Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 72829 

The estimate of the time required for 

record preparation and maintenance is 

based on Agency communications with 

industry. Other information needed to 

calculate the total burden hours (i.e., 

manufacturing sites, number of type A 

medicated articles being manufactured, 

etc.) are derived from Agency records 

and experience. 

Dated: November 19, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29687 Filed 11–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Los Alamos Historical Document 

Retrieval and Assessment (LAHDRA) 

Project 

The Centers for Disease Control and 

Prevention (CDC) and the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) announces the following 

meeting. 

Name: Public Meeting to release CDC’s 

recommendations to the Department of 

Energy resulting from the release of the Final 

Report of the Los Alamos Historical 

Document Retrieval and Assessment 

(LAHDRA)Project. 

Time and Date: 5 p.m.–7 p.m., (Mountain 

Time), Wednesday, December 8, 2010 and 5 

p.m.–7 p.m. Thursday, December 9, 2010. 

Place: December 8, 2010, Santa Claran 

Hotel & Casino in Espanola (25 miles north 

of Santa Fe on US 84/285), 460 Riverside 

Drive, Espanola, New Mexico 87532, 

telephone 877–505–4949. 

December 9, 2010, Tularosa Senior & 

Community Center in Tularosa (14 miles 

north of Alamogordo on US 70), 1050 

Bookout Rd., Tularosa, New Mexico 88352, 

telephone 575–585–4532. 

Status: Open to the public, limited only by 

the space available. The meeting room(s) 

accommodates approximately 100 people. 

Background: Under a Memorandum of 

Understanding (MOU) signed in December 

1990 with the Department of Energy (DOE) 

and replaced by MOUs signed in 1996 and 

2000, the Department of Health and Human 

Services (HHS) was given the responsibility 

and resources for conducting analytic 

epidemiologic investigations of residents of 

communities in the vicinity of DOE facilities, 

workers at DOE facilities, and other persons 

potentially exposed to radiation or to 

potential hazards from non-nuclear energy 

production use. HHS delegated program 

responsibility to CDC. 

In addition, a memo was signed in October 

1990 and renewed in November 1992, 1996, 

and in 2000, between the Agency for Toxic 

Substances and Disease Registry (ATSDR) 

and DOE. The MOU delineates the 

responsibilities and procedures for ATSDR’s 

public health activities at DOE sites required 

under sections 104, 105, 107, and 120 of the 

Comprehensive Environmental Response, 

Compensation, and Liability Act (CERCLA or 

a Superfund). These activities include health 

consultations and public health assessments 

at DOE sites listed on, or proposed for, the 

Superfund National Priorities List and at 

sites that are the subject of petitions from the 

public; and other health-related activities 

such as epidemiologic studies, health 

surveillance, exposure and disease registries, 

health education, substance-specific applied 

research, emergency response, and 

preparation of toxicological profiles. 

Purpose: This study group was charged 

with locating, evaluating, cataloguing, and 

copying documents that contain information 

about historical chemical or radionuclide 

releases from facilities at the Los Alamos 

National Laboratory and Trinity Site since its 

inception. The purpose of this meeting is to 

release the CDC’s recommendations to the 

Department of Energy as a result of the 

release of the Final Report (http:// 

www.Lahdra.org). 

Matters to Be Discussed: Agenda items for 

the December 8th meeting include a 

presentation from the National Center for 

Environmental Health (NCEH) and poster 

sessions on various report topics. There will 

be time for the public to ask questions. At the 

December 9th meeting, ChemRisk personnel 

will present on the Final Report’s Trinity Site 

chapter. All agenda items are subject to 

change as priorities dictate. 

Contact Person for Additional Information: 

Phillip R. Green, Public Health Advisor, 

Radiation Studies Branch, Division of 

Environmental Hazards and Health Effects, 

NCEH, CDC, 1600 Clifton Road, NE., 

(Mailstop F–58), Atlanta, Georgia 30333, 

telephone 770/488–3748, fax 770/488–1539, 

or e-mail address: prg1@cdc.gov. 

Dated: November 19, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–29778 Filed 11–24–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–M–0402, FDA– 

2010–M–0361, and FDA–2010–M–0519] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the Agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 


srobinson on DSKHWCL6B1PROD with NOTICES
72830 Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from July 1, 2010, through 

September 30, 2010. There were no 

denial actions during this period. The 

list provides the manufacturer’s name, 

the product’s generic name or the trade 

name, and the approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 

2010, THROUGH SEPTEMBER 30, 2010 

PMA No. 

Docket No. Applicant Trade name Approval date 

P080027, FDA–2010–M–0402 ............... OraSure Technologies, Inc ................... ORAQUICK HCV RAPID ANTIBODY 

TEST.

June 25, 2010. 

P050034, FDA–2010–M–0361 ............... Vision Care Ophthalmic Technologies, 

Ltd.

IMPLANTABLE MINIATURE TELESCOPE.July 1, 2010. 

P080026, FDA–2010–M–0519 ............... Abbott Molecular, Inc ............................ ABBOTT REALTIME HBV ASSAY ....... August 13, 2010. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: November 18, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–29731 Filed 11–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3229–N] 

Medicare Program; Quality 

Improvement Organization (QIO) 

Contracts: Solicitation of Proposals 

From In-State QIOs—Idaho, Maine, 

South Carolina, and Vermont 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice fulfills the 

Secretary’s obligation under section 

1153(i) of the Social Security Act (the 

Act) to provide at least 6 months’ 

advance notice of the expiration dates of 

contracts with out-of-State Quality 

Improvement Organizations (QIOs) 

before renewing any of those QIOs’ 

contracts. It also specifies the period of 

time in which in-State QIOs may submit 

a proposal for those contracts. 

DATES: Interested organizations may 

submit a proposal to perform the QIO 

work in any of the States listed in this 

announcement. The request for proposal 

(RFP) will be made available to all 

interested organizations through the 

Federal Business Opportunities (http:// 

www.fedbizopps.gov) Web site. CMS 

anticipates that the RFP for the QIO 

contracts will be released sometime 

during the month of February 2011. 

Interested organizations should monitor 

the Federal Business Opportunities Web 

site for all information relating to the 

RFP. 

ADDRESSES: Proposals for the contracts 

must be submitted to the Centers for 

Medicare & Medicaid Services, 

Acquisitions and Grants Groups, 

OAGM, Attn.: Naomi Haney-Ceresa, 

7500 Security Boulevard, Mail Stop C2– 

21–15, Baltimore, Maryland 21244– 

1850. 

FOR FURTHER INFORMATION CONTACT: 

Alfreda Staton, (410) 786–4194. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Peer Review Improvement Act of 

1982 (title I, subtitle C of the Tax Equity 

and Fiscal Responsibility Act of 1982 

(TEFRA), Pub. L. 97–248) amended Part 

B of title XI of the Act (the Act) by 

establishing the Utilization and Quality 

Control Peer Review Organization 

program. 

Utilization and Quality Control Peer 

Review Organizations, now known as 

Quality Improvement Organizations 

(QIOs), currently review certain health 

care services furnished under title XVIII 

of the Social Security Act (the Act) 

(Medicare) to determine whether those 

services are reasonable, medically 

necessary, provided in the appropriate 

setting, and are of a quality that meets 

professionally recognized standards. 

QIO activities are a part of the Health 

Care Quality Improvement Program 

(HCQIP), a program that supports our 

mission to ensure health care quality for 

our beneficiaries. The HCQIP rests on 

the belief that a plan’s, provider’s, or 

practitioner’s own internal quality 

management system is key to good 

performance. The HCQIP is carried out 

locally by the QIO in each State. Under 

the HCQIP, QIOs provide critical tools 

(for example, quality indicators and 

information) for plans, providers, and 

practitioners to improve the quality of 

care provided to Medicare beneficiaries. 

The Congress created the QIO program 

in part to redirect, simplify, and 

enhance the cost-effectiveness and 

efficiency of the peer review process. 

In June 1984, we began awarding 

contracts to QIOs. We currently 

maintain 53 QIO contracts with 

organizations that provide medical 

review activities for the 50 States, the 

District of Columbia, Puerto Rico, and 

the Virgin Islands. The organizations 

that are eligible to contract as QIOs have 

satisfactorily demonstrated that they are 

either physician-sponsored or 

physician-access organizations in 

accordance with section 1152 of the Act 

and our regulations at 42 CFR 475.102 

and 475.103. A physician-sponsored 

organization is one that is both 

composed of a substantial number of the 

licensed doctors of medicine and 

osteopathy practicing medicine or 

surgery in the respective review area 

and who are representative of the 

physicians practicing in the review area. 

A physician-access organization is one 

that has available to it, by arrangement 

or otherwise, the services of a sufficient 

number of licensed doctors of medicine 

or osteopathy practicing medicine or 

surgery in the review area to ensure 

adequate peer review of the services 

furnished by the various medical 

specialties and subspecialties. In 

addition, a QIO cannot be a health care 

facility, health care facility association, 

a health care facility affiliate, or in most 

cases a payor organization. (The 

regulations provide that, in the event 

CMS determines no otherwise qualified 

non-payor organization is available to 

undertake a given QIO contract, CMS 

may select a payor organization which 

otherwise meets certain requirements to 

be eligible to conduct Utilization and 

Quality Control Peer Review as 

specified in Part B of Title XI of the Act 

and its implementing regulations.) 

Section 1152(2) of the Act requires QIOs 

to perform review functions in an 


srobinson on DSKHWCL6B1PROD with NOTICES