21744 Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices 

• Fax: 202–501–4067. 

• Mail: General Services 

Administration, Regulatory Secretariat 

(MVCB), 1275 First Street, NE., 

Washington, DC 20417. Attn: Hada 

Flowers/IC 3090–0200. 

Instructions: Please submit comments 

only and cite Information Collection 

3090–0200, in all correspondence 

related to this collection. All comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal and/or business 

confidential information provided. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The General Services Administration 

is requesting that the Office of 

Management and Budget (OMB) review 

and approve information collection, 

3090–0200, Sealed Bidding. The 

information requested regarding an 

offeror’s monthly production capability 

is needed to make progressive awards to 

ensure coverage of stock items. 

B. Annual Reporting Burden 

Respondents: 10. 

Responses per Respondent: 1. 

Hours per Response: .5. 

Total Burden Hours: 5. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVCB), 1275 

First Street, NE., Washington, DC 20417, 

telephone (202) 501–4755. Please cite 

OMB Control No. 3090–0200, Sealed 

Bidding, in all correspondence. 

Dated: April 11, 2011. 

Millisa Gary, 

Acting Director, Office of Governmentwide 

Acquisition Policy. 

[FR Doc. 2011–9264 Filed 4–15–11; 8:45 am] 

BILLING CODE 6820–61–P 

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: ‘‘Patient 

Safety Organization Certification for 

Initial Listing and Related Forms, 

Patient Safety Confidentiality Complaint 

Form, and Common Formats. 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 June 17, 2011. 

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 

e-mail at dorislefkowitz@AHRQ.hhs.gov. 

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 (hereafter the 

Patient Safety Act), 42 U.S.C. 299b–21 

to 299b–26, 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 improve 

patient safety 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 will be able to 

identify patterns of failures and propose 

measures to eliminate or reduce patient 

safety 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 (hereafter the Patient Safety 

Rule), 42 CFR part 3, which became 

effective on January 19, 2009. The 

Patient Safety Rule establishes a 

framework by which hospitals, doctors, 

and other health care providers may 

voluntarily report information to PSOs, 

on a privileged and confidential basis, 

for the aggregation and analysis of 

patient safety events. In addition, the 

Patient Safety Rule outlines the 

requirements that entities must meet to 

become PSOs and the process by which 

the Secretary of HHS (hereafter the 

Secretary) will review and accept 

certifications and list PSOs. 

In addition to the Patient Safety Act 

and the Patient Safety Rule, HHS issued 

Guidance Regarding Patient Safety 

Organizations’ Reporting Obligations 

and the Patient Safety and Quality 

Improvement Act of 2005 (hereafter 

Guidance) on December 30, 2010. The 

Guidance addresses questions that have 

arisen regarding the obligations of PSOs 

where they or the organization of which 

they are a part are legally obligated 

under the Federal Food, Drug, and 

Cosmetic Act (FDCA) and its 

implementing regulations to report 

certain information to the Food and 

Drug Administration (FDA) and to 

provide FDA with access to its records, 

including access during an inspection of 

its facilities. This Guidance applies to 

all entities that seek to be or are PSOs 

or component PSOs that have 

mandatory FDA-reporting obligations 

under the FDCA and its implementing 

regulations (‘‘FDA-regulated reporting 

entities’’) or are organizationally related 

to such FDA-regulated reporting entities 

(e.g., parent organizations, subsidiaries, 

sibling organizations). 

When PSOs meet the requirements of 

the Patient Safety Act, the information 

collected and the analyses and 

deliberations regarding the information 

receive Federal confidentiality and 

privilege protections under this 

legislation. The Secretary delegated 

authority to the Director of the Office for 

Civil Rights (OCR) to enforce the 

confidentiality protections of the Patient 

Safety Act. 71 Federal Register 28701– 

28702 (May 17, 2006). OCR is 

responsible for enforcing protections 

regarding patient safety work product 

(PSWP), which generally includes 

information that could improve patient 

safety, health care quality, or health care 

outcomes and (1) is assembled or 

developed by a provider for reporting to 

a PSO and is reported to a PSO or (2) 

is developed by a PSO for the conduct 

of patient safety activities. Civil money 

penalties may be imposed for knowing 

or reckless impermissible disclosures of 


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Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices 21745 

PSWP. AHRQ implements and 

administers the rest of the Patient Safety 

Act’s provisions. 

Pursuant to 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, 

will meet other criteria. To remain listed 

for renewable three-year periods, a PSO 

must recertify that it meets these 

obligations and will 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 

order for the Secretary to administer the 

Patient Safety Act and Rule, the entities 

seeking to be listed and to remain listed 

must complete the proposed forms 

attached hereto. 

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, which is to be 

completed by an entity seeking to be 

listed by the Secretary as a PSO for an 

initial three-year period, contains 

certifications that the entity meets the 

requirements for listing as a PSO, in 

accordance with 42 U.S.C. 299b–24(a)(1) 

and 42 CFR 3.102. 

2. PSO Certification for Continued 

Listing Form. In accordance with 42 

U.S.C. 299b–24(a)(2) and the Patient 

Safety Rule, this form is to be completed 

by a listed PSO seeking continued 

listing as a PSO by the Secretary for an 

additional three year period. 

3. PSO Two Bona Fide Contracts 

Requirement Certification Form. To 

remain listed, a PSO must have 

contracts with more than one provider, 

within successive 24 month periods, 

beginning with the date of its initial 

listing. 42 U.S.C. 299(b)(1)(C). This form 

is to be used by a PSO to certify whether 

it has met this requirement. 

4. PSO Disclosure Statement Form. A 

PSO must submit this form when it (i) 

has a Patient Safety Act contract with a 

health care provider and (ii) it has 

financial, reporting, and contractual 

relationships with that contracting 

provider or is not independent of that 

contracting provider. 42 U.S.C. 299b–24; 

42 CFR 3.102(d)(2). 

5. PSO Information Form. This form 

gathers information on PSOs and the 

type of healthcare providers and settings 

that they are working with to conduct 

patient safety activities in order to 

improve patient safety. It is designed to 

collect a minimum level of data 

necessary to develop aggregate statistics 

relating to the Patient Safety Act, 

including types of institutions 

participating and their general location 

in the US. This information will be 

included in AHRQ’s annual quality 

report, as required by 42 U.S.C. 299b– 

23(c). 

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 our 

office so that we have a basis for initial 

processing of those complaints. 

In addition, AHRQ is requesting 

approval for a set of common definitions 

and reporting formats (hereafter 

Common Formats). Pursuant to 42 

U.S.C. 299b–23(b), AHRQ coordinates 

the development of the Common 

Formats that allow PSOs and health care 

providers to voluntarily collect and 

submit standardized information 

regarding patient safety events. 

Estimated Annual Respondent Burden 

While there are a number of 

information collection forms described 

below, they will be implemented at 

different times and frequency due to the 

voluntary nature of seeking listing as a 

PSO and using the Common Formats. 

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 

75,764 hours annually and the total cost 

burden is estimated to be $2,538,852 

annually. 

PSO Certification for Initial Listing Form 

The average annual burden for the 

collection of information requested by 

the certification forms for initial listing 

is based upon a total average estimate of 

15 respondents per year and an 

estimated time of 18 hours per response. 

This collection of information takes 

place on an ongoing basis. 

Certification for Continued Listing Form 

The average annual burden for the 

collection of information requested by 

the certification form for continued 

listing is based upon the estimate that 

90% of the listed PSOs during the 

3 years of this clearance, or 24 PSOs 

annually, will submit forms with an 

estimated time of eight hours per 

response. The Certification for 

Continued Listing Form will be 

completed by any interested PSO at 

least 75 days before the end of its 

current three-year listing period. 

Two Bona Fide Contracts Requirement 

Certification 

The average annual burden for the 

collection of information requested by 

the two-contract requirement is based 

upon an estimate of 40 respondents per 

year and an estimated one hour per 

response. This collection of information 

takes place when the PSO notifies the 

Secretary that it has entered into two 

contracts. 

Disclosure Statement Form 

AHRQ assumes that only a small 

percentage of entities will need to file a 

disclosure form. However, AHRQ is 

providing a high estimate of 7 

respondents annually and thus 

presumably overestimating respondent 

burden. The average annual burden 

estimate of 21 hours for the collection 

of information requested by the 

disclosure form is based upon an 

estimated three hours per response. This 

information collection takes place when 

a PSO first reports having any of the 

specified types of additional 

relationships with a health care 

provider with which it has a contract to 

carry out patient safety activities. 

Information Form 

The overall annual burden estimate of 

240 hours for the collection of 

information requested by the PSO 

Information Form is based upon an 

estimate of 80 respondents per year and 

an estimated three hours per response. 

This information collection will begin 

in 2011; newly listed PSOs will first 

report in the calendar year after their 

listing by the HHS Secretary. 

Patient Safety Confidentiality 

Complaint Form 

The overall annual burden estimate of 

1 hour for the collection of information 

requested by the form is based on an 

estimate of two respondents per year 

and an estimated 20 minutes per 

response. OCR’s information collection 

using this form will not begin until after 

there is at least one PSO receiving and 

generating PSWP and there is an 

allegation of a violation of the statutory 

protection of PSWP. 

Common Formats 

AHRQ estimates that 5% FTE of a 

Patient Safety Manager at a hospital will 

be spent to administer the Common 

Formats, which is approximately 100 

hours a year. AHRQ estimates the 

number of hospitals using Common 

Formats in the first year as 500, then 

750 in year 2, and 1000 in year 3, for 

an annual average of 750 over 3 years. 


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21746 Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Patient Safety Organization Certification for Initial Listing Form ..................... 15 1 18 270 

Certification for Continued Listing Form .......................................................... 24 1 8 192 

Two Bona Fide Contracts Requirement Form ................................................. 40 1 1 40 

Disclosure Statement Form ............................................................................. 7 1 3 21 

Information Form ............................................................................................. 80 1 3 240 

Patient Safety Confidentiality Complaint Form ................................................ 2 1 20/60 1 

Common Formats ............................................................................................ 750 1 100 75,000 

Total .......................................................................................................... 918 NA NA 75,764

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total burden 

cost 

Certification for Initial Listing Form .................................................................. 15 270 $33.51 $9,048 

Certification for Continued Listing Form .......................................................... 24 192 33.51 6,434 

Two Bona Fide Contracts Requirement Form ................................................. 40 40 33.51 1,340 

Disclosure Statement Form ............................................................................. 7 21 33.51 704 

Information Form ............................................................................................. 80 240 33.51 8,042

Patient Safety Confidentiality Complaint Form ................................................ 2 1 33.51 34 

Common Formats ............................................................................................ 750 75,000 33.51 2,513,250 

Total .......................................................................................................... 918 75,764 NA 2,538,852 

* Based upon the mean of the hourly wages for healthcare practitioner and technical occupation, National Compensation Survey, May 2009, 

‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

a. AHRQ 

The total cost to the Federal 

Government for the PSO forms and 

Common Formats is $1,737,390 per 

year, including project management and 

support for the review and 

administration of the PSO forms and the 

development and maintenance of the 

Common Formats. 

b. OCR 

Through an interagency agreement 

(IAA), OCR provides management for 

and support of the enforcement of the 

confidentiality protections of the Patient 

Safety Act and the Patient Safety Rule. 

The cost of this IAA is approximately 

$300,000 annually. 

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 healthcare 

research and healthcare 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. 

Dated: March 29, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–9252 Filed 4–15–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Generic Clearance 

for the Collection of Qualitative 

Feedback on Agency Service Delivery 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice. 

SUMMARY: As part of a Federal 

Government-wide effort to streamline 

the process to seek feedback from the 

public on service delivery, AHRQ [has 

submitted a Generic Information 

Collection Request (Generic ICR): 

‘‘Generic Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery’’ to OMB for approval under 

the Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.). 

This proposed information collection 

was previously published in the Federal 

Register on December 22nd, 2010 (75 

FR 80542) and allowed 60 days for 

public comment. No comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. 

DATES: Comments must be submitted 

May 18, 2011. 

ADDRESSES: Written comments may be 

submitted to: AHRQ’s OMB Desk Officer 

by fax at (202) 395–6974 (attention: 

AHRQ’s desk officer) or by e-mail at 

OIRAsubmission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

FOR FURTHER INFORMATION CONTACT: To 

request additional information, please 

contact: Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at 

doris.lefkowitz@AHRO.hhs.gov. 


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