115 S2434 RS: Animal Drug and Animal Generic Drug User Fee Amendments of 2018
U.S. Senate
2018-02-15
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.

IICalendar No. 341115th CONGRESS2d SessionS. 2434IN THE SENATE OF THE UNITED STATESFebruary 15, 2018Mr. Alexander introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsMarch 7, 2018Reported by Mr. Alexander, with an amendmentStrike out all after the enacting clause and insert the part printed in italicA BILLTo amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new
			 animal drugs and generic new animal drugs.

 1.Short titleThis Act may be cited as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018. 2.Table of contents; references in Act (a)Table of contentsThe table of contents for this Act is as follows:Sec. 1. Short title.Sec. 2. Table of contents; references in Act.Title I—Fees relating to animal drugsSec. 101. Short title; finding.Sec. 102. Definitions.Sec. 103. Authority to assess and use animal drug fees.Sec. 104. Reauthorization; reporting requirements.Sec. 105. Savings clause.Sec. 106. Effective date.Sec. 107. Sunset dates.Title II—Fees relating to generic animal drugsSec. 201. Short title; finding.Sec. 202. Authority to assess and use generic new animal drug fees.Sec. 203. Reauthorization; reporting requirements.Sec. 204. Savings clause.Sec. 205. Effective date.Sec. 206. Sunset dates.Title III—Miscellaneous provisionsSec. 301. Electronic submissions.Sec. 302. Index of legally marketed unapproved new animal drugs for minor species.Sec. 303. Misbranded drugs and devices.
 (b)References in ActExcept as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
			IFees relating to animal drugs
			101.Short title; finding
 (a)Short titleThis title may be cited as the Animal Drug User Fee Amendments of 2018. (b)FindingCongress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.
 102.DefinitionsSection 739 (21 U.S.C. 379j–11) is amended— (1)by amending paragraph (1) to read as follows:

 (1)(A)The term animal drug application means— (i)an application for approval of any new animal drug submitted under section 512(b)(1); or
 (ii)an application for conditional approval of a new animal drug submitted under section 571. (B)Such term does not include either a new animal drug application submitted under section 512(b)(2) or a supplemental animal drug application.; and
 (2)in paragraph (8), by adding at the end the following:  (I)The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval..
				103.Authority to assess and use animal drug fees
 (a)Fee revenue amountsSection 740(b) (21 U.S.C. 379j–12(b)) is amended— (1)in paragraph (1)—
 (A)in subparagraph (A)— (i)by striking 2014 and inserting 2019; and
 (ii)by striking $23,600,000 and inserting $30,331,240; and (B)in subparagraph (B)—
 (i)by striking 2015 through 2018 and inserting 2020 through 2023; and (ii)by striking $21,600,000 and inserting $29,931,240; and
 (2)in paragraph (2), in the matter preceding subparagraph (A), by striking determined and inserting established. (b)Annual fee setting; adjustments (1)Inflation adjustmentSection 740(c)(2) (21 U.S.C. 379j–12(c)(2)) is amended—
 (A)in the matter preceding subparagraph (A)— (i)by striking For fiscal year 2015 and inserting (A) For fiscal year 2020; and
 (ii)by inserting multiplying such revenue amounts by before an amount; (B)by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively;
 (C)by striking the flush text at the end; and (D)by adding at the end the following new subparagraph:

 (B)Compounded basisThe adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year..
 (2)Workload adjustmentsParagraph (3) of section 740(c) (21 U.S.C. 379j–12(c)) is amended to read as follows:  (3)Workload adjustments (A)In generalFor fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraphs (B) and (C). With respect to such adjustment—
 (i)such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary; and
 (ii)the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies.
 (B)Reduction of workload-based increase by amount of certain excess collectionsFor each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
 (C)Rule of applicationUnder no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2)..
 (3)Final year adjustmentSection 740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— (A)by striking 2018 each place it appears and inserting 2023; and
 (B)by striking 2019 and inserting 2024. (c)Exemptions from feesSection 740(d) (21 U.S.C. 379j–12(d)) is amended—
 (1)in the subsection heading, by inserting ; exemptions from fees after reduction; (2)by striking the heading of paragraph (1) and inserting Waiver or reduction; and
 (3)by adding at the end the following:  (4)Exemptions from fees (A)Certain labeling supplements To add number of approved applicationFees under this section shall not apply with respect to any person who—
 (i)not later than September 30, 2023, submits a supplemental animal drug application relating to a new animal drug application approved under section 512, solely to add the new animal drug application number to the labeling of the drug in the manner specified in section 502(w)(3); and
 (ii)otherwise would be subject to fees under this section solely on the basis of such supplemental application.
 (B)Certain animal drug applicationsFees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H..
					(d)Crediting and availability of fees
 (1)Authorization of appropriationsSection 740(g)(3) (21 U.S.C. 379j–12(g)(3)) is amended— (A)by striking 2014 through 2018 and inserting 2019 through 2023;
 (B)by striking determined and inserting established; and (C)by striking paragraph (4) and inserting paragraph (5).
 (2)Excess collectionsSection 740(g) (21 U.S.C. 379j–12(g)) is amended by striking paragraph (4) and inserting the following:

 (4)Excess collectionsIf the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as described in paragraph (1).
							(5)Recovery of collection shortfalls
 (A)In generalSubject to subparagraph (B)— (i)for fiscal year 2021, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2019 falls below the amount of fees authorized for fiscal year 2019 under paragraph (3);
 (ii)for fiscal year 2022, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2020 falls below the amount of fees authorized for fiscal year 2020 under paragraph (3); and
 (iii)for fiscal year 2023, the amount of fees otherwise authorized to be collected under this section shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2021 and 2022 (including estimated collections for fiscal year 2022) falls below the cumulative amount of fees authorized for such fiscal years under paragraph (3).
									(B)Reduction of shortfall-based fee increase by prior year excess collections
 (i)In generalSubject to clause (ii), the Secretary shall, in such manner as the Secretary determines appropriate, reduce any fee increase otherwise applicable for a fiscal year under subparagraph (A) by the amount of any excess collections under this section for preceding fiscal years (after fiscal year 2018).
 (ii)Workload-based fee accountingIn applying clause (i), the Secretary shall account for the reduction of workload-based fee revenue increases by excess collections under subsection (c)(3)(B), in such manner as needed to provide that no portion of any excess collections described in clause (i) is applied for purposes of reducing fee increases under both such subsection (c)(3)(B) and this paragraph.
 (C)Rule of applicationUnder no circumstances shall adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted or otherwise affected under subsection (c)..
 104.Reauthorization; reporting requirementsSection 740A (21 U.S.C. 379j–13) is amended— (1)in subsection (a), by striking 2013 and inserting 2018;
 (2)by striking 2014 each place it appears in subsections (a) and (b) and inserting 2019; and (3)in subsection (d), by striking 2018 each place it appears and inserting 2023.
 105.Savings clauseNotwithstanding the amendments made by this title, part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019.
 106.Effective dateThe amendments made by this title shall take effect on October 1, 2018, or the date of the enactment of this Act, whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2018, regardless of the date of the enactment of this Act.
			107.Sunset dates
 (a)AuthorizationSection 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall cease to be effective October 1, 2023.
 (b)Reporting requirementsSection 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2024.
 (c)Previous sunset provisionEffective October 1, 2018, subsections (a) and (b) of section 107 of the Animal Drug User Fee Amendments of 2013 (Public Law 113–14) are repealed.
				IIFees relating to generic animal drugs
			201.Short title; finding
 (a)Short titleThis title may be cited as the Animal Generic Drug User Fee Amendments of 2018. (b)FindingCongress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.
				202.Authority to assess and use generic new animal drug fees
 (a)Fee revenue amountsSubsection (b) of section 741 (21 U.S.C. 379j–21) is amended to read as follows:  (b)Fee revenue amounts (1)In generalSubject to subsections (c), (d), (f), and (g), for each of fiscal years 2019 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $18,336,340.
 (2)Types of feesOf the total revenue amount established for a fiscal year under paragraph (1)— (A)25 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug);
 (B)37.5 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and
 (C)37.5 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors)..
				(b)Annual fee setting; adjustments
 (1)Inflation adjustmentSection 741(c) (21 U.S.C. 379j–21(c)) is amended— (A)by redesignating paragraphs (2) through (4) as paragraphs (3) through (5), respectively; and
 (B)by inserting after paragraph (1) the following:  (2)Inflation adjustment (A)In generalFor fiscal year 2020 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
 (i)one; (ii)the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and
 (iii)the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available.
 (B)Compounded basisThe adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year..
 (2)Workload adjustmentsParagraph (3) of section 741(c) (21 U.S.C. 379j–21(c)), as redesignated, is amended to read as follows:

							(3)Workload adjustments
 (A)In generalFor fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—
 (i)this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary; and
 (ii)the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.
 (B)Reduction of workload-based increase by amount of certain excess collectionsFor each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
 (C)Rule of applicationUnder no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2)..
 (3)Final year adjustmentParagraph (4) of section 741(c) (21 U.S.C. 379j–21(c)), as redesignated, is amended by— (A)striking 2018 each place it appears and inserting 2023; and
 (B)striking 2019 and inserting 2024. (c)Fee waiver or reduction; exemption from feesSubsection (d) of section 741 (21 U.S.C. 379j–21) is amended to read as follows:

						(d)Fee waiver or reduction; exemption from fees
 (1)Fee waiver or reductionThe Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.
 (2)Exemption from feesFees under this section shall not apply with respect to any person who— (A)not later than September 30, 2023, submits a supplemental abbreviated application for a generic new animal drug approved under section 512, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3); and
 (B)otherwise would be subject to fees under this section solely on the basis of such supplemental abbreviated application..
 (d)Crediting and availability of feesSection 741(g) (21 U.S.C. 379j–21) is amended by striking paragraph (3) and inserting the following paragraphs:

 (3)Authorization of appropriationsFor each of the fiscal years 2019 through 2023, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
 (4)Excess collectionsIf the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as described in paragraph (1)..
 203.Reauthorization; reporting requirementsSection 742 (21 U.S.C. 379j–22) is amended— (1)in subsection (a), by striking 2013 and inserting 2018;
 (2)by striking 2014 each place it appears in subsections (a) and (b) and inserting 2019; and (3)in subsection (d), by striking 2018 each place it appears and inserting 2023.
 204.Savings clauseNotwithstanding the amendments made by this title, part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019.
 205.Effective dateThe amendments made by this title shall take effect on October 1, 2018, or the date of the enactment of this Act, whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act.
			206.Sunset dates
 (a)AuthorizationSection 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2023.
 (b)Reporting requirementsSection 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2024.
 (c)Previous sunset provisionEffective October 1, 2018, subsections (a) and (b) of section 206 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113–14) are repealed.
				IIIMiscellaneous provisions
			301.Electronic submissions
 (a)New animal drug applications and abbreviated applications for a generic new animal drugSection 512(b) (21 U.S.C. 360b(b)) is amended by adding at the end the following:  (4)Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require..
 (b)Conditional approval of new animal drugs for minor use and minor speciesSection 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at the end the following:  (4)Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require..
 302.Index of legally marketed unapproved new animal drugs for minor speciesEffective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc–1(h)) is amended— (1)by amending paragraph (1) to read as follows:

 (1)LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF. (followed by the applicable minor species index file number and a period) Extra-label use is prohibited.;; and
 (2)in paragraph (2), by striking other animals and inserting food-producing animals. 303.Misbranded drugs and devices (a)In generalSection 502(w) (21 U.S.C. 352(w)) is amended—
 (1)in paragraph (1), by striking ; or and inserting ;; (2)in paragraph (2), by striking the period and inserting ; or; and
 (3)by adding at the end the following:  (3)for which an application has been approved under section 512 and the labeling of such drug does not include the application number in the format: Approved by FDA under (A)NADA # xxx-xxx, except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug..
 (b)ApplicabilitySection 502(w)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on September 30, 2023.

 1.Short titleThis Act may be cited as the Animal Drug and Animal Generic Drug User Fee Amendments of 2018. 2.Table of contents; references in Act (a)Table of contentsThe table of contents for this Act is as follows:Sec. 1. Short title.Sec. 2. Table of contents; references in Act.TITLE I—Fees relating to animal drugsSec. 101. Short title; finding.Sec. 102. Definitions.Sec. 103. Authority to assess and use animal drug fees.Sec. 104. Reauthorization; reporting requirements.Sec. 105. Savings clause.Sec. 106. Effective date.Sec. 107. Sunset dates.TITLE II—Fees relating to generic animal drugsSec. 201. Short title; finding.Sec. 202. Authority to assess and use generic new animal drug fees.Sec. 203. Reauthorization; reporting requirements.Sec. 204. Savings clause.Sec. 205. Effective date.Sec. 206. Sunset dates.TITLE III—Miscellaneous provisionsSec. 301. Electronic submissions.Sec. 302. Index of legally marketed unapproved new animal drugs for minor species.Sec. 303. Misbranded drugs and devices.Sec. 304. Issuance of recommendations.Sec. 305. Guidance addressing investigation designs.Sec. 306. Food additives intended for use in animal food.
 (b)References in ActExcept as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
			IFees relating to animal drugs
			101.Short title; finding
 (a)Short titleThis title may be cited as the Animal Drug User Fee Amendments of 2018. (b)FindingCongress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.
 102.DefinitionsSection 739 (21 U.S.C. 379j–11) is amended— (1)by amending paragraph (1) to read as follows:

 (1)(A)The term animal drug application means— (i)an application for approval of any new animal drug submitted under section 512(b)(1); or
 (ii)an application for conditional approval of a new animal drug submitted under section 571. (B)Such term does not include either a new animal drug application submitted under section 512(b)(2) or a supplemental animal drug application.; and
 (2)in paragraph (8), by adding at the end the following:  (I)The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval..
				103.Authority to assess and use animal drug fees
 (a)Fee revenue amountsSection 740(b) (21 U.S.C. 379j–12(b)) is amended— (1)in paragraph (1)—
 (A)in subparagraph (A)— (i)by striking 2014 and inserting 2019; and
 (ii)by striking $23,600,000 and inserting $30,331,240; and (B)in subparagraph (B)—
 (i)by striking 2015 through 2018 and inserting 2020 through 2023; and (ii)by striking $21,600,000 and inserting $29,931,240; and
 (2)in paragraph (2), in the matter preceding subparagraph (A), by striking determined and inserting established. (b)Annual fee setting; adjustments (1)Inflation adjustmentSection 740(c)(2) (21 U.S.C. 379j–12(c)(2)) is amended—
 (A)in the matter preceding subparagraph (A)— (i)by striking For fiscal year 2015 and inserting (A) For fiscal year 2020; and
 (ii)by inserting multiplying such revenue amounts by before an amount; (B)by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively;
 (C)by striking the flush text at the end; and (D)by adding at the end the following new subparagraph:

 (B)Compounded basisThe adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year..
 (2)Workload adjustmentsParagraph (3) of section 740(c) (21 U.S.C. 379j–12(c)) is amended to read as follows:  (3)Workload adjustments (A)In generalFor fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraphs (B) and (C). With respect to such adjustment—
 (i)such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary; and
 (ii)the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies.
 (B)Reduction of workload-based increase by amount of certain excess collectionsFor each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
 (C)Rule of applicationUnder no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2)..
 (3)Final year adjustmentSection 740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— (A)by striking 2018 each place it appears and inserting 2023; and
 (B)by striking 2019 and inserting 2024. (c)Exemptions from feesSection 740(d) (21 U.S.C. 379j–12(d)) is amended—
 (1)in the subsection heading, by inserting ; exemptions from fees after reduction; (2)by striking the heading of paragraph (1) and inserting Waiver or reduction; and
 (3)by adding at the end the following:  (4)Exemptions from fees (A)Certain labeling supplements To add number of approved applicationFees under this section shall not apply with respect to any person who—
 (i)not later than September 30, 2023, submits a supplemental animal drug application relating to a new animal drug application approved under section 512, solely to add the new animal drug application number to the labeling of the drug in the manner specified in section 502(w)(3); and
 (ii)otherwise would be subject to fees under this section solely on the basis of such supplemental application.
 (B)Certain animal drug applicationsFees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H..
					(d)Crediting and availability of fees
 (1)Authorization of appropriationsSection 740(g)(3) (21 U.S.C. 379j–12(g)(3)) is amended— (A)by striking 2014 through 2018 and inserting 2019 through 2023;
 (B)by striking determined and inserting established; and (C)by striking paragraph (4) and inserting paragraph (5).
 (2)Excess collectionsSection 740(g) (21 U.S.C. 379j–12(g)) is amended by striking paragraph (4) and inserting the following:

 (4)Excess collectionsIf the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).
							(5)Recovery of collection shortfalls
 (A)In generalSubject to subparagraph (B)— (i)for fiscal year 2021, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2019 falls below the amount of fees authorized for fiscal year 2019 under paragraph (3);
 (ii)for fiscal year 2022, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2020 falls below the amount of fees authorized for fiscal year 2020 under paragraph (3); and
 (iii)for fiscal year 2023, the amount of fees otherwise authorized to be collected under this section shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2021 and 2022 (including estimated collections for fiscal year 2022) falls below the cumulative amount of fees authorized for such fiscal years under paragraph (3).
									(B)Reduction of shortfall-based fee increase by prior year excess collections
 (i)In generalSubject to clause (ii), the Secretary shall, in such manner as the Secretary determines appropriate, reduce any fee increase otherwise applicable for a fiscal year under subparagraph (A) by the amount of any excess collections under this section for preceding fiscal years (after fiscal year 2018).
 (ii)Workload-based fee accountingIn applying clause (i), the Secretary shall account for the reduction of workload-based fee revenue increases by excess collections under subsection (c)(3)(B), in such manner as needed to provide that no portion of any excess collections described in clause (i) is applied for purposes of reducing fee increases under both such subsection (c)(3)(B) and this paragraph.
 (C)Rule of applicationUnder no circumstances shall adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted or otherwise affected under subsection (c)..
 104.Reauthorization; reporting requirementsSection 740A (21 U.S.C. 379j–13) is amended— (1)in subsection (a), by striking 2013 and inserting 2018;
 (2)by striking 2014 each place it appears in subsections (a) and (b) and inserting 2019; and (3)in subsection (d), by striking 2018 each place it appears and inserting 2023.
 105.Savings clauseNotwithstanding the amendments made by this title, part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019.
 106.Effective dateThe amendments made by this title shall take effect on October 1, 2018, or the date of the enactment of this Act, whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2018, regardless of the date of the enactment of this Act.
			107.Sunset dates
 (a)AuthorizationSection 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall cease to be effective October 1, 2023.
 (b)Reporting requirementsSection 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2024.
 (c)Previous sunset provisionEffective October 1, 2018, subsections (a) and (b) of section 107 of the Animal Drug User Fee Amendments of 2013 (Public Law 113–14) are repealed.
				IIFees relating to generic animal drugs
			201.Short title; finding
 (a)Short titleThis title may be cited as the Animal Generic Drug User Fee Amendments of 2018. (b)FindingCongress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.
				202.Authority to assess and use generic new animal drug fees
 (a)Fee revenue amountsSubsection (b) of section 741 (21 U.S.C. 379j–21) is amended to read as follows:  (b)Fee revenue amounts (1)In generalSubject to subsections (c), (d), (f), and (g), for each of fiscal years 2019 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $18,336,340.
 (2)Types of feesOf the total revenue amount established for a fiscal year under paragraph (1)— (A)25 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug);
 (B)37.5 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and
 (C)37.5 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors)..
				(b)Annual fee setting; adjustments
 (1)Inflation adjustmentSection 741(c) (21 U.S.C. 379j–21(c)) is amended— (A)by redesignating paragraphs (2) through (4) as paragraphs (3) through (5), respectively; and
 (B)by inserting after paragraph (1) the following:  (2)Inflation adjustment (A)In generalFor fiscal year 2020 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—
 (i)one; (ii)the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and
 (iii)the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available.
 (B)Compounded basisThe adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year..
 (2)Workload adjustmentsParagraph (3) of section 741(c) (21 U.S.C. 379j–21(c)), as redesignated, is amended to read as follows:

							(3)Workload adjustments
 (A)In generalFor fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—
 (i)this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary; and
 (ii)the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.
 (B)Reduction of workload-based increase by amount of certain excess collectionsFor each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.
 (C)Rule of applicationUnder no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2)..
 (3)Final year adjustmentParagraph (4) of section 741(c) (21 U.S.C. 379j–21(c)), as redesignated, is amended by— (A)striking 2018 each place it appears and inserting 2023; and
 (B)striking 2019 and inserting 2024. (c)Fee waiver or reduction; exemption from feesSubsection (d) of section 741 (21 U.S.C. 379j–21) is amended to read as follows:

						(d)Fee waiver or reduction; exemption from fees
 (1)Fee waiver or reductionThe Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.
 (2)Exemption from feesFees under this section shall not apply with respect to any person who— (A)not later than September 30, 2023, submits a supplemental abbreviated application for a generic new animal drug approved under section 512, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3); and
 (B)otherwise would be subject to fees under this section solely on the basis of such supplemental abbreviated application..
 (d)Crediting and availability of feesSection 741(g) (21 U.S.C. 379j–21) is amended by striking paragraph (3) and inserting the following paragraphs:

 (3)Authorization of appropriationsFor each of the fiscal years 2019 through 2023, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).
 (4)Excess collectionsIf the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1)..
 203.Reauthorization; reporting requirementsSection 742 (21 U.S.C. 379j–22) is amended— (1)in subsection (a), by striking 2013 and inserting 2018;
 (2)by striking 2014 each place it appears in subsections (a) and (b) and inserting 2019; and (3)in subsection (d), by striking 2018 each place it appears and inserting 2023.
 204.Savings clauseNotwithstanding the amendments made by this title, part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019.
 205.Effective dateThe amendments made by this title shall take effect on October 1, 2018, or the date of the enactment of this Act, whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act.
			206.Sunset dates
 (a)AuthorizationSection 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2023.
 (b)Reporting requirementsSection 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2024.
 (c)Previous sunset provisionEffective October 1, 2018, subsections (a) and (b) of section 206 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113–14) are repealed.
				IIIMiscellaneous provisions
			301.Electronic submissions
 (a)New animal drug applications and abbreviated applications for a generic new animal drugSection 512(b) (21 U.S.C. 360b(b)) is amended by adding at the end the following:  (4)Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require..
 (b)Conditional approval of new animal drugs for minor use and minor speciesSection 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at the end the following:  (4)Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require..
 302.Index of legally marketed unapproved new animal drugs for minor speciesEffective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc–1(h)) is amended— (1)by amending paragraph (1) to read as follows:

 (1)LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF. (followed by the applicable minor species index file number and a period) Extra-label use is prohibited.;; and
 (2)in paragraph (2), by striking other animals and inserting food-producing animals. 303.Misbranded drugs and devices (a)In generalSection 502(w) (21 U.S.C. 352(w)) is amended—
 (1)in paragraph (1), by striking ; or and inserting ;; (2)in paragraph (2), by striking the period and inserting ; or; and
 (3)by adding at the end the following:  (3)for which an application has been approved under section 512 and the labeling of such drug does not include the application number in the format: Approved by FDA under (A)NADA # xxx-xxx, except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug..
 (b)ApplicabilitySection 502(w)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on September 30, 2023.
 304.Issuance of recommendationsNot later than September 30, 2019, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall issue recommendations that the Secretary, in the letters described in section 101(b) of the Animal Drug User Fee Amendments of 2013 (Public Law 113–14), agreed to develop regarding the feasibility of pursuing statutory revisions that may expand the use of conditional approval of new animal drugs under section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc) to appropriate categories of new animal drugs.
			305.Guidance addressing investigation designs
 (a)In generalFor purposes of assisting sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints (referred to in this section as elements of investigations) into proposed clinical investigation protocols and applications for new animal drugs under sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 360ccc), the Secretary of Health and Human Services (referred to in this section as the Secretary) shall issue guidance addressing the use of such elements of investigations in the development and regulatory review of such new animal drugs.
 (b)ContentsThe guidance under subsection (a) shall address how the Secretary will evaluate the elements of investigations proposed or submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) of such Act, and how sponsors of such applications may obtain feedback from the Secretary on technical issues related to such investigations prior to the submission of an application to the Secretary.
 (c)MeetingPrior to issuing the guidance under subsection (a), the Secretary shall consult with stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers, through a public meeting to be held not later than 1 year after the date of enactment of this Act.
 (d)TimingThe Secretary shall issue a draft guidance under subsection (a) not later than 1 year after the date of the public meeting under subsection (c), and shall finalize such guidance not later than 1 year after the date on which the public comment period on such draft guidance ends.
				306.Food additives intended for use in animal food
 (a)Food additive petitions for animal foodSection 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended by adding at the end the following:

 (k)Food additives intended for use in animal food(1)In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.
 (2)The Secretary shall post on the internet website of the Food and Drug Administration, no later than March 1 of each year, on—
 (A)the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;
 (B)how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and
 (C)the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.
 (3)In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement..
 (b)Ensuring the safety of pet foodSection 1002(a) of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2102(a)) is amended—
 (1)by striking paragraph (1); and (2)by redesignating paragraphs (2) and (3) as paragraphs (1) and (2), respectively.
					(c)Guidance on pre-petition consultation process for animal food additives
 (1)In generalNot later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary) shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food.
 (2)ContentsThe guidance under paragraph (1) shall include— (A)the recommended format to submit to the Food and Drug Administration existing data, including any applicable foreign data, for assessment prior to submission of a food additive petition for animal food under section 409(b) of the Federal Food, Drug, and Cosmetic Act;
 (B)the manner and the number of days by which the Food and Drug Administration intends to review and respond to such existing data, including with respect to providing a scientific rationale for any additional data request;
 (C)circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section 409(b);
 (D)the manner in which the Secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than 50 days; and
 (E)best practices for communication between the Food and Drug Administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives.
 (3)Final guidanceThe guidance under paragraph (1) shall be finalized, withdrawn, or reissued not later than 1 year after the close of the comment period on the draft guidance.March 7, 2018Reported with an amendment


116 S3328 IS: Biliteracy Education Seal and Teaching Act
U.S. Senate
2020-02-25
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II116th CONGRESS2d SessionS. 3328IN THE SENATE OF THE UNITED STATESFebruary 25, 2020Mr. Schatz introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo award grants to States to establish or improve, and carry out, Seal of Biliteracy programs to recognize high-level student proficiency in speaking, reading, and writing in both English and a second language.1.Short titleThis Act may be cited as the Biliteracy Education Seal and Teaching Act or the BEST Act.2.FindingsCongress finds the following:(1)The people of the United States celebrate cultural and linguistic diversity and seek to prepare students with skills to succeed in the 21st century.(2)It is fitting to commend the dedication of students who have achieved proficiency in multiple languages and to encourage their peers to follow in their footsteps.(3)The congressionally requested Commission on Language Learning, in its 2017 report America's Languages: Investing in Language Education for the 21st Century, notes the pressing national need for more people of the United States who are proficient in two or more languages for national security, economic growth, and the fulfillment of the potential of all people of the United States.(4)The Commission on Language Learning also notes the extensive cognitive, educational, and employment benefits deriving from biliteracy.(5)Biliteracy in general correlates with higher graduation rates, higher grade point averages, higher rates of matriculation into higher education, and higher earnings for all students, regardless of background.(6)The study of America’s languages in elementary and secondary schools should be encouraged because it contributes to a student’s cognitive development and to the national economy and security.(7)Recognition of student achievement in language proficiency will enable institutions of higher education and employers to readily recognize and acknowledge the valuable expertise of bilingual students in academia and the workplace.(8)States such as Utah, Arizona, Washington, and New Mexico have developed innovative testing methods for languages, including Native American languages, where no formal proficiency test currently exists.(9)The use of proficiency in a government-recognized official Native American language as the base language for a Seal of Biliteracy, with proficiency in any additional partner language demonstrated through tested proficiency, has been successfully demonstrated in Hawaii.(10)Students in every State and every school should be able to benefit from a Seal of Biliteracy program.3.DefinitionsIn this Act:(1)ESEA definitionsThe terms English learner, secondary school, and State have the meanings given those terms in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).(2)Native American languagesThe term Native American languages has the meaning given the term in section 103 of the Native American Languages Act (25 U.S.C. 2902).(3)Seal of Biliteracy programThe term Seal of Biliteracy program means any program described in section 4(a) that is established or improved, and carried out, with funds received under this Act. (4)Second languageThe term second language means any language other than English (or a Native American language, pursuant to section 4(a)(2)), including Braille, American Sign Language, or a Classical language.(5)SecretaryThe term Secretary means the Secretary of Education. 4.Grants for State Seal of Biliteracy programs(a)Establishment of program(1)In generalFrom amounts made available under subsection (f), the Secretary shall award grants, on a competitive basis, to States to enable the States to establish or improve, and carry out, Seal of Biliteracy programs to recognize student proficiency in speaking, reading, and writing in both English and a second language.(2)Inclusion of Native American languagesNotwithstanding paragraph (1), each Seal of Biliteracy program shall contain provisions allowing the use of Native American languages, including allowing speakers of any Native American language recognized as official by any American government, including any Tribal government, to use equivalent proficiency in speaking, reading, and writing in the Native American language in lieu of proficiency in speaking, reading, and writing in English.(3)DurationA grant awarded under this section shall be for a period of 2 years, and may be renewed at the discretion of the Secretary.(4)RenewalAt the end of a grant term, a State that receives a grant under this section may reapply for a grant under this section.(5)LimitationsA State shall not receive more than 1 grant under this section at any time.(6)Return of unspent grant fundsEach State that receives a grant under this section shall return any unspent grant funds not later than 6 months after the date on which the term for the grant ends.(b)Grant applicationA State that desires a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information and assurances as the Secretary may require, including—(1)a description of the criteria a student must meet to demonstrate the proficiency in speaking, reading, and writing in both languages necessary for the State Seal of Biliteracy program;(2)a detailed description of the State's plan—(A)to ensure that English learners and former English learners are included in the State Seal of Biliteracy program;(B)to ensure that—(i)all languages, including Native American languages, can be tested for the State Seal of Biliteracy program; and(ii)Native American language speakers and learners are included in the State Seal of Biliteracy program, including students at tribally controlled schools and at schools funded by the Bureau of Indian Education; and(C)to reach students, including eligible students described in subsection (c)(2) and English learners, their parents, and schools with information regarding the State Seal of Biliteracy program;(3)an assurance that a student who meets the requirements under paragraph (1) and subsection (c) receives—(A)a permanent seal or other marker on the student's secondary school diploma or its equivalent; and(B)documentation of proficiency on the student's official academic transcript; and(4)an assurance that a student is not charged a fee for providing information under subsection (c)(1).(c)Student participation in a Seal of Biliteracy program(1)In generalTo participate in a Seal of Biliteracy program, a student shall provide information to the State that serves the student at such time, in such manner, and including such information and assurances as the State may require, including an assurance that the student has met the criteria established by the State under subsection (b)(1).(2)Student eligibility for participationA student who gained proficiency in a second language outside of school may apply under paragraph (1) to participate in a Seal of Biliteracy program.(d)Use of fundsGrant funds made available under this section shall be used for—(1)the administrative costs of establishing or improving, and carrying out, a Seal of Biliteracy program that meets the requirements of subsection (b); and(2)public outreach and education about the Seal of Biliteracy program.(e)ReportNot later than 18 months after receiving a grant under this section, a State shall issue a report to the Secretary describing the implementation of the Seal of Biliteracy program for which the State received the grant.(f)Authorization of appropriationsThere are authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2021 through 2025.


110 HR 3029 IH: Bear Protection Act of

U.S. House of Representatives
2007-07-12
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
		110th CONGRESS
		1st Session
		H. R. 3029
		IN THE HOUSE OF REPRESENTATIVES

			July 12, 2007
			Mr. Grijalva (for
			 himself, Mr. Campbell of California,
			 Mr. Conyers,
			 Mr. George Miller of California,
			 Mr. Farr, Mr. Fortenberry, Ms.
			 Schakowsky, Mr. Gutierrez,
			 Mrs. McCarthy of New York,
			 Mr. Serrano,
			 Ms. DeLauro,
			 Mr. Kucinich,
			 Mr. Lewis of Georgia,
			 Mr. Nadler,
			 Mr. Udall of Colorado,
			 Mr. Rangel,
			 Mr. Hinchey, and
			 Mr. Davis of Illinois) introduced the
			 following bill; which was referred to the Committee on Natural Resources, and in
			 addition to the Committees on Foreign
			 Affairs and Ways and
			 Means, for a period to be subsequently determined by the
			 Speaker, in each case for consideration of such provisions as fall within the
			 jurisdiction of the committee concerned

		A BILL
		To conserve global bear populations by prohibiting the
		  importation, exportation, and interstate trade of bear viscera and items,
		  products, or substances containing, or labeled or advertised as containing,
		  bear viscera, and for other purposes.

		1.Short titleThis Act may be cited as the
			 Bear Protection Act of
			 2007.
		2.FindingsCongress finds that—
			(1)all 8 extant
			 species of bear—Asian black bear, brown bear, polar bear, American black bear,
			 spectacled bear, giant panda, sun bear, and sloth bear—are listed on Appendix I
			 or II of the Convention on International Trade in Endangered Species of Wild
			 Fauna and Flora (27 UST 1087; TIAS 8249) (referred to in this section as
			 CITES);
			(2)Article XIV of CITES
			 provides that Parties to CITES may adopt stricter domestic measures regarding
			 the conditions for trade, taking, possession, or transport of species listed on
			 Appendix I or II, and the Parties to CITES adopted a resolution in 1997 (Conf.
			 10.8) urging the Parties to take immediate action to demonstrably reduce the
			 illegal trade in bear parts;
			(3)thousands of bears
			 in Asia are cruelly confined in small cages to be milked for their bile, and
			 the wild Asian bear population has declined significantly in recent years, as a
			 result of habitat loss and poaching due to a strong demand for bear viscera
			 used in traditional medicines and cosmetics;
			(4)Federal and State
			 undercover operations have revealed that American bears have been poached for
			 their viscera;
			(5)while most
			 American black bear populations are generally stable or increasing, commercial
			 trade could stimulate poaching and threaten certain populations if the demand
			 for bear viscera increases; and
			(6)prohibitions
			 against the importation into the United States and exportation from the United
			 States, as well as prohibitions against the interstate trade, of bear viscera
			 and products containing, or labeled or advertised as containing, bear viscera
			 will assist in ensuring that the United States does not contribute to the
			 decline of any bear population as a result of the commercial trade in bear
			 viscera.
			3.PurposesThe purpose of this Act is to ensure the
			 long-term viability of the world’s 8 bear species by—
			(1)prohibiting
			 interstate and international trade in bear viscera and products containing, or
			 labeled or advertised as containing, bear viscera;
			(2)encouraging
			 bilateral and multilateral efforts to eliminate such trade; and
			(3)ensuring that
			 adequate Federal legislation exists with respect to domestic trade in bear
			 viscera and products containing, or labeled or advertised as containing, bear
			 viscera.
			4.DefinitionsIn this Act:
			(1)Bear
			 visceraThe term bear viscera means the body fluids
			 or internal organs, including the gallbladder and its contents but not
			 including blood or brains, of a species of bear.
			(2)ImportThe
			 term import means to land on, bring into, or introduce into any
			 place subject to the jurisdiction of the United States, whether or not the
			 landing, bringing, or introduction constitutes an importation within the
			 meaning of the customs laws of the United States.
			(3)PersonThe
			 term person means—
				(A)an individual,
			 corporation, partnership, trust, association, or other private entity;
				(B)an officer,
			 employee, agent, department, or instrumentality of—
					(i)the
			 Federal Government;
					(ii)any
			 State, municipality, or political subdivision of a State; or
					(iii)any foreign
			 government;
					(C)any other entity
			 subject to the jurisdiction of the United States.
				(4)SecretaryThe
			 term Secretary means the Secretary of the Interior.
			(5)StateThe
			 term State means a State, the District of Columbia, the
			 Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Commonwealth of the
			 Northern Mariana Islands, American Samoa, and any other territory,
			 commonwealth, or possession of the United States.
			(6)TransportThe
			 term transport means to move, convey, carry, or ship by any means,
			 or to deliver or receive for the purpose of movement, conveyance, carriage, or
			 shipment.
			5.Prohibited
			 acts
			(a)In
			 GeneralExcept as provided in subsection (b), a person shall
			 not—
				(1)import into, or
			 export from, the United States bear viscera or any product, item, or substance
			 containing, or labeled or advertised as containing, bear viscera; or
				(2)sell or barter,
			 offer to sell or barter, purchase, possess, transport, deliver, or receive, in
			 interstate or foreign commerce, bear viscera or any product, item, or substance
			 containing, or labeled or advertised as containing, bear viscera.
				(b)Exception for
			 Wildlife Law Enforcement PurposesA person described in
			 subparagraph (B) of section 4(3) may import into, or export from, the United
			 States, or transport between States, bear viscera or any product, item, or
			 substance containing, or labeled or advertised as containing, bear viscera if
			 the importation, exportation, or transportation—
				(1)is solely for
			 purposes of enforcing laws relating to the protection of wildlife; and
				(2)is authorized by a
			 valid permit issued under Appendix I or II of the Convention on International
			 Trade in Endangered Species of Wild Fauna and Flora (27 UST 1087; TIAS 8249),
			 in any case in which such a permit is required under the Convention.
				6.Penalties and
			 enforcement
			(a)Criminal
			 PenaltiesA person that knowingly violates section 5 shall be
			 fined under title 18, United States Code, imprisoned not more than 1 year, or
			 both.
			(b)Civil
			 Penalties
				(1)AmountA
			 person that knowingly violates section 5 may be assessed a civil penalty by the
			 Secretary of not more than $25,000 for each violation.
				(2)Manner of
			 assessment and collectionA civil penalty under this subsection
			 shall be assessed, and may be collected, in the manner in which a civil penalty
			 under the Endangered Species Act of
			 1973 may be assessed and collected under section 11(a) of that Act
			 (16 U.S.C. 1540(a)).
				(c)Seizure and
			 ForfeitureAny bear viscera or any product, item, or substance
			 exported, imported, sold, bartered, attempted to be exported, imported, sold,
			 bartered, offered for sale or barter, purchased, possessed, transported,
			 delivered, or received in violation of this section (including any regulation
			 issued under this section) shall be seized and forfeited to the United
			 States.
			(d)RegulationsAfter
			 consultation with the Secretary of the Treasury and the United States Trade
			 Representative, the Secretary shall issue such regulations as are necessary to
			 carry out this section.
			(e)EnforcementThe
			 Secretary, the Secretary of the Treasury, and the Secretary of the department
			 in which the Coast Guard is operating shall enforce this section in the manner
			 in which the Secretaries carry out enforcement activities under section 11(e)
			 of the Endangered Species Act of 1973
			 (16 U.S.C. 1540(e)).
			(f)Use of Penalty
			 AmountsAmounts received as penalties, fines, or forfeiture of
			 property under this section shall be used in accordance with section 6(d) of
			 the Lacey Act Amendments of 1981 (16 U.S.C. 3375(d)).
			7.Discussions
			 concerning bear conservation and the bear parts tradeThe Secretary shall continue discussions
			 concerning trade in bear viscera with the appropriate representatives of
			 Parties to the Convention on International Trade in Endangered Species of Wild
			 Fauna and Flora and with other representatives of countries that are not party
			 to the Convention which are determined by the Secretary and the United States
			 Trade Representative to be the leading importers, exporters, or consumers of
			 bear viscera, in order to seek to establish coordinated efforts with these
			 countries to protect bears.
		8.Certain rights not
			 affectedExcept as provided in
			 section 5, nothing in this Act shall be construed to affect the regulation by
			 any State of its bear population or to affect the hunting of bears that is
			 lawful under applicable State laws and regulations.


		I
		112th CONGRESS
		2d Session
		H. R. 6191
		IN THE HOUSE OF REPRESENTATIVES

			July 25, 2012
			Mr. Deutch introduced
			 the following bill; which was referred to the
			 Committee on Energy and
			 Commerce, and in addition to the Committee on
			 Agriculture, for a period
			 to be subsequently determined by the Speaker, in each case for consideration of
			 such provisions as fall within the jurisdiction of the committee
			 concerned

		A BILL
		To establish programs in the executive branch to permit
		  the labeling of certain products that do not contain any carcinogens as
		  Cancer-Free, and for other purposes.

		1.Short titleThis Act may be cited as the
			 Cancer-Free Label Act of
			 2012.
		2.Findings and
			 purpose
			(a)FindingsCongress finds the following:
				(1)Approximately 1.5 million Americans,
			 including children, are diagnosed with cancer annually.
				(2)Over 500,000
			 Americans die from cancer every year.
				(3)Less than 5
			 percent of all cancers are caused by genetic factors.
				(4)Cancer is the top
			 cause of disease-related death for American children and adolescents.
				(5)Children are more
			 vulnerable to environmental carcinogens than adults.
				(6)Reducing exposure
			 to carcinogens reduces risk of cancer.
				(7)The average
			 consumer currently lacks the ability to easily identify products that do not
			 contain carcinogens.
				(8)Consumers benefit
			 from additional information about the potential health impact of products they
			 use.
				(9)When comparing
			 products to purchase for their families, many consumers use potential health
			 impact as a determining factor.
				(10)The 2008–2009
			 Annual Report of the President’s Cancer Panel urges action to prevent
			 environmental and occupational exposure to carcinogens.
				(b)PurposeThe purpose of this Act is to enable
			 consumers to reduce their exposure to carcinogens by allowing manufacturers to
			 affix a Cancer-Free label to products that do not contain known or probable
			 carcinogens through a voluntary process that does not require public disclosure
			 of trade secrets.
			3.Cancer-Free
			 labels
			(a)In
			 generalThe head of each
			 Federal department or agency that regulates a covered product shall establish
			 in that department or agency a program to permit the labeling of covered
			 products that do not contain any carcinogens as Cancer-Free.
			(b)Development of
			 labelThe heads of each
			 Federal department or agency that regulates a covered product shall coordinate
			 to develop an easily recognizable label to be affixed to a covered product to
			 signify that the product has been approved for labeling as
			 Cancer-Free. Such label shall include the following notice:
			 This product does not contain known or likely carcinogens that increase
			 your risk of cancer..
			(c)Premarket
			 approval of label
				(1)In
			 generalIt shall be unlawful to introduce or offer for
			 introduction into interstate commerce a covered product affixed with a
			 Cancer-Free label described under subsection (b)—
					(A)if the head of
			 each Federal department or agency that regulates the product has not approved
			 an application submitted under paragraph (2) for the labeling of the product as
			 Cancer-Free; or
					(B)if the product
			 contains any substance that is not listed in such application.
					(2)ApplicationAny
			 person may submit an application for the labeling of a covered product as
			 Cancer-Free. Such application shall include a list of all the
			 substances contained within the product, and shall be accompanied by a sample
			 of the product.
				(3)Criteria for
			 approvalThe head of each Federal department or agency to which
			 an application is submitted under paragraph (2) shall approve the application
			 if such head determines that—
					(A)the application
			 accurately lists all substances contained in the product;
					(B)the product does
			 not contain any carcinogens;
					(C)the product does not contain any substances
			 that display carcinogenicity upon degradation, upon interactions with other
			 substances contained within the product or exposed to the product, during
			 storage or transportation, or during intended use of the product, as determined
			 by such head based on previous findings made by such department or agency;
			 and
					(D)the applicant has demonstrated a plan to
			 comply with guidance issued under subsection (e) relating to manufacture,
			 storage, and transportation.
					(4)Confidentiality
			 of informationAny
			 information provided to the head of a Federal department or agency under
			 paragraph (2)—
					(A)shall be kept confidential by such
			 department or agency, and shall be treated as trade secrets or confidential
			 information for purposes of section 552(b)(4) of title 5, United States Code,
			 and section 1905 of title 18, United States Code;
					(B)may not be used
			 for any purpose other than approval of an application under this subsection;
			 and
					(C)may not be made
			 public except with the prior written consent of the applicant.
					Submission
			 of an application under paragraph (2) does not constitute disclosure of trade
			 secrets by the applicant or public disclosure for the determination of
			 patentability, and any information contained in an application may not be used
			 as prior art to a claimed invention.(5)Label
			 integrityThe head of each
			 agency to which applications are submitted under paragraph (2) shall—
					(A)conduct random
			 testing of covered products for which applications are submitted for approval
			 under such paragraph to ensure that the applications accurately list all the
			 substances contained in such products;
					(B)conduct random
			 audits of facilities in which such covered products are manufactured;
			 and
					(C)take reasonable measures to ensure
			 compliance with agency guidance issued under subsection (e) relating to
			 manufacture, storage, and transportation of such covered products.
					(6)FeesThe
			 head of each Federal department or agency may charge a reasonable fee for the
			 submission and approval of an application under paragraph (2). The amount of
			 such fee shall be the amount necessary to result in an estimated total revenue
			 from all such fees received by the department or agency that is equal to the
			 estimated total cost of the program established by the department or agency
			 under subparagraph (a).
				(d)Penalty for
			 violationsIn addition to any
			 other penalty authorized by law, any person who knowingly violates subparagraph
			 (A) or (B) of subsection (c)(1) shall be subject to a civil penalty of not more
			 than $100,000.
			(e)Guidance To
			 prevent indirect introduction of carcinogensThe head of each
			 Federal department or agency that regulates a covered product shall issue
			 guidance to prevent the introduction of carcinogens into such covered product
			 during the manufacture, storage, and transportation of such covered
			 product.
			(f)National
			 listThe head of each Federal
			 department or agency that regulates a covered product shall each post on the
			 public website of that department or agency a list of all covered products
			 regulated by that department or agency that have been approved for labeling as
			 Cancer-Free.
			(g)DefinitionsIn
			 this section:
				(1)CarcinogenThe
			 term carcinogen means any of the following:
					(A)A substance listed
			 in the National Toxicology Program Report on Carcinogens as known to be a human
			 carcinogen or reasonably anticipated to be a human carcinogen.
					(B)A substance
			 described in the Environmental Protection Agency Integrated Risk Information
			 System as carcinogenic to humans or likely to be carcinogenic to humans.
					(2)Covered
			 productThe term covered product means any product
			 offered for sale that—
					(A)is regulated by the Food and Drug
			 Administration, the Environmental Protection Agency, the Department of
			 Agriculture, or the Consumer Product Safety Commission; and
					(B)is intended for
			 individual or residential use.


		II

		109th CONGRESS

		1st Session

		S. 2086

		IN THE SENATE OF THE UNITED STATES

			December 13, 2005

			Mr. Lautenberg (for

			 himself and Mr. Smith) introduced the

			 following bill; which was read twice and referred to the

			 Committee on

			 Finance

		A BILL

		To amend the Internal Revenue Code of 1986 to modify the

		  definition of compensation for purposes of determining the limits on

		  contributions to individual retirement accounts and annuities, and for other

		  purposes.

		1.Short titleThis Act may be cited as the

			 IRA Equity Act of

			 2005.

		2.Computation of limits

			 on IRA and Roth IRA contributions

			(a)Certain wage

			 replacement income treated as compensation

				(1)Wage

			 replacement incomeSection

			 219(f) of the Internal Revenue Code of 1986 (relating to other definitions and

			 special rules) is amended by adding at the end the following new

			 paragraph:

						(8)Treatment of

				certain wage replacement income as compensation

							(A)In

				generalNotwithstanding paragraph (1), applicable wage

				replacement income not otherwise treated as compensation shall be treated as

				compensation for purposes of this section.

							(B)Applicable wage

				replacement incomeFor purposes of this paragraph, the term

				applicable wage replacement income means any amount received by an

				individual—

								(i)as the result of

				the individual having become disabled,

								(ii)as unemployment

				compensation (as defined in section 85(b)),

								(iii)under workmen's

				compensation acts, or

								(iv)which

				constitutes wage replacement income under regulations prescribed by the

				Secretary.

				(2)Certain

			 excludable amounts may be taken into account for purposes of Roth

			 IRAsSection 408A(c)(2) of such Code (relating to contribution

			 limit) is amended by adding at the end the following new flush sentence:

						In

				determining the maximum amount under subparagraph (A), subsections (b)(1)(B)

				and (c) of section 219 shall be applied by taking into account compensation

				described in section 219(f)(8) without regard to whether it is includible in

				gross income.

				(3)Effective

			 dateThe amendments made by this subsection shall apply to

			 taxable years beginning after December 31, 2004.

				(b)Computation of

			 maximum IRA deduction for Roth IRAs using compensation from 2 preceding taxable

			 years

				(1)In

			 generalSection 408A(c) of the Internal Revenue Code of 1986

			 (relating to treatment of contributions) is amended by adding at the end the

			 following new paragraph:

						(8)Compensation

				from preceding 2 years may be taken into account

							(A)In

				generalA taxpayer may elect for purposes of paragraph (2) to

				take into account any unused compensation from the 2 taxable years immediately

				preceding the taxable year.

							(B)Unused

				compensationFor purposes of this paragraph, the term

				unused compensation means with respect to an individual for any

				taxable year the compensation includible in the individual's gross income for

				the taxable year reduced by the sum of—

								(i)the amount

				allowed as a deduction under 219(a) to such individual for such taxable

				year,

								(ii)the amount of

				any designated nondeductible contribution (as defined in section 408(o)) on

				behalf of such individual for such taxable year,

								(iii)the amount of

				any contribution on behalf of such individual to a Roth IRA under this section

				for such taxable year, and

								(iv)the amount of

				compensation includible in such individual's gross income for such taxable year

				taken into account under section 219(c) in determining the limitation under

				section 219 or paragraph (2) for the individual's spouse.

								(C)Application to

				special rule for married individualsUnder rules prescribed by

				the Secretary, in applying section 219(c) for any taxable year for purposes of

				applying paragraph (2)(A), unused compensation of an individual or an

				individual's spouse for the 2 taxable years immediately preceding the taxable

				year may be taken into account.

				(2)Effective

			 dateThe amendment made by this subsection shall apply to taxable

			 years beginning after December 31, 2004, but unused compensation for taxable

			 years beginning before January 1, 2005, may be taken into account for taxable

			 years beginning after December 31, 2004.


		I
		111th CONGRESS
		1st Session
		H. R. 3407
		IN THE HOUSE OF REPRESENTATIVES

			July 30, 2009
			Mr. Buyer (for
			 himself, Mr. Michaud, and
			 Mr. Brown of South Carolina)
			 introduced the following bill; which was referred to the
			 Committee on Veterans’
			 Affairs

		A BILL
		To amend title 38, United States Code, to make certain
		  improvements to laws administered by the Secretary of Veterans Affairs relating
		  to benefits for severely injured veterans, and for other
		  purposes.

		1.Short titleThis Act may be cited as the
			 Severely Injured Veterans Benefit Improvement Act of
			 2009.
		2.Increase in rate
			 of special monthly compensation for severely injured veteransSection 1114(r) of title 38, United States
			 Code, is amended—
			(1)in paragraph (1),
			 by striking $1,893 and inserting $2,840;
			 and
			(2)in paragraph (2),
			 by striking $2,820 and inserting 4,230.
			3.Eligibility of
			 disabled veterans and members of the Armed Forces with severe burn injuries for
			 automobiles and adaptive equipment
			(a)EligibilityParagraph
			 (1) of section 3901 is amended—
				(1)in subparagraph
			 (A)—
					(A)in the matter
			 preceding clause (i), by striking or (iii) below and inserting
			 (iii), or (iv); and
					(B)by adding at the
			 end the following new clause:

							(iv)A
				severe burn injury (as determined pursuant to regulations prescribed by the
				Secretary).
							;
				and
					(2)in subparagraph
			 (B), by striking or (iii) and inserting (iii), or
			 (iv).
				(b)Stylistic
			 AmendmentsSuch section is further amended—
				(1)in the matter
			 preceding paragraph (1), by striking chapter— and inserting
			 chapter:;
				(2)in paragraph
			 (1)—
					(A)in the matter
			 preceding subparagraph (A), by striking means— and inserting
			 means the following:;
					(B)in subparagraph
			 (A)—
						(i)in
			 the matter preceding clause (i), by striking any veteran and
			 inserting Any veteran;
						(ii)in
			 clauses (i) and (ii), by striking the semicolon at the end and inserting a
			 period; and
						(iii)in
			 clause (iii), by striking or and inserting a period; and
						(C)in subparagraph
			 (B), by striking any member and inserting Any
			 member.
					4.Increase in
			 non-service-connected disability pension for certain veterans of a period of
			 warSection 1521(e) of title
			 38, United States Code, is amended—
			(1)by striking $4,340 and
			 inserting 4,774; and
			(2)by striking
			 $5,441 and inserting $5,985.
			5.Eligibility of
			 veterans with traumatic brain injury for aid and attendance
			 benefitsSection 1114(o) of
			 title 38, United States Code, is amended by inserting after prosthetic
			 appliances, the following: or if the veteran has suffered
			 traumatic brain injury,.
		6.Authority of Secretary
			 of Veterans Affairs to increase Medal of Honor special pension
			(a)Authority To
			 increase rate of special pensionSubsection (a) of section 1562
			 of title 38, United States Code, is amended—
				(1)by inserting (1) after
			 (a); and
				(2)by adding at the
			 end the following new paragraph:

						(2)(A)Subject to the
				availability of appropriations for this purpose in advance in an appropriations
				Act, the Secretary may increase the rate of the special pension otherwise in
				effect under paragraph (1) by not more than $1,000.
							(B)The Secretary may not increase the rate of
				a special pension under subparagraph (A) after the Secretary has expended all
				the funds specifically provided for such purpose in an appropriations
				Act.
							(C)The authority under subparagraph (A)
				expires on September 30,
				2013.
							.
				(b)Conforming
			 amendmentSubsection (f)(1)
			 of such section is amended by striking this section and
			 inserting subsection (a)(1).
			7.Extension of
			 provisions relating to pensions for certain hospitalized veteransSection 5503(d)(7) of title 38, United
			 States Code, is amended by striking September 30, 2011 and
			 inserting September 30, 2021.
		8.Effective
			 dateThe amendments made by
			 this Act shall take effect on September 30, 2011.


I
112th CONGRESS
1st Session
H. R. 1855
IN THE HOUSE OF REPRESENTATIVES

May 11, 2011
Mr. Walz of Minnesota (for himself and Mr. Bilirakis) introduced the following bill; which was referred to the Committee on Veterans’ Affairs

A BILL
To amend title 38, United States Code, to improve the provision of rehabilitative services for veterans with traumatic brain injury, and for other purposes.

1.Short titleThis Act may be cited as the Veterans’ Traumatic Brain Injury Rehabilitative Services’ Improvements Act of 2011.
2.Rehabilitative services for veterans with traumatic brain injury
(a)Rehabilitation plans and servicesSection 1710C of title 38, United States Code, is amended—
(1)in subsection (a)(1), by inserting before the semicolon the following: with the goal of maximizing the individual’s independence and quality of life;
(2)in subsection (b)—
(A)in paragraph (1)—
(i)by inserting after improving the following: (and sustaining improvement in);
(ii)by inserting behavioral, after cognitive;
(iii)by inserting and mental health after functioning; and
(iv)by inserting , quality of life, after independence;
(B)in paragraph (2), by inserting rehabilitative services and before rehabilitative components; and
(C)in paragraph (3)—
(i)by striking treatments the first place it appears and inserting services; and
(ii)by striking treatments and the second place it appears; and
(3)by adding at the end the following new subsection:

(h)For purposes of this section, and sections 1710D and 1710E of this title, the term rehabilitative services includes—
(1)rehabilitative services, as defined in section 1701(8) of this title;
(2)services (which may be of ongoing duration) to sustain, and prevent loss of, functional gains that have been achieved; and
(3)any other services or supports that may contribute to maximizing an individual’s independence and quality of life.
(b)ProgramSection 1710D(a) of title 38, United States Code, is amended—
(1)by inserting and rehabilitative services after long-term care; and
(2)by striking treatment.
(c)Cooperative agreementsSection 1710E(a) of title 38, United States Code, is amended by inserting , including rehabilitative services, after medical services.


116 S4037 IS: Patient Credit Protection Act of 2020
U.S. Senate
2020-06-23
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. 4037IN THE SENATE OF THE UNITED STATESJune 23, 2020Mrs. Loeffler introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban AffairsA BILLTo amend the Fair Credit Reporting Act to protect the credit of patients with substantial medical bills.1.Short titleThis Act may be cited as the Patient Credit Protection Act of 2020.2.Credit protection for patients(a)Information excluded from consumer reports(1)In generalSection 605(a) of the Fair Credit Reporting Act (15 U.S.C. 1681c(a)) is amended by adding at the end the following:(9)Debts incurred in a collection account with a medical industry code if, based on information furnished by the provider of medical treatment— (A)the consumer was covered by a health benefit plan at the time of the event giving rise to the collection; and(B)the collection is for an outstanding balance after the consumer's share of copayments, deductibles, and coinsurance owed for medical treatment have been paid or are being paid as part of a payment plan. (10)Debts incurred by a consumer for payment for unconscionably excessive medical expenses for health care items and services furnished at a participating hospital (as defined in section 1867(e)(2) of the Social Security Act (42 U.S.C. 1395dd(e)(2)))—(A)without the express written consent of the provider of the health care items and services; and(B)without providing a fair opportunity for the consumer to challenge or appeal, as defined by the Secretary of Health and Human Services, the cost of the medical bill or bills for such health care items and services as unconscionably excessive in the relevant, private health care market (including in the individual and group markets) and prevent such reporting for costs to a consumer reporting agency by the collector of the debt that the Secretary determines are unconscionably excessive in the relevant, private health care market in accordance with guidance issued by the Secretary pursuant to section 2(a)(2) of the Patient Credit Protection Act of 2020. .(2)Guidance(A)DefinitionsIn this paragraph—(i)the terms consumer, consumer report, consumer reporting agency, and Federal banking agency have the meanings given those terms in section 603 of the Fair Credit Reporting Act (15 U.S.C. 1681a);(ii)the term participating hospital has the meaning given the term in section 1867(e)(2) of the Social Security Act (42 U.S.C. 1395dd(e)(2)); and(iii)the term Secretary means the Secretary of Health and Human Services.(B)IssuanceNot later than 180 days after the date of enactment of this Act, the Secretary, in consultation with the Director of the Bureau of Consumer Financial Protection, the Federal Trade Commission, the Federal banking agencies, and the National Credit Union Administration, shall issue guidance to carry out paragraph (10) of section 605(a) of the Fair Credit Reporting Act (15 U.S.C. 1681c(a)), as added by paragraph (1).(C)ContentsThe guidance issued under subparagraph (B) shall provide—(i)the circumstances under which a consumer with an outstanding balance for copayments, deductibles, coinsurance, or other medical expenses for health care items or services furnished at a participating hospital may, before the collector of the debt reports that balance to a consumer reporting agency, challenge or appeal the cost of the medical bill or bills for those health care items and services as unconscionably excessive in the relevant, private health care market, including in the individual and group markets;(ii)that the determination of whether the costs described in clause (i) are unconscionably excessive shall be by the Secretary made by taking into consideration information made public by hospitals pursuant to part 180 of title 45, Code of Federal Regulations, or any successor regulation;(iii)a framework for timely resolution if the costs described in clause (i) are determined to be unconscionably excessive; (iv)that in no case shall a consumer reporting agency be held liable for reporting information that violates paragraph (10) of section 605(a) of the Fair Credit Reporting Act (15 U.S.C. 1681c(a)), as added by paragraph (1), if they were not furnished with necessary information or did not have reason to know of such a violation; and(v)that debts incurred by a consumer for payment for unconscionably excessive medical expenses in the process to challenge or appeal the cost of the medical bill or bills described in clause (i) shall not be reported to a consumer reporting agency until after a determination of the challenge or appeal has been made, including if the process keeps medical debt from being reported to a consumer reporting agency beyond the a 180-day waiting period before including medical debt on a consumer's credit report, at which time if the medical debt is determined to not be unconscionably excessive, the debt shall be immediately made available to the consumer reporting agency. (D)Rule of constructionNothing in this paragraph shall be interpreted to allow the Secretary to institute a price structure for the reimbursement of medical costs.(b)Removal of impairment from medical debtSection 611 of the Fair Credit Reporting Act (15 U.S.C. 1681i) is amended by adding at the end the following:(h)Removal of impairment from medical debtWhen notified that a debt incurred by an individual for payment for medical expenses has been paid in full or that such an individual is in regular compliance with a periodic payment plan between the provider and consumer to settle such debt, any impairment resulting from that debt must be removed within 30 days..