82 FR 12605 - Supplemental Evidence and Data Request on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 82, Issue 42 (March 6, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 42 (March 6, 2017)
| Page Range | 12605-12610 | |
| FR Document | 2017-04193 |
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)] [Notices] [Pages 12605-12610] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04193] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submissions. ----------------------------------------------------------------------- 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 of Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). DATES: Submission Deadline on or before April 5, 2017. ADDRESSES: Email submissions: src.org">[email protected]src.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. Box 69539, Portland, OR 97239. Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239. FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: src.org">[email protected]src.org. 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 Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors. 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 Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://www.effectivehealthcare.AHRQ.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2428. This is to notify the public that the EPC Program would find the following information on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors helpful: [ssquf] A list of completed studies that your organization has sponsored for this indication. 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, please provide a summary, including the following elements: 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, and analyzed; as well as effectiveness and efficacy, and safety results. [ssquf] A list of ongoing studies that your organization has sponsored for this [[Page 12606]] indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including 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 indication and an index outlining the relevant information in each submitted file. Your contribution will be very beneficial to the EPC Program. The contents of all submissions will be made available to the public upon request. 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 indications 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 Web site 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/index.cfm/join-the-email-list1/. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The Key Questions Sodium 1. Among adults and children of all age groups (including both sexes and pregnant and lactating women), what is the effect (benefits and harms) of interventions to reduce dietary sodium intake on blood pressure at the time of the study and in later life? I. Do other minerals (e.g., potassium, calcium, magnesium) modify the effect of sodium? II. Among subpopulations defined by sex, race/ethnicity, age (children, adolescents, young adults, older adults, elderly), and for women (pregnancy and lactation). III. Among subpopulations defined by hypertension, diabetes, and obesity health status. 2. Among adults and children, what is the association between dietary sodium intake and blood pressure? I. Among subpopulations defined by sex, race/ethnicity and age (children, adolescents, young adults, older adults, elderly). II. Among subpopulations defined by hypertension, diabetes, and obesity health status. 3. Among adults, what is the effect (benefits and harms) of interventions to reduce dietary sodium intake on cardiovascular disease (CVD) and kidney disease morbidity and mortality and on total mortality? I. Do other minerals (e.g., potassium, calcium, magnesium) modify the effect of sodium? II. Among subpopulations defined by sex, race/ethnicity, age (adults, older adults, elderly), and for women (pregnancy and lactation). III. Among subpopulations defined by hypertension, diabetes, obesity and renal health status. 4. Among adults, what is the association between dietary sodium intake and CVD, coronary heart disease (CHD), stroke and kidney disease morbidity and mortality and between dietary sodium intake and total mortality? I. Do other minerals (e.g., potassium, calcium, magnesium) modify the association with sodium? II. Among subpopulations defined by sex, race/ethnicity, age (adults, older adults, elderly), and for women (pregnancy and lactation). III. Among subpopulations defined by hypertension, diabetes, obesity and renal health status. Potassium 5. Among children and adults, what is the effect of interventions to increase potassium intake on blood pressure and kidney stone formation? I. Do other minerals (e.g., sodium, calcium, magnesium) modify the effect of potassium? II. Among subpopulations defined by sex, race/ethnicity, age (children, adolescents, young adults, older adults, elderly), and for women (pregnancy and lactation). III. Among subpopulations defined by hypertension, diabetes, obesity and renal health status. 6. Among children and adults, what is the association between potassium intake and blood pressure and kidney stone formation? I. Among subpopulations defined by sex, race/ethnicity, and age (children, adolescents, young adults, older adults, elderly). II. Among subpopulations defined by hypertension, diabetes, and obesity health status. 7. Among adults, what is the effect of interventions aimed at increasing potassium intake on CVD, and kidney disease morbidity and mortality, and total mortality? I. Do other minerals modify the effect of potassium (e.g., sodium, calcium, magnesium)? II. Among subpopulations defined by sex, race/ethnicity, age (young adults, older adults, elderly), and for women (pregnancy and lactation). III. Among subpopulations defined by hypertension, diabetes, obesity and renal health status. 8. Among adults, what is the association between dietary potassium intake and CVD, CHD, stroke and kidney disease morbidity and mortality and between dietary potassium and total mortality? I. Do other minerals (e.g., sodium, calcium, magnesium) modify the association with potassium? II. Among subpopulations defined by sex, race/ethnicity, age (young adults, older adults, elderly), and for women (pregnancy and lactation). III. Among subpopulations defined by hypertension, diabetes, and obesity health status. PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Key Question 1 I. Population A. Studies in human participants will be eligible for inclusion in the review, with the exception of studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer. II. Interventions A. Studies evaluating interventions to reduce dietary sodium intake that specify the oral consumption from food or supplements of quantified amounts of sodium and sodium chloride (salt) or sodium-to- potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/- 3% or more. Interventions simultaneously addressing sodium and potassium intake that document sodium/potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded. III. Comparators A. Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of sodium intake, or studies that alter sodium/potassium ratio in other ways [[Page 12607]] will be included if they control for other nutrient levels. IV. Outcomes A. Studies reporting on blood pressure outcomes (e.g., systolic blood pressure, diastolic blood pressure, rate of hypertensive/non- hypertensive participants, incident hypertension, percent of participants at blood pressure goal, and change in blood pressure) will be eligible. V. Timing A. Studies reporting on an intervention period of at least four weeks will be eligible. VI. Setting A. Studies in outpatient settings will be eligible. VII. Study Design A. Parallel RCTs and cross-over RCTs with a washout period of two weeks or more will be eligible. Key Question 2 I. Population A. Studies in community-dwelling (non-institutionalized) human participants will be eligible for inclusion in the review with the exception of studies exclusively reporting on patients with pre- existing conditions specific to the clinical outcome of interest, as well as studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer. II. Exposure A. Studies that measure the intake (oral consumption from food or supplements of quantified amounts of sodium and sodium chloride [salt] or sodium-to-potassium ratio) with validated measures or that use biomarker values to assess sodium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of salt substitute with intervention/exposure adherence measure, and food diaries with reported validation [adherence check, electronic prompts]) will be eligible. Observational studies that report a weight change of +/- 3% or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies relying only on serum sodium levels, composition of salt substitute without intervention/exposure adherence measure, food diaries without reported validation, use of a published food frequency questionnaire, or partial or spot urine without reported prediction equation will be excluded. III. Comparator A. Studies comparing groups with different documented sodium intake or biomarker values for sodium will be eligible. Studies where differences in sodium intake or values are confounded with alteration of other nutrient levels will be excluded. IV. Outcomes A. Studies reporting on blood pressure outcomes (e.g., systolic blood pressure, diastolic blood pressure, rate of hypertensive/non- hypertensive participants, incident hypertension, percent of participants at blood pressure goal, change in blood pressure) will be eligible. Studies that do not report baseline blood pressure status will be excluded. V. Timing A. Studies reporting on an intervention period of at least four weeks will be eligible. VI. Setting A. Studies in community-dwelling participants will be eligible. VII. Study Design A. Prospective cohort studies and nested case-control studies, where at least two groups are compared based on measured sodium intake or biomarker values will be eligible. Retrospective studies, case series, cross-sectional studies or surveys, and case reports will be excluded. Key Question 3 I. Population A. Studies in human adults will be eligible for inclusion in the review. Studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer will be excluded. II. Intervention A. Studies evaluating interventions to reduce dietary sodium intake that specify the oral consumption from food or supplements of quantified amounts of sodium and sodium chloride (salt) or sodium-to- potassium ratio will be eligible. Studies with trial arms in which participants demonstrate a weight change of +/- 3% or more will be excluded. Interventions simultaneously addressing sodium and potassium intake with documents sodium/potassium ratio are eligible. All other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded. III. Comparators A. Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of sodium intake, or studies that alter sodium/potassium ratio in other ways will be included if they control for other nutrient levels. IV. Outcomes A. Studies reporting on mortality (all-cause, CVD, CHD, or renal); cardiovascular disease morbidity, including acute coronary syndrome (unstable angina and myocardial infarction), stroke, myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non- ST elevation myocardial infarction [NSTEMI]), requiring coronary revascularization procedures (angioplasty, coronary stent placement, coronary artery bypass), other atherosclerotic revascularization procedures (carotid endarterectomy), left ventricular hypertrophy, hospitalization for heart failure, hospitalization for any cause of coronary heart disease or cardiovascular disease, or combined CVD morbidity and mortality; or reporting on renal function intermediary and clinical outcomes including creatinine clearance (CrCl), serum creatinine (SCr), glomerular filtration rate (GFR), end stage renal disease, chronic kidney disease (CKD), albuminuria or proteinuria (including urine albumin-to-creatinine ratio, urine albumin dipstick level, urine protein-to-creatinine ratio, albumin excretion rate), kidney stone incidence, or acute kidney injury will be eligible. V. Timing A. Only interventions of two years or longer will be included for kidney disease outcomes; only interventions of three months or longer will be included for cardiovascular disease outcomes; all other studies need to report on an intervention period of at least four weeks to be eligible. VI. Setting A. Studies in outpatient settings will be eligible. VII. Study Design A. Parallel RCTs and cross-over RCTs with a washout period of two weeks or more will be eligible. [[Page 12608]] Key Question 4 I. Population A. Studies in community-dwelling (non-institutionalized) adults will be eligible for inclusion in the review with the exception of studies exclusively reporting on patients with pre-existing conditions specific to the clinical outcomes of interest, as well as studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer. II. Exposure A. Studies that measure the intake (oral consumption from food or supplements of quantified amounts of sodium and sodium chloride [salt] or sodium-to-potassium ratio) with validated measures or use biomarker values to assess sodium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of salt substitute with intervention/exposure adherence measure, and food diaries with reported validation [adherence check, electronic prompts]) will be eligible. Observational studies that report a weight change of +/- 3% or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies relying only on serum sodium levels, composition of salt substitute without intervention/exposure adherence measure, food diaries without reported validation, use of a published food frequency questionnaire, or partial or spot urine without reported prediction equation will be excluded. III. Comparator A. Studies comparing groups with different documented sodium intake or biomarker values for sodium will be eligible. Studies where differences in sodium intake or values are confounded with alteration of other nutrient levels will be excluded. IV. Outcomes A. Studies reporting on mortality (all-cause, CVD, CHD, or renal); cardiovascular mortality; cardiovascular disease morbidity, including coronary heart disease (CHD), acute coronary syndrome (unstable angina and myocardial infarction), stroke, myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non-ST elevation myocardial infarction [NSTEMI]), requiring coronary revascularization procedures (angioplasty, coronary stent placement, coronary artery bypass), other atherosclerotic revascularization procedures (carotid endarterectomy), left ventricular hypertrophy, hospitalization for heart failure, or hospitalization for any cause of coronary heart disease or cardiovascular disease, or combined CVD morbidity and mortality; or reporting on renal function intermediary and clinical outcomes including creatinine clearance (CrCl), serum creatinine (SCr), glomerular filtration rate (GFR), end stage renal disease, chronic kidney disease (CKD), albuminuria/proteinuria (including, urine albumin-to-creatinine ratio, urine albumin dipstick level, urine protein-to-creatinine ratio, albumin excretion rate), acute kidney injury will be eligible. Studies that do not report baseline data for the outcomes of interest will be excluded. V. Timing A. Studies reporting exclusively on kidney disease outcomes need to report follow up periods of at least two years, studies reporting exclusively on cardiovascular disease outcomes or stroke need to report on follow up periods of at least 12 months duration; studies reporting on other outcomes need to evaluate exposure lasting at least four weeks to be eligible. VI. Setting A. Studies in community-dwelling participants will be eligible. VII. Study Design A. Prospective cohort studies and nested case-control studies, where at least two groups are compared based on measured sodium intake or biomarker values will be eligible. Retrospective studies, case series, cross-sectional studies or surveys, and case reports will be excluded. Key Question 5 I. Population A. Studies in human participants will be eligible for inclusion in the review; studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer will be excluded. II. Interventions A. Studies evaluating interventions to increase dietary potassium intake that specify the oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/- 3% or more among adults. Interventions simultaneously addressing sodium and potassium intake with documents sodium/potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded. III. Comparators A. Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of potassium intake, or studies that alter sodium/potassium ratio in other ways will be included if they control for other nutrient levels. IV. Outcomes A. Studies reporting on blood pressure outcomes (e.g., systolic blood pressure, diastolic blood pressure, rate of hypertensive/non- hypertensive participants, hypertension incidence, percent of participants at blood pressure goal, change in blood pressure) and incident kidney stones or kidney stone regrowth will be eligible. V. Timing A. Studies reporting exclusively on kidney stone formation need to report on an intervention period of two years; all other studies need to report on an intervention period of at least four weeks to be eligible. VI. Setting A. Studies in outpatient settings will be eligible. VII. Study Design A. Parallel RCTs and cross-over RCTs with a washout period of two weeks or more will be eligible. Key Question 6 I. Population A. Studies in community-dwelling (non-institutionalized) human participants will be eligible for inclusion in the review; studies reporting exclusively on patients with pre-existing conditions specific to the clinical outcomes of interest, as well as studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer will be excluded. II. Exposure A. Studies that measure intake (oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio) with validated measures or use biomarkers values to assess potassium level (at least one 24-hour urinary analysis with or without [[Page 12609]] reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of potassium supplement with intervention/exposure adherence measure, use of a published food frequency questionnaire, and food diaries) will be eligible. Observational studies that report a weight change of +/- 3% or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies measuring potassium intake by reporting chemical analysis of diet without intervention/exposure adherence measures, composition of potassium supplement without intervention/exposure measure, or serum potassium will be excluded. III. Comparator A. Studies comparing groups with different documented potassium intake, serum potassium levels, or urinary potassium excretion will be eligible. Studies where differences in potassium intake or values are confounded with alteration of other nutrient levels will be excluded. IV. Outcomes A. Studies reporting on blood pressure outcomes (e.g., systolic blood pressure, diastolic blood pressure, rate of hypertensive/non- hypertensive participants, hypertension incidence, percent of participants at blood pressure goal, change in blood pressure), and kidney stone incident or kidney stone regrowth will be eligible. Studies that do not report baseline blood pressure status and the presence or absence of kidney stones will be excluded. V. Timing A. Studies exclusively reporting on kidney stone formation need to follow participants for at least five years; all other studies need to report on exposure of at least four weeks to be eligible. VI. Setting A. Studies in community-dwelling participants will be eligible. VII. Study Design A. Prospective cohort studies and nested case-control studies, where at least two groups are compared based on measured potassium intake or biomarker values will be eligible. Retrospective studies, case series, cross-sectional studies or surveys, and case reports will be excluded. Key Question 7 I. Population A. Studies in adults will be eligible for inclusion in the review; studies reporting exclusively on patients with heart failure, end stage renal disease, HIV, or cancer will be excluded. II. Interventions A. Studies evaluating interventions to increase dietary potassium intake that specify the oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/- 3% or more. Interventions simultaneously addressing sodium and potassium intake with documents sodium/potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded. III. Comparators A. Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of potassium intake, or studies that alter sodium/potassium ratio in other ways will be included if they control for other nutrient levels. IV. Outcomes A. Studies reporting on mortality (all-cause, CVD, CHD, or renal); cardiovascular disease morbidity, including acute coronary syndrome (unstable angina and myocardial infarction), stroke, myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non- ST elevation myocardial infarction [NSTEMI]), requiring coronary revascularization procedures (angioplasty, coronary stent placement, coronary artery bypass), other atherosclerotic revascularization procedures (carotid endarterectomy), left ventricular hypertrophy, hospitalization for heart failure, or hospitalization for any cause of coronary heart disease or cardiovascular disease, or combined CVD morbidity and mortality; or reporting on renal function intermediary and clinical outcomes including creatinine clearance (CrCl), serum creatinine (SCr), glomerular filtration rate (GFR), end stage renal disease, chronic kidney disease (CKD), albuminuria or proteinuria (including urine albumin-to-creatinine ratio, urine albumin dipstick level, urine protein-to-creatinine ratio, albumin excretion rate), kidney stone incidence, or acute kidney injury will be eligible. V. Timing A. Studies reporting exclusively on kidney disease outcomes need to report on an intervention period of two years, studies reporting on cardiovascular disease or stroke need to report on an intervention period of three months; all other studies need to report on an intervention period of at least four weeks to be eligible. VI. Setting A. Studies in outpatient settings will be eligible. VII. Study Design A. Parallel RCTs and cross-over RCTs with a washout period of two weeks or more will be eligible. Key Question 8 I. Population A. Studies in community-dwelling (non-institutionalized) adults will be eligible for inclusion in the review with the exception of studies exclusively reporting on patients with pre-existing conditions specific to the clinical outcomes of interest, as well as studies exclusively reporting on patients with end stage renal disease, heart failure, HIV, or cancer. II. Exposure A. Studies that measure intake (oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio) with validated measures or use biomarkers values to assess potassium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of potassium supplement with intervention/exposure adherence measure, use of a published food frequency questionnaire, and food diaries) will be eligible. Observational studies that report a weight change of +/- 3% or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies measuring potassium intake by reporting chemical analysis of diet without intervention/exposure adherence measures, composition of potassium supplement without intervention/exposure measure, or serum potassium will be excluded. III. Comparator A. Studies comparing groups with different documented potassium intake, serum potassium levels, or urinary potassium excretion will be eligible. [[Page 12610]] Studies where differences in potassium intake or values are confounded with alteration of other nutrient levels will be excluded. IV. Outcomes A. Studies reporting on mortality (all-cause, CVD, CHD, or renal); cardiovascular disease morbidity, including coronary heart disease (CHD), acute coronary syndrome (unstable angina and myocardial infarction), stroke, myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non-ST elevation myocardial infarction [NSTEMI]), requiring coronary revascularization procedures (angioplasty, coronary stent placement, coronary artery bypass), other atherosclerotic revascularization procedures (carotid endarterectomy), left ventricular hypertrophy, hospitalization for heart failure, or hospitalization for any cause of coronary heart disease or cardiovascular disease, or combined CVD morbidity and mortality; or reporting on renal function intermediary and clinical outcomes including creatinine clearance (CrCl), serum creatinine (SCr), glomerular filtration rate (GFR), end stage renal disease, chronic kidney disease (CKD), albuminuria/proteinuria (including urine albumin- to-creatinine ratio, urine albumin dipstick level, urine protein-to- creatinine ratio, albumin excretion rate), kidney stone incidence, or acute kidney injury will be eligible. Studies that do not report baseline data on the outcomes of interest will be excluded. V. Timing A. Studies reporting exclusively on kidney stone formation need to follow participants for at least five years, studies reporting exclusively on kidney disease need to follow participants for at least two years, studies reporting exclusively on cardiovascular disease or stroke need to follow patients for at least 12 months; all other studies need to report on an exposure period of at least four weeks to be eligible. VI. Setting A. Studies in community-dwelling participants will be eligible. VII. Study Design A. Prospective cohort studies and nested case-control studies, where at least two groups are compared based on measured potassium intake or biomarker values will be eligible. Retrospective studies, case series, cross-sectional studies or surveys, and case reports will be excluded. Sharon B. Arnold, Acting AHRQ Director. [FR Doc. 2017-04193 Filed 3-3-17; 8:45 am] BILLING CODE 4160-90-P
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identification number or foreign country comment to the following address: Coordinator, P.O. Box 69539, Portland,
equivalent, passport number, financial Federal Trade Commission, Office of the OR 97239.
account number, or credit or debit card Secretary, Constitution Center, 400 7th Shipping Address (FedEx, UPS, etc.):
number. You are also solely responsible Street SW., 5th Floor, Suite 5610 Portland VA Research Foundation,
for making sure that your comment does (Annex J), Washington, DC 20024. If Scientific Resource Center, ATTN:
not include any sensitive health possible, submit your paper comment to Scientific Information Packet
information, like medical records or the Commission by courier or overnight Coordinator, 3710 SW U.S. Veterans
other individually identifiable health service. Hospital Road, Mail Code: R&D 71,
information. In addition, do not include The FTC Act and other laws that the Portland, OR 97239.
any ‘‘[t]rade secret or any commercial or Commission administers permit the FOR FURTHER INFORMATION CONTACT:
financial information which is . . . collection of public comments to Ryan McKenna, Telephone: 503–220–
privileged or confidential’’ as provided consider and use in this proceeding as 8262 ext. 51723 or Email: SEADS@epc-
in Section 6(f) of the FTC Act 15 U.S.C. appropriate. The Commission will src.org.
46(f), and FTC Rule 4.10(a)(2), 16 CFR consider all timely and responsive SUPPLEMENTARY INFORMATION: The
4.10(a)(2). In particular, do not include public comments that it receives on or Agency for Healthcare Research and
competitively sensitive information before May 5, 2017. For information on Quality has commissioned the
such as costs, sales statistics, the Commission’s privacy policy, Evidence-based Practice Centers (EPC)
inventories, formulas, patterns, devices, including routine uses permitted by the Program to complete a review of the
manufacturing processes, or customer Privacy Act, see http://www.ftc.gov/ftc/ evidence for Effects of Dietary Sodium
names. privacy.htm. and Potassium Intake on Chronic
If you want the Commission to give Disease Outcomes and Related Risk
your comment confidential treatment, David C. Shonka,
Factors.
you must file it in paper form, with a Acting General Counsel. The EPC Program is dedicated to
request for confidential treatment, and [FR Doc. 2017–04289 Filed 3–3–17; 8:45 am] identifying as many studies as possible
you have to follow the procedure BILLING CODE 6750–01–P that are relevant to the questions for
explained in FTC Rule 4.9(c).16 Your each of its reviews. In order to do so, we
comment will be kept confidential only are supplementing the usual manual
if the FTC General Counsel grants your DEPARTMENT OF HEALTH AND and electronic database searches of the
request in accordance with the law and HUMAN SERVICES literature by requesting information
the public interest. Once your comment from the public (e.g., details of studies
is posted, as legally required by FTC Agency for Healthcare Research and conducted). We are looking for studies
Rule 4.9(b), we cannot redact or remove Quality that report on Effects of Dietary Sodium
your comment from the FTC’s public and Potassium Intake on Chronic
record, including the FTC’s Web site, Supplemental Evidence and Data Disease Outcomes and Related Risk
unless you submit a confidentiality Request on Effects of Dietary Sodium Factors, including those that describe
request that meets the requirements for and Potassium Intake on Chronic adverse events. The entire research
such treatment under FTC Rule 4.9(c), Disease Outcomes and Related Risk protocol, including the key questions, is
and the General Counsel grants that Factors also available online at: https://
request in accordance with the law and www.effectivehealthcare.AHRQ.gov/
AGENCY: Agency for Healthcare Research
the public interest, as explained above. index.cfm/search-for-guides-reviews-
Postal mail addressed to the and Quality (AHRQ), HHS.
and-reports/?pageaction=display
Commission is subject to delay due to ACTION: Request for Supplemental
product&productid=2428.
heightened security screening. As a Evidence and Data Submissions. This is to notify the public that the
result, we encourage you to submit your EPC Program would find the following
SUMMARY: The Agency for Healthcare
comments online. To make sure that the information on Effects of Dietary
Research and Quality (AHRQ) is seeking
Commission considers your online Sodium and Potassium Intake on
scientific information submissions from
comment, you must file it at https:// Chronic Disease Outcomes and Related
the public. Scientific information is
ftcpublic.commentworks.com/ftc/ Risk Factors helpful:
being solicited to inform our review of
funeralrulepra, by following the
Effects of Dietary Sodium and D A list of completed studies that
instructions on the web-based form. If your organization has sponsored for this
Potassium Intake on Chronic Disease
this Notice appears at http:// indication. In the list, please indicate
Outcomes and Related Risk Factors,
www.regulations.gov/#!home, you also whether results are available on
which is currently being conducted by
may file a comment through that Web ClinicalTrials.gov along with the
site. the AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to ClinicalTrials.gov trial number.
If you file your comment on paper, D For completed studies that do not
write ‘‘Funeral Rule PRA Comment: published and unpublished pertinent
have results on ClinicalTrials.gov,
FTC File No. P084401’’ on your scientific information will improve the
please provide a summary, including
comment and on the envelope, and mail quality of this review. AHRQ is
the following elements: Study number;
your comment to the following address: conducting this systematic review study period; design, methodology;
Federal Trade Commission, Office of the pursuant to Section 902(a) of the Public indication and diagnosis; proper use
Secretary, 600 Pennsylvania Avenue Health Service Act, 42 U.S.C. 299a(a).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
instructions; inclusion and exclusion
NW., Suite CC–5610 (Annex J), DATES: Submission Deadline on or criteria; primary and secondary
Washington, DC 20580, or deliver your before April 5, 2017. outcomes; baseline characteristics;
ADDRESSES: Email submissions: number of patients screened, eligible,
16 In particular, the written request for SEADS@epc-src.org. enrolled, lost to follow up, withdrawn,
confidential treatment that accompanies the Print submissions: Mailing Address: and analyzed; as well as effectiveness
comment must include the factual and legal basis
for the request, and must identify the specific
Portland VA Research Foundation, and efficacy, and safety results.
portions of the comment to be withheld from the Scientific Resource Center, ATTN: D A list of ongoing studies that your
public record. See FTC Rule 4.9(c), 16 CFR 4.9(c). Scientific Information Packet organization has sponsored for this
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![Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices 12607
will be included if they control for other without reported prediction equation intervention components will be
nutrient levels. will be excluded. excluded.
IV. Outcomes III. Comparator III. Comparators
A. Studies reporting on blood A. Studies comparing groups with
A. Studies comparing interventions to
pressure outcomes (e.g., systolic blood different documented sodium intake or
placebo or control diets will be eligible.
pressure, diastolic blood pressure, rate biomarker values for sodium will be
of hypertensive/non-hypertensive Studies comparing an experimental diet
eligible. Studies where differences in
participants, incident hypertension, sodium intake or values are confounded to usual diet, studies comparing levels
percent of participants at blood pressure with alteration of other nutrient levels of sodium intake, or studies that alter
goal, and change in blood pressure) will will be excluded. sodium/potassium ratio in other ways
be eligible. will be included if they control for other
IV. Outcomes nutrient levels.
V. Timing A. Studies reporting on blood IV. Outcomes
A. Studies reporting on an pressure outcomes (e.g., systolic blood
intervention period of at least four pressure, diastolic blood pressure, rate A. Studies reporting on mortality (all-
weeks will be eligible. of hypertensive/non-hypertensive cause, CVD, CHD, or renal);
VI. Setting participants, incident hypertension, cardiovascular disease morbidity,
percent of participants at blood pressure including acute coronary syndrome
A. Studies in outpatient settings will goal, change in blood pressure) will be (unstable angina and myocardial
be eligible. eligible. Studies that do not report infarction), stroke, myocardial infarction
VII. Study Design baseline blood pressure status will be (ST-segment elevation myocardial
excluded. infarction [STEMI] and non-ST
A. Parallel RCTs and cross-over RCTs
with a washout period of two weeks or V. Timing elevation myocardial infarction
more will be eligible. [NSTEMI]), requiring coronary
A. Studies reporting on an
revascularization procedures
Key Question 2 intervention period of at least four
(angioplasty, coronary stent placement,
weeks will be eligible.
I. Population coronary artery bypass), other
A. Studies in community-dwelling VI. Setting atherosclerotic revascularization
(non-institutionalized) human A. Studies in community-dwelling procedures (carotid endarterectomy),
participants will be eligible for participants will be eligible. left ventricular hypertrophy,
inclusion in the review with the hospitalization for heart failure,
VII. Study Design hospitalization for any cause of
exception of studies exclusively
reporting on patients with pre-existing A. Prospective cohort studies and coronary heart disease or cardiovascular
conditions specific to the clinical nested case-control studies, where at disease, or combined CVD morbidity
outcome of interest, as well as studies least two groups are compared based on and mortality; or reporting on renal
exclusively reporting on patients with measured sodium intake or biomarker function intermediary and clinical
end stage renal disease, heart failure, values will be eligible. Retrospective outcomes including creatinine clearance
HIV, or cancer. studies, case series, cross-sectional (CrCl), serum creatinine (SCr),
studies or surveys, and case reports will glomerular filtration rate (GFR), end
II. Exposure be excluded. stage renal disease, chronic kidney
A. Studies that measure the intake disease (CKD), albuminuria or
Key Question 3
(oral consumption from food or proteinuria (including urine albumin-to-
supplements of quantified amounts of I. Population creatinine ratio, urine albumin dipstick
sodium and sodium chloride [salt] or A. Studies in human adults will be level, urine protein-to-creatinine ratio,
sodium-to-potassium ratio) with eligible for inclusion in the review. albumin excretion rate), kidney stone
validated measures or that use Studies exclusively reporting on incidence, or acute kidney injury will be
biomarker values to assess sodium level patients with end stage renal disease, eligible.
(at least one 24-hour urinary analysis heart failure, HIV, or cancer will be
with or without reported quality control V. Timing
excluded.
measure, chemical analysis of diet with A. Only interventions of two years or
intervention/exposure adherence II. Intervention
longer will be included for kidney
measure, composition of salt substitute A. Studies evaluating interventions to disease outcomes; only interventions of
with intervention/exposure adherence reduce dietary sodium intake that three months or longer will be included
measure, and food diaries with reported specify the oral consumption from food for cardiovascular disease outcomes; all
validation [adherence check, electronic or supplements of quantified amounts of other studies need to report on an
prompts]) will be eligible. Observational sodium and sodium chloride (salt) or intervention period of at least four
studies that report a weight change of sodium-to-potassium ratio will be weeks to be eligible.
+/¥ 3% or more (in any exposure eligible. Studies with trial arms in
group) among adults; multicomponent which participants demonstrate a VI. Setting
asabaliauskas on DSK3SPTVN1PROD with NOTICES
studies that do not properly control for weight change of +/¥ 3% or more will
confounders; and studies relying only be excluded. Interventions A. Studies in outpatient settings will
on serum sodium levels, composition of simultaneously addressing sodium and be eligible.
salt substitute without intervention/ potassium intake with documents VII. Study Design
exposure adherence measure, food sodium/potassium ratio are eligible. All
diaries without reported validation, use other multicomponent interventions in A. Parallel RCTs and cross-over RCTs
of a published food frequency which the effect of sodium reduction with a washout period of two weeks or
questionnaire, or partial or spot urine cannot be disaggregated from other more will be eligible.
VerDate Sep<11>2014 19:24 Mar 03, 2017 Jkt 241001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1](https://thefederalregister.org/doc/82_FR_12647/page/3.svg)
![12608 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
Key Question 4 atherosclerotic revascularization potassium intake with documents
I. Population procedures (carotid endarterectomy), sodium/potassium ratio are eligible; all
left ventricular hypertrophy, other multicomponent interventions in
A. Studies in community-dwelling hospitalization for heart failure, or which the effect of sodium reduction
(non-institutionalized) adults will be hospitalization for any cause of cannot be disaggregated from other
eligible for inclusion in the review with coronary heart disease or cardiovascular intervention components will be
the exception of studies exclusively disease, or combined CVD morbidity excluded.
reporting on patients with pre-existing and mortality; or reporting on renal
conditions specific to the clinical function intermediary and clinical III. Comparators
outcomes of interest, as well as studies outcomes including creatinine clearance A. Studies comparing interventions to
exclusively reporting on patients with (CrCl), serum creatinine (SCr), placebo or control diets will be eligible.
end stage renal disease, heart failure, glomerular filtration rate (GFR), end Studies comparing an experimental diet
HIV, or cancer. stage renal disease, chronic kidney to usual diet, studies comparing levels
II. Exposure disease (CKD), albuminuria/proteinuria of potassium intake, or studies that alter
(including, urine albumin-to-creatinine sodium/potassium ratio in other ways
A. Studies that measure the intake ratio, urine albumin dipstick level, will be included if they control for other
(oral consumption from food or urine protein-to-creatinine ratio, nutrient levels.
supplements of quantified amounts of albumin excretion rate), acute kidney
sodium and sodium chloride [salt] or IV. Outcomes
injury will be eligible. Studies that do
sodium-to-potassium ratio) with not report baseline data for the A. Studies reporting on blood
validated measures or use biomarker outcomes of interest will be excluded. pressure outcomes (e.g., systolic blood
values to assess sodium level (at least pressure, diastolic blood pressure, rate
one 24-hour urinary analysis with or V. Timing of hypertensive/non-hypertensive
without reported quality control A. Studies reporting exclusively on participants, hypertension incidence,
measure, chemical analysis of diet with kidney disease outcomes need to report percent of participants at blood pressure
intervention/exposure adherence follow up periods of at least two years, goal, change in blood pressure) and
measure, composition of salt substitute studies reporting exclusively on incident kidney stones or kidney stone
with intervention/exposure adherence cardiovascular disease outcomes or regrowth will be eligible.
measure, and food diaries with reported stroke need to report on follow up
validation [adherence check, electronic V. Timing
periods of at least 12 months duration;
prompts]) will be eligible. Observational studies reporting on other outcomes A. Studies reporting exclusively on
studies that report a weight change of need to evaluate exposure lasting at kidney stone formation need to report
+/¥ 3% or more (in any exposure least four weeks to be eligible. on an intervention period of two years;
group) among adults; multicomponent all other studies need to report on an
studies that do not properly control for VI. Setting intervention period of at least four
confounders; and studies relying only A. Studies in community-dwelling weeks to be eligible.
on serum sodium levels, composition of participants will be eligible.
VI. Setting
salt substitute without intervention/ VII. Study Design
exposure adherence measure, food A. Studies in outpatient settings will
diaries without reported validation, use A. Prospective cohort studies and be eligible.
of a published food frequency nested case-control studies, where at
least two groups are compared based on VII. Study Design
questionnaire, or partial or spot urine
without reported prediction equation measured sodium intake or biomarker A. Parallel RCTs and cross-over RCTs
will be excluded. values will be eligible. Retrospective with a washout period of two weeks or
studies, case series, cross-sectional more will be eligible.
III. Comparator studies or surveys, and case reports will Key Question 6
A. Studies comparing groups with be excluded.
different documented sodium intake or I. Population
Key Question 5
biomarker values for sodium will be A. Studies in community-dwelling
eligible. Studies where differences in I. Population (non-institutionalized) human
sodium intake or values are confounded A. Studies in human participants will participants will be eligible for
with alteration of other nutrient levels be eligible for inclusion in the review; inclusion in the review; studies
will be excluded. studies exclusively reporting on patients reporting exclusively on patients with
with end stage renal disease, heart pre-existing conditions specific to the
IV. Outcomes
failure, HIV, or cancer will be excluded. clinical outcomes of interest, as well as
A. Studies reporting on mortality (all- studies exclusively reporting on patients
cause, CVD, CHD, or renal); II. Interventions
with end stage renal disease, heart
cardiovascular mortality; cardiovascular A. Studies evaluating interventions to failure, HIV, or cancer will be excluded.
disease morbidity, including coronary increase dietary potassium intake that
heart disease (CHD), acute coronary specify the oral consumption from food II. Exposure
syndrome (unstable angina and or supplements of quantified amounts of A. Studies that measure intake (oral
asabaliauskas on DSK3SPTVN1PROD with NOTICES
myocardial infarction), stroke, potassium, potassium supplements, salt consumption from food or supplements
myocardial infarction (ST-segment substitutes such as potassium chloride, of quantified amounts of potassium,
elevation myocardial infarction [STEMI] or sodium-to-potassium ratio will be potassium supplements, salt substitutes
and non-ST elevation myocardial eligible, with the exception of trial arms such as potassium chloride, or sodium-
infarction [NSTEMI]), requiring in which participants demonstrate a to-potassium ratio) with validated
coronary revascularization procedures weight change of +/¥ 3% or more measures or use biomarkers values to
(angioplasty, coronary stent placement, among adults. Interventions assess potassium level (at least one 24-
coronary artery bypass), other simultaneously addressing sodium and hour urinary analysis with or without
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![Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices 12609
reported quality control measure, reporting exclusively on patients with V. Timing
chemical analysis of diet with heart failure, end stage renal disease, A. Studies reporting exclusively on
intervention/exposure adherence HIV, or cancer will be excluded. kidney disease outcomes need to report
measure, composition of potassium on an intervention period of two years,
II. Interventions
supplement with intervention/exposure studies reporting on cardiovascular
adherence measure, use of a published A. Studies evaluating interventions to disease or stroke need to report on an
food frequency questionnaire, and food increase dietary potassium intake that intervention period of three months; all
diaries) will be eligible. Observational specify the oral consumption from food other studies need to report on an
studies that report a weight change of or supplements of quantified amounts of intervention period of at least four
+/¥ 3% or more (in any exposure potassium, potassium supplements, salt weeks to be eligible.
group) among adults; multicomponent substitutes such as potassium chloride,
studies that do not properly control for or sodium-to-potassium ratio will be VI. Setting
confounders; and studies measuring eligible, with the exception of trial arms A. Studies in outpatient settings will
potassium intake by reporting chemical in which participants demonstrate a be eligible.
analysis of diet without intervention/ weight change of +/¥ 3% or more.
exposure adherence measures, Interventions simultaneously addressing VII. Study Design
composition of potassium supplement sodium and potassium intake with A. Parallel RCTs and cross-over RCTs
without intervention/exposure measure, documents sodium/potassium ratio are with a washout period of two weeks or
or serum potassium will be excluded. eligible; all other multicomponent more will be eligible.
III. Comparator interventions in which the effect of
sodium reduction cannot be Key Question 8
A. Studies comparing groups with disaggregated from other intervention I. Population
different documented potassium intake, components will be excluded.
serum potassium levels, or urinary A. Studies in community-dwelling
potassium excretion will be eligible. III. Comparators (non-institutionalized) adults will be
Studies where differences in potassium eligible for inclusion in the review with
A. Studies comparing interventions to the exception of studies exclusively
intake or values are confounded with placebo or control diets will be eligible.
alteration of other nutrient levels will be reporting on patients with pre-existing
Studies comparing an experimental diet conditions specific to the clinical
excluded. to usual diet, studies comparing levels outcomes of interest, as well as studies
IV. Outcomes of potassium intake, or studies that alter exclusively reporting on patients with
sodium/potassium ratio in other ways end stage renal disease, heart failure,
A. Studies reporting on blood
will be included if they control for other HIV, or cancer.
pressure outcomes (e.g., systolic blood
nutrient levels.
pressure, diastolic blood pressure, rate II. Exposure
of hypertensive/non-hypertensive IV. Outcomes
participants, hypertension incidence, A. Studies that measure intake (oral
percent of participants at blood pressure A. Studies reporting on mortality (all- consumption from food or supplements
goal, change in blood pressure), and cause, CVD, CHD, or renal); of quantified amounts of potassium,
kidney stone incident or kidney stone cardiovascular disease morbidity, potassium supplements, salt substitutes
regrowth will be eligible. Studies that including acute coronary syndrome such as potassium chloride, or sodium-
do not report baseline blood pressure (unstable angina and myocardial to-potassium ratio) with validated
status and the presence or absence of infarction), stroke, myocardial infarction measures or use biomarkers values to
kidney stones will be excluded. (ST-segment elevation myocardial assess potassium level (at least one 24-
infarction [STEMI] and non-ST hour urinary analysis with or without
V. Timing elevation myocardial infarction reported quality control measure,
A. Studies exclusively reporting on [NSTEMI]), requiring coronary chemical analysis of diet with
kidney stone formation need to follow revascularization procedures intervention/exposure adherence
participants for at least five years; all (angioplasty, coronary stent placement, measure, composition of potassium
other studies need to report on exposure coronary artery bypass), other supplement with intervention/exposure
of at least four weeks to be eligible. atherosclerotic revascularization adherence measure, use of a published
procedures (carotid endarterectomy), food frequency questionnaire, and food
VI. Setting left ventricular hypertrophy, diaries) will be eligible. Observational
A. Studies in community-dwelling hospitalization for heart failure, or studies that report a weight change of
participants will be eligible. hospitalization for any cause of +/¥ 3% or more (in any exposure
coronary heart disease or cardiovascular group) among adults; multicomponent
VII. Study Design
disease, or combined CVD morbidity studies that do not properly control for
A. Prospective cohort studies and and mortality; or reporting on renal confounders; and studies measuring
nested case-control studies, where at function intermediary and clinical potassium intake by reporting chemical
least two groups are compared based on outcomes including creatinine clearance analysis of diet without intervention/
measured potassium intake or (CrCl), serum creatinine (SCr), exposure adherence measures,
biomarker values will be eligible. glomerular filtration rate (GFR), end
asabaliauskas on DSK3SPTVN1PROD with NOTICES
composition of potassium supplement
Retrospective studies, case series, cross- stage renal disease, chronic kidney without intervention/exposure measure,
sectional studies or surveys, and case disease (CKD), albuminuria or or serum potassium will be excluded.
reports will be excluded. proteinuria (including urine albumin-to-
creatinine ratio, urine albumin dipstick III. Comparator
Key Question 7
level, urine protein-to-creatinine ratio, A. Studies comparing groups with
I. Population albumin excretion rate), kidney stone different documented potassium intake,
A. Studies in adults will be eligible incidence, or acute kidney injury will be serum potassium levels, or urinary
for inclusion in the review; studies eligible. potassium excretion will be eligible.
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![12610 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
Studies where differences in potassium sectional studies or surveys, and case Telephone: 202–795–7334. Fax: 202–
intake or values are confounded with reports will be excluded. 795–7334. Email: Allison.Cruz@
alteration of other nutrient levels will be acl.hhs.gov.
Sharon B. Arnold,
excluded. SUPPLEMENTARY INFORMATION: The
Acting AHRQ Director.
IV. Outcomes [FR Doc. 2017–04193 Filed 3–3–17; 8:45 am]
PCPID acts in an advisory capacity to
the President and the Secretary of
BILLING CODE 4160–90–P
A. Studies reporting on mortality (all- Health and Human Services on a broad
cause, CVD, CHD, or renal); range of topics relating to programs,
cardiovascular disease morbidity, DEPARTMENT OF HEALTH AND services and support for individuals
including coronary heart disease (CHD), HUMAN SERVICES with intellectual disabilities. The PCPID
acute coronary syndrome (unstable executive order stipulates that the
angina and myocardial infarction), Administration for Community Living Committee shall: (1) Provide such
stroke, myocardial infarction (ST- advice concerning intellectual
segment elevation myocardial infarction Administration on Intellectual and disabilities as the President or the
[STEMI] and non-ST elevation Developmental Disabilities, President’s Secretary of Health and Human Services
myocardial infarction [NSTEMI]), Committee for People With Intellectual may request; and (2) provide advice to
requiring coronary revascularization Disabilities the President concerning the following
procedures (angioplasty, coronary stent for people with intellectual disabilities:
AGENCY: Administration for Community (A) Expansion of educational
placement, coronary artery bypass), Living, HHS. opportunities; (B) promotion of
other atherosclerotic revascularization ACTION: Notice. homeownership; (C) assurance of
procedures (carotid endarterectomy),
workplace integration; (D) improvement
left ventricular hypertrophy, DATES: Thursday, March 23, 2017 from of transportation options; (E) expansion
hospitalization for heart failure, or 8:30 a.m. to 5:00 p.m.; and Friday, of full access to community living; and
hospitalization for any cause of March 24, 2017 from 9:00 a.m. to 3:00 (F) increasing access to assistive and
coronary heart disease or cardiovascular p.m. universally designed technologies.
disease, or combined CVD morbidity These meetings will be open to the
and mortality; or reporting on renal general public. Dated: February 27, 2017.
function intermediary and clinical Bob Williams,
ADDRESSES: These meetings will be held
outcomes including creatinine clearance in U.S. Department of Health and Acting Designated Federal Official, PCPID,
(CrCl), serum creatinine (SCr), Administration on Disabilities (AoD).
Human Services/Hubert H. Humphrey
glomerular filtration rate (GFR), end [FR Doc. 2017–04165 Filed 3–3–17; 8:45 am]
Building located at 200
stage renal disease, chronic kidney IndependenceAvenue SW., Conference BILLING CODE 4154–01–P
disease (CKD), albuminuria/proteinuria Room 705A, Washington, DC 20201.
(including urine albumin-to-creatinine Individuals who would like to
DEPARTMENT OF HEALTH AND
ratio, urine albumin dipstick level, participate via conference call may do
HUMAN SERVICES
urine protein-to-creatinine ratio, so by dialing toll-free #: 1–800–779–
albumin excretion rate), kidney stone 4694, when prompted enter pass code: Administration for Community Living
incidence, or acute kidney injury will be 4511687. Individuals whose full
eligible. Studies that do not report participation in the meeting will require Agency Information Collection
baseline data on the outcomes of special accommodations (e.g., sign Activities; Proposed Collection; Public
interest will be excluded. language interpreting services, assistive Comment Request; Extension of a
listening devices, materials in Currently Approved Information
V. Timing alternative format such as large print or Collection (ICR–REV); Centers for
A. Studies reporting exclusively on Braille) should notify Ms. Allison Cruz, Independent Living Annual
Director, Office of Innovation, via email Performance Report (CILPPR);
kidney stone formation need to follow
at Allison.Cruz@acl.hhs.gov, or via Correction
participants for at least five years,
telephone at 202–795–7334, no later
studies reporting exclusively on kidney AGENCY: Independent Living
than Monday, March 6, 2017. The
disease need to follow participants for at Administration, Administration for
PCPID will attempt to accommodate
least two years, studies reporting Community Living, HHS.
requests made after this date, but cannot
exclusively on cardiovascular disease or guarantee the ability to grant requests ACTION: Notice of correction.
stroke need to follow patients for at least received after the deadline. All meeting
12 months; all other studies need to SUMMARY: The Administration for
sites are barrier free, consistent with the Community Living published a
report on an exposure period of at least Americans with Disabilities Act (ADA)
four weeks to be eligible. proposed collection of information
and the Federal Advisory Committee document in the Federal Register on
VI. Setting Act (FACA). February 23, 2017. (82 FR 11471 and
AGENDA: The Committee Members will 11472) The document contained an
A. Studies in community-dwelling discuss preparation of the PCPID 2017 incorrect date and email address. In
participants will be eligible. Report to the President, including its addition under the heading ‘‘New
asabaliauskas on DSK3SPTVN1PROD with NOTICES
VII. Study Design content and format, and related data Requirements’’, the first paragraph was
collection and analysis required to revised.
A. Prospective cohort studies and complete the writing of the Report. FOR FURTHER INFORMATION CONTACT:
nested case-control studies, where at ADDITIONAL INFORMATION: For further Corinna Styles, 202–795–7446.
least two groups are compared based on information, please contact Ms. Allison Corrections:
measured potassium intake or Cruz, Director, Office of Innovation, 330 Under the DATES section, page 11471,
biomarker values will be eligible. C Street SW., Switzer Building, Room column two, correct the notice to read:
Retrospective studies, case series, cross- 1114, Washington, DC 20201. ‘‘Submit written or electronic comments
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Document Created: 2017-03-04 00:07:07
Document Modified: 2017-03-04 00:07:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for Supplemental Evidence and Data Submissions. | |
| Dates | Submission Deadline on or before April 5, 2017. | |
| Contact | Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected] | |
| FR Citation | 82 FR 12605 |
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