§ 282. Director of National Institutes of Health
(a)
Appointment
The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) of this section and as the Secretary may otherwise prescribe.
(b)
Duties and authority
In carrying out the purposes of section
241 of this title, the Secretary, acting through the Director of NIH—
(1)
shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;
(2)
shall coordinate and oversee the operation of the national research institutes, national centers, and administrative entities within the National Institutes of Health;
(3)
shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
(4)
shall assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing minority and other health disparities;
(5)
shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health;
(6)
shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;
(7)
(A)
shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—
(i)
identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;
(8)
shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers—
(9)
shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section
289a of this title and that, after such review, the research is reviewed in accordance with section
289a–1
(a)(2) of this title by the appropriate advisory council under section
284a of this title before the research proposals are approved for funding;
(10)
shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;
(11)
(A)
shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section
288 of this title; and
(12)
may, from funds appropriated under section
282a
(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;
(13)
may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;
(14)
for the national research institutes and administrative entities within the National Institutes of Health—
(16)
may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups;
(17)
may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;
(18)
may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;
(19)
may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;
(21)
may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter;
(22)
may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter
74 of title
38; and
(23)
shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.
The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.
(c)
Availability of substances and organisms for research
The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(d)
Services of experts or consultants; number; payment of expenses, conditions, recovery
(1)
The Director of NIH may obtain (in accordance with section
3109 of title
5, but without regard to the limitation in such section on the period of service) the services of not more than 220 experts or consultants, with scientific or other professional qualifications, for the National Institutes of Health.
(2)
(A)
Except as provided in subparagraph (B), experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.
(B)
Expenses specified in subparagraph (A) shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph.
(e)
Dissemination of research information
The Director of NIH shall—
(2)
coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes;
(3)
promote the effective transfer of the information described in paragraph (2) to the health care community and to entities that require such information;
(5)
ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the general public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (Public Law 102–73).
(f)
Associate Director for Prevention; functions
There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—
(g)
Enhancing competitiveness of certain entities in obtaining research funds
(1)
(A)
In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director of the National Center for Research Resources, shall establish a program to enhance the competitiveness of such entities in obtaining funds from the national research institutes for conducting biomedical and behavioral research.
(B)
The entities referred to in subparagraph (A) are entities that conduct biomedical and behavioral research and are located in a State in which the aggregate success rate for applications to the national research institutes for assistance for such research by the entities in the State has historically constituted a low success rate of obtaining such funds, relative to such aggregate rate for such entities in other States.
(C)
With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in carrying out the program established under such subparagraph, may—
(h)
Increased participation of women and disadvantaged individuals in biomedical and behavioral research
The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.
(i)
Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions
(1)
(A)
The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the “data bank”). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information.
(B)
The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.
(2)
In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers.
(3)
The data bank shall include the following:
(A)
A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section
355
(i) of title
21, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, a point of contact for those wanting to enroll in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol.
(B)
Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available—
(i)
under a treatment investigational new drug application that has been submitted to the Secretary under section
360bbb
(c) of title
21; or
(ii)
as a Group C cancer drug (as defined by the National Cancer Institute).
The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.
(4)
The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.
(j)
Expanded clinical trial registry data bank
(1)
Definitions; requirement
(A)
Definitions
In this subsection:
(i)
Applicable clinical trial
The term “applicable clinical trial” means an applicable device clinical trial or an applicable drug clinical trial.
(ii)
Applicable device clinical trial
The term “applicable device clinical trial” means—
(I)
a prospective clinical study of health outcomes comparing an intervention with a device subject to section
360
(k),
360e, or
360j
(m) of title
21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and
(iii)
Applicable drug clinical trial
(I)
In general
The term “applicable drug clinical trial” means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section
355 of title
21 or to section
262 of this title.
(iv)
Clinical trial information
The term “clinical trial information” means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).
(v)
Completion date
The term “completion date” means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.
(vii)
Drug
The term “drug” means a drug as defined in section
321
(g) of title
21 or a biological product as defined in section
262 of this title.
(viii)
Ongoing
The term “ongoing” means, with respect to a clinical trial of a drug or a device and to a date, that—
(ix)
Responsible party
The term “responsible party”, with respect to a clinical trial of a drug or device, means—
(I)
the sponsor of the clinical trial (as defined in section
50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or
(II)
the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.
(2)
Expansion of clinical trial registry data bank with respect to clinical trial information
(A)
In general
(i)
Expansion of data bank
To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the “registry data bank”). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.
(ll)
outcomes, including primary and secondary outcome measures;
(II)
recruitment information, including—
(gg)
in the case of an applicable drug clinical trial, if the drug is not approved under section
355 of title
21 or licensed under section
262 of this title, specify whether or not there is expanded access to the drug under section
360bbb of title
21 for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;
(IV)
administrative data (which the Secretary may make publicly available as necessary), including—
(cc)
the Food and Drug Administration IND/IDE protocol number and the record verification date.
(I)
The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.
(II)
The name of the intervention, including any drug or device being studied in the clinical trial.
(VI)
The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization.
(VIII)
The National Clinical Trial number or other study identification for the clinical trial.
(ii)
Additional searchable category
Not later than 18 months after September 27, 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
(iii)
Other elements
The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis.
(iv)
Format
The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared.
(C)
Data submission
The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, September 27, 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of [1] subparagraph (A)(ii) not later than the later of—
(iii)
in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on September 27, 2007, 1 year after September 27, 2007.
(I)
not earlier than the date of clearance under section
360
(k) of title
21, or approval under section
360e or
360j
(m) of title
21, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date; or
(II)
for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary.
(3)
Expansion of registry data bank to include results of clinical trials
(A)
Linking registry data bank to existing results
(i)
In general
Beginning not later than 90 days after September 27, 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial—
(I)
not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or
(II)
not later than 30 days after the results information described in clause (ii) becomes publicly available.
(I)
FDA information
The Secretary shall ensure that the registry data bank includes links to the following information:
(aa)
If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial.
(bb)
If an applicable drug clinical trial was conducted under section
355a or
355c of title
21, a link to the posted Food and Drug Administration assessment of the results of such trial.
(cc)
Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any.
(dd)
For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section
355
(l)(2) of title
21.
(ee)
For an applicable device clinical trial, in the case of a premarket application under section
360e of title
21, the detailed summary of information respecting the safety and effectiveness of the device required under section
360j
(h)(1) of title
21, or, in the case of a report under section
360
(k) of title
21, the section
360
(k) summary of the safety and effectiveness data required under section
807.95(d) of title
21, Code of Federal Regulations (or any successor regulation).
(II)
NIH information
The Secretary shall ensure that the registry data bank includes links to the following information:
(bb)
The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.
(iii)
Results for existing data bank entries
The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to September 27, 2007, as available.
(i)
expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the “registry and results data bank”);
(iii)
post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and
(iv)
in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public.
(C)
Basic results
Not later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under section
355 of title
21 or licensed under section
262 of this title or a device that is cleared under section
360
(k) of title
21 or approved under section
360e or
360j
(m) of title
21, the following elements:
(i)
Demographic and baseline characteristics of patient sample
A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.
(ii)
Primary and secondary outcomes
The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.
(iii)
Point of contact
A point of contact for scientific information about the clinical trial results.
(iv)
Certain agreements
Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.
(i)
Expansion by rulemaking
To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after September 27, 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph.
(I)
Approved products
The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for—
(aa)
each applicable drug clinical trial for a drug that is approved under section
355 of title
21 or licensed under section
262 of this title; and
(bb)
each applicable device clinical trial for a device that is cleared under section
360
(k) of title
21 or approved under section
360e or
360j