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Federal law — U.S. Code and appendices · legal_authorities
In division B, the term “competitive procedures” means procedures under which an agency enters into a contract pursuant to full and open competition.
Source: Supplied U.S. Code snapshot — release unconfirmed · 41 U.S.C. § 132
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Source file: Laws/federal/codes/united-states-code/title-41/section-132-competitive-procedures--14fedf5570.md
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Source location: Title 41, Chapter 1, § 132; chapter-001-chapter-1.md
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Authorized expenses for administration** Except as provided in subsection (b), the Secretary of the Interior may use available amounts under [section 669c(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title16-section669c/a/1&num=0&edition=prelim) only for expenses for administration that directly support the implementation of this chapter that consist of— (1) personnel costs of employees for the work hours of each employee spent directly administering this chapter, as those hours are certified by the supervisor of the employee; (2) support costs directly associated with personnel costs authorized under paragraph (1), excluding costs associated with staffing and operation of regional offices of the United States Fish and Wildlife Service and the Department of the Interior other than for the purposes of this chapter; (3) costs of determining under [section 669e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title16-section669e/a&num=0&edition=prelim) whether State comprehensive plans and projects are substantial in character and design; (4) overhead costs, including the costs of general administrative services, that are directly attributable to administration of this chapter and are based on— (A) actual costs, as determined by a direct cost allocation methodology approved by the Director of the Office of Management and Budget for use by Federal agencies; and (B) in the case of costs that are not determinable under subparagraph (A), an amount per employee authorized under paragraph (1) that does not exceed the amount charged or assessed for costs per full-time equivalent employee for any other division or program of the United States Fish and Wildlife Service; (5) costs incurred in auditin
Source: Supplied U.S. Code snapshot — release unconfirmed · 16 U.S.C. § 669h
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Authorized expenses for administration** Except as provided in subsection (b), the Secretary of the Interior may use available amounts under [section 777c(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title16-section777c/b&num=0&edition=prelim) only for expenses for administration that directly support the implementation of this chapter that consist of— (1) personnel costs of employees for the work hours of each employee spent directly administering this chapter, as those hours are certified by the supervisor of the employee; (2) support costs directly associated with personnel costs authorized under paragraph (1), excluding costs associated with staffing and operation of regional offices of the United States Fish and Wildlife Service and the Department of the Interior other than for the purposes of this chapter; (3) costs of determining under [section 777e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title16-section777e/a&num=0&edition=prelim) whether State comprehensive plans and projects are substantial in character and design; (4) overhead costs, including the costs of general administrative services, that are directly attributable to administration of this chapter and are based on— (A) actual costs, as determined by a direct cost allocation methodology approved by the Director of the Office of Management and Budget for use by Federal agencies; and (B) in the case of costs that are not determinable under subparagraph (A), an amount per employee authorized under paragraph (1) that does not exceed the amount charged or assessed for costs per full-time equivalent employee for any other division or program of the United States Fish and Wildlife Service; (5) costs incurred in auditing, ev
Source: Supplied U.S. Code snapshot — release unconfirmed · 16 U.S.C. § 777h
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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
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Contract** (1) **In general** — For purposes of activities conducted under this chapter, the Secretary shall identify and have in effect a contract with a consensus-based entity, such as the National Quality Forum, that meets the requirements described in subsection (c). Such contract shall provide that the entity will perform the duties described in subsection (b). (2) **Timing for first contract** — As soon as practicable after July 15, 2008, the Secretary shall enter into the first contract under paragraph (1). (3) **Period of contract** — A contract under paragraph (1) shall be for a period of 4 years (except as may be renewed after a subsequent bidding process). (4) **Competitive procedures** — Competitive procedures (as defined in [section 132 of title 41](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section132&num=0&edition=prelim)) shall be used to enter into a contract under paragraph (1). **(b) Duties** The duties described in this subsection are the following: (1) **Priority setting process** — The entity shall synthesize evidence and convene key stakeholders to make recommendations, with respect to activities conducted under this chapter, on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In making such recommendations, the entity shall— (A) ensure that priority is given to measures— (i) that address the health care provided to patients with prevalent, high-cost chronic diseases; (ii) with the greatest potential for improving the quality, efficiency, and patient-centeredness of health care; and (iii) that may be implemented rapidly due to existing evidence, standards of care, or other reasons; and (B) take into account measures that—
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395lll
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment of PDP regions; service areas** (1) **Coverage of entire PDP region** — The service area for a prescription drug plan shall consist of an entire PDP region established under paragraph (2). (2) **Establishment of PDP regions** (A) *In general* — The Secretary shall establish, and may revise, PDP regions in a manner that is consistent with the requirements for the establishment and revision of MA regions under subparagraphs (B) and (C) of [section 1395w–27a(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–27a/a/2&num=0&edition=prelim). (B) *Relation to MA regions* — To the extent practicable, PDP regions shall be the same as MA regions under [section 1395w–27a(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–27a/a/2&num=0&edition=prelim). The Secretary may establish PDP regions which are not the same as MA regions if the Secretary determines that the establishment of different regions under this part would improve access to benefits under this part. (C) *Authority for territories* — The Secretary shall establish, and may revise, PDP regions for areas in States that are not within the 50 States or the District of Columbia. (3) **National plan** — Nothing in this subsection shall be construed as preventing a prescription drug plan from being offered in more than one PDP region (including all PDP regions). **(b) Submission of bids, premiums, and related information** (1) **In general** — A PDP sponsor shall submit to the Secretary information described in paragraph (2) with respect to each prescription drug plan it offers. Such information shall be submitted at the same time and in a similar manner to the manner in which information de
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395w–134
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** (1) **Authority** — The Secretary shall establish, by order, appropriate Federal manufactured home construction and safety standards, each of which— (A) shall— (i) be reasonable and practical; (ii) meet high standards of protection consistent with the purposes of this chapter; and (iii) be performance-based and objectively stated, unless clearly inappropriate; and (B) except as provided in subsection (b), shall be established in accordance with the consensus standards development process. (2) **Consensus standards and regulatory development process** (A) *Initial agreement* — Not later than 180 days after December 27, 2000, the Secretary shall enter into a contract with an administering organization. The contractual agreement shall— (i) terminate on the date on which a contract is entered into under subparagraph (B); and (ii) require the administering organization to— (I) recommend the initial members of the consensus committee under paragraph (3); (II) administer the consensus standards development process until the termination of that agreement; and (III) administer the consensus development and interpretation process for procedural and enforcement regulations and regulations specifying the permissible scope and conduct of monitoring until the termination of that agreement. (B) *Competitively procured contract* — Upon the expiration of the 4-year period beginning on the date on which all members of the consensus committee are appointed under paragraph (3), the Secretary shall, using competitive procedures (as such term is defined in [section 132 of title 41](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section132&num=0&edition=prelim)), enter into a competitively
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 5403
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Federal law — U.S. Code and appendices · legal_authorities
Page 10 TITLE 41—PUBLIC CONTRACTS § 131 HISTORICAL AND REVISION NOTES—CONTINUED Revised Section Source (U.S. Code) Source (Statutes at Large) 41:403(8). Pub. L. 93–400, § 4(8), for- merly § 4(9), as added Pub. L. 98–577, title I, § 102(3), Oct. 30, 1984, 98 Stat. 3067; redesignated as § 4(8), Pub. L. 100–679, § 3(c), Nov. 17, 1988, 102 Stat. 4056; Pub. L. 103–355, title VIII, § 8001(b)(1)–(3), Oct. 13, 1994, 108 Stat. 3386. SUBCHAPTER II—DIVISION B DEFINITIONS § 131. Acquisition In division B, the term ‘‘acquisition’’— (1) means the process of acquiring, with ap- propriated amounts, by contract for purchase or lease, property or services (including con- struction) that support the missions and goals of an executive agency, from the point at which the requirements of the executive agen- cy are established in consultation with the chief acquisition officer of the executive agen- cy; and (2) includes— (A) the process of acquiring property or services that are already in existence, or that must be created, developed, dem- onstrated, and evaluated; (B) the description of requirements to sat- isfy agency needs; (C) solicitation and selection of sources; (D) award of contracts; (E) contract performance; (F) contract financing; (G) management and measurement of con- tract performance through final delivery and payment; and (H) technical and management functions directly related to the process of fulfilling agency requirements by contract. (Pub. L. 111–350, § 3, Jan. 4, 2011, 124 Stat. 3682.) HISTORICAL AND REVISION NOTES Revised Section Source (U.S. Code) Source (Statutes at Large) 131 ............. 41:403(16). Pub. L. 93–400, § 4(16), as added Pub. L. 108–136, title XIV, § 1411, Nov. 24, 2003, 117 Stat. 1663. § 132. Competitive pro
Source: Supplied 2024 U.S. Code historical extraction · 41 U.S.C. § 132
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