 0910-0001; and 
the collections of information pertaining to submissions of biologics 
license applications in 21 CFR part 601 have been approved under OMB 
control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or 
https://www.regulations.gov.

    Dated: November 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26051 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P