Records

What are records?
Is every document I work with (regardless of media) considered a record?
What should I treat as a records in my office?
How can I reduce the volume of records I have in my office?
Why do we have to do manage records?
What are my records responsibilities as a manager or employee?
What does "disposition of records" mean? Do I throw them away?
How are records disposed of?
How can I benefit from good records management?
Who is responsible for records created or received and maintained by FDA contractors?

1. What are records?

By law, Federal records are:

all documentary materials, regardless of physical form, including:
- letters
- memorandums
- completed forms
- statistical and narrative reports
- graphics
- photographic prints and negatives
- motion picture film
- audio and video recordings
- electronic records
- maps
- architectural, engineering, and other drawings
made or received by an agency of the U.S. Government under Federal law or in connection with the transaction of public business, and
preserved or appropriate for preservation as evidence of agency functions, organization, and activities or
because of the value of the information they contain (see 44 U.S.C. 3301).

2. Is every document I work with (regardless of media) considered a record?

No. In most programs, probably a quarter of the paper volume is actually record material that needs to be retained for any length of time. Much of what is in most offices is either reference material which can be destroyed when no longer needed. Even working papers are records, although they generally need to be maintained for a shorter period of time. See 44 U.S.C. 3301 for the definition of a record. Listed below is the definitions of non-records materials and documentary materials.

Non-records materials are Federally owned informational materials that do not meet the statutory definition of records (44 U.S.C. 3301) or that have been excluded from coverage by the definition. Non records materials are extra copies of documents kept only for reference, stocks of publications and processed documents, and library or museum materials intended solely for reference or exhibit (See 36 CFR 1222.14).
"Documentary materials" is a collective term for records, non-record materials, and personal files that refers to all media containing recorded information, regardless of the nature of the media or the method(s)or circumstance(s) of recording.

3. What should I treat as a record in my office?

From a records management perspective, a document is a record in your office if:

Your office created it.
Your office acted on it.
Your office received it for action.
Your office is designated as the custodian because of oversight duties or for other reasons.
Your office needs it to document its activities or decisions.

4. How can I reduce the volume of records I have in my office?

Use records schedules as a guide to eliminating unnecessary records. Retention of each type of records maintained in your office is governed by a records schedule which has been rigorously reviewed to ensure the records are kept a sufficient length of time. Schedules are reviewed and approved by the Agency and the Archivist of the United States and serve as the legal authority for destruction of records or their transfer to the National Archives.

Here are other methods for reducing the amount of paper in your office:

Review your files for outdated reference materials and discard (recycle) superseded or obsolete items.
Microfilm your records. In most cases if they are properly filmed, the paper original can be destroyed.
Use image technology to eliminate the need to keep massive amounts of paper on site.

5. Why do we have to manage records?

First, because it is required by Federal statutes and regulations. By complying with Federal recordkeeping requirements, FDA can achieve adequate and proper documentation of Agency policies and transactions, as well as effective and economical management of agency operations related to the creation, maintenance, use, and disposition of records.

Furthermore, adequate and proper documentation of Agency policies and transactions provides a record of the conduct of Agency business that is:

complete and accurate to the extent required to document the organization, function, policies, decisions, procedures, and essential transactions of the agency, and
designed to furnish the information necessary to protect the legal and financial rights of the Government and of persons directly affected by the agency's activities.

6. What are my responsibilities as a manager or employee?

Essentially, there are three major responsibilities:

Create the records necessary to document the activities for which you are responsible;
Maintain records that are received/created by the Agency in a manner that allows for them to be safely stored and efficiently accessed when necessary.
Dispose of records in accordance with Agency and Federal regulations.

7. What does "disposition of records' means? Do I throw them away?

No. Disposition refers to the final arrangement determined for the records. Depending on the type of record, and in accordance with the Records Control (Retention) Schedules, some are destroyed after a certain period of time; others are permanently transferred to the National Archive, transferred to a Federal record center for temporary retention, or even donated to appropriate organizations. All records are disposed of in accordance with the Records Control (Retention) Schedules.

8. How are records disposed of?

Records are disposed of in accordance with the Records Control (Retention) Schedules as follows:

Destruction. NARA approves temporary records for destruction after a specified retention period. Records are considered temporary if at some point, they are no longer needed for the conduct of business. Refer to (36 CFR 1226.24), "How must agencies destroy temporary records?" for further guidance.
Transfer. NARA approves inactive records to be transferred to regional records services facilities (Federal Records Centers) after the retention period. Records service facilities provide temporary storage and also reference services for records that are needed infrequently by the creating agency, but are not yet eligible for destruction or transfer to the National Archives. Records stored at regional services facilities remain in the legal custody of the creating agency. The Washington National Records Center serves as the Regional Records Services Facility for the Washington DC area. (Please note that other Federal Records Centers located in various geographical areas serve FDA Regional Offices.)
NARA approves permanent records (those that have been authorized by NARA to have sufficient historical or other value to warrant permanent preservation) to be transferred to NARA, College Park, Maryland, and archived. Once records are transferred to NARA, they are under the legal custody of NARA.
Donation. Upon NARA's approval, temporary records may be donated to an eligible person or organization after the authorized retention period has expired. Refer to (36 CFR 1226.26).

9. How can I benefit from good records management?

You benefit several ways.

Free up office space for other purposes.
Allow quicker retrieval of documents.
Provide better documentation with less paper.
Save money on space, equipment, and staff time.
Comply with Federal and Agency requirements.

10. Who is responsible for records created or received and maintained by FDA contractors?

FDA project officers, work assignment managers and other technical representatives should take adequate steps to safeguard records created, processed, or in the possession of a contractor or a non-Federal entity. Federal law requires that the Agency specify the delivery of all data necessary for the adequate and proper documentation of contractor-operated programs. Moreover, all data created for Government use and delivered to, or under the legal control of, the Government must be managed in accordance with Federal law. Refer to (36 CFR 1222.32).