• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Regulatory Information

  • Print
  • Share
  • E-mail

Section Contents Menu

Freedom of Information

09-10-0009 Special Studies and Surveys on FDA-Regulated Products, HHS/FDA/OM

System name:

Special Studies and Surveys on FDA-Regulated Products, HHS/FDA/OM.

Security classification:

None.

System location:

Division of Contracts and Procurement Management, Office of Contracts and Grants Management, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, MD 20857.

A current list of contact sites is available by writing to the system manager at the address below.

Categories of individuals covered by the system:

Individuals, specialty groups, and households participating voluntarily in studies and surveys conducted or sponsored by FDA.

Categories of records in the system:

Data collected vary with each study/survey. Normal standard information for individuals or household members varies but could include name, age, sex, marital status, address or locale of residence, etc. Nondemographic items relate to experience with, or opinions about, a particular product. Patient medical records may be included in some cases involving specific health problems.

Authority for maintenance of the system:

Section 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

Purpose(s):

Used to provide data on individuals, specialty groups, e.g., physicians and households participating voluntarily in studies and surveys conducted or sponsored by FDA.

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

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

2. 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.

3. Disclosure may be made to HHS contractors and their staff in order to accomplish the purpose for which the records are collected. The recipients are required to protect such records from improper disclosure.

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:

Questionnaires and data are filed in standard filing equipment. Some statistical data are stored on magnetic tape.

Retrievability:

Accessed by ID number assigned by FDA or contractor during collection process. Individual files are maintained in agency and/or contractor's custody until all collection procedures are completed.

Safeguards:

1. Authorized users: Authorized program personnel.

2. Physical safeguards: Questionnaires and data are maintained in locked containers in secured area. Magnetic tapes are maintained in secured computer facilities. Locked buildings, locked rooms, locked file cabinets and locked tape vaults.

3. Procedural (or technical) safeguards: Access limited by computer password which is changed periodically. Confidentiality safeguards with respect to these records are required to be maintained.

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:

Questionnaires and data are retained until all statistical problems are resolved; then destroyed. The records are destroyed by shredding, burning, or other appropriate means so as to render them illegible.

System manager(s) and address:

Chief, Division of Contracts and Procurement Management, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, MD 20857.

Office of Epidemiology and Biostatistics (HFD–700), Rockville, MD 20857

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 procedure. Requesters should also reasonably specify the record contents being sought. An individual who requests notification of, or access to, a medical record shall, at the time the request is made, designate in writing a responsible representative who will be willing to review the records and inform the subject individual of its contents at the representative's discretion. You may also request an accounting of disclosures that have been made of your record, if any.

Contesting record procedures:

Contact the official at the address specified under Notification Procedure above 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 or patient's medical records, depending on the type of survey or study.

Systems exempted from certain provisions of the act:

None.

______________________ 

 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.