[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49383-49385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1298]


Acute Myeloid Leukemia: Developing Drugs and Biological Products 
for Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Acute 
Myeloid Leukemia: Developing Drugs and Biological Products for 
Treatment.'' This draft guidance is intended to assist sponsors in the 
clinical development of drugs and biological products for the treatment 
of acute myeloid leukemia (AML). This draft guidance addresses FDA's 
current thinking regarding the overall development program and clinical 
trial designs for the development of drugs and biological products to 
support an indication of treatment of AML, including indications 
limited to an individual phase of treatment (for example, maintenance, 
transplantation preparative regimen, etc.). The draft guidance 
addresses the topics of general drug development, efficacy endpoints, 
and exploratory and confirmatory trial considerations for AML drug 
development. In addition, the draft guidance addresses investigational 
new drug applications, new drug applications, and biologics licensing 
applications for AML drugs.

DATES: Submit either electronic or written comments on the draft 
guidance by October 13, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 information, or other information that identifies you in 
the body of your

[[Page 49384]]

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-2020-D-1298 for ``Acute Myeloid Leukemia: Developing Drugs and 
Biological Products for Treatment.'' 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.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 
Division of Drug Information, 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, 
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. 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: Donna Przepiorka, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2116, Silver Spring, MD 20993-0002, 301-
796-5358; 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

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological 
Products for Treatment.'' This draft guidance is intended to assist 
sponsors in the clinical development of drugs and biological products 
for the treatment of AML. This draft guidance includes FDA's current 
thinking regarding the overall development program and clinical trial 
designs to support an indication of treatment of AML, including 
indications limited to an individual phase of treatment.
    New classes of drugs are being developed as alternatives to the 
standard cytotoxic drugs for the treatment of AML. The following 
factors contribute substantially to the complexity of clinical 
development programs for such new drugs: The expansion of treatment 
intent, broadening of the intended population, and development of a 
wide range of new drug classes as alternatives to cytotoxic drugs. This 
draft guidance includes FDA's thinking regarding general drug 
development considerations, efficacy endpoints, exploratory and 
confirmatory trial considerations, and regulatory submissions for AML 
drugs to facilitate the development of new drugs for the treatment of 
AML.
    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 ``Acute 
Myeloid Leukemia: Developing Drugs and Biological Products for 
Treatment.'' 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 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. 3501-3521). The 
collections of information in 21 CFR 312 have been approved under OMB 
control number 0910-0014; 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 601 have been approved under 
0910-0338; and the collections of information in 21 CFR 201.56 and 
201.57 have been approved under OMB control number 0910-0572.

III. Electronic Access

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


[[Page 49385]]


    Dated: August 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17714 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P