federal_register: 05-23545
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 05-23545 | Revocation of Status of Specific Products; Group A Streptococcus; Companion Document to Direct Final Rule | Proposed Rule | The Food and Drug Administration (FDA) is proposing to remove the regulation applicable to the status of specific products; Group A streptococcus. FDA is proposing to remove 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this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed change is noncontroversial, and we do not anticipate any significant adverse comments. 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. | 2005-12-02 | 2005 | 12 | https://www.federalregister.gov/documents/2005/12/02/05-23545/revocation-of-status-of-specific-products-group-a-streptococcus-companion-document-to-direct-final | https://www.govinfo.gov/content/pkg/FR-2005-12-02/pdf/05-23545.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to remove the regulation applicable to the status of specific products; Group A streptococcus. FDA is proposing to remove the regulation because the existing requirement for Group A streptococcus... |