21 USC § 360dd - Open protocols for investigations of drugs for rare diseases or conditions

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If a drug is designated under section 360bb of this title as a drug for a rare disease or condition and if notice of a claimed exemption under section 355 (i) of this title or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.

Source

(June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a),Jan. 4, 1983, 96 Stat. 2051.)

The table below lists the classification updates, since Jan. 7, 2011, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Friday, May 13, 2011

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

How To Use

Multiple entries for a section are listed most recent first, within the section.

The Session Year indicates which session of Congress was responsible for the changes classified. The Congress number forms the first part of the Public Law number; each Congress has two sessions.

Abbreviations used in the Description of Change column:

An empty field implies a standard amendment.
"new" means a new section or new note, or all new text of an existing section or note.
"nt" means note.
"nt [tbl]" means note [table].
"prec" means preceding.
"fr" means a transfer from another section.
"to" means a transfer to another section.
"omitted" means the section is omitted.
"repealed" means the section is repealed.
"nt ed change" and "ed change" - See the Editorial Classification Change Table [pdf].

The Public Law field is linked to the development of the law in the Thomas system at the Library of Congress.

The Statutes at Large field is linked to the text of the law, in the context of its volume of the Statutes at Large, at the Government Printing Office. Please note that it takes a while for these pages to get posted, so for very recent legislation, you need to look at the "enrolled" version at the Thomas site.

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Sections with change type "new" are a special case, still under development. All are now listed, at the title level only.

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General Reference

Refer to the LRC (Law Revision Council) for explanations about the US Code from the folks who put it all together.

You can look for information about what it is and is not, which titles are positive law, the schedule of Supplements, etc. Under download you can find the source data we use here (GPO locator files), as well as, PDF files that look just like the paper books (these may be rather large).

Refer to the Thomas site for changes that have not yet made it into the classification tables.

21 USC	Description of Change	Session Year	Public Law	Statutes at Large

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

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.

21 CFR - Title 21—Food and Drugs

21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR 20 - PUBLIC INFORMATION

21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR 316 - ORPHAN DRUGS

21 CFR 5 - ORGANIZATION

21 CFR 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

21 CFR 7 - ENFORCEMENT POLICY

21 USC § 360dd - Open protocols for investigations of drugs for rare diseases or conditions

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