| 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
6/29/1998
Revised 10/8/1999
|
| 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Draft guidance for industry on info program on clinical trials for serious or life-threatening diseases: establishment of a data bank |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Draft guidance on information program on clinical trials for serious or life-threatening diseases: implementation plan |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
Proposed Rule 6/28/1999
(64 FR 34608)
(69 FR 18728)
Guidance (Final) 11/19/1999
Revised Guidance (4/8/2004)
|
| 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
FR Notice
Modifications to list
11-14-2000
FR Notice
Modifications to list
5-4-2001
FR Notice
Modifications to list
|
| 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
November 2000
|
| 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
Draft
11/10/1999
|
| 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
Draft Published 3/19/1999
COMPLETED
Final 3/6/2000
|
| 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
FR 9/18/2000
|
| 406** |
Agency plan for statutory compliance |
Report |
11/21/1998
COMPLETED 11/20/1998
FR 11/24/1998
Correction (12/17/1998):
|
| 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
FR Notice 4/29/1999
|
| 413** |
Mercury compounds--develop list and analysis |
Task |
11/21/1999
COMPLETED
11/19/1999
|
| 417 |
Registration of foreign establishments US Agent-807.40 |
Regulation |
None
COMPLETED
PR 5/14/1999
Final rule
11/27/01
|
|
H. Report allergenic patch test kits; requests for comments or data 105-307, Sec. 17 |
FR Notice |
None
COMPLETED 10/1/1998
FR Notice
|
