Fed Regist. 1998 Oct 22;63(204):56555-9.
The Food and Drug Administration (FDA) is correcting its regulations governing mammography, published in a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The regulations are effective April 28, 1999; except section 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which become effective October 28, 2002. The October 28, 1997, document was published with some inadvertent typographical errors. Some of those errors were corrected in a document entitled "Quality Mammography Standards; Correction" that appeared in the Federal Register of November 10, 1997, but additional typographical errors occurred in the publication of this document. In addition, since November 10, 1997, certain other problems with the text of the regulations have been identified that, if uncorrected, would lead to unforeseen and undesirable consequences. This document corrects those errors.
美国食品药品监督管理局(FDA)正在修订其关于乳房X光检查的法规,这些法规发表在一份题为《优质乳房X光检查标准》的文件中,该文件于1997年10月28日刊登在《联邦公报》上。这些法规于1999年4月28日生效;但第900.12(b)(8)(i)、(e)(4)(iii)(B)和(e)(5)(i)(B)部分于2002年10月28日生效。1997年10月28日的文件在发布时存在一些无意的排版错误。其中一些错误在一份题为《优质乳房X光检查标准;勘误》的文件中得到了纠正,该文件于1997年11月10日刊登在《联邦公报》上,但这份文件在发布时又出现了其他排版错误。此外,自1997年11月10日以来,法规文本还发现了某些其他问题,如果不加以纠正,将导致不可预见的不良后果。本文件纠正了这些错误。