Supplemental Evidence and Data Request on Disparities and Barriers for Pediatric Cancer Survivorship Care, 42855-42857 [2020-15190]

Download as PDF Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices Estimated Annual Capital or Other Non-labor Costs: $77,960. Abstract: The Fuel Rating Rule establishes standard procedures for determining, certifying, and disclosing the octane rating of automotive gasoline and the automotive fuel rating of alternative liquid automotive fuels, as required by the Petroleum Marketing Practices Act. 15 U.S.C. 2822(a)–(c). The Rule also requires refiners, producers, importers, distributors, and retailers to retain records showing how the ratings were determined, including delivery tickets or letters of certification. khammond on DSKJM1Z7X2PROD with NOTICES Request for Comment On May 4, 2020, the FTC sought public comment on the information collection requirements associated with the Rule. 85 FR 26470. 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In addition, your comment should not include any ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’ —as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Josephine Liu, Assistant General Counsel for Legal Counsel. [FR Doc. 2020–15226 Filed 7–14–20; 8:45 am] BILLING CODE 6750–01–P 1 The Commission received four non-germane comments. VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Disparities and Barriers for Pediatric Cancer Survivorship Care Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data 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 on Disparities and Barriers for Pediatric Cancer Survivorship Care, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before 30 days after the date of publication of this Notice. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. Print submissions: Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301–427–1496 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Disparities and Barriers for Pediatric Cancer Survivorship Care. AHRQ is conducting this systematic review pursuant to Section 903 of the Public Health Service Act, 42 U.S.C. 299a–1. 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 42855 literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Disparities and Barriers for Pediatric Cancer Survivorship Care, including those that describe adverse events. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/products/ pediatric-cancer-survivorship/protocol. This is to notify the public that the EPC Program would find the following information on Disparities and Barriers for Pediatric Cancer Survivorship Care 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, 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 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 is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on 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 website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https:// E:\FR\FM\15JYN1.SGM 15JYN1 42856 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices www.effectivehealthcare.ahrq.gov/ email-updates. 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. Guiding Questions (GQs) The brief will be facilitated by guiding questions, documenting research and Key Informant input. GQ1. What are the disparities in survivorship care for pediatric cancer survivors? GQ2. What are the barriers to survivorship care for pediatric cancer survivors who experience disparities? GQ3. What are proposed strategies for addressing those barriers? GQ4. What published and unpublished studies have assessed these strategies? GQ5. What are future directions for research in addressing barriers to survivorship care for pediatric cancer survivors? Inclusion Exclusion All GQs: • Childhood cancer survivors (CCS) of all ages. We will accept the authors’ definition of CCS. Mixed samples will be included where studies include at least 50% CCS or report a subgroup analysis. In studies not self-identifying as CCS research, we will apply the following criteria: Diagnosed before age 21, received primary acute treatment for cancer, currently in remission, eligible to receive survivorship care services, care plans, and/or models of followup care. GQ1: • Survivorship care. We will include studies addressing healthcare approaches aimed at the health and wellbeing of cancer survivors. All GQs: • Studies that predominantly include other populations than CCS, that include patients diagnosed predominantly after the age of 20, that had other conditions than cancer, or that are currently undergoing treatment for cancer. PICOTSS (populations, interventions, comparators, outcomes, timing, settings, study designs) PICOTSS Population ..................................................................... Independent variables and interventions ..................... Comparators ................................................................. khammond on DSKJM1Z7X2PROD with NOTICES Outcomes ..................................................................... VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 GQ2: • Barriers and facilitators of survivorship care for CCS. GQ3, GQ4, GQ5: • Strategies to address barriers to survivorship care and to reduce care disparities. We will include care initiatives, structured care programs, care plan, care models, and healthcare interventions aiming to address barriers or disparities. Strategies may target CCS (e.g., providing patient information), healthcare providers (e.g., initiating training), or healthcare systems (e.g., implementing health information technologies such as telemedicine). GQ1, GQ2: • We will accept the authors’ choice of a participant characteristic comparator. Studies may compare subgroups to the general population of CCS or compare multiple participant subgroups defined by participant characteristics (e.g., race/ethnicity, socioeconomic status, gender, rural residence, educational attainment or patient or their parents, other disparate population). GQ3: • Strategies do not need to document alternative care models in detail as long as the difference of the proposed survivorship care strategy to usual care is described. GQ4, GQ5: • Studies comparing participant subgroups as defined in GQ1 and GQ2 and studies comparing to other care strategies (no intervention, waitlist, usual care, other active strategies aiming to address barriers or disparities). GQ1, GQ2: • Disparities and barriers (causes of disparity) in: Æ Any patient outcomes related to utilization of survivorship care services, care plans, or models of care. Æ Intermediate health outcomes and adverse events (short-term). Æ Mortality (long-term, not related to cancer). Æ Late effects and morbidity (including psychosocial). Æ Quality of life and wellbeing and satisfaction with care. Æ Cost and resource utilization. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 All GQs: • Studies without reference to survivorship care and studies not addressing care disparities, barriers to care, or strategies outside of healthcare. All GQs: • Studies not addressing patient characteristics or intervention characteristics. All GQs: • Studies that do not relate to disparities or barriers to survivorship care for pediatric survivors. E:\FR\FM\15JYN1.SGM 15JYN1 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices PICOTSS (populations, interventions, comparators, outcomes, timing, settings, study designs) PICOTSS Timing ........................................................................... Setting(s) ...................................................................... Study design and other limiters .................................... Dated: July 9, 2020. Virginia Mackay-Smith, Associate Director. Exclusion GQ3: • Strategies will be documented regardless of any information on outcome effects, but strategies need to aim to prevent, reduce, or mitigate disparities and barriers to survivorship care. GQ4: • Changes (reduction) in disparities between comparison groups for outcomes listed in GQ1 and GQ2. GQ5: • Ongoing and upcoming studies need to indicate that the study will report on outcomes eligible for GQ1, GQ2, or GQ4. All GQs: • No timing restriction apply. Studies may address CCS who recently or long in the past experienced pediatric cancer and are now in remission. All GQs: • All care settings applicable to US settings will be eligible, including primary, secondary, and tertiary care; inpatient and outpatient care; pediatric and adult care context. All GQs: • English-language publications. GQ1, GQ2, GQ4, GQ5: • Primary studies reporting empirical data (including both quantitative and qualitative data). GQ1, GQ2: • Studies may either report on distinct subgroups, e.g., dividing the sample by geographic characteristic and reporting data separately for rural and for urban participants or studies may report associations with participant characteristics, e.g., reporting correlations with a factor of interest such as gender differences. GQ3: • Strategies have to have been empirically tested in a research study reporting on the outcomes of interest or have been suggested by an authoritative source such as a clinical practice guideline or relevant professional organization. GQ 4: • Studies with concurrent (e.g., randomized controlled trial) or historic comparator (e.g., organizational pre-post studies). Studies with results published in clinicaltrials.gov will be included regardless of whether a journal publication is available. GQ5: • Ongoing and upcoming studies have to have a published protocol or are registered in a research registry. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2020–15190 Filed 7–14–20; 8:45 am] Administration for Community Living Agency Information Collection Activities; Proposed Collection; Comment Request; Title VI Program Performance Report (OMB 0985–0007) BILLING CODE 4160–90–P khammond on DSKJM1Z7X2PROD with NOTICES Inclusion Administration for Community Living, HHS. ACTION: Notice. AGENCY: The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of SUMMARY: VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 42857 All GQs: • No exclusions apply. All GQs: • Studies in resource-limited settings such as developing countries will be reviewed for comparability with US settings. All GQs: • Evaluations reported only in abbreviated format (e.g., in a conference abstract) with the exception of trial records. • Studies exclusively reported in non-English publications. • Systematic reviews will be retained for reference mining but are not eligible for inclusion. information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Proposed Revised Collection and solicits comments on the information collection requirements related to the extension of the Title VI Program Performance Report. E:\FR\FM\15JYN1.SGM 15JYN1

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[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42855-42857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Disparities and 
Barriers for Pediatric Cancer Survivorship Care

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 on Disparities and 
Barriers for Pediatric Cancer Survivorship Care, which is currently 
being conducted by the AHRQ's Evidence-based Practice Centers (EPC) 
Program. Access to published and unpublished pertinent scientific 
information will improve the quality of this review.

DATES:  Submission Deadline on or before 30 days after the date of 
publication of this Notice.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Disparities and 
Barriers for Pediatric Cancer Survivorship Care. AHRQ is conducting 
this systematic review pursuant to Section 903 of the Public Health 
Service Act, 42 U.S.C. 299a-1.
    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 Disparities and Barriers for Pediatric Cancer 
Survivorship Care, including those that describe adverse events. The 
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/pediatric-cancer-survivorship/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Disparities and Barriers for Pediatric Cancer 
Survivorship Care 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, 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 is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on 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 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://

[[Page 42856]]

www.effectivehealthcare.ahrq.gov/email-updates.
    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.

Guiding Questions (GQs)

    The brief will be facilitated by guiding questions, documenting 
research and Key Informant input.
    GQ1. What are the disparities in survivorship care for pediatric 
cancer survivors?
    GQ2. What are the barriers to survivorship care for pediatric 
cancer survivors who experience disparities?
    GQ3. What are proposed strategies for addressing those barriers?
    GQ4. What published and unpublished studies have assessed these 
strategies?
    GQ5. What are future directions for research in addressing barriers 
to survivorship care for pediatric cancer survivors?

----------------------------------------------------------------------------------------------------------------
PICOTSS  (populations, interventions,
    comparators, outcomes, timing,                      Inclusion                            Exclusion
   settings, study designs) PICOTSS
----------------------------------------------------------------------------------------------------------------
Population...........................  All GQs:                                    All GQs:
                                           Childhood cancer survivors          Studies that
                                           (CCS) of all ages. We will accept the       predominantly include
                                           authors' definition of CCS. Mixed           other populations than
                                           samples will be included where studies      CCS, that include
                                           include at least 50% CCS or report a        patients diagnosed
                                           subgroup analysis. In studies not self-     predominantly after the
                                           identifying as CCS research, we will        age of 20, that had other
                                           apply the following criteria:               conditions than cancer,
                                           Diagnosed before age 21, received           or that are currently
                                           primary acute treatment for cancer,         undergoing treatment for
                                           currently in remission, eligible to         cancer.
                                           receive survivorship care services,
                                           care plans, and/or models of follow-up
                                           care.
Independent variables and              GQ1:                                        All GQs:
 interventions.
                                           Survivorship care. We will          Studies without
                                           include studies addressing healthcare       reference to survivorship
                                           approaches aimed at the health and          care and studies not
                                           wellbeing of cancer survivors.              addressing care
                                                                                       disparities, barriers to
                                                                                       care, or strategies
                                                                                       outside of healthcare.
                                       GQ2:
                                           Barriers and facilitators of
                                           survivorship care for CCS.
                                       GQ3, GQ4, GQ5:
                                           Strategies to address barriers
                                           to survivorship care and to reduce
                                           care disparities. We will include care
                                           initiatives, structured care programs,
                                           care plan, care models, and healthcare
                                           interventions aiming to address
                                           barriers or disparities. Strategies
                                           may target CCS (e.g., providing
                                           patient information), healthcare
                                           providers (e.g., initiating training),
                                           or healthcare systems (e.g.,
                                           implementing health information
                                           technologies such as telemedicine).
Comparators..........................  GQ1, GQ2:                                   All GQs:
                                           We will accept the authors'         Studies not
                                           choice of a participant characteristic      addressing patient
                                           comparator. Studies may compare             characteristics or
                                           subgroups to the general population of      intervention
                                           CCS or compare multiple participant         characteristics.
                                           subgroups defined by participant
                                           characteristics (e.g., race/ethnicity,
                                           socioeconomic status, gender, rural
                                           residence, educational attainment or
                                           patient or their parents, other
                                           disparate population).
                                       GQ3:
                                           Strategies do not need to
                                           document alternative care models in
                                           detail as long as the difference of
                                           the proposed survivorship care
                                           strategy to usual care is described.
                                       GQ4, GQ5:
                                           Studies comparing participant
                                           subgroups as defined in GQ1 and GQ2
                                           and studies comparing to other care
                                           strategies (no intervention, waitlist,
                                           usual care, other active strategies
                                           aiming to address barriers or
                                           disparities).
Outcomes.............................  GQ1, GQ2:                                   All GQs:
                                           Disparities and barriers            Studies that do
                                           (causes of disparity) in:                   not relate to disparities
                                       [cir] Any patient outcomes related to           or barriers to
                                        utilization of survivorship care               survivorship care for
                                        services, care plans, or models of care.       pediatric survivors.
                                            [cir] Intermediate health outcomes
                                             and adverse events (short-term).
                                            [cir] Mortality (long-term, not
                                             related to cancer).
                                            [cir] Late effects and morbidity
                                             (including psychosocial).
                                            [cir] Quality of life and wellbeing
                                             and satisfaction with care.
                                            [cir] Cost and resource utilization.

[[Page 42857]]

 
                                       GQ3:
                                           Strategies will be documented
                                           regardless of any information on
                                           outcome effects, but strategies need
                                           to aim to prevent, reduce, or mitigate
                                           disparities and barriers to
                                           survivorship care.
                                       GQ4:
                                           Changes (reduction) in
                                           disparities between comparison groups
                                           for outcomes listed in GQ1 and GQ2.
                                       GQ5:
                                           Ongoing and upcoming studies
                                           need to indicate that the study will
                                           report on outcomes eligible for GQ1,
                                           GQ2, or GQ4.
Timing...............................  All GQs:                                    All GQs:
                                           No timing restriction apply.        No exclusions
                                           Studies may address CCS who recently        apply.
                                           or long in the past experienced
                                           pediatric cancer and are now in
                                           remission.
Setting(s)...........................  All GQs:                                    All GQs:
                                           All care settings applicable        Studies in
                                           to US settings will be eligible,            resource-limited settings
                                           including primary, secondary, and           such as developing
                                           tertiary care; inpatient and                countries will be
                                           outpatient care; pediatric and adult        reviewed for
                                           care context.                               comparability with US
                                                                                       settings.
Study design and other limiters......  All GQs:                                    All GQs:
                                           English-language publications.      Evaluations
                                       GQ1, GQ2, GQ4, GQ5:                             reported only in
                                        Primary studies reporting              abbreviated format (e.g.,
                                        empirical data (including both                 in a conference abstract)
                                        quantitative and qualitative data).            with the exception of
                                       GQ1, GQ2:                                       trial records.
                                        Studies may either report on        Studies exclusively
                                        distinct subgroups, e.g., dividing the      reported in non-English
                                        sample by geographic characteristic and     publications.
                                        reporting data separately for rural and     Systematic reviews
                                        for urban participants or studies may       will be retained for
                                        report associations with participant        reference mining but are not
                                        characteristics, e.g., reporting            eligible for inclusion.
                                        correlations with a factor of interest
                                        such as gender differences.
                                       GQ3:
                                           Strategies have to have been
                                           empirically tested in a research study
                                           reporting on the outcomes of interest
                                           or have been suggested by an
                                           authoritative source such as a
                                           clinical practice guideline or
                                           relevant professional organization.
                                       GQ 4:
                                           Studies with concurrent (e.g.,
                                           randomized controlled trial) or
                                           historic comparator (e.g.,
                                           organizational pre-post studies).
                                           Studies with results published in
                                           clinicaltrials.gov will be included
                                           regardless of whether a journal
                                           publication is available.
                                       GQ5:
                                           Ongoing and upcoming studies
                                           have to have a published protocol or
                                           are registered in a research registry.
----------------------------------------------------------------------------------------------------------------


    Dated: July 9, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020-15190 Filed 7-14-20; 8:45 am]
BILLING CODE 4160-90-P