Document 8V2gpQR1ngZBJXRVpXyNNy9km

MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION TO Heinz J. Eiermann, Director DATE: May 16, 1975 Division of Cosmetics Technology (HFF-440) FROM : F. N. Marzulli SUBJECT: Critique of J & J Report Submitted with Letter of April 3, 1975 to R. M. Schaffner, Ph.D. I have read the report submitted by Johnson & Johnson Co. and am prepared to discuss this with their representatives in detail, at their convenience. The J & J people do not appear to be using the modified Draize technique as described in Illustrated Guide of 1965-(see attached photocopy). At that time, the grading method was changed so that each portion of the eye is considered independently without re ference to a total score and four parameters are measured, i.e., a-conjunctival redness, b-conjunctival chemosis, c-corneal injury and d-iritis. Furthermore, area of involvement is not taken into consideration. In the J & J paper, only one parameter for conjunctival effects is reported and it is not clear which this is. In addition, area of involvement is used in arriving at the score and this is no longer recommended. In their (J & J) evaluation of the method we propose, the main point of difference appears to be with regard to the fluorescLn technique. We are~prepared to discuss this in detail with them. I bring the following points to their attention at this time. 1. Ophthalmologists generally recognize the usefulness of the fluorescin technique for disclosing of the corneal epithelium and corneal erosion. They use it in particular in evaluating the fi\t of contact lenses as well as disclosing various forms of corneal injury. 2. J & J recommends using fluorescin solutions in place of steri-strip paper. We should point out that ophthalmologists have discarded the use of fluorescin solutions in favor of steri-strip paper because the former provides a growth medium for P. aeruginosa. 3r. lela?. StessaBa* SIT-446 ISsat SU SB75 Asbesto Hi&cgsls la Cosaetie lale. I ba abe opp& rtzsslt? t# v i s l z vrtth lr&fsassg' Salkeff* la Frisy, ssreh 21st, 1575. ^orlsg tfcis te&- ssart e th$ S*s Yitsaesk se de&It alth tfefe i toifci fig gfciaa of asbestos isirtffgsls is tale* 2&a sdaarals s f h yeotseem era : eferycfcXe3 c r e a d itt #a asthcpbjlita. It ms jr e&ersfcaaiag ttet tale w ases esasetic tale aly? & sacles feeisg obt&laa s^st tbe coanter st b* se ta l! Isvel. It aXae> %rss losderstsadi^ tfett soet of te s a b le s vero fres tas alt& States t^era ^srrs ^ ? s r s l iros teat Brlsla. Z heit labor*taary 1 e sia g ste ^ -stssa ia g eteeraa -siere&eefFp for g&j&nri- f&*tiax+ Thaf re s^ar* th tais t4&efeajf$se s?eil balew 12 easitlrity fer ekrys^te as tresULtea sad at afccssfc 22 2&r sstbs^fcyllite. sSt thfelr&l8S^,grlTtSlgsrbfeaesraad. lesI tskscb^oselasbbeeastcotes* stghsaret Btkeas!sr;f^?f$fisrata*4sl%esy Esestm tPaofoela? at the s-^inrce, sot a the refcsil tem , la addttioK, rim sossltteU^ sf Estfess in l^rofessor SeliSsaff*s surrey as $r*tr titas $s t& sa$r tote bj Br* Be&ley a fas? .yesrs age. IseasptBsMi tsra #sta bases* tkaretee* are ot ......................... eeesalag t IPrefessor S&Ik eff, sos f t Aaerl ean ssa^Ifcs- siso eestaised asbestos. Be 414 st g teas- detalla as tisis la aa egolBg wBfvegr. Frofesssr Sallkfeff 4i sote t&at ekrysetile, wltb th sir asalyfcieal tfecteateMsa Ifeas bees fetss isx es^ esKsetic tales. Be state tte t tke^ sre taere teassse tvm as & tba rs&ek bsa fres Sslefe tbe tale iaaa t^talsa*.. 1. Slmpdro,