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§1315.32. Obtaining a procurement quota. — Inbound Citations

21 C.F.R. § 1315.32

Cited by 3 regulations in release Current.

Citations to 21 C.F.R. § 1315.32 as a whole

  • (4) Projected demand for each chemical as indicated by procurement and import quotas requested pursuant to § 1315.32; and
  • (a) For the purpose of determining procurement quotas pursuant to § 1315.32, each registered manufacturer shall be allowed as part of such quota an amount sufficient to maintain an inventory:
    (1) Except as provided in paragraph (a)(3) of this section, for current manufacturers, 35 percent of his average estimated net disposal for the current calendar year and the last preceding calendar year; or
    (2) Except as provided in paragraph (a)(4) of this section, for new manufacturers, 35 percent of his reasonably estimated net disposal for the next calendar year as determined by the Administrator.
    (3) For current liquid injectable dosage-form manufacturers, 50 percent of his average estimated net disposal for the current calendar year and the last preceding calendar year; or
    (4) For new liquid injectable dosage-form manufacturers, 50 percent of his reasonably estimated net disposal for the next calendar year as determined by the Administrator.

Citations to §1315.32(h)

  • (a) A registrant may authorize one or more individuals, whether or not located at his registered location, to sign certifications required under § 1315.32(h) on the registrant's behalf by executing a power of attorney for each such individual. The registrant shall retain the power of attorney in the files, with certifications required by § 1315.32(h), for the same period as any certification bearing the signature of the attorney. The power of attorney must be available for inspection together with other certification records.