Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 93293 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Prehospital EMS Blood 

Transfusion and Fluid Interventions for 

Hemorrhagic Shock 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Supplemental 

Evidence and Data Submission 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review on 

Prehospital EMS Blood Transfusion and 

Fluid Interventions for Hemorrhagic 

Shock, which is currently being 

conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program. 

Access to published and unpublished 

pertinent scientific information will 

improve the quality of this review. 

DATES: Submission Deadline on or 

before December 26, 2024. 

ADDRESSES: 

Email submissions: epc@ahrq.hhs.gov 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality, 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857. 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality, ATTN: EPC 

SEADs Coordinator, 5600 Fishers Lane, 

Mail Stop 06E77D, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Carper, Telephone: 301–427–1656 

or Email: epc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Program to complete a review of the 

evidence for Prehospital EMS Blood 

Transfusion and Fluid Interventions for 

Hemorrhagic Shock. AHRQ is 

conducting this review pursuant to 

Section 902 of the Public Health Service 

Act, 42 U.S.C. 299a. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Prehospital EMS Blood 

Transfusion and Fluid Interventions for 

Hemorrhagic Shock. The entire research 

protocol is available online at: https://

effectivehealthcare.ahrq.gov/products/ 

ems-blood-transfusion/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Prehospital EMS Blood 

Transfusion and Fluid Interventions for 

Hemorrhagic Shock helpful: 

D A list of completed studies that 

your organization has sponsored for this 

topic. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements, if relevant: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to follow-up/withdrawn/ 

analyzed, effectiveness/efficacy, and 

safety results. 

D A list of ongoing studies that your 

organization has sponsored for this 

topic. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including, if relevant, a study 

number, the study period, design, 

methodology, indication and diagnosis, 

proper use instructions, inclusion and 

exclusion criteria, and primary and 

secondary outcomes. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this topic and an index 

outlining the relevant information in 

each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 

be publicly available or able to be made 

public. Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on topics not included in 

the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program website and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

https://effectivehealthcare.ahrq.gov/ 

email-updates. 

The review will answer the following 

questions. This information is provided 

as background. AHRQ is not requesting 

that the public provide answers to these 

questions. 

Key Questions (KQ) 

KQ 1 

a. What are the benefits and harms of 

transfusion of whole blood for patients 

requiring prehospital hemorrhagic 

shock resuscitation? 

b. Are the benefits and harms 

modified by: 

i. EMS protocols (including but not 

limited to transfusion volume, adjuvant 

medication coadministration such as 

tranexamic acid [TXA] and calcium 

salts, or crystalloid fluid coinfusion; 

transfusion equipment, and transfusion 

route)? 

ii. Patient characteristics (including 

but not limited to age, sex, 

comorbidities, preexisting medications 

[anti-platelets, anti-coagulants, heart 

rate control medications], or mechanism 

of injury/condition)? 

iii. Characteristics of the EMS system 

(including air/helicopter medical 

ambulance, ground ambulance, EMS 

clinician certification, or service 

delivery model [such as fire-based, 

private, third service], and logistics 

related to blood administrations 

[intercept model, blood stored on 

ambulance])? 

KQ 2 

a. What are the benefits and harms of 

transfusion of PRBCs for patients 

requiring prehospital hemorrhagic 

shock resuscitation? 

b. Are the benefits and harms 

modified by: 

i. EMS protocols (including but not 

limited to transfusion volume, adjuvant 

medication coadministration such as 

TXA and calcium salts, or crystalloid 

fluid coinfusion; transfusion equipment, 

and transfusion route)? 

ii. Patient characteristics (including 

but not limited to age, sex, 

comorbidities, preexisting medications 

[anti-platelets, anti-coagulants, heart 

rate control medications], or mechanism 

of injury/condition)? 

iii. Characteristics of the EMS system 

(including air/helicopter medical 

ambulance, ground ambulance, EMS 

clinician certification, or service 

delivery model [such as fire-based, 

private, third service], and logistics 

related to blood administrations 

[intercept model, blood stored on 

ambulance])? 

KQ 3 

a. What are the benefits and harms of 

transfusion of plasma for patients 


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93294 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 

requiring prehospital hemorrhagic 

shock resuscitation? 

b. Are the benefits and harms 

modified by: 

i. EMS protocols (including but not 

limited to transfusion volume, adjuvant 

medication coadministration such as 

TXA and calcium salts, or crystalloid 

fluid coinfusion, transfusion equipment, 

and transfusion route)? 

ii. Patient characteristics (including 

but not limited to age, sex, 

comorbidities, preexisting medications 

[anti-platelets, anti-coagulants, heart 

rate control medications], or mechanism 

of injury/condition)? 

iii. Characteristics of the EMS system 

(including air/helicopter medical 

ambulance, ground ambulance, EMS 

clinician certification, or service 

delivery model [such as fire-based, 

private, third service], logistics related 

to blood administrations [intercept 

model, blood stored on ambulance])? 

KQ 4 

a. What are the benefits and harms of 

infusion of crystalloid fluids for patients 

requiring prehospital hemorrhagic 

shock resuscitation? 

b. Are the benefits and harms 

modified by: 

i. EMS protocols (including but not 

limited to volume infused, or adjuvant 

medication coadministration such as 

TXA and calcium salts, or transfusion 

equipment and transfusion route)? 

ii. Patient characteristics (including 

but not limited to age, sex, 

comorbidities, preexisting medications 

[anti-platelets, anti-coagulants, heart 

rate control medications], or mechanism 

of injury/condition)? 

iii. Characteristics of the EMS system 

(such as air/helicopter medical 

ambulance, ground ambulance, 

personnel certification, or service 

delivery model [such as fire-based, 

private, third service], and logistics 

related to blood administrations 

[intercept model, blood stored on 

ambulance])? 

KQ 5 

a. What are the benefits and harms of 

different strategies (therapeutic, 

logistical, or both combined) and 

interventions (whole blood, PRBCs, 

plasma, and crystalloid fluid) for 

patients requiring prehospital 

hemorrhagic shock resuscitation? 

b. Are the benefits and harms 

modified by: 

i. EMS protocol (including but not 

limited to transfusion volume, adjuvant 

medication coadministration such as 

TXA and calcium salts, or crystalloid 

fluid coinfusion, and transfusion 

equipment and transfusion route)? 

ii. Patient characteristics (including 

but not limited to age, sex, nature of 

illness, comorbidities, preexisting 

medications [anti-platelets, anticoagulants, heart rate control 

medications], or mechanism of injury/ 

condition)? 

iii. Characteristics of the EMS system 

(including air/helicopter medical 

ambulance, ground ambulance, EMS 

clinician certification, or service 

delivery model [such as fire-based, 

private, third service], logistics related 

to blood administrations [intercept 

model, blood stored on ambulance])? 

KQ 6 

What specific areas of future research 

are essential for closing existing 

evidence gaps surrounding prehospital 

hemorrhagic shock resuscitation and 

prehospital blood transfusion? What are 

the precise scientific questions, optimal 

study designs, targeted study 

populations, and the various transfusion 

intervention protocols that need to be 

studied? 

Contextual Question (CQ) 

CQ 1 

What are the barriers to and 

facilitators of implementation of 

effective prehospital blood product 

transfusion programs utilizing a 

systems-level approach? Barriers and 

facilitators could include EMS agency 

costs, EMS agency reimbursement, cost 

effectiveness, blood product 

maintenance and logistics, partnerships 

with blood banks, medical oversight 

including real-time medical direction, 

and diagnostic tools. 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

PRELIMINARY PICOTS CRITERIA

PICOTS Inclusion criteria Exclusion criteria 

Populations ...................................... • Patients requiring prehospital hemorrhagic shock resuscitation 

treated in the prehospital setting by emergency medical services 

clinicians.

• Individuals who do not require 

prehospital hemorrhagic shock 

resuscitation. 

• Individuals not treated by emergency medical services clinicians. 

Intervention ...................................... • KQ1: whole blood .............................................................................. • Other types of resuscitation. 

• KQ2: PRBCs.

• KQ3: plasma (e.g., fresh frozen, liquid, dried, etc.).

• KQ4: crystalloid fluids.

• KQ5: strategies as specified in each publication.

• KQ6: NA.

• CQ1: NA.

Comparator ..................................... • KQ1 to 4 ............................................................................................. • KQ1 to KQ5: no comparison. 

Æ Head-to-head comparisons between transfusion options to 

treat prehospital hemorrhagic shock patients.

Æ Comparison to usual care as specified in each publication in 

another group or time period.

• KQ5: strategies as specified in each publication.

• KQ6: NA.

• CQ1: NA.

Outcomes ........................................ Patient Health Outcomes (highest priority) ........................................... • Cost-effectiveness, other outcomes. 

• Mortality/survival.

Æ To arrival at hospital.

Æ To hospital discharge.

Æ Any period less than or equal to 30 days post-emergency.

• Morbidity after discharge.


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Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 93295 

PRELIMINARY PICOTS CRITERIA—Continued 

PICOTS Inclusion criteria Exclusion criteria 

Æ Glasgow Outcome Scale, Glasgow Outcome Scale Extended, 

Modified Rankin Scale, Cerebral Performance Category.

• Length of stay.

Æ Hospital free days.

Æ ICU free days.

Intermediate Outcomes in the prehospital or ED setting.

• Physiological indicators (including but not limited to the following).

Æ Systolic blood pressure.

Æ Diastolic blood pressure.

Æ Mean arterial pressure.

Æ Heart rate.

Æ Respiratory rate.

Æ Respiratory failure.

Æ ROSC.

Æ Shock index.

Æ Body temperature.

Æ End tidal CO2 (EtCO2).

Æ Level of Consciousness.

D GCS.

D AVPU.

Æ Blood lactate level.

Process Outcomes.

• Time from EMS arrival to initial transfusion of blood product or infusion of crystalloid fluid.

• Amount of blood product transfused or crystalloid fluid infused 

(total: prehospital and hospital) vs. (hospital only).

Adverse Events/Harms (including but not limited to the following).

• Allergic reaction.

• Febrile nonhemolytic reaction.

• Acute hemolytic reaction.

• Transfusion-related acute lung injury [TRALI].

• Transfusion-associated circulatory overload [TACO].

• Infection.

• Fluid overload.

• Citrate toxicity.

• Delay to definitive care based on arrival time.

• Isoimmunization.

• Hemolysis.

• Harms related to the method of administration.

• Risk of clotting when Ringer’s lactate solution combined with blood.

Timing .............................................. • Outcomes up to 30 days post-injury .................................................. • Outcomes more than 30 days 

post-injury. 

Setting ............................................. • Prehospital .........................................................................................

• US and International studies published in English language from 

Very High and High HDI a countries..

• ED. 

• Inpatient, surgery. 

• Studies conducted in countries 

rated less than High in the 

HDI a. 

Study Design ................................... • RCTs .................................................................................................. • Systematic reviews (we will use 

reference lists to identify studies 

for possible inclusion). 

• Prospective comparative studies ....................................................... • Case series. 

• Retrospective comparative studies .................................................... • Descriptive studies. 

• Case control studies .......................................................................... • Letters to the editor. 

• Before/after studies ............................................................................ • Opinion papers. 

• Time series ........................................................................................ • Studies published prior to 1990, 

to focus on contemporary evidence and practices relevant to 

current prehospital hemorrhagic 

shock resuscitation protocols. 

• For CQ1 only: qualitative studies that specifically collect data about 

barriers to and facilitators of implementing prehospital blood product transfusion programs (e.g., descriptive case studies, evaluations, QI reports), interviews, focus groups.

Abbreviations: AVPU = Alert, Voice, Pain, Unresponsive; CQ = Contextual Question; ED = emergency department; EMS = emergency medical 

services; GCS = Glasgow Coma Scale; HDI = Human Development Index; ICU = intensive care unit; KQ = Key Question; NA = not applicable; 

PICOTS = population, interventions, comparators, outcomes, timing, and setting; PRBC = packed red blood cell; QI = quality improvement; RCT 

= randomized controlled trial; ROSC = return of spontaneous circulation. a United Nations Development Programme. Human Development Index. Retrieved from https://hdr.undp.org/data-center/human-developmentindex#/indicies/HDI. 


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93296 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 

Dated: November 21, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–27679 Filed 11–25–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–25–0728; Docket No. CDC–2024– 

0095] 

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 continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled National 

Notifiable Diseases Surveillance System. 

This data collection provides the official 

source of statistics in the United States 

for nationally notifiable conditions. 

DATES: CDC must receive written 

comments on or before January 27, 

2025. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2024– 

0095 by either of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.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 

H21–8, Atlanta, Georgia 30329; 

Telephone: 404–639–7570; 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; 

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; and 

5. Assess information collection costs. 

Proposed Project 

National Notifiable Diseases 

Surveillance System (OMB Control No. 

0920–0728, Exp. 3/31/2027)— 

Revision—Office of Public Health Data, 

Surveillance, and Technology 

(OPHDST), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Public Health Services Act (42 

U.S.C. 241) authorizes CDC to 

disseminate nationally notifiable 

condition information. The National 

Notifiable Diseases Surveillance System 

(NNDSS) is based on data collected at 

the State, territorial and local levels 

because of legislation and regulations in 

those jurisdictions that require health 

care providers, medical laboratories, 

and other entities to submit healthrelated data on reportable conditions to 

public health departments. These 

reportable conditions, which include 

infectious and non-infectious diseases, 

vary by jurisdiction depending upon 

each jurisdiction’s health priorities and 

needs. Each year, the Council of State 

and Territorial Epidemiologists (CSTE), 

supported by CDC, determines which 

reportable conditions should be 

designated nationally notifiable or 

under standardized surveillance, under 

which a set of uniform criteria used to 

define a disease for public health 

surveillance to enable public health 

officials to classify and count cases 

consistently across reporting 

jurisdictions. 

CDC requests a three-year approval for 

a Revision for the NNDSS (OMB Control 

No. 0920–0728, Exp. 03/31/2027) to: (1) 

receive case notification data for Chagas 

disease, yersiniosis (non-pestis), and 

injuries related to firearms, new 

conditions under standardized 

surveillance; and (2) receive new 

disease-specific data elements for 

toxoplasmosis and congenital 

toxoplasmosis. Like all other conditions 

NNDSS receives data for, CSTE voted to 

add the standardized public health case 

definition of these cases and data 

elements. Revising the NNDSS 

information collection to include these 

cases is necessary for NNDSS to receive 

these voluntary data as standardized 

case information. Data submission from 

reporting jurisdictions on these and all 

other NNDSS conditions is voluntary. 

The NNDSS currently facilitates the 

submission and aggregation of case 

notification data voluntarily submitted 

to CDC from 60 jurisdictions: public 

health departments in every U.S. State, 

New York City, Washington DC, five 

U.S. territories (American Samoa, the 

Commonwealth of Northern Mariana 

Islands, Guam, Puerto Rico, and the U.S. 

Virgin Islands), and three freely 

associated States (Federated States of 

Micronesia, the Republic of the 

Marshall Islands, and the Republic of 

Palau). This information is shared 

across jurisdictional boundaries and 

both surveillance and prevention and 

control activities are coordinated at 

regional and national levels. 

Approximately 90% of case 

notifications are encrypted and 

submitted to NNDSS electronically from 

already existing databases by automated 

electronic messages. When automated 

transmission is not possible, case 

notifications are faxed, emailed, 


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