[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Notices]
[Pages 9130-9132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0363]


Cancer Clinical Trial Eligibility Criteria: Patients With Human 
Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus 
Infections; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Cancer 
Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B 
Virus, or Hepatitis C Virus Infections.'' This draft guidance is one in 
a series of guidances that provide recommendations regarding 
eligibility criteria for clinical trials of drugs or biological 
products regulated by the Center for Drug Evaluation and Research 
(CDER) and the Center for Biologics Evaluation and Research (CBER) for 
the treatment of cancer. Specifically, this draft guidance includes 
recommendations on the inclusion of patients with human 
immunodeficiency virus (HIV), hepatitis B virus (HBV) infections, and 
hepatitis C virus (HCV) infections. Exclusion of patients with HIV, 
HBV, or HCV infections remains common in most studies of 
investigational drugs. Expanding cancer clinical trial eligibility to 
be more inclusive of patients with HIV, HBV, or HCV infections is 
justified in many cases, and may accelerate the development of 
effective therapies in cancer patients with these chronic infections.

DATES: Submit either electronic or written comments on the draft 
guidance by May 13, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

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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-0363 for ``Cancer Clinical Trial Eligibility Criteria: 
Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus 
Infections.'' 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 ``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, CBER, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002; Division of Drug Information, CDER, Food 
and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 
4th Floor, 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: 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; or Julia Beaver, Center for Drug Evaluation and Research, 
Food and Drug Administration, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with 
HIV, Hepatitis B Virus, and Hepatitis C Virus Infections.'' This draft 
guidance provides recommendations on the inclusion of patients with 
HIV, HBV, and HCV infections in clinical trials of drugs or biological 
products regulated by CDER and CBER for the treatment of cancer.
    A clinical trial's eligibility criteria are essential components of 
the trial, defining the characteristics of the study population. 
Eligibility criteria should be developed taking into consideration the 
mechanism of action of the drug, the targeted disease or patient 
population, the anticipated safety of the investigational drug, and the 
ability to recruit trial participants from the patient population to 
meet the objectives of the clinical trial. However, some eligibility 
criteria have become commonly accepted over time or used as a template 
across trials without clear scientific or clinical rationale. 
Unnecessarily restrictive eligibility criteria may slow patient 
accrual, limit patients' access to clinical trials, and lead to trial 
results that do not fully represent treatment effects in the patient 
population that will ultimately use the drug. Broadening cancer trial 
eligibility criteria can maximize the generalizability of trial results 
and the ability to understand the therapy's benefit-risk profile across 
the patient population likely to use the drug in clinical practice 
without jeopardizing patient safety.
    The draft guidance recommends that eligibility criteria regarding 
patients with HIV, HBV, or HCV infections address requirements 
regarding relevant concurrent antiviral and other therapies (e.g., 
antibiotic prophylaxis) and degree of immunocompetence appropriate for 
a given cancer, investigational drug, and intended use population. The 
recommendations for eligibility criteria for patients with cancer and 
concurrent HIV infection are focused on evaluation of immune function 
and HIV therapy. The recommendations for eligibility criteria for 
cancer patients with evidence of chronic HBV or with current or history 
of HCV are focused on liver-related laboratories and HBV/HCV therapy.
    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 ``Cancer 
Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B 
Virus, and Hepatitis C Virus Infections.'' 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

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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 312 have been approved under OMB 
control number 0910-0014; 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: March 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04572 Filed 3-12-19; 8:45 am]
 BILLING CODE 4164-01-P