9336 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Notices 

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, Department of Health and 

Human Services. 

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) allow information 

collection related to implementation of 

the Patient Safety and Quality 

Improvement Act of 2005, 42 U.S.C. 

299b–21 to 299b–26, in: ‘‘Patient Safety 

Organization Certification and Related 

Forms and a Patient Safety 

Confidentiality Complaint Form.’’ In 

accordance with the Paperwork 

Reduction Act of 1995, 44 U.S.C. 

3506(c)(2)(A), AHRQ invites the public 

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by April 21, 2008. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, 540 

Gaither Road, Room #5036; Rockville, 

MD 20850, or by e-mail 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 AHRQ’s Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ, Reports 

Clearance Officer, (301) 427–1477. 

SUPPLEMENTARY INFORMATION: ‘‘Patient 

Safety Organization Certification and 

Related Forms and a Patient Safety 

Confidentiality Complaint Form.’’

The Department of Health and Human 

Services (HHS) Agency for Healthcare 

Research and Quality (AHRQ) has been 

delegated the authority to implement 

the provisions of the Patient Safety and 

Quality Improvement Act of 2005 (for 

brevity referenced here as the Patient 

Safety Act) that call for submission to 

the Secretary of certifications by entities 

seeking to become listed by the 

Secretary as Patient Safety 

Organizations (PSOs). These entities 

must certify that they meet or will meet 

specified statutory criteria and 

requirements for PSOs. 

The HHS Office for Civil Rights (OCR) 

has been delegated the authority to 

enforce the provisions of the Patient 

Safety Act that mandate confidentiality 

of ‘‘patient safety work product.’’ This 

term is defined in the statute, at 42 

U.S.C. 299b–21(7), and further 

explained in the related Notice of 

Proposed Rulemaking published in the 

Federal Register on February 12, 2008, 

73 FR 8112–8183. Individuals may 

voluntarily submit complaints to OCR if 

they believe that an individual or 

organization in possession of patient 

safety work product unlawfully 

disclosed it. 

Methods of Collection 

While there are a number of 

information collection forms described 

below, they will be implemented at 

different times, some near the end of the 

three-year approval period for these 

standard forms. The forms for 

certifications of information will collect 

only the minimum amount of 

information from entities necessary for 

the Secretary to determine compliance 

with statutory requirements for PSOs, 

i.e., each of the required certification 

forms will consist of short attestations 

followed by ‘‘yes’’ and‘‘no’’ checkboxes 

to be checked and initiated. 

Initial PSO Certification and PSO 

Recertification Forms 

The Patient Safety Act, in 42 U.S.C. 

299b–24(a) and the proposed rule in 45 

CFR 3.102 provide that an entity may 

seek an initial three-year listing as a 

PSO by submitting an initial 

certification that it has policies and 

procedures in place to perform eight 

patient safety activities (enumerated in 

the statute and the proposed regulation), 

and that it will comply, upon listing, 

with seven other statutory criteria. The 

draft initial certification form also 

includes four questions related to other 

requirements for listing related to 

eligibility and pertinent organizational 

history. Similarly, the proposed 

certification form for continued listing 

as a PSO (for each successive three-year 

period after the initial listing period) 

would require certifications that the 

PSO is performing, and will continue to 

perform, the eight patient safety 

activities, and is complying with, and 

will continue to comply with, the seven 

statutory criteria. The average annual 

burden in the first three years of 17 

hours per year for the collection of 

information requested by the 

certification forms for initial and 

continued listing is based upon a total 

average estimate of 33 respondents per 

year and an estimated time of 30 

minutes per response. Information 

collection, i.e., collection of initial 

certification forms, will begin as soon as 

the forms are approved for use. 

Collection of forms for continued listing 

will not begin until several months 

before a date that is three years after the 

first PSOs are listed by the Secretary. 

(See Note after Exhibit 1.) 

Two-Contract Certification 

To implement 42 U.S.C. 299b–

24(b)(1)(C), AHRQ plans to adopt the 

following procedure, published in the 

proposed regulation: In order to 

maintain its PSO listing, a PSO will be 

required only to submit a brief 

attestation, at least once in every 24- 

month period after its initial date of 

listing, indicating that it has entered 

into contracts with two providers. The 

annualized burden of 8 hours for the 

collection of information requested by 

the two-contract requirement is based 

upon an estimate of 33 respondents per 

year and an estimated 15 minutes per 

response. This collection of information 

will begin when the first PSO timely 

notifies the Secretary that it has entered 

into two contracts. 

Disclosure Form 

The Patient Safety statute at 42 U.S.C. 

299b–24(b)(1)(E) requires a PSO to fully 

disclose information to the Secretary if 

the PSO has additional financial, 

contractual, or reporting relationships 

with any provider to which the PSO 

provides services pursuant to the 

Patient Safety Act under contract or if 

the PSO is managed or controlled by, or 

is not operated independently from, any 

of its contracting providers. Disclosure 

forms will be collected only when a 

PSO has such relationships with a 

contracting provider to report. The 

Secretary is required to review each 

disclosure statement and make public 

findings as to whether a PSO can fairly 

and accurately carry out its 

responsibilities. AHRQ assumes that 

only a small percentage of entities will 

need to file such disclosure forms. 

However, AHRQ is providing a high 

estimate of 17 respondents annually and 

thus presumably overestimating 

respondent burden. In summary, the 

annual burden of 8 hours for the 

collection of information requested by 

the disclosure form is based upon the 

high estimate of 17 respondents per year 

and an estimated 30 minutes per 

response. This information collection 

will begin when 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. 


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Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Notices 9337 

PSO Information Form 

Annual completion of a PSO 

information form will be voluntary and 

will provide information to HHS on the 

type of healthcare settings that PSOs are 

working with to carry out patient safety 

activities. This form is designed to 

collect a minimum amount of data in 

order to gather aggregate statistics on the 

reach of the Patient Safety Act with 

respect to types of institutions 

participating and their general location 

in the United States. This information 

will be included in AHRQ’s annual 

quality report, as required under Section 

923(c) of the Patient Safety Act. No 

PSO-specific data will be released 

without PSO consent. The overall 

annual burden estimate of 17 hours for 

the collection of information requested 

by the PSO Information Form is based 

upon an estimate of 33 respondents per 

year and an estimated 30 minutes per 

response. This information collection 

will begin toward the end of the 

calendar year in which the first PSOs 

are listed by the Secretary. 

OCR Complaint Form 

The complaint form will collect from 

individuals only the minimum amount 

of information necessary for OCR to 

process and assess incoming 

complaints. The overall annual burden 

estimate of 17 hours for the collection 

of information requested by the 

underlying form is based upon an 

estimate of 50 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 patient safety work product 

and there is an allegation of a violation 

of the statutory protection of patient 

safety work product. 

All Administrative Forms 

The overall maximum anticipated 

annual burden estimate is 75 hours for 

all the above-described collections of 

information. Because the forms filled 

out by PSOs vary over each of their first 

three years, the table below includes 

three-year total estimates divided by 

three to arrive at an annual estimate of 

burden hours. (See below.) 

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 Form ............................................... 100/3 1 30/60 17 

Recertification Form* ....................................................................................... 50/3 1 30/60 8 

Disclosure Form ............................................................................................... 50/3 1 30/60 8 

Two-Contract Requirement Form** ................................................................. 100/3 1 15/60 8 

Information Form*** ......................................................................................... 100/3 1 30/60 17 

Patient Safety Confidentiality Complaint Form ................................................ 150/3 1 20/60 17 

Total**** .................................................................................................... 500/3 na na 75 

Note: * The Recertification Form will be completed by any interested PSO at least 45 days before the end of its current three-year listing period. The three-year period for computing respondent burden begins with the date when the approved forms are officially made available for submission. Thus the burden period does not correspond exactly to the three-year period of listing. The burden period begins shortly (approximately 

30 days) before any PSO’s listing period. As a result, the burden for the first PSOs to submit certifications for continued listing at least 45 days 

before their listing lapses is likely to fall just before the three-year anniversary of their first burden, i.e. their completion of their initial certifications 

and before the end of their third year of listing. We assume completing this form will require 30 minutes, the same time as for the Certification 

Form. In the out-years, we expect the number of PSOs to remain stable, with the number of new entrants offset by the number of entities that 

will relinquish their status or be revoked. 

** The Two-Contract Requirement Form will be completed by each PSO within the 24-month period after initial listing by the Secretary. 

*** The Information Form will collect data by calendar year, beginning close to the end of the calendar year when PSOs are first listed. 

**** A total of 100 PSOs are expected to apply over three years: 50 in year 1; 25 in year 2; and 25 in year 3. Relationship Disclosure, TwoContract, and even voluntary Information Forms may be submitted by individual PSOs in different years. OCR is anticipating considerable variation in the number of complaints per year. Hence we have expressed the total for each year as the average of the expected total over the three 

year collection period. 

EXHIBIT 2.—ESTIMATED ANNUALIZED COST BURDEN

Form Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate 

Total cost 

burden 

Patient Safety Organization Certification Form ............................................... 100/3 17 $29.82 $506.94 

Recertification Form ......................................................................................... 50/3 8 29.82 238.56 

Disclosure Form ............................................................................................... 50/3 8 29.82 238.56 

Two-Contract Requirement Form .................................................................... 100/3 8 29.82 506.94 

Information Form ............................................................................................. 100/3 17 29.82 506.94 

Patient Safety Confidentiality Complaint Form ................................................ 150/3 17 29.82 506.94 

Total .......................................................................................................... 500/3 67 29.82 2,504.88 

Estimated Annual Costs to the Federal 

Government 

a. AHRQ 

By statute, AHRQ must collect and 

review certifications from an entity that 

seeks listing or continued listing as PSO 

under the Patient Safety Act. Additional 

information collection is also required 

for entities to remain listed as a PSO 

(i.e., submissions regarding compliance 

with the two-contract requirement and 

reports of certain relationships between 

a PSO and each of its contracting 

providers). The cost to AHRQ of 

processing the information collected 

with the above-described forms is 

minimal; an estimated equivalent of 

only approximately 0.05 FTE or $7,500 

per year for each agency and virtually 

no new overhead costs. 


rwilkins on PROD1PC63 with NOTICES
9338 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Notices 

Description Amount 

Personnel and Support Staff .... $7,500 

Consultant (sub-contractor) 

services ................................. 0 

Equipment ................................. 0 

Supplies .................................... 0 

All other expenses .................... 0 

Average Annual Cost ........ 7,500 

b. OCR 

OCR cannot conduct its work without 

collecting information through its 

proposed complaint forms. Even if OCR 

did not use complaint forms and only 

took information orally, it would still 

have to capture the same information in 

order to begin processing a complaint. 

Therefore, the incremental cost to OCR 

of processing the information collected 

from the complaint form is minimal and 

is equivalent to only approximately 0.05 

FTE or $7,500 per year, with virtually 

no new overhead costs. 

Description Amount 

Personnel and Support Staff .... $7,500 

Consultant (sub-contractor) 

services ................................. 0 

Equipment ................................. 0 

Supplies .................................... 0 

All other expenses .................... 0 

Average Annual Cost ........ 7,500 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on the above-described 

AHRQ and OCR information collection 

to implement the Patient Safety Act 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, quality 

improvement and information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: February 13, 2008. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 08–757 Filed 2–19–08; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Solicitation for Nominations for New 

Clinical Preventive Health Topics To 

Be Considered for Review by the 

United States Preventive Services Task 

Force 

AGENCY: Agency for Healthcare Research 

Quality (AHRQ), DHHS. 

ACTION: Solicit for new topic 

nominations. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) invites 

individuals and organizations to 

nominate primary and secondary 

prevention topics pertaining to clinical 

preventive services that they would like 

the United States Preventive Services 

Task Force (USPSTF) to consider for 

review. All topics previously reviewed 

by the USPSTF are available on AHRQ’s 

Web site, http:// 

www.preventiveservices.ahrq.gov. 

The USPSTF is an independent panel 

of experts that makes evidence-based 

recommendations regarding the 

provision of clinical preventive services. 

Clinical preventive services include 

screening, counseling and preventive 

medications associated with primary 

care. The USPSTF makes 

recommendations about preventive 

services for asymptomatic people—

people without recognized signs or 

symptoms of the specific conditions 

targeted by the preventive service. 

Topics can be nominated by 

individuals, organizations, evidencebased practice centers (EPC) and 

USPSTF members. The USPSTF will 

consider nominations in two steps. The 

USPSTF will first determine if the 

service is eligible, i.e., constitutes 

primary or secondary prevention 

applicable to healthy asymptomatic 

persons; is primary care feasible or 

referable from primary care; and 

addresses a condition with a substantial 

health burden. As a second step, within 

eligible topics, the USPSTF will 

prioritize based on the following set of 

criteria: public health importance 

(burden of suffering, potential of 

preventive service to reduce the 

burden); and potential for greatest Task 

Force impact (e.g., clinical controversy, 

practice does not reflect evidence, 

inappropriate timing in delivery of 

services). 

Basic Topic Nomination Requirements 

Nominations must be no more than 

500 words in length and must include 

the information listed below. 

Nominations may include supporting 

documentation; reference lists and other 

supporting documents are not counted 

against the 500 word limit, but should 

not exceed ten pages. 

Required information: 

1. Name of topic. 

2. Rationale for consideration by the 

USPSTF, describing: 

a. Characterization as primary or 

secondary prevention topic (screening, 

counseling or preventive medication). 

b. Primary care relevance (applicable 

clinical preventive service must be 

provided by a primary care provider or 

initiated in the primary care setting 

which can be defined as family practice, 

internal medicine, pediatrics or 

obstetrics/gynecology). 

c. Public health importance (burden 

of disease/suffering, potential of 

preventive service to reduce burden, 

including effective interventions). 

Citations and supporting documents are 

recommended. 

d. Potential impact of USPSTF’s 

review of the topic, i.e., change in 

clinical practice, research focus, etc. 

DATES: Topic nominations should be 

submitted by March 21, 2008 in order to 

be considered for 2008–2010. AHRQ 

will not reply to submissions in 

response to the request for nominations, 

but will consider all topic nominations 

during the selection process. If a topic 

is selected for review by the USPSTF, 

the nominator will be notified by 

AHRQ. 

ADDRESSES: Please submit nominations 

to: Gloria Washington, ATTN: USPSTF 

Topic Nominations, Center for Primary 

Care, Prevention & Clinical 

Partnerships, Agency for Healthcare 

Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, Fax: 

301.427.1595, E-mail: 

gloria.washington@ahrq.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Therese Miller at 

therese.miller@ahrq.hhs.gov or Gloria 

Washington at 

gloria.washington@ahrq.hhs.gov. 

Arrangement for Public Inspection: 

All nominations will be available for 

public inspections by appointment at 

the Center for Primary Care, Prevention 

& Clinical Partnerships, 301.427.1500, 

weekdays between 10 a.m. and 5 p.m. 

(Eastern time). 

SUPPLEMENTARY INFORMATION: 


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