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21 U.S.C. § 355–2 — Actions for delays of generic drugs and biosimilar biological products
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section—
(1) the term “commercially reasonable, market-based terms” means—
(A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in [section 1395w–3a(c)(6)(B) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–3a/c/6/B&num=0&edition=prelim);
(B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and
(C) no additional conditions are imposed on the sale of the covered product;
(2) the term “covered product”—
(A) means—
(i) any drug approved under subsection (c) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or biological product licensed under subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim);
(ii) any combination of a drug or biological product described in clause (i); or
(iii) when reasonably necessary to support approval of an application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and
(B) does not include any drug or biologica
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Stable record: federal_law:legal_authorities:record_usc_94ad7d8f74f33538cf95d21a
Source file: Laws/federal/codes/united-states-code/title-21/section-3552-actions-for-delays-of-generic-drugs-and-biosimilar-biological-products--95d68130ce.md
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Source location: Title 21, Chapter 9, § 355–2; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section—
(1) the term “commercially reasonable, market-based terms” means—
(A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in [section 1395w–3a(c)(6)(B) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–3a/c/6/B&num=0&edition=prelim);
(B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and
(C) no additional conditions are imposed on the sale of the covered product;
(2) the term “covered product”—
(A) means—
(i) any drug approved under subsection (c) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or biological product licensed under subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim);
(ii) any combination of a drug or biological product described in clause (i); or
(iii) when reasonably necessary to support approval of an application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and
(B) does not include any drug or biological product that appears on the drug shortage list in effect under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim), unless—
(i) the drug or biological product has been on the drug shortage list in effect under such [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim) continuously for more than 6 months; or
(ii) the Secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage.
(3) the term “device” has the meaning given the term in [section 321 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim);
(4) the term “eligible product developer” means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or for licensing pursuant to an application under [section 262(k) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/k&num=0&edition=prelim);
(5) the term “license holder” means the holder of an application approved under subsection (c) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or the holder of a license under subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a covered product;
(6) the term “REMS” means a risk evaluation and mitigation strategy under [section 355–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355-1&num=0&edition=prelim);
(7) the term “REMS with ETASU” means a REMS that contains elements to assure safe use under [section 355–1(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355–1/f&num=0&edition=prelim);
(8) the term “Secretary” means the Secretary of Health and Human Services;
(9) the term “single, shared system of elements to assure safe use” means a single, shared system of elements to assure safe use under [section 355–1(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355–1/f&num=0&edition=prelim); and
(10) the term “sufficient quantities” means an amount of a covered product that the eligible product developer determines allows it to—
(A) conduct testing to support an application under—
(i) subsection (b)(2) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim); or
(ii) [section 262(k) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/k&num=0&edition=prelim); and
(B) fulfill any regulatory requirements relating to approval of such an application.
**(b) Civil action for failure to provide sufficient quantities of a covered product**
(1) **In general** — An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms.
(2) **Elements**
(A) *In general* — To prevail in a civil action brought under paragraph (1), an eligible product developer shall prove, by a preponderance of the evidence—
(i) that—
(I) the covered product is not subject to a REMS with ETASU; or
(II) if the covered product is subject to a REMS with ETASU—
(aa) the eligible product developer has obtained a covered product authorization from the Secretary in accordance with subparagraph (B); and
(bb) the eligible product developer has provided a copy of the covered product authorization to the license holder;
(ii) that, as of the date on which the civil action is filed, the eligible product developer has not obtained sufficient quantities of the covered product on commercially reasonable, market-based terms;
(iii) that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder, and such request—
(I) was sent to a named corporate officer of the license holder;
(II) was made by certified or registered mail with return receipt requested;
(III) specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual; and
(IV) specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product; and
(iv) that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable, market-based terms—
(I) for a covered product that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered product; and
(II) for a covered product that is subject to a REMS with ETASU, by 31 days after the later of—
(aa) the date on which the license holder received the request for the covered product; or
(bb) the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with subparagraph (B).
(B) *Authorization for covered product subject to a REMS with ETASU*
(i) *Request* — An eligible product developer may submit to the Secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU.
(ii) *Authorization* — Not later than 120 days after the date on which a request under clause (i) is received, the Secretary shall, by written notice, authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU for purposes of—
(I) development and testing that does not involve human clinical trials, if the eligible product developer has agreed to comply with any conditions the Secretary determines necessary; or
(II) development and testing that involves human clinical trials, if the eligible product developer has—
(aa)
(AA) submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered product; or
(BB) otherwise satisfied the Secretary that such protections will be provided; and
(bb) met any other requirements the Secretary may establish.
(iii) *Notice* — A covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the REMS for the covered product.
(3) **Affirmative defense** — In a civil action brought under paragraph (1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—
(A) that, on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder—
(i) neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered product; and
(ii) neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable, market-based terms;
(B) that—
(i) the license holder sells the covered product through agents, distributors, or wholesalers;
(ii) the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered products to eligible product developers; and
(iii) the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or
(C) that the license holder made an offer to the individual specified pursuant to paragraph (2)(A)(iii)(III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms—
(i) for a covered product that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 7 days after the date on which the eligible product developer received such offer from the license holder; or
(ii) for a covered product that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered product, and the eligible product developer did not accept such offer by the date that is 10 days after the date on which the eligible product developer received such offer from the license holder.
(4) **Remedies**
(A) *In general* — If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—
(i) order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;
(ii) award to the eligible product developer reasonable attorney’s fees and costs of the civil action; and
(iii) award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—
(I) that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or
(II) that the license holder failed to comply with an order issued under clause (i).
(B) *Maximum monetary amount* — A monetary amount awarded under subparagraph (A)(iii) shall not be greater than the revenue that the license holder earned on the covered product during the period—
(i) beginning on—
(I) for a covered product that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or
(II) for a covered product that is subject to a REMS with ETASU, the date that is 31 days after the later of—
(aa) the date on which the license holder received the request; or
(bb) the date on which the license holder received a copy of the covered product authorization issued by the Secretary in accordance with paragraph (2)(B); and
(ii) ending on the date on which the eligible product developer received sufficient quantities of the covered product.
(C) *Avoidance of delay* — The court may issue an order under subparagraph (A)(i) before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause (ii) or (iii) of subparagraph (A), or the amount of any such award.
**(c) Limitation of liability** A license holder for a covered product shall not be liable for any claim under Federal, State, or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered product by the eligible product developer.
**(d) Omitted**
**(e) Rule of construction**
(1) **Definition** — In this subsection, the term “antitrust laws”—
(A) has the meaning given the term in subsection (a) of [section 12 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section12&num=0&edition=prelim); and
(B) includes [section 45 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section45&num=0&edition=prelim) to the extent that such section applies to unfair methods of competition.
(2) **Antitrust laws** — Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.
**(f) Omitted**
**(g) Rule of construction** Nothing in this section, the amendments made by this section, or in [section 355–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355-1&num=0&edition=prelim), shall be construed as—
(1) prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this section; or
(2) in any way negating the applicability of a REMS with ETASU, as otherwise required under such [section 355–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355-1&num=0&edition=prelim), with respect to such covered product.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a)** “Antitrust laws,” as used herein, includes the Act entitled “An Act to protect trade and commerce against unlawful restraints and monopolies,” approved July second, eighteen hundred and ninety; sections seventy-three to seventy-six, inclusive, of an Act entitled “An Act to reduce taxation, to provide revenue for the Government, and for other purposes,” of August twenty-seventh, eighteen hundred and ninety-four; an Act entitled “An Act to amend sections seventy-three and seventy-six of the Act of August twenty-seventh, eighteen hundred and ninety-four, entitled ‘An Act to reduce taxation, to provide revenue for the Government, and for other purposes,’ ” approved February twelfth, nineteen hundred and thirteen; and also this Act.“Commerce,” as used herein, means trade or commerce among the several States and with foreign nations, or between the District of Columbia or any Territory of the United States and any State, Territory, or foreign nation, or between any insular possessions or other places under the jurisdiction of the United States, or between any such possession or place and any State or Territory of the United States or the District of Columbia or any foreign nation, or within the District of Columbia or any Territory or any insular possession or other place under the jurisdiction of the United States: Provided, That nothing in this Act contained shall apply to the Philippine Islands. The word “person” or “persons” wherever used in this Act shall be deemed to include corporations and associations existing under or authorized by the laws of either the United States, the laws of any of the Territories, the laws of any State, or the laws of any foreign country.
**(b)** This Act may be cited as the “Clayton Act”.
Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 12
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Declaration of unlawfulness; power to prohibit unfair practices; inapplicability to foreign trade**
(1) Unfair methods of competition in or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are hereby declared unlawful.
(2) The Commission is hereby empowered and directed to prevent persons, partnerships, or corporations, except banks, savings and loan institutions described in [section 57a(f)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section57a/f/3&num=0&edition=prelim), Federal credit unions described in [section 57a(f)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section57a/f/4&num=0&edition=prelim), common carriers subject to the Acts to regulate commerce, air carriers and foreign air carriers subject to part A of subtitle VII of title 49, and persons, partnerships, or corporations insofar as they are subject to the Packers and Stockyards Act, 1921, as amended [[7 U.S.C. 181](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section181&num=0&edition=prelim) et seq.], except as provided in section 406(b) of said Act [[7 U.S.C. 227(b)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section227/b&num=0&edition=prelim)], from using unfair methods of competition in or affecting commerce and unfair or deceptive acts or practices in or affecting commerce.
(3) This subsection shall not apply to unfair methods of competition involving commerce with foreign nations (other than import commerce) unless—
(A) such methods of competition have a direct, substantial, and reasonably foreseeable effect—
(i) on commerce which is not commerce with foreign nations, or on import commerce with foreign nations; or
Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 45
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
**(b) Contents** For each drug on such list, the Secretary shall include the following information:
(1) The name of the drug in shortage, including the National Drug Code number for such drug.
(2) The name of each manufacturer of such drug.
(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:
(A) Requirements related to complying with good manufacturing practices.
(B) Regulatory delay.
(C) Shortage of an active ingredient.
(D) Shortage of an inactive ingredient component.
(E) Discontinuance of the manufacture of the drug.
(F) Delay in shipping of the drug.
(G) Demand increase for the drug.
(4) The estimated duration of the shortage as determined by the Secretary.
**(c) Public availability**
(1) **In general** — Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
(2) **Trade secrets and confidential information** — Nothing in this section alters or amends [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) or [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim).
(3) **Public health exception** — The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or [section 356c(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/c&num=0&edition=prelim) if the Secretary determines that disclosure of such information would advers
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356e
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Not later than 90 days after March 23, 2010, the Secretary shall establish a temporary high risk health insurance pool program to provide health insurance coverage for eligible individuals during the period beginning on the date on which such program is established and ending on January 1, 2014.
**(b) Administration**
(1) **In general** — The Secretary may carry out the program under this section directly or through contracts to eligible entities.
(2) **Eligible entities** — To be eligible for a contract under paragraph (1), an entity shall—
(A) be a State or nonprofit private entity;
(B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and
(C) agree to utilize contract funding to establish and administer a qualified high risk pool for eligible individuals.
(3) **Maintenance of effort** — To be eligible to enter into a contract with the Secretary under this subsection, a State shall agree not to reduce the annual amount the State expended for the operation of one or more State high risk pools during the year preceding the year in which such contract is entered into.
**(c) Qualified high risk pool**
(1) **In general** — Amounts made available under this section shall be used to establish a qualified high risk pool that meets the requirements of paragraph (2).
(2) **Requirements** — A qualified high risk pool meets the requirements of this paragraph if such pool—
(A) provides to all eligible individuals health insurance coverage that does not impose any preexisting condition exclusion with respect to such coverage;
(B) provides health insurance coverage—
(i) in which the issuer’s share of the total allowed costs of benefits provided under such co
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 18001
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.