81 FR 81770 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 223 (November 18, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81770-81772 | |
| FR Document | 2016-27705 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81770-81772] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27705] ======================================================================= ----------------------------------------------------------------------- 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: ``Pharmacy Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. DATES: Comments on this notice must be received by January 17, 2017. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [email protected]. Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]. SUPPLEMENTARY INFORMATION: Proposed Project Pharmacy Survey on Patient Safety Culture Comparative Database In 1999, the Institute of Medicine called for health care organizations to develop a ``culture of safety'' such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Pharmacy Survey on Patient Safety Culture with OMB approval (OMB NO. 0935-0183; Approved 08/12/2011). The survey is designed to enable pharmacies to assess staff opinions about patient and medication safety and quality-assurance issuesand includes 36 items that measure 11 dimensions of patient safety culture. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in October 2012 on the AHRQ Web site. The AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database consists of data from the AHRQ Pharmacy Survey on Patient Safety Culture. Pharmacies in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Pharmacy SOPS Database is modeled after three other SOPS databases: Hospital SOPS [OMB NO. 0935-0162; Approved 05/04/2010]; Medical Office SOPS [OMB NO. 0935-0196; Approved 06/12/12]; and Nursing Home SOPS [OMB NO. 0935-0195; Approved 06/12/12] that were originally developed by AHRQ in response to requests from hospitals, medical offices, and nursing homes interested in knowing how their patient safety culture survey results compare to those of other similar health care organizations. Rationale for the information collection. The Pharmacy SOPS survey and the Pharmacy SOPS Comparative Database will support AHRQ's goals of promoting improvements in the quality and safety of health care in pharmacy settings. The survey, toolkit materials, and comparative database results are all made publicly available on AHRQ's Web site. Technical assistance is provided by AHRQ through its contractor at no charge to pharmacies, to facilitate the use of these materials for pharmacy patient safety and quality improvement. Request for information collection approval. The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) reapprove, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database; OMB NO. 0935-0218, last approved on June 12, 2014. This database will: (1) Allow pharmacies to compare their patient safety culture survey results with those of other pharmacies, (2) provide data to pharmacies to facilitate internal assessment and learning in the patient safety improvement process, and (3) provide supplemental information to help pharmacies identify their strengths and areas with potential for improvement in patient safety culture. This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research 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; quality measure and development, and database development. 42 U.S.C. 299a(a)(1), (2), and 8. Method of Collection To achieve the goal of this project the following activities and data collections will be implemented: (1) Pharmacy Eligibility and Registration Form--The point of contact (POC), often the pharmacy manager of a participating organization, completes a number of data submission steps and forms, beginning with completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the pharmacy and initiate the registration process. (2) Data Use Agreement--The purpose of the data use agreement, completed by the pharmacy POC, is to state how data submitted by pharmacies will be used and provides confidentiality assurances. (3) Pharmacy Site Information Form--The purpose of this form, completed by the pharmacy POC, is to collect background characteristics of the pharmacy. This information will be used to analyze data collected with the Pharmacy SOPS survey. (4) Data Files Submission--POCs upload their data file(s), using the community pharmacy or hospital pharmacy data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted. The number of submissions to the database is likely to vary each year because pharmacies do not administer [[Page 81771]] the survey and submit data every year. Data submission is typically handled by one POC who is either a pharmacy manager or a survey vendor who contracts with a pharmacy to collect and submit its data. POCs submit data on behalf of 3 pharmacies, on average, because many pharmacies are part of a multi-pharmacy system, or the POC is a vendor that is submitting data for multiple pharmacies. Survey data from the AHRQ Pharmacy Survey on Patient Safety Culture are used to produce three types of products: (1) A Pharmacy SOPS Comparative Database Report that is made publicly available on the AHRQ Web site (see http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/pharmacy/pharm-reports.html), (2) Individual Pharmacy Survey Feedback Reports that are confidential, customized reports produced for each pharmacy that submits data to the database (the number of reports produced is based on the number of pharmacies submitting each year); and (3) Research data sets of individual-level and pharmacy-level de-identified data to enable researchers to conduct analyses. Pharmacies are asked to voluntarily submit their Pharmacy SOPS survey data to the comparative database. The data are then cleaned and aggregated and used to produce a Comparative Database Report that displays averages, standard deviations, and percentile scores on the survey's 36 items and 11 patient safety culture dimensions, as well as displaying these results by pharmacy characteristics (pharmacy type, number of locations, average number of prescriptions dispensed per week, etc.) and respondent characteristics (staff position, tenure, and hours worked per week). Data submitted by pharmacies are also used to give each pharmacy its own customized survey feedback report that presents the pharmacy's results compared to the latest comparative database results. If a pharmacy submits data more than once, its survey feedback report also presents trend data, comparing its previous and most recent data. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 100 POCs from community pharmacies and 50 POCs from hospital pharmacies, each representing an average of 3 individual pharmacies, will complete the database submission steps and forms. Completing the eligibility and registration form will take about 5 minutes. The Pharmacy Site Information Form is completed by all POCs for each of their pharmacies (150 x 3 = 450 forms in total) and is estimated to take 5 minutes to complete. Each POC will complete a data use agreement which takes 3 minutes to complete and submitting the data will take an hour on average. The total burden is estimated to be 209 hours. Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $11,222 annually. Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Number of Form name respondents/ responses per Hours per Total burden POCs POC response hours ---------------------------------------------------------------------------------------------------------------- Eligibility and Registration Form............... 150 1 5/60 13 Data Use Agreement.............................. 150 1 3/60 8 Pharmacy Site Information Form.................. 150 3 5/60 38 Data Files Submission........................... 150 1 1 150 --------------------------------------------------------------- Total....................................... NA NA NA 209 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Form name respondents/ Total burden Average hourly Total cost POCs hours wage rate * burden ---------------------------------------------------------------------------------------------------------------- Eligibility and Registration Form............... 150 13 $53.69 $698 Data Use Agreement.............................. 150 8 53.69 430 Pharmacy Site Information Form.................. 150 38 53.69 2,040 Data Files Submission........................... 150 150 53.69 8,054 --------------------------------------------------------------- Total....................................... NA 209 NA 11,222 ---------------------------------------------------------------------------------------------------------------- * Based on the weighted average hourly wage in community pharmacies for 100 General and Operations Managers (11- 1021; $49.26) and 50 General and Operations Managers (11-1021; $62.56) obtained from the May 2015 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 446110--Pharmacies and Drug Stores (located at http://www.bls.gov/oes/current/naics5_446110.htm) and NAICS 622000--Hospitals (located at http://www.bls.gov/oes/current/naics3_622000.htm). 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 [[Page 81772]] comments will become a matter of public record. Sharon B. Arnold, Deputy Director. [FR Doc. 2016-27705 Filed 11-17-16; 8:45 am] BILLING CODE 4160-90-P
![81770 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
5. Capital Market and L Fund Proposed Project Paperwork Reduction Act of 1995,
6. 2017 Proposed Internal Audit AHRQ’s collection of information for
Pharmacy Survey on Patient Safety
Schedule the AHRQ Pharmacy Survey on Patient
Culture Comparative Database
Safety Culture (Pharmacy SOPS)
7. Blended Retirement Update In 1999, the Institute of Medicine Comparative Database; OMB NO. 0935–
Closed Session called for health care organizations to 0218, last approved on June 12, 2014.
develop a ‘‘culture of safety’’ such that This database will:
Information covered under 5 U.S.C. their workforce and processes focus on (1) Allow pharmacies to compare
552b(c)(4), c(6), and (c)(9)(B). improving the reliability and safety of their patient safety culture survey
care for patients (IOM, 1999; To Err is results with those of other pharmacies,
Adjourn Human: Building a Safer Health (2) provide data to pharmacies to
System). To respond to the need for facilitate internal assessment and
CONTACT PERSON FOR MORE INFORMATION:
tools to assess patient safety culture in learning in the patient safety
Kimberly Weaver, Director, Office of health care, AHRQ developed and pilot improvement process, and
External Affairs, (202) 942–1640. tested the Pharmacy Survey on Patient (3) provide supplemental information
Dated: November 16, 2016. Safety Culture with OMB approval to help pharmacies identify their
Megan Grumbine, (OMB NO. 0935–0183; Approved 08/12/ strengths and areas with potential for
General Counsel, Federal Retirement Thrift 2011). The survey is designed to enable improvement in patient safety culture.
Investment Board. pharmacies to assess staff opinions This study is being conducted by
[FR Doc. 2016–27980 Filed 11–16–16; 4:15 pm] about patient and medication safety and AHRQ through its contractor, Westat,
BILLING CODE 6760–01–P quality-assurance issuesand includes 36 pursuant to AHRQ’s statutory authority
items that measure 11 dimensions of to conduct and support research on
patient safety culture. AHRQ made the health care and on systems for the
survey publicly available along with a delivery of such care, including
DEPARTMENT OF HEALTH AND Survey User’s Guide and other toolkit activities with respect to the quality,
HUMAN SERVICES materials in October 2012 on the AHRQ effectiveness, efficiency,
Web site. appropriateness and value of health care
Agency for Healthcare Research and The AHRQ Pharmacy Survey on services; quality measure and
Quality Patient Safety Culture (Pharmacy SOPS) development, and database
Comparative Database consists of data development. 42 U.S.C. 299a(a)(1), (2),
Agency Information Collection from the AHRQ Pharmacy Survey on and 8.
Activities: Proposed Collection; Patient Safety Culture. Pharmacies in
Comment Request the U.S. are asked to voluntarily submit Method of Collection
data from the survey to AHRQ, through To achieve the goal of this project the
AGENCY:Agency for Healthcare Research its contractor, Westat. The Pharmacy following activities and data collections
and Quality, HHS. SOPS Database is modeled after three will be implemented:
ACTION: Notice. other SOPS databases: Hospital SOPS (1) Pharmacy Eligibility and
[OMB NO. 0935–0162; Approved 05/04/ Registration Form—The point of contact
2010]; Medical Office SOPS [OMB NO. (POC), often the pharmacy manager of a
SUMMARY: This notice announces the
0935–0196; Approved 06/12/12]; and participating organization, completes a
intention of the Agency for Healthcare
Nursing Home SOPS [OMB NO. 0935– number of data submission steps and
Research and Quality (AHRQ) to request
0195; Approved 06/12/12] that were forms, beginning with completion of an
that the Office of Management and
originally developed by AHRQ in online Eligibility and Registration Form.
Budget (OMB) approve the proposed
response to requests from hospitals, The purpose of this form is to collect
information collection project:
medical offices, and nursing homes basic demographic information about
‘‘Pharmacy Survey on Patient Safety
interested in knowing how their patient the pharmacy and initiate the
Culture Comparative Database.’’ In
safety culture survey results compare to registration process.
accordance with the Paperwork
those of other similar health care (2) Data Use Agreement—The purpose
Reduction Act, 44 U.S.C. 3501–3521,
organizations. of the data use agreement, completed by
AHRQ invites the public to comment on Rationale for the information the pharmacy POC, is to state how data
this proposed information collection. collection. The Pharmacy SOPS survey submitted by pharmacies will be used
DATES: Comments on this notice must be and the Pharmacy SOPS Comparative and provides confidentiality assurances.
received by January 17, 2017. Database will support AHRQ’s goals of (3) Pharmacy Site Information Form—
promoting improvements in the quality The purpose of this form, completed by
ADDRESSES: Written comments should and safety of health care in pharmacy the pharmacy POC, is to collect
be submitted to: Doris Lefkowitz, settings. The survey, toolkit materials, background characteristics of the
Reports Clearance Officer, AHRQ, by and comparative database results are all pharmacy. This information will be
email at doris.lefkowitz@AHRQ.hhs.gov. made publicly available on AHRQ’s used to analyze data collected with the
Copies of the proposed collection Web site. Technical assistance is Pharmacy SOPS survey.
plans, data collection instruments, and provided by AHRQ through its (4) Data Files Submission—POCs
specific details on the estimated burden contractor at no charge to pharmacies, to upload their data file(s), using the
can be obtained from the AHRQ Reports facilitate the use of these materials for community pharmacy or hospital
mstockstill on DSK3G9T082PROD with NOTICES
Clearance Officer. pharmacy patient safety and quality pharmacy data file specifications, to
FOR FURTHER INFORMATION CONTACT:
improvement. ensure that users submit standardized
Request for information collection and consistent data in the way variables
Doris Lefkowitz, AHRQ Reports
approval. The Agency for Healthcare are named, coded, and formatted.
Clearance Officer, (301) 427–1477, or by
Research and Quality (AHRQ) requests The number of submissions to the
email at doris.lefkowitz@AHRQ.hhs.gov.
that the Office of Management and database is likely to vary each year
SUPPLEMENTARY INFORMATION: Budget (OMB) reapprove, under the because pharmacies do not administer
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![81772 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
comments will become a matter of 2. By regular mail. You may mail Information Collection: Programs for
public record. written comments to the following All-inclusive Care of the Elderly (PACE)
address: CMS, Office of Strategic and Supporting Regulations in 42 CFR
Sharon B. Arnold,
Operations and Regulatory Affairs, part 460; Use: This information
Deputy Director. collection addresses all operational
Division of Regulations Development,
[FR Doc. 2016–27705 Filed 11–17–16; 8:45 am] Attention: Document Identifier/OMB components of the PACE program (as
BILLING CODE 4160–90–P Control Number lll, Room C4–26– defined in 42 CFR part 460) with the
05, 7500 Security Boulevard, Baltimore, exception of the application process
Maryland 21244–1850. (§ 460.12). In this iteration the
DEPARTMENT OF HEALTH AND To obtain copies of a supporting application is removed from this control
HUMAN SERVICES statement and any related forms for the number and moved under a new
Centers for Medicare & Medicaid proposed collection(s) summarized in information collection request with a
this notice, you may make your request new CMS identification number (CMS–
Services
using one of following: 10631). An OMB control number
[Document Identifier: CMS–R–244] 1. Access CMS’ Web site address at specific to the application process is
http://www.cms.hhs.gov/ pending.
Agency Information Collection PaperworkReductionActof1995. The CMS–10631 information
Activities: Proposed Collection; 2. Email your request, including your collection request was submitted to
Comment Request address, phone number, OMB number, OMB on October 6, 2016, under ICR
AGENCY: Centers for Medicare & and CMS document identifier, to Reference No: 201610–0938–001. When
Medicaid Services, HHS. Paperwork@cms.hhs.gov. approved, the control number can be
ACTION: Notice. 3. Call the Reports Clearance Office at found on www.reginfo.gov/public/.
(410) 786–1326. We are removing the application
SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT:
requirements and burden since this
Medicaid Services (CMS) is announcing Reports Clearance Office at (410) 786– CMS–R–244 package is lengthy and we
an opportunity for the public to 1326. recognize that it can be somewhat time
comment on CMS’ intention to collect consuming to review. We believe the
information from the public. Under the SUPPLEMENTARY INFORMATION: change will help streamline the public
Paperwork Reduction Act of 1995 (the Contents and OMB’s review of the application as
PRA), federal agencies are required to well as the remaining requirements and
publish notice in the Federal Register This notice sets out a summary of the burden under this CMS–R–244 package.
concerning each proposed collection of use and burden associated with the Form Number: CMS–R–244 (OMB
information (including each proposed following information collections. More control number: 0938–0790); Frequency:
extension or reinstatement of an existing detailed information can be found in Once and occasionally; Affected Public:
collection of information) and to allow each collection’s supporting statement Private sector (Business or other for-
60 days for public comment on the and associated materials (see profits and Not-for-profit institutions);
ADDRESSES). Number of Respondents: 130; Total
proposed action. Interested persons are
invited to send comments regarding our CMS–R–244 Programs for All- Annual Responses: 145,455; Total
burden estimates or any other aspect of Inclusive Care of the Elderly (PACE) and Annual Hours: 61,350. (For policy
this collection of information, including Supporting Regulations in 42 CFR Part questions regarding this collection
any of the following subjects: (1) The 460 contact Debbie Van Hoven at 410–786–
necessity and utility of the proposed 6625).
Under the PRA (44 U.S.C. 3501–
information collection for the proper Dated: November 15, 2016.
3520), federal agencies must obtain
performance of the agency’s functions; William N. Parham, III,
approval from the Office of Management
(2) the accuracy of the estimated Director, Paperwork Reduction Staff, Office
and Budget (OMB) for each collection of
burden; (3) ways to enhance the quality, of Strategic Operations and Regulatory
information they conduct or sponsor.
utility, and clarity of the information to Affairs.
The term ‘‘collection of information’’ is
be collected; and (4) the use of [FR Doc. 2016–27836 Filed 11–17–16; 8:45 am]
defined in 44 U.S.C. 3502(3) and 5 CFR
automated collection techniques or
1320.3(c) and includes agency requests BILLING CODE 4120–01–P
other forms of information technology to
or requirements that members of the
minimize the information collection
public submit reports, keep records, or
burden. DEPARTMENT OF HEALTH AND
provide information to a third party.
DATES: Comments must be received by Section 3506(c)(2)(A) of the PRA HUMAN SERVICES
January 17, 2017. requires federal agencies to publish a Food and Drug Administration
ADDRESSES: When commenting, please 60-day notice in the Federal Register
reference the document identifier or concerning each proposed collection of [Docket No. FDA–2013–N–0804]
OMB control number. To be assured information, including each proposed
consideration, comments and extension or reinstatement of an existing Agency Information Collection
recommendations must be submitted in collection of information, before Activities; Proposed Collection;
any one of the following ways: submitting the collection to OMB for Comment Request; Premarket
1. Electronically. You may send your Notification
mstockstill on DSK3G9T082PROD with NOTICES
approval. To comply with this
comments electronically to http:// requirement, CMS is publishing this AGENCY: Food and Drug Administration,
www.regulations.gov. Follow the notice. HHS.
instructions for ‘‘Comment or ACTION: Notice.
Submission’’ or ‘‘More Search Options’’ Information Collection
to find the information collection 1. Type of Information Collection SUMMARY: The Food and Drug
document(s) that are accepting Request: Revision of a currently Administration (FDA) is announcing an
comments. approved collection; Title of opportunity for public comment on the
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Document Created: 2018-02-14 08:31:18
Document Modified: 2018-02-14 08:31:18
| 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 17, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 81 FR 81770 |
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