Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 2071 

Staphylococcus aureus, and Salmonella, 

Ms. Izurieta failed to do so. Ms. Izurieta 

also distributed shipments of dairy 

products after learning that FDA had 

slated specific shipments for 

examination due to concerns of 

adulteration with E. coli, S. aureus, and 

Salmonella. Ms. Izurieta failed to 

redeliver for destruction and 

exportation shipments of dairy products 

that FDA had determined to be 

adulterated with E. coli, S. aureus, and 

Salmonella and that were not 

authorized for entry into the United 

States. Ms. Izurieta then distributed 

dairy products that were adulterated 

and not authorized for entry into the 

United States. This conduct was in 

violation of 18 U.S.C. 545. 

From approximately April 18, 2007, 

and continuing to approximately 

December 7, 2010, Ms. Izurieta 

fraudulently and knowingly imported 

and brought into the United States 

merchandise contrary to law. Further, 

Ms. Izurieta failed to redeliver, export, 

and destroy with FDA supervision the 

dairy products and other food products 

contained in these shipments after 

receiving notice from FDA regarding 

concerns about the adulteration of these 

products with E. coli, S. aureus, and/or 

Salmonella. 

As a result of her conviction, on 

September 28, 2011, FDA sent Ms. 

Izurieta a notice by certified mail 

proposing to debar her for a period of 

30 years from importing articles of food 

or offering such articles for import into 

the United States. The proposal was 

based on a finding under section 

306(b)(1)(C) of the FD&C Act that Ms. 

Izurieta was convicted of six felony 

counts under Federal law for conduct 

relating to the importation into the 

United States of an article of food 

because she conspired to and did 

commit offenses related to the 

importation of dairy products and other 

products into the United States, and a 

determination, after consideration of the 

factors set forth in section 306(c)(3) of 

the FD&C Act that Ms. Izurieta should 

be subject to the maximum possible 

period of debarment. The proposal also 

offered Ms. Izurieta an opportunity to 

request a hearing, providing her 30 days 

from the date of receipt of the letter in 

which to file the request, and advised 

her that failure to request a hearing 

constituted a waiver of the opportunity 

for a hearing and of any contentions 

concerning this action. Ms. Izurieta 

failed to respond within the timeframe 

prescribed by regulation and has, 

therefore, waived her opportunity for a 

hearing and waived any contentions 

concerning her debarment (21 CFR part 

12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(b)(1)(C) of the 

FD&C Act, and under authority 

delegated to the Director (Staff Manual 

Guide 1410.35), finds that Ms. Anneri 

Izurieta has been convicted of six felony 

counts under Federal law for conduct 

relating to the importation of an article 

of food into the United States and that 

she is subject to the full period of 

debarment. 

As a result of the foregoing finding, 

Ms. Izurieta is debarred for a period of 

30 years from importing articles of food 

or offering such articles for import into 

the United States, effective (see DATES). 

Under section 301(cc) of the FD&C Act 

(21 U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of an article of food by, with the 

assistance of, or at the direction of Ms. 

Izurieta is a prohibited act. 

Any application by Ms. Izurieta for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2011– 

N–0589 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: January 4, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–542 Filed 1–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–M–0502, FDA– 

2011–M–0503, FDA–2011–M–0563, FDA– 

2011–M–0564, FDA–2011–M–0600, FDA– 

2011–M–0601, FDA–2011–M–0630, and 

FDA–2011–M–0707] 

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 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 

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, 2011, through 

September 30, 2011. 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

2072 Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 

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

2011, THROUGH SEPTEMBER 30, 2011 

PMA No. 

Docket No. Applicant Trade name Approval date 

P100031, FDA–2011–M– 

0502.

Roche Diagnostics Corp. ..... ELECSYS ANTI–HBC IMMUNOASSAY & ELECSYS 

PRECICONTROL ANTI–HBC.

June 22, 2011. 

P100032, FDA–2011–M– 

0503.

Roche Diagnostics Corp. ..... ELECSYS ANTI–HBC IMMUNOASSAY, ELECSYS 

PRECICONTROL ANTI–HBC FOR USE ON THE 

ELECSYS 2010 IMMUNOASSAY ANALYZER.

June 27, 2011. 

P100001, FDA–2011–M– 

0563.

Ortho-Clinical Diagnostics, 

Inc..

VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI– 

HBE REAGENT PACK, VITROS 

IMMUNODIAGNOSTIC PRODUCTS ANTI–HBE CALIBRATOR, AND VITROS IMMUNODIAGNOSTIC 

PRODUCTS ANTI–HBE CONTROLS.

July 20, 2011. 

P110001, FDA–2011–M– 

0564.

Abbott Vascular ................... RX HERCULINK ELITE RENAL STENT SYSTEM ........... July 20, 2011. 

P100044, FDA–2011–M– 

0600.

Intersect ENT ....................... PROPEL ............................................................................. August 11, 2011. 

P110020, FDA–2011–M– 

0601.

Roche Molecular Systems, 

Inc..

COBAS 4800 BRAF V600 MUTATION TEST ................... August 17, 2011. 

P110012, FDA–2011–M– 

0630.

Abbott Molecular, Inc. .......... VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS 

PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK 

POSITIVE CONTROL SLIDES.

August 26, 2011. 

H100006, FDA–2011–M– 

0707.

Synapse Biomedical, Inc. .... NEURX DPS DIAPHRAGM PACING SYSTEM ................ September 28, 2011. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

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

Dated: January 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–537 Filed 1–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Prevalence, Incidence, 

Epidemiology and Molecular Variants 

of HIV in Blood Donors in Brazil 

SUMMARY: In compliance with the 

requirement of Section 3506(c) (2) (A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: 

Prevalence, Incidence, Epidemiology 

and Molecular Variants of HIV in Blood 

Donors in Brazil. Type of Information 

Collection Request: Extension (OMB No. 

0925–0597). Need and Use of 

Information Collection: Establishing and 

monitoring viral prevalence and 

incidence rates, and identifying 

behavioral risk behaviors for HIV 

infection among donors are critical steps 

to assessing and reducing risk of HIV 

transmission through blood transfusion. 

Detecting donors with recently acquired 

HIV infection is particularly critical as 

it enables characterization of the viral 

subtypes currently transmitted within 

the screened population. In addition to 

characterizing genotypes of recently 

infected donors for purposes of blood 

safety, molecular surveillance of 

incident HIV infections in blood donors 

serves important public health roles by 

identifying new HIV infections for antiretroviral treatment, and enabling 

documentation of the rates of primary 

transmission of anti-viral drug resistant 

strains in the community. This study is 

a continuation of a previous research 

project which enrolled eligible HIV 

positive blood donors and analyzed HIV 

molecular variants and their association 

with risk. 

This previous project was conducted 

by the NHLBI Retrovirus Epidemiology 

Donor Study—II (REDS–II) International 

Brazil program and included not only 

data collection on HIV seropositive 

donors but also collection of risk factor 

data on uninfected donors. The current 

Recipient Epidemiology and Donor 

Evaluation Study—(REDS–III) research 

proposal is a continuation of the 

previous REDS–II project at the same 

four blood centers in Brazil, located in 

the cities of Sao Paulo, Recife, Rio de 

Janeiro and Belo Horizonte, but this 

time restricted to the study of HIVpositive subjects. 

The primary study aims are to 

continue monitoring HIV molecular 

variants and risk behaviors in blood 

donors in Brazil, and to evaluate HIV 

subtype and drug resistance profiles 

among HIV positive donors according to 

HIV infection status (recent versus longstanding infection), year of donation, 

and site of collection. Additional study 

objectives include determining trends in 

HIV molecular variants and risk factors 

associated with HIV infection by 

combining data collected in the 

previous REDS–II project with that 

which will be obtained in the planned 

research activities. 

Nucleic acid testing (NAT) testing for 

HIV is currently being implemented in 

Brazil. It will be important to continue 

to collect molecular surveillance and 

risk factor data on HIV infections, 

especially now that infections that 

might not have been identified by 

serology testing alone could be 

recognized through the use of NAT. 

NAT-only infections represent very 

recently acquired infections. The NAT 

assay will be used at the four REDS–III 

blood centers in Brazil during the 

planned research activities. In addition, 

in order to distinguish between recent 

seroconversion and long-standing 

infection, samples from all HIV 

antibody- dual reactive donations and/ 

or NAT positive donations will be tested 

by the Recent Infection Testing 

mstockstill on DSK4VPTVN1PROD with NOTICES