Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83087 

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 new information 

collection requirement regarding 

documents, records, reports, and 

processes associated with determining 

compliance with FAR part 25, 

Protecting Life in Global Health 

Assistance. 

DATES: Submit comments on or before 

January 20, 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. 9000–0200, 

Protecting Life in Global Health 

Assistance. 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: 

Email FARPolicy@gsa.gov or call 202– 

969–4075. 

SUPPLEMENTARY INFORMATION: 

A. OMB Control Number, Title, and 

Any Associated Form(s): 9000–0200, 

Protecting Life in Global Health. 

B. Needs and Uses 

The Secretary of State approved on 

May 9, 2017, a plan to implement the 

manner in which U.S. Government 

Departments and Agencies will apply 

the provisions of the ‘‘Mexico City 

Policy,’’ which was reinstated in the 

January 23, 2017 Presidential 

Memorandum, to foreign 

nongovernmental organizations (NGOs) 

that receive U.S. funding for global 

health assistance; this included the 

extension of the policy to Federal 

contracts. This clearance covers the 

information contractors must keep and 

make available to the Government to 

comply with the requirements of FAR 

clause 52.225–XX. 

a. 52.225–XX(c)(2)(i) requires foreign 

prime contractors to allow authorized 

Government representatives to inspect 

documents and materials maintained or 

prepared by the Contractor in the usual 

course of its operations that describe the 

health activities implemented by the 

Contractor. 

b. 52.225–XX(j)(1)(ii)(A) requires 

foreign subcontractors to allow 

authorized Government representatives 

to inspect documents and materials 

maintained or prepared by the 

subcontractor in the usual course of its 

operations that describe the health 

activities of the subcontractor. 

c. 52.225–XX(e) requires the 

Contractor to provide the Contracting 

Officer a request for consent to 

subcontract if the contract includes the 

clause at FAR 52.244–2, Subcontracts. 

d. 52.225–XX(g)(2) requires the 

Contractor to provide the Contracting 

Officer the results of a subcontractor 

review when the Government has 

reason to believe that a foreign 

subcontractor may have violated the 

requirements of this clause. 

e. 52.225–XX(j)(2) and (j)(3) requires 

the Contractor to review the foreign 

subcontractor’s health program to 

determine if a violation has occurred, 

and to consult with the Contracting 

Officer prior to terminating the 

subcontract or determining other 

corrective action is warranted. 

C. Annual Burden 

Respondents: 253. 

Total Annual Responses: 1,089. 

Total Burden Hours: 38,992. 

D. Public Comment 

A 60-day proposed rule was 

published within the proposed FAR rule 

(2018–002, Protecting Life in Global 

Health) in the Federal Register at 85 FR 

56549, on September 14, 2020. Some 

comments regarding the Paperwork 

Reduction Burden were received; 

however, it did not change the estimate 

of the burden. 

Comment: The proposed rule 

provided an estimate of the public 

reporting burden for required 

information collection of nearly 39,000 

total response burden hours. Please 

provide the assumptions and 

methodology used in calculating this 

estimate. 

Response: Requesters may obtain a 

copy of the supporting statement from 

GSA. 

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. 9000–0200, Protecting Life 

in Global Health. 

William F. Clark, 

Director,Office of Governmentwide 

Acquisition Policy,Office of Acquisition 

Policy,Office of Governmentwide Policy. 

[FR Doc. 2020–28152 Filed 12–18–20; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-21–21AC; Docket No. CDC–2020– 

0110] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled The GAIN (Greater Access and 

Impact with NAT) Study: Improving 

HIV Diagnosis, Linkage to Care, and 

Prevention Services with HIV Point-ofCare Nucleic Acid Tests (NATs). GAIN 

is an implementation study to compare 

a point-of-care nucleic acid HIV test 

(HIV RNA POC NAT) to standard labbased HIV testing. 

DATES: CDC must receive written 

comments on or before February 19, 

2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2020– 

0110 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

83088 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

Disease Control and Prevention, 1600 

Clifton Road, NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road, NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7118; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

5. Assess information collection costs. 

Proposed Project 

The GAIN (Greater Access and Impact 

with NAT) Study: Improving HIV 

Diagnosis, Linkage to Care, and 

Prevention Services with HIV Point-ofCare Nucleic Acid Tests (NATs)— 

NEW—National Center for HIV/AIDS, 

STD, and TB Prevention (NCHHSTP), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Current rapid point-of-care (POC) HIV 

testing technologies do not reliably 

detect the earliest HIV infections and 

lab-based testing can introduce delays 

while patients wait for test results. 

During this time, patients can drop out 

of care and remain at high-risk to 

acquire HIV. Direct molecular detection 

of HIV through nucleic acid tests 

(NATs) can identify early HIV 

infections, which have high potential 

for transmission. NATs that are used at 

the point-of-care (POC NAT) can 

provide results in 60 to 90 minutes. 

Obtaining timely molecular test results 

from a POC NAT in clinics or 

community settings can expand 

prevention as well as HIV treatment 

services, improve our reach into 

disproportionately affected populations, 

and provide opportunities to approach 

the goal of no new HIV infections. The 

purpose of this research is to develop 

feasible and effective models for using 

HIV POC NATs to: (1) Improve PrEP 

initiation, and duration of PrEP use, 

among persons at high-risk for acquiring 

HIV infection; and (2) reduce the time 

between testing in community-based 

and clinical-based settings and linkage 

to HIV care, ART initiation, and viral 

suppression. 

GAIN is an implementation study to 

compare a point-of-care nucleic acid 

HIV test (HIV RNA POC NAT) to 

standard lab-based HIV testing. Study 

activities include: 1. Retrospective 

baseline data collection from clinical 

site electronic medical records. This 

will establish baseline PrEP and HIV 

care metrics for comparison after study 

implementation; 2. A longitudinal, 

prospective study of HIV-negative 

patients seeking HIV testing and/or PrEP 

services; 3. A longitudinal, prospective 

study of HIV-positive patients seeking 

STI testing; 4. An RCT of POC NAT or 

Standard of Care for HIV-positive 

patients; 5. A survey, interviews, and 

focus groups examining POC NAT 

acceptability among HIV-negative and 

HIV-positive patients; 6. A crosssectional comparison of several pointof-care NATs among HIV-positive 

patients; 7. Acceptability/feasibility 

assessment among clinical and 

community providers and costing 

analyses. These data will be analyzed 

and disseminated to describe the realworld performance and clinical effects 

of HIV RNA POC NAT testing 

technology. This study will develop 

functional models to integrate HIV RNA 

POC NAT testing technology into HIV 

prevention and treatment services. 

There are no costs to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Participants in prospective study of HIV-negative 

patients seeking HIV testing and/or PrEP services.

Consent form ................

HIPPA form ..................

1150 

1150 

1 

1 

30/60 

10/60 

575 

192 

Release of information 

form.

1150 1 10/60 192 

Study visit survey ......... 1150 1 15/60 288 

Participants in prospective study of HIV-positive 

patients seeking STI testing.

Consent form ................

HIPPA form ..................

125 

125 

1 

1 

30/60 

10/60 

63 

21 

Release of information 

form.

125 1 10/60 21 

Study visit survey ......... 125 1 15/60 31 

Participants in RCT of POC NAT or Standard of 

Care for HIV-positive patients.

Consent form ................

HIPPA form ..................

250 

250 

1 

1 

30/60 

10/60 

125 

42 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83089 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Release of information 

form.

250 1 10/60 42 

Study visit survey ......... 250 1 15/60 63 

Participants in survey group examining POC 

NAT acceptability.

POC NAT acceptability 

survey.

87 1 20/60 29 

Participants in cross-sectional comparison of 

several point-of-care NATs.

Consent ........................

Release of information 

form.

250 

250 

1 

1 

30/60 

10/60 

125 

42 

Study visit survey ......... 250 1 15/60 63 

Acceptability/feasibility assessment among clinical and community providers.POC NAT acceptability 

survey, focus group, 

or interview.

25 1 1 25 

Total ............................................................... ....................................... ........................ ........................ ........................ 1,667 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2020–28113 Filed 12–18–20; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2020–0122] 

Advisory Committee on Immunization 

Practices (ACIP); Correction 

Notice is hereby given of a change in 

the meeting of the Advisory Committee 

on Immunization Practices (ACIP); 

December 11, 2020, 12:00 p.m.–5:00 

p.m., EST; and December 13, 2020, 

12:00 p.m.–4:00 p.m., EST (times 

subject to change, see the ACIP website 

for any updates: http://www.cdc.gov/ 

vaccines/acip/index.html) which was 

published in the Federal Register on 

December 9, 2020, Volume 85, Number 

237, pages 79814–79815. 

The meeting dates and times should 

read as follows: 

DATES: 

The meeting will be held on 

December 11, 2020 from 12:00 p.m. to 

5:00 p.m., EST and December 12, 2020 

from 11:00 a.m. to 3:00 p.m., EST (times 

subject to change, see the ACIP website 

for any updates: http://www.cdc.gov/ 

vaccines/acip/index.html). 

Written comments must be received 

on or before December 14, 2020. 

The meeting is open to the public. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Thomas, ACIP Committee 

Management Specialist, Centers for 

Disease Control and Prevention, 

National Center for Immunization and 

Respiratory Diseases, 1600 Clifton Road, 

NE, MS–H24–8, Atlanta, GA 30329– 

4027; Telephone: 404–639–8367; Email: 

ACIP@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2020–28091 Filed 12–18–20; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–21–20OJ] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘National YRBS 

Test-Retest Reliability Study’’ to the 

Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on June 2, 2020 to obtain 

comments from the public and affected 

agencies. CDC received no comments to 

the 60 day Federal Register Notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed 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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding