80_FR_77227 80 FR 76989 - Agency Information Collection Activities: Proposed Collection; Comment Request

80 FR 76989 - 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)

Page Range76989-76990
FR Document2015-31158

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: ``Developing a Registry of Registries.'' 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 received no substantive comments from the public. The purpose of this notice is to allow an additional 30 days for public comment.

Federal Register, Volume 80 Issue 238 (Friday, December 11, 2015) 
[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)]
[Notices]
[Pages 76989-76990]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31158]



[[Page 76989]]

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 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: ``Developing a Registry of Registries.'' 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 received no substantive comments from the public. 
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] (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 Renewal of an Existing Project: OMB 
Control Number 0935-0203.
    The Registry of Patient Registries (RoPR) is a web-based 
application, and does not require users to submit any type of paper 
form.
    The RoPR collects patient registry data in two (2) ways: Users are 
able to enter information into the web-based system manually, or use an 
automated upload feature.
    Information being collected in the RoPR Record is visible to the 
public and patient registries visiting the RoPR Web site, and is 
available for public use in this capacity.
    The RoPR system provides email notification to registry holders 
informing them on an annual basis of the need to update basic 
statistics and contact information, but it is the responsibility of the 
registry holder to update the information.
    If a Registry Profile has not been reviewed and updated to the RoPR 
search site within four (4) years, it is archived.
    As of August 8, 2015, the RoPR has 138 patient registries listed.

 ``Developing a Registry of Registries''

    Patient registries have received significant attention and funding 
in recent years. Similar to controlled studies, patient registries 
represent some burden to patients (e.g., time to complete patient 
reported outcome measures, risk of loss of privacy), who often 
participate voluntarily in hopes of improving knowledge about a disease 
or condition. Patient registries also represent a substantial 
investment of health research resources. Despite these factors, patient 
registries are not required to be registered in ClinicalTrials.gov, 
presenting the potential for duplication of efforts and insufficient 
dissemination of findings that are not published in the peer-reviewed 
literature. To fulfill the obligation of advancing the quality and 
specificity of patient health care, and to ensure that resources are 
used in the most efficient manner, patient registries need to be listed 
in a manner similar to that of trials in ClinicalTrials.gov.
    By creating a central point of collection for information about all 
patient registries in the United States, the RoPR furthers AHRQ's goals 
by making information regarding quality, appropriateness, and 
effectiveness of health services (and patient registries in particular) 
more readily available in a central location.
    This research has the following goals:
    (1) Maintaining and updating the RoPR database system to be 
compatible with ClinicalTrials.gov; meeting the following objectives:
    a. Providing a searchable database of patient registries in the 
United States (to promote collaboration, reduce redundancy, and improve 
transparency);
    b. Facilitating the use of common data fields and definitions in 
similar health conditions (to improve opportunities for sharing, 
comparing, and linkage) and free-text search field for highlighting 
information specific to an individual registry;
    c. Providing a public repository of searchable summary results 
(including results from registries that have not yet been published in 
the peer-reviewed literature);
    d. Offering a search tool to locate existing data that researchers 
can request for use in new studies; and
    e. Serving as a recruitment tool for researchers and patients 
interested in participating in patient registries.
    This study is being conducted by AHRQ through its contractor L&M 
Policy Research and Quintiles, a sub-contractor to L&M, pursuant to 
AHRQ's statutory authority to conduct and support research and 
disseminate information on health care and on systems for the delivery 
of such care, including activities with respect to the quality, 
effectiveness, efficiency, appropriateness and value of health care 
services and with respect to database development. 42 U.S.C. 299a(a)(1) 
and (8).

Method of Collection

    To achieve the goals of this project, the following data 
collections will be implemented:
    (1) Collect information from users who populate the RoPR database 
system, which will achieve all of the above goals.
    (2) There are tentative plans for a user satisfaction survey to be 
enabled within the RoPR system, in the second quarter of 2016. The 
purpose of this survey is to obtain user/stakeholder feedback to 
evaluate priorities for future enhancements. Its full nature and design 
is in the concept stage still and so is not part of the Estimated 
Annual Respondent Burden. However, for the purpose of full disclosure, 
plans for the survey are being disclosed in this notice.
    The purpose and the use of the RoPR is to provide a readily 
available public resource strictly for patient registries, following 
the model of ClinicalTrials.gov, allowing for the increased 
availability and efficacy of patient registries. The information being 
collected in the RoPR Record is visible to the public visiting the RoPR 
Web site, and is readily available for public use. The RoPR is an 
ongoing data collection initiative.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to participate in the RoPR. Between July 2014 and 
June 2015, 59 new respondents had entered their RoPR record, utilizing 
either a manual or electronic upload data entry method.
    Each respondent need enter his or her new RoPR record only once, 
and this process is estimated to take 45 minutes. The RoPR system sends 
an automated reminder to any registry owner who has not updated his or 
her RoPR record in the past year. An estimated 57.25% (79 records) of 
all RoPR records were

[[Page 76990]]

eligible for updates between July 2014 and June 2015, either by the 
registry owner's initiative, or when prompted by the automated RoPR 
reminder. This update process takes about 15 minutes. As the RoPR 
continues to grow and more patient registry records are added over 
time, this percentage represents a growing, cumulative number.
    In February 2015, Quintiles conducted a knowledge transfer webinar 
for registry contacts learn how to enter new records into the RoPR. As 
a result of the knowledge gained during these processes, it is 
estimated that it takes users 45 minutes to manually enter a new RoPR 
record; 15 minutes to upload a new RoPR record (an average of 30 
minutes using either method). It takes 15 minutes for a person to 
review and make updates to an existing RoPR record. The total 
respondent burden is estimated to be a maximum of 64 hours annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per    Minutes per    Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
New RoPR Record (manually--entered or uploaded                59               1           45/60           44.25
 electronically method).........................
Review/update existing RoPR Record..............              79               1           15/60           19.75
                                                 ---------------------------------------------------------------
    Total.......................................             138  ..............  ..............            64.0
----------------------------------------------------------------------------------------------------------------

    Exhibit 2 shows the estimated cost burden associated with the 
respondent's time to participate in the RoPR. The total cost burden to 
respondents is estimated at an average of $1,799.60 annually.

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours       rate [dagger]      burden
----------------------------------------------------------------------------------------------------------------
New RoPR Record (manually--entered or uploaded                59           44.25          $36.54          $1,617
 electronically method).........................
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 concerns about using the 
RoPR system and turning user feedback into future system maintenance 
and upgrade initiatives (increasing the usability of the RoPR and 
lowering the burden of entering patient registry information), plans 
for a voluntary user satisfaction survey are being considered for 2Q 
2016. Its full nature and design is in the concept stage. Therefore, 
this survey is not part of the Estimated Annualized Respondent Hourly/
Cost Burden noted in Exhibits 1 and 2.

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 
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. 2015-31158 Filed 12-10-15; 8:45 am]
 BILLING CODE 4160-90-P

Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices 76989 DEPARTMENT OF HEALTH AND responsibility of the registry holder to e. Serving as a recruitment tool for HUMAN SERVICES update the information. researchers and patients interested in If a Registry Profile has not been participating in patient registries. Agency for Healthcare Research and reviewed and updated to the RoPR This study is being conducted by Quality search site within four (4) years, it is AHRQ through its contractor L&M archived. Policy Research and Quintiles, a sub- Agency Information Collection As of August 8, 2015, the RoPR has contractor to L&M, pursuant to AHRQ’s Activities: Proposed Collection; 138 patient registries listed. statutory authority to conduct and Comment Request support research and disseminate ‘‘Developing a Registry of Registries’’ AGENCY: Agency for Healthcare Research information on health care and on Patient registries have received systems for the delivery of such care, and Quality, HHS. significant attention and funding in including activities with respect to the ACTION: Notice. recent years. Similar to controlled quality, effectiveness, efficiency, studies, patient registries represent appropriateness and value of health care SUMMARY: This notice announces the some burden to patients (e.g., time to services and with respect to database intention of the Agency for Healthcare complete patient reported outcome development. 42 U.S.C. 299a(a)(1) and Research and Quality (AHRQ) to request measures, risk of loss of privacy), who (8). that the Office of Management and often participate voluntarily in hopes of Budget (OMB) approve the proposed Method of Collection improving knowledge about a disease or information collection project: condition. Patient registries also To achieve the goals of this project, ‘‘Developing a Registry of Registries.’’ In represent a substantial investment of the following data collections will be accordance with the Paperwork health research resources. Despite these implemented: Reduction Act, 44 U.S.C. 3501–3521, (1) Collect information from users factors, patient registries are not AHRQ invites the public to comment on who populate the RoPR database required to be registered in this proposed information collection. system, which will achieve all of the ClinicalTrials.gov, presenting the This proposed information collection above goals. potential for duplication of efforts and was previously published in the Federal (2) There are tentative plans for a user insufficient dissemination of findings Register on September 21st, 2015 and satisfaction survey to be enabled within that are not published in the peer- allowed 60 days for public comment. the RoPR system, in the second quarter reviewed literature. To fulfill the AHRQ received no substantive of 2016. The purpose of this survey is obligation of advancing the quality and comments from the public. The purpose to obtain user/stakeholder feedback to specificity of patient health care, and to of this notice is to allow an additional evaluate priorities for future ensure that resources are used in the 30 days for public comment. enhancements. Its full nature and design most efficient manner, patient registries DATES: Comments on this notice must be need to be listed in a manner similar to is in the concept stage still and so is not received by January 11, 2016. that of trials in ClinicalTrials.gov. part of the Estimated Annual ADDRESSES: Written comments should By creating a central point of Respondent Burden. However, for the be submitted to: AHRQ’s OMB Desk collection for information about all purpose of full disclosure, plans for the Officer by fax at (202) 395–6974 patient registries in the United States, survey are being disclosed in this (attention: AHRQ’s desk officer) or by the RoPR furthers AHRQ’s goals by notice. email at OIRA_submission@ making information regarding quality, The purpose and the use of the RoPR omb.eop.gov (attention: AHRQ’s desk appropriateness, and effectiveness of is to provide a readily available public officer). health services (and patient registries in resource strictly for patient registries, particular) more readily available in a following the model of FOR FURTHER INFORMATION CONTACT: central location. ClinicalTrials.gov, allowing for the Doris Lefkowitz, AHRQ Reports This research has the following goals: increased availability and efficacy of Clearance Officer, (301) 427–1477, or by (1) Maintaining and updating the patient registries. The information being email at doris.lefkowitz@AHRQ.hhs.gov. RoPR database system to be compatible collected in the RoPR Record is visible SUPPLEMENTARY INFORMATION: Proposed with ClinicalTrials.gov; meeting the to the public visiting the RoPR Web site, Renewal of an Existing Project: OMB following objectives: and is readily available for public use. Control Number 0935–0203. a. Providing a searchable database of The RoPR is an ongoing data collection The Registry of Patient Registries patient registries in the United States (to initiative. (RoPR) is a web-based application, and promote collaboration, reduce does not require users to submit any Estimated Annual Respondent Burden redundancy, and improve type of paper form. transparency); Exhibit 1 shows the estimated The RoPR collects patient registry b. Facilitating the use of common data annualized burden hours for the data in two (2) ways: Users are able to fields and definitions in similar health respondent’s time to participate in the enter information into the web-based conditions (to improve opportunities for RoPR. Between July 2014 and June system manually, or use an automated sharing, comparing, and linkage) and 2015, 59 new respondents had entered upload feature. free-text search field for highlighting their RoPR record, utilizing either a Information being collected in the information specific to an individual manual or electronic upload data entry RoPR Record is visible to the public and registry; method. patient registries visiting the RoPR Web Each respondent need enter his or her jstallworth on DSK7TPTVN1PROD with NOTICES c. Providing a public repository of site, and is available for public use in searchable summary results (including new RoPR record only once, and this this capacity. results from registries that have not yet process is estimated to take 45 minutes. The RoPR system provides email been published in the peer-reviewed The RoPR system sends an automated notification to registry holders literature); reminder to any registry owner who has informing them on an annual basis of d. Offering a search tool to locate not updated his or her RoPR record in the need to update basic statistics and existing data that researchers can the past year. An estimated 57.25% (79 contact information, but it is the request for use in new studies; and records) of all RoPR records were VerDate Sep<11>2014 14:55 Dec 10, 2015 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\11DEN1.SGM 11DEN1

76990 Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices 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. VerDate Sep<11>2014 18:51 Dec 10, 2015 Jkt 238001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\11DEN1.SGM 11DEN1


Document Created: 2018-03-02 09:13:41
Document Modified: 2018-03-02 09:13:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this notice must be received by January 11, 2016.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation80 FR 76989 
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