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
Which regulatory tool is used to formally notify the public of an agency's intent to develop or amend a regulation before the proposed rule is published?
Answer: Advance Notice of Proposed Rulemaking (ANPRM)
An ANPRM solicits early public input on regulatory concepts before the agency drafts a proposed rule.
Under the Congressional Review Act (CRA), Congress has how many days to review and potentially disapprove a major rule before it takes effect?
Answer: 60 legislative days
The CRA provides Congress 60 legislative days to review major rules and pass a joint resolution of disapproval.
A Regulatory Impact Analysis (RIA) is required for rules deemed 'economically significant.' What annual economic effect threshold triggers this designation under EO 12866?
Answer: $100 million
EO 12866 defines an economically significant rule as one with an annual economic effect of $100 million or more.
When a regulatory agency publishes a Direct Final Rule, what event would cause the agency to withdraw it before its effective date?
Answer: Receipt of a significant adverse comment
Agencies withdraw a Direct Final Rule if they receive a significant adverse comment, then proceed through standard notice-and-comment rulemaking.
Which principle requires that a regulatory agency's policy interpretations be consistent with its previously issued guidance and regulations to avoid arbitrary agency action?
Answer: Reasoned consistency
Reasoned consistency requires agencies to either follow prior interpretations or provide adequate justification for departing from them.
In FDA rulemaking, what is the purpose of a 'safe harbor' provision within a final rule?
Answer: To protect entities from enforcement if they meet specified conditions
A safe harbor provision protects regulated entities from enforcement action when they comply with specifically defined conditions or practices.
Which document type does an agency use to communicate its current enforcement priorities and compliance expectations without going through notice-and-comment rulemaking?
Answer: Guidance Document
Guidance documents allow agencies to communicate policy expectations and enforcement priorities without the procedural requirements of formal rulemaking.