CFR Subpart A

CFR Subpart A
in effect

21 C.F.R. § 1401.1 Purpose.

The purpose of this part is to prescribe rules, guidelines and procedures to implement the Freedom of Information Act (FOIA), as amended, 5 U.S.C. 552.

21 C.F.R. § 1401.2 The Office of National Drug Control Policy—organization and functions.

(a) The Office of National Drug Control Policy (ONDCP or Agency) was created by the Anti-Drug Abuse Act of 1988, 21 U.S.C. 1501 et seq., and reauthorized under the SUPPORT for Patients and Communities Act, 21 U.S.C. 1701 et seq. and several appropriations acts. The mission of ONDCP is to coordinate the anti-drug efforts of the various agencies and departments of the Federal Government, to consult with States and localities and assist their anti-drug efforts, and to annually promulgate the National Drug Control Strategy. ONDCP is headed by the Director of National Drug Control Policy. (b) ONDCP's Office of External and Legislative Affairs is responsible for providing information to the press and to the general public. If members of the public have general questions about ONDCP, they may email the Office of External and Legislative Affairs at mediainquiry@ondcp.eop.gov. This email address should not be used to make FOIA requests. All oral requests for information under FOIA will be rejected.

21 C.F.R. § 1401.3 Definitions.

For the purpose of this part, all the terms defined in the Freedom of Information Act apply. Commercial use request is a request that asks for information for a use or a purpose that furthers a commercial, trade, or profit interest, which can include furthering those interests through litigation. An agency's decision to place a requester in the commercial use category will be made on a case-by-case basis based on the requester's intended use of the information. Agencies will notify requesters of their placement in this category. Direct costs means the expense actually expended to search, review, or duplicate in response to a FOIA request. For example, direct costs include 116% of the salary of the employee performing work (i.e., the basic rate of pay for the employee plus 16 percent of that rate to cover benefits) and the actual costs incurred while operating equipment. Duplicate means the process of making a copy of a document. Such copies may take the form of paper, microform, audio-visual materials, or machine-readable documentation. Educational institution is any school that operates a program of scholarly research. A requester in this fee category must show that the request is made in connection with his or her role at the educational institution. Agency may seek verification from the requester that the request furthers scholarly research, and agency will advise requesters of their placement in this category. Fee waiver means the waiver or reduction of processing fees if a requester can demonstrate that certain statutory standards are satisfied, including that the information is in the public interest and is not requested for a commercial interest. FOIA public liaison means a supervisory agency FOIA official who assists in reducing delays, increasing transparency and understanding of the status of requests, and resolving disputes between the requester and ONDCP. Noncommercial scientific institution is an institution that is not operated on a “commercial” basis and that is operated solely for the purpose of conducting scientific research the results of which are not intended to promote any particular product or industry. A requester in this category must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are sought to further scientific research and are not for a commercial use. Agency will advise requesters of their placement in this category. OGIS means the Office of Government Information Services of the National Archives and Records Administration. OGIS offers FOIA dispute resolution services, which is a voluntary process. If ONDCP agrees to participate in the dispute resolution services provided by OGIS, ONDCP will actively engage as a partner to the process in an attempt to resolve the dispute. Records and any other terms used in this part in reference to information includes any information that would be an agency record subject to the requirements of this part when maintained in any format, including electronic format. Representative of the news media is any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into distinct work, and distributes that work to an audience. The term “news” means information that is about current events or information that would be of interest to the public. Examples of news media entities include television or radio stations that broadcast “news” to the public at large and publishers of periodicals that disseminate “news” and make their products available through a variety of means to the general public, including news organizations that disseminate solely on the internet. A request for records supporting the news-dissemination function of the requester will not be considered to be for a commercial use. “Freelance” journalists who demonstrate a solid basis for expecting publication through a news media entity will be considered as a representative of the news media. A publishing contract would provide the clearest evidence that publication is expected; however, the Agency can also consider a requester's past publication record in making this determination. The Agency will advise requesters of their placement in this category. Request means a letter or other written communication seeking records or information under FOIA. Requester category means one of the three categories that ONDCP will place requesters in for the purpose of determining whether a requester will be charged fees for search, review, and duplication. The categories are: commercial use requests; non-commercial scientific or educational institutions or news media requesters; and all other requesters. Review means the process of examining documents that are located during a search to determine if any portion should lawfully be withheld. It is the processing of determining disclosability. Review time includes processing any record for disclosure, such as doing all that is necessary to prepare the record for disclosure, including the process of redacting the record and marking the appropriate exemptions. Review costs are properly charged even if a record ultimately is not disclosed. Review time also includes time spent both obtaining and considering any formal objection to disclosure made by a confidential commercial information submitter under § 1401.18, but it does not include time spent resolving general legal or policy issues regarding the application of exemptions. Search means to review, manually or by automated means, agency records for the purpose of locating those records responsive to a request.

21 C.F.R. § 1401.4 Access to information.

The Office of National Drug Control Policy makes available information pertaining to matters issued, adopted, or promulgated by ONDCP, that are within the scope of 5 U.S.C. 552(a)(2). Such information is located at https://www.whitehouse.gov/ondcp. Included in that information are ONDCP's proactive disclosures. Proactive disclosures are records that have been requested three or more times, or that have been released to a requester and that ONDCP determines have become, or are likely to become, the subject of subsequent requests for substantially the same records.

21 C.F.R. § 1401.5 Records requiring consultation.

Requests for records that are in ONDCP's custody but in which other agencies have equities shall be reviewed by ONDCP and then ONDCP will either consult with or refer the records to the other agency or agencies for further processing. (a) Consultation. When records originated with ONDCP, but contain within them information of interest to another agency or other Federal government office, ONDCP will consult with that other entity prior to making a release determination. (b) Referral—(1) Determination. When ONDCP believes that a different agency or component is best able to determine whether to disclose the record, ONDCP will refer the responsibility for responding to the request regarding that record to that agency. Ordinarily, the agency that originated the record is presumed to be the best agency to make the disclosure determination. However, if the agency processing the request and the originating agency jointly agree that the agency processing the request is in the best position to respond regarding the record, then the record may be handled as a consultation. (2) Documentation. Whenever ONDCP refers any part of the responsibility for responding to a request to another agency, it must document the referral, maintain a copy of the record that it refers, and notify the requester of the referral, informing the requester of the name(s) of the agency to which the record was referred, including that agency's FOIA contact information. (3) Coordination. The standard referral procedure is not appropriate where disclosure of the identity of the agency to which the referral would be made could harm an interest protected by an applicable exemption, such as the exemptions that protect personal privacy or national security interests. In order to avoid harm to an interest protected by an applicable exemption, the agency that received the request should coordinate with the originating agency to seek its views on the disclosability of the record. The release determination for the record that is the subject of the coordination should then be conveyed to the requester by the agency that originally received the request. (c) Classified information. On receipt of any request involving classified information, ONDCP must determine whether the information is currently and properly classified in accordance with applicable classification rules. Whenever a request involves a record containing information that has been classified or may be appropriate for classification by another agency under any applicable executive order concerning the classification of records, the receiving agency must refer the responsibility for responding to the request regarding that information to the agency that classified the information, or that should consider the information for classification. Whenever an agency's record contains information that has been derivatively classified (for example, when it contains information classified by another agency), the agency must refer the responsibility for responding to that portion of the request to the agency that classified the underlying information. (d) Timing of responses to consultations and referrals. All consultations and referrals received by ONDCP will be handled according to the date that the first agency received the perfected FOIA request. (e) Agreements regarding consultations and referrals. ONDCP may establish agreements with other agencies to eliminate the need for consultations or referrals with respect to particular types of records.

21 C.F.R. § 1401.6 How to request records—form and content.

(a) You must describe the records you seek in sufficient detail and in writing to enable ONDCP personnel to locate them with a reasonable amount of effort. To satisfy this requirement, you should be as detailed as possible when describing the records you seek. To the extent possible, each request must reasonably describe the record(s) sought including the type of document, specific event or action, title or name, author, recipient, subject matter of the record, date or time period, location, and all other pertinent data. Before or after submitting their requests, requesters may contact ONDCP's FOIA Public Liaison to discuss the records they seek and for assistance in describing the records. A list of Agency FOIA Public Liaisons is available at https://www.foia.gov/#agency-search. (b)(1) If you are making a request for records about yourself, you must comply with the verification of identity provision set forth in § 1401.21(f) of this part. (2) If a request for records pertains to a third party, you may receive greater access by submitting either a notarized authorization signed by that individual or an unsworn declaration under 26 U.S.C. 1746 by that individual authorizing disclosure of the records to you. If the other individual is deceased, you should submit proof of death such as a copy of the death certificate or an obituary. As an exercise of administrative discretion, ONDCP may require you to provide additional information if necessary in order to verify that a particular individual has consented to disclosure. (c) Requesters may specify the preferred form or format (including electronic formats) for the records they seek. ONDCP will try to accommodate formatting requests if the record is readily reproducible in that form or format. (d) Whenever it is appropriate to do so, ONDCP automatically processes a Privacy Act request for access to records under both the Privacy Act and the FOIA, following the rules contained in this part. ONDCP processes a request under both the FOIA and Privacy Act so you will receive the maximum amount of information available to you by law. (e) Requests must be received by ONDCP through methods specified on the FOIA page of ONDCP's website: https://www.whitehouse.gov/ondcp/about/foia-and-legal/. Requests may be emailed at any time to FOIA@ondcp.eop.gov or mailed to SSDMD/RDS; ONDCP Office of General Counsel; Joint Base Anacostia-Bolling (JBAB) Bldg. 410/Door 123; 250 Murray Lane SW, Washington, DC 20509. Email requests are strongly preferred. (f) The words “FOIA REQUEST” or “REQUEST FOR RECORDS” should be clearly marked on all FOIA request communications. The time limitations imposed by § 1401.7(a) will not begin until ONDCP identifies a communication as a FOIA request. (g) You must provide contact information, such as your phone number, email address and mailing address, so we will be able to communicate with you about your request and provide released records. If we cannot contact you, or you do not respond within 20 calendar days to our request for clarification, we will close your request. (h) To protect our computer systems, ONDCP reserves the right to not open attachments to emailed request. Please include your request within the body of your email.

21 C.F.R. § 1401.7 Responses—form and content.

(a) Determinations. The General Counsel, or designee, will determine within 20 days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of a FOIA request whether it is appropriate to grant the request and will provide written notification to the person making the request. The notification shall also advise the person making the request of any fees assessed under § 1401.11 through 13. ONDCP will inform the requester of the availability of its FOIA Public Liaison. (b) Tracking number. ONDCP will assign it an individualized tracking number if it will take longer than 10 working days to process and may assign such a tracking number for less than 10 working days at our discretion. (c) Adverse determinations. If ONDCP makes an adverse determination denying a request in any respect, it must notify the requester of that determination in writing. Adverse determinations, or denials of requests, include decisions that: The requested record is exempt, in whole or in part; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; or the requested record is not readily reproducible in the form or format sought by the requester. Adverse determinations also include denials involving fees or fee waiver matters or denials of requests for expedited processing. (d) Content of denial. The denial must be signed by the head of the agency or designee and must include: (1) The name and title or position of the person responsible for the denial; (2) A brief statement of the reasons for the denial, including any FOIA exemption applied by the agency in denying the request; (3) An estimate of the volume of any records or information withheld, such as the number of pages or some other reasonable form of estimation, although such an estimate is not required if the volume is otherwise indicated by deletions marked on records that are disclosed in part or if providing an estimate would harm an interest protected by an applicable exemption; and (4) A statement that the denial may be appealed to the Director or his/her designee within 90 days of the date of the response. The requirements for making an appeal are specified in § 1401.10. (5) A statement notifying the requester of the assistance available from the agency's FOIA Public Liaison and the dispute resolution services offered by OGIS.

21 C.F.R. § 1401.8 Expedited process.

(a) A request for expedited processing may be made at any time. ONDCP must process requests and appeals on an expedited basis whenever it is determined that they involve: (1) Circumstances in which the lack of expedited treatment could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or (2) An urgency to inform the public about an actual or alleged Federal Government activity, beyond the public's right to know about government activity generally, and the request is made by a person primarily engaged in disseminating information. (b) A requester who seeks expedited processing must submit a statement, certified to be true and correct, explaining in detail the basis for requesting expedited processing. For example, under paragraph (a)(2) of this section, a requester who is not a full-time member of the news media must establish that the requester is a person who is primarily engaged in information dissemination, though it need not be the requester's sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request, beyond the public's right to know about government activity generally. The existence of numerous articles published on a given subject can be helpful in establishing the requirement that there be an “urgency to inform” the public on the topic. The formality of certification may be waived as a matter of administrative discretion. (c) Within 10 days of receipt of a request for expedited processing, ONDCP will decide whether to grant it and will notify the requester of the decision. If a request for expedited treatment is granted, the request will be given priority and will be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision will be acted on expeditiously.

21 C.F.R. § 1401.9 Extension of time.

(a) In unusual circumstances, ONDCP may extend the time limit prescribed in § 1401.7(a), (b) or § 1401.8 by written notice to the FOIA requester. The notice will state the reasons for the extension. (b) The phrase “unusual circumstances” means: (1) The requested records are located in establishments that are separated from the office processing the request; (2) A voluminous amount of separate and distinct records are demanded in a single request; or (3) Another agency or two or more components in the same agency have substantial interest in the determination of the request. (c) Whenever ONDCP cannot meet the statutory time limit for processing a request because of “unusual circumstances,” as defined by 5 U.S.C. 552(a)(b)(B), and ONDCP extends the time limit on that basis, the agency must, before expiration of the 20-day period to respond, notify the requester in writing of the unusual circumstances involved and of the date by which ONDCP estimates processing of the request will be completed. Where the extension exceeds 10 working days, ONDCP must, as described by the FOIA, provide the requester with an opportunity to modify the request or arrange an alternative time period for processing the original or modified request. The Agency must make available its designated FOIA contact or its FOIA Public Liaison for this purpose. The Agency must also alert requesters to the availability of the Office of Government Information Services (OGIS) to provide dispute resolution services. (d) To satisfy unusual circumstances under the FOIA, ONDCP may aggregate requests in cases where it reasonably appears that multiple requests, submitted either by a requester or by a group of requesters acting in concert, constitute a single request that would otherwise involve unusual circumstances. ONDCP cannot aggregate multiple requests that involve unrelated matters.

21 C.F.R. § 1401.10 Appeal procedures.

(a) An appeal to the ONDCP must explain the reasoning and factual basis for the appeal. It must be received by email at FOIA@ondcp.eop.gov or another method specified on the FOIA page of ONDCP's website within 90 days of the date of the response. The appeal must be in writing, addressed to SSDMD/RDS; ONDCP Office of General Counsel; Joint Base Anacostia-Bolling (JBAB) Bldg. 410/Door 123; 250 Murray Lane SW, Washington, DC 20509. The communication should clearly be labeled as a “Freedom of Information Act Appeal.” (b) The Director or designee will decide the appeal within 20 days (excepting Saturdays, Sundays, and legal public holidays). If the Director or designee deny an appeal in whole or in part, the written determination will contain the reason for the denial, the name and title of the person responsible for the denial, any FOIA exemptions applied, and the provisions for judicial review of the denial and ruling on appeal provided in 5 U.S.C. 552(a)(4). The denial will also inform the requester of the dispute resolution services offered by OGIS as a non-exclusive alternate to litigation. If ONDCP agrees to participate in voluntary dispute resolution services provided by OGIS, it will actively engage in an attempt to resolve the dispute.

21 C.F.R. § 1401.11 Fees to be charged—general.

ONDCP will assess a fee to process FOIA requests in accordance with the provisions of this section and Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget (“OMB Guidelines”). ONDCP shall ensure that searches, review and duplication are conducted in the most efficient and the least expensive manner. ONDCP will ordinarily collect all applicable fees before sending copies of records to a requester. ONDCP will charge the following fees unless a waiver or reduction of fees is granted under § 1401.15, or the total fee to be charged is less than $25.00. ONDCP will notify you if we estimate that charges will exceed $25.00 including a breakdown of the fees for search, review or duplication and whether applicable entitlements to duplication and search at no charge have been provided. ONDCP will not process your request until you either commit in writing to pay the actual or estimated total fee, or designate some amount of fees you are willing to pay. (a) Search for records. ONDCP will charge $77.00 per hour, which is a blended hourly rate for all personnel that respond to FOIA requests plus 16 percent of that rate to cover benefits. (b) Review of records. ONDCP will charge $77.00 per hour, which is a blended hourly rate for all personnel that responded to FOIA requests plus 16 percent of that rate to cover benefits. Records or portions of records withheld under an exemption subsequently determined not to apply may be reviewed to determine the applicability of exemptions not considered. The cost for a subsequent review is assessable. (c) Duplication of records. We will charge duplication fees to all requesters. We will honor your preference for receiving a record in a particular format if we can readily reproduce it in the form or format requested. If we provide photocopies, we will make one copy per request at the cost of $.10 per page. For copies of records produced on tapes, disks or other media, we will charge the direct costs of producing the copy, including operator time. Where we must scan paper documents in order to comply with your preference to receive the records in an electronic format, we will charge you the direct costs associated with scanning those materials. For other forms of duplication, we will charge the direct costs. We will provide the first 100 pages of duplication (or the cost equivalent for other media) without charge except for requesters seeking records for a commercial use. (d) Other charges. ONDCP will recover the costs of providing other services such as certifying records or sending records by special methods.

21 C.F.R. § 1401.12 Fees to be charged—miscellaneous provisions.

(a) Payment for FOIA services may be made by check or money order made payable to the Treasury of the United States. (b) ONDCP may require advance payment where the estimated fee exceeds $250, or a requester previously failed to pay within 30 days of the billing date. (c) ONDCP may assess interest charges beginning the 31st day of billing. Interest will be at the rate prescribed in section 3717 of title 31 of the United States Code and will accrue from the date of the billing. (d) ONDCP may assess search charges where records are not located or where records are exempt from disclosure. (e) ONDCP may aggregate individual requests for fee purposes in accordance with 1401.16.

21 C.F.R. § 1401.13 Fees to be charged—categories of requesters.

(a) There are three categories of FOIA requesters: Commercial use requests; educational, non-commercial scientific institutions or representatives of the news media; and all other requesters. (b) The specific levels of fees for each of these categories are: (1) Commercial use request. ONDCP will recover the full direct cost of providing search, review and duplication services. Commercial use requests will not receive free search-time or free reproduction of documents. (2) Educational and non-commercial scientific institution request. ONDCP will charge the cost of reproduction, excluding charges for the first 100 pages. Requesters must demonstrate the request is authorized by and under the auspices of a qualifying institution and that the records are sought for scholarly or scientific research not a commercial use. (3) Request from representative of the news media. ONDCP will charge the cost of reproduction, excluding charges for the first 100 pages. Requesters must meet the criteria in § 1401.3, and the request must not be made for a commercial use. A request that supports the news dissemination function of the requester shall not be considered a commercial use. (4) All other requesters. ONDCP will recover the full direct cost of the search and the reproduction of records, excluding the first 100 pages of reproduction and the first two hours of search time.

21 C.F.R. § 1401.14 Restrictions on charging fees.

(a) No search fees will be charged for requests by educational institutions (unless the records are sought for a commercial use), noncommercial scientific institutions, or representatives of the news media. (b) If ONDCP fails to comply with the FOIA's time limits in which to respond to a request, it may not charge search fees, or, in the instances of requests from requesters described in § 1401.13(b)(2), may not charge duplication fees, except as described in paragraphs (c), (d), and (e) of this section. (c) If ONDCP determines that unusual circumstances as defined by the FOIA apply and the agency provided timely written notice to the requester in accordance with the FOIA, a failure to comply with the time limit shall be excused for an additional 10 days. (d) If ONDCP determines that unusual circumstances as defined by the FOIA apply, and more than 5,000 pages are necessary to respond to the request, the agency may charge search fees, or, in the case of requesters described in § 1401.13(b)(2) of this section, may charge duplication fees if the following steps are taken. ONDCP must have provided timely written notice of unusual circumstances to the requester in accordance with the FOIA and the agency must have discussed with the requester via written mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii). If this exception is satisfied, ONDCP may charge all applicable fees incurred in the processing of the request. (e) If a court has determined that exceptional circumstances exist as defined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court order. (f) No search or review fees will be charged for a quarter-hour period unless more than half of that period is required for search or review. (g) When, after first deducting the 100 free pages (or its cost equivalent) and the first two hours of search, a total fee calculated under paragraph (c) of this section is $25.00 or less for any request, no fee will be charged.

21 C.F.R. § 1401.15 Waiver or reduction of fees.

Requirements for waiver or reduction of fees: (a) Requesters may seek a waiver of fees by submitting a written application demonstrating how disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in the commercial interest of the requester. (b) ONDCP must furnish records responsive to a request without charge or at a reduced rate when it determines, based on all available information, that disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in the commercial interest of the requester. In deciding whether this standard is satisfied the agency must consider the factors described in paragraphs (b)(1) through (3) of this section: (1) Disclosure of the requested information would shed light on the operations or activities of the government. The subject of the request must concern identifiable operations or activities of the Federal Government with a connection that is direct and clear, not remote or attenuated. (2) Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities. This factor is satisfied when the following criteria are met: (i) Disclosure of the requested records must be meaningfully informative about government operations or activities. The disclosure of information that already is in the public domain, in either the same or a substantially identical form, would not be meaningfully informative if nothing new would be added to the public's understanding. (ii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area as well as the requester's ability and intention to effectively convey information to the public must be considered. ONDCP will presume that a representative of the news media will satisfy this consideration. (3) The disclosure must not be primarily in the commercial interest of the requester. To determine whether disclosure of the requested information is primarily in the commercial interest of the requester, ONDCP will consider the following criteria: (i) ONDCP must identify whether the requester has any commercial interest that would be furthered by the requested disclosure. A commercial interest includes any commercial, trade, or profit interest. Requesters must be given an opportunity to provide explanatory information regarding this consideration. (ii) If there is an identified commercial interest, the component must determine whether that is the primary interest furthered by the request. A waiver or reduction of fees is justified when the requirements of § 1401.15(a) are satisfied and any commercial interest is not the primary interest furthered by the request. ONDCP ordinarily will presume that when a news media requester has satisfied the requirements of § 1401.15(a), the request is not primarily in the commercial interest of the requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return will not be presumed to primarily serve the public interest. (c) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver shall be granted for those records. (d) Requests for a waiver or reduction of fees should be made when the request is first submitted to ONDCP and should address the criteria referenced above. A requester may submit a fee waiver request at a later time so long as the underlying record request is pending or on administrative appeal. When a requester who has committed to pay fees subsequently asks for a waiver of those fees and that waiver is denied, the requester shall be required to pay any costs incurred up to the date the fee waiver request was received.

21 C.F.R. § 1401.16 Aggregation of requests.

When ONDCP reasonably believes that a requester or a group of requesters acting in concert is attempting to divide a single request into a series of requests for the purpose of avoiding fees, the Agency may aggregate those requests and charge accordingly. The Agency may presume that multiple requests of this type made within a 30-day period have been made in order to avoid fees. For requests separated by a longer period, ONDCP will aggregate them only where there is a reasonable basis for determining that aggregation is warranted in view of all the circumstances involved. Multiple requests involving unrelated matters cannot be aggregated.

21 C.F.R. § 1401.17 Markings on released documents.

When requested records contain matters that are exempted under 5 U.S.C. 552(b), but such exempted matters can be reasonably segregated from the remainder of the records, the records shall be disclosed by ONDCP with the necessary redactions. If records are disclosed in part, ONDCP will mark them to show the amount and location of information redacted and the exemption(s) under which the redactions were made unless doing so would harm an interest protected by an applicable exemption.

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) 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: (i) The requested information has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or (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) 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) ONDCP determines that the information is exempt under the FOIA, and therefore will not be disclosed; (2) The information has been lawfully published or has been officially made available to the public; (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) 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) ONDCP must specify a reasonable time period within which the submitter must respond to the notice referenced above. (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) 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) A statement of the reasons why each of the submitter's disclosure objections was not sustained; (2) A description of the information to be disclosed or copies of the records as ONDCP intends to release them; and (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.

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