Policy Development & Implementation Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Policy Development & Implementation flashcards as text
When FDA issues a 'final guidance' document, what is a regulated company's legal obligation to comply with it?
Answer: Compliance is voluntary, but the company must justify using a different approach
FDA guidance documents are not legally binding; companies may use alternative approaches but must demonstrate they meet the underlying regulatory standard.
What is the significance of the 'preamble' to a final rule published in the Federal Register?
Answer: It provides the agency's reasoning and responses to comments, which courts use to interpret the rule
The preamble documents the agency's rationale and responses to public comments, and courts rely on it to interpret the final rule's meaning and intent.
A company submits comments on a proposed rule but the agency's final rule does not address those comments. What legal remedy may the company pursue?
Answer: Petition for judicial review arguing the rule is arbitrary and capricious
Failure to address significant comments may render a rule arbitrary and capricious under APA Section 706, providing grounds for judicial review.
Which regulatory strategy involves setting a performance outcome that regulated entities must achieve while allowing flexibility in how they achieve it?
Answer: Performance-based standard
Performance-based standards specify the required outcome or result, giving regulated entities flexibility to choose the most efficient compliance method.
Under EO 13771 (during Trump Administration), agencies were generally required to follow which cost-offset principle when issuing new regulations?
Answer: Every new regulation must be offset by repealing two existing regulations
EO 13771 required agencies to repeal two existing regulations for every new regulation issued, subject to a net-zero cost requirement.
What is the primary purpose of a 'transition period' or 'grandfathering' clause in a new regulation?
Answer: To allow existing operations or products to continue under old requirements for a defined period
Grandfathering allows existing operations or products to continue under prior requirements for a specified time, giving affected parties time to transition to compliance.
Which process allows stakeholders to formally request that an agency initiate a rulemaking to address a regulatory gap or update an existing rule?
Answer: Citizen petition
A citizen petition is the formal mechanism through which any person can request an agency to issue, amend, or revoke a regulation.