Department of Health and Human Services January 8, 2008 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program.'' This guidance provides premarket approval application (PMA) applicants with information about the bioresearch monitoring (BIMO) review process. This includes a BIMO evaluation of clinical and nonclinical information in the PMA and certain PMA supplements as well as preapproval BIMO inspections. The procedural information outlined in this document should help applicants and FDA to better understand the BIMO review and inspection so it can proceed in a timely manner.
Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29); Withdrawal
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29) (CPG Sec. 555.700). CPG Sec. 555.700 is no longer necessary because the policy stated in the CPG is obsolete. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft revision of CPG Sec. 575.100 Pesticide Chemical Residues in Food and FeedEnforcement Criteria (CPG 7141.01) (CPG Sec 575.100).
Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.'' This guidance document explains for premarket approval application (PMA) applicants the process involved with the review of a PMA manufacturing section and inspection of the manufacturing operations described in the manufacturing section. This guidance is also generally applicable to the process involved with the review of manufacturing information in certain PMA supplements. The procedural information outlined in this document should help applicants and FDA schedule and complete their work in a timely manner.
Draft, Revised Compliance Policy Guide Sec. 575.100 Pesticide Chemical Residues in Food-Enforcement Criteria (CPG 7141.01); Availability
The Food and Drug Administration (FDA) is announcing the availability of draft, revised Compliance Policy Guide (CPG) Sec. 575.100 Pesticide Chemical Residues in FoodEnforcement Criteria (CPG 7141.01) (the draft CPG). The draft CPG is intended to provide guidance to FDA staff on FDA's internal enforcement processes concerning pesticide chemical residues in food. Elsewhere in this issue of the Federal Register, FDA is announcing the withdrawal of Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29) (CPG Sec. 555.700).
Notice of hearing: Reconsideration of Disapproval of California's State Plan Amendment (SPA) 06-019B
This notice announces an administrative hearing to be held on February 15, 2008, at the CMS San Francisco Regional Office, 90 7th Street, 5th Floor, Room 5A, San Francisco, California 94103, to reconsider CMS' decision to disapprove California's SPA 06-019B. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by January 23, 2008.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Panel Meeting on the Murine Local Lymph Node Assay; Availability of Draft Background Review Documents; Request for Comments
NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces an independent scientific peer review panel meeting to evaluate modifications and new applications for the Murine Local Lymph Node Assay (LLNA). The LLNA is an alternative test method that can be used to determine the allergic contact dermatitis potential of chemicals and products. The panel will review the following: The validation status of three modified LLNA test method protocols that use non-radioactive probe chemicals. The validation status of a LLNA limit dose procedure. The use of the LLNA to test mixtures, aqueous solutions, and metals (applicability domain for the LLNA). The use of the LLNA to determine potency (potential for causing allergic contact dermatitis). Revised draft recommended performance standards for the LLNA. At this meeting, the panel will peer review the draft background review documents and revised draft LLNA performance standards for each topic and evaluate the extent that established validation and acceptance criteria have been appropriately addressed. The panel will also comment on the extent that the review documents support draft ICCVAM recommendations on proposed test method protocols, proposed uses of the LLNA, and the revised draft LLNA performance standards. NICEATM invites public comments on the draft background review documents, draft ICCVAM test recommendations, draft test method protocols, and revised draft LLNA performance standards. All documents will be available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm by January 8, 2008.
Head Start Program
This final rule implements the addition of family child care as a Head Start and Early Head Start program option. Family child care is care and education provided to children in a private home or other family-like setting. In keeping with the goal of designing programs that meet family and community needs, some Head Start and Early Head Start agencies have identified family child care as an effective Head Start service delivery model.
Medicare Program; Option for Prescription Drug Plans To Lower Their Premiums for Low-Income Subsidy Beneficiaries
This proposed rule would provide for an option for Medicare Prescription Drug Plan (PDP) Sponsors to offer a separate prescription drug premium amount for low-income subsidy (LIS) individuals subject to certain conditions. We are proposing to allow PDP Sponsors to offer a reduced premium amount for LIS-eligible individuals to ensure that at least five PDP Sponsors in every PDP region would have a PDP with a premium at or below the premium subsidy amount. This provision will help to ensure there are a sufficient number of organizations offering zero-premium plans in each region and reduce the number of LIS beneficiary reassignments to other organizations.
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