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 

1There 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. 

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. 

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 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. 

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: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 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 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 


lotter on DSK11XQN23PROD with NOTICES1
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 

[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 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of intent; reopening of 

comment period. 

SUMMARY: 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. 

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– 

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 


lotter on DSK11XQN23PROD with NOTICES1