Source: http://www.law.cornell.edu/uscode/text/21/360ccc-1?quicktabs_8=0
Timestamp: 2015-01-31 10:28:50
Document Index: 436089224

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 572', '§ 102', '§ 4321']

21 U.S. Code § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter V › Part F › § 360ccc–1 21 U.S. Code § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species
Establishment and content (1)
The Secretary shall establish an index limited to—
new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-food life stage of a food-producing minor species, where safety for humans is demonstrated in accordance with the standard of section 360b
(d) of this title (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance).
Conferences Any person intending to file a request under this section shall be entitled to one or more conferences to discuss the requirements for indexing a new animal drug.
Request for determination of eligibility for inclusion in index (1)
Any person may submit a request to the Secretary for a determination whether a new animal drug may be eligible for inclusion in the index. Such a request shall include—
information sufficient to support the conclusion that the proposed use of the new animal drug is safe under section 360b
(d) of this title with respect to individuals exposed to the new animal drug through its manufacture or use; and
Within 90 days after the submission of a request for a determination of eligibility for indexing based on subsection (a)(1)(A) of this section, or 180 days for a request submitted based on subsection (a)(1)(B) of this section, the Secretary shall grant or deny the request, and notify the person who requested such determination of the Secretary’s decision. The Secretary shall grant the request if the Secretary finds that—
the proposed use of the drug meets the conditions of subparagraph (A) or (B) of subsection (a)(1) of this section, as appropriate;
Request for addition to index (1)
With respect to a new animal drug for which the Secretary has made a determination of eligibility under subsection (c) of this section, the person who made such a request may ask that the Secretary add the new animal drug to the index established under subsection (a) of this section. The request for addition to the index shall include—
a copy of the Secretary’s determination of eligibility issued under subsection (c) of this section;
The report required in paragraph (1) shall—
A qualified expert panel, as used in this section, is a panel that—
Within 180 days after the receipt of a request for listing a new animal drug in the index, the Secretary shall grant or deny the request. The Secretary shall grant the request if the request for indexing continues to meet the eligibility criteria in subsection (a) of this section and the Secretary finds, on the basis of the report of the qualified expert panel and other information available to the Secretary, that the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question. If the Secretary denies the request, the Secretary shall thereafter provide due notice and the opportunity for an informal conference. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review.
Index contents; publication (1)
The index established under subsection (a) of this section shall include the following information for each listed drug—
Removal from index; suspended listing (1)
If the Secretary finds, after due notice to the person who requested the index listing and an opportunity for an informal conference, that—
If the Secretary finds that there is a reasonable probability that the use of the drug would present a risk to the health of humans or other animals, the Secretary may—
Regulations concerning exemptions for investigational use For purposes of indexing new animal drugs under this section, to the extent consistent with the public health, the Secretary shall promulgate regulations for exempting from the operation of section 360b of this title minor species new animal drugs and animal feeds bearing or containing new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of minor species animal drugs. Such regulations may, at the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable the Secretary to evaluate the safety and effectiveness of such article in the event of the filing of a request for an index listing pursuant to this section.
Labeling contents The labeling of a new animal drug that is the subject of an index listing shall state, prominently and conspicuously—
“Not approved by fda.— Legally marketed as an FDA indexed product. Extra-label use is prohibited.”;
In the case of any new animal drug for which an index listing pursuant to subsection (a) of this section is in effect, the person who has an index listing shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience, and other data or information, received or otherwise obtained by such person with respect to such drug, or with respect to animal feeds bearing or containing such drug, as the Secretary may by general regulation, or by order with respect to such listing, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (f) of this section. Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary.
Public disclosure of safety and effectiveness data (1)
Safety and effectiveness data and information which has been submitted in support of a request for a new animal drug to be indexed under this section and which has not been previously disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown—
(June 25, 1938, ch. 675, § 572, as added Pub. L. 108–282, title I, § 102(b)(4),Aug. 2, 2004, 118 Stat. 896.)
The National Environmental Policy Act of 1969, referred to in subsec. (c)(1)(E), is Pub. L. 91–190, Jan. 1, 1970, 83 Stat. 852, as amended, which is classified generally to chapter 55 (§ 4321 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 4321 of Title 42 and Tables.