[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68460-68462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26994]


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Qualification Process for Drug Development Tools; Draft Guidance 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation 
and Research (CBER) are announcing the availability of a draft guidance 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 Act's mandate to issue guidance on this qualification 
process and related Prescription Drug User Fee Act (PDUFA) VI 
commitments. It elaborates on the new qualification process and 
transparency requirements and discusses the taxonomy for biomarkers and 
other DDTs, and the draft guidance of the same name issued January 7, 
2014, is withdrawn.

DATES: Submit either electronic or written comments on the draft 
guidance by February 14, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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

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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.
     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.'' CDER and CBER 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), 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 (CBER), 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 draft 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 draft guidance 
for industry and FDA staff entitled ``Qualification Process for Drug 
Development Tools.'' Passed into law in December 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 and engage with 
biomedical research consortia. In addition, Congress directed CDER and 
CBER to establish 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, both to solicit public input about implementing the 
new qualification process under section 507 and about the Biomarkers, 
EndpointS, and other Tools (BEST) glossary as the taxonomy for 
classifying types of DDTs, including biomarkers. CDER and CBER are 
issuing this draft guidance to implement the 507 qualification process, 
meeting Cures Act mandates and related PDUFA VI commitments.
    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 must follow the three-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 draft guidance.
    The Cures Act includes transparency provisions that require CDER 
and CBER 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 draft guidance.
    CDER and CBER convened a public meeting on December 11, 2018, made 
available a discussion guide on the implementation of the new section 
507 qualification process, and identified the taxonomy (the BEST 
glossary) for classifying types of DDTs. CDER and CBER have considered 
public comments made during the meeting and submitted to the docket in 
developing this draft guidance. This guidance meets the Cures Act's 
mandate to issue guidance on the section 507 qualification process and 
related PDUFA VI commitments. This guidance does not address 
evidentiary standards or performance criteria for purposes of DDT 
qualification. It also does not address the qualification of medical 
device development tools or the programs under the Center for Devices 
and

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Radiological Health oversight, which are not addressed in section 507.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``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

    This draft guidance contains information collection that is subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The information 
collection has been approved under OMB control numbers 0910-0001 and 
0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at 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: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26994 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P


