Department of Health and Human Services March 2, 2011 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is requesting nominations to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation. The Advisory Council on Blood Stem Cell Transplantation was established pursuant to Public Law 109-129 as amended by Public Law 111-264; 42 U.S.C. 274k; Section 379 of the Public Health Service Act. In accordance with Public Law 92-463, the Council was chartered on December 19, 2006.

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 (the PRA).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 December 23, 2010 (75 FR 80830) 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: Generic Submission of Technology Transfer Center (TTC) External Customer Satisfaction Surveys (NCI). Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of these web-based surveys are to: obtain information on the satisfaction of TTC's external customers with TTC customer services; collect information of preferred and expected communications channels of TTC's external customers; and assess the strategic direction of companies engaging in collaborations and alliances with the NIH. The needs of external technology transfer customers and stakeholders have never been assessed systematically. Input from these groups is essential for defining workflow process improvements for services provided by the NCI TTC to the research community. The results will be used to strengthen the operations of the NCI TTC, including the Competitive Service Center. This questionnaire adheres to The Public Health Service Act, Section 413 (42 USC 285a-2) which authorizes the Director of the National Cancer Institute in carrying out the National Cancer Program to ``encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research;'' Frequency of Response: Once. Affected Public: Private Sector. Type of Respondents: Managers, Executives and Directors from Foundations, Not-for-Profit and For- profit organizations that conduct research and development in biomedical applications. The three year reporting burden is estimated in Table 1, as is a standard request for generic submissions. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined that NILSTAT (nystatin powder (oral, 100%)) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nystatin powder (oral, 100%) if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is confirming the effective date of March 30, 2011, for the final rule that appeared in the Federal Register of November 15, 2010 (75 FR 69586). The direct final rule amends the regulations regarding new animal drugs for minor use and minor species (MUMS) to update language and clarify the intent of the regulations consistent with the preambles to the proposed and final rules. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

The Food and Drug Administration (FDA) is amending the food additive regulations to permit the use of hydrogen peroxide as an antimicrobial agent in the manufacture of modified whey by ultrafiltration methods. This action is in response to a petition filed by Fonterra (USA), Inc.