Department of Health and Human Services September 2011 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 320
Medicare and Medicaid Programs; Approval of the Joint Commission's Continued Deeming Authority for Critical Access Hospitals
This notice announces our decision to approve the Joint Commission for continued recognition as a national accreditation program for critical access hospitals (CAHs) seeking to participate in the Medicare or Medicaid programs.
Oral Dosage Form New Animal Drugs; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The ANADA provides for use of tylosin tartrate soluble powder in chickens, turkeys, swine, and honey bees.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Uses
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.
Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To Assess Concerns; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Reproductive and Developmental ToxicitiesIntegrating Study Results to Assess Concerns.'' This guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable. The guidance is intended for drug developers planning to submit new drug applications (NDAs) and biologics licensing applications (BLAs), and who are assessing nonclinical toxicity information.
National Practitioner Data Bank; Name Change of Proactive Disclosure Service (PDS) to Continuous Query
On March 7, 2007, the Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), published in the Federal Register a notice announcing the implementation of a prototype for querying the National Practitioner Data Bank (NPDB), then known as Proactive Disclosure Service (PDS). This notice announces that the prototype status is removed and that PDS is now known as Continuous Query.
Determination That LOXITANE (Loxapine Succinate) Capsules and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the four drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 21, 2010 (75 FR 42455). The document withdrew approval of 27 new drug applications (NDAs) and 58 abbreviated new drug applications (ANDAs) from multiple applicants. The published document excluded a footnote in the table. This document corrects that error.
Guidance for Industry; Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient.'' The guidance clarifies for manufacturers who produce foods containing a pistachio- derived product as an ingredient that there is a risk that Salmonella species may be present in the incoming pistachio-derived product, and recommends measures to address that risk.
Patient Safety Organizations: Delisting for Cause of Patient Safety Organization One, Inc.
Patient Safety Organization One, Inc.: AHRQ has delisted Patient Safety Organization One, Inc. as a Patient Safety Organization (PSO) pursuant to 42 CFR 3.108(b). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Pub. L. 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule.
Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled ``Marketed Unapproved DrugsCompliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 440.100). CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required FDA approval for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that are being commercially used or sold as of September 19, 2011. All unapproved new drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth in CPG 440.100.
Proposed Collection; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI). Type of Information Collection Request: Reinstatement with change of a previously approved collection (OMB No. 0925-0405, expiration 02/28/2011). Need and Use of Information Collection: By conducting a fourth cohort follow-up survey in an ongoing cohort study of U.S. Radiologic Technologists (USRT), updated information will be collected on cancer and other medical outcomes, personal medical radiation procedures, and other risk factors from all participants, plus detailed employment data from subgroups of participants who performed or assisted with fluoroscopically-guided or radioisotope procedures. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 23,454 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. The fourth survey will be administered by mail to approximately 93,000 living and located cohort members who completed at least one of the three previous surveys to collect information on new cancers and other disease outcomes, detailed work patterns and practices from technologists who worked with radioisotopes and interventional radiography procedures, and new or updated risk factors that may influence health risks. New occupational and medical radiation exposure information will be used to improve radiation dose estimates. The annual reporting burden is reported in Table 1. There are no capital costs, operating costs and/or maintenance costs to report.
Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long range (75 year) projection methods and assumptions in projecting Medicare health expenditures and projecting National Health Expenditures and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately project health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy.
Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Solid Organ Transplantation
With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) requests public comment on the draft Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation (Draft Guideline). The Draft Guideline can be found at https://www.regulations.gov under Docket No. CDC-2011-0011. Also found at the docket is a supporting document for reference, the Evidence Report. The Evidence Report includes primary evidence, studies, and data tables that were used by the Guideline authors in developing the recommendations in the Guideline. The Draft Guideline is for use by organ procurement organizations (OPOs); transplant centers, including physicians, nurses, administrators, and clinical coordinators; laboratory personnel responsible for testing and storing donor and recipient specimens; and persons responsible for developing, implementing, and evaluating infection prevention and control programs for OPOs and transplant centers. This Draft Guideline provides evidence-based recommendations for reducing unexpected transmission of HIV, HBV and HCV from deceased and living organ donors.
Animal Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions regarding the features FDA should propose for the next ADUFA program. Date and Time: The meeting will be held on November 7, 2011, from 9 a.m. to 12 noon. Location: The meeting will be held at the Food and Drug Administration, 7519 Standish Pl., 3d floor, Rm. A, Rockville, MD 20855. If you require special accommodations, please contact Patricia Arnwine (see Contact Person) at least 7 days before the meeting. Contact Person: Donal Parks, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240- 276-8688, FAX: 240-276-9744, Donal.Parks@fda.hhs.gov, or Patricia Arnwine, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240-276-9724, FAX: 240-276- 9744, Patricia.Arnwine@fda.hhs.gov. Comments: Regardless of attendance at the meeting, interested persons may submit either electronic or written comments regarding this document. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. Comments received by October 26, 2011, will be taken into consideration before the public meeting. Transcripts: Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActA DUFA/ ucm042891.htm approximately 30 days after the meeting.
Magnetic Resonance Imaging Safety; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Magnetic Resonance Imaging (MRI) Safety Public Workshop.'' The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging (MRI) and approaches to mitigate risks. The overall goal is to discuss strategies to minimize patient and staff risk in the MRI environment.
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