Department of Health and Human Services August 7, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending to September 10, 2007, the comment period for the proposed rule published in the Federal Register of June 11, 2007 (72 FR 32030). The proposed rule would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for oral pressurized metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. FDA is taking this action in response to a request for an extension.

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 Office of the Director, 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: A Process Evaluation of the NIH Director's Pioneer Award (NDPA) Program. Type of Information Collection Request: Extension of a currently approved collection. Need and Use of Information Collection: This study will assess the NDPA Program operations and the outputs of the identification, evaluation and selection process. The primary objectives of the study are to: (1) Assess the NDPA award selection process; (2) determine if the program was implemented as planned; and (3) determine if the process was conducted in accordance with the overall mission of the NDPA program. The findings will provide valuable information concerning: (1) The characteristics of applicants and reviewers; (2) the criteria used to evaluate and select awardees; and (3) aspects of the process that could be revised or improved. Frequency of Response: Once. Affected Public: none. Type of Respondents: Applicants, Reviewers and Panelists, Liaisons. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Frequency of Response: Once. Affected Public: none. Type of Respondents: Applicants, Reviewers and Panelists. Estimated Number of Respondents: 710; Estimated Number of Responses per Respondent: 1: Average Burden Hours Per Response: .25 (15 minutes), and Estimated Total Annual Burden Hours Requested: 177.50 and the annualized cost to respondents is estimated at $9,662.50. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Table l and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 25, 2007, pages 29338-29339, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Application for the Pharmacology Research Associate Program. Type of Information Collection Request: Extension of a currently approved collection. Need and Use of Information Collection: The Pharmacology Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with a Ph.D. degree in pharmacology or a related science, M.D., or other professional degree through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in pharmacological research for key positions in academic, industrial, and Federal research laboratories. Frequency of Response: Once a year. Affected Public: Individuals or households; businesses or other for-profit. Type of Respondents: Applicants and referees. The annual reporting burden is as follows:

This notice describes the procedure utilized for implementing Section 6053(b) of the Deficit Reduction Act of 2005, Public Law 109- 171 for fiscal year 2008. Section 6053(b) of the Deficit Reduction Act provides for a modification of the Federal Medical Assistance Percentages for any state which has a significant number of evacuees from Hurricane Katrina. This notice also includes an interpretation of evacuee. HHS issued a notice on January 25, 2007, announcing for public comment, a proposed methodology to implement the requirements of Section 6053(b). The notice allowed 30 days for public comment. We received one timely comment from the Texas Health and Human Services Commission. The comment letter contained several suggestions which are summarized and responded to below.

The Food and Drug Administration (FDA) has determined that DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 milligrams (mg) per 5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dextroamphetamine sulfate oral solution, 5 mg/5 mL.

The Food and Drug Administration (FDA) has determined that PREVACID NAPRAPAC 250 (copackaged lansoprazole delayed-release 15- milligram (mg) capsules and naproxen 250-mg tablets) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for copackaged lansoprazole delayed-release 15-mg capsules and naproxen 250-mg tablets.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Dow Chemical Company, Madison, Illinios, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 22, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at Los Alamos National Laboratory, Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 22, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC: