Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection regarding the manufacture of infant formula, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Standardizing Antibiotic Use in Long-Term Care Settings SAUL) Study.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

Section 13405(c) of the Health Information Technology for Economic and Clinical Health (HITECH) Act expands an individual's right under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to receive an accounting of disclosures of protected health information made by HIPAA covered entities and their business associates. In particular, section 13405(c) of the HITECH Act requires the Department of Health and Human Services (``Department'' or ``HHS'') to revise the HIPAA Privacy Rule to require covered entities to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record. This document is a request for information (RFI) to help us better understand the interests of individuals with respect to learning of such disclosures, the administrative burden on covered entities and business associates of accounting for such disclosures, and other information that may inform the Department's rulemaking in this area.