Department of Health and Human Services June 30, 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 Institute of Child Health and Human Development (NICHD), 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. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23608-23609, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study specifically and of federally funded biomedical research overall. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Formative Research Studies for the National Children's Study (NCS) Type of Information Collection Request: RENEWAL of OMB Clearance 0925-0590, Expiration June 30, 2011 Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

The Department of Health and Human Services (DHHS) is seeking public comment on the proposed data collection standards for race, ethnicity, sex, primary language and disability status, as required by Section 4302 of the Affordable Care Act. The proposed data collection standards are now available on the HHS Web site minorityhealth.hhs.gov/ section4302.

This proposed rule would retract the policy adopted in the calendar year 2011 Physician Fee Schedule final rule with comment period that requires the signature of a physician or qualified non- physician practitioner on a requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS). In addition, this proposed rule would reinstate the prior policy that the signature of a physician or qualified non-physician practitioner is not required on a requisition for Medicare purposes for a clinical diagnostic laboratory test paid under the CLFS.