Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2609 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than February 15, 2024. 

A. Federal Reserve Bank of Chicago 

(Colette A. Fried, Assistant Vice 

President) 230 South LaSalle Street, 

Chicago, Illinois 60690–1414. 

Comments can also be sent 

electronically to 

Comments.applications@chi.frb.org: 

1. Northstar Financial Group, Inc., 

Bad Axe, Michigan; to acquire 

Mainstreet Community Bank of Florida, 

DeLand, Florida. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2024–00691 Filed 1–12–24; 8:45 am] 

BILLING CODE P 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisitions of Shares of a Bank or 

Bank Holding Company 

The notificants listed below have 

applied under the Change in Bank 

Control Act (Act) (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire shares of a bank 

or bank holding company. The factors 

that are considered in acting on the 

applications are set forth in paragraph 7 

of the Act (12 U.S.C. 1817(j)(7)). 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in paragraph 7 of 

the Act. 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than January 31, 2023. 

A. Federal Reserve Bank of 

Philadelphia (William Spaniel, Senior 

Vice President) 10 Independence Mall, 

Philadelphia, Pennsylvania 19106. 

Comments can also be sent 

electronically to 

comments.applications@phil.frb.org: 

1. Kenneth R. Lehman, Fort 

Lauderdale, Florida; to acquire voting 

shares of Blue Ridge Bankshares, Inc., 

Charlottesville, Virginia, and thereby 

indirectly acquire voting shares of Blue 

Ridge Bank, National Association, 

Martinsville, Virginia. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2024–00692 Filed 1–12–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on The Effect of Dietary 

Digestible Carbohydrate Intake on Risk 

of Type 2 Diabetes, Growth, Size, and 

Body Composition 

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 

The Effect of Dietary Digestible 

Carbohydrate Intake on Risk of Type 2 

Diabetes, Growth, Size, and Body 

Composition, 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 February 15, 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 The Effect of Dietary 

Digestible Carbohydrate Intake on Risk 

of Type 2 Diabetes, Growth, Size, and 

Body Composition. 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 The Effect of Dietary 

Digestible Carbohydrate Intake on Risk 

of Type 2 Diabetes, Growth, Size, and 

Body Composition. The entire research 

protocol is available online at: https://

effectivehealthcare.ahrq.gov/products/ 

effect-dietary-digestible. 

This is to notify the public that the 

EPC Program would find the following 

information on The Effect of Dietary 

Digestible Carbohydrate Intake on Risk 

of Type 2 Diabetes, Growth, Size, and 

Body Composition 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, 


ddrumheller on DSK120RN23PROD with NOTICES1
2610 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 

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://www.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 digestible carbohydrate intake 

and the incidence of type 2 diabetes 

(T2D) and effect on growth, size, and 

body composition (i.e., obesity, 

overweight, body weight and 

composition)? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY

DESIGN (PICOTS) 

PICOTS 

elements Inclusion criteria Exclusion criteria 

Population ......... • Participants who are generally healthy, including participants who are determined to be 

overweight/obese, women who are pregnant or 

lactating.

• Age of participants: 

Æ Between 2 and 9 years (before puberty) ..

Æ Between 9 and 17 years ...........................

Æ 18 years and older. 

• Studies that enroll participants with diseases/health-related conditions 

that impact carbohydrate absorption or metabolism including cancer 

and malabsorption syndromes. 

• Studies that exclusively enroll participants hospitalized with an illness or 

injury. 

• Studies that exclusively enroll participants with type 1 or 2 diabetes 

(i.e., studies that aim to treat participants who have already been diagnosed with the endpoint outcomes of interest). 

• Studies designed to induce weight loss or treat patients who are determined to be overweight and obese through energy restriction or 

hypocaloric diets for the purposes of treating additional or other medical 

conditions. 

• Studies that exclusively enroll participants who are determined to be 

undernourished, underweight, stunted, or wasted. 

• Studies that enroll participants who are prebariatric or postbariatric surgery. 

• Exclude participants less than 2 years old. 

Interventions ..... • Total dietary digestible carbohydrate intake 

from foods, beverages, and dietary supplements.

Æ Total dietary digestible carbohydrate intake defined as collective starch and 

sugar intake; carbohydrate intake not including dietary fiber).

• A dietary pattern that quantifies the intake of 

total dietary digestible carbohydrates and allows the isolation of the effect of carbohydrate 

intake from the effect of the intake of other 

macronutrients.

• Studies that do not specify the amount of total digestible carbohydrate 

intake (e.g., studies that only report type or source of digestible carbohydrate). 

• Studies that do not describe the entire macronutrient distribution of the 

diet (i.e., studies that do not report total digestible carbohydrate, total 

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

• Studies that only assess digestible carbohydrate intake via infusions 

(rather than the GI tract). 

• Studies that primarily measure postprandial responses, as opposed to 

longer term studies. 

• 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 digestible carbohydrate. 

Comparators ..... • Different total dietary digestible carbohydrate 

intake level(s).

• Comparison of different sources of carbohydrates without specifying the 

amount of carbohydrate intake. 

• Studies that do not attempt to control for the energy intake of participants such that comparisons are made on an isocaloric basis. 

• Comparisons of available carbohydrate exposure should not be confounded by differences in participants’ energy intake. 

Outcomes .......... • Incidence of type 2 diabetes ............................. • Type 1 Diabetes. 

• Incidence of gestational diabetes.

• Surrogate markers suggesting prediabetes or 

abnormal glycemia.

Æ HbA1C level.

Æ Glucose tolerance/insulin resistance/insulin sensitivity.

• Growth, size, and body composition.

Æ Body weight.

Æ BMI.

Æ Body circumference.

Æ Body composition and distribution.

Æ Classifications of underweight, healthy 

weight, overweight, and obesity.


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2611 

INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY

DESIGN (PICOTS)—Continued 

PICOTS 

elements Inclusion criteria Exclusion criteria 

Timing ............... • Type 2 diabetes ................................................ • Any intervention length <12 weeks. 

• Minimum intervention length of 12 weeks Effect on growth, size, and body composition.

Æ Minimum intervention length of 12 weeks.

Settings ............. • All except hospital and acute care .................... • Hospital and acute care. 

Study design ..... • Randomized controlled trials .............................

• Nonrandomized controlled trials, including 

quasi-experimental and controlled before-andafter studies.

• Prospective cohort studies ................................

• Nested case-control studies ..............................

• Relevant systematic reviews, or meta-analyses 

(used for identifying additional studies).

• In vitro studies, nonoriginal data (e.g., narrative reviews, scoping reviews, editorials, letters, or erratum), retrospective cohort studies, case 

series, qualitative studies, cost-benefit analysis, cross-sectional (i.e., 

nonlongitudinal) studies, survey. 

Publications ....... • Studies published in English only .....................

• Studies published in peer-reviewed journals ....

• Studies published at and after the year 2000 ..

• Non-English language studies. 

Abbreviations: BMI = body mass index; HbA1c = hemoglobin A1C; GI = gastrointestinal; KQ = Key Question; PICOTS = populations, interventions, comparators, outcomes, timing, and settings; RCT = randomized controlled trial; U.S. = United States 

Dated: January 8, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–00618 Filed 1–12–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Updating the Measurement 

Criteria for AHRQ’s National 

Healthcare Quality and Disparities 

Report (NHQDR) 

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 

Updating the Measurement Criteria for 

AHRQ’s National Healthcare Quality 

and Disparities Report (NHQDR), 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 February 15, 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 Updating the Measurement 

Criteria for AHRQ’s National Healthcare 

Quality and Disparities Report 

(NHQDR). 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 Updating the 

Measurement Criteria for AHRQ’s 

National Healthcare Quality and 

Disparities Report (NHQDR). The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/measurement-criteria-qdr/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Updating the 

Measurement Criteria for AHRQ’s 

National Healthcare Quality and 

Disparities Report (NHQDR) 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 


ddrumheller on DSK120RN23PROD with NOTICES1