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data include all studies and tests of an ingredient or a product on animals and humans and all studies and tests on the ingredient or product for identity, stability, purity, potency, bioavailability, performance, and usefulness.
$ 20.115 Product codes for manufac
turing or sales dates. Data or information in Food and Drug Administration files which provide a means for deciphering or decoding a manufacturing date or sales date or use date contained on the label or in labeling or otherwise used in connection with a product subject to the jurisdiction of the Food and Drug Administration are available for public disclosure.
$ 20.112 Voluntary drug experience re
ports submitted by physicians and
hospitals. (a) A voluntary drug experience report to the Food and Drug Administration on FDA Form 3500 shall be handled in accordance with the rules established in $ 20.111(c)(3)(iii).
(b) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report.
$ 20.116 Drug and device listing infor
mation. Information submitted to the Food and rug Administration pursuant to section 510 (a)-(j) of the act shall be subject only to the special disclosure provisions established in $8 207.37 and 807.37 of this chapter. [42 FR 42526, Aug. 23, 1977)
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62 FR 52249, Oct. 7, 1997)
$ 20.113 Voluntary product defect re
ports. Voluntary reports of defects in products subject to the jurisdiction of the Food and Drug Administration are available for public disclosure:
(a) If the report is submitted by the manufacturer, after deletion of data and information falling within the exemptions established in $ 20.61 for trade secrets and confidential commercial or financial information and in $20.63 for personal privacy.
(b) If the report is submitted by any person other than the manufacturer, after deletion of names and other information that would identify the person submitting the report and any data or information falling within the exemption established in $20.63 for personal privacy.
$ 20.117 New drug information.
(a) The following computer printouts are available for public inspection in the Food and Drug Administration's Freedom of Information Public Room:
(1) A numerical listing of all new drug applications and abbreviated new drug applications approved since 1938, showing the NDA number, the trade name, the applicant, the approval date, and, where applicable, the date the approval was withdrawn and the date the Food and Drug Administration was notified that marketing of the product was discontinued.
(2) A numerical listing of all new drug applications and abbreviated new drug applications approved since 1938 which are still approved, showing the same information as is specified in paragraph (a)(1) of this section except that it does not show a withdrawal date.
(3) A listing of new drug applications, abbreviated
drug applications, which were approved since 1938 and which are still approved, covering marketed prescription drug products except prescription drug products covered by applications deemed approved under the Drug Amendments of 1962 and not yet determined to be effective in the Drug Efficacy Study Implementation program. The listing includes the name of the active ingredient, the type of
Subpart C-Requirements for Specific
Categories of Records 21.30 Records of contractors. 21.31 Records stored by the National Ar
chives and Records Administration. 21.32 Personnel records. 21.33 Medical records.
dosage form, the route of administration, the trade name of the product, the name of the application holder, and the strength or potency of the product. The listing also includes, for each active ingredient in a particular dosage form for which there is more than one approved application, an evaluation of the therapeutic equivalence of the drug products covered by such applications.
(b) Other computer printouts containing IND and NDA information are available to the extent that they do not reveal data or information prohibited from disclosure under $8 20.61, 312.130, and 314.430 of this chapter. [42 FR 15616, Mar. 22, 1977, as amended at 45 FR 72608, Oct. 31, 1980; 46 FR 8457, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999)
Subpart D-Procedures for Notification of
and Access to Records in Privacy Act
Record Systems 21.40 Procedures for submitting requests for
notification and access. 21.41 Processing of requests. 21.42 Responses to requests. 21.43 Access to requested records. 21.44 Verification of identity. 21.45 Fees.
$ 20.118 Advisory committee records.
All advisory committee records shall be handled in accordance with the rules established in parts 10, 12, 13, 14, 15, 16, and 19 of this chapter.
Subpart E-Procedures for Requests for
Amendment of Records 21.50 Procedures for submitting requests for
amendment of records. 21.51 Responses to requests for amendment
of records. 21.52 Administrative appeals of refusals to
amend records. 21.53 Notation and disclosure of disputed
records. 21.54 Amended or disputed records received
from other agencies.
$ 20.119 Lists of names and addresses.
Names and addresses of individuals in Food and Drug Administration records shall not be sold or rented. Names and addresses shall not be disclosed if disclosure is prohibited as a clearly unwarranted invasion of personal privacy, e.g., lists of names and home addresses of Food and Drug Administration employees, which shall not be disclosed under $ 20.110.
21.60 Policy. 21.61 Exempt systems. 21.65 Access to records in exempt systems.
Subpart G-Disclosure of Records in Pri
vacy Act Record Systems to Persons Other Than the Subject Individual
PART 21— PROTECTION OF
Subpart A-General Provisions
Sec. 21.1 Scope. 21.3 Definitions. 21.10 Policy concerning records about indi
21.70 Disclosure and intra-agency use of
records in Privacy Act Record Systems;
no accounting required. 21.71 Disclosure of records in Privacy Act
Record Systems; accounting required. 21.72 Individual consent to disclosure of
records to other persons. 21.73 Accuracy, completeness, timeliness,
and relevance of records disclosed from
Privacy Act Record Systems. 21.74 Providing notice that a record is dis
Subpart B-food and Drug Administration
Privacy Act Record Systems
21.20 Procedures for notice of Food and
Drug Administration Privacy Act Record
Systems. 21.21 Changes in systems and new systems.
puted. 21.75 Rights of legal guardians.
AUTHORITY: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
SOURCE: 42 FR 15626, Mar. 22, 1977, unless otherwise noted.
Subpart A-General Provisions
Administration, except as provided in $21.32. Such records are subject to regulations of the Office of Personnel Management in 5 CFR parts 293, 294, and 297.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985)
$ 21.1 Scope.
(a) This part establishes procedures to implement the Privacy Act of 1974 (5 U.S.C. 552a). It applies to records about individuals that are maintained, collected, used, or disclosed by the Food and Drug Administration and contained in Privacy Act Record Systems.
(b) This part does not:
(1) Apply to Food and Drug Administration record systems that are not Privacy Act Record Systems or make available to an individual records that may include references to him but that are not retrieved by his name or other personal identifier, whether or not contained in a Privacy Act Record System. part 20 of this chapter (the public information regulations, and other regulations referred to therein determine when records are made available in such cases.
(2) Make any records available to persons other than (i) individuals who are the subjects of the records, (ii) persons accompanying such individuals under $21.43, (iii) persons provided records pursuant to individual consent under $ 21.72, or (iv) persons acting on behalf of such individuals as legal guardians under $21.75. Part 20 of this chapter (the public information regulations) and other regulations referred to therein determine when Food and Drug Administration records are disclosable to members of the public generally. Subpart G of this part limits the provisions of part 20 of this chapter with respect to disclosures of records about individuals from Privacy Act Record Systems to persons other than individuals who are the subjects of the records.
(3) Make available information compiled by the Food and Drug Administration in reasonable anticipation of court litigation or formal administrative proceedings. The availability of such information to any member of the public, including any subject individual or party to such litigation or proceeding shall be governed by applicable constitutional principles, rules of discovery, and part 20 of this chapter (the public information regulations).
(4) Apply to personnel records maintained by the Division of Human Resources Management, Food and Drug
$ 21.3 Definitions.
As used in this part:
(a) Individual means a natural living person who is a citizen of the United States or an alien lawfully admitted for permanent residence. Individual does not include sole proprietorships, partnerships, or corporations engaged in the production or distribution of products regulated by the Food and Drug Administration or with which the Food and Drug Administration has business dealings. Any such business enterprise that is identified by the name of one or more individuals is not an individual within the meaning of this part. Employees of regulated business enterprises are considered individuals. Accordingly, physicians and other health professionals who are engaged in business as proprietors of establishments regulated by the Food and Drug Administration are not considered individuals; however, physicians and other health professionals who are engaged in clinical investigations, employed by regulated enterprises, or the subjects of records concerning their own health, e.g., exposure to excessive radiation, are considered individuals. Food and Drug Administration employees, consultants, and advisory committee members, State and local officials, and consumers are considered individuals.
(b) Records about individuals means items, collections, or groupings of information about individuals contained in Privacy Act Record Systems, including, but not limited to education, financial transactions, medical history, criminal history, or employment history, that contain names or personal identifiers.
(c) Privacy Act Record System means a system of records about individuals under the control of the Food and Drug Administration from which information is retrieved by individual names or other personal identifiers. The term includes such a system of records whether subject to a notice published by the Food and Drug Administration, the Department, or another agency. Where records are retrieved only by personal identifiers other than individual names, a system of records is not a Privacy Act Record System if the Food and Drug Administration cannot, by reference to information under its control, or by reference to records of contractors that are subject to this part under $21.30, ascertain the identity of individuals who are the subjects of the records.
(d) Personal identifiers includes individual names, identifying numbers, symbols, or other identifying designations assigned to individuals. Personal identifiers does not include names, numbers, symbols, or other identifying designations that identify products, establishments, or actions.
(e) Personnel records means any personal information maintained in a Privacy Act Record System that is needed for personnel management programs or processes such as staffing, employee development, retirement, and grievances and appeals.
(f) Department means Department of Health and Human Services.
Act Record System as defined in 821.3(c) that is not covered by a notice published by the Department, the Office of Personnel Management, or another agency.
(b) The notice shall include the following information:
(1) The name and location(s) of the system.
(2) The categories of individuals about whom records are maintained in the system.
(3) The categories of records maintained in the system.
(4) The authority for the system.
(5) Each routine use of the records contained in the system (i.e., use outside the Department of Health and Human Services that is compatible with the purpose for which the records were collected and described in the notice) including the categories of users and the purposes of such use.
(6) The policies and practices of the Food and Drug Administration regarding storage, retrievability (i.e., how the records are indexed and what intraagency uses are made of the records), access controls, retention, and disposal of the records in that system.
(7) The title and business address of the official who is responsible for the system of records.
(8) The notification procedure, i.e., the address of the FDA Privacy Act Coordinator, whom any individual can contact to seek notification whether the system contains a record about him/her.
(9) The record access and contest procedures, which shall be the same as the notification procedure except that a reference shall be included to any exemption from access and contest.
(10) Where any records in the system are subject to an exemption under $ 21.61, a reference to this exemption.
(11) The categories of sources of records in the system. [42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981)
§ 21.10 Policy concerning records
about individuals. Information about individuals in Food and Drug Administration records shall be collected, maintained, used, and disseminated so as to protect the right to privacy of the individual to the fullest possible extent consistent with laws relating to disclosure of information to the general public, the law enforcement responsibilities of the agency, and administrative and program management needs.
Subpart B-Food and Drug Ad
ministration Privacy Act Record Systems
$ 21.20 Procedures for notice of Food
and Drug Administration Privacy
Act Record Systems. (a) The Food and Drug Administration shall issue in the FEDERAL REGISTER on or before August 30 of each year a notice concerning each Privacy
$ 21.21 Changes in systems and new
systems. (a) The Food and Drug Administration shall notify the designated Department official, the Office of Management and Budget (Information Systems Division), and the Congress of
proposals to change or establish Privacy Act Record Systems in accordance with procedures of the Department and the Office of Management and Budget.
(b) The Food and Drug Administration shall issue a notice, in accordance with paragraph (d) of this section and $21.20(b), of any change in a Privacy Act Record System which:
(1) Increases the number or types of individuals about whom records are maintained;
(2) Expands the type or amount of information about individuals that is maintained;
(3) Increases the number of categories of agencies or other persons who may have access to those records;
(4) Alters the manner in which the records are organized so as to change the nature or scope of those records, such as the combining of two or more existing systems;
(5) Modifies the way in which the system operates or its location(s) in a manner that alters the process by which individuals can exercise their rights under this part, such as the ways in which they seek access or request amendment of a record; or
(6) Changes the equipment configuration on which the system is operated so as to create the potential for greater access, such as adding a telecommunications capability.
(c) The Food and Drug Administration shall issue a notice of its intention to establish new Privacy Act Record Systems in accordance with paragraph (d) of this section and $21.20(b).
(d) Notices under paragraphs (b) and (c) of this section shall be published in the FEDERAL REGISTER for comment at least 30 days prior to implementation of the proposed changes or establishment of new systems. Interested persons shall have the opportunity to submit written data, views, or arguments on such proposed new uses or systems.
Drug Administration functions, from which information is retrieved by individual names or other personal identifiers, may be subject to the provisions of this part. If the contract is agreed to
or after September 27, 1975, the criminal penalties set forth in 5 U.S.C. 552a(i) are applicable to such tractor, and any employee of such contractor, for disclosures prohibited in $21.71 or for maintenance of a system of records without notice as required in $21.20.
(b) A contract is considered to accomplish a Food and Drug Administration function if the proposal or activity it supports is principally operated on behalf of and is under the direct management of the Food and Drug Administration. Systems of records from which information is retrieved by individual names or other personal identifiers and that are operated under contracts to accomplish Food and Drug Administration functions are deemed to be maintained by the agency and shall be subject to the procedures and requirements of this part.
(c) A contract is not considered to accomplish a Food and Drug Administration function if the program or activity it supports is not principally operated on behalf of, or is not under the direct management of, the Food and Drug Administration. For example, this part does not apply to systems of records:
(1) Operated under contract with the Food and Drug Administration by State or local government agencies, or organizations representing such agencies, when such agencies or organizations are also performing State or local government functions.
(2) Operated by contractors with the Food and Drug Administration by individuals or organizations whose primary function is delivery of health services, such as hospitals, physicians, pharmacists, and other health professionals, and that report information concerning products, e.g., injuries or product defects, to the Food and Drug Administration. Before such contractors submit information to the Food and Drug Administration, the names and other personal identifiers of patients or research subjects in any medical or similar report, test, study, or other research project shall be deleted,
Subpart C-Requirements for Specific Categories of Records
$ 21.30 Records of contractors.
(a) Systems of records that are required to be operated, or as a matter of practical necessity must be operated, by contractors to accomplish Food and