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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