22906 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

Dated: April 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08230 Filed 4–15–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0430] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for Quick Turnaround Testing of 

Communication Effectiveness 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) 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, 

including each proposed extension of an 

existing collection of information, and 


khammond on DSKJM1Z7X2PROD with NOTICESEN18AP22.029</GPH>

Dr. Florian Vogel 

Chief Process Officer 

CENTOGENE GmbH 

Am Strande? 

18055 Rostocl( 

Germany 

&DRUG 

Re: Revocation ofEUA202546 

Dear Dr. Vogel: 

March 17, 2022 

This letter is. in response to the request from CENTOGENE US, LLC. ("Centogene"), received 

on March 14, 2022, that the U.S. Food and Drug Administration (FDA) revoke the EUAforthe 

CentoSure SA RS-Co V ·2 RT-PCR Assay issued on September 29, 2020, and amended on August 

13, 2021, and September 23, 2021. Centogene indicated that it does not offer this test anymore. 

FDA understands Centogene and has notified associated laboratories to also stop using this test 

The authorization ofa device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U. S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). BecauseCentogenehas notified FDA that it does not 

offer the CentoSure SARS-CoV-2 RT-PCR Assay anymore and requested FDA revoke the EUA 

for the CentoSure SARS-CoV-2 RT-PCR Assay, FDA has determined that it is appropriate to 

protect the public health or safety to revoke this authorization. Accordingly, FDA herebyrevokes 

EUA202546 for the CentoSureSARS-CoV-2 RT-PCRAssay, pursuantto section 564(g)(2)(C) 

of the Act. As of the date of this letter, the CentoSure SARS-CoV-2 RT-PCR Assay is no longer 

authorized for emergency use by FDA 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(11)(1) 

of the Act. 

Sincerely, 

Isl 

Jacqueline A. O'Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 

Cc: Justin Bingham, CENTOGENE US, LLC. 
Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22907 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection entitled ‘‘Generic Clearance 

for Quick Turnaround Testing of 

Communication Effectiveness.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 17, 2022. 

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 June 17, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 17, 2022. 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– 

2019–N–0430 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Generic 

Clearance for Quick Turnaround Testing 

of Communication Effectiveness.’’ 

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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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, 

including each proposed extension of an 

existing 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. 

Generic Clearance for Quick 

Turnaround Testing of Communication 

Effectiveness 

OMB Control Number 0910–0876— 

Extension 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353) enables 

FDA to better protect public health by 

helping to ensure the safety and security 

of the food supply. It enables FDA to 

focus more on preventing food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

FSMA recognizes the important role 

consumers and stakeholders play in 

ensuring the safety of the food supply, 


khammond on DSKJM1Z7X2PROD with NOTICES
22908 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

which helps ensure that suppliers 

produce food that meets U.S. safety 

standards. 

Occasionally, FDA will need to 

communicate with consumers and other 

stakeholders about immediate health 

issues which could affect public health 

and safety. This collection of 

information allows the use of fast-track 

methods of communication such as 

quick turnaround surveys, focus groups, 

and in-depth interviews collected from 

consumers and other stakeholders to 

communicate FDA issues of immediate 

and important public health 

significance. We plan on using these 

methods of communication to collect 

vital public health and safety 

information. 

For example, these methods of 

communication might be used when 

there is a foodborne illness outbreak, 

food recall, or other situation requiring 

expedited FDA food, dietary 

supplement, cosmetics, or animal food 

or feed communications. So that FDA 

may better protect the public health, the 

Agency needs quick turnaround 

information provided by this collection 

of information to help ensure its 

messaging has reached the target 

audience, has been effective, and, if 

needed, to update its communications 

during these events. 

Respondents to this collection of 

information include a wide range of 

consumers and other FDA stakeholders 

such as producers and manufacturers of 

FDA-regulated food and cosmetic 

products, dietary supplements, and 

animal food and feed. Participation will 

be voluntary. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

In-depth Interviews, Cognitive Interviews Screener 45 1 45 0.083 (5 minutes) ..... 4 

In-depth Interviews, Cognitive Interviews ................. 9 1 9 1 ................................ 9 

In-depth Interviews Screener .................................... 900 1 900 0.083 (5 minutes) ..... 75 

In-depth Interviews ................................................... 180 1 180 1 ................................ 180 

Survey Cognitive Interviews Screener ..................... 45 1 45 0.083 (5 minutes) ..... 4 

Survey Cognitive Interviews ..................................... 9 1 9 1 ................................ 9 

Pretest survey screener ............................................ 750 1 750 0.083 (5 minutes) ..... 62 

Pretest survey ........................................................... 150 1 150 0.25 (15 minutes) ..... 38 

Self-Administered Surveys—Study Screener ........... 75,000 1 75,000 0.083 (5 minutes) ..... 6,225 

Self-Administered Surveys ....................................... 15,000 1 15,000 0.25 (15 minutes) ..... 3,750 

Focus Group/Small Group, Cognitive Groups 

Screener.

180 1 180 0.083 (5 minutes) ..... 15 

Focus Group/Small Group, Cognitive Groups .......... 60 1 60 1.5 (90 minutes) ....... 90 

Focus Group/Small Group Participant Screening .... 720 1 720 0.083 (5 minutes) ..... 60 

Focus Group/Small Group Discussion ..................... 240 1 240 1.5 (90 minutes) ....... 360 

Total ................................................................... ........................ ........................ ........................ ................................... 10,881 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08189 Filed 4–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Ending the HIV/HCV Epidemics in 

Indian Country: A Program for 

American Indian/Alaska Native Tribes 

and Urban Indian Communities 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2022–IHS–ETHIC–0001. 

Assistance Listing (Catalog of Federal 

Domestic Assistance or CFDA) Number: 

93.933. 

Key Dates 

Application Deadline Date: June 17, 

2022. 

Earliest Anticipated Start Date: 

August 1, 2022. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting applications for a cooperative 

agreement for the Ending the Human 

Immunodeficiency Virus (HIV) and 

Hepatitis C Virus (HCV) Epidemics in 

Indian Country (ETHIC) program. This 

program is authorized under the Snyder 

Act, 25 U.S.C. 13; the Transfer Act, 42 

U.S.C. 2001(a); and the Indian Health 

Care Improvement Act, 25 U.S.C. 1621q, 

1660e. This program is described in the 

Assistance Listings located at https://

sam.gov/content/home (formerly known 

as the CFDA) under 93.933. 

Background 

In February 2019, the White House 

announced a new initiative, Ending the 

HIV Epidemic in the U.S. (EHE). This 

10-year initiative beginning with fiscal 

year (FY) 2020, seeks to achieve the 

critical goal of reducing new HIV 

infections in the United States (U.S.) to 

less than 3,000 per year by 2030. The 

first phase of the initiative focuses on 48 

counties, Washington, DC, San Juan, 

Puerto Rico, and seven states with a 

substantial rural HIV burden. By 

focusing on these geographic focus areas 

(see https://files.hiv.gov/s3fs-public/ 

Ending-the-HIV-Epidemic-Countiesand-Territories.pdf) in the first phase of 

the initiative, the U.S. Department of 

Health and Human Services (HHS) 

plans to reduce new HIV infections by 

75 percent within five years. To reduce 

new HIV infections in the U.S. by 75 

percent by 2025 and 90 percent by 2030, 

EHE focuses on four key strategies that 

together can end the HIV epidemic in 

the U.S.: Diagnose, Treat, Prevent, and 

Respond. In this cooperative agreement, 

the IHS directs applicants to implement 

activities specific to strategies one, two, 

and three: Diagnose, Treat, and Prevent. 

EHE is a collaboration of HHS 

agencies, primarily the Health 

Resources and Services Administration, 

the Centers for Disease Control and 


khammond on DSKJM1Z7X2PROD with NOTICES