; (2) by striking (b) Upon completion and inserting (b)(1) Upon completion ; and (3) by adding at the end the following: (2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 505 for which a notification has been submitted in accordance with section 506C is, or has been in the last 5 years, listed on the drug shortage list under section 506E, or that is described in section 505(j)(11)(A), a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages. Such offices shall ensure timely and effective coordination regarding the reviews of such report and overseeing the alignment of any feedback regarding such report, or corrective or preventative actions, after consideration of the systematic benefits and risks to public health, patient safety, the drug supply and drug supply chain, and timely patient access to such drugs. . (f) Effective date The amendments made by this section and section 4121 shall take effect on the date that is 180 days after the date of enactment of this Act. 4123. GAO report on intra-agency coordination (a) In general Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report examining the Food and Drug Administration's intra-agency coordination, communication, and decision making in assessing drug shortage risks, and taking corrective action. (b) Content The report shall include— (1) consideration of— (A) risks associated with violations of current good manufacturing practices; (B) corrective and preventative actions with respect to such violations requested by the Food and Drug Administration