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<bill bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public">
	<form>
		<distribution-code display="yes">II</distribution-code>
		<congress>112th CONGRESS</congress>
		<session>2d Session</session>
		<legis-num>S. 3345</legis-num>
		<current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber>
		<action>
			<action-date date="20120627">June 27, 2012</action-date>
			<action-desc><sponsor name-id="S223">Mrs. Boxer</sponsor> (for herself
			 and <cosponsor name-id="S173">Mr. Kerry</cosponsor>) introduced the following
			 bill; which was read twice and referred to the
			 <committee-name committee-id="SSHR00">Committee on Health, Education, Labor,
			 and Pensions</committee-name></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>To provide for research and education to improve
		  screening, detection and diagnosis of prostate cancer. </official-title>
	</form>
	<legis-body>
		<section id="S1" section-type="section-one"><enum>1.</enum><header>Short
			 title</header><text display-inline="no-display-inline">This Act may be cited as
			 the <quote><short-title>Prostate Cancer Detection Research
			 and Education Act</short-title></quote>.</text>
		</section><section id="idf3ca459356de463ebf0e9a83a62e4eef"><enum>2.</enum><header>Plan to develop
			 and validate a test or tests for prostate cancer</header>
			<subsection id="id1361b326448f42ee9b370d7df65992a7"><enum>(a)</enum><header>In
			 general</header><text>The Secretary of Health and Human Services (referred to
			 in this Act as the <term>Secretary</term>), acting through the Director of the
			 National Institutes of Health, shall establish an advisory council on prostate
			 cancer (referred to in this Act as the <term>advisory council</term>) to draft
			 a plan for the development and validation of an accurate test or tests, such as
			 biomarkers or imaging, to detect and diagnose prostate cancer.</text>
			</subsection><subsection id="id590caaa689ab4cef80b2112a467273cb"><enum>(b)</enum><header>Advisory
			 council</header>
				<paragraph id="id3bb6e87aa83546fcaba5850edd1da38a"><enum>(1)</enum><header>Membership</header>
					<subparagraph id="iddf75503dca4944b0a77b7643bd28bd3b"><enum>(A)</enum><header>Federal
			 members</header><text>The advisory council shall be comprised of the following
			 experts:</text>
						<clause id="id044ea8133c0a45c08af3005b02e2f64c"><enum>(i)</enum><text>A
			 designee of the Centers for Disease Control and Prevention.</text>
						</clause><clause id="id0cc28589a85d4b9f81ac78912691e98f"><enum>(ii)</enum><text>A
			 designee of the Centers for Medicare &amp; Medicaid Services.</text>
						</clause><clause id="id55e9ddc59a6d4146b5275b378e88f000"><enum>(iii)</enum><text>A
			 designee of the Office of the Director of the National Cancer Institute.</text>
						</clause><clause id="idbf6c4f148cdd4c529c832f6ac8b284ff"><enum>(iv)</enum><text>A
			 designee of the Director of the Department of Defense Congressionally Directed
			 Medical Research Program.</text>
						</clause><clause id="idab963803ad56430aab5cf9f6e8969cbc"><enum>(v)</enum><text>A
			 designee of the Director of the National Institute of Biomedical Imaging and
			 Bioengineering.</text>
						</clause><clause id="id56f26c2deb454aff9c2177ae0518cd2f"><enum>(vi)</enum><text>A
			 designee of the Director of the National Institute of General Medical
			 Sciences.</text>
						</clause><clause id="idb2af823175b04ee69596aae2e2b29e84"><enum>(vii)</enum><text>A
			 designee of the Director of the National Institute on Minority Health and
			 Health Disparities.</text>
						</clause><clause id="id4249ef1f794f4354a9e674da2990fdc9"><enum>(viii)</enum><text>A designee of
			 the Office of the Director of the National Institutes of Health.</text>
						</clause><clause id="id84b35f4ada264fb8a8f8c6d296d72089"><enum>(ix)</enum><text>A
			 designee of the Food and Drug Administration.</text>
						</clause><clause id="id24a9292447ef426c8bd03580e81a44d2"><enum>(x)</enum><text>A
			 designee of the Agency for Healthcare Research and Quality.</text>
						</clause><clause id="id524156afdcda4fdfb9f65ce56b043550"><enum>(xi)</enum><text>A
			 designee of the Director of the Telemedicine and Advanced Technology Research
			 Center of the Department of Defense.</text>
						</clause></subparagraph><subparagraph id="ida12b5dc3f70b4ca1ac276475bf04ff5e"><enum>(B)</enum><header>Non-federal
			 members</header><text>In addition to the members described in subparagraph (A),
			 the advisory council shall include 8 expert members from outside the Federal
			 Government to be appointed by the Secretary, which shall include—</text>
						<clause id="iddbb5b3d289714157a6c16464f924f0bf"><enum>(i)</enum><text>2
			 prostate cancer patient advocates;</text>
						</clause><clause id="id73071e9fff94401ea1f9cad941b344ff"><enum>(ii)</enum><text>2
			 health care providers with a range of expertise and experience in prostate
			 cancer; and</text>
						</clause><clause id="id56e07a34c7ce400982f0f4d5e478b313"><enum>(iii)</enum><text>4
			 leading researchers with prostate cancer-related expertise in a range of
			 clinical disciplines.</text>
						</clause></subparagraph></paragraph><paragraph id="id35eff15f53854988bc28ad8d2074492e"><enum>(2)</enum><header>Meetings</header><text>The
			 advisory council shall meet quarterly and such meetings shall be open to the
			 public.</text>
				</paragraph><paragraph id="idae7d198339a34848bafa1b46e4988bb2"><enum>(3)</enum><header>Advice</header><text>The
			 advisory council shall advise the Secretary, or the Secretary’s
			 designee.</text>
				</paragraph><paragraph id="id13bdf583a2484776bae757408f05adde"><enum>(4)</enum><header>Annual
			 report</header><text>Not later than 1 year after the date of enactment of this
			 Act, the advisory council shall provide to the Secretary, or the Secretary’s
			 designee and Congress—</text>
					<subparagraph id="id602decc854554628a7880d665369feac"><enum>(A)</enum><text>an initial
			 evaluation of all Federally funded efforts in prostate cancer research relating
			 to the development and validation of an accurate test or tests to detect and
			 diagnose prostate cancer;</text>
					</subparagraph><subparagraph id="idf36609e24a0f4bf08b768e752b8ec176"><enum>(B)</enum><text>a plan for the
			 development and validation of a reliable test or tests for the detection and
			 accurate diagnosis of prostate cancer; and</text>
					</subparagraph><subparagraph id="id732a2d0291f04a3e9feadaeb2ec8b971"><enum>(C)</enum><text>a set of
			 standards for prostate cancer screening, developed in coordination with the
			 United States Preventive Services Task Force, to ensure that any tools for
			 screening, detection, and diagnosis developed in accordance with the plan under
			 subparagraph (B) will meet the requirements of the Task Force for
			 recommendation as a proven preventive or diagnostic service.</text>
					</subparagraph></paragraph><paragraph id="id795df4bd5da1447583f1e3b5c44c3f83"><enum>(5)</enum><header>Termination</header><text>The
			 advisory council shall terminate on December 31, 2016.</text>
				</paragraph></subsection><subsection id="id88ae2cb11cda459692bdab7f9c0e3263"><enum>(c)</enum><header>Funding</header><text>The
			 Secretary may make available $1,000,000 from amounts appropriated to the
			 National Institutes of Health for each of fiscal years 2013 through 2017 to
			 carry out this section.</text>
			</subsection></section><section id="id27e38ed9c4cb445ba065ee2e7d7a46b3"><enum>3.</enum><header>Coordination and
			 intensification of prostate cancer research</header>
			<subsection id="idd5f70ffae0df4f7b89dfdd7c4b8d420d"><enum>(a)</enum><header>In
			 general</header><text>The Director of the National Institutes of Health, in
			 consultation with the Secretary of Defense, shall coordinate and intensify
			 research in accordance with the plan developed under section 2(b)(4)(B), with
			 particular attention provided to leveraging existing research to develop and
			 validate a test or tests, such as biomarkers or imaging, to detect and
			 accurately diagnose prostate cancer in order to improve quality of life for
			 millions of Americans, and decrease health care system costs.</text>
			</subsection><subsection id="id2E41DD103F634796A54EC19DCF399BA2"><enum>(b)</enum><header>Funding</header><text>The
			 Secretary may make available $30,000,000 from amounts appropriated to the
			 National Institutes of Health for each of fiscal years 2014 through 2018 to
			 carry out this section.</text>
			</subsection></section><section id="ida665a6424d4940e7949a9bc516214069"><enum>4.</enum><header>Public awareness
			 and education campaign</header>
			<subsection id="iddf8628305109455d92f82d1378f1356a"><enum>(a)</enum><header>National
			 campaign</header><text>The Secretary, in coordination with the Director of the
			 National Institutes of Health and the Director of the Centers for Disease
			 Control and Prevention, shall carry out a national campaign to increase the
			 awareness and knowledge of prostate cancer.</text>
			</subsection><subsection id="idfec0f1f7bb0742ec87557cc09d24611b"><enum>(b)</enum><header>Requirements</header><text>The
			 national campaign conducted under subsection (a) shall include—</text>
				<paragraph id="id4da6ef28fa2b40b39cfacaf3a4fc96d5"><enum>(1)</enum><text>roles for the
			 National Cancer Institute, the National Institute on Minority Health and Health
			 Disparities, the Office on Minority Health of the Department of Health and
			 Human Services, and the Office of Minority Health of the Centers for Disease
			 Control and Prevention; and</text>
				</paragraph><paragraph id="id998cb4f4822c446a9350fb796852e8ce"><enum>(2)</enum><text>the development
			 and distribution of written educational materials, and the development and
			 placing of public service announcements, that are intended to encourage men to
			 seek prostate cancer screening when symptoms are present, when they have a
			 family history of prostate cancer, or if they belong to a high-risk
			 population.</text>
				</paragraph></subsection><subsection id="idbf1257c0cbfe428eb5ecedb330f289b6"><enum>(c)</enum><header>Racial
			 disparities</header><text>In developing the national campaign under subsection
			 (a), the Secretary shall recognize and address—</text>
				<paragraph id="id0fe5df677fcf4eb9a4da139de805aa26"><enum>(1)</enum><text>the racial
			 disparities in the incidences of prostate cancer and mortality rates with
			 respect to such disease; and</text>
				</paragraph><paragraph id="id678aa017eccd41ccae9627579cbb496a"><enum>(2)</enum><text>any barriers in
			 access to patient care and participation in clinical trials that are specific
			 to racial minorities.</text>
				</paragraph></subsection><subsection id="id1b991532738a45f4a902007efc0fccea"><enum>(d)</enum><header>Grants</header><text>The
			 Secretary shall establish a program to award grants to nonprofit private
			 entities to enable such entities to test alternative outreach and education
			 strategies to increase the awareness and knowledge of Americans with respect to
			 prostate cancer.</text>
			</subsection><subsection id="idd94a2fc85e854219b8673b526dd278ec"><enum>(e)</enum><header>Authorization
			 of appropriations</header><text>There is authorized to be appropriated to carry
			 out this section, $5,000,000 for each of fiscal years 2013 through 2017.</text>
			</subsection></section></legis-body>
</bill>
