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Federal Register / Vol. 49. No. 107 / Friday, June 1, 1984 / Rules and Regulations 23007
restriction or the agency otherwise finds good cause for the earlier effective date. FDA believes that delaying the change made by the amendment to § 630.11 would be contrary to the public interest. As discussed above. questions have been raised in litigation about whether the vaccine used in the clinical trials conducted in 1962 for the approval of the sole license for oral poliovirus vaccine met all of the technical requirements in 630.11. FDA believes it is in the interest of the public health to make the amendment effective as soon as possible to make certain that questions concerning whether the vaccine lots used in the original clinical trials technically conformed with the requirements of the additional standards in 21 CFR 630.10 to 830.17 do not cast doubt on the safety of the vaccine and on the continued viability of the polio immunization program. As noted above, oral poliovirus vaccine is the vaccine of choice in the United States. Asa result of the use of the vaccine. cases of paralytic poliomyelitis have been reduced from 18.000 in 1953 to only 8 cases in 1983. Moreover. the several minor outbreaks of poliomyelitis arising in 1970. 1972, and 1979 in unimrnunized populations in the United States and abroad make clear that the immunization pregnant is essential to the protection of the public health. FDA emphasizes that the lots used in the clinical trials submitted in support of the license were properly judged to be safe for purposes of the initial licensure decision and that. in view of the technical nature of any possible deficiencies in the lots, FDA does not believe that action to revoke the license under § 601.5 is warranted. However. although the continued availability of the vaccine may not be in immediate
jeopardy. any possible doubts. whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation's public health objectives. Accordingly. because of the importance of the vaccine and of maintaining public confidence in the immunization program that depends on it. good cause exists to issue these amendments as a final rule effective immediately. The fact that the amendment relieves a restriction also justifies making the rule effective immediately. List of Subjects in 21 CFR Part 630 Biologics. Therefore, under the Federal Food. Drug, and Cosmetic Act (secs. 201. 502. 505, 701, 52 Stat. 1040-1042 as amended, 1050-1053 as amended, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948 (21 U.S.C. 321. 352, 355. 371)), the Public Health Service Act (sec. 351. 58 Stat. 702 as amended (42 U.S.C. 262)). and the Administrative Procedure Act (secs. 4. 10. 60 Stat. 238 and 243 as amended (5 U.S.C. 553. 701-706)1 and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10), Part 630 is amended by revising § 630.11, to read as follows:
PART 630—ADDITIONAL STANDARDS FOR VIRAL VACCINE
§ 630.11 Clinical trials to quality for license. To qualify for license. the antigenicity of the vaccine shall have been determined by clinical trials of adequate statistical design conducted in compliance with Part 56 of this chapter unless exempted under § 50.104 or
granted a waiver under § 56.105. and with Part 50 of this chapter. Such clinical trials shall be conducted with five lots of poliovirus vaccine which have been manufactured by the same methods. Type specific neutralizing antibody shall be induced in 80 percent or more of susceptibles when administered orally as a single dose, or in 90 percent or more of susceptibles when administered orally after a series of doses. A separate clinical trial shall have been conducted for each monovalent and each polyvalent vaccine for which a license application is made. Interested persons may. on or before July 31. 1984. submit to the Dockets Management Branch (address above) written comments regarding this rulentaking. Two copies of any comments are to be submitted. except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Such comments will be considered in determining whether the amendment made in this document should be modified. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Effective date. This regulation is effective June 1, 1984. (Secs. 201, 502. 505, 701, 52 Stat. 1040-1042 as amended. 1050-1053 as amended. 1055-1056 as amended by 70 Stat. 919 and 72 Stat. au (21 U.S.C. 321. 352. 355. 371); sec. 351. 58 Stat. 702 as amended (42 U.S.C. 264 secs. 4, lo. 69 Stat. 238 and 243 as amended (5 U.S.C. 553. 701-706)) Dated: May 29, 1984. Mari, Novitch. Acting Commissioner of Food and Drugs. (FR Doc 84-14.11 5.40-64, 4:50 pm, BILIANG CODE 4160-01-011