Regulatory Information
FDAAA Implementation Chart
For additional information about the implementation of the Prescription Drug User Fee Act (PDUFA) IV and the Medical Device User Fee and Modernization Act (MDUFMA) 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 Federal Register notice published 10/12/07 HTML or PDF | OC/OFM – David Miller |
| 103 | Contract with independent accounting firm to study workload adjuster & make recommendations | 10-31-2008 | Contract awarded 8/14/08. Study was completed on 3/31/09. HTML or PDF | 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 HTML or PDF | 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 HTML or PDF | 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 HTML or PDF | 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 web site | 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 FDA has posted new guidance on MDUFMA web site HTML or PDF FR Notice published 10/23/07 HTML or PDF | 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 - David Miller | |
| 213 | Make annual fiscal and performance reports available to the public on FDA's web site | 2-28-2009 | (Fiscal Report) OFM - David Miller(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 web site. | 01-15-2012 | OC | |
| 222 | Registration | Federal Register notice on Agency Information Collection Activities published 10/1/08 Federal Register notice on Agency Information Collection Activities published 12/12/08 | 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 Federal Register notice on Agency Information Collection Activities published 12/12/08 | OC/OIM - Denver Presley, Jr. | |
| 224 | Electronic registration and listing | Federal Register notice on Agency Information Collection Activities published 10/1/08 Federal Register notice on Agency Information Collection Activities published 12/12/08 Federal Register notice on final guidance published 6/1/09 | OC/OIM - Denver Presley, Jr. | |
| 226 | Promulgate regulations requiring the label of devices to bear a unique identifier | 2/12/09 Public Workshop Notice published on 1/15/09; comments due 2/27/09 HTML or PDF | 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 | ||
| 229 | GAO shall conduct a study of nosocomial infections attributable to new and reused medical devices | 09-27-2008 | GAO study published 9/26/08 HTML or PDF | OC - Claudia Grillo |
| 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 | Report to Congress sent 12/2/08 HTML or PDF | 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 | Federal Register Notice published on 8/5/08; comments due 11/3/08 HTML or PDF | 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 web site | CDRH and OC |
| 305 | Demonstration grants for improving pediatric device availability.
| Pediatric Device Consortia Grant Program Request for Applications Federal Register Notice published 5/4/09; applications due 6/15/09
Four pediatric medical device consortia grants have been awarded by Office of Orphan Products Development. Grantees include Michigan Pediatric Device Consortium; the Pediatric Cardiovascular Device Consortium at Boston Children's Hospital; the UCSF Pediatric Device Cosortium; and SRI International's MISTRAL constortium. | OC/OOPD - Linda C. Ulrich or Debra Y. Lewis
| |
| 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 | Retrospective Review completed available at PDF | CDER – Lisa Mathis | |
| 402 | Tracking of Assessments and Labeling Changes in a public information web site | Labeling changes web site formulated and located at Pediatric Exclusivity Labeling Changes. | CDER – Lisa Mathis | |
| 402 | Initiate guidance to industry related to the scope of pediatric studies required under PREA based on retrospective review | 08-31-2010 | Status: Guidance drafted and has begun final clearance. | 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 | 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 Final Rule Federal Register published 10/28/08 Federal Register notice on agency collection acitivities, comment request, and experimental study published 11/26/08; comments due 1/26/09 | CDER – Lisa Mathis |
| 505 | Tracking of Assessments and Labeling Changes in a public information web site | Pediatric Labeling Changes web site | 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
Dr. Jesse Goodman appointed Acting Chief Scientist announced on 4/13/09 | OC | |
| 701 | Develop and implement strategies for outreach and recruitment of advisory committee members | Completed | 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
02-01-2009 | 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 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 HTML or PDF | 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 | Links available for clinical trials registry at clinicaltrials.gov | OSHI – Terry Toigo FDA AA CLINICAL TRIALS |
| 801 | NIH is to hold a public meeting to provide an opportunity for input from interested parties with regard to regulations for expanded registry and results data bank | 03-25-09 | The public meeting will be held on Monday, April 20, 2009 from 9:00am to 5:00pm | |
| 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 | 12-29-09 | The Notice of Proposed Rulemaking (NPRM) proposing the update to FDA's informed consent regulations was published on 12/29/09. HTML | OSHI – Terry Toigo FDA AA CLINICAL TRIALS |
| 801 | Issue guidance on how certain requirements apply to pediatric post-market surveillance under 402(j) of the PHSA, as amended | 09-27-2008 | NIH guidance on PRS and U.S. Public Law 110-85 http://prsinfo.clinicaltrials.gov/fdaaa.html | OSHI – Terry Toigo FDA AA CLINICAL TRIALS |
| 801 | Submission of certification with applications and submissions to FDA | 12-26-2007 | Federal Register Notice published 12/12/07 Draft certification guidance issued 4/08
| OSHI – Terry Toigo FDA AA CLINICAL TRIALS |
| 901 | Promulgate regulations related to expanded access for patients with serious or life-threatening conditions | Final Rules for Expanded Access published 8/12/09 HTML | CDER | |
| 901 | Issue regulation on postmarketing studies and clinical trials | Draft guidance Federal Register Notice published on 7/15/09
Final Guidance for required postmarketing studies and clinical trials published 3/31/11. Postmarketing Studies and Clinical Trials | CDER - Nancy Clark | |
| 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 Federal Register notice on Agency Information Collection Activities published on 12/30/08; comments due 1/29/09
Regulation published 3/29/10 - Federal Register notice PDF | CDER – Tom Abrams |
| 901 | Report to Congress on the ability of DTC ads to communicate to subsets of the general population. | Report to Congress: Direct-to-Consumer Advertising’s Ability to Communicate to Subsets of the General Population; Barriers to the Participation of Population Subsets in Clinical Drug Trials
Comments Related to Required Report on Direct-to-Consumer Advertising Federal Register notice published on 4/28/08 | CDER – Tom Abrams | |
| 901 | Recommendations to be included in Report to Congress addressing best practice approaches on increasing participation of subsets of the population in clinical drug trials | Report to Congress: Direct-to-Consumer Advertising’s Ability to Communicate to Subsets of the General Population; Barriers to the Participation of Population Subsets in Clinical Drug Trials
Participation of Certain Population Subsets in Clinical Drug Trials Federal Register notice published 1/13/09; Comments due 2/27/09 | OC – Jarilyn Dupont | |
| 901 | Guidance on format and content that should be used for submissions of proposed REMS | Draft guidance Federal Register notice published on 10/1/09 HTML or PDF Draft Guidance | CDER - Kathleen Frost and CBER - Stephen Ripley | |
| 904 | Report to Congress on how best to communicate risk-benefit and REMS to the public | 09-27-2008 | Report to Congress sent on August 31, 2009. Completed 8/31/09 PDF | 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 | Federal Register Notice published on 3/27/08
9/24-25/09 Public Workshop Federal Register Notice published 7/10/09; register by 8/17/09
| 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 Federal Register Notice published 1/16/09; HTML or PDF
Final Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (March 2010) HTML or PDF Federal Register Notice published on 3/29/10 PDF
Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop (February 15-16, 2011) | OPPP - Ilisa Bernstein |
| 914 | Annual Report to Congress on delays in approvals because of citizen petitions | First annual report to Congress sent on April 28, 2009. Second annual report to Congress sent on February 19, 2010 | CDER – Nancy Boocker | |
| 914 | Report to Congress on ways to encourage the early submissions of petitions under Section 505(q) | 09-27-2008 | Draft Guidance for Industry on Citizen Petitions and Petitions Federal Register notice published 1/21/09; comments due 3/23/09 HTML or PDF | CDER – Nancy Boocker |
| 915 | Develop an internet web site 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 web site published 10/15/08 | CDER - Sally Winthrop |
| 917 | Establish the Advisory Committee on Risk Communication | Risk Communication Advisory Committee established 6/5/07. 2008 Meetings were held on: 2009 Meetings were held on: | OPL - Lee Zwanziger | |
| 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 HTML or PDF | OPPP - Jill Hartzler Warner | |
| 919 | Issue a report in response to the 2006 Institute of Medicine report | 09-27-2008 | IOM report completed on July 17, 2009 | 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.
Proposed rule Federal Register notice published 9/29/08
Withdrawal of the Direct Final Rule Federal Register notice published 2/10/09 | CDER – Helen Winkle |
| 921 | Report to Congress on how the Agency addresses post-market safety issues | 09-27-2009 | CDER | |
| 921 | Post a quarterly report on the Adverse Event Reporting System web site of any new safety information - | Updated quarterly
| CDER - Ann McMahon | |
| 921 | Annual Report to Congress on the Review Entire of Backlog of Postmarket Safety Commitments to Evaluate which require Revision/Elimination | First annual report sent to Congress 9/4/09. Second sent 11/10/10. | 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 HTML or PDF 5/13/08 Public Meeting transcripts | CVM - Tracey Forfa |
| 1002 | Early Warning Surveillance System | 09-27-2008 | Pet Food Recalls: Main web site Pet Food Recalls: Searchable web site Reporting a Pet Food Complaint:Safety Reporting Portal
| 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 Draft Guidance Federal Register Notice published on 6/16/09; comments due 7/16/09 Federal Register notice published on 6/26/09 Public Workshops: Federal Register Notice of Availability published on 9/9/09
| CFSAN – Faye Feldstein
CFSAN - Juanita Yates (public workshop questions)
|
| 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 | Report to Congress sent 11/24/08 HTML | 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 web site a report concerning pesticide residue monitoring program | 06-01-2008 | Pesticide Program Pesticide Monitoring Database 2007 published on 7/31/09. 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 | SMG 2126.3 Review of FDA-Related Articles and Speeches HTML | OC/OCS – Matt Warren | |
| 1102 | Establish the amount of a priority review user fee for priority review voucher program | 09-30-2008 | 12/12/08 Public Hearing Notice published on 11/6/08; requests for oral presentations and comments due 11/17/08 Draft Guidance for Industry: | CDER – Theresa Mullin |
| 1111 | Make available on FDA web site any clinically susceptible concentrations (values that characterize bacteria) | Federal Register Notice published on 6/12/08; comments due 8/11/08
Final Guidance published 6/26/09. | 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 | USP Model Guidelines - in effect as of September 27, 2007 | CDER |
