Proposed Data Collection Submitted for Public Comment and Recommendations

As Enacted ( Federal Register)

Cited authorities 1

Cited in

Published date	21 December 2020
Citation	85 FR 83087
Record Number	2020-28113
Section	Notices
Court	Centers For Disease Control And Prevention,Health And Human Services Department

83087

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

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-of-

Care 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 lab-

based 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

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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-of-

Care 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 cross-

sectional comparison of several point-

of-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 real-

world 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.

STIMATED

NNUALIZED

URDEN

OURS

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 serv-

ices.

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

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

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83089

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

STIMATED

NNUALIZED

URDEN

OURS

—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

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

Acceptability/feasibility assessment among clin-

ical 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

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;

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

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Proposed Data Collection Submitted for Public Comment and Recommendations

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