116 HR 1109 : Mental Health Services for Students Act of 2020
U.S. House of Representatives
2020-09-30
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IIB116th CONGRESS2d SessionH. R. 1109IN THE SENATE OF THE UNITED STATESSeptember 30 (legislative day, September 29), 2020Received; read twice and referred to the Committee on Health, Education, Labor, and PensionsAN ACTTo amend the Public Health Service Act to revise and extend projects relating to children and to provide access to school-based comprehensive mental health programs.1.Short titleThis Act may be cited as the Mental Health Services for Students Act of 2020.2.Amendments to the Public Health Service Act(a)Technical amendmentsThe second part G (relating to services provided through religious organizations) of title V of the Public Health Service Act (42 U.S.C. 290kk et seq.) is amended—(1)by redesignating such part as part J; and(2)by redesignating sections 581 through 584 as sections 596 through 596C, respectively.(b)School-Based mental health and childrenSection 581 of the Public Health Service Act (42 U.S.C. 290hh) (relating to children and violence) is amended to read as follows:581.School-based mental health; children and adolescents(a)In generalThe Secretary, in consultation with the Secretary of Education, shall, through grants, contracts, or cooperative agreements awarded to eligible entities described in subsection (c), provide comprehensive school-based mental health services and supports to assist children in local communities and schools (including schools funded by the Bureau of Indian Education) dealing with traumatic experiences, grief, bereavement, risk of suicide, and violence. Such services and supports shall be—(1)developmentally, linguistically, and culturally appropriate;(2)trauma-informed; and(3)incorporate positive behavioral interventions and supports.(b)ActivitiesGrants, contracts, or cooperative agreements awarded under subsection (a), shall, as appropriate, be used for—(1)implementation of school and community-based mental health programs that—(A)build awareness of individual trauma and the intergenerational, continuum of impacts of trauma on populations;(B)train appropriate staff to identify, and screen for, signs of trauma exposure, mental health disorders, or risk of suicide; and(C)incorporate positive behavioral interventions, family engagement, student treatment, and multigenerational supports to foster the health and development of children, prevent mental health disorders, and ameliorate the impact of trauma;(2)technical assistance to local communities with respect to the development of programs described in paragraph (1);(3)facilitating community partnerships among families, students, law enforcement agencies, education agencies, mental health and substance use disorder service systems, family-based mental health service systems, child welfare agencies, health care providers (including primary care physicians, mental health professionals, and other professionals who specialize in children’s mental health such as child and adolescent psychiatrists), institutions of higher education, faith-based programs, trauma networks, and other community-based systems to address child and adolescent trauma, mental health issues, and violence; and(4)establishing mechanisms for children and adolescents to report incidents of violence or plans by other children, adolescents, or adults to commit violence.(c)Requirements(1)In generalTo be eligible for a grant, contract, or cooperative agreement under subsection (a), an entity shall be a partnership that includes—(A)a State educational agency, as defined in section 8101 of the Elementary and Secondary Education Act of 1965, in coordination with one or more local educational agencies, as defined in section 8101 of the Elementary and Secondary Education Act of 1965, or a consortium of any entities described in subparagraph (B), (C), (D), or (E) of section 8101(30) of such Act; and(B)at least 1 community-based mental health provider, including a public or private mental health entity, health care entity, family-based mental health entity, trauma network, or other community-based entity, as determined by the Secretary (and which may include additional entities such as a human services agency, law enforcement or juvenile justice entity, child welfare agency, agency, an institution of higher education, or another entity, as determined by the Secretary).(2)Compliance with HIPAAAny patient records developed by covered entities through activities under the grant shall meet the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.(3)Compliance with FERPASection 444 of the General Education Provisions Act (commonly known as the Family Educational Rights and Privacy Act of 1974) shall apply to any entity that is a member of the partnership in the same manner that such section applies to an educational agency or institution (as that term is defined in such section).(d)Geographical distributionThe Secretary shall ensure that grants, contracts, or cooperative agreements under subsection (a) will be distributed equitably among the regions of the country and among urban and rural areas.(e)Duration of awardsWith respect to a grant, contract, or cooperative agreement under subsection (a), the period during which payments under such an award will be made to the recipient shall be 5 years, with options for renewal.(f)Evaluation and measures of outcomes(1)Development of processThe Assistant Secretary shall develop a fiscally appropriate process for evaluating activities carried out under this section. Such process shall include—(A)the development of guidelines for the submission of program data by grant, contract, or cooperative agreement recipients;(B)the development of measures of outcomes (in accordance with paragraph (2)) to be applied by such recipients in evaluating programs carried out under this section; and(C)the submission of annual reports by such recipients concerning the effectiveness of programs carried out under this section.(2)Measures of outcomesThe Assistant Secretary shall develop measures of outcomes to be applied by recipients of assistance under this section to evaluate the effectiveness of programs carried out under this section, including outcomes related to the student, family, and local educational systems supported by this Act.(3)Submission of annual dataAn eligible entity described in subsection (c) that receives a grant, contract, or cooperative agreement under this section shall annually submit to the Assistant Secretary a report that includes data to evaluate the success of the program carried out by the entity based on whether such program is achieving the purposes of the program. Such reports shall utilize the measures of outcomes under paragraph (2) in a reasonable manner to demonstrate the progress of the program in achieving such purposes.(4)Evaluation by assistant secretaryBased on the data submitted under paragraph (3), the Assistant Secretary shall annually submit to Congress a report concerning the results and effectiveness of the programs carried out with assistance received under this section.(5)LimitationAn eligible entity shall use not more than 20 percent of amounts received under a grant under this section to carry out evaluation activities under this subsection.(g)Information and educationThe Secretary shall disseminate best practices based on the findings of the knowledge development and application under this section.(h)Amount of grants and authorization of appropriations(1)Amount of grantsA grant under this section shall be in an amount that is not more than $2,000,000 for each of the first 5 fiscal years following the date of enactment of the Mental Health Services for Students Act of 2019. The Secretary shall determine the amount of each such grant based on the population of children up to age 21 of the area to be served under the grant.(2)Authorization of appropriationsThere is authorized to be appropriated to carry out this section, $130,000,000 for each of fiscal years 2021 through 2024..(c)Conforming amendmentPart G of title V of the Public Health Service Act (42 U.S.C. 290hh et seq.), as amended by subsection (b), is further amended by striking the part designation and heading and inserting the following:GSchool-based mental health.Passed the House of Representatives September 29, 2020.Cheryl L. Johnson,Clerk.


114 S2207 IS: To require the Secretary of State to offer rewards of not less than $10,000,000 for information that leads to the arrest or conviction of suspects in connection with the bombing of Pan Am Flight 103.
U.S. Senate
2015-10-27
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		II
		114th CONGRESS1st Session
		S. 2207
		IN THE SENATE OF THE UNITED STATES

			October 27, 2015
			Mr. Menendez (for himself, Mr. Schumer, Mrs. Gillibrand, and Mr. Booker) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations

		A BILL
		To require the Secretary of State to offer rewards of not less than $10,000,000 for information
			 that leads
			 to the arrest or conviction of suspects in connection with the bombing
			 of Pan Am Flight 103.

		1.Rewards authorized
 In accordance with the Rewards for Justice program authorized under section 36(b) of the State Department Basic Authorities Act of 1956 (22 U.S.C. 2708(b)), the Secretary of State shall offer a reward of not less than $10,000,000 to any individual who furnishes information leading to the arrest or conviction in any country of any individual responsible for the 1988 bombing of Pan Am Flight 103.


113 HR 2768 : Taxpayer Bill of Rights Act of 2013
U.S. House of Representatives
2013-08-01
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		IIB
		113th CONGRESS
		1st Session
		H. R. 2768
		IN THE SENATE OF THE UNITED
		  STATES

			August 1, 2013
			Received; read twice and referred to the
			 Committee on
			 Finance

		AN ACT
		To amend the Internal Revenue Code of 1986
		  to clarify that a duty of the Commissioner of Internal Revenue is to ensure
		  that Internal Revenue Service employees are familiar with and act in accord
		  with certain taxpayer rights.

		1.Short titleThis Act may be cited as the
			 Taxpayer Bill of Rights Act of
			 2013.
		2.Duty to ensure
			 that IRS employees are familiar with and act in accord with certain taxpayer
			 rightsSection
			 7803(a) of the Internal Revenue Code of 1986
			 is amended by redesignating paragraph (3) as paragraph (4) and by inserting
			 after paragraph (2) the following new paragraph:

				(3)Execution of
				Duties in Accord with Taxpayer RightsIn discharging his duties, the Commissioner
				shall ensure that employees of the Internal Revenue Service are familiar with
				and act in accord with taxpayer rights as afforded by other provisions of this
				title, including—
					(A)the right to be
				informed,
					(B)the right to be
				assisted,
					(C)the right to be
				heard,
					(D)the right to pay
				no more than the correct amount of tax,
					(E)the right of
				appeal,
					(F)the right to
				certainty,
					(G)the right to
				privacy,
					(H)the right to
				confidentiality,
					(I)the right to
				representation, and
					(J)the right to a
				fair and just tax
				system.
					.

			Passed the House of
			 Representatives July 31, 2013.
			Karen L. Haas,
			Clerk


116 S1951 IS: Designing Accounting Safeguards To Help Broaden Oversight and Regulations on Data
U.S. Senate
2019-06-25
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II
116th CONGRESS1st Session
S. 1951
IN THE SENATE OF THE UNITED STATES

June 25, 2019
Mr. Warner (for himself and Mr. Hawley) introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban Affairs

A BILL
To require the Securities and Exchange Commission to promulgate regulations relating to the disclosure of certain commercial data, and for other purposes.

1.Short title This Act may be cited as the Designing Accounting Safeguards To Help Broaden Oversight and Regulations on Data.  2.DefinitionsIn this Act:
(1)Commercial data operatorThe term commercial data operator means an entity acting in its capacity as a consumer online services provider or data broker that— (A)generates a material amount of revenue from the use, collection, processing, sale, or sharing of the user data; and
(B)has more than 100,000,000 unique monthly visitors or users in the United States for a majority of months during the previous 1-year period.  (2)CommissionThe term Commission means the Securities and Exchange Commission.
(3)IssuerThe term issuer has the meaning given the term in section 3(a) of the Securities and Exchange Act of 1934 (15 U.S.C. 78c(a)).  (4)UserThe term user means an individual consumer who uses an online service designed for consumer use by a commercial data operator.
(5)User dataThe term user data means any information that identifies, relates to, describes, is capable of being associated with, or could reasonably be linked with an individual user, whether directly submitted to the commercial data operator by the user or derived from the observed activity of the user by the commercial data operator.  3.Commercial data operators (a)Requirements (1)In generalA commercial data operator shall—
(A)on a routine basis, and not less frequently than once every 90 days— (i)provide each user of the commercial data operator with an assessment of the economic value that the commercial data operator places on the data of that user; and
(ii)in a clear and conspicuous manner, in accordance with paragraph (3), identify to each user of the commercial data operator— (I)the types of data collected from users of the commercial data operator, whether by the commercial data operator or another person pursuant to an agreement with the commercial data operator; and
(II)the ways that the data of a user of the commercial data operator is used if the use is not directly or exclusively related to the online service that the commercial data operator provides to the user; and  (B)except as provided in paragraph (2), provide a user of the commercial data operator with the ability to delete all data, in the aggregate and for an individual field, that the commercial data operator possesses, or maintains control or access to with respect to the user, through—
(i)a single setting; or  (ii)another clear and conspicuous mechanism by which the user may make such a deletion.
(2)Deletion exceptions
(A)In generalA commercial data operator shall comply with a user directive to delete, in whole or in part, the data of the user except— (i)in cases where there is a legal obligation of the commercial data operator to maintain the data;
(ii)for the establishment, exercise, or defense of legal claims; or  (iii)if the data is necessary to detect security incidents, protect against malicious, deceptive, fraudulent, or illegal activity, or assist in the prosecution of those responsible for such activity.
(B)RetentionA commercial data operator may not retain any more user data than is necessary to carry out an activity described in clauses (i) through (iii) of subparagraph (A).  (3)AvailabilityA commercial data operator shall ensure that all disclosures required under subsection (a) are available to a user of the commercial data operator—
(A)on and after the date on which the commercial data operator makes the identification; and  (B)through any normal mechanism by which a user may interact with the online service provided by the commercial data operator.
(4)Unfair and deceptive acts or practices
(A)Unfair or deceptive acts or practicesA violation of this subsection shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under section 18(a)(1)(B) of the Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).  (B)Powers of Federal Trade Commission (i)In generalThe Federal Trade Commission shall enforce this subsection in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and made a part of this subsection.
(ii)Privileges and immunitiesAny person who violates this subsection shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act (15 U.S.C. 41 et seq.).  (b)RegulationsNot later than 1 year after the date of enactment of this Act, the Federal Trade Commission shall promulgate regulations carrying out subsection (a).
4.SEC disclosures
(a)In generalSection 13 of the Securities Exchange Act of 1934 (15 U.S.C. 78m) is amended by adding at the end the following:  (s)Disclosure relating to aggregate value of user data held by commercial data operators (1)DefinitionsIn this subsection:
(A)Commercial data operatorThe term commercial data operator means an entity acting in its capacity as a consumer online services provider or data broker that— (i)generates a material amount of revenue directly from the use, collection, processing, sale, or sharing of the user data; and
(ii)has more than 100,000,000 unique monthly visitors or users in the United States for a majority of months during the previous 1-year period;  (B)UserThe term user means an individual consumer who uses an online service designed for consumer use by a commercial data operator.
(C)User dataThe term user data means any information that identifies, relates to, describes, is capable of being associated with, or could reasonably be linked with an individual user, whether directly submitted to the commercial data operator by the user or derived from the observed activity of the user by the commercial data operator.  (2)DisclosureEach issuer that is, or is a consolidated subsidiary of, a commercial data operator and is required to file an annual or quarterly report under subsection (a) shall disclose in that report the aggregate value, if material, of—
(A)user data that the commercial data operator holds;  (B)contracts with third parties for the collection of user data through the online service provided by the commercial data operator; and
(C)any other item that the Commission determines, by rule, is necessary or useful for the protection of investors and in the public interest.  (3)Valuation methodology (A)In generalThe Commission, in consultation with appropriate standards settings organizations, shall develop a method or methods for calculating the value of user data required to be disclosed under paragraph (2).
(B)ConsiderationsIn developing the method under subparagraph (A), the Commission shall promote comparability in calculating the value of data across commercial data operators that utilize user data in a similar manner while taking into account the potential need to develop distinct methods for calculating the value of data for different uses, sectors, and business models. .  (b)Qualitative disclosureNot later than 1 year after the date of enactment of this subsection, the Commission shall amend section 229.306 of title 17, Code of Federal Regulations, to require a commercial data operator that is an issuer subject to section 13 or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m, 78o(d)) to provide quantitative and qualitative disclosures about the value of user data held, including—
(1)technical and legal measures in place to protect user data held by the commercial data operator;  (2)an assessment of financial and legal risks associated with storing the type and quantity of user data held by the commercial data operator;
(3)each source of user data held by the commercial data operator, whether by sale, a direct consumer relationship, an indirect consumer relationship, or other means;  (4)each discrete revenue generating operation of the commercial data operator and any subsidiary or affiliate that relies on user data;
(5)the entry into any contract valued at more than $10,000,000 with a third party for the collection, licensing, or sharing by the third party pursuant to an agreement with the commercial data operator;  (6)the amount of revenue derived from obtaining, collecting, processing, selling, using or sharing user data during the reporting period;
(7)how changes in the measurement of aggregate fair value of user data affect the reported performance and cash flows of the issuer; and  (8)any acquisition of user data in the preceding reporting period valued at more than $100,000,000.
(c)Report
(1)In generalNot later than 3 years after the date of enactment of this Act, the Commission shall submit to the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives a report on— (A)the nature, timing, and extent of the disclosure practices of commercial data operators;
(B)an assessment of the valuation methodologies and practices employed by commercial data operators in developing and submitting disclosures to the public;  (C)an evaluation of the methods of delivery and presentation of the disclosures required by this Act, and the amendments made by this Act; and
(D)recommendations for the improvement of the methods described in paragraph (3), including developing standards to enhance comparability and utility for investors.  (2)RulemakingNot later than 180 days after the date on which the report required under paragraph (1) is submitted, the Commission shall promulgate a proposed regulation implementing the recommendations described in paragraph (1)(D).


113 S1318 IS: Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians Act
U.S. Senate
2013-07-18
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		II
		113th CONGRESS
		1st Session
		S. 1318
		IN THE SENATE OF THE UNITED STATES

			July 18, 2013
			Mr. Schumer (for himself
			 and Mr. Grassley) introduced the
			 following bill; which was read twice and referred to the
			 Committee on
			 Finance

		A BILL
		To amend title XIX of the Social Security Act to cover
		  physician services delivered by podiatric physicians to ensure access by
		  Medicaid beneficiaries to appropriate quality foot and ankle care, to amend
		  title XVIII of such Act to modify the requirements for diabetic shoes to be
		  included under Medicare, and for other purposes.

		1.Short titleThis Act may be cited as the
			 Helping Ensure Life- and Limb-Saving
			 Access to Podiatric Physicians Act or the
			 HELLPP
			 Act.
		2.Including
			 podiatrists as physicians under the Medicaid program
			(a)In
			 generalSection 1905(a)(5)(A)
			 of the Social Security Act (42 U.S.C. 1396d(a)(5)(A)) is amended by striking
			 section 1861(r)(1) and inserting paragraphs (1) and (3)
			 of section 1861(r).
			(b)Effective
			 date
				(1)In
			 generalExcept as provided in
			 paragraph (2), the amendment made by subsection (a) shall apply to services
			 furnished on or after January 1, 2014.
				(2)Extension of
			 effective date for State law amendmentIn the case of a State plan under title XIX
			 of the Social Security Act (42 U.S.C. 1396 et seq.) which the Secretary of
			 Health and Human Services determines requires State legislation in order for
			 the plan to meet the additional requirement imposed by the amendment made by
			 subsection (a), the State plan shall not be regarded as failing to comply with
			 the requirements of such title solely on the basis of its failure to meet these
			 additional requirements before the first day of the first calendar quarter
			 beginning after the close of the first regular session of the State legislature
			 that begins after the date of enactment of this Act. For purposes of the
			 previous sentence, in the case of a State that has a 2-year legislative
			 session, each year of the session is considered to be a separate regular
			 session of the State legislature.
				3.Modifications to
			 requirements for diabetic shoes to be included under medical and other health
			 services under Medicare
			(a)In
			 generalSection 1861(s)(12)
			 of the Social Security Act (42 U.S.C. 1395x(s)(12)) is amended to read as
			 follows:

					(12)subject to section 4072(e) of the Omnibus
				Budget Reconciliation Act of 1987, extra-depth shoes with inserts or custom
				molded shoes (in this paragraph referred to as therapeutic
				shoes) with inserts for an individual with diabetes, if—
						(A)the physician who
				is managing the individual’s diabetic condition—
							(i)documents that the
				individual has diabetes;
							(ii)certifies that
				the individual is under a comprehensive plan of care related to the
				individual’s diabetic condition; and
							(iii)documents
				agreement with the prescribing podiatrist or other qualified physician (as
				established by the Secretary) that it is medically necessary for the individual
				to have such extra-depth shoes with inserts of custom molded shoes with
				inserts;
							(B)the therapeutic
				shoes are prescribed by a podiatrist or other qualified physician (as
				established by the Secretary) who—
							(i)examines the
				individual and determines the medical necessity for the individual to receive
				the therapeutic shoes; and
							(ii)communicates in
				writing the medical necessity to a certifying doctor of medicine or osteopathy
				for the individual to have therapeutic shoes along with findings that the
				individual has peripheral neuropathy with evidence of callus formation, a
				history of pre-ulcerative calluses, a history of previous ulceration, foot
				deformity, previous amputation, or poor circulation; and
							(C)the therapeutic
				shoes are fitted and furnished by a podiatrist or other qualified supplier
				individual (as established by the Secretary), such as a pedorthist or
				orthotist, who is not the physician described in subparagraph (A) (unless the
				Secretary finds that the physician is the only such qualified individual in the
				area);
						.
			(b)Effective
			 dateThe amendment made by subsection (a) shall apply with
			 respect to items and services furnished on or after January 1, 2014.
			4.Budget savings:
			 strengthening Medicaid program integrity through continuous levy on payments to
			 Medicaid providers and suppliers
			(a)In
			 generalSection 6331(h)(2) of the Internal Revenue Code of 1986
			 (defining specified payment) is amended by striking and at the
			 end of subparagraph (B), by striking the period at the end of subparagraph (C)
			 and inserting , and, and by adding at the end the following new
			 subparagraph:

					(D)any payment to any
				Medicaid provider or supplier under a State plan under title XIX of the Social
				Security
				Act.
					.
			(b)Effective
			 dateThe amendments made by this section shall apply to levies
			 issued after the date of the enactment of this Act.


114 HR 1412 IH: Arizona Borderlands Protection and Preservation Act
U.S. House of Representatives
2015-03-17
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I
114th CONGRESS 1st Session
H. R. 1412
IN THE HOUSE OF REPRESENTATIVES

March 17, 2015
Mr. Salmon (for himself, Mr. Franks of Arizona, Mr. Schweikert, and Mr. Gosar) introduced the following bill; which was referred to the Committee on Natural Resources, and in addition to the Committee on Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL
To achieve border security on certain Federal lands along the Southern border.

1.Short titleThis Act may be cited as the Arizona Borderlands Protection and Preservation Act. 2.DefinitionsIn this Act:
(1)Border securityThe term border security means— (A)the functioning and operational capability to conduct continuous and integrated manned or unmanned, monitoring, sensing, or surveillance of 100 percent of Southern border mileage or the immediate vicinity of the Southern border; and
(B)the apprehension or turn back of not fewer than 90 percent of illegal entries across the Southern border during a fiscal year. (2)Federal landsThe term Federal lands includes all land under the control of the Secretary concerned that is located within the Southwest border region in the Tucson and Yuma sectors of United States Border Patrol along the Southern border.
(3)SecretaryThe term Secretary means the Secretary of Homeland Security. (4)Secretary concernedThe term Secretary concerned means—
(A)with respect to land under the jurisdiction of the Secretary of Agriculture, the Secretary of Agriculture; and (B)with respect to land under the jurisdiction of the Secretary of the Interior, the Secretary of the Interior.
(5)Southern borderThe term Southern border means the international border between the United States and Mexico. 3.Support for border security needs (a)In generalTo achieve border security on Federal lands—
(1)the Secretary and the Secretary concerned, notwithstanding any other provision of law, shall provide U.S. Customs and Border Protection personnel with immediate access to Federal lands for security activities, including— (A)routine motorized patrols; and
(B)the deployment of communications, surveillance, and detection equipment; and (2)the Secretary concerned may provide education and training to U.S. Customs and Border Protection personnel on the natural and cultural resources present on individual Federal land units.
(b)Intermingled State and private landSubsection (a) shall not apply to any private or State-owned land within the boundaries of Federal lands.


109 HR 3154 IH: Infectious Diseases Research and Development Act of 2005
U.S. House of Representatives
2005-06-30
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I
109th CONGRESS
1st Session
H. R. 3154
IN THE HOUSE OF REPRESENTATIVES

June 30, 2005
Mrs. Cubin (for herself, Mr. Baird, Mr. Matheson, Mr. Baker, Mr. LaHood, Mr. Bonner, Mr. Davis of Alabama, Mr. Gingrey, and Mr. Weldon of Florida) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL
To provide incentives for pharmaceutical companies, biotechnology companies, and medical device companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent an infectious disease, and for other purposes.

1.Short titleThis Act may be cited as the Infectious Diseases Research and Development Act of 2005.
2.FindingsThe Congress finds as follows:
(1)Infections caused by resistant bacteria can strike anyone, including the young and the old, the healthy and the chronically ill. Antibiotic resistance is a particularly serious problem for patients whose immune systems are compromised, such as people with HIV/AIDS and patients in critical care units.
(2)About 2 million people acquire bacterial infections in United States hospitals each year, and 90,000 die as a result. About 70 percent of those infections are resistant to at least one drug. The trends toward increasing numbers of infection and increasing drug resistance show no sign of abating.
(3)Resistant pathogens lead to higher health care costs because they often require more expensive drugs and extended hospital stays. The total cost to United States society is nearly $5,000,000,000 annually.
(4)The Institute of Medicine, the Infectious Diseases Society of America, and Federal officials have identified antibiotic resistance and the dearth of antibiotic research and development as increasing threats to United States public health.
(5)Without innovative public policy and additional financial support, fewer and fewer antibiotics will be available to treat the increasing number of drug-resistant and dangerous microbes that threaten Americans and the global community.
(6)The pipeline of new antibiotics is drying up. Major pharmaceutical companies are losing interest in the antibiotics market because these drugs simply are not as profitable as drugs that treat chronic (long-term) conditions and lifestyle issues.
(7)Drug research and development is expensive, risky, and time-consuming. An aggressive research and development program initiated today would likely require 10 or more years and an investment of $800,000,000 to $1,700,000,000 to bring a new drug to market.
(8)Resistant bacterial infections are not only a public health problem; they have national and global security implications as well.
(9)The Institute of Medicine in its 2004 report entitled The Threat of Pandemic Influenza stated that the United States is not adequately prepared to deal with the next pandemic of influenza.
(10)The Centers for Disease Control and Prevention estimates that, without adequate preparation, 100,000 to 250,000 deaths could occur in the United States from a mild pandemic of influenza.
(11)The limited influenza vaccine market and few dedicated manufacturers pose a substantial challenge to the Nation’s preparedness efforts. Currently, there are two manufacturers of influenza vaccine for the United States market. In 2004, the Food and Drug Administration suspended a manufacturer’s license due to bacterial contamination. This action led to a shortage of injectable influenza vaccine in the United States.
(12)New rapid diagnostics would greatly reduce the cost and time needed to conduct clinical trials for new anti-infectives. For many infectious diseases, there currently are no rapid diagnostic tests available to assist in identifying eligible patients for clinical trials. Cutting costs and time will serve as incentives for greater investment in this area. In addition, new rapid diagnostics will permit physicians to diagnose specific bacterial infections in their patients. This will enable physicians to prescribe the most appropriate therapies, including antibiotics, which will slow the evolution of new antimicrobial resistance.
3.DefinitionsIn this Act:
(1)The term antibiotic drug has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
(2)The term antiviral means a drug or biological product intended for human use that impedes the reproduction of a virus.
(3)The term biological product has the meaning given to that term in section 351 of the Public Health Service Act (42 U.S.C. 262).
(4)The term device has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
(5)The term diagnostic test means a device or product used to detect the presence, concentration, or characteristics of an infectious human disease.
(6)The term drug has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
(7)The term qualified infectious disease product means any antibiotic drug, antiviral, diagnostic test, or vaccine that is developed for the purpose of treating, detecting, preventing, or identifying—
(A)a qualifying pathogen (for the period beginning on the date of the enactment of this Act and ending on commencement of the period described in subparagraph (B)); or
(B)an infectious pathogen identified by the Commission under section 319E–1(b) of the Public Health Service Act, as added by section 10 of this Act (for the period beginning on the date on which the Commission on Infectious Diseases Product Development first identifies infectious pathogens under such section).
(8)The term qualifying pathogen means—
(A)community-acquired methicillin-resistant staphylococcus areus (CA–MRSA);
(B)life-threatening gram negative bacteria, such as Escherichia coli (E. coli), Acinetobacter, Klebsiella species, and Pseudomonas aeruginosa;
(C)influenza; or
(D)any other infectious pathogen identified for purposes of this Act by the Secretary of Health and Human Services, in concurrence with infectious disease clinicians and appropriate professional associations, as a significant threat to public health because of drug resistance or other factors (or likely to become such a threat).
(9)The term vaccine means a vaccine intended for human use.
4.Liability protection
(a)ApplicabilityThis section applies when—
(1)an individual is injured or dies as the result of a use or misuse of a qualified infectious disease product (other than a vaccine);
(2)a person is entitled, by reason of such injury or death, to recover damages from a manufacturer of the product; and
(3)such manufacturer was, as of the date of such injury or death, in substantial compliance with all applicable Federal requirements with respect to the product.
(b)Federal action requiredThe district courts of the United States shall have jurisdiction over a civil action covered by subsection (a). Such a civil action may not be brought in any Federal, State, or local court other than a district court of the United States.
(c)Limitation on punitive damagesIn a civil action covered by subsection (a), the person may recover punitive damages from the manufacturer to the extent otherwise available by law, except that—
(1)it must be proven, in addition to any other matter that must be proven, that the manufacturer—
(A)acted with malicious intent to injure the individual; or
(B)deliberately failed to avoid unnecessary injury that the manufacturer knew the individual was substantially certain to suffer; and
(2)the person may not recover punitive damages from the manufacturer if the person does not recover compensatory damages from the manufacturer.
(d)Limitation on non-economic damagesIn a civil action covered by subsection (a), the person may recover non-economic damages from the manufacturer to the extent otherwise available by law, except that the amount of such damages may not exceed $250,000.
5.Patent protection
(a)PurposeThe purpose of this section is to provide an incentive for research and development relating to qualified infectious disease products.
(b)Restoration of patent terms
(1)In generalChapter 14 of title 35, United States Code, is amended by inserting after section 156 the following:

156a.Restoration of patent terms relating to qualified infectious disease products
(a)DefinitionsIn this section—
(1)the term diagnostic test has the meaning given to that term in section 3 of the Infectious Diseases Research and Development Act of 2005;
(2)the term qualified infectious disease product has the meaning given to that term in section 3 of the Infectious Diseases Research and Development Act of 2005;
(3)the term regulatory review period means the period of time that—
(A)starts on the date that is the later of—
(i)the date that an eligible patent sought to be extended under this section is issued;
(ii)the date that an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective for the product; or
(iii)the date on which an investigational device exemption is approved pursuant to section 520(g) of the Federal Food, Drug and Cosmetic Act; and
(B)ends on the date that is—
(i)in the case of a drug, the date on which an application submitted for such drug under section 505(b) of the Federal Food, Drug, and Cosmetic Act is approved;
(ii)in the case of a biologic, the date on which an application submitted under section 351 of the Public Health Service Act is approved; or
(iii)in the case of a medical device, the date on which an application for premarket approval submitted for such device under the Federal Food, Drug, and Cosmetic Act is approved; and
(4)the term eligible patent means a patent that—
(A)claims a qualified infectious disease product, or claims an active ingredient of such product, or a process of making or using the product or an active ingredient of such product; and
(B)is owned by or licensed to an entity that sponsored the application described in paragraph (3)(B) for the product.
(b)Patent term extensionThe term of an eligible patent shall be extended from the expiration date of the patent that would otherwise apply, which shall include any patent term adjustment granted under section 154(b), by a period equal to the number of days in the regulatory review period if each of the following is met:
(1)An application in conformance with the requirements of subsection (c) is submitted to the Director by either the owner of record of the patent or its agent by the later of 60 days after the end of the regulatory review period or 45 days after issuance of the patent.
(2)The patent that is the basis of the application has not been previously extended under this section, or under section 156.
(3)The term of the patent that is the basis of the application has not expired before the date that the application is submitted under subsection (c).
(4)The regulatory review period for the qualified infectious disease product has not been relied upon to support an application to extend the term of another patent under this section or under section 156.
(c)Administrative provisions
(1)In generalTo obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director.
(2)ContentThe application shall contain—
(A)a description of the qualified infectious disease product and the Federal statute under which regulatory review occurred;
(B)the identity of the patent for which an extension is sought under this section; and
(C)such other information as the Director may require including to establish that the applicant meets the requirements of this section.
(3)Irrevocable electionThe submission of an application under this section is an irrevocable election of the application of this section to the patent that is the basis of the application. A patent that has been the basis of an application made under this section may not be the subject of an application made under section 156 or 158..
(2)Technical and conforming amendmentThe table of sections for chapter 14 of title 35, United States Code, is amended by inserting after the item relating to section 156 the following:

156a. Restoration of patent terms relating to qualified infectious disease products.
(c)Extension of patent terms
(1)Certification of successful development
(A)ApplicationAn entity may submit to the Secretary of Health and Human Services (in this section referred to as the Secretary) an application for certification that the entity—
(i)has successfully developed a qualified infectious disease prevention product, as that term is defined in section 158 of title 35, United States Code; and
(ii)the entity may receive a patent term extension under the provisions of such section.
(B)CertificationWith respect to an application submitted by an entity under this paragraph, the Secretary shall—
(i)approve the application if the Secretary determines that the entity has successfully developed the qualified infectious disease prevention product;
(ii)deny the application if the Secretary determines that the entity has not successfully developed the product; and
(iii)notify the entity of the approval or denial, and the reasons therefore.
(C)Successful developmentIn carrying out subparagraph (B), the Secretary shall determine that an entity has successfully developed a product if—
(i)the product is a qualified infectious disease prevention product; and
(ii)the product has been approved under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
(D)Effect of certificationIf the Secretary approves an application submitted by an entity under this paragraph, the entity may use the patent extension provisions of section 158 of title 35, United States Code.
(E)ApplicationThis paragraph and the amendment made by paragraph (2) apply only with respect to a product that is approved under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act after the date of the enactment of this Act.
(2)In generalChapter 14 of title 35, United States Code, is amended by adding at the end the following:

158.Extension of patent terms relating to qualified infectious disease prevention products.
(a)DefinitionsIn this section:
(1)The term qualified infectious disease prevention product means a qualified infectious disease prevention product, as that term is defined in section 3 of the Infectious Diseases Research and Development Act of 2005.
(2)The term designated product means a drug, antibiotic drug, or device, as those terms are defined in section 201 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321), or a biological product, as that term is defined in section 351 of the Public Health Service Act.
(3)The term diagnostic test has the meaning given to that term in section 3 of the Infectious Diseases Research and Development Act of 2005.
(4)The term eligible entity means a natural or legal person that has successfully developed a qualified infectious disease prevention product.
(5)The term eligible patent means a patent that at the time the eligible entity entered into the contract to develop the qualified infectious disease prevention product involved, was owned by or licensed to that eligible entity, and claims a designated product, an active ingredient of a designated product, a method of making or using a designated product or a method of making or using an active ingredient of a designated product.
(b)Patent term extensionThe term of an eligible patent shall be extended for a period of 2 years, in addition to the term which would otherwise apply except for this section, if—
(1)an application under subsection (c) is submitted to the Director by either the owner of record of the patent or its agent on or before the date specified in subsection (c)(3);
(2)the patent has not been previously extended under this section, or under section 156 or 156a;
(3)the patent has not expired before the date that the application is submitted;
(4)the term of no other patent has been extended based on the certification being relied upon by the eligible entity to request extension of the patent; and
(5)no other patent that claims the designated product, an active ingredient of the designated product, a method of making or using a designated product or a method of making or using an active ingredient of a designated product has been extended under this section or under section 156a.
(c)Administrative provisions
(1)In generalTo obtain an extension of the term of a patent under this section, the owner of record of the patent or the agent of the owner shall submit an application to the Director.
(2)ContentAn application filed under this section shall contain—
(A)a description of the approved qualified infectious disease prevention product and the Federal statute under which regulatory review occurred;
(B)the identity of the eligible patent for which an extension is sought under this section;
(C)the identity of the eligible entity and the applicant (if different from the eligible entity);
(D)the identity of the designated product to which the eligible patent relates;
(E)information concerning the certification specified in section 5(c)(1) of the Infectious Diseases Research and Development Act of 2005 being relied upon as the basis of the extension being requested;
(F)information indicating that the entity owned or licensed the eligible patent at the time it entered into the contract to develop the qualified infectious disease prevention product; and
(G)such other information as the Director may require including to establish that the applicant meets the requirements of this section.
(3)Submission of applicationAn application under this section shall be submitted to the Director within 60 days after the date of the certification specified in section 5(c)(1) of the Infectious Diseases Research and Development Act of 2005 that is being relied upon to request extension of the patent that is the subject of the application.
(d)Irrevocable electionThe submission of an application under this section is an irrevocable election of the application of this section to the patent that is the basis of the application. A patent that has been the basis of an application made under this section may not be the subject of an application made under sections 156 or 156a..
(3)Technical and conforming amendmentThe table of sections for chapter 14 of title 35, United States Code, is amended by adding at the end the following:

158. Extension of patent terms relating to countermeasure products..
6.Accelerated approval of qualified infectious disease products
(a)Designation as fast-track product
(1)In generalThe Secretary of Health and Human Services shall designate qualified infectious disease products as fast-track products, pursuant to section 506 or section 515(d)(5), as applicable, of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e(5)). Such designation may be made prior to the submission of—
(A)a request for designation by the sponsor or applicant; or
(B)an application for the investigation of the qualified infectious disease product under section 505 or 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262).
(2)Rule of constructionNothing in this section shall be construed to prohibit a sponsor or applicant from declining a designation under paragraph (1).
(b)Grants for clinical testsSubpart 6 of part C of title IV of the Public Health Service Act (42 U.S.C. 285f et seq.) is amended by adding at the end the following:

447C.Clinical trials on qualified infectious disease products
(a)GrantsIn carrying out section 446, the Director of the Institute shall expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products, including by awarding grants for such clinical trials.
(b)DefinitionIn this section, the term qualified infectious disease product has the meaning given to that term in section 3 of the Infectious Diseases Research and Development Act of 2005..
7.Tax credit for medical research related to developing qualified infectious disease products
(a)In generalSubpart D of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986 (relating to business-related credits) is amended by adding at the end the following new section:

45J.Credit for medical research related to developing qualified infectious disease products
(a)General ruleFor purposes of section 38, the infectious disease research credit determined under this section for the taxable year is an amount equal to 35 percent of the qualified infectious disease research expenses for the taxable year.
(b)Qualified infectious disease research expensesFor purposes of this section—
(1)Qualified infectious disease research expensesExcept as otherwise provided in this subsection, the term qualified infectious disease research expenses means the amounts which are paid or incurred by the taxpayer during the taxable year with respect to any research and development of qualified infectious disease products which would be described in subsection (b) of section 41 if such subsection were applied with the modifications set forth in paragraph (2).
(2)Modifications; increased incentive for contract research paymentsFor purposes of paragraph (1), subsection (b) of section 41 shall be applied—
(A)by substituting qualified infectious disease research for qualified research each place it appears in paragraphs (2) and (3) of such subsection, and
(B)by substituting 100 percent for 65 percent in paragraph (3)(A) of such subsection.
(3)Exclusion for amounts funded by grants, etcThe term qualified infectious disease research expenses shall not include any amount to the extent such amount is funded by any grant, contract, or otherwise by another person (or any governmental entity).
(4)Qualified infectious disease researchThe term qualified infectious disease research means qualified research (as defined in section 41(d)) which relates to the development of a qualified infectious disease product, except that qualified infectious disease research shall include expenses related to re-formulating existing qualified infectious disease products.
(5)Qualified infectious disease productsThe term qualified infectious disease products has the meaning given such term in section 3 of the Infectious Diseases Research and Development Act of 2005.
(c)Coordination with credit for increasing research expenditures
(1)In generalExcept as provided in paragraph (2), any qualified infectious disease research expenses for a taxable year to which an election under this section applies shall not be taken into account for purposes of determining the credit allowable under section 41 for such taxable year.
(2)Expenses included in determining base period research expensesAny qualified infectious disease research expenses for any taxable year which are qualified research expenses (within the meaning of section 41(b)) shall be taken into account in determining base period research expenses for purposes of applying section 41 to subsequent taxable years.
(d)Special rules
(1)Certain rules made applicableRules similar to the rules of paragraphs (1) and (2) of section 41(f) shall apply for purposes of this section.
(2)Coordination with credit for clinical testing expenses for certain drugs for rare diseasesAny qualified infectious disease research expenses for a taxable year to which an election under this section applies shall not be taken into account for purposes of determining the credit allowable under section 45C for such taxable year.
(3)ElectionThis section shall apply to any taxpayer for any taxable year only if such taxpayer elects (at such time and in such manner as the Secretary may by regulations prescribe) to have this section apply for such taxable year..
(b)Inclusion in general business creditSection 38(b) of the Internal Revenue Code of 1986 is amended by striking plus at the end of paragraph (18), by striking the period at the end of paragraph (19) and inserting , plus, and by adding at the end the following new paragraph:

(20)the infectious disease research credit determined under section 45J..
(c)Denial of double benefitSection 280C of the Internal Revenue Code of 1986 (relating to certain expenses for which credits are allowable) is amended by adding at the end the following new subsection:

(e)Credit for qualified infectious disease research expenses
(1)In generalNo deduction shall be allowed for that portion of the qualified infectious disease research expenses (as defined in section 45J(b)) otherwise allowable as a deduction for the taxable year which is equal to the amount of the credit determined for such taxable year under section 45J(a).
(2)Certain rules to applyRules similar to the rules of paragraphs (2), (3), and (4) of subsection (c) shall apply for purposes of this subsection..
(d)Deduction for unused portion of creditSection 196(c) of the Internal Revenue Code of 1986 (defining qualified business credits) is amended by striking and at the end of paragraph (11), by striking the period at the end of paragraph (12) and inserting , and, and by adding at the end the following new paragraph:

(13)the infectious disease research credit determined under section 45J(a) (other than such credit determined under the rules of section 280C(e)(2))..
(e)Technical amendmentThe table of sections for subpart D of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:

Sec. 45J. Credit for medical research related to developing qualified infectious disease products.
(f)Effective dateThe amendments made by this section shall apply to taxable years beginning after December 31, 2004.
8.Incentives for the construction of qualified infectious disease products manufacturing facilities
(a)Qualified infectious disease products manufacturing facilities investment tax credit
(1)Allowance of creditSection 46 of the Internal Revenue Code of 1986 (relating to amount of investment credit) is amended by striking and at the end of paragraph (1), by striking the period at the end of paragraph (2) and inserting , and, and by adding at the end the following new paragraph:

(3)the qualified infectious disease products manufacturing facilities investment credit..
(2)Amount of creditSubpart E of part IV of subchapter A of chapter 1 of such Code (relating to rules for computing investment credit) is amended by inserting after section 48 the following new section:

48A.Qualified infectious disease products manufacturing facilities credit
(a)In generalFor purposes of section 46, the qualified infectious disease products manufacturing facilities investment credit for any taxable year is an amount equal to 20 percent of the qualified investment for such taxable year.
(b)Qualified investment
(1)In generalFor purposes of subsection (a), the qualified investment for any taxable year is the basis of each qualified infectious disease products manufacturing facilities property placed in service by the taxpayer during such taxable year.
(2)Qualified infectious disease products manufacturing facilities propertyFor purposes of this section, the term qualified infectious disease products manufacturing facilities property means real and tangible personal property—
(A)
(i)the original use of which commences with the taxpayer, or
(ii)which is acquired through purchase (as defined by section 179(d)(2)),
(B)which is depreciable under section 167,
(C)which is used for the manufacture, distribution, or research and development of qualified infectious disease products, and
(D)which is in compliance with any standards and regulations which are promulgated by the Food and Drug Administration, the Occupational Safety and Health Administration, or the Environmental Protection Agency and which are applicable to such property.
(3)Qualified infectious disease productsFor purposes of this subsection, the term qualified infectious disease products has the meaning given such term in section 3 of the Infectious Diseases Research and Development Act of 2005.
(c)Certain progress expenditure rules made applicableRules similar to rules of subsections (c)(4) and (d) of section 46 (as in effect on the day before the date of the enactment of the Revenue Reconciliation Act of 1990) shall apply for purposes of this subsection.
(d)TerminationThis subsection shall not apply to any property placed in service after December 31, 2009..
(b)Technical amendments
(1)Clause (iii) of section 49(a)(1)(C) of such Code is amended to read as follows:

(iii)the basis of any qualified infectious disease products manufacturing facilities property..
(2)Subparagraph (E) of section 50(a)(2) of such Code is amended by inserting or 48A(c) before the period.
(3)The table of sections for subpart E of part IV of subchapter A of chapter 1 of such Code is amended by inserting after the item relating to section 48 the following:

Sec. 48A. Qualified infectious disease products manufacturing facilities credit.
(c)Effective dateThe amendments made by this section shall apply to property placed in service after December 31, 2004, under rules similar to the rules of section 48(m) of the Internal Revenue Code of 1986 (as in effect on the day before the date of enactment of the Revenue Reconciliation Act of 1990).
9.Combating antimicrobial resistanceSubsection (g) of section 319E of the Public Health Service Act (42 U.S.C. 247d–5) is amended to read as follows:

(g)Authorization of appropriations
(1)AuthorizationThere are authorized to be appropriated to carry out this section $40,000,000 for fiscal year 2001 and such sums as may be necessary for each of fiscal years 2002 through 2006.
(2)Allocation
(A)In generalOf the amount appropriated to carry out this section for a fiscal year, the Secretary shall make available not less than $25,000,000 for activities of the Centers for Disease Control and Prevention under subsections (b), (c), (d), and (e).
(B)Ratable reductionIf amounts appropriated to carry out this section for a fiscal year are less than $25,000,000, the Secretary shall ratably reduce the amount to be made available under subparagraph (A)..
10.Commission on Infectious Diseases Product DevelopmentPart B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319E the following:

319E–1.Commission on Infectious Diseases Product Development
(a)EstablishmentThere is established a permanent commission to be known as the Commission on Infectious Diseases Product Development.
(b)Duties
(1)Identification of pathogensThe Commission shall—
(A)not later than the end of calendar year 2006, identify the infectious pathogens that are (or are likely to become) a significant threat to public health because of drug resistance or other factors;
(B)taking into consideration the risks and benefits to public health, make recommendations to the Secretary on how best to address such pathogens, including through the development of qualified infectious disease products to prevent, detect, and treat such pathogens; and
(C)periodically review and update the list of pathogens identified under subparagraph (A).
(2)RecommendationsNot later than 90 days after the date of the enactment of this section, the Commission shall submit a report to the Secretary containing recommendations on the actions the Secretary should take to ensure that a sufficient quantity of vaccines and anti-virals are available to treat the American population in the event of a pandemic influenza outbreak.
(c)Antimicrobial Resistance Task ForceIn carrying out this section, the Commission shall consult with the Antimicrobial Resistance Task Force established under section 319–E.
(d)Membership
(1)In generalThe Commission shall be composed of—
(A)not more than 19 voting members appointed by the President under paragraph (2); and
(B)the nonvoting ex officio members listed in paragraph (3).
(2)Voting membersThe President shall appoint not more than 19 voting members of the Commission as follows:
(A)12 of the voting members shall be appointed from among the leading representatives (including individuals in industry) of the infectious disease medical, research, pharmaceutical, and biological communities.
(B)7 of the voting members—
(i)shall be appointed from among the general public; and
(ii)shall include leaders in the fields of public policy, law, health policy, economics, and management.
(3)Nonvoting ex officio membersThe Commission shall include the following nonvoting ex officio members:
(A)The Secretary of Homeland Security (or the Secretary’s designee).
(B)The Secretary of Health and Human Services (or the Secretary’s designee).
(C)The Director of the National Institutes of Health (or the Director’s designee).
(D)The Commissioner of Food and Drugs (or the Commissioner’s designee).
(E)The Director of the Centers for Disease Control and Prevention (or the Director’s designee).
(F)The Assistant Secretary of Defense for Health Affairs (or the Assistant Secretary’s designee).
(G)The Under Secretary for Health of the Department of Veterans Affairs (or the Under Secretary’s designee).
(H)The Secretary of Agriculture (or the Secretary’s designee).
(I)Such additional ex officio members as the Secretary determines necessary for the Commission to carry out its functions.
(4)TermsEach member appointed under paragraph (2) shall be appointed for a term of 6 years.
(5)VacanciesAny member appointed to fill a vacancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member’s term until a successor has taken office. A vacancy in the Commission shall be filled in the manner in which the original appointment was made.
(6)Basic pay
(A)Rates of payMembers of the Commission who are officers or employees of the United States shall not receive any compensation for service on the Commission. The other members of the Commission shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the Commission, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–15 of the General Schedule.
(B)Travel expensesEach member of the Commission shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5, United States Code.
(7)ChairpersonThe Chairperson of the Commission shall be a representative of the infectious disease medical or research community selected by the President from among the members appointed under subsection (d)(2). The term of office of the Chairperson shall be 2 years.
(8)MeetingsThe Commission shall meet at the call of the Chairperson of the Commission or the Secretary, but not less than 4 times each year.
(e)Director and Staff of Commission; Experts and Consultants
(1)DirectorThe Commission shall have a Director who shall be appointed by the Commission.
(2)StaffThe Director of the Commission may appoint such additional personnel as the Director considers appropriate.
(3)Applicability of Certain Civil Services LawsThe Director and staff of the Commission shall be appointed without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, and shall be paid without regard to the provisions of chapter 51 and subchapter III of chapter 53 of that title relating to classification of positions and General Schedule pay rates, except that the rate of pay for the Director and staff of the Commission may not exceed the daily equivalent of the annual rate in effect for grade GS–15 of the General Schedule.
(4)Experts and ConsultantsThe Commission may procure temporary and intermittent services under section 3109(b) of title 5, United States Code.
(5)Staff of Federal AgenciesUpon the request of the Commission, the head of any Federal agency may detail, without reimbursement, any of the personnel of such agency to the Commission to assist in carrying out the duties of the Commission. Any such detail shall not interrupt or otherwise affect the civil service status or privileges of the Federal employee.
(f)Powers of Commission
(1)Hearings and sessionsThe Commission may, for the purpose of carrying out this Act, hold hearings, sit and act at times and places, take testimony, and receive evidence as the Commission considers appropriate.
(2)Powers of members and agentsAny member or agent of the Commission may, if authorized by the Commission, take any action which the Commission is authorized to take by this section.
(3)MailsThe Commission may use the United States mails in the same manner and under the same conditions as other departments and agencies of the United States.
(4)Administrative support servicesUpon the request of the Commission, the Administrator of General Services shall provide to the Commission, on a reimbursable basis, the administrative support services necessary for the Commission to carry out its responsibilities under this section.
(g)Annual reportsNot later than the end of calendar year 2006 and annually thereafter, the Commission shall prepare and submit to the President, the appropriate committees of the Congress, and the Secretary of Health and Human Services a report that contains a detailed statement of the recommendations, findings, and conclusions of the Commission. Each such report shall include an updated list of the infectious pathogens identified by the Commission pursuant to subsection (b)(1)(A).
(h)DefinitionsIn this section:
(1)The term Commission means the Commission on Infectious Diseases Product Development established under this section.
(2)The term qualified infectious disease product has the meaning given to that term in section 3 of the Infectious Diseases Research and Development Act of 2005.
(i)Authorization of appropriationsTo carry out this section, there are authorized to be appropriated $3,000,000 for fiscal year 2006 and such sums as may be necessary for each subsequent fiscal year..
11.Clinical trial guidelines for antibiotic drugsChapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following:

511.Clinical trial guidelines for antibiotic drugs
(a)In generalNot later than 1 year after the date of enactment of the Infectious Diseases Research and Development Act of 2005, the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidelines for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat resistant pathogens, bacterial meningitis, acute bacterial sinusitis, acute bacterial otitis media, and acute exacerbation of chronic bronchitis. Such guidelines shall indicate the appropriate animal models of infection, in vitro techniques, and valid microbiologic surrogate markers.
(b)ReviewNot later than 5 years after the date of enactment of the Infectious Diseases Research and Development Act of 2005, the Secretary, acting through the Commissioner of Food and Drugs, shall review and update the guidelines described under subsection (a) to reflect developments in scientific and medical information and technology..


		II
		111th CONGRESS
		2d Session
		S. 3170
		IN THE SENATE OF THE UNITED STATES

			March 25, 2010
			Mr. Bond (for himself
			 and Mr. Inouye) introduced the following
			 bill; which was read twice and referred to the
			 Committee on
			 Finance

		A BILL
		To provide for preferential duty treatment to certain
		  apparel articles of the Philippines.

		1.Short
			 titleThis Act may be cited as
			 the Save Our Industries Act of
			 2010 or the SAVE
			 Act.
		2.Findings;
			 purposes
			(a)FindingsCongress
			 finds the following:
				(1)The United States
			 and the Republic of the Philippines (in this Act referred to as the
			 Philippines), a former colony, share deep historical and cultural
			 connections. The United States has developed preferential trading relations
			 with former colonies such as the Marshall Islands, the Federated States of
			 Micronesia, and the Republic of Palau.
				(2)The Philippines
			 represents a tremendous economic potential and enduring political and security
			 significance to the United States.
				(3)The United States
			 and the Philippines maintain a fair trading relationship that should be
			 expanded to the mutual benefit of both countries. In 2008, United States
			 exports to the Philippines were valued at $8,300,000,000, and United States
			 imports from the Philippines were valued at $8,700,000,000.
				(4)United States
			 textile exports to the Philippines were valued at nearly $20,000,000 in 2008,
			 consisting mostly of broadwoven, industrial or specialty, and nonwoven fabrics.
			 The potential for export growth in this area can sustain and create thousands
			 of jobs.
				(5)The Philippines'
			 textile and apparel industries, like that of their counterparts in the United
			 States, share the same challenges and risks stemming from the end of the
			 textile and apparel quota system and from the end of United States safeguards
			 that continued to control apparel imports from the People's Republic of China
			 until January 1, 2009.
				(6)The United States
			 apparel fabrics industry is heavily dependent on sewing outside the United
			 States, and, for the first time, United States textile manufacturers would have
			 a program that utilizes sewing done in an Asian country. In contrast, most
			 sewing of United States fabric occurs in the Western Hemisphere, with about 75
			 percent of United States fabric exports presently going to countries that are
			 parties to the North American Free Trade Agreement and the Dominican
			 Republic-Central America-United States Free Trade Agreement. Increased demand
			 for United States fabric in Asia will increase opportunities for the United
			 States industry.
				(7)Apparel producers
			 in the Western Hemisphere are excellent at making basic garments such as
			 T-shirts and standard 5-pocket jeans. However, the needle capability does not
			 exist to make high-fashion, more sophisticated garments such as embroidered
			 T-shirts and fashion jeans with embellishments. Such apparel manufacturing is
			 done almost exclusively in Asia.
				(8)A program that
			 provides preferential duty treatment for certain apparel articles of the
			 Philippines will provide a strong incentive for Philippine apparel
			 manufacturers to use United States fabrics, which will open new opportunities
			 for the United States textile industry and increase opportunities for United
			 States yarn manufactures. At the same time, the United States would be provided
			 a more diverse range of sourcing opportunities.
				(b)PurposesThe
			 purposes of this Act are—
				(1)to encourage
			 higher levels of trade in textiles and apparel between the United States and
			 the Philippines and enhance the commercial well-being of their respective
			 industries in times of global economic hardship;
				(2)to enhance and
			 broaden the economic, security, and political ties between the United States
			 and the Philippines;
				(3)to stimulate
			 economic activity and development throughout the Philippines, including regions
			 such as Manila and Mindanao; and
				(4)to provide a
			 stepping stone to an eventual free trade agreement between the United States
			 and the Philippines, either bilaterally or as part of a regional
			 agreement.
				3.DefinitionsIn this Act:
			(1)Classification
			 under the HTSThe term
			 classification under the HTS means, with respect to an article,
			 the 8-digit subheading under which the article is classified in the HTS.
			(2)HTSThe
			 term HTS means the Harmonized Tariff Schedule of the United
			 States.
			(3)EnteredThe
			 term entered means entered, or withdrawn from warehouse for
			 consumption, in the customs territory of the United States.
			(4)Knit-to-shapeAn
			 article is knit-to-shape if 50 percent or more of the exterior
			 surface area of the article is formed by major parts that have been knitted or
			 crocheted directly to the shape used in the article, with no consideration
			 being given to patch pockets, appliques, or the like. Minor cutting, trimming,
			 or sewing of those major parts shall not affect the determination of whether an
			 article is knit-to-shape.
			(5)Wholly
			 assembledAn article is wholly assembled in the Philippines
			 or the United States if—
				(A)all components of
			 the article pre-existed in essentially the same condition as the components
			 exist in the finished article and the components were combined to form the
			 finished article in the Philippines or the United States; and
				(B)the article is
			 comprised of at least 2 components.
				(6)Wholly
			 formedA yarn is wholly formed in the United
			 States if all of the yarn forming and finishing operations, starting
			 with the extrusion of filaments, strips, film, or sheet, and including slitting
			 a film or sheet into strip, or the spinning of all fibers into yarn, or both,
			 and ending with a finished yarn or plied yarn, takes place in the United
			 States.
			4.Trade
			 benefits
			(a)Eligible
			 apparel articleFor purposes of this section, an eligible apparel
			 article is any one of the following:
				(1)Men's and boys'
			 cotton shirts, T-shirts and tank tops (other than underwear T-shirts and tank
			 tops), pullovers, sweatshirts, tops, and similar articles classifiable under
			 subheading 6105.10, 6105.90, 6109.10, 6110.20, 6110.90, 6112.11, or 6114.20 of
			 the HTS.
				(2)Women's and
			 girls' cotton shirts, blouses, T-shirts and tank tops (other than underwear
			 T-shirts and tank tops), pullovers, sweatshirts, tops, and similar articles
			 classifiable under subheading 6106.10, 6106.90, 6109.10, 6110.20, 6110.90,
			 6112.11, 6114.20, or 6117.90 of the HTS.
				(3)Men's and boys'
			 cotton trousers, breeches, and shorts classifiable under subheading 6103.10,
			 6103.42, 6103.49, 6112.11, 6113.00, 6203.19, 6203.42, 6203.49, 6210.40, 6211.20
			 6211.32 of the HTS.
				(4)Women's and
			 girls' cotton trousers, breeches, and shorts classifiable under subheading
			 6104.19, 6104.62, 6104.69, 6112.11, 6113.00, 6117.90, 6204.12, 6204.19,
			 6204.62, 6204.69, 6210.50, 6211.20, 6211.42, or 6217.90 of the HTS.
				(5)Men's and boys'
			 cotton underpants, briefs, underwear-type T-shirts and singlets, thermal
			 undershirts, other undershirts, and similar articles classifiable under
			 subheading 6107.11, 6109.10, 6207.11, or 6207.91 of the HTS.
				(6)Men's and boys'
			 manmade fiber underpants, briefs, underwear-type T-shirts and singlets, thermal
			 undershirts, other undershirts, and similar articles classifiable under
			 subheading 6107.12, 6109.90, 6207.19, or 6207.99 of the HTS.
				(7)Men's and boys'
			 manmade fiber shirts, T-shirts, tank tops (other than underwear T-shirts and
			 tank tops), pullovers, sweatshirts, tops, and similar articles classifiable
			 under subheading 6105.20, 6105.90, 6110.30, 6110.90, 6112.12, 6112.19, or
			 6114.30 of the HTS.
				(8)Women's and
			 girls' manmade fiber shirts, blouses, T-shirts, tank tops (other than underwear
			 T-shirts and tank tops), pullovers, sweatshirts, tops, and similar articles
			 classifiable under subheading 6106.20, 6106.90, 6110.30, 6110.90, 6112.12,
			 6112.19, 6114.30, or 6117.90 of the HTS.
				(9)Men's and boys'
			 manmade fiber trousers, breeches, and shorts classifiable under subheading
			 6103.43, 6103.49, 6112.12, 6112.19, 6112.20, 6113.00, 6203.43, 6203.49,
			 6210.40, 6211.20, or 6211.33 of the HTS.
				(10)Women's and
			 girls' manmade fiber trousers, breeches, and shorts classifiable under
			 subheading 6104.63, 6104.69, 6112.12, 6112.19, 6112.20, 6113.00, 6117.90,
			 6204.63, 6204.69, 6210.50, 6211.20, 6211.43, or 6217.90 of the HTS.
				(11)Men's and boys'
			 manmade fiber shirts classifiable under subheading 6205.30, 6205.90, or 6211.33
			 of the HTS.
				(12)Cotton
			 brassieres and other body support garments classifiable under subheading
			 6212.10, 6212.20, or 6212.30 of the HTS.
				(13)Manmade fiber
			 brassieres and other body support garments classifiable under subheading
			 6212.10, 6212.20, or 6212.30 of the HTS.
				(14)Manmade fiber
			 swimwear classifiable under subheading 6112.31, 6112.41, 6211.11, or 6211.12 of
			 the HTS.
				(15)Cotton swimwear
			 classifiable under subheading 6112.39, 6112.49, 6211.11, or 6211.12 of the
			 HTS.
				(16)Men’s and boys’
			 manmade fiber coats, overcoats, carcoats, capes, cloaks, anoraks (including
			 ski-jackets), windbreakers, padded sleeveless jackets with attachments for
			 sleeves, and similar articles classifiable under subheading 6101.30, 6101.90,
			 6112.12, 6112.19, 6112.20, or 6113.00 of the HTS.
				(17)Women’s and
			 girls’ manmade fiber coats, overcoats, carcoats, capes, cloaks, anoraks
			 (including ski-jackets), windbreakers, padded sleeveless jackets with
			 attachments for sleeves, and similar articles classifiable under subheading
			 6102.30, 6102.90, 6104.33, 6104.39, 6112.12, 6112.19, 6112.20, 6113.00, or
			 6117.90 of the HTS.
				(b)Duty-Free
			 treatment for certain eligible apparel articles
				(1)Duty-free
			 treatmentSubject to paragraphs (2) and (3), an eligible apparel
			 article shall enter the United States free of duty if the article is wholly
			 assembled in the United States or the Philippines, or both, and if the
			 component determining the article's classification under the HTS consists
			 entirely of—
					(A)fabric cut in the
			 United States or the Philippines, or both, from fabric wholly formed in the
			 United States from yarns wholly formed in the United States;
					(B)components
			 knit-to-shape in the United States from yarns wholly formed in the United
			 States; or
					(C)any combination
			 of the fabric or components knit-to-shape described in subparagraphs (A) and
			 (B).
					(2)Dyeing,
			 printing, or finishingAn apparel article described in paragraph
			 (1) shall be ineligible for duty-free treatment under such paragraph if the
			 component determining the article's classification under the HTS comprises any
			 fabric, fabric component, or component knit-to-shape in the United States that
			 was dyed, printed, or finished at any place other than in the United
			 States.
				(3)Other
			 processesAn apparel article described in paragraph (1) shall not
			 be disqualified from eligibility for duty-free treatment under such paragraph
			 because it undergoes stone-washing, enzyme-washing, acid-washing,
			 permapressing, oven-baking, bleaching, garment-dyeing, screen printing, or
			 other similar processes in either the United States or the Philippines.
				(c)Duty reduction
			 for certain eligible apparel articles
				(1)Duty
			 reductionAn eligible apparel article shall enter the United
			 States at a reduced rate of duty specified in paragraph (2) if it is wholly
			 assembled in the United States or the Philippines, or both, and if the
			 component determining the article's classification under the HTS consists
			 entirely of—
					(A)fabric cut in the
			 United States or the Philippines, or both, from fabric wholly formed in the
			 United States or the Philippines, or both, from yarns wholly formed in the
			 United States;
					(B)components
			 knit-to-shape in the United States or the Philippines, or both, from yarns
			 wholly formed in the United States; or
					(C)any combination
			 of fabric or components knit-to-shape that are described in subparagraphs (A)
			 and (B).
					(2)Reduced tariff
			 rateAn eligible apparel article described in paragraph (1) shall
			 be subject to duty in an amount that is equal to 50 percent of the column 1
			 rate of duty that applies to the apparel article under its classification under
			 the HTS.
				(d)Articles
			 eligible under both subsection (b) and
			 subsection (c)An eligible
			 apparel article that meets the requirements of both subsections (b) and (c)
			 shall be eligible for duty-free treatment under subsection (b).
			(e)De
			 minimis
				(1)In
			 generalAn eligible apparel article that is otherwise eligible
			 for preferential treatment under this section shall not be ineligible for such
			 preferential treatment because fibers or yarns used in the production of the
			 component that determines the article's classification under the HTS do not
			 meet the requirements of subsection (b) or (c), if the total weight of all such
			 fibers or yarns in the component that determines the article's classification
			 under the HTS is not more than 10 percent of the total weight of that
			 component.
				(2)Elastomeric
			 yarnsNotwithstanding paragraph (1), an article described in
			 subsection (b) or (c) that contains elastomeric yarns in the component of the
			 article that determines the article's classification under the HTS shall be
			 eligible for duty-free treatment under this section only if such elastomeric
			 yarns are wholly formed in the United States or the Philippines.
				(3)Direct
			 shipmentAny apparel article described in subsection (b) or (c)
			 is an eligible article only if it is imported directly into the United States
			 from the Philippines.
				(f)Single
			 transformation rulesAny of the following apparel articles that
			 are wholly assembled, or knit-to-shape, in the Philippines from any combination
			 of fabrics, fabric components, components knit-to-shape, or yarns and are
			 imported directly into the United States from the Philippines shall enter the
			 United States free of duty, without regard to the source of the fabric, fabric
			 components, components knit-to-shape, or yarns from which the articles are
			 made:
				(1)Any apparel
			 article that is of a type listed in chapter rule 3, 4, or 5 for chapter 61 of
			 the HTS (as such chapter rules are contained in paragraph 1 of section A of the
			 Annex to Proclamation 8213 of the President of December 20, 2007) as being
			 excluded from the scope of such chapter rule, when such chapter rule is applied
			 to determine whether an apparel article is an originating good for purposes of
			 general note 29(n) to the HTS, except that, for purposes of this paragraph, a
			 reference in any such chapter rule to 6104.12.00 shall be deemed
			 to be a reference to 6104.19.60.
				(2)Except for
			 brassieres classified in subheading 6212.10 of the HTS, any apparel article
			 that is of a type listed in chapter rule 3(a), 4(a), or 5(a) for chapter 62 of
			 the HTS, as such chapter rule is contained in paragraph 9 of section A of the
			 Annex to Proclamation 8213 of the President of December 20, 2007.
				(3)Any article not
			 described in paragraph (1) or (2) that is any of the following:
					(A)Baby garments,
			 clothing accessories, and headwear classifiable under subheading 6111.20,
			 6111.30, 6111.90, 6209.20, 6209.30, 6209.90, or 6505.90 of the HTS.
					(B)Women's and
			 girls' cotton coats, overcoats, carcoats, capes, cloaks, anoraks (including
			 ski-jackets), windbreakers, padded sleeveless jackets with attachments for
			 sleeves, and similar articles classifiable under subheading 6102.20, 6102.90,
			 6104.19, 6104.32, 6112.11, 6113.00, 6117.90, 6202.12, 6202.19, 6202.92,
			 6202.99, 6204.12, 6204.19, 6204.32, 6204.39, 6210.30, 6210.50, 6211.20,
			 6211.42, or 6217.90 of the HTS.
					(C)Cotton dresses
			 classifiable under subheading 6104.42, 6104.49, 6204.42, or 6204.49 of the
			 HTS.
					(D)Manmade fiber
			 dresses classifiable under subheading 6104.43, 6104.44, 6104.49, 6204.43,
			 6204.44, or 6204.49 of the HTS.
					(E)Men's and boys'
			 cotton shirts classifiable under subheading 6205.20, 6205.90, or 6211.32 of the
			 HTS.
					(F)Cotton pajamas
			 and sleepwear classifiable under subheading 6107.21, 6107.91, 6108.31, 6207.21,
			 6207.91, or 6208.21 of the HTS.
					(G)Manmade fiber
			 pajamas and sleepwear classifiable under subheading 6107.22, 6107.99, 6108.32,
			 6207.22, 6207.99, or 6208.22 of the HTS.
					(H)Women's and
			 girls' wool coats, overcoats, carcoats, capes, cloaks, anoraks (including
			 ski-jackets), windbreakers, padded sleeveless jackets with attachments for
			 sleeves, and similar articles classifiable under subheading 6102.10, 6102.30,
			 6102.90, 6104.31, 6104.33, 6117.90, 6202.11, 6202.13, 6202.19, 6202.91,
			 6202.93, 6202.99, 6204.31, 6204.33, 6204.39, 6211.20, 6211.41, or 6117.90 of
			 the HTS.
					(I)Wool skirts
			 classifiable under subheading 6104.51, 6104.53, 6104.59, 6204.51, 6204.53, or
			 6204.59 of the HTS.
					(J)Women's and
			 girls' wool trousers, breeches, and shorts classifiable under subheading
			 6104.61, 6104.63, 6104.69, 6117.90, 6204.61, 6204.63, 6204.69, 6211.20,
			 6211.41, or 6217.90 of the HTS.
					(K)Women's and
			 girls' cotton shirts and blouses classifiable under subheading 6206.10,
			 6206.30, 6206.90, 6211.42, or 6217.90 of the HTS.
					(L)Women's and
			 girls' manmade fiber shirts, blouses, shirt-blouses, sleeveless tank styles,
			 and similar upper body garments classifiable under subheading 6206.10, 6206.40,
			 6206.90, 6211.43, or 6217.90 of the HTS.
					(M)Men’s and boys’
			 wool coats, overcoats, carcoats, capes, cloaks, anoraks (including
			 ski-jackets), windbreakers, padded sleeveless jackets with attachments for
			 sleeves, and similar articles classifiable under subheading 6101.30, 6101.90,
			 6201.11, 6201.13, 6201.19, 6201.91, 6201.93, 6201.99, 6211.20, or 6211.39 of
			 the HTS.
					(N)Women's and
			 girls' manmade fiber coats, overcoats, carcoats, capes, cloaks, anoraks
			 (including ski-jackets), windbreakers, padded sleeveless jackets with
			 attachments for sleeves, and similar articles classifiable under subheading
			 6202.13, 6202.19, 6202.93, 6202.99, 6204.33, 6204.39, 6210.30, 6210.50,
			 6211.20, 6211.43, or 6217.90 of the HTS.
					(O)Cotton skirts
			 classifiable under subheading 6104.19, 6104.52, 6104.59, 6204.12, 6204.19,
			 6204.52, or 6204.59 of the HTS.
					(P)Manmade fiber
			 skirts classifiable under subheading 6104.53, 6104.59, 6204.53, or 6204.59 of
			 the HTS.
					(Q)Men's and boys'
			 manmade fiber coats, overcoats, carcoats, capes, cloaks, anoraks (including
			 ski-jackets), windbreakers, padded sleeveless jackets with attachments for
			 sleeves, and similar articles classifiable under subheading 6201.13, 6201.19,
			 6201.93, 6201.99, 6210.20, 6210.40, 6211.20, or 6211.33 of the HTS.
					(R)Women's and
			 girls' cotton slips, petticoats, briefs, panties, and underwear classifiable
			 under subheading 6108.19, 6108.21, 6108.91, 6109.10, 6208.19, or 6208.91 of the
			 HTS.
					(S)Women's and
			 girls' manmade fiber slips, petticoats, briefs, panties, and underwear
			 classifiable under subheading 6108.11, 6108.22, 6108.92, 6109.90, 6208.11, or
			 6208.92 of the HTS.
					(g)Review and
			 reportThe Comptroller General of the United States shall, not
			 later than 24 months after the date of the enactment of this Act, review the
			 program established under this section for the purpose of evaluating the
			 effectiveness of, and making recommendations to Congress for improvements in,
			 the program.
			(h)Enforcement
				(1)Presidential
			 certification of conditionsNo apparel article shall be afforded
			 the preferential treatment under this section unless the President certifies to
			 Congress that the Philippines is meeting the following conditions:
					(A)The Philippines
			 has reestablished the Electronic Visa Information System (ELVIS) to assist with
			 prevention of transshipment of apparel articles and the use of counterfeit
			 documents relating to the importation of apparel articles into the United
			 States.
					(B)The Philippines
			 is enforcing the Memorandum of Understanding between the United States of
			 America and the Republic of the Philippines Concerning Cooperation in Trade in
			 Textile and Apparel Goods, signed on August 23, 2006.
					(C)The Philippines
			 agrees to provide, on a timely basis at the request of U.S. Customs and Border
			 Protection, and consistently with the manner in which the records are kept in
			 the Philippines, a report on exports from the Philippines of apparel articles
			 eligible for preferential treatment under this section, and on imports into the
			 Philippines of yarns, fabrics, fabric components, or components knit-to-shape
			 that are wholly formed in the United States.
					(D)The Philippines
			 agrees to cooperate fully with the United States to address and take action
			 necessary to prevent circumvention as provided in Article 5 of the Agreement on
			 Textiles and Clothing referred to in section 101(d)(4) of the Uruguay Round
			 Agreements Act (19 U.S.C. 3511(d)(4)).
					(E)The Philippines
			 agrees to require Philippines producers and exporters of articles eligible for
			 preferential treatment under this section to maintain, for at least 5 years
			 after the date of export, complete records of the production and the export of
			 such articles, including records of yarns, fabrics, fabric components, and
			 components knit-to-shape and used in the production of such articles.
					(F)The Philippines
			 agrees to provide, on a timely basis, at the request of U.S. Customs and Border
			 Protection, documentation establishing the country of origin of articles
			 eligible for preferential treatment under this section, as used by that country
			 in reimplementing an effective visa system.
					(G)The Philippines
			 is to establish, within 60 days after the date of the President's certification
			 under this paragraph, procedures that allow the Office of Textiles and Apparel
			 of the Department of Commerce (OTEXA) to obtain information when fabric wholly
			 formed in the United States is exported to the Philippines to allow for
			 monitoring and verification before the imports of apparel articles containing
			 the fabric for which preferential treatment is sought under this section reach
			 the United States. The information provided upon export of the fabrics shall
			 include, among other things, the name of the importer of the fabric in the
			 Philippines, the 8-digit HTS subheading covering the apparel articles to be
			 made from the fabric, and the quantity of the apparel articles to be made from
			 the fabric for importation into the United States.
					(H)The Philippines
			 has enacted legislation or promulgated regulations to allow for the seizure of
			 merchandise physically transiting the territory of the Philippines and appears
			 to be destined for the United States in circumvention of the provisions of this
			 Act.
					(i)Customs
			 procedures
				(1)In
			 general
					(A)Penalties for
			 exportersIf the President determines, based on sufficient
			 evidence, that an exporter has engaged in transshipments as defined in
			 paragraph (2), then the President shall deny for a period of 5 years all
			 benefits under section 4 to such exporter, any successor of such exporter, and
			 any other entity owned or operated by the principal of the exporter.
					(B)Penalties for
			 importersIf the President determines, based on sufficient
			 evidence, that an importer has engaged in transshipments as defined in
			 paragraph (2), then the President shall deny for a period of 5 years all
			 benefits under section 4 to such importer, any successor of such importer, or
			 any entity owned or operated by the principal of the importer.
					(2)Definition of
			 transhipmentAs used in paragraph (1), transshipment has occurred
			 when preferential treatment for an apparel article under this section has been
			 claimed on the basis of material false information concerning the country of
			 origin, manufacture, processing, or assembly of the article or of any fabric,
			 fabric component, or component knit-to-shape from which the apparel article was
			 assembled. For purposes of this paragraph, false information is material if
			 disclosure of the true information would have meant that the article is or was
			 ineligible for preferential treatment under this section.
				(j)Proclamation
			 authorityThe President shall issue a proclamation to carry out
			 this section not later than 60 days after the date of the enactment of this
			 Act. The President shall consult with the Committee on Ways and Means of the
			 House of Representatives and the Committee on Finance of the Senate in
			 preparing such proclamation.
			5.Effective
			 dateThis Act shall apply to
			 articles entered, or withdrawn from warehouse for consumption, on or after the
			 15th day after the date on which the President issues the proclamation required
			 by section 4(j).
		6.Termination
			(a)In
			 generalThe preferential duty treatment provided under this Act
			 shall remain in effect for a period of 10 years beginning on the effective date
			 provided for in section 5.
			(b)GSP
			 EligibilityThe preferential duty treatment provided under this
			 Act shall terminate if and when the Philippines becomes ineligible for
			 designation as a beneficiary developing country under title V of the Trade Act
			 of 1974 (19 U.S.C. 2461 et seq.).