21 C.F.R. § 1401.18 – Confidential commercial information.

(a) Definitions. As used in this section:
Confidential commercial information means commercial or financial information obtained by ONDCP from a submitter that may be protected from disclosure under Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4).
Submitter means any person or entity, including a corporation, State, or foreign government, but not including another Federal Government entity, that provides confidential commercial information, either directly or indirectly to the Federal Government.
(b) Designation of confidential commercial information. A submitter of confidential commercial information must use good faith efforts to designate by appropriate markings, at the time of submission, any portion of its submission that it considers to be protected from disclosure under Exemption 4. These designations expire 10 years after the date of the submission unless the submitter requests and provides justification for a longer designation period.
(c) When notice to submitters is required.
1. (1) ONDCP must promptly provide written notice to the submitter of confidential commercial information whenever records containing such information are requested under the FOIA if ONDCP determines that it may be required to disclose the records, provided:
  1. (i) The requested information has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or
  2. (ii) ONDCP has a reason to believe that the requested information may be protected from disclosure under Exemption 4, but has not yet determined whether the information is protected from disclosure.
2. (2) The notice must either describe the commercial information requested or include a copy of the requested records or portions of records containing the information. In cases involving a voluminous number of submitters, ONDCP may post or publish a notice in a place or manner reasonably likely to inform the submitters of the proposed disclosure, instead of sending individual notifications.
(d) Exceptions to submitter notice requirements. The notice requirements of this section do not apply if:
1. (1) ONDCP determines that the information is exempt under the FOIA, and therefore will not be disclosed;
2. (2) The information has been lawfully published or has been officially made available to the public;
3. (3) Disclosure of the information is required by a statute other than the FOIA or by a regulation issued in accordance with the requirements of Executive Order 12600 of June 23, 1987; or
4. (4) The designation made by the submitter under paragraph (b) of this section appears obviously frivolous. In such case, ONDCP must give the submitter written notice of any final decision to disclose the information within a reasonable number of days prior to a specified disclosure date.
(e) Opportunity to object to disclosure.
1. (1) ONDCP must specify a reasonable time period within which the submitter must respond to the notice referenced above.
2. (2) If a submitter has any objections to disclosure, it should provide ONDCP a detailed written statement that specifies all grounds for withholding the particular information under any exemption of the FOIA. In order to rely on Exemption 4 as the basis for nondisclosure, the submitter must explain why the information constitutes a trade secret or commercial or financial information that is confidential.
3. (3) A submitter who fails to respond within the time period specified in the notice will be considered to have no objection to disclosure of the information. ONDCP is not required to consider any information received after the date of any disclosure decision. Any information provided by a submitter under this subpart may itself be subject to disclosure under the FOIA.
(f) Analysis of objections. ONDCP must consider a submitter's objections and specific grounds for nondisclosure in deciding whether to disclose the requested information.
(g) Notice of intent to disclose. Whenever ONDCP decides to disclose information over the objection of a submitter, ONDCP must provide the submitter written notice, which must include:
1. (1) A statement of the reasons why each of the submitter's disclosure objections was not sustained;
2. (2) A description of the information to be disclosed or copies of the records as ONDCP intends to release them; and
3. (3) A specified disclosure date, which must be a reasonable time after the notice.
(h) Notice of FOIA lawsuit. Whenever a requester files a lawsuit seeking to compel the disclosure of confidential commercial information, ONDCP must promptly notify the submitter.
(i) Requester notification. ONDCP must notify the requester whenever it provides the submitter with notice and an opportunity to object to disclosure; whenever it notifies the submitter of its intent to disclose the requested information; and whenever a submitter files a lawsuit to prevent the disclosure of the information.
(j) No right or benefit. The requirements of this section such as notification do not create any right or benefit, substantive or procedural, enforceable at law or in equity by a party against the United States, its agencies, its officers, or any person.