Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 57045 

http://www.cdc.gov/niosh/docs/2010- 

167/. 

Background: The NIOSH Alert: 

Preventing Occupational Exposures to 

Antineoplastic and Other Hazardous 

Drugs in Health Care Settings was 

published in September 2004 (http:// 

www.cdc.gov/niosh/docs/2004-165/). 

From that time until June 2007, 

approximately 60 new drugs have 

received FDA approval and 

approximately 60 drugs have received 

special warnings (usually black box 

warnings) based on reported adverse 

effects in patients. An additional 18 

drugs were included from the updated 

NIH Hazardous Drug List. From this list 

of approximately 150 drugs, 62 drugs 

were determined to have one or more 

characteristic of a hazardous drug and 

published for comment in NIOSH 

Docket Number 105. 

After expert panel review, public 

review and comment, input from 

stakeholders and review of the scientific 

literature NIOSH proposed a second, 

draft list of hazardous drugs that was 

published in NIOSH Docket 105A. The 

second, draft list identified 24 drugs 

that fit the NIOSH definition of 

hazardous drugs. The second draft list 

also proposed removing Bacillus 

Calmette-Guerin (BCG), based on 

additional comments received by 

NIOSH. 

Following the second Federal Register 

Notice, BCG was reinstated to the list 

and a total of 21 new drugs were added 

to the 2004 list in Appendix A of the 

Alert. 

This guidance document does not 

have the force and effect of law. 

FOR FURTHER INFORMATION CONTACT: 

Barbara MacKenzie, NIOSH, Robert A. 

Taft Laboratories, 4676 Columbia 

Parkway, MS–C26, Cincinnati, OH 

45226, Telephone (513) 533–8132, email hazardousdrugs@cdc.gov. 

Reference: NIOSH List of 

Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings 2010. Web 

address for this document: http:// 

www.cdc.gov/niosh/docs/2010-167/. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–23239 Filed 9–16–10; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

Food and Drug Administration 

[Docket No. FDA–2010–N–0308] 

Parallel Review of Medical Products 

AGENCIES: Centers for Medicare and 

Medicaid Services; Food and Drug 

Administration, HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) and the Centers 

for Medicare and Medicaid Services 

(CMS) are considering establishing a 

process for overlapping evaluations of 

premarket, FDA-regulated medical 

products when the product sponsor and 

both agencies agree to such parallel 

review. This process will serve the 

public interest by reducing the time 

between FDA marketing approval or 

clearance decisions and CMS national 

coverage determinations (NCDs). The 

agencies are establishing a docket to 

receive information and comment from 

the public on what products would be 

appropriate for parallel review by the 

two agencies, what procedures should 

be developed, how a parallel review 

process should be implemented, and 

other issues related to the effective 

operation of the process. The agencies 

are also announcing their intent to 

create a pilot program for parallel 

review of medical devices. The pilot 

program will begin after both agencies 

have reviewed the public comments on 

this notice. A memorandum of 

understanding (MOU) concerning the 

exchange of data and information has 

been completed between the two 

agencies. See http://www.fda.gov/ 

AboutFDA/PartnershipsCollaborations/ 

MemorandaofUnderstandingMOUs/ 

DomesticMOUs/ucm217585.htm. 

DATES: Submit either electronic or 

written comments by December 16, 

2010. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

General questions about parallel 

review: Peter Beckerman, Office of 

Policy, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–4830, e-mail: 

peter.beckerman@fda.hhs.gov, or 

Tamara Syrek Jensen, Centers for 

Medicare and Medicaid Services, 

7500 Security Blvd., Baltimore, MD 

21244, e-mail: 

Tamara.Syrekjensen@cms.hhs.gov. 

For device sponsors interested in 

requesting voluntary parallel 

review: Markham C. Luke, Center 

for Devices and Radiological 

Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–5550, e-mail: 

markham.luke@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA and CMS share a common 

interest in improving the health of 

patients through the availability of safe, 

effective, and affordable medical 

products and fostering medical product 

innovations. 

The mission of the FDA is to protect 

and promote the public health. It 

accomplishes this task, in part, by the 

following: 

• Assuring the safety, efficacy, and 

quality of human drugs, biological 

products, and medical devices; 

• Fostering innovations to make 

medical products safer and more 

effective; and 

• Helping health care providers and 

the public get the accurate, sciencebased information they need to use 

medical products to improve public 

health. 

The mission of CMS is to ensure 

effective, up-to-date Medicare coverage 

and to promote the continual 

improvement of the quality care for its 

beneficiaries. CMS accomplishes this 

mission by continuing to transform and 

modernize America’s health care 

system, in part, by the following: 

• Fostering accurate and predictable 

payments, 

• Ensuring high-value health care, 

• Promoting understanding of CMS 

programs among beneficiaries, the 

health care community, and the public. 

Through coordinated decisions 

regarding medical products, FDA and 

CMS can affect public health in critical 

ways: FDA in determining the safety 

and effectiveness of those products and 

CMS in providing beneficial coverage 

and appropriate payment for covered 

items and services involving those 

products. Both agencies believe they 

should address the growing need to 

improve public health by speeding 

consumer access to and spurring the 

development of new, affordable, 

reliable, safer, and more effective 

medical products and services. FDA and 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
57046 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 

CMS are working together to identify 

areas in which they can collaborate to 

achieve these goals and parallel review 

provides one such opportunity. 

A. Innovative Medical Products are 

Difficult to Develop 

The recent boom in new basic science 

discoveries has generated hope for the 

development of new treatments and 

diagnostics for serious illnesses. 

However, there is concern as to whether 

there are adequate resources available 

for bringing the most innovative 

medical devices to market. The number 

of new drug and biologic applications 

submitted to FDA has been declining for 

several years for reasons not wholly 

clear. Inefficiencies and rising costs 

appear to account for only part of the 

reluctance to embark on new medical 

product development. The limited 

predictability of market access may also 

hinder investment in the development 

of innovative therapies and diagnostics. 

Reducing the time between marketing 

approval or clearance and obtaining 

third party payment (‘‘approval-topayment’’ time) can produce savings for 

sponsors and improve public health 

through overlapping medical review of 

data/evidence leading to more timely 

patient access to those new products. 

Currently, medical product 

development and coverage and payment 

of new therapies and diagnostics 

generally occur in a serial manner. First, 

a new medical product is submitted to 

FDA, which determines whether it 

meets applicable safety and 

effectiveness standards for commercial 

marketing. Next, the company seeks 

coverage from the payer who in turn 

determines the payment rate for the 

product. 

Timely access to innovative medical 

technologies has been identified as a 

significant issue in the delivery of high 

quality health care. Manufacturers of 

innovative medical products have said 

that after undergoing the FDA approval 

process the availability of their products 

to consumers is often slow because, in 

order to obtain coverage and payment 

from third-party payers, the 

manufacturers must go through a second 

review process by such payers. This is 

in part because the materials submitted 

by manufacturers for FDA review are, 

for various reasons, not generally made 

available to third-party payers prior to 

FDA approval or clearance. In addition, 

the materials submitted by 

manufacturers to FDA may not 

adequately address the issues of 

importance to payers, such as 

community or home based use outside 

of clinical trial protocols, 

generalizability of the results to target 

populations that may have not been 

studied, and the incremental clinical 

utility of these products compared to 

currently available technologies. 

Although CMS is only one of many 

third-party payers and provides 

insurance benefits to select populations, 

the agency plays a leading role in 

healthcare through its coverage and 

payment decisions. Because many thirdparty payers tend to follow CMS’ lead, 

a positive national coverage or payment 

decision by CMS often promotes rapid 

adoption of a new therapy by the 

medical community. However, a 

positive coverage decision after a long 

time lag following FDA approval or 

clearance can delay consumer access to 

new medical products. 

B. Differences in FDA and CMS Review 

FDA premarket review and CMS 

national coverage determinations differ 

significantly. Each process operates 

under different statutory standards and 

each asks different questions to meet its 

respective mandates. The FDA 

premarket review generally assesses the 

safety and effectiveness of these medical 

products. Even within FDA’s review 

processes, there are differences in types 

of evaluation depending upon the 

application under consideration (for 

example, premarket approval 

applications (PMAs) must meet 

standards different from premarket 

notifications (510(k)s)). 

CMS serves a different function by 

providing health insurance to protect 

the nation’s aged and disabled persons 

from the substantial burdens of illness. 

Under section 1862(a)(1) of the Social 

Security Act (the Act), CMS makes 

determinations regarding the coverage 

of specific items and services. In short, 

CMS must make multiple decisions: It 

must decide what items and services it 

can and should pay for; how it should 

accomplish the payment; and how 

much to pay. 

CMS’ evaluation of medical products 

depends on the type of request. For 

most NCDs, CMS evaluates whether a 

medical product or service is reasonable 

and necessary to diagnose or treat an 

illness or injury affecting the Medicare 

population. This evaluation includes 

review of appropriate outcomes data, 

such as whether the product provides 

improved, equivalent, or 

complementary health outcomes in the 

Medicare population as compared to 

alternative treatments or diagnostics 

already covered by the program. CMS 

may also evaluate medical product 

indications that have not been approved 

or cleared by FDA, so-called 

unapproved or off-label uses. 

C. Parallel Review—Opportunity To 

Speed Patient Access To Beneficial 

Medical Products 

Under current practice, CMS does not 

routinely undertake an NCD unless it 

receives a complete formal external 

request. At times, CMS may also 

internally generate a request. Because 

local fiscal intermediaries, carriers, or 

Medicare Administrative Contractors 

are able to make decisions within their 

own jurisdictions, Medicare coverage 

and payment can occur in the absence 

of a NCD, such as from the initial 

market availability of a new technology. 

CMS usually begins its national 

coverage decision making process for 

FDA-regulated medical products after 

they have been approved or cleared by 

FDA. Because FDA does not approve or 

clear all the marketing applications it 

reviews, such serial processing ensures 

that CMS does not expend its limited 

resources assessing medical products 

that never reach the U.S. market. In 

addition, the CMS NCD process is 

subject to strict statutory time limits (9 

to 12 months from the opening to 

publication of the final decision) that 

cannot be extended if a manufacturer 

should encounter an unexpected delay 

in obtaining FDA approval or clearance. 

However, this serial review process has 

been subject to criticism because it 

potentially causes delay in consumer 

access to beneficial medical products. 

Overlapping evaluations by FDA and 

CMS for innovative products could 

speed consumer access to those new 

products by reducing the time span 

between marketing approval or 

clearance decisions and national 

coverage/payment determinations. 

From time to time CMS finds that 

developers of new technology fail to 

recognize the differences between the 

regulatory requirements of FDA and 

CMS. They may undertake clinical 

studies that are designed to address 

FDA questions but do not adequately 

address CMS questions concerning the 

impact of the technology on Medicare 

beneficiary health outcomes. This 

omission can slow the developer’s quest 

for Medicare coverage. We believe that 

a parallel review process can furnish an 

opportunity to educate developers 

regarding clinical study designs that are 

more likely to simultaneously address 

both FDA and CMS questions. 

To potentially accelerate consumer 

access to new, particularly innovative, 

safe and effective medical products, 

FDA and CMS intend to establish a 

process for parallel review. Parallel 

review could also create incentives for 

venture capitalists and companies to 

increase their investment in innovative 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 57047 

medical products by reducing the time 

to return on investment for those 

products eligible for parallel review. 

The agencies envision parallel review 

as a collaborative effort in which CMS 

will begin its NCD-related review 

process to determine whether the 

product is reasonable and necessary for 

the Medicare population while FDA is 

completing its premarket review. 

However, before developing and 

implementing such a process, the 

agencies believe that important issues 

must be resolved. For example, to avoid 

CMS reaching a coverage determination 

deadline before FDA has completed its 

review process and to minimize the 

possibility that CMS will begin its 

coverage process for a product that is 

subsequently not approved or cleared by 

FDA, the CMS process and FDA process 

should be carefully staged. FDA and 

CMS also seek comment on whether 

they should establish a voluntary 

process to allow companies to meet 

with both agencies to develop clinical 

trial protocols that would meet each 

agency’s respective statutory standard 

rather than potentially conducting 

separate clinical studies. 

This notice provides the first 

opportunity for the public to comment 

on these issues. The public will have a 

second opportunity to provide input 

should the agencies subsequently issue, 

as they currently intend, a joint draft 

guidance or other appropriate 

documents, describing the proposed 

process. The agencies envision that the 

decision to undertake the parallel 

review process with respect to a specific 

product will be at the request of the 

manufacturer and with the agreement of 

both agencies, thus making the process 

voluntary for all parties involved. FDA 

would make its approval or clearance 

determination first because CMS would 

not ordinarily provide coverage to a 

product not approved or cleared by FDA 

for marketing in the United States. In 

addition, CMS has statutory 

requirements (for example, CMS must 

issue a proposed coverage decision 

memorandum for comment) that make it 

impossible for the issuance of an NCD 

simultaneous with an FDA approval or 

clearance. 

Parallel review would be a variation 

of the usual serial review process. 

Sponsors would be able to request use 

of this process in seeking an NCD. The 

regulatory standards and evidentiary 

standards used by FDA and CMS for 

decision-making would not change; 

under any review scenario, each agency 

would continue to make its decision 

under its respective authority and with 

its own standards, independent of the 

other. The sponsor requesting parallel 

review would be expected to meet the 

legal requirements, including data 

submission requirements, for both FDA 

premarket review or clearance and of an 

NCD request by CMS. Once formal 

procedures are developed, the agencies 

will work on making the data 

submissions efficient and 

nonduplicative with the intent of 

making parallel review less burdensome 

than if the sponsor went to each agency 

in serial fashion. Parallel review 

between the FDA and CMS would 

include only CMS coverage 

determination reviews and not any 

reviews of payment mechanisms. 

By means of this notice, we are 

opening a public comment docket to 

solicit comment from the public on the 

parallel review process. We are 

interested in comments on all aspects of 

the process as we have explained it, 

including what categories of products 

are most appropriate for such review, 

the timing of parallel review, what 

procedures should be developed, how 

such a review process should be 

implemented, and what efficiencies 

could be achieved. After reviewing the 

public comments, FDA and CMS intend 

to issue a joint draft guidance describing 

the parallel review process and the 

procedures each agency would use for 

its implementation. 

After review of the public comments 

on this notice, both agencies will 

consider a small number of requests 

from sponsors of innovative medical 

devices for parallel review on a pilot 

basis. (No new statutory authorities 

would be required to pursue such a 

pilot because FDA and CMS are 

continuing to comply with all aspects of 

current law.) The agencies will 

announce procedures for participating 

in the pilot at that time as well as 

criteria for participation. For general 

questions about parallel review, contact 

the persons listed in the ‘‘FOR FURTHER

INFORMATION CONTACT’’ section of this 

document. Device sponsors interested in 

requesting voluntary parallel review 

should contact the person noted as the 

contact listed in the ‘‘FOR FURTHER

INFORMATION CONTACT’’ section of this 

notice. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

To assist interested parties, we are 

asking for public comment on the 

following issues: 

1. Should anyone other than the 

product sponsor be able to initiate a 

request for parallel review (for example, 

the FDA, CMS, an interested third 

party)? 

2. For which classes of products 

would consumers, payers, or sponsors 

benefit most from parallel review? Why? 

3. FDA and CMS may propose to limit 

the number of products concurrently 

under parallel review. How should 

limits be placed on the number and/or 

type of products concurrently under 

parallel review? Should CMS be 

permitted to review indications for 

which the sponsor is not seeking FDA 

clearance or approval under parallel 

review? 

4. Are there disadvantages to parallel 

review? 

5. Are there any barriers (for example, 

regulatory, legal, scientific) to parallel 

review and if so, how might they be 

overcome? 

6. Should a voluntary process be put 

in place to encourage the conduct of 

clinical trials that are appropriately 

designed to support both FDA approval/ 

clearance and CMS national coverage 

decisions? If so, what process should be 

established? 

7. What criteria should the FDA and 

CMS use to decide whether to grant a 

request for parallel review? 

8. At what point during FDA 

premarket review for prescription drugs, 

biologics, and medical devices, should 

parallel review begin in order to reduce 

the time between FDA marketing 

approval or clearance decisions and 

CMS national coverage decisions while 

avoiding the risk that CMS would 

initiate an NCD for a product whose 

premarket application the FDA 

subsequently does not approve or clear? 

9. How should parallel review be 

implemented? Should the agencies use 

means in addition to a guidance 

document, such as designating agency 

liaisons, to educate sponsors about 

parallel review? 

10. When, if at all, should the 

agencies offer joint meetings to 

interested sponsors during parallel 

review? Before parallel review begins? 

Before a premarket application is 

submitted to the FDA? 

11. Should FDA and CMS have access 

to the same data and information about 

the product during parallel review? 

(Note: Both agencies will protect the 

confidentiality of proprietary 

information used in the parallel review 

process, as they currently do under their 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
57048 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 

respective approval/clearance and 

coverage processes.) 

12. It is CMS’ policy to inform the 

public when it begins an NCD process 

for a particular product. However, under 

applicable statutes and FDA’s 

regulations, the existence of a premarket 

application is considered confidential 

commercial information prior to 

approval or clearance unless the 

sponsor has publicly acknowledged the 

application. With the consent of the 

sponsor, should CMS make public that 

it has begun the NCD process, as part of 

parallel review, for a product still 

undergoing FDA premarket review? As 

a condition of the agencies’ agreement 

to initiate parallel review, should a 

sponsor have to inform the public, or 

consent to the agencies informing the 

public, that the product will be 

evaluated under parallel review? If the 

sponsor declines to consent to 

disclosure, should it be permitted to 

request parallel review anyway, which 

would prevent CMS from disclosing the 

NCD process until after the product is 

approved by the FDA? How can the 

transparency of CMS’ NCD process be 

reconciled with the need to retain 

confidentiality of certain commercial 

information? 

13. At present, sponsors whose 

medical products will undergo both 

FDA premarket review and CMS 

national coverage review submit 

separate application packages to FDA 

and CMS that, in part, contain the same 

data, and, in part, contain different data. 

Keeping in mind the limited resources 

available to the agencies, what steps can 

the agencies take to minimize 

duplication of data submissions? Would 

the use of electronic submissions reduce 

submission burdens and facilitate data 

transfers? Are there other steps the 

agencies can take to streamline a 

parallel review process without 

modifying the regulatory standards and 

evidentiary requirements of both 

agencies? Would the transparency of 

CMS’ NCD process subject the FDA to 

additional public pressure regarding 

marketing authorization? 

14. Should the agencies convene a 

joint advisory committee to consider 

common issues needing public 

discussion and advice during the 

parallel review process? 

15. What other concerns or 

considerations should the agencies take 

into account when developing a process 

for parallel review? 

16. Once FDA and CMS have opened 

a parallel review should a sponsor be 

able to terminate or withdraw the 

request for parallel review? If this 

happens, should that information be 

made public? 

17. Sponsors who submit a PMA or 

510(k) to the FDA generally must pay a 

user fee. One key advantage of parallel 

review is to streamline the current 

process by allowing engagement by a 

sponsor with both FDA and CMS 

concurrently. Earlier engagement could 

shorten the time between FDA approval 

or clearance of the PMA or 510(k) and 

a coverage decision from CMS. Parallel 

review could, however, entail additional 

costs for the agencies (for example, if 

the product ultimately does not receive 

FDA approval or clearance). Changes to 

a user fee would also require legislative 

changes. Given these factors, should the 

current Medical Device User Fee be 

restructured to support the FDA and 

CMS costs of this parallel review and if 

so, how? 

Dated: September 10, 2010. 

Margaret A. Hamburg, 

Commissioner of Food and Drugs. 

Dated: July 29, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–23252 Filed 9–16–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: 

Voluntary Delisting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of delisting. 

SUMMARY: AHRQ has accepted a 

notification of voluntary relinquishment 

from the Coalition for Quality and 

Patient Safety of Chicagoland (CQPS) of 

its status as a Patient Safety 

Organization (PSO). The Patient Safety 

and Quality Improvement Act of 2005 

(Patient Safety Act), Public Law 109–41, 

42 U.S.C. 299b–21–b–26, provides for 

the formation of PSOs, which collect, 

aggregate, and analyze confidential 

information regarding the quality and 

safety of health care 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. A PSO can be ‘‘delisted’’ by 

the Secretary if it is found to no longer 

meet the requirements of the Patient 

Safety Act and Patient Safety Rule, 

including when a PSO chooses to 

voluntarily relinquish its status as a 

PSO for any reason. 

DATES: The directories for both listed 

and delisted PSOs are ongoing and 

reviewed weekly by AHRQ. The 

delisting was effective at 12 Midnight 

ET (2400) on May 25, 2010. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS Web site: http:// 

www.pso.AHRQ.gov/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.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity is to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule (PDF file, 450 KB PDF Help) 

relating to the listing and operation of 

PSOs. Section 3.108(d) of the Patient 

Safety Rule requires AHRQ to provide 

public notice when it removes a PSO 

from listing. AHRQ has accepted a 

notification from the Coalition for 

Quality and Patient Safety of 

Chicagoland (CQPS), PSO number 

P0027, to voluntarily relinquish its 

status as a component PSO of the 

Institute of Medicine of Chicago. COPS’ 

notification stated that the Institute of 

Medicine of Chicago has relinquished 

its ownership of CQPS and transferred 

all of its assets to a successor 

organization, Project Patient Care, Inc. 

Accordingly, CQPS was delisted 

effective 12 Midnight ET (2400) on May 

25, 2010. AHRQ has received and 

accepted certification from the Coalition 

for Quality and Patient Safety of 

Chicagoland PSO (CQPS PSO), PSO 

Number P0090, for listing as a 

component PSO of Project Patient Care, 

Inc. The listing was effective at 12:01 

a.m. ET (2401) on May 26, 2010. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.gov/ 

index.html. 


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