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

This notice provides notice of CDC's intent to fund additional Approved but Unfunded (ABU) cooperative agreement applications previously received and competed in response to CDC Funding Opportunity, CDC-RFA-DP09-912ARRA09, ``Communities Putting Prevention to Work'' (CPPW). It is the intent of CDC to fund additional previously received applications with Patient Protection Affordable Care Act (PPACA), Section 4002, appropriations. To this end, CDC will remove the following ARRA-Specific Requirements published in the aforementioned funding opportunity announcement:

This proposed rule proposes to implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). The proposed ESRD QIP would reduce ESRD payments by up to 2.0 percent for dialysis providers and facilities that fail to meet or exceed a total performance score for performance standards established with respect to certain specified measures.

The U.S. Department of Health and Human Services, in its role as the Chair of the Interagency Working Group on Youth Programs, is announcing a meeting to solicit input from the public that will inform the development of a strategic plan for federal youth policy.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for trivalent influenza vaccines. In addition, to ensure that influenza vaccine information materials are available at the beginning of the upcoming influenza vaccination season, the proposed materials included in this notice are also considered interim vaccine information materials covering influenza vaccines for use pending issuance of final influenza materials following completion of the formal NCVIA development process.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for measles, mumps rubella (MMR); varicella, and measles, mumps, rubella; and varicella (MMRV).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Centers for Medicare and Medicaid Services (CMS), both part of the U.S. Department of Health and Human Services. The purpose of the MOU is to promote collaboration and enhance knowledge of efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to further enhance information sharing efforts through more efficient and robust inter- agency activities; promote efficient utilization of tools and expertise for product analysis, validation, and risk identification; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.

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 information collection provisions in the guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables.''

This notice announces COLA's voluntary withdrawal from the specialty of Pathology. COLA is an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program.

The Food and Drug Administration (FDA) is announcing that the U.S. Pharmacopeial Convention has filed a petition proposing that the food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition.

The Food and Drug Administration (FDA) is announcing its determination that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 milligrams/milliliter (mg/mL), 1 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nandrolone decanoate, 200 mg/mL, 1 mL, if all other legal and regulatory requirements are met.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in:

The Food and Drug Administration (FDA) has determined that the five 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.