Department of Health and Human Services January 9, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

This notice announces the final priority data needs for two priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR's toxicological profiles by the logical scientific approach described in a decision guide published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs announced in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research needed pursuant to ATSDR's authority under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. The needs identified here do not represent the priority data needs for any other agency or program. Consistent with section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the President, the Administrator of ATSDR, or the Administrator of the Environmental Protection Agency (EPA) from exercising any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. ATSDR worked with other federal programs to determine common substance-specific data needs and mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. Table 1 presents the priority data needs for acrolein and barium, two priority substances included in the ATSDR Priority List of Hazardous Substances (73 FR 12178, March 6, 2008). These priority data needs were initially announced by ATSDR in the Federal Register on September 8, 2006 (71 FR 53102). The public was invited to comment on these data needs for these two substances during a 90-day period. No public comments were received. These priority data needs and accompanying documents were reviewed by EPA and the National Institute of Environmental Health Sciences (NIEHS), and will be addressed by the mechanisms described in the ``Implementation of Substance-Specific Applied Research Program'' section of this Federal Register Notice.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.