GPhA criticism of US NIH over PHS Act implementation

The US Generic Pharmaceutical Association (GPhA) has written to the National Institutes of Health to express concerns as to whether a  company submitting an Abbreviated New Drug Application (or a 505(b)(2)  application) containing the results of an in vivo bioequivalence study  must certify on Form FDA 3674 that new Public Health Service Act's  Section 402(j), as added by Title VIII of the Food and Drug  Administration Amendments Act, applies and that in vivo bioequivalence  studies have to been registered at the NIH's on-line clinical trial  registry (ClinicalTrials.gov).