21 CFR 21.45 - Fees. | Title 21 - Food and Drugs | Code of Federal Regulations

prev | next

§ 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 made to provide access to the record, e.g., computer printout where no 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.

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

Title 21 published on 2012-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2013-01-15; vol. 78 # 10 - Tuesday, January 15, 2013

78 FR 2892 - Privacy Act, Exempt Record System; Withdrawal

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-00723
RIN
Docket No.	FDA-2011-N-0252

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary

Direct final rule; withdrawal.

Effective Date: The direct final rule published at 77 FR 51910, August 28, 2012, is withdrawn effective January 10, 2013.

21 CFR Part 21

Summary

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing the direct final rule that August 28, 2012. HHS/FDA published the direct final rule to exempt scientific research misconduct proceedings records from certain requirements of the Privacy Act of 1974 in order to protect records compiled in the course of misconduct inquiries and investigations, and to safeguard the identity of confidential sources. The comment period closed on November 13, 2012. HHS/FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

2012-08-28; vol. 77 # 167 - Tuesday, August 28, 2012

77 FR 51910 - Privacy Act, Exempt Record System

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-20889
RIN
Docket No.	FDA-2011-N-0252

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary

Direct final rule.

This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date.

21 CFR Part 21

Summary

The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 552 - Public information; agency rules, opinions, orders, records, and proceedings

§ 552a - Records maintained on individuals

USC : Title 21 - FOOD AND DRUGS

§ 371 - Regulations and hearings

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 21 after this date.

2013-01-15; vol. 78 # 10 - Tuesday, January 15, 2013

78 FR 2892 - Privacy Act, Exempt Record System; Withdrawal

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-00723
RIN
Docket No.	FDA-2011-N-0252

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary

Direct final rule; withdrawal.

Effective Date: The direct final rule published at 77 FR 51910, August 28, 2012, is withdrawn effective January 10, 2013.

21 CFR Part 21

Summary

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing the direct final rule that August 28, 2012. HHS/FDA published the direct final rule to exempt scientific research misconduct proceedings records from certain requirements of the Privacy Act of 1974 in order to protect records compiled in the course of misconduct inquiries and investigations, and to safeguard the identity of confidential sources. The comment period closed on November 13, 2012. HHS/FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

2012-08-28; vol. 77 # 167 - Tuesday, August 28, 2012

77 FR 51910 - Privacy Act, Exempt Record System

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-20889
RIN
Docket No.	FDA-2011-N-0252

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary

Direct final rule.

This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date.

21 CFR Part 21

Summary

The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.

77 FR 51949 - Privacy Act, Exempt Record System

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-20890
RIN
Docket No.	FDA-2011-N-0252

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary

Proposed rule.

Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives any significant adverse comments, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. HHS/FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.

21 CFR Part 21

Summary

The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA proposes to exempt this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations.

21 CFR 21.45 - Fees.

CFR Toolbox

Law about... Articles from Wex

Find a Lawyer

Get Involved