Department of Health and Human Services January 2007 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 238
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Definition of “Patient”
Section 602 of Public Law 102-585, the ``Veterans Health Care Act of 1992,'' enacted Section 340B of the Public Health Service (PHS) Act ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that in order to obtain Medicaid reimbursement for its covered outpatient drugs, a manufacturer must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price to covered entities for outpatient drugs that will not exceed an amount determined under a statutory formula. Section 340B is administered as the ``340B Drug Pricing Program'' and is commonly referred to as ``the 340B Program.'' Section 340B states that it is illegal for covered entities to sell medications purchased under the 340B Program to persons who are not considered ``patients'' of the covered entity. The purpose of this notice is to inform interested parties of proposed clarifications to the definition of ``patient'' for whom the covered entity can purchase discounted pharmaceuticals under the 340B Program. This clarification is necessary to protect the integrity of the 340B Program and to assist covered entities and other participants in their compliance efforts.
Notice Regarding 340B Drug Pricing Program-Contract Pharmacy Services
Section 340B of the Public Health Service Act implements a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of proposed guidelines regarding contract pharmacy services that will allow covered entities to utilize contract pharmacy services arrangements previously limited to the Alternative Methods Demonstration Project program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
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 information collection regarding the manufacture of infant formula, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping.
Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
The Food and Drug Administration (FDA) is amending its food labeling regulations for the expanded use of the nutrient content claim ``lean'' on the labels of foods categorized as ``mixed dishes not measurable with a cup'' that meet certain criteria for total fat, saturated fat, and cholesterol content. This final rule responds to a nutrient content claim petition submitted by Nestl[eacute] Prepared Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic Act (the act). This action is also being taken to provide reliable information that would assist consumers in maintaining healthy dietary practices.
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. FDA is proposing these actions as part of its continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of, bovine spongiform encephalopathy (BSE) and related human disease in the United States.
Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Withdrawal
The Food and Drug Administration (FDA) published a direct final rule that appeared in the Federal Register of September 25, 2006 (71 FR 55729), that would have amended certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002, are necessary in a 510(k). FDA stated in the direct final rule that, if it received a significant adverse comment by December 11, 2006, FDA would publish a notice of withdrawal. FDA received two comments and considers at least one of these comments a significant adverse comment and, therefore, is withdrawing the direct final rule. Accordingly, the agency will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of September 25, 2006 (71 FR 55748) as a companion to the direct final rule.
Advisory Committee on Organ Transplantation
The Advisory Committee on Organ Transplantation (ACOT) will be conducting a conference call to discuss the revision of the Uniform Anatomical Gift Act (UAGA).
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.'' This guidance document describes a means by which quality control material for cystic fibrosis nucleic acid assays may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify quality control material for cystic fibrosis nucleic acid assays into class II (special controls). This guidance document is being immediately implemented as the special control for quality control material for cystic fibrosis nucleic acid assays, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
The Food and Drug Administration (FDA) is classifying quality control material for cystic fibrosis nucleic acid assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 14 approved new animal drug applications (NADAs) from ADM Animal Health & Nutrition Division to ADM Alliance Nutrition, Inc.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Jong Hyuk Park, Ph.D., University of Pittsburgh: Based on accumulated evidence including the University of Pittsburgh (UP) investigation committee report and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Jong Hyuk Park, Ph.D., former postdoctoral fellow, Pittsburgh Development Center of the Magee-Womens Research Institute, UP, engaged in research misconduct in research funded by National Center for Research Resources (NCRR), National Institutes of Health (NIH), grant R24 RR13632 and National Institute of Child Health and Human Development (NICHD), NIH, grant P01 HD047675. Specifically, Dr. Park: (1) Intentionally and knowingly falsified various versions of two figures in a manuscript entitled ``Rhesus Embryonic Stem Cells Established by Nuclear Transfer: Tetraploid ESCs Differ from Fertilized Ones'' that was being prepared for submission to Nature; (2) Repeatedly misrepresented to the UP investigative panel the accuracy of one of the figures; (3) Presented the false figures as true to members of the laboratory; and (4) Falsified the record of revisions of the figures by deleting all prior versions from the laboratory server. ORI has implemented the following administrative actions for a period of three (3) years, beginning on November 29, 2006: (1) Dr. Park is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR Part 76; and (2) Dr. Park is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
In Vitro Diagnostic Multivariate Index Assays; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting is intended to provide a public forum during which FDA will hear presentations and comments from interested stakeholders regarding the draft guidance entitled ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.'' This draft guidance is intended to provide clarification on FDA's approach to regulation of in vitro diagnostic multivariate index assays. FDA is seeking comments on this draft guidance.
Medical Devices 101: An Educational Forum; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the FDA Medical Device Industry Coalition (FMDIC) and the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Medical Devices 101: An Educational Forum.'' This public workshop is intended to provide an overview on FDA's medical device requirements to entrepreneurs, startup companies, and small businesses. Date and Time: The public workshop will be held on February 9, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St. in Dallas, TX. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: oraswrsbr@fda.hhs.gov. Registration: Registration by January 26, 2007, is strongly encouraged. The RMSBDC has a $75 early registration fee to cover the cost of facilities, materials, and refreshments. Please submit your registration as soon as possible. Registration at the site may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration after January 26, 2007, is $99 payable to RMSBDC. If you need special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 7 days in advance. Registration Form Instructions: To register, please complete the RMSBDC registration form and submit along with payment to RMSBDC, Attn: Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the completed registration form to RMSBDC at 214-860-5867. To obtain a copy of the registration form, please call RMSBDC at 214-860-5887 or 214- 860-5849. The registration form is also available online at https:// www.ntsbdc.org/. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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 requests for exemption from the food additive listing regulation requirements that are submitted under part 170 (21 CFR part 170).
International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E15 Terminology in Pharmacogenomics.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The draft guidance is intended facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.
Conventional Foods Being Marketed as “Functional Foods”; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to March 5, 2007, the comment period for the notice of public hearing that appeared in the Federal Register of October 25, 2006 (71 FR 62400). In the notice of public hearing, FDA requested comments on how the agency should regulate conventional foods marketed as ``functional foods'' under its existing legal authority. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
New Animal Drugs For Use in Animal Feeds; Monensin
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 Elanco Animal Health. The supplemental NADA revises the concentration of monensin in Type C medicated feeds used for improved feed efficiency, and for the prevention and control of coccidiosis in cattle fed in confinement for slaughter.
Notice of Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
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