Job Description: FDA’s Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP), Division of Information Disclosure Policy (DIDP), is responsible for control, management, coordination, and development of CDER’s disclosure activities. Qualified candidates clear important and sensitive CDER responses to requests received under the Freedom of Information Act as amended (FOIA), and by careful evaluation, ensure that all such responses are accurate and contain only information which is considered disclosable as provided under FOIA, the Privacy Act, and FDA’s implementing regulations. Job Responsibilities: DIDP is recruiting for the position of Regulatory Counsel. The duties performed include a broad range of issues concerning FOIA, the Trade Secrets Act, the Privacy Act, the Federal Food, Drug, and Cosmetic (FDC) Act, and related statutes and regulations implemented by FDA. Job Requirements: Performs a legal review of CDER records to determine whether, before being made available for public disclosure, they should be redacted, in part or in their entirety, under applicable FOIA exemption, other statutory provision, or, in the context of third-party subpoenas, any applicable privilege in the Federal Rules of Civil Procedure. Drafts responses to requests for the disclosure of information, including requests under FOIA, by analyzing the request, directing an appropriate search, obtaining the responsive documents, performing a legal review to determine if information is exempt from disclosure, redacting information that is exempt from disclosure, preparing a letter that provides the documents and explains what information is being withheld from disclosure, and obtaining necessary clearances for releasing the records. Assists with contacting CDER and FDA components, including other Centers and the Office of Chief Counsel, on important and sensitive issues regarding information disclosure. Informs the Branch Chief of all sensitive requests for information, discusses the issues with the Branch Chief, and obtains approval for the response and other related actions. Reviews CDER responses to requests for information. Ensures that requests for information are satisfied in a timely manner and by careful evaluation that all such responses are accurate and contain only information considered disclosable as provided under FOIA, the Privacy Act, the FDC Act, and HHS and FDA's implementing regulations. Keeps abreast of current developments in CDER to correctly handle and process disclosure inquiries. The incumbent must have sensitivity to emerging problems that are reflected in disclosure inquiries and must develop legally supportable recommendations for CDER action to address the problems. These recommendations are directed to the affected units, within CDER, through the Director of DIDP. The incumbent ensures appropriate consideration and resolution of such problems. Job Details: Company: FDA Vacancy Type: Full Time Job Location: Hagerstown, MD, US Application Deadline: N/A Apply Here Jobsvilla.net
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