FDAMA Implementation Chart of Completed Items
| SECTION | DESCRIPTION | DOCUMENT TYPE | STATUTORY DEADLINE |
|---|---|---|---|
| 101 | Review performance goals; meeting management goals; clinical hold responses; major dispute resolution; special protocol assignments/agreements; electronic applications and submissions; simplification of action letters; discipline reviews/IR letters; two level resubmission class 1 & 2 | Task | Phased in over 5 years COMPLETED |
| 104 | Annual Report to Congress--Performance | Report | Annually--60 days after end of fiscal year 12/16/1998 1/19/2000 3/19/2001 COMPLETED |
| 104 | Annual Report to Congress--Financial | Report | Annually--120 days after end of fiscal year 2/16/2000 1/19/2001 COMPLETED |
| 111 | Pediatric exclusivity guidance document | Guidance | None COMPLETED |
| 111** | Pediatrics--list of approved drugs needing information | FR Notice | May 20, 1998 Final list COMPLETED 5/20/1998 |
| 111** | Pediatrics--study and report to Congress | Task | Jan. 1, 2001 COMPLETED January 2001 |
| 112** | Fast Track--policies and procedures on fast track products | Guidance | 11/21/1998 COMPLETED 11/17/1998 |
| 112** | Fast track--disseminate to physicians and others a description of section | Task | COMPLETED (covered in previous guidance) |
| 112** | Fast track--develop program to encourage development of surrogate endpoints | Task | None COMPLETED NIH/FDA Conference April 1999 Book/Article March 2001 |
| 113** | Draft guidance for industry on info program on clinical trials for serious or life-threatening diseases: establishment of a data bank | Guidance | None Final 3/18/2002 NIH Press Release (2-29-2000) |
| 113 | Draft guidance on information program on clinical trials for serious or life-threatening diseases: implementation plan | Guidance | None Final 3/18/02 |
| 113b | Feasibility of adding medical devices to clinical trial registry--report to Congress | Report | None COMPLETED 11-26-1999 |
| 114** | Healthcare economic info--participate in Comptroller General study of program | Task | May 21, 2002 GAO will contact FDA when it plans to start this study. |
| 115** | Women and minorities in clinical trials--develop procedures (as appropriate) | Guidance | None COMPLETED (covered in existing guidance) |
| 116** | Changes to an approved NDA or ANDA | Guidance | None COMPLETED |
| 116 | Manufacturing changes | Guidance | None COMPLETED 10/1/1999 |
| 116** | Manufacturing changes | Regulation | COMPLETED 12/13/2006 Final Rule 11/21/1999 |
| 117 | Streamlining clinical research--revise 312, particularly clinical holds | Regulation | None COMPLETED Direct Final Rule: 12/14/1998 |
| 117 | Submitting and reviewing complete responses to clinical holds | Guidance | None COMPLETED 5/14/1998 |
| 118** | Data requirements--provide guidance on the use of abbreviated study reports in an NDA and BLA | Guidance | 11/21/1998 DRAFT 9/21/1998 COMPLETED 9/13/1999 |
| 119** | Content and review of applications--guidance for reviewers setting standards for review | Guidance | None COMPLETED 4-27-1999 (existing guidance sufficient) |
| 119 | Formal meetings with sponsors and applicants of PDUFA products | Guidance | None Draft Published 3/19/1999 COMPLETED Final 3/6/2000 |
| 119(a) | Draft guidance for industry on special protocol assessment | Guidance | None Draft 2/8/2000 Final 5/16/2002 |
| 120 | Scientific advisory panels- guidance on statutory requirements | Guidance | None COMPLETED 11/2/1998 |
| 121** | PET--revoke current PET rules and policies | Regulation | SD: 12/21/1997 COMPLETED 12/19/1997 |
| 121 | PET--notice in FR terminating three previous docs | FR Notice | 12/21/1997 COMPLETED 12/19/1997 |
| 121 | PET--505(b)(2) notice of safety and effectiveness | FR Notice | None COMPLETED 3/7/2000 |
| 122** | Radiopharmaceuticals--requirements for review of radiopharmaceuticals | Guidance | None Revised Draft 7/31/2000 Notice Guidance COMPLETED Final Guidances (6/22/2004) |
| 122** | Radiopharmaceuticals--new requirements for review of radiopharmaceuticals | Regulation | 5/20/1999 COMPLETED Proposed Rule 5/20/1998 Final Rule 5/17/1999 |
| 123** | Biologics modernization--regulations for BLAs | Regulation | None COMPLETED (PR) 7/29/1998 FR 10/19/1999 |
| 125 | Antibiotics--conforming changes to regs to delete antibiotic monographs | Regulation | None COMPLETED 5/12/1998 |
| 125 | Antibiotics--antibiotic certification program | Regulation | None COMPLETED 1/5/1999 |
| 125 | Insulin--Conforming changes to regs to delete insulin certification program | Regulation | None COMPLETED 5/13/1998 |
| 125 | Antibiotic guidance document | Guidance | None COMPLETED 6/11/1998 |
| 125(b) | Drug master files for antibiotic drug substances | Guidance | None COMPLETED 11/26/1999 |
| 126 | Elimination of labeling requirements | Guidance | None COMPLETED 3/13/1998 Revised guidance COMPLETED 7/20/1998 |
| 126 | Elimination of certain labeling requirements--revise 201 and 329 regarding "Rx only"/"Caution: May be Habit-Forming" labeling | Regulation | None Proposed Rule 4-10-2000 Final Rule 2/1/2002 |
| 127** | Pharmacy compounding--list of drugs that have been removed or withdrawn from the market that may not be compounded | Regulation | None (effective 11/21/1998) COMPLETED(FR) 3/8/1999 Additions (PR) 1/4/2000 |
| 127 | Pharmacy compounding--establish compounding advisory committee | Task | None Notice COMPLETED 3/10/1998 |
| 127 | Pharmacy compounding--Section 127 | Guidance | None COMPLETED 11/20/1998 |
| 129** | Sunscreens-complete final rule | Regulation | COMPLETED FR 5/21/1999 FR Amended 6/7/2000 |
| 130 | Postmarketing studies--revise 314 and 601 to require annual progress reports | Regulation | None COMPLETED Proposed Rule 11/30/1999 FR 10-26-00 Delay of Effective Date 2/16/2001 Effective Date 4/30/2001 |
| 130 | Reports on status of postmarketing studies | Guidance | None Draft 4/3/2001 Final Guidance |
| 130** | Postmarketing approval studies--summary of annual reports and legislative recommendations submitted to Congress | Task | Annual Report 3/12/2002 COMPLETED |
| 201** | New Section in 812, allow minor manufacturing changes or minor changes to clinical protocol | Regulation | 11/21/1998 COMPLETED 11/20/1998 |
| 201/205 | Early collaboration procedures | Guidance | None COMPLETED 2/19/98 Revised 2/28/2001 |
| 202 | PMA/510(k) expedited review | Guidance | None COMPLETED 3/20/1998 |
| 203 | Humanitarian use--75 day review, repeal of 18 month term | Regulation | None COMPLETED 11/3/1998 Final Rule |
| 204 | Procedures for declaration of conformity | Guidance | None COMPLETED 2/19/1998 |
| 204 | List of recognized standards | FR Notice | None COMPLETED 10/16/1998 FR notice
7-12-1999 |
| 205 | Evidence models for the least burdensome means to market | Guidance | None Draft 9/1/1999 |
| 205 | Manufacturing changes--30-day notice; 135-day review of supplements | Regulation | None COMPLETED 10/8/1998 |
| 205 | PMA supplement manufacturing changes--30- day notices | Guidance | None COMPLETED 2/19/1998 |
| 205 | Scope of review--labeling changes; intended uses/510(k)s | Guidance | None COMPLETED 2/19/1998 |
| 205 | Least burdensome provisions of FDAMA: concept and principles | Guidance | None Draft 5/3/ 2001 Notice Final Guidance (10/4/2002) |
| 206 | Procedures for class II exemption petitions | Guidance | None COMPLETED 2/19/1998 |
| 206 | Codify classification regs re: exemptions, class I | Regulation | None Proposed Rule 11/10/1998 COMPLETED Final Rule 1/13/2000 |
| 206 | Codify classification regs re: exemptions, class II | Regulation | None COMPLETED Final Rule 11/3/1998 |
| 206(c)(1)** | General/specific use | Guidance | 8/18/1998 COMPLETED Draft guidance 5/22/1998 Final guidance 11/4/1998 |
| 206 | Day 1 guidance | Guidance | None COMPLETED 2/6/1998 |
| Overview of FDA Modernization Act of 1997/Medical Device Provisions | Guidance | None COMPLETED 2/19/1998 | |
| 206 | Class I & II exemptions from 510(k) | FR Notice | 1/20/1998 (Class II) COMPLETED 1/20/1998 (Class II) COMPLETED 2/2/1998 (Class I) |
| 207 | Content requirements for de novo classification requests | Guidance | None COMPLETED 2/19/1998 |
| 208 | Amended panel procedures | Guidance | None COMPLETED 3/20/1998 Revised 7/22/2000 |
| 209 | Procedures for PMA collaborative review | Guidance | None COMPLETED 2/19/1998 |
| 210 | Guidance for staff, industry and third parties--implementation of third-party programs | Guidance | None COMPLETED 10/30/1998 Revised 7/17/2000 Revised 3/7/2001 |
| 210** | Third party pilot--accreditation procedures | FR Notice | 5/20/1998 COMPLETED 5/20/1998 |
| 210** | FDA accepts accredited person recommendations on 510(k)s | Task | 11/21/1998 COMPLETED 11/21/1998 |
| 210** | Report to Congress on inclusion of certain devices within the accredited persons program--third-party review. | Task | Nov. 21, 2000 COMPLETED |
| 210 | Expand list of devices eligible for third-party review | Task | None COMPLETED 5/20/1998 Updated 2/8/1999 Updated 1/26/2001 |
| 210 | List of accredited persons | Task | COMPLETED 10/2/1998 |
| 211 | Tracking list | FR Notice | None COMPLETED Revised 1/21/2000 Proposed Amendments 4/24/2000 |
| 212 | Postmarket surveillance | Regulation | None PR 8/29/2000 FR 6/6/2002 |
| 212 | Guidance on procedures to determine application of postmarket surveillance strategies | Guidance | None COMPLETED 2/19/1998 |
| 212 | Guidance on procedures for review of postmarket surveillance submissions | Guidance | None COMPLETED 2/19/1998 Revised 11/2/1998 |
| 212 | SMDA to FDAMA: Guidance on FDA's transition plan for existing postmarket surveillance protocols | Guidance | None COMPLETED 11/2/1998 |
| 212 | Criteria and approaches for postmarket surveillance | Guidance | None COMPLETED 11/2/1998 |
| 213 | Reporting corrections and removals | Regulation | None COMPLETED 8/7/1998 |
| 213 | Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting | Regulation | None Proposed Rule 5/12/1998 Final Rule 1/26/2000Technical Amendment 5/8/2001 |
| 213(b) | Establishment registration and device listing | Regulation | None COMPLETED 9/29/1998 |
| 213** | Sentinel reporting | Report | 11/21/1999 COMPLETED 9/20/1999 |
| 216 | Guidance on section 216 of FDAMA | Guidance | None COMPLETED 8/8/2000 |
| 302 | Amend existing regulations on health claim and nutrient content claim petitions to make timeframes consistent with the statute | Regulation | None COMPLETED 5/14/1998 |
| 303 and 304 | Notification of health claim or nutrient content claim based on authoritative statement of a scientific body | Guidance | COMPLETED 6/11/1998 |
| 305 | Amend existing regulation on referral statements on food labels | Regulation | COMPLETED 5/15/1998 |
| 306 | Amend existing regulation to conform to disclosure of radiation section--21 CFR 179.26 | Regulation | None COMPLETED 8/17/1998 |
| 306 Conf. report | Act on language in conference report to publish proposed amendments to current regs relating to irradiated food | Regulation | None COMPLETED 2/17/1999 |
| 307** | Make final determination on irradiation petition (to be done by regulation) | Regulation | 1/20/1998 COMPLETED 12/3/1997 |
| 309 Conf. report | Resolve regulatory authority issues, arising from FQPA, for antimicrobials used as food contact substances (Jt. explanatory statement of the committee of conference) | Task | None COMPLETED 10/30/1998 (P.L. 105-324) and 10-9-1998 |
| 309 | Create regulations to implement food contact substances premarket notification system: environmental regulations | Regulation | None Direct Final Rule 5/10/2000 COMPLETED |
| 309 | Food contact substance notification system: administrative guidance for main procedural regulation | Guidance | None COMPLETED Draft 7/12/2000 |
| 309 | Premarket notifications for food contact substances: chemistry | Guidance | None COMPLETED Draft 11/10/1999 |
| 309 | Premarket notifications for food contact substances: toxicology | Guidance | None COMPLETED |
| 309 | Food contact substance notification system: main procedural regulation | Regulation | Completed Proposed Rule 7/12/2000 Final Rule 5/21/2002 |
| 309** | Provide reports (through FY 2003) to Congress on estimate of costs of carrying out the food contact substances notification program | Report | Annually COMPLETED |
| 401** | Information on off-label uses | Regulation | 11/21/1998 11/20/1998 Final Rule (63 FR 64556) Sunset at Sep. 30, 2006 |
| 402 | Expanded access to investigational therapies and diagnostics | Guidance | None COMPLETED 2/19/1998 |
| 403(a) | Supplemental applications-standards for prompt review | Guidance | 5/20/1998 COMPLETED 5/14/1998 |
| 403(a) | Supplemental applications--standards for prompt review | Notice | None COMPLETED FR Notice 2/7/2000 |
| 403(a)(c) | Standards for prompt review of supplements | FR Notice | 5/20/1998 COMPLETED 5/20/1998 |
| 403(b) | PMAs and PMA supplements: use of published literature, use of previously submitted materials, and priority review | Guidance | 5/20/1998 COMPLETED 5/20/1998 |
| 403(b)(1) | Clarify circumstances for using published material as basis for approving supplemental applications | FR Notice | None COMPLETED 11/6/2000 |
| 403(b)(2) | Clarify and facilitate submission of data for supplemental applications | Guidance | 5/20/1998 FR Notice 2/8/2000 Final Guidance 10/28/2002 |
| 403(b)** | Approval of supplemental applications--complete guidance to clarify requirements for submission of supplements | Guidance | 5/20/1998 COMPLETED 5/15/1998 |
| 403(c)** | Designate an individual to encourage prompt review of supplements and to work with sponsors | Task | None COMPLETED 2/3/1999 |
| 403(c) | Designate an individual to encourage prompt review of supplements and to work with sponsors | Notice | None COMPLETED 5/21/1998 |
| 403(c) | Designate an individual to encourage prompt review of supplements and to work with sponsors | Notice | None COMPLETED FR Notice 2/7/2000 |
| 404** | Dispute resolution--procedures and special advisory committee | Regulation | 11/21/1998 COMPLETED (FR) 11/17/1998 |
| 404 | Handbook of existing appeals processes | Guidance | None COMPLETED 2/19/1998 |
| 404 | Formal dispute resolution above division level | Guidance | None COMPLETED |
| 404 | Draft guidance on resolving scientific disputes concerning the regulation of medical devices; administrative procedures on use of the medical devices dispute resolution panel | Guidance | None Draft Published 4/27/1999 |
| 405 | Training for GGPs | Task | None |
| 405** | Good guidance practices | Regulation | July 1, 2000 COMPLETED |
| 406** | Agency plan for statutory compliance | Report | 11/21/1998 COMPLETED 11/20/1998 FR 11/24/1998 |
| 406 | Mechanisms for meeting review time periods | Report | 7/1/1999 COMPLETED 7/1/1999 |
| 407** | Multicenter report on information systems. | Report | 11/21/1998 COMPLETED 12/17/1998 |
| 408** | Conduct training and education programs for employees, work with CDC on fellowship and training programs. | Task | None COMPLETED |
| 409** | Centers for Education, Research and Therapeutics (CERTS)--establish demo program | Task | None COMPLETED 9/29/1999 |
| 410** | Plan for mutual recognition of GMP inspections | FR Notice | 5/20/1998 COMPLETED 5/20/1998 |
| 412 | National uniformity--revise part 201--labeling provisions (OTC products) | Regulation | None COMPLETED |
| 413 | National uniformity--labeling provisions (OTC products) | Guidance | COMPLETED 4/9/1998 |
| 413 | Notice asking manufacturers to provide FDA with information on mercury compounds in drugs and foods | FR Notice | None COMPLETED 12/14/1998 |
| 413** | Mercury compounds--develop list and analysis | Task | 11/21/1999 COMPLETED |
| 417 | Registration of foreign establishments US Agent-807.40 | Regulation | None COMPLETED |
| H. Report allergenic patch test kits; requests for comments or data 105-307, Sec. 17 | FR Notice | None COMPLETED 10/1/1998 FR Notice |