 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
For additional information about the implementation of the Prescription Drug User Fee Act (PDUFA) IV and the Medical Device User Fee Act (MDUFA) please go to these FDA web sites:
SECTION |
DESCRIPTION |
TARGET DATE |
ACTIONS COMPLETED/ DOCUMENTS AVAILABLE |
AGENCY CONTACT |
|---|---|---|---|---|
103 |
Workload adjuster modified to user active INDs |
08-01-2008 |
Completed |
OC/OFM – Helio Chaves and David Miller |
103 |
Contract with independent accounting firm to study workload adjuster & make recommendations |
10-31-2008 |
|
OC/OPPP – John Hassenplug and Bill Hagan |
104 |
Publish FR notice NLT 30 days after enactment requesting persons to notify Secty of number of DTC ads they intend to submit in next fy |
10-25-2007 |
Published Federal Register Notice of termination
10/25/2007 |
CDER – Tom Abrams |
104 |
Publish fees for DTC review NLT 90 days after enactment in FY08 and NLT August 1 in each FY after FY08 |
12-26-2007 |
Program no longer exists. Published Federal
Register Notice of termination 1/16/2008 |
CDER- Tom Abrams |
104 |
If Secretary has not received $11.25M in advisory review fees and operating reserves combined the program shall not commence and all collected fees shall be refunded |
02-26-2009 |
Program no longer exists. Published Federal
Register Notice of termination 1/16/2008 |
CDER – Tom Abrams |
105 |
Prepare and submit to SenateHELP and House E&C Committees report on progress in achieving performance goals |
01-28-2009 |
|
OC |
105 |
Report on implementation of fees during such fiscal year |
01-28-2009 |
|
OPPP |
105 |
Prior to beginning negotiations with regulated industry on reauthorization of PDUFA after 2012, the secretary shall publish an FR notice requesting public input on the reauthorization |
03-01-2010 |
|
OPPP |
105 |
Prior to beginning negotiations with regulated industry on reauthorization of PDUFA after 2012, the secretary shall hold a public meeting at which public may present views on reauthorization |
06-01-2010 |
|
OPPP |
105 |
Public Review of Recommendations for PDUFA V--after negotiations with industry Secty shall publish recs, provide 30 day comment period and hold public meeting; revise recs as necessary |
09-01-2011 |
|
OPPP |
105 |
Transmittal of revised recommendations to Congress |
01-15-2012 |
|
OPPP |
105 |
Publication of minutes of all negotiation meetings on FDA's website |
08-01-2011 |
|
OPPP |
212 |
If fewer than 12,250 establishments register during FY 2009, FDA may increase the annual establishment registration fee for FYs 2010 through 2012 by no more than an additional 8.5%; If FDA increases the fee, publish a Federal Register explaining the increase. |
08-01-2009 |
|
CDRH – Terry McDonald |
212 |
Provide a means for a foreign business not submitting Federal (U.S) income tax return to qualify as a "small business" |
10-27-2007 |
Completed |
Division of Small Manufacturers, International, and Consumer Assistance 800-638-2041 |
212 |
Determine whether medical device user fees for FY 2012 must be reduced to offset excess fee collections during FYs 2008 through 2011. |
8-1-2011 |
|
OFM |
213 |
Annual performance report to Congress |
01-28-2009 |
|
OPPP/OPL – John Uzzell |
213 |
Annual fiscal report to Congress |
01-28-2009 |
|
OFM - Helio Chaves |
213 |
Make annual fiscal and performance reports available to the public on FDA's website |
2-28-2009 |
|
(Fiscal Report) OFM - Helio Chaves (Performance Report) OPPP/OPL – John Uzzell |
213 |
Consult with Congress, outside stakeholders, and public to develop recommendations for MDUFA goals for reauthorization for years after 2012. Transmit recommendations to Congress. Before submission to Congress, publish an FR notice, hold a public meeting, and allow for 30 days to pass following the public meeting for written comment, and consult with public and patient groups at least once a month during negotiations. Provide minutes from all reauthorization negotiation meetings on FDA's website. |
01-15-2012 |
|
OC |
222 |
Registration |
|
Federal Register notice on Agency Information Collection Activities published 10/1/08 |
OC/OIM - Denver Presley, Jr. |
223 |
Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by registrants |
|
Federal Register notice on Agency Information Collection Activities published 10/1/08 |
OC/OIM - Denver Presley, Jr. |
224 |
Electronic registration and listing |
|
Federal Register notice on Agency Information Collection Activities published 10/1/08 |
OC/OIM - Denver Presley, Jr. |
226 |
Promulgate regulations requiring the label of devices to bear a unique identifier |
|
|
CDRH – Jay Crowley |
228 |
Revise guidance on third-party inspection program to reflect changes relating to notice to be provided that an accredited person may not be used; information FDA may request about compliance or an accredited person; and how to obtain review of an FDA decision to disqualify accredited person |
|
|
CDRH – John Stigi |
230 |
Report to Congress on labeling on the relationship between the use of indoor tanning devices and development of skin cancer/damage |
09-27-2008 |
|
CDRH – John McCrohan |
302 |
Annual report on number of devices related to pediatrics |
03-27-2009 |
|
CDRH – Barbara Buch |
303 |
Guidance to institutional review committees on how to evaluate requests for approval of exempted devices |
03-25-2008 |
Submit to Congress a report on the number of vacancies and disclosures related to Advisory Committees Federal Register Notice published on 8/5/08; comments due 11/3/08 |
CDRH – Stephen Rhodes |
304 |
FDA supporting lead of NIH to submit a plan for expanding pediatric medical device research & development to Congress. |
03-25-2008 |
Draft Pediatric Device Development Plan (PDF) dated June 2008 published on NIH website |
CDRH and OC |
402 |
PeRC (Pediatric Review Committee/Internal Review Committee) shall conduct a retrospective review of a sample of waivers and deferrals, and shall issue recommendations to review divisions based on Committee's review |
09-27-2008 |
|
CDER – Lisa Mathis |
402 |
Tracking of Assessments and Labeling Changes in a public information website |
|
|
CDER – Lisa Mathis |
402 |
Initiate guidance to industry related to the scope of pediatric studies require under PREA |
|
|
CDER – Lisa Mathis |
403 |
Establish an internal committee within FDA to review both BPCA and PREA related activities |
10-27-2007 |
Created Committee |
CDER – Lisa Mathis |
502 |
Review BPCA activities (same as Committee created in Section 403) |
|
|
CDER – Lisa Mathis |
502 |
Toll-Free Number for Adverse Events on Labeling for Human Drug Products - Proposed Rule to take effect on January 1, 2008 unless final rule issued |
01-01-2008 |
Law took effect 1/1/08 |
CDER – Lisa Mathis |
505 |
Tracking of Assessments and Labeling Changes in a public information website |
|
|
CDER – Lisa Mathis |
601 |
Appoint Board of Foundation |
10-27-2007 |
Appointed Board of Foundation |
OC – Lisa Rovin |
602 |
Create Office of the Chief Scientist, appoint Chief Scientist, includes an array of coordination and tracking duties |
|
Completed on April 9, 2008 |
OC |
701 |
Develop and implement strategies for outreach and recruitment of advisory committee members |
|
|
OPPP |
701 |
Determine for FY 07 the total number of advisory committee members participating in meetings and the number who received an exception; determine the percentage receiving exceptions |
|
Completed |
OPPP |
701 |
Submit to Congress a report on the number of vacancies and disclosures related to Advisory Committees |
02-01-2008 |
Report to Congress sent 5/19/08 |
OPPP |
701 |
Publicly disclose the nature and amount of a committee member's financial interest and the justification for the waiver |
|
Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Federal Register notice published 10/31/07 Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Federal Register notice published 8/5/08 |
OPPP - Jill Hartzler Warner |
701 |
Review guidance regarding advisory committee conflict of interest waiver determinations |
|
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Federal Register notice published 8/5/08 |
OPPP - Jill Hartzler Warner |
801 |
Ensure that the registry includes links to the results of efficacy trials or trials conducted post-approval, any FDA Advisory Committee summaries, and FDA Public Health Advisories |
12-26-2007 |
|
OSHI – Terry Toigo |
801 |
Update investigational drug regulations to include in informed consent documents that a statement certifying that clinical trial information has or will be submitted to registry |
|
|
OSHI – Terry Toigo |
801 |
Issue guidance on how certain requirements apply to pediatric post-market surveillance under 402(j) of the PHSA, as amended |
09-27-2008 |
|
OSHI – Terry Toigo |
801 |
Submission of certification with applications and submissions to FDA |
12-26-2007 |
OSHI – Terry Toigo |
|
901 |
Promulgate regulations related to expanded access for patients with serious or life-threatening conditions |
|
|
CDER |
901 |
Issue regulations on the standards for determining whether advertisements are clear, conspicuous, and neutral as it relates to side effects and contraindications |
03-25-2010 |
Federal Register notice on Agency Information Collection Activities published on 8/6/08; comments due 9/5/08 |
CDER – Tom Abrams |
901 |
Report to Congress on the ability of DTC ads to communicate to subsets of the general population. |
|
Comments Related to Required Report on Direct-to-Consumer Advertising Federal Register notice published on 4/28/08 |
CDER – Tom Abrams |
904 |
Report to Congress on how best to communicate risk-benefit and REMS to the public |
09-27-2008 |
|
CDER – Theresa Mullin |
905 |
Report to Congress on use of post-market surveillance system |
09-27-2011 |
|
CDER – Melissa Robb |
905 |
Procedures for routine contracting with qualified entities for advanced analysis of drug safety data |
03-25-2011 |
|
CDER – Melissa Robb |
906 |
Conduct study in consultation with advisory committee on risk communication to determine if adverse event statement is appropriate for TV ads |
03-25-2008 |
Report delivered to Congress 5/12/08. |
CDER – Tom Abrams |
909 |
Certain drugs deemed to have REMS |
|
CDER – Mary Dempsey |
|
911 |
Issue guidance on conducting clinical trials involving antimicrobials to treat acute bacterial sinusitis. |
09-27-2008 |
Clinical Trials involving Antimicrobials
Acute Bacterial Sinusitis Guidance published in draft 10/30/07. |
CDER – Ed Cox |
911 |
Issue guidance on conducting clinical trials involving antimicrobials to treat acute bacterial otitis media. |
09-27-2008 |
Clinical Trials involving Antimicrobials
to Treat Acute Bacterial Otitis Media Guidance published in draft 1/18/08. |
CDER – Ed Cox |
911 |
Issue guidance on conducting clinical trials involving antimicrobials to treat acute bacterial exacerbation of chronic bronchitis. |
09-27-2008 |
Conducting clinical trials involving antimicrobials to treat acute bacterial exacerbation of chronic bronchitis published in draft 8/25/08 |
CDER – Ed Cox |
912 |
Prohibit the introduction into interstate commerce any food to which has been added certain drugs or biological products, unless the drug or biological product meets certain requirements |
|
Federal Register Notice published on 7/29/08; comments due 10/27/08 |
CFSAN – Catherine L. Copp |
913 |
Develop standardized numerical identifier for prescription drugs and develop standards for identification, validation, authentication, and tracking/tracing of Rx drugs |
03-27-2010 |
Federal Register Notices published on 3/20/08:
FDA-2008-N-0120 |
OPPP - Ilisa Bernstein |
914 |
Annual Report to Congress on delays in approvals because of citizen petitions |
|
|
CDER – Nancy Boocker |
914 |
Report to Congress on ways to encourage the early submissions of petitions under Section 505(q) |
09-27-2008 |
|
CDER – Nancy Boocker |
915 |
Develop an internet website that provides drug safety information to patients and providers by: including searchable drug safety info, patient labeling and package inserts, lists of each drug, link to clinical trial registry data bank, submission of adverse event reports through the Internet etc. |
09-27-2008 |
Postmarket Drug Safety Information for Patients and Providers website published 10/15/08 |
CDER - Paul Seligman and Sally Winthrop |
918 |
Referral to Advisory Committee |
|
Draft Guidance for the Public and the Food and Drug Administration Staff on Convening Advisory Committee Meetings; Federal Register notice published 8/5/08; comments due 10/6/08 |
OPPP - Jill Hartzler Warner |
919 |
Issue a report in response to the 2006 Institute of Medicine report |
09-27-2008 |
|
CDER – Jane Axelrad |
920 |
Publish a complete list of authorized generic drugs and notify certain federal agencies |
06-27-2008 |
Published FDA Listing of Authorized
Generics on 6/27/08. |
CDER – Helen Winkle |
921 |
Report to Congress on how the Agency addresses post-market safety issues |
09-27-2009 |
|
CDER - Ann McMahon |
921 |
Annual Report to Congress on the Review Entire of Backlog of Postmarket Safety Commitments to Evaluate which require Revision/Elimination |
|
|
CDER – Cathryn Lee |
1002 |
Regulation for (1) Ingredient Standards and Definitions; (2) Processing Standards; and (3) Labeling Standards Including nutritional and ingredient information |
09-27-2009 |
Federal Register Notice published on 4/21/08; comments due 6/13/08 |
CVM - |
1002 |
Early Warning Surveillance System |
09-27-2008 |
|
CVM |
1003 |
Ensuring efficient and effective communication during a recall. Create searchable public database for recalled human and pet foods. |
|
|
ORA -Carolyn Becker |
1005 |
Establish a Reportable Food Registry to which instances of reportable food may be submitted via an electronic portal and a unique number is issued to the person submitting the report upon receipt |
09-27-2008 |
Federal Register Notice published on 5/27/08;
comments due 8/11/08 |
CFSAN – Faye Feldstein |
1005 |
Issue guidance to industry about how to submit reports to the electronic Reportable Food Registry and providing notifications to other persons |
06-27-2008 |
|
CFSAN – Faye Feldstein |
1006 |
Report to Congress on specifics of aquaculture and seafood inspection program, the feasibility of developing a traceability system and provide an assessment of risks associated with particular contaminants and banned substances |
03-25-2008 |
|
CFSAN – Donald Kraemer |
1007 |
Work with NOAA to produce report on environmental risks associated with genetically engineered seafood |
|
|
CVM |
1009 |
Annual Report to Congress on FDA food regulation and inspection for the preceding year |
|
|
ORA - Carolyn Becker |
1010 |
Submit to Congress and publish on FDA website a report concerning pesticide residue monitoring program |
06-01-2008 |
Reports published on 8/4/08. Ginseng Dietary Supplements Special Survey (CFSAN Assignments and Field
Regulatory Monitoring |
CFSAN – Nega Beru |
1010 |
Commissioner of Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce and the head of the Agricultural Marketing Service shall enter into a memorandum of understanding to permit inclusion of data in reports related to testing carried out by FSIS and AMS |
|
|
CFSAN – Nega Beru |
1101 |
Make publicly available written procedures to implement policy on review and clearance of scientific articles |
|
|
OPPP – Phil Chao |
1102 |
Establish the amount of a priority review user fee for priority review voucher program |
09-30-2008 |
Draft Guidance for Industry: |
CDER – Theresa Mullin |
1111 |
Make available on FDA website any clinically susceptible concentrations (values that characterize bacteria) |
|
Federal Register Notice published
on 6/12/08; comments due 8/11/08 |
CDER – Nancy Boocker |
1112 |
Convene a public meeting re: serious and life-threatening diseases due to antimicrobial resistance |
|
Notice of April 28, 2008 Public Hearing and Request for Comments |
CDER – Ed Cox |
1113 |
Publication of List developed by USP pursuant to Section 1860D-4(b)(3)(C)(ii) of the Social Security Act |
|
CDER |
