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108hr5252ih
(2) Investigation For purposes of this section, the term investigation means a clinical investigation within the meaning of section 505(i) (in the case of drug), or within the meaning of section 520(g) (in the case of a device), as applicable, except that such term does not include such an investigation that does not ...
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relation to data bank on clinical trials (a) Premarket application or report If a person submits to the Secretary an application under section 505(b) or 515 or a report under section 510(k), and one or more of the investigations presented to the Secretary by the person for purposes of the application or report are in...
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the following applies: (1) The person is subject to a civil penalty— (A) in any case in which information on the investigation has not, as of the date on which the application or report is submitted to the Secretary, been submitted to the data bank described in such section 491A to the same extent as would have been re...
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information on the investigation is not submitted to the data bank to the same extent as would be required if the investigation were subject to such requirements.
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(2) If the person is subject to a civil penalty under paragraph (1), the Secretary, in addition to such penalty, may, after notice and an opportunity for a hearing, consider the person to be ineligible for any future exemptions under section 505(i) or 520(g)(2)(A) for any investigation until the information involved is...
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or an advertisement or other descriptive printed matter, for a drug or device for human use and the labeling, advertisement, or other matter refers to an investigation that is not subject to requirements under section 565 or under section 491A of the Public Health Service, and if the person was the principal investigat...
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been submitted to the data bank described in such section 491A to the same extent as would have been required as of such date if the investigation had been subject to such requirements (without regard to timeframes for the submission of information that would have applied before such date under such section); and (2) i...
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(c) Amount of civil penalty; procedure A civil penalty under subsection (a)(1) or (b) shall be not more than a total of $15,000 for all violations adjudicated in a single proceeding in the case of an individual, and $10,000 per day until the violation is corrected in the case of any other person, except that if the pe...
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Paragraphs (3) through (5) of section 303(f) apply to the imposition of such a penalty to the same extent and in the same manner as such paragraphs apply to a penalty imposed under paragraph (1) or (2) of such section. (d) Biologics license application Subsections (a) and (c) apply with respect to a biologics license ...
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(e) Definitions For purposes of this section: (1) The term investigation has the meaning given such term in section 565(g). (2) The term responsible person has the meaning given such term in section 491A(j) of the Public Health Service Act. 4.
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Rule of construction regarding authority of Secretary for public disclosure of information on clinical trials This Act and the amendments made by this Act may not be construed as limiting the authority of the Secretary of Health and Human Services to disclose to the public information on clinical trials to determine t...
108hr4509ih
1. Authorizing Board of Regents of Smithsonian Institution to Carry out Activities in Support of veritas astrophysical observatory project The Board of Regents of the Smithsonian Institution is authorized to carry out activities in support of the collaborative Very Energetic Radiation Imaging Telescope Array System (V...
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1. Eva Holtzman Post Office (a) Designation The facility of the United States Postal Service located at United States Route 1 in Ridgeway, North Carolina, shall be known and designated as the Eva Holtzman Post Office. (b) References Any reference in a law, map, regulation, document, paper, or other record of the Uni...
108hr4428ih
1. Duty free treatment for tents from certain middle eastern countries (a) Duty free treatment Notwithstanding any other provision of law, the President shall provide duty-free treatment for any eligible article from a beneficiary country designated under section 2. (b) Eligible article For purposes of this Act, the...
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Designation of eligible countries (a) In general The President shall, upon the enactment of this Act designate each country listed in subsection (d) as a beneficiary country unless, and shall thereafter withdraw such designation from any such countries if— (1) the country is listed by the United States Department of ...
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(b) Reviews Beginning 1 year after the date of the enactment of this Act, and annually thereafter, the President shall conduct a review to determine if a basis exists for withdrawing the designation of a country as a beneficiary country under this Act. In determining whether or not to withdraw such designation, the Pr...
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and government ownership of economic assets; (B) the rule of law and the right to due process, a fair trial, and equal protection under the law; (C) political pluralism, a climate free of political intimidation and restrictions on peaceful political activity, and democratic elections that meet international standards o...
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(E) economic policies that reduce poverty, increase the availability of health care and educational opportunities, expand physical infrastructure, promote the development of private enterprise, and encourage the formation of capital markets through micro-credit or other programs; (F) a system to combat corruption and b...
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and acceptable conditions of work; and (H) policies that provide a high level of environmental protection; (2) the country’s record on activities that undermine United States national security or foreign policy interests, and support of a peaceful resolution of the Israeli-Palestinian conflict; (3) whether the country ...
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(4) the country’s participation in the primary, secondary, or tertiary economic boycott of Israel; and (5) whether the country otherwise meets the eligibility criteria set forth in subsection (b)(2) of section 502 of the Trade Act of 1974 ( 19 U.S.C. 2462 ), other than subparagraph (B) of such subsection. (c) Continuin...
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(d) Countries eligible for designation The countries referred to in subsection (a) are the following countries of the greater Middle East or their successor political entities: (1) Afghanistan. (2) Algeria. (3) Azerbaijan. (4) Bahrain. (5) Bangladesh. (6) Egypt. (7) Iraq. (8) Kuwait. (9) Lebanon. (10) Morocco. (11) Om...
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(17) United Arab Emirates. (18) Yemen. (e) The Palestinian authority (1) Designation The President is authorized to designate the Palestinian Authority or its successor political entity as a beneficiary political entity which, if so designated, shall be eligible for the duty-free treatment under this Act as if it wer...
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(C) does not engage in gross violations of internationally recognized human rights, and is making continuing and verifiable progress on the protection of internationally recognized human rights, including freedom of speech and the press, freedom of peaceful assembly and association, and freedom of religion; and (D) acc...
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(f) Notification of Congress In any case in which the President withdraws the designation of a country as a beneficiary country under subsection (a) or (c), or withdraws the designation of the Palestinian Authority under subsection (d)(2), the President shall notify the Congress of such withdrawal and the reasons ther...
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or manufacture of 1 or more beneficiary countries if— (A) that article is imported directly from a beneficiary country into the customs territory of the United States; and (B) the sum of— (i) the cost or value of the materials produced in 1 or more beneficiary countries, plus (ii) the direct cost of processing operatio...
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Content For purposes of determining the percentage referred to in paragraph (1)(B), if the cost or value of materials produced in the customs territory of the United States is included with respect to an article to which this paragraph applies, an amount not to exceed 15 percent of the appraised value of the article a...
108hr4543ih
1. Short title This Act may be cited as the Post-Abortion Depression Research and Care Act. 2. Findings The Congress finds as follows: (1) About 3,000,000 women per year in the United States have an unplanned or unwanted pregnancy, and approximately 1,186,000 of these pregnancies end in elective abortion. (2) Abortio...
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They may have difficulty in bonding with new babies, become overprotective parents or develop problems in their relationship with their spouses. Problems such as eating disorders, depression and suicide attempts have also been traced to past abortions. (3) The symptoms of post-abortion depression include bouts of cryin...
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(4) Women who aborted a first pregnancy are four times more likely to report substance abuse compared to those who suffered a natural loss of their first pregnancy, and they are five times more likely to report subsequent substance abuse than women who carried to term. (5) Greater thought suppression is associated with...
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(7) Post-abortion depression often relates to the lack of understanding in society and the medical community of the complexity of post-abortion depression, and economic pressures placed on hospitals and providers are contributing factors. (8) Social pressure to have an abortion can be directly related to higher levels ...
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(10) While there have been many studies regarding the emotional aftermath of abortion, very little research has been sponsored by the National Institutes of Health. 101. Expansion and intensification of activities of national Institute of mental health (a) In general The Secretary of Health and Human Services, acting...
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(b) Coordination with other Institutes The Director of the Institute shall coordinate the activities of the Director under subsection (a) with similar activities conducted by the other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have re...
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Activities under such subsection shall include conducting and supporting the following: (1) Basic research concerning the etiology and causes of the conditions. (2) Epidemiological studies to address the frequency and natural history of the conditions and the differences among racial and ethnic groups with respect to t...
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(d) Longitudinal study (1) In general The Director of the Institute shall conduct a national longitudinal study to determine the incidence and prevalence of cases of post-abortion conditions, and the symptoms, severity, and duration of such cases, toward the goal of more fully identifying the characteristics of such ...
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(e) Authorization of appropriations For the purpose of carrying out this section, there is authorized to be appropriated $3,000,000 for each of the fiscal years 2005 through 2009. 201.
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Establishment of program of grants (a) In general The Secretary of Health and Human Services (in this title referred to as the “Secretary”) shall in accordance with this title make grants to provide for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the deliver...
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(b) Recipients of grants A grant under subsection (a) may be made to an entity only if the entity— (1) is a public or nonprofit private entity, which may include a State or local government; a public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center...
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(c) Certain activities To the extent practicable and appropriate, the Secretary shall ensure that projects under subsection (a) provide services for the diagnosis and management of post-abortion conditions. Activities that the Secretary may authorize for such projects may also include the following: (1) Delivering or ...
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(2) Delivering or enhancing inpatient care management services that ensure the well being of the mother and family and the future development of the infant. (3) Improving the quality, availability, and organization of health care and support services (including transportation services, attendant care, homemaker service...
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(d) Integration with other programs To the extent practicable and appropriate, the Secretary shall integrate the program under this title with other grant programs carried out by the Secretary, including the program under section 330 of the Public Health Service Act. (e) Limitation on amount of grants A grant under s...
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Certain requirements A grant may be made under section 201 only if the applicant involved makes the following agreements: (1) Not more than 5 percent of the grant will be used for administration, accounting, reporting, and program oversight functions. (2) The grant will be used to supplement and not supplant funds fro...
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As deemed appropriate by the Secretary, such limitations on charges may vary based on the financial circumstances of the individual receiving services. (4) The grant will not be expended to make payment for services authorized under section 201(a) to the extent that payment has been made, or can reasonably be expected ...
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(5) The applicant will, at each site at which the applicant provides services under section 201(a), post a conspicuous notice informing individuals who receive the services of any Federal policies that apply to the applicant with respect to the imposition of charges on such individuals. 203. Technical assistance The S...
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Authorization of appropriations For the purpose of carrying out this title, there is authorized to be appropriated $300,000 for each of the fiscal years 2005 through 2009.
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1. Environmental review for renewable energy projects (a) Compliance with NEPA for renewable energy projects Notwithstanding any other law, in preparing an environmental assessment or environmental impact statement required under section 102 of the National Environmental Policy Act of 1969 ( 42 U.S.C.
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4332 ) with respect to any action authorizing a renewable energy project under the jurisdiction of a Federal agency— (1) no Federal agency is required to identify alternative project locations or actions other than the proposed action and the no action alternative; and (2) no Federal agency is required to analyze the e...
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(b) Consideration of alternatives In any environmental assessment or environmental impact statement referred to in subsection (a), the Federal agency shall only identify and analyze the environmental effects and potential mitigation measures of— (1) the proposed action; and (2) the no action alternative. (c) Public co...
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Notwithstanding any other law, compliance with this subsection is deemed to satisfy section 102(2) of the National Environmental Policy Act of 1969 ( 42 U.S.C. 4332(2) ) and the applicable regulations and administrative guidelines with respect to proposed renewable energy projects.
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(d) Definition For purposes of this section, the term renewable energy project — (1) means any proposal to utilize an energy source other than nuclear power or the combustion of coal, oil or natural gas; and (2) includes but is not be limited to the use of wind, solar, geothermal, or tidal forces to generate energy.
108hr5019ih
1. Certain pepperoncini prepared or preserved otherwise than by vinegar or acetic acid (a) In general Subchapter II of chapter 99 of the Harmonized Tariff Schedule of the United States is amended by inserting in numerical sequence the following new heading: 9902.20.06 Pepperoncini, prepared or preserved otherwise tha...
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(b) Effective date The amendment made by subsection (a) applies to articles entered, or withdrawn from warehouse for consumption, on or after the 15th day after the date of the enactment of this Act.
108hr5362ih
1. Dedesignation The former Federal Building located at 500 Fannin Street in Shreveport, Louisiana, designated on October 28, 1978, by Public Law 95–545 , as the Joe Waggoner Federal Building shall no longer be known as the Joe Waggoner Federal Building. 2. References Any reference in a law, map, regulation, document...
108hr4535ih
1. Pigment Red 208 (a) In general Heading 9902.32.27 of the Harmonized Tariff Schedule of the United States is amended by striking 12/31/2002 and inserting 12/31/2006. (b) Effective date The amendment made by subsection (a) applies with respect to goods entered, or withdrawn from warehouse for consumption, on or aft...
108hr4391ih
1. Short title This Act may be cited as the Public Servant Retirement Protection Act. 2. Repeal of current windfall elimination provision Paragraph (7) of section 215(a) of the Social Security Act ( 42 U.S.C. 415(a)(7) ) is repealed. 3.
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Replacement of the windfall elimination provision with a formula equalizing benefits for certain individuals with non-covered employment (a) Substitution of proportional formula for formula based on covered portion of periodic benefit (1) In general Section 215(a) of the Social Security Act (as amended by section 2 ...
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who— (i) attains age 62 after 1985 (except where he or she became entitled to a disability insurance benefit before 1986 and remained so entitled in any of the 12 months immediately preceding his or her attainment of age 62), or (ii) would attain age 62 after 1985 and becomes eligible for a disability insurance benefit...
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(II) a payment by a social security system of a foreign country based on an agreement concluded between the United States and such foreign country pursuant to section 233, and (III) a payment based wholly on service as a member of a uniformed service (as defined in section 210(m)) which is based in whole or in part upo...
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the primary insurance amount of that individual during his or her concurrent entitlement to such monthly periodic payment and to old-age or disability insurance benefits shall be computed or recomputed under subparagraph (B) or subparagraph (D) (as applicable). (B) In the case of an individual who first performs servic...
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the individual’s primary insurance amount shall be the product derived by multiplying— (i) the individual’s primary insurance amount, as determined under paragraph (1) of this subsection and subparagraph (C)(i) of this paragraph, by (ii) a fraction— (I) the numerator of which is the individual’s average indexed monthly...
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to the next lower multiple of $0.10. (C) (i) For purposes of determining an individual’s primary insurance amount pursuant to subparagraph (B)(i), the individual’s average indexed monthly earnings shall be determined by treating all service performed after 1950 on which the individual’s monthly periodic payment referre...
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(ii) For purposes of determining average indexed monthly earnings as described in clause (i), the Commissioner of Social Security shall provide by regulation for a method for determining the amount of wages derived from service performed after 1950 on which the individual’s periodic benefit is based and which is to be ...
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Such method shall provide for reliance on employment records which are provided to the Commissioner and which constitute a reasonable basis for treatment of service as employment for such purposes, together with such other information received by the Commissioner as the Commissioner may consider appropriate as a reason...
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if paragraph (1) of this subsection would apply to such individual (except for subparagraph (A) of this paragraph), there shall first be computed an amount equal to the individual's primary insurance amount under paragraph (1) of this subsection, except that for purposes of such computation the percentage of the indivi...
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except that such second amount shall be reduced by an amount equal to one-half of the portion of the monthly periodic payment which is attributable to noncovered service performed after 1956 (with such attribution being based on the proportionate number of years of such noncovered service) and to which the individual i...
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There shall then be computed (without regard to this paragraph) a third amount, which shall be equal to the individual’s primary insurance amount determined under subparagraph (B) as if subparagraph (B) applied in the case of such individual. The individual's primary insurance amount shall be the largest of the three a...
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0 percent with respect to individuals who become eligible (as defined in paragraph (3)(B)) for old-age insurance benefits (or became eligible as so defined for disability insurance benefits before attaining age 62) in 1986; (II) 70.0 percent with respect to individuals who so become eligible in 1987; (III) 60.0 percent...
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0 percent with respect to individuals who so become eligible in 1990 or thereafter. (E) (i) Any periodic payment which otherwise meets the requirements of subparagraph (A), but which is paid on other than a monthly basis, shall be allocated on a basis equivalent to a monthly payment (as determined by the Commissioner o...
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(ii) In the case of an individual who has elected to receive a periodic payment that has been reduced so as to provide a survivor's benefit to any other individual, the payment shall be deemed to be increased (for purposes of any computation under this paragraph or subsection (d)(3) by the amount of such reduction. (ii...
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(F) (i) Subparagraph (D) shall not apply in the case of an individual who has 30 years or more of coverage. In the case of an individual who has more than 20 years of coverage but less than 30 years of coverage (as so defined),
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the percent specified in the applicable subdivision of subparagraph (D)(ii) shall (if such percent is smaller than the applicable percent specified in the following table) be deemed to be the applicable percent specified in the following table: If the number of such individual’s years of coverage (as so defined) is: Th...
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the term year of coverage shall have the meaning provided in paragraph (1)(C)(ii), except that the reference to 15 percent therein shall be deemed to be a reference to 25 percent. (G) An individual’s primary insurance amount determined under this paragraph shall be deemed to be computed under paragraph (1) of this subs...
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1984— (i) is an employee performing service to which social security coverage is extended on that date solely by reason of the amendments made by section 101 of the Social Security Amendments of 1983; or (ii) is an employee of a nonprofit organization which (on December 31, 1983) did not have in effect a waiver certifi...
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unless social security coverage had previously extended to service performed by such individual as an employee of that organization under a waiver certificate which was subsequently (prior to December 31, 1983) terminated. (2) Conforming amendments (A) Section 215(d)(3) of such Act ( 42 U.S.C.
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415(d)(3) ) is amended— (i) by striking subsection (a)(7)(C) each place it appears and inserting subsection (a)(7)(E) ; (ii) by striking subparagraph (E) and inserting subparagraph (H) ; and (iii) by striking subparagraph (D) and inserting subparagraph (F)(i). (B) Section 215(f)(9)(A) of such Act ( 42 U.S.C. 415(f)(9)(...
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Effective date The amendments made by this Act shall apply with respect to monthly insurance benefits for months commencing with or after the 12th calendar month following the date of the enactment of this Act. Notwithstanding section 215(f) of the Social Security Act, the Commissioner of Social Security shall recompu...
108hr5307ih
1. Illumination of Gateway Arch in honor of breast cancer awareness month In honor of breast cancer awareness month, the Secretary of the Interior shall authorize the Gateway Arch in St. Louis, Missouri, to be illuminated by pink lights for a certain period of time in October, to be designated by the Secretary of the ...
108hr4849ih
1. Short title This Act may be cited as the Retirement Security for Life Act of 2004. 2. Findings The Congress finds the following: (1) Just over half of all United States workers actively participate in tax-deferred retirement savings plans which are comprised of assets of nearly $5,000,000,000,000.
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(2) Congress has historically promoted policies that will encourage greater private savings for retirement, but has not devoted the same attention to developing policies that will help people manage the savings once they reach retirement age; (3) Qualified retirement savings plans are the product of such policies and p...
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(6) The commitment of Congress to creating incentives to promote private savings and to manage accumulated savings does not supercede the responsibility of Congress to reduce the national debt and bring the Federal budget back into balance. (7) Failure to address long term savings issues will only serve to increase the...
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(9) Encouraging the prudent management of accumulated savings and personal responsibility for retirement income security will reduce the potential financial threat to well-established entitlement programs for senior citizens. (10) The budget impact of this Act will be mitigated through the legislative process so that t...
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Exclusion for lifetime annuity payments (a) Lifetime annuity payments under annuity contracts Subsection (b) of section 72 of the Internal Revenue Code (relating to annuities) is amended by adding at the end thereof the following new paragraph: (5) Exclusion for lifetime annuity payments (A) In general In the case ...
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For purposes of the preceding sentence, the amount excludible from gross income in any taxable year shall not exceed $20,000.
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(B) Cost-of-living adjustment In the case of taxable years beginning after December 31, 2005, the $20,000 amounts in subparagraph (A) shall be increased by an amount equal to— (i) such dollar amount, multiplied by (ii) the cost-of-living adjustment determined under section 1(f)(3) for the calendar year in which the ta...
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If any amount as increased under the preceding sentence is not a multiple of $500, such amount shall be rounded to the next lower multiple of $500. (C) Application of paragraph Subparagraph (A) shall not apply to— (i) any amount received under an eligible deferred compensation plan (as defined in section 457(b)) or un...
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(ii) any amount paid under an annuity contract that is received by the beneficiary under the contract— (I) after the death of the annuitant in the case of payments described in subsection (c)(5)(A)(ii)(III), unless the beneficiary is the surviving spouse of the annuitant, or (II) after the death of the annuitant and jo...
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or (iii) any annuity contract that is a qualified funding asset (as defined in section 130(d)), but without regard to whether there is a qualified assignment. (D) Investment in the contract For purposes of this section, the investment in the contract shall be determined without regard to this paragraph. (b) Definition...
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the term lifetime annuity payment means any amount received as an annuity under any portion of an annuity contract, but only if— (i) the only person (or persons in the case of payments described in subclause (II) or (IV) of clause (ii)) legally entitled (by operation of the contract, a trust, or other legally enforceab...
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and (ii) such amount is part of a series of substantially equal periodic payments made not less frequently than annually over— (I) the life of the annuitant, (II) the lives of the annuitant and a joint annuitant, but only if the annuitant is the spouse of the joint annuitant as of the annuity starting date or the diffe...
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or (IV) the lives of the annuitant and a joint annuitant with a minimum period of payments or with a minimum amount that must be paid in any event, but only if the annuitant is the spouse of the joint annuitant as of the annuity starting date or the difference in age between the annuitant and joint annuitant is 15 year...
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annuity payments shall not fail to be treated as part of a series of substantially equal periodic payments— (I) because the amount of the periodic payments may vary in accordance with investment experience, reallocations among investment options, actuarial gains or losses, cost of living indices, a constant percentage ...
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but only if at all times such period is no longer than one calendar year. (B) Annuity contract For purposes of subparagraph (A) and subsections (b)(5) and (w), the term annuity contract means a commercial annuity (as defined by section 3405(e)(6)), other than an endowment or life insurance contract.
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(C) Minimum period of payments For purposes of subparagraph (A), the term minimum period of payments means a guaranteed term of payments that does not exceed the greater of 10 years or— (i) the life expectancy of the annuitant as of the annuity starting date, in the case of lifetime annuity payments described in subpa...
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For purposes of this subparagraph, life expectancy shall be computed with reference to the tables prescribed by the Secretary under paragraph (3). For purposes of subsection (w)(1)(C)(ii), the permissible minimum period of payments shall be determined as of the annuity starting date and reduced by one for each subseque...
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the term minimum amount that must be paid in any event means an amount payable to the designated beneficiary under an annuity contract that is in the nature of a refund and does not exceed the greater of the amount applied to produce the lifetime annuity payments under the contract or the amount, if any, available for ...
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(c) Recapture tax for lifetime annuity payments Section 72 of such Code is amended by redesignating subsection (w) as subsection (x) and inserting after subsection (v) the following new subsection (w): (w) Recapture tax for modifications to or reductions in lifetime annuity payments (1) In general If any amount rece...
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(B) after the date of receipt of the first lifetime annuity payment under the contract an annuitant receives a lump sum and thereafter is to receive annuity payments in a reduced amount under the contract, or (C) after the date of receipt of the first lifetime annuity payment under the contract the dollar amount of any...
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a minimum period of payments within the meaning of subsection (c)(5)(C) or a minimum amount that must be paid in any event (within the meaning of subsection (c)(5)(D)), then gross income for the first taxable year in which such modification or reduction occurs shall be increased by the recapture amount.
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(2) Recapture amount (A) In general For purposes of this subsection, the recapture amount shall be the amount, determined under rules prescribed by the Secretary, equal to the amount that (but for subsection (b)(5)) would have been includible in the taxpayer’s gross income if the modification or reduction described i...
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(B) Deferral period For purposes of this subsection, the term deferral period means the period beginning with the taxable year in which (without regard to subsection (b)(5)) the payment would have been includible in gross income and ending with the taxable year in which the modification described in paragraph (1) occu...
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(B) becomes a chronically ill individual within the meaning of section 7702B(c)(2), or (C) encounters hardship. (d) Lifetime distributions of life insurance death benefits (1) In general Subsection (d) of section 101 of such Code (relating to life insurance proceeds) is amended by adding at the end thereof the follow...