§ 112.161 What general requirements apply to records required under this part?
§ 112.162 Where must I store records?
§ 112.163 May I use existing records to satisfy the requirements of this part?
§ 112.164 How long must I keep records?
§ 112.165 What formats are acceptable for the records I keep?
§ 112.166 What requirements apply for making records available and accessible to FDA?
§ 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?

Terms Used In CFR > Title 21 > Chapter I > Subchapter B > Part 112 > Subpart O - Records

  • 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.
  • covered produce: refers to the harvestable or harvested part of the crop. See 21 CFR 112.3
  • 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

  • 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.
  • project: means any undertaking eligible for assistance under title 23 of the United States Code. See 23 CFR 627.3