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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link=blue vlink=purple><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D'><o:p>&nbsp;</o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri",sans-serif;color:#1F497D'><o:p>&nbsp;</o:p></span></p><p class=MsoNormal><b><span style='font-size:11.0pt;font-family:"Calibri",sans-serif'>From:</span></b><span style='font-size:11.0pt;font-family:"Calibri",sans-serif'> jean public &lt;jeanpublic1@gmail.com&gt; <br><b>Sent:</b> Monday, April 1, 2019 1:22 PM<br><b>To:</b> Lefkowitz, Doris C. (AHRQ/CFACT) &lt;Doris.Lefkowitz@ahrq.hhs.gov&gt;; scoops@huffpost.com<br><b>Subject:</b> Re: comment<o:p></o:p></span></p><p class=MsoNormal><o:p>&nbsp;</o:p></p><div><p class=MsoNormal>public commenton federal register<o:p></o:p></p><div><p class=MsoNormal><o:p>&nbsp;</o:p></p></div><div><p class=MsoNormal>on the collection of medical inforation, one has to wonder why the informationand research on those injuredin breastcanceer mastectomy so tha their lymph systems are not working properly and are swelling up on their body - where is the research grant to have breast cancer surgeons stop harming the lymph systemin their breast cancer surgery. the patient goesin for treatment of breast cancer but then gets the injury of lymphedema and horrible pain and swelling on their body from that same surgeon. that cannot be tolerated. first, do not harm. the patient is left with a disease from that surgery that will cost her financial penury for the rest of her/his life to relieve the pain and swelling that hjas been injured to that lymph system. and the healing property of the lymph system is also lost. where is the reseeach grant on investigation of better procedures gongon here. this comment is for the public record. please receipt. jeanpubliee <a href="mailto:jeanpublic1@gmail.com">jeanpublic1@gmail.com</a><o:p></o:p></p></div></div><p class=MsoNormal><o:p>&nbsp;</o:p></p><div><div><p class=MsoNormal>On Sun, Mar 31, 2019 at 3:14 PM jean public &lt;<a href="mailto:jeanpublic1@gmail.com">jeanpublic1@gmail.com</a>&gt; wrote:<o:p></o:p></p></div><blockquote style='border:none;border-left:solid #CCCCCC 1.0pt;padding:0in 0in 0in 6.0pt;margin-left:4.8pt;margin-right:0in'><div><pre><span style='color:black'>Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]<o:p></o:p></span></pre><pre><span style='color:black'>[Notices]<o:p></o:p></span></pre><pre><span style='color:black'>[Pages 12254-12256]<o:p></o:p></span></pre><pre><span style='color:black'>From the Federal Register Online via the Government Publishing Office [<a href="https://protect2.fireeye.com/url?k=5811c5b1-0444cc61-5811f48e-0cc47a6a52de-b9560da69a0ebfe7&amp;u=http://www.gpo.gov/" target="_blank">https://protect2.fireeye.com/url?k=35b27299-69e77b49-35b243a6-0cc47a6a52de-25c067186607ae7d&amp;u=http://www.gpo.gov/</a>]<o:p></o:p></span></pre><pre><span style='color:black'>[FR Doc No: 2019-06192]<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>-----------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>DEPARTMENT OF HEALTH AND HUMAN SERVICES<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Agency for Healthcare Research and Quality<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Agency Information Collection Activities: Proposed Collection; <o:p></o:p></span></pre><pre><span style='color:black'>Comment Request<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>AGENCY: Agency for Healthcare Research and Quality, HHS.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>ACTION: Notice.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>-----------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>SUMMARY: This notice announces the intention of the Agency for <o:p></o:p></span></pre><pre><span style='color:black'>Healthcare Research and Quality (AHRQ) to request that the Office of <o:p></o:p></span></pre><pre><span style='color:black'>Management and Budget (OMB) approve the proposed information collection <o:p></o:p></span></pre><pre><span style='color:black'>project ``Online Submission Form for Supplemental Evidence and Data for <o:p></o:p></span></pre><pre><span style='color:black'>Systematic Reviews for the Evidence-based Practice Center Program.''<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>DATES: Comments on this notice must be received by May 31, 2019.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, <o:p></o:p></span></pre><pre><span style='color:black'>Reports Clearance Officer, AHRQ, by email at <o:p></o:p></span></pre><pre><span style='color:black'><a href="mailto:doris.lefkowitz@AHRQ.hhs.gov" target="_blank">doris.lefkowitz@AHRQ.hhs.gov</a>.<o:p></o:p></span></pre><pre><span style='color:black'>    Copies of the proposed collection plans, data collection <o:p></o:p></span></pre><pre><span style='color:black'>instruments, and specific details on the estimated burden can be <o:p></o:p></span></pre><pre><span style='color:black'>obtained from the AHRQ Reports Clearance Officer.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports <o:p></o:p></span></pre><pre><span style='color:black'>Clearance Officer, (301) 427-1477, or by email at <o:p></o:p></span></pre><pre><span style='color:black'><a href="mailto:doris.lefkowitz@AHRQ.hhs.gov" target="_blank">doris.lefkowitz@AHRQ.hhs.gov</a>.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>SUPPLEMENTARY INFORMATION: <o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Proposed Project<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Online Submission Form for Supplemental Evidence and Data for <o:p></o:p></span></pre><pre><span style='color:black'>Systematic Reviews for the Evidence-Based Practice Center Program<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-<o:p></o:p></span></pre><pre><span style='color:black'>3521, AHRQ invites the public to comment on this proposed information <o:p></o:p></span></pre><pre><span style='color:black'>collection. The AHRQ Evidence-based Practice Center (EPC) Program <o:p></o:p></span></pre><pre><span style='color:black'>develops evidence reports and technology assessments that summarize <o:p></o:p></span></pre><pre><span style='color:black'>evidence for federal and other partners on topics relevant to clinical <o:p></o:p></span></pre><pre><span style='color:black'>and other health care organization and delivery issues--specifically <o:p></o:p></span></pre><pre><span style='color:black'>those that are common, expensive, and/or significant for the Medicare <o:p></o:p></span></pre><pre><span style='color:black'>and Medicaid populations. Better understanding and use of evidence in <o:p></o:p></span></pre><pre><span style='color:black'>practice, policy, and delivery of care improves the quality of health <o:p></o:p></span></pre><pre><span style='color:black'>care.<o:p></o:p></span></pre><pre><span style='color:black'>    These reports, reviews, and technology assessments are based on <o:p></o:p></span></pre><pre><span style='color:black'>rigorous, comprehensive syntheses and analyses of the scientific <o:p></o:p></span></pre><pre><span style='color:black'>literature on topics. EPC reports and assessments emphasize explicit <o:p></o:p></span></pre><pre><span style='color:black'>and detailed documentation of methods, rationale, and assumptions. EPC <o:p></o:p></span></pre><pre><span style='color:black'>reports are conducted in accordance with an established policy on <o:p></o:p></span></pre><pre><span style='color:black'>financial and nonfinancial interests.<o:p></o:p></span></pre><pre><span style='color:black'>    This research has the following goals:<o:p></o:p></span></pre><pre><span style='color:black'>    [cir] Use research methods to gather knowledge on the effectiveness <o:p></o:p></span></pre><pre><span style='color:black'>or comparative effectiveness of treatments, screening, diagnostic, <o:p></o:p></span></pre><pre><span style='color:black'>management or health care delivery strategies for specific medical <o:p></o:p></span></pre><pre><span style='color:black'>conditions, both published and unpublished, to evaluate the quality of <o:p></o:p></span></pre><pre><span style='color:black'>research studies and the evidence from these studies.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>[[Page 12255]]<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span
style='color:black'>    [cir] Promote the use of evidence in health care decision making to <o:p></o:p></span></pre><pre><span style='color:black'>improve health care and health<o:p></o:p></span></pre><pre><span style='color:black'>    [cir] Identify research gaps to inform future research investments<o:p></o:p></span></pre><pre><span style='color:black'>    The 2011 Institute of Medicine report ``Finding What Works in <o:p></o:p></span></pre><pre><span style='color:black'>Health Care: Standards for Systematic Review'' includes an assessment <o:p></o:p></span></pre><pre><span style='color:black'>of publication bias through the identification of unpublished studies. <o:p></o:p></span></pre><pre><span style='color:black'>This is an important source for bias which could affect the nature and <o:p></o:p></span></pre><pre><span style='color:black'>direction of research findings. Identifying and including the results <o:p></o:p></span></pre><pre><span style='color:black'>of these additional unpublished studies may provide a more complete and <o:p></o:p></span></pre><pre><span style='color:black'>accurate assessment of an intervention's effect on outcomes. An <o:p></o:p></span></pre><pre><span style='color:black'>important way to identify unpublished studies is through requests to <o:p></o:p></span></pre><pre><span style='color:black'>medical device manufacturers, pharmaceutical companies, and other <o:p></o:p></span></pre><pre><span style='color:black'>intervention developers.<o:p></o:p></span></pre><pre><span style='color:black'>    The proposed project involves sending a notification via an email <o:p></o:p></span></pre><pre><span style='color:black'>listserv and via Federal Register notice as needed of the opportunity <o:p></o:p></span></pre><pre><span style='color:black'>to submit information on unpublished studies or other scientific <o:p></o:p></span></pre><pre><span style='color:black'>information to the EPC Program website, with one request per systematic <o:p></o:p></span></pre><pre><span style='color:black'>review topic. Because research on each topic must be completed in a <o:p></o:p></span></pre><pre><span style='color:black'>timely manner in order for it to be useful, the collections are never <o:p></o:p></span></pre><pre><span style='color:black'>ongoing--there is one request and collection per topic. Investigators <o:p></o:p></span></pre><pre><span style='color:black'>in the EPC Program will review the information and assess potential <o:p></o:p></span></pre><pre><span style='color:black'>risk of bias from both published and unpublished studies and its impact <o:p></o:p></span></pre><pre><span style='color:black'>on the EPC Program's findings.<o:p></o:p></span></pre><pre><span style='color:black'>    This study is being conducted by AHRQ, pursuant to AHRQ's statutory <o:p></o:p></span></pre><pre><span style='color:black'>authority to conduct and support research on health care and on systems <o:p></o:p></span></pre><pre><span style='color:black'>for the delivery of such care, including activities with respect to the <o:p></o:p></span></pre><pre><span style='color:black'>quality, effectiveness, efficiency, appropriateness and value of health <o:p></o:p></span></pre><pre><span style='color:black'>care services. 42 U.S.C 299a(a)(1).<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Method of Collection<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>    To achieve the goals of this project the following data collections <o:p></o:p></span></pre><pre><span style='color:black'>will be implemented:<o:p></o:p></span></pre><pre><span style='color:black'>     Online Submission Form Instrument. This information is <o:p></o:p></span></pre><pre><span style='color:black'>collected for the purposes of providing supplemental evidence and data <o:p></o:p></span></pre><pre><span style='color:black'>for systematic reviews (SEADS). The purpose of SEADS requests is not to <o:p></o:p></span></pre><pre><span style='color:black'>collect generalizable data, but to supplement the published and grey <o:p></o:p></span></pre><pre><span style='color:black'>literature searches EPC investigators are conducting. The online <o:p></o:p></span></pre><pre><span style='color:black'>submission form (OSF) collects data from respondents on their name and <o:p></o:p></span></pre><pre><span style='color:black'>the information packet. This happens following notification of <o:p></o:p></span></pre><pre><span style='color:black'>opportunity to submit via email listserv and/or Federal Register notice <o:p></o:p></span></pre><pre><span style='color:black'>as needed, with one request per topic. For the purposes of meta-<o:p></o:p></span></pre><pre><span style='color:black'>analyses, trial summary data from missing and unidentified studies are <o:p></o:p></span></pre><pre><span style='color:black'>sought. For the purposes of constructing evidence tables and quality <o:p></o:p></span></pre><pre><span style='color:black'>ratings (e.g., on public reporting of cost measures or health <o:p></o:p></span></pre><pre><span style='color:black'>information exchange), data can vary (e.g., URLs, study designs, and <o:p></o:p></span></pre><pre><span style='color:black'>consumer-mediated exchange forms). Submitters are informed of the types <o:p></o:p></span></pre><pre><span style='color:black'>of information that would be most helpful to include in the information <o:p></o:p></span></pre><pre><span style='color:black'>packet, which includes a list of all sponsored but unpublished studies <o:p></o:p></span></pre><pre><span style='color:black'>(both completed and ongoing), as well as comment on the completeness of <o:p></o:p></span></pre><pre><span style='color:black'>information provided.<o:p></o:p></span></pre><pre><span style='color:black'>    The EPC Program currently uses a broad-based email announcement via <o:p></o:p></span></pre><pre><span style='color:black'>email listserv and a Federal Register notice, as needed, to publicize <o:p></o:p></span></pre><pre><span style='color:black'>the opportunity to submit scientific information about each topic. The <o:p></o:p></span></pre><pre><span style='color:black'>proposed project does not duplicate other available sources of this <o:p></o:p></span></pre><pre><span style='color:black'>information. Available study registries and databases may not <o:p></o:p></span></pre><pre><span style='color:black'>sufficiently inform the Program's research. The EPC Program does not <o:p></o:p></span></pre><pre><span style='color:black'>anticipate more than 15 topics per year with SEADS requests.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Estimated Annual Respondent Burden<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>    Exhibit 1 presents estimates of the reporting burden hours for the <o:p></o:p></span></pre><pre><span style='color:black'>data collection efforts. Time estimates are based on pilot testing of <o:p></o:p></span></pre><pre><span style='color:black'>materials and what can reasonably be requested of respondents. The <o:p></o:p></span></pre><pre><span style='color:black'>number of respondents listed in ``Number of respondents per SEADS <o:p></o:p></span></pre><pre><span style='color:black'>request'' of Exhibit 1 reflects a projected 33% response rate with <o:p></o:p></span></pre><pre><span style='color:black'>approximately 1-2 responses per request and assumes about 15 SEADS <o:p></o:p></span></pre><pre><span style='color:black'>requests per year.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>                                                      Exhibit 1--Estimated Annualized Burden Hours<o:p></o:p></span></pre><pre><span style='color:black'>--------------------------------------------------------------------------------------------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'>                                                                     Number of SEADS<o:p></o:p></span></pre><pre><span style='color:black'>                                                    Number of SEADS    request that      Number of      Annual number      Hours per       Total burden<o:p></o:p></span></pre><pre><span style='color:black'>                     Form name                          requests         receive       responses per       of SEADS         response     hours per annum<o:p></o:p></span></pre><pre><span style='color:black'>                                                                         response      SEADS request      responses<o:p></o:p></span></pre><pre><span style='color:black'>--------------------------------------------------------------------------------------------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'>Online Submission Form (OSF)......................              15                5              1.5              7.5            15/60             1.87<o:p></o:p></span></pre><pre><span style='color:black'>--------------------------------------------------------------------------------------------------------------------------------------------------------<o:p></o:p></span></pre
><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>                                   Exhibit 2--Estimated Annualized Cost Burden<o:p></o:p></span></pre><pre><span style='color:black'>----------------------------------------------------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'>                                                                   Total burden<o:p></o:p></span></pre><pre><span style='color:black'>                    Form name                        Number of       hours per    Average hourly    Total cost<o:p></o:p></span></pre><pre><span style='color:black'>                                                  SEADS requests       SEADS        wage rate *       burden<o:p></o:p></span></pre><pre><span style='color:black'>----------------------------------------------------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'>OSF.............................................              15            1.87      $61.39 \a\         $115.10<o:p></o:p></span></pre><pre><span style='color:black'>----------------------------------------------------------------------------------------------------------------<o:p></o:p></span></pre><pre><span style='color:black'>* Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United<o:p></o:p></span></pre><pre><span style='color:black'>  States, U.S. Department of Labor, Bureau of Labor Statistics. <a href="https://www.bls.gov/oes/current/oes_nat.htm#11-0000" target="_blank">https://www.bls.gov/oes/current/oes_nat.htm#11-0000</a> 0000.<o:p></o:p></span></pre><pre><span style='color:black'>\a\ Based on the mean wages for Public Relations and Fundraising Managers, 11-2031, the occupational group most<o:p></o:p></span></pre><pre><span style='color:black'>  likely tasked with completing the OSF.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Request for Comments<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>    In accordance with the Paperwork Reduction Act, comments on AHRQ's <o:p></o:p></span></pre><pre><span style='color:black'>information collection are requested with regard to any of the <o:p></o:p></span></pre><pre><span style='color:black'>following: (a) Whether the proposed collection of information is <o:p></o:p></span></pre><pre><span style='color:black'>necessary for the proper performance of AHRQ's health care research and <o:p></o:p></span></pre><pre><span style='color:black'>health care information dissemination functions, including whether the <o:p></o:p></span></pre><pre><span style='color:black'>information will have practical utility; (b) the accuracy of AHRQ's <o:p></o:p></span></pre><pre><span style='color:black'>estimate of burden (including hours and costs) of the proposed <o:p></o:p></span></pre><pre><span style='color:black'>collection(s) of information; (c) ways to enhance the quality, utility <o:p></o:p></span></pre><pre><span style='color:black'>and clarity of the information to be collected; and (d) ways to <o:p></o:p></span></pre><pre><span style='color:black'>minimize the burden of the collection of information upon the <o:p></o:p></span></pre><pre><span style='color:black'>respondents, including the use of<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>[[Page 12256]]<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>automated collection techniques or other forms of information <o:p></o:p></span></pre><pre><span style='color:black'>technology.<o:p></o:p></span></pre><pre><span style='color:black'>    Comments submitted in response to this notice will be summarized <o:p></o:p></span></pre><pre><span style='color:black'>and included in the Agency's subsequent request for OMB approval of the <o:p></o:p></span></pre><pre><span style='color:black'>proposed information collection. All comments will become a matter of <o:p></o:p></span></pre><pre><span style='color:black'>public record.<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><pre><span style='color:black'>Gopal Khanna,<o:p></o:p></span></pre><pre><span style='color:black'>Director.<o:p></o:p></span></pre><pre><span style='color:black'>[FR Doc. 2019-06192 Filed 3-29-19; 8:45 am]<o:p></o:p></span></pre><pre><span style='color:black'> BILLING CODE 4160-90-P<o:p></o:p></span></pre><pre><span style='color:black'><o:p>&nbsp;</o:p></span></pre><p class=MsoNormal><o:p>&nbsp;</o:p></p></div></blockquote></div></div></body></html>###############################################################################################################################################################################################################################################################################################################################################################################################################################################################################################F#W#:# #########################################################F#W#:# #c#o#m#m#e#n#t###########################################E#x#t#r#a#c#t#L#a#n#g#u#a#g#e#1#.#0#############################E#x#t#r#a#c#t#L#a#n#g#u#a#g#e################################### ###&###########################################################[#{#
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