Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 93603 

SUPPLEMENTARY INFORMATION: The notice 

document submitted by Commission 

staff for publication contained a 

typographical error; specifically, the 

expiration date for the current OMB 

clearance was off by one year in the 

SUMMARY. 

Correction 

In notice FR Doc. 2024–25559 

appearing at 89 FR 87575 in the Federal 

Register of Monday, November 4, 2024, 

make the following correction. On page 

87576, in the last sentence of the 

SUMMARY section, the date of ‘‘January 

30, 2024’’ is corrected to read ‘‘January 

31, 2025’’. 

Dated: November 20, 2024. 

April J. Tabor, 

Secretary. 

[FR Doc. 2024–27794 Filed 11–26–24; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Dietary Intake of 

Polyunsaturated Fatty Acids 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 Intake of Polyunsaturated Fatty 

Acids and Plasma Lipid and 

Cardiovascular Events, which is 

currently being conducted by the 

AHRQ’s Evidence-based 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published and unpublished pertinent 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 27, 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 Intake of 

Polyunsaturated Fatty Acids 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 Intake of 

Polyunsaturated Fatty Acids and 

Plasma Lipid and Cardiovascular 

Events. The entire research protocol is 

available online at: https://

effectivehealthcare.ahrq.gov/products/ 

polyunsaturated-fatty/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Dietary Intake of 

Polyunsaturated Fatty Acids 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 different 

dietary polyunsaturated fatty acid intake 

on plasma lipid concentrations in the 

general population? 

KQ 2: What are the effects of different 

dietary polyunsaturated fatty acid intake 

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: 


ddrumheller on DSK120RN23PROD with NOTICES1
93604 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 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 

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: 

Dietary intake of 

Total n-3 or total n-6 PUFA 

Individual PUFA (e.g., linoleic, ALA, EPA, DHA) 

Combination of long-chain PUFA (e.g., 

EPA+DHA+DPA; DHA+ALA) 

PUFA intake must be defined or described prospectively 

Studies must specify daily quantity of PUFA intake 

Key Question 1: 

For studies in children, 

Æ Include multicomponent interventions (e.g., diet 

+ exercise vs. exercise) 

Æ Infant formula 

• Studies that do not quantify PUFA intake as either g/ 

day or % of total energy intake from PUFA. 

• Analyses with PUFA intake as a continuous variable. 

• Fatty acid intake via infusion (not orally). 

• Food products or dietary supplements not widely 

available to U.S. consumers. 

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

vs. exercise or plant sterols + diet vs. plant sterols) 

that do not isolate the effect or association of PUFA. 

• 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. 

• DHA and/or EPA n-3 FA dose >4 g/d. 

• Enteral feeding. 

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

Dietary intake of a different level of fatty acids relevant 

to the exposure 

No added/supplement PUFA 

Placebo supplements 

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 PUFA dietary exposure (e.g., comparison of 

undefined quantiles). 

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

• 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. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 93605 

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: 

• 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. 

• 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 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. 

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 

PUFA—CV event pair (e.g., EPA 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 


ddrumheller on DSK120RN23PROD with NOTICES1
93606 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 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 

Key Question 2: 

• Minimum follow-up 

Æ If population has no CV risk factors (or 

unselected general population): 10 years 

Æ If population has one or more CV risk factors: 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; PUFA = polyunsaturated fatty acids; ALA = alpha-linolenic acid; EPA = eicosapentaenoic 

aci; DHA= docosahexaenoic acid; DPA = docosapentaenoic acid; n-3 = Omega 3; n-6 = Omega 6; FA = fatty acid; c = cholesterol; LDL = lowdensity 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 21, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–27798 Filed 11–26–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention, pursuant to Public Law 92– 

463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

CE25–021, Research Grants for 

Preventing Violence and Violence 

Related Injury. 

Dates: February 19–20, 2025. 

Times: 10 a.m.–5 p.m., EST. 

Place: Web Conference. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Carlisha Gentles, Pharm.D., B.C.P.S., 

C.D.C.E.S., Scientific Review Officer, 

National Center for Injury Prevention 

and Control, Centers for Disease Control 

and Prevention, 4770 Buford Highway 

NE, Mailstop S106–9, Atlanta, Georgia 

30341. Telephone: (770) 488–1504; 

Email: CGentles@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

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, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2024–27857 Filed 11–26–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention, pursuant to Public Law 92– 

463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel; 

(SEP)—CE25–025, Rigorous Evaluation 

of Community- and Societal-Level 

Primary Prevention Approaches to 

Prevent Adverse Childhood Experiences 

(ACEs): Expanding the Best Available 

Evidence. 

Dates: February 25–26, 2025. 

Times: 10 a.m.–5 p.m., EST. 

Place: Web Conference. 

Agenda: To review and evaluate grant 

applications. 


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