Health Resources and Services Administration October 2012 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration's (HRSA) Maternal and Child Health Bureau (MCHB) plans to move forward in implementing annual changes to the State Title V MCH Block Grant allocations, beginning in Federal Fiscal Year (FY) 2013, using the U.S. Census Bureau's 3-year American Community Survey (ACS) poverty estimates. Title V MCH Block Grant funds are currently allocated to states based in part on a calculation of the number of children living in poverty (in an individual state) as compared to the total number of children living in poverty in the United States. Historically, data for the number of children in poverty in each state came from the Decennial Census. As the Census Bureau has replaced the Decennial Census long- form sample questionnaire with the ACS, MCHB plans to use the ACS as its source for this data. In order to maintain balance between precision and currency, annual changes to the State Title V MCH Block Grant allocations will be based on a rolling average of the 3-year ACS poverty estimates. Yearly changes in the MCH Block Grant allocations for individual states will be buffered by the use of shared data for two of the three data years in the rolling period estimate. According to the U.S. Census Bureau, the ACS is the best source of survey-based state-level income and poverty estimates. Moreover, ACS child poverty estimates are produced annually, and their use will allow the Block Grant allocation proportions to be updated more frequently than every 10 years.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)[Extension] Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act), ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that a manufacturer who participates in Medicaid must sign a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge enrolled covered entities a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B Drug Pricing Program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs (OPA) developed a dispute resolution process for manufacturers and covered entities, as well as manufacturer guidelines for audit of covered entities (Federal Register Final Notice, December 12, 1996 (Vol. 61, No. 240, pp. 65406-65413)). Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:

The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement award under the Rural Health Network Development Program to the Siloam Springs Regional Health Cooperative, Inc. This non-competitive replacement award will continue activities to improve the treatment and prevention of chronic disease, increase provider knowledge and effective use of health information technology and perform network development activities to ensure the sustainability and viability of a rural health network in order to serve rural, medically underserved residents in rural, northwest Arkansas and northeast Oklahoma.

The Health Resources and Services Administration (HRSA)'s Bureau of Health Professions is issuing a non-competitive single source program expansion supplement award to the University of Guam School of Nursing, an Area Health Education Center (AHEC) Program grantee, to coordinate the U.S. Affiliated Pacific Islands (USAPI) Nursing Program Capacity Strengthening and Quality Improvement Initiative. In fiscal year (FY) 2012, $203,703 will be available to fund this award. The Guam/Micronesia AHEC is uniquely qualified and has the capacity, capability, expertise, experience, and infrastructure to expeditiously, effectively, and efficiently implement the project within their existing educational programming. The University of Guam School of Nursing is the only nationally accredited baccalaureate nursing education program in the Pacific. Its focus is on health careers training and development, as well as improving the health careers pipeline in the region.