Revocation of status of specific products; Group A streptococcus. Direct final rule.
The Food and Drug Administration (FDA) is removing the regulation applicable to the status of specific products; Group A streptococcus. FDA is removing the regulation because the existing requirement for Group A streptococcus organisms and derivatives is both obsolete and a perceived impediment to the development of Group A streptococcus vaccines. The regulation was written to apply to a group of products that are no longer on the market. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. We are issuing the removal directly as a final rule because it is noncontroversial, and there is little likelihood that we will receive any significant adverse comments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
D000942:Antigens, Bacterial / Q000009:adverse effects / Q000627:therapeutic use; D001688:Biological Products / Q000145:classification; D006801:Humans; D013290:Streptococcal Infections / Q000517:prevention & control; D022541:Streptococcal Vaccines / Q000627:therapeutic use; D013297:Streptococcus pyogenes / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration; D015164:Vaccines, Inactivated / Q000627:therapeutic use
D000942:Antigens, Bacterial; D001688:Biological Products; D022541:Streptococcal Vaccines; D015164:Vaccines, Inactivated