Scientific Information Request on Omega 3 Fatty Acids and Cardiovascular Disease-Update, 48105-48107 [2015-19659]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 154 / Tuesday, August 11, 2015 / Notices hours; Address discrepancies: 4 hours; Risk-based pricing: Notice to consumers, 5 hours; Furnisher duties: Policies and procedures, 40 hours and Notice of frivolous disputes to consumers, 14 minutes. Number of respondents: Negative information notice: 1,500 financial institutions; Affiliate marketing: Notices to consumers, 1,402 financial institutions and 1,282,000 Consumer response; Red flags: 2,024 financial institutions; Address discrepancies: 1,500 financial institutions; Risk-based pricing: Notice to consumers, 1,500 financial institutions; Furnisher duties: Policies and procedures, 1,500 financial institutions and 611,966, Notice of frivolous disputes to consumers. General description of report: This information collection is mandatory pursuant to Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5519) and the FCRA (15 U.S.C. 1681m, 1681w, and 1681s). Because the notices and disclosures required are not provided to the Federal Reserve, and all records thereof are maintained at state member banks, no issue of confidentiality arises under the Freedom of Information Act. Abstract: The Fair Credit Reporting Act (FCRA) was enacted in 1970 based on a Congressional finding that the banking system is dependent on fair and accurate credit reporting.1 The FCRA was enacted to ensure consumer reporting agencies exercise their responsibilities with fairness, impartiality, and a respect for the consumer’s right to privacy. The FCRA requires consumer reporting agencies to adopt reasonable procedures that are fair and equitable to the consumer with regard to the confidentiality, accuracy, relevancy, and proper utilization of consumer information. Congress substantially amended the FCRA upon the passage of the Fair and Accurate Credit Transactions Act of 2003 (FACT Act).2 The FACT Act created many new responsibilities for consumer reporting agencies and users of consumer reports. It contained many new consumer disclosure requirements, as well as provisions to address identity theft. In addition, the FACT Act provided consumers with the right to obtain a copy of their consumer report annually without cost. Improving consumers’ access to their credit report is intended to help increase the 1 The FCRA is one part of the Consumer Credit Protection Act which also includes the Truth in Lending Act, Equal Credit Opportunity Act, and Fair Debt Collection Practices Act. 15 U.S.C. 1601 et seq. 2 Public Law 108–159, 117 Stat. 1952. VerDate Sep<11>2014 16:44 Aug 10, 2015 Jkt 235001 accuracy of data in the consumer reporting system. Since 2011, the Consumer Financial Protection Bureau has been responsible for issuing most FCRA regulations. The Federal Reserve retained rule-writing authority for certain provisions of the FCRA applicable to motor vehicle dealers and provisions of the FCRA that require identity theft prevention programs, regulate the disposal of consumer information, and require card issuers to validate consumers’ notifications of changes of address. Board of Governors of the Federal Reserve System, August 6, 2015. Robert deV. Frierson, Secretary of the Board. [FR Doc. 2015–19656 Filed 8–10–15; 8:45 am] BILLING CODE 6210–01–P 48105 Market Street, San Francisco, California 94105–1579: 1. Carpenter Bank Partners, Inc., CCFW, Inc., (dba Carpenter & Company), Carpenter Fund Management Company, LLC, Carpenter Fund Manager GP, LLC, Carpenter Community BancFund, L.P., and Carpenter Community BancFund-A, L.P., all in Irvine, California; to acquire additional voting shares up to approximately 32.6 percent of Pacific Mercantile Bancorp, and thereby indirectly acquire voting shares of Pacific Mercantile Bank, both in Costa Mesa, California. Board of Governors of the Federal Reserve System, August 5, 2015. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2015–19666 Filed 8–10–15; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies DEPARTMENT OF HEALTH AND HUMAN SERVICES The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 4, 2015. A. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Agency for Healthcare Research and Quality PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Scientific Information Request on Omega 3 Fatty Acids and Cardiovascular Disease—Update Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. 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 of Omega 3 Fatty Acids and Cardiovascular Disease—Update, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Programs. 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 September 10, 2015. ADDRESSES: Online submissions: http:// effectivehealthcare.AHRQ.gov/ index.cfm/submit-scientificinformation-packets/. Please select the study for which you are submitting information from the list to upload your documents. Email submissions: SIPS@epc-src.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: SUMMARY: E:\FR\FM\11AUN1.SGM 11AUN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 48106 Federal Register / Vol. 80, No. 154 / Tuesday, August 11, 2015 / Notices Scientific Information Packet Coordinator, PO 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. 58653 or Email: SIPS@epcsrc.org. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Programs to complete a review of the evidence for Omega 3 Fatty Acids and Cardiovascular Disease—Update. 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 Omega 3 Fatty Acids and Cardiovascular Disease—Update, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: http://effective healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?page action=displayproduct&product ID=2060. This notice is to notify the public that the EPC Program would find the following information on Omega 3 Fatty Acids and Cardiovascular Disease— Update helpful: D 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. D 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/ analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the VerDate Sep<11>2014 16:44 Aug 10, 2015 Jkt 235001 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. D 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 can 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: http://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 entire research protocol, is available online at: http://effectivehealthcare.AHRQ.gov/ search-for-guides-reviews-and-reports/ ?pageaction=display product&productID=2060. The Key Questions 1. What is the efficacy or association of n-3 Fatty Acids (FA) (eicosapentaenoic acid [EPA], docosahexaenoic acid [DHA]EPA+DHA, docosapentaenoic acid [DPA], stearidonic acid [SDA], alpha-linolenic acid [ALA], or total n-3 Fatty Acids) exposures in reducing cardiovascular disease (CVD) outcomes (incident CVD events including all-cause mortality, CVD mortality, non-fatal CVD events, new diagnosis of CVD, peripheral vascular disease, congestive heart failure, major arrhythmias, and hypertension diagnosis) and specific CVD risk factors (blood pressure, key plasma lipids)? Æ What is the efficacy or association of n-3 FA in preventing CVD outcomes in people PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 D Without known CVD (primary prevention) D At high risk for CVD (primary prevention) D With known CVD (secondary prevention)? Æ What is the relative efficacy of different n-3 FAs on CVD outcomes and risk factors? Æ Can the CVD outcomes be ordered by strength of intervention effect of n3 FAs? 2. n-3 FA variables and modifiers: Æ How does the efficacy or association of n-3 FA in preventing CVD outcomes and with CVD risk factors differ in subpopulations, including men, premenopausal women, postmenopausal women, and different age or race/ethnicity groups? Æ What are the effects of potential confounders or interacting factors—such as plasma lipids, body mass index, blood pressure, diabetes, kidney disease, other nutrients or supplements, and drugs (e.g., statins, aspirin, diabetes drugs, hormone replacement therapy)? Æ What is the efficacy or association of different ratios of n-3 FA components in dietary supplements or biomarkers, on CVD outcomes and risk factors? Æ How does the efficacy or association of n-3 FA on CVD outcomes and risk factors differ by ratios of different n-3 FAs—DHA, EPA, and ALA, or other n-3 FAs? Æ How does the efficacy or association of n-3 FA on CVD outcomes and risk factors differ by source (e.g., fish and seafood, common plant oils (e.g., soybean, canola), fish oil supplements, fungal-algal supplements, flaxseed oil supplements)? Æ How does the ratio of n-6 FA to n3 FA intakes or biomarker concentrations affect the efficacy or association of n-3 FA on CVD outcomes and risk factors? Æ Is there a threshold or doseresponse relationship between n-3 FA exposures and CVD outcomes and risk factors? Does the study type affect these relationships? Æ How does the duration of intervention or exposure influence the effect of n-3 FA on CVD outcomes and risk factors? Æ What is the effect of baseline n-3 FA status (intake or biomarkers) on the efficacy of n-3 FA intake or supplementation on CVD outcomes and risk factors? 3. Adverse events: Æ What adverse effects are related to n-3 FA intake or biomarker concentrations (in studies of CVD outcomes and risk factors)? Æ What adverse events are reported specifically among people with CVD or E:\FR\FM\11AUN1.SGM 11AUN1 Federal Register / Vol. 80, No. 154 / Tuesday, August 11, 2015 / Notices diabetes (in studies of CVD outcomes and risk factors)? PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting) Populations • Healthy adults (≥18 yr) without CVD or with low to intermediate risk for CVD • Adults at high risk for CVD (e.g., with diabetes, cardiometabolic syndrome, hypertension, dyslipidemia, nondialysis chronic kidney disease) • Adults with clinical CVD (e.g., history of myocardial infarction, angina, transient ischemic attacks) • Exclude populations chosen for having a non-CVD or non-diabetesrelated disease (e.g., cancer, gastrointestinal disease, rheumatic disease, dialysis) Interventions/Exposures • n-3 FA supplements • n-3 FA supplemented foods (e.g., eggs) • n-3 FA content in diet (e.g., from food frequency questionnaires) • Biomarkers of n-3 FA intake • n-3 content of food or supplements must be quantified (e.g., exclude fish diet studies where only servings/week defined, Mediterranean diet studies without n-3 quantified). n-3 quantification can be of total n-3 FA, of a specific n-3 FA (e.g., ALA) or of combined EPA+DHA (‘‘marine oil’’). • Exclude n-3 FA dose ≥6 g/day (except for adverse events) • Exclude weight loss interventions asabaliauskas on DSK5VPTVN1PROD with NOTICES Comparators • Placebo or no n-3 FA intervention • Different n-3 FA source intervention • Different n-3 FA concentration intervention • Different n-3 FA dietary exposure (e.g., comparison of quantiles) • Different n-3 FA biomarker levels (e.g., comparison of quantiles) Outcomes • All-cause mortality • Cardiovascular, cerebrovascular, and peripheral vascular events: Æ Fatal vascular events (e.g., due to myocardial infarction, stroke) Æ Non-fatal vascular events (e.g., myocardial infarction, stroke/ cardiovascular accident, transient ischemic attack, unstable angina) Æ Coronary heart disease, new diagnosis Æ Congestive heart failure, new diagnosis Æ Cerebrovascular disease, new diagnosis Æ Peripheral vascular disease, new diagnosis Æ Ventricular arrhythmia, new diagnosis VerDate Sep<11>2014 16:44 Aug 10, 2015 Jkt 235001 Æ Supraventricular arrhythmia, new diagnosis Æ Major vascular interventions/ procedures (e.g, revascularization, thrombolysis, lower extremity amputation, defibrillator placement) • Major CVD risk factors (intermediate outcomes): Æ Blood pressure (new-onset hypertension, systolic, diastolic, and mean arterial pressure) Æ Key plasma lipids (i.e., high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDLc], total/HDL-c ratio, LDL-c/HDL-c ratio, triglycerides) • Adverse events (e.g., bleeding, major gastrointestinal disturbance), only from intervention studies of supplements Timing • Clinical outcomes, including newonset hypertension (all study designs): ≥1 year followup (and intervention duration, as applicable) • Intermediate outcomes (blood pressure and plasma lipids) (all study designs): ≥1 month followup • Adverse events (all study designs): No minimum followup Setting Community-Dwelling (NonInstitutionalized) Individuals Study Design • Randomized Controlled Trials (RCTs) (all outcomes) • Randomized cross-over studies (blood pressure and plasma lipids, adverse events), minimum washout period to be determined • Prospective nonrandomized comparative studies (clinical outcomes, adverse events) • Prospective cohort (single group) studies, where groups are compared based on n-3 FA intake or intake biomarker values (clinical outcomes) • Exclude: Retrospective or case control studies or cross-sectional studies (but include prospective nested case control studies). Studies must have measure of intake prior to outcome. • Minimum sample sizes (All outcomes: To be determined) • English language publications Sharon B. Arnold, Deputy Director. [FR Doc. 2015–19659 Filed 8–10–15; 8:45 am] BILLING CODE 4160–90–P PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 48107 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Omega 3 Fatty Acids and Maternal and Child Health Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. 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 of Omega 3 Fatty Acids and Maternal and Child Health, which is currently being conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Programs. 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). SUMMARY: Submission Deadline on or before September 10, 2015. ADDRESSES: Online submissions: http:// effectivehealthcare.AHRQ.gov/ index.cfm/submit-scientific-information -packets/. Please select the study for which you are submitting information from the list to upload your documents. Email submissions: SIPS@epc-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. 58653 or Email: SIPS@epcsrc.org. DATES: SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Programs to complete a review of the evidence for Omega 3 Fatty Acids and Maternal and Child Health. The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 80, Number 154 (Tuesday, August 11, 2015)]
[Notices]
[Pages 48105-48107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19659]


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

Agency for Healthcare Research and Quality


Scientific Information Request on Omega 3 Fatty Acids and 
Cardiovascular Disease--Update

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Scientific Information 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 Omega 3 Fatty 
Acids and Cardiovascular Disease--Update, which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. 
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 September 10, 2015.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list to upload 
your documents.

Email submissions: src.org">SIPS@epc-src.org. Print submissions: Mailing 
Address: Portland VA Research Foundation, Scientific Resource Center, 
ATTN:

[[Page 48106]]

Scientific Information Packet Coordinator, PO 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. 58653 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Programs to complete a review of the evidence for Omega 3 Fatty Acids 
and Cardiovascular Disease--Update.
    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 Omega 3 Fatty Acids and Cardiovascular Disease--Update, 
including those that describe adverse events. The entire research 
protocol, including the key questions, is also available online at: 
http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2060.
    This notice is to notify the public that the EPC Program would find 
the following information on Omega 3 Fatty Acids and Cardiovascular 
Disease--Update 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/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this 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 can 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: http://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 entire research 
protocol, is available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2060.

The Key Questions

    1. What is the efficacy or association of n-3 Fatty Acids (FA) 
(eicosapentaenoic acid [EPA], docosahexaenoic acid [DHA]EPA+DHA, 
docosapentaenoic acid [DPA], stearidonic acid [SDA], alpha-linolenic 
acid [ALA], or total n-3 Fatty Acids) exposures in reducing 
cardiovascular disease (CVD) outcomes (incident CVD events including 
all-cause mortality, CVD mortality, non-fatal CVD events, new diagnosis 
of CVD, peripheral vascular disease, congestive heart failure, major 
arrhythmias, and hypertension diagnosis) and specific CVD risk factors 
(blood pressure, key plasma lipids)?
    [cir] What is the efficacy or association of n-3 FA in preventing 
CVD outcomes in people
    [ssquf] Without known CVD (primary prevention)
    [ssquf] At high risk for CVD (primary prevention)
    [ssquf] With known CVD (secondary prevention)?
    [cir] What is the relative efficacy of different n-3 FAs on CVD 
outcomes and risk factors?
    [cir] Can the CVD outcomes be ordered by strength of intervention 
effect of n-3 FAs?
    2. n-3 FA variables and modifiers:
    [cir] How does the efficacy or association of n-3 FA in preventing 
CVD outcomes and with CVD risk factors differ in subpopulations, 
including men, premenopausal women, postmenopausal women, and different 
age or race/ethnicity groups?
    [cir] What are the effects of potential confounders or interacting 
factors--such as plasma lipids, body mass index, blood pressure, 
diabetes, kidney disease, other nutrients or supplements, and drugs 
(e.g., statins, aspirin, diabetes drugs, hormone replacement therapy)?
    [cir] What is the efficacy or association of different ratios of n-
3 FA components in dietary supplements or biomarkers, on CVD outcomes 
and risk factors?
    [cir] How does the efficacy or association of n-3 FA on CVD 
outcomes and risk factors differ by ratios of different n-3 FAs--DHA, 
EPA, and ALA, or other n-3 FAs?
    [cir] How does the efficacy or association of n-3 FA on CVD 
outcomes and risk factors differ by source (e.g., fish and seafood, 
common plant oils (e.g., soybean, canola), fish oil supplements, 
fungal-algal supplements, flaxseed oil supplements)?
    [cir] How does the ratio of n-6 FA to n-3 FA intakes or biomarker 
concentrations affect the efficacy or association of n-3 FA on CVD 
outcomes and risk factors?
    [cir] Is there a threshold or dose-response relationship between n-
3 FA exposures and CVD outcomes and risk factors? Does the study type 
affect these relationships?
    [cir] How does the duration of intervention or exposure influence 
the effect of n-3 FA on CVD outcomes and risk factors?
    [cir] What is the effect of baseline n-3 FA status (intake or 
biomarkers) on the efficacy of n-3 FA intake or supplementation on CVD 
outcomes and risk factors?
    3. Adverse events:
    [cir] What adverse effects are related to n-3 FA intake or 
biomarker concentrations (in studies of CVD outcomes and risk factors)?
    [cir] What adverse events are reported specifically among people 
with CVD or

[[Page 48107]]

diabetes (in studies of CVD outcomes and risk factors)?

PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)

Populations

 Healthy adults (>=18 yr) without CVD or with low to 
intermediate risk for CVD
 Adults at high risk for CVD (e.g., with diabetes, 
cardiometabolic syndrome, hypertension, dyslipidemia, non-dialysis 
chronic kidney disease)
 Adults with clinical CVD (e.g., history of myocardial 
infarction, angina, transient ischemic attacks)
 Exclude populations chosen for having a non-CVD or non-
diabetes-related disease (e.g., cancer, gastrointestinal disease, 
rheumatic disease, dialysis)

Interventions/Exposures

 n-3 FA supplements
 n-3 FA supplemented foods (e.g., eggs)
 n-3 FA content in diet (e.g., from food frequency 
questionnaires)
 Biomarkers of n-3 FA intake
 n-3 content of food or supplements must be quantified (e.g., 
exclude fish diet studies where only servings/week defined, 
Mediterranean diet studies without n-3 quantified). n-3 quantification 
can be of total n-3 FA, of a specific n-3 FA (e.g., ALA) or of combined 
EPA+DHA (``marine oil'').
 Exclude n-3 FA dose >=6 g/day (except for adverse events)
 Exclude weight loss interventions

Comparators

 Placebo or no n-3 FA intervention
 Different n-3 FA source intervention
 Different n-3 FA concentration intervention
 Different n-3 FA dietary exposure (e.g., comparison of 
quantiles)
 Different n-3 FA biomarker levels (e.g., comparison of 
quantiles)

Outcomes

 All-cause mortality
 Cardiovascular, cerebrovascular, and peripheral vascular 
events:
[cir] Fatal vascular events (e.g., due to myocardial infarction, 
stroke)
[cir] Non-fatal vascular events (e.g., myocardial infarction, stroke/
cardiovascular accident, transient ischemic attack, unstable angina)
[cir] Coronary heart disease, new diagnosis
[cir] Congestive heart failure, new diagnosis
[cir] Cerebrovascular disease, new diagnosis
[cir] Peripheral vascular disease, new diagnosis
[cir] Ventricular arrhythmia, new diagnosis
[cir] Supraventricular arrhythmia, new diagnosis
[cir] Major vascular interventions/procedures (e.g, revascularization, 
thrombolysis, lower extremity amputation, defibrillator placement)
 Major CVD risk factors (intermediate outcomes):
[cir] Blood pressure (new-onset hypertension, systolic, diastolic, and 
mean arterial pressure)
[cir] Key plasma lipids (i.e., high density lipoprotein cholesterol 
[HDL-c], low density lipoprotein cholesterol [LDL-c], total/HDL-c 
ratio, LDL-c/HDL-c ratio, triglycerides)
 Adverse events (e.g., bleeding, major gastrointestinal 
disturbance), only from intervention studies of supplements

Timing

 Clinical outcomes, including new-onset hypertension (all study 
designs): >=1 year followup (and intervention duration, as applicable)
 Intermediate outcomes (blood pressure and plasma lipids) (all 
study designs): >=1 month followup
 Adverse events (all study designs): No minimum followup

Setting

Community-Dwelling (Non-Institutionalized) Individuals Study Design
 Randomized Controlled Trials (RCTs) (all outcomes)
 Randomized cross-over studies (blood pressure and plasma 
lipids, adverse events), minimum washout period to be determined
 Prospective nonrandomized comparative studies (clinical 
outcomes, adverse events)
 Prospective cohort (single group) studies, where groups are 
compared based on n-3 FA intake or intake biomarker values (clinical 
outcomes)
 Exclude: Retrospective or case control studies or cross-
sectional studies (but include prospective nested case control 
studies). Studies must have measure of intake prior to outcome.
 Minimum sample sizes (All outcomes: To be determined)
 English language publications

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015-19659 Filed 8-10-15; 8:45 am]
 BILLING CODE 4160-90-P