Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations
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.
Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs
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 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.