[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49743-49744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20494]


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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 Clinical Trial Designs for Drugs and Biological Products; 
Draft Guidance for Industry; Availability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) is announcing 
the availability of a draft guidance for industry entitled 
``Interacting with the FDA on Complex Innovative Clinical Trial Designs 
for Drugs and Biological Products.'' The draft guidance document 
provides recommendations to sponsors and applicants on interacting with 
the FDA on complex innovative clinical trial design (CID) proposals for 
drugs or biological products. In accordance with the mandate under the 
21st Century Cures Act (Cures Act), the draft guidance discusses the 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.

DATES: Submit either electronic or written comments on the draft 
guidance by December 23, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-D-3679 for ``Interacting with the FDA on Complex Innovative 
Clinical Trial Designs for Drugs and Biological Products; Draft 
Guidance for Industry.'' 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.'' 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

[[Page 49744]]

``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 Office of Communication, Outreach and Development (OCOD), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002 or the Office of Communications, Division of Drug 
Information, Center for Drug Evaluation and Research (CDER), Food and 
Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th 
Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist the office in processing your requests. The draft 
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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, CBER, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911; or Scott Goldie, CDER, 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 draft guidance for industry 
entitled ``Interacting with the FDA on Complex Innovative Clinical 
Trial Designs for Drugs and Biological Products.'' The draft guidance 
document provides recommendations to sponsors and applicants on 
interacting with the 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. In accordance with the Cures Act 
mandate, the draft 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.
    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 ``Interacting 
with the FDA on Complex Innovative Clinical 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 requirements of the applicable statutes 
and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520); 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 the guidance for industry entitled 
``Special Protocol Assessment,'' have been approved under 0910-0470.

III. Electronic Access

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

    Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20494 Filed 9-20-19; 8:45 am]
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