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21 U.S.C. § 399i — Food and Drug Administration Working Capital Fund
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** There is hereby established in the Treasury of the United States a Working Capital Fund (the Fund) to be administered by the Food and Drug Administration (FDA), without fiscal year limitation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the purchase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, the needs of the FDA and requisitions of other Government Offices, and (2) such other services as the Commissioner of the FDA, subject to review by the Secretary of Health and Human Services, determines may be performed more advantageously as central services. The Fund shall be reimbursed from applicable discretionary resources, notwithstanding any otherwise applicable purpose limitations, available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated or actual charges for personal services, materials, equipment, information technology, and other expenses. Charges for equipment and information technology shall include costs associated with maintenance, repair, and depreciation (including improvement and replacement).
**(b) Appropriations** Of any discretionary resources appropriated in this Act for fiscal year 2018 for “Department of Health and Human Services, Food and Drug Administration, Salaries and Expenses”, not to exceed $5,000,000 of amounts available as of September 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable purpose limitations.
**(c) Emergency funds excluded** No amounts may be transferred pursuant
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Source file: Laws/federal/codes/united-states-code/title-21/section-399i-food-and-drug-administration-working-capital-fund--0592da91b6.md
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Source location: Title 21, Chapter 9, § 399i; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** There is hereby established in the Treasury of the United States a Working Capital Fund (the Fund) to be administered by the Food and Drug Administration (FDA), without fiscal year limitation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the purchase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, the needs of the FDA and requisitions of other Government Offices, and (2) such other services as the Commissioner of the FDA, subject to review by the Secretary of Health and Human Services, determines may be performed more advantageously as central services. The Fund shall be reimbursed from applicable discretionary resources, notwithstanding any otherwise applicable purpose limitations, available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated or actual charges for personal services, materials, equipment, information technology, and other expenses. Charges for equipment and information technology shall include costs associated with maintenance, repair, and depreciation (including improvement and replacement).
**(b) Appropriations** Of any discretionary resources appropriated in this Act for fiscal year 2018 for “Department of Health and Human Services, Food and Drug Administration, Salaries and Expenses”, not to exceed $5,000,000 of amounts available as of September 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable purpose limitations.
**(c) Emergency funds excluded** No amounts may be transferred pursuant to this section that are designated by the Congress as an emergency requirement pursuant to a concurrent resolution on the budget or the Balanced Budget and Emergency Deficit Control Act of 1985.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Enforcement in House of Representatives** It shall not be in order in the House of Representatives to consider a rule or order that waives the application of [section 658d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title2-section658d&num=0&edition=prelim).
**(b) Disposition of points of order**
(1) **Application to House of Representatives** — This subsection shall apply only to the House of Representatives.
(2) **Threshold burden** — In order to be cognizable by the Chair, a point of order under [section 658d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title2-section658d&num=0&edition=prelim) or subsection (a) of this section must specify the precise language on which it is premised.
(3) **Question of consideration** — As disposition of points of order under [section 658d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title2-section658d&num=0&edition=prelim) or subsection (a) of this section, the Chair shall put the question of consideration with respect to the proposition that is the subject of the points of order.
(4) **Debate and intervening motions** — A question of consideration under this section shall be debatable for 10 minutes by each Member initiating a point of order and for 10 minutes by an opponent on each point of order, but shall otherwise be decided without intervening motion except one that the House adjourn or that the Committee of the Whole rise, as the case may be.
(5) **Effect on amendment in order as original text** — The disposition of the question of consideration under this subsection with respect to a bill or joint resolution shall be considered also to determine the question of consideration under this subsection with respect to an amendm
Source: Supplied U.S. Code snapshot — release unconfirmed · 2 U.S.C. § 661
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Omitted**
**(b) General statement of budget enforcement through sequestration** This subchapter provides for budget enforcement as called for in House Concurrent Resolution 84 (105th Congress, 1st session).
**(c) Definitions** As used in this subchapter:
(1) The terms “budget authority”, “new budget authority”, “outlays”, and “deficit” have the meanings given to such terms in section 3 of the Congressional Budget and Impoundment Control Act of 1974 [[2 U.S.C. 622](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title2-section622&num=0&edition=prelim)] and “discretionary spending limit” shall mean the amounts specified in [section 901 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title2-section901&num=0&edition=prelim).
(2) The terms “sequester” and “sequestration” refer to or mean the cancellation of budgetary resources provided by discretionary appropriations or direct spending law.
(3) The term “breach” means, for any fiscal year, the amount (if any) by which new budget authority or outlays for that year (within a category of discretionary appropriations) is above that category’s discretionary spending limit for new budget authority or outlays for that year, as the case may be.
(4)
(A) The term “nonsecurity category” means all discretionary appropriations not included in the security category defined in subparagraph (B).
(B) The term “security category” includes discretionary appropriations associated with agency budgets for the Department of Defense, the Department of Homeland Security, the Department of Veterans Affairs, the National Nuclear Security Administration, the intelligence community management account (95–0401–0–1–054), and all budget accounts in budget function 150 (international affairs).
(C
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** This subchapter shall not apply to the credit or insurance activities of the Federal Deposit Insurance Corporation, National Credit Union Administration, Resolution Trust Corporation, Pension Benefit Guaranty Corporation, National Flood Insurance, National Insurance Development Fund, Crop Insurance, or Tennessee Valley Authority.
**(b) Study** The Director and the Director of the Congressional Budget Office shall each study whether the accounting for Federal deposit insurance programs should be on a cash basis on the same basis as loan guarantees, or on a different basis. Each Director shall report findings and recommendations to the President and the Congress on or before May 31, 1991.
**(c) Access to data** For the purposes of subsection (b), the Office of Management and Budget and the Congressional Budget Office shall have access to all agency data that may facilitate these studies.
Source: Supplied U.S. Code snapshot — release unconfirmed · 2 U.S.C. § 621
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** The receipts and disbursements of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and the taxes imposed under sections 1401 and 3101 of the Internal Revenue Code of 1986 shall not be included in the totals of the budget of the United States Government as submitted by the President or of the congressional budget and shall be exempt from any general budget limitation imposed by statute on expenditures and net lending (budget outlays) of the United States Government.
**(b)** No provision of law enacted after December 12, 1985 (other than a provision of an appropriation Act that appropriated funds authorized under this chapter as in effect on December 12, 1985) may provide for payments from the general fund of the Treasury to any Trust Fund specified in subsection (a) or for payments from any such Trust Fund to the general fund of the Treasury.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 911
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Federal law — U.S. Code and appendices · legal_authorities
Page 717
TITLE 21—FOOD AND DRUGS
§ 399i
Congress on the role of the Food and Drug Ad-
ministration in supporting advanced and con-
tinuous pharmaceutical manufacturing, in-
cluding—
(A) a national framework of principles re-
lated to the implementation of advanced and
continuous pharmaceutical manufacturing;
(B) a plan for the development of Federal
regulations and guidance to support and fa-
cilitate the incorporation of advanced or
continuous manufacturing into the develop-
ment of pharmaceuticals;
(C) a plan for development of Federal regu-
lations or guidance related to the review of
advanced and continuous pharmaceutical
manufacturing, including how such manu-
facturing practices may be incorporated into
the review of medical product applications;
and
(D) a summary of relevant feedback re-
lated to improving advanced and continuous
pharmaceutical
manufacturing
solicited
from the public, which may include other in-
stitutions of higher education, nonprofit or-
ganizations, and large and small pharma-
ceutical manufacturers, including generic
and nonprescription manufacturers, and con-
tract manufacturers, and other relevant en-
tities.
(h) Definitions
In this section:
(1) Advanced and continuous pharmaceutical
manufacturing
The term ‘‘advanced and continuous phar-
maceutical manufacturing’’ refers to a method
of pharmaceutical manufacturing, or a com-
bination of pharmaceutical manufacturing
methods—
(A) that incorporates a novel technology,
or uses an established technique or tech-
nology in a new or innovative way, that en-
hances drug quality or improves the manu-
facturing process for a drug, including proc-
esses that may apply to advanced therapies
and the production of biological products,
such as cell and gene therapies; or
(B) for
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 399i
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