Department of Health and Human Services January 2008 – Federal Register Recent Federal Regulation Documents
Results 251 - 291 of 291
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.
Meeting Being Planned to Obtain Public Input for Ensuring the Safety of Pet Food
The Food and Drug Administration (FDA) is announcing its intention to schedule and hold a public meeting early in 2008 to obtain input from stakeholder groups, including, but not limited to, the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers for the development of ingredient, processing, and labeling standards to ensure the safety of pet food. These standards were mandated by the FDA Amendments Act of 2007 (FDAAA). Date, Time, and Location: The date, time, and location for the 2008 public meeting will be announced in a subsequent notice that will be published in the Federal Register a later date. Addresses: A docket has been opened at FDA to receive any comments in advance of the public meeting. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either https://www.fda.gov/dockets/ecomments or https:// www.regulations.gov.
National Institute on Drug Abuse Draft Strategic Plan
The National Institute on Drug Abuse (NIDA) is developing a strategic plan for the next 5 years, and invites the public to provide comments on a draft of this plan. The draft plan will be publicly available through the NIDA Draft Strategic Plan Web page (https:// www.drugabuse.gov/StrategicPlan/) for 30 days from the publication of this Notice. The public is invited to provide comments via the e-mail address or the postal address listed on the NIDA Draft Strategic Plan Web page. Background: NIDA is the lead Federal agency for research on drug abuse and addiction. For the past three decades, NIDA has led the way in supporting research to prevent and treat drug abuse and addiction and mitigate the impact of their consequencesparticularly the spread of HIV/AIDS and other infectious diseases. Given recent revolutionary advances in drug abuse research, NIDA has recently undergone a strategic planning process gathering recommendations from the National Advisory Council on Drug Abuse and from ongoing dialogue with our various stakeholder groups to establish achievable goals and objectives for the future. NIDA's draft Strategic Plan outlines four major goal areas Prevention, Treatment, HIV/AIDS, and Cross Cutting Prioritieseach with Strategic Objectives that will guide NIDA's research agenda for the future. The public is invited to review this draft plan and provide comments. The draft plan may be viewed at https://www.drugabuse.gov/ StrategicPlan/, and hard copies are available by calling 301- 443-1124 or by sending a letter requesting a copy (that includes your mailing address) to: National Institute on Drug Abuse, Attn: Draft Strategic Plan, 6001 Executive Blvd., Suite 5213, MSC 9561, Bethesda, MD 20892-9561. 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 NIDA Strategic Planning Web page at https:// www.drugabuse.gov/StrategicPlan/, or to the postal address listed above. Comments Due Date: Comments regarding NIDA's draft Strategic Plan should be submitted via e-mail to stratplan@nida.nih.gov no later than 30 days after the publication of this Notice. Comments mailed to the above postal address must be postmarked by the same date.
Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments
On March 31, 2006, the Food and Drug Administration (FDA) charged the Science Board to evaluate FDA's science-based capacities to meet current and future public health challenges. The Science Board established a subcommittee on science and technology to perform the review and draft a report of findings and preliminary recommendations. The subcommittee report was presented and discussed at the December 3, 2007, Science Board Advisory Committee meeting, at which time the Science Board decided to obtain comments from the public on the subcommittee report. FDA is soliciting public comment on the subcommittee report on behalf of the Science Board.
Intramammary Dosage Form New Animal Drugs; Pirlimycin
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 Pharmacia and Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA extends the dosage regimen for pirlimycin hydrochloride intramammary infusion in lactating dairy cattle to daily treatment for up to 8 days.
New Animal Drugs For Use in Animal Feed; Semduramicin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Phibro Animal Health. The NADA provides for use of a Type A medicated article containing semduramicin (as semduramicin sodium biomass) to manufacture Type C medicated broiler chicken feed for the prevention of coccidiosis.
Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until February 8, 2008, the comment period for the draft guidance for industry entitled ``Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval,'' published in the Federal Register of October 15, 2007 (72 FR 58312). The draft guidance informed industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and asked sponsors to amend ongoing or completed studies accordingly. FDA is taking this action in response to a request for an extension of the comment period to allow interested persons additional time to review the draft guidance and submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
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 requirements governing applications for FDA approval to market a new drug.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice amends the meeting date for the 19th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). Revised Meeting Date: January 22, 2008, from 8:30 to 12:00 p.m. (previously scheduled on January 15, 2008).
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.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations
The Interagency Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM announce the upcoming ``Scientific Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations.'' The goals of the workshop are to: (1) Review the state-of-the-science and identify knowledge gaps regarding the key pathways involved in acute systemic toxicity. (2) Recommend how these knowledge gaps can be addressed by collecting mechanistic biomarker data during currently required in vivo safety testing. (3) Recommend how key in vivo pathway information can be used to develop more predictive mechanism-based in vitro test systems and earlier, more humane endpoints for in vivo test methods. (4) Recommend how mechanism-based in vitro test systems and earlier, more humane endpoints can be used to further reduce, refine, and eventually replace animal use for acute systemic toxicity testing while ensuring the protection of human and animal health. This workshop is open to the public with attendance limited only by the space available.
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
The Food and Drug Administration (FDA) is issuing an interim final rule to codify the provisions of the proposed rule entitled ``Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products'' (69 FR 21778, April 22, 2004) (the toll-free number proposed rule or proposed rule) that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act (the act). The added statement includes a toll- free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints.
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 (§ 414.50)
This final rule delays 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 of this chapter) 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.
Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-Making Capacity
On September 5, 2007, the Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) issued a notice in the Federal Register (Vol. 72, No. 171, pages 5096650970) seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research. A 90-day comment period was established upon publication of that notice. The purpose of this notice is to inform all interested parties that the comment period originally identified in the September 5, 2007 Federal Register has been extended for forty one days, in order to maximize the opportunity for interested individuals and organizations to provide information and comments to HHS on this topic.
Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.'' The purpose of this guidance document is to recommend an interactive premarket review process for these submissions that is designed to expedite FDA's review of device applications while continuing to assure device safety and effectiveness, in accordance with the goals of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.
Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist the dietary supplement industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
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