Supplemental Evidence and Data Request on Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries, 17428-17430 [2017-07157]

Download as PDF 17428 Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices Method of Collection To achieve the goals of this project, the following data collections will be implemented: AHRQ Research Reporting System (ARRS)—Grantees and vendors use the ARRS system to report project progress and important preliminary findings for grants and contracts funded by the Agency. Grantees and vendors submit progress reports on a monthly or quarterly basis which are reviewed by AHRQ personnel. All users access the ARRS system through a secure online interface which requires a user I.D. and password entered through the ARRS login screen. When status reports are due AHRQ notifies principal investigators and vendors via email. The ARRS is an automated, userfriendly resource that is utilized by AHRQ staff for preparing, distributing, and reviewing reporting requests to grantees and vendors for the purpose of information sharing. AHRQ personnel are able to systematically search the information collected and stored in the ARRS database. Personnel will also use the information to address internal and/ or external requests for information regarding grant progress, preliminary findings, and other requests, such as Freedom of Information Act requests and producing responses related to federally mandated programs and regulations. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents. It will take grantees and vendors an estimated 10 minutes to enter the necessary data into the ARRS System and reporting will occur four times annually. The total annualized burden hours are estimated to be 333 hours. Exhibit 2 shows the estimated annualized cost burden for the respondents. The total estimated cost burden for respondents is $12,454. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Number of responses per respondent Hours per response Total burden hours Data entry into ARRS ...................................................................................... 500 4 10/60 333 Total .......................................................................................................... 500 N/A N/A 333 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name Total burden hours Average hourly wage rate * Total cost burden Data entry into ARRS ...................................................................................... 500 333 $37.40 $12,454 Total .......................................................................................................... 500 333 N/A 12,454 * Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2015,’’ U.S. Department of Labor, Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_ nat.htm#29-0000. srobinson on DSK5SPTVN1PROD with NOTICES Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All VerDate Sep<11>2014 20:18 Apr 10, 2017 Jkt 241001 comments will become a matter of public record. Sharon B. Arnold, Acting Director. [FR Doc. 2017–07156 Filed 4–10–17; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries 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 SUMMARY: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 scientific information submissions from the public. Scientific information is being solicited to inform our review of Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries, which is currently being conducted by the AHRQ’s Evidence-based Practice CentersProgram. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before May 11, 2017. ADDRESSES: Email submissions: SEADS@epcsrc.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 E:\FR\FM\11APN1.SGM 11APN1 srobinson on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices 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: SEADS@epcsrc.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 Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). 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 Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https:// effectivehealthcare.ahrq.gov/search-forguides-reviews-and-reports/ ?pageaction=displayproduct &productID=2455 This is to notify the public that the EPC Program would find the following information on Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries 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. VerDate Sep<11>2014 20:18 Apr 10, 2017 Jkt 241001 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 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 KQ 1a. What is the effectiveness and harms of programs and policies on initiation, duration, and exclusivity of breastfeeding? KQ 1b. To what extent do the effectiveness and harms of programs and policies on initiation, duration, and exclusivity of breastfeeding differ for subpopulations of women defined by sociodemographic factors (e.g., age, race, ethnicity, socioeconomic status)? KQ 1c. To what extent do intervention-related characteristics (e.g., type of breast pump provided—manual or electric; delivery personnel) influence the initiation, duration, and exclusivity of breast feeding? KQ 2a. What are the comparative benefits and harms for maternal health outcomes among women who breastfeed for different intensities and durations? PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 17429 KQ 2b. To what extent do benefits and harms for maternal health outcomes differ for subpopulations of women defined by age, race, ethnicity, and comorbidity? Population(s) KQs 1, 2: Childbearing women and adolescents; we will also search for evidence on subgroups of women defined by age, race, ethnicity, comorbidity, and socioeconomic status (including insurance status and payer type). Interventions/Exposure KQ 1: Community, workplace, and health care system-based interventions aimed at promoting and supporting breastfeeding, including the following: Health plan benefits, state and federal policies or programs (e.g., WIC programs), hospital implementation of the BFHI, workplace or school-based programs, and others. For studies assessing the effectiveness of BFHI, we will include studies evaluating full and partial implementation (at least 3 steps) of the 10 steps. KQ 2: Exposure to breastfeeding. Comparators KQ 1: No intervention (or usual practice); comparisons of two interventions that differ in content or intensity. KQ 2: No breastfeeding; shorter duration of breastfeeding (e.g., breastfeeding for 1 month vs. 12 months) and/or less intensive breastfeeding (e.g., exclusive breastfeeding vs. mixed feeding or formula feeding). Outcomes KQ 1: Rates of breastfeeding initiation; duration and exclusivity of breastfeeding, adverse effects of interventions (e.g., guilt about not breastfeeding, workplace discrimination, and other reported harms). KQ 2: Postpartum depression, breast cancer, ovarian cancer, osteoporosis, cardiovascular outcomes (e.g., stroke, myocardial infarction), postpartum weight change, type 2 diabetes, hypertension. Timing KQs 1, 2: We will have no minimum study duration or length of follow up. Settings KQs 1, 2: Studies conducted in a developed country [‘‘very high’’ (KQs 1, 2) and ‘‘high’’ (KQ 1) human development index per the United Nations Development Programme 40. E:\FR\FM\11APN1.SGM 11APN1 17430 Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices Study Design KQ 1: Randomized and nonrandomized controlled clinical trials; prospective cohort studies with concurrent control groups; systematic reviews; for studies assessing policy or system-level interventions, we will also include pre-post studies with repeated outcome measures before and after the intervention. KQ 2: Randomized and nonrandomized controlled clinical trials; cohort studies; case-control studies; systematic reviews. Sharon B. Arnold, Acting Director. [FR Doc. 2017–07157 Filed 4–10–17; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Lower Limb Prosthesis 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 of Lower Limb Prosthesis, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before May 11, 2017. ADDRESSES: Email submissions: SEADS@epcsrc.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: SEADS@epcsrc.org. srobinson on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:18 Apr 10, 2017 Jkt 241001 The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Lower Limb Prosthesis (LLP). AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). 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 Lower Limb Prosthesis, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https:// effectivehealthcare.ahrq.gov/search-forguides-reviews-and-reports/ ?pageaction=displayproduct&product ID=2451 This is to notify the public that the EPC Program would find the following information on Lower Limb Prosthesis 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 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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 Key Question 1 What assessment techniques used to measure functional ability of adults with major lower limb amputation have been evaluated in the published literature? I. What are the measurement properties of these techniques, including: Reliability, validity, responsiveness, minimal detectable change, and minimal important difference? II. What are the characteristics of the participants in studies evaluating measurement properties of assessment techniques? Key Question 2 What prediction tools used to predict functional outcomes in adults with major lower limb amputation have been evaluated in the published literature? I. What are their characteristics, including technical quality (reliability, validity, responsiveness), minimal detectable change, and minimal important difference? II. What are the characteristics of the participants in these studies? Key Question 3 What functional outcome measurement tools used to assess adults who use a lower limb prosthesis (LLP) have been evaluated in the published literature? I. What are their characteristics, including technical quality (reliability, E:\FR\FM\11APN1.SGM 11APN1

Agencies

[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17428-17430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07157]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Systematic Review of 
Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal 
Health Outcomes in Developed Countries

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 Systematic 
Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, 
and Maternal Health Outcomes in Developed Countries, which is currently 
being conducted by the AHRQ's Evidence-based Practice CentersProgram. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review.

DATES: Submission Deadline on or before May 11, 2017.

ADDRESSES: 
    Email submissions: src.org">SEADS@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

[[Page 17429]]

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">SEADS@epc-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 Systematic Review of 
Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal 
Health Outcomes in Developed Countries. AHRQ is conducting this 
systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).
    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 Systematic Review of Breastfeeding Programs and 
Policies, Breastfeeding Uptake, and Maternal Health Outcomes in 
Developed Countries, including those that describe adverse events. The 
entire research protocol, including the key questions, is also 
available online at: https://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2455
    This is to notify the public that the EPC Program would find the 
following information on Systematic Review of Breastfeeding Programs 
and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in 
Developed Countries 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 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

    KQ 1a. What is the effectiveness and harms of programs and policies 
on initiation, duration, and exclusivity of breastfeeding?
    KQ 1b. To what extent do the effectiveness and harms of programs 
and policies on initiation, duration, and exclusivity of breastfeeding 
differ for subpopulations of women defined by sociodemographic factors 
(e.g., age, race, ethnicity, socioeconomic status)?
    KQ 1c. To what extent do intervention-related characteristics 
(e.g., type of breast pump provided--manual or electric; delivery 
personnel) influence the initiation, duration, and exclusivity of 
breast feeding?
    KQ 2a. What are the comparative benefits and harms for maternal 
health outcomes among women who breastfeed for different intensities 
and durations?
    KQ 2b. To what extent do benefits and harms for maternal health 
outcomes differ for subpopulations of women defined by age, race, 
ethnicity, and comorbidity?

Population(s)

    KQs 1, 2: Childbearing women and adolescents; we will also search 
for evidence on subgroups of women defined by age, race, ethnicity, 
comorbidity, and socioeconomic status (including insurance status and 
payer type).

Interventions/Exposure

    KQ 1: Community, workplace, and health care system-based 
interventions aimed at promoting and supporting breastfeeding, 
including the following: Health plan benefits, state and federal 
policies or programs (e.g., WIC programs), hospital implementation of 
the BFHI, workplace or school-based programs, and others. For studies 
assessing the effectiveness of BFHI, we will include studies evaluating 
full and partial implementation (at least 3 steps) of the 10 steps.
    KQ 2: Exposure to breastfeeding.

Comparators

    KQ 1: No intervention (or usual practice); comparisons of two 
interventions that differ in content or intensity.
    KQ 2: No breastfeeding; shorter duration of breastfeeding (e.g., 
breastfeeding for 1 month vs. 12 months) and/or less intensive 
breastfeeding (e.g., exclusive breastfeeding vs. mixed feeding or 
formula feeding).

Outcomes

    KQ 1: Rates of breastfeeding initiation; duration and exclusivity 
of breastfeeding, adverse effects of interventions (e.g., guilt about 
not breastfeeding, workplace discrimination, and other reported harms).
    KQ 2: Postpartum depression, breast cancer, ovarian cancer, 
osteoporosis, cardiovascular outcomes (e.g., stroke, myocardial 
infarction), postpartum weight change, type 2 diabetes, hypertension.

Timing

    KQs 1, 2: We will have no minimum study duration or length of 
follow up.

Settings

    KQs 1, 2: Studies conducted in a developed country [``very high'' 
(KQs 1, 2) and ``high'' (KQ 1) human development index per the United 
Nations Development Programme 40.

[[Page 17430]]

Study Design

    KQ 1: Randomized and non-randomized controlled clinical trials; 
prospective cohort studies with concurrent control groups; systematic 
reviews; for studies assessing policy or system-level interventions, we 
will also include pre-post studies with repeated outcome measures 
before and after the intervention.
    KQ 2: Randomized and non-randomized controlled clinical trials; 
cohort studies; case-control studies; systematic reviews.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-07157 Filed 4-10-17; 8:45 am]
 BILLING CODE 4160-90-P