Supplemental Evidence and Data Request on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Cardiovascular Disease, 2226-2228 [2024-00505]

Download as PDF 2226 Federal Register / Vol. 89, No. 9 / Friday, January 12, 2024 / Notices khammond on DSKJM1Z7X2PROD with NOTICES statutory definition of a CFI certain advantages over non-CFI insured depository institutions in qualifying for Bank membership, and in the purposes for which they may receive long-term advances and the collateral they may pledge to secure advances.1 Section 2(10)(A) of the Bank Act and § 1263.1 of FHFA’s regulations define a CFI as any Bank member the deposits of which are insured by the Federal Deposit Insurance Corporation and that has average total assets below the statutory cap.2 The Bank Act was amended in 2008 to set the statutory cap at $1 billion and to require FHFA to adjust the cap annually to reflect the percentage increase in the CPI–U, as published by the DOL.3 For 2023, FHFA set the CFI asset cap at $1,417,000,000, which reflected a 7.1 percent increase over 2022, based upon the increase in the CPI–U between 2021 and 2022.4 II. The CFI Asset Cap for 2024 As of January 1, 2024, FHFA will increase the CFI asset cap to $1,461,000,000, which reflects a 3.1 percent increase in the unadjusted CPI– U from November 2022 to November 2023. Consistent with the practice of other Federal agencies required to calculate and make annual adjustments based on CPI–U changes, FHFA bases the annual adjustment to the CFI asset cap on the percentage increase in the CPI–U from November of the year prior to the preceding calendar year to November of the preceding calendar year, because the November figures represent the most recent available data as of January 1st of the current calendar year. The new CFI asset cap was obtained by applying the percentage increase in the CPI–U to the unrounded amount for the preceding year and rounding to the nearest million, as has been FHFA’s practice for all previous adjustments. In calculating the CFI asset cap, FHFA uses CPI–U data that have not been seasonally adjusted (i.e., the data have not been adjusted to remove the estimated effect of price changes that normally occur at the same time and in about the same magnitude every year). The DOL encourages use of unadjusted CPI–U data in applying ‘‘escalation’’ provisions such as that governing the CFI asset cap, because the factors that are used to seasonally adjust the data are amended annually, and seasonally adjusted data that are published earlier 1 See 12 U.S.C. 1424(a), 1430(a). 12 U.S.C. 1422(10)(A); 12 CFR 1263.1. 3 See 12 U.S.C. 1422(10)(B); 12 CFR 1263.1 (defining the term ‘‘CFI asset cap’’). 4 See 87 FR 80184 (Dec. 29, 2022). 2 See VerDate Sep<11>2014 00:38 Jan 12, 2024 Jkt 262001 are subject to revision for up to five years following their original release. Unadjusted data are not routinely subject to revision, and previously published unadjusted data are only corrected when significant calculation errors are discovered. Joshua R. Stallings, Deputy Director, Division of Federal Home Loan Bank Regulation, Federal Housing Finance Agency. [FR Doc. 2024–00491 Filed 1–11–24; 8:45 am] BILLING CODE 8070–01–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 Cardiovascular Disease Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submission. AGENCY: 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 Cardiovascular Disease, 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 12, 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. SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 Cardiovascular Disease. 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 Cardiovascular Disease. The entire research protocol is available online at: https://effective healthcare.ahrq.gov/products/riskcardiovascular-disease. 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 Cardiovascular Disease 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\12JAN1.SGM 12JAN1 Federal Register / Vol. 89, No. 9 / Friday, January 12, 2024 / Notices 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 2227 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 cardiovascular disease? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting) khammond on DSKJM1Z7X2PROD with NOTICES 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 years and 9 years (before puberty). Æ Between 9 and 17 years. Æ 18 years and older. 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. Comparators ........................ • Different total dietary digestible carbohydrate intake level(s). Outcomes ............................. • Intermediate outcomes: Æ LDL cholesterol (LDL). Æ Total cholesterol (TC). Æ HDL cholesterol (HDL). Æ Non-HDL cholesterol. Æ TC:HDL ratio. Æ LDL:HDL ratio. Æ Triglycerides. Æ Blood pressure (systolic and/or diastolic) and hypertension. • Final outcomes: Æ Cardiovascular disease (e.g., myocardial infarction, coronary heart disease, congestive heart failure, peripheral artery disease). Æ Stroke. Æ Cardiovascular disease-related mortality. • Participants with diseases/health-related conditions that impact carbohydrate absorption or metabolism, cancer, and malabsorption syndromes. • Participants hospitalized with an illness or injury. • Participants with the endpoint outcomes of CVD (i.e., studies that aim to treat participants already been diagnosed with the endpoint outcomes of interest). • Participants who intend to reduce weight or receive treatments for being overweight and having obesity through energy restriction or hypocaloric diets for the purposes of treating additional or other medical conditions. • Participants who are determined to be undernourished, underweight, stunted, or wasted. • Participants who are pre-bariatric or post-bariatric surgery. • People younger than 2 years old. • 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. • Comparison of different sources of carbohydrate without specifying amount of carbohydrate intake. • Studies that do not attempt to control for 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. • Hypertensive disorders during pregnancy and/or lactation (e.g., chronic hypertension, gestational hypertension, preeclampsia-eclampsia, chronic hypertension with superimposed preeclampsia). VerDate Sep<11>2014 00:38 Jan 12, 2024 Jkt 262001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1 2228 Federal Register / Vol. 89, No. 9 / Friday, January 12, 2024 / Notices INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)—Continued PICOTS elements Timing .................................. Settings ................................ Study design ........................ Inclusion criteria • • • • • • • Publications .......................... • • • Exclusion criteria At least 4 weeks .......................................................... All except hospital and acute care .............................. Randomized controlled trials ....................................... Nonrandomized controlled trials, including quasi-experimental and controlled before-and-after studies. Prospective cohort studies. Nested case-control studies. Relevant systematic reviews, or meta-analyses (used for identifying additional studies). Studies published in English only ............................... Studies published in peer-reviewed journals. Studies published at and after the year 2000. • Less than 4 weeks. • Hospital and acute care. • 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. • Non-English language studies. Abbreviations: CVD = cardiovascular disease; GI = gastrointestinal; HDL = high-density lipoprotein; KQ = Key Question; LDL = low-density lipoprotein PICOTS = populations, interventions, comparators, outcomes, timing, and settings; RCT = randomized controlled trial; TC = total cholesterol; U.S. = United States. Dated: January 8, 2024. Marquita Cullom, Associate Director. [FR Doc. 2024–00505 Filed 1–11–24; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; CAREWare Customer Satisfaction and Usage Survey, OMB No. 0906–xxxx–New Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30-day comment period for this notice has closed. DATES: Comments on this ICR should be received no later than February 12, 2024. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 00:38 Jan 12, 2024 Jkt 262001 information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Joella Roland, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 3983. SUPPLEMENTARY INFORMATION: Information Collection Request Title: CAREWare Customer Satisfaction and Usage Survey, OMB No. 0906–xxxx– New. Abstract: HRSA developed CAREWare, a software application first released in 2000, to help meet the data collection and reporting needs of Ryan White HIV/AIDS Program (RWHAP) grant recipients. The secure software is a free, electronic health and social support services information system for RWHAP grant recipients and their subrecipients to assist in the data requirement submissions that inform the development of the Ryan White HIV/AIDS Program Service Report, the AIDS Drug Assistance Program Data Report, the Ending the HIV Epidemic Initiative Triannual Report, and the voluntary Clinical Quality Measures Performance Measures module. Over time, the software has evolved into a comprehensive health information system and is now the source of more than half of all the RWHAP client-level data received from recipients and subrecipients of RWHAP grant funding. CAREWare software manages HIV clinical and support service data from more than 360,000 client records in 48 states; Washington, DC; Puerto Rico; and the U.S. Virgin Islands. The CAREWare software application contains customizable modules for tracking demographic information, PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 services, medications, laboratory test results, immunization history, diagnoses (updated with International Classification of Diseases, Tenth Revision codes), referrals to outside agencies, and an appointment scheduler. There is a custom report generator and a performance measures module that supports quality of care initiatives at the provider level. The software also has several ways to import data from third-party sources, including commercial labs and other electronic health records (using both Health Level Seven and simple Comma Separated Value-formatted files), HIV surveillance systems, and for RWHAP Part B AIDS Drug Assistance Programs, pharmacy benefit programs. The software and user support materials can be accessed here: https://hab.hrsa.gov/program-grantsmanagement/careware. 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[Federal Register Volume 89, Number 9 (Friday, January 12, 2024)]
[Notices]
[Pages 2226-2228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00505]


=======================================================================
-----------------------------------------------------------------------

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 Cardiovascular Disease

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 Cardiovascular 
Disease, 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 12, 2024.

ADDRESSES: 
    Email submissions: [email protected].
    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: [email protected].

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 Cardiovascular Disease. 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 Cardiovascular Disease.
    The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/risk-cardiovascular-disease.
    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 Cardiovascular Disease helpful:
    [ssquf] 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.
    [ssquf] 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.
    [ssquf] 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.
    [ssquf] 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.

[[Page 2227]]

    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 cardiovascular disease?

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      Participants with
                               are generally         diseases/health-
                               healthy, including    related conditions
                               participants who      that impact
                               are determined to     carbohydrate
                               be overweight/        absorption or
                               obese, women who      metabolism, cancer,
                               are pregnant or       and malabsorption
                               lactating.            syndromes.
                               Age of       
                               participants:.        Participants
                              [cir] Between 2        hospitalized with
                               years and 9 years     an illness or
                               (before puberty)..    injury.
                              [cir] Between 9 and   
                               17 years..            Participants with
                              [cir] 18 years and     the endpoint
                               older..               outcomes of CVD
                                                     (i.e., studies that
                                                     aim to treat
                                                     participants
                                                     already been
                                                     diagnosed with the
                                                     endpoint outcomes
                                                     of interest).
                                                    
                                                     Participants who
                                                     intend to reduce
                                                     weight or receive
                                                     treatments for
                                                     being overweight
                                                     and having obesity
                                                     through energy
                                                     restriction or
                                                     hypocaloric diets
                                                     for the purposes of
                                                     treating additional
                                                     or other medical
                                                     conditions.
                                                    
                                                     Participants who
                                                     are determined to
                                                     be undernourished,
                                                     underweight,
                                                     stunted, or wasted.
                                                    
                                                     Participants who
                                                     are pre-bariatric
                                                     or post-bariatric
                                                     surgery.
                                                     People
                                                     younger than 2
                                                     years old.
Interventions...............   Total         Studies
                               dietary digestible    that do not specify
                               carbohydrate intake   the amount of total
                               from foods,           digestible
                               beverages, and        carbohydrate intake
                               dietary supplements.  (e.g., studies that
                              [cir] Total dietary    only report type or
                               digestible            source of
                               carbohydrate intake   digestible
                               defined as            carbohydrate).
                               collective starch     Studies
                               and sugar intake;     that do not
                               carbohydrate intake   describe the entire
                               not including         macronutrient
                               dietary fiber..       distribution of the
                               A dietary     diet (i.e., studies
                               pattern that          that do not report
                               quantifies the        total digestible
                               intake of total       carbohydrate, total
                               dietary digestible    fat, and total
                               carbohydrates and     protein contents of
                               allows the            experimental or
                               isolation of the      baseline diets).
                               effect of             Studies
                               carbohydrate intake   that only assess
                               from the effect of    digestible
                               the intake of other   carbohydrate intake
                               macronutrients..      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     Comparison
                               total dietary         of different
                               digestible            sources of
                               carbohydrate intake   carbohydrate
                               level(s).             without specifying
                                                     amount of
                                                     carbohydrate
                                                     intake.
                                                     Studies
                                                     that do not attempt
                                                     to control for
                                                     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....................                
                               Intermediate          Hypertensive
                               outcomes:             disorders during
                              [cir] LDL              pregnancy and/or
                               cholesterol (LDL)..   lactation (e.g.,
                              [cir] Total            chronic
                               cholesterol (TC)..    hypertension,
                              [cir] HDL              gestational
                               cholesterol (HDL)..   hypertension,
                              [cir] Non-HDL          preeclampsia-
                               cholesterol..         eclampsia, chronic
                              [cir] TC:HDL ratio..   hypertension with
                              [cir] LDL:HDL ratio.   superimposed
                              [cir] Triglycerides.   preeclampsia).
                              [cir] Blood pressure
                               (systolic and/or
                               diastolic) and
                               hypertension..
                               Final
                               outcomes:
                              [cir] Cardiovascular
                               disease (e.g.,
                               myocardial
                               infarction,
                               coronary heart
                               disease, congestive
                               heart failure,
                               peripheral artery
                               disease)..
                              [cir] Stroke........
                              [cir] Cardiovascular
                               disease-related
                               mortality..

[[Page 2228]]

 
Timing......................   At least 4    Less than 4
                               weeks.                weeks.
Settings....................   All except    Hospital
                               hospital and acute    and acute care.
                               care.
Study design................   Randomized    In vitro
                               controlled trials.    studies,
                                             nonoriginal data
                               Nonrandomized         (e.g., narrative
                               controlled trials,    reviews, scoping
                               including quasi-      reviews,
                               experimental and      editorials,
                               controlled before-    letters, or
                               and-after studies..   erratum),
                               Prospective   retrospective
                               cohort studies..      cohort studies,
                               Nested case-  case series,
                               control studies..     qualitative
                               Relevant      studies, cost-
                               systematic reviews,   benefit analysis,
                               or meta-analyses      cross-sectional
                               (used for             (i.e.,
                               identifying           nonlongitudinal)
                               additional            studies, survey.
                               studies)..
Publications................   Studies       Non-English
                               published in          language studies.
                               English only.
                               Studies
                               published in peer-
                               reviewed journals..
                               Studies
                               published at and
                               after the year
                               2000..
------------------------------------------------------------------------
Abbreviations: CVD = cardiovascular disease; GI = gastrointestinal; HDL
  = high-density lipoprotein; KQ = Key Question; LDL = low-density
  lipoprotein PICOTS = populations, interventions, comparators,
  outcomes, timing, and settings; RCT = randomized controlled trial; TC
  = total cholesterol; U.S. = United States.


    Dated: January 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-00505 Filed 1-11-24; 8:45 am]
BILLING CODE 4160-90-P


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