Sample records for fee form fda

  1. The Prescription Drug User Fee Act: Cause for Concern?

    PubMed

    Gabay, Michael

    2018-04-01

    The Prescription Drug User Fee Act (PDUFA) was originally enacted into law in 1992. PDUFA provides the Food and Drug Administration (FDA) with needed revenue in the form of various fees paid by drug and biologic manufacturers. The FDA utilizes this revenue to streamline the review and approval process for medications. Since the enactment of PDUFA, the median approval time for priority new drug applications and biologics license applications has reduced significantly. The FDA views PDUFA as a successful program that provides a consistent revenue stream to the agency, improves access to medications for patients, and allows industry to have a more predictable product review timeline. However, critics of PDUFA cite concerns including the potential for a lack of FDA independence and medication safety issues involving drugs approved after the existence of PDUFA.

  2. 78 FR 46954 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0536...; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information...

  3. 77 FR 36279 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0194... Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of...

  4. 78 FR 8543 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0536... Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

  5. 77 FR 29663 - Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471...; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain...

  6. 77 FR 64523 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471... Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

  7. 78 FR 48689 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471...; Prescription Drug User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled...

  8. 77 FR 41984 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0708... Request; Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed...

  9. 77 FR 66620 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0748... Request; Generic Drug User Fee Cover Sheet; Form FDA 3794 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

  10. 75 FR 24707 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0483...; Medical Device User Fee Cover Sheet--Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information...

  11. 75 FR 2866 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0483... Request; Medical Device User Fee Cover Sheet--Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

  12. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Implementation of the...

  13. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements... critical and measurable enhancements to FDA's generic drugs program. GDUFA establishes fees for abbreviated... current thinking on generic drug user fee amendments of 2012. It does not create or confer any rights for...

  14. 77 FR 45634 - Biosimilar User Fee Rates for Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0007] Biosimilar User Fee Rates for Fiscal Year 2013 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for...

  15. 75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381... fee program. The number of human generic drug applications awaiting FDA action and the median review... needed for presentations, FDA reserves the right to terminate the meeting early. If you need special...

  16. 76 FR 79195 - Animal Drug User Fee Act; Reopening of the Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS... notice, FDA requested comments on the Animal Drug User Fee Act (ADUFA) program to date and solicited...

  17. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and... assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA...). The draft guidance, when finalized, will represent the Agency's current thinking on ``Generic Drug...

  18. 75 FR 55589 - Fee for Using a Priority Review Voucher in Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0463] Fee for Using a Priority Review Voucher in Fiscal Year 2011 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the fee rates for using a...

  19. 75 FR 49502 - Medical Device User Fee Act; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-13

    ... Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the...)) requires that, before FDA begins negotiations with the regulated industry on user fee reauthorization, we...

  20. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ...] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014 AGENCY: Food and Drug... and payment procedures for fiscal year (FY) 2014 generic new animal drug user fees. The Federal Food... for FY 2014. FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry...

  1. 76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...

  2. 76 FR 76738 - Generic Drug User Fee; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. The Food and Drug Administration (FDA) is announcing a public meeting to...

  3. Economic Impacts of the Generic Drug User Fee Act Fee Structure.

    PubMed

    Dong, Ke; Boehm, Garth; Zheng, Qiang

    2017-06-01

    A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. To look at the economic impact of the GDUFA fee structure. We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  4. 76 FR 6475 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0603... Request; Animal Drug User Fees and Fee Waivers and Reductions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection...

  5. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0547] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates and...

  6. 76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for...

  7. 77 FR 45639 - Prescription Drug User Fee Rates for Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... compensation and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4... preceding FY 2013. The 3 year average is 2.17 percent. Table 1--FDA Personnel Compensation and Benefits (PC... 108.25 122.3 The FY 2013 application fee is estimated by dividing the average number of full...

  8. 78 FR 66746 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ...] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014... and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will... documents, FDA has committed to updating its Web site in a timely manner to reflect the Agency's review of...

  9. 75 FR 63845 - Medical Device User Fees; Public Meeting; Extension of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ...] Medical Device User Fees; Public Meeting; Extension of Comment Period AGENCY: Food and Drug Administration... stakeholders on the Agency's medical user fee program and requested suggestions regarding the commitments FDA... interested stakeholders to discuss the Agency's medical user fee program and requested suggestions regarding...

  10. The generic drug user fee amendments: an economic perspective

    PubMed Central

    Berndt, Ernst R; Murphy, Stephen J

    2018-01-01

    Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

  11. 76 FR 66723 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-27

    ...The Food and Drug Administration (FDA) is extending the comment period to November 30, 2011, for the notice entitled, ``Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012'' that appeared in the Federal Register of August 1, 2011 (76 FR 45820). In that document, FDA announced the establishment of a docket to obtain comments that would be considered in establishing the fee rates for fiscal year (FY) 2013. In particular, the Agency provided the current FY 2012 fees and requested public comments to the document and intends to consider such comments, as well as experience and additional data gained in implementing these fees in FY 2012, in establishing the fee rates for FY 2013. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

  12. 76 FR 33307 - Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ...] Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period AGENCY: Food and Drug... on the development of a generic drug user fee program. The Agency is taking this action to allow..., 75 FR 47820, FDA published a notice soliciting comment on development of a generic drug user fee...

  13. 78 FR 46955 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ...] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2014 animal drug user fees. The Federal Food, Drug, and Cosmetic... submissions. This notice establishes the fee rates for FY 2014. FOR FURTHER INFORMATION CONTACT: Visit FDA's...

  14. 21 CFR 314.72 - Change in ownership of an application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...

  15. 21 CFR 314.72 - Change in ownership of an application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...

  16. 21 CFR 314.72 - Change in ownership of an application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...

  17. 21 CFR 314.72 - Change in ownership of an application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications § 314.72... required to be kept under § 314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in § 20.45 of FDA's public...

  18. 77 FR 23267 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324..., FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business... Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...

  19. 75 FR 32483 - Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0128... participation. SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to request that public... academic experts--notify FDA of their intent to participate in periodic consultation meetings on...

  20. 75 FR 2874 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0486... Request; Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee.... SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information...

  1. 78 FR 23569 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324...; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small...: The Food and Drug Administration (FDA) is announcing that a collection of information entitled...

  2. 76 FR 27062 - Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for... adhere to these principles, and performance goals for this program. FDA plans to review the comments... drug marketing applications were submitted each year for FDA review. The number of participants in the...

  3. 21 CFR 314.65 - Withdrawal by the applicant of an unapproved application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... application and will provide a copy to the applicant on request under the fee schedule in § 20.45 of FDA's...

  4. 21 CFR 314.65 - Withdrawal by the applicant of an unapproved application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... application and will provide a copy to the applicant on request under the fee schedule in § 20.45 of FDA's...

  5. 21 CFR 314.65 - Withdrawal by the applicant of an unapproved application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... application and will provide a copy to the applicant on request under the fee schedule in § 20.45 of FDA's...

  6. 21 CFR 314.65 - Withdrawal by the applicant of an unapproved application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Applications... application and will provide a copy to the applicant on request under the fee schedule in § 20.45 of FDA's...

  7. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...

  8. 75 FR 58411 - Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... health industry that submits new animal drug applications to CVM's Office of New Animal Drug Evaluation... agreed to in the Animal Drug User Fee Amendments (ADUFA II) of 2008 ( http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm044941.htm ). The ONADE will be soliciting feedback on both the e...

  9. 75 FR 45632 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... available to you after you submit a cover sheet. Click the ``Pay Now'' button.) On your check, bank draft... 2011, FDA is assuming that the number of applications that will pay fees in FY 2011 will equal the... applications subject to the criteria set forth is section 512(d)(4) of the act which pay half of the full fee...

  10. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...] Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment AGENCY: Food and... the availability for public comment of the draft information technology (IT) plan entitled ``GDUFA Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing business...

  11. 78 FR 78367 - Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...] Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment AGENCY... announcing the availability for public comment of the draft information technology (IT) plan entitled ``PDUFA V Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing...

  12. 78 FR 21613 - Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... syndrome; narcolepsy; neurological manifestations of inborn errors of metabolism; Parkinson's disease and... available therapies. Patients who live with a disease have a direct stake in the outcome of FDA's decisions... of applications for new drugs in certain disease areas. For FDA's review divisions, this kind of...

  13. 76 FR 56201 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect... and upgrade its information technology systems. At the same time, FDA committed to complete reviews in...\\ Since PDUFA was enacted, the median approval time of original NDAs and BLAs has been reduced by about 50...

  14. 76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment...

  15. 75 FR 53702 - Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2010-N-0389] Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  16. 75 FR 76472 - Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0602] Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate...

  17. 77 FR 51814 - Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0882] Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug...

  18. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    .... FDA-2013-N-0402] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public... public meeting that will provide an overview of the current status of the regulatory science initiatives... societies, and other interested stakeholders-- as it fulfills its statutory requirement under the Generic...

  19. 75 FR 69093 - Prescription Drug User Fee Act; Reopening of the Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... review program after negotiations with the regulated industry conclude. FDA expects that this additional...)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires that before FDA begins negotiations with the... requires public review of the recommendations for the human drug review program after negotiations with the...

  20. 76 FR 14028 - Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... is reopening the comment period for the expected duration of the active negotiation phase to ensure... throughout the negotiation phase, FDA is reopening the comment period until June 30, 2011. FDA expects that the public component of the GDUF negotiations will be complete by the end of June 2011. Therefore, the...

  1. 76 FR 45831 - Prescription Drug User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... annual change in cost, per FDA full time equivalent (FTE), of all personnel compensation and benefits... and benefits per FTE over the previous 5 of the most recent 6 FYs (FY 2006 through FY 2010). The data... percent. Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change Annual...

  2. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and...

  3. 76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... paper check: All paper checks must be in U.S. currency from a U.S. bank and made payable to the Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION...

  4. 76 FR 45820 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... of sick leave 80 10 days of training 80 2 hours of meetings per week 80 Net Supported Direct FDA Work... implementing these user fees in FY 2013. II. Estimating the Average Cost of a Supported Direct FDA Work Hour... Direct Work Hour in FY 2010 In general, the starting point for estimating the full cost per direct work...

  5. Utilization of smoking cessation medication benefits among medicaid fee-for-service enrollees 1999-2008.

    PubMed

    Kahende, Jennifer; Malarcher, Ann; England, Lucinda; Zhang, Lei; Mowery, Paul; Xu, Xin; Sevilimedu, Varadan; Rolle, Italia

    2017-01-01

    To assess state coverage and utilization of Medicaid smoking cessation medication benefits among fee-for-service enrollees who smoked cigarettes. We used the linked National Health Interview Survey (survey years 1995, 1997-2005) and the Medicaid Analytic eXtract files (1999-2008) to assess utilization of smoking cessation medication benefits among 5,982 cigarette smokers aged 18-64 years enrolled in Medicaid fee-for-service whose state Medicaid insurance covered at least one cessation medication. We excluded visits during pregnancy, and those covered by managed care or under dual enrollment (Medicaid and Medicare). Multivariate logistic regression was used to determine correlates of cessation medication benefit utilization among Medicaid fee-for-service enrollees, including measures of drug coverage (comprehensive cessation medication coverage, number of medications in state benefit, varenicline coverage), individual-level demographics at NHIS interview, age at Medicaid enrollment, and state-level cigarette excise taxes, statewide smoke-free laws, and per-capita tobacco control funding. In 1999, the percent of smokers with ≥1 medication claims was 5.7% in the 30 states that covered at least one Food and Drug Administration (FDA)-approved cessation medication; this increased to 9.9% in 2008 in the 44 states that covered at least one FDA-approved medication (p<0.01). Cessation medication utilization was greater among older individuals (≥ 25 years), females, non-Hispanic whites, and those with higher educational attainment. Comprehensive coverage, the number of smoking cessation medications covered and varenicline coverage were all positively associated with utilization; cigarette excise tax and per-capita tobacco control funding were also positively associated with utilization. Utilization of medication benefits among fee-for-service Medicaid enrollees increased from 1999-2008 and varied by individual and state-level characteristics. Given that the Affordable Care Act bars state Medicaid programs from excluding any FDA-approved cessation medications from coverage as of January 2014, monitoring Medicaid cessation medication claims may be beneficial for informing efforts to increase utilization and maximize smoking cessation.

  6. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... costs to total FDA costs of the review of human generic drug activities for the first 3 of the preceding... review of human generic drug activities. Since the first year of the Generic Drug User Fee Program has... activities other than PC&B (see section 744B(c)(1)(C) of the FD&C Act). Table 3 of this document provides the...

  7. 75 FR 12555 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... negotiations with the regulated industry on PDUFA reauthorization, we publish a notice in the Federal Register...)(2)) of the FD&C Act requires that before FDA begins negotiations with the regulated industry on...

  8. Utilization of smoking cessation medication benefits among medicaid fee-for-service enrollees 1999–2008

    PubMed Central

    Kahende, Jennifer; England, Lucinda; Zhang, Lei; Mowery, Paul; Xu, Xin; Sevilimedu, Varadan; Rolle, Italia

    2017-01-01

    Objective To assess state coverage and utilization of Medicaid smoking cessation medication benefits among fee-for-service enrollees who smoked cigarettes. Methods We used the linked National Health Interview Survey (survey years 1995, 1997–2005) and the Medicaid Analytic eXtract files (1999–2008) to assess utilization of smoking cessation medication benefits among 5,982 cigarette smokers aged 18–64 years enrolled in Medicaid fee-for-service whose state Medicaid insurance covered at least one cessation medication. We excluded visits during pregnancy, and those covered by managed care or under dual enrollment (Medicaid and Medicare). Multivariate logistic regression was used to determine correlates of cessation medication benefit utilization among Medicaid fee-for-service enrollees, including measures of drug coverage (comprehensive cessation medication coverage, number of medications in state benefit, varenicline coverage), individual-level demographics at NHIS interview, age at Medicaid enrollment, and state-level cigarette excise taxes, statewide smoke-free laws, and per-capita tobacco control funding. Results In 1999, the percent of smokers with ≥1 medication claims was 5.7% in the 30 states that covered at least one Food and Drug Administration (FDA)-approved cessation medication; this increased to 9.9% in 2008 in the 44 states that covered at least one FDA-approved medication (p<0.01). Cessation medication utilization was greater among older individuals (≥ 25 years), females, non-Hispanic whites, and those with higher educational attainment. Comprehensive coverage, the number of smoking cessation medications covered and varenicline coverage were all positively associated with utilization; cigarette excise tax and per-capita tobacco control funding were also positively associated with utilization. Conclusions Utilization of medication benefits among fee-for-service Medicaid enrollees increased from 1999–2008 and varied by individual and state-level characteristics. Given that the Affordable Care Act bars state Medicaid programs from excluding any FDA-approved cessation medications from coverage as of January 2014, monitoring Medicaid cessation medication claims may be beneficial for informing efforts to increase utilization and maximize smoking cessation. PMID:28207744

  9. 76 FR 53478 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-26

    ...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 1, 2011 (76 FR 45820). The document announced the fiscal year 2012 fee rates for certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections that are mandated in the FDA Food Safety Modernization Act (FSMA). The document was published with two typographical errors. This document corrects those errors.

  10. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ... Employee registering $500. prior to/after May13. FDA Planning Committee Members and (free) Fee Waived..., affiliation, mailing address, phone number, fax number, and email address, along with a check or money order...

  11. 77 FR 58848 - Prescription Drug User Fee Act V Patient-Focused Drug Development; Consultation Meetings; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ...' participants (non- FDA employees) is through Building 1 where routine security check procedures will be... headquarters versus those in other locations who have less physical access. 4. How to support engagement of...

  12. 78 FR 54656 - Fee for Using a Priority Review Voucher in Fiscal Year 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... months, FDA estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non... checks to: U.S. Bank, Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101...

  13. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... nonmember ($525.00) FDA Employee (free) Fee Waived If you need special accommodations due to a disability..., telephone, fax number, and e-mail, along with a check or money order payable to ``SoCRA''. Mail to: SoCRA...

  14. 78 FR 65329 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... Safety Testing of Sunlamp Products'' Form FDA 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' Form FDA 3633''General Variance Request'' Form FDA 3634 ``Television Products Annual Report'' Form FDA 3635 ``Laser Light Show Notification'' Form FDA 3636 ``Guide for Preparing...

  15. 78 FR 35279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products'' FDA Form 3637...

  16. 75 FR 26964 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... of Sunlamps and Sunlamp Products'' FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing...

  17. 75 FR 77647 - Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The... reauthorization negotiations with the regulated industry. ADDRESSES: Submit notification of intention to... groups at least once every month during negotiations with the regulated industry to continue discussions...

  18. Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.

    PubMed

    Berndt, Ernst R; Gottschalk, Adrian H B; Philipson, Tomas J; Strobeck, Matthew W

    2005-07-01

    The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite the FDA drug-review process. Here, we review data on drug approvals and drug-approval times, both as a whole and by therapeutic class, which demonstrate that implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA's safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.

  19. 78 FR 26374 - An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ... XV, ``Improving FDA Performance Management,'' subsection B, which was reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. The assessment will be conducted by an... Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061...

  20. 75 FR 46952 - Prescription Drug User Fee Rates for Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-04

    ... average change in pay per FTE (4.53 percent) is the highest of the three factors, it becomes the inflation... pay change for the previous fiscal year for Federal employees stationed in the Washington, DC metropolitan area; or (3) the average annual change in cost, per full time equivalent (FTE) FDA position, of...

  1. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

    PubMed

    Rosania, Larry

    2010-01-01

    Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

  2. 76 FR 53910 - Fee for Using a Priority Review Voucher in Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... ordinarily takes 10 months into 6 months, OPP estimates that a multiplier of 1.67 (10 months divided by 6... FY 2010. Dividing $6,856,000 (rounded to the nearest thousand dollars) by 13 (the total number of... adjust the FY 2010 cost figure above by the average amount by which FDA's average salary and benefit...

  3. 77 FR 56649 - Fee for Using a Priority Review Voucher in Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... months, OPP estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non... which FDA's average salary and benefit costs increased in the 3 years prior to FY 2012, to adjust the FY... that requests a street address, the courier can deliver the checks to: U.S. Bank, Attention: Government...

  4. 77 FR 70449 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to... notice announces the Web site location of the two lists of guidance documents which CDRH is intending to... list. FDA and CDRH priorities are subject to change at any time. Topics on this and past guidance...

  5. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

    PubMed

    2008-07-10

    The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

  6. Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

    PubMed

    Deyo, Richard A

    2004-01-01

    Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

  7. Incentives for orphan drug research and development in the United States.

    PubMed

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Szeinbach, Sheryl L; Visaria, Jay

    2008-12-16

    The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

  8. 75 FR 75175 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-02

    ... exceed cost... 0 1 0 2 0 740(d)(1)(C) Free choice feeds.. 2 1 2 2 4 740(d)(1)(D) Minor use or minor 52 1... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0603... Fee Waivers and Reductions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  9. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device... Responses Response Total hours CDRH 3601 110 1 110 2 220 CBER 3601 4 1 4 2 8 Total Hours 228 \\1\\ There are...

  10. 76 FR 61709 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0708] Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal...: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

  11. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...

  12. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...

  13. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...

  14. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...

  15. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and 2301? How can I get them? Can I use computer-generated equivalents? 514.80(d) Reporting forms. How... provided on the forms. Computer-generated equivalents of Form FDA 1932 or Form FDA 2301, approved by FDA... Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764. (e) Records to...

  16. 75 FR 8963 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... Annual Report'' FDA Form 3642 ``General Correspondence'' FDA Form 3643 ``Microwave Oven Products Annual... Television Products'' FDA Form 3660 ``Guidance for Preparing Reports on Radiation Safety of Microwave Ovens... ``Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens)'' The most likely...

  17. 78 FR 65334 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... information, including certain labeling information, to FDA for approval to market a product in interstate... and in a form that FDA can process, review, and archive. This requirement is in addition to the....12(b) in table 1 of this document. In July 1997, FDA revised Form FDA 356h ``Application to Market a...

  18. 48 CFR 853.236-70 - VA Form 10-6298, Architect-Engineer Fee Proposal.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false VA Form 10-6298, Architect-Engineer Fee Proposal. 853.236-70 Section 853.236-70 Federal Acquisition Regulations System DEPARTMENT OF...-Engineer Fee Proposal. VA Form 10-6298, Architect-Engineer Fee Proposal, shall be used as prescribed in 836...

  19. 48 CFR 853.236-70 - VA Form 10-6298, Architect-Engineer Fee Proposal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false VA Form 10-6298, Architect-Engineer Fee Proposal. 853.236-70 Section 853.236-70 Federal Acquisition Regulations System DEPARTMENT OF...-Engineer Fee Proposal. VA Form 10-6298, Architect-Engineer Fee Proposal, shall be used as prescribed in 836...

  20. 43 CFR 3216.14 - What filing fees and forms does a transfer require?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... for three leases, submit three times the fee for “Assignment and transfer of record title or operating... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false What filing fees and forms does a transfer... LEASING Transfers § 3216.14 What filing fees and forms does a transfer require? With each transfer request...

  1. 43 CFR 3216.14 - What filing fees and forms does a transfer require?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... for three leases, submit three times the fee for “Assignment and transfer of record title or operating... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false What filing fees and forms does a transfer... LEASING Transfers § 3216.14 What filing fees and forms does a transfer require? With each transfer request...

  2. 43 CFR 3216.14 - What filing fees and forms does a transfer require?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... for three leases, submit three times the fee for “Assignment and transfer of record title or operating... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false What filing fees and forms does a transfer... LEASING Transfers § 3216.14 What filing fees and forms does a transfer require? With each transfer request...

  3. 43 CFR 3216.14 - What filing fees and forms does a transfer require?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... for three leases, submit three times the fee for “Assignment and transfer of record title or operating... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false What filing fees and forms does a transfer... LEASING Transfers § 3216.14 What filing fees and forms does a transfer require? With each transfer request...

  4. 78 FR 46423 - Proposed Information Collection (Application for Reimbursement of National Test Fee) Activity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... (Application for Reimbursement of National Test Fee) Activity; Comment Request AGENCY: Veterans Benefits.... Title: Application for Reimbursement of National Test Fee, VA Form 22-0810. OMB Control Number: 2900..., and eligible dependents complete VA Form 22-0810 to request reimbursement of national test fees. VA...

  5. 75 FR 62187 - Proposed Information Collection (Application for Reimbursement of National Test Fee) Activity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-07

    ... (Application for Reimbursement of National Test Fee) Activity: Comment Request AGENCY: Veterans Benefits.... Title: Application for Reimbursement of National Test Fee, VA Form 22-0810. OMB Control Number: 2900..., and eligible dependents complete VA Form 22-0810 to request reimbursement of national test fees. VA...

  6. The intersection of urban form and mileage fees : findings from the Oregon road user fee pilot program

    DOT National Transportation Integrated Search

    2011-03-01

    This report analyzes data from the 2006-2007 Oregon Road User Fee Pilot Program to assess if and how urban form variables correlate with travel behavior changes that participants made in response to the mileage fee program. The study tested the impac...

  7. 37 CFR 1.311 - Notice of allowance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... fee, in which case the issue fee and publication fee (§ 1.211(e)) must both be paid within three... notice of allowance will operate as a request to charge the correct issue fee or any publication fee due... incorrect issue fee or publication fee; or (2) A fee transmittal form (or letter) for payment of issue fee...

  8. 77 FR 51818 - Agency Information Collection Activities; User Fees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... Activities; User Fees AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: 30... review and approval in accordance with the Paperwork Reduction Act: User Fees. This is a proposed...: User Fees. OMB Number: 1651-0052. Form Number: CBP Forms 339A, 339C and 339V. Abstract: The...

  9. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... regulatory fee payment (including a regulatory fee payment submitted with an application in the wireless radio service) made by credit card or money order must be submitted with a completed FCC Form 159...

  10. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... regulatory fee payment (including a regulatory fee payment submitted with an application in the wireless radio service) made by credit card or money order must be submitted with a completed FCC Form 159...

  11. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... regulatory fee payment (including a regulatory fee payment submitted with an application in the wireless radio service) made by credit card or money order must be submitted with a completed FCC Form 159...

  12. 75 FR 78807 - Agency Information Collection (Application for Reimbursement of National Test Fee) Activity Under...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... (Application for Reimbursement of National Test Fee) Activity Under OMB Review AGENCY: Veterans Benefits... Reimbursement of National Test Fee, VA Form 22-0810. OMB Control Number: 2900-0706. Type of Review: Extension of... complete VA Form 22-0810 to request reimbursement of national test fees. VA will use the data collected to...

  13. 49 CFR 1572.405 - Procedures for collection by TSA.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Collection Fee, Threat Assessment Fee, and FBI Fee. (a) Imposition of fees. (1) An individual who applies to... Collection Fee, Threat Assessment Fee, and FBI Fee, in a form and manner approved by TSA, when the individual... accordance with the provisions of 31 U.S.C. 9701 and other applicable Federal law. (3) The FBI Fee required...

  14. 49 CFR 1572.405 - Procedures for collection by TSA.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Collection Fee, Threat Assessment Fee, and FBI Fee. (a) Imposition of fees. (1) An individual who applies to... Collection Fee, Threat Assessment Fee, and FBI Fee, in a form and manner approved by TSA, when the individual... accordance with the provisions of 31 U.S.C. 9701 and other applicable Federal law. (3) The FBI Fee required...

  15. 48 CFR 353.370-674 - Form HHS 674, Structured Approach Profit/Fee Objective.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Form HHS 674, Structured Approach Profit/Fee Objective. 353.370-674 Section 353.370-674 Federal Acquisition Regulations System..., Structured Approach Profit/Fee Objective. This form is available from local cost advisory personnel or PSC...

  16. 76 FR 29777 - Re-registration Procedures for Temporary Protected Status (TPS) Beneficiaries Under the Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... Status for Haiti. Fees for the Form I-821, Form I-765, and biometric services fee are also described in 8 CFR 103.7(b). Biometric Services Fee Biometrics (such as fingerprints) are required for all applicants 14 years of age or older. Those applicants must submit a biometric services fee. As previously stated...

  17. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

  18. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

  19. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

  20. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

  1. 21 CFR 1.393 - What information must FDA include in the detention order?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...

  2. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and... investigation means that before or during the investigation, the applicant was named in Form FDA-1571 filed with FDA as the sponsor of the investigational new drug application under which the investigation was...

  3. Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.

    PubMed

    Light, Donald W; Lexchin, Joel; Darrow, Jonathan J

    2013-01-01

    Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. © 2013 American Society of Law, Medicine & Ethics, Inc.

  4. 78 FR 25749 - Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-02

    ... language)-enabled Adobe PDF form, Form FDA 3331--Automated to submit new drug application (NDA) and...-enabled Adobe PDF form, Form FDA 3331--Automated, will be available for piloting between May 1, 2013, and... modernize the FAR submission and review pathway using an XML-enabled PDF form to enable integration with...

  5. 75 FR 60487 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... Fingerprint Processing Fee is included as part of this fee. The New Trading Permit Holder Orientation & Exam... Application and related documentation, one Responsible Person's Orientation & Exam Fee and Fingerprint Fee... individuals on a TPH organization's Form BD. This fee includes the related Fingerprint Processing Fee. This...

  6. 41 CFR 301-71.212 - Should we report late payment fees as wages on a Form W-2?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false Should we report late payment fees as wages on a Form W-2? 301-71.212 Section 301-71.212 Public Contracts and Property... late payment fees as wages on a Form W-2? No, the Internal Revenue Service (IRS) has determined that...

  7. 40 CFR 1027.140 - What reporting and recordkeeping requirements apply under this part?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS FEES FOR ENGINE, VEHICLE, AND EQUIPMENT COMPLIANCE...) Filling out fee filing forms under § 1027.130. (b) Retaining fee records, including reduced fee...

  8. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  9. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  10. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  11. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  12. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... application. (a) FDA will refuse to approve an abbreviated application for a new drug under section 505(j) of... FDA with respect to the active ingredient, route of administration, dosage form, or strength that is...

  13. 78 FR 5463 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... currently assessing any additional data requirements. In this regard, FDA published an Advance Notice of... report. Here, e-form FDA 3744a and reporting via the Electronic Submission Gateway are provided by FDA... January 17, 2012 (77 FR 2302), FDA published a 60-day notice requesting public comment on the proposed...

  14. 7 CFR 28.115 - Fees and costs; payment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Fees and costs; payment. 28.115 Section 28.115... Fees and Costs § 28.115 Fees and costs; payment. All charges for practical forms of cotton standards and all fees and expenses for services of inspection of bales and supervision of sampling...

  15. 49 CFR 1572.403 - Procedures for collection by States.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Threat Assessment Fee and the FBI Fee. (a) Imposition of fees. (1) An individual who applies to obtain or... FBI Fee, in a form and manner approved by TSA and the State, when the individual submits the... other applicable Federal law. (3) The FBI Fee required for the FBI to process fingerprint identification...

  16. 49 CFR 1572.403 - Procedures for collection by States.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Threat Assessment Fee and the FBI Fee. (a) Imposition of fees. (1) An individual who applies to obtain or... FBI Fee, in a form and manner approved by TSA and the State, when the individual submits the... other applicable Federal law. (3) The FBI Fee required for the FBI to process fingerprint identification...

  17. 41 CFR 301-52.22 - Will any late payment fees I receive be reported as wages on a Form W-2?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false Will any late payment fees I receive be reported as wages on a Form W-2? 301-52.22 Section 301-52.22 Public Contracts and... Will any late payment fees I receive be reported as wages on a Form W-2? No, the Internal Revenue...

  18. 21 CFR 807.22 - How and where to register establishments and list devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... use of the device. In lieu of form FDA-2892, tapes for computer input or hard copy computer output may by submitted if equivalent in all elements of information as specified in form FDA-2892. All formats...

  19. 75 FR 78806 - Agency Information Collection (Create Payment Request for the VA Funding Fee Payment System (VA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... Payment Request for the VA Funding Fee Payment System (VA FFPS); a Computer Generated Funding Fee Receipt.... 2900-0474.'' SUPPLEMENTARY INFORMATION: Title: Create Payment Request for the VA Funding Fee Payment System (VA FFPS); a Computer Generated Funding Fee Receipt, VA Form 26-8986. OMB Control Number: 2900...

  20. 46 CFR 5.401 - Payment of witness fees and allowances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Payment of witness fees and allowances. 5.401 Section 5... INVESTIGATION REGULATIONS-PERSONNEL ACTION Witness Fees § 5.401 Payment of witness fees and allowances. (a) Duly... (Standard Form 1157) accompanied by any necessary receipts. (b) Fees and allowances will be paid as provided...

  1. Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

    PubMed

    Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

    2014-09-01

    Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs.

  2. 78 FR 59771 - Proposed Information Collection (Create Payment Request for the VA Funding Fee Payment System (VA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... Payment Request for the VA Funding Fee Payment System (VA FFPS); a Computer Generated Funding Fee Receipt.... Title: Create Payment Request for the VA Funding Fee Payment System (VA FFPS); A Computer Generated Funding Fee Receipt, VA Form 26-8986. OMB Control Number: 2900-0474. Type of Review: Revision of a...

  3. 76 FR 26305 - Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0275... Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  4. 77 FR 33469 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0536... Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

  5. 75 FR 31794 - Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0406...--Statement of Investigator (Form FDA 1572); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of an information...

  6. 78 FR 33846 - Agency Information Collection Activities; Proposed Collection; Comment Request; Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0579... Deviations in Manufacturing; Forms FDA 3486 and 3486A AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

  7. 77 FR 14809 - Agency Information Collection Activities: Proposed Collection; Comment Request; Biosimilars User...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0194... Cover Sheet; Form FDA 3792 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

  8. 76 FR 48167 - Agency Information Collection Activities; Proposed Collection; Comment Request; Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0508... Registration and Product Listing, Form FDA 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the...

  9. 78 FR 32629 - Post Allowance and Refiling

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... issue fee payments. The USPTO is removing the fee costs associated with the information requirements in... have annual (non-hour) costs in the form of postage costs. There are fees associated with the...-hour) cost burden for this collection. Item Current fee amount Certificate of Correction (PTO/SB/ $100...

  10. 49 CFR 360.3 - Filing fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... INSURANCE § 360.3 Filing fees. (a) Manner of payment. (1) Except for the insurance fees described in the... withdrawn. (d) Related or consolidated proceedings. (1) Separate fees need not be paid for related... requests for multiple types of operating authority filed on forms in the OP-1 series under the regulations...

  11. 49 CFR 360.3 - Filing fees.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... INSURANCE § 360.3 Filing fees. (a) Manner of payment. (1) Except for the insurance fees described in the... withdrawn. (d) Related or consolidated proceedings. (1) Separate fees need not be paid for related... requests for multiple types of operating authority filed on forms in the OP-1 series under the regulations...

  12. 49 CFR 360.3 - Filing fees.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... INSURANCE § 360.3 Filing fees. (a) Manner of payment. (1) Except for the insurance fees described in the... withdrawn. (d) Related or consolidated proceedings. (1) Separate fees need not be paid for related... requests for multiple types of operating authority filed on forms in the OP-1 series under the regulations...

  13. 49 CFR 360.3 - Filing fees.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... INSURANCE § 360.3 Filing fees. (a) Manner of payment. (1) Except for the insurance fees described in the... withdrawn. (d) Related or consolidated proceedings. (1) Separate fees need not be paid for related... requests for multiple types of operating authority filed on forms in the OP-1 series under the regulations...

  14. Find a NCCAOM Certified Practitioner

    MedlinePlus

    ... Diplomate Fees Forms and Documents Publications Academy Website Ethics and Disciplinary Review Special Events Applicants Applicants Home ... Fees Forms and Documents ADA Accommodations State Licensure Ethics and Disciplinary Review Applicants Special Events PDA Providers ...

  15. 22 CFR 51.50 - Form of payment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Form of payment. 51.50 Section 51.50 Foreign Relations DEPARTMENT OF STATE NATIONALITY AND PASSPORTS PASSPORTS Fees § 51.50 Form of payment. Passport fees must be paid in U.S. currency or in other forms of payments permitted by the Department. ...

  16. 22 CFR 51.50 - Form of payment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Form of payment. 51.50 Section 51.50 Foreign Relations DEPARTMENT OF STATE NATIONALITY AND PASSPORTS PASSPORTS Fees § 51.50 Form of payment. Passport fees must be paid in U.S. currency or in other forms of payments permitted by the Department. ...

  17. 22 CFR 51.50 - Form of payment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Form of payment. 51.50 Section 51.50 Foreign Relations DEPARTMENT OF STATE NATIONALITY AND PASSPORTS PASSPORTS Fees § 51.50 Form of payment. Passport fees must be paid in U.S. currency or in other forms of payments permitted by the Department. ...

  18. 22 CFR 51.50 - Form of payment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Form of payment. 51.50 Section 51.50 Foreign Relations DEPARTMENT OF STATE NATIONALITY AND PASSPORTS PASSPORTS Fees § 51.50 Form of payment. Passport fees must be paid in U.S. currency or in other forms of payments permitted by the Department. ...

  19. 22 CFR 51.50 - Form of payment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Form of payment. 51.50 Section 51.50 Foreign Relations DEPARTMENT OF STATE NATIONALITY AND PASSPORTS PASSPORTS Fees § 51.50 Form of payment. Passport fees must be paid in U.S. currency or in other forms of payments permitted by the Department. ...

  20. 76 FR 40808 - Oral Dosage Form New Animal Drugs; Amprolium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  1. 77 FR 15961 - Oral Dosage Form New Animal Drugs; Phenylpropanolamine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Phenylpropanolamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

  2. 76 FR 59023 - Oral Dosage Form New Animal Drugs; Tylosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  3. 75 FR 67031 - Oral Dosage Form New Animal Drugs; Domperidone

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Domperidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  4. 77 FR 3927 - Oral Dosage Form New Animal Drugs; Deracoxib

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  5. 77 FR 15960 - Oral Dosage Form New Animal Drugs; Pergolide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Pergolide AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  6. 76 FR 18648 - Oral Dosage Form New Animal Drugs; Robenacoxib

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Robenacoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  7. 76 FR 78149 - Oral Dosage Form New Animal Drugs; Estriol

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Estriol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  8. 76 FR 38554 - Oral Dosage Form New Animal Drugs; Amprolium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    .... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross...

  9. 77 FR 4226 - Oral Dosage Form New Animal Drugs; Gentamicin Sulfate

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    .... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Gentamicin Sulfate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA...

  10. 75 FR 76259 - Oral Dosage Form New Animal Drugs; Tylosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by...

  11. 75 FR 54492 - Oral Dosage Form New Animal Drugs; Tiamulin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal...

  12. 77 FR 43844 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0748... Cover Sheet; Form FDA 3794 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed...

  13. 76 FR 3910 - Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0015... Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...

  14. 78 FR 27969 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1131... Request; New Animal Drug Applications and Supporting Regulations and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a...

  15. 75 FR 2865 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0488... on Forms FDA 1932, 1932a, and 2301 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has...

  16. 75 FR 27347 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0545... Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  17. 77 FR 20025 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0508... Establishment Registration and Product Listing, Form FDA 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information...

  18. 78 FR 72893 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0579... Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  19. 78 FR 35277 - Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0653... Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...

  20. 77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1131... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment...

  1. 75 FR 4081 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0019... Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity...

  2. 75 FR 32786 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0019..., Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  3. 75 FR 80854 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ..., ``Financial EDI Authorization''; NUREG/BR-0254, Payment Methods; and NRC Form 629, ``Authorization for Payment... licensing fees, and inspection fees to the NRC. The NRC Form 628, ``Financial EDI Authorization,'' provides...

  4. 76 FR 40229 - Oral Dosage Form New Animal Drugs; Change of Sponsor

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    .... FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH...

  5. 75 FR 54018 - Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  6. 78 FR 76412 - Agency Information Collection (Application for Reimbursement of National Test Fee) Activity Under...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... (Application for Reimbursement of National Test Fee) Activity Under OMB Review AGENCY: Veterans Benefits... National Test Fee, VA Form 22-0810. OMB Control Number: 2900-0706. Type of Review: Revision of a currently... to request reimbursement of national test fees. VA will use the data collected to determine the...

  7. 7 CFR 500.25 - Payment of fees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... enters into an agreement to allow USNA visitors and users to make payment in the form of a credit card, USNA visitors and users who are assessed user fees may pay those fees with a credit card subject to the...

  8. 7 CFR 500.25 - Payment of fees.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... enters into an agreement to allow USNA visitors and users to make payment in the form of a credit card, USNA visitors and users who are assessed user fees may pay those fees with a credit card subject to the...

  9. 7 CFR 500.25 - Payment of fees.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... enters into an agreement to allow USNA visitors and users to make payment in the form of a credit card, USNA visitors and users who are assessed user fees may pay those fees with a credit card subject to the...

  10. 7 CFR 500.25 - Payment of fees.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... enters into an agreement to allow USNA visitors and users to make payment in the form of a credit card, USNA visitors and users who are assessed user fees may pay those fees with a credit card subject to the...

  11. 7 CFR 500.25 - Payment of fees.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... enters into an agreement to allow USNA visitors and users to make payment in the form of a credit card, USNA visitors and users who are assessed user fees may pay those fees with a credit card subject to the...

  12. Estimated cost efficacy of systemic treatments that are approved by the US Food and Drug Administration for the treatment of moderate to severe psoriasis.

    PubMed

    D'Souza, Logan S; Payette, Michael J

    2015-04-01

    Newer psoriasis treatments tout higher efficacy but are generally more expensive. We sought to estimate the cost efficacy of systemic psoriasis treatments that have been approved by the US Food and Drug Administration (FDA). A literature review of systemic psoriasis treatments that have been approved by the FDA was performed for the primary end point of a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Medication cost was referenced by wholesale acquisition cost (WAC), laboratory fees were obtained from the American Medical Association, and office visit fees are standard at our university. Total expenses were standardized by calculating cost per month of treatment considering the number needed to treat (NNT) to achieve PASI 75. Methotrexate ($794.05-1502.51) and cyclosporine ($1410.14-1843.55) had the lowest monthly costs per NNT to achieve PASI 75. The most costly therapies were infliximab ($8704.68-15,235.52) and ustekinumab 90 mg ($12,505.26-14,256.75). Monthly costs per NNT to achieve PASI 75 for other therapies were as follows: narrowband ultraviolet B light phototherapy ($2924.73), adalimumab ($3974.61-7678.78), acitretin ($4137.71-14,148.53), ustekinumab 45 mg ($7177.89-7263.99), psoralen plus ultraviolet A light phototherapy ($7499.46-8834.98), and etanercept ($8284.71-10,674.89). Drug rebates and incentives, potential adverse effects, comorbidity risk reduction, ambassador programs, and combination therapies were excluded. Our study provides meaningful cost efficacy data that may influence psoriasis treatment selection. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  13. 76 FR 52333 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... Form (OMB Control Number 0910-NEW) On June 22, 2009, the President signed the Family Smoking Prevention... Flavor Ban Violations. This new form will be posted on FDA's Web site, and information may be submitted.... Since a similar type of reporting went into effect for the cigarette flavor ban, FDA has received...

  14. 75 FR 20913 - Center for Devices and Radiological Health; New Address Information

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ... information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that... components of the agency's CDRH. The changes are the result of the relocation of these offices to FDA's White... with FDA Form 3500A. You may obtain the coding manual from CDRH's Web site at http://www.fda.gov/Safety...

  15. Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing

    PubMed Central

    Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S.

    2011-01-01

    Background Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Methods and Findings Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1–14). Six “teaser” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Conclusions Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information. PMID:21858076

  16. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    PubMed

    Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

    2011-01-01

    Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.

  17. 78 FR 3900 - Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ... facility fee, we divide the $132,945,000 by the total number of facilities (758) which gives us a domestic... domestic API facility fee, we divide the $23,415,000 by the total number of facilities (885) which gives us..., Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank...

  18. Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

    PubMed

    2004-03-16

    The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

  19. 8 CFR 248.3 - Application.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 212(d)(3) of the Act and 8 CFR 212.15(n). [36 FR 9001, May 18, 1971, as amended at 48 FR 14593, Apr. 5... the fee prescribed in 8 CFR 103.7(b) and in accordance with the form instructions. (a) Petition by... forms designated by USCIS with the fee prescribed in 8 CFR 103.7(b)(1) and in accordance with the form...

  20. 8 CFR 248.3 - Application.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 212(d)(3) of the Act and 8 CFR 212.15(n). [36 FR 9001, May 18, 1971, as amended at 48 FR 14593, Apr. 5... the fee prescribed in 8 CFR 103.7(b) and in accordance with the form instructions. (a) Petition by... forms designated by USCIS with the fee prescribed in 8 CFR 103.7(b)(1) and in accordance with the form...

  1. 8 CFR 248.3 - Application.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 212(d)(3) of the Act and 8 CFR 212.15(n). [36 FR 9001, May 18, 1971, as amended at 48 FR 14593, Apr. 5... the fee prescribed in 8 CFR 103.7(b) and in accordance with the form instructions. (a) Petition by... forms designated by USCIS with the fee prescribed in 8 CFR 103.7(b)(1) and in accordance with the form...

  2. 22 CFR 1304.9 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... granted under paragraph (c) of this section. Payment of fees should be in U.S. Dollars in the form of... waiver or reduction of fees has been granted pursuant to paragraph (c) of this section: (1) Duplications... well as the costs of operator/programmer salary apportionable to the search. MCC is not required to...

  3. 22 CFR 1304.9 - Fees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... granted under paragraph (c) of this section. Payment of fees should be in U.S. Dollars in the form of... waiver or reduction of fees has been granted pursuant to paragraph (c) of this section: (1) Duplications... well as the costs of operator/programmer salary apportionable to the search. MCC is not required to...

  4. 46 CFR 308.3 - Applications for insurance; warranties; supporting documents; payment of binder fees.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... documents; payment of binder fees. 308.3 Section 308.3 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.3 Applications for insurance; warranties; supporting documents; payment of binder fees. (a) Application, binder forms. A single application for War...

  5. 46 CFR 308.3 - Applications for insurance; warranties; supporting documents; payment of binder fees.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... documents; payment of binder fees. 308.3 Section 308.3 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.3 Applications for insurance; warranties; supporting documents; payment of binder fees. (a) Application, binder forms. A single application for War...

  6. 46 CFR 308.3 - Applications for insurance; warranties; supporting documents; payment of binder fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... documents; payment of binder fees. 308.3 Section 308.3 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.3 Applications for insurance; warranties; supporting documents; payment of binder fees. (a) Application, binder forms. A single application for War...

  7. 46 CFR 308.3 - Applications for insurance; warranties; supporting documents; payment of binder fees.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... documents; payment of binder fees. 308.3 Section 308.3 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.3 Applications for insurance; warranties; supporting documents; payment of binder fees. (a) Application, binder forms. A single application for War...

  8. 21 CFR 803.40 - If I am an importer, what kinds of individual adverse event reports must I submit, when must I...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... facilities, individuals, or medical or scientific literature, whether published or unpublished, that... injury. This report must contain the information required by § 803.42, on FDA form 3500A or an electronic.... This report must contain information required by § 803.42, on FDA form 3500A or an electronic...

  9. 21 CFR 803.40 - If I am an importer, what kinds of individual adverse event reports must I submit, when must I...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... facilities, individuals, or medical or scientific literature, whether published or unpublished, that... injury. This report must contain the information required by § 803.42, on FDA form 3500A or an electronic.... This report must contain information required by § 803.42, on FDA form 3500A or an electronic...

  10. The effects of impact fees in urban form and congestion in Florida for period 4/1/2010 to 11/30/2011.

    DOT National Transportation Integrated Search

    2011-11-01

    This study analyzes the effect of impact fees in urban form and congestion through a combination of methods including econometric analysis, GIS techniques, and interviews with planning officials. The results show that there is some evidence that impa...

  11. 13 CFR 107.300 - License application form and fee.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false License application form and fee. 107.300 Section 107.300 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Qualifying for an SBIC License Applying for An Sbic License § 107.300 License...

  12. Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

    PubMed

    Javitt, Gail H; Hudson, Kathy

    2003-01-01

    The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

  13. 77 FR 42554 - Agency Information Collection (Application for Fee or Personnel Designation) Activity Under OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... (Application for Fee or Personnel Designation) Activity Under OMB Review AGENCY: Veterans Benefits...: Application for Fee or Personnel Designation, VA Form 26- 6681. OMB Control Number: 2900-0113. Type of Review... the applicant's experience in the real estate valuation field. An agency may not conduct or sponsor...

  14. 76 FR 26750 - Agency Information Collection Activities: New Information Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-09

    ... collection under review: Visa Processing Fee Payment; OMB control No. 1615-New. The Department of Homeland... . When submitting comments by e-mail please make sure to add Visa Processing Fee Payment in the subject...: Visa Processing Fee Payment. (3) Agency form number, if any, and the applicable component of the...

  15. 31 CFR 25.401 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Fees. 25.401 Section 25.401 Money and Finance: Treasury Office of the Secretary of the Treasury PREPAYMENT OF FOREIGN MILITARY SALES LOANS MADE... FINANCING BANK AND GUARANTEED BY THE DEFENSE SECURITY ASSISTANCE AGENCY Form of Private Loan § 25.401 Fees...

  16. Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

    PubMed

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

    2016-04-01

    Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

  17. 76 FR 42684 - Statutory Invention Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... 3.00 Totals 8 10.00 There is annual (non-hour) cost burden in the way of filing fees associated with...) Filing fee $ cost burden (a) (b) (a x b) (c) Statutory Invention Registration (Requested prior to 2 $920...) respondent cost burden for this collection in the form of postage costs and filing fees will be $8,170. IV...

  18. 76 FR 18399 - Changes To Implement the Prioritized Examination Track (Track I) of the Enhanced Examination...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-04

    ... questioned whether the processing fee was required only if early publication was requested. Response: Both... fee for requesting early publication. Comment 5: A few comments indicated that the fee for prioritized... applicant being unable to amend the claims to place them in independent form after a final rejection where...

  19. 78 FR 2465 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-11

    ..., fingerprint card and a combined payment of fees to FINRA. Through the CRD system, FINRA maintains the... applicability of the fee to Form BD processing. Increasing the manual fingerprint processing fee from $13 to $30... each set of fingerprint results and identifying information that have been processed through another...

  20. 78 FR 3947 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ..., fingerprint card and a combined payment of fees to FINRA. Through the CRD system, FINRA maintains the... applicability of the fee to Form BD processing. Increasing the manual fingerprint processing fee from $13 to $30... each set of fingerprint results and identifying information that have been processed through another...

  1. Polyimides Derived from Novel Asymmetric Dianhydrides

    NASA Technical Reports Server (NTRS)

    Chuang, Chun-Hua (Inventor)

    2012-01-01

    This invention relates to the compositions and processes for preparing thermoset and thermoplastic polyimides derived from novel asymmetrical dianhydrides: specifically 2,3,3',4' benzophenone dianhydride (a-BTDA), and 3,4'-(hexafluoroisopropylidene)diphthalic anhydride (a-6FDA). The a-BTDA anhydride is prepared by Suzuki coupling with catalysts from a mixed anhydride of 3,4-dimethylbenzoic acid or 2,3-dimethylbenzoic acid with 2,3-dimethylphenylboronic acid or 3,4-dimethylphenylboronic acid respectively, to form 2,3,3',4'-tetramethylbenzophenone which is oxidized to form 2,3,3',4'-benzophenonetetracarboxylic acid followed by cyclodehydration to obtain a-BTDA. The a-6FDA is prepared by nucleophilic triflouoromethylation of 2,3,3',4'-tetramethylbenzophenone with trifluoromethyltrimethylsilane to form 3,4'-(trifluoromethylmethanol)-bis(o-xylene) which is converted to 3,4'-(hexafluoroisopropylidene-bis(o-xylene). The 3,4'-(hexafluoroisopropylidene)-bis(o-xylene) is oxidized to the corresponding tetraacid followed by cyclodehydration to yield a-6FDA.

  2. New technology in electrophysiology: FDA process and perspective.

    PubMed

    Selzman, Kimberly A; Fellman, Mark; Farb, Andrew; de Del Castillo, Sergio; Zuckerman, Bram

    2016-10-01

    The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

  3. 37 CFR 2.207 - Methods of payment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process the charge... fees to a credit card. If credit card information is provided on a form or document other than a form...

  4. Search Science Adventures at Fermilab

    Science.gov Websites

    fossils from the Field Museum. Create your own prehistoric landscape. Learn about the new finds in Information Form and bring it to class the first day. Fee: $225/person Session 1: June 25-29, 2018, 9:00 AM a Participant Information Form and bring it to class the first day. Fee: $225/person Session 1: June

  5. Search Science Adventures at Fermilab

    Science.gov Websites

    and learn with real fossils from the Field Museum. Create your own prehistoric landscape. Learn about a Participant Information Form and bring it to class the first day. Fee: $225/person Session 1: June . You must also fill out a Participant Information Form and bring it to class the first day. Fee: $225

  6. 37 CFR 2.207 - Methods of payment.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process the charge... fees to a credit card. If credit card information is provided on a form or document other than a form...

  7. 37 CFR 2.207 - Methods of payment.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process the charge... fees to a credit card. If credit card information is provided on a form or document other than a form...

  8. 37 CFR 2.207 - Methods of payment.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process the charge... fees to a credit card. If credit card information is provided on a form or document other than a form...

  9. 21 CFR 720.3 - How and where to file.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.3 How and where to file. Forms FDA 2512 and FDA 2514 (“Discontinuance of Commercial Distribution of Cosmetic Product Formulation...

  10. 78 FR 2470 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-11

    ... to do so by submitting a single form, fingerprint card and a combined payment of fees to FINRA... the manual fingerprint processing fee from $13 to $30.\\10\\ \\10\\ See Section (4)(b)(6) of Schedule A to... fee would be ``processing and posting to the CRD system each set of fingerprint results and...

  11. 21 CFR 720.3 - How and where to file.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.3 How and where to file. Forms FDA 2512 and FDA 2514 (“Discontinuance of Commercial Distribution of Cosmetic Product Formulation...

  12. 21 CFR 720.3 - How and where to file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.3 How and where to file. Forms FDA 2512 and FDA 2514 (“Discontinuance of Commercial Distribution of Cosmetic Product Formulation...

  13. 21 CFR 720.3 - How and where to file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.3 How and where to file. Forms FDA 2512 and FDA 2514 (“Discontinuance of Commercial Distribution of Cosmetic Product Formulation...

  14. 21 CFR 720.3 - How and where to file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.3 How and where to file. Forms FDA 2512 and FDA 2514 (“Discontinuance of Commercial Distribution of Cosmetic Product Formulation...

  15. Generic Pharmaceutical Association (GPhA) - 2015 CMC Workshop (June 9-10, 2015 - Bethesda, Maryland, USA).

    PubMed

    Komlos, D

    2015-07-01

    Nearly 400 professionals attended the 2-day Generic Pharmaceutical Association (GPhA) workshop dedicated to fostering discussions on the FDA's chemistry, manufacturing and controls (CMC) expectations for abbreviated new drug applications (ANDAs), enhanced regulatory filing requirements, and other topics, as CMC takes root in the Office of Pharmaceutical Quality (OPQ). Following the keynote address by Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research (CDER) and Acting Director of OPQ, and an update from the Office of Generic Drugs (OGD) by Ted Sherwood, Acting Director of the OGD's Office of Regulatory Operations, plenary sessions took place covering OPQ updates, management plans, Generic Drug User Fee Amendments of 2012 (GDUFA) backlog, year 1 and 2 cohorts, drug substance, defining starting materials, quality related refuse-to-receive standards, risk and team-based integrated quality assessment, deficiencies and information requests - CMC submissions, emerging technologies, compliance and inspection, lifecycle management of drug products, quality metrics, pharmaceutically relevant dissolution specifications, and communication and project management. This report will provide a summary of conference highlights. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  16. Fundamental Aspects of the Financing of Information Centres

    ERIC Educational Resources Information Center

    Schwuchow, Werner

    1973-01-01

    Five aspects of financing information centers are discussed: source of funds (public or private), profit-making ability, tax revenues versus fee sources, fee calculation, and forms of tariff structures. (4 references) (SJ)

  17. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

    PubMed

    Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B

    2016-07-01

    The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.

  18. 21 CFR 207.25 - Information required in registration and drug listing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...

  19. 21 CFR 207.25 - Information required in registration and drug listing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...

  20. 21 CFR 207.25 - Information required in registration and drug listing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...

  1. 21 CFR 207.25 - Information required in registration and drug listing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...

  2. 21 CFR 207.25 - Information required in registration and drug listing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-2657 or in conjunction with the FDA voluntary inventory on Form FDA-2422 (Survey Report of Marketed... blood bank, a quantitative listing of the active ingredient(s). Unless the quantitative listing is...)(iii), the registrant may limit the quantitative listing of ingredients to each variation of level of...

  3. 75 FR 9576 - Civil Nuclear Policy Mission to Central and Eastern Europe

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-03

    .... civil nuclear industry. Increasing energy demands, dependence on Russian fossil fuels, and a small but... form of a participation fee is required. The participation fee, which will cover one representative...

  4. 18 CFR 250.6 - Form of application to be filed by distributor under section 7(a), seeking gas service of not...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73... lines, legal fees, financing fees and engineering fees, and briefly state how the estimates were derived...

  5. 18 CFR 250.6 - Form of application to be filed by distributor under section 7(a), seeking gas service of not...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73... lines, legal fees, financing fees and engineering fees, and briefly state how the estimates were derived...

  6. 18 CFR 250.6 - Form of application to be filed by distributor under section 7(a), seeking gas service of not...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73... lines, legal fees, financing fees and engineering fees, and briefly state how the estimates were derived...

  7. 18 CFR 250.6 - Form of application to be filed by distributor under section 7(a), seeking gas service of not...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73... lines, legal fees, financing fees and engineering fees, and briefly state how the estimates were derived...

  8. 18 CFR 250.6 - Form of application to be filed by distributor under section 7(a), seeking gas service of not...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73..., commercial and industrial customers for each of the first three years of proposed operations (Mcf at 14.73... lines, legal fees, financing fees and engineering fees, and briefly state how the estimates were derived...

  9. The advantages of cost plus award fee contracts

    NASA Technical Reports Server (NTRS)

    Keathley, William C.

    1994-01-01

    A Cost Plus Award Fee contract is the best procurement vehicle for the high-tech, one-of-a-kind, development projects that constitute most of NASA'S projects. The use of this type of contract requires more government and contractor effort than any other forms of contracts. An award fee contract is described as an arrangement whereby the government periodically awards a fee consistent with the cost, schedule and technical performance that is achieved by a contractor during a preset period with preset award fee pools. It's the only contracting method where both the government and contractor goals are closely linked. It also has a built-in mechanism to conveniently alter and emphasize program events in order to current external and internal situations. The award fee process also demands good communication between government and contractor participants.

  10. 37 CFR 201.15 - Special handling of pending claims requiring expedited processing for purposes of litigation.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... that the applicant is about to file suit for infringement of the copyright in a work that is the subject of the application. (d) Form of request for Special Handling and for waiver of fee. A request for Special Handling and for a waiver of the Special Handling fee must be submitted in the form of an...

  11. 36 CFR 51.5 - What information will the prospectus include?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., include, but are not limited to the following: (1) The minimum acceptable franchise fee or other forms of... out by department for the three most recent years; franchise fees charged under the current concession...

  12. 36 CFR 51.5 - What information will the prospectus include?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., include, but are not limited to the following: (1) The minimum acceptable franchise fee or other forms of... out by department for the three most recent years; franchise fees charged under the current concession...

  13. 36 CFR 51.5 - What information will the prospectus include?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., include, but are not limited to the following: (1) The minimum acceptable franchise fee or other forms of... out by department for the three most recent years; franchise fees charged under the current concession...

  14. 36 CFR 51.5 - What information will the prospectus include?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., include, but are not limited to the following: (1) The minimum acceptable franchise fee or other forms of... out by department for the three most recent years; franchise fees charged under the current concession...

  15. 36 CFR 51.5 - What information will the prospectus include?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., include, but are not limited to the following: (1) The minimum acceptable franchise fee or other forms of... out by department for the three most recent years; franchise fees charged under the current concession...

  16. Antiperspirant drug products for over-the-counter human use; final monograph. Final rule.

    PubMed

    2003-06-09

    The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention.

  17. 77 FR 9608 - American Chemistry Council; Filing of Food Additive Petition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... abandoned. PC resins are formed by the condensation of 4,4'-isopropylenediphenol (i.e., Bisphenol A (BPA...'- isopropylenediphenol (i.e., BPA), and carbonyl chloride or diphenyl carbonate. II. Abandonment Under section 409(i) of.... Separate from FDA's consideration of this petition, FDA is actively assessing the safety of BPA (see 75 FR...

  18. 78 FR 68705 - Premerger Notification; Reporting and Waiting Period Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ....\\6\\ An exclusive license is substantively the same as buying the patent or part of the patent... through the FDA approval process, nor to effectively market or promote it in drug form after FDA approval... promotion of the drug. There is a great deal of uncertainty involved because the transfer takes place very...

  19. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the coding manual from CDRH's Web site at http://www.fda.gov/cdrh/mdr/mdr-forms.html; and from the... Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 240-276-3151, or e-mail to [email protected]CDRH.FDA.GOV...

  20. 76 FR 17989 - Proposed Collection; Comment Request for Form 8951

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-31

    ... proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995... 8951, Compliance Fee for Employee Plans Voluntary Correction Program Submission. DATES: [email protected] . SUPPLEMENTARY INFORMATION: Title: Compliance Fee for Employee Plans Voluntary Correction...

  1. 77 FR 14018 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31) into law. The... 3734 for Cigarette Flavor Ban Violations. This new form will be posted on FDA's Web site, and... similar type of reporting went into effect for the cigarette flavor ban, FDA has received several reports...

  2. 78 FR 35273 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ..., to FDA for approval to market a product in interstate commerce. The container and package labeling... be in electronic format and in a form that FDA can process, review, and archive. This requirement is... 356h ``Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize...

  3. Center for Cancer Research plays key role in first FDA-approved drug for treatment of Merkel cell carcinoma | Center for Cancer Research

    Cancer.gov

    The Center for Cancer Research’s ability to rapidly deploy integrated basic and clinical research teams at a single site facilitated the rapid FDA approval of the immunotherapy drug avelumab for metastatic Merkel cell carcinoma, a rare, aggressive form of skin cancer. Learn more...  

  4. Some Sleep Drugs Can Impair Driving

    MedlinePlus

    ... prescribed sleep medications. Some sleep drugs contain an extended-release form of zolpidem that stays in the ... the regular form. FDA is particularly concerned about extended-release forms of zolpidem. They are sold as ...

  5. 76 FR 37660 - Amendment of the Schedule of Application Fees Set Forth In Sections 1.1102 Through 1.1109 of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    .... This clarification is intended to rectify a possible inconsistency throughout the Commission's rules... fee need not accompany a high bidder's long-form application, on the other. To rectify this...

  6. Blueprint for prescriber continuing education program.

    PubMed

    2012-06-01

    On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.

  7. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... instrument and cover mass media, common carrier, international, and cable service fee payments. Each... Section 1.1158 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Schedule.... dollars and drawn on a United States financial institution and made payable to the Federal Communications...

  8. 78 FR 64220 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0804... Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) and the... sheet form, assists respondents in categorizing administrative 510(k) information for submission to FDA...

  9. 14 CFR 1206.700 - Schedule of fees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... photographs, blueprints, videotapes, engineering drawings, hard copies of aperture cards, etc., the fee...) Records will be provided in a form or format specified by the requester if they are readily reproducible in such format with reasonable efforts. If the records are not readily reproducible in the requested...

  10. 8 CFR 1003.8 - Fees before the Board.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....8 Aliens and Nationality EXECUTIVE OFFICE FOR IMMIGRATION REVIEW, DEPARTMENT OF JUSTICE GENERAL PROVISIONS EXECUTIVE OFFICE FOR IMMIGRATION REVIEW Board of Immigration Appeals § 1003.8 Fees before the... form authorized by the Executive Office for Immigration Review. When paid by check or money order, the...

  11. Prevalence and cost of insomnia in a state Medicaid fee-for-service population based on diagnostic codes and prescription utilization.

    PubMed

    Roy, Anuja N; Smith, Michael

    2010-05-01

    The aims of this research were to estimate prevalence of insomnia, describe the utilization patterns of physician office services and prescription medications for insomnia, and estimate related costs in a Medicaid population. A cross-sectional descriptive analysis using data from the West Virginia (WV) Medicaid fee-for-service paid claims records for the year 2003 was conducted. Recipients with a diagnosis related to insomnia or a prescription claim for an FDA-approved drug for insomnia or trazodone were selected as the study sample. Costs were from the perspective of WV Medicaid. The overall prevalence of insomnia was 74.3 per 1000 recipients. Adults 45-64years of age, females, and whites had the highest prevalence and office visit rates for insomnia among demographic groups. A majority of dollars spent on insomnia treatment was for prescription drugs. Zolpidem and trazodone accounted for 88% of prescription claims; however, 84% of the total dollars paid for prescriptions was for zolpidem. Among the WV Medicaid population, rates of insomnia and office visit use for insomnia varied by demographic groups. There was greater use of zolpidem and trazodone than benzodiazepine drugs. This study provides baseline estimates that can be used for ongoing surveillance of insomnia. Copyright 2010 Elsevier B.V. All rights reserved.

  12. 76 FR 62100 - Approval of Filing Fees for Exempt Reporting Advisers and Private Fund Advisers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... fund assets, combined liquidity fund and registered money market fund assets or private equity fund... Fees for Exempt Reporting Advisers and Private Fund Advisers AGENCY: Securities and Exchange Commission... fund advisers filing Form PF. SUMMARY: The Securities and Exchange Commission (``Commission'') is...

  13. 48 CFR 52.203-5 - Covenant Against Contingent Fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... REGULATION (CONTINUED) CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and... employed or retained to solicit or obtain this contract upon an agreement or understanding for a contingent fee, except a bona fide employee or agency. For breach or violation of this warranty, the Government...

  14. 32 CFR 1662.6 - Fee schedule; waiver of fees.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... as costs of space, and heating or lighting the facility in which the records are stored. (2) The term... copies may take the form of paper copy, microform, audio-visual materials, or machine readable... institution of vocational education, which operates a program or programs of scholarly research. (7) The term...

  15. 32 CFR 1662.6 - Fee schedule; waiver of fees.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... as costs of space, and heating or lighting the facility in which the records are stored. (2) The term... copies may take the form of paper copy, microform, audio-visual materials, or machine readable... institution of vocational education, which operates a program or programs of scholarly research. (7) The term...

  16. 76 FR 59424 - Notice of Proposed Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... request for the Abandoned Mine Reclamation Fund--Fee Collection and Coal Production Reporting and the form... cost. DATES: OMB has up to 60 days to approve or disapprove the information collections but may respond... 30 CFR 870--Abandoned Mine Reclamation Fund--Fee Collection and Coal Production Reporting and the...

  17. Coming Soon to a Pharmacy Near You.

    PubMed

    Dubois, Wil

    2016-01-01

    Recent FDA approvals introduce both cheaper insulin in the form of a biosimilar and lipid-lowering agents with prices that rival the cost of cancer drugs. They also give us brand new ways to lower blood glucose and repair the damage done when glucose control fails. Hundreds more are in the pipeline, of which one or two per year will win marketing approval from the FDA.

  18. 78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    .... FDA-2012-N-0677] Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant AGENCY: Food...) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III... proposing to revise the classification of blade-form endosseous dental implants. DATES: Submit either...

  19. 8 CFR 103.7 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., remittance may be made by bank international money order or foreign draft drawn on a financial institution in... petition for school certification—$1,700, plus a site visit fee of $655 for each location listed on the..., mutilated, or destroyed, or for a change in name—$290. Form I-94.For issuance of Arrival/Departure Record at...

  20. 77 FR 3844 - Agency Information Collection (Architect-Engineer Fee Proposal) Activity Under OMB Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... (Architect--Engineer Fee Proposal) Activity Under OMB Review AGENCY: Veterans Health Administration...) of 1995 (44 U.S.C. 3501-21), this notice announces that the Veterans Health Administration... the scope and complexity of the project. VA Form 10-6298 is used to obtain such proposal and...

  1. 37 CFR 1.23 - Methods of payment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... made by credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process... authorization to charge fees to a credit card. If credit card information is provided on a form or document...

  2. 77 FR 49426 - Notice of Inquiry Regarding Adjustment of Fees for Trademark Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... by reducing the TEAS Plus filing fee and by providing a discount on applications filed using the regular TEAS application form, if the applicant authorizes email communication and agrees to file all... for filing by a paper application; $325 per class for filing electronically using TEAS; $275 per class...

  3. 37 CFR 7.11 - Requirements for international application originating from the United States.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... international application That is either filed through TEAS, or typed on the official paper form issued by the... through TEAS, the international application fees for all classes, and the fees for all designated... international application is filed through TEAS, an e-mail address for receipt of correspondence from the Office...

  4. 37 CFR 1.23 - Methods of payment.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... made by credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process... authorization to charge fees to a credit card. If credit card information is provided on a form or document...

  5. 37 CFR 1.23 - Methods of payment.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... made by credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process... authorization to charge fees to a credit card. If credit card information is provided on a form or document...

  6. 37 CFR 1.23 - Methods of payment.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... made by credit card, except for replenishing a deposit account. Payment of a fee by credit card must specify the amount to be charged to the credit card and such other information as is necessary to process... authorization to charge fees to a credit card. If credit card information is provided on a form or document...

  7. 24 CFR 954.300 - Eligible activities.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... is held in fee-simple title, land-trust, or long-term ground lease with a term at least equal to that... manufactured housing unit does not hold fee-simple title to the land on which the unit is located, the owner... purchase. (b) Forms of assistance. A grantee may invest HOME funds as equity investments, interest-bearing...

  8. 22 CFR 42.67 - Execution of application, registration, and fingerprinting.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Application for Immigrant Visas § 42.67...) Application fee. A fee is prescribed for each application for an immigrant visa. It shall be collected prior... applicant shall be required to read the Form DS-230, Application for Immigrant Visa and Alien Registration...

  9. 76 FR 29158 - Amendment of the Schedule of Application Fees Set

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ... filings in the wireless telecommunications services. Those services designated with an asterisk in the... Commission, Wireless Bureau Applications, P.O. Box 979097, St. Louis, MO 63197-9000. Service FCC Form No. Fee... 120.00 PBMM d. Transfer of Control 603 & 159 60.00 PATM Spectrum Leasing for Public 608 & 159 60.00...

  10. 37 CFR 7.11 - Requirements for international application originating from the United States.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... international application That is either filed through TEAS, or typed on the official paper form issued by the... through TEAS, the international application fees for all classes, and the fees for all designated... international application is filed through TEAS, an e-mail address for receipt of correspondence from the Office...

  11. 18 CFR 1310.3 - Assessment of administrative charge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... rights-of-way—$100-$1,500. (5) Quota deer hunt or turkey hunt applications—$5-$25. (b) Basis of charge... deer hunt and turkey hunt application fees. A fee for each person in the amount prescribed by the responsible land manager must accompany the complete application form for a quota deer hunt and turkey hunt...

  12. 18 CFR 1310.3 - Assessment of administrative charge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... rights-of-way—$100-$1,500. (5) Quota deer hunt or turkey hunt applications—$5-$25. (b) Basis of charge... deer hunt and turkey hunt application fees. A fee for each person in the amount prescribed by the responsible land manager must accompany the complete application form for a quota deer hunt and turkey hunt...

  13. 18 CFR 1310.3 - Assessment of administrative charge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... rights-of-way—$100-$1,500. (5) Quota deer hunt or turkey hunt applications—$5-$25. (b) Basis of charge... deer hunt and turkey hunt application fees. A fee for each person in the amount prescribed by the responsible land manager must accompany the complete application form for a quota deer hunt and turkey hunt...

  14. 18 CFR 1310.3 - Assessment of administrative charge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... rights-of-way—$100-$1,500. (5) Quota deer hunt or turkey hunt applications—$5-$25. (b) Basis of charge... deer hunt and turkey hunt application fees. A fee for each person in the amount prescribed by the responsible land manager must accompany the complete application form for a quota deer hunt and turkey hunt...

  15. 18 CFR 1310.3 - Assessment of administrative charge.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... rights-of-way—$100-$1,500. (5) Quota deer hunt or turkey hunt applications—$5-$25. (b) Basis of charge... deer hunt and turkey hunt application fees. A fee for each person in the amount prescribed by the responsible land manager must accompany the complete application form for a quota deer hunt and turkey hunt...

  16. 77 FR 50521 - Agency Information Collection Activities: Request for an Individual Fee Waiver, Form Number I-912...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615... Security, U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information... Immigration Services (USCIS) to make a determination that the applicant is unable to pay the application fee...

  17. Additives In Meat and Poultry Products

    MedlinePlus

    ... Forms Standard Forms FSIS United States Department of Agriculture Food Safety and Inspection Service About FSIS District ... Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) shares responsibility with FDA for the safety ...

  18. Migration Amendment Act 1987 (No. 133 of 1987), 16 December 1987.

    PubMed

    1988-01-01

    This Act does the following, among other things: 1) requires that certain requests relating to entry permits, visas, and return endorsements are not considered to have been made unless in writing in accordance with the relevant approved forms and unless any fee payable has been made; 2) makes "operators," as well as charterers, liable for the carriage of persons to Australia without documentation; and 3) provides that international air operators shall pay immigration clearance fees payable by passengers whether or not the operator has collected the fees from the passengers. full text

  19. Evaluating the effect of a proposed logistics fee cap on pharmaceuticals in South Africa--a pre and post analysis.

    PubMed

    Bangalee, Varsha; Suleman, Fatima

    2015-11-26

    South Africa has proposed the implementation of a maximum logistics fee paid by pharmaceutical manufacturers to wholesalers and distributors. However very little knowledge exists of the effects, unintended or otherwise, of the implementation of these proposed regulations, which are required to guide further policy development and implementation. The objectives of this study was to therefore evaluate the effects of the proposed logistics fee cap on different pharmaceuticals and different dosage forms, as well as to observe the logistics fee contribution to the Single Exit Price. Private sector medicine prices were sourced from the South African Medicine Price Registry as at 20 December 2013. For each medicine the maximum logistics fee was calculated based on the 2012 proposed government guidelines. The logistics fee as a percentage of the final Single Exit Price was calculated, as part of the analysis of results. Out of the 47 medicines in the overall sample from the current study, only 16 medicines showed a decrease in the Single Exit Price with the application of the maximum logistics fee cap. This study reveals the need for greater transparency of the mark ups along the distribution chain as well as further research with regards to the costing of logistics fees of similar pharmaceuticals.

  20. Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration

    PubMed Central

    Sullivan, Helen W.; Aikin, Kathryn J.; Chung-Davies, Eunice; Wade, Michael

    2016-01-01

    The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources. PMID:27149513

  1. America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

    PubMed

    Card, Melissa M

    2013-01-01

    R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

  2. 77 FR 64768 - International Mailing Services: Proposed Product and Price Changes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-23

    ... flexibility for mailers who pay for postage with a permit imprint, to now pay the fee using the same permit imprint account. Previously, the only option to pay the fee was for mailers to apply ordinary stamps, meter imprints, or PC Postage[supreg] imprints to PS Form 3877, Firm Mailing Book for Accountable Mail...

  3. 76 FR 67004 - Order Approving Filing Fees for Exempt Reporting Advisers and Private Fund Advisers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-28

    ... billion or more in hedge fund assets, combined liquidity fund and registered money market fund assets or...] Order Approving Filing Fees for Exempt Reporting Advisers and Private Fund Advisers Section 204(c) of... funds (a ``private fund adviser'') to file proposed Form PF on a periodic basis.\\2\\ On September 30...

  4. Supreme Court to Hear Case on Union Fees

    ERIC Educational Resources Information Center

    Honawar, Vaishali

    2006-01-01

    The U.S. Supreme Court agreed last September 2006 to take up the issue of when a teachers' union may spend the money it collects in the form of "agency fees" from nonmembers on political causes. The justices said they would review a Washington state law that requires nonmembers to "affirmatively consent," or opt in, before a…

  5. 20 CFR 30.505 - What procedures will OWCP follow before it pays any compensation?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... covered Part B employee's or a covered Part E employee's claim for damage to real or personal property... operation like filing fees, travel expenses, witness fees, and court reporter costs for transcripts.... Failure to sign and return the form within the required time may be deemed to be a rejection of the...

  6. 78 FR 2473 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-11

    ..., fingerprint card and a combined payment of fees to FINRA. Through the CRD system, FINRA maintains the... incorporate the applicability of the fee to Form BD processing. Increasing the manual fingerprint processing... posting to the CRD system each set of fingerprint results and identifying information that have been...

  7. 12 CFR 1026.60 - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may... pursuant to paragraph (c), (d)(2), (e)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10...

  8. 12 CFR 226.5a - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may...)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10 in appendix G to this part...

  9. 12 CFR 226.5a - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may...), (d)(2), (e)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10 in appendix G to...

  10. 12 CFR 1026.60 - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may... pursuant to paragraph (c), (d)(2), (e)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10...

  11. 12 CFR 1026.60 - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may... pursuant to paragraph (c), (d)(2), (e)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10...

  12. 12 CFR 226.5a - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may...), (d)(2), (e)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10 in appendix G to...

  13. 12 CFR 226.5a - Credit and charge card applications and solicitations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... states in the table. (2) Fees for issuance or availability. (i) Any annual or other periodic fee that may...)(1) or (f) of this section generally shall be in the form of a table with headings, content, and format substantially similar to any of the applicable tables found in G-10 in appendix G to this part...

  14. 78 FR 13695 - Information Collection: Renewable Energy and Alternate Uses of Existing Facilities on the Outer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... activities, facilities, safety equipment, inspections and tests, and natural and manmade hazards near the... one line on BOEM-0005 to match language on a similar form for the oil and gas program; this does not.... 111 Within 30 days of .5 4 fee submissions. 2 receiving bill, submit processing fee payments for BOEM...

  15. 40 CFR 1027.130 - How do I make a fee payment?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... method available for payment online at www.Pay.gov., or as specified in EPA guidance. (b) Send a... www.Pay.gov., or as provided in EPA guidance. These forms are available on the Internet at http://www.epa.gov/otaq/guidance.htm. (c) You must pay the fee amount due before we will start to process an...

  16. 40 CFR 1027.130 - How do I make a fee payment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... method available for payment online at www.Pay.gov., or as specified in EPA guidance. (b) Send a... www.Pay.gov., or as provided in EPA guidance. These forms are available on the Internet at http://www.epa.gov/otaq/guidance.htm. (c) You must pay the fee amount due before we will start to process an...

  17. 78 FR 1892 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-09

    ...-regulatory organizations (``SRO'') to do so by submitting a single form, fingerprint card and a combined.... 78c(a)(39). FINRA currently collects a fee of $27.50 to process the first and third fingerprint submission by a member, either electronically or via a hard copy fingerprint card. And the fee is $13.00 for...

  18. 75 FR 6781 - Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-10

    ... dues, fees and other charges among its members. Among other things, the change to the fee schedule... the Commission's Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or Send an e-mail to... all comments on the Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml ). Copies of...

  19. 75 FR 6766 - Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-10

    ... dues, fees and other charges among its members. Among other things, the change to the fee schedule... Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or Send an e-mail to [email protected] Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml ). Copies of the submission, all...

  20. Establishment of revisit user fee program for Medicare survey and certification activities. Final rule.

    PubMed

    2007-09-19

    This final rule will establish a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification, or substantiated complaint surveys and require a revisit to confirm that corrections to previously-identified deficiencies have been remedied. Consistent with the President's long-term goal to promote quality of health care and to cut the deficit in half by fiscal year (FY) 2009, the FY 2007 Department of Health and Human Services' (HHS) budget request included both new mandatory savings proposals and a requirement that user fees be applied to health care providers that have failed to comply with Federal quality of care requirements. The "Revisit User Fees" will affect only those providers or suppliers for which a revisit is required to confirm that previously-identified failures to meet federal quality of care requirements have been remedied. The fees are estimated at $37.3 million annually and will recover the costs associated with the Medicare Survey and Certification program's revisit surveys. The fees will take effect on the date of publication of the final rule and will be in effect until the date that the continued authority provided by Congress expires. At the time of publication of this regulation the applicable date is September 30, 2007. If no legislation is enacted, the fees are not retroactive to the beginning of the fiscal year. Any provider or supplier that has a revisit survey conducted on or after the date of publication will be assessed a revisit user fee and will be notified of the assessment upon data system reconciliation which can occur following the closing of the fiscal year. The fees will be available to CMS until expended. The revisit user fee is included in the President's proposed FY 2008 budget. We note through the publication of this final rule that if authority for the revisit user fee is continued, we will use the current fee schedule in this rule for the assessment of such fees until such time as a new fee schedule notice is proposed and published in final form.

  1. Investigating Non-Invasive Hemodynamic Monitoring Devices Using Severe Dengue as a Surrogate for Trauma-Induced Shock

    DTIC Science & Technology

    2014-12-01

    dengue hemorrhagic fever. In future work we will continue to evaluate the use of pulse wave forms to predict shock and will assess other...Index Three laboratory Phase I clinical trials have been completed to support a 510(k) application for FDA approval of the first prototype Pulse ... Oximeter with the CRI algorithm and capability for real-time continuous collection of photoplethymographic (PPG) analog signals. An FDA-cleared

  2. Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.

    PubMed

    Hukkanen, Renee R; Halpern, Wendy G; Vidal, Justin D

    2016-10-01

    In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents. © The Author(s) 2016.

  3. Characteristics of FDA drug recalls: A 30-month analysis.

    PubMed

    Hall, Kelsey; Stewart, Tyler; Chang, Jongwha; Freeman, Maisha Kelly

    2016-02-15

    The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed. All FDA-issued recalls for drugs (prescription and nonprescription, including dietary supplements) and biological products issued from June 20, 2012, to December 31, 2014, were included in this retrospective analysis. Data for all drug recalls were downloaded and sorted by the inclusion criteria from weekly FDA enforcement reports. The following data were analyzed: product type, recall firm, type of recall firm (compounding or noncompounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription or nonprescription), reason for recall, recall initiation date, and recall report date. A total of 21,120 products were recalled during the 30-month study period. Of these, 3,045 drug products (14.4%) met the inclusion criteria and were analyzed. A total of 348 total manufacturers were associated with recalled drug products. The 5 firms most frequently involved in recalls accounted for 299, 273, 212, 118, and 112 recalls. The most common reasons for recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. There was a significant association between FDA recall classification and the following outcomes: reasons for recall, product availability, type of recall firm, and form of communication. An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  4. In My Own Time: Tuition Fees, Class Time and Student Effort in Non-Formal (Or Continuing) Education

    ERIC Educational Resources Information Center

    Bolli, Thomas; Johnes, Geraint

    2015-01-01

    We develop and empirically test a model which examines the impact of changes in class time and tuition fees on student effort in the form of private study. The data come from the European Union's Adult Education Survey, conducted over the period 2005-2008. We find, in line with theoretical predictions, that the time students devote to private…

  5. The Decision-Making and Changing Behavioural Dynamics of Potential Higher Education Students: The Impacts of Increasing Tuition Fees in England

    ERIC Educational Resources Information Center

    Wilkins, Stephen; Shams, Farshid; Huisman, Jeroen

    2013-01-01

    Recent changes in the English tuition fee policies have spurred a debate on the impacts on student choices for higher education. Expectations range from a sharp decrease in participation in higher education to relatively little change in student demand. We surveyed 1549 year 12 sixth-form students from four institutions spread geographically…

  6. Value-based formulas for purchasing. PEHP's designated service provider program: value-based purchasing through global fees.

    PubMed

    Emery, D W

    1997-01-01

    In many circles, managed care and capitation have become synonymous; unfortunately, the assumptions informing capitation are based on a flawed unidimensional model of risk. PEHP of Utah has rejected the unidimensional model and has therefore embraced a multidimensional model of risk that suggests that global fees are the optimal purchasing modality. A globally priced episode of care forms a natural unit of analysis that enhances purchasing clarity, allows providers to more efficiently focus on the Marginal Rate of Technical Substitution, and conforms to the multidimensional reality of risk. Most importantly, global fees simultaneously maximize patient choice and provider cost consciousness.

  7. Food and Drug Administration: Helping pharmacists ensure that patients receive high-quality medicines.

    PubMed

    Kremzner, Mary

    2016-01-01

    Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ). This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight. With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems. Published by Elsevier Inc.

  8. A newly introduced comprehensive consultation fee in the national health insurance system in Japan: a promotive effect of multidisciplinary medical care in the field of radiation oncology--results from a questionnaire survey.

    PubMed

    Igaki, Hiroshi; Onishi, Hiroshi; Nakagawa, Keiichi; Dokiya, Takushi; Nemoto, Kenji; Shigematsu, Naoyuki; Nishimura, Yasumasa; Hiraoka, Masahiro

    2013-12-01

    The consultation fee for outpatient radiotherapy was newly introduced in the national health insurance system in Japan in April 2012. We conducted a survey on the use of this consultation fee and its effect on clinical practices. The health insurance committee of the Japanese Society of Therapeutic Radiology and Oncology conducted a questionnaire survey. The questionnaire form was mailed to 160 councilors of the Society, the target questionees. A total of 94 answers (58% of the target questionees) sent back were used for analyses. The analyses revealed that 75% of the hospitals charged most of the patients who receive radiotherapy in an outpatient setting a consultation fee. The introduction of the consultation fee led to some changes in radiation oncology clinics, as evidenced by the response of 'more careful observations by medical staff' in 37% of questionees and a 12% increase in the number of full-time radiation oncology nurses. It was also shown that the vast majority (92%) of radiation oncologists expected a positive influence of the consultation fee on radiation oncology clinics in Japan. Our questionnaire survey revealed the present status of the use of a newly introduced consultation fee for outpatient radiotherapy, and the results suggested its possible effect on promoting a multidisciplinary medical care system in radiation oncology departments in Japan.

  9. Concise Review: The U.S. Food and Drug Administration and Regenerative Medicine.

    PubMed

    Witten, Celia M; McFarland, Richard D; Simek, Stephanie L

    2015-12-01

    Regenerative medicine (RM) is a popular term for a field of scientific and medical research. There is not one universally accepted definition of RM, but it is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. RM products have the potential to provide treatments for a number of unmet needs but have substantial scientific and regulatory challenges that need to be addressed for this potential to be fully realized. FDA has established formal regulatory definitions for biologics, medical devices, and combination products, as well as human cells and tissues. Regenerative medicine products regulated by FDA are classified on the basis of these definitions, and the classification forms the basis for determining the regulatory requirements to each specific product. FDA regulations are generally written to allow the agency flexibility to accommodate new scientific questions raised by novel and evolving technologies. FDA efforts to facilitate product development in this novel and promising area include working with individual sponsors, interacting with the scientific and industry communities, participating in standards development, and developing policy and guidance. Regenerative medicine is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. This article provides an overview of the efforts of the U.S. Food and Drug Administration (FDA) to facilitate product development in the field commonly known was regenerative medicine. It provides an introduction to the processes by which FDA works with individual sponsors, interacts with the scientific and industry communities, participates in standards development, and develops formal FDA policy and guidance. ©AlphaMed Press.

  10. Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

    PubMed

    Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

    The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

  11. 8 CFR 286.9 - Fee for processing applications and issuing documentation at land border Ports-of-Entry.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .../Departure Record, for admission at a land border Port-of-Entry must remit the required fee for issuance of... Card, issued by the DOS, or a passport and combined B-1/B-2 visa and non-biometric BCC (or similar stamp in a passport) issued by the DOS, who is required to be issued Form I-94, Arrival/Departure Record...

  12. 8 CFR 286.9 - Fee for processing applications and issuing documentation at land border Ports-of-Entry.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .../Departure Record, for admission at a land border Port-of-Entry must remit the required fee for issuance of... Card, issued by the DOS, or a passport and combined B-1/B-2 visa and non-biometric BCC (or similar stamp in a passport) issued by the DOS, who is required to be issued Form I-94, Arrival/Departure Record...

  13. 8 CFR 286.9 - Fee for processing applications and issuing documentation at land border Ports-of-Entry.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...), Arrival/Departure Record, for admission at a land border Port-of-Entry must remit the required fee for... Card, issued by the DOS, or a passport and combined B-1/B-2 visa and non-biometric BCC (or similar stamp in a passport) issued by the DOS, who is required to be issued Form I-94, Arrival/Departure Record...

  14. 8 CFR 286.9 - Fee for processing applications and issuing documentation at land border Ports-of-Entry.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .../Departure Record, for admission at a land border Port-of-Entry must remit the required fee for issuance of... Card, issued by the DOS, or a passport and combined B-1/B-2 visa and non-biometric BCC (or similar stamp in a passport) issued by the DOS, who is required to be issued Form I-94, Arrival/Departure Record...

  15. 8 CFR 286.9 - Fee for processing applications and issuing documentation at land border Ports-of-Entry.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .../Departure Record, for admission at a land border Port-of-Entry must remit the required fee for issuance of... Card, issued by the DOS, or a passport and combined B-1/B-2 visa and non-biometric BCC (or similar stamp in a passport) issued by the DOS, who is required to be issued Form I-94, Arrival/Departure Record...

  16. Aspartame intolerance.

    PubMed

    Garriga, M M; Metcalfe, D D

    1988-12-01

    Aspartame is a food additive marketed under the brand name Nutrasweet. Aspartame is a white, odorless, crystalline powder and consists of two amino acids, L-aspartic acid and L-phenylalanine. It is 180 times as sweet as sugar. The Food and Drug Administration (FDA) first allowed its use in dry foods in July 1981 and then approved its use in carbonated beverages in July 1983. It has subsequently been approved for use in a number of materials including multivitamins, fruit juices, stick-type confections, breath mints, and iced tea. The FDA requires the statement "phenylketonurics: contains phenylalanine" on labels of food products containing aspartame because individuals with phenylketonuria (PKU) must restrict their intake of phenylalanine. Aspartame is judged to be free of long-term cancer risks. Aspartame is not stable under certain conditions including baking and cooking, and prolonged exposure to acid conditions. In such situations it loses its sweetness. Products formed from aspartame include its component amino acids (phenylalanine and aspartic acid), methanol, and diketopiperazine (DKP). Animal studies show DKP to be nontoxic. Methanol occurs in small amounts and does not exceed that formed during consumption of many foods including fresh fruits and vegetables. FDA's Center for Food Safety and Applied Nutrition (CFSAN) monitors aspartame's safety in part through reports of adverse reactions. After aspartame was approved for use in carbonated beverages, the FDA received an increased number of reports concerning adverse reactions related to aspartame. The Centers for Disease Control (CDC) reviewed these reports, which included complaints of neurologic, gastrointestinal, andallergic reactions.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

    PubMed Central

    Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

    2017-01-01

    Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies’ transparency records and recognise exemplary companies may encourage further progress. PMID:29208616

  18. The use of Food and Drug Administration 510(k) notifications in patent litigation.

    PubMed

    Tolomeo, Deborah E

    2004-01-01

    The U.S. Food and Drug Administration (FDA) 510(k) approval process provides medical device companies with the ability to market a device after the company establishes that the device to the marketed is "substantially equivalent" to one or more predicate devices. Companies that submit 510(k) notifications should be aware, however, that a 510(k) notification is a public document that may later reappear as evidence in patent litigation. Courts have considered 510(k) notifications to be relevant evidence in determining direct and contributory infringement, patent invalidity, and patent unenforceability due to inequitable conduct before the U.S. Patent and Trademark Office (USPTO). In one case, the court held that a substantial equivalence determination by FDA constituted evidence that can be "construed as an admission of infringement." The court also has relied on a 510(k) notification to support a finding of personal liability for a corporate officer who signed the 510(k) notification to be evidence of willful and deliberate conduct, and have awarded treble damages and reasonable attorney's fees to the prevailing party. The potential for increased risk in patent litigation is important for practitioners in the medical device industry, because more than seventy-five percent of medical devices are approved for marketing through the 510(k) process. This article reviews a number of patent cases in which a court has admitted a 510(k) notification as relevant evidence, and proposes general strategies for avoiding these situations.

  19. 77 FR 26281 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ..., paper, filter, or other part of each tobacco product by brand or by quantity in each brand and subbrand... developed paper forms (Form FDA 3742-- Registration and Listing for Owners and Operators of [[Page 26283... an alternative submission tool. Both the eSubmitter application and the paper forms can be accessed...

  20. Use and Costs Under the Iowa Capitation Drug Program

    PubMed Central

    Yesalis, Charles E.; Norwood, G. Joseph; Lipson, David P.; Helling, Dennis K.; Burmeister, Leon F.; Fisher, Wayne P.

    1981-01-01

    This article evaluates changes in the use of drug services and the corresponding costs when the conventional fee-for-service system for reimbursement of pharmacists under Medicaid is replaced by a capitation system. The fee-for-service system usually covers ingredient costs plus a fixed professional dispensing fee. The capitation system provided a cash payment (which varied by aid category and season of the year) per Medicaid eligible the first of each month. We examined drug use and costs in two experimental rural counties during a 1-year preperiod in which the fee-for-service form of reimbursement was employed, as well as a 2-year postperiod in which the capitation system was used. We compared the results with use and cost patterns in two other rural counties which remained on the fee-for-service system during the same 3-year period. Drug use was similar among control and experimental counties with the exception of nursing home patients; use in this category decreased under capitation and increased under fee-for-service. Using three measures of drug cost: 1) average cost of a day's drug therapy; 2) average drug costs per recipient; and 3) average Medicaid expenditures for drug services per recipient, we observed significant savings under the capitation reimbursement system as compared to the fee-for-service system. We attributed savings under capitation to shifts in prescribing and dispensing behavior, as well as changes in use by nursing home patients. Based upon these findings, the total savings resulting from implementing capitation would be approximately 16 percent when compared to fee-for-service reimbursement. PMID:10309472

  1. 75 FR 21162 - Certain Other Dosage Form New Animal Drugs; Detomidine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-23

    .... FDA-2010-N-0002] Certain Other Dosage Form New Animal Drugs; Detomidine AGENCY: Food and Drug... NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation... prescription use of DORMOSEDAN GEL (detomidine hydrochloride) for sedation and restraint of horses. The...

  2. 76 FR 3488 - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    .... FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin... combination drug injectable solution containing oxytetracycline and flunixin meglumine in cattle. [[Page 3489... veterinary prescription use of HEXASOL (oxytetracycline and flunixin meglumine) Injection for the treatment...

  3. 21 CFR 720.2 - Times for filing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.2 Times for filing. Within 180 days after forms are made available to the industry, Form FDA 2512 should be filed for each cosmetic...

  4. 21 CFR 720.2 - Times for filing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.2 Times for filing. Within 180 days after forms are made available to the industry, Form FDA 2512 should be filed for each cosmetic...

  5. 21 CFR 720.2 - Times for filing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.2 Times for filing. Within 180 days after forms are made available to the industry, Form FDA 2512 should be filed for each cosmetic...

  6. 21 CFR 720.2 - Times for filing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.2 Times for filing. Within 180 days after forms are made available to the industry, Form FDA 2512 should be filed for each cosmetic...

  7. Free versus subsidised healthcare: options for fee exemptions, access to care for vulnerable groups and effects on the health system in Burkina Faso.

    PubMed

    Yaogo, Maurice

    2017-07-12

    The many forms of healthcare fee exemptions implemented in Burkina Faso since the 2000s have varied between total exemption (free) and cost subsidisation. This article examines both options, their contextual variations and the ways in which they affect access to healthcare for vulnerable people as well as the operation of the health system. This research is part of an interdisciplinary regional program on the elimination of user fees for health services in West Africa (Burkina Faso, Mali and Niger). A conceptual framework and a chronological review of policy interventions are used as references to summarise the results of the three qualitative studies presented. Historical reference points are used to describe the emergence of healthcare fee exemption policies in Burkina Faso and the events that influenced their adoption. The joint analysis of opinions on options for fee exemption focuses on the different types of repercussions on access to healthcare and the operation of the health system. In conjunction with the twists and turns of the gradual development of a national health policy and in response to international recommendations, healthcare fee exemptions have evolved since colonisation. The limitations of the changes introduced with cost recovery and the barriers to healthcare access for the poorest people led to the adoption of the current sectorial fee exemptions. The results provide information on the reasons for the changes that have occurred over time. The nuanced perspectives of different categories of people surveyed about fee exemption options show that, beyond the perceived effects on healthcare access and the health system, the issue is one of more equitable governance. In principle, the fee exemption measures are intended to provide improved healthcare access for vulnerable groups. In practice, the negative effects on the operation of the health system advocate for reforms to harmonise the changes to multifaceted fee exemptions and the actual needs to promote effectiveness and sustainability.

  8. 17 CFR 275.204(b)-1 - Reporting by investment advisers to private funds.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... report on Form PF is due no later than the last day on which your next update would be timely in... the filing fee. (e) Updates to Form PF. You must file an updated Form PF: (1) At least annually, no...

  9. 17 CFR 275.204(b)-1 - Reporting by investment advisers to private funds.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... report on Form PF is due no later than the last day on which your next update would be timely in... the filing fee. (e) Updates to Form PF. You must file an updated Form PF: (1) At least annually, no...

  10. 17 CFR 275.204(b)-1 - Reporting by investment advisers to private funds.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... report on Form PF is due no later than the last day on which your next update would be timely in... the filing fee. (e) Updates to Form PF. You must file an updated Form PF: (1) At least annually, no...

  11. 77 FR 41663 - Surety Bond Guarantee Program-Quick Bond Application and Agreement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-16

    ... other things, clarify the procedures for submitting application forms and paying fees, and deletes an obsolete reference to a form. DATES: This rule is effective August 15, 2012. FOR FURTHER INFORMATION... SBG Program regulations, including clarifying the procedures for submitting application forms and...

  12. Protocol: a realist review of user fee exemption policies for health services in Africa.

    PubMed

    Robert, Emilie; Ridde, Valéry; Marchal, Bruno; Fournier, Pierre

    2012-01-01

    Background Four years prior to the Millenium Development Goals (MDGs) deadline, low- and middle-income countries and international stakeholders are looking for evidence-based policies to improve access to healthcare for the most vulnerable populations. User fee exemption policies are one of the potential solutions. However, the evidence is disparate, and systematic reviews have failed to provide valuable lessons. The authors propose to produce an innovative synthesis of the available evidence on user fee exemption policies in Africa to feed the policy-making process. Methods The authors will carry out a realist review to answer the following research question: what are the outcomes of user fee exemption policies implemented in Africa? why do they produce such outcomes? and what contextual elements come into play? This type of review aims to understand how contextual elements influence the production of outcomes through the activation of specific mechanisms, in the form of context-mechanism-outcome configurations. The review will be conducted in five steps: (1) identifying with key stakeholders the mechanisms underlying user fee exemption policies to develop the analytical framework, (2) searching for and selecting primary data, (3) assessing the quality of evidence using the Mixed-Method Appraisal Tool, (4) extracting the data using the analytical framework and (5) synthesising the data in the form of context-mechanism-outcomes configurations. The output will be a middle-range theory specifying how user fee exemption policies work, for what populations and under what circumstances. Ethics and dissemination The two main target audiences are researchers who are looking for examples to implement a realist review, and policy-makers and international stakeholders looking for lessons learnt on user fee exemption. For the latter, a knowledge-sharing strategy involving local scientific and policy networks will be implemented. The study has been approved by the ethics committee of the CHUM Research Centre (CR-CHUM). It received funding from the Canadian Institutes of Health Research. The funders will not have any role in study design; collection, management, analysis, and interpretation of data; writing of the report and the decision to submit the report for publication, including who will have ultimate authority over each of these activities.

  13. Digital mammography. Why hasn't it been approved for U.S. hospitals?

    PubMed

    2000-01-01

    Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

  14. Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration.

    PubMed

    Wykoff, Charles C; Clark, W Lloyd; Nielsen, Jared S; Brill, Joel V; Greene, Laurence S; Heggen, Cherilyn L

    2018-02-01

    The introduction of anti-vascular endothelial growth factor (anti-VEGF) drugs to ophthalmology has revolutionized the treatment of neovascular age-related macular degeneration (nAMD). Despite this significant progress, gaps and challenges persist in the diagnosis of nAMD, initiation of treatment, and management of frequent intravitreal injections. Thus, nAMD remains a leading cause of blindness in the United States. To present current knowledge, evidence, and expert perspectives on anti-VEGF therapies in nAMD to support managed care professionals and providers in decision making and collaborative strategies to overcome barriers to optimize anti-VEGF treatment outcomes among nAMD patients. Three anti-VEGF therapies currently form the mainstay of treatment for nAMD, including 2 therapies approved by the FDA for treatment of nAMD (aflibercept and ranibizumab) and 1 therapy approved by the FDA for oncology indications and used off-label for treatment of nAMD (bevacizumab). In clinical trials, each of the 3 agents maintained visual acuity (VA) in approximately 90% or more of nAMD patients over 2 years. However, in long-term and real-world settings, significant gaps and challenges in diagnosis, treatment, and management pose barriers to achieving optimal outcomes for patients with nAMD. Many considerations, including individual patient characteristics, on-label versus off-label treatment, repackaging, and financial considerations, add to the complexity of nAMD decision making and management. Many factors may contribute to additional challenges leading to suboptimal long-term outcomes among nAMD patients, such as delays in diagnosis and/or treatment approval and initiation, individual patient response to different anti-VEGF therapies, lapses in physician regimentation of anti-VEGF injection and monitoring, and inadequate patient adherence to treatment and monitoring. These latter factors highlight the considerable logistical, emotional, and financial burdens of long-term, frequent intravitreal injections and the vital importance of personalized approaches to anti-VEGF treatment decision making and management for patients with nAMD. To address these challenges and reduce the number of yearly injections, studies have examined alternative dosing regimens, including extended fixed intervals, as needed, and treat-and-extend strategies in specific nAMD patient populations. New clinical evidence and insights into expert clinical practice discussed in this article can support managed care professionals in the key role they play in addressing challenges in nAMD treatment and management and optimizing patient outcomes through appropriate management of anti-VEGF treatment. PRIME Education is an independent medical education company and has been an accredited provider of continuing education for 23 years. There is no fee for this activity as it is sponsored by PRIME through an educational grant from Regeneron. All authors contributed to the writing and reviewing of the article. Wykoff reports consultancies/research grants from Alcon Laboratories, Genentech/Roche, Clearside, and Iconic Therapeutics; consultancies/honoraria, research grants, and speaker fees from Allergan and Regeneron; research grants from Allegro, Apellis, Aura, NEI, NIH, Novartis, OHR Pharmaceuticals, Ophthotech, pSivida, Roche, Santen, SciFluor, Tyrogenex; and consultancies for Alimera Sciences, Alnylam Pharmaceuticals, Bayer, DORC, ONL Therapeutics, Thrombogenics, and Valeant. Clark reports advisory board work, consultancies, research grants, and speaker fees from Genentech/Roche and Regeneron and consultancy for Bayer. Brill reports consultancies for Aries Pharma, Avella, BaroNova, Braeburn Pharmaceuticals, Cardinal Health, Endogastric Solutions, GeneNews, Halt Medical, Lumendi, Medtronic, Monteris Medical, Natera, Phosphorus, Rebiotix, Seno Medical, UCB, Vermillion, Echosens, and HAP Innovations. Brill is a shareholder in EndoChoice, GeneNews, SonarMD, and SynerZ and reports advisory board work with Nestle Health Sciences, Indivior Pharmaceuticals, Eli Lilly, Blue Earth Diagnostics, Bayer, and AstraZeneca. Nielson reports advisory board work/consultancy and research grants for Genentech/Roche; advisory board work and research grants from Regeneron; and research grants from Alcon and Ophthotech.

  15. 75 FR 9333 - Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    .... FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin AGENCY: Food and... dose range for use of an injectable solution of tilmicosin phosphate for treatment of respiratory... 300 (tilmicosin injection, USP) Injection, available by veterinary prescription for use in the...

  16. 76 FR 16533 - Certain Other Dosage Form New Animal Drugs; Detomidine; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    .... FDA-2010-N-0002] Certain Other Dosage Form New Animal Drugs; Detomidine; Correction AGENCY: Food and... paragraph describing limitations to the approved conditions of use for detomidine hydrochloride oromucosal... conditions of use for detomidine hydrochloride oromucosal gel in horses. This correction is being made to...

  17. 76 FR 72619 - Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 [Docket No. FDA-2011-N-0003] Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug...

  18. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-03

    ...ApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.regulations.../Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http...), in a format that FDA can process, review, and archive. Currently, the Agency can process, review, and...

  19. Arsenic in Food

    MedlinePlus

    ... It is found in water, air, food, and soil in organic and inorganic forms. The FDA has ... of arsenic compounds in water, food, air, and soil: organic and inorganic (these together are referred to ...

  20. 76 FR 43331 - Labor-Management Relations Information Collection Requests

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... FEDERAL MEDIATION AND CONCILIATION SERVICE Labor-Management Relations Information Collection... the following public information collection requests (ICR) to the Office of Management and Budget (OMB... information collection requests are FMCS forms: Arbitrator's Report and Fee Statement (Agency Form R-19...

  1. 7 CFR 28.126 - Loaning of forms and exhibits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY STANDARDS AND STANDARD CONTAINER... Fees and Costs § 28.126 Loaning of forms and exhibits. In the discretion of the Director, limited...

  2. 76 FR 22610 - Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-22

    .... FDA-2011-N-0003] Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin AGENCY: Food... amending the animal drug regulations to reflect approval of a supplemental new animal drug application... INFORMATION: Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a...

  3. 75 FR 13225 - Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    .... FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal Drugs; Flunixin AGENCY: Food and... amending the animal drug regulations to reflect approval of an original abbreviated new animal drug... copy of BANAMINE-S, sponsored by Schering-Plough Animal Health Corp. under NADA 101-479. The ANADA is...

  4. 75 FR 12981 - Oral Dosage Form New Animal Drugs; Tetracycline Powder

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-18

    .... FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Tetracycline Powder AGENCY: Food and Drug... amending the animal drug regulations to reflect approval of a supplemental new animal drug application... approval of this product. This change is being made to improve the accuracy of the animal drug regulations...

  5. 77 FR 4226 - Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    .... FDA-2011-N-0003] Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin AGENCY: Food... amending the animal drug regulations to reflect approval of a supplemental new animal drug application.... 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug...

  6. 21 CFR 720.2 - Times for filing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Times for filing. 720.2 Section 720.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS... days after forms are made available to the industry, Form FDA 2512 should be filed for each cosmetic...

  7. 32 CFR Table 1 to Part 855 - Purpose of Use/Verification/Approval Authority/Fees

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... change of station, etc.) or for private, non revenue flights Social security number in block 1 on DD Form... of a uniformed service member Identification card (DD Form 1173) number or social security number... Form 1173) number or social security number, identification card expiration date, sponsor's retirement...

  8. 32 CFR Table 1 to Part 855 - Purpose of Use/Verification/Approval Authority/Fees

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... change of station, etc.) or for private, non revenue flights Social security number in block 1 on DD Form... of a uniformed service member Identification card (DD Form 1173) number or social security number... Form 1173) number or social security number, identification card expiration date, sponsor's retirement...

  9. 7 CFR 28.123 - Costs of practical forms of cotton standards.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Costs of practical forms of cotton standards. 28.123... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Regulations Under the United States Cotton Standards Act Fees and Costs § 28.123 Costs of practical forms of cotton standards. The costs of practical...

  10. 7 CFR 28.123 - Costs of practical forms of cotton standards.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Costs of practical forms of cotton standards. 28.123... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Regulations Under the United States Cotton Standards Act Fees and Costs § 28.123 Costs of practical forms of cotton standards. The costs of practical...

  11. 7 CFR 28.123 - Costs of practical forms of cotton standards.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Costs of practical forms of cotton standards. 28.123... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Regulations Under the United States Cotton Standards Act Fees and Costs § 28.123 Costs of practical forms of cotton standards. The costs of practical...

  12. 7 CFR 28.123 - Costs of practical forms of cotton standards.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Costs of practical forms of cotton standards. 28.123... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Regulations Under the United States Cotton Standards Act Fees and Costs § 28.123 Costs of practical forms of cotton standards. The costs of practical...

  13. 7 CFR 28.123 - Costs of practical forms of cotton standards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Costs of practical forms of cotton standards. 28.123... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Regulations Under the United States Cotton Standards Act Fees and Costs § 28.123 Costs of practical forms of cotton standards. The costs of practical...

  14. 44 CFR 5.45 - Form of payment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Form of payment. 5.45 Section... SECURITY GENERAL PRODUCTION OR DISCLOSURE OF INFORMATION Fees § 5.45 Form of payment. Payment shall be by check or money order payable to the Federal Emergency Management Agency and shall be addressed to the...

  15. 44 CFR 6.84 - Form of payment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Form of payment. 6.84 Section... SECURITY GENERAL IMPLEMENTATION OF THE PRIVACY ACT OF 1974 Fees § 6.84 Form of payment. Payment shall be by check or money order payable to The Federal Emergency Management Agency and shall be addressed to the...

  16. 37 CFR 201.3 - Fees for registration, recordation, and related services, special services, and services...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) Registration of a claim in a group of contributions to periodicals (Form GR/CP), published photographs, or... updates thereto or group registration of published photographs 35 Forms GR/CP, PA, SR, VA and SE (paper...

  17. 37 CFR 201.3 - Fees for registration, recordation, and related services, special services, and services...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Registration of a claim in a group of contributions to periodicals (Form GR/CP), published photographs, or... updates thereto or group registration of published photographs 35 Forms GR/CP, PA, SR, VA and SE (paper...

  18. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

    PubMed

    Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

    2017-12-05

    To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.

    PubMed

    Seife, Charles

    2015-04-01

    Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature. To identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature. Cross-sectional analysis of publicly available documents, dated from January 1, 1998, to September 30, 2013, describing FDA inspections of clinical trial sites in which significant evidence of objectionable conditions or practices was found. For each inspection document that could be linked to a specific published clinical trial, the main measure was a yes/no determination of whether there was mention in the peer-reviewed literature of problems the FDA had identified. Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published. When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

  20. Medicine and Pregnancy

    MedlinePlus

    ... and Prevention MotherToBaby text4baby March of Dimes 4. Report Problems. First, tell your healthcare provider about any ... a reporting form sent to you by mail. Report problems online . What to Report to FDA You ...

  1. Advances in Behavioral Laboratory Methods that Inform Tobacco Regulatory Science: A TCORS Working Group Special Issue

    PubMed Central

    Wright, M. Jerry; Valentine, Gerald

    2017-01-01

    Objective The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) created unprecented enabling conditions for establishing national regulatory policy that reduces the burden of public health and societal problems associated with tobacco product use. The Center for Tobacco Products (CTP), created by the FDA to implement the TCA, developed a first-of-its-kind FDA/National Institutes of Health (NIH) collaborative program to fund Tobacco Centers of Regulatory Science (TCORS). Methods To assist the TCORS with addressing research priorites, working groups (WGs) comprised of FDA-CTP liasions and TCORS investigators were formed. Under the direction of the Center for Evaluation and Coordination of Trainin and Research (CECTR), the TCORS WGs seek to develop tangible work products in their respective areas of focus. Results The focus of the behavioral pharmacology WG evolved from publishing a narrow paper on behavioral methods in electronic cigarette research to a collection of papers on advances in behavioral laboratory methods that may inform tobacco regulatory science. Conclusion This Special Issue contains articles that address all of the CTP research priorities and demonstrates how advances in behavioral laboratory methods made by TCORS investigators can inform FDA efforst to regulate tobacco products. PMID:29152546

  2. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.

    PubMed

    Moore, Thomas J; Furberg, Curt D; Mattison, Donald R; Cohen, Michael R

    2016-06-01

    Adverse drug event reports to the US Food and Drug Administration (FDA) remain the primary tool for identifying serious drug adverse effects without adequate existing warnings. We assessed the completeness of reports the FDA received in 2014. Serious adverse drug event reports were evaluated for whether they included age, gender, event date, and at least one medical term describing the event in computer excerpts. Report sources were direct reports to the FDA, manufacturer expedited reports about events without adequate warnings, and manufacturer periodic reports about events with existing warnings. In 2014, the FDA received 528,192 new case reports indicating a serious or fatal outcome, 25,038 (4.7%) directly from health professionals and consumers, and 503,154 (95.3%) from drug manufacturers. Overall, 21,595 (86.2%) of serious reports submitted directly to the FDA provided data for all four completeness variables, compared with 271,022 (40.4%) of manufacturer expedited reports and 24,988 (51.3%) of periodic reports. Among manufacturer serious reports, 37.9% lacked age and 46.9% had no event date. Performance by 25 manufacturers submitting 5000 or more reports varied from 24.4% complete on all variables to 67% complete. Patient death cases had the lowest completeness scores in all categories. By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency. The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  3. Dental insurance: A systematic review.

    PubMed

    Garla, Bharath Kumar; Satish, G; Divya, K T

    2014-12-01

    To review uses of finance in dentistry. A search of 25 electronic databases and World Wide Web was conducted. Relevant journals were hand searched and further information was requested from authors. Inclusion criteria were a predefined hierarchy of evidence and objectives. Study validity was assessed with checklists. Two reviewers independently screened sources, extracted data, and assessed validity. Insurance has come of ages and has become the mainstay of payment in many developed countries. So much so that all the alternative forms of payment which originated as an alternative to fee for service now depend on insurance at one point or the other. Fee for service is still the major form of payment in many developing countries including India. It is preferred in many instances since the payment is made immediately.

  4. A cost effectiveness study of eribulin versus standard single-agent cytotoxic chemotherapy for women with previously treated metastatic breast cancer.

    PubMed

    Lopes, Gilberto; Glück, Stefan; Avancha, Kiran; Montero, Alberto J

    2013-01-01

    Eribulin was FDA approved in 2012 as a treatment for patients with MBC who have previously received at least two prior chemotherapy regimens. The aim of this analysis was to assess the cost effectiveness of eribulin versus the three most commonly utilized drugs (TPC) in the EMBRACE trial: vinorelbine, gemcitabine, and capecitabine (X); and to other branded FDA approved drugs: ixabepilone (I), liposomal-doxorubicin (D), and nab-paclitaxel. We created a decision-analytical and a Markov model using clinical data from the EMBRACE trial. Health utilities were derived from the published literature. Costs for drug acquisition, physician visits, and laboratory tests were obtained from Medicare Services Drug Payment Table and Physician Fee Schedule and are represented in 2012 USD. Life-years saved (LY), quality-adjusted life years (QALY), and incremental cost effectiveness ratio (ICER) were calculated. Eribulin added 0.208 LY and 0.119 QALY with an incremental cost over TPC of $25,458, and therefore an ICER of $213,742 per QALY. The main drivers of the model were drug cost, PFS, OS, and health utility values. The results of the model were robust in sensitivity analyses. Relative to I, D, A, and X, the ICER for eribulin was $76,823, $109,283, $129,773, and $167,267, respectively. Even with a more contemporary willingness-to-pay threshold of approximately $120,000 per QALY, eribulin was not found to be cost effective in the treatment of MBC relative to TPC; relative to some more expensive branded drugs, eribulin appears to be cost effective.

  5. 14 CFR 47.63 - Application.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REGISTRATION Dealers' Aircraft Registration Certificate § 47.63 Application. A manufacturer or dealer that wishes to obtain a Dealer's Aircraft Registration Certificate, AC Form 8050-6, must submit— (a) A Dealer's Aircraft Registration Certificate Application, AC Form 8050-5; and (b) The fee required by § 47.17...

  6. 14 CFR 47.63 - Application.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... REGISTRATION Dealers' Aircraft Registration Certificate § 47.63 Application. A manufacturer or dealer that wishes to obtain a Dealer's Aircraft Registration Certificate, AC Form 8050-6, must submit— (a) A Dealer's Aircraft Registration Certificate Application, AC Form 8050-5; and (b) The fee required by § 47.17...

  7. 76 FR 51039 - Statement of Organizations, Functions, and Delegations of Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... Bioequivalence II, Division of Microbiology, Division of Clinical Review, and Division of Chemistry IV. In...FDA/ReportsManualsForms/StaffManualGuides/default.htm . Dated: August 10, 2011. Leslie Kux, Acting...

  8. 78 FR 52776 - Documents to Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: August 20, 2013...

  9. 76 FR 66311 - Draft Documents To Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    .../DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , or http...

  10. 78 FR 10181 - Documents To Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: February 8, 2013...

  11. An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

    PubMed Central

    Chatterjee, Satabdi; Patel, Harshali K.; Sansgiry, Sujit S.

    Objective To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. Methods Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL), and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market. Results In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6%) followed by unsubstantiated efficacy claims (18.6%). Warning letters were primarily directed to manufacturers of cardiovascular (14.6%), anti-microbial (14.6%), and CNS (12.5%) drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%). Conclusions The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health. PMID:24155837

  12. Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.

    PubMed

    Frank, Cassie; Himmelstein, David U; Woolhandler, Steffie; Bor, David H; Wolfe, Sidney M; Heymann, Orlaith; Zallman, Leah; Lasser, Karen E

    2014-08-01

    After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. Project HOPE—The People-to-People Health Foundation, Inc.

  13. 37 CFR 1.77 - Arrangement of application elements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Arrangement of application... § 1.77 Arrangement of application elements. (a) The elements of the application, if applicable, should appear in the following order: (1) Utility application transmittal form. (2) Fee transmittal form. (3...

  14. 37 CFR 1.77 - Arrangement of application elements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Arrangement of application... § 1.77 Arrangement of application elements. (a) The elements of the application, if applicable, should appear in the following order: (1) Utility application transmittal form. (2) Fee transmittal form. (3...

  15. 37 CFR 1.77 - Arrangement of application elements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Arrangement of application... § 1.77 Arrangement of application elements. (a) The elements of the application, if applicable, should appear in the following order: (1) Utility application transmittal form. (2) Fee transmittal form. (3...

  16. 37 CFR 1.77 - Arrangement of application elements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Arrangement of application... § 1.77 Arrangement of application elements. (a) The elements of the application, if applicable, should appear in the following order: (1) Utility application transmittal form. (2) Fee transmittal form. (3...

  17. 28 CFR 16.11 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... a requester's specified preference of form or format of disclosure if the record is readily... professional education, or an institution of vocational education, that operates a program of scholarly...

  18. What is greener than a VMT tax? The case for an indexed energy user fee to finance us surface transportation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Greene, David L

    Highway finance in the United States is perceived by many to be in a state of crisis, primarily due to the erosion of motor fuel tax revenues due to inflation, fuel economy improvement, increased use of alternative sources of energy and diversion of revenues to other purposes. Monitoring vehicle miles of travel (VMT) and charging highway users per mile has been proposed as a replacement for the motor fuel tax. A VMT user fee, however, does not encourage energy efficiency in vehicle design, purchase and operation, as would a user fee levied on all forms of commercial energy used formore » transportation and indexed to the average efficiency of vehicles on the road and to inflation. An indexed roadway user toll on energy (IRoUTE) would induce two to four times as much reduction in greenhouse gas (GHG) emissions and petroleum use as a pure VMT user fee. However, it is not a substitute for pricing GHG emissions and would make only a small but useful contribution to reducing petroleum dependence. An indexed energy user fee cannot adequately address the problems of traffic congestion and heavy vehicle cost responsibility. It could, however, be a key component of a comprehensive system of financing surface transportation that would eventually also include time and place specific monitoring of VMT for congestion pricing, externality charges and heavy vehicle user fees.« less

  19. 75 FR 76315 - Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... Federal waters. The FDA has determined that oceanographic conditions and alga sampling data suggest that.... These toxins are produced by the alga Alexandrium fundyense, which can form blooms commonly referred to...

  20. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... filling out form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect... Drug Reaction, Lack of Effectiveness, Product Defect Report.'' II. Significance of Guidance This level...

  1. 78 FR 22554 - Document to Support Submission of an Electronic Common Technical Document-Specifications for File...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements...Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: April 10, 2013. Leslie Kux...

  2. 49 CFR 701.11 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... others. Amtrak shall honor a requester's specified preference for the form or format of disclosure if the... higher education, an institution of professional education, or an institution of vocational education...

  3. 13 CFR 102.6 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... specified preference of form or format of disclosure if the record is readily reproducible with reasonable... accredited or state-certified institution of vocational education that operates a program of scholarly...

  4. 18 CFR 1301.10 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... example, magnetic tape or disk), among others. TVA shall honor a requester's specified preference of form... education, or an institution of professional education, or an institution of vocational education, that...

  5. 36 CFR 1600.10 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Foundation will honor your specified preference of form or format of disclosure if the record is readily... higher education, an institution of professional education, and an institution of vocational education...

  6. 6 CFR 5.11 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... Components shall honor a requester's specified preference of form or format of disclosure if the record is... education, an institution of professional education, or an institution of vocational education, that...

  7. 15 CFR 4.11 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... or disk), among others. A component shall honor a requester's specified preference of form or format... institution of professional education, or an institution of vocational education, that operates a program of...

  8. 36 CFR 62.2 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... fossil evidence of the development of life. Natural region is a distinct physiographic province having... holding easements or less than fee interests (including leaseholds) of any form. A Native American tribe...

  9. 36 CFR 62.2 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... fossil evidence of the development of life. Natural region is a distinct physiographic province having... holding easements or less than fee interests (including leaseholds) of any form. A Native American tribe...

  10. 36 CFR 62.2 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... fossil evidence of the development of life. Natural region is a distinct physiographic province having... holding easements or less than fee interests (including leaseholds) of any form. A Native American tribe...

  11. 36 CFR 62.2 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... fossil evidence of the development of life. Natural region is a distinct physiographic province having... holding easements or less than fee interests (including leaseholds) of any form. A Native American tribe...

  12. 36 CFR 62.2 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... fossil evidence of the development of life. Natural region is a distinct physiographic province having... holding easements or less than fee interests (including leaseholds) of any form. A Native American tribe...

  13. 76 FR 49649 - Oral Dosage Form New Animal Drugs; Change of Sponsor; Chlortetracycline; Sulfamethazine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ...;Prices of new books are listed in the first FEDERAL REGISTER issue of each #0;week. #0; #0; #0; #0;#0... wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 has informed FDA that it...-0003] Oral Dosage Form New Animal Drugs; Change of Sponsor; Chlortetracycline; Sulfamethazine AGENCY...

  14. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

    PubMed

    Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E

    Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. To identify the reasons that FDA marketing approval for new drugs was delayed or denied. A retrospective review of FDA documents and extraction of data were performed. We examined all drug applications first submitted to the FDA between 2000 and 2012 for new molecular entities (NMEs), which are active ingredients never before marketed in the United States in any form. Using FDA correspondence and reviews, we investigated the reasons NMEs failed to obtain FDA approval. Reasons for delayed FDA approval or nonapproval of NME applications. Of the 302 identified NME applications, 151 (50%) were approved when first submitted and 222 (73.5%) were ultimately approved. Seventy-one applications required 1 or more resubmissions before approval, with a median delay to approval of 435 days following the first unsuccessful submission. Of the unsuccessful first-time applications, 24 (15.9%) included uncertainties related to dose selection, 20 (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, 20 (13.2%) inconsistent results when different end points were tested, 17 (11.3%) inconsistent results when different trials or study sites were compared, and 20 (13.2%) poor efficacy when compared with the standard of care. The frequency of safety deficiencies was similar among never-approved drugs compared with those with delayed approval (43 of 80 never approved [53.8%] vs 37 of 71 eventually approved [52.1%]; difference, 1.7% [95% CI, -14.86% to 18.05%]; P = .87). However, efficacy deficiencies were significantly more frequent among the never-approved drugs than among those with delayed approvals (61 of 80 never approved [76.3%] vs 28 of 71 eventually approved [39.4%]; difference, 36.9% [95% CI, 20.25% to 50.86%]; P < .001). Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable study end points, accounted for significant delays in the approval of new drugs. Understanding the reasons for previous failures is helpful to improve the efficiency of clinical development for new drugs.

  15. 32 CFR 701.41 - FOIA fee terms.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... can take the form of paper copy, microfiche, audiovisual, or machine readable documentation (e.g... duplication of computer tapes and audiovisual, the actual cost, including the operator's time, shall be...

  16. FDA actions against misleading or unsubstantiated economic and quality-of-life promotional claims: an analysis of warning letters and notices of violation.

    PubMed

    Stewart, Kate A; Neumann, Peter J

    2002-01-01

    The objective of this study was to understand the types of economic and quality-of-life promotional claims the FDA considers false or misleading. Publicly available FDA letters (n = 569) sent to pharmaceutical companies from 1997 through 2001 for inappropriate promotional claims were reviewed. A standard data collection form was developed, including six categories for economic violations and three for QOL violations. For QOL, only letters with explicit violations for false or misleading claims using the words "quality of life" or patient "well-being" were considered. Other information collected included type of regulatory letter and media in which violations were found. Twenty-eight (4.9%) letters cited false and/or misleading economic claims. The most common economic violation was "unsupported comparative claim of effectiveness, safety, or interchangeability" (n = 14). Twenty-eight (4.9%) letters cited QOL violations, of which four contained both economic and QOL violations. The most common QOL violation was "lack of substantial evidence for QOL claims" (n = 15). None of the FDA letters used the term "patient reported outcomes." Violations were found most frequently in brochure and Web site-based promotions. The body of evidence that is emerging illustrates how the FDA is regulating promotional material containing misleading or unsubstantiated economic and QOL claims. However, knowing what constitutes an appropriate claim remains challenging because there are no formal guidelines describing what constitutes a violation, nor what level of substantiating evidence is required. More guidance may be needed to ensure appropriate use of these claims in drug promotions.

  17. 37 CFR 102.11 - Fees.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... The FOIA Officer shall honor a requester's specified preference of form or format of disclosure if the... education, or an institution of vocational education, that operates a program of scholarly research. To be...

  18. 32 CFR 701.41 - FOIA fee terms.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... OFFICIAL RECORDS AVAILABILITY OF DEPARTMENT OF THE NAVY RECORDS AND PUBLICATION OF DEPARTMENT OF THE NAVY... can take the form of paper copy, microfiche, audiovisual, or machine readable documentation (e.g...

  19. 76 FR 34080 - Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing... existing FDA regulations governing temporary marketing permit applications. DATES: Submit either electronic... appropriate, and other forms of information technology. Temporary Marketing Permit Applications--21 CFR 130.17...

  20. 76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    .... FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities... comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA... controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is...

  1. 78 FR 26088 - Agency Information Collection Activities: Submission to OMB for a New Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-03

    ... form relates to a budget or estimate of the legal fees, costs, and expenses that outside counsel would... average number of respondents, burden, and total annual cost appear below. The estimated number of... and the representations and certifications form. The NCUA estimated the total annual cost by...

  2. 47 CFR 1.1158 - Form of payment for regulatory fees.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Commission or by Visa, Mastercard, American Express or Discover credit cards only. The Commission discourages... submitted with an application in the wireless radio service) made by credit card or money order must be submitted with a completed FCC Form 159. Failure to accurately enter the credit card number and date of...

  3. 76 FR 45303 - Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... Management and Budget for approval. Form F-6 (17 CFR 239.36) is a form used by foreign companies to register..., fees charged, and a description of the ADRs. No special information regarding the foreign company is required to be prepared or disclosed, although the foreign company must be one which periodically furnishes...

  4. 48 CFR 16.306 - Cost-plus-fixed-fee contracts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... preliminary exploration, studies, and risk reduction have indicated a high degree of probability that the... the scope of work by stating a definite goal or target and specifying an end product. This form of... increases the estimated cost. (2) The term form describes the scope of work in general terms and obligates...

  5. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  6. 21 CFR 1271.25 - What information is required for establishment registration and HCT/P listing?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... registration and HCT/P listing? 1271.25 Section 1271.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... HCT/P listing? (a) Your establishment registration Form FDA 3356 must include: (1) The legal name(s... registration and HCT/P listing form is true and accurate, to the best of his or her knowledge. (b) Your HCT/P...

  7. 21 CFR 1271.25 - What information is required for establishment registration and HCT/P listing?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... registration and HCT/P listing? 1271.25 Section 1271.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... HCT/P listing? (a) Your establishment registration Form FDA 3356 must include: (1) The legal name(s... registration and HCT/P listing form is true and accurate, to the best of his or her knowledge. (b) Your HCT/P...

  8. Payment mechanism and GP self-selection: capitation versus fee for service.

    PubMed

    Allard, Marie; Jelovac, Izabela; Léger, Pierre-Thomas

    2014-06-01

    This paper analyzes the consequences of allowing gatekeeping general practitioners (GPs) to select their payment mechanism. We model GPs' behavior under the most common payment schemes (capitation and fee for service) and when GPs can select one among them. Our analysis considers GP heterogeneity in terms of both ability and concern for their patients' health. We show that when the costs of wasteful referrals to costly specialized care are relatively high, fee for service payments are optimal to maximize the expected patients' health net of treatment costs. Conversely, when the losses associated with failed referrals of severely ill patients are relatively high, we show that either GPs' self-selection of a payment form or capitation is optimal. Last, we extend our analysis to endogenous effort and to competition among GPs. In both cases, we show that self-selection is never optimal.

  9. 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

    PubMed

    Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Needham, Shane; Couerbe, Philippe; Lansing, Tim; Bhatti, Masood; Sheldon, Curtis; Hayes, Roger; Islam, Rafiq; Lin, Zhongping; Garofolo, Wei; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocha, Thais; Jardieu, Paula; Truog, James; Lin, Jenny; Lundberg, Richard; Breau, Alan; Dilger, Carmen; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Jenkins, Rand; Nicholson, Robert; Lin, Ming Hung; Karnik, Shane; DeMaio, William; Smith, Kirk; Cojocaru, Laura; Allen, Mike; Fatmi, Saadya; Sayyarpour, Farhad; Malone, Michele; Fang, Xinping

    2012-04-01

    The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.

  10. Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

    NASA Technical Reports Server (NTRS)

    Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

    2007-01-01

    Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

  11. Charging for hospital pharmaceutical services: flat free based on the medication record.

    PubMed

    Wyatt, B K

    1979-03-01

    A 200-bed hospital's change in pricing drug products from a cost-plus-fee system to a flat fee per dose based on the medication administration record (MAR) is described. With the flat-fee system, drug charges are not recorded when the drug is dispensed by the pharmacy; data for charging doses are obtained directly from the MAR forms generated by the nursing staff. Charges are 55 cents per oral or suppository dose and $3.00 per injection dose. Drugs administered intravenously, topical drugs, injections costing more than $10.00 per dose, and miscellaneous nondrug items are still charged on a cost-plus-fee basis. Man-hours are saved in the pharmacy department because of the elimination of the pricing function and maintenance of price lists. The need for nursing staff to charge for any doses administered from emergency or Schedule II floor-stock supplies is eliminated. The workload for business office personnel is reduced because the number of individual charges is less than with the cost-plus charging system. The system is accepted by patients and third-party payers and has made a complete unit dose drug distribution system possible at lower cost.

  12. Chern-Simons-Antoniadis-Savvidy forms and standard supergravity

    NASA Astrophysics Data System (ADS)

    Izaurieta, F.; Salgado, P.; Salgado, S.

    2017-04-01

    In the context of the so called the Chern-Simons-Antoniadis-Savvidy (ChSAS) forms, we use the methods for FDA decomposition in 1-forms to construct a four-dimensional ChSAS supergravity action for the Maxwell superalgebra. On the another hand, we use the Extended Cartan Homotopy Formula to find a method that allows the separation of the ChSAS action into bulk and boundary contributions and permits the splitting of the bulk Lagrangian into pieces that reflect the particular subspace structure of the gauge algebra.

  13. Fee-for-service cancer rehabilitation programs improve health-related quality of life.

    PubMed

    Kirkham, A A; Neil-Sztramko, S E; Morgan, J; Hodson, S; Weller, S; McRae, T; Campbell, K L

    2016-08-01

    Rigorously applied exercise interventions undertaken in a research setting result in improved health-related quality of life (hrqol) in cancer survivors, but research to demonstrate effective translation of that research to practice is needed. The objective of the present study was to determine the effect of fee-for-service cancer rehabilitation programs in the community on hrqol and on self-reported physical activity and its correlates. After enrolment and 17 ± 4 weeks later, new clients (n = 48) to two fee-for-service cancer rehabilitation programs completed the 36-Item Short Form Health Survey (rand-36: rand Corporation, Santa Monica, CA, U.S.A.), the Godin Leisure-Time Exercise Questionnaire, and questions about physical activity correlates. Normal fee-for-service operations were maintained, including a fitness assessment and individualized exercise programs supervised in a group or one-on-one setting, with no minimum attendance required. Fees were associated with the assessment and with each exercise session. Of the 48 participants, 36 (75%) completed both questionnaires. Improvements in the physical functioning, role physical, pain, and energy/fatigue scales on the rand-36 exceeded minimally important differences and were of a magnitude similar to improvements reported in structured, rigorously applied, and free research interventions. Self-reported levels of vigorous-intensity (p = 0.021), but not moderate-intensity (p = 0.831) physical activity increased. The number of perceived barriers to exercise (p = 0.035) and the prevalence of fatigue as a barrier (p = 0.003) decreased. Exercise self-efficacy improved only in participants who attended 11 or more sessions (p = 0.002). Exercise enjoyment did not change (p = 0.629). Enrolment in fee-for-service cancer rehabilitation programs results in meaningful improvements in hrqol comparable to those reported by research interventions, among other benefits. The fee-for-service model could be an effective model for delivery of exercise to more cancer survivors.

  14. 76 FR 26318 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Based Standard for Fire Protection for Light Water Reactor Electric Generating Plants, 2001 Edition... or other forms of information technology? The public may examine and have copied, for a fee, publicly...

  15. 76 FR 26319 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Based Standard for Fire Protection for Light Water Reactor Electric Generating Plants, 2001 Edition... techniques or other forms of information technology? The public may examine and have copied, for a fee...

  16. 49 CFR 1511.5 - Imposition of Aviation Security Infrastructure Fees.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... completed form to the Transportation Security Administration by May 18, 2002. (e) In the case of a merger, acquisition, corporate restructuring, reorganization, or name change involving an air carrier or foreign air...

  17. 32 CFR Table 1 to Part 855 - Purpose of Use/Verification/Approval Authority/Fees

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... change of station, etc.) or for private, non revenue flights Social security number in block 1 on DD Form... other available aircraft for official Government business travel Supervisor's endorsement in block 4 of... be listed in block 4 of the DD Form 2401. An official government document, such as an SF 1169, US...

  18. 32 CFR Table 1 to Part 855 - Purpose of Use/Verification/Approval Authority/Fees

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... change of station, etc.) or for private, non revenue flights Social security number in block 1 on DD Form... other available aircraft for official Government business travel Supervisor's endorsement in block 4 of... be listed in block 4 of the DD Form 2401. An official government document, such as an SF 1169, US...

  19. 32 CFR Table 1 to Part 855 - Purpose of Use/Verification/Approval Authority/Fees

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... change of station, etc.) or for private, non revenue flights Social security number in block 1 on DD Form... other available aircraft for official Government business travel Supervisor's endorsement in block 4 of... be listed in block 4 of the DD Form 2401. An official government document, such as an SF 1169, US...

  20. New Antiretroviral Therapies for Pediatric HIV Infection

    PubMed Central

    Morris, Jennifer L.; Kraus, Donna M.

    2005-01-01

    Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome affect millions of children worldwide. The development of antiretroviral therapy has significantly improved the morbidity and mortality of pediatric patients infected with HIV. Currently, 4 classes of antiretroviral agents exist: nucleoside / nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, and entry inhibitors. A total of 21 single-entity antiretroviral agents and 4 co-formulated antiretroviral products hold Food and Drug Administration (FDA) approval for treatment of HIV-1 infection. However, not all of these agents are indicated for use in patients less than 18 years of age. Since the year 2000, 7 new antiretroviral agents (atazanavir, emtricitabine, enfuvirtide, fosamprenavir, lopinavir/ritonavir, tenofovir, and tipranavir) have been approved by the FDA for use in adult patients as part of combination therapy for the treatment of HIV-1 infection. Although only 3 of these newer agents (emtricitabine, enfuvirtide, and lopinavir/ritonavir) are currently FDA approved for use in pediatric patients, pediatric clinical studies of the other 4 new agents are currently underway. The purpose of this article is to review these 7 new antiretroviral agents and describe their roles in the treatment of pediatric HIV infection. For each drug, the following information will be addressed: FDA-approved indication and age groups, clinical efficacy, pharmacokinetics, adverse drug reactions, clinically relevant drug interactions, pediatric and adult dosing, dosage forms, administration, and place in the treatment of pediatric HIV infection. PMID:23118639

  1. The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

    PubMed

    Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

    2017-05-03

    The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

  2. Regulatory Requirements for Devices for the Handicapped.

    ERIC Educational Resources Information Center

    Stigi, John, Ed.; Rivera, Richard J., Ed.

    This booklet explains in question/answer form the basic regulatory requirements established by the Food and Drug Administration (FDA) of the federal government concerning the manufacture, marketing and distribution of medical devices (including implantable devices and devices previously regulated as drugs) for persons with disabilities. Topics…

  3. 76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... regarding how and when data collection forms and standard operating procedures should be included with the... topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or...

  4. 21 CFR 720.6 - Amendments to statement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.6 Amendments to statement... a cosmetic product should be submitted by filing an amended Form FDA 2512 within 60 days after the...

  5. 21 CFR 720.6 - Amendments to statement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.6 Amendments to statement... a cosmetic product should be submitted by filing an amended Form FDA 2512 within 60 days after the...

  6. 21 CFR 720.1 - Who should file.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.1 Who should file. Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic...

  7. 21 CFR 720.6 - Amendments to statement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.6 Amendments to statement... a cosmetic product should be submitted by filing an amended Form FDA 2512 within 60 days after the...

  8. 21 CFR 720.1 - Who should file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.1 Who should file. Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic...

  9. 21 CFR 720.6 - Amendments to statement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.6 Amendments to statement... a cosmetic product should be submitted by filing an amended Form FDA 2512 within 60 days after the...

  10. 21 CFR 720.1 - Who should file.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.1 Who should file. Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic...

  11. 21 CFR 720.1 - Who should file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.1 Who should file. Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic...

  12. 21 CFR 720.1 - Who should file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.1 Who should file. Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic...

  13. 21 CFR 720.6 - Amendments to statement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.6 Amendments to statement... a cosmetic product should be submitted by filing an amended Form FDA 2512 within 60 days after the...

  14. Identification of new drug candidates against Borrelia burgdorferi using high-throughput screening.

    PubMed

    Pothineni, Venkata Raveendra; Wagh, Dhananjay; Babar, Mustafeez Mujtaba; Inayathullah, Mohammed; Solow-Cordero, David; Kim, Kwang-Min; Samineni, Aneesh V; Parekh, Mansi B; Tayebi, Lobat; Rajadas, Jayakumar

    2016-01-01

    Lyme disease is the most common zoonotic bacterial disease in North America. It is estimated that >300,000 cases per annum are reported in USA alone. A total of 10%-20% of patients who have been treated with antibiotic therapy report the recrudescence of symptoms, such as muscle and joint pain, psychosocial and cognitive difficulties, and generalized fatigue. This condition is referred to as posttreatment Lyme disease syndrome. While there is no evidence for the presence of viable infectious organisms in individuals with posttreatment Lyme disease syndrome, some researchers found surviving Borrelia burgdorferi population in rodents and primates even after antibiotic treatment. Although such observations need more ratification, there is unmet need for developing the therapeutic agents that focus on removing the persisting bacterial form of B. burgdorferi in rodent and nonhuman primates. For this purpose, high-throughput screening was done using BacTiter-Glo assay for four compound libraries to identify candidates that stop the growth of B. burgdorferi in vitro. The four chemical libraries containing 4,366 compounds (80% Food and Drug Administration [FDA] approved) that were screened are Library of Pharmacologically Active Compounds (LOPAC1280), the National Institutes of Health Clinical Collection, the Microsource Spectrum, and the Biomol FDA. We subsequently identified 150 unique compounds, which inhibited >90% of B. burgdorferi growth at a concentration of <25 µM. These 150 unique compounds comprise many safe antibiotics, chemical compounds, and also small molecules from plant sources. Of the 150 unique compounds, 101 compounds are FDA approved. We selected the top 20 FDA-approved molecules based on safety and potency and studied their minimum inhibitory concentration and minimum bactericidal concentration. The promising safe FDA-approved candidates that show low minimum inhibitory concentration and minimum bactericidal concentration values can be chosen as lead molecules for further advanced studies.

  15. 78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...

  16. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  17. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability...\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg...

  18. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...

  19. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...

  20. Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations.

    PubMed

    Gong, Jun; Chehrazi-Raffle, Alexander; Reddi, Srikanth; Salgia, Ravi

    2018-01-23

    Early preclinical evidence provided the rationale for programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) blockade as a potential form of cancer immunotherapy given that activation of the PD-1/PD-L1 axis putatively served as a mechanism for tumor evasion of host tumor antigen-specific T-cell immunity. Early-phase studies investigating several humanized monoclonal IgG4 antibodies targeting PD-1 and PD-L1 in advanced solid tumors paved way for the development of the first PD-1 inhibitors, nivolumab and pembrolizumab, approved by the Food and Drug Administration (FDA) in 2014. The number of FDA-approved agents of this class is rapidly enlarging with indications for treatment spanning across a spectrum of malignancies. The purpose of this review is to highlight the clinical development of PD-1 and PD-L1 inhibitors in cancer therapy to date. In particular, we focus on detailing the registration trials that have led to FDA-approved indications of anti-PD-1 and anti-PD-L1 therapies in cancer. As the number of PD-1/PD-L1 inhibitors continues to grow, predictive biomarkers, mechanisms of resistance, hyperprogressors, treatment duration and treatment beyond progression, immune-related toxicities, and clinical trial design are key concepts in need of further consideration to optimize the anticancer potential of this class of immunotherapy.

  1. Development Considerations for Nanocrystal Drug Products.

    PubMed

    Chen, Mei-Ling; John, Mathew; Lee, Sau L; Tyner, Katherine M

    2017-05-01

    Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date. Over 60% of the submissions were for the oral route of administration. Based on the Biopharmaceutics Classification System (BCS), most nanocrystal drugs submitted to the FDA are class II compounds that possess low aqueous solubility and high intestinal permeability. Impact of food on drug bioavailability was reduced for most nanocrystal formulations as compared with their micronized counterparts. For all routes of administration, dose proportionality was observed for some, but not all, nanocrystal products. Particular emphasis in the development of nanocrystal products was placed on the in-process tests and controls at critical manufacturing steps (such as milling process), mitigation and control of process-related impurities, and the stability of APIs or polymorphic form (s) during manufacturing and upon storage. This emphasis resulted in identifying challenges to the development of these products including accurate determination of particle size (distribution) of drug substance and/or nanocrystal colloidal dispersion, identification of polymorphic form (s), and establishment of drug substance/product specifications.

  2. 78 FR 42555 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-16

    ... (NPPs), electric power companies, and any person eligible under the Atomic Energy Act to apply for ESPs... or other forms of information technology? The public may examine and have copied for a fee publicly...

  3. Fermilab Ed Office - Guided Tour Request Form

    Science.gov Websites

    of Attendees:* Total Fee: $50 ($50 for every 20 attendees) Preferred Date 1:* (e.g., "September 27, 2015") Preferred Date 2:* (e.g., "September 28, 2015") Preferred Date 3:* (e.g

  4. 78 FR 66076 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... Dose History.'' 2. Current OMB approval number: 3150-0005. 3. How often the collection is required: On... or other forms of information technology? The public may examine and have copied for fee publicly...

  5. 75 FR 18751 - Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ...-0190] Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation... information: (1) The date by which egg producers must register their farm with FDA, (2) the address and telephone number for requesting copies of Form 3733, and (3) the address to which egg producers must send...

  6. 21 CFR 803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health...-3151; (d) On the Internet at http://www.fda.gov/medwatch/getforms.htm. [72 FR 17399, Apr. 9, 2007] ...

  7. Perceptions of the Food and Drug Administration as a Tobacco Regulator

    PubMed Central

    Jarman, Kristen L.; Ranney, Leah M.; Baker, Hannah M.; Vallejos, Quirina M.; Goldstein, Adam O.

    2017-01-01

    Objectives The U. S. Food and Drug Administration (FDA) now has regulatory authority over all tobacco products. Little is known about public awareness and perceptions of FDA in their new role as a tobacco regulator. This research utilizes focus groups to examine perceptions of FDA as a tobacco regulator so that FDA can better communicate with the public about this role. Methods We conducted 6 focus groups in 2014 among a diverse sample of smokers and non-smokers. Participants were asked if they had heard of FDA, what they knew about FDA, if they associated FDA with tobacco, and their thoughts about this FDA role. Results A total of 41 individuals participated. Although nearly all participants had heard of FDA, most were not aware of FDA’s regulatory authority over tobacco products, did not associate the role of FDA with tobacco, and some drew comparisons between FDA’s work in tobacco and their work regulating food and drugs. Conclusion Data suggest that although public awareness of FDA regulatory authority over tobacco is low, with proper public education, the public may find FDA to be a trustworthy source of tobacco regulation. PMID:29051917

  8. 43 CFR 3830.20 - Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and oil shale fees. 3830.20 Section 3830.20 Public Lands..., initial maintenance fees, annual maintenance fees and oil shale fees. ...

  9. 43 CFR 3830.20 - Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and oil shale fees. 3830.20 Section 3830.20 Public Lands..., initial maintenance fees, annual maintenance fees and oil shale fees. ...

  10. 43 CFR 3830.20 - Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and oil shale fees. 3830.20 Section 3830.20 Public Lands..., initial maintenance fees, annual maintenance fees and oil shale fees. ...

  11. 43 CFR 3830.20 - Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Payment of service charges, location fees, initial maintenance fees, annual maintenance fees and oil shale fees. 3830.20 Section 3830.20 Public Lands..., initial maintenance fees, annual maintenance fees and oil shale fees. ...

  12. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

    PubMed

    Cook, Daniel M; Gurugubelli, Rama K; Bero, Lisa A

    2009-01-01

    The US FDA increasingly applies risk management to drug safety policy. Little is known about the process by which the FDA approves labelling changes. Although advisory committees can recommend any of the risk management tools, including the use of 'black-box warnings', it is unknown whether they deliberate on these questions or how they apply the principles of risk minimization or management during their considerations of drug licensing. To examine the process by which risk management is considered by the FDA, including the role of FDA advisory committees. We also aimed to identify and describe drug labelling changes and additions, including the prevalence of black-box warnings. We electronically obtained publicly available information regarding drug approvals, drug revisions and advisory committee meetings over 3 years (2004-6) from the FDA. Data in the form of meeting transcripts and full histories of labelling changes were collected on drugs discussed by advisory committees. We then searched and qualitatively analysed the meeting transcripts to identify themes in the discussion. We also created a database of all prescription drug labelling changes for 3 years and examined which drugs have had the most changes. We describe the risk management consideration process and report the frequency and characteristics of labelling changes. Excerpts from the transcripts are selected to illustrate both typical and atypical features of the discussion. A total of 174 black-box changes were made in the 3-year period of our study, of which 77 were new black-box warnings and 97 were revisions in black-box warnings. Of 77 new black-box warning additions, only 11 drugs were discussed by the advisory committees. Of the 17 most frequently revised drug labels in these 3 years, two were discussed in the advisory committee meetings. Advisory meeting discussions revealed confusion about black-box warnings and emphasized potential consequences of the warnings rather than their content. The safety labelling of drugs on the market is changed often. Panels of advisors consider only a few drugs, rarely discuss the labelling requirements, and display confusion about applying black-box warnings. The creation and application of black-box warnings on prescription medications should receive closer attention from the FDA and its advisors.

  13. Biologics, Pharmacovigilance, and Patient Safety: It's All in the Name.

    PubMed

    Stevenson, James G; Green, Larry

    2016-08-01

    The most appropriate naming convention for biologics and biosimilars has been an area of significant debate. The ultimate decision will have an impact on patient safety, pharmacovigilance program effectiveness, and, potentially, the overall adoption of biosimilars in the United States. This article reviews some of the advantages and disadvantages of various naming approaches. For clarity in communication, optimal pharmacovigilance, and patient safety, it is recommended that biosimilars be named with a common USAN (United States Adopted Name) with the reference product, along with a suffix that is memorable, such as one associated with the original manufacturer of the product. This approach supports the FDA's mission of protecting patient safety and public health, while minimizing the possibility of inadvertent switching of products and facilitating effective pharmacovigilance. No funding supported the writing of this article. Stevenson reports consulting fees from Amgen, Inc., AbbVie, and Pfizer and is employed by Visante. Green is employed by and owns stock in Amgen, Inc. Article concept was contributed primarily by Stevenson, along with Green. The manuscript was written and revised primarily by Stevenson, along with Green. Both authors contributed equally to data interpretation.

  14. 76 FR 21350 - Auction of 700 MHz Band Licenses Scheduled for July 19, 2011; Notice and Filing Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ... delinquencies. 70. On the short-form application, an applicant must certify under penalty of perjury that it... default and delinquency disclosure requirements in the context of the short-form application process. For... application fees, the provisions of 47 CFR 1.2105(a) and 1.2106(a) regarding default and delinquency in...

  15. Dysphagia in Amyotrophic Lateral Sclerosis: Relationships between disease progression and Fiberoptic Endoscopic Evaluation of Swallowing.

    PubMed

    Fattori, Bruno; Siciliano, Gabriele; Mancini, Valentina; Bastiani, Luca; Bongioanni, Paolo; Caldarazzo Ienco, Elena; Barillari, Maria R; Romeo, Salvatore O; Nacci, Andrea

    2017-06-01

    Our aim was to evaluate the relationship between the disease severity of Amyotrophic Lateral Sclerosis (ALS) and the following parameters of Fiberoptic Endoscopic Evaluation of Swallowing (FEES): premature spillage, post-swallowing residue and aspiration. We studied 202 patients (95 women and 107 men) with ALS; of these, 136 had spinal and 66 had bulbar onset. They were analyzed according to the Amyotrophic Lateral Sclerosis Functioning Rating Scale (ALSFRS) and the b-ALSFRS subscale (bulbar scale). All subjects underwent FEES. Post-swallowing residue was classified into four classes (0-3); premature spillage and aspiration were considered either present or absent. Spearman's correlation test showed a highly significant correlation (p<0.0001) between the value of ALSFRS and b-ALSFRS and the FEES parameters as the following: disease severity and dysphagia severity are closely related, both in spinal and bulbar onset, no matter what bolus texture was used. Spearman's Rho was more significant for post-swallowing residue, ≤-0.500 with all three consistencies (p<0.0001) in spinal onset and -0.520 only with liquid bolus (p<0.0001) in bulbar onset. Independent T-Test revealed a significant difference (p<0.0001) between the mean ALSFRS and b-ALSFRS scores and the presence/absence of aspiration. For the premature spillage in spinal onset (ALSFRS), we found a statistically significant difference for all three bolus textures (p<0.0001). Analysis of variance for the post-swallowing residue in spinal onset (ALSFRS) revealed a statistically significant difference (p<0.0001) for most of the comparisons between groups for all three textures. For the premature spillage in bulbar onset (b-ALSFRS), we found a statistically significant difference for all three textures (p<0.0001). Analysis of variance for the post-swallowing residue in bulbar onset (b-ALSFRS) showed a statistically significant difference (p<0.0001) for most of the comparisons between groups for all three textures. Kruskal-Wallis test showed a highly significant association between the classes of severity in bulbar forms and all the FEES parameters, no matter what type of bolus was administered (p<0.0001), whereas a significant correlation in spinal forms only for post-swallowing residue with solid (p=0.026) and semisolid (p=0.031) boluses. There is a highly significant relationship as the following between the FEES parameters and the disease severity assessed via ALSFRS and b-ALSFRS: classes of greater severity entail a greater deterioration of FEES parameters. FEES can be considered a good indicator of the dysphagia severity and a useful test for the follow-up of dysphagia in patients with ALS, whether of spinal or bulbar onset. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. 36 CFR 1120.25 - Form of requests.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Request.” The envelope in which the request is sent should be prominently marked with the letters “FOIA.... Under § 1120.33(d), the failure to state willingness to pay fees as high as are anticipated by the A...

  17. Statistical and operational summaries

    NASA Technical Reports Server (NTRS)

    Disalvo, J.

    1972-01-01

    Statistical progress indicator forms are presented on the financial management of the research allocations. Promotional activities, conference participants, and services are tabulated. The staffing and activity levels are also discussed, as well as the fee schedule revision and the standard interest profile offerings.

  18. 7 CFR 1486.303 - What specific contracting procedures must be adhered to?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... claims resulting from suits, challenges, or other disputes based on contracts entered into by the... description of the requirements for the services to be procured; (5) Perform some form of fee, price, or cost...

  19. 7 CFR 1486.303 - What specific contracting procedures must be adhered to?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... financial liability for any costs or claims resulting from suits, challenges, or other disputes based on...) Perform some form of fee, price, or cost analysis, such as a comparison of price quotations to market...

  20. 7 CFR 1486.303 - What specific contracting procedures must be adhered to?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... claims resulting from suits, challenges, or other disputes based on contracts entered into by the... description of the requirements for the services to be procured; (5) Perform some form of fee, price, or cost...

  1. 7 CFR 1486.303 - What specific contracting procedures must be adhered to?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... claims resulting from suits, challenges, or other disputes based on contracts entered into by the... description of the requirements for the services to be procured; (5) Perform some form of fee, price, or cost...

  2. 12 CFR 344.6 - Notification by agreement; alternative forms and times of notification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....5. The bank may charge a reasonable fee for providing the information described in § 344.5. (d) Cash management sweep accounts. A bank effecting a securities transaction for a cash management sweep account...

  3. 21 CFR 515.10 - Medicated feed mill license applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Medicated feed mill license applications. 515.10... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Applications § 515.10 Medicated feed mill license applications. (a) Medicated feed mill license applications (Forms FDA 3448) may...

  4. Using Oncolytic Viruses to Treat Cancer

    Cancer.gov

    Cancer treatments known as oncolytic viruses are being tested in clinical trials, and one, T-VEC or Imlygic®, has been approved by the FDA. Research now suggests that these treatments work not only by infecting and killing tumor cells, but that they may also be a form of cancer immunotherapy.

  5. 75 FR 38699 - Implantation or Injectable Dosage Form New Animal Drugs; Propofol

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-06

    ...The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of propofol as an anesthetic in dogs and cats.

  6. Potassium Iodide ("KI"): Instructions to Make Potassium Iodide Solution for Use During a Nuclear Emergency (Liquid Form)

    MedlinePlus

    ... high capacity to mask the saltiness while low fat milk has little capacity to cover the saltiness of KI. This work was completed through a FDA contract with the Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee, Memphis, TN ...

  7. 21 CFR 601.14 - Regulatory submissions in electronic format.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Regulatory submissions in electronic format. 601... SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.14 Regulatory submissions in electronic format. (a) General. Electronic format submissions must be in a form that FDA can process, review, and...

  8. 21 CFR 601.14 - Regulatory submissions in electronic format.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Regulatory submissions in electronic format. 601... SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.14 Regulatory submissions in electronic format. (a) General. Electronic format submissions must be in a form that FDA can process, review, and...

  9. 21 CFR 601.14 - Regulatory submissions in electronic format.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Regulatory submissions in electronic format. 601... SERVICES (CONTINUED) BIOLOGICS LICENSING Biologics Licensing § 601.14 Regulatory submissions in electronic format. (a) General. Electronic format submissions must be in a form that FDA can process, review, and...

  10. Soy Foods for Enhancing Women's Health.

    ERIC Educational Resources Information Center

    Fly, Alyce D.

    2002-01-01

    Describes the forms of soy available as food ingredients and foods, the components in soy that may be important to women's health, the FDA health claim permitted for soy foods and ingredients, and research studies examining the role of soy in reducing cholesterol, cancer risk, osteoporosis, and symptoms of menopause. (Contains references.) (SM)

  11. 21 CFR 720.7 - Notification of person submitting cosmetic product ingredient statement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Notification of person submitting cosmetic product... AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.7 Notification of person submitting cosmetic product ingredient statement. When Form FDA...

  12. 21 CFR 720.7 - Notification of person submitting cosmetic product ingredient statement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of person submitting cosmetic product... AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.7 Notification of person submitting cosmetic product ingredient statement. When Form FDA...

  13. 21 CFR 720.7 - Notification of person submitting cosmetic product ingredient statement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Notification of person submitting cosmetic product... AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.7 Notification of person submitting cosmetic product ingredient statement. When Form FDA...

  14. 21 CFR 720.7 - Notification of person submitting cosmetic product ingredient statement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of person submitting cosmetic product... AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.7 Notification of person submitting cosmetic product ingredient statement. When Form FDA...

  15. 21 CFR 720.7 - Notification of person submitting cosmetic product ingredient statement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Notification of person submitting cosmetic product... AND HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.7 Notification of person submitting cosmetic product ingredient statement. When Form FDA...

  16. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

  17. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

  18. 36 CFR 13.980 - Other FDA closures and restrictions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...

  19. 21 CFR 314.102 - Communications between FDA and applicants.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...

  20. FDA Kids' Home Page

    MedlinePlus

    ... and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical ... 日本語 | فارسی | English FDA Accessibility Careers FDA Basics FOIA No FEAR Act ...

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