33708 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

[OMB Control No. 9000–0154; Docket No. 

2021–0053; Sequence No. 7] 

Submission for OMB Review; 

Construction Wage Rate 

Requirements—Price Adjustment 

(Actual Method) 

AGENCY: Department of Defense (DOD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Notice. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act, the 

Regulatory Secretariat Division has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve a revision and extension of 

a previously approved information 

collection requirement regarding 

construction wage rate requirements— 

price adjustment (Actual Method). 

DATES: Submit comments on or before 

July 26, 2021. 

ADDRESSES: Written comments and 

recommendations for this information 

collection should be sent within 30 days 

of publication of this notice to 

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. 

Additionally, submit a copy to GSA 

through http://www.regulations.gov and 

follow the instructions on the site. This 

website provides the ability to type 

short comments directly into the 

comment field or attach a file for 

lengthier comments. 

Instructions: All items submitted 

must cite OMB Control No. 9000–0154, 

Construction Wage Rate Requirements— 

Price Adjustment (Actual Method). 

Comments received generally will be 

posted without change to http://

www.regulations.gov, including any 

personal and/or business confidential 

information provided. To confirm 

receipt of your comment(s), please 

check www.regulations.gov, 

approximately two-to-three days after 

submission to verify posting. If there are 

difficulties submitting comments, 

contact the GSA Regulatory Secretariat 

Division at 202–501–4755 or 

GSARegSec@gsa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Zenaida Delgado, Procurement Analyst, 

at telephone 202–969–7207, or 

zenaida.delgado@gsa.gov. 

SUPPLEMENTARY INFORMATION: 

A. OMB Control Number, Title, and 

Any Associated Form(s) 

9000–0154, Construction Wage Rate 

Requirements—Price Adjustment 

(Actual Method). 

B. Need and Uses 

This clearance covers the information 

that contractors must submit to comply 

with the following Federal Acquisition 

Regulation (FAR) requirements: 

• 52.222–32, Construction Wage Rate 

Requirements—Price Adjustment 

(Actual Method). This clause requires 

contractors to submit at the exercise of 

each option to extend the term of the 

contract, a statement of the amount 

claimed for incorporation of the most 

current Department of Labor wage 

determination, and any relevant 

supporting data, including payroll 

records, that the contracting officer may 

reasonably require. 

Contracting officers use the 

information to establish the contract’s 

construction requirements price 

adjustment to reflect the contractor’s 

actual increase or decrease in wages and 

fringe benefits. 

C. Annual Burden 

Respondents: 506. 

Total Annual Responses: 506. 

Total Burden Hours: 20,240. 

D. Public Comment 

A 60-day notice was published in the 

Federal Register at 86 FR 20699, on 

April 21, 2021. No comments were 

received. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division, by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0154, Construction 

Wage Rate Requirements—Price 

Adjustment (Actual Method). 

William Clark, 

Director, Office of Governmentwide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Governmentwide Policy. 

[FR Doc. 2021–13628 Filed 6–24–21; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Delegation of Authority 

Notice is hereby given that I have 

delegated the authority to designate 

chairs and invite members to serve on 

the Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel to the Centers for 

Disease Control and Prevention Director 

(CDC) and the Agency for Toxic 

Substances and Disease Registry 

(ATSDR) Administrator. This authority 

may be redelegated by the CDC Director, 

or the ATSDR Administrator. 

This delegation became effective upon 

date of signature. In addition, I hereby 

affirm and ratify any actions taken by 

you or your subordinates that involved 

the exercise of the authorities delegated 

herein, or substantially similar 

authorities vested in me by prior annual 

HHS appropriations acts, prior to the 

effective date of the delegation. 

Dated: June 15, 2021. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2021–13605 Filed 6–24–21; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0386] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Class II Special 

Controls for Human Immunodeficiency 

Virus Serological Diagnostic and 

Supplemental Tests and Human 

Immunodeficiency Virus Nucleic Acid 

Diagnostic and Supplemental Tests 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency or we) 

is announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on class II special 

controls for human immunodeficiency 


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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33709 

virus (HIV) serological diagnostic and 

supplemental tests and HIV nucleic acid 

(NAT) diagnostic and supplemental 

tests. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 24, 2021. 

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 August 24, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 24, 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–0386 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Class II 

Special Controls for Human 

Immunodeficiency Virus Serological 

Diagnostic and Supplemental Tests and 

Human Immunodeficiency Virus 

Nucleic Acid Diagnostic and 

Supplemental Tests.’’ 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 

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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Class II Special Controls for Human 

Immunodeficiency Virus Serological 

Diagnostic and Supplemental Tests and 

Human Immunodeficiency Virus 

Nucleic Acid Diagnostic and 

Supplemental Tests 

OMB Control Number 0910–NEW 

In the Federal Register of February 

21, 2020 (85 FR 10110), we published a 

proposed order to reclassify certain HIV 

serological diagnostic and supplemental 

tests and HIV NAT diagnostic and 

supplemental tests from class III 

(premarket approval) into class II 

(special controls) (the proposed order). 

In the proposed order, FDA proposed 

special controls that the Agency 

believes are necessary to provide a 


lotter on DSK11XQN23PROD with NOTICES1
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: 


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