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Federal Register/Vol. 70, No. 242/Monday, December 75180 Federal Register / Vol. 70, No. 242 / Monday, December 19, 2005 / Notices Control System, Medicare contractors DEPARTMENT OF HEALTH AND survey local welfare staff to gather in- and the Coordination of Benefit HUMAN SERVICES depth qualitative information on how Contractor, Common Working File, CMS workers interpret the policies and apply Regional Offices, an agency of a State Administration for Children and them in specific instances. The results government, Medicare beneficiaries and Families of this study should give the non-Medicare beneficiaries that have an Administration for Children and approved or denied WC Medicare Set- Proposed Information Collection Activity; Comment Request Families (ACF) a better understanding aside arrangement to cover future of possible outcomes of various sanction medical costs resulting from an injury Proposed Projects policies, which in turn will help ACF incurred while employed and the Social Title: Sanction Policies Task Order. design a research program to study the Security Administration. effect of sanctions. OMB No.: New Collection. SYSTEMS EXEMPTED FROM CERTAIN PROVISION Respondents: A maximum of 324 OF THE ACT: Description: This study is designed to determine how local welfare offices welfare staff in local welfare offices. None. implement sanction policies in the [FR Doc. E5–7486 Filed 12–16–05; 8:45 am] Temporary Assistance for Needy BILLING CODE 4120–03–P Families program. This study will ANNUAL BURDEN ESTIMATES Number of Average Number of responses burden Total burden Instrument respondents per respond- hours per re- hours ent sponse In-person Survey and Telephone Interviews ................................................... 324 1 .85 275 Estimated Total Annual Burden Dated: December 12, 2005. thereby determining if it may remain Hours: 275. Robert Sargis, licensed and on the market; issue a final In compliance with the requirements Reports Clearance Officer. response to recommendations made in of section 3506(c)(2)(A) of the [FR Doc. 05–24174 Filed 12–16–05; 8:45 am] the Panel’s report, and; respond to Paperwork Reduction Act of 1995, the BILLING CODE 4184–01–M comments on the previously published Administration for Children and proposed order. The final rule and final Families is soliciting public comment order concerning bacterial vaccines and on the specific aspects of the DEPARTMENT OF HEALTH AND toxoids other than AVA is published HUMAN SERVICES elsewhere in this issue of the Federal information collection described above. Register. Copies of the proposed collection of Food and Drug Administration information can be obtained and DATES: The final order on categorization comments may be forwarded by writing [Docket No. 1980N–0208] of AVA is effective December 19, 2005. to the Administration for Children and FOR FURTHER INFORMATION CONTACT: Biological Products; Bacterial Kathleen Swisher, Center for Biologics Families, Office of Administration, Vaccines and Toxoids; Implementation Evaluation and Research (HFM–17), Office of Information Services, 370 of Efficacy Review; Anthrax Vaccine L’Enfant Promenade, SW., Washington, Adsorbed; Final Order Food and Drug Administration, 1401 DC 20447, Attn: ACF Reports Clearance Rockville Pike, Suite 200N, Rockville, Officer. E-mail address: AGENCY: Food and Drug Administration, MD 20852–1448, 301–827–6210. [email protected]. All requests HHS. SUPPLEMENTARY INFORMATION: should be identified by the title of the ACTION: Notice. information collection. Table of Contents SUMMARY: The Food and Drug I. Introduction The Department specifically requests Administration (FDA) proposed, among comments on: (a) Whether the proposed II. Background other things, to classify Anthrax Vaccine A. General Description of the collection of information is necessary Adsorbed (AVA) on the basis of findings ‘‘Efficacy Review’’ for Biological for the proper performance of the and recommendations of the Panel on Products Licensed Before July 1972 functions of the agency, including Review of Bacterial Vaccines and B. The December 1985 Proposal whether the information shall have Toxoids (the Panel) on December 13, C. Additional Proceedings Following practical utility; (b) the accuracy of the 1985. The Panel reviewed the safety, the December 1985 Proposal agency’s estimate of the burden of the efficacy, and labeling of bacterial III. Categorization of Anthrax Vaccine proposed collection of information; (c) vaccines and toxoids with standards of Adsorbed—Final Order the quality, utility, and clarity of the potency, bacterial antitoxins, and A. Efficacy of Anthrax Vaccine information to be collected; and (d) immune globulins. After the initial final Adsorbed ways to minimize the burden of the rule and final order was vacated by the collection of information on United States District Court for the B. Safety of Anthrax Vaccine respondents, including through the use District of Columbia on October 27, Adsorbed of automated collection techniques or 2004, FDA published a new proposed other forms of information technology. rule and proposed order on December C. The Panel’s General Statement: Consideration will be given to 29, 2004. The purpose of this final order Anthrax Vaccine, Adsorbed, comments and suggestions submitted is to categorize AVA according to the Description of Product within 60 days of this publication. evidence of its safety and effectiveness, D. The Panel’s Specific Product VerDate Aug<31>2005 18:59 Dec 16, 2005 Jkt 208001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 70, No. 242 / Monday, December 19, 2005 / Notices 75181 Review: Anthrax Vaccine Adsorbed: Health Service Act, was transferred to any condition relating to active Efficacy FDA (37 FR 12865, June 29, 1972). FDA components, labeling, tests appropriate E. The Panel’s Specific Product then assumed responsibility for before release of products, product Review: Anthrax Vaccine Adsorbed: reviewing the previously licensed standards, or other conditions necessary Labeling biological products. In the Federal or appropriate for a biological product’s IV. Comments on the December 2004 Register of February 13, 1973 (38 FR safety and effectiveness. Anthrax Vaccine Adsorbed (AVA) 4319), FDA issued procedures for the In accordance with § 601.25, after Proposed Order and FDA’s Responses review of the safety, effectiveness, and reviewing the conclusions and labeling of biological products licensed A. Comments Supporting Placing recommendations of the review panels, before July 1, 1972. This process was AVA into Category I FDA would publish in the Federal eventually codified in § 601.25 (38 FR B. Comments on the Evidence of Register a proposed order containing: Safety and Effectiveness of AVA 32048 at 32052, November 20, 1973). (1) A statement designating the 1. Brachman Study Under the panel assignments published biological products reviewed into 2. CDC Surveillance Data in the Federal Register of June 19, 1974 Categories I, II, IIIA, or IIIB, (2) a 3. CDC Open Label Safety Study (39 FR 21176), FDA assigned each description of the testing necessary for 4. DoD Pilot Study and Safety Data review of a biological product to one of Category IIIA biological products, and 5. Long-Term Safety Monitoring and the following groups: (1) Bacterial Additional Studies vaccines and bacterial antigens with ‘‘no (3) the complete panel report. Under the C. Comments Describing Adverse U.S. standard of potency,’’ (2) bacterial proposed order, FDA would propose to Events vaccines and toxoids with standards of revoke the licenses of those products 1. Review of Adverse Event Reports potency, (3) viral vaccines and designated into Category II and Category Submitted to the Docket rickettsial vaccines, (4) allergenic IIIB. After reviewing public comments, 2. Summary of Adverse Event Reports extracts, (5) skin test antigens, and (6) FDA would publish a final order on the Submitted to the Docket blood and blood derivatives. matters covered in the proposed order. D. Comments on the Vaccine Used in Under § 601.25, FDA assigned the B. The December 1985 Proposal the Studies initial review of each of the six E. Comments about Allegedly biological product categories to a The Panel was convened in a July 12, Contaminated Vaccine and separate independent advisory panel 1973, organizational meeting, which Inspectional Observations consisting of qualified experts. Each was followed by multiple working F. Comments on Labeling panel was charged with preparing for meetings until February 2, 1979. The G. Additional Comments the Commissioner of Food and Drugs an Panel completed its final report in H. Comments on Matters Outside the advisory report which was to: (1) August 1979. In that report, the Panel Scope of this Proceeding Evaluate the safety and effectiveness of found that AVA, manufactured by V. FDA’s Responses to Additional Panel the biological products for which a Michigan Department of Public Health Recommendations license had been issued, (2) review their (MDPH, now BioPort), License No. 99,1 VI. References labeling, and (3) identify the biological was safe and effective for its intended products that are safe, effective, and not use and recommended that the vaccine I. Introduction misbranded. Each advisory panel report be placed into Category I. The Panel Biological products licensed before was also to include recommendations based its evaluation of the safety and July 1972 are subject to a review classifying the products reviewed into efficacy of AVA on two studies: The one of three
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