|
*Executive Committee Member
CHAIR
*C. Boyden Gray
2445 M Street NW
Washington, DC 20037-1435
CHAIR-ELECT
*Neil R. Eisner
U. S. Department of Transportation
400 7th Street, SW, Room 10424 (C-50)
Washington, DC 20590
VICE CHAIR
*Thomas D. Morgan
George Washington University Law School
720 20th Street, NW
Washington, DC 20052
SECRETARY
*Cynthia A. Drew
U.S. Department of Justice
ENRD/PO Box 23986
Washington, DC 20552-3986
ASSISTANT SECRETARY
Jonathan J. Rusch
Washington, DC
BUDGET OFFICER
*David W. Roderer
Office of Federal Housing Enterprise Oversight
1700 G Street, NW, 4th Floor
Washington, DC 20552
ASSISTANT BUDGET OFFICER
Daniel Cohen
Washington, DC
SECTION DELEGATES TO THE
HOUSE OF DELEGATES
*Ernest Gellhorn
George Mason University School of Law
2907 Normanstone Lane
Washington, DC 20008
*Ronald A, Cass
Boston University School of Law
765 Commonwealth Avenue
Boston, MA 02215
IMMEDIATE PAST CHAIR
*Ronald M. Levin
Washington University School of Law
Campus Box 1120
St. Louis, MO 63130
COUNCIL MEMBERS
Stephen Calkins
Detroit, MI
H. Russell Frisby
Washington, DC
Daniel B. Rodriguez
San Diego, CA
Lynne K. Zusman
Washington, DC
John F. Cooney
Washington, DC
David Frederick
Washington, DC
Lisa A. Whitney
New York, NY
Renee M. Landers
Boston, MA
John F. Duffy
Williamsburg, VA
Cynthia R. Farina
Ithaca, NY
Leonard A. Leo
Washington, DC
Sidney A. Shapiro
Lawrence, KS
COUNCIL MEMBERS EX OFFICIO STATE ADMINISTRATIVE LAW
Jim Rossi
Tallahassee, FL
EXECUTIVE BRANCH
Viet Dinh
Washington, DC
LEGISLATIVE BRANCH
Hannah Sistare
Washington, DC
JUDICIARY
Merrick Garland
Washington, DC
ADMINISTRATIVE JUDICIARY
Judith Ann Dowd
Washington, DC
ADMINISTRATIVE & REGULATORY
LAW NEWS
EDITOR
William F. Funk
Portland, OR
ASSOCIATE EDITOR
William S. Morrow, Jr.
Washington, DC
ADMINISTRATIVE LAW REVIEW
CHAIR OF FACULTY BOARD
Thomas O. Sargentich
Washington, DC
STUDENT EDITOR-IN-CHIEF
Allison Carle
Washington, DC
ABA BOARD OF GOVERNORS LIAISON
Hunter Patrick
Cody, WY
YOUNG LAWYERS DIVISION LIAISON
Lori Davis
Lexington, KY
LAW STUDENT DIVISION LIAISON
Christine Monte
Washington, DC
|
740 15th Street, NW
Washington, DC 20005-1022
(202) 662-1582
May
31, 2002
Dear
Director:
The
Section of Administrative Law and Regulatory Practice of the American Bar
Association is pleased to submit comments on the proposed guidance for data
quality that your agency has proposed under Section 515 of Public Law
106-554. The views expressed herein are presented on behalf of the Section
of Administrative Law and Regulatory Practice. They have not been approved
by the House of Delegates or the Board of Governors of the American Bar
Association and, accordingly, should not be construed as representing the
position of the Association.These comments are focused on the mechanisms
proposed for implementation of section 515’s "correction of
information that does not comply with (OMB guidance)". In commenting
on the mechanisms we hope to improve them; these comments do not suggest
that any of the substantive objectives of the agency discussed in your
published proposal would or would not have our Section’s support. Because
many of the nation’s experts in the administrative process and information
policy are members of our Section, we hope to speak to the process and procedural
aspects of the proposed guidelines.
1.
We
endorse the creation of a user-friendly website that will describe means by
which to submit requests for correction. (HHS Guidelines, Page 18 of 20,
Part I, section E, para. 2) Facilitating the corrections process is fully
consistent with the OMB guidelines and the purposes of Section 515.
2.
The
Department should adopt a position defining "influential" at a
level that is more aligned with Section 515’s desire for quality in the
data used by federal agencies for their "important" decisions
(See OMB Guidance, 67 F.R. 8455 col. 2). NIH makes a reasonable
determination (VII, Page 32 of 36) of the types of disseminated information
that "have the potential of being considered influential". The
NIH acknowledges that how information will be used "cannot always be
anticipated" so the term "influential" is broadened to
include research and recommendations.
3.
By
contrast, we do not support the FDA choice to limit "influential"
information to only those rulemakings or actions that are expected to
"have an annual effect on the economy of $100 million or more".
This seems quite narrow – making it rare that a study would be subjected to
the transparency measures accorded to influential information. (FDA Draft
Guidelines, Page 25 of 33, Item VII A para. 2) "Important" FDA
policy decisions and rules may have an effect under a level of $100,000,000
effects but still be important to major constituencies.
4.
This
choice of an extremely high threshold by FDA and perhaps other HHS entities
will frustrate the purpose of section 515, because there will be so few
times that an analysis of supporting data’s reproducibility will be exposed
for public view. For example, FDA adopted a rule on hypoallergenic
cosmetics that depended on a survey commissioned by another federal agency;
the methodological flaws of that survey led the sponsor of that survey to
disclaim its validity; the survey was central support for the FDA rule;
when FDA’s rule was challenged the rule was vacated (not remanded) by the
D.C. Circuit in 1977 and that rulemaking has never been attempted again.
(Almay v Califano, 569 F.2d 674 (D.C. Cir., 1977)) For those who are
concerned with allergens in cosmetics, the study was "important"
but may have had under $100,000,000 effects. This correction procedure
enables smaller businesses to have input into a process previously
thought accessible only by larger companies with substantial lobbying
funds.
5.
Adaptation
of the Safe Drinking Water Act principles to risk decisions that are not
classic "risk assessments" has been attempted by several HHS
agencies. We note that the FDA at page 29 of 33, item VIII-C, commits
itself to disseminate risk information in "comprehensive, informative
and understandable" ways. We suggest FDA move this closer to the SDWA
norms by adding to this a statement of uncertainties or a brief data that
fail to support the conclusion drawn by the agency study (OMB, 67 F.R. 8458
col. 1 items (iv, v))
6.
We
commend that provision in NIH Guidelines at part VI(4) that if a complaint
is determined not to be legitimate, the NIH data owner "must provide a
clear explanation of the rationale for that determination to the
complainant." The response is also directed to explain the basis for
the support and substantiation given to the data as it was prepared. This
directive is a prudent method of response; agency communication about why a
decision was made can be very helpful in fostering positive outcomes and in
deterring further appeals of the challenged statement.
Thank
you for considering these comments. If you wish clarification of any
portions, please contact Professor James O’Reilly, Chair of the Committee
on Government Information & Privacy, at (513) 556-0062.
Sincerely,
C.
Boyden Gray
Section
Chair
|
