J. 44 n. 27). See 21 C.F.R § 10.20. Yet Lannett has had an opportunity to request a Part 12 hearing since May 17, 2016, which is the date of the rescission and the date that FDA issued a Complete Response letter notifying Lannett that its ANDA cannot be approved because of cGMP deficiencies.

It is also not uncommon for those with rights to, and scientific knowledge about, an innovator drug to provide FDA with technical information during the ANDA review process to ensure an accurate determination of bioequivalence and compliance with other requirements. The process for submitting such information is by filing a “Citizen Petition” under 21 C.F.R. §§ 10.20, 10.25, and 10.

The Declarations Submitted in Support of Plaintiffs’ Summary Judgment Motion In an effort to restrict my consideration of declarations submitted by the plaintiffs in the current proceeding, the defendants invoke a rule which they claim precluded their own consideration of materials that were not part of the Citizen Petition docket. The only regulation cited by the defendants is 21 C.F.R. § 10.20(c), which provides that “[i]nformation referred to or relied upon in a submission is to be included in full and may not be incorporated by reference, unless previously submitted in the same proceeding.” This is no more than a stylistic rule which says that any material explicitly relied on in a submission must be included in full.

See 21 C.F.R. §314.430(b), (d); see also 21 C.F.R. §10.20(j)(2)-(3) & pt. 20 (disclosure provisions as necessary of proper conduct of hearing).

FDA regulations permit the filing of a “Citizen Petition” by which those with rights to or Case 1:06-cv-01487-RMU Document 13 Filed 12/18/2006 Page 1 of 5 2 knowledge about the innovator drug may call to the FDA’s attention information to ensure an accurate determination of bioequivalence and compliance with other requirements. See 21 C.F.R. §§ 10.20, 10.25, and 10.30.