; (II) informed consent regulations; and (III) investigational use requirements in section 587R. (I) To the extent the application seeks authorization to make modifications to the test within the scope of the approval, a change protocol that includes validation procedures and acceptance criteria for anticipated modifications that could be made to the test within the scope of the approval. (J) Proposed labeling, in accordance with the requirements of section 587K. (K) Such other data or information as the Secretary may require in accordance with the least burdensome requirements of subsection (j). (3) Guidance for premarket and special premarket applications In accordance with section 5 of the Verifying Accurate Leading-edge IVCT Development Act of 2020 , the Secretary shall issue draft guidance detailing the information to be provided in a premarket application and special premarket application under this section. The Secretary shall issue final guidance not later than 90 calendar days after the close of the comment period for such guidance. (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. (d) Special premarket review (1) In general Any person may file with the Secretary an application for special premarket approval for— (A) an instrument; (B) a specimen receptacle