BRIEFING

 Bifidobacterium bifidum. This proposal is based on the version of the monograph official as of August 1, 2023. On the basis of comments received, it is proposed to make the following revisions:

1. Add Bifidobacterium bifidum BGN4 to the Definition.

2. Add Table 1 in Identification B with primer sets, primer sequences, and the Acceptance criteria for strains Bb-06 and BGN4.

3. Add Table 2 in Identification B with the PCR sample preparation and amplification conditions for each strain.

4. Provide additional options for the types of electrophoresis systems recommended for the analysis of the PCR amplification products in Identification B.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (NBDS: B. Koshy)

 Correspondence Number— C321937