[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Pages 10905-10906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4133]
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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 (AHRQ), Department
of Health and Human Services (HHS).
ACTION: Notice.
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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
[email protected]. Copies of this proposed form and specific
details on the estimated burden can be obtained from AHRQs Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427-1477.
SUPPLEMENTARY INFORMATION:
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
form.
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
and
[[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]
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