Impact of ADUFA IV Enhancements on Sample Clauses

Impact of ADUFA IV Enhancements on. User Fee Revenue The FY 2019 baseline for ADUFA IV is $30,331,240, which includes a $400,000 one-time cost for information technology enhancement. For each year from FY 2020 through FY 2023, the annual statutory revenue amounts established in section 741(b) of the FD&C Act (21 U.S.C. 379j–21(b)) will be further adjusted by the inflation adjuster, the workload adjuster, if applicable, and will include $900,000 per year for tissue method trials. The total 5-year revenue planned for ADUFA I was $47,000,000. The total 5- year revenue planned for XXXXX XX was $98,000,000. The total 5-year revenue planned for XXXXX XXX was $114,000,000. It is estimated that the total 5-year revenue for ADUFA IV will be $150,000,000. The fee revenue distribution in XXXXX XX will remain the same as ADUFA III: 20 percent from application fees; 27 percent from product fees; 26 percent from establishment fees; and 27 percent from sponsor fees. Dated: October 20, 2017. Xxxxxx Xxx, Associate Commissioner for Policy. [FR Doc. 2017–23172 Filed 10–24–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–2021] Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. the 60-day timeframe and there is a any excess collections available to need for minor amendments. If any of the above conditions cannot be met, the ADAA combination medicated feed application performance metric will be placed in the original enhance the review process in real time. The proposal provides authority for the Secretary of Health and Human Services (the Secretary) when setting fees to reduce a calculated workload SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Deciding When to Submit a 510(k) for a Software Change Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49383 to an Existing Device.’’ FDA is issuing this final guidance document to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. FDA is correcting an error in the docket number assigned to the ‘‘Deciding When to Submit a 510(k) for a Software Change to an Existing Device’’ notice of availability when it published in the Federa...
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  • Distributions; Xxxxxx Xxx Guaranty On or before each Determination Date (or as soon thereafter as is reasonably practicable), Xxxxxx Mae shall calculate the Lower Tier Distribution Amount for the current calendar month. On each Distribution Date, Xxxxxx Xxx shall withdraw from the Certificate Account the portion of the Lower Tier Distribution Amount distributable thereon and shall make the distributions to the Holders of the related Lower Tier Regular Classes in the respective amounts and in the applicable manner determined pursuant to Section 2.02. In the event that the amount on deposit in the Certificate Account on any Distribution Date shall be less than the applicable portion of the Lower Tier Distribution Amount distributable thereon, Xxxxxx Mae shall provide from its own funds the amount of any such insufficiency. In addition, in the event that (i) the applicable portion of the Lower Tier Distribution Amount shall be insufficient to pay all interest due and payable on the related Lower Tier Regular Classes on such Distribution Date or (ii) such Distribution Date is a Final Distribution Date for any Class and the distribution on such Distribution Date of the applicable portion of the Lower Tier Distribution Amount will not be sufficient to reduce the Class Balance of such Class to zero on such Final Distribution Date, then Xxxxxx Xxx shall (a) withdraw from the Certificate Account, such amount as shall be necessary to remedy such insufficiency and (b) to the extent that funds in the Certificate Account shall be insufficient therefor, apply its own funds towards remedying the same.

  • Cost Recovery for RSTEP Requests by Registry Operator for the approval of Additional Services pursuant to Section 2.1 may be referred by ICANN to the Registry Services Technical Evaluation Panel (“RSTEP”) pursuant to that process at xxxx://xxx.xxxxx.xxx/en/registries/rsep/. In the event that such requests are referred to RSTEP, Registry Operator shall remit to ICANN the invoiced cost of the RSTEP review within fourteen (14) calendar days of receipt of a copy of the RSTEP invoice from ICANN, unless ICANN determines, in its sole and absolute discretion, to pay all or any portion of the invoiced cost of such RSTEP review.

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Secondary / Post-Secondary Program Alignment Welding HIGH SCHOOL COURSE SEQUENCE 9th Grade 10th Grade 11th Grade 12th Grade English 9 Algebra I World History/Geography Biology World Language Phys Ed/Health English 10 Geometry U.S. History/Geography Physics or Chemistry World Language Visual/Performing/Applied Arts English 11 Algebra II Civics/Economics Welding English 12 Math Credit Science Credit Welding WASHTENAW COMMUNITY COLLEGE Welding Associate in Applied Science Semester 1 Math Elective(s)* 3 WAF 105 Introduction to Welding Processes 2 WAF 111 Oxy-fuel Welding 4 WAF 112 Shielded Metal Arc Welding 4 Semester Total 13 Semester 2 Speech Elective(s) 3 WAF 106 Blueprint Reading for Welders 3 WAF 123 Advanced Oxy-fuel Welding 4 WAF 124 Advanced Shielded Metal Arc Welding 4 Semester Total 14 Semester 3 Arts/Human. Elective(s) 3 Computer Lit. Elective(s) 3 WAF 215 Advanced Gas Tungsten Arc Welding 4 WAF 288 Gas Metal Arc Welding 4 Semester Total 14 Semester 4 WAF 200 Layout Theory Welding 3 WAF 210 Welding Metallurgy 3 Soc. Sci. Elective(s) 3 WAF 226 Specialized Welding Procedures 4 Semester Total 13 Semester 5 Nat. Sci. Elective(s) 4 WAF 227 Basic Fabrication 3 WAF 229 Shape Cutting Operations 3 Writing Elective(s) 3 Semester Total 13 Program Totals 67

  • Errors on Paycheques In the event of an error on an employee's pay, the correction will be made in the pay period following the date on which the underpayment comes to the Employer's attention. If the error results in an employee being underpaid by one (1) day's pay or more, the Employer will provide payment for the shortfall within three (3) business days from the date it is notified of the error. If the Employer makes an overpayment of a day’s pay or less for an employee, the overpayment will be deducted on the pay period following the date that the error is discovered. If the error is in excess of a normal day’s pay, the Employer will be reimbursed based on a mutually satisfactory arrangement between the employee and the Employer.

  • When Must Distributions from a Xxxxxxxxx Education Savings Account Begin? Distribution of a Xxxxxxxxx Education Savings Account must be made (or otherwise will be deemed made) no later than 30 days from the earlier of the beneficiary’s death or attainment of age 30. A distribution from a Xxxxxxxxx Education Savings Account may be rolled over to another beneficiary’s Xxxxxxxxx Education Savings Account according to the requirements of Section (4). Note that the Economic Growth and Tax Relief Reconciliation Act of 2001 waives the distribution age limitation if the beneficiary of the Xxxxxxxxx Education Savings Account is a “Special Needs” student.

  • What Forms of Distribution Are Available from a Xxxxxxxxx Education Savings Account Distributions may be made as a lump sum of the entire account, or distributions of a portion of the account may be made as requested.

  • PROCUREMENT OF AGREEMENT CONSULTANT represents and warrants that no person or selling agent has been employed or retained by CONSULTANT to solicit or secure this Agreement upon an agreement or upon an understanding for a commission, percentage, a brokerage fee, contingent fee or any other compensation. CONSULTANT further represents and warrants that no payment, gift or thing of value has been made, given or promised to obtain this or any other agreement between the parties. CONSULTANT makes such representations and warranties to induce the COUNTY to enter into this Agreement and the COUNTY relies upon such representations and warranties in the execution hereof. For a breach or violation of such representations or warranties, the COUNTY shall have the right to annul this Agreement without liability, entitling the COUNTY to recover all monies paid hereunder and CONSULTANT shall not make claim for or be entitled to recover, any sum or sums otherwise due under this Agreement. This remedy, if effected, shall not constitute the sole remedy afforded the COUNTY for such falsity or breach, not shall it constitute a waiver of the COUNTY’s right to claim damages or otherwise refuse payment or to take any other action provided for by law or pursuant to this Agreement.

  • When Must Distributions from a Xxxx XXX Begin Unlike Traditional IRAs, there is no requirement that you begin distribution of your account during your lifetime at any particular age.

  • DISTRIBUTION OF CONTRACTOR PRICE LIST AND CONTRACT APPENDICES Contractor shall provide Authorized Users with electronic copies of the Contract, including price lists and Appendices, upon request. OGS CENTRALIZED CONTRACT MODIFICATIONS Contract Updates will be handled as provided in Appendix C – Contract Modification Procedures.

  • Dissemination of Research Findings and Acknowledgement of Controlled-Access Datasets Subject to the NIH GDS Policy It is NIH’s intent to promote the dissemination of research findings from use of controlled-access dataset(s) subject to the NIH GDS Policy as widely as possible through scientific publication or other appropriate public dissemination mechanisms. Approved Users are strongly encouraged to publish their results in peer-reviewed journals and to present research findings at scientific meetings.

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