2068 Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 

contact Jean Close at (410) 786–2804 or 

Melissa Musotto at (410) 786–6962. For 

all other issues call (410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by March 13, 2012: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number CMS–R–306 (0938– 

0833), Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850. 

Dated: January 6, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–593 Filed 1–12–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Temporary Assistance for Needy 

Families/National Directory of New 

Hires Match Results Report. 

OMB No.: 0970–0311. 

Description: Section 453(j)(3) of the 

Social Security Act (the Act) allows for 

matching between the National 

Directory of New Hires (maintained by 

the Federal Office of Child Support 

Enforcement (OCSE) and State TANF 

Agencies for purposes of carrying out 

responsibilities under programs funded 

under part A of Title IV of the Act. To 

assist OCSE and the Office of Family 

Assistance (OFA) in measuring savings 

to the TANF program attributable to the 

use of NDNH data matches, the State 

TANF Agencies have agreed to provide 

OCSE with a written description of the 

performance outputs and outcomes 

attributable to the State TANF Agency’s 

use of NDNH match results. This 

information will help OCSE 

demonstrate how the NDNH supports 

the OCSE’s mission and strategic goals. 

Respondents: State TANF Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

TANF/NDNH Match Results Report ................................................................ 12 4 0.17 8.16 

Estimated Total Annual Burden 

Hours: 8.16. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: (202) 

395–7285, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–568 Filed 1–12–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0755] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Implementation of 

Sections 222, 223, and 224 of the Food 

and Drug Administration Amendments 

Act of 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

13, 2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

(202) 395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0625. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, (301) 796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 2069 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Implementation of Sections 222, 223, 

and 224 of the Food and Drug 

Administration Amendments Act of 

2007—(OMB Control Number 0910– 

0625)—Extension 

Sections 222, 223, and 224 of FDAAA, 

which were in effect on October 1, 2007, 

require that device establishment 

registrations and listings under section 

510 of the Federal Food, Drug, and 

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

360), including the submission of 

updated information, be submitted to 

the Secretary by electronic means, 

unless the Secretary grants a request for 

waiver of the requirement because the 

use of electronic means is not 

reasonable for the person requesting the 

waiver. There are approximately 24,000 

establishments that are electronically 

registered as of September 2011. 

Section 222 of FDAAA amends 

sections 510(b) of the FD&C Act to 

require domestic establishments to 

register annually during the period 

beginning October 1 and ending 

December 31 of each year. Section 222 

of FDAAA also amends section 510(i)(1) 

of the FD&C Act to require foreign 

establishments to register immediately 

upon first engaging in one of the 

covered device activities described 

under the statute, and in addition, they 

must also register annually during the 

time period beginning October 1 and 

ending December 31 of each year. 

Further, section 223 of FDAAA amends 

section 510(j)(2) of the FD&C Act to 

require establishments to list their 

devices with FDA annually, during the 

time period beginning October 1 and 

ending December 31 of each year. 

Under FDAAA, device establishment 

owners and operators are required to 

keep their registration and device listing 

information up-to-date using the 

Agency’s new electronic system. 

Owners and operators of new device 

establishments must use the electronic 

system to create new accounts, new 

registration records, and new device 

listings. Section 224 of FDAAA amends 

section 510(p) of the FD&C Act by 

allowing an affected person to request a 

waiver from the requirement to register 

electronically when the ‘‘use of 

electronic means’’ is not reasonable for 

the person. 

The estimates in table 1 of this 

document are based on FDA’s 

experience, data from the device 

registration and listing database, and 

our estimates of the time needed to 

complete the previously required forms. 

We estimate that the time needed to 

enter registration and listing 

information electronically using FDA 

Form 3673 will not differ significantly 

from the time needed to fill in the paper 

forms (FDA Forms 2891, 2891a, and 

2892) that previously were used for this 

purpose because the information 

required is essentially identical. 

In addition, under section 224 of 

FDAAA, device establishment owner/ 

operators, for whom registering and 

listing by electronic means is not 

reasonable, may request a waiver from 

the Secretary. Because a device 

establishment’s owner/operator is 

required to register and list, they would 

need only to have access to a computer, 

Internet, and an email address for 

registration and listing by electronic 

means, the Agency did not anticipate 

receipt of a large number of requests for 

waivers. From the October through 

December 2007 timeframe, FDA 

received fewer than 10 requests for 

waivers for the requirement to submit 

registration and listing information 

electronically. As data for more than 

16,000 establishments were received 

electronically for the same period, these 

requests amount to less than 1 percent 

of the total number of establishments 

that have responded. The number of 

waiver requests received through fiscal 

year 2011 has remained consistently 

less than 1 percent. 

Based on information taken from our 

databases, FDA estimates that there are 

21,254 owner/operators who 

collectively register a total of 24,000 

device establishments. The number of 

respondents listed for section 222 of 

FDAAA in table 1 of this document is 

21,254, which corresponds to the 

number of owner/operators who 

annually register. In addition, FDA 

estimates that 3,504 owner/operators are 

initial importers who must register their 

establishments but who, under FDA’s 

existing regulations, are not required to 

list their devices unless they initiate or 

develop the specifications for the 

devices or repackage or relabel the 

devices. The number of respondents 

included in table 1 of this document for 

section 223 of FDAAA is 17,750, which 

corresponds to the number of owner/ 

operators who annually list one or more 

devices (21,254 ¥ 3,504 = 17,750). 

To calculate the burden estimate for 

waiver requests under section 224 of 

FDAAA, we assume as stated 

previously, that less than 1 percent of 

the 24,000 total device establishments 

would request waivers from FDA. This 

means the total number of waiver 

requests would probably not exceed 14 

requests (24,000 x 0.0006). We also 

estimate that the one-time burden on 

these establishments would be an hour 

of time for a mid-level manager to draft, 

approve, and mail a letter. In addition, 

FDA estimates the total number of 

establishments will increase by 2,162 

new establishments each year. Of the 

2,162 new registrants each year, we 

assume that less than 1 percent (i.e., 1) 

of these will also request waivers each 

year. The total, therefore, is 14 waiver 

requests, which could increase by only 

one additional request each year. 

Based on the number of owner 

operators of foreign establishments 

reflected in our current database, 

approximately 8,067 owner operators 

will spend an hour annually identifying 

the name, address, telephone and fax 

numbers, email address, and registration 

number, if any has been assigned, of any 

importer of the establishment’s devices 

that is known to the foreign 

establishment. 

Also based on the current number of 

owner/operators in the FDA database, 

we estimate that approximately 1,305 

owner operators will spend .25 hours 

each year to identify changes in their 

U.S. agent’s name, address, or phone 

number to FDA. 

The burden estimate for 

recordkeeping requirements under 

section 222 of FDAAA in table 2 of this 

document complies with the 

requirement that owners or operators 

keep a list of officers, directors, and 

partners for each establishment. Owners 

or operators will need to provide this 

information only upon request from 

FDA. However, it is assumed that some 

effort will need to be expended for 

keeping such lists current. 

The burden estimate for the 

recordkeeping requirements under 

section 223 of FDAAA in table 2 of this 

document reflect other recordkeeping 

requirements for devices listed with 

FDA and the requirement to provide 

these records upon request from FDA. 

These estimates are based on FDA 

experience. 

In the Federal Register of November 

3, 2011 (76 FR 68195), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

mstockstill on DSK4VPTVN1PROD with NOTICES

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