Department of Health and Human Services October 25, 2012 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement in the amount of $103,685 to the University of Oklahoma, National Resource Center for Youth Development, Tulsa, OK, to support expanded technical assistance to address emerging technical assistance needs for States and Tribes as they seek to implement legislation and changing programs dedicated to former foster youth. The grantee is the recipient of a cooperative agreement to administer the National Resource Center for Youth Development (NRCYD). The grantee has been providing technical assistance services through a cooperative agreement since September 30, 2009, pursuant to the legislative authority of the Promoting Safe and Stable Families Program, Section 436(d), Title IV-B, subpart 2, of the Social Security Act (42 U.S.C. 629e).

The Administration for Children and Families, Office of Head Start, announces the award of single-source program expansion supplement grants to four grantees in the Head Start/Early Head Start American Indian and Alaska Native (AIAN) grantees to support their participation in the Tribal Early Learning Initiative. Each of the following grantees is receiving a supplement in the amount of $15,750.

The Food and Drug Administration (FDA) is announcing the rate for the backlog fee related to generic drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II API drug master files (DMFs) to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes the FY 2013 rate for the backlog fee ($17,434). This fee is effective on October 1, 2012.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single-source program expansion supplement grant in the amount of $100,000 to the Tribal Law and Policy Institute, West Hollywood, CA, to provide new or modified technical assistance to assist States and Tribes in implementing the Administration on Children, Youth and Families' well-being framework in the context of the new requirements of the Child and Family Services Improvement and Innovation Act (Pub. L. 112-34) and explore the need for technical assistance to Tribes in the development of oversight plans for prescription medicines for children in Tribal foster care systems. The Tribal Law and Policy Institute administers the National Resource Center for Tribes (NRC4Tribes) under a cooperative agreement where technical assistance is provided to Tribes to assist in building organizational capacity so that Tribes may operate their own foster care programs under title IV-E of the Social Security Act. Under the agreement, Tribal Law and Policy Institute identifies promising practices in Tribal child welfare systems, identifies and effectively implements community, and culturally-based strategies and resources that strengthen Tribal child and family services.