Health Resources and Services Administration 2014 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA)'s Bureau of Health Workforce is issuing a single-case deviation from competition requirements for the Virginia Health Workforce Development Authority (VHWDA) Area Health Education Center (AHEC) Point of Service Maintenance and Enhancement (POSME) Award (Grant U77HP26289) to extend the duration of the grant, through August 31, 2017.

HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Health Resources and Services Administration (HRSA) will be issuing non-competitive awards for the HCOP program. Approximately $9.8 million will be made available in the form of grants to the awardees listed in the chart below for the budget period beginning September 1, 2014. We have determined the need for significant program changes prior to launching a new competition to the field. This will enable the Bureau of Health Workforce to thoughtfully redesign the current program to ensure that it meets the needs of both the government and the field, and conduct a single competition in fiscal year (FY) 2015.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

HRSA will be issuing a 1-year non-competitive continuation budget period beyond the planned 3-year project period for the Autism Intervention Research Network on Behavioral Health (AIR-B Network) and the Autism Intervention Research Network on Physical Health (AIR-P Network) programs. Approximately $1,500,000 in funding will be made available in the form of a cooperative agreement to the University of California Los Angeles (UCLA), Cooperative Agreement Number UA3MC11055, during the budget period of September 1, 2014, through August 31, 2015. Approximately $3,000,000 in funding will be made available in the form of a cooperative agreement to the Massachusetts General Hospital (MGH), Cooperative Agreement Number UA3MC11054, during the budget period of September 1, 2014, through August 31, 2015. The AIR-B Network (UA3MC 11055) and the AIR-P Network (UA3MC11054) programs, CFDA No. 93.110, are authorized by the Public Health Service Act, Sec. 399BB(f) (42 U.S.C. 280i-1(f)), as amended by the Combating Autism Reauthorization Act of 2011 (Pub. L. 112-32), which is scheduled to sunset on September 30, 2014. The AIR-B Network is an interdisciplinary, multi-site network of researchers working together with communities to provide national leadership in research to improve the behavioral, mental, social, and/ or cognitive health and wellbeing of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities. The AIR-B Network conducts protocol-based research to advance effective intervention strategies aimed at improving social and behavioral health and well-being among underserved children and adolescents with ASD, in both home and school settings; provides a research environment that is supportive of the professional development of emerging researchers interested in autism intervention research; disseminates critical information on its research findings to inform researchers, care providers, policymakers, other stakeholders in the field, and the public, including families with children and adolescents with ASD; and promotes the translation of network findings into practice settings and communities that will result in improved care. The AIR-P Network is an interdisciplinary, multi-site research network of clinicians and researchers that provides national leadership in research to improve the physical health and well-being of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities. The AIR-P Network conducts protocol-based research to advance effective treatment strategies; develops and updates evidence-based guidelines and validates tools for interventions; provides a research environment that supports the professional development of emerging researchers interested in autism intervention research; disseminates critical information on its research findings to inform researchers, care providers, policymakers, other stakeholders in the field, and the public, including families with children and adolescents with ASD; and promotes the translation of findings into practice settings and communities that will result in improved care.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with the responsibility for considering and acting upon the petitions.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Office of Rural Health Policy (ORHP) in the Health Resources and Services Administration (HRSA) published a 60-day public notice in the Federal Register on November 5, 2012 (Federal Register volume 77, number 214, 66471-66476) describing a methodology for designating U.S. frontier areas. The Frontier and Remote Area (FAR) Codes methodology was developed in a collaborative project between ORHP and the Economic Research Service (ERS) in the U.S. Department of Agriculture (USDA). This notice responds to the comments received during this 60-day public notice.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.

On January 27, 2014, HRSA published Policy Information Notice (PIN) 2014-01 to convey and clarify statutory and regulatory governance requirements for section 330-funded health centers and look-alikes. The PIN, ``Health Center Program Governance,'' and HRSA's ``Comments and Response on Draft PIN: Health Center Program Governance'' are available on the Internet at https://www.bphc.hrsa.gov/policiesregulations/ policies/pin201401.html, and constitutes final agency guidance.