[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Pages 10905-10906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4133]



Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department 
of Health and Human Services (HHS).

ACTION: Notice.


SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42 
U.S.C. 299b-21 to b-26, (Patient Safety Act), and its implementing 
regulation at 42 CFR part 3, provides for the formation of Patient 
Safety Organizations (PSO5), which collect, aggregate, and analyze 
confidential information regarding the quality and safety of healthcare 
delivery. On December 30, 2010, HHS issued ``Guidance Regarding Patient 
Safety Organizations' Reporting Obligations and the Patient Safety and 
Quality Improvement Act of 2005'' (Guidance) which can be accessed 
electronically at: http://www.PSO.AHRQ.gov/regulations/guidance.pdf.
    This notice announces the intention of AHRQ to request that the 
Office of Management and Budget (OMB) amend the approved clearance, OMB 
No. 0935-0143, that allows information collection related to 
implementation of the Patient Safety Act. This amendment includes a new 
attestation form related to the Guidance. In accordance with the 
Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public 
to comment on this proposed information collection. The purpose of this 
notice is to allow 30 days for public comment on the new attestation 
form related to the Guidance.

DATES: Comments on this notice must be received by March 30, 2011.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
AHRQ, Reports Clearance Officer, by fax at (301) 427-1000 (attention: 
AHRQ Reports Clearance Officer) or by e-mail at 
doris.lefkowitz@AHRQ.hhs.gov. Copies of this proposed form and specific 
details on the estimated burden can be obtained from AHRQs Reports 
Clearance Officer.

Clearance Officer, (301) 427-1477.


Proposed Form

    This notice proposes the addition of a new attestation form, 
``Supplemental Attestations Regarding FDA Reporting Obligations Of 
PSOs,'' to the existing approved clearance, ``Patient Safety 
Organization Certification for Initial Listing and Related Forms and a 
Patient Safety Confidentiality Complaint Form'' (OMB No. 0935-0143).
    In order to implement the Patient Safety Act, HHS issued the 
Patient Safety and Quality Improvement Final Rule (Patient Safety 
Rule), published in the Federal Register on November 21, 2008: 73 FR 
70731-70814. Pursuant to the Patient Safety Rule, entities seeking to 
become and remain listed by the Secretary as PSOs submit certifications 
to the Secretary. These entities must certify that they meet or will 
meet specified statutory criteria and requirements for PSOs, as further 
explained in the Patient Safety Rule.
    On December 30, 2010, HHS issued Guidance to address 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 and its implementing regulations 
to report certain information to the FDA and to provide FDA with access 
to its records, including access during an inspection of its 
facilities. This proposed form will collect information from PSOs as 
described in the Guidance.

Methods of Collection

    Existing PSOs will be required to complete this proposed form 
immediately; an entity seeking listing as a PSO will be required to 
complete this proposed form at the time it submits its certifications 
for initial listing. Every entity completing this proposed form will be 
required to attest whether it is subject to the Guidance. Entities that 
are subject to the Guidance will be required to make one to three 
additional attestations. To complete this form, a respondent will need 
to review each attestation, check the appropriate ``yes' or ``no'' box 
that follows each applicable attestation, and complete and sign the 
    The burden estimate for completing this form is 15 minutes per 
respondent; fewer than 100 entities are expected to submit responses.

Estimated Annual Costs to the Federal Government

    Under the Patient Safety Act and Patient Safety Rule, AHRQ collects 
and reviews certifications from entities that seek listing or continued 
listing as PSOs. Entities applying to be PSOs and existing PSOs may 
also be required to provide additional information to AHRQ. The cost to 
AHRQ of processing the information collected with the above-described 
form is minimal: An estimated equivalent of approximately 0.01 FTE or 
$1,500 and no new overhead costs.

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on the 
above described attestation form 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, 
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 

[[Page 10906]]

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 15, 2011.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2011-4133 Filed 2-25-11; 8:45 am]