Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 5187

Subject name and address Effective

date 

PAWTUCKET, RI 

PINKERTON, LINDA .................. 1/19/2005 

ONEIDA, NY 

RADOMSKI, JULIENNE ............. 1/19/2005 

LEESBURG, VA 

RAYMOND, JERRY ................... 1/19/2005 

SPRINGFIELD, MO 

RENICK, LISA ............................ 1/19/2005 

BOISE, ID 

RENKEN, CAREY ...................... 1/19/2005 

DENVER, CO 

RIVERA, ANGEL ........................ 1/19/2005 

HONDO, TX 

ROBERTS, FAITH ...................... 1/19/2005 

MIAMI, FL 

SACCONE, MARGUERITE ........ 1/19/2005 

FT LAUDERDALE, FL 

SALTER, DEBORAH .................. 1/19/2005 

COLUMBIA, AL 

SANFORD, CYNTHIA ................ 1/19/2005 

ENGLEWOOD, CO 

SANTIAGO, JAMIE .................... 1/19/2005 

CLEVELAND, OH 

SCOTT, CLINTON ...................... 1/19/2005 

LONG BEACH, CA 

SHAH, KAMLESH ...................... 1/19/2005 

ONTARIO, CA 

SIMMONS, CAROLYN ............... 1/19/2005 

BRISTOL, VA 

SMITH, KAREN .......................... 1/19/2005 

SALT LAKE CITY, UT 

SMITH, RAMONA ....................... 1/19/2005 

CAROLINA BEACH, NC 

SOARES, KIM ............................ 1/19/2005 

SWANSEA, RI 

SOWLES, CHARLENE ............... 1/19/2005 

PHOENIX, AZ 

STROBLE, LAURA ..................... 1/19/2005 

WEST DOVER, VT 

STUDLEY, KATHLEEN .............. 1/19/2005 

RUMFORD, RI 

SWAIN, JEREMY ....................... 1/19/2005 

COVENTRY, RI 

TAYLOR, DONALD .................... 1/19/2005 

HAVRE, MT 

TAYLOR, MATTHEW ................. 1/19/2005 

CLEARFIELD, UT 

TAYLOR, MEL ............................ 1/19/2005 

SAN LEANDRO, CA 

THAN-RIDDLE, KHIN ................. 1/19/2005 

GAMBRILLS, MD 

TILLEY-BISBEE, COURTNEY ... 1/19/2005 

SCOTTSDALE, AZ 

TOPPING, GARY ....................... 1/19/2005 

DERBY, KS 

VALDIVIA, CARLOS ................... 1/19/2005 

OXNARD, CA 

VARGOVICH, KAREN ................ 1/19/2005 

OROFINO, ID 

VARNUM, ROLAND ................... 1/19/2005 

LAKE CHARLES, LA 

VINLUAN, ELEANOR ................. 1/19/2005 

CHEYENNE, WY 

WALLACE, FREDRICK .............. 1/19/2005 

BESSEMER, AL 

WALLACE, SELENA .................. 1/19/2005 

LAKE CITY, FL 

WASHINGTON, CARNELLA ...... 1/19/2005 

OAKLAND, CA 

WEBER, SUSAN ........................ 1/19/2005 

COLORADO SPRINGS, CO 

WILKERSON, NINA ................... 1/19/2005 

PHOENIX, AZ 

Subject name and address Effective

date 

WILLIAMS, APRIL ...................... 1/19/2005 

PARACHUTE, CO 

WILLIAMS, REBECCA ............... 1/19/2005 

AURORA, CO 

WOLAN, NANCY ........................ 1/19/2005 

TAMPA, FL 

YOUNG, KISHA .......................... 1/19/2005 

LONGVIEW, WA 

FEDERAL/STATE EXCLUSION/

SUSPENSION

RYDER, JON .............................. 1/19/2005

EUGENE, OR 

FRAUD/KICKBACKS/PROHIBITED ACTS/

SETTLEMENT AGREEMENTS

GARCIA, GULLERMO ................ 11/4/2004 

MIAMI, FL 

GONSALVES, WALLACE .......... 9/23/2004 

MINERSVILLE, PA 

PATE, JIVA ................................. 11/1/2004 

MYRTLE BEACH, SC 

OWNED/CONTROLLED BY CONVICTED 

ENTITY

ALPHA HERBS & VITAMINS ..... 1/19/2005 

HOUSTON, TX 

ALPHA SENIOR HEALTH 

GROUP ................................... 1/19/2005 

HOUSTON, TX 

AVIONIX MEDICAL DEVICES, 

INC .......................................... 1/19/2005 

MIDLAND, TX 

HEALTH RESOURCES & 

REHAB .................................... 1/19/2005 

HOUSTON, TX 

HEALTH RESOURCES & 

REHAB CENTER .................... 1/19/2005 

HOUSTON, TX 

JORGENSON DRUG, INC ......... 1/19/2005 

ROUNDUP, MT 

MARITIME HEALTH SERVICES 

OF TAMPA, INC ..................... 1/19/2005 

TAMPA, FL 

SEELIN MEDICAL, INC ............. 1/19/2005 

MIDLAND, TX 

DEFAULT ON HEAL LOAN

BEAMS, JEFFREY ..................... 1/19/2005 

TAMPA, FL 

BULEN, JERRY .......................... 1/19/2005 

BRANDON, FL 

EAGLE, DONALD ....................... 1/19/2005 

GRAND ISLAND, FL 

GREEN, MICHAEL ..................... 1/19/2005 

MAITLAND, FL 

HASLEY, STEVEN ..................... 1/19/2005 

MELBOURNE, FL 

HEISLER, HOPE ........................ 1/19/2005 

PUNTA GORDA, FL 

JOSEPH, BRAD ......................... 1/19/2005 

PITTSBURGH, PA 

LIGHT, DAVID ............................ 1/19/2005 

WINTER GARDEN, FL 

MARIN, MELODY ....................... 1/19/2005 

VAN NUYS, CA 

MARQUEZ, EVELYN ................. 1/19/2005 

LOS ANGELES, CA 

NEALY, JOY ............................... 1/19/2005 

ATLANTA, GA 

Subject name and address Effective

date 

ROGEL-ELLIOTT, VALERIE ...... 1/19/2005 

SEMINOLE, FL 

SMITH, MICHAEL ...................... 1/19/2005 

TORRANCE, CA 

STANBRIDGE, GARY ................ 1/19/2005 

WHITTIER, CA 

VAFAEE, MOHAMMAD .............. 1/19/2005 

SANTA MONICA, CA 

YANG, SHENG ........................... 1/19/2005 

FOUNTAIN VALLEY, CA 

OWNERS OF EXCLUDED ENTITIES

RATHOD, BABUBHAI ................ 1/19/2005 

MT PLEASANT, MI 

Dated: January 24, 2005. 

Katherine B. Petrowski, 

Director, Exclusions Staff, Office of Inspector 

General.

[FR Doc. 05–1788 Filed 1–31–05; 8:45 am] 

BILLING CODE 4150–04–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Reporting of Pregnancy Success Rates 

From Assisted Reproductive 

Technology Programs

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS).

ACTION: Notice.

SUMMARY: The CDC is tasked with 

implementing the Fertility Clinic 

Success Rate and Certification Act of 

1992 (FCSRCA), Public Law 102–493. 

As mandated by this law CDC publishes 

annual reports of pregnancy success 

rates from ART clinics and embryo 

laboratory certification status of these 

clinics. Section 2(a) of Public Law 102–

493 (42 U.S.C. 263a–1) requires that 

each assisted reproductive technology 

(ART) program shall annually report to 

the Secretary, through the Centers for 

Disease Control and Prevention, (a) 

pregnancy success rates achieved by 

such ART programs, and (b) the identity 

of each embryo laboratory used by such 

ART programs, and whether the 

laboratory is certified or has applied for 

such certification under this act. Section 

(6) states that the Secretary, through the 

CDC, shall annually publish and 

distribute to the States and the public, 

pregnancy success rates reported to the 

Secretary under section 2(a)(1) and, in 

the case of an assisted reproductive 

technology program which failed to 

report one or more success rates as 

required under such section, the name 

5188 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 

of each such program and each 

pregnancy success rate which the 

program failed to report. 

This Announcement includes 

information on the change in the data 

collection contractor and the change in 

the approved data reporting system for 

the 2004, 2005, 2006, 2007, and 2008 

ART data reporting years in accordance 

with the FCSRCA. This Announcement 

supplements the September 1, 2000 and 

the February 5, 2004, notices.

SUPPLEMENTARY INFORMATION: CDC has 

contracted with Westat to develop a 

data reporting system and to collect 

annual clinic-specific and cycle-specific 

data from all practicing assisted 

reproductive technology clinics in the 

U.S. and its territories for the 2004, 

2005, 2006, 2007, and 2008 ART data 

reporting years. The contract covers 

clinic tracking, data collection and 

quality assurance, and validation 

activities. As such, Westat is the new 

contractor for ART data collection for 

the 2004 through 2008 ART data 

reporting years. 

The new Web-based data reporting 

system (developed by Westat) for the 

2004, 2005, 2006, 2007, and 2008 ART 

data reporting years will be called the 

National ART Surveillance System 

(NASS). As such, NASS will be the only 

approved data reporting system for 2004 

through 2008 ART data submissions. 

ART programs should be aware that 

Westat will develop and provide all 

necessary instruction materials for 

extracting and importing data from 

other electronic medical record systems 

into NASS and for checking imported 

data to ensure that it retains the 

accuracy and compatibility of the data 

entry system from which it was 

extracted. 

The anticipated deadline for reporting 

is December 15 of the year 1 year 

subsequent to the reporting year in 

question. (For example, the anticipated 

deadline to report data on cycles 

initiated in 2004 is December 15, 2005.) 

An ART program will not be considered 

to be in compliance with the federal 

reporting requirements of FCSRCA if the 

ART program was in operation in the 

full year that is being reported, i.e., the 

clinic was in operation after January 1 

of the reporting year, and fails to submit 

a dataset to Westat in the required data 

reporting system (NASS) by the 

reporting deadline. ART programs 

considered to not be compliant with the 

federal reporting requirements of 

FCSRCA will be listed as non-reporters 

in the published report. 

The data reporting activities and the 

amount and type of data collected will 

be similar to the current system 

requirements outlined in the September 

1, 2000 Federal Register notice (Volume 

65, No. 171, pages 53310–53316). CDC 

has completely funded the data 

reporting activities for the 2004 through 

2008 reporting years. Thus, ART 

programs will not be charged fees to 

obtain the new reporting system or to 

submit data using the new reporting 

system. 

Validation activities for the 2004 

through 2008 data reporting years will 

be similar to those described in the 

September 1, 2000 Federal Register

notice (Volume 65, No. 171, pages 

53310–53316). Westat will provide the 

necessary personnel to perform the 

validation site visits. 

Each ART program should be aware 

that the Paperwork Reduction Act is 

applicable to this data collection. Under 

the Paperwork Reduction Act of 1995, a 

Federal agency shall not conduct or 

sponsor a collection of information from 

ten or more persons other than Federal 

employees, unless the agency has 

submitted a Standard Form 83, 

Clearance Request, to the Director of the 

Office of Management and Budget 

(OMB), and OMB has approved the 

collection of information. A person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

CDC has obtained OMB approval to 

collect this data under OMB control No. 

0920–0556. 

CDC will continue to provide 

information to all ART programs 

regarding data collection activities as 

information becomes available.

FOR FURTHER INFORMATION CONTACT:

Victoria Wright, Assisted Reproductive 

Technology Epidemiology Unit at (770) 

488–6384.

Dated: January 25, 2005. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention.

[FR Doc. 05–1787 Filed 1–31–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0029]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Infant Formula 

Recall Regulations

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements related to the recall of 

infant formula.

DATES: Submit written or electronic 

comments on the collection of 

information by April 4, 2005.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the