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42 U.S.C. § 237 — Orphan Products Board
Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment; composition; chairman** There is established in the Department of Health and Human Services a board for the development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for Health of the Department of Health and Human Services and representatives, selected by the Secretary, of the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board.
**(b) Function** The function of the Board shall be to promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles for such diseases or conditions.
**(c) Duties with respect to drugs for rare diseases or conditions** In the case of drugs for rare diseases or conditions the Board shall—
(1) evaluate—
(A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 360aa](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360aa&num=0&edition=prelim) et seq.] on the development of such drugs, and
(B) the implementation of such subchapter; 11 So in original. The semicolon probably should be a comma.
(2) evaluate the activities of the National Institutes of Health for the development of drugs for such diseases or conditions,
(3) assure appropriate coordination among the Food and
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 237
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Stable record: federal_law:legal_authorities:record_usc_83f63c7379529e6ba4ae0c07
Source file: Laws/federal/codes/united-states-code/title-42/section-237-orphan-products-board--5caddad12e.md
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Source location: Title 42, Chapter 6A, § 237; chapter-6a-public-health-service.md
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**(a) Establishment; composition; chairman** There is established in the Department of Health and Human Services a board for the development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for Health of the Department of Health and Human Services and representatives, selected by the Secretary, of the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board.
**(b) Function** The function of the Board shall be to promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles for such diseases or conditions.
**(c) Duties with respect to drugs for rare diseases or conditions** In the case of drugs for rare diseases or conditions the Board shall—
(1) evaluate—
(A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 360aa](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360aa&num=0&edition=prelim) et seq.] on the development of such drugs, and
(B) the implementation of such subchapter; 11 So in original. The semicolon probably should be a comma.
(2) evaluate the activities of the National Institutes of Health for the development of drugs for such diseases or conditions,
(3) assure appropriate coordination among the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention in the carrying out of their respective functions relating to the development of drugs for such diseases or conditions to assure that the activities of each agency are complementary,
(4) assure appropriate coordination among all interested Federal agencies, manufacturers, and organizations representing patients, in their activities relating to such drugs,
(5) with the consent of the sponsor of a drug for a rare disease or condition exempt under section 505(i) of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355(i)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim)] or regulations issued under such section, inform physicians and the public respecting the availability of such drug for such disease or condition and inform physicians and the public respecting the availability of drugs approved under section 505(c) of such Act [[21 U.S.C. 355(c)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c&num=0&edition=prelim)] or licensed under [section 262 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for rare diseases or conditions,
(6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions, seek investigators to facilitate the development of such drugs, and seek business entities to participate in the distribution of such drugs, and
(7) recognize the efforts of public and private entities and individuals in seeking the development of drugs for rare diseases or conditions and in developing such drugs.
**(d) Consultation** The Board shall consult with interested persons respecting the activities of the Board under this section and as part of such consultation shall provide the opportunity for the submission of oral views.
**(e) Annual report; contents** The Board shall submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives an annual report—
(1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 360bb](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim)] for a rare disease or condition,
(2) describing the activities of the Board, and
(3) containing the results of the evaluations carried out by the Board.
The Director of the National Institutes of Health shall submit to the Board for inclusion in the annual report a report on the rare disease and condition research activities of the Institutes of the National Institutes of Health; the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H 22 See References in Text note below. of title 26; and the Secretary of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under [section 360ee of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ee&num=0&edition=prelim) for the development of drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Request by sponsor; response by Secretary** The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—
(1) it may be approved for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(2) if the drug is a biological product, it may be licensed for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or licensing of such drug for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
**(b) Regulations** The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360aa
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Request by sponsor; preconditions; “rare disease or condition” defined**
(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—
(A) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim),
the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) 11 See References in Text note below. respecting the designation of the drug.
(2) For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,0
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bb
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General rule** For purposes of section 38, the credit determined under this section for the taxable year is an amount equal to 25 percent of the qualified clinical testing expenses for the taxable year.
**(b) Qualified clinical testing expenses** For purposes of this section—
(1) **Qualified clinical testing expenses**
(A) *In general* — Except as otherwise provided in this paragraph, the term “qualified clinical testing expenses” means the amounts which are paid or incurred by the taxpayer during the taxable year which would be described in subsection (b) of section 41 if such subsection were applied with the modifications set forth in subparagraph (B).
(B) *Modifications* — For purposes of subparagraph (A), subsection (b) of section 41 shall be applied—
(i) by substituting “clinical testing” for “qualified research” each place it appears in paragraphs (2) and (3) of such subsection, and
(ii) by substituting “100 percent” for “65 percent” in paragraph (3)(A) of such subsection.
(C) *Exclusion for amounts funded by grants, etc.* — The term “qualified clinical testing expenses” shall not include any amount to the extent such amount is funded by any grant, contract, or otherwise by another person (or any governmental entity).
(2) **Clinical testing**
(A) *In general* — The term “clinical testing” means any human clinical testing—
(i) which is carried out under an exemption for a drug being tested for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section),
(ii) which occurs—
(I) after the date such drug is designated under section 526 of such Act, and
(II) before the date on which an application with respect to such drug is approved under
Source: Supplied U.S. Code snapshot — release unconfirmed · 26 U.S.C. § 45C
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a)**
(1) When requested by a committee of Congress having jurisdiction over receipts or appropriations, the President shall provide the committee with assistance and information.
(2) When requested by a committee of Congress, additional information related to the amount of an appropriation originally requested by an Office of Inspector General shall be submitted to the committee.
**(b)** When requested by a committee of Congress, by the Comptroller General, or by the Director of the Congressional Budget Office, the Secretary of the Treasury, the Director of the Office of Management and Budget, and the head of each executive agency shall—
(1) provide information on the location and kind of available fiscal, budget, and program information;
(2) to the extent practicable, prepare summary tables of that fiscal, budget, and program information and related information the committee, the Comptroller General, or the Director of the Congressional Budget Office considers necessary; and
(3) provide a program evaluation carried out or commissioned by an executive agency.
**(c)** In cooperation with the Director of the Congressional Budget Office, the Secretary, and the Director of the Office of Management and Budget, the Comptroller General shall—
(1) establish and maintain a current directory of sources of, and information systems for, fiscal, budget, and program information and a brief description of the contents of each source and system;
(2) when requested, provide assistance to committees of Congress and members of Congress in obtaining information from the sources in the directory; and
(3) when requested, provide assistance to committees and, to the extent practicable, to members of Congress in evaluating the information obtained from the sources in the directory
Source: Supplied U.S. Code snapshot — release unconfirmed · 31 U.S.C. § 1113
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Federal law — U.S. Code and appendices · legal_authorities
<a id="section-29"></a>
Source: U.S. Code supplied Markdown snapshot · 26 U.S.C. § 28
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Federal law — U.S. Code and appendices · legal_authorities
<a id="section-45"></a>
Source: U.S. Code supplied Markdown snapshot · 26 U.S.C. § 44H
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** For the purpose described in subsection (b), the Secretary, acting through the Director of the Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined in accordance with [section 300x–7 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300x-7&num=0&edition=prelim). The Secretary shall make a grant to the State of the allotment made for the State for the fiscal year if the State submits to the Secretary an application in accordance with [section 300x–6 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300x-6&num=0&edition=prelim).
**(b) Purpose of grants** A funding agreement for a grant under subsection (a) is that, subject to [section 300x–5 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300x-5&num=0&edition=prelim), the State involved will expend the grant only for the purpose of—
(1) providing community mental health services for adults with a serious mental illness and children with a serious emotional disturbance as defined in accordance with [section 300x–1(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300x–1/c&num=0&edition=prelim);
(2) carrying out the plan submitted under [section 300x–1(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300x–1/a&num=0&edition=prelim) by the State for the fiscal year involved;
(3) evaluating programs and services carried out under the plan; and
(4) planning, administration, and educational activities related to providing services under the plan.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 300x
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment of program; Secretary; functions** The Secretary of Health and Human Services (hereinafter in this section referred to as the “Secretary”) shall establish and carry out a program to inform the public of any dangers to human health presented by cigarette smoking. In carrying out such program, the Secretary shall—
(1) conduct and support research on the effect of cigarette smoking on human health and develop materials for informing the public of such effect;
(2) coordinate all research and educational programs and other activities within the Department of Health and Human Services (hereinafter in this section referred to as the “Department”) which relate to the effect of cigarette smoking on human health and coordinate, through the Interagency Committee on Smoking and Health (established under subsection (b)), such activities with similar activities of other Federal agencies and of private agencies;
(3) establish and maintain a liaison with appropriate private entities, other Federal agencies, and State and local public agencies respecting activities relating to the effect of cigarette smoking on human health;
(4) collect, analyze, and disseminate (through publications, bibliographies, and otherwise) information, studies, and other data relating to the effect of cigarette smoking on human health, and develop standards, criteria, and methodologies for improved information programs related to smoking and health;
(5) compile and make available information on State and local laws relating to the use and consumption of cigarettes; and
(6) undertake any other additional information and research activities which the Secretary determines necessary and appropriate to carry out this section.
**(b) Interagency Committee on Smoking and Health; composition;
Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 1341
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Federal law — U.S. Code and appendices · legal_authorities
The oath of office shall be administered by the President of the Senate to each Senator who shall be elected, previous to his taking his seat.
Source: Supplied U.S. Code snapshot — release unconfirmed · 2 U.S.C. § 21
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