; and (ii) provide the requestor of the drug with a reasonable opportunity to provide additional information. (C) Failure to submit sufficient information If the requestor fails to provide such additional information within the prescribed time, or if the Secretary determines that such additional information does not demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient, the drug as modified is a new drug within the meaning of section 201(p) and shall be deemed to be misbranded under section 502(ee). (3) Determining whether change will affect safety or effectiveness (A) In general The Secretary shall issue one or more administrative orders under subsection (c) specifying requirements for determining whether a minor change made by a requestor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product, together with guidance for applying those orders to specific dosage forms. (B) Standard practices and special needs of populations The orders and guidance issued by the Secretary under subparagraph (A) shall take into account relevant public standards and standard practices for evaluating the quality of drug products and may take into account special needs of populations, including children. (e) Information submitted by requestors (1) Confidential information Any information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an administrative order under this section (or any minor change under subsection (d)) and is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, shall not be disclosed to the public unless the requestor consents to that disclosure.