Federal Reports

The Prescription Drug User Fee Act (PDUFA) of 1992, P.L. No. 102-571, authorized the Food and Drug Administration (FDA) to collect prescription drug user fees from pharmaceutical and biotechnology companies seeking FDA approval of certain human drug and biological products to expedite the review of human drug applications. Congress must reauthorize the PDUFA every 5 years; it was renewed in 1997, 2002, 2007, 2012, and 2017. FDA expects to use the prescription drug user fees it collects under the PDUFA to meet its goals for the timely review of human drug applications. We performed this audit to determine whether FDA accurately computed prescription drug user fee rates.

The report represents the first product in OIG’s review of the Economic Development Administration’s (EDA) implementation of the Bipartisan Budget Act of 2018 (the Act). The purpose of this report is to highlight key EDA oversight challenges and best practices—based on prior OIG reports and other agencies’ relevant work—and identify actions EDA should take now in support of the Act’s requirements.

To see our report, click on the link below

The OIG investigated allegations that a former Bureau of Land Management (BLM) employee provided confidential procurement information to a prospective contractor to give it an unfair advantage on a contract bid. The complainant alleged the former employee provided the information while still employed by BLM and, after retiring, went to work for the contractor. We also investigated allegations the former employee influenced a change to the GSA schedule type to allow the contractor to be eligible to bid on the contract.Our investigation found no evidence that the former employee had access to or provided any confidential procurement information, and we confirmed the former employee never worked for the contractor in question. We also found no evidence the former employee was involved in the decision to change the GSA schedule type or had any other influence on the contract award.

We found that the fire alarm and suppression systems are not fully functioning despite $1.2 million in contract awards to repair the systems.

The OIG investigated allegations that approximately $30,000 in checks issued erroneously by the Office of the Special Trustee for American Indians (OST) in the name of a deceased tribal member had been fraudulently negotiated after his death.We found that the decedent’s son received the checks, endorsed them with his own signature, and cashed them. The son admitted he took the checks and acknowledged he knew it was wrong to do so.We also learned that the OST did not have a process in place to identify beneficiaries who had died. In this instance, the decedent’s sister attempted to report his death to OST, but she did not have sufficient information to complete the required report when she called the OST’s Trust Beneficiary Call Center. The center did not follow up with the sister and did not remove the decedent from its list of beneficiaries.We referred this matter to the United States Attorney’s Office for the District of New Mexico, which declined to prosecute.We will conduct an inspection of OST to determine internal control weakness that allowed the fraud to occur.

: In July 2017, the Federal Emergency Management Agency (FEMA) reported that it awarded 252 projects under the Public Assistance alternative procedures pilot program valued at $11.9 billion, with just 26 of those projects (10.32 percent) closed. During our fieldwork, we gained access to FEMA’s grant management system of record and reviewed supporting documentation for the project worksheets in our scope to determine if FEMA followed its criteria when validating cost estimates. However, FEMA did not sufficiently document actions that it took to validate subrecipient cost estimates to ensure costs are reasonable. Of the three obligated projects we reviewed during our fieldwork, we did not find evidence that FEMA completed the required steps identified to validate the reasonableness of subrecipient cost estimates.