§ 112.171 Who may request a variance from the requirements of this part?
§ 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
§ 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?
§ 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
§ 112.175 Who responds to a petition requesting a variance?
§ 112.176 What process applies to a petition requesting a variance?
§ 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?
§ 112.178 Under what circumstances may FDA deny a petition requesting a variance?
§ 112.179 When does a variance approved by FDA become effective?
§ 112.180 Under what circumstances may FDA modify or revoke an approved variance?
§ 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?
§ 112.182 What are the permissible types of variances that may be granted?

Terms Used In CFR > Title 21 > Chapter I > Subchapter B > Part 112 > Subpart P - Variances

  • Allegation: something that someone says happened.
  • Baseline: Projection of the receipts, outlays, and other budget amounts that would ensue in the future without any change in existing policy. Baseline projections are used to gauge the extent to which proposed legislation, if enacted into law, would alter current spending and revenue levels.
  • Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • covered produce: refers to the harvestable or harvested part of the crop. See 21 CFR 112.3
  • Dependent: A person dependent for support upon another.
  • Docket: A log containing brief entries of court proceedings.
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • farm: includes operations that, in addition to these activities:

    (i) Pack or hold raw agricultural commodities;

    (ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in paragraph (1)(iii)(B)(1) of this definition; and

    (iii) Manufacture/process food, provided that:

    (A) All food used in such activities is consumed on that farm or another farm under the same management; or

    (B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:

    (1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);

    (2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and

    (3) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or

    (2) Secondary activities farm. See 21 CFR 112.3

  • Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
  • Freedom of Information Act: A federal law that mandates that all the records created and kept by federal agencies in the executive branch of government must be open for public inspection and copying. The only exceptions are those records that fall into one of nine exempted categories listed in the statute. Source: OCC
  • Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
  • Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Power of attorney: A written instrument which authorizes one person to act as another's agent or attorney. The power of attorney may be for a definite, specific act, or it may be general in nature. The terms of the written power of attorney may specify when it will expire. If not, the power of attorney usually expires when the person granting it dies. Source: OCC
  • project: means any undertaking eligible for assistance under title 23 of the United States Code. See 23 CFR 627.3
  • Prosecute: To charge someone with a crime. A prosecutor tries a criminal case on behalf of the government.
  • Recipient: includes , but is not limited to:

    (1) State-level agencies that administer, or are financed in whole or in part with, WIA Title I funds;

    (2) State Employment Security Agencies;

    (3) State and local Workforce Investment Boards;

    (4) LWIA grant recipients;

    (5) One-Stop operators;

    (6) Service providers, including eligible training providers;

    (7) On-the-Job Training (OJT) employers;

    (8) Job Corps contractors and center operators, excluding the operators of federally-operated Job Corps centers;

    (9) Job Corps national training contractors;

    (10) Outreach and admissions agencies, including Job Corps contractors that perform these functions;

    (11) Placement agencies, including Job Corps contractors that perform these functions; and

    (12) Other National Program recipients. See 29 CFR 37.4

  • Statute: A law passed by a legislature.
  • Statute of limitations: A law that sets the time within which parties must take action to enforce their rights.
  • Testimony: Evidence presented orally by witnesses during trials or before grand juries.
  • Trustee: A person or institution holding and administering property in trust.