MITCH McCONNELX
KENTUCKY

COMMITTEES:
AGRICULTURE
APPROPRIATIONS
ENVIRONMENT AND PUBUC WORKS
RULES
ETHICS (CHAIRMAN)

lEnited States Senate
WASHINGTON. DC 20S10-1702
1202) 224-2541

January 25, 1996
The Honorable Charles A. Bowsher
Comptroller General
General Accounting Office
441 G Street, NW, Room 7100
Washington, D.C. 20548
Dear Mr. Bowsher:
As you know, the Senate Appropriations Subcommittee on
Agriculture, Rural Development, and Related Agencies has
jurisdiction over the Food and Drug Administration (FDA). As a
member of that Subcommittee, I have repeatedly and unsuccessfully
attempted to obtain information from the FDA regarding its
expenditures on a plan to assert jurisdiction over tobacco
products.
The FDA has failed to fully or adequately comply with my requests
for information, thus compromising the Subcommittee's ability to
perform its program oversight responsibilities and, in effect,
challenging the authority of the Senate. What is most disturbing
is that on August 11, 1995, while continuing to disregard my
requests, the FDA proposed sweeping new regulations over
cigarettes and smokeless tobacco.
My request is twofold. First, I ask that GAO investigate the
FDA's failure to comply with my multiple requests for financial
information pertaining to this issue. GAO should determine:
a. how my requests were handled;
b. whether any documents or information were withheld from
the Subcommittee;
c. if documents were withheld, who made the decision to
withhold the information or records and the rationale for
that decision; and
d. all documents, memoranda, and notes (including electronic
messages) pertaining to my request.
Second, I request that the appropriate GAO division review and
report on the appropriated monies spent by the FDA in connection
with its proposed regulation of tobacco products. The intent of
the report is to aid the Subcommittee in assessing: -

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Source: https://www.industrydocuments.ucsf.edu/docs/kjlm0037

 The Honorable Charles A. Bowsher
January 25, 1996
Page 2
a. how
FDA
b. the
the

much money was and will continue to be spent by the
on this non-core activity; and
diversion of appropriated monies and resources from
core activities of the Agency.

My concern is not just this specific regulation, but the time,
effort and tax dollars TDA expended in developing such a farreaching regulation—and the burden it placed on the FDA's other,
core activities.
I request that your investigation include answers to questions I
have previously asked of FDA, which are attached. Also enclosed
are copies of documents previously .transmitted between the FDA
and me.
Given that the Senate Appropriations Committee will soon begin
its work on the FY 1997 appropriations bills, I ask that this
report and investigation commence and be completed as soon as
possible. Specifically, I would like a final report completed by
March 1, 1996. Thank you for your assistance.

;H MCCONNELL
UNITED STATES SENATOR
Enclosure
MM/dh
CC: Honorable Thad Cochran

Source: https://www.industrydocuments.ucsf.edu/docs/kjlm0037

 1. What was the amount of appropriated monies spent by or on
behalf of the FDA. on the tobacco products investigation and
proposed rulemaking in FY 1994, FY 1995, and FY 1996?
2. State the budgeted and/or expected amount of appropriated,
monies to be spent on the proposed rulemaking through FY 1997?
3. State the estimated number of employees and any other persons
(including any private individual or organization) and the
amount of appropriated monies necessary to implement and
enforce the proposed regulations, if adopted in their current
form.
4. State the number of employees, detailees, or consultants
currently working, in any form or manner, on the proposed
rulemaking. How many will continue working on this regulation
through FY 1997?
5. State FDA's timetable for completion of review of the public
comments submitted for the proposed regulation and expected
date of publication of the final regulation.
6. State the number of FDA employees involved in the
investigation of tobacco and related issues including
formulation of the proposed rulemaking in FY 1994, FY 1995,
and FY 1996.
7. State what division those employees are assigned to for
budgetary purposes (stating specifically how many employees
were used from each division) and other responsibilities of
these individuals within the Agency.
8. List each employee, consultant, de'tailee, or any other person
(including any private individual or organization) who
contributed in any manner to the investigation, development of
the proposed rule (including reviewing and/or responding to
public comments received by the Agency) and analysis issued
by the FDA on August 11, 1995. Describe the contribution of
each and the remuneration provided, if any. Include in the
list any individual who provided suggestions on how to
structure the proposed rule.

TI16130017
Source: https://www.industrydocuments.ucsf.edu/docs/kjlm0037