Not later than one year after the date of the approval of an application under section 355(j) of this title with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.
21 U.S. Code § 356h - Competitive generic therapies
(a) In general
(b) Designation process
(4) DesignationNot later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—
determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and
(c) ActionsIn expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:
Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.
(d) Reporting requirement
(e) DefinitionsIn this section:
(2) The term “inadequate generic competition” means, with respect to a drug, there is not more than one approved drugs  on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is—
the reference listed drug; or
 So in original. Probably should be .
Statutory Notes and Related Subsidiaries
Guidance; Amended Regulations
“(1) In general.—
“(A) Issuance.—The Secretary of Health and Human Services shall—
not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.
“(B) Contents.—The guidance issued under this paragraph shall—
specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and
include good review management practices for competitive generic therapies.
“(2) Amended regulations.—
The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act [Aug. 18, 2017].”