
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC236]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
        SUBCHAPTER I--ADMINISTRATION AND MISCELLANEOUS PROVISIONS
 
                         Part A--Administration
 
Sec. 236. Orphan Products Board


(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 et seq.] on the development of 
        such drugs, and
            (B) the implementation of such subchapter; \1\
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    \1\ 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)] 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)] or 
    licensed under section 262 of this title 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] 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 \2\ 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 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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    \2\ See References in Text note below.
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(July 1, 1944, ch. 373, title II, Sec. 227, as added Pub. L. 97-414, 
Sec. 3, Jan. 4, 1983, 96 Stat. 2051; amended Pub. L. 99-514, Sec. 2, 
Oct. 22, 1986, 100 Stat. 2095; Pub. L. 102-321, title I, Sec. 163(b)(1), 
July 10, 1992, 106 Stat. 375; Pub. L. 102-531, title III, 
Sec. 312(d)(1), Oct. 27, 1992, 106 Stat. 3504.)

                       References in Text

    The Federal Food, Drug, and Cosmetic Act, referred to in subsec. 
(c)(1)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended. 
Subchapter B of the Federal Food, Drug, and Cosmetic Act probably means 
subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act 
which is classified generally to part B (section 360aa et seq.) of 
subchapter V of chapter 9 of Title 21, Food and Drugs. For complete 
classification of this Act to the Code, see section 301 of Title 21 and 
Tables.
    Section 44H of title 26, referred to in subsec. (e), was renumbered 
section 28 of title 26, by Pub. L. 98-369, div. A, title IV, 
Sec. 471(c)(1), July 18, 1984, 98 Stat. 826, and subsequently renumbered 
section 45C of title 26 by Pub. L. 104-188, title I, Sec. 1205(a)(1), 
Aug. 20, 1996, 110 Stat. 1775.


                            Prior Provisions

    A prior section 236, act July 1, 1944, ch. 373, title II, Sec. 227, 
formerly title III, Sec. 310B, as added Oct. 30, 1970, Pub. L. 91-515, 
title II, Sec. 280, 84 Stat. 1307; renumbered Sec. 227 and amended July 
23, 1974, Pub. L. 93-353, title I, Sec. 102(f), 88 Stat. 362, related to 
an annual report by Secretary on activities related to health facilities 
and services and expenditure of funds, prior to repeal by Pub. L. 97-35, 
title XXI, Sec. 2193(b)(4), Aug. 13, 1981, 95 Stat. 827.


                               Amendments

    1992--Subsec. (a). Pub. L. 102-531 substituted ``Centers for Disease 
Control and Prevention'' for ``Centers for Disease Control''.
    Subsec. (c)(2). Pub. L. 102-321, Sec. 163(b)(1)(A), which directed 
the striking out of ``, and the Alcohol, Drug Abuse, and Mental Health 
Administration'', was executed by striking ``and the Alcohol, Drug 
Abuse, and Mental Health Administration'' after ``National Institutes of 
Health'' to reflect the probable intent of Congress.
    Subsec. (c)(3). Pub. L. 102-531 substituted ``Centers for Disease 
Control and Prevention'' for ``Centers for Disease Control''.
    Pub. L. 102-321, Sec. 163(b)(1)(B), struck out ``, the Alcohol, Drug 
Abuse, and Mental Health Administration,'' after ``National Institutes 
of Health''.
    Subsec. (e). Pub. L. 102-321, Sec. 163(b)(1)(C), (D), in concluding 
provisions, struck out ``and the Administrator of the Alcohol, Drug 
Abuse, and Mental Health Administration'' after ``National Institutes of 
Health'' the first place appearing and ``and the Alcohol, Drug Abuse, 
and Mental Health Administration'' after ``National Institutes of 
Health'' the second place appearing.
    1986--Subsec. (e). Pub. L. 99-514 substituted ``Internal Revenue 
Code of 1986'' for ``Internal Revenue Code of 1954'', which for purposes 
of codification was translated as ``title 26'' thus requiring no change 
in text.

                         Change of Name

    Committee on Energy and Commerce of House of Representatives treated 
as referring to Committee on Commerce of House of Representatives by 
section 1(a) of Pub. L. 104-14, set out as a note preceding section 21 
of Title 2, The Congress.


                    Effective Date of 1992 Amendment

    Section 801 of Pub. L. 102-321 provided that:
    ``(a) In General.--This Act [See Tables for classification] takes 
effect on the date of the enactment of this Act [July 10, 1992], subject 
to subsections (b) through (d).
    ``(b) Amendments.--The amendments described in this Act are made on 
the date of the enactment of this Act and take effect on such date, 
except as provided in subsections (c) and (d).
    ``(c) Reorganization Under Title I.--Title I [Secs. 101-171] takes 
effect on October 1, 1992. The amendments described in such title are 
made on such date and take effect on such date.
    ``(d) Programs Providing Financial Assistance.--
        ``(1) Fiscal year 1993 and subsequent years.--In the case of any 
    program making awards of grants, cooperative agreements, or 
    contracts, the amendments made by this Act are effective for awards 
    made on or after October 1, 1992.
        ``(2) Prior fiscal years.--
            ``(A) Except as provided in subparagraph (B), in the case of 
        any program making awards of grants, cooperative agreements, or 
        contracts, if the program began operation prior to the date of 
        the enactment of this Act [July 10, 1992] and the program is 
        amended by this Act, awards made prior to October 1, 1992, shall 
        continue to be subject to the terms and conditions upon which 
        such awards were made, notwithstanding the amendments made by 
        this Act.
            ``(B) Subparagraph (A) does not apply with respect to the 
        amendments made by this Act to part B of title XIX of the Public 
        Health Service Act [section 300x et seq. of this title]. Section 
        205(a) [set out as a note under section 300x of this title] 
        applies with respect to the program established in such part.''


Use of ``CDC'' as Acronym for Centers for Disease Control and Prevention

    Section 312(i) of Pub. L. 102-531 provided that: ``The amendments 
made by this section [amending this section, sections 247d, 280b to 
280b-2, 285c-4, 285d-7, 285m-4, 289c, 290aa-9, 290bb-1, 300u-5, 300aa-2, 
300aa-19, 300aa-26, 300cc, 300cc-2, 300cc-15, 300cc-17, 300cc-20, 300cc-
31, 300ee-1, 300ee-2, 300ee-31, 300ee-32, 300ee-34, 300ff-11 to 300ff-
13, 300ff-17, 300ff-27, 300ff-28, 300ff-41, 300ff-43, 300ff-49, 300ff-
75, 4841, and 9604 of this title, section 1341 of Title 15, Commerce and 
Trade, section 2001 of Title 25, Indians, and provisions set out as 
notes under sections 241 and 281 of this title and section 303 of Title 
38, Veterans' Benefits] may not be construed as prohibiting the Director 
of the Centers for Disease Control and Prevention from utilizing for 
official purposes the term `CDC' as an acronym for such Centers.''


                 National Commission on Orphan Diseases

    Pub. L. 99-91, Sec. 4, Aug. 15, 1985, 99 Stat. 388, as amended by 
Pub. L. 100-290, Sec. 4, Apr. 18, 1988, 102 Stat. 92; Pub. L. 102-321, 
title I, Sec. 163(c)(1), July 10, 1992, 106 Stat. 376, provided that:
    ``(a) Establishment.--There is established the National Commission 
on Orphan Diseases (hereinafter referred to as the `Commission').
    ``(b) Duty.--The Commission shall assess the activities of the 
National Institutes of Health, the Food and Drug Administration, other 
public agencies, and private entities in connection with--
        ``(1) basic research conducted on rare diseases;
        ``(2) the use in research on rare diseases of knowledge 
    developed in other research;
        ``(3) applied and clinical research on the prevention, 
    diagnosis, and treatment of rare diseases; and
        ``(4) the dissemination to the public, health care 
    professionals, researchers, and drug and medical device 
    manufacturers of knowledge developed in research on rare diseases 
    and other diseases which can be used in the prevention, diagnosis, 
    and treatment of rare diseases.
    ``(c) Review Requirements.--In assessing the activities of the 
National Institutes of Health, and the Food and Drug Administration in 
connection with research on rare diseases, the Commission shall review--
        ``(1) the appropriateness of the priorities currently placed on 
    research on rare diseases;
        ``(2) the relative effectiveness of grants and contracts when 
    used to fund research on rare diseases;
        ``(3) the appropriateness of specific requirements applicable to 
    applications for funds for research on rare diseases taking into 
    consideration the reasonable capacity of applicants to meet such 
    requirements;
        ``(4) the adequacy of the scientific basis for such research, 
    including the adequacy of the research facilities and research 
    resources used in such research and the appropriateness of the 
    scientific training of the personnel engaged in such research;
        ``(5) the effectiveness of activities undertaken to encourage 
    such research;
        ``(6) the organization of the peer review process applicable to 
    applications for funds for such research to determine if the 
    organization of the peer review process could be revised to improve 
    the effectiveness of the review provided to proposals for research 
    on rare diseases;
        ``(7) the effectiveness of the coordination between the national 
    research institutes of the National Institutes of Health, the Food 
    and Drug Administration, and private entities in supporting such 
    research; and
        ``(8) the effectiveness of activities undertaken to assure that 
    knowledge developed in research on nonrare diseases is, when 
    appropriate, used in research on rare diseases.
    ``(d) Composition.--The Commission shall be composed of twenty 
members appointed by the Secretary of Health and Human Services as 
follows:
        ``(1) Ten members shall be appointed from individuals who are 
    not officers or employees of the Government and who by virtue of 
    their training or experience in research on rare diseases or in the 
    treatment of rare diseases are qualified to serve on the Commission.
        ``(2) Five members shall be appointed from individuals who are 
    not officers or employees of the Government and who have a rare 
    disease or are employed to represent or are members of an 
    organization concerned about rare disease.
        ``(3) Four nonvoting members shall be appointed for the 
    directors of the national research institutes of the National 
    Institutes of Health which the Secretary determines are involved 
    with rare diseases.
        ``(4) One nonvoting member shall be appointed from officers or 
    employees of the Food and Drug Administration who the Secretary 
    determines are involved with rare diseases.
A vacancy in the Commission shall be filled in the manner in which the 
original appointment was made. If any member of the Commission who was 
appointed to the Commission as a director of a national research 
institute or as an officer or employee of the Food and Drug 
Administration leaves that office or position, or if any member of the 
Commission who was appointed from persons who are not officers or 
employees of the Government becomes an officer or employee of the 
Government, such member may continue as a member of the Commission for 
not longer than the ninety-day period beginning on the date such member 
leaves that office or position or becomes such an officer or employee, 
as the case may be.
    ``(e) Term.--Members shall be appointed for the life of the 
Commission.
    ``(f) Compensation.--
        ``(1) Except as provided in paragraph (2), members of the 
    Commission shall each be entitled to receive compensation at a rate 
    not to exceed the daily equivalent of the annual rate of basic pay 
    in effect for grade GS-18 of the General Schedule for each day 
    (including traveltime) during which they are engaged in the actual 
    performance of duties as members of the Commission.
        ``(2) Members of the Commission who are full-time officers or 
    employees of the Government shall receive no additional pay by 
    reason of their service on the Commission.
    ``(g) Chairman.--The Chairman of the Commission shall be designated 
by the members of the Commission.
    ``(h) Staff.--Subject to such rules as may be prescribed by the 
Commission, the Commission may appoint and fix the pay of such personnel 
as it determines are necessary to enable the Commission to carry out its 
functions. Personnel shall be appointed subject to the provisions of 
title 5, United States Code, governing appointments in the competitive 
service, and shall be paid in accordance with the provisions of chapter 
51 and subchapter III of chapter 53 of such title relating to 
classification and General Schedule pay rates.
    ``(i) Experts and Consultants.--Subject to such rules as may be 
prescribed by the Commission, the Commission may procure temporary and 
intermittent services under section 3109(b) of title 5 of the United 
States Code, but at rates for individuals not to exceed the daily 
equivalent of the basic pay payable for grade GS-15 of the General 
Schedule.
    ``(j) Detail of Personnel.--Upon request of the Commission, the head 
of any Federal agency is authorized to detail, on a reimbursable basis, 
any of the personnel of such agency to the Commission to assist the 
Commission in carrying out its functions.
    ``(k) Administrative Support Services.--The Administrator of General 
Services shall provide to the Commission on a reimbursable basis such 
administrative support services as the Commission may request.
    ``(l) General Authority.--The Commission may, for the purpose of 
carrying out this section, hold such hearings, sit and act at such times 
and places, take such testimony, and receive such evidence, as the 
Commission considers appropriate.
    ``(m) Information.--The Commission may secure directly from any 
department or agency of the United States information necessary to 
enable it to carry out this section. Upon request of the Chairman, the 
head of such department or agency shall furnish such information to the 
Commission.
    ``(n) Report.--The Commission shall transmit to the Secretary and to 
each House of the Congress a report not later than February 1, 1989, on 
the activities of the Commission. The report shall contain a detailed 
statement of the findings and conclusions of the Commission, together 
with its recommendations for--
        ``(1) a long range plan for the use of public and private 
    resources to improve research into rare diseases and to assist in 
    the prevention, diagnosis, and treatment of rare diseases; and
        ``(2) such legislation or administrative actions as it considers 
    appropriate.
    ``(o) Termination.--The Commission shall terminate 90 days after the 
date of the submittal of its report under subsection (n).
    ``(p) Funds.--The Director of the National Institutes of Health 
shall make available $1,000,000 to the Commission from appropriations 
for fiscal year 1986 for the National Institutes of Health.''
