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, § 471(c)(1), July 18, 1984, 98 Stat. 826, and subsequently renumbered section 45C of title 26 by Pub. L. 104–188, title I, § 1205(a)(1), Aug. 20, 1996, 110 Stat. 1775.
A prior section 236, act July 1, 1944, ch. 373, title II, § 227, formerly title III, § 310B, as added Oct. 30, 1970, Pub. L. 91–515, title II, § 280, 84 Stat. 1307; renumbered § 227 and amended July 23, 1974, Pub. L. 93–353, title I, § 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, § 2193(b)(4), Aug. 13, 1981, 95 Stat. 827.
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, § 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, § 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, § 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 Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
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. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Effective Date of 1992 Amendment
Pub. L. 102–321, title VIII, § 801, July 10, 1992, 106 Stat. 441, provided that:
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).
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 [§§ 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.—
Except as provided in subparagraph (B), in the case of any program
making awards of grants, cooperative agreements, or contracts, if the program
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.
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 [42 U.S.C. 300x
et seq.]. Section 205(a) [42 U.S.C. 300x
note] applies with respect to the program established in such part.”
Termination of Reporting Requirements
For termination, effective May 15, 2000, of provisions in subsec. (e) of this section relating to the requirement to submit an annual report to certain committees of Congress, see section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and page 101 of House Document No. 103–7.
Use of “CDC” as Acronym for Centers for Disease Control and Prevention
Pub. L. 102–531, title III, § 312(i), Oct. 27, 1992, 106 Stat. 3506, provided that:
“The amendments made by this section [amending this section, sections 247d
, 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
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, § 4, Aug. 15, 1985, 99 Stat. 388, as amended by Pub. L. 100–290, § 4, Apr. 18, 1988, 102 Stat. 92; Pub. L. 102–321, title I, § 163(c)(1), July 10, 1992, 106 Stat. 376, provided that:
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—
the use in research
on rare diseases of knowledge developed in other research
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—
the appropriateness of the priorities currently placed on research
on rare diseases;
the relative effectiveness of grants
and contracts when used to fund research
on rare diseases;
the appropriateness of specific requirements applicable to applications for funds
on rare diseases taking into consideration the reasonable capacity of applicants
to meet such requirements;
the adequacy of the scientific basis for such research
, including the adequacy of the research
facilities and researchresources
used in such research and the appropriateness of the scientific training of the personnel engaged in such research;
the effectiveness of activities undertaken to encourage such research
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;
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
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:
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.
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.
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.
Members shall be appointed for the life of the Commission
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.
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.
The Chairman of the Commission
shall be designated by the members
of the Commission.
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.—
of General Services shall provide to the Commission on a reimbursable basis such administrative support services as the Commission may request.
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
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—
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
such legislation or administrative actions as it considers appropriate.
shall terminate 90 days after the date of the submittal of its report under subsection (n).
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.”