Redacting a FOIA Request

Redacting a FOIA Request – Tips & Insights

The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request copies of records not normally prepared for public distribution. This includes regulatory submissions (e.g., NDAs, 510(k)s, PMTA, etc.) and enforcement materials and correspondence (e.g., Warning Letter responses, Form 483s, It Has Come to Our Attention (IHCTOA) letters, etc.). Redacting a FOIA request means protecting sensitive information including information competitors might love to have.

What Can Be Requested?

FOIA pertains to existing records only and does not require FDA to create new records to comply with a request. It also does not require FDA to collect information it does not have or to do research or analyze data for a requestor. In addition, FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable period of time.

Redacting a FOIA Request

Under FOIA, certain records may be withheld in whole or in part from the requestor if they fall within one of nine FOIA exemptions. To redact a FOIA request one of the exemptions must apply. Six of these exemptions most often form the basis for the withholding of information by the FDA:

Exemption 2: Protects certain records related solely to FDA’s internal rules and practices.

Exemption 3: Protects information that is prohibited from disclosure by other laws.

Exemption 4: Protects trade secrets and confidential commercial or financial information.

Exemption 5: Protects certain inter-agency and intra-agency communications.

Exemption 6: Protects information about individuals in personnel, medical, and similar files when disclosure would constitute a clearly unwarranted invasion of privacy.

Exemption 7: Protects records or information compiled for law enforcement purposes when disclosure (A) could reasonably be expected to interfere with enforcement proceedings; (B) would deprive a person of a right to a fair trial or an impartial adjudication; (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy; (D) could reasonably be expected to disclose the identity of a confidential source; (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be expected to risk circumvention of the law; or (F) could reasonably be expected to endanger the life or physical safety of an individual.

In the event FDA relies on one or more FOIA exemptions to deny a requestor access to records, a letter stating the reasons for denying the records will be sent to the requestor. The letter will also notify the requestor of the right to appeal the agency’s denial determination. More specific information on these exemptions and on other aspects of our FOIA program is contained in FDA’s FOIA implementation regulations, 21 CFR Part 20.

Redacting a FOIA Request – Tips

The top tips when redacting a FOIA Request:

  • Be sensitive to deadlines to reply to FOIA officers but don’t rush
  • Be specific in why a FOIA exemption applies, a robust rationale goes a long ways
  • FOIA exemptions don’t protect everything so be reasonable
  • Don’t forget to express reasonably likely harms from disclosure
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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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