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Privacy Act Notice: This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. §552a(e)(3).
(1) The collection of this information is authorized by the Federal Food, Drug and Cosmetic Act (21 U.S.C. §371 et seq.). FDA’s collection and use of information concerning Advisory Committee activities is authorized by 5 U.S.C. §§3302 and 3361, the Federal Advisory Committee Act (5 U.S.C. Appendix 2), and the Government in the Sunshine Act (5 U.S.C. §552b).
(2) FDA will use the information you submit to determine qualifications for positions on Federal Advisory Committees. If you are selected, FDA will publish your curriculum vitae (CV), and any subsequent updates to your CV that you provide to the FDA, on FDA’s web site, without removing or redacting any information.
(3) FDA may disclose information to recipients outside the FDA and the Department of Health and Human Services (HHS, the Department) as follows:
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In furtherance of FDA’s goal of ensuring transparency regarding the qualifications of individuals selected to serve on FDA advisory committees, FDA posts the CV of each member of FDA advisory committees publicly on http://www.fda.gov/AdvisoryCommittees/. FDA will post the CV of all nominees accepted as members, as the CVs were submitted, without removing or redacting information. FDA also requests that existing advisory committee members submit updated versions of their CVs, typically on a yearly basis, and these updated CVs will be posted as well. FDA will be requiring that all CVs submitted be accompanied by a written consent form stating that, if the nominee is accepted as a member of an FDA advisory committee, the individual consents to the publication of the individual’s CV to FDA’s web site, without FDA removing or redacting any information. The consent form requires that the nominee affirm that the CV does not include any confidential information, including information pertaining to third parties that the nominee is not permitted to disclose.
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If required by law, statute, regulation, or other binding authority, an annual report may be issued to the President, and administrative reports may be provided when requested to the Office of Management and Budget (OMB) and the General Services Administration (GSA).
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In the event that this system of records indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether federal, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation or order issued pursuant thereto.
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In the event the Department deems it desirable or necessary, in determining whether particular records are required to be disclosed under the Freedom of Information Act, disclosure may be made to the Department of Justice for the purpose of obtaining its advice.
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In the event of litigation where the defendant is (a) the Department, any component of the Department, or any employee of the Department in his or her official capacity; (b) the United States where the Department determines that the a claim, if successful, is likely to directly affect the operations of the Department or any of its components; or (c) any Department employee in his or her individual capacity where the Justice Department has agreed to represent such employee, the Department may disclose such records as it deems desirable or necessary to the Department of Justice to enable that Department to present an effective defense, provided such disclosure is compatible with the purpose for which the records were collected.
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Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
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Records may be disclosed to student volunteers, individuals working under a personal services contract, and other individuals performing functions for the Department but technically not having the status of agency employees, if they need access to the records in order to perform their assigned agency functions.
(4) Your application for participating in these activities is voluntary. Should you choose to apply, it is mandatory that you provide the requested information. Failure to supply the information may prevent FDA from considering your application.
Additional details regarding HHS and FDA use of application records is available online:
http://www.hhs.gov/foia/privacy/recordsnotices/09900059.html and
http://www.hhs.gov/foia/privacy/recordsnotices/09900080.html.
General FDA policies on privacy and information management are also available online at http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/default.htm and
http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm.
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