Department of Health and Human Services September 20, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
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.
Re-allotment of FY 2006 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
In accordance with Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), Title XXVI of the Omnibus Budget Reconciliation Act of 1981 (42 U.S.C. 8621, et seq.), as amended, a notice was published in the Federal Register on August 1, 2007 announcing the Secretary's preliminary determination that $326,894 in Fiscal Year (FY) 2006 funds may be available for re-allotment. After a 30-day comment period, this amount has not changed. This notice announces that $326,894 will be re-allotted to current Low Income Home Energy Assistance Program (LIHEAP) grantees. Pursuant to the statute cited above, funds will be re-allotted to LIHEAP grantees based upon the normal allocation formula as if the funds had been appropriated for FY 2007. No subgrantees or other entities may apply for these funds.
Notice of Availability of Final Policy Guidance
The Health Resources and Services Administration (HRSA) is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-16) to describe and clarify the circumstances under which Federal Tort Claims Act (FTCA)deemed Health Center Program grantees are covered under the FTCA as they respond to emergencies. The PIN, ``Federal Tort Claims Act Coverage for Health Center Program Grantees Responding to Emergencies,'' and the Agency's ``Response to Public Comments'' are available on the Internet at https://bphc.hrsa.gov/ policy/pin0716.
Notice of Availability of Final Policy Guidance
The Health Resources and Services Administration (HRSA) is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-15) to provide guidance on emergency management expectations for health centers to assist them in planning and preparing for future emergencies through the development and maintenance of an effective and appropriate emergency management strategy. The PIN, ``Health Center Emergency Management Program Expectations,'' and the Agency's ``Response to Public Comments'' are available on the Internet at http:/ /bphc.hrsa.gov/policy/pin0715. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver comprehensive, culturally competent, quality primary health care services to patients regardless of their ability to pay. Charges for health care services are set according to income. On February 27, 2007, HRSA made the draft PIN available for public comment on HRSA's Web site. The purpose of the PIN was to provide guidance on emergency management expectations for health centers to assist them in planning and preparing for future emergencies. Comments were due to HRSA by April 13, 2007. Comments were received from 31 organizations and/or individuals. After review and careful consideration of all comments received, HRSA amended the PIN to incorporate certain recommendations from the public. The final PIN reflects these changes. In addition to making the final PIN available on HRSA's Web site, HRSA is also posting the Agency's ``Response to Public Comments.'' The purpose of the document is to summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments did not result in a revision to the PIN, explanations are provided.
Educational Workshops on Current Good Manufacturing Practices; Public Workshops
The Food and Drug Administration (FDA) is announcing a series of educational workshops on quality pharmaceutical production under current good manufacturing practice (CGMP). The workshops, which will be held in collaboration with the Parenteral Drug Association (PDA), are intended to educate participants on current methods for compliance with good manufacturing practices (GMP). The workshops are being offered to help ensure effective CGMP programs and to further the common goals of FDA and providers of quality pharmaceutical products.
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is proposing to amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs. If the essential-use designation is removed, epinephrine MDIs containing an ODS could not be marketed after a suitable transition period. We will hold an open public meeting on the essential use of epinephrine on a date to be announced later.
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