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(1) Mailing a copy of the records to the requesting individual, or

(2) Permitting the requesting individual to review the records in person between 9 a.m. and 4 p.m. at the office of the FDA Privacy Act Coordinator, at the Freedom of Information Staff Public Room at the address shown in $20.30 of this chapter, or at any Food and Drug Administration field office listed in $5.115 of this chapter or at another location or time upon which the Food and Drug Administration and the individual agree. Arrangement for such review can be made by consultation between the FDA Privacy Act Coordinator and the individual. An individual seeking to review records in person shall generally be permitted access to the file copy, except that where the records include nondisclosable information, a copy shall be made of that portion of the records, with the nondisclosable information blocked out. Where the individual is not given a copy of the record to retain, no charge shall be made for the cost of copying a record to make it available to an individual who reviews a record in person under this paragraph.

(b) An individual may request that a record be disclosed to or discussed in the presence of another individual, such as an attorney. The individual may be required to furnish a written statement authorizing the disclosure or discussion in such other individual's presence.

(C) The Food and Drug Administration will make every reasonable effort to assure that records made available under this section can be understood by the individual, such as by providing an oral or written explanation of the records.

required to be disclosed to any member of the public under part 20 of this chapter (the public information regulations).

(b) An individual who appears in person for access to records about himself shall be required to provide at least one document to identify himself, e.g., driver's license, passport, or alien or voter registration card to verify his identity. If an individual does not have any such document or requests access to records about himself without appearing in person under circumstances in which his identity cannot be verified from the request itself, he shall be required to certify in writing that he is the individual he claims to be and that he understands that the knowing and willful request for or acquisition of a record pertaining to individual under false pretenses is a criminal offense subject to a $5,000 fine.

(c) In making requests under $21.75, a parent of a minor child or legal guardian of an incompetent individual may be required to verify his relationship to the minor child or the incompetent individual, in addition to verifying his own identity, by providing a copy of the minor's birth certificate, a court order, or other evidence of guardianship.

(d) Where an individual seeks access to particularly sensitive records, such as medical records, the individual may be required to provide additional information beyond that specified in paragraph (b) or (c) of this section, such as the individual's years of attendance at a particular educational institution, rank attained in the uniformed services, date or place of birth, names of parents, an occupation, or the specific times the individual received medical treatment.

(42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981)

$21.44 Verification of identity.

(a) An individual seeking access to records in a Privacy Act Record System may be required to comply with reasonable requirements to enable the Food and Drug Administration to determine his identity. The identification required shall be suitable considering the nature of the records sought. No identification shall be required to receive access to information that is

$21.45 Fees.

(a) Where applicable, fees for copying records shall be charged in accordance with the schedule set forth in this section. Fees may only be charged where an individual has requested that a copy be made of a record to which he is granted access. No fee may be charged for making a search of a Privacy Act Record System whether the search is manual, mechanical, or electronic. Where a copy of the record must be

no

made to provide access to the record, e.g., computer printout where screen reading is available, the copy shall be made available to the individual without cost. Where a medical record is made available to a representative designated by the individual under $21.33, no fee will be charged.

(b) The fee schedule is as follows:

(1) Copying of records susceptible to photocopying—$.10 per page.

(2) Copying of records not susceptible to photocopying, e.g., punch cards or magnetic tapes—at actual cost to the determined on a case-by-case basis.

(3) No charge will be made if the total amount of copying for an individual does not exceed $25.

(c) When a fee is to be assessed, the individual shall be notified prior to the processing of the copies, and be given an opportunity to amend his request. Payment shall be made by check or money order made payable to the “Food and Drug Administration,” and shall be sent to the Accounting Branch (HFA-120), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Advance deposit shall be required where the total amount exceeds $50.

(2) If the accuracy, relevancy, timeliness, or completeness of the records may be contested in any other pending or imminent agency proceeding, the Food and Drug Administration may refer the individual to the other proceeding as the appropriate means to obtain relief. If the accuracy, relevance, timeliness, or completeness of a record is, or has been, an issue in another agency proceeding, the request under this section shall be disposed of in accordance with the decision in the other proceeding, absent unusual circumstances.

(c) Requests to amend records shall be submitted, in writing, to the FDA Privacy Act Coordinator in accordance with $21.40(b). Such requests shall include information sufficient to enable the Food and Drug Administration to locate the record, a brief description of the items of information requested to be amended, and the reasons why the record should be amended together with any appropriate documentation or arguments in support of the requested amendment. An edited copy of the record showing the described amendment may be included. Verification of identity should be provided in accordance with $21.44.

(d) Written acknowledgement of the receipt of a request to amend a record shall be provided within 10 working days to the individual who requested the amendment. Such acknowledgement may request any additional information needed to verify identity or make a determination. No acknowledgement need be made if the request can be reviewed, processed, and the individual notified of the agency's agreement with the request or refusal within the 10-day period. [42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981)

[42 FR 15626, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989)

Subpart E-Procedures for Re

quests for Amendment of Records

$21.50 Procedures for submitting re

quests for amendment of records. (a) An individual who received access to a record about himself under subpart D of this part may request that the record be amended if he believes that the record or an item of information is not accurate, relevant to a Food and Drug Administration

purpose, timely, or complete.

(b) Amendments under this subpart shall not violate existing statute, regulation, or administrative procedure.

(1) This subpart does not permit alteration of evidence presented in the course of judicial proceedings or Food and Drug Administration adjudicatory or rule making proceedings or collateral attack upon that which has already been the subject of any such proceedings.

$21.51 Responses to requests for

amendment of records. (a) The Food and Drug Administration shall take one of the following actions on a request for amendment of records as promptly as possible:

(1) Amend any portion of the record which the agency has

determined, based upon a preponderance of the evidence, is not accurate, relevant to a record as amended, to all previous recipients of the record.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981)

Food and Drug Administration purpose, timely, or complete, and, in accordance with paragraph (d)(3) of this section, inform the individual and previous recipients of the record that has been amended of the amendment.

(2) Inform the individual of its refusal to amend any portion of the record in the manner requested, the reason for the refusal, and the opportunity for administrative appeal to the Commissioner of Food and Drugs. Except as provided in $21.32, such refusal may only be issued by the Associate Commissioner for Public Affairs or his or her designate.

(3) Where another agency was the source of and has control of the record, refer the request to that agency.

(b) The agency may, for good cause, extend the period for taking action an additional 30 working days if notice is provided to the individual explaining the circumstances of the delay.

(c) The officials charged with reviewing a record to determine how to respond to a request to amend it, shall assess its accuracy, relevance to a Food and Drug Administration purpose, timeliness, or completeness. The determination shall be made in the light of the purpose for which the records or system is used, the agency's need for the record, and the possible adverse consequences to the individual from the record if not amended. Whenever the Food and Drug Administration receives a request for deletion of a record, or portions of a record, it shall consider anew whether the contested information in the record is relevant and necessary to a Food and Drug Administration purpose.

(d) If the Food and Drug Administration agrees with an individual's request, it shall take the following actions:

(1) So inform the individual in writing.

(2) In accordance with statute, regulation, or procedure, amend the record to make it accurate, relevant to a Food and Drug Administration purpose, timely, or complete, making note of the date and fact of the amendment.

(3) If an accounting was made under $21.71(d) of a disclosure of the record under $21.71(a), provide a copy of the

$21.52 Administrative appeals of re

fusals to amend records. (a) If an individual disagrees with a refusal under $21.51(a)(2) to amend a record, he or she may appeal that refusal to the Commissioner of Food and Drugs, Rm. 14–71, 5600 Fishers Lane, Rockville, MD 20857.

(b) If, upon appeal, the Commissioner upholds the refusal to amend the record as requested, he shall inform the individual:

(1) Of his decision and the reasons for it.

(2) Of the individual's right to file with the Food and Drug Administration a concise statement of the individual's reasons for disagreeing with the agency's decision not to amend the record as requested.

(3) That the statement of disagreement will be made available to all persons listed in an accounting as having previously received the record and any person to whom the record is subsequently disclosed together with, in the discretion of the Food and Drug Administration, a brief statement summarizing its reasons for refusing to amend the record. Any individual who includes false information in the statement of disagreement filed with the Food and Drug Administration may be subject to penalties under 18 U.S.C. 1001, the False Reports to the Government Act.

(4) That the individual has a right to seek judicial review of the refusal to amend the record.

(c) If the Commissioner on administrative appeal or a court on judicial review determines that the record should be amended in accordance with the individual's request, the Food and Drug Administration shall proceed in accordance with $21.51(d).

(d) A final determination on the individual's administrative appeal of the initial refusal to amend the record shall be concluded within 30 working days of the request for such review statement of disagreement and the agency statement, if any.

under paragraph (a) of this section, unless the Commissioner extends such period for good cause and informs the individual in writing of the reasons for the delay and of the approximate date on which a decision of the appeal can be expected. [42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985]

of

$ 21.53 Notation and disclosure of dis

puted records. When an individual has filed a statement

disagreement under $ 21.52(b)(2), the Food and Drug Administration shall:

(a) Mark any portion of the record that is disputed to assure that the record will clearly show that portion is disputed whenever the record is disclosed.

(b) In any subsequent disclosure under $21.70 or $21.71(a), provide a copy of the statement of disagreement and, if the Food and Drug Administration deems it appropriate, a concise statement of the agency's reasons for not making the amendment(s) requested. While the individual shall have access to any such statement, it shall not be subject to a request for amendment under $21.50.

(c) If an accounting was made under $21.71(d) and (e) of a disclosure of the record under $21.71(a), provide to all previous recipients of the record a copy of the statement of disagreement and the agency statement, if any.

Subpart F-Exemptions $21.60 Policy.

It is the policy of the Food and Drug Administration that record systems should be exempted from the Privacy Act only to the extent essential to the performance of law enforcement functions under the laws that are administered and enforced by the Food and Drug Administration or that govern the agency $ 21.61 Exempt systems.

(a) Investigatory records compiled for law enforcement purposes, including criminal law enforcement purposes, in the Food and Drug Administration Privacy Act Record Systems listed in paragraph (b) of this section are exempt from the following provisions of the Privacy Act (5 U.S.C. 552a) and of this part:

(1) Such records are exempt from 5 U.S.C. 552a(c)(3) and $21.71(e)(4), requiring that an individual be provided with the accounting of disclosures of records about himself from a Privacy Act Record System.

(2) Except where access is required under 5 U.S.C. 552a(k)(2) and $21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1) through (4) and (f)) and $8 21.40 through 21.54, requiring procedures for an individual to be given notification of and access to records about himself in a Privacy Act Record System and to be allowed to challenge the accuracy, relevance, timeliness, and completeness of such records.

(3) Such records are exempt from 5 U.S.C. 552a(e)(4)(G) and (H) and § 21.20(b)(1) requiring inclusion in the notice for the system of information about agency procedures for notification, access, and contest.

(4) Such rds are exempt from 5 U.S.C. 552a(e)(3) requiring that individuals asked to supply information be provided a form outlining the authority for the request, the purposes for which the information will be used, the routine uses in the notice for the Privacy Act Record System, and the consequences to the individual of not providing the information, but only with

$ 21.54 Amended or disputed records

received from other agencies. Whenever the Food and Drug Administration is notified that a record that it received from another agency was amended or is the subject of a statement of disagreement, the Food and Drug Administration shall:

(a) Discard the record, or clearly note the amendment or the fact of disagreement in its copy of the record, and

(b) Refer persons who subsequently request the record to the agency that provided it.

(c) If an accounting was made under $ 21.71 (d) and (e) of the disclosure of the record under $21.71(a), inform all previous recipients of the record about the amendment or provide to them the

respect to records compiled by the Food and Drug Administration in a criminal law enforcement investigation where the conduct of the investigation would be prejudiced by such procedures.

(b) Records in the following Food and Drug Administration Privacy Act Record Systems that concern individuals who are subject to Food and Drug Administration enforcement action and consist of investigatory records compiled for law enforcement purposes, including criminal law enforcement purposes, are exempt under 5 U.S.C. 552a(j)(2) and (k)(2) from the provisions enumerated in paragraph (a) of this section:

(1) Bio-research Monitoring Information System-HHS/FDA/09–10_0010.

(2) Regulated Industry Employee Enforcement Records—HHS/FDA/ACMO/ 09–10-002.

(3) Employee Conduct Investigative Records—HHS/FDA/ACMO/09–10-0013.

(c) The system described in paragraph (b)(3) of this section includes investigatory records compiled solely for the purpose of determining suitability, eligibility, or qualification for Federal civilian employment, military service, Federal contracts, and access to classified information. These records are exempt from disclosure under 5 U.S.C. 552a(k)(5) to the extent that the disclosure would reveal the identity of a source who furnished information to the Government under a promise of confidentiality, which must be an express promise if the information was furnished after September 27, 1975. Any individual who is refused access to a record that would reveal a confidential source shall be advised in a general way that the record includes information that would reveal a confidential source.

cerning whether any records about him exist and request access to such records where they are retrieved by his name or other personal identifier.

(b) An individual making a request under paragraph (a) of this section;

(1) May be given access to the records where available under part 20 of this chapter (the public information regulations) or the Commissioner may, in his discretion, entertain a request under any or all of the provisions of $821.40 through 21.54; and

(2) Shall be given access upon request if the records requested are subject to 5 U.S.C. 552a(k)(2) and not to 5 U.S.C. 552a(j)(2) (i.e., because they consist of investigatory material compiled for law enforcement purposes other than criminal law enforcement purposes) and maintenance of the records resulted in denial to the individual of any right, benefit, or privilege to which he would otherwise be entitled by Federal law, or for which he would otherwise be eligible. An individual given access to a record under this paragraph (b)(2) is not entitled to seek amendment under subpart E of this part. The FDA may refuse to disclose a record that would reveal the identity of a source who furnished information to the Government under a promise of confidentiality, which must be an express promise if the information was furnished on or after September 27, 1975. Any individual refused access to a record that would reveal a confidential source shall be advised in a general way that the record contains information that would reveal a confidential source.

(c) The Commissioner shall not make available any record that is prohibited from public disclosure under $20.82(b) of this chapter.

(d) Discretionary disclosure of record pursuant to paragraph (b)(1) of this section shall not set a precedent for discretionary disclosure of a similar or related record and shall not obligate the Commissioner to exercise his discretion to disclose any other record in a system that is exempt under $21.61.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985]

a

$ 21.65 Access to records in exempt

systems. (a) Where a Privacy Act Record System is exempt and the requested records are unavailable under $21.61, an individual may nevertheless make a request under $21.40 for notification con

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