Department of Health and Human Services December 4, 2007 – Federal Register Recent Federal Regulation Documents
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DSM Nutritional Products, Inc.; Filing of Color Additive Petition
The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.
National Institute of Mental Health Draft Strategic Plan
The National Institute of Mental Health (NIMH) is developing a strategic plan for the next 3-5 years, and invites the public to provide comments on a draft of this plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (https://www.nimh.nih.gov/about/strategic-planning-reports/nim h-draft- strategic-plan.shtml) from November 20, 2007 through December 21, 2007. The public is invited to provide comments via the e-mail address or the postal address listed on the NIMH Draft Strategic Plan Web page. Background: NIMH is the lead Federal agency for research on mental and behavioral disorders and has as its mission to reduce the burden of these disorders through research on mind, brain, and behavior. The Institute's goal is to generate research that will transform the prevention of and recovery from mental disorders. To inspire and support research that will make a difference for those living with mental illness, the Institute is developing a Strategic Plan to help direct this complex research effort and bring into sharper focus the methods, questions, and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders, ultimately paving the way toward cures. NIMH's draft Strategic Plan outlines several Strategic Objectives that will guide the research agenda for the Institute over the next several years. The public is invited to review this draft plan and provide comments between November 20, 2007 and December 21, 2007. The draft plan may be viewed at https://www.nimh.nih.gov/about/strategic- planning-reports/nimh-draft-strategic-plan.shtml, and hard copies are available by calling 1-866-615-6464 (toll free) or by sending a letter requesting a copy (that includes your mailing address) to: National Institute of Mental Health, Attn: Draft Strategic Plan, 8280 Greensboro Drive, Suite 300, McLean, Virginia 22102. Request for Comments: The public is invited to provide comments on the draft Strategic Plan. Comments may be sent to the email address listed on the NIMH Strategic Planning Web page at https:// www.nimh.nih.gov/about/strategic-planning-reports/nimh-draft- strategic- plan.shtml, or sent to the postal address listed above.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and- comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals; Withdrawal
The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.
Medicare Program, Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III), Correction
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on September 5, 2007 entitled ``Medicare Program, Physicians'' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III).''
Medicaid Program; Optional State Plan Case Management Services
This interim final rule with comment period revises current Medicaid regulations to incorporate changes made by section 6052 of the Deficit Reduction Act of 2005. In addition, it incorporates provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985, the Omnibus Budget Reconciliation Act of 1986, the Tax Reform Act of 1986, the Omnibus Budget Reconciliation Act of 1987, and the Technical and Miscellaneous Revenue Act of 1988, concerning case management and targeted case management services. This interim final rule with comment period will provide for optional coverage of case management services or targeted case management services furnished according to section 1905(a)(19) and section 1915(g) of the Social Security Act. This interim final rule with comment period clarifies the situations in which Medicaid will pay for case management activities and also clarifies when payment will not be consistent with proper and efficient operation of the Medicaid program, and is not available.
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