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REGULATORY REVIEW HEALTH CARE WORKING GROUP Name Agency Phone Fax Jennifer Klein DPC 456-2599 456-2878 Chris Jennings DPC 456-5560 456-7431 Kim O'Neill NEC/DPC 456-5587 456-7431 Judith Riggins Agriculture 720-4150 690-4437 Mike Taylor Agriculture 720-7025 690-4437 Jon Baker CEA 395-1410 5614 395-6853 Eric Wolff CEA 395-1410 395-6853 Chris Cerf WH Counsel 456-6229 456-2146 Douglas Letter WH Counsel 456-7901 456-1647 Bill Schultz FDA 301-443-2854 Tom Ault HHS 410-966-5635 401-966-0594 Chris Bladen HHS 690-6870 401-7321 Anna Boyd HHS 690-6111 690-7203 Claudia Cooley HHS/Office of the Secretary 690-5627 690-7203 Judy Feder HHS/ASPE 690-7858 690-7383 Harriet Rabb HHS/OGC 690-7741 690-7998 Jacquelyn White HHS 690-5627 690-7203 Jerry Stem DOJ 514-6753 307-0097 Jean Logan NPR 632-0334 632-0390 Shannah Koss OMB 395-7318 395-5167 Laurel Illston OMB 395-7809 Nelson Reyneri OSHA 219-9196 219-6064 Mary Lou Keener VA 273-6660 273-6671 Bob Knisely OVP/NPR 366-3282 366-3640 703-757-0292 (Home) MEMORANDUM To: Elaine Kamarck Greg Simon Sally Katzen From: Chris Jennings Date: April 18, 1995 Re: Timeline cc: Jennifer Klein Shannah Koss Attached is the implementation timeline for the regulatory reforms outlined in the recently released FDA report. We can all use this to keep on top of the agency to follow through on the Administration's promised timeframe. I hope you find this useful. Please call me with any questions at 6-5660. REGO DEVICE PROPOSALS PROPOSAL IMPLEMENTATION/TIMELINE Medical Device Exemptions from Premarket proposed reclassification and exemption by Notification June 1995 Elimination of the Reference List immediate review of products on list Medical Device External Review Pilot pilot program will begin Oct. 1995 Program Device User Fees legislation proposed in 1996 budget Device Exports legislation; proposed regulation for IDE devices by Oct. 1995 Effectiveness of Devices published statement by July 1995 Harmonization of Standards testing: guideline development within 2 years GMPs: guidelines within 2 years REGO DRUG PROPOSALS PROPOSAL IMPLEMENTATION/TIMELINE Eliminating Many Requirements for FDA Drugs: tablet form, guidance document by Approval of Manufacturing Changes Dec. 1995 other forms, guidance document by Dec. 1996 Biologics: 1st round guidance document immediately 2nd round proposed regulation by Jan. 1996 New Policy to Permit Use of Small-Scale and guidance document by July 1995 Pilot Facilities During Development of Biologics Revision of Labeling Requirements for proposed regulation by Oct. 1995 Biological Products Antibiotic and Insulin Standards and Insulin legislation Certification Environmental Assessments for Human Drugs proposed regulation by Jan. 1995 Drug Exports legislation Effectiveness of Drugs published statement by July 1995 Harmonization testing: guideline development within 2 years GMPs: guidelines within 2 years animal drugs: guidelines within 3 years Robert A. Knisely 202-366-3640 11/5/95 4:10 PM 4/4 JAN 05 '95 03:59PM BUREAU OF TRANSPORTATION STATS P.3 Regulatory Policy Reviews (As of 1/5/95) Phone Fax INTERNET address OVP (NPR staff) Elaine Kamarck 456-2816 456-6429 Bob Knisely 366-3282 366-3640 [email protected] Jean Logan 632-0344 632-0390 [email protected] Jeff Lubbers 254-7050 254-3077 [email protected] Steve Tidrick 632-0150 x128 632-0390 [email protected] OIRA Sally Katzen 395-4852 395-3047 Don Arbuckle 395-7343 395-7285 Art Fraas 395-3084 395-7285 no internet address Gary Rowe 395-1247 395-3047 OEP Katie McGinty Keith Laughlin 456-6224 456-2710 no internet address NEC Michael Deich 456-2801 456-2223 [email protected] Ellen Seidman 456-2802 456-2223 [email protected] Peter Yu 456-2801 456-2223 yu_p@a1,eop.gov CEA Joe Stiglitz Jonathan Baker 395-5614 395-6809 no internet address OSTP Jack Gibbons 456-7116 456-6021 [email protected] MRC Greenwood 456-6130 456-6027 [email protected] Mark Schaefer 456-6080 456-6025 [email protected] Skip Johns 456-6033 456-6023 [email protected] DPC Carol Rasco 456-2216 456-7028 Paul Weinstein 456-5577 456-7028 [email protected] Jennifer Klein 456-2599 456-7028 [email protected] Gaynor McCowan 456-5575 456-7028 [email protected] Mike Schmidt 456-5567 456-7028 [email protected] WH Counsel Abner Mikva Steven Neuwirth 456-2632 456-1647 [email protected] Fax changes to Steve Tidrick at 632-0390 Schedule for Health Industry Regulatory Review Initiative January 12 Reach conclusion on issues to be presented January 19 Review of presentation, including case studies, description of past regulatory approaches, new vision for future (with specific proposals and discussion of why we rejected other new approaches) January 24 Additional review of presentation January 27 (?) Practice presentation for DPC February 2 Presentation to Vice President THE WHITE HOUSE WASHINGTON January 5, 1995 MEMORANDUM FOR THE VICE PRESIDENT FROM: CAROL RASCO CHR SUBJECT: Regulatory Reform Initiative The purpose of this memorandum is to update on the status of the three DPC-led working groups of your regulatory review initiative. Prior to the Christmas break, I appointed the chairs of the three groups: 1. Education -- Bill Galston, Gaynor McCown 2. Workplace Safety -- Michael Waldman, Michael Schmidt 3. Health Industry Regulation/ Food and Drug Regulation -- Chris Jennings, Jennifer Klein The working groups are off to a fast start and the chairs have convened several meetings with the appropriate agency representatives. Because of the urgency of this initiative, I wanted to provide you with an outline of our proposed presentation from the three working groups. All three groups are planning, within the two hours allotted with you, to do the following: 1. Provide you with two to four major areas of reforms with pros and cons on both bold and moderate options. All three working groups believe it is necessary to focus on a few areas that offer the best chance for regulatory improvement (low-hanging fruit). 2. Each group will try to bring a customer-service perspective to the presentation. For example, the education working group is looking at regulations through the viewpoint of a principal and a college president. The other two working groups will follow a similar approach. 3. Each group will provide case studies of certain regulatory areas to provide a context of real life experiences. 4. Each group will try to focus on why past regulatory choices were made and what implications we can draw from them. 5. Each group will explore a vision of a different future. Prior to the presentation, we would like to circulate the materials at least 24 hours in advance. In addition, I am planning to have a dry run of the presentations made to me before the meetings with you. Please advise me if this plan of action meets with your approval. DECISION Approve Discuss Further Organization of Teams for NPR Phase II IA. Large Agency Teams Effort National Security and International Affairs Defense State Intelligence Community Natural Resources, Energy, and Science Agriculture Environmental Protection Agency Interior National Science Foundation NASA Human Resources Education Labor Health and Human Services (part) Social Security Administration Health and Personnel Veterans Affairs Health and Human Services (part) General Government Commerce Small Business Administration Justice Federal Emergency Management Agency Treasury Postal Service IB. Small Agency Teams Effort (number of teams to be determined to cover the roughly 120 small agencies). Could group by major cabinet agency or by natural clusters, such as: -- International Affairs (17 agencies) -- Natural Resources (13 agencies) -- Cultural Activities (17 agencies) -- Education (8 agencies) -- Human Resources (13 agencies) -- Business and Trade (8 agencies) -- Financial Services (17 agencies) -- Legal (7 agencies) -- Other (18 agencies) II. Federalism and Devolution Effort -Bev Godwin - side- by-side III. Regulatory Reinvention Effort look at 6 major IV. Implementation of NPR Phase I works 0.7 this issue -- Streamlining -- Customer Service Standards -- Virtual Department of Business -- Public Service Reform V. Support: Research and Special Skills Staff Subsidy Identification Effort Streamlining Effort Customer Survey Skills Privatization Effort Individual Empowerment Effort VI. Legislative-Executive Relations Lorraine Miller VII Since, OFFICE OF THE VICE PRESIDENT WASHINGTON January 5, 1995 MEMORANDUM FOR HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES FROM ELAINE KAMARCK, SENIOR POLICY ADVISOR TO THE VICE PRESIDENT and BOB STONE, PROJECT DIRECTOR, NATIONAL PERFORMANCE REVIEW State SUBJECT: Second Phase of the National Performance Review The Vice President's memo of January 3 (same subject) started a review to "examine the basic missions of government, looking at every single government program and agency to find and eliminate things that don't need to be done by the federal government [and to] sort out how best to do the things government should continue to do." The NPR and OMB staffs put together the attached chart to lay out a logical set of steps to go through in analyzing existing government programs or functions. It has helped us to think through the process; we think it would be worth your time to go through its steps mentally as you figure out how to carry out the Vice President's charge. We hope it helps. Attachment: Decision Tree Chart NATIONAL PERFORMANCE Sample Decision Tree for Analyzing Agency Programs REVIEW Gary Existing Program or Function President of the United Mates Is this program or function critical to the agency's mission based on "customer" Input? YES NO Can it be done as well or better at the state or local level? Terminate Privatize YES NO Give Sell Away Devolve to Other Govt's Is there any way to cut cost or improve performance by introducing competition? Best chances for introducing competition Same $ Fewer $ Similar services available YES NO commercially; e.g., food service, scientific research Rapidly changing technology; How can NPR principles be applied to put customers first, e.g., information technology cut red tape, and empower employees? Services paid directly by customers; e.g., Alaskan Franchise Privatize Power, air traffic control Continue Reinvented Multiple federal locations; Operation e.g., six shipyards, six IRS revenue centers Strictly internal services; e.g. Govt. Contract Require Fed. Govt. Vouchers travel, payroll Corporation for Services units to Compete 01/24/95 12:20 001 The White House 1 may / amount TOTAL I TALER DOMESTIC POLICY FACSIMILE TRANSMISSION COVER SHEET TO: Jennifer Klein/ Bill Galston FAX NUMBER: 6-2878 TELEPHONE NUMBER: FROM: Jeremy Ben - Ami TELEPHONE NUMBER: 6- 5584 PAGES (INCLUDING COVER): 4 COMMENTS: 01/24/95 12:20 002 January 24, 1995 MEMORANDUM TO DPC STAFF From: Jeremy Ben-Ami Subject: Assignments to REGO II Teams Attached please find assignments to the REGO II Teams for the second round of the NPR. As Elaine Kamarck described to us when she spoke at the DPC meeting a couple of weeks ago, these teams will be working parallel to the agency-driven teams. The goal is to set up a healthy tension so that the ideas developed are as bold as possible. The National Performance Review staff should be in touch shortly to set up initial meetings of the teams. The clusters have been organized to correspond to the OMB PADs, Brian should be involved in all meetings and discussions relating to the three Natural Resources agencies. Mike, Gaynor, and Lynn should coordinate with me on the Human Resources agencies (please invite me to initial meetings). Chris, Jennifer, and Diana should discuss how to coordinate the HHS/health work. Bill will be the lead on the federalism/devolution team, but Paul and Gaynor should work closely together to staff him. I hope this is clear. Please keep me posted on meetings and progress, and feel free to come to me with questions. We will use one of our staff meetings in February to share thoughts about how the process is going. cc: Carol Rasco 01/24/95 12:20 1 003 DPC ASSIGNMENTS TO REGO II TEAMS IA. Large Agency Team Efforts National Security and International Affairs No representation Natural Resources, Energy, and Science Cluster Lead: Brian Burke Agriculture - Brian Burke, Marion Berry EPA - Brian Burke Interior - Brian Burke, Mike Schmidt (for BIA) Human Resources Cluster Lead: Jeremy Ben-Ami Education - Gaynor McCown Labor - Mike Schmidt Social Security - Lynn Margherio HHS (non health) - Jeremy Ben-Ami Health and Personnel Cluster Lead: Chris Jennings/Jennifer Klein HHS (Health) - Chris Jennings, Jennifer Klein, Diana Fortuna VA - Lynn Margherio General Government Cluster Lead: Paul Weinstein Staff on all agencies: Mickey Levitan IB. Small Agency Team Efforts Gaynor McCown/Mickey Levitan 01/24/95 12:21 0 004 П. Federalism and Devolution Bill Galston, Lead Paul Weinstein Gaynor McCown III. Regulatory Reinvention Paul Weinstein, Michael Waldman, Leads Staff already assigned IV. Implementation of REGO I No new staff assignments V. Support: Research and Special Skills Staff Subsidy Identification: Paul Weinstein Streamlining: Paul Weinstein Customer Survey Skills: Paul Weinstein Privatization: Paul Weinstein, Mickey Levitan Individual Empowerment: Bruce Reed, Paul Weinstein, Jeremy Ben-Ami VI. Legislative/Executive Relations No staff assignments VII. US Postal Service Mickey Levitan OPTIONAL FORM 99 (7-90) Regulatory Policy Reviews FAX TRANSMITTA (As of 1/30/95) To Ft JENNIFER KLEIN Dept./Agency PI Phone Fax INTERNET Fax , I 6-2878 OVP (NPR staff) NON 7540-01-317-7368 5099-101 Elaine Kamarck 456-2816 456-6429 Bob Knisely 366-3282 366-3640 [email protected] Jean Logan 632-0344 632-0390 [email protected] Jeff Lubbers 254-7050 254-3077 [email protected] Steve Tidrick 632-0150 x126 632-0390 [email protected] OIRA Sally Katzen 395-4852 395-3047 Don Arbuckle 395-7343 395-7285 no Internet address Art Fraas 395-3084 395-7285 no internet address Gary Rowe 395-1247 395-3047 no Internet address Molly Poag 395-7340 395-7245 no internet address OEP Katle McGinty 456-6224 456-2710 no Internet address Keith Laughlin 456-6224 456-2710 no Internet address NEC Michael Deich 456-2801 456-2223 [email protected] Ellen Seidman 456-2802 458-2223 [email protected] Peter Yu 456-2801 456-2223 [email protected] CEA Joe Stiglitz Jonathan Baker 395-5614 395-6809 no Internet address OSTP Jack Gibbons 456-7116 456-6021 [email protected] MRC Greenwood 456-6130 456-6027 [email protected] Mark Schaefer 456-6080 458-8025 [email protected] Skip Johns 456-6033 456-6023 [email protected] Henry Kelly 456-6034 456-6023 [email protected] Tim Newell 456-6020 456-6019 [email protected] DPC Carol Rasco 456-2216 456-7028 Paul Welnstein 456-5577 456-7028 [email protected] Jennifer Klein 456-2599 456-2878 [email protected] Gaynor McCowan 456-5575 456-7028 [email protected] Mike Schmidt 458-5567 456-7028 [email protected] Chris Jennings 456-5560 456-7431 [email protected] Mike Waldron 456-2216 458-7028 [email protected] Stacey Rubin 456-5585 456-7431 [email protected] WH Counsel - Abner Mikva Stephen Neuwirth 456-7903 456-1647 [email protected] Beth Nolan 458-6229 458-2146 [email protected] Fax changes to Steve Tidrick at 632-0390 CR//T/70 12:08 VVIIIO DOMESTIC POLICY FACSIMILE TRANSMISSION COVER SHEET TO: Please distribute to all WU/DPC shaff FAX NUMBER: 6-7870 TELEPHONE NUMBER: 6-2316 FROM: Paul Wainstein (BEAR) TELEPHONE NUMBER: PAGES (INCLUDING COVER): 4 COMMENTS: NATIONAL PERFORMANCE REVIEW, PHASE II AGENCY PRESENTATIONS SCHEDULE as of 02/13/95 (12:30 p.m.) Agency Agency Agency- Agency Head Package Due Meeting with Advisory Agency Meeting with to Steering Steering Group Follow- Revised the VP and AGENCY Group Contact Group up Meeting Package Due OMB Director NASA 2/08 2/10 Friday 2/13 Monday Wednesday OEOB 248 DONE 4:00 pm 5:00 - 6:00 pm No Small Agencies INTERIOR 116 5/56 Thursday 2/17 Friday Tentative Tuesday OEOB 248 4:00 pm 3:00 . 4:00 pm 14 small 2/13 2/16 Thursday 2/17 Friday agencies Monday OEOB 475 4:00 pm 4:00 - 5:00 pm COMMERCE 2/15 2/17 Friday 2/21 Tuesday Wednesday OEOB 472 4:00 pm 4:00 . 5:00 pm 7 small agencies TP 2/22Wednesday 2.23 Thursday Coordinating OEOB 180 Council 4:00 - 5:00 pm DOU 2/21 2/23 Thursday Tuesday OCOB 476 4:00 pm 4:00 - - 5:00 pm Selective 2/23 Thursday 2/24 Friday Service OEOB 248 5:00 - 5:30 pm VA 3.22 2/24 Friday 2/27 Monday Wednesday OEOB 248 4:00 pm 3:00 4:00 pm 1 of 3 02/17/95 12:09 Agency Agency Agency- Agency Head Package Due Meeting with Advisory Agency Meeting with to Steering Steering Group Follow- Revised the VP and AGENCY Group Contact Group up Meeting Package Due OMB Director Court of 2/24 Friday 2/27 Monday Veterans OEOB 248 Appcais 4:00 - 4:15 pm SBA 2/22 2/24 Friday 2/27 Monday Tentative Wednesday OEOB 248 4:00 pm 4:30 5:30 pm STATE 2/23 2/27 Monday 2/28 Tuesday Thursday OEOB 248 4:00 pm 3:00 - 4:00 pm 12 small 2/27 Monday 2/28 Tuesday agencies OEOB 472 4:00 - 5:00 pm EDUCATION 2/24 2/28 Tuesday 3/1 Wednesday Friday OEOB 248 4:00 pm 3:00 - 4:00 pm LABOR 2/24 2/28 Tuesday 3/1 Wednesday Problem Friday OEOB 472 4:00 pm 4:00 - 5:00 pm NSF 2/27 3/1 Wednesday 3/2 Thursday Monday OEOB 248 4:00 pm 11:00 -12:00 HHS 2/27 3/1 Wednesday 32 Thursday Tentative Monday OEOB 248 4:00 pm 1:00 - 2:00 pm 29 small 3/2 Thursday 3/3 Friday agencies related OEOB 248 to Education 3:00 - 5:00 pm 14 small agencies related to Labor 2 small agencies related to NSF DOJ 2/28 3/2 Thursday 3/3 Friday Tuesday OEOB 472 4:00 pm 5:00 - 6:00 pm 2 of 3 02/17/95 12:09 004 Agency Agency Agency- Agency Head Package Due Meeting with Advisory Agency Meeting with lo Steering Steering Group Follow- Revised the VP and AGENCY Group Contact Group up Meeting Package Due OMB Director TREASURY 3/1 3/3 Friday 3/6 Monday Wednesday OEOB 248 4:00 pm 3:00 - 4:00 pm 12 small 3/3 Friday 3/6 Monday agencies related OEOB 472 to Justice 4:00 - 5:00 pm 19 small agencies related to Treasury SSA 3/2 3/6 Monday 3/7 Tuesday Thursday OEOB 472 4:00 pm 3:00 - 4:00 pm FEMA 3/2 3/6 Monday 3/7 Tuesday Thursday OEOB 248 4:00 pm 4:00 . 5:00 pm Postal Service 3/3 3/7 Tuesday 3/8 Wednesday Friday OEOB 472 4:00 pm 3:00 - 4:00 pm Intelligence 3/3 3/7 Tuesday 3/8 Wednesday Friday OEOB 248 4:00 pm 4:00 - 5:00 pm Agriculture 3/6 3/8 Wednesday 3/9 Thursday Problem Monday OEOB 180 4:00 pm 3:00 - 4:00 pm ; small agencies 3/8 Wednesday 3/9 Thursday Problem OEOB 248 4:00 - 5:00 pm special EPA 3/7 3/9 Thursday 3/10 Thursday Tentative Tuesday OEOB 248 4:00 pm 1:00 - 2:00 20 small 3/10 Friday 3/13 Mondav agencies OEOB 248 3:00 5:30 pm 3 of 3 THE WHITE HOUSE WASHINGTON Call Clandia March 4, 1995 How to handle? MEMORANDUM FOR HEADS OF DEPARTMENTS AND AGENCIES SUBJECT: Regulatory Reinvention Initiative Last week, I announced this Administration's plans for further reform of the Federal regulatory system. This is a central part of reinventing our Government. All Americans want the benefits of effective regulation: clean water, safe workplaces, whole- some food, sound financial institutions. But, too often the rules are drafted with such detailed lists of dos and don'ts that the objectives they seek to achieve are undermined. Clear goals and cooperation would work better. Too often, businesses, especially small ones, face a profusion of overlapping and sometimes conflicting rules. We have already made real progress in reforming regulation. This memorandum will build on the regulatory philosophy set forth in Executive Order No. 12866 of September 30, 1993, "Regulatory Planning and Review," which is premised on the recognition of the legitimate role of government to govern, but to do SO in a focused, tailored, and sensible way. In the year and a half since that order was signed, we have opened the rulemaking process to the public, we have increased cooperation and coordination among the Federal agencies, and we have seen good processes produce good decisions. However, not all agencies have taken the steps necessary to implement regulatory reform. To reaffirm and implement the principles of Executive Order No. 12866, regulatory reform must be a top priority. Accordingly, I direct you to focus on the following four steps, which are an integral part of our ongoing Regulatory Reform Initiative. 2 FIRST: CUT OBSOLETE REGULATIONS I direct you to conduct a page-by-page review of all of your agency regulations now in force and eliminate or revise those that are outdated or otherwise in need of reform. Your review should include careful consideration of at least the following issues: Is this regulation obsolete? Could its intended goal be achieved in more efficient, less intrusive ways? Are there better private sector alternatives, such as market mechanisms, that can better achieve the public good envisioned by the regulation? Could private business, setting its own standards and being subject to public accountability, do the job as well? Could the States or local governments do the job, making Federal regulation unnecessary? This review should build on the work already being done by your agencies under section 5 of Executive Order No. 12866. Your regulatory review task force should be headed by one of your appointees who should be given your full support and should, to the extent practicable, be freed of other duties. I further direct you to deliver to me by June 1 a list of regulations that you plan to eliminate or modify with a copy of the report sent to Sally Katzen, Administrator of the Office of Information and Regulatory Affairs (OIRA). The list should distinguish between the regulations that can be modified or eliminated administratively and those that require legislative authority for modification or elimination. SECOND: REWARD RESULTS, NOT RED TAPE I direct you to change the way you measure the performance of both your agency and your frontline regulators so as to focus on results, not process and punishment. For example, Occupational Safety and Health Administration (OSHA) inspectors should not be evaluated by the number of citations they write, nor should officials of the Consumer Product Safety Commission be judged by the number of boxes of consumer goods that are detained in shipment. This change in measurement should involve a two-step process. 3 First, you should identify appropriate performance measures and prepare a draft in clear, understandable terms, of the results you are seeking to achieve through your regulatory program. The draft should be circulated to frontline regulators for review and comment. This is the same work needed to meet the requirements of the Government Performance and Results Act of 1993. Second, you should evaluate and reward employees based on the realization of those measures/goals. By no later than June 1, I direct you to (a) eliminate all internal personnel performance measures based on process (number of visits made, etc.) and punishment (number of viola- tions found, amount of fines levied, etc.), and (b) provide to the National Performance Review (NPR) staff a catalogue of the changes that you are making in existing internal performance evaluations to reward employees. You should also provide material describing shifts in resource allocation from enforcement to compliance. THIRD: GET OUT OF WASHINGTON AND CREATE GRASSROOTS PARTNERSHIPS I direct you to promptly convene groups consisting of frontline regulators and the people affected by their regulations. These conversations should take place around the country -- at our cleanup sites, our factories, our ports. I further direct you to submit a schedule of your planned meetings to the NPR staff by March 30 and work with NPR in following through on those meetings. FOURTH: NEGOTIATE, DON'T DICTATE It is time to move from a process where lawyers and bureaucrats write volumes of regulations to one where people work in partnership to issue sensible regulations that impose the least burden without sacrificing rational and necessary protections. In September 1993, I asked each of you to identify at least one rule that could be conducted through negotiated rulemaking (or to explain why such could not be done) in order to promote consensual rulemaking as opposed to the more traditional rulemaking that has dominated the regulatory arena. I now direct you to expand substantially your efforts to promote consensual rulemaking. To this end, you should submit to OIRA, no later than March 30, a list of upcoming rulemakings that can be converted into negotiated rulemakings. I have directed Sally Katzen to review your lists with a view toward making clear to the regulated community that we want to work together productively on even the most difficult subjects. 4 To facilitate our ability to learn from those affected by regulation, I will amend Executive Order No. 12838 (which requires agencies to reduce the number of advisory committees that they use and to limit the future use of such committees) to allow for advisory committees established for negotiated rulemakings. I also intend to take additional steps to increase our ability to learn from those affected by regulation. While many laws and rules that limit the ability of regulators to talk with those being regulated were imposed to curb abuse, they now often serve as a barrier to meaningful communication between the regulators and the regulated. To address this problem, and to promote consensus building and a less adversarial environment, I direct you to review all of your administrative ex parte rules and eliminate any that restrict communication prior to the publication of a proposed rule - - other than rules requiring the simple disclosure of the time, place, purpose, and participants of meetings (as in Executive Order No. 12866). We will also begin drafting legislation that will carve out exemptions to the Federal Advisory Committee Act to promote a better understanding of the issues, such as exemptions for meetings with State/local/tribal governments and with scientific or technical advisors. I also ask you to think about other ways to promote better communication, consensus building, and a less adversarial environment. Please send your ideas to the Office of the Vice President. As I said on Tuesday, February 21, 1995, you are to make regulatory reform a top priority. Good government demands it and your full cooperation is crucial. William