80 FR 76990 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 80, Issue 238 (December 11, 2015)
Agency for Healthcare Research and Quality
Federal Register Volume 80, Issue 238 (December 11, 2015)
| Page Range | 76990-76992 | |
| FR Document | 2015-31159 |
[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)] [Notices] [Pages 76990-76992] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31159] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Submission Form for Supplemental Evidence and Data for Systematic reviews for the Evidence-based Practice Center Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 21st, 2015 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by January 11, 2016. ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at [email protected] [[Page 76991]] eop.gov (attention: AHRQ's desk officer). FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]. SUPPLEMENTARY INFORMATION: Proposed Project This is a new activity of AHRQ's Evidence-based Practice Center Program. Evidence-Based Practice Center Program AHRQ's Evidence-based Practice Center (EPC) Program develops evidence reports and technology assessments on topics relevant to clinical and other health care organization and delivery issues-- specifically those that are common, expensive, and/or significant for the Medicare and Medicaid populations. For example recent reviews have focused on clinical conditions, such as ``Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer''; health delivery topics such as ``Management Strategies to Reduce Psychiatric Admissions''; and specific technologies such as ``Imaging Techniques for Treatment Evaluation for Metastatic Breast Cancer.'' These evidence reports include systematic reviews and technical briefs, and provide an essential foundation from which to understand what we know from existing research and what critical research gaps remain. These reports, reviews, and technology assessments are based on rigorous, comprehensive syntheses and analyses of the scientific literature on topics. EPC reports and assessments emphasize explicit and detailed documentation of methods, rationale, and assumptions. EPC reports are conducted in accordance with an established policy on financial and nonfinancial interests. These scientific syntheses may include meta- analyses and cost analyses. The EPC Program supports AHRQ's mission by synthesizing and disseminating the available research as a ``science partner'' with private and public organizations in their efforts to improve the quality, effectiveness, and appropriateness of health care. The EPC Program is a trusted source of rigorous, comprehensive, and unbiased evidence reviews for stakeholders. The resulting evidence reports and technology assessments are used by Federal and State agencies, private- sector professional societies, health delivery systems, providers, payers, and others committed to evidence-based health care. These end users may use EPC Program evidence reports to inform policy decisions, clinical practice guidelines, and other health care decisions. EPC research has the following goals: [cir] Use research methods to gather knowledge on the effectiveness of certain treatments for specific medical conditions, both published and unpublished, to evaluate the quality of research studies and the evidence from these studies. [cir] Promote the use of evidence in health care decision making to improve health care and health. [cir] Identify research gaps to inform future research investments. The Institute of Medicine standards for quality systematic reviews include an assessment of publication bias through the identification of unpublished studies. This is an important source for bias which could affect the nature and direction of research findings. Identifying and including the results of these additional unpublished studies may provide a more complete and accurate assessment of an intervention's effect on outcomes. An important way to identify unpublished studies is through requests to medical device manufacturers, pharmaceutical companies, and other intervention developers. The proposed project involves sending a request letter to relevant medical device manufacturers, pharmaceutical companies and other intervention developers to invite them to submit unpublished studies or other scientific information to the EPC Program Web site, with one request per systematic review topic. Because research on each topic must be completed in a timely manner in order for it to be useful, the collections are never ongoing--there is one request and collection per topic. Investigators in the EPC Program will review the information and assess potential risk of bias from both published and unpublished studies and its impact on the EPC Program's findings. AHRQ believes the display of these assessments in the systematic review's evidence tables will improve the response and submission rates of industry stakeholders by informing the health care community of the impact of potential bias on the research conclusions, and for health care decision making. This activity is being conducted by AHRQ's EPC Program through its contractor, the Scientific Resource Center (SRC), pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care and to disseminate government- funded research relevant to comparative clinical effectiveness research. 42 U.S.C. 299a(a); 42 U.S.C. 299b-37(a). Method of Collection To achieve the goals of this project the following data collections will be implemented:Online Submission Form Instrument. This information is collected for the purposes of providing supplemental evidence and data for systematic reviews (SEADS). The online submission form (OSF) collects data from respondents on their organization name, their product's name, and whether they are providing all information on requested studies characteristic of the review in progress. This happens following receipt of a request letter from the SRC. These requests will be sent to relevant sponsors of preventive and treatment interventions (e.g., medical device manufacturers, pharmaceuticals, and other intervention and health care system developers), with one request per topic. For the purposes of meta-analyses, trial summary data from missing and unidentified studies are sought. For the purposes of constructing evidence tables and quality ratings (e.g. on public reporting of cost measures or health information exchange), data can vary (e.g., URLs, study designs, and consumer-mediated exchange forms). Information on both completed and ongoing studies are requested. The EPC Program, through the SRC, currently uses a Federal Register notice and broad-based email announcement to stakeholders to allow the public to know about each topic, and the opportunity to submit scientific information. In 2014, the Program sent 517 notifications to 336 industry stakeholders. Of those 517 announcements sent, 14.1% received a response; 56.2% of the responses (or 7.9% of all requests) contained submissions of information on the results of interventions. This experience has prompted this proposed project. The additional use of direct requests to relevant organizations would improve the Program's ability to obtain this information. Contacting intervention sponsors for missing and potentially unidentified studies could improve the impact of research efforts and downstream dissemination efforts and could positively impact the health of individuals, burdened by poor health along with their supporting communities. Including information about response data to these requests to more accurately characterize the [[Page 76992]] completeness of the evidence in the systematic reviews may also address this issue. The proposed project does not duplicate other available sources of this information. Available study registries and databases may not be complete to sufficiently inform the Program's research. The purpose of SEADS requests is not to collect generalizable data, but to supplement the published and grey literature searches EPC investigators are conducting. Furthermore, considering the evidence and data included in responses collected from industry stakeholders, an assessment pertaining to the completeness of the evidence-base will be produced. This, AHRQ believes, will increase the value of AHRQ's research reviews to end users and potentially provide stakeholders a better understanding of how their submissions are used. Estimated Annual Respondent Burden Exhibit 1 presents estimates of the reporting burden hours for the data collection efforts. Time estimates are based on pilot testing of materials and what can reasonably be requested of respondents. The number of respondents listed in ``Number of respondents per SEADS request'' of Exhibit 1 reflects a projected 80% response rate. Online Submission Form: A form for submitting scientific evidence and data related to medical interventions sponsored by organizations and individuals such as pharmaceutical companies and independent researchers. The form has three required fields: The organization's name, the intervention in question, and whether the information they provide is all the information they know to exist. They may upload documents and they are also provided a data entry form if they wish to offer greater details on their studies. An Optional Data Entry Form is available as an alternative to the Online Submission form. The time requirements for response would be same as the Online Submission Form. Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of respondents Number of Hours per Total burden Form name per SEADS responses per response hours per request respondent SEADS ---------------------------------------------------------------------------------------------------------------- Online Submission Form (OSF).................... 70 1 15/60 17.5 --------------------------------------------------------------- Total....................................... 70 1 15/60 17.5 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Total burden Average Form name SEADS hours per hourly wage Total cost requests SEADS rate * burden ---------------------------------------------------------------------------------------------------------------- OSF............................................. 70 17.5 \a\ $55.48 $970.90 --------------------------------------------------------------- Total....................................... 70 17.5 55.48 970.90 ---------------------------------------------------------------------------------------------------------------- * Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#b29-0000 0000. \a\ Based on the mean wages for Public Relations and Fundraising Managers, 11-2031, the occupational group most likely tasked with completing the OSF. 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 comments will become a matter of public record. Sharon Arnold, Deputy Director. [FR Doc. 2015-31159 Filed 12-10-15; 8:45 am] BILLING CODE 4160-90-P
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eligible for updates between July 2014 over time, this percentage represents a new RoPR record; 15 minutes to upload
and June 2015, either by the registry growing, cumulative number. a new RoPR record (an average of 30
owner’s initiative, or when prompted by In February 2015, Quintiles minutes using either method). It takes
the automated RoPR reminder. This conducted a knowledge transfer webinar 15 minutes for a person to review and
update process takes about 15 minutes. for registry contacts learn how to enter make updates to an existing RoPR
As the RoPR continues to grow and new records into the RoPR. As a result record. The total respondent burden is
more patient registry records are added of the knowledge gained during these estimated to be a maximum of 64 hours
processes, it is estimated that it takes annually.
users 45 minutes to manually enter a
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Number of Minutes per Total burden
Form name responses per
respondents response hours
respondent
New RoPR Record (manually—entered or uploaded electronically method) 59 1 45/60 44.25
Review/update existing RoPR Record ............................................................ 79 1 15/60 19.75
Total .......................................................................................................... 138 ........................ ........................ 64.0
Exhibit 2 shows the estimated cost time to participate in the RoPR. The estimated at an average of $1,799.60
burden associated with the respondent’s total cost burden to respondents is annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate †
New RoPR Record (manually—entered or uploaded electronically method) 59 44.25 $36.54 $1,617
Review/update existing RoPR Record ............................................................ 79 19.75 36.54 721.67
Total .......................................................................................................... 138 64 ........................ 2,339
* Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000. National Compensation Survey: Occupational
wages in the United States May 2014, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Available at: http://www.bls.gov/oes/current/oes_
nat.htm#b29-0000.
In order to highlight patient registry information to be collected; and (d) ACTION: Notice.
concerns about using the RoPR system ways to minimize the burden of the
and turning user feedback into future collection of information upon the SUMMARY: This notice announces the
system maintenance and upgrade respondents, including the use of intention of the Agency for Healthcare
initiatives (increasing the usability of automated collection techniques or Research and Quality (AHRQ) to request
the RoPR and lowering the burden of other forms of information technology. that the Office of Management and
entering patient registry information), Comments submitted in response to Budget (OMB) approve the proposed
plans for a voluntary user satisfaction this notice will be summarized and information collection project: ‘‘Online
survey are being considered for 2Q included in the Agency’s subsequent Submission Form for Supplemental
2016. Its full nature and design is in the request for OMB approval of the Evidence and Data for Systematic
concept stage. Therefore, this survey is proposed information collection. All reviews for the Evidence-based Practice
not part of the Estimated Annualized comments will become a matter of Center Program.’’ In accordance with
Respondent Hourly/Cost Burden noted public record. the Paperwork Reduction Act, 44 U.S.C.
in Exhibits 1 and 2. 3501–3521, AHRQ invites the public to
Sharon Arnold, comment on this proposed information
Request for Comments Deputy Director. collection.
In accordance with the Paperwork [FR Doc. 2015–31158 Filed 12–10–15; 8:45 am] This proposed information collection
Reduction Act, comments on AHRQ’s BILLING CODE 4160–90–P was previously published in the Federal
information collection are requested Register on September 21st, 2015 and
with regard to any of the following: (a) allowed 60 days for public comment.
Whether the proposed collection of DEPARTMENT OF HEALTH AND AHRQ did not receive any substantive
information is necessary for the proper HUMAN SERVICES comments. The purpose of this notice is
performance of AHRQ health care to allow an additional 30 days for public
research and information dissemination Agency for Healthcare Research and comment.
jstallworth on DSK7TPTVN1PROD with NOTICES
functions, including whether the Quality DATES: Comments on this notice must be
information will have practical utility; received by January 11, 2016.
Agency Information Collection
(b) the accuracy of AHRQ’s estimate of Activities: Proposed Collection; ADDRESSES: Written comments should
burden (including hours and costs) of Comment Request be submitted to: AHRQ’s OMB Desk
the proposed collection(s) of Officer by fax at (202) 395–6974
information; (c) ways to enhance the AGENCY:Agency for Healthcare Research (attention: AHRQ’s desk officer) or by
quality, utility, and clarity of the and Quality, HHS. email at OIRA_submission@omb.
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![76992 Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices
completeness of the evidence in the believes, will increase the value of related to medical interventions
systematic reviews may also address AHRQ’s research reviews to end users sponsored by organizations and
this issue. and potentially provide stakeholders a individuals such as pharmaceutical
The proposed project does not better understanding of how their companies and independent
duplicate other available sources of this submissions are used. researchers. The form has three required
information. Available study registries fields: The organization’s name, the
and databases may not be complete to Estimated Annual Respondent Burden
intervention in question, and whether
sufficiently inform the Program’s Exhibit 1 presents estimates of the the information they provide is all the
research. reporting burden hours for the data information they know to exist. They
The purpose of SEADS requests is not collection efforts. Time estimates are
may upload documents and they are
to collect generalizable data, but to based on pilot testing of materials and
also provided a data entry form if they
supplement the published and grey what can reasonably be requested of
wish to offer greater details on their
literature searches EPC investigators are respondents. The number of
conducting. Furthermore, considering studies.
respondents listed in ‘‘Number of
the evidence and data included in respondents per SEADS request’’ of An Optional Data Entry Form is
responses collected from industry Exhibit 1 reflects a projected 80% available as an alternative to the Online
stakeholders, an assessment pertaining response rate. Submission form. The time
to the completeness of the evidence- Online Submission Form: A form for requirements for response would be
base will be produced. This, AHRQ submitting scientific evidence and data same as the Online Submission Form.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Number of Total burden
respondents Hours per
Form name responses per hours per
per SEADS response
respondent SEADS
request
Online Submission Form (OSF) ...................................................................... 70 1 15/60 17.5
Total .......................................................................................................... 70 1 15/60 17.5
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of Total burden Average Total cost
Form name SEADS hours per hourly wage burden
requests SEADS rate *
OSF .................................................................................................................. 70 17.5 a $55.48 $970.90
Total .......................................................................................................... 70 17.5 55.48 970.90
* Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.
a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with com-
pleting the OSF.
Request for Comments included in the Agency’s subsequent to the Office of Management and Budget
request for OMB approval of the (OMB) for review and approval in
In accordance with the Paperwork proposed information collection. All accordance with the Paperwork
Reduction Act, comments on AHRQ’s comments will become a matter of Reduction Act of 1995. The notice for
information collection are requested public record. the proposed information collection is
with regard to any of the following: (a) published to obtain comments from the
Whether the proposed collection of Sharon Arnold,
public and affected agencies.
information is necessary for the proper Deputy Director. Written comments and suggestions
performance of AHRQ health care [FR Doc. 2015–31159 Filed 12–10–15; 8:45 am] from the public and affected agencies
research and health care information BILLING CODE 4160–90–P concerning the proposed collection of
dissemination functions, including information are encouraged. Your
whether the information will have comments should address any of the
practical utility; (b) the accuracy of DEPARTMENT OF HEALTH AND following: (a) Evaluate whether the
AHRQ’s estimate of burden (including HUMAN SERVICES proposed collection of information is
hours and costs) of the proposed necessary for the proper performance of
collection(s) of information; (c) ways to Centers for Disease Control and the functions of the agency, including
enhance the quality, utility, and clarity Prevention whether the information will have
of the information to be collected; and practical utility; (b) Evaluate the
jstallworth on DSK7TPTVN1PROD with NOTICES
(d) ways to minimize the burden of the [30Day–16–0950] accuracy of the agencies estimate of the
collection of information upon the burden of the proposed collection of
respondents, including the use of Agency Forms Undergoing Paperwork
Reduction Act Review information, including the validity of
automated collection techniques or the methodology and assumptions used;
other forms of information technology. The Centers for Disease Control and (c) Enhance the quality, utility, and
Comments submitted in response to Prevention (CDC) has submitted the clarity of the information to be
this notice will be summarized and following information collection request collected; (d) Minimize the burden of
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Document Created: 2018-03-02 09:13:47
Document Modified: 2018-03-02 09:13:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by January 11, 2016. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 80 FR 76990 |
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