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This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Regulatory Policy (ORP) is to provide Center oversight and leadership in the development of regulations, policies, procedures, and guidance’s that affect the drug approval process, and in the development of new legislation. Also, ORP manages the disclosure of official records and information under the Freedom of Information Act, Privacy Act, other statutes, and Food and Drug Administration’s public disclosure regulations.
The mission of the Division of Disclosure Policy (DIDP) is to provide Center oversight and leadership in the disclosure of official records and information under the Freedom of Information Act, Privacy Act, other statutes, and FDA's public disclosure regulations.
Duties/Responsibilities
As a Regulatory Counsel in the Division of Disclosure Policy (DIDP) within the Office of Regulatory Policy (ORP), the incumbent will be responsible for providing analyses and advice on the interpretation of laws, regulations, and policies and guidance applicable for FDA regulated products. Participate or provide leadership in the development, implementation, and evaluation of regulations and policies as they relate to the Agency’s programs and activities to ensure the safety, efficacy, and quality of FDA regulated products.
Band A:
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 Freedom of Information Act 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 the Freedom of Information Act, 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 Center 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 Center 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 the Freedom of Information Act, the Privacy Act, the Federal Food, Drug, and Cosmetic (FD&C) Act, and the Department's and FDA's implementing regulations.
Keeps abreast of current developments in the Center 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 Center action to address the problems. These recommendations are directed to the affected units, within the Center, through the Director of DIDP. The Incumbent ensures appropriate consideration and resolution of such problems.
Assists with providing guidance and direction to Center personnel involved with handling responses to requests for information and other disclosure activities. This requires an understanding of the Freedom of Information Act, the Privacy Act, pertinent sections of the Federal Food, Drug, and Cosmetic (FD&C) Act, and the Departments and Agency's implementing regulations and policies. Keeps abreast of all changes to the statutes and regulations to ensure Center compliance at all times.
Due to the importance and sensitivity of the duties performed by the incumbent, Center professional staff are instructed to give the necessary priority attention to requests for information assigned by the incumbent. The timely nature of these matters requires the incumbent to discuss issues with Center professional staff (e.g., Division Directors, consumer safety officers, medical and scientific personnel).
Supervisory Responsibilities: N/A
How to Apply
Submit resume or curriculum vitae with cover letter by October 31, 2024, to: CDER-ORP-Cures-Hiring@fda.hhs.gov. On the subject line, please reference “Regulatory Counsel Band A”. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
How I Will Be Evaluated
Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.
Announcement Contact
For questions regarding this Cures position, please contact CDER-ORP-Cures-Hiring@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.
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