[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81925-81927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3679]


Interacting With the Food and Drug Administration on Complex 
Innovative Trial Designs for Drugs and Biological Products; 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) is announcing 
the availability of a final guidance entitled ``Interacting with the 
FDA on Complex Innovative Trial Designs for Drugs and Biological 
Products.'' The guidance provides recommendations to sponsors and 
applicants on interacting with FDA on complex innovative trial design 
(CID) proposals for drugs or biological products. FDA is issuing this 
guidance to satisfy, in part, a mandate under the 21st Century Cures 
Act (Cures Act). In accordance with the Cures Act mandate, this 
guidance discusses the use of novel trial designs in the development 
and regulatory review of drugs and biological products, how sponsors 
may obtain feedback on technical issues related to modeling and 
simulation, and

[[Page 81926]]

the types of quantitative and qualitative information that should be 
submitted for review. The guidance announced in this notice finalizes 
the draft guidance of the same title dated September 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on December 17, 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-D-3679 for ``Interacting with the FDA on Complex Innovative 
Trial Designs for Drugs and Biological Products.'' 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.
    <bullet> 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 the guidance to 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 the office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, 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; or Scott Goldie, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 
3557, Silver Spring, MD 20993-0002, 301-796-2055.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Interacting with the FDA on Complex Innovative Trial Designs for 
Drugs and Biological Products.'' The guidance provides recommendations 
to sponsors and applicants on interacting with FDA on CID proposals for 
drugs or biological products. FDA is issuing this guidance to satisfy, 
in part, a mandate under section 3021 of the Cures Act (Pub. L. 114-
255). In accordance with the Cures Act mandate, the guidance discusses 
the use of novel trial designs in the development and regulatory review 
of drugs and biological products, how sponsors may obtain feedback on 
technical issues related to modeling and simulation, and the types of 
quantitative and qualitative information that should be submitted for 
review.
    In the Federal Register of September 23, 2019 (84 FR 49743), FDA 
announced the availability of the draft guidance of the same title 
dated September 2019. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. Changes made to the guidance include the incorporation of 
example CID proposals submitted to FDA's CID Pilot Program, and 
revision of the discussion of alternative operating characteristics for 
Bayesian trial designs. In addition, editorial changes were made to 
improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated September 2019.
    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 ``Interacting with the FDA on Complex 
Innovative Trial Designs for Drugs and Biological Products.'' 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

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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 collections of information found in FDA 
regulations. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required for this guidance. The previously approved 
collections of information are subject to review by the OMB under the 
PRA. The collections of information in 21 CFR part 314 have been 
approved under OMB control number 0910-0001; the collections of 
information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; and the collections of information 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27813 Filed 12-16-20; 8:45 am]
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