48082 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

Sara Luckhaupt at sluckhaupt@cdc.gov 

or (513) 841–4123 for information about 

how to register for the meeting. 

ADDRESSES: Oral comments given at the 

meeting will be recorded and included 

in the NIOSH–187 docket. You may 

submit comments, identified by docket 

number NIOSH–187, by any of the 

following methods: 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

All information received in response to 

this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, 4676 Columbia Parkway, 

Cincinnati, Ohio 45226. A complete 

electronic docket containing all 

comments submitted will be available 

on the NIOSH Web page at http:// 

www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. 

Background: The NHSN is an 

Internet-based surveillance system 

established in 2005 by the CDC Division 

of Healthcare Quality Promotion 

(DHQP) that includes both patient safety 

and healthcare personnel health and 

safety modules. The proposed 

enhancement to the NHSN will 

electronically link and integrate a wide 

variety of ongoing occupational health 

surveillance activities and facilitate 

more accurate and timely prevention 

strategies, while meeting necessary 

confidentiality and security 

requirements. 

This project focuses on surveillance 

and prevention of four occupational 

health outcomes among healthcare 

workers: (1) Traumatic injuries in the 

workplace (specifically: (a) 

musculoskeletal disorders due to patient 

handling and working in awkward 

postures, (b) slips, trips, and falls, and 

(c) workplace violence); (2) dermatitis 

due to workplace exposures; (3) workrelated asthma; and (4) airborne 

transmission of tuberculosis in the 

workplace. Once these enhancements to 

NHSN are successfully implemented, 

additional occupational health metrics 

can be added to the system to address 

emerging problems such as pandemic 

influenza. 

The success of this project will 

depend on the participation of 

healthcare facilities in the surveillance 

system. Because the stakeholders 

themselves will be the central users of 

our proposed additions to NHSN, they 

will be extensively involved in every 

stage of this project—including initial 

development, implementation, and 

evaluation of the new module and event 

forms. This meeting will provide an 

opportunity for stakeholders to 

contribute to the initial development of 

the data collection forms. 

FOR FURTHER INFORMATION CONTACT: 

Ahmed Gomaa, Robert A. Taft 

Laboratories, MS–R17, 4676 Columbia 

Parkway, Cincinnati, OH 45226, 

telephone (513) 841–4337, or Sara 

Luckhaupt, same address, telephone 

(513) 841–4123. 

References: National Healthcare Safety 

Network (NHSN)—http:// 

www.cdc.gov/nhsn/index.html. 

Healthcare Personnel Safety 

Component—http://www.cdc.gov/ 

nhsn/hps.html. 

Dated: September 14, 2009. 

Tanja Popovic, 

Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–22656 Filed 9–18–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: A 

Compliance Self-Assessment Guide 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of Availability—Patient 

Safety Organizations: A Compliance 

Self-Assessment Guide. 

SUMMARY: AHRQ is announcing the 

availability of a document entitled: 

‘‘Patient Safety Organizations: A 

Compliance Self-Assessment Guide.’’ 

The Patient Safety and Quality 

Improvement Act of 2005, Public Law 

109–41, 42 U.S.C. 299–b21—b–26 

(Patient Safety Act) provides for the 

formation of Patient Safety 

Organizations (PSOs), which collect, 

aggregate, and analyze confidential 

information regarding the quality and 

safety of healthcare delivery. The 

Patient Safety and Quality Improvement 

Final Rule (Patient Safety Rule) (42 CFR 

part 3) authorizes AHRQ, on behalf of 

the Secretary of HHS, to: list as a PSO 

an entity that attests that it meets the 

statutory and regulatory requirements 

for listing; and request additional 

information and conduct reviews 

(including announced or unannounced 

site visits) to assess PSO compliance. To 

assist PSOs in making the required 

attestations and preparing for a 

compliance review, AHRQ developed 

the sample questions in this guide to 

encourage each PSO to take a thorough 

and systematic approach to compliance. 

The guide recognizes that each PSO’s 

approach to compliance may be 

different based upon the specific 

mission it has chosen, the specific 

activities and expertise it offers to 

healthcare providers, and its size and 

mode of operation. Thus, these 

questions are merely illustrative; some 

questions will not be applicable or even 

appropriate for every PSO. The guide 

does not establish new standards or 

requirements beyond those that are 

established by the Patient Safety Rule. 

DATES: Availability of resource. 

ADDRESSES: ‘‘Patient Safety 

Organizations: A Compliance SelfAssessment Guide’’ can be accessed 

electronically at the following HHS Web 

site: http://www.pso.ahrg.qov/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Diane Cousins, RPh., Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427 1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; E-mail: 

pso@ahrq.hhs.qov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act establishes a 

framework by which healthcare 

providers can report information 

voluntarily to PSOs, on a privileged and 

confidential basis, for the aggregation 

and analysis of patient safety events and 

quality concerns. A PSO is an entity 

listed by the Secretary of HHS, which 

has a primary focus to conduct activities 

to improve patient safety and the quality 

of healthcare delivery. 

The requirements governing PSOs are 

set forth in subpart B of the Patient 

Safety Rule. These include: the 

requirements that an entity must meet to 

become, and remain listed, as a PSO; the 

procedures and processes for assessing 

an entity’s eligibility; the processes for 

ensuring a PSO’s compliance with the 

requirements of the Patient Safety Rule, 

and for correcting deficiencies in a 

PSO’s compliance; and the process by 

which a PSO can voluntarily relinquish 

its listing or, in the case of a PSO that 

does not correct one or more 

deficiencies, the process for delisting a 

PSO for cause. Within the framework 

established by the Patient Safety Act, 

PSOs are a source of expert advice for 

providers, and PSOs enable providers to 

take advantage of the potential for 

significant aggregation of patient safety 

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Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48083 

events within the protections of the 

Patient Safety Act and Patient Safety 

Rule. As a result, healthcare providers, 

and those committed to improving the 

safety and quality of patient care, have 

a strong interest in the integrity of PSOs 

and their ability to carry out this 

statutory mission. 

AHRQ administers the provisions of 

the Patient Safety Rule relating to listing 

and operation of PSOs, which are the 

focus of this guide. The HHS Office for 

Civil Rights is responsible for enforcing 

the confidentiality protections of the 

Patient Safety Act and Patient Safety 

Rule. 

For an entity to be listed, and remain 

listed, as a PSO, the Patient Safety Rule 

relies primarily upon a system of 

attestations. An entity seeking listing for 

a three-year period as a PSO must 

submit to AHRQ a form, Certification for 

Initial Listing, to attest that it meets the 

Patient Safety Rule’s eligibility and 

listing requirements at the time the 

entity submits its certifications. During 

its period of listing, a PSO must submit 

a form, Two Bona Fide Contract 

Requirement, every two years attesting 

that it has at least two contracts with 

different providers. If the PSO has other 

relationships, specified in section 

3.102(d)(2), with any contracting 

provider, it must also submit the form, 

PSO Disclosure Statement, regarding its 

relationships with the provider and 

attest to the completeness and accuracy 

of its disclosures. Finally, a PSO must 

submit the form, Certification for 

Continued Listing, to seek continued 

listing for an additional three-year 

period and attest that it meets the 

requirements for continued listing. This 

process places the burden for 

understanding and complying with the 

Patient Safety Rule on the PSO. 

The Patient Safety Rule also 

authorizes AHRQ to assess or verify 

PSO compliance with the rule’s 

requirements at any time through 

requests for information or by 

conducting announced or unannounced 

reviews of, or site visits to, PSOs 

(section 3.110). In addition to routine 

compliance reviews, AHRQ may also 

conduct site visits or request additional 

information if, for example, AHRQ 

becomes aware that a PSO is not in 

compliance with the requirements of the 

statute or the Patient Safety Rule. 

The Patient Safety Rule provides 

PSOs latitude in complying with its 

requirements. In part, this reflects a 

recognition that PSOs will vary in terms 

of size, complexity, and sophistication 

and, over time, PSOs will vary 

significantly in the breadth and scope of 

their activities. For example, PSOs can 

be local, regional, or national in 

orientation; they can focus narrowly or 

broadly in terms of the clinical or 

analytic services they offer providers; 

they can target their services toward one 

type of healthcare facility or multiple 

healthcare settings; and, they are likely 

to vary in the sophistication and 

complexity of information technology 

employed. 

Each PSO will need to develop its 

approach to compliance by taking into 

account the specific mission it has 

chosen for itself, the specific activities 

and expertise it offers to healthcare 

providers, and its size and mode of 

operation. As a consequence, AHRQ 

developed this self-assessment guide 

recognizing that individual PSOs are 

likely to approach compliance from 

different perspectives. Thus, the guide 

does not propose a uniform approach to 

compliance, Instead, the guide presents 

sample questions—some of which may 

not be applicable or appropriate to a 

specific PSO—to encourage each PSO to 

take a comprehensive and systematic 

approach to compliance that best meets 

its circumstances. 

The questions in the guide do not 

establish new standards or 

requirements; they are only presented 

for an illustrative purpose. If there is 

any inadvertent discrepancy between 

the text of the guide and the Patient 

Safety Rule, PSOs should consider the 

text of the rule as authoritative. 

More information on the ‘‘Patient 

Safety Organizations: A Compliance Self 

Assessment Guide’’ and PSOs can be 

obtained through AHRQ’s PSO Web site: 

http://www.pso.ahrq.qov/index.html. 

Dated: September 11, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–22594 Filed 9–18–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0441] 

Promotion of Food and Drug 

Administration-Regulated Medical 

Products Using the Internet and Social 

Media Tools; Notice of Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Drug Evaluation and Research (CDER), 

in collaboration with FDA’s Center for 

Biologics Evaluation and Research 

(CBER), Center for Veterinary Medicine 

(CVM), and Center for Devices and 

Radiological Health (CDRH), is 

announcing a public hearing to discuss 

issues related to the promotion of FDAregulated medical products (including 

prescription drugs for humans and 

animals, prescription biologics, and 

medical devices) using the Internet and 

social media tools. FDA is seeking 

participation in the public hearing and 

written comments from all interested 

parties, including, but not limited to, 

consumers, patients, caregivers, health 

care professionals, patient groups, 

Internet vendors, advertising agencies, 

and the regulated industry. This 

meeting and the written comments are 

intended to help guide FDA in making 

policy decisions on the promotion of 

human and animal prescription drugs 

and biologics and medical devices using 

the Internet and social media tools. FDA 

is seeking input on a number of specific 

questions but is interested in any other 

pertinent information participants in the 

hearing would like to share. 

Dates and Times: The public hearing 

will be held on November 12 and 13, 

2009, from 8 a.m. to 5 p.m. each day. 

Submit written or electronic registration 

by close of business on October 9, 2009. 

Written and electronic comments will 

be accepted until February 28, 2010. 

Location: The public hearing will be 

held at the National Transportation 

Safety Board Conference Center, 429 

L’Enfant Plaza, SW., Washington, DC 

20594, 202–314–6305; Metro: L’Enfant 

Plaza station on the yellow, green, 

orange, and blue lines; see: http:// 

ntsb.gov/events/newlocation.htm. (FDA 

has verified the Web site address, but 

FDA is not responsible for any changes 

to the Web site after this document 

publishes in the Federal Register.) 

ADDRESSES: Submit written registration 

and written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic registration and 

electronic comments, identified with 

the docket number found in brackets in 

the heading of this document, to http:// 

www.regulations.gov. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the hearing 

(see section VI of this document). 

Registration to Attend and/or to 

Participate in the Meeting: Seating at the 

hearing is limited. People interested in 

attending should submit written or 

electronic registration as specified above 

mstockstill on DSKH9S0YB1PROD with NOTICES