Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 5187-5188 [05-1787]

Download as PDF 5187 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices Effective date Subject name and address PAWTUCKET, RI PINKERTON, LINDA .................. ONEIDA, NY RADOMSKI, JULIENNE ............. LEESBURG, VA RAYMOND, JERRY ................... SPRINGFIELD, MO RENICK, LISA ............................ BOISE, ID RENKEN, CAREY ...................... DENVER, CO RIVERA, ANGEL ........................ HONDO, TX ROBERTS, FAITH ...................... MIAMI, FL SACCONE, MARGUERITE ........ FT LAUDERDALE, FL SALTER, DEBORAH .................. COLUMBIA, AL SANFORD, CYNTHIA ................ ENGLEWOOD, CO SANTIAGO, JAMIE .................... CLEVELAND, OH SCOTT, CLINTON ...................... LONG BEACH, CA SHAH, KAMLESH ...................... ONTARIO, CA SIMMONS, CAROLYN ............... BRISTOL, VA SMITH, KAREN .......................... SALT LAKE CITY, UT SMITH, RAMONA ....................... CAROLINA BEACH, NC SOARES, KIM ............................ SWANSEA, RI SOWLES, CHARLENE ............... PHOENIX, AZ STROBLE, LAURA ..................... WEST DOVER, VT STUDLEY, KATHLEEN .............. RUMFORD, RI SWAIN, JEREMY ....................... COVENTRY, RI TAYLOR, DONALD .................... HAVRE, MT TAYLOR, MATTHEW ................. CLEARFIELD, UT TAYLOR, MEL ............................ SAN LEANDRO, CA THAN-RIDDLE, KHIN ................. GAMBRILLS, MD TILLEY-BISBEE, COURTNEY ... SCOTTSDALE, AZ TOPPING, GARY ....................... DERBY, KS VALDIVIA, CARLOS ................... OXNARD, CA VARGOVICH, KAREN ................ OROFINO, ID VARNUM, ROLAND ................... LAKE CHARLES, LA VINLUAN, ELEANOR ................. CHEYENNE, WY WALLACE, FREDRICK .............. BESSEMER, AL WALLACE, SELENA .................. LAKE CITY, FL WASHINGTON, CARNELLA ...... OAKLAND, CA WEBER, SUSAN ........................ COLORADO SPRINGS, CO WILKERSON, NINA ................... PHOENIX, AZ VerDate jul<14>2003 15:06 Jan 31, 2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 Subject name and address Effective date Subject name and address Effective date WILLIAMS, APRIL ...................... PARACHUTE, CO WILLIAMS, REBECCA ............... AURORA, CO WOLAN, NANCY ........................ TAMPA, FL YOUNG, KISHA .......................... LONGVIEW, WA 1/19/2005 ROGEL-ELLIOTT, VALERIE ...... SEMINOLE, FL SMITH, MICHAEL ...................... TORRANCE, CA STANBRIDGE, GARY ................ WHITTIER, CA VAFAEE, MOHAMMAD .............. SANTA MONICA, CA YANG, SHENG ........................... FOUNTAIN VALLEY, CA 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 1/19/2005 Jkt 205001 1/19/2005 1/19/2005 1/19/2005 1/19/2005 RATHOD, BABUBHAI ................ MT PLEASANT, MI FRAUD/KICKBACKS/PROHIBITED ACTS/ SETTLEMENT AGREEMENTS GARCIA, GULLERMO ................ MIAMI, FL GONSALVES, WALLACE .......... MINERSVILLE, PA PATE, JIVA ................................. MYRTLE BEACH, SC 11/4/2004 9/23/2004 11/1/2004 OWNED/CONTROLLED BY CONVICTED ENTITY 1/19/2005 1/19/2005 1/19/2005 1/19/2005 OWNERS OF EXCLUDED ENTITIES RYDER, JON .............................. EUGENE, OR 1/19/2005 1/19/2005 1/19/2005 FEDERAL/STATE EXCLUSION/ SUSPENSION 1/19/2005 1/19/2005 1/19/2005 ALPHA HERBS & VITAMINS ..... HOUSTON, TX ALPHA SENIOR HEALTH GROUP ................................... HOUSTON, TX AVIONIX MEDICAL DEVICES, INC .......................................... MIDLAND, TX HEALTH RESOURCES & REHAB .................................... HOUSTON, TX HEALTH RESOURCES & REHAB CENTER .................... HOUSTON, TX JORGENSON DRUG, INC ......... ROUNDUP, MT MARITIME HEALTH SERVICES OF TAMPA, INC ..................... TAMPA, FL SEELIN MEDICAL, INC ............. MIDLAND, TX 1/19/2005 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 1/19/2005 1/19/2005 Centers for Disease Control and Prevention Reporting of Pregnancy Success Rates From Assisted Reproductive 1/19/2005 Technology Programs Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS). ACTION: Notice. 1/19/2005 SUMMARY: The CDC is tasked with 1/19/2005 implementing the Fertility Clinic Success Rate and Certification Act of 1/19/2005 1992 (FCSRCA), Public Law 102–493. As mandated by this law CDC publishes 1/19/2005 annual reports of pregnancy success rates from ART clinics and embryo laboratory certification status of these DEFAULT ON HEAL LOAN clinics. Section 2(a) of Public Law 102– BEAMS, JEFFREY ..................... 1/19/2005 493 (42 U.S.C. 263a–1) requires that each assisted reproductive technology TAMPA, FL BULEN, JERRY .......................... 1/19/2005 (ART) program shall annually report to BRANDON, FL the Secretary, through the Centers for EAGLE, DONALD ....................... 1/19/2005 Disease Control and Prevention, (a) GRAND ISLAND, FL pregnancy success rates achieved by GREEN, MICHAEL ..................... 1/19/2005 such ART programs, and (b) the identity MAITLAND, FL HASLEY, STEVEN ..................... 1/19/2005 of each embryo laboratory used by such ART programs, and whether the MELBOURNE, FL HEISLER, HOPE ........................ 1/19/2005 laboratory is certified or has applied for such certification under this act. Section PUNTA GORDA, FL JOSEPH, BRAD ......................... 1/19/2005 (6) states that the Secretary, through the PITTSBURGH, PA CDC, shall annually publish and LIGHT, DAVID ............................ 1/19/2005 distribute to the States and the public, WINTER GARDEN, FL pregnancy success rates reported to the MARIN, MELODY ....................... 1/19/2005 Secretary under section 2(a)(1) and, in VAN NUYS, CA MARQUEZ, EVELYN ................. 1/19/2005 the case of an assisted reproductive technology program which failed to LOS ANGELES, CA NEALY, JOY ............................... 1/19/2005 report one or more success rates as ATLANTA, GA required under such section, the name PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 1/19/2005 AGENCY: E:\FR\FM\01FEN1.SGM 01FEN1 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 VerDate jul<14>2003 15:06 Jan 31, 2005 Jkt 205001 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: PO 00000 Notice. Frm 00060 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

[Federal Register Volume 70, Number 20 (Tuesday, February 1, 2005)]
[Notices]
[Pages 5187-5188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1787]


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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

[[Page 5188]]

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