(72)
#38. Memo dated August
29, l974 from Dr. G. L. Schoenhard to
Dr. K.S.
Rao.
#39. Table 1 - Summary
of Average Body Weights and Weight gain
(%change/
week) from the FDA
Statistical Analysis.
#40. Table 2 - Summary
of food intake (g/day and g/kg./day and
dosage
(mg./kg./day) from
the FDA STatistical Analysis
#41. Table 3 - Summary
of Food Efficiency (g. gained/100g. actual
food
consumed) calculated
in the FDA STatistical Analysis.
#42. Computer printout
of FDA Statistical Analysis of food intake
and
body weight data.
#43. Pathology report
from Division of Pathology, Bureau of
Foods, con-
cerning uterine polyps,
along with correspondence, and memo from
Janet Springer.
#44. Pathology report
from Armed Forces Institute of Pathology,
concerning
uterine polyps.
#45. Pathology report
from Massachusetts Institute of Technology,
concern-
ing uterine polyps.
#46. Written account
of interviews with Dr. Jean Taylor on
6/2/77, 6/3/77,
and 6/7/77.
#47. Written account
of interview with Judy Beauchamp on 6/2/77.
#48. Written account
of interview with Barbara Bickford on
6/1/77.
#49. Written account
of interview with Clifford J. Seul on
6/2/77.
#50. Written account
of interview with Bartolome R. Tangonan
on 6/1/77.
#51. Written account
of interviews with Tony Martinez on 5/19/77,6/3/77,
7/7/77, and 8/2/77.
#52. Written account
of interview with Ted Reichert on 5/24/77.
#53. Written account
of interview with Barbara Bickford and
Clif Seul
on 6/2/77.
#54. Written account
of interview with Judith Schmal on 6/2/77
and
6/7/77.
#55. List of animals
bled at 104 and 114 weeks.
#56. Written account
of interview with Alan Mitchell on 7/20/77.
#57. Written account
of interview with Raymond G. Schroeder
on 7/18/77.
#58. Injection records
showing administration of penicillin,
dates of
administration, rat
numbers, and units injected.
#59. Methodology
for "Phenistix" determination
of phenylketones in urine.
(73)
#60. Dr. Frith's
report of examination of slides for DKP
study
(E-77/78).
#61. Key for animal
identification card numbers used on the
body/feeder
weight teletype sheets.
#62. Chart correlating
animal cage numbers with pathology numbers,
arranged by dose
group.
#63. Chronological
list of pathology numbers and corresponding
animal
cage numbers.
#64. Organizational
charts showing responsibility during the
time that
study E-77/78 was
conducted.
#65. Volume entitled
"tissue masses & deaths".
Chronological list
of all animals that
died, during study, and dates that masses
were
first observed.
#66. Charts of days
on study for each animal.
#67. Calendar for
duration of study showing starting dates,
days and weeks
for each group.
#68. Survival table.
#69. Charts of Housing/Dosage
Groups.
#70. "Observations
for Drug Effects" records for housing
groups A through
F.
#71. "Observations
for Drug Effects" records for housing
groups G through
M.
#72. Ophthalmoscopic
records and copies of pathology sheets
that have
ophthalmoscopic findings.
#73. Life table analysis
and statistics on body weight and food
consumption data
by Dennis Wilson, Div. of Mathematics,
Bureau of
Foods.
#74. Evaluation of
feeding study on DKP, a conversion product
of
Aspartame, by Janet
Springer/Ann Ducca, FDA Division on Mathematics.
#75. Volume A - teletype
sheets for body and feeder weight data,
housing
groups.
Volume B - "
Volume C - "
#76. Copy of Searle
Computer Program.
#77. Volume of protocols,
organ weights, dosage, hematology, urinalysis,
blood chemistry,
and protein electrophoresis.
#78. Complete gross
pathology sheets, males.
#79. Complete gross
pathology sheets, females.
#80. Key to slide
tissue identification numbers and abbreviations.
#81. Key to stain
abbreviations.
(74)
#82. Copies of submission
appendix tables relating to hematology,
clinical chemistry,
urinalysis, and electrophoresis, along
with
check marks showing
errors, and attached copies of raw data
sheets documenting
the errors.
#83. Copies of submission
appendix tables for organ weights, with
errors indicated,
and copies of pathology sheets documenting
the errors.
#84. Data sheets
showing the phenylketones test erroneously
labeled
"phenylalanine".
Signed by:
John S. Arnold
Investigator
David M. Eerspamer
Investigator
Dr. Jean Taylor
Toxicologist
Dr. Leonard Friedman
Biochemist
(75)
Addendum:
Exhibit #85 - Copy
of Volume 1 of the submission to FDA.
Exhibit #86 - Copy
of Volume 2 of the submission to FDA,
consisting
of the individual
pathology summaries, both gross and
microscopic.
Exhibit #87 - Statistical
analysis of Blood and Clinical Chemistry
Data by Dennis Wilson,
Division of Mathematics, HFF-
110.
Exhibit #88 - Copies
of pages from Histology accession book
#770C,
and Histology inventory
sheets.
Exhibit #89 - Documents
from Searle's Math-Stat. Dept. concerning
statistical analysis
of study 988S73.
Signed
Jerome Bressler
Team Leader
