2070 Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDAAA Section of the 2007 amendments FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

222 3 ......................................................... 3673 21,254 1 21,254 0 .75 15,941 

222 2 ......................................................... 3673 2,162 1 2,162 0 .50 1,081 

222 3 ......................................................... 3673 8,067 1 8,067 1 8,067 

222 3 ......................................................... 3673 1,305 1 1,305 0 .25 326 

223 3 ......................................................... 3673 17,750 1 17,750 1 17,750 

224 (waiver request) 2 .............................. 3673 14 1 14 1 14 

224 (waiver request) 3 .............................. 3673 1 1 1 2 2 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 43,181 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2One-time burden. 

3Annual recurring burden. 

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN1

FDAAA Section of the 2007 amendments Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

222 2 ..................................................................................... 23,806 1 23,806 0 .25 5,952 

223 2 ..................................................................................... 11,746 4 46,984 0 .5 23,492 

Total .............................................................................. ........................ ........................ ........................ ........................ 29,444 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Recurring burden. 

Dated: January 9, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–503 Filed 1–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0589] 

Anneri Izurieta: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Anneri Izurieta for a period of 30 years 

from importing articles of food or 

offering such articles for importation 

into the United States. FDA bases this 

order on a finding 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. Ms. Izurieta was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. As of November 4, 2011 (30 

days after receipt of the notice), Ms. 

Izurieta had not responded. Ms. 

Izurieta’s failure to respond constitutes 

a waiver of her right to a hearing 

concerning this action. 

DATES: This order is effective January 

13, 2012. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Dr., Rockville, MD 

20857, (301) 796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. 

On May 11, 2011, in the U.S. District 

Court for the Southern District of 

Florida, Ms. Izurieta was convicted of 

one count of conspiracy to smuggle 

goods into the United States, in 

violation of 18 U.S.C. 371, and five 

counts of smuggling goods into the 

United States, in violation of 18 U.S.C. 

545. The U.S. District Court for the 

Southern District of Florida entered 

judgment against Ms. Izurieta on July 

29, 2011. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein for 

conduct relating to the importation into 

the United States of any food. The 

factual basis for these convictions is as 

follows: On or about April 18, 2007, and 

continuing through on or about 

December 23, 2010, in violation of 18 

U.S.C. 371, Ms. Izurieta knowingly, and 

with the intent to further the object of 

the conspiracy, conspired with others to 

commit an offense against the United 

States to fraudulently and knowingly 

import and bring into the United States 

merchandise contrary to law in 

violation of 18 U.S.C. 545. Specifically, 

Ms. Izurieta conspired to distribute and 

sell imported dairy products that FDA 

had detained after receiving notice from 

FDA that the dairy products were 

suspected to be adulterated. 

While serving as president and 

director of Naver Trading, Ms. Izurieta 

caused dairy products and other food to 

be imported from Honduras and 

Nicaragua. Despite a request from FDA 

to disclose the location of shipments of 

dairy products after learning that FDA 

had slated specific shipments for 

examination due to concerns of 

adulteration with Escherichia coli, 

mstockstill on DSK4VPTVN1PROD with NOTICES

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. 

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