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. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Notices 57049 

Dated: September 3, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–23077 Filed 9–16–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

Extension of Agency Information 

Collection Activity Under OMB Review: 

Office of Law Enforcement/Federal Air 

Marshal Service Mental Health 

Certification 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: 30-day notice. 

SUMMARY: This notice announces that 

the Transportation Security 

Administration (TSA) has forwarded the 

Information Collection Request (ICR), 

Office of Management and Budget 

(OMB) control number 1652–0043, 

abstracted below to OMB for review and 

approval of an extension of the 

currently approved collection under the 

Paperwork Reduction Act (PRA). The 

ICR describes the nature of the 

information collection and its expected 

burden. TSA published a Federal 

Register notice, with a 60-day comment 

period soliciting comments, of the 

following collection of information on 

June 16, 2010, 75 FR 34148. The 

collection involves a certification form 

that applicants for the Federal Air 

Marshal positions are required to 

complete regarding their mental health 

history. 

DATES: Send your comments by October 

18, 2010. A comment to OMB is most 

effective if OMB receives it within 30 

days of publication. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

the proposed information collection to 

the Office of Information and Regulatory 

Affairs, OMB. Comments should be 

addressed to Desk Officer, Department 

of Homeland Security/TSA, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Joanna Johnson, TSA PRA Officer, 

Office of Information Technology (OIT), 

TSA–11, Transportation Security 

Administration, 601 South 12th Street, 

Arlington, VA 20598–6011; telephone 

(571) 227–3651; e-mail 

TSAPRA@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a valid OMB control 

number. The ICR documentation is 

available at http://www.reginfo.gov. 

Therefore, in preparation for OMB 

review and approval of the following 

information collection, TSA is soliciting 

comments to— 

(1) Evaluate whether the proposed 

information requirement is necessary for 

the proper performance of the functions 

of the agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including using 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Information Collection Requirement 

Title: Office of Law Enforcement/ 

Federal Air Marshal Service Mental 

Health Certification. 

Type of Request: Extension of a 

currently approved collection. 

OMB Control Number: 1652–0043. 

Form(s): TSA Form 1164. 

Affected Public: Law Enforcement 

Officers/Air Marshal Applicants. 

Abstract: TSA policy requires that 

applicants for Federal Air Marshal 

(FAM) positions meet certain medical 

standards, including whether the 

individual has an established medical 

history or clinical diagnosis of 

psychosis, neurosis, or any other 

personality or mental disorder that 

clearly demonstrates a potential hazard 

to the performance of FAM duties or the 

safety of self or others. 

Number of Respondents: 10,000. 

Estimated Annual Burden Hours: An 

estimated 10,000 hours annually. 

Issued in Arlington, Virginia, on 

September 13, 2010. 

Joanna Johnson, 

TSA Paperwork Reduction Act Officer, Office 

of Information Technology. 

[FR Doc. 2010–23193 Filed 9–16–10; 8:45 am] 

BILLING CODE 9110–05–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–777, Application for 

Replacement of Northern Mariana Card 

ACTION: Correction to 30-day notice of 

Information Collection Under Review: 

Form I–777, Application for 

Replacement of Northern Mariana Card; 

OMB Control No. 1615–0042. 

* * * * * 

On August 26, 2010, USCIS published 

a 30-day notice in the Federal Register 

at 75 FR 52540. The 30-day notice 

contained a spelling error in the title of 

Form I–777 throughout the document. 

This notice advises the public that the 

title of the Form I–777 should read 

‘‘Application for Replacement of 

Northern Mariana Card’’, instead of 

‘‘Application for Replacement of 

Northern Marina Card’’. 

Written comments and/or suggestions 

regarding the item(s) contained in the 

30-day notice published on August 26, 

2010, especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Department of Homeland Security 

(DHS), and to the Office of Management 

and Budget (OMB) USCIS Desk Officer. 

Comments may be submitted to: USCIS, 

Chief, Regulatory Products Division, 111 

Massachusetts Avenue, Washington, DC 

20529–2210. Comments may also be 

submitted to DHS via facsimile to 202– 

272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to the OMB USCIS 

Desk Officer via facsimile at 202–395– 

5806 or via e-mail at 

oira_submission@omb.eop.gov. 

When submitting comments by e-mail 

please make sure to add OMB Control 

Number 1615–0042 in the subject box. 

If you need a copy of the information 

collection instrument, please visit the 

Web site at: http://www.regulations.gov. 

We may also be contacted at: USCIS, 

Regulatory Products Division, 111 

Massachusetts Avenue, NW., 

Washington, DC 20529–2210; 

Telephone 202–272–8377. 

Dated: September 14, 2010. 

Sunday Aigbe, 

Chief, Regulatory Products Division, U.S. 

Citizenship and Immigration Services, 

Department of Homeland Security. 

[FR Doc. 2010–23344 Filed 9–16–10; 8:45 am] 

BILLING CODE 9111–97–P 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1