this paragraph, such determination shall 
be based on whether the covered entity in-
volved exercises effective control over that 
researcher’s activities. For purposes of the 
preceding sentence, effective control may 
include membership and privileges of staff 
or the ability to terminate staff member-
ship or discipline staff. 
(c) LIABILITY.—The Director of the Office of Human 
Research Protection, the Director of the National Insti-
tutes of Health, and the Director of the National Cancer 
Institute shall issue guidance for entities awarded grants 
by such Federal agencies to provide instruction on how 
such entities may best address concerns or issues relating 
to the liability that institutions or researchers may incur 
as a result of using the facilitated review process of the 
Central Institutional Review Board Initiative, as spon-
sored by the National Cancer Institute. 
SEC. 5. ENHANCED FOCUS AND REPORTING ON CANCER 
RESEARCH. 
Part C of title IV of the Public Health Service Act 
(42 U.S.C. 285 et seq.) is amended by inserting after sec-
tion 417A the following: 
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‘‘SEC. 417B. ENHANCED FOCUS AND REPORTING ON CAN-
CER RESEARCH. 
‘‘(a) ANNUAL INDEPENDENT REPORT.— 
‘‘(1) IN GENERAL.—The Director of the Insti-
tute shall complete an annual independent report 
that shall be submitted to Congress on the same 
date that the annual budget estimate described in 
section 413(b)(9) is submitted to the President. 
‘‘(2) CONTENTS OF REPORT.— 
‘‘(A) CANCER
CATEGORIES.—The report 
required under paragraph (1) shall address the 
following categories of cancer: 
‘‘(i) Cancers that result in a 5-year 
survival rate of less than 50 percent. 
‘‘(ii) Cancers in which the incidence 
rate is fewer than 15 cases per 100,000 
people, or fewer than 40,000 new cases per 
year. 
‘‘(B) INFORMATION.—With regard to each 
of the categories of cancer described in sub-
paragraph (A), the report shall contain infor-
mation regarding— 
‘‘(i) a strategic plan for reducing the 
mortality rate for the annual year, includ-
ing specific research areas of interest and 
budget amounts; 
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‘‘(ii) identification of any barriers to 
implementing the strategic plan described 
in clause (i) for the annual year; 
‘‘(iii) if the report for the prior year 
contained a strategic plan described in 
clause (i), an assessment of the success of 
such plan; 
‘‘(iv) the total amount of grant fund-
ing, including the total dollar amount 
awarded per grant and per funding year, 
under— 
‘‘(I) the National Cancer Insti-
tute; and 
‘‘(II) the National Institutes of 
Health; 
‘‘(v) the percentage of grant applica-
tions favorably reviewed by the Institute 
that the Institute funded in the previous 
annual year; 
‘‘(vi) the total number of grant appli-
cations, with greater than 50 percent rel-
evance to each of the categories of cancer 
described in subparagraph (A), received by 
the Institute for awards in the previous an-
nual year; 
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‘‘(vii) the total number of grants 
awarded, with greater than 50 percent rel-
evance to each of the categories of cancer 
described in subparagraph (A), for the pre-
vious annual year and the number of 
awards per grant type, including the Com-
mon Scientific Outline designation specific 
to each such grant; and 
‘‘(viii) the total number of primary in-
vestigators that received grants from the 
Institute for projects with greater than 50 
percent relevance to each of the categories 
of cancer described in paragraph (1), in-
cluding the total number of awards grant-
ed to experienced investigators and the 
total number of awards granted to inves-
tigators receiving their first grant from the 
National Institutes of Health. 
‘‘(3) DEFINITION.—In this section, the term 
‘annual year’ means the year for which the strategic 
plan described in paragraph (2)(B)(i) applies, which 
shall be the same fiscal year for which the Director 
of the Institute submits the annual budget estimate 
described in section 413(b)(9) for that year. 
‘‘(b) GRANT PROGRAM.— 
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‘‘(1) IN GENERAL.—The Director of the Insti-
tute, in cooperation with the Director of the Fogarty 
International Center for Advanced Study in the 
Health Sciences and the Directors of other Insti-
tutes, as appropriate, shall award grants to re-
searchers to conduct research regarding cancers for 
which— 
‘‘(A) the incidence is fewer than 40,000 
new cases per year; and 
‘‘(B) the 5-year survival rate is less than 
50 percent. 
‘‘(2) PRIORITIZATION.—In awarding grants for 
research regarding cancers described in paragraph 
(1)(A), the Director of the Institute shall give pri-
ority to collaborative research projects between adult 
and pediatric cancer research, with preference for 
projects building upon existing multi-institutional re-
search infrastructures. 
‘‘(3) TISSUE SAMPLES.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Director of the Institute 
shall require each recipient receiving a grant 
under this subsection to submit tissue samples 
to designated tumor banks. 
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‘‘(B) WAIVER.—The Director of the Insti-
tute may grant a waiver of the requirement de-
scribed in subparagraph (A) to a recipient who 
receives a grant for research described in para-
graph (1)(B) and who submits an application 
for such waiver to the Director of the Institute, 
in the manner in which such Director may re-
quire.’’. 
SEC. 6. CONTINUING ACCESS TO CARE FOR PREVENTION 
AND EARLY DETECTION. 
(a) PREVENTIVE HEALTH MEASURES WITH RE-
SPECT TO COLORECTAL CANCER.—Part B of title III of 
the Public Health Service Act (42 U.S.C. 243 et seq.) is 
amended by inserting after section 317T the following new 
section: 
‘‘SEC. 317U. PREVENTIVE HEALTH MEASURES WITH RE-
SPECT TO COLORECTAL CANCER. 
‘‘(a) GRANT PROGRAM AUTHORIZATION.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, may make grants to eligible 
entities for the purpose of carrying out a program 
described in subsection (b). An eligible entity that is 
a recipient of a grant under this subsection may use 
such grant to carry out such programs directly or 
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through grants to, or contracts with, public and not- 
for-profit private entities. 
‘‘(2) ELIGIBLE
ENTITY
DEFINED.—For pur-
poses of this section, the term ‘eligible entity’ in-
cludes the following: 
‘‘(A) A State, including, in addition to the 
several States, the District of Columbia, Guam, 
the Commonwealth of Puerto Rico, the North-
ern Mariana Islands, the Virgin Islands, Amer-
ican Samoa, and the Trust Territory of the Pa-
cific Islands. 
‘‘(B) An Indian tribe or tribal organiza-
tion, as such terms are defined in section 4 of 
the Indian Self-Determination and Education 
Assistance Act. 
‘‘(b) PROGRAMS DESCRIBED.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), a 
program described in this subsection is a program 
for planning or implementing each of the following: 
‘‘(A) Providing screenings for colorectal 
cancer to individuals who— 
‘‘(i) are 50 years of age or older; or 
‘‘(ii)(I) are under 50 years of age; and 
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‘‘(II) are at high risk for such cancer, 
as determined in accordance with sub-
section (e)(2). 
‘‘(B) Providing appropriate case manage-
ment and referrals for medical treatment of in-
dividuals screened pursuant to subparagraph 
(A). 
‘‘(C) Ensuring (directly or through coordi-
nation or an arrangement with health care pro-
viders or programs) the full continuum of fol-
low-up and cancer care for individuals so 
screened, including appropriate follow-up for 
abnormal tests, diagnostic services, therapeutic 
services, and treatment of detected cancers and 
management of unanticipated medical complica-
tions. 
‘‘(D) Carrying out activities to improve the 
education, training, and skills of health profes-
sionals (including allied health professionals) in 
the detection and control of colorectal cancer, 
which activities are carried out pursuant to the 
participation of the health professionals in the 
program. 
‘‘(E) Establishing mechanisms through 
which the eligible entity involved can monitor 
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the quality of screening and diagnostic follow- 
up procedures for colorectal cancer, including 
the interpretation of such procedures. 
‘‘(F) Evaluating the activities described in 
this subsection through appropriate surveillance 
and program monitoring activities. 
‘‘(G) Developing and disseminating find-
ings derived through such evaluations and the 
collection of data on outcomes. 
‘‘(H) Developing and disseminating public 
information and education programs for the de-
tection and control of colorectal cancer and pro-
moting the benefits of receiving screenings 
through this program. 
‘‘(2) SUPPLEMENT
NOT
SUPPLANT.—In the 
case of an eligible entity that implements a universal 
colorectal screening program under which the eligi-
ble entity makes available funds for activities de-
scribed in subparagraph (A), (B), or (C) of para-
graph (1), such entity shall be able to receive grant 
funds under subsection (a) only for purposes of— 
‘‘(A) carrying out those activities under 
this subsection that are not so funded; or 
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‘‘(B) supplementing (and not supplanting) 
funds made available by the entity for such 
funded program. 
‘‘(c) PRIORITY FOR LOW-INCOME, UNINSURED, AND 
UNDERINSURED INDIVIDUALS.—A grant may be made 
under subsection (a) to an eligible entity only if the eligible 
entity agrees that, in providing screenings under sub-
section (b)(1)(A), the eligible entity will give priority to 
low-income individuals who lack adequate coverage, as de-
termined by the Secretary, under health insurance and 
health plans with respect to screenings for colorectal can-
cer. 
‘‘(d) SPECIAL CONSIDERATION FOR CERTAIN APPLI-
CANTS.—In making grants under subsection (a) for a fis-
cal year, the Secretary shall give special consideration to 
the following eligible entities: 
‘‘(1) In the case of services under such sub-
section for women, to such entities that, for such 
year, are grantees under title XV. 
‘‘(2) In the case of services under such sub-
section for men, to such entities that, for such year, 
are grantees under section 317D. 
‘‘(3) To such entities that coordinate with other 
Federal, State, and local colorectal cancer programs. 
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‘‘(4) To such entities with an existing program 
to provide cancer screening to individuals. 
‘‘(e) USE OF CERTAIN STANDARDS UNDER MEDI-
CARE PROGRAM.—A grant may be made under subsection 
(a) to an eligible entity only if the eligible entity provides, 
as applicable, assurances as follows: 
‘‘(1) Screenings under subsection (b)(1)(A) will 
be carried out as preventive health measures in ac-
cordance with evidence-based screening guidelines 
and procedures and in accordance with the standard 
of care required for purposes of title XVIII of the 
Social Security Act to carry out colorectal screening 
tests defined in section 1861(pp)(1) of such Act. 
‘‘(2) An individual will be considered high risk 
for purposes of subsection (b)(1)(A)(ii) only if the 
individual is high risk within the meaning of section 
1861(pp)(2) of such Act. 
‘‘(3) The payment made from the grant for a 
screening procedure under subsection (b)(1)(A) will 
not exceed the amount that would be paid under 
part B of title XVIII of such Act if payment were 
made under such part for furnishing the procedure 
to an individual enrolled under such part. 
‘‘(f) RELATIONSHIP TO ITEMS AND SERVICES UNDER 
OTHER PROGRAMS.—A grant under subsection (a) may 
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be made to an eligible entity only if the eligible entity, 
as applicable, provides assurances that the grant will not 
be expended to make payment for any item or service to 
the extent that payment has been made, or can reasonably 
be expected to be made, with respect to such item or serv-
ice— 
‘‘(1) under any State compensation program, 
under an insurance policy, or under any Federal or 
State health benefits program; or 
‘‘(2) by an entity that provides health services 
on a prepaid basis. 
‘‘(g) RECORDS AND AUDITS.—A grant under sub-
section (a) may be made to an eligible entity only if the 
eligible entity provides assurances that the eligible entity 
will— 
‘‘(1) establish such fiscal control and fund ac-
counting procedures as may be necessary to ensure 
proper disbursal of, and accounting for, amounts re-
ceived under subsection (a); and 
‘‘(2) upon request, provide records maintained 
pursuant to paragraph (1) to the Secretary or the 
Comptroller General of the United States for pur-
poses of auditing the expenditures of the grant by 
the eligible entity. 
‘‘(h) REQUIREMENT OF MATCHING FUNDS.— 
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‘‘(1) IN
GENERAL.—The Secretary may not 
make a grant under subsection (a) to an eligible en-
tity for a fiscal year unless the eligible entity agrees, 
with respect to the costs to be incurred by the eligi-
ble entity for such fiscal year in carrying out the ac-
tivities described in subsection (b), to make available 
non-Federal contributions (in cash or in kind under 
paragraph (2)) toward such costs in an amount 
equal to not less than $1 for each $3 of Federal 
funds provided in the grant for such fiscal year. 
Such contributions may be made directly or through 
donations from public or private entities. 
‘‘(2) DETERMINATION
OF
AMOUNT
OF
NON- 
FEDERAL CONTRIBUTION.— 
‘‘(A) IN GENERAL.—Non-Federal contribu-
tions required in paragraph (1) may be in cash 
or in kind, fairly evaluated, including equipment 
or services (and excluding indirect or overhead 
costs). Amounts provided by the Federal Gov-
ernment, or services assisted or subsidized to 
any significant extent by the Federal Govern-
ment, may not be included in determining the 
amount of such non-Federal contributions. 
‘‘(B) 
MAINTENANCE
OF
EFFORT.—In 
making a determination of the amount of non- 
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Federal contributions for purposes of paragraph 
(1), the Secretary may include only non-Federal 
contributions in excess of the average amount 
of non-Federal contributions made by the eligi-
ble entity involved toward the activities de-
scribed in subsection (b) for the 2-year period 
preceding the first fiscal year for which the eli-
gible entity is applying to receive a grant under 
subsection (a). 
‘‘(C) INCLUSION OF RELEVANT NON-FED-
ERAL
CONTRIBUTIONS
FOR
MEDICAID.—In 
making a determination of the amount of non- 
Federal contributions for purposes of paragraph 
(1), the Secretary shall, subject to subpara-
graphs (A) and (B) of this paragraph, include 
any non-Federal amounts expended pursuant to 
title XIX of the Social Security Act by the eligi-
ble entity involved toward the activities de-
scribed in subparagraphs (A) and (B) of sub-
section (b)(1). 
‘‘(i) ADDITIONAL REQUIREMENTS.— 
‘‘(1) LIMITATION
ON
ADMINISTRATIVE
EX-
PENSES.—The Secretary may not make a grant to 
an eligible entity under subsection (a) unless the eli-
gible entity provides assurances that not more than 
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10 percent of the grant will be expended for admin-
istrative expenses with respect to the activities fund-
ed by the grant. 
‘‘(2) STATEWIDE PROVISION OF SERVICES.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary may not make a grant 
under subsection (a) to an eligible entity unless 
the eligible entity provides assurances that any 
program funded by such grant will be made 
available throughout the State, including avail-
ability to members of an Indian tribe or tribal 
organization (as such terms are defined in sec-
tion 4 of the Indian Self-Determination and 
Education Assistance Act). 
‘‘(B) WAIVER.—The Secretary may waive 
the requirement under subparagraph (A) for an 
eligible entity if the Secretary determines that 
compliance by the eligible entity with the re-
quirement would result in an inefficient alloca-
tion of resources with respect to carrying out 
the purposes described in subsection (a). 
‘‘(j) TECHNICAL ASSISTANCE
AND PROVISION
OF 
SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.— 
‘‘(1) TECHNICAL ASSISTANCE.—The Secretary 
may provide training and technical assistance with 
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respect to the planning, development, and operation 
of any program funded by a grant under subsection 
(a). The Secretary may provide such technical as-
sistance directly to eligible entities or through grants 
to, or contracts with, public and private entities. 
‘‘(2) PROVISION OF SUPPLIES AND SERVICES IN 
LIEU OF GRANT FUNDS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), upon the request of an eligible entity 
receiving a grant under subsection (a), the Sec-
retary for the purpose of aiding the eligible en-
tity to carry out a program under subsection 
(b)— 
‘‘(i) may provide supplies, equipment, 
and services to the eligible entity; and 
‘‘(ii) may detail to the eligible entity 
any officer or employee of the Department 
of Health and Human Services. 
‘‘(B) CORRESPONDING REDUCTION IN PAY-
MENTS.—With respect to a request made by an 
eligible entity under subparagraph (A), the Sec-
retary shall reduce the amount of payments 
made under the grant under subsection (a) to 
the eligible entity by an amount equal to the 
fair market value of any supplies, equipment, or 
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services provided by the Secretary and the costs 
of detailing personnel (including pay, allow-
ances, and travel expenses) under subparagraph 
(A). The Secretary shall, for the payment of ex-
penses incurred in complying with such request, 
expend the amounts withheld. 
‘‘(k) REPORTS.—A grant under subsection (a) may 
be made only if the applicant involved agrees to submit 
to the Secretary such reports as the Secretary may require 
with respect to the grant. 
‘‘(l) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN
GENERAL.—For the purpose of car-
rying out this section, there are authorized to be ap-
propriated— 
‘‘(A) for fiscal year 2012, $50,000,000; 
‘‘(B) for fiscal year 2013, $75,000,000; 
‘‘(C) for fiscal year 2014, $150,000,000; 
‘‘(D) for fiscal year 2015, $200,000,000; 
and 
‘‘(E) for fiscal year 2016, $250,000,000. 
‘‘(2) SET-ASIDE
FOR
TECHNICAL
ASSISTANCE 
AND PROVISION OF SUPPLIES AND SERVICES.—Of 
the amount appropriated under paragraph (1) for a 
fiscal year, the Secretary shall reserve not to exceed 
20 percent for carrying out subsection (j).’’. 
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