Department of Health and Human Services March 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System.'' This guidance document describes a means by which drug metabolizing enzyme genotyping systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify drug metabolizing enzyme genotyping systems into class II (special controls). This guidance document is immediately in effect as the special control for drug metabolizing enzyme genotyping systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.'' This guidance document describes a means by which instrumentation for clinical multiplex test systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify instrumentation for clinical multiplex test systems into class II (special controls). This guidance document is immediately in effect as the special control for instrumentation for clinical multiplex test systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The National Toxicology Program (NTP) announces availability of the document, ``A National Toxicology Program for the 21st Century: A Roadmap for the Future,'' and invites attendance at the symposium, ``The National Toxicology Program: A Quarter Century of Toxicology for Public Health'' on May 10-11, 2005, at the National Academy of Sciences in Washington, DC. This meeting will reflect on the history of the NTP and its impact on public health since its establishment in 1978 and unveil the NTP's plans and directions for the future.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Assessment of the Use of Special Funding for Research on Type 1 Diabetes Provided by the Balanced Budget Act of 1997 (Pub. L. 105-33), the FY 2001 Consolidated Appropriations Act (Pub. L. 106-554), and the Public Health Service Act Amendment for Diabetes (Pub. L. 107-360). Type of Information Collection Request: Revision, OMB control number 0925-0503; expiration date: 06/30/2005. Need and Use of Information Collection: This survey will be one source of input into a statutorily mandated assessment and report to the Congress on special funding for research on type 1 diabetes provided by the Balanced Budget Act of 1997, (Pub. L. 105-33), the FY 2001 Consolidated Appropriations Act, (Pub. L. 106- 554), and the Public Health Service Act Amendment for Diabetes, (Pub. L. 107-360). Collectively, these Acts provided $1.14 billion in special funds to the Department of Health and Human Services (HHS) for research aimed at understanding, treating and preventing type 1 diabetes and its complications. The Secretary of HHS subsequently designated to NIDDK the lead responsibility in the Department for developing a process for allocation of these funds. The primary objective of the survey is to gain information, via a brief questionnaire, from NIH research grantees, who were the primary recipients of these special funds, concerning their views on the impact of the type 1 diabetes research funding with respect to: (1) Advancing scientific accomplishments involving innovative, clinically relevant, and multidisciplinary research on type 1 diabetes; (2) developing resources or reagents useful for type 1 diabetes research; and (3) increasing the number and quality of type 1 diabetes investigators. The responses will provide valuable information concerning how the funds have facilitated research as intended by these Acts of Congress. The results will also help determine how research progress from these special congressional initiatives fits within the continuum of diabetes research, and how these funds have contributed to the field of type 1 diabetes research and NIH efforts to combat this challenging health problem. Information from this study will aid in evaluation of the process by which the research goals for use of the special type 1 diabetes funds have been developed and are being pursued. Responses already collected from this survey were analyzed as part of an interim program assessment that was published by the NIDDK in April, 2003 https://www.niddk.nih.gov/federal/ planning/type 1specialfund/. This revised survey will contribute to a statutorily mandated report, due to Congress on January 1, 2007, evaluating the process and efforts under this program and assessing research initiatives funded by these Acts of Congress. Frequency of Response: The initial survey will require a one time response; though, respondents may be contacted again in the event of future congressionally mandated reports on the use of the special type 1 diabetes research funds. Affected Public: Research scientists who received the special funds about which Congress has mandated in law the requirements for an evaluation report. Type of Respondents: Laboratory and clinical investigators who have received support from the special type 1 diabetes funds provided under the laws previously cited. The annual reporting burden is as follows: Estimated Number of Respondents: 500; Estimated Number of Responses per Respondent: 1 (Respondents will be given one questionnaire containing an estimated fifteen questions.); Average Burden Hours Per Response: 1; and Estimated Total Annual Burden Hours Requested: 500. The annualized total cost to respondents is estimated at: $25,000. It is expected that the respondents will be contacted vie e-mail and that their responses will be collected through an Internet-accessible questionnaire. These measures will reduce the burden on the respondents and the overall costs of administering the study. Because different types of awards have been made with the special type 1 diabetes funds, the questionnaire may be tailored such that respondents will only be asked to answer a subset of questions that pertain to their particular type of award(s). No respondent will be asked to answer more than a total of fifteen questions, at least one-third of which will be answered with a ``yes'' or ``no'' or a one- word response. There are no Capital Costs, Operating or Maintenance Costs to report. Request For Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

The Food and Drug Administration (FDA) is announcing the availability of a new Web-based system to electronically obtain a user fee payment identification number and to submit your Prescription Drug User Fee (PDUFA) cover sheet (FDA Form 3397) to the Office of Financial Management. The system will enable FDA to electronically track your company's application payments and will allow your organization to obtain the user fee payment identification number over the Web. By making the user fee payment identification number and the PDUFA cover sheet available on-line, we will be able to improve service, one of PDUFA's performance goals.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on September 28, 1993.