		II
		111th CONGRESS
		1st Session
		S. 726
		IN THE SENATE OF THE UNITED STATES

			March 26, 2009
			Mr. Schumer (for
			 himself, Ms. Collins,
			 Mr. Brown, Mr.
			 Vitter, Ms. Stabenow,
			 Mr. Martinez, and
			 Mrs. Shaheen) introduced the following
			 bill; which was read twice and referred to the
			 Committee on Health, Education, Labor,
			 and Pensions

		A BILL
		To amend the Public Health Service Act to provide for the
		  licensing of biosimilar and biogeneric biological products, and for other
		  purposes.

		1.Short titleThis Act may be cited as the
			 Promoting Innovation and Access to
			 Life-Saving Medicine Act.
		2.Definitions
			(a)LicensureSection 351(i) of the Public Health Service
			 Act (42 U.S.C. 262(i)) is amended—
				(1)by striking
			 In this section, the term biological product means
			 and inserting the following:

						In this
			 section:(1)The term
				biological product means
						;
				and
				(2)by adding at the
			 end the following:

						(2)The term abbreviated biological
				product application means an abbreviated application for a license of a
				biological product that relies in part on data or information in an application
				for another biological product licensed under this section or approved under
				section 505 of the Federal Food, Drug, and Cosmetic Act.
						(3)The term
				reference product means the single licensed biological product,
				approved under subsection (a) or (k), against which a biological product is
				evaluated for demonstration of safety, potency, or purity.
						(4)The term final action means,
				with respect to an abbreviated biological product application, the Secretary’s
				issuance of a final action letter to the sponsor of an abbreviated biological
				product application which—
							(A)approves the
				application; or
							(B)disapproves the
				application and sets forth in detail an enumeration of the specific
				deficiencies in the particular application and of the specific, enumerated
				actions the sponsor would be required to take in order for the sponsor to
				receive a final action letter that approves such application.
							(5)The term final action date
				means, with respect to an abbreviated biological product application, the date
				by which the Secretary must take a final action on the application pursuant to
				subsection (k)(13).
						(6)The term
				reviewing division means the division responsible for the review
				of an application for approval of a biological product (including all
				scientific and medical matters, chemistry, manufacturing, and
				controls).
						.
				(b)Fees
				(1)Rule of
			 constructionThe definition of a human drug application in
			 section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1))
			 shall be construed to include applications under section 351(k) of the Public
			 Health Service Act, as added by section 3, in addition to applications under
			 section 351(a) of such Act.
				(2)SupplementSection
			 735(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(2)) is
			 amended by adding at the end the following: Notwithstanding the
			 preceding sentence, any request for an interchangeability determination under
			 section 351(k) of the Public Health Service Act shall be treated as a
			 supplement for purposes of this part, irrespective of whether such request is
			 included in an application for licensure of a biological product or a
			 subsequent submission..
				3.Regulation of
			 biosimilar and biogeneric biological products
			(a)In
			 generalSection 351 of the Public Health Service Act (42 U.S.C.
			 262), as amended by section 2, is further amended—
				(1)in subsection
			 (a)(1)(A), by inserting under this subsection or subsection (k)
			 after biologics license; and
				(2)by adding at the
			 end the following subsection:

						(k)Regulation of
				biosimilar and interchangeable biological products
							(1)BiosimilarIn
				this subsection, the term biosimilar or
				biosimilarity, in reference to a biological product, means no
				clinically meaningful differences between the biological product and the
				reference product would be expected in terms of the safety, purity, and potency
				if treatment were to be initiated with the biological product instead of the
				reference product.
							(2)InterchangeabilityIn
				this subsection, the term interchangeable or
				interchangeability means, with respect to a given condition of
				use, that—
								(A)the biological
				product is biosimilar to the reference product; and
								(B)if the biological
				product is intended to be administered more than once to a given patient, the
				patient can be switched one or more times between the reference product and the
				biological product without an expected increase in the risk of adverse effects,
				including a clinically significant change in immunogenicity, or
				diminished effectiveness, compared to the expected risks from continuing to use
				the reference product without such switching.
								(3)Submission of an
				abbreviated biological product applicationAny person may file
				with the Secretary an abbreviated biological product application. Any such
				application shall include the following:
								(A)Information
				demonstrating that the biological product and reference product contain highly
				similar molecular structural features, notwithstanding minor differences in
				heterogeneity profile, impurities, or degradation patterns.
								(B)Information
				demonstrating that the biological product is biosimilar to (as defined in
				paragraph (1)) or interchangeable with (as defined in paragraph (2)) the
				reference product for the condition or conditions of use prescribed,
				recommended, or suggested in the proposed labeling based upon, in the
				discretion of the Secretary—
									(i)information
				derived from chemical, physical, and biological assays, and other non-clinical
				laboratory studies; and
									(ii)information from
				any necessary clinical study or studies sufficient to confirm safety, purity,
				and potency.
									Any
				studies under clause (ii) shall be designed to avoid duplicative and unethical
				clinical testing.(C)Information
				demonstrating that the biological product and reference product utilize the
				same mechanism or mechanisms of action for the condition or conditions of use
				prescribed, recommended, or suggested in the proposed labeling, but only to the
				extent the mechanism or mechanisms of action are known for the reference
				product or can reasonably be determined. If the applicant seeks to rely on a
				demonstration of biosimilarity or interchangeability for a single condition of
				use to support approval of additional conditions of use that share the same
				mechanism or mechanisms of action, information demonstrating that such reliance
				is scientifically appropriate.
								(D)Information to
				show that the condition or conditions of use prescribed, recommended, or
				suggested in the proposed labeling for the biological product have been
				previously approved for the reference product.
								(E)Information to
				show that the route of administration, the dosage form, and the strength of the
				biological product are the same as those of the reference product.
								(F)Information
				demonstrating that the facility in which the biological product is
				manufactured, processed, packed, or held meets standards designed to ensure
				that the biological product continues to be safe, pure, and potent.
								(4)Other
				applicationsAny person, including a person who has not conducted
				and does not have a right of reference to the studies in the application for a
				reference product, may submit an abbreviated biological product application
				under this paragraph for a biological product that differs from, or
				incorporates a change to, the reference product with respect to one or more
				characteristics described in subparagraphs (A) through (E) of paragraph (3),
				including a difference in safety, purity, or potency, so long as the
				application contains sufficient information to establish the safety, purity,
				and potency of the biological product for its proposed condition or conditions
				of use.
							(5)Approval of
				biosimilar or interchangeable biological products
								(A)Determination of
				biosimilarityUpon review of an application submitted under
				paragraph (3) for a biological product and any other information available to
				the Secretary, including information in the application for the reference
				product, the Secretary shall issue a biosimilar biological product license for
				the conditions of use prescribed, recommended, or suggested in the proposed
				labeling for the product, unless the Secretary finds and informs the applicant
				(including provision of a detailed explanation) that—
									(i)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the biological product and the reference
				product contain highly similar molecular structural features, notwithstanding
				minor differences in heterogeneity profile, impurities, or degradation
				patterns;
									(ii)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the biological product is biosimilar to
				the reference product for the condition or conditions of use prescribed,
				recommended, or suggested in the labeling proposed in the application;
									(iii)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the biological product and reference
				product utilize the same mechanism or mechanisms of action for the conditions
				of use prescribed, recommended, or suggested in the proposed labeling for the
				biological product, unless the mechanism or mechanisms of action are not known
				and cannot reasonably be determined for the reference product for such
				condition or conditions;
									(iv)if the applicant
				has demonstrated biosimilarity for a single condition of use sharing the same
				mechanism of action as other conditions of use of the reference product, and
				has sought approval of one or more such other conditions of use on the basis of
				such demonstration, information submitted in the application and any other
				information available to the Secretary is insufficient to show the safety,
				purity, and potency of one or more such other conditions of use;
									(v)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the route of administration, the dosage
				form, and the strength of the biological product are the same as those of the
				reference product;
									(vi)information
				submitted in the application and any other information available to the
				Secretary is insufficient to show that the condition or conditions of use
				prescribed, recommended, or suggested in the proposed labeling for the
				biological product are limited to one or more of the same use or uses as have
				been previously approved for the reference product;
									(vii)information
				submitted in the application and any other information available to the
				Secretary shows (I) the inactive ingredients of the biological product are
				unsafe for use under the conditions prescribed, recommended, or suggested in
				the proposed labeling for the biological product, or (II) the composition of
				the biological product is unsafe under such conditions because of the type or
				quantity of inactive ingredients included or the manner in which the inactive
				ingredients are included;
									(viii)information
				submitted in the application and any other information available to the
				Secretary fails to demonstrate that the facility in which the biological
				product is manufactured, processed, packed, or held meets standards designed to
				ensure that the biological product continues to be safe, pure, and
				potent;
									(ix)the Secretary
				has, for reasons of safety, purity, or potency, other than reasons that are
				unique to the reference product—
										(I)withdrawn or
				suspended the license of the reference product;
										(II)published a
				notice of opportunity for hearing to withdraw such license; or
										(III)determined that
				the reference product has been withdrawn from sale; or
										(x)the application
				contains an untrue statement of material fact.
									(B)Determinations
				on interchangeabilitySubject to subparagraph (C) and paragraph
				(11), upon issuing a product license for a biological product under
				subparagraph (A), the Secretary shall make and publish one of the following
				determinations:
									(i)Such product is
				interchangeable with the reference product for one or more specified conditions
				of use prescribed, recommended, or suggested in the labeling of the biological
				product.
									(ii)Interchangeability
				has not been established, but the approved product is as safe and effective for
				its approved uses as the reference product.
									(C)Determination of
				interchangeability of subsequent biological productIf the
				Secretary determines that an application meets the approval requirements of
				subparagraph (A), and, prior to the issuance of a product license, the
				Secretary has made a determination of interchangeability of another biological
				product and the reference product for which the exclusivity period under
				paragraph (11) has not expired, the Secretary shall—
									(i)issue the product
				license for the subsequent biological product; and
									(ii)defer issuing any
				determination of interchangeability as to the subsequent biological product and
				the reference product until the exclusivity period under paragraph (11) has
				expired.
									(6)Designation of
				official name
								(A)In
				generalIf, pursuant to section 508 of the Federal Food, Drug,
				and Cosmetic Act, the Secretary determines that designation of an official name
				for a biosimilar biological product is necessary or desirable in the interests
				of usefulness or simplicity, the Secretary shall designate the same official
				name for the biosimilar biological product as the Secretary designated for the
				reference product.
								(B)LimitationThis
				paragraph shall not apply to products approved under paragraph (7).
								(C)Report to
				CongressNot later than 5
				years after the date of the enactment of this subsection, the Comptroller
				General of the United States shall submit a report to the Congress on public
				health and economic impacts associated with practices for designating the
				official names of biosimilar biological products in the United States and in
				other countries that approve biosimilar biological products.
								(7)Other approval
				provisionsThe Secretary shall approve an application for a
				license submitted under paragraph (4) if the application and any other
				information available to the Secretary, including information in the
				application for the reference product, are sufficient to establish the safety,
				purity, and potency of the biosimilar biological product for the proposed
				condition or conditions of use for such product.
							(8)Establishing
				interchangeability for biosimilar biological products
								(A)In
				generalIn an original application or a supplement to an
				application under this subsection, an applicant may submit information to the
				Secretary to demonstrate the interchangeability of a biosimilar biological
				product and the reference product. An applicant may withdraw a request for an
				interchangeability determination at any time. A request for an
				interchangeability determination submitted after the filing of an application
				shall be considered a major amendment to the application. Except as provided in
				paragraph (11), nothing in this subsection shall be construed to prohibit the
				Secretary from making a determination of interchangeability at any time after
				approval.
								(B)GuidanceWithin
				2 years after enactment of this subsection, the Secretary shall issue guidance
				regarding standards and requirements for interchangeability. The Secretary is
				authorized to make determinations of interchangeability under paragraph (5)(B)
				prior to issuing guidance under this subparagraph.
								(9)Interchangeability
				labeling for interchangeable biological productsExcept as
				provided in paragraph (11), upon a determination of interchangeability, the
				Secretary shall, at the request of the applicant, provide for the label of the
				interchangeable biological product to include a statement that the biological
				product is interchangeable with the reference product for the conditions of use
				prescribed, recommended, or suggested in the labeling for which
				interchangeability has been established.
							(10)Delay of
				approval
								(A)Applicable delay
				period
									(i)5-year
				periodIf an application under this subsection refers to a
				biological product described in clause (i) of subparagraph (B), the Secretary
				may not approve such application before the expiration of—
										(I)the 5-year period
				beginning on such product’s approval date; or
										(II)such period, as
				extended under subparagraph (D).
										(ii)3-year
				periodIf an application under this subsection refers to a
				biological product described in subparagraph (C), the Secretary may not approve
				such application for the conditions of approval of such product before the
				expiration of—
										(I)the 3-year period
				beginning on such product’s approval date; or
										(II)such period, as
				extended under subparagraph (D).
										(B)No major
				substance previously approved
									(i)In
				generalA biological product is described in this clause
				if—
										(I)an application is
				submitted for such product under subsection (a);
										(II)no major
				substance of the product, nor any highly similar major substance, has been
				approved in any other application under subsection (a);
										(III)the application
				submitted for such product is approved after the date of the enactment of this
				subsection; and
										(IV)the application
				submitted for such product could not and did not rely on any clinical safety,
				purity, or potency study in any other application approved under this section
				or any clinical safety or effectiveness study in any application approved under
				section 505 of the Federal Food, Drug, and Cosmetic Act.
										(ii)ExclusionsBiological
				products not described in clause (i) include the following:
										(I)Protein biological
				products that differ in structure solely due to post-translational events,
				infidelity of translation or transcription, or minor differences in amino acid
				sequence.
										(II)Polysaccharide
				biological products with similar saccharide repeating units, even if the number
				of units differ and even if there are differences in post-polymerization
				modifications.
										(III)Glycosylated
				protein products that differ in structure solely due to post-translational
				events, infidelity of translation or transcription, or minor differences in
				amino acid sequence, and if they had similar saccharide repeating units, even
				if the number of units differ and even if there were differences in
				post-polymerization modifications.
										(IV)Polynucleotide
				biological products with identical sequence of purine and pyrimidine bases (or
				their derivatives) bound to an identical sugar backbone (ribose, deoxyribose,
				or modifications of these sugars).
										(V)Closely related,
				complex partly definable biological products with similar therapeutic intent,
				such as live viral products for the same indication.
										The Secretary
				may by regulation identify additional biological products not described in
				clause (i).(C)Major substance
				previously approvedA biological product is described in this
				subparagraph if—
									(i)an
				application is submitted for such product under subsection (a);
									(ii)such product
				includes a major substance that has been approved in another application under
				subsection (a), or any highly similar major substance;
									(iii)the application
				submitted for such product is approved after the date of the enactment of this
				subsection;
									(iv)the application
				submitted for such product contains reports of new clinical investigations
				(other than pharmacokinetic or pharmacodynamic studies) essential to the
				approval of the application and conducted or sponsored by the applicant;
				and
									(v)the product
				represents a significant therapeutic advance, which may include demonstration
				of safety, purity, and potency for a significant new indication or
				subpopulation, other than a pediatric subpopulation.
									(D)(i)SupplementIf
				a supplement to an application approved under subsection (a) is approved no
				later than 1 year before the expiration of a period to which the applicant is
				entitled under subparagraph (A), the period described in subparagraph (A)
				shall, except as provided in clause (ii), be extended by 6 months if—
										(I)the supplement contains reports of new
				clinical investigations (other than pharmacokinetic or pharmacodynamic studies)
				essential to the approval of the supplement and conducted or sponsored by the
				person submitting the supplement; and
										(II)the change provides a significant
				therapeutic advance, which may include demonstration of safety, purity, and
				potency for a significant new indication or subpopulation, other than a
				pediatric subpopulation.
										(ii)AdjustmentAny
				period of market exclusivity extended under subclause (I) or (II) of clause (i)
				for a biological product shall be reduced by 3 months if the organization
				designated under subparagraph (E) notifies the Secretary that, with respect to
				any major substance contained in the biological product, the combined annual
				gross sales in the United States for all biological products—
										(I)containing the major substance;
				and
										(II)owned or marketed by the applicant or
				its affiliates;
										exceeded
				$1,000,000,000 in the calendar year preceding approval of the supplement
				involved.(iii)LimitationOnly
				one extension under this subparagraph may be granted for any biological
				product.
									(E)(i)DesignationThe Secretary shall designate an
				organization other than the Food and Drug Administration to make the
				determination of combined annual gross sales described in clause (ii). Prior to
				designating such organization, the Secretary shall determine that such
				organization is independent and is qualified to evaluate the sales of
				pharmaceutical products. The Secretary shall re-evaluate the designation of
				such organization once every 3 years.
									(ii)NotificationThe
				organization designated under clause (i) shall—
										(I)determine, with respect to each major
				substance contained in each biological product that is the subject of a pending
				supplement under subparagraph (D)(i), the amount of the combined annual gross
				sales in the United States in the preceding calendar year for all biological
				products—
											(aa)containing the major substance;
				and
											(bb)owned or marketed by the applicant or
				its affiliates; and
											(II)notify the Secretary of such
				determination.
										(F)DefinitionIn
				this paragraph, the term approval date means the date of approval
				of an application for the biological product under subsection (a).
								(11)Exclusivity
								(A)In
				generalUpon review of an abbreviated biological product
				application relying on the same reference product for which a prior biological
				product has received a determination of interchangeability for any condition of
				use, the Secretary shall not make a determination under paragraph (5)(B) that
				the second or subsequent biological product is interchangeable for any
				condition of use, and no holder of a biological product license approved under
				subsection (a) shall manufacture, market, sell, or distribute a rebranded
				interchangeable biological product, directly or indirectly, or authorize any
				other person to manufacture, market, sell, or distribute a rebranded
				interchangeable biological product, for any condition of use, until the earlier
				of—
									(i)180 days after the
				first commercial marketing of the first interchangeable biological product to
				be approved as interchangeable for that reference product;
									(ii)one year
				after—
										(I)a final court
				decision in favor of the applicant on all patents in suit in an action
				instituted under paragraph (18)(C) against the applicant that submitted the
				application for the first approved interchangeable biological product;
				or
										(II)the dismissal
				with or without prejudice of an action instituted under paragraph (18)(C)
				against the applicant that submitted the application for the first approved
				interchangeable biological product; or
										(iii)(I)36 months after approval
				of the first interchangeable biological product if the applicant has been sued
				under paragraph (18)(C) and such litigation is still ongoing within such
				36-month period; or
										(II)one year after approval in the event
				that the first approved interchangeable biological product applicant has not
				been sued under paragraph (18)(C).
										For
				purposes of this subparagraph, the term final court decision means
				a final decision of a court from which no appeal (other than a petition to the
				United States Supreme Court for a writ of certiorari) has been or can be
				taken.(B)Rebranded
				interchangeable biological productFor purposes of this
				subsection, the term rebranded interchangeable biological
				product—
									(i)means any
				rebranded interchangeable version of the reference product involved that the
				holder of the biological product license approved under subsection (a) for that
				reference product seeks to commence marketing, selling, or distributing,
				directly or indirectly; and
									(ii)does not include
				any product to be marketed, sold, or distributed—
										(I)by an entity
				eligible for exclusivity with respect to such product under this paragraph;
				or
										(II)after expiration
				of any exclusivity with respect to such product under this paragraph.
										(12)HearingIf
				the Secretary decides to disapprove an abbreviated biological product
				application, the Secretary shall give the applicant notice of an opportunity
				for a hearing before the Secretary on the question of whether such application
				is approvable. If the applicant elects to accept the opportunity for hearing by
				written request within 30 days after such notice, such hearing shall commence
				not more than 90 days after the expiration of such 30 days unless the Secretary
				and the applicant otherwise agree. Any such hearing shall thereafter be
				conducted on an expedited basis, and the Secretary’s order thereon shall be
				issued within 90 days after the date fixed by the Secretary for filing final
				briefs.
							(13)Final action
				date
								(A)In
				generalThe Secretary shall take a final action on an abbreviated
				biological product application by the date that is 10 calendar months following
				the sponsor’s submission of such application, or 180 days following the
				Secretary’s notification to the applicant that its application has been
				accepted for filing, whichever is earlier.
								(B)ExtensionThe
				final action date provided by subparagraph (A) with respect to an application
				may be extended for such period of time as is agreed to by the Secretary and
				the applicant in a jointly executed written agreement that is counter-signed by
				the Secretary and the applicant no later than 30 days prior to—
									(i)such final action
				date; or
									(ii)the date on which
				any prior extension under this subparagraph expires.
									(14)Request for
				delay of final actionSubject to paragraph (19)(A)(i) and
				notwithstanding any other provision of law, the Secretary shall not fail or
				refuse to take a final action on an abbreviated biological product application
				by the final action date on the basis that a person, other than the biosimilar
				biological product applicant, has requested (in a petition or otherwise) that
				the Secretary refuse to take or otherwise defer such final action, and no court
				shall enjoin the Secretary from taking final action or stay the effect of final
				action previously taken by the Secretary, except by issuance of a permanent
				injunction based upon an express finding of clear and convincing evidence that
				the person seeking to have the Secretary refuse to take or otherwise to defer
				final action by the final action date—
								(A)has prevailed on
				the merits of the person’s complaint against the Secretary;
								(B)will suffer
				imminent and actual irreparable injury, constituting more than irrecoverable
				economic loss, and that also will threaten imminent destruction of such
				person’s business; and
								(C)has an interest
				that outweighs the overwhelming interest that the public has in obtaining
				prompt access to a biosimilar biological product.
								(15)Report on
				extensions of final action dateThe Secretary shall prepare and
				submit to the President, the Committee on Energy and Commerce of the House of
				Representatives, and the Committee on Health, Education, Labor, and Pensions of
				the Senate a report regarding any jointly executed written agreement to extend
				the final action date under this Act within 15 calendar days after the joint
				execution of any such written agreement.
							(16)Report on
				failure to take final actionThe Secretary shall prepare and
				submit annually to the President, the Committee on Energy and Commerce of the
				House of Representatives, and the Committee on Health, Education, Labor, and
				Pensions of the Senate a report detailing the specific and particularized
				reasons enumerated by the reviewing division for each instance of the
				Secretary’s failure to take final action by the final action date in the
				previous year.
							(17)RegulationsThe
				Secretary shall establish, by regulation within 2 years after the date of the
				enactment of this subsection, requirements for the efficient review, approval,
				suspension, and revocation of abbreviated biological product applications under
				this subsection. The Secretary may not use the absence of final regulations as
				a basis for the Secretary to fail to act on an application submitted under this
				subsection.
							(18)Patents
								(A)Request for
				patent information
									(i)In
				generalAt any time, including at the initial stages of
				development, an applicant or a prospective applicant under this subsection may
				send a written request for patent information to the holder of the approved
				application for the reference product. The holder of the approved application
				for the reference product shall, not later than 60 days after the date on which
				the holder receives the request, provide to the applicant or prospective
				applicant a list of all those patents owned by, licensed to, or otherwise under
				the control of, the holder of the approved application that the holder believes
				in good faith relate to the reference product, including patents that claim the
				approved biological product, any formulation of such product, any method of
				using such product, any component of such product, or any method or process
				that can be used to manufacture such product or component, regardless of
				whether that method or process is used to manufacture the reference
				product.
									(ii)UpdatesFor
				a period of 2 years beginning on the date on which the holder of the approved
				application for the reference product receives the request for information, the
				holder shall send to the applicant or prospective applicant updates of its
				response to the request for information by identifying all relevant patents
				issued or licensed to the holder after the initial response under clause (i).
				Any such update must be provided, in the case of a new patent, not later than
				30 days after the date on which the patent is issued and, in the case of a
				license, not later than 30 days after the date on which the holder obtains the
				license.
									(iii)Additional
				requestsThe applicant may submit additional requests under
				clause (i) for patent information, and each such request shall be subject to
				the requirements of this paragraph.
									(iv)Notification to
				patent holderWithin 30 days of receiving a request under this
				subparagraph, the holder of the approved application for the reference product
				shall give notice of such request to the owner of any patent licensed to, or
				otherwise under the control of, the holder that is identified by the holder
				pursuant to clause (i).
									(B)Patent
				notificationsAt any time after submitting an application under
				this subsection, the applicant may provide a notice of the application with
				respect to any one or more patents identified by the holder of the reference
				product pursuant to subparagraph (A) or with respect to any one or more patents
				owned by, licensed to, or otherwise under the control of the holder of the
				approved application, but not identified pursuant to subparagraph (A). An
				applicant may submit additional notices at any time, and each notice shall be
				subject to the provisions of this subparagraph. Each notice shall—
									(i)be
				sent to the holder of the approved application for the reference product and to
				the owner of any patent identified by the holder pursuant to subparagraph
				(A);
									(ii)include a
				detailed statement of the factual and legal bases for the applicant’s belief
				that the patents included in the notice are invalid, are unenforceable, or will
				not be infringed by the commercial sale of the product for which approval is
				being sought under this subsection; and
									(iii)be submitted to
				the Federal Trade Commission, which shall treat such notice as
				confidential.
									(C)Action for
				infringementWithin 45 days after the date on which the holder of
				the approved application for the reference product, or the owner of a patent,
				receives a notice under subparagraph (B), the holder or patent owner may bring
				an action for infringement only with respect to the patent or patents included
				in the notice.
								(D)Limitation on
				declaratory judgment actionsWith respect to any patent relating
				to a product that is the subject of an application under this subsection, the
				recipient of a notice under subparagraph (B) with respect to that application
				may not, prior to the commercial marketing of the product, bring any action
				under section 2201 of title 28, United States Code, for a declaration of
				infringement, validity, or enforceability of any such patent that was not
				identified in the notice.
								(E)Declaratory
				judgment action
									(i)In
				generalWith respect to any patent identified in a notification
				under subparagraph (A) or (B) for which the holder, or the owner of the
				patent—
										(I)has not brought an
				action for infringement under subparagraph (C); or
										(II)has brought an
				action for infringement under subparagraph (C), but subsequently dismissed that
				action without prejudice;
										the applicant
				may bring an action for a declaratory judgment under section 2201 of title 28,
				United States Code, that such patent is invalid or not infringed by the
				biological product at issue.(ii)Case or
				controversyThe courts of the United States shall have, and shall
				exercise, subject matter jurisdiction to hear such an action to the full extent
				permitted by article III of the Constitution.
									(F)Discretion of
				applicantsAn applicant or prospective applicant for a biosimilar
				biological product under this subsection may not be compelled, by court order
				or otherwise, to initiate the procedures set forth in this paragraph. Nothing
				in this paragraph requires an applicant or a prospective applicant to invoke
				the procedures set forth in this paragraph.
								(19)Petitions and
				civil actions regarding approval of certain applications
								(A)In
				generalWith respect to a pending application submitted under
				paragraph (3) or (4), if a petition is submitted to the Secretary that seeks to
				have the Secretary take, or refrain from taking, any form of action relating to
				the approval of the application, including a delay in the effective date of the
				application, the following applies, subject to subparagraph (E):
									(i)(I)The Secretary may not,
				on the basis of the petition, delay approval of the application unless the
				Secretary determines, within 30 days after receiving the petition, that a delay
				is necessary to protect the public health. Consideration of a petition shall be
				separate and apart from the review and approval of the application.
										(II)With respect to a determination by the
				Secretary under subclause (I) that a delay is necessary to protect the public
				health:
											(aa)The Secretary shall publish on the
				Internet site of the Food and Drug Administration a statement providing the
				reasons underlying the determination.
											(bb)Not later than 10 days after making
				the determination, the Secretary shall provide notice to the sponsor of the
				application and an opportunity for a meeting with the Commissioner to discuss
				the determination.
											(ii)The Secretary
				shall take final agency action on the petition not later than 180 days after
				the date on which the petition is submitted. The Secretary shall not extend
				such period, even with the consent of the petitioner, for any reason, including
				based upon the submission of comments relating to the petition or supplemental
				information supplied by the petitioner.
									(iii)The Secretary
				may not consider the petition for review unless it is signed and contains the
				following verification: I certify that, to my best knowledge and belief:
				(a) this petition includes all information and views upon which the petition
				relies; (b) this petition includes representative data and/or information known
				to the petitioner which are unfavorable to the petition; and (c) I have taken
				reasonable steps to ensure that any representative data and/or information
				which are unfavorable to the petition were disclosed to me. I further certify
				that the information upon which I have based the action requested herein first
				became known to the party on whose behalf this petition is submitted on or
				about the following date: [___]. I received or expect to receive payments,
				including cash and other forms of consideration, from the following persons or
				organizations to file this petition: [___]. I verify under penalty of perjury
				that the foregoing is true and correct..
									(B)Denial based on
				intent to delayIf the Secretary determines that a petition or
				supplement to the petition was submitted with the primary purpose of delaying
				the licensure or the approval of a condition of use for a biological product,
				the Secretary may deny the petition at any point based on such determination.
				The Secretary may issue guidance to describe the factors that will be used to
				determine under this subparagraph whether a petition is submitted with the
				primary purpose of delaying the approval of an application.
								(C)Exhaustion of
				administrative remedies
									(i)Final agency
				action within 180 daysThe Secretary shall be considered to have
				taken final agency action on a petition referred to in subparagraph (A)
				if—
										(I)during the 180-day
				period referred to in clause (ii) of such subparagraph, the Secretary makes a
				final decision within the meaning of section 10.45(d) of title 21, Code of
				Federal Regulations (or any successor regulations); or
										(II)such period
				expires without the Secretary having made such a final decision, in which case
				the petition shall be deemed to have been denied.
										(ii)Dismissal of
				certain civil actionsIf a civil action is filed with respect to
				a petition referred to in subparagraph (A) before final agency action within
				the meaning of clause (i) has occurred, the court shall dismiss the action for
				failure to exhaust administrative remedies.
									(D)Applicability of
				certain regulationsThe provisions of this section are in
				addition to the requirements for the submission of a petition to the Secretary
				that apply under section 10.30 or 10.35 of title 21, Code of Federal
				Regulations (or any successor regulations).
								(E)Annual report on
				delays in approvals per petitionsThe Secretary shall annually
				submit to the Congress a report that specifies—
									(i)the number of
				applications under this subsection that were approved during the preceding
				12-month period;
									(ii)the number of
				such applications whose effective dates were delayed by petitions referred to
				in subparagraph (A) during such period; and
									(iii)the number of
				days by which the applications were so delayed.
									(F)ExceptionThis
				paragraph does not apply to a petition that is made by the sponsor of an
				application under this subsection and that seeks only to have the Secretary
				take or refrain from taking any form of action with respect to that
				application.
								(G)DefinitionFor
				purposes of this paragraph, the term petition includes any request
				to the Secretary, without regard to whether the request is characterized as a
				petition.
								(20)Authorization
				of appropriationsTo carry out this subsection, there are
				authorized to be appropriated such sums as may be necessary for fiscal years
				2010 and
				2011.
							.
				(b)Additional
			 amendments
				(1)VenueSection
			 1404 of title 28, United States Code, is amended by adding at the end the
			 following:

						(e)Venue in certain
				patent infringement disputes
							(1)In
				generalIn any action for patent infringement brought by the
				holder or owner of the patent pursuant to section 351(k)(18)(C) of the Public
				Health Service Act, the defendant may move to transfer the action to any other
				district in which jurisdiction is proper.
							(2)TimingThe
				schedule applicable to a motion under paragraph (1) is as follows:
								(A)A motion under
				paragraph (1) shall be filed by the defendant no later than 45 days after
				service of the complaint.
								(B)A response to such
				a motion, if any, shall be filed no later than 20 days after service of the
				motion.
								(C)A reply to such
				response, if any, shall be filed no later than 10 days after service of the
				response.
								(D)The schedule set
				forth in this paragraph may be modified only by agreement of all
				parties.
								(3)ResolutionWhen
				ruling on any motion filed under paragraph (2), the greatest weight shall be
				given to the following factors:
								(A)The interest in
				identifying a district court in which the case will be adjudicated
				expeditiously.
								(B)The strong public
				interest in obtaining prompt judicial resolution of patent disputes so that the
				biological product which is the subject of the patent dispute may be brought to
				market as expeditiously as possible, consistent with fair and prompt resolution
				of patent disputes.
								(4)No
				delayAn action described in paragraph (1) shall proceed as
				expeditiously as possible while the court considers a motion under this
				subsection, and the court may not stay the proceedings because a motion under
				this subsection has been
				filed.
							.
				(2)PatentsSection
			 271(e) of title 35, United States Code, is amended—
					(A)in paragraph
			 (2)—
						(i)by
			 striking or at the end of subparagraph (A);
						(ii)by
			 adding or at the end of subparagraph (B);
						(iii)by
			 inserting after subparagraph (B) the following:

								(C)a notice described
				in section 351(k)(18)(B) of the Public Health Service Act, but only with
				respect to a patent identified in such
				notice,
								;
				and
						(iv)in
			 the matter following subparagraph (C) (as inserted by clause (iii) of this
			 subparagraph), by inserting before the period the following: , or if the
			 notice described in subparagraph (C) is provided in connection with an
			 application to obtain a license to engage in the commercial manufacture, use,
			 or sale of a biological product claimed in a patent or the use of which is
			 claimed in a patent before the expiration of such patent;
						(B)by adding at the
			 end the following paragraph:

							(6)(A)This paragraph applies
				in the case of a patent—
									(i)which is disclosed in a response to
				a request for patent information pursuant to subparagraph (A) of section
				351(k)(18) of the Public Health Service Act;
									(ii)with respect to which a notice was
				provided pursuant to subparagraph (B) of such section; and
									(iii)for which an action for
				infringement of the patent—
										(I)was brought after the expiration of the
				45-day period described in subparagraph (C) of such section; or
										(II)was brought before the expiration of the
				45-day period described in subclause (I), but which was dismissed without
				prejudice or was not prosecuted to judgment in good faith.
										(B)In an action for infringement of a
				patent described in subparagraph (A), the sole and exclusive remedy that may be
				granted by a court, upon a finding that the person who submitted the notice
				described in subparagraph (A)(ii) infringed the patent, or that any person
				induced or contributed to infringement of the patent, shall be a reasonable
				royalty.
								(C)The owner or licensee of a patent that
				should have been disclosed in response to a request for patent information made
				by an applicant pursuant to subparagraph (A) of section 351(k)(18) of the
				Public Health Service Act, but that was not timely disclosed under that
				subparagraph, may not bring an action under this title for infringement of that
				patent.
								;
					(C)in paragraph
			 (5)—
						(i)by
			 adding (A) in front of Where; and
						(ii)by
			 adding the following subparagraph:

								(B)Where a person has
				provided a notice described in subparagraph (B) of section 351(k)(18) of the
				Public Health Service Act, and neither the holder for the approved biological
				product or the owner of a patent identified in the notice brought an action for
				infringement of such patent before the expiration of 45 days after the date on
				which the notice was received, the courts of the United States shall, to the
				extent consistent with the Constitution, have and exercise subject matter
				jurisdiction in any action brought by such person under section 2201 of title
				28 for a declaratory judgement that such patent is invalid or not
				infringed.
								;
				and
						(D)in paragraph (4),
			 by striking in paragraph (2) in both places it appears and
			 inserting in subparagraphs (2)(A) or (2)(B).
					(3)Conforming
			 amendments
					(A)Title
			 28Section 2201(b) of title 28, United States Code, is amended by
			 inserting before the period the following: , or section 351 of the
			 Public Health Service Act.
					(B)Public health
			 service actSubjection (j) of section 351 of the Public Health
			 Service Act (42 U.S.C. 262) is amended by inserting or subsection
			 (k) after subsection (a).
					(c)Review of
			 applications submitted during exclusivity periods
				(1)User fee
			 goals
					(A)RevisionWithin
			 180 days after the date of the enactment of this Act, the Secretary of Health
			 and Human Services, in consultation with the relevant stakeholders, shall
			 revise the PDUFA reauthorization performance goals and procedures with respect
			 to the user fee goals for abbreviated biological product applications under
			 section 351(k) of the Public Health Service Act, as added by subsection (a) of
			 this section, that are submitted more than 2 years in advance of the expiration
			 of any period of exclusive marketing to which the reference drug is entitled
			 under subsection (k)(10) or subsection (l) of section 351 of the Public Health
			 Service Act, as added by subsection (a) of this section and section 4
			 respectively.
					(B)ConsiderationsIn
			 revising the user fee goals for applications described in subparagraph (A), the
			 Secretary shall consider—
						(i)the
			 need to provide sufficient time so that a decision on whether to approve the
			 application can be made in advance of the expiration of any exclusivity, and
			 considering the possibility that amendments will be necessary after the initial
			 decision and prior to approval; and
						(ii)the
			 importance of conserving agency resources.
						(2)Review
			 prioritiesIn setting priorities with respect to the review of
			 applications described in paragraph (1)(A), the Secretary shall take into
			 account the number of years in advance of the expiration of any exclusivity
			 granted to the reference drug that an application was submitted.
				(3)Submission of
			 revised performance goals to congressThe Secretary shall, within
			 30 days after revising the PDUFA reauthorization performance goals and
			 procedures under this subsection, submit to the Committee on Energy and
			 Commerce of the House of Representatives and the Committee on Health,
			 Education, Labor, and Pensions of the Senate a letter describing the revised
			 goals and the basis for such revisions.
				(4)DefinitionsIn
			 this subsection:
					(A)The terms
			 abbreviated biological product application and reference
			 product have the meanings given to those terms in section 351(i) of the
			 Public Health Service Act, as amended by section 2(a).
					(B)The term
			 PDUFA reauthorization performance goals and procedures means the
			 performance goals and procedures of the Food and Drug Administration, agreed to
			 for purposes of the reauthorization of part 2 of subchapter C of chapter VII of
			 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 279g et seq.; relating to
			 the prescription drug user fee program) for fiscal year 2008 and succeeding
			 fiscal years.
					4.Pediatric studies
			 of biological productsSection
			 351 of the Public Health Service Act (42 U.S.C. 262), as amended by section 3,
			 is further amended by adding at the end the following:

				(l)Pediatric
				studies
					(1)Application of
				certain provisionsThe provisions of section 505A of the Federal
				Food, Drug, and Cosmetic Act shall, except as inconsistent with this section,
				apply to biological products approved under subsection (a) or (k) of this
				section to the same extent and in the same manner as such provisions apply to
				drugs approved under subsection (c) or (j), respectively, of section 505 of the
				Federal Food, Drug, and Cosmetic Act.
					(2)Market
				exclusively for new biological productsIf, prior to approval of an application
				that is submitted under subsection (a) of this section, the Secretary
				determines that information relating to the use of a new biological product in
				the pediatric population may produce health benefits in that population, the
				Secretary makes a written request for pediatric studies (which shall include a
				timeframe for completing such studies), the applicant agrees to the request,
				such studies are completed using appropriate formulations for each age group
				for which the study is requested within any such timeframe, and the reports
				thereof are submitted and accepted in accordance with section 505A(d)(3) of the
				Federal Food, Drug, and Cosmetic Act—
						(A)the period for such
				biological product referred to in subparagraph (A) of subsection (k)(10),
				including any extension under subparagraph (D) of such subsection, is extended
				by 6 months; and
						(B)if the biological
				product is designated under section 526 for a rare disease or condition, the
				period for such biological product referred to in section 527(a) is deemed to
				be 7 years and 6 months rather than 7 years.
						(3)Market
				exclusivity for already-marketed biological productsIf the Secretary determines that
				information relating to the use of a licensed biological product in the
				pediatric population may produce health benefits in that population and makes a
				written request to the holder of an approved application under subsection (a)
				of this section for pediatric studies (which shall include a timeframe for
				completing such studies), the holder agrees to the request, such studies are
				completed using appropriate formulations for each age group for which the study
				is requested within any such timeframe, and the reports thereof are submitted
				and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug,
				and Cosmetic Act—
						(A)the period for such biological product
				referred to in subparagraph (A) of subsection (k)(10), including any extension
				under subparagraph (D) of such subsection, is extended by 6 months; and
						(B)if the biological
				product is designated under section 526 for a rare disease or condition, the
				period for such biological product referred to in section 527(a) is deemed to
				be 7 years and 6 months rather than 7 years.
						(4)ExceptionThe
				Secretary shall not extend the period referred to in paragraph (2)(A), (2)(B),
				(3)(A), or (3)(B) if the determination under section 505A(d)(3) is made later
				than 9 months prior to the expiration of such
				period.
					.


 HR 5023 ENR: To name the Department of Veterans Affairs community-based outpatient clinic in Youngstown, Ohio, as the “Carl Nunziato VA Clinic”.
U.S. House of Representatives

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
One Hundred Sixteenth Congress of the United States of AmericaAt the Second SessionBegun and held at the City of Washington on Friday, the third day of January, two thousand and twenty
H. R. 5023

AN ACT
To name the Department of Veterans Affairs community-based outpatient clinic in Youngstown, Ohio, as the Carl Nunziato VA Clinic.

1.FindingsCongress makes the following findings: (1)Carl Nunziato graduated from Youngstown State University ROTC as the Distinguished Military Graduate in 1961 and commissioned into the U.S. Army.
(2)While serving, Major (ret.) Nunziato was stationed in Thailand during the Laotian Crisis. Major Nunziato later served two voluntary tours of combat duty in Vietnam.  (3)On his second tour, then-Captain Nunziato was severely injured, losing both legs from a mortar attack while protecting a small Vietnamese village in Soui Da.
(4)Major Nunziato spent two years at Walter Reed Military Hospital recovering from his wounds. He then returned home to Northeastern Ohio where he enrolled in Case Western University Law School earning a degree in 1971. Following retirement from active duty, Major Nunziato continuously championed the rights of veterans and the disabled, while establishing a distinguished career in banking and finance.  (5)Due to Major Nunziato’s tireless efforts, a Department of Veterans Affairs outpatient clinic was established in Youngstown. Additionally, his exhaustive work throughout Mahoning County has brought curb cuts, wheel chair ramps and other accessibility measures to county public buildings, universities and courthouses, affording more independence to local disabled population. These efforts were borne from witnessing fellow disabled veterans denied justice and equality, after having fought and sacrificed for those same principles.
2.Name of Department of Veterans Affairs community-based outpatient clinic, Youngstown, OhioThe Department of Veterans Affairs community-based outpatient clinic in Youngstown, Ohio, shall, after the date of the enactment of this Act, be known and designated as the Carl Nunziato VA Clinic. Any reference to such clinic in any law, regulation, map, document, record, or other paper of the United States shall be considered to be a reference to the Carl Nunziato VA Clinic.   Speaker of the House of Representatives.Vice President of the United States and President of the Senate.


I
108th CONGRESS
2d Session
H. R. 4539
IN THE HOUSE OF REPRESENTATIVES

June 9, 2004
Mr. Langevin introduced the following bill; which was referred to the Committee on Ways and Means

A BILL
To suspend temporarily the duty on Pigment Yellow 214.

1.Pigment Yellow 214
(a)In generalSubchapter II of chapter 99 of the Harmonized Tariff Schedule of the United States is amended by inserting in numerical sequence the following new heading:

9902.34.52Pigment Yellow 214 (CAS No. 254430–12–5) (provided for in subheading 3204.17.90)FreeNo changeNo changeOn or before 12/31/2006 .
(b)Effective dateThe amendment made by subsection (a) applies with respect to goods entered, or withdrawn from warehouse for consumption, on or after the 15th day after the date of the enactment of this Act.


116 HRES 1174 IH: Expressing support for the designation of October 2020 as “National Co-Op Month” and commending the cooperative business model and the member-owners, businesses, employees, farmers, ranchers, and practitioners that use the cooperative business model to positively impact the economy and society.
U.S. House of Representatives
2020-10-01
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.

IV116th CONGRESS2d SessionH. RES. 1174IN THE HOUSE OF REPRESENTATIVESOctober 1, 2020Mr. Pocan (for himself, Mr. Baird, Mr. Case, Mr. Khanna, Mr. Kind, Mr. San Nicolas, and Mr. Welch) submitted the following resolution; which was referred to the Committee on Energy and CommerceRESOLUTIONExpressing support for the designation of October 2020 as National Co-Op Month and commending the cooperative business model and the member-owners, businesses, employees, farmers, ranchers, and practitioners that use the cooperative business model to positively impact the economy and society.Whereas during the global COVID–19 pandemic, cooperatives have taken extraordinary steps to serve their member-owners and communities;Whereas a cooperative—(1)is a business that is owned and governed by its members, who are the individuals who use the business, create the products of the business, or manage the operation of the business; and(2)operates under the 7 principles of—(A)voluntary open membership;(B)democratic control;(C)owner economic participation;(D)autonomy and independence; (E)education, training, and information;(F)cooperation among cooperatives; and(G)concern for community;Whereas cooperative entrepreneurs can be found in almost every economic sector in the United States, throughout all 50 States and territories, and every congressional district in the United States;Whereas cooperatives help farmers increase incomes and become more resilient to economic business cycles by working together to plan and prepare for the future, while contributing significantly to the economic activity in the United States agriculture and food markets;Whereas the roughly 1,800 agricultural cooperatives in America operate more than 8,000 facilities, employ $96 billion in assets, and generate nearly $204 billion in business;Whereas the majority of America’s 2 million farmers belong to an agricultural cooperative;Whereas agricultural cooperatives offer members the opportunity to tap into the commodity value-added profits throughout the handling, processing, and distribution chains;Whereas member owners in agricultural cooperatives are dedicated to providing the highest quality product for consumers;Whereas agricultural cooperatives add significant benefits to the economic well-being of rural America by providing over 250,000 jobs with annual wages totaling over $8 billion;Whereas agricultural cooperatives provide resources such as low-cost supplies, effective marketing, and services to their member-owners;Whereas farmer members in agricultural cooperatives have the opportunity to pool resources and reinvest profits into its members’ communities;Whereas the principles of cooperation and the cooperative business model help smallholder farmers organize themselves and gain access to local and global markets, training, improved inputs, and aggregated sales and marketing;Whereas the cooperative business model provides farmers ownership over their economic decisions, a focus on learning, and a broader understanding of environmental and social concerns;Whereas the cooperative business model has been used throughout American history to advance civil rights and to help ensure that all people have equal access to economic opportunity;Whereas cooperative values promote self-determination and democratic rights for all people;Whereas the comprehensive global food security strategy established under section 5 of the Global Food Security Act of 2016 (22 U.S.C. 9304) (commonly known as Feed the Future) and the Cooperative Development Program of the United States Agency for International Development use cooperative principles and the cooperative business model to advance international development, nutrition, resilience, and economic security;Whereas the Interagency Working Group on Cooperative Development—(1)is an interagency group that is coordinated and chaired by the Secretary of Agriculture to foster cooperative development and ensure coordination with Federal agencies and national and local cooperative organizations that have cooperative programs and interests; and (2)as of the date of introduction of this resolution, had organized 4 meetings;Whereas the bipartisan Congressional Cooperative Business Caucus unites Members of Congress to—(1)create a better informed electorate and a more educated public on the important role that cooperatives play in the economy of the United States and the world;(2)promote the cooperative business model, because that model ensures that consumers have access to high-quality goods and services at competitive prices and costs that improve the lives of individuals, families, and their communities; and(3)address and correct awareness challenges among the public and within the Federal Government relating to what cooperatives look like, who participates in cooperatives, where cooperatives are located, and why individuals choose cooperatives;Whereas the Bureau of the Census, as part of the 2017 Economic Census, asked each business if the business was organized as a cooperative, and the responses of businesses yielded both quantitative and qualitative data on the effects and importance of cooperatives across the economy of the United States;Whereas throughout the rural United States, many utility services providers operate as cooperatives and are tasked with the delivery of public services such as electricity, water, telecommunications, and broadband in areas where investor-owned utility companies typically do not operate;Whereas utility cooperatives have innovated to meet evolving needs of their member-owners and help rural individuals in the United States prosper;Whereas in the financial services sector, cooperatives, including credit unions, farm credit banks, and other financing organizations that lend to cooperatives, provide numerous benefits to the member-owners of those cooperatives;Whereas member-owners of cooperatives vote in board elections, and earned profits cycle back into cost-saving programs or return as dividend payments;Whereas purchasing and shared service cooperatives allow independent and franchise businesses to thrive;Whereas food cooperatives range in size from small, local buying clubs to multistore regional giants that compete with chain stores with locations across the United States;Whereas in the housing sector, housing cooperatives and resident-owned communities in which members own the building or land—(1)are an alternative to conventional rental apartments, manufactured home parks, and condominiums; and(2)empower each resident with ownership and responsibility;Whereas housing cooperatives have roots dating to the late 1800s and are increasingly becoming a housing alternative for students at colleges throughout the United States;Whereas shared equity housing cooperatives are a critical option for preserving long-term, affordable housing;Whereas cooperatives allow residents of manufactured home communities to collectively purchase the land on which they live, providing stability and the opportunity to self-govern;Whereas, as of 2019, not less than 1,000 manufactured home communities were resident owned, accounting for approximately 2 percent of all manufactured home communities;Whereas the growth of worker cooperatives in the United States is allowing more workers to own and have greater control over their businesses;Whereas many small businesses convert to cooperatives when faced with closure or buyout, ensuring the business can continue to serve its community; andWhereas the cooperative business model allows business owners to retire and transfer business ownership to employees or consumers, protecting local ownership and supporting local communities: Now, therefore, be itThat the House of Representatives—(1)expresses support for the designation of National Co-Op Month;(2)commends the cooperative business model for—(A)its contributions to the economy;(B)the jobs it creates; and(C)its positive impacts on local communities;(3)expresses confidence in, and support for, cooperatives to continue their successes;(4)will seek to pass legislation that provides for studying, supporting, encouraging, and promoting the use of the cooperative business model across all policy areas; and(5)will be mindful in crafting legislation that affects business models that are not the cooperative business model so that the legislation does not adversely affect the cooperative business model.


114 HR 701 IH: Helping Families Save for Education Act
U.S. House of Representatives
2015-02-04
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. 701
		IN THE HOUSE OF REPRESENTATIVES

			February 4, 2015
			Mr. Walberg (for himself and Mr. Kildee) introduced the following bill; which was referred to the Committee on Ways and Means

		A BILL
		To amend the Internal Revenue Code of 1986 to expand access to Coverdell education savings
			 accounts.

 1.Short titleThis Act may be cited as the Helping Families Save for Education Act. 2.FindingsThe Congress finds the following:
 (1)College costs have increased tremendously over the past decade. When adjusted for inflation, the average published price for in-State students at public four-year universities is 42-percent higher than it was a decade ago and more than twice as high as it was 20 years ago. The price of private nonprofit four-year institutions has increased 24 percent during the last 10 years and 66 percent during the last 20 years.
 (2)Federal financial aid for students has also increased rapidly but failed to mitigate the issues of rising college costs. Between the 2003–2004 academic year and the 2013–2014 academic year, the amount of Federal financial aid in the form of Pell Grants, Federal student aid, campus based aid, veterans educational benefits, and tax credits increased from $73.5 billion to $164.5 billion or by 124 percent beyond the rate of inflation. The Federal Government’s share of total student aid is 69 percent.
 (3)Students continue to borrow more than they can afford. During the 2012–2013 academic year, approximately 60 percent of students who earned bachelor’s degrees from the public and private nonprofit institutions at which they began their studies graduated with debt. These students borrowed an average of $27,300, an increase of 13 percent compared to 5 years ago and an increase of 19 percent compared to 10 years ago.
			3.Expansion of Coverdell education savings accounts
 (a)Increase in age limitation of beneficiary after which contributions to account cannot be madeSection 530(b)(1)(A)(ii) of the Internal Revenue Code of 1986 is amended by striking age 18 and inserting age 22. (b)Increase in annual dollar limitation on contributions to accountSection 530(b)(1)(A)(iii) of such Code is amended by striking $2,000 and inserting $10,000.
			(c)Effective dates
 (1)Increase in age limitationThe amendments made by subsection (a) shall apply to contributions made after the date of the enactment of this Act.
 (2)Increase in annual dollar limitation on contributionsThe amendments made by subsection (b) shall apply to contributions made in taxable years ending after the date of the enactment of this Act.


IV
111th CONGRESS
1st Session
H. RES. 501
In the House of Representatives, U. S.,

June 4, 2009

RESOLUTION
Providing for consideration of the bill (H.R. 626) to provide that 4 of the 12 weeks of parental leave made available to a Federal employee shall be paid leave, and for other purposes.

That at any time after the adoption of this resolution the Speaker may, pursuant to clause 2(b) of rule XVIII, declare the House resolved into the Committee of the Whole House on the state of the Union for consideration of the bill (H.R. 626) to provide that 4 of the 12 weeks of parental leave made available to a Federal employee shall be paid leave, and for other purposes. The first reading of the bill shall be dispensed with. All points of order against consideration of the bill are waived except those arising under clause 9 or 10 of rule XXI. General debate shall be confined to the bill and shall not exceed one hour equally divided and controlled by the chair and ranking minority member of the Committee on Oversight and Government Reform. After general debate the bill shall be considered for amendment under the five-minute rule. The bill shall be considered as read. All points of order against provisions in the bill are waived. Notwithstanding clause 11 of rule XVIII, no amendment to the bill shall be in order except those printed in the report of the Committee on Rules accompanying this resolution. Each such amendment may be offered only in the order printed in the report, may be offered only by a Member designated in the report, shall be considered as read, shall be debatable for the time specified in the report equally divided and controlled by the proponent and an opponent, shall not be subject to amendment, and shall not be subject to a demand for division of the question in the House or in the Committee of the Whole. All points of order against such amendments are waived except those arising under clause 9 or 10 of rule XXI. At the conclusion of consideration of the bill for amendment the Committee shall rise and report the bill to the House with such amendments as may have been adopted. The previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions.

Lorraine C. Miller,Clerk.


115 HR 1626 IH: Student Agriculture Protection Act of 2017
U.S. House of Representatives
2017-03-20
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.

I115th CONGRESS1st SessionH. R. 1626IN THE HOUSE OF REPRESENTATIVESMarch 20, 2017Mr. McCaul introduced the following bill; which was referred to the Committee on Ways and MeansA BILLTo amend the Internal Revenue Code of 1986 to exclude from gross income certain amounts realized on
			 the disposition of property raised or produced by a student farmer, and
			 for other purposes.

 1.Short titleThis Act may be cited as the Student Agriculture Protection Act of 2017. 2.Exclusion of certain gain by student farmers from gross income (a)In generalPart III of subchapter B of chapter 1 of the Internal Revenue Code of 1986 is amended by inserting after section 139F the following new section:

					139G.Gain from property produced or raised by a student farmer
 (a)In generalIn the case of a student farmer, gross income shall not include so much of the gain from qualified dispositions during the taxable year as does not exceed $5,000.
 (b)DefinitionsFor purposes of this section— (1)Student farmerThe term student farmer means an individual who has not attained age 19 and who is enrolled in—
 (A)a program established by the National FFA Organization, (B)a 4–H Club or other program established by 4–H, or
 (C)any student agriculture program similar in nature to a club or program described in subparagraph (A) or (B) which is under the direction or guidance of an agricultural educator, advisor, or club leader.
								(2)Qualified disposition
 (A)In generalThe term qualified disposition means a sale or exchange of qualified property by or on behalf of a student farmer (determined as of the date of the sale or exchange) which occurs—
 (i)during an activity of a type described in paragraph (2)(B) or (3)(B) of section 513(d), or (ii)under the supervision of a program described in subparagraph (A), (B), or (C) of paragraph (1).
 (B)Qualified propertyFor purposes of subparagraph (A), the term qualified property means personal property, including livestock, crops, and agricultural mechanics or shop projects, produced or raised—
 (i)by the student farmer by or on behalf of whom the sale or exchange is made, and (ii)under the supervision of a program described in subparagraph (A), (B), or (C) of paragraph (1)..
 (b)Conforming amendmentThe table of sections for part III of subchapter B of chapter 1 of the Internal Revenue Code of 1986 is amended by inserting after the item relating to section 139F the following new item:

						Sec. 139G. Gain from property produced or raised by a student farmer..
 (c)Effective dateThe amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.


115 HR 249 IH: Defunding United Nations Act of 2017
U.S. House of Representatives
2017-01-04
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.

I115th CONGRESS1st SessionH. R. 249IN THE HOUSE OF REPRESENTATIVESJanuary 4, 2017Mr. Babin introduced the following bill; which was referred to the Committee on Foreign AffairsA BILLTo prohibit United States voluntary contributions to the regular budget of the United Nations or
			 any United Nations agency, and for other purposes.

 1.Short titleThis Act may be cited as the Defunding United Nations Act of 2017. 2.Prohibition on United States voluntary contributions to the United Nations and United Nations agencies (a)In generalNo funds made available to any Federal department or agency may be used to make United States voluntary contributions to the regular budget of the United Nations or any United Nations agency.
 (b)Effective dateSubsection (a) applies with respect to funds made available for fiscal year 2017 and subsequent fiscal years.


I
One Hundred Twelfth Congress of the United States of America At the First SessionBegun and held at the City of Washington on Wednesday, the fifth day of January, two thousand and eleven
H. R. 1843

AN ACT
To designate the facility of the United States Postal Service located at 489 Army Drive in Barrigada, Guam, as the John Pangelinan Gerber Post Office Building.

1.John Pangelinan Gerber Post Office Building
(a)DesignationThe facility of the United States Postal Service located at 489 Army Drive in Barrigada, Guam, shall be known and designated as the John Pangelinan Gerber Post Office Building.
(b)ReferencesAny reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the John Pangelinan Gerber Post Office Building.
 Speaker of the House of Representatives.Vice President of the United States and President of the Senate.


		I
		112th CONGRESS
		1st Session
		H. R. 603
		IN THE HOUSE OF REPRESENTATIVES

			February 10, 2011
			Mr. Harper (for
			 himself and Mrs. McMorris Rodgers)
			 introduced the following bill; which was referred to the
			 Committee on Energy and
			 Commerce

		A BILL
		To amend the Developmental Disabilities
		  Assistance and Bill of Rights Act of 2000 to provide assistance to States for
		  development and implementation of an individual transition plan for each
		  individual with a developmental disability in the State who is making the
		  transition from the secondary school system into adulthood, and for other
		  purposes.

		1.Short title; table of
			 contents
			(a)Short
			 titleThis Act may be cited
			 as the Transition toward Excellence, Achievement, and
			 Mobility through Empowerment Act of 2011 or the
			 TEAM–Empowerment Act of 2011.
			(b)Table of
			 contentsThe table of contents of this Act is as follows:

					Sec. 1. Short title; table of contents.
					Sec. 2. Findings and purposes.
					Sec. 3. Individualized transition plans; transition planning
				and services administrative units.

			2.Findings and
			 purposes
			(a)FindingsCongress finds the following:
				(1)Evidence-based
			 research has conclusively documented that youth with significant disabilities
			 who were educated in inclusive settings, were exposed to work experience and
			 career exploration, and participated in a paid work experience while in school
			 had better postsecondary outcomes and higher rates of sustainable
			 employment.
				(2)Higher rates of
			 self-determination, in which individuals with significant disabilities and
			 their families have direct control over the decisionmaking process in order to
			 ensure an appropriate individualized transition strategy, lead to better
			 outcomes.
				(3)Regulations and
			 processes allowing for flexibility in the blending and braiding of government
			 funds to ensure seamless, collaborative strategies during the transition
			 process lead to better outcomes for individuals with significant
			 disabilities.
				(4)Agency officials
			 involved directly in the provision of supports and services during a youth’s
			 transition into adulthood and beyond must be provided additional training to
			 become properly prepared to adequately address the individual transition needs
			 of students with significant disabilities.
				(b)PurposesThe purposes of this Act are the
			 following:
				(1)Create a holistic
			 system across multiple partners focused on successful transition of youth with
			 significant disabilities into adulthood.
				(2)Create a systemic
			 focus on achieving high expectations for all youth, through equality of
			 opportunity, full participation through self-determination and informed choice,
			 outcomes related to post-secondary options that lead to competitive integrated
			 employment and economic self-sufficiency.
				(3)Promote innovative
			 strategies to foster academic, professional, and social inclusion, and the
			 solidification of long-term supports and services required to ensure full
			 integration into the community setting.
				(4)Better define and
			 coordinate specific services related to the effective transition of youth with
			 significant disabilities.
				(5)Eliminate barriers
			 and promote incentives for multiple stakeholders to collaborate and improve
			 transition opportunities for youth with significant disabilities.
				3.Individualized
			 transition plans; transition planning and services administrative
			 unitsTitle I of the
			 Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C.
			 15001 et seq.) is amended by adding at the end the following:

				FAdult transition
				system
					171.DefinitionsIn this subtitle:
						(1)The term asset development
				means a strategy to assist low-income workers and job seekers, including
				individuals with disabilities, move toward economic security and greater
				financial self-sufficiency through income preservation, effective money and
				credit management, the pursuit of post-secondary education, the purchase of a
				home, business startup and growth, and the setting aside of resources for
				longer-term needs and retirement.
						(2)The term
				individualized education program has the meaning given such term
				in section 602 of the Individuals with Disabilities Education Act.
						(3)The term
				integrated employment means work compensated at the greater of
				minimum wage or competitive wages with related employment benefits, occurring
				in a typical work setting where the employee with the disability—
							(A)interacts or has
				the opportunity to interact continuously with nondisabled co-workers;
							(B)has an opportunity
				for advancement and mobility; and
							(C)is preferably
				engaged in full-time employment.
							(4)The term
				ITP means an individual transition plan developed under section
				173.
						(5)The term
				local educational agency has the meaning given to such term in
				section 9101 of the Elementary and Secondary Education Act of 1965.
						(6)The term
				secondary school has the meaning given to such term in section
				9101 of the Elementary and Secondary Education Act of 1965.
						(7)The term State intellectual and
				developmental disabilities agency means the primary State agency or
				subdivision with administrative, programmatic, and operational responsibility
				for the full range of services and supports furnished to individuals with
				intellectual and developmental disabilities.
						(8)The term TPS administrative
				unit refers to the transition planning and services administrative unit
				of a State established in accordance with section 174.
						(9)(A)The term transition services
				means a coordinated set of activities for a student, designed within an
				outcome-oriented process, that promotes movement from school to post school
				activities, including postsecondary education, vocational training, integrated
				employment (including supported employment and customized employment),
				continuing and adult education, adult services, asset development services,
				independent living, or community participation.
							(B)The coordinated set of activities
				shall be based upon the individual student’s needs, taking into account the
				student’s preferences and interests, and shall include instruction, community
				experiences, the development of employment and other post school adult living
				objectives; school-based preparatory experiences, career preparation, and
				integrated work-based learning experiences (inclusive of in-school, after
				school and work experiences outside the traditional school setting where other
				youth without disabilities are engaged in similar activities); youth
				development and leadership; connecting activities; training in self-advocacy,
				self-determination skills, and peer mentoring; family involvement and supports;
				and, when appropriate, acquisition of daily living skills and functional
				vocational evaluation.
							(C)Such term does not include the use of
				facility-based employment and activity settings, such as sheltered workshops,
				day habilitation centers, and enclave work settings. Additionally, the
				coordinated set of activities should lead to the attainment of at least one of
				the following outcomes: post-secondary education, long-term integrated
				employment (including supported employment or customized employment), asset
				development, independent living, and community participation.
							172.State
				assistanceFor each fiscal
				year, the Secretary, acting through the Commissioner of the Administration on
				Developmental Disabilities, shall—
						(1)make grants on a
				competitive basis to States that agree to carry out the activities required of
				States under this subtitle; and
						(2)among the States receiving grants under
				paragraph (1), allocate payments pursuant to a formula that—
							(A)is established by
				the Secretary, acting through the Commissioner; and
							(B)takes into
				consideration an estimate of the number of individuals to be served under this
				subtitle in each State.
							173.Individualized
				transition plans
						(a)In
				generalEach State that
				receives assistance under this subtitle shall, with respect to each individual
				with a developmental disability in the State who is making the transition from
				the secondary school system into adulthood, develop, and assist in the
				implementation of, an individual transition plan to coordinate transition
				services intended to assist the individual in achieving the outcomes of
				integrated employment, postsecondary education, independent living, and
				community engagement.
						(b)FormulationAn
				ITP shall be—
							(1)coordinated with any pre-existing
				transition services being provided to the individual as a result of an
				individualized education program developed for the individual prior to exiting
				secondary school pursuant to the Individuals with Disabilities Education
				Act;
							(2)developed not
				later than 30 days after the date on which the individual graduates from or
				otherwise exits the State’s secondary school system; and
							(3)applicable through
				the date on which the individual attains 26 years of age;
							(4)reviewed annually
				and updated as needed; and
							(5)developed during
				in-person meetings that—
								(A)are led by the TPS
				administrative unit of the State intellectual and developmental disabilities
				agency established under section 174; and
								(B)at a minimum, include the following
				stakeholders: the individual, the individual’s family, a transition broker (as
				described in section 174), a representative of the State vocational
				rehabilitation agency, relevant service providers that are contracted by the
				State or chosen by the individual and the individual’s family or guardian to
				provide transition services, the transition coordinator of the local
				educational agency (where available, during the first year the individual exits
				the secondary school system), assistive technology experts (as appropriate),
				and representatives of the workforce development sector.
								(c)ContentsAn ITP shall include strategies for the
				implementation of service models and practices with documented effectiveness
				that—
							(1)address and
				emphasize the 5 areas of postsecondary educational experiences, career
				preparation and work-based learning experiences, development and leadership,
				connecting activities, and family involvement and supports;
							(2)identify the needs
				of the individual in each of these 5 areas and articulate how the State and its
				agencies will meet those needs; and
							(3)will advance
				economic self-sufficiency with specific asset development goals and identify
				specific tools for advancing economic self-sufficiency, such as favorable tax
				benefits, work incentives, matched savings plans, education financing, and
				effective strategies to manage a budget, money, and credit.
							174.Transition
				planning and services administrative unit
						(a)EstablishmentEach State that receives assistance under
				this subtitle shall establish and maintain a transition planning and services
				(TPS) administrative unit within the State intellectual and developmental
				disabilities agency.
						(b)ResponsibilitiesThe primary focus of a TPS administrative
				unit shall be to assist individuals with a developmental disability in the
				State to make the transition from the secondary school system into adulthood.
				The responsibilities of the TPS administrative unit shall include the
				following:
							(1)Individual
				transition planThe TPS
				administrative unit shall have responsibility for developing and assisting in
				the implementation of ITPs.
							(2)Transition
				brokers
								(A)In
				generalThe TPS administrative unit shall employ or otherwise
				secure the services of transition brokers.
								(B)RoleA
				transition broker of the TPS administrative unit shall—
									(i)facilitate
				coordination among State agencies in the development of ITPs; and
									(ii)provide
				assistance to individuals with developmental disabilities, consistent with the
				individual’s ITP, in navigating the complex system of supports and services
				available through Federal and State programs.
									(C)QualificationsTo
				be eligible to serve as a transition broker of the TPS administrative unit, an
				individual shall possess two or more of the following qualifications:
									(i)Expertise relating
				to individuals with developmental disabilities, benefits planning, the
				provision of transition services, employment and job development, and
				negotiating among various State stakeholders.
									(ii)Experience with
				and knowledge of the generic workforce development sector, vocational
				rehabilitation, and job development.
									(iii)Knowledge and expertise in the use of tools
				to advance asset development and economic self-sufficiency, including favorable
				tax benefits, work incentives, matched savings plans, education financing, and
				effective strategies to manage a budget, money, and credit.
									(iv)Knowledge about self-direction and
				person-centered planning processes.
									(D)AssignmentA transition broker of the TPS
				administrative unit shall be assigned to an individual upon—
									(i)the individual or
				the individual’s family or guardian selecting the broker; and
									(ii)the State
				intellectual and developmental disabilities agency approving the
				selection.
									(3)Self-advocacy,
				self-determination skills, and peer mentoringThe TPS
				administrative unit shall offer strategies and training to individuals with
				developmental disabilities and their families regarding self-advocacy,
				self-determination skills, and peer mentoring to improve the ability of such
				individuals to advocate and negotiate on their own behalf.
							(4)Effective
				information and resourcesThe
				TPS administrative unit shall provide information to individuals with
				developmental disabilities and their families on Federal and State services,
				supports, and regulations, including with respect to asset development,
				insurance and benefit programs, financial savings tools, and asset or income
				limits that affect eligibility for Federal and State means-tested services,
				supports, or programs. Such information shall be easily understood and updated
				on a quarterly basis each year.
							(c)Fostering
				multiagency collaborationThe
				State intellectual and developmental disabilities agency of each State that
				receives assistance under this subtitle shall facilitate memoranda of
				understanding among key State agencies for the purpose of coordinating and
				improving the services and supports provided by such agencies to individuals
				with developmental disabilities during the transition into adulthood.
						175.Annual
				reportNot later than the end
				of fiscal year 2012, and annually thereafter, the Secretary shall submit a
				report to the Congress containing an evaluation of the implementation and
				effectiveness of this subtitle, including an evaluation of—
						(1)the number of
				individuals in each State who had an ITP developed on their behalf over the
				past fiscal year;
						(2)progress made at
				the individual level in implementing the objectives of ITPs developed since the
				date of enactment; and
						(3)with respect to
				individuals for whom an ITP is developed, their employment status, education
				status, income level, race, gender, and current residence.
						176.Authorization
				of appropriationsTo carry out
				this subtitle, there is authorized to be appropriated $50,000,000 for each of
				fiscal years 2012 through
				2016.
					.


110 HRES 1215 IH: Honoring the Armed Forces from the Inland

U.S. House of Representatives
2008-05-20
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.

		IV
		110th CONGRESS
		2d Session
		H. RES. 1215
		IN THE HOUSE OF REPRESENTATIVES

			May 20, 2008
			Mr. Baca submitted
			 the following resolution; which was referred to the
			 Committee on Armed
			 Services

		RESOLUTION
		Honoring the Armed Forces from the Inland
		  Empire in California and their families for their extraordinary sacrifices
		  serving the United States in Operation Enduring Freedom and Operation Iraqi
		  Freedom.

		Whereas the Armed Forces includes all branches of the
			 military, including the National Guard and Reserves;
		Whereas more than 1,700,000 members of the Armed Forces
			 have been deployed in Operation Enduring Freedom or Operation Iraqi Freedom
			 since September 2001;
		Whereas over 450 Californians have died in Afghanistan and
			 Iraq, many of whom were from the communities of the Inland Empire;
		Whereas over 3,300 Californians have been wounded in
			 battle in Afghanistan and Iraq, many of whom are from the communities of the
			 Inland Empire;
		Whereas both physical and mental injuries sustained during
			 combat have a life-altering impact on those who served our Nation, as well as
			 their families;
		Whereas members of the Armed Forces from the Inland Empire
			 have been killed and injured in operations to bring peace and stability, in the
			 name of democracy;
		Whereas the Inland Empire region of southern California
			 includes San Bernardino County and Riverside County; and
		Whereas members of the Armed Forces from the Inland Empire
			 have served honorably in their mission to fight terrorism and protect the
			 greater security of the United States: Now, therefore, be it

		That the House of
			 Representatives—
			(1)recognizes that
			 the members of the Armed Forces from the Inland Empire gave, and continue to
			 give, to our Nation;
			(2)commits to
			 providing wounded warriors with the highest quality of medical care available,
			 including for their families during the recovery process;
			(3)commends the
			 actions of private citizens and organizations from the Inland Empire who
			 volunteer to support America’s wounded warriors;
			(4)encourages Members
			 and all citizens to take steps to show support and appreciation for all
			 returning troops;
			(5)honors and
			 recognizes the sacrifices made by the members of the Armed Forces from the
			 Inland Empire, and that of their families; and
			(6)understands that
			 the American people are forever grateful to the members of the Armed Forces
			 from the Inland Empire for the service they have provided to the United
			 States.


116 S3937 IS: Special Diabetes Programs for Indians Reauthorization Act of 2020
U.S. Senate
2020-06-10
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.

II116th CONGRESS2d SessionS. 3937IN THE SENATE OF THE UNITED STATESJune 10, 2020Ms. McSally (for herself, Ms. Sinema, and Ms. Murkowski) introduced the following bill; which was read twice and referred to the Committee on Indian AffairsA BILLTo amend section 330C of the Public Health Service Act to reauthorize special programs for Indians for providing services for the prevention and treatment of diabetes, and for other purposes.1.Short titleThis Act may be cited as the Special Diabetes Programs for Indians Reauthorization Act of 2020.2.Reauthorization of special diabetes programs for Indians for diabetes services(a)FundingSection 330C(c)(2)(D) of the Public Health Service Act (42 U.S.C. 254c–3(c)(2)(D)) is amended by striking $25,068,493 for the period beginning on October 1, 2020, and ending on November 30, 2020 and inserting $200,000,000 for each of fiscal years 2021 through 2025.(b)Delivery of fundsSection 330C(b) of the Public Health Service Act (42 U.S.C. 254c–3(b)) is amended—(1)by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively, and indenting appropriately;(2)in the matter preceding subparagraph (A) (as so redesignated), by striking For purposes of and inserting the following: (1)Eligible entitiesFor purposes of; and(3)by adding at the end the following:(2)Delivery of fundsOn request from an Indian tribe or tribal organization, the Secretary shall award a grant under this section pursuant to a contract, cooperative agreement, or compact under, as applicable, title I or V of the Indian Self-Determination and Education Assistance Act..


IA
One Hundred Eleventh Congress of the United States of America
At the First SessionBegun and held at the City of Washington on Tuesday, the sixth day of January, two thousand and nine
H. J. RES. 64

JOINT RESOLUTION
Making further continuing appropriations for fiscal year 2010, and for other purposes.

That the Continuing Appropriations Resolution, 2010 (division B of Public Law 111–68) is further amended by striking the date specified in section 106(3) and inserting December 23, 2009.

Speaker of the House of Representatives.Vice President of the United States and President of the Senate.