Supplemental Evidence and Data Request on Fiber Intake and Laxation Outcomes, 21521-21523 [2024-06595]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 61 / Thursday, March 28, 2024 / Notices Statutory authority for the collection of information associated with the CBPA is contained in Sections 154(i), 307, 308, 309, and 319 of the Communications Act of 1934, as amended, the Community Broadcasters Protection Act of 1999, and the Middle Class Tax Relief and Job Creation Act of 2012. Total Annual Burden: 460 hours. Annual Cost Burden: $41,725. Needs and Uses: The FCC Form 2100, Schedule F is used by Low Power TV (LPTV) stations that seek to convert to Class A status; existing Class A stations seeking a license to cover their authorized construction permit facilities; and Class A stations entering into a channel sharing agreement. The FCC Form 2100, Schedule F requires a series of certifications by the Class A applicant as prescribed by the Community Broadcasters Protection Act of 1999 (CBPA). Licensees will be required to provide weekly announcements to their listeners: (1) informing them that the applicant has applied for a Class A license and (2) announcing the public’s opportunity to comment on the application prior to Commission action. On December 11, 2023, the Commission adopted a Report and Order, FCC 23–112, to implement the Low Power Protection Act (LPPA or Act), which was enacted on January 5, 2023. The LPPA provides certain low power television (LPTV) stations with a limited window of opportunity to apply for primary spectrum use status as Class A television stations. The Report and Order establishes the period during which eligible stations may file applications for Class A status, eligibility and interference requirements, and the process for submitting applications. The Report and Order provides that applications to convert to Class A status under the Low Power Protection Act must be filed using FCC Form 2100, Schedule F. The application form requires certifications by the applicant as prescribed by the LPPA. This submission is being made to OMB for approval of the modified FCC Form 2100, Schedule F. In addition, LPTV stations that file an application to convert to Class A status must provide local public notice of the filing of the application pursuant to 47 CFR 73.3580(c). Specifically, the station must both broadcast on-air announcements and give online notice. This submission also reflects the burden associated with that information collection and is also being made to request Office of Management and Budget (OMB) approval of that collection. VerDate Sep<11>2014 20:27 Mar 27, 2024 Jkt 262001 Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary. [FR Doc. 2024–06603 Filed 3–27–24; 8:45 am] BILLING CODE 6712–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Fiber Intake and Laxation Outcomes 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 Fiber Intake and Laxation Outcomes, 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 April 29, 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 Fiber Intake and Laxation Outcomes. 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 SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 21521 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 Fiber Intake and Laxation Outcomes. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/products/ fiber-intake/protocol. This is to notify the public that the EPC Program would find the following information on Fiber Intake and Laxation Outcomes 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, E:\FR\FM\28MRN1.SGM 28MRN1 21522 Federal Register / Vol. 89, No. 61 / Thursday, March 28, 2024 / Notices 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. KQ 1a: How does the association vary among people in different life stages? Key Question (KQ) KQ 1: What is the association between fiber intake and laxation/gut motility in apparently healthy individuals? 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 ............................ • Individuals of any age, including pregnant or lactating women. • General population, including individuals with overweight/obese and those at elevated cardiometabolic disease risk. Æ Overweight/obese. Æ Hyperglycemia and related conditions, including type 2 diabetes. Æ Dyslipidemia. Æ Hypertension/high blood pressure. Interventions ......................... • Fiber intake, including different types and sources of fiber. • Fiber naturally occurring in food, enriched in food, dietary supplements, and diets that can be defined on the basis of fiber content. Æ Must specify quantity of fiber intake. Comparators ........................ • • • • • • • • • • • Those with diseases/health-related conditions or taking medications that could impact gut motility/laxation (e.g., irritable bowel syndrome; chronic constipation; lactose intolerance; use of medications that stimulate laxation or cause constipation). • Those with chronic constipation (100% of study population), including functional constipation. • Study eligibility criteria includes ‘‘abnormal laxation’’ as defined by either a minimum or maximum number of defecations per week (or equivalent). • Those with other gastrointestinal-related conditions, symptoms, diagnoses; Æ Including diverticulosis. • Those with diseases/health-related conditions or taking medications that could alter the gut microbiota composition/diversity (e.g., antibiotics). • Those with cancer, gastrointestinal disease, undernutrition, or who have had gut resection or bariatric surgery. • Those with acute illness or injury. • Pre-term babies (gestational age <37 weeks), babies with low birth weight (<2,500 g) or small for gestational age (per study criteria). • Enteral/tube fed. • Animal, in vitro, or other non-human studies. • Diets (or other interventions or exposures) where the fiber intake has not been quantified or explicitly specified. • Combinations of fiber (from food or dietary supplements) and other entities with a purported effect on motility, digestion, or microbiota (e.g., psyllium + probiotic). • Combinations of fiber supplements and other entities (e.g., minerals, vitamins). • Other entities with a purported effect on motility, digestion, or microbiota (e.g., probiotic). • Alternative food group diets (e.g., red meat, fish, high protein). • Fiber + probiotic (etc.) vs. no intervention or placebo. • Fiber + probiotic (etc.) vs. same probiotic (etc.). • Fiber vs. probiotic (etc.). • High-fiber diet vs. red meat diet (etc.). Interventions vs. Comparators. Outcomes ............................. ddrumheller on DSK120RN23PROD with NOTICES1 Subgroups of interest ........... Design .................................. VerDate Sep<11>2014 20:27 Mar 27, 2024 Different levels (dosages) of fiber. No added fiber or placebo. Different types or sources of fiber. Different formulations of fiber. Fiber (supplement) vs. no fiber (supplement). Higher fiber (diet) vs. lower fiber (diet). Fiber vs. alternative fiber. Fiber vs. alternative fiber dose. Fiber vs. alternative fiber formulation. Laxation (i.e., gut motility). Æ Fecal frequency (e.g., number of defecations per week). Æ Gastrointestinal transit time. D Bristol stool scale (stool consistency). D Dye, marker studies. Æ Fecal output, weight/bulk (g/day). Æ Ease of defecation (e.g., constipation). • Specific life stages: Æ Infants. Æ Children and adolescents. Æ Adults (19–64). Æ Older adults (≥65). Æ Pregnant or postpartum. Æ Sex (male, female). • Randomized controlled trials. Æ Parallel or cross-over. • N ≥10/group. Jkt 262001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 • Other disease or health outcomes. • Flatulence, eructation, bloating, etc. None. • Observational studies. • All other study designs. E:\FR\FM\28MRN1.SGM 28MRN1 Federal Register / Vol. 89, No. 61 / Thursday, March 28, 2024 / Notices 21523 STUDY ELIGIBILITY CRITERIA BASED ON POPULATION, INTERVENTION, COMPARATOR, OUTCOME (PICO), AND OTHER ELEMENTS—Continued Element Inclusion criteria Timing .................................. • Minimum duration of intervention: 2 weeks. • In cross-over studies, any change in outcome measure must exclude data from the first week after end of any prior treatments. This may be accomplished by a washout period of at least 1 week. • General population. • English language. • Published in peer-reviewed journals. Setting .................................. Publication ............................ Dated: March 18, 2024. Marquita Cullom, Associate Director. BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–R–38 and CMS–10400] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by May 28, 2024. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: 20:27 Mar 27, 2024 None. • Hospital or other acute care settings. • Non-English language text. • Conference abstracts and other non-peer-reviewed data. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: ADDRESSES: [FR Doc. 2024–06595 Filed 3–27–24; 8:45 am] VerDate Sep<11>2014 Exclusion criteria Jkt 262001 Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–R–38 Conditions for Certification for Rural Health Clinics and Conditions for Coverage for Federally Qualified Health Centers in 42 CFR 491 CMS–10400 Establishment of Qualified Health Plans and American Health Benefit Exchanges PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Under the 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. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Conditions for Certification for Rural Health Clinics and Conditions for Coverage for Federally Qualified Health Centers in 42 CFR 491; Use: The Conditions for Medicare Certification (CfCs) for Rural Health Clinics (RHCs) are based on criteria prescribed in law and designed to ensure that each RHC has properly trained staff to provide appropriate care and to assure a safe physical environment for patients. The information collection requirements described herein are needed to implement the Medicare and Medicaid CfCs for a total of 5,349 RHCs. These requirements are similar in intent to standards developed by industry organizations such as the Joint Commission on Accreditation of Hospitals, and the National League of Nursing/American Public Association, and merely reflect accepted standards of management and care to which rural health clinics must adhere. E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[Federal Register Volume 89, Number 61 (Thursday, March 28, 2024)]
[Notices]
[Pages 21521-21523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06595]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Fiber Intake and 
Laxation Outcomes

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 Fiber Intake and 
Laxation Outcomes, 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 April 29, 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 Fiber Intake and 
Laxation Outcomes. 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 Fiber Intake and Laxation Outcomes. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/fiber-intake/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Fiber Intake and Laxation Outcomes 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.
    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,

[[Page 21522]]

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 Question (KQ)

    KQ 1: What is the association between fiber intake and laxation/gut 
motility in apparently healthy individuals?
    KQ 1a: How does the association vary among people in different life 
stages?

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...............................   Individuals of any age,           Those with
                                            including pregnant or lactating women.    diseases/health-related
                                            General population, including     conditions or taking
                                            individuals with overweight/obese and     medications that could
                                            those at elevated cardiometabolic         impact gut motility/
                                            disease risk.                             laxation (e.g., irritable
                                            [cir] Overweight/obese.                   bowel syndrome; chronic
                                            [cir] Hyperglycemia and related           constipation; lactose
                                            conditions, including type 2 diabetes.    intolerance; use of
                                            [cir] Dyslipidemia.                       medications that stimulate
                                            [cir] Hypertension/high blood pressure.   laxation or cause
                                                                                      constipation).
                                                                                      Those with chronic
                                                                                      constipation (100% of
                                                                                      study population),
                                                                                      including functional
                                                                                      constipation.
                                                                                      Study eligibility
                                                                                      criteria includes
                                                                                      ``abnormal laxation'' as
                                                                                      defined by either a
                                                                                      minimum or maximum number
                                                                                      of defecations per week
                                                                                      (or equivalent).
                                                                                      Those with other
                                                                                      gastrointestinal-related
                                                                                      conditions, symptoms,
                                                                                      diagnoses;
                                                                                      [cir] Including
                                                                                      diverticulosis.
                                                                                      Those with
                                                                                      diseases/health-related
                                                                                      conditions or taking
                                                                                      medications that could
                                                                                      alter the gut microbiota
                                                                                      composition/diversity
                                                                                      (e.g., antibiotics).
                                                                                      Those with cancer,
                                                                                      gastrointestinal disease,
                                                                                      undernutrition, or who
                                                                                      have had gut resection or
                                                                                      bariatric surgery.
                                                                                      Those with acute
                                                                                      illness or injury.
                                                                                      Pre-term babies
                                                                                      (gestational age <37
                                                                                      weeks), babies with low
                                                                                      birth weight (<2,500 g) or
                                                                                      small for gestational age
                                                                                      (per study criteria).
                                                                                      Enteral/tube fed.
                                                                                      Animal, in vitro,
                                                                                      or other non-human
                                                                                      studies.
Interventions............................   Fiber intake, including           Diets (or other
                                            different types and sources of fiber.     interventions or
                                            Fiber naturally occurring in      exposures) where the fiber
                                            food, enriched in food, dietary           intake has not been
                                            supplements, and diets that can be        quantified or explicitly
                                            defined on the basis of fiber content.    specified.
                                            [cir] Must specify quantity of fiber      Combinations of
                                            intake.                                   fiber (from food or
                                                                                      dietary supplements) and
                                                                                      other entities with a
                                                                                      purported effect on
                                                                                      motility, digestion, or
                                                                                      microbiota (e.g., psyllium
                                                                                      + probiotic).
                                                                                      Combinations of
                                                                                      fiber supplements and
                                                                                      other entities (e.g.,
                                                                                      minerals, vitamins).
Comparators..............................   Different levels (dosages) of     Other entities
                                            fiber.                                    with a purported effect on
                                            No added fiber or placebo.        motility, digestion, or
                                            Different types or sources of     microbiota (e.g.,
                                            fiber.                                    probiotic).
                                            Different formulations of         Alternative food
                                            fiber.                                    group diets (e.g., red
                                                                                      meat, fish, high protein).
Interventions vs. Comparators............   Fiber (supplement) vs. no fiber   Fiber + probiotic
                                            (supplement).                             (etc.) vs. no intervention
                                            Higher fiber (diet) vs. lower     or placebo.
                                            fiber (diet).                             Fiber + probiotic
                                            Fiber vs. alternative fiber.      (etc.) vs. same probiotic
                                            Fiber vs. alternative fiber       (etc.).
                                            dose.                                     Fiber vs.
                                            Fiber vs. alternative fiber       probiotic (etc.).
                                            formulation.                              High-fiber diet
                                                                                      vs. red meat diet (etc.).
Outcomes.................................   Laxation (i.e., gut motility).    Other disease or
                                            [cir] Fecal frequency (e.g., number of    health outcomes.
                                            defecations per week).                    Flatulence,
                                            [cir] Gastrointestinal transit time.      eructation, bloating, etc.
                                            [ssquf] Bristol stool scale (stool
                                            consistency).
                                            [ssquf] Dye, marker studies.
                                            [cir] Fecal output, weight/bulk (g/
                                            day).
                                            [cir] Ease of defecation (e.g.,
                                            constipation).
Subgroups of interest....................   Specific life stages:            None.
                                            [cir] Infants.
                                            [cir] Children and adolescents.
                                            [cir] Adults (19-64).
                                            [cir] Older adults (>=65).
                                            [cir] Pregnant or postpartum.
                                            [cir] Sex (male, female).
Design...................................   Randomized controlled trials.     Observational
                                            [cir] Parallel or cross-over.             studies.
                                            N >=10/group.                     All other study
                                                                                      designs.

[[Page 21523]]

 
Timing...................................   Minimum duration of              None.
                                            intervention: 2 weeks.
                                            In cross-over studies, any
                                            change in outcome measure must exclude
                                            data from the first week after end of
                                            any prior treatments. This may be
                                            accomplished by a washout period of at
                                            least 1 week.
Setting..................................   General population.               Hospital or other
                                                                                      acute care settings.
Publication..............................   English language.                 Non-English
                                            Published in peer-reviewed        language text.
                                            journals.                                 Conference
                                                                                      abstracts and other non-
                                                                                      peer-reviewed data.
----------------------------------------------------------------------------------------------------------------


    Dated: March 18, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-06595 Filed 3-27-24; 8:45 am]
BILLING CODE 4160-90-P


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