Department of Health and Human Services January 2008 โ€“ Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 291
Human Cells, Tissues, and Cellular and Tissue-Based Products
Document Number: 08-55500
Type: Rule
Date: 2008-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 08-160
Type: Notice
Date: 2008-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 08-159
Type: Notice
Date: 2008-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 08-158
Type: Notice
Date: 2008-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 08-157
Type: Notice
Date: 2008-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 08-156
Type: Notice
Date: 2008-01-18
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Self-Directed Personal Assistance Services Program State Plan Option (Cash and Counseling)
Document Number: 08-115
Type: Proposed Rule
Date: 2008-01-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule provides guidance to States that want to administer self-directed personal assistance services through their State plans.
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: E8-836
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Intramammary Dosage Forms; Cephapirin Sodium
Document Number: E8-816
Type: Rule
Date: 2008-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs provide for revisions to the labeling of two cephapirin sodium products administered by intramammary infusion to lactating cows for the treatment of mastitis.
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: E8-814
Type: Notice
Date: 2008-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: E8-779
Type: Notice
Date: 2008-01-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Research Resources; Notice of Closed Meeting
Document Number: 08-138
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 08-137
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 08-136
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 08-135
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 08-134
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 08-133
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 08-132
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 08-131
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infections Diseases; Notice of Closed Meeting
Document Number: 08-130
Type: Notice
Date: 2008-01-17
Agency: Department of Health and Human Services, National Institutes of Health
User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Program Will Not Be Implemented
Document Number: E8-740
Type: Notice
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not ``provided in advance in appropriations Acts'' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn.
Oral Dosage Form New Animal Drugs; Firocoxib Tablets
Document Number: E8-730
Type: Rule
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery.
Psychopharmacologic Drugs Advisory Committee; Amendment of Notice
Document Number: E8-726
Type: Notice
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
Document Number: E8-702
Type: Proposed Rule
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA) to codify the agency's longstanding view on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review of such change. FDA is proposing to reaffirm its longstanding position that a supplemental application submitted under those provisions is appropriate to amend the labeling for an approved product only to reflect newly acquired information, as well as to clarify that such a supplemental application may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or device. The amendments proposed by this document are intended to reflect the agency's existing practices with respect to supplemental applications submitted to FDA.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Document Number: E8-699
Type: Rule
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis.
Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability
Document Number: E8-675
Type: Notice
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a risk assessment on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed this risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of a risk management plan for animal clones and their progeny. The risk management plan takes into account the risks identified in the risk assessment and sets out measures that FDA will use to manage those risks. In addition, FDA is announcing availability of guidance for industry 179. This guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed.
National Institute of Child Health and Human Development; Longitudinal Investigation of Fertility and the Environment Study
Document Number: E8-609
Type: Notice
Date: 2008-01-16
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This is a request for renewal of an information collection request that was approved (OMB Clearance 0925-0543) following publication in the Federal Register on January 9, 2004, page 1589 and December 2, 2004, page 70153. Proposed Collection: Title: Longitudinal Investigation of Fertility and the Environment Study. Type of Information Collection Request: Renewal of OMB Clearance 0925-0543. Need and Use of Information Collection: This study will assess the relation between select environmental factors and human fecundity and fertility. This research originally proposed to recruit 960 couples who are interested in becoming pregnant and willing to participate in a longitudinal study. Fewer than expected couples were enrolled during the first three years of the project (n=350), predominantly due to the fact that more couples were ineligible for participation than had been originally estimated. In light of this fact, the revised study plan is to enroll a total of 500 couples (i.e., 150 additional couples), a sample size that will not compromise the main study objectives. Fecundity will be measured by the time required for the couples to achieve pregnancy, while fertility will be measured by the ability of couples to have a live born infant. Couples who are unable to conceive within 12 months of trying or who experience a miscarriage also will be identified and considered to have fecundity-related impairments. The study's primary environmental exposures include: Organochlorine pesticides and polychlorinated biphenyls; metals; fluorinated compounds; phytoestrogens; and phthalates. A growing body of literature suggests these compounds may exert effects on human reproduction and development; however, definitive data are lacking serving as the impetus for this study. Couples will participate in a 20-30 minute baseline interview and be instructed in the use of home fertility monitors and pregnancy kits for counting the time required for pregnancy and detecting pregnancy. Blood and urine samples will be collected at baseline from both partners of the couple for measurement of the environmental exposures. Two semen samples from male partners and two saliva samples from female partners also will be requested. Semen samples will be used to assess male fecundity as measured primarily by sperm concentration and morphology. Saliva samples will be used for the measurement of cortisol levels as a marker of stress among female partners so that the relation between environmental factors, stress and human reproduction can be assessed. The findings will provide valuable information regarding the effect of environmental contaminants on sensitive markers of human reproduction and development, filling critical data gaps. Moreover, these environmental exposures will be analyzed in the context of other lifestyle exposures, consistent with the manner in which human beings are exposed. Frequency of Response: Following the baseline interview, couples will each complete a five-minute daily diary on select lifestyle factors. Women will perform daily fertility testing and pregnancy testing at day of expected menses using a dipstick test in urine. Each test will require approximately five minutes for completion. This testing and diary reporting is required only up to the time women become pregnant, which on average should be in 2-3 months. Men will provide two semen samples, a month apart, requiring approximately 20 minutes for each collection, and women will collect two saliva samples, a month apart, requiring approximately five minutes. Participating couples will be given a choice to submit their information by mail or to send it electronically to the Data Coordinating Center. This option will be available throughout data collection in the event couples change their minds about how they would like to submit information. Bio-specimens will be collected by study participants and research nurses, where appropriate, and forwarded in prepaid delivery packages to the study's laboratories. Affected Public: Individuals from participating communities. Type of Respondents: Men and women aged 18-40 years. Revised Estimated Number of Respondents: 1,000. Revised Estimated Number of Response Sets per Respondent: 6 per women and 3 per men over approximately two years. Average Burden Hours per Response: .1947 for women and .31975 for men. Revised Estimated Total Annual Burden Hours Requested: 1,658 for women and 889 for men. The revised burden estimates represent a 48 percent reduction in the originally requested burden. There is no cost to respondents. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) The necessity of the proposed collection of information for the proper performance of the function of the agency, including the practical utility of the information; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Submission for OMB Review; Comment Request; Quality of Life Outcomes in Neurological Disorders
Document Number: E8-606
Type: Notice
Date: 2008-01-16
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on September 24, 2007, page number 54269 and allowed 60 days for public comment. One public comment was received; also received were one request for the data collection plans and proposed instruments and a request for information on a related Web site. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Quality of Life Outcomes in Neurological Disorders; Type of Information Collection Request: New; Form Number: NA; Need and Use of Information Collection: In order to improve outcome measurement in clinical trials of neurological conditions, NINDS is developing a health-related quality of life (HRQL) measurement system for major neurological diseases that affect the United States population. This measurement system must be consistent enough across the selected conditions to allow for cross-disease comparison, and yet flexible enough to capture condition-specific HRQL issues. The primary end users of this measurement system will be clinical trialists and other clinical neurology researchers; however the measurement system will also be appropriate for clinical practice. The proposed information collection will support psychometric testing of HRQL item banks and testing of Spanish translation of the final questionnaires. Frequency of Response: Once; Affected Public: Individuals; Type of Respondent: Adults and children. The annual reporting burden is shown in the following table. There are no Capital Costs, Operating Costs or Maintenance Costs to report.
The Statement of Organization, Functions, and Delegations of Authority
Document Number: 08-125
Type: Notice
Date: 2008-01-16
Agency: Department of Health and Human Services, National Institutes of Health
Notification of Exception to Competition
Document Number: E8-582
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is issuing a non-competitive program expansion supplement to the National Health Care for the Homeless Council (NHCHC) to provide expanded training and technical assistance to HRSA-funded grantees serving individuals who are homeless. Authority: This activity is under the authority of the Public Health Service Act, section 330(l). Catalog of Federal Domestic Assistance Number: 93.224. Background: The National Health Care for the Homeless Council (NHCHC) is a cooperative agreement grantee that provides training and technical assistance support to health centers that serve homeless individuals and families. The NHCHC requires supplemental funding to provide, through expanded regional and national training activities, a broader and enriched menu of support for HRSA grantees, including Health Care for the Homeless (HCH) administrators, clinicians, and members of HCH Boards of Directors and consumer advisory groups. Amount: The amount of the award is $225,000. Project Period: July 1, 2006, to June 30, 2008. Budget Period Supplemented: July 1, 2007, to June 30, 2008. Justification for The Exception to Competition: Given the recent growth of the HCH component of HRSA's Health Center program, it is critical that expanded regional and national training be provided in as timely a manner as possible. This supplemental request is being awarded noncompetitively because, at this time, there are no other organizations with the expertise to complete these activities, and no other organization is prepared to provide these services within the timeframe in which they are needed. Due to the emerging and urgent needs of the HCH program, this supplemental request and the activities proposed are essential to ensuring successful delivery of health care to the target population.
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: E8-581
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; Correcting Amendment
Document Number: E8-576
Type: Rule
Date: 2008-01-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This correcting amendment corrects several technical and typographical errors in the regulations text of the final rule with comment period that appeared in the November 27, 2007 Federal Register (72 FR 66222). The final rule with comment period addressed performance standards for diagnostic testing facilities and standards and requirements related to therapy services under Medicare Parts A and B.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Document Number: E8-573
Type: Notice
Date: 2008-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Announcement of First Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
Document Number: E8-572
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the first in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2020 to be held in Washington, DC. These meetings will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
Document Number: E8-571
Type: Notice
Date: 2008-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
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 procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMEA) of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3602A
Document Number: E8-569
Type: Notice
Date: 2008-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
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 FDA Form 3602A, which will allow a foreign business to qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
Advisory Committees; Tentative Schedule of Meetings for 2008
Document Number: E8-567
Type: Notice
Date: 2008-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2008. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.
Meeting of the National Vaccine Advisory Committee
Document Number: E8-565
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Delay of the Date of Applicability of the Revised Anti-Markup Provisions for Certain Services Furnished in Certain Locations (ยง 414.50); Correction
Document Number: E8-561
Type: Rule
Date: 2008-01-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects typographical errors identified in the final rule that appeared in the January 3, 2008 Federal Register (73 FR 404). The final rule delayed until January 1, 2009 the applicability of the anti-markup provisions in Sec. 414.50, as revised at 72 FR 66222, except with respect to the technical component of a purchased diagnostic test and with respect to any anatomic pathology diagnostic testing services furnished in space that is utilized by a physician group practice as a ``centralized building'' (as defined at Sec. 411.351) for purposes of complying with the physician self-referral rules and does not qualify as a ``same building'' under Sec. 411.355(b)(2)(i) of this chapter.
State Offices of Rural Health Grant Program
Document Number: E8-551
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive (GPD) 3.01 governing indirect cost recovery for one of its grant programs. The GPD states ``HHS considers activities conducted by grantees that result in indirect charges a necessary and appropriate part of HHS grants, and HHS awarding offices must reimburse their share of these costs.'' Although HRSA typically reimburses grantees for their full share of administrative overhead represented in approved indirect cost rates, the agency believes, in the case of its State Offices of Rural Health (SORH) Grant Program, that full recovery of overhead expenditures would be detrimental to the SORH grantees' ability to adequately conduct all the activities mandated in the authorizing legislation. Limiting indirect cost recovery is necessary because eleven of fifty SORH grantees are located in academic settings that have established indirect cost rates in the range of 30 to 50 percent or even higher. It is in the best interest of the program to limit the indirect cost recovery to not more than 15 percent of allowable total direct costs, thus leaving 85 percent of the grant funds to conduct the activities required by the grant program. This limitation would be applicable to all awardees of the State Offices of Rural Health Grant Program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
Document Number: E8-542
Type: Notice
Date: 2008-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Advisory Council on Migrant Health; Notice of Meeting
Document Number: E8-526
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
Small Rural Hospital Improvement Grant Program
Document Number: E8-525
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive (GPD) 3.01 governing indirect cost recovery for one of its grant programs. The GPD states ``HHS considers activities conducted by grantees that result in indirect charges a necessary and appropriate part of HHS grants, and HHS awarding offices must reimburse their share of these costs.'' Although HRSA typically reimburses grantees for their full share of administrative overhead represented in approved indirect cost rates (which can be up to 50 percent or higher), the Agency believes, in the case of its Small Rural Hospital Improvement Grant Program (SHIP), that full recovery of overhead expenditures would be detrimental to the ability to adequately conduct the activities mandated in the authorizing legislation. The purpose of the SHIP grant program is to assist eligible small rural hospitals in implementing Prospective Payments Systems (PPS), compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations, and to reduce medical errors and to support quality improvement. Funding for the SHIP grant program is routed first through the State Offices of Rural Health (SORH); they are then distributed evenly by the SORH to the individual hospitals. This process creates efficiencies because of the large number of eligible hospitals and relatively small size of each award. In fiscal year 2007, $14,508,691 was awarded to 1,622 hospitals (approximately $8,945 each) in 46 States. Thus, the SORH is the official grantee of record for the State, as the recipient of the award and fiscal intermediary for the Federal government in distributing the funds. It is in the best interest of the SHIP grant program to limit the total administrative cost recovery to 5 percent of the Federal award, thereby allowing 95 percent of available grant funds to be used to carry out the required program activities. Since the SHIP grant program began in FY 02, through FY 07, the administrative costs have been restricted. Indirect costs were not allowed and there was a five percent maximum of other costs, for administrative costs, within the grant guidance. The SORHs voluntarily decided to limit these cost categories. For FY 07, the average administrative charge was only 3.64 percent. Thus, the cap on administrative costs has worked well. Limiting administrative costs is necessary because 20 percent of SHIP grantees are located in academic settings that have established indirect cost rates in the range of 30 to 50 percent. Without a limitation on the amount of grant funds allocated for administrative costs, the SORH grantee could potentially charge its full indirect cost rate and the grant awards would be significantly less for each small rural hospital. As much as 50 percent of the grant award could be consumed by indirect costs, depending upon the host institution's indirect cost rate. This would significantly reduce the amount of funds available to initiate and maintain the activities of the grant. A limitation on administrative costs will ensure that each hospital, not an unintended source, receives the maximum amount of funding. The limitations placed on these cost categories will ensure that the majority of funding is routed to the small rural hospitals, to be used for the prescribed intents and purposes of the grant program. A continued limitation on administrative costs for future SHIP grant cycles will help to assure that small rural hospitals receive the appropriated support, necessary to carry out the objectives of the grant program. The limitation would be applicable to all grantees of the Small Rural Hospital Improvement Grant Program.
Drug Safety and Risk Management Advisory Committee; Amendment of Notice
Document Number: E8-490
Type: Notice
Date: 2008-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
Fogarty International Center; Notice of Meeting
Document Number: 08-99
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-98
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 08-97
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 08-96
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 08-95
Type: Notice
Date: 2008-01-15
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; Corrections
Document Number: 07-6308
Type: Rule
Date: 2008-01-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This correction notice corrects several technical and typographical errors in the final rule with comment period that appeared in the November 27, 2007 Federal Register (72 FR 66222). The final rule with comment period addressed Medicare Part B payment policy, including the physician fee schedule (PFS) that is applicable for calendar year (CY) 2008; the competitive acquisition program (CAP); clinical lab fee schedule issues; performance standards for diagnostic testing facilities; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); physician self-referral issues; and standards and requirements related to therapy services under Medicare Parts A and B. The final rule with comment period also updated the list of services subject to the physician self-referral prohibitions.