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Code · CFR · Title 21 — Food and Drugs · Part 1401 — Public Availability of Information · § 1401.7

§ 1401.7. Responses—form and content.

405 words·~2 min read·/us/cfr/t21/s§ 1401.7

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(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.
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