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

The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough, cold, or allergy, Docket Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N- 0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), have been withdrawn. Therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar (IRS) product that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice.

The Food and Drug Administration (FDA) is amending its regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature- indicating devices, in addition to mercury-in-glass thermometers, during processing. This final rule also establishes recordkeeping requirements relating to temperature-indicating devices and reference devices maintained by the processor and allows for the use of advanced technology for measuring and recording temperatures during processing. Finally, this final rule includes metric equivalents of avoirdupois (U.S.) measurements where appropriate. This final rule will allow low- acid canned food processors to transition from mercury-in-glass thermometers to alternative temperature-indicating devices. Use of temperature-indicating devices that do not contain mercury will eliminate concerns about potential contamination of the food or the processing environment from broken mercury-in-glass thermometers. Elsewhere in this issue of the Federal Register, FDA is publishing a 30-day notice announcing that it has submitted the information collection provisions of this final rule to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). The notice also invites the public to submit comments on the information provisions to OMB. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions of the final rule.

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.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-fourth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ ohrp/sachrp/mtgings/.