; and (iii) for nonclinical laboratory studies involving the test, if applicable, a statement that studies were conducted in compliance with applicable good laboratory practices. (H) To the extent the application seeks authorization to make modifications to the test within the scope of the approval that are not otherwise permitted without premarket review under this subchapter, a proposed 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. (I) Proposed labeling, in accordance with the requirements of section 587L. (J) Such other data or information as the Secretary may require in accordance with the least burdensome requirements under section 587AA(c). (4) Regulation for premarket and abbreviated premarket applications Not later than 3 years after the date of enactment of the VALID Act of 2023 , the Secretary shall promulgate final regulations detailing the information to be provided in a premarket application and abbreviated premarket application under this section. (5) Refuse to file a premarket or abbreviated premarket application The Secretary may refuse to file an application under this section only for lack of completeness or legibility of the application. If, after receipt of an application under this section, the Secretary refuses to file such an application, the Secretary shall provide to the developer, within 45 calendar days of receipt of such application submitted under this subsection or within 30 calendar days of receipt of an application submitted under subsection (b), a description of the reason for such refusal, and identify the information required, if any, to allow for the filing of the application. (6) Substantive review for deficient application If, after receipt of an application under this section, the Secretary determines that any portion of such application is materially deficient, the Secretary shall provide to the applicant a description of such material deficiencies