The Code of Federal Regulations of the United States of America

1.13

Institutes of higher education receiving financial assistance for graduate fellowship programs under title IV of the National Defense Education Act.

To keep all records supporting claims for Federal payments.

Retention period: (1) For 3 years after the close of the fiscal year to which such records relate; or (2) until they are notified that such records are not needed for program administration review; or (3) until they are notified of the completion of the Department's fiscal audit, whichever is later.

The records involved in any claims which have been questioned shall be further maintained until necessary adjustments have been made and the adjustments have been reviewed and cleared by the Department. 45 CFR 145.5

1.14 State and local educational agen

cies receiving financial assistance for guidance and counseling and testing programs under title V of the National Defense Education Act.

To keep all records supporting claims for Federal grants or relating to the accountability of the grantee agency for

expenditures of Federal grants and matching funds.

Retention period: (1) For 3 years after the close of the fiscal year in which the expenditure was made by the State or local educational agency; or (2) until the State agency is notified that such records are not needed for program administration review; or (3) until the State agency is notified of the completion of the Department's fiscal audit, whichever is later.

The records involved in any claim or expenditure which has been questioned shall be further maintained until necessary adjustments have been made and the adjustments have been reviewed and cleared by the Department.

Records supporting accountability for nonconsumable equipment purchased under the program with Federal financial participation and costing $50.00 or more shall be kept until notification of the completion of the review and audit covering the disposition of such equipment. 45 CFR 143.18

1.15 State educational agencies receiving financial assistance under section 1009 of the National Defense Education Act for improvement of statistical services.

To keep all records supporting claims for Federal grants or relating to the accountability of the grantee agency for expenditure of Federal grants and matching funds.

Retention period: (1) For 3 years after the close of the fiscal year in which the expenditure was made by the State educational agency; or (2) until the State agency is notified that such records are not needed for program administration review; or (3) until the State agency is notified of the completion of the Department's fiscal audit, whichever is later.

Records supporting accountability for nonconsumable equipment purchased under the program with Federal financial participation and costing $10 or more per unit shall be kept until notification of the completion of the Department's review and audit covering the

disposition of such equipment. 45 CFR 140.7 1.16 State and local educational agen

cies receiving financial assistance for the education of children of lowincome families, pursuant to title I of the Elementary and Secondary Education Act of 1965, which amended Public Law 81-874. [Amended]

(a) To keep all records supporting claims for Federal grants under title I of the act or relating to the accountability for expenditure of such grants.

Retention period: (1) For 3 years after close of fiscal year in which expenditure was made; or (2) until notified that such records are not needed for administrative review; or (3) until notified of the completion of the fiscal audit, whichever is later.

(b) To keep all other records developed under a program or project under this title.

Retention period: For 3 years after the completion of the program or project.

The records involved in any claim or expenditure which has been questioned shall be further maintained until necessary adjustments have been made and such adjustments have been reviewed and approved by the Department. 45 CFR 116.54

1.17 State and local educational agencies receiving financial assistance for school library resources, textbooks, and other instructional materials, under title II of the Elementary and Secondary Education Act of 1965. [Amended]

To keep records supporting claims for Federal grants or relating to the accountability of the grantee agency for expenditure of such grants.

Retention period: (1) For 3 years after the close of the fiscal year in which the expenditure was made; or (2) until notified that such records are not needed for program administration review; or (3) until notified of the completion of the fiscal audit, whichever is later.

Where equipment which costs $100 or more per unit is purchased with Federal funds for use in administration of the State plan, records supporting accountability shall be maintained for the useful life of the equipment or until completion of the Department's review and

audit covering the disposition of such equipment, whichever is sooner.

1.18 Local educational agencies receiving financial assistance under title III of Elementary and Secondary Education Act of 1965 for supplementary educational centers and services.

To keep all records pertaining to the grant.

Retention period: (1) For 3 years after close of fiscal year in which expenditures are liquidated, (2) until notification that such records are not needed for program administrative review; and (3) until notification of completion of Federal fiscal audit.

Where equipment which costs $100 or more per item is purchased under an approved project, records supporting accountability shall be maintained until notification of the completion of the review and audit covering the disposition of such equipment.

Records pertaining to any claim or expenditure which has been questioned at time of audit shall be maintained until necessary adjustments have been reviewed and cleared by the Department. 45 CFR 118.31, 118.40

1.19 Recipients of Federal financial

assistance for research and research related activities in the field of education and for construction of national and regional research facilities under the Cooperative Research Act, as amended by title IV of the Elementary and Secondary Education Act of 1965.

To keep all records supporting claims under Federal grants or relating to the accountability of Federal funds.

Retention period: (1) For 3 years after close of the fiscal year in which expenditure was made, (2) until notification that such records are not needed for program administration review; or (3) until notification of completion of Federal fiscal audit, whichever is later.

Where nonconsumable equipment costing $250 or more per unit is pur

chased in whole or in part, with Federal funds, the grantee shall maintain inventories and other records supporting accountability for such equipment until grantee is notified of the completion of the Department's review and audit covering the disposition of such equipment.

Records pertaining to any claim or expenditure questioned at time of audit shall be maintained until necessary adjustments have been reviewed and cleared by the Department. 45 CFR 151.18

1.20

State educational agencies receiving financial assistance under title V of the Elementary and Secondary Education Act of 1965 to strengthen State departments of education.

To keep all records supporting claims for Federal grants or relating to the accountability of such State agency for expenditure of such grants and relating to the expenditure of any non-Federal funds necessary for matching or supplementing the Federal share of such grants.

Retention period: (1) For 3 years after the close of the fiscal year in which the expenditure was made by the State educational agency; or (2) until the State agency is notified that such records are not needed for administrative review; or (3) until the State agency is notified of the completion of the Department's fiscal audit, whichever is later.

Where equipment which costs $100 or more per unit is purchased by the State with Federal financial participation, inventories and other records supporting accountability shall be maintained until the State agency is notified of the completion of the Department's review and audit covering the disposition of such equipment.

until completion of the Federal fiscal audit or the regularly conducted Federal administrative review, whichever is later.

Records involved in any claim or expenditure which has been questioned shall be further maintained until necessary adjustments have been made and such adjustments have been reviewed and approved by the Federal agency making such review. 45 CFR 112.16 1.22 Local educational agencies receiving financial assistance for current expenditures in areas affected by major disasters. [Added]

To keep all records supporting claims for such Federal funds.

Retention period: 3 years following fiscal year to which claim relates, or until completion of the fiscal audit or the regularly conducted Federal administrative review and notification the case is closed, whichever is later.

Records involved in any claim or expenditure which has been questioned shall be further maintained until necessary adjustments have been made and such adjustments have been reviewed and approved by the Federal agency making such review. 45 CFR 113.19 1.23 State commissions and institutions receiving financial assistance for acquisition of equipment to improve undergraduate instruction in institutions of higher education under the Higher Education Act of 1965. [Added]

(a) State commissions. To maintain records of case files on each application received and of all proceedings by which it establishes relative priorities and recommended Federal shares for eligible projects considered.

(b) Institutions. To maintain all accounting records relating to approval of projects and to verification of the applicant's maintenance of effort, including bank deposits, canceled checks, etc.

Retention period: (a) 2 years after final action or each such closing date; (b) 3 years after completion of project or until applicant is notified of the Government's audit, whichever is later. 45 CFR 171.8

1.24 School systems receiving Federal assistance. [Added]

To maintain all records relating to personnel actions, transportation (routes and schedules), and student assignments and transfers including all choice forms and transfer applications submitted to

the school system in compliance with title VI of the Civil Rights Act of 1964. Retention period: 3 years. 45 CFR 80.6, 181.19, 181.35, 181.55

1.25

State agencies or institutions receiving financial assistance for community service and continuing education programs under the Higher Education Act of 1965. [Added]

To maintain all records supporting claims for Federal grants or relating to accountability for expenditure of such grants or of matching funds.

Retention period: Until notified that such records are not needed for program administration review or of completion of Department's fiscal audit, whichever is sooner.

Records involved in any claim or expenditure which has been questioned shall be maintained until necessary adjustments have been reviewed and cleared by the Department. 45 CFR 173.29

2.1

Persons introducing shipment or delivery of unlabeled food into interstate commerce and operators of establishments processing, labeling, and repacking.

Persons shipping unlabeled food interstate and operators of establishments processing, labeling, or repacking such food, where such persons and such operator are not the same person, shall keep written agreements containing such specifications as will insure that such food will not be adulterated or misbranded upon completion of such processing, labeling, or repacking.

Retention period: 2 years after final shipment or delivery of such food from such establishment. 21 CFR 5.2

2.2

Persons introducing shipment or delivery of unlabeled drugs and devices into interstate commerce and operators of establishments processing, labeling, and repacking.

Persons shipping unlabeled drugs and devices into interstate commerce and operators of establishments processing, labeling, or repacking such drugs and devices, where such persons and such operator are not the same person, shall keep written agreements containing such specifications as will insure that such drugs or devices will not be adulterated or misbranded upon completion of such processing, labeling, or repacking.

Retention period: 2 years after final shipment or delivery of such drugs or devices from such establishment. 21 CFR 1.107

2.3

Persons introducing shipment or delivery of unlabeled cosmetics into interstate commerce and operators of establishments processing, labeling, and repacking.

Persons shipping unlabeled cosmetics interstate and operators of establishments processing, labeling, or repacking such cosmetics, where such persons and such operator are not the same person shall keep written agreements containing such specifications as will insure that such cosmetics will not be adulterated or misbranded upon completion of such processing, labeling, or repacking. Retention period: 2 years after final shipment or delivery of such cosmetics from such establishment. 21 CFR 1.204 2.4

Persons introducing shipment or delivery of unlabeled hazardous substances into interstate commerce and operators of establishments receiving and labeling such substances. Persons shipping unlabeled household containers of hazardous substances interstate and operators of establishments receiving and labeling such hazardous substances, where the person and the operator are not the same person, shall keep written agreements containing such specifications as will insure that such hazardous substances will not be misbranded upon completion of such labeling.

Retention perfod: 2 years after final shipment or delivery of such hazardous substance from such establishment. 21 CFR 191.64

2.5

Packers of processed shrimp and canned oysters operating under the seafood inspection service.

Shall keep shipping records covering shipments from each lot of inspected seafood.

Retention period: At least 2 years. 21 CFR 85.9, 85.24

2.6 Sponsors and investigators of new drugs and antibiotic drugs for investigational use; persons shipping new drugs and antibiotic drugs for laboratory study or for clinical investigation in animals; sponsors of clinical investigations in animals. [Amended]

(a) Sponsors of new drugs and antibiotic drugs for investigational use shall keep and maintain: (1) complete records of each shipment and delivery to an investigator, and (2) accurate progress reports of the investigation and significant findings, together with any significant changes in the informational material supplied to investigators.

Retention period: 2 years after a new-drug application or an antibiotic form 5 is approved for the drug or, if unapproved, 2 years after shipment and delivery for investigational use is discontinued and the Food and Drug Administration is so notified. 21 CFR 130.3, 144.8

(b) Investigators of new drugs and antibiotic drugs shall maintain: (1) complete records of disposition of the drug, and (2) case histories and other data pertinent to the investigation of each individual treated with the drug.

Retention period: 2 years after a newdrug application or an antibiotic form 5 is approved for the drug or, if unapproved, 2 years after the investigation is discontinued. 21 CFR 130.3, 144.8

(c) Persons introducing a shipment or other delivery interstate of a newdrug or an antibiotic drug for laboratory study or for clinical investigation in animals shall keep and maintain complete records of each shipment and delivery including the name and post office address of the expert or investigator to whom the drug is shipped and the date, quantity, and batch or code mark of each shipment and delivery.

Retention period: 2 years after such shipment and delivery. 21 CFR 130.3, 130.3a, 144.8

(d) Sponsors of clinical investigations in animals shall keep and maintain all reports received from investigators.

Retention period: 2 years after the termination of the investigation or approval of a new-drug application. 21 CFR 130.3, 130.3a, 144.8

2.6a Manufacturers, processors, packers, and holders of finished pharmaceuticals.

To maintain records of all written or verbal complaints for each product and the evaluation and action relating to such complaints.

Retention period: Not specified. 21 CFR 133.14

2.7

Persons requesting certification of antibiotic drugs; persons introducing shipment or delivery of antibiotic drugs into interstate commerce and operators of establishments processing, labeling, storing, repacking, and manufacturing.

(a) Persons requesting certification of antibiotic drugs shall keep complete records of all shipments and deliveries of each batch or part thereof.

(b) Persons shipping antibiotic drugs interstate for processing, labeling, storing, repacking, and manufacturing, and operators of such establishments, whether or not the shipper, shall keep complete records of all shipments and deliveries of each batch or part thereof.

(c) Persons engaged in manufacturing, compounding, processing, packing, or labeling an antibiotic drug for which a certificate or release has been issued or whose name appears on the labeling of an antibiotic drug as its manufacturer, packer, or shipper shall maintain such records and make such reports as are necessary to facilitate a determination whether any such certification or release should be rescinded or whether any regulation should be amended or repealed.

Retention period: (a) and (b) 3 years from date of shipment or delivery and/or receipt of same; (c) Not specified. (a) 21 CFR 146.5; (b) 21 CFR 144.3-144.7; (c) 21 CFR 146.14(d)

Photostatic or other permanent reproductions may be used as substitutes for records identified in this section after the first 2 years of retention. 21 CFR 144.23, 146.7

2.8 Persons petitioning for exemption from certification for antibiotic drugs intended for local or topical use. [Added]

Shall keep records of all laboratory tests and assays required as a condition

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