Department of Health and Human Services April 22, 2011 – Federal Register Recent Federal Regulation Documents

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 Cancer Institute (NCI), 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: Health Information National Trends Survey 4 (HINTS 4) (OMB 0925-0538, Exp 11/30/2008). Type of Information Collection Request: Reinstatement with Change. Need and Use of Information Collection: HINTS 4 will provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of cancer-related behavior. The Public Health Services Act, Sections 411 (42 U.S.C. 285a) and 412 (42 U.S.C. 285a-1.1 and 285a-1.3), outline the research and information dissemination mission of the NCI which authorizes the collection of this information. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 18+). The annual reporting burden is documented in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) published a document in the Federal Register of March 2, 2011 (76 FR 11490), providing notice of the voluntary withdrawal of approval of eight new animal drug applications (NADAs). That document contained an error in the preamble. FDA is correcting the name and address for the sponsor of five of the NADAs. This correction is being made to improve the accuracy of the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA provides for the addition of a pathogen to the indications for use of enrofloxacin solution in cattle, as a single injection, for the treatment of respiratory disease.

This notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accreditation program for organizations that provide outpatient physical therapy and speech-language pathology services seeking to participate in the Medicare or Medicaid programs.