92932 Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 

also be sent electronically to 

Applications.Comments@atl.frb.org: 

1. First Commerce Bancorp, Inc., 

Lewisburg, Tennessee; to acquire 

Peoples Bank of Middle Tennessee, 

Shelbyville, Tennessee. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Associate Secretary of the Board. 

[FR Doc. 2024–27573 Filed 11–22–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Dietary Saturated Fat 

Replacement and Plasma Lipid and 

Cardiovascular Events 

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 

Dietary Saturated Fat Replacement and 

Plasma Lipid and Cardiovascular 

Events, 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Access to published and unpublished 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 Dietary Saturated Fat 

Replacement and Plasma Lipid and 

Cardiovascular Events. 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 Dietary Saturated Fat 

Replacement and Plasma Lipid and 

Cardiovascular Events. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/saturated-fat-replacement/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Dietary Saturated Fat 

Replacement and Plasma Lipid and 

Cardiovascular Events 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: What are the effects of replacing 

dietary intake of total or individual 

saturated fatty acids with unsaturated, 

mono-unsaturated or polyunsaturated 

fatty acids, carbohydrates, or protein on 

plasma lipid concentrations in the 

general population? 

KQ 2: What are the effects of replacing 

dietary intake of total or individual 

saturated fatty acids with unsaturated, 

mono-unsaturated or polyunsaturated 

fatty acids, carbohydrates, or protein on 

cardiovascular events in the general 

population? 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING) 

[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements] 

Element Inclusion criteria Exclusion criteria 

Population .......................................................... Both Key Questions ......................................... Both Key Questions 


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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92933 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements] 

Element Inclusion criteria Exclusion criteria 

General population, without CVD, with or without modifiable CV risk factors, including.

Æ Dyslipidemia (including if taking lipid 

lowering medications).

Æ Overweight/obese .................................

Æ Hyperglycemia and related conditions, 

including type 2 diabetes.

Æ Hypertension/high blood pressure ........

Key Question 1 .................................................

Children and adults ..........................................

Key Question 2 .................................................

Adults (≥18 years old) ......................................

• Participants with a health-related condition 

or taking medications that impact fat absorption, fat metabolism. 

• Participants taking weight loss medications, 

including glucagon-like peptide-1 agonists. 

• Undernourished, underweight, stunted, or 

wasted participants. 

• Participants who are pre- or post-bariatric 

surgery. 

• Participants with other chronic diseases 

(e.g., cancer, gastrointestinal disease, rheumatic disease, chronic kidney disease, 

neurologic diseases), including type 1 diabetes. 

• Participants with clinical CVD (e.g., history 

of myocardial infarction, angina, stroke, arrhythmia), including congenital heart diseases, or familial hypercholesterolemia. 

Interventions ...................................................... Both Key Questions ......................................... Both Key Questions 

• Diets with a lower intake of total saturated 

fatty acids.

• Diets with a lower intake of individual saturated fatty acids.

• Diets with a lower intake of a combination 

of saturated fatty acids other than stearic 

acid (ranging from C8 to C16; i.e., caprylic, 

caproic, lauric, myristic, palmitic).

• Saturated fatty acid intake is exchanged for: 

Æ Carbohydrates, including different types 

(complex including fiber, refined, sugars).

Æ Protein ...................................................

Æ Unsaturated fatty acids, any .................

Æ Mono-unsaturated fatty acids (MUFA) ..

Æ Polyunsaturated fatty acids (PUFA) ......

Æ Combination of the above .....................

• Dietary intake must be defined or described 

prospectively (in real time).

• Must specify daily quantity of dietary saturated fat intake.

• Studies that do not quantify fatty acid intake 

as either g/day or % of total energy intake 

from saturated fat. 

• Analyses with fat intake as a continuous 

variable. 

• Fatty acid intake during a single meal or 

eating occasion. 

• Fatty acid intake via infusion (not orally). 

• Food products or dietary supplements not 

widely available to U.S. consumers. 

• Multi-component interventions (e.g., diet + 

exercise vs. exercise or plant sterols + diet 

vs. plant sterols) (adult studies). 

• Multi-component interventions of statins + 

diet where statins are being initiated. Dietary interventions among existing statin 

users will be included. 

• Interventions designed to induce weight loss 

or treat overweight and obesity through energy restriction or hypocaloric diets. 

• Interventions designed for the purposes of 

treating medical conditions other than modifiable CV risk factors. 

• Enteral feeding. 

Key Question 1 .................................................

For studies in children, 

Æ Include multicomponent interventions 

(e.g., diet + exercise vs. exercise).

Æ Infant formula.

Comparators ...................................................... Both Key Questions ......................................... Both Key Questions 

• Diets with no exchange and, thus, a higher 

intake of total saturated fatty acids, individual saturated fatty acids, or combination 

of saturated fatty acids.

• Well defined conventional or usual diet .......

• Diets with same reduction in saturated fat 

intake but different replacement (e.g., 6% 

saturated fatty acids in all arms, replaced 

with protein vs. replaced with carbohydrates).

Diets with a caloric intake that are significantly 

higher or lower than the intervention/exposure diet. 

Diets or interventions that vary substantially in 

intake of macronutrients (or other factors) 

other than the intervention and comparator 

of interest. 

Different dietary fat exposure (e.g., comparison of undefined quantiles). 

Outcomes .......................................................... Key Question 1 ................................................. Key Question 1 


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92934 Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements] 

Element Inclusion criteria Exclusion criteria 

• Plasma lipoprotein concentrations ................

Æ LDL cholesterol (LDL-c) ........................

Æ HDL cholesterol (HDL-c) .......................

Æ Non-HDL-cholesterol .............................

Æ Triglycerides (triacylglycerol) (Tg) .........

Æ Lipoprotein(a) ........................................

Æ Apolipoprotein B (ApoB) .......................

• Total cholesterol (TC). 

• TC:HDL ratio. 

• LDL:HDL ratio. 

• Chylomicrons. 

• VLDL-c. 

• IDL-c. 

• Other apolipoproteins. 

• Lipoprotein profiles. 

• Evaluations of fatty acid biomarker levels. 

Key Question 2 .................................................

• Cardiovascular events 

Æ Atherosclerotic cardiovascular disease 

(total).

Æ Major adverse cardiac (or cerebral) 

events (MAC[C]E).

Æ Specific cardiovascular events 

D Myocardial infarction 

D Coronary heart/artery disease 

D Peripheral vascular/artery disease

Æ Revascularization (for studies published after 1995).

Æ Cardiovascular disease-related mortality.

Æ Stroke ....................................................

Æ Incident atrial fibrillation ........................

Key Question 2 

• Other cardiac or vascular related outcomes. 

• Participant reported events. 

Subgroups/effect modifiers of interest ............... Both Key Questions ......................................... None. 

Æ Specific life stages 

Æ Infants (for Key Question 1 only) 

Æ Children and adolescents (for Key 

Question 1 only).

Æ Adults (19–64) 

Æ Older adults (≥65) 

Æ Pregnant or postpartum 

Æ Menopausal status.

• Other characteristics 

Æ Sex (male, female) 

Æ Socioeconomic status 

Æ Social determinants of health 

Æ Race/ethnicity 

Æ Physical activity level 

Æ Anthropometry 

Æ Health status, including type 2 diabetes 

Æ Percent of total energy intake replaced 

Æ Dietary trans fatty acid intake 

Æ Baseline lipid concentrations 

Æ Dietary cholesterol intake.

Design ................................................................ Key Question 1 ................................................. Both Key Questions 

• Studies of adults ...........................................

Æ Parallel or cross-over randomized controlled trials (RCTs).

D n ≥25/group * ..................................

• Studies of children ........................................

Æ Parallel or cross-over RCTs ..................

D n ≥25/group * ..................................

Æ Nonrandomized comparative studies 

D Must account for potential confounders.

D Dietary intake must be defined or 

described prospectively.

D n ≥50/group * 

• Observational studies that do not account 

for confounders. 

• Analyses of dietary fat as a continuous variable (e.g., RR per g/day intake) without an 

analysis at a threshold (e.g., RR for > vs < 

threshold). 

• All other study designs. 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92935 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements] 

Element Inclusion criteria Exclusion criteria 

Key Question 2 .................................................

• Studies of adults 

Æ Parallel or cross-over RCTs 

D n ≥25/group * 

Æ Nonrandomized comparative studies 

D Must account for potential confounders.

D Dietary intake must be defined or 

described prospectively.

D We will aim for a minimum of about 

10 observational studies for each 

specific intervention—CV event 

pair (e.g., reduced saturated fat 

and stroke). We will thus select the 

largest observational studies within 

each category.†.

D n ≥100/group.

Timing ................................................................ Key Question 1 ................................................. None. 

• Minimum intervention length: 4 weeks .........

• In cross-over studies, any change in outcome measure must exclude data from the 

first week after end of any prior treatments 

Key Question 2 .................................................

• Minimum follow-up 

Æ If population has no CV risk factors: 10 

years.

Æ If population has one or more CV risk 

factors (or unselected general population): 5 years.

Setting ................................................................ • General community settings, including nursing homes, assisted living facilities, etc.• Hospital or other acute care settings. 

• Institutionalized, confined settings (e.g., 

prisons) 

Publication ......................................................... • English language 

• Published in peer-reviewed journals.

* Minimum sample size may be altered depending on the number of eligible studies found. 

† Applying this approach for the 2016 AHRQ report n-3 fatty acids and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223), 

we included: for cardiac event outcomes, observational studies with at least 10,000 participants; for stroke outcomes, at least 3000 participants; 

for arrhythmia outcomes, at least 2000 participants; congestive heart failure outcomes, at least 700 participants; and for peripheral vascular disease events and MACE outcomes, at least 500 participants. In all instances, if a study meets eligibility criteria for any outcome, we will extract all 

outcomes of interest from that study; therefore, there will be multiple instances of studies being included for an outcome even though the study 

might not have met study size criteria for that specific outcome. 

CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c = cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density lipoprotein; HDL high-density lipoprotein; TC—total cholesterol; Tg = Triglycerides/ 

Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key question; N = 

number of participants. 

Dated: November 19, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–27488 Filed 11–22–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[30Day–25–0047] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) has submitted the information 

collection request titled ‘‘Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery’’ to the Office of Management 

and Budget (OMB) for review and 

approval. ATSDR previously published 

a ‘‘Proposed Data Collection Submitted 

for Public Comment and 

Recommendations’’ notice on August 

16, 2024, to obtain comments from the 

public and affected agencies. ATSDR 

did not receive comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

ATSDR 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, 


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