ANP 3.90% 8.0¢ antisense therapeutics limited

An FDA Act that may be relvant to ATL-1102 FDA

  1. 417 Posts.
    lightbulb Created with Sketch. 110
    Maybe we will be looking at one of these one day in the not too distant future
    Tedious but defined information of the Act.


    SEC. 908. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER INCENTIVE PROGRAM. Subchapter B of chapter V (21 U.S.C. 360aa et seq.) is amended by adding at the end the following: ‘‘SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES. ‘‘(a) DEFINITIONS.—In this section: ‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application as defined in section 735(1), means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012. ‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 505(b)(1) or section 351(a) of the Public Health Service Act after the date of approval of the rare pediatric disease product application. ‘‘(3) RARE PEDIATRIC DISEASE.—The term ‘rare pediatric disease’ means a disease that meets each of the following criteria: ‘‘(A) The disease primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. ‘‘(B) The disease is a rare disease or condition, within the meaning of section 526. ‘‘(4) RARE PEDIATRIC DISEASE PRODUCT APPLICATION.—The term ‘rare pediatric disease product application’ means a human drug application, as defined in section 735(1), that— ‘‘(A) is for a drug or biological product— Deadline. 21 USC 360ff. VerDate Mar 15 2010 11:12 Aug 08, 2012 Jkt 019139 PO 00144 Frm 00102 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL144.112 GPO1 PsN: PUBL144 wwoods2 on DSKR6SHH1PROD with PUBLIC LAWS PUBLIC LAW 112–144—JULY 9, 2012 126 STAT. 1095 ‘‘(i) that is for the prevention or treatment of a rare pediatric disease; and ‘‘(ii) that contains no active ingredient (including any ester or salt of the active ingredient) that has been previously approved in any other application under section 505(b)(1), 505(b)(2), or 505(j) of this Act or section 351(a) or 351(k) of the Public Health Service Act; ‘‘(B) is submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act; ‘‘(C) the Secretary deems eligible for priority review; ‘‘(D) that relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population; ‘‘(E) that does not seek approval for an adult indication in the original rare pediatric disease product application; and ‘‘(F) is approved after the date of the enactment of the Prescription Drug User Fee Amendments of 2012. ‘‘(b) PRIORITY REVIEW VOUCHER.— ‘‘(1) IN GENERAL.—The Secretary shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the Secretary of such rare pediatric disease product application. ‘‘(2) TRANSFERABILITY.— ‘‘(A) IN GENERAL.—The sponsor of a rare pediatric disease product application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. ‘‘(B) NOTIFICATION OF TRANSFER.—Each person to whom a voucher is transferred shall notify the Secretary of such change in ownership of the voucher not later than 30 days after such transfer. ‘‘(3) LIMITATION.—A sponsor of a rare pediatric disease product application may not receive a priority review voucher under this section if the rare pediatric disease product application was submitted to the Secretary prior to the date that is 90 days after the date of enactment of the Prescription Drug User Fee Amendments of 2012. ‘‘(4) NOTIFICATION.— ‘‘(A) IN GENERAL.—The sponsor of a human drug application shall notify the Secretary not later than 90 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section. ‘‘(B) TRANSFER AFTER NOTICE.—The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor Deadline. Time period. Deadline. VerDate Mar 15 2010 11:12 Aug 08, 2012 Jkt 019139 PO 00144 Frm 00103 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL144.112 GPO1 PsN: PUBL144 wwoods2 on DSKR6SHH1PROD with PUBLIC LAWS 126 STAT. 1096 PUBLIC LAW 112–144—JULY 9, 2012 has not yet submitted the human drug application described in the notification. ‘‘(5) TERMINATION OF AUTHORITY.—The Secretary may not award any priority review vouchers under paragraph (1) after the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section. ‘‘(c) PRIORITY REVIEW USER FEE.— ‘‘(1) IN GENERAL.—The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under chapter VII. ‘‘(2) FEE AMOUNT.—The amount of the priority review user fee shall be determined each fiscal year by the Secretary, based on the difference between— ‘‘(A) the average cost incurred by the Food and Drug Administration in the review of a human drug application subject to priority review in the previous fiscal year; and ‘‘(B) the average cost incurred by the Food and Drug Administration in the review of a human drug application that is not subject to priority review in the previous fiscal year. ‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2012, the amount of the priority review user fee for that fiscal year. ‘‘(4) PAYMENT.— ‘‘(A) IN GENERAL.—The priority review user fee required by this subsection shall be due upon the notification by a sponsor of the intent of such sponsor to use the voucher, as specified in subsection (b)(4)(A). All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law. ‘‘(B) COMPLETE APPLICATION.—An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees. ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR REFUNDS.—The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section. ‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to this subsection for any fiscal year— ‘‘(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and ‘‘(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriations Acts. ‘‘(d) DESIGNATION PROCESS.— ‘‘(1) IN GENERAL.—Upon the request of the manufacturer or the sponsor of a new drug, the Secretary may designate— Effective date. Time period. VerDate Mar 15 2010 11:12 Aug 08, 2012 Jkt 019139 PO 00144 Frm 00104 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL144.112 GPO1 PsN: PUBL144 wwoods2 on DSKR6SHH1PROD with PUBLIC LAWS PUBLIC LAW 112–144—JULY 9, 2012 126 STAT. 1097 ‘‘(A) the new drug as a drug for a rare pediatric disease; and ‘‘(B) the application for the new drug as a rare pediatric disease product application. ‘‘(2) REQUEST FOR DESIGNATION.—The request for a designation under paragraph (1) shall be made at the same time a request for designation of orphan disease status under section 526 or fast-track designation under section 506 is made. Requesting designation under this subsection is not a prerequisite to receiving a priority review voucher under this section. ‘‘(3) DETERMINATION BY SECRETARY.—Not later than 60 days after a request is submitted under paragraph (1), the Secretary shall determine whether— ‘‘(A) the disease or condition that is the subject of such request is a rare pediatric disease; and ‘‘(B) the application for the new drug is a rare pediatric disease product application. ‘‘(e) MARKETING OF RARE PEDIATRIC DISEASE PRODUCTS.— ‘‘(1) REVOCATION.—The Secretary may revoke any priority review voucher awarded under subsection (b) if the rare pediatric disease product for which such voucher was awarded is not marketed in the United States within the 365-day period beginning on the date of the approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act. ‘‘(2) POSTAPPROVAL PRODUCTION REPORT.—The sponsor of an approved rare pediatric disease product shall submit a report to the Secretary not later than 5 years after the approval of the applicable rare pediatric disease product application. Such report shall provide the following information, with respect to each of the first 4 years after approval of such product: ‘‘(A) The estimated population in the United States suffering from the rare pediatric disease. ‘‘(B) The estimated demand in the United States for such rare pediatric disease product. ‘‘(C) The actual amount of such rare pediatric disease product distributed in the United States. ‘‘(f) NOTICE AND REPORT.— ‘‘(1) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary shall publish a notice in the Federal Register and on the Internet Web site of the Food and Drug Administration not later than 30 days after the occurrence of each of the following: ‘‘(A) The Secretary issues a priority review voucher under this section. ‘‘(B) The Secretary approves a drug pursuant to an application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for which the sponsor of the application used a priority review voucher under this section. ‘‘(2) NOTIFICATION.—If, after the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, a sponsor of an application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act Time period. Federal Register, publication. Web posting. Time period. Deadline. VerDate Mar 15 2010 11:12 Aug 08, 2012 Jkt 019139 PO 00144 Frm 00105 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL144.112 GPO1 PsN: PUBL144 wwoods2 on DSKR6SHH1PROD with PUBLIC LAWS 126 STAT. 1098 PUBLIC LAW 112–144—JULY 9, 2012 for a drug uses a priority review voucher under this section for such application, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a document— ‘‘(A) notifying such Committees of the use of such voucher; and ‘‘(B) identifying the drug for which such priority review voucher is used. ‘‘(g) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this Act. ‘‘(h) RELATION TO OTHER PROVISIONS.—The provisions of this section shall supplement, not supplant, any other provisions of this Act or the Public Health Service Act that encourage the development of drugs for tropical diseases and rare pediatric diseases. ‘‘(i) GAO STUDY AND REPORT.— ‘‘(1) STUDY.— ‘‘(A) IN GENERAL.—Beginning on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, the Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under this section in the development of human drug products that treat or prevent such diseases. ‘‘(B) CONTENTS OF STUDY.—In conducting the study under subparagraph (A), the Comptroller General shall examine the following: ‘‘(i) The indications for which each rare disease product for which a priority review voucher was awarded was approved under section 505 or section 351 of the Public Health Service Act. ‘‘(ii) Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval of such a rare disease product. ‘‘(iii) The value of the priority review voucher if transferred. ‘‘(iv) Identification of each drug for which a priority review voucher was used. ‘‘(v) The length of the period of time between the date on which a priority review voucher was awarded and the date on which it was used. ‘‘(2) REPORT.—Not later than 1 year after the date under paragraph (1)(A), the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report containing the results of the study under paragraph (1).’’.
 
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