Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 90695 

Department of Interior 

Blanchard, Mary Josie, Deputy Director, 

Environmental Protection 

Compliance, MaryJosie_Blanchard@

ios.doi.gov, 202–208–3406 

State of Florida 

Blalock, Adam, Deputy Secretary for 

Ecosystem Restoration, 

Adam.Blalock@floridadep.gov, 850– 

245–2118 

State of Alabama 

Blankenship, Chris, Commissioner, 

Alabama Department of Conservation 

and Natural Resources, 

Chris.blankenship@dcnr.alabama.gov, 

334–242–3486 

Environmental Protection Agency 

Wyatt, Marc, Director, Gulf of Mexico 

Division, Wyatt.marc@epa.gov, 228– 

679–5915 

Keala J. Hughes, 

Director of External Affairs & Tribal Relations, 

Gulf Coast Ecosystem Restoration Council. 

[FR Doc. 2024–26818 Filed 11–15–24; 8:45 am] 

BILLING CODE 6560–58–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Dietary Total Fat Intake 

and Dietary Polyunsaturated Fatty Acid 

Intake and Child Growth and 

Development Outcomes: A Systematic 

Review 

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 Total Fat Intake and Dietary 

Polyunsaturated Fatty Acid Intake and 

Child Growth and Development 

Outcomes: A Systematic Review, 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published and unpublished pertinent 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 18, 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 Total Fat Intake 

and Dietary Polyunsaturated Fatty Acid 

Intake and Child Growth and 

Development Outcomes: A Systematic 

Review. 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 Total Fat Intake 

and Dietary Polyunsaturated Fatty Acid 

Intake and Child Growth and 

Development Outcomes: A Systematic 

Review. The entire research protocol is 

available online at: https://

effectivehealthcare.ahrq.gov/products/ 

child-growth-development-outcomes/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Dietary Total Fat Intake 

and Dietary Polyunsaturated Fatty Acid 

Intake and Child Growth and 

Development Outcomes: A Systematic 

Review 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 is the association between 

dietary intake of omega-6 and/or omega3 polyunsaturated fatty acids during 

pregnancy and risk of preterm birth? 

KQ 1a: How are these associations 

affected by intervention/exposure 

characteristics (for example, the ratio of 

different fatty acids)? 

KQ 2: What is the association between 

dietary intake of omega-6 and/or omega3 polyunsaturated fatty acids during 

pregnancy and/or lactation and infant/ 

child growth and developmental 

outcomes? 

KQ 2a: How are these associations 

affected by intervention/exposure 

characteristics (for example, the ratio of 

different fatty acids)? 


lotter on DSK11XQN23PROD with NOTICES1
90696 Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 

KQ 3: What is the association between 

dietary intake of total fat in individuals 

birth through 18 years of age and 

measures of growth and development? 

KQ4: What is the association between 

dietary intake of omega-6 and/or omega3 polyunsaturated fatty acids in 

individuals birth through 18 years of age 

and measures of growth and 

development? 

PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN) 

Element Inclusion criteria Exclusion criteria 

Population ............................ Exposure population: 

• Individuals who are pregnant (KQ1) and/or lactating (KQ2) of any age or individuals from birth 

through 18 years of age (KQ3 and 4) from the 

general population (including those with overweight/obesity) not affected by a disease or 

health-related condition that impacts fat absorption and/or metabolism; or taking medications 

that alter the absorption or metabolism of dietary 

fatty acid 

Outcome population: 

• Offspring of the pregnant individual (birth 

through 18 years) not taking medications or affected by a disease or health-related condition 

that impacts fat absorption and/or metabolism 

Note: given the distinction between chronological age 

versus pubertal stage, as well as heterogeneity in enrollment across age ranges, for studies meeting all 

other eligibility criteria, we will consider exceptions to 

the age criterion.a

• Non-human participants (e.g., animal studies, in-vitro 

models). 

• Studies that enroll participants taking medications or 

with diseases/health-related conditions that impact 

fatty acid absorption or metabolism (e.g., Crohn’s disease, ulcerative colitis, short-gut syndrome, cystic fibrosis, celiac). This includes cancer and malabsorption syndromes. 

• Studies that exclusively enroll participants hospitalized with an illness or injury. 

• Studies designed to induce weight loss or treat overweight and obesity through energy restriction or 

hypocaloric diets for the purposes of treating additional or other medical conditions. 

• Studies that exclusively enroll participants with severe undernourishment, underweight, stunting, or 

wasting. 

• Studies that enroll participants who are pre- or postbariatric surgery. 

• Studies with enrollment exclusively of: pre-term babies (gestational age <37 weeks), babies admitted to 

the NICU, babies that have low birth weight 

(<2,500g) and/or babies that are small for gestational 

age (for assessment of infant and child growth parameters and developmental outcomes). 

• Studies that enroll infants with conditions treated/prevent by dietary supplementation (e.g., G- or GJtubes, fatty acid oxidation disorders, necrotizing 

enterocolitis, attention deficit (and/or hyperactivity) 

disorder, ADHD, autism, etc.). 

Intervention (Exposure) ........ KQ1, 2, and 4: 

• Dietary intake of total omega-3 PUFA, total 

omega-6 PUFA, or total PUFA (omega-3 and 

omega-6) 

• Dietary intake of individual PUFA (examples: linoleic, alpha-linolenic, EPA, DHA) 

• Dietary intake of a combination of long-chain 

PUFA (example: EPA+DHA+DPA; DHA+ARA) 

• Dietary intake of polyunsaturated fatty acids in 

terms of a ratio (example, n-6:n-3 PUFA, 

DHA:ARA) 

KQ3: 

• Total dietary fat intake (as either grams/day or % 

of total energy intake from fat) 

• A dietary pattern that describes and quantifies 

intake of total dietary carbohydrate, total fat, and 

total protein content (examples: low/high-fat diet; 

low/high-carbohydrate diet; high-protein; 

ketogenic diet) 

Note: Dietary intake can be from foods, supplements, 

and/or supplemented foods.b

KQ1, 2, and 4: 

• Studies that do not quantify PUFA intake as either grams/day or % of total energy intake from 

PUFA (e.g., studies where exposure is number 

of fish servings per week). 

• Studies that do not provide absolute intake of 

fatty acids included in ratios. 

• Studies that only assess fatty acid biomarker 

wt% of total or concentrations. 

• Studies that only assess fatty acid intake via infusions (parenteral [intralipid] or stable isotope). 

• Studies that only assess exposure to fatty acids 

from a single meal, or eating occasion such that 

usual intake cannot be inferred. 

• Studies that examine food products or dietary 

supplements not widely available to U.S. consumers. 

• Multi-component interventions that do not isolate 

the effect or association of the PUFA exposure. 

• Observational studies that do not account for 

any confounders. 

• Studies designed to induce weight loss or treat 

participants who are determined to be overweight and obese through energy restriction or 

hypocaloric diets for the purposes of treating additional or other medical conditions. 

KQ3: 

• Studies that do not describe the energy and entire macronutrient distribution of the diet (i.e., 

studies that do not report total carbohydrate, 

total fat, and total protein contents of experimental or baseline diets). 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 90697 

PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN)—Continued 

Element Inclusion criteria Exclusion criteria 

Comparator .......................... KQ1, 2, and 4: 

• Placebo 

• Dietary intake of a different amount of fatty acids 

relevant to the exposure: 

Æ Total omega-3 

Æ Total omega-6 

Æ Individual PUFA 

Æ Combination of long-chain PUFA 

Æ Intake of PUFA in terms of a ratio 

KQ3: 

• Dietary intake of a different amount of total fat 

• Diet(s) with an energy intake that is statistically significantly higher or lower than the intervention/exposure diet (e.g., not isocaloric comparison). 

• Studies that do not have a statistically significant difference between groups in PUFA or total fat intake. 

• Studies comparing undefined exposures (e.g., comparisons of undefined quartiles). 

Outcome ............................... KQ2, 3, and 4: 

Infant and child (birth through 18 years) growth parameters 

• Birth weight 

• Weight and Weight-for-age percentile or Z-score 

adjusted for gestational age 

• Length or Height and Length-for-age or Heightfor-age percentile and Z-score adjusted for gestational age 

• Head circumference and Head circumference 

percentile and Z-score adjusted for gestational 

age 

Infant and child (birth through 18 years) developmental 

outcomes c

• Cognitive/neurological 

• Language/communication 

• Movement/physical 

• Visual function/acuity 

• Social/emotional learning 

KQ1: 

• Risk of preterm birth 

• BMI, BMI z-score. 

• Body composition and distribution (e.g., % fat mass, 

fat-free mass, skin fold thicknesses). 

• Incidence and prevalence of overweight, obesity. 

Timing .................................. • All exposure or intervention durations will be included 

Setting .................................. • Outpatient; all settings except hospital and acute 

care will be included 

• Inpatient; hospital and acute care. 

Study Design ........................ • Randomized controlled trials 

• Prospective cohort studies 

• Nested case-control studies 

• Narrative reviews. 

• Systematic reviews. 

• Meta-analyses. 

• Scoping reviews. 

• Umbrella reviews. 

• Retrospective cohort studies. 

• Non-randomized controlled trials, including quasi-experimental and controlled before-and-after studies. 

• Cross-sectional studies. 

• Case-control studies. 

• All other study designs. 

Geographic Location ............ • Locations with food products or dietary supplements 

widely available to U.S. and/or Canadian consumers 

• Countries rated very high on the Human Development Index (HDI) d at the time of data collection 

• Locations not rated very high on the HDI. 

Study Size ............................ • Studies including power calculations or effect sizes 

• Studies with N ≥30 participants (for randomized clinical trials [RCTs]): ≥10 participants analyzed per 

study arm) 

• Studies with N <30 participants (for RCTs: <10 participants analyzed per study arm), without power calculations or effect sizes. 

• Case studies and n = 1 samples. 

• Non-randomized studies that do not account for any 

potential confounders. 

Language ............................. • Articles published in English • Articles published in languages other than English. 

Publication Dates ................. • Articles published during or after 2000 • Articles published prior to 2000. 

aFor studies meeting all other eligibility criteria, studies enrolling populations aged 0 to older than 19 years will be included if: (a) results are 

stratified by age group, allowing extraction of data for participants aged through 18 years; or (b) 85% of the population is aged through 18 years, 

if results are not stratified by age group. The one exception is studies of adolescents; for those meeting all other eligibility criteria, studies enrolling adolescents through age 26, regardless of result stratification or percentage of population aged through 18 years, will be included. See the 

Study Selection section. b Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary ingredients (including vitamins, 

minerals, herbs or other botanicals, amino acids, and other substances) intended to be taken by mouth as a pill, capsule, table, or liquid, and 

that is labeled on the front panel as being a dietary supplement. cSee Section IV for an example table of measures with periodicity. 

d United Nations Development Programme Human Development Reports, https://hdr.undp.org/data-center/human-development-index#/indicies/ 

HDI. 


lotter on DSK11XQN23PROD with NOTICES1
90698 Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 

Dated: November 8, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–26783 Filed 11–15–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–25–25AW; Docket No. CDC–2024– 

0094] 

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 proposed information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled National 

Concussion Surveillance System. This 

data collection is designed to allow CDC 

to calculate the prevalence and 

incidence of traumatic brain injuries 

(TBI) for both adults and children, and 

the circumstances related to TBIs 

occurring in the preceding year. 

DATES: CDC must receive written 

comments on or before January 17, 

2025. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2024– 

0094 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, 

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 Concussion Surveillance 

System—New—National Center for 

Injury Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

In 2014, an Institute of Medicine 

(IOM) report titled ‘‘Sports-Related 

Concussions in Youth: Improving the 

Science, Changing the Culture,’’ 

recommended that the U.S. Centers for 

Disease Control and Prevention (CDC) 

establish and oversee a national 

surveillance system to accurately 

determine the incidence of sportsrelated concussions [i.e., mild traumatic 

brain injuries, or TBIs], including those 

in youth ages five to 21. The report 

further recommended that the cause, 

nature, and extent of the concussive 

injury also should be collected, 

including the sport or activity, level of 

competition, and signs and symptoms 

consistent with a concussion. The IOM 

recommendation was made because 

there were significant gaps in 

understanding of TBI, including 

concussion, incidence and prevalence 

estimates. Current non-fatal TBI 

surveillance estimates typically utilize 

emergency department (ED) or 

hospitalization-focused data sources. 

But these sources cannot account for 

injuries that go untreated or injuries 

diagnosed in primary care, urgent care, 

or specialty care settings, potentially 

missing information on millions of TBIs 

sustained each year. Without an 

accurate understanding of the burden, 

trends, and characteristics of these 

injuries, it is challenging to design or 

focus effective prevention programs, 

policies, or practices. The consequences 

from TBI are staggering, with many 

resulting in intensive and long-term care 

needs. This data collection could help 

fill significant knowledge gaps and 

inform prevention efforts across the 

country. 

The purpose of this data collection is 

to calculate the 12-month prevalence 

and incidence of TBI for both adults and 

children, and the circumstances related 

to TBIs occurring in the preceding 12 

months. The data collection instrument 

is largely based on the instrument used 

during the pilot that utilized cognitive 

testing prior to deployment. Data 

collected will include reports of head 

injuries experienced in the preceding 12 

months, and the most recent head injury 

reported will be assessed for symptoms 

of TBI. We will also query respondents 

who sustained a head injury regarding 

the mechanism of injury (cause) and 

circumstances related to the TBI, 

medical care received, impact on social 

and school functioning, and information 

related to returning to work/school/ 

play. 

Data will be analyzed to produce 

nationally representative 12-month 

incidence and prevalence estimates of 

non-fatal TBI in children (ages 5–17) 

and adults. Data collected are likely to 

be used by state and local governments, 

researchers, voluntary health 

organizations, physicians, health 

educators, workplace wellness 


lotter on DSK11XQN23PROD with NOTICES1