US21 CFR21 CFR Part 317Secondary legislationIn force

Qualifying Pathogens

21 CFR Part 317 defines 'qualifying pathogens' under the Federal Food, Drug, and Cosmetic Act—microorganisms posing serious public health threats for which expedited drug development pathways apply. The regulation lists 21 qualifying pathogens including Mycobacterium tuberculosis, Staphylococcus aureus, and Streptococcus pneumoniae.

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PART 317—QUALIFYING PATHOGENS

§ 317.1 [Reserved]

§ 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.

The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:

(a) Acinetobacter species.

(b) Aspergillus species.

(c) Burkholderia cepacia complex.

(d) Campylobacter species.

(e) Candida species.

(f) Clostridium difficile.

(g) Coccidioides species.

(h) Cryptococcus species.

(i) Enterobacteriaceae.

(j) Enterococcus species.

(k) Helicobacter pylori.

(l) Mycobacterium tuberculosis complex.

(m) Neisseria gonorrhoeae.

(n) Neisseria meningitidis.

(o) Non-tuberculous mycobacteria species.

(p) Pseudomonas species.

(q) Staphylococcus aureus.

(r) Streptococcus agalactiae.

(s) Streptococcus pneumoniae.

(t) Streptococcus pyogenes.

(u) Vibrio cholerae.

المصدر

https://www.ecfr.gov/current/title-21/part-317

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