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Freedom of Information

Privacy Act

FDA is pleased to provide the following materials regarding the Agency's privacy program.


How to Make a Privacy Act Request

Please see the FDA's Privacy Regulations for a detailed description on how to submit a Privacy Act Request.


The Systems of Records Notices (SORNs) listed below are specific to systems maintained by FDA.  SORNs for other Department of Health and Human Services (HHS) systems are available online at http://www.hhs.gov/foia/privacy/sorns.html. SORNs published by other agencies outside HHS and which apply to records across the federal government are available line at http://dpclo.defense.gov/Privacy/SORNsIndex/GovernmentWideNotices.aspx.

In a June 27, 2014 Federal Register Notice FDA added certain standard “routine uses” to the Agency’s remaining SORNs. These added routine uses provide for appropriate disclosures of records to support responding to security breaches, to contract employees, to record keeping authorities, to authorities when a record indicates a violation of law, and to the U.S. Department of Justice in the course of obtaining Freedom of Information Act guidance.  These routine uses are described in more detail in the June 27, 2014 Notice available online at http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15022.pdf. The routine uses now appear within the SORNs listed below.

The following FDA Privacy Act systems are associated with one or more SORNs.  The applicable FDA, HHS and/or Government-wide SORNs are identified by number following the system name.  The Privacy Impact Assessments (PIAs) noted above under Privacy Program Resources contain descriptions of the systems.


FDA Systems Associated With Other SORNs


Deleted SORNs

On December 8, 2014, FDA published a SORN for records regarding FDA Commissioning of State and Local Officials, HHS/FDA/ORA, System No. 09-10-0022 (79 FR 72687).  This notice also deleted the following SORN which was rendered obsolete: http://www.gpo.gov/fdsys/pkg/FR-2014-12-08/pdf/2014-28634.pdf
FDA Credential Holder File, HHS/FDA/OC, System No. 09-10-0003
On June 27, 2014 FDA deleted the following four System of Records Notices for record systems no longer in use. The Federal Register Notice of this deletion is available online at http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15022.pdf.
• Science Advisor Research Associate Program, HHS/FDA/ORA, System No. 09–10–0007. First published in the Federal Register, September 29, 1977 (42 FR 51922 at 52146).
 Radiation Protection Program Personnel Monitoring System, HHS/FDA/CDRH, System No. 09–10–0008. First published in the Federal Register, September 29, 1977 (42 FR 51922 at 52147) and published as revised with updated system location and manager information, December 31, 1992 (57 FR 62828 at 62829).
 Certified Retort Operators, HHS/FDA/CFSAN, System No. 09–10–0011. First published in the Federal Register, September 29, 1977 (42 FR 51922 at 52148) and published as revised with minor changes, December 29, 1993 (58 FR 69056).
 Epidemiological Research Studies of the Center for Devices and Radiological Health, HHS/FDA/CDRH, System No. 09–10–0017. First published in the Federal Register, May 29, 1979 (44 FR 30765 at 30766) and republished with minor changes in December 28, 1994 (59 FR 67087).

Contact FDA

Privacy Act Program

Division of Freedom of Information

Office of the Executive Secretariat, OC

5630 Fishers Lane

Room 1035

Rockville, MD 20857