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

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Administration for Children and Families (ACF) is publishing notice of a new system of records, entitled ``Administration for Children and Families' National Responsible Fatherhood Pledge Campaign (NRFPC).''

The Administration on Aging (AoA) 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 the information collection requirements relating to the Alzheimer's Disease Supportive Services Program.

The National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the Center of Disease Control (CDC) seek comments from the public on the impact of eliminating the correction window from the electronic grant application submission process on our applicant organizations and the timing of such a change.

The Food and Drug Administration (FDA) has determined that the 15 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

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 the estimated reporting and recordkeeping burden associated with the Mammography Quality Standards Act requirements.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADAs provides for use of single-ingredient Type A medicated articles containing zilpaterol, melengestrol, monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter.

The Food and Drug Administration (FDA or the agency) is announcing a public hearing to obtain input on the scope and implementation of potential expanded access programs with direct-acting antiviral agents (DAAs) for the treatment of chronic hepatitis C (CHC) infection in patients with unmet medical need. This public hearing is being held to obtain comments from the public on eligibility criteria that should be used for patient enrollment in expanded access protocols involving DAAs and to elicit suggestions for designs of protocols for treatment investigational new drug applications (INDs) involving DAAs and other expanded access protocols. In addition, the agency would like public input on types of studies that should be conducted to obtain information on patients with unmet medical need including those with the greatest risk of progression of liver disease and/or the lowest predicted virologic response rates.