Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings; Draft Guidance for Sponsors; Availability, 33710-33712 [2021-13585]

Download as PDF 33710 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices reasonable assurance of safety and effectiveness for these devices. The proposed special controls would require the submission of a log of all complaints annually for a period of 5 years following FDA clearance of a traditional premarket notification (510(k)) submission for a device within the scope of the proposed order. Currently, manufacturers of HIV serological diagnostic and supplemental tests and HIV NAT diagnostic and supplemental tests are subject to FDA regulations in part 820 (21 CFR part 820), which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Manufacturers are required to maintain complaint files and to review and evaluate complaints for these devices under § 820.198 (21 CFR 820.198). Complaints required to be reported in the annual logs under the proposed special controls, such as certain complaints involving unusually high invalid rates or issues with users conducting the test, may not meet the definition of a medical device report required to be reported to FDA under 21 CFR part 803 (medical device reporting; currently approved under OMB control number 0910–0437), but could potentially affect the safety and efficacy of these devices. If the proposed order is finalized, we intend to review the information in the complaint logs in a timely manner and engage with manufacturers as necessary. The submission of the complaint log would provide us with earlier notification of concerns and enable us to determine whether they have been adequately addressed. The Agency usually would not evaluate this kind of complaint information until an FDA inspection, which typically occurs less frequently than annually. We believe implementing these specific reporting measures as part of the special controls would be necessary to provide a reasonable assurance of safety and effectiveness for HIV diagnostic and supplemental tests subject to the proposed order. Description of Respondents: The respondents to the information collection are manufacturers of HIV diagnostic and supplemental test devices that would be subject to the proposed order, if finalized. Finalizing the proposed order would add classification regulations for these devices in 21 CFR part 866 (Immunology and Microbiology Devices) at 21 CFR 866.3956 for the HIV serological diagnostic and supplemental tests, and 21 CFR 866.3957 for the HIV NAT diagnostic and supplemental tests, and establish special controls necessary to provide reasonable assurance of their safety and effectiveness. As described above, the special controls would require the submission of a log of all complaints annually for a period of 5 years following FDA clearance of a traditional 510(k) submission for one of these devices. We estimate the reporting burden hours associated with the proposed order, if finalized, to be approximately 30 reporting burden hours. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR citation, activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Proposed 21 CFR 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii), Submission of log to FDA ................. 10 1 10 3 30 lotter on DSK11XQN23PROD with NOTICES1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate of the average burden per response on our experience with other types of annual report submissions. We base our estimate of the number of affected respondents on the expected number of manufacturers that would be submitting a 510(k) for a new device or changes to an existing device that would require a 510(k). As noted above, manufacturers of the devices subject to the proposed order must already maintain complaint files and review and evaluate complaints under § 820.198. If the proposed order is finalized as proposed, we estimate it would take a manufacturer approximately 3 hours annually to review their existing records, prepare the complaint log, and submit it to FDA. Although respondents may submit the information electronically through the FDA Electronic Submission Gateway, on paper, or electronic media (e.g., CD, DVD) to the Center for Biologics Evaluation and Research’s Document Control Center, we assume that all manufacturers will submit their logs electronically. VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 Dated: June 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–13580 Filed 6–24–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1802] Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in NonCurative Settings; Draft Guidance for Sponsors; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for sponsors entitled ‘‘Cancer Clinical Trial Eligibility Criteria: SUMMARY: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 Approach to Available Therapy in NonCurative Settings.’’ The draft guidance provides recommendations to sponsors of clinical trials of investigational cancer drugs regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment options) for their cancer in the non-curative setting. The draft guidance is intended to facilitate increased clinical trial options for patients with non-curable cancers by recognizing that, with appropriate informed consent, it may be reasonable for patients to be eligible for inclusion in trials of investigational cancer drugs, regardless of whether they have received available therapy, in the non-curative setting. Submit either electronic or written comments on the draft guidance by August 24, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: You may submit comments on any guidance at any time as follows: ADDRESSES: E:\FR\FM\25JNN1.SGM 25JNN1 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 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’’). lotter on DSK11XQN23PROD with NOTICES1 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–1802 for ‘‘Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.’’ 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. • 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 VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 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-201509-18/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 draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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: Jennifer Gao, Oncology Center of Excellence, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2135, Silver Spring, MD 20993–0002, 240–402–4683; Chana Weinstock, Center for Drug Evaluation and Research, Food and Drug PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 33711 Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2357, Silver Spring, MD 20993–0002, 240–402–2625; 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 sponsors entitled ‘‘Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.’’ The draft guidance provides recommendations regarding the inclusion of patients who have not received available therapy for their cancer in clinical trials of investigational cancer drugs and biological products in the non-curative setting. For the purpose of this draft guidance, non-curative is defined as circumstances where there is extremely low likelihood for cure or for prolonged and/or near normal survival with available therapies (i.e., hematologic malignancies or solid tumors that are unresectable, locally advanced, or metastatic cancer with unfavorable longterm overall survival). For clinical trials of products regulated under part 312 (21 CFR part 312), FDA must determine that study subjects are not exposed to an unreasonable and significant risk of illness or injury (21 CFR 312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed. Therefore, eligibility criteria should generally require that patients have received available therapy(ies) that offer the potential for cure in a substantial proportion of patients in clinical trials evaluating investigational cancer drugs. Alternatively, such available therapy should be administered to all patients in the trial, where the investigational drug is added to such therapy. However, eligibility criteria in which patients receive an investigational drug(s) in lieu of available therapy are reasonable in the non-curative setting when patients have been provided with adequate information to make an informed decision on trial participation. The draft guidance also describes information that should be included in the informed consent when this approach is taken. The draft guidance further includes recommendations regarding efficacy analyses when this approach is taken. 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 E:\FR\FM\25JNN1.SGM 25JNN1 33712 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices on ‘‘Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.’’ 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 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. 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 OMB under the PRA. The collections of information in part 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; 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 draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: June 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–13585 Filed 6–24–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1 [Docket No. FDA–2021–N–0352] Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-theCounter Use; Reopening of Comment Period Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of intent; reopening of comment period. AGENCY: VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 The Food and Drug Administration (FDA or Agency) is reopening the comment period for public scoping on the environmental impact statement (EIS) described in the notice entitled ‘‘Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use’’ that appeared in the Federal Register of May 13, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period for public scoping on the EIS identified in the notice published May 13, 2021 (86 FR 26224). To ensure the Agency considers your comments before it begins work on the draft EIS, submit either electronic or written comments on the scoping process discussed in the notice by July 14, 2021. If a virtual public scoping meeting is scheduled, FDA will announce the date and time via the weblink ‘‘Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products’’ on the Agency’s web page ‘‘Guidance, Compliance, & Regulatory Information,’’ available at https://www.fda.gov/drugs/guidancecompliance-regulatory-information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 14, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 14, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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– 2021–N–0352 for ‘‘Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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. • 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 E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33710-33712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13585]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1802]


Cancer Clinical Trial Eligibility Criteria: Approach to Available 
Therapy in Non-Curative Settings; Draft Guidance for Sponsors; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for sponsors entitled ``Cancer 
Clinical Trial Eligibility Criteria: Approach to Available Therapy in 
Non-Curative Settings.'' The draft guidance provides recommendations to 
sponsors of clinical trials of investigational cancer drugs regarding 
the inclusion of patients who have not previously received available 
therapy (commonly referred to as existing treatment options) for their 
cancer in the non-curative setting. The draft guidance is intended to 
facilitate increased clinical trial options for patients with non-
curable cancers by recognizing that, with appropriate informed consent, 
it may be reasonable for patients to be eligible for inclusion in 
trials of investigational cancer drugs, regardless of whether they have 
received available therapy, in the non-curative setting.

DATES: Submit either electronic or written comments on the draft 
guidance by August 24, 2021 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:

[[Page 33711]]

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-2020-D-1802 for ``Cancer Clinical Trial Eligibility Criteria: 
Approach to Available Therapy in Non-Curative Settings.'' 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.
     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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, 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: Jennifer Gao, Oncology Center of 
Excellence, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 2135, Silver Spring, MD 20993-0002, 240-402-4683; Chana 
Weinstock, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2357, Silver 
Spring, MD 20993-0002, 240-402-2625; 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 sponsors 
entitled ``Cancer Clinical Trial Eligibility Criteria: Approach to 
Available Therapy in Non-Curative Settings.'' The draft guidance 
provides recommendations regarding the inclusion of patients who have 
not received available therapy for their cancer in clinical trials of 
investigational cancer drugs and biological products in the non-
curative setting. For the purpose of this draft guidance, non-curative 
is defined as circumstances where there is extremely low likelihood for 
cure or for prolonged and/or near normal survival with available 
therapies (i.e., hematologic malignancies or solid tumors that are 
unresectable, locally advanced, or metastatic cancer with unfavorable 
long-term overall survival).
    For clinical trials of products regulated under part 312 (21 CFR 
part 312), FDA must determine that study subjects are not exposed to an 
unreasonable and significant risk of illness or injury (21 CFR 
312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed. 
Therefore, eligibility criteria should generally require that patients 
have received available therapy(ies) that offer the potential for cure 
in a substantial proportion of patients in clinical trials evaluating 
investigational cancer drugs. Alternatively, such available therapy 
should be administered to all patients in the trial, where the 
investigational drug is added to such therapy. However, eligibility 
criteria in which patients receive an investigational drug(s) in lieu 
of available therapy are reasonable in the non-curative setting when 
patients have been provided with adequate information to make an 
informed decision on trial participation. The draft guidance also 
describes information that should be included in the informed consent 
when this approach is taken. The draft guidance further includes 
recommendations regarding efficacy analyses when this approach is 
taken.
    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

[[Page 33712]]

on ``Cancer Clinical Trial Eligibility Criteria: Approach to Available 
Therapy in Non-Curative Settings.'' 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. 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 OMB under the PRA. The collections 
of information in part 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; 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 draft guidance 
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13585 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P
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