Health Resources and Services Administration February 2013 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request
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 especially 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. 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 sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge 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 discount 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 develop audit guidelines 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. 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 ICR are summarized in the table below. The annual estimate of burden is as follows:
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Part C funds to the Hoboken Community Healthcare, Inc., Hoboken, New Jersey.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will be providing a one-time noncompetitive Part C funds award to DFHS, Lagrange, Georgia.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Part C funds to the Aaron E. Henry Community Health Center (AEHCHC), Clarksville, Mississippi.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Ryan White HIV/AIDS Program (Part C) funds to the University of Pittsburgh Medical Center, Presbyterian Shadyside, Pittsburgh, Pennsylvania.
Current Traumatic Brain Injury State Implementation Partnership Grantees; Non-Competitive One-Year Extension Funds
The Health Resources and Services Administration (HRSA) will issue funding for a non-competitive one-year extension for the State Implementation Partnerships (H21) awards to current grantees whose awards are scheduled to end in fiscal year (FY) 2013. Up to $250,000 per grantee will be awarded over a one-year extended project period. The HRSA TBI Program was initially authorized by the Traumatic Brain Injury Act of 1996 (Pub. L. 104-166) and was most recently reauthorized by the Traumatic Brain Injury Act of 2008 (Pub. L. 110- 206). Under this authority, the HRSA TBI Program is charged with improving access to rehabilitation and other services for individuals with traumatic brain injury and their families. The TBI State Implementation Partnership Grants support activities that complement existing state infrastructure to provide needed services following TBI. Through comprehensive and periodic needs and resources assessments, activities supported by grant funds are aligned with the highest priority areas as determined by providers, individuals with TBI and their families, advocates, and other stakeholders. Recipients of grant funds are expected to modify infrastructure in such a way that improvements in service delivery will be sustained beyond the grant period. As part of this charge, grantees must specifically have or develop the following four core components: (1) A Statewide Advisory Board consisting of members of the community, and representatives of other state agencies with an interest in TBI, such as State Departments of Health, Rehabilitation, Human Services, Education, Transportation, or Labor. This board should also have strong representation from individuals with TBI and/or family members; and also organizations that serve individuals with TBI; and other service providers, medical and non-medical; (2) A designated state agency that takes responsibility for carrying out activities of the grant; (3) A statewide needs and resources assessment; and (4) A comprehensive Statewide Action Plan for assisting individuals with TBI and their families to increase access to needed services and supports.
National Advisory Council on the National Health Service Corps; Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) vacancies on the National Advisory Council (NAC) on the National Health Service Corps (NHSC). The NAC on NHSC was established in 1978.
Agency Information Collection Activities; Proposed Collection, Comment Request
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 especially 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: Corps Community Day Event FormNEW Abstract: Corps Community Day was created in 2011 and celebrates the National Health Service Corps (NHSC) every October during National Primary Care Week. The NHSC is a program administered by the Bureau of Clinician Recruitment and Service (BCRS) within HRSA. The goals of Corps Community Day encompass the following: increase awareness of the NHSC to potential applicants and the greater primary health community; create a sense of community and connectedness among NHSC program participants, alumni, partners, and staff; and underscore the NHSC's role in bringing primary health care services to the nation's neediest communities. Current program participants, alumni, NHSC Ambassadors, sites, primary care organizations, and professional associations plan events and report the details of their events to BCRS so that they can be added to the state-by-state map of events. In order to avoid duplication of effort, eliminate confusion regarding allowable event dates, avoid data entry errors, and implement a brief post-event satisfaction survey, BCRS would like to implement a standard form that event planners will use to report to BCRS. The fillable form will be available online and will have less than 20 fields for event planners to populate to submit for inclusion on the map. There will also be approximately five fields to populate following the event to measure satisfaction. Both the pre-event and post-event data fields will be held in one form. 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:
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