Program

Biosimilar Biological Product Review Program

Department: HHS

The cabinet-level department or independent agency responsible for the program

Agency: Food and Drug Administration

The specific agency or sub-agency that administers the program

Program Type:Direct Benefit

The functional category of the program

In Official FIP? Not represented

(Regulatory approval system, not assistance-style listing.)

Confidence Level: High

Authorizing Statute: 42 U.S.C. 262(k)

Funding Status: User fees + annual appropriations

Primary Source: https://uscode.house.gov/download/download.shtml

Notes: Review of biosimilar and interchangeable biological products.

Additional details about data sources and custom mapping of data are available on the Data Details page.

Outlays (millions)

Actual money spent in FY2024

$0

Source: TAS-based mapping (high confidence)

Obligations (millions)

Money the government committed to spend in FY2024

$128.5

Source: TAS-based mapping (high confidence)

Budget Authority (millions)

The amount Congress authorized agencies to commit

$128.5

Source: Estimate: budget authority set equal to outlays for mandatory/benefit-style programs; see Fiscal Method.

Revenue Loss (millions)

Estimated revenue not collected due to tax policy (tax expenditures)

$0

Source: TAS-based mapping (high confidence)

Primary Amount

The primary fiscal measure used for the program

$0

Dollar Basis

The primary fiscal measure used for the program

Outlays

Note: Primary basis is outlays; value is exact where available, otherwise an estimate anchored to agency/program FY2024 scale. Reconciliation round: estimated outlay-bearing rows were scaled proportionally so the primary-basis FY2024 outlays subtotal equals the reference federal outlay total.

Dollar Quality

How directly the dollar amount reflects observed data

Estimated

Actual = reported or observed spending, Estimated = derived from modeling or mapping, Carry-Zero = structural row with no direct dollars