Agency Information Collection Activities: Proposed Collection; Comment Request, 26036-26039 [2021-09973]

Download as PDF 26036 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number. DATES: Written comments should be submitted on or before July 12, 2021. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible. Direct all PRA comments to Cathy Williams, FCC, via email to PRA@ fcc.gov and to Cathy.Williams@fcc.gov. FOR FURTHER INFORMATION CONTACT: For additional information about the information collection, contact Cathy Williams at (202) 418–2918. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060–0874. Title: Consumer Complaint Center: Informal Consumer Complaints. Form Number: N/A. Type of Review: Revision of a currently approved collection. Respondents: Individuals or households; Business or other for-profit entities; Not for profit institutions; State, Local or Tribal Government. Number of Respondents and Responses: 292,937 respondents; 292,937 responses. Estimated Time per Response: 15 minutes (.25 hour) to 1 hour. Frequency of Response: On occasion reporting requirement. Obligation to Respond: Voluntary. The statutory authority for this collection is contained in 47 U.S.C. 208 of the Communications Act of 1934, as amended (the Act). Total Annual Burden: 73,244 hours. Total Annual Cost: None. Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC’s updated system of records notice (SORN), FCC/CGB–1, ‘‘Informal Complaints, Inquiries and Requests for khammond on DSKJM1Z7X2PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 Dispute Assistance.’’ As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB–1 ‘‘Informal Complaints, Inquiries, and Requests for Dispute Assistance,’’ in the Federal Register on August 15, 2014 (79 FR 48152) which became effective on September 24, 2014. It may be reviewed at https:// www.fcc.gov/general/privacy-actinformation#systems. Privacy Impact Assessment: The FCC completed a Privacy Impact Assessment (PIA) on June 28, 2007. It may be reviewed at http://www.fcc.gov/omd/ privacyact/Privacy-ImpactAssessment.html. Needs and Uses: The Commission consolidated all of the FCC informal consumer complaint intake into an online consumer complaint portal, which allows the Commission to better manage the collection of informal consumer complaints. Informal consumer complaints consist of informal consumer complaints, inquiries and comments. This revised information collection requests OMB approval for the addition of a layer of consumer reported complaint information related to the National DeafBlind Equipment Distribution Program rules. The information collection burdens associated with these complaints is being transferred from OMB Control Number 3060–1225 (National Deaf-Blind Equipment Distribution Program) to OMB Control Number 3060–0874 to enable consumers to file complaints related to the National Deaf-Blind Equipment Distribution Program rules through the Commission’s Consumer Complaint Center. other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than May 27, 2021. A. Federal Reserve Bank of Dallas (Karen Smith, Director, Applications) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. The Trust Department at FirstBank Southwest, Amarillo, Texas; to retain voting shares of FirstPerryton Bancorp, Inc. (‘‘Company’’), Perryton, Texas, by becoming trustee of the Carl Ellis Separate Property FPB Stock Revocable Trust, Amarillo, Texas, which owns Company stock and thereby indirectly owns First Bank Southwest, Perryton, Texas. Additionally, the Ellis Family Trust—Julie Ellis FirstBank Southwest Trust S, and the Trust Department at FirstBank Southwest, as trustee, to acquire voting shares of the Company and to join the Ellis Family Group, a group acting in concert, all of Amarillo, Texas. Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary. Board of Governors of the Federal Reserve System, May 7, 2021. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2021–10002 Filed 5–11–21; 8:45 am] BILLING CODE 6712–01–P [FR Doc. 2021–10016 Filed 5–11–21; 8:45 am] BILLING CODE P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The public portions of the applications listed below, as well as PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request SUMMARY: E:\FR\FM\12MYN1.SGM 12MYN1 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices that the Office of Management and Budget (OMB) approve the proposed information collection project ‘‘Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.’’ Comments on this notice must be received by July 12, 2021 ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 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 doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: DATES: Proposed Project khammond on DSKJM1Z7X2PROD with NOTICES ‘‘Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats’’ The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine’s 1999 report, To Err is Human: Building a Safer Health System. The goal of the statute is to create a national learning system. By providing incentives of nation-wide confidentiality and legal privilege, the Patient Safety Act learning system improves patient safety and quality by providing an incentive for health care providers to work voluntarily with experts in patient safety to reduce risks and hazards to the safety and quality of patient care. The Patient Safety Act signifies the Federal Government’s commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs are able to identify VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 patterns of failures and propose measures to eliminate or reduce risks and hazards. In order to implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule, 42 CFR part 3) which became effective on January 19, 2009. The Patient Safety Rule outlines the requirements that entities must meet to become and remain listed as PSOs, the process by which the Secretary of HHS (Secretary) will accept certifications and list PSOs, and provisions pertaining to the confidentiality and privilege protections for patient safety work product (PSWP). When specific statutory requirements are met, the information collected and the analyses and deliberations regarding the information receive confidentiality and privilege protections under this legislation. The Secretary delegated authority to the Director of the Office for Civil Rights (OCR) to interpret and enforce the confidentiality protections of the Patient Safety Act (Federal Register, Vol. 71, No. 95, May 17, 2006, p. 28701–2). AHRQ implements and administers the rest of the statute’s provisions. Pursuant to the Patient Safety Rule (42 CFR 3.102), an entity that seeks to be listed as a PSO by the Secretary must certify that it meets certain requirements and, upon listing, would meet other criteria. To remain listed for renewable three-year periods, a PSO must re-certify that it meets these obligations and would continue to meet them while listed. The Patient Safety Act and Patient Safety Rule also impose other obligations discussed below that a PSO must meet to remain listed. In accordance with the requirements of the Patient Safety Rule (see, e.g., 42 CFR 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), and 3.112), the entities seeking to be listed and to remain listed must complete the proposed forms, in order to attest to compliance with statutory criteria and the corresponding regulatory requirements. Method of Collection With this submission, AHRQ is requesting approval of the following proposed administrative forms: 1. PSO Certification for Initial Listing Form. This form, containing certifications of eligibility and a capacity and intention to comply with statutory criteria and regulatory requirements, is to be completed, in accordance with 42 U.S.C. 299b–24(a)(1) and the above-cited regulatory certification provisions, by an entity PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 26037 seeking to be listed by the Secretary as a PSO for an initial three-year period. 2. PSO Certification for Continued Listing Form. In accordance with 42 U.S.C. 299b–24(a)(2) and the abovecited regulatory certification provisions, this form is to be completed by a listed PSO seeking continued listing by the Secretary as a PSO for each successive three-year period. 3. PSO Two Bona Fide Contracts Requirement Certification Form. To remain listed, a PSO must meet the requirement in 42 U.S.C. 299b– 24(b)(1)(C) that it has contracts with more than one provider, within successive 24-month periods, beginning with the date of the PSO’s initial listing. This form is to be used by a PSO to certify whether it has met this statutory requirement and the corresponding regulatory provision. 4. PSO Disclosure Statement Form. This form provides detailed instructions to a PSO regarding the disclosure statement it must submit and provides for the required certification by the PSO of the statement’s accuracy in accordance with 42 U.S.C. 299b– 24(b)(1)(E), when it (i) has a contract with a provider to carry out patient safety activities, and (ii) it has other financial, reporting, or contractual relationship(s) with that contracting provider, or it is not managed, controlled, and operated independently from that contracting provider. In accordance with the Patient Safety Act and the Patient Safety Rule, the Secretary is required to review each such report and make public findings as to whether a PSO can fairly and accurately carry out its responsibilities. 5. PSO Profile Form. This form is designed to collect voluntarily a minimum level of data necessary to develop aggregate statistics relating to PSOs, the types of providers they work with, and their general location in the US. The PSO Profile is intended to be completed annually by all PSOs that are ‘‘AHRQ-listed’’ during any part of the previous calendar year. This information is collected by AHRQ’s PSO Privacy Protection Center (PSOPPC) and is used to populate the AHRQ PSO selection tool on the AHRQ PSO website, to generate slides presented at the PSO Annual Meeting, and to develop content for the AHRQ National Healthcare Quality and Disparities Report, an annual quality report required by 42 U.S.C. 299b–2(b)(2). 6. PSO Change of Listing Information Form. The Secretary is required under 42 U.S.C. 299b–24(d) to maintain a publicly available list of PSOs. Under the Patient Safety Rule, that list includes, among other information, each E:\FR\FM\12MYN1.SGM 12MYN1 khammond on DSKJM1Z7X2PROD with NOTICES 26038 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices PSO’s current contact information. The Patient Safety Rule, at 42 CFR 3.102(a)(1)(vi), also requires that, during its period of listing, a PSO must promptly notify the Secretary of any changes in the accuracy of the information submitted for listing. 7. PSO Voluntary Relinquishment Form. A PSO may voluntarily relinquish its status as a PSO for any reason. Pursuant to 42 CFR 3.108(c)(2), in order for the Secretary to accept a PSO’s notification of voluntary relinquishment, the notice must contain certain attestations and future contact information. This form provides an efficient manner for a PSO seeking voluntary relinquishment to provide all of the required information. OCR is requesting approval of the following administrative form: Patient Safety Confidentiality Complaint Form. The purpose of this collection is to allow OCR to collect the minimum information needed from individuals filing patient safety confidentiality complaints with OCR so that there is a basis for initial processing of those complaints. In addition, AHRQ is requesting approval for a set of common definitions and reporting formats (Common Formats). As authorized by 42 U.S.C. 299b–23(b), AHRQ coordinates the development of the Common Formats that facilitate aggregation of comparable data at local, PSO, regional and national levels. The Common Formats allow PSOs and health care providers to voluntarily collect and submit standardized information regarding patient safety events to fulfill the national learning system envisioned by the Patient Safety Act. OMB previously approved the Common Formats and forms described above in 2008, 2011, 2014, and 2018. AHRQ will use these forms, other than the Patient Safety Confidentiality Complaint Form, to obtain information necessary to carry out its authority to implement the Patient Safety Act and Patient Safety Rule. This includes obtaining initial and subsequent certifications from entities seeking to be or remain listed as PSOs and for making the statutorily required determinations prior to and during an entity’s period of listing as a PSO. The PSO Division, housed in AHRQ’s Center for Quality Improvement and Patient Safety, uses this information. OCR will use the Patient Safety Confidentiality Complaint Form to collect information for the initial assessment of an incoming complaint. The form is modeled on OCR’s form for complaints alleging violations of the VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 privacy of protected health information. Use of the form is voluntary. It may help a complainant provide the essential information. Alternatively, a complainant may choose to submit a complaint in the form of a letter or electronically. An individual who needs help to submit a complaint in writing may call OCR for assistance. Estimated Annual Respondent Burden The PSO information collection forms described below will be implemented at different times and frequencies due to the voluntary nature of seeking listing and remaining listed as a PSO, filing an OCR Patient Safety Confidentiality Complaint Form, and using the Common Formats. The burden estimates are based on the average of the form submissions received over the past three years. Exhibit 1 shows the estimated annualized burden hours for the respondent to provide the requested information, and Exhibit 2 shows the estimated annualized cost burden associated with the respondents’ time to provide the requested information. The total burden hours are estimated to be 100,795.83 hours annually and the total cost burden is estimated to be $4,053,000.33 annually. PSO Certification for Initial Listing Form: The average annual burden for the collection of information requested by the certification form for initial listing is based upon a total average estimate of 10 respondents per year and an estimated time of 18 hours per response. The estimated response number includes submissions by not only entities listed as PSOs, but also entities that submit initial listing forms that do not become PSOs. After submitting a PSO Certification for Initial Listing Form, an entity may withdraw its form or submit a revised form, particularly after receiving technical assistance from AHRQ. In addition, AHRQ, on behalf of the Secretary, may deny listing if an entity does not meet the requirements of the Patient Safety Act and Patient Safety Rule. PSO Certification for Continued Listing Form: The average annual burden for the collection of information requested by the certification form for continued listing has an estimated time of eight hours per response and 42 responses annually. The PSO Certification for Continued Listing Form must be completed by any interested PSO at least 75 days before the end of its current three-year listing period. PSO Two Bona Fide Contracts Requirement Certification Form: The average annual burden for the collection of information requested by the PSO PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Two Bona Fide Contract Certification Form is based upon an estimate of 51 respondents per year and an estimated one hour per response. This collection of information takes place once per 24month period when the PSO notifies the Secretary that it has two contracts with providers that meet the requirements. PSO Disclosure Statement Form: The average burden for the collection of information requested by the Disclosure Statement Form is based upon an estimate of two respondents per year and estimated three hours per response. This information collection takes place within 45 days of when a PSO begins having any of the specified types of additional relationships with a provider with which it has a contract to carry out patient safety activities. PSO Profile Form. The overall annual burden for the collection of information requested by the PSO Profile Form is based upon an estimate of 72 respondents per year and an estimated three hours per response. The collection of information takes place annually; newly listed PSOs may first submit the form in the calendar year after their initial listing by the Secretary. PSO Change of Listing Information Form: The average annual burden for the collection of information requested by the PSO Change of Listing Information Form is based upon an estimate of 54 respondents per year and an estimated time of five minutes per response. This collection of information takes place on an ongoing basis as needed when there are changes to the PSO’s listing information. PSO Voluntary Relinquishment Form: The average annual burden for the collection of information requested by the PSO Voluntary Relinquishment Form is based upon a total average estimate of four respondents per year and an estimated time of thirty minutes per response. OCR Patient Safety Confidentiality Complaint Form: The overall annual burden estimate for the collection of information requested by the OCR Patient Safety Confidentiality Complaint Form is based on an estimate of one respondent per year and an estimated twenty minutes per response. The voluntary use of the form may occur when an allegation of a violation of the confidentiality protections of the Patient Safety Act is made. Common Formats: AHRQ estimates that 5% full time equivalent (FTE) of a patient safety manager at a facility will be spent to administer the Common Formats, which is approximately 100 hours a year. The use of the formats by PSOs and other entities is voluntary and is on an ongoing basis. This estimate of E:\FR\FM\12MYN1.SGM 12MYN1 26039 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices the 1,000 respondents is based on the feedback that AHRQ has received during meetings and technical assistance calls from PSOs and other entities that have been utilizing the formats. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Form Hours per response Total burden hours PSO Certification for Initial Listing Form ......................................................... PSO Certification for Continued Listing Form ................................................. PSO Two Bona Fide Contracts Requirement Form ........................................ PSO Disclosure Statement Form .................................................................... PSO Profile Form ............................................................................................ PSO Change of Listing Information ................................................................. PSO Voluntary Relinquishment Form .............................................................. OCR Patient Safety Confidentiality Complaint Form ....................................... Common Formats ............................................................................................ 10 42 51 2 72 54 4 1 1,000 1 1 1 1 1 1 1 1 1 18 8 1 3 3 05/60 30/60 20/60 100 180 336 51 6 216 4.50 2 .33 100,000 Total .......................................................................................................... ........................ NA NA 100,795.83 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Total burden hours Number of respondents Form Average hourly wage rate * Total cost PSO Certification for Initial Listing Form ......................................................... PSO Certification for Continued Listing Form ................................................. PSO Two Bona Fide Contracts Requirement Form ........................................ PSO Disclosure Statement Form .................................................................... PSO Profile Form ............................................................................................ PSO Change of Listing Form .......................................................................... PSO Voluntary Relinquishment Form .............................................................. OCR Patient Safety Confidentiality Complaint Form ....................................... Common Formats ............................................................................................ 10 42 51 2 72 54 4 1 1,000 180 336 51 6 216 4.50 2 .33 100,000 $40.21 40.21 40.21 40.21 40.21 40.21 40.21 40.21 40.21 $7,237.80 13,510.56 2,050.71 241.26 8,685.36 180.95 80.42 13.27 4,021,000.00 Total .......................................................................................................... ........................ ........................ ........................ 4,053,000.33 * Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29–0000, National Compensation Survey, May 2019, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ https://www.bls.gov/oes/current/oes290000.htm. khammond on DSKJM1Z7X2PROD with NOTICES Request for Comments In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, 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’s health care research and health care information dissemination functions, including whether the information will have practical utility; and, for OCR’s enforcement of confidentiality; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 comments will become a matter of public record. Dated: May 6, 2021. Marquita Cullom, Associate Director. [FR Doc. 2021–09973 Filed 5–11–21; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–7062–N] Request for Nominations and Announcement of the Advisory Panel on Outreach and Education (APOE) May 26, 2021 Virtual Meeting Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Notice. AGENCY: This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). This meeting is open to the public. DATES: Meeting Date: Wednesday, May 26, 2021 from 12:00 p.m. to 5:00 p.m. eastern daylight time (e.d.t). Deadline for Meeting Registration, Presentations, Special Accommodations, and Comments: Wednesday, May 19, 2021, 5:00 p.m. (e.d.t). Deadline for Submitting Nominations: Nominations will be considered if we receive them at the appropriate address, E:\FR\FM\12MYN1.SGM 12MYN1

Agencies

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26036-26039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09973]


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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

[[Page 26037]]

that the Office of Management and Budget (OMB) approve the proposed 
information collection project ``Patient Safety Organization 
Certification for Initial Listing and Related Forms, Patient Safety 
Confidentiality Complaint Form, and Common Formats.''

DATES: Comments on this notice must be received by July 12, 2021

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

``Patient Safety Organization Certification for Initial Listing and 
Related Forms, Patient Safety Confidentiality Complaint Form, and 
Common Formats''

    The Patient Safety and Quality Improvement Act of 2005 (Patient 
Safety Act), signed into law on July 29, 2005, was enacted in response 
to growing concern about patient safety in the United States and the 
Institute of Medicine's 1999 report, To Err is Human: Building a Safer 
Health System. The goal of the statute is to create a national learning 
system. By providing incentives of nation-wide confidentiality and 
legal privilege, the Patient Safety Act learning system improves 
patient safety and quality by providing an incentive for health care 
providers to work voluntarily with experts in patient safety to reduce 
risks and hazards to the safety and quality of patient care. The 
Patient Safety Act signifies the Federal Government's commitment to 
fostering a culture of patient safety among health care providers; it 
offers a mechanism for creating an environment in which the causes of 
risks and hazards to patient safety can be thoroughly and honestly 
examined and discussed without fear of penalties and liabilities. It 
provides for the voluntary formation of Patient Safety Organizations 
(PSOs) that can collect, aggregate, and analyze confidential 
information reported voluntarily by health care providers. By analyzing 
substantial amounts of patient safety event information across multiple 
institutions, PSOs are able to identify patterns of failures and 
propose measures to eliminate or reduce risks and hazards.
    In order to implement the Patient Safety Act, the Department of 
Health and Human Services (HHS) issued the Patient Safety and Quality 
Improvement Final Rule (Patient Safety Rule, 42 CFR part 3) which 
became effective on January 19, 2009. The Patient Safety Rule outlines 
the requirements that entities must meet to become and remain listed as 
PSOs, the process by which the Secretary of HHS (Secretary) will accept 
certifications and list PSOs, and provisions pertaining to the 
confidentiality and privilege protections for patient safety work 
product (PSWP).
    When specific statutory requirements are met, the information 
collected and the analyses and deliberations regarding the information 
receive confidentiality and privilege protections under this 
legislation. The Secretary delegated authority to the Director of the 
Office for Civil Rights (OCR) to interpret and enforce the 
confidentiality protections of the Patient Safety Act (Federal 
Register, Vol. 71, No. 95, May 17, 2006, p. 28701-2). AHRQ implements 
and administers the rest of the statute's provisions.
    Pursuant to the Patient Safety Rule (42 CFR 3.102), an entity that 
seeks to be listed as a PSO by the Secretary must certify that it meets 
certain requirements and, upon listing, would meet other criteria. To 
remain listed for renewable three-year periods, a PSO must re-certify 
that it meets these obligations and would continue to meet them while 
listed. The Patient Safety Act and Patient Safety Rule also impose 
other obligations discussed below that a PSO must meet to remain 
listed. In accordance with the requirements of the Patient Safety Rule 
(see, e.g., 42 CFR 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), and 
3.112), the entities seeking to be listed and to remain listed must 
complete the proposed forms, in order to attest to compliance with 
statutory criteria and the corresponding regulatory requirements.

Method of Collection

    With this submission, AHRQ is requesting approval of the following 
proposed administrative forms:
    1. PSO Certification for Initial Listing Form. This form, 
containing certifications of eligibility and a capacity and intention 
to comply with statutory criteria and regulatory requirements, is to be 
completed, in accordance with 42 U.S.C. 299b-24(a)(1) and the above-
cited regulatory certification provisions, by an entity seeking to be 
listed by the Secretary as a PSO for an initial three-year period.
    2. PSO Certification for Continued Listing Form. In accordance with 
42 U.S.C. 299b-24(a)(2) and the above-cited regulatory certification 
provisions, this form is to be completed by a listed PSO seeking 
continued listing by the Secretary as a PSO for each successive three-
year period.
    3. PSO Two Bona Fide Contracts Requirement Certification Form. To 
remain listed, a PSO must meet the requirement in 42 U.S.C. 299b-
24(b)(1)(C) that it has contracts with more than one provider, within 
successive 24-month periods, beginning with the date of the PSO's 
initial listing. This form is to be used by a PSO to certify whether it 
has met this statutory requirement and the corresponding regulatory 
provision.
    4. PSO Disclosure Statement Form. This form provides detailed 
instructions to a PSO regarding the disclosure statement it must submit 
and provides for the required certification by the PSO of the 
statement's accuracy in accordance with 42 U.S.C. 299b-24(b)(1)(E), 
when it (i) has a contract with a provider to carry out patient safety 
activities, and (ii) it has other financial, reporting, or contractual 
relationship(s) with that contracting provider, or it is not managed, 
controlled, and operated independently from that contracting provider. 
In accordance with the Patient Safety Act and the Patient Safety Rule, 
the Secretary is required to review each such report and make public 
findings as to whether a PSO can fairly and accurately carry out its 
responsibilities.
    5. PSO Profile Form. This form is designed to collect voluntarily a 
minimum level of data necessary to develop aggregate statistics 
relating to PSOs, the types of providers they work with, and their 
general location in the US. The PSO Profile is intended to be completed 
annually by all PSOs that are ``AHRQ-listed'' during any part of the 
previous calendar year. This information is collected by AHRQ's PSO 
Privacy Protection Center (PSOPPC) and is used to populate the AHRQ PSO 
selection tool on the AHRQ PSO website, to generate slides presented at 
the PSO Annual Meeting, and to develop content for the AHRQ National 
Healthcare Quality and Disparities Report, an annual quality report 
required by 42 U.S.C. 299b-2(b)(2).
    6. PSO Change of Listing Information Form. The Secretary is 
required under 42 U.S.C. 299b-24(d) to maintain a publicly available 
list of PSOs. Under the Patient Safety Rule, that list includes, among 
other information, each

[[Page 26038]]

PSO's current contact information. The Patient Safety Rule, at 42 CFR 
3.102(a)(1)(vi), also requires that, during its period of listing, a 
PSO must promptly notify the Secretary of any changes in the accuracy 
of the information submitted for listing.
    7. PSO Voluntary Relinquishment Form. A PSO may voluntarily 
relinquish its status as a PSO for any reason. Pursuant to 42 CFR 
3.108(c)(2), in order for the Secretary to accept a PSO's notification 
of voluntary relinquishment, the notice must contain certain 
attestations and future contact information. This form provides an 
efficient manner for a PSO seeking voluntary relinquishment to provide 
all of the required information.
    OCR is requesting approval of the following administrative form:

Patient Safety Confidentiality Complaint Form. The purpose of this 
collection is to allow OCR to collect the minimum information needed 
from individuals filing patient safety confidentiality complaints with 
OCR so that there is a basis for initial processing of those 
complaints.

    In addition, AHRQ is requesting approval for a set of common 
definitions and reporting formats (Common Formats). As authorized by 42 
U.S.C. 299b-23(b), AHRQ coordinates the development of the Common 
Formats that facilitate aggregation of comparable data at local, PSO, 
regional and national levels. The Common Formats allow PSOs and health 
care providers to voluntarily collect and submit standardized 
information regarding patient safety events to fulfill the national 
learning system envisioned by the Patient Safety Act.
    OMB previously approved the Common Formats and forms described 
above in 2008, 2011, 2014, and 2018. AHRQ will use these forms, other 
than the Patient Safety Confidentiality Complaint Form, to obtain 
information necessary to carry out its authority to implement the 
Patient Safety Act and Patient Safety Rule. This includes obtaining 
initial and subsequent certifications from entities seeking to be or 
remain listed as PSOs and for making the statutorily required 
determinations prior to and during an entity's period of listing as a 
PSO. The PSO Division, housed in AHRQ's Center for Quality Improvement 
and Patient Safety, uses this information.
    OCR will use the Patient Safety Confidentiality Complaint Form to 
collect information for the initial assessment of an incoming 
complaint. The form is modeled on OCR's form for complaints alleging 
violations of the privacy of protected health information. Use of the 
form is voluntary. It may help a complainant provide the essential 
information. Alternatively, a complainant may choose to submit a 
complaint in the form of a letter or electronically. An individual who 
needs help to submit a complaint in writing may call OCR for 
assistance.

Estimated Annual Respondent Burden

    The PSO information collection forms described below will be 
implemented at different times and frequencies due to the voluntary 
nature of seeking listing and remaining listed as a PSO, filing an OCR 
Patient Safety Confidentiality Complaint Form, and using the Common 
Formats. The burden estimates are based on the average of the form 
submissions received over the past three years.
    Exhibit 1 shows the estimated annualized burden hours for the 
respondent to provide the requested information, and Exhibit 2 shows 
the estimated annualized cost burden associated with the respondents' 
time to provide the requested information. The total burden hours are 
estimated to be 100,795.83 hours annually and the total cost burden is 
estimated to be $4,053,000.33 annually.
    PSO Certification for Initial Listing Form: The average annual 
burden for the collection of information requested by the certification 
form for initial listing is based upon a total average estimate of 10 
respondents per year and an estimated time of 18 hours per response. 
The estimated response number includes submissions by not only entities 
listed as PSOs, but also entities that submit initial listing forms 
that do not become PSOs. After submitting a PSO Certification for 
Initial Listing Form, an entity may withdraw its form or submit a 
revised form, particularly after receiving technical assistance from 
AHRQ. In addition, AHRQ, on behalf of the Secretary, may deny listing 
if an entity does not meet the requirements of the Patient Safety Act 
and Patient Safety Rule.
    PSO Certification for Continued Listing Form: The average annual 
burden for the collection of information requested by the certification 
form for continued listing has an estimated time of eight hours per 
response and 42 responses annually. The PSO Certification for Continued 
Listing Form must be completed by any interested PSO at least 75 days 
before the end of its current three-year listing period.
    PSO Two Bona Fide Contracts Requirement Certification Form: The 
average annual burden for the collection of information requested by 
the PSO Two Bona Fide Contract Certification Form is based upon an 
estimate of 51 respondents per year and an estimated one hour per 
response. This collection of information takes place once per 24-month 
period when the PSO notifies the Secretary that it has two contracts 
with providers that meet the requirements.
    PSO Disclosure Statement Form: The average burden for the 
collection of information requested by the Disclosure Statement Form is 
based upon an estimate of two respondents per year and estimated three 
hours per response. This information collection takes place within 45 
days of when a PSO begins having any of the specified types of 
additional relationships with a provider with which it has a contract 
to carry out patient safety activities.
    PSO Profile Form. The overall annual burden for the collection of 
information requested by the PSO Profile Form is based upon an estimate 
of 72 respondents per year and an estimated three hours per response. 
The collection of information takes place annually; newly listed PSOs 
may first submit the form in the calendar year after their initial 
listing by the Secretary.
    PSO Change of Listing Information Form: The average annual burden 
for the collection of information requested by the PSO Change of 
Listing Information Form is based upon an estimate of 54 respondents 
per year and an estimated time of five minutes per response. This 
collection of information takes place on an ongoing basis as needed 
when there are changes to the PSO's listing information.
    PSO Voluntary Relinquishment Form: The average annual burden for 
the collection of information requested by the PSO Voluntary 
Relinquishment Form is based upon a total average estimate of four 
respondents per year and an estimated time of thirty minutes per 
response.
    OCR Patient Safety Confidentiality Complaint Form: The overall 
annual burden estimate for the collection of information requested by 
the OCR Patient Safety Confidentiality Complaint Form is based on an 
estimate of one respondent per year and an estimated twenty minutes per 
response. The voluntary use of the form may occur when an allegation of 
a violation of the confidentiality protections of the Patient Safety 
Act is made.
    Common Formats: AHRQ estimates that 5% full time equivalent (FTE) 
of a patient safety manager at a facility will be spent to administer 
the Common Formats, which is approximately 100 hours a year. The use of 
the formats by PSOs and other entities is voluntary and is on an 
ongoing basis. This estimate of

[[Page 26039]]

the 1,000 respondents is based on the feedback that AHRQ has received 
during meetings and technical assistance calls from PSOs and other 
entities that have been utilizing the formats.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                      Form                           Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
PSO Certification for Initial Listing Form......              10               1              18             180
PSO Certification for Continued Listing Form....              42               1               8             336
PSO Two Bona Fide Contracts Requirement Form....              51               1               1              51
PSO Disclosure Statement Form...................               2               1               3               6
PSO Profile Form................................              72               1               3             216
PSO Change of Listing Information...............              54               1           05/60            4.50
PSO Voluntary Relinquishment Form...............               4               1           30/60               2
OCR Patient Safety Confidentiality Complaint                   1               1           20/60             .33
 Form...........................................
Common Formats..................................           1,000               1             100         100,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............              NA              NA      100,795.83
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly
                      Form                          respondents        hours        wage rate *     Total cost
----------------------------------------------------------------------------------------------------------------
PSO Certification for Initial Listing Form......              10             180          $40.21       $7,237.80
PSO Certification for Continued Listing Form....              42             336           40.21       13,510.56
PSO Two Bona Fide Contracts Requirement Form....              51              51           40.21        2,050.71
PSO Disclosure Statement Form...................               2               6           40.21          241.26
PSO Profile Form................................              72             216           40.21        8,685.36
PSO Change of Listing Form......................              54            4.50           40.21          180.95
PSO Voluntary Relinquishment Form...............               4               2           40.21           80.42
OCR Patient Safety Confidentiality Complaint                   1             .33           40.21           13.27
 Form...........................................
Common Formats..................................           1,000         100,000           40.21    4,021,000.00
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............    4,053,000.33
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29-
  0000, National Compensation Survey, May 2019, ``U.S. Department of Labor, Bureau of Labor Statistics.'' https://www.bls.gov/oes/current/oes290000.htm.

Request for Comments

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, 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's health 
care research and health care information dissemination functions, 
including whether the information will have practical utility; and, for 
OCR's enforcement of confidentiality; (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.

    Dated: May 6, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-09973 Filed 5-11-21; 8:45 am]
BILLING CODE 4160-90-P