09-10-0002 Regulated Industry Employee enforcement Records, HHS/FDA/OC

System name:

Regulated Industry Employee Enforcement Records, HHS/FDA/OC.

Security classification:

None.

System location:

FDA employees:

Administrative Services Branch (HFA-210), 5600 Fishers Lane, Rockville, MD 20857

Investigations Operations Branch (HFC-132), 5600 Fishers Lane, Rockville, MD 20857

Administrative, Investigations, and Compliance Branches at Field/District Offices. For the location of Field/District Offices, see Appendix A.

For the location of Federal Records Centers, see Appendix B.

Categories of individuals covered by the system:

Employees of enterprises regulated by the Food and Drug Administration (FDA) and other individuals subject to FDA enforcement actions.

Categories of records in the system:

Includes correspondence, memoranda, inspection reports, and related documents that are investigatory material compiled for law enforcement purposes.

Authority for maintenance of the system:

Federal Food, Drug and Cosmetic Act (21 U.S.C. 321 et seq.), the Public Health Service Act (42 U.S.C. 201 et seq.), and authority delegated to the Commissioner, 21 CFR part 5.

Purpose(s):

To provide records used by FDA employees in investigations of possible violation of the law.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses: ¹ 

1. Records that indicate violation or potential violation of law may be: (1) Referred for investigation and possible enforcement action under the applicable Federal, State, or foreign laws to the Department of Justice and other appropriate Federal agencies; an appropriate State food and drug enforcement health agency or licensing authority; or, the government of a foreign country; or (2) disclosed in administrative or court proceeding in determining whether a record is relevant to an Agency decision concerning documents of investigatory materials.

2. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from that congressional office at the request of that individual.

3. The Department of Health and Human Services (HHS) may disclose information from this system of records to the Department of Justice, or to a court or other tribunal, when

(a) HHS, or any component thereof; or

(b) Any HHS employee in his or her official capacity; or

(c) Any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or

(d) The United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components,

Is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the court or other tribunal, is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.

4. Disclosure may be made to appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department’s efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and necessary for that assistance.

5. Disclosure may be made to the National Archives and Records Administration and/or the General Services Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.

6. Disclosure may be made to contractors and other persons who perform services for the agency related to this system of records and who need access to the records to perform those services. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.

7. When a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, disclosure may be made to the appropriate public authority, whether federal, foreign, state, local, or tribal, or otherwise, responsible for enforcing, investigating or prosecuting such violation, if the information disclosed is relevant to the responsibilities of the agency or public authority.

8. In the event HHS/FDA 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.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

Storage:

Manual files are maintained in letter-size folders. Automated files are maintained on computer discs and tapes stored ina locked safe.

Retrievability:

Indexed by company or subject, sometimes with individual name in a cross-index on an automated index system.

Safeguards:

1. Authorized users: Administrative Services Branch and Office of Regulatory Affairs personnel.

2. Physical safeguards: Records are kept in locked cabinets in a secured area, locked rooms, locked buildings and limited access to authorized personnel. Computer tapes and discs are stored in a locked safe.

3. Procedural (or technical) safeguards: Computer software providing restricted commands.

4. Implementation guidelines: Safeguards are established in accordance with Chapter 45–13 and PHS hf: 45–13 of the Department's General Administration Manual and Part 6 of the Department's ADP Systems Manual.

Retention and disposal:

Records may be retired to a Federal Records Center and subsequently disposed of in accordance with FDA's Records Control Schedule. The Records Control Schedule and disposal standard for these records may be obtained by writing to the system manager at the address below.

System manager(s) and address:

The policy coordinating official for this system of records is also the system manager for the Investigations Operations Branch.

Chief, Administrative Services Branch (HFA–210), 5600 Fishers Lane, Rockville, MD 20857

Assistant to the Director, Investigations Operations Branch (HFC–132), Office of Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857

Director, Office of Criminal Investigations, Office of Regulatory Affairs, (HFC-300), 7500 Standish Place, Suite 250N, Rockville, MD 20855

Administrative, Investigative and Compliance Branches at Field/District Offices, see Appendix A.

Notification procedure:

An individual may learn if a record exists about him or her upon written request, with notarized signature if request is made by mail, or with identification if request is made in person, directed to:

FDA Privacy Act Coordinator (HFI–30), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857

Record access procedures:

Same as notification procedures. Requesters should also reasonably specify the record contents being sought. Access to record systems which have been granted an exemption from the Privacy Act access requirement may be made at the discretion of the system manager. If access is denied to requested records, an appeal may be made to:

Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857

You may also request an accounting of disclosures that have been made of your record, if any.

Contesting record procedures:

If access has been granted, contact the official at the address specified under notification procedures and reasonably identify the record, specify the information being contested, the corrective action sought, and your reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely or irrelevant.

Record source categories:

Individual on whom the record is maintained, from third parties such as consumers, scientists, representatives of other companies, state agencies, or developed by FDA during investigations for law enforcement purposes.

Systems exempted from certain provisions of the act: ²

This system is exempt from access and contest and certain other provisions of the Privacy Act (5 U.S.C. 552a (c)(3), (d)(1) to (4), (e)(3), (e)(4)(G) to (H) and (f), to the extent that it includes investigatory material compiled for law enforcement purposes, including criminal law enforcement purposes, where access would be likely to prejudice the conduct of the investigation.

Appendix A– Addresses and working hours of the Food and Drug Administration Field Offices

The following is a list of the Food and Drug Administration Field Offices, their addresses and working hours where individuals may have access to records in Food and Drug Administration Privacy Act Record Systems:

NORTHEAST REGION

Regional Office

830 Third Avenue, Brooklyn, NY 11232, Office hours: 8 am to 4:30 pm (e.s.t.).

District Offices

One Montvale Avenue, 3rd Floor, Stoneham, MA 02180, Office hours: 8 am. to 4:30 pm (e.s.t.).

850 Third Avenue, 4th Floor, Brooklyn, NY 11232–1593, Office hours: 8 am to 4:30 pm (e.s.t.).

599 Delaware Avenue, Buffalo, NY 14202, Office hours: 8 am to 4:30 pm (e.s.t.).

Regional Laboratory

850 Third Avenue, 4th Floor, Brooklyn, NY 11232–1593, Office hours: 8 am to 4:30 pm (e.s.t.).

Winchester Engineering and Analytical Center (WEAC), 109 Holton Street, Winchester, MA 01890.

MID-ATLANTIC REGION

Regional Office

2nd and Chestnut Streets, Room 900, Philadelphia, PA 19106, Office hours: 8 am to 4:30 pm (e.s.t.).

District Offices

2nd and Chestnut Streets, Room 900, Philadelphia, PA 19106, Office hours: 8 am to 4:30 pm (e.s.t.).

61 Main Street, West Orange, NJ 07052, Office hours: 8 am to 4:30 pm (e.s.t.).

900 Madison Avenue, Baltimore, MD 21201, Office hours: 7:45 am to 4:15 pm (e.s.t.).

1141 Central Parkway, Cincinnati, OH 45202–1097, Office hours: 8 am to 4:30 pm (e.s.t.).

SOUTHEAST REGION

Regional Office

60 Eighth Street, NE, Atlanta, GA 30309, Office hours: 8 am to 4:30 pm (e.s.t.).

District Offices

60 Eighth Street, NE, Atlanta, GA 30309, Office hours: 8 am to 4:30 pm (e.s.t.).

297 Plus Park Boulevard, Nashville, TN 37217, Office hours: 8 am to 4:30 pm (c.t.).

7200 Lake Ellenor Drive, Suite 120, Orlando, FL 32809, Office hours: 8 am to 4:30 pm (e.s.t.).

4298 Elysian Fields Avenue, New Orleans, LA 70122, Office hours: 8 am to 4:30 pm (c.t.).

Fernandez Juncos Avenue, Puerta de Tierra, San Juan, PR 00906–5719, Office hours: 8 am to 4:30 pm (e.s.t.).

Regional Laboratory

60 Eighth Street, NE, Atlanta, GA 30309, Office hours: 8 am to 4:30 pm (e.s.t.).

MIDWEST REGION

Regional Office

20 N. Michigan Avenue, Room 550, Chicago, IL 60602, Working hours: 8 am to 4:30 pm (e.s.t.).

District Offices

433 W. Van Buren Street, Room 1222, Chicago, IL 60607, Working hours: 8 am to 4:30 p.m. (e.s.t.).

1560 East Jefferson Avenue, Detroit, MI 48207, Office hours: 8 am to 4:30 pm (e.s.t.).

240 Hennepin Avenue, Minneapolis, MN 55401, Office hours: 8 am to 4:30 pm (c.t.).

SOUTHWEST REGION

Regional Office

3032 Bryan Street, Dallas, TX 75204, Office hours: 8 am to 4:30 (c.t.).

District Offices

3032 Bryan Street, Dallas, TX 75204, Office hours: 8 am to 4:30 (c.t.).

1009 Cherry Street, Kansas City, MO 64106, Office hours: 8 am to 4:30 pm (c.t.).

Denver Federal Center, Building 20, PO Box 25087, Denver, CO 80225–0087, Working hours: 8 am to 4:30 pm (m.t.).

PACIFIC REGION

Regional Office

Federal Office Building, Room 526, 50 U.N. Plaza, San Francisco, CA 94102, Working hours: 8 am to 4:30 pm (p.t.).

District Offices

Federal Office Building, Room 526, 50 U.N. Plaza, San Francisco, CA 94102, Working hours: 8 am to 4:30 pm (p.t.).

1521 W. Pico Boulevard, Los Angeles, CA 90015–2486, Office hours: 8 am to 4:30 pm (p.t.).

22201 23rd Drive, SE, Bothell, WA 98021–4421, Office hours: 8 am to 4:30 pm (c.t.).

Appendix B—General Services Administration, Federal Archives, and Records Centers

National Centers:

District of Columbia, Maryland, Virginia, and West Virginia except for U.S. Court records for Maryland, Virginia, and West Virginia: Washington National Records Center, Washington, DC 20409.

National Personnel Records Center (Civilian Personnel Records), 111 Winnebago Street, St. Louis, MO 63118.

National Personnel Records Center (Military Personnel Records), 9700 Page Boulevard, St. Louis, MO 63132.

Regional Centers

Maine, Vermont, New Hampshire, Massachusetts, Connecticut, and Rhode Island, Federal Archives and Records Center, 380 Trapelo Road, Waltham, MA 02154.

New York, New Jersey, Puerto Rico, the Virgin Islands, and the Panama Canal Zone, Federal Records Center, Military Ocean Terminal, Building 22, Bayonne, NJ 07002–5388.

Delaware, Pennsylvania, and U.S. Court records for Maryland, Virginia, and West Virginia, Federal Records Center, 5000 Wissahickon Avenue, Philadelphia, PA 19144.

North Carolina, South Carolina, Tennessee, Mississipi, Alabama, Georgia, Florida and Kentucky, Federal Records Center, 1557 St. Joseph Avenue, East Point, GA 30344.

Illinois, Wisconsin, Minnesota, and U.S. Court records for Indiana, Michigan, and Ohio, Federal Records Center, 7358 South Pulaski Road, Chicago, IL 60629.

Indiana, Michigan, and Ohio except for U.S. Court records, Federal Records Center, 3150 Springboro Road, Dayton, OH 45439.

Kansas, Iowa, Nebraska, and Missouri, Federal Records Center, 2306 East Bannister Road, Kansas City, MO 64131.

Texas, Oklahoma, Arkansas, Louisiana, and New Mexico, Federal Records Center, PO Box 6216, Fort Worth, TX 76115.

Shipping address only (do not use for mail), 4900 Hemphill Street, Building 1, Dock 1, Fort Worth, TX.

Colorado, Wyoming, Utah, Montana, North Dakota, and South Dakota, Federal Records Center, PO Box 25307, Denver, CO 80225.

American Samoa, California, except Southern California, and Nevada, except Clark County, Federal Records Center, 1000 Commodore Drive, San Bruno, CA 94066.

Arizona; Clark County, Nevada; and Southern California (counties of San Luis Obispo, Kern, San Bernardino, Santa Barbara, Ventura, Los Angeles, Riverside, Orange, Imperial, Inyo, and San Diego). Federal Records Center, 24000 Avila Road, 1st Floor, PO Box 6719, Laguna Niguel, CA 92677.

Washington, Oregon, Idaho, Alaska, Hawaii, and Pacific Ocean areas (except American Samoa), Federal Records Center, 6125 Sand Point Way NE, Seattle, WA 98115.

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¹ In a June 27, 2014 Federal Register Notice FDA added certain standard routine uses to this and other FDA SORNs. The Federal Register Notice of this action describes the routine uses in more detail and is available online at http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/pdf/2014-15022.pdf. The routine uses added to this SORN appear as routine uses number 4 through 8 below.

² Federal Register notices regarding the exemptions for this system are available online: Notice of Proposed Rulemaking and Final Rule.