Health Resources and Services Administration May 2006 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-8286
Type: Notice
Date: 2006-05-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: E6-8285
Type: Notice
Date: 2006-05-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Smallpox Vaccine Injury Compensation Program: Administrative Implementation
Document Number: 06-4762
Type: Rule
Date: 2006-05-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term ``child'' survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.
Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table
Document Number: 06-4761
Type: Rule
Date: 2006-05-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.
Agency Information Collection Activities: Proposed Collection Comment Request
Document Number: E6-7726
Type: Notice
Date: 2006-05-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E6-7667
Type: Notice
Date: 2006-05-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E6-7666
Type: Notice
Date: 2006-05-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: E6-7665
Type: Notice
Date: 2006-05-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Advisory Committee on Infant Mortality; Notice of Meeting
Document Number: E6-7662
Type: Notice
Date: 2006-05-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Companion Document to Direct Final Rule
Document Number: 06-4370
Type: Proposed Rule
Date: 2006-05-12
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are proposing to amend their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs. The regulation of other recovered blood vessels would remain unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed changes are noncontroversial, and we do not anticipate any significant adverse comments. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
Document Number: 06-4369
Type: Rule
Date: 2006-05-12
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are amending their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We are issuing these amendments directly as a final rule because they are noncontroversial, and there is little likelihood that we will receive any significant adverse comments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children; Notice of Meeting
Document Number: E6-7020
Type: Notice
Date: 2006-05-09
Agency: Department of Health and Human Services, Health Resources and Services Administration