58280 Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Notices 

ESTIMATES OF ANNUALIZED BURDEN HOURS—Continued 

Respondent Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total burden 

(in hours) 

Total ............................... ....................................................................... ........................ ........................ ........................ 233 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–18363 Filed 8–24–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–23–1309] 

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 ‘‘Enterprise 

Laboratory Information Management 

System’’ 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 09, 

2023, to obtain comments from the 

public and affected agencies. CDC did 

not receive comments related to the 

previous 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 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Enterprise Laboratory Information 

Management System (OMB Control No. 

0920–1309, Exp. 11/30/2023)— 

Revision—National Center for Emerging 

and Zoonotic Infectious Diseases 

(NCEZID), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The collection of specimen 

information designated for testing by the 

CDC occurs on a regular and recurring 

basis (multiple times per day) using an 

electronic PDF file called the CDC 

Specimen Submission 50.34 Form or an 

electronic XSLX file called the Global 

File Accessioning Template. Hospitals, 

doctor’s offices, medical clinics, 

commercial testing labs, universities, 

state public health laboratories, U.S. 

Federal institutions and foreign 

institutions use the CDC Specimen 

Submission 50.34 Form when 

submitting a single specimen to CDC 

Infectious Diseases laboratories for 

testing. The CDC Specimen Submission 

50.34 Form consists of over 200 data 

entry fields (of which five are 

mandatory fields that must be 

completed by the submitter) that 

captures information about the 

specimen being sent to the CDC for 

testing. The type of data captured on the 

50.34 Form identifies the origin of the 

specimen (human, animal, food, 

environmental, medical device or 

biologic), CDC test order name/code, 

specimen information, patient 

information (as applicable), animal 

information (as applicable) information 

about the submitting organization 

requesting the testing, patient history (as 

applicable), owner information and 

animal history (as applicable) and 

epidemiological information. The 

collection of this type of data is 

pertinent in ensuring a specimen’s 

testing results are linked to the correct 

patient and the final test reports are 

delivered to the appropriate submitting 

organization to aid in making proper 

health-related decisions related to the 

patient. Furthermore, the data provided 

on this form may be used by the CDC 

to identify sources of potential 

outbreaks and other public-health 

related events. When the form is filled 

out, a user in the submitting 

organization prints a hard copy of it that 

will be included in the specimen’s 

shipping package sent to the CDC. The 

printed form has barcodes on it that 

allow the CDC testing laboratory to scan 

its data directly into ELIMS where the 

specimen’s testing lifecycle is tracked 

and managed. 

Likewise, the Global File 

Accessioning Template records the 

same data as the 50.34 Form but 

provides the capability to submit 

information for a batch of specimens 

(typically 50–1,000 specimens per 

batch) to a specific CDC laboratory for 

testing. The CDC testing laboratory 

electronically uploads the Global File 

Accessioning Template into ELIMS 

where the batch of specimens are then 

logged and are ready to be tracked 

through their respective testing and 

reporting workflow. 

CDC requests OMB approval for an 

estimated 2,153 annualized burden 

hours. There is no cost to respondents 

other than their time to participate. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Notices 58281 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Medical Scientists, Except Epidemiologists, State Public 

Health Lab, Medical Assistant, Doctor’s Office/Hospital.

CDC Specimen Submission 

50.34 Form.

2,098 12 5/60 

Medical Assistant, Doctor’s Office/Hospital ............................ Global File Accessioning 

Template.

15 11 20/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–18362 Filed 8–24–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Award of a Single-Source 

Cooperative Agreement To Fund 

icddr,b (International Centre for 

Diarrhoeal Disease Research, 

Bangladesh) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), announces the 

award of approximately $6,000,000, for 

Year 1 funding to icddr,b. The award 

will support high quality public health 

research and surveillance activities to 

further strengthen the ability of the 

Government of Bangladesh and other 

global partners to detect, prevent, and 

respond to disease threats. Funding 

amounts for years 2–5 will be set at 

continuation. 

DATES: The period for this award will be 

September 30, 2024 through September 

29, 2029. 

FOR FURTHER INFORMATION CONTACT: Lata 

Kumar, Global Health Center, Centers 

for Disease Control and Prevention, 

Atlanta, GA, 30033, Telephone: 404– 

639–7618, email: lek7@cdc.gov. 

SUPPLEMENTARY INFORMATION: The 

single-source award will support high 

quality public health and 

implementation science research that 

will guide stakeholders to prioritize 

resources, develop policies, and 

implement practices and interventions 

that will help mitigate the impact of 

health threats on the Bangladeshi 

population and globally. icddr,b is in a 

unique position to conduct this work, as 

it is the only non-diplomatic partner 

that CDC is aware of that has the legal 

authority and operational expertise to 

process the import of laboratory 

supplies and reagents, including time 

sensitive reagents. Surveillance 

activities contemplated under this 

award detect and isolate highconsequence pathogens whose handling 

and storage require advanced 

biocontainment skills and capacity. 

icddr,b’s clinical microbiology 

laboratory meets the international 

standards of quality and is ISO 15189– 

2012 accredited and the institute has a 

strong and active institutional biosafety 

committee and Senior Biosafety Officer. 

icddr,b is the most biosafety capable 

institution in the country to execute 

critical ongoing studies on pathogens 

having pandemic potential such as 

Nipah virus, the testing of human, avian 

and bovine surveillance samples with 

unknown etiology, and studies of C. 

auris and influenza. To CDC’s 

knowledge, icddr,b is the only 

institution in Bangladesh with the 

capability to handle such pathogens 

according to international biosecurity 

standards. Furthermore, icddr,b has 

agreements with major biomedical 

transportation organizations and 

maintains a material transfer agreement 

(MTA) with CDC for the shipping of 

swabs, blood, serum and DNA. 

Summary of the Award 

Recipient: icddr,b (International 

Centre for Diarrhoeal Disease Research, 

Bangladesh). 

Purpose of the Award: The purpose of 

this award is to further strengthen the 

ability of the Government of Bangladesh 

and other global partners to detect, 

prevent, and respond to disease threats 

through high quality public health 

research and surveillance activities. 

Specifically, the individual activities 

under this cooperative agreement will: 

(a) determine burden, trends, etiology, 

and risk factors of priority diseases in 

Bangladesh, (b) develop and evaluate 

interventions and diagnostics, (c) 

evaluate the effectiveness of 

vaccinations to inform global policy, 

and (d) strengthen the Government of 

Bangladesh’s surveillance, laboratory, 

and outbreak response capacity. 

Amount of Award: The approximate 

year 1 funding amount will be 

$6,000,000 in Federal Fiscal Year (FY) 

2024 funds, subject to the availability of 

funds. Funding amounts for years 2–5 

will be set at continuation. 

Authority: This program is authorized 

under section 301(a) of the Public 

Health Service Act [42 U.S.C. 241(a)], as 

amended and section 307 of the Public 

Health Service Act [42 U.S.C. 242l]. 

Period of Performance: September 30, 

2024 through September 29, 2029. 

Dated: August 22, 2023. 

Terrance Perry, 

Chief Grants Management Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–18369 Filed 8–24–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10143] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 


ddrumheller on DSK120RN23PROD with NOTICES1