00086 VALID Act Refused Or Deficient Application
From the VALID Act “SEC. 587B. Premarket review.
“(c) Application.—
“(4) REFUSE TO FILE A PREMARKET OR SPECIAL PREMARKET APPLICATION.—If, after receipt of an application under this section, the Secretary refuses to file such application, the Secretary shall provide to the developer, within 60 calendar days of receipt of such application, a description of the reason for such refusal, and identify the information required, if any, to allow for the filing of the application.
“(5) SUBSTANTIVE REVIEW FOR DEFICIENT APPLICATION.—If, after receipt of an application under this section, the Secretary determines that any portion of such application is deficient, the Secretary shall provide to the applicant, within 75 calendar days of receipt of such application, a description of such deficiencies and identify the information required to correct such deficiencies.
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