Department of Health and Human Services August 12, 2022 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry GFI #111 (VICH GL19(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #109 (VICH GL15(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry GFI #114 (VICH GL21(R1)) entitled ``Effectiveness of Anthelmintics: Specific Recommendations for ChickensGallus gallus (Revision 1).'' This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes. This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #90 (VICH GL7(R1)) entitled ``Effectiveness of Anthelmintics: General Recommendations (Revision 1).'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/ regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Cervical Degenerative Disease Treatment, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.