Department of Health and Human Services April 1, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening until May 2, 2011, the comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published in the Federal Register of February 7, 2011 (76 FR 6623). In the notice, FDA requested public comment regarding the March 8 and 9, 2011, meeting of the panel to discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims. FDA is reopening the comment period to update comments and to receive any new information.

The National Institutes of Health (NIH) hereby announces the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2011. The BPCA seeks to improve the level of informationin scientific publications and on the labelabout pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations and publish a list of drugs/needs in pediatric therapeutics. This notice fulfills the requirement to publish that list.

In FY 2011, the Office of Community Services (OCS) will coordinate with the Administration on Native Americans (ANA) to implement the Native Asset Building Initiative, through which the two offices will support Tribes and Native organizations in planning and implementing comprehensive asset-building projects. The initiative will feature special grants through the Assets for Independence (AFI) program. These grants will be in addition to the annual AFI grants that OCS will award in FY 2011. In contrast to the annual awards, though, the eligibility criteria to be listed for these AFI grants in the ``Native Asset Building Initiative'' will vary from the annual AFI awards' eligibility criteria. This is because the criteria used to determine eligibility for these special initiative awards will be more consistent with those used to determine eligibility in the ANA grant program with which OCS is coordinating. Consequently, the eligibility for the special AFI grants will be limited to Native 501(c)(3) non- profits serving Native Americans; Federally recognized Tribal governments or Alaska Native Villages, as defined in the Alaska Native Claims Settlement Act, that are joint applicants with a 501(c)(3) Native non-profit organization; and Native non-profit organizations designated by the Secretary of the Treasury as Community Development Financial Institutions and Native non-profit credit unions designated by the National Credit Union Administration as low-income credit unions that demonstrate a collaborative relationship with a local community based organization whose activities are designed to address poverty and the needs of community members for economic independence and stability. Other entities will not be eligible for awards under this initiative, but will continue to be eligible for awards under the annual AFI funding opportunity announcement that was published issued for FY 2011 through FY 2013 on February 24, 2011 on https://www.acf.hhs.gov/grants/ open/foa/view/HHS-2011-ACF-OCS-EI-0137. It is estimated that OCS will award up to 10 AFI program grants under Native Asset Building Initiative, with overall funding of approximately $2,500,000 toward the initiative. It is anticipated that each recipient of these special AFI grants will also receive a separate ANA award for their project. In addition to these special AFI awards, we estimate that $15,000,000 in grants will be awarded in FY 2011 under the annual AFI funding opportunity announcement published on February 24, 2011.