; and (B) involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the proposed method of nonclinical testing. (4) Engagement of external experts In reviewing a request under subsection (a), the Secretary may— (A) through the use of cooperative agreements or other appropriate mechanisms, consult with biomedical research consortia and other expert stakeholders with specific expertise in nonclinical testing methods; and (B) consider recommendations of biomedical research consortia or other qualified experts in deciding whether to grant or deny the request. (5) Review of requests (A) Timing Not later than 180 calendar days after the receipt of a request under subsection (a), the Secretary shall determine whether to grant or deny the request. (B) Determination In reviewing a nonclinical testing method pursuant to a request under subsection (a), the Secretary shall determine whether to grant or deny the request based on whether the method satisfies the criteria listed in subsection (b) as demonstrated by— (i) the information submitted in the request or supplements thereto; and (ii) any additional information provided by external experts. (C) Qualification decision If the Secretary determines pursuant to subparagraph (B) that a nonclinical testing method satisfies the criteria listed in subsection (b), the Secretary shall grant the request for qualification of the method in a particular context of use. (d) Effects of qualification If the Secretary qualifies a nonclinical testing method pursuant to a request under this section— (1) the method shall be available for use by the holder of the qualification or a person authorized by such holder for drug development in the particular context of use for which the method is qualified