Department of Health and Human Services June 2006 – Federal Register Recent Federal Regulation Documents
Results 201 - 319 of 319
Carbinoxamine Products; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products. Numerous drug products containing carbinoxamine are marketed without approved applications and many are inappropriately labeled for use in infants and young children. Drug products containing carbinoxamine are new drugs that require approved applications. One firm has approved applications to market products containing carbinoxamine. In addition, there is information showing that carbinoxamine should not be used in children under 2 years of age. Manufacturers who wish to market carbinoxamine products that do not already have FDA approval must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance entitled ``Marketed Unapproved Drugs Compliance Policy Guide.''
Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Marketed Unapproved Drugs Compliance Policy Guide.'' The guidance describes how FDA intends to exercise its enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. This document supersedes section 440.100 entitled ``Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 7132c.02) of the Compliance Policy Guide (CPG). It applies to any new drug required to have FDA approval for marketing, including new drugs covered by the over-the- counter (OTC) review.
Determination of Regulatory Review Period for Purposes of Patent Extension; CETROTIDE
The Food and Drug Administration (FDA) has determined the regulatory review period for CETROTIDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
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.
Assistant Secretary for Planning & Evaluation Medicaid Program; Meeting of the Medicaid Commission
This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.
National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health Insurance Policy
Subtitle 2 of Title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended (the Act), governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary), provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The Secretary now proposes a new method of calculating the average cost of a health insurance policy.
Alltech, Inc.; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2253) proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1
The Food and Drug Administration (FDA) is announcing that a collection of information entitled `` Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Oral Dosage Form New Animal Drugs; Oxibendazole Suspension
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 Pfizer, Inc. The supplemental NADA provides for revised food safety labeling for oxibendazole suspension administered orally to horses as an antiparasitic.
Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
The Food and Drug Administration (FDA) Minneapolis District, in cooperation with the Association of Clinical Research Professionals (ACRP), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, August 23, 2006, from 8 a.m. to 5 p.m. and Thursday, August 24, 2006, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at The Northland Inn, 7025 Northland Dr., Brooklyn Park, MN 55428, 800-441-6422 or 763-536- 8300, FAX: 763-536-8790. Contact: Amy C. Johnson, Public Affairs Specialist, Food and Drug Administration, 212 3rd Ave. South Minneapolis, MN 55401, 612-758-7131, FAX: 612-334-4134, e-mail: amy.johnson@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $220 (ACRP Minnesota chapter member), $280 (nonmember), or $220 (Government employee). Make registration fee payable to ACRP, and mail to the attention of Paul Below, 441 Timberland Dr., Burnsville, MN 55337. To register via the Internet please go to https://mnacrp.org/ or contact the ACRP webmaster at webmaster@mnacrp.org. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact Paul Below for ACRP at 441 Timberland Dr., Burnsville, MN 55337, 952-882-4083, FAX: 952-223-1665, e-mail: webmaster@mnacrp.org. Attendees are responsible for their own accommodations. To make reservations at the Northland Inn at a rate of $119.00 plus tax, please contact the Northland Inn (see Location). The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Amy Johnson (see Contact) at least 7 days in advance of the workshop.
Oral Dosage Form New Animal Drugs; Oxibendazole Paste
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 Pfizer, Inc. The supplemental NADA provides for revised food safety labeling for oxibendazole paste administered orally to horses as an antiparasitic.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORJ) and the Assistant Secretary for Health have taken final action in the following case: Steven Anthony Leadon, Ph.D., University of North Carolina: Based on the report of an investigation conducted by the University of North Carolina (UNC) at Chapel Hill and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Steven Anthony Leadon, Ph.D., former Professor of Radiation Oncology, Department of Radiology, School of Medicine, UNC, engaged in scientific misconduct while supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA40453-09 to 15. Specifically, PHS found that Dr. Landon engaged in scientific misconduct by falsifying DNA samples and constructing falsified figures for experiments done in his laboratory to support claimed findings of defects in a DNA repair process that involved rapid repair of DNA damage in the transcribed strand of active genes, included in four grant applications and in eight publications and one published manuscript, which were included as an Appendix to the Voluntary Exclusion Agreement entered into by Dr. Leadon and are as follows: Figures 1, 2, and 3 in the article by Gowen, L.C., Avrutskaya, A.V., Latour, A.M., Koller, B.H., & Leadon, S.A. ``BRCAI Required for Transcription-Coupled Repair of Oxidation DNA Damage.'' Science 281:109-1012, 1988. In grant application 2 R01 CA40453-14 (p. 9), this article was used as justification for proposed research on BRCA1 and related proteins that may be required for transcription-coupled DNA repair of oxidative DNA damage. Data from the research reported in this paper was also used as preliminary data (Figure 2, p. 16) to support proposed experiments on BRCA1. Figures 1A, 2A, and 3 in the article by Leadon, S.A. & Avrutskaya, A. ``Differential Involvement of the Human Mismatch Repair Proteins, hMLH1 and hMSH2 in Transcription-coupled Repair.'' Cancer Research 57:3784-3791, 1997. Figures 1 and 3 in the article by Leadon, S.A. & Avrutskaya, A.V. ``Requirement for DNA Mismatch Repair Proteins in the Transcription Coupled Repair of Thymine Glycols in Saccharomyces cerevisiae.'' Mutation Research 407:177-187, 1998. Figures 7B and 7C in the article by Cressman, V.L., Backlund, D.C., Avrutskaya, A.V., Leadon, S.A., & Koller, B.H. ``Growth retardation, DNA repair defects, and lack of spermatogenesis in BRCA1- deficient mice.'' Molecular and Cellular Biology 19:7061-7075, 1999. Figures 1 A-D, 3A, 3C, ajd 3D and graphs in the unpublished manuscript by Rauscher, F. J. III, Jensen, D.E., Patel, G., Fredericks, W.J., Schultz, D.C., Proctor, M., Sekido, Y., Minna, J., Chernova, T.A., Wilkinson, K.D., Avrutskaya, A.V., & Leadon, S.A. ``BRCA1-associated ubiquitin hydrolase required for transcription- coupled repair of oxidative DNA damage.'' Submitted to Science on May 16, 2001. In figure 4 in grant application 2 R01 CA40453-14 (pp. 17- 18), data from this unpublished manuscript was used regarding BAP1 defects in TCR. Figure 1A and 3A in the article by Cooper, P.K., Nouspikel, T., Clarkson, S.g., and Leadon, S.A., ``Defective transcription-coupled repair of oxidative base damage in Cockayne syndrome patients from XP group G,'' Science 275: 9907ndash993, 1997. In NIH grant application R01 CA40453-10A1, some of the same data for XPG or XP-G/CS cells from this Science article were included by Dr. Leadon as graphs (Figures 4 and 5, pp. 25-27) before the Science paper was published. Figure 1C, 2A and 2B in the article by LePage, F., Kwoh, E.E., Avrutskaya, A., Gentil, A., Leadon, S.A., Sarasin, A., & Cooper, P.K. ``Transcription-coupled repair of 8-oxoguanine: requirement for XPG, TFIIH, and CSB and implications for Cockayne Syndrome.'' Cell 101:159-171, 2000. Figure 7 in grant application 1 R01 CA092390-01. Figures 1 and 2 and Table 1 in the article by Leadon, S.A., Barbee, S.L., & Dunn, A.B. ``The yeast RAD2, but not RAD1, gene is involved in the transcription-coupled repair of thymine glycols.'' Mutation Research 337:169-178, 1995. Figure 6 in the article Nouspikel, T., Lalle, P., Leadon, S.A., Cooper, P.K., & Clarkson, S.g. ``A common mutational pattern in Cockayne syndrome patients from xeroderma pigmentosum group G: Implications for a second XPG function,'' Proc. Nat. Acad. Sci. USA 94, 3116-3121, 1997. Dr. Leadon's position is that he did not engage in scientific misconduct. His position is that a systematic error was introduced into the experiments in question and he recognizes that it could have influenced or accounted for the results. Dr. Leadon states that he has entered into a Voluntary Exclusion Agreement (Agreement) because he cannot sustain the significant financial burden of a legal proceeding to resolve the disagreements between his position and that of HHS. By entering into this Agreement, Dr. Leadon has voluntarily agreed: (1) To exclude himself from knowingly contracting or subcontracting with any agency of the United States Government and from eligibility or knowing involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR Part 76 for a period of five (5) years, beginning on May 10, 2006; (2) To exclude himself 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 consultant for a period of five (5) years, beginning on May 10, 2006; and (3) To submit letters of retraction to the editors of the journals listed below within ten (10) business days from the effective date of this Agreement, stating as follows:
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
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 requirements for Administrative Detention and Banned Medical Devices.
Office of the National Coordinator for Health Information Technology; Nationwide Health Information Network Forum
This notice announces the first forum of the Office of the National Coordinator for Health Information Technology to address the Nationwide Health Information Network functional requirements. The Forum is open to the public and will discuss the requirements needed for a Nationwide Health Information Network that facilitates the accurate, appropriate, timely, and secure exchange of health information.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Olfactory Test Device.'' This guidance document describes a means by which the olfactory test device may comply with the requirement of special controls for class II devices. It includes recommendations for validation of device performance and labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls).
Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
The Food and Drug Administration (FDA) is classifying the olfactory test device 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: Olfactory Test Device.'' 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 is the special control for the device.
Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.
2005 White House Conference on Aging
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will discuss items related to the final report of the Conference during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection as part of an AHRQ contract for ``Privacy and Security Solutions for Interoperable Electronic Health Information Exchange'' (the Assessment). In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ is submitting a request to OMB for emergency review. AHRQ is requesting an emergency review of this collection because the information is needed for subsequent health information technology projects later this year. Because subcontracts were solicited and awarded to the States, it was not possible to accurately quantify the public burden earlier this year. Data collection subcontract proposals were solicited from States and until they were reviewed, selected, awarded and accepted, it was not possible to accurately quantify the public burden earlier.
The Data Measures, Data Composites, and National Standards To Be Used in the Child and Family Services Reviews
On November 7, 2005, the Administration for Children and Families (ACF) published a notice in the Federal Register soliciting comment regarding its proposal to replace the six data measures used as part of the assessment of State performance on the Federal Child and Family Services Review (CFSR) with six data composites (70 FR 67479). Based on the results of our data analyses and a review of comments from the field, ACF made the following decisions: The CFSR will use a State's performance on two individual data measures as part of the assessment of the State's substantial conformity with CFSR Safety Outcome 1Children are, first and foremost, protected from abuse and neglect. A national standard is established for each of these measures. The CFSR will use a State's performance on four data composites as part of the assessment of the State's substantial conformity with CFSR Permanency Outcome 1Children have permanency and stability in their living situations. A national standard is established for each of these data composites. This announcement presents the following information: The decisions made by the Children's Bureau regarding use of data composites for the Federal Child and Family Services Review (CFSR); The composites and additional data that will be used as part of the assessment of a State's substantial conformity with the CFSR requirements; and Descriptive statistics relevant to each composite and measure, including the score that will serve as the national standard for the second round of the CFSR. Where relevant, the announcement addresses key comments from the field in response to the Federal Register notice. The announcement also includes the following attachments: Attachment A: Data to be included in the CFSR State Data Profile. Attachment B: Methodology for Composite Construction.
Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection, 200 Milligram/Milliliter
The Food and Drug Administration (FDA) is amending the animal drug regulations to correct the indications for use for the 200 milligram (mg)/milliliter (mL) strength of oxytetracycline injectable solution used in beef cattle for the treatment and control of various bacterial diseases. This action is being taken to improve the accuracy of the regulations.
Request for Applications for the National Faith-Based and National Community Cardiovascular Disease Prevention Programs for High-Risk Women
The Office on Women's Health (OWH) and the Office of Minority Health (OMH) within the Office of Public Health and Science, and the Office of Research on Women's Health (ORWH) within the National Institutes of Health (NIH), Department of Health and Human Services (DHHS), are interested in establishing national faith-based and/or national community cardiovascular disease (CVD) prevention programs. The purpose of the programs is to reduce CVD mortality and morbidity among high-risk women in the United States through medical screening and risk behavior modification. The CVD prevention programs will be targeted towards high-risk racial and ethnic minority women, aged 40 years and older; however, all high-risk women shall be eligible to participate in the programs regardless of race, religion, or age. Each grantee shall implement one program in 10 faith-based or community-based sites across the United States, including urban and rural areas. The main goal will be for program participants to increase their level of physical activity and establish or maintain a healthy weight over the course of the program. The educational phase of the program shall consist of eight bi-weekly sessions that shall counsel women on all of the major risk factors for CVDsmoking, Type 2 diabetes, hypertension, cholesterol, obesity, and physical inactivity while primarily focusing on controlling weight and increasing physical activity. The maintenance phase of the project shall consist of regularly scheduled, interactive maintenance sessions that shall be designed by program participants. During both phases, participants will be screened for all six major CVD risk factors. All counseling and maintenance sessions shall include small group discussions and a physical activity component focused on reducing risk. These awards focus on President Bush's agenda to broaden Federal efforts to work with faith-based and community organizations. As such, each applicant must either: (1) Be a national faith-based or national community organization that has a network of at least 10 sites across the United States with large populations of high-risk racial and ethnic minority women, aged 40 years and older, or (2) partner with a national faith-based or national community organization that has a network of at least 10 sites across the United States with large populations of high- risk racial and ethnic minority women, aged 40 years and older. Non- profit and for profit organizations that meet the above criteria are eligible to apply. Faith-based organizations, community-based organizations, tribal entities, educational institutions, community health centers, and government entities that meet the above criteria are also eligible and encouraged to apply.
Prospective Grant of Co-Exclusive License: Human Monoclonal Antibody, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a co-exclusive license to practice the inventions embodied in: 1. U.S. Provisional Patent Application Serial No. S/N 60/378,406, PCT/US03/14905, NIH (DHHS) Ref. No. E-144-2002/1-PCT-02 converted into 03733940.5 (E-144-2002/1-EP-04) filed in Europe on November 25, 2004, and 2003239356 (E-144-2002/1-AU-05) filed in Australia October 29, 2004, 10/512,966 (E-144-2002/1-US-03) filed in USA October 28, 2004, as well as 2485120 (E-144-2002/1-CA-06) filed in Canada May 6, 2003, entitled: ``Identification of Novel Broadly Cross-Reactive Neutralizing Human Monoclonal Antibodies''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC). 2. U.S. Patent Application, S/N 60/506,946 (E-316-2003/0-US-01), PCT/US2004/31878 (E-316-2003/0-PCT-02) entered the national stage filing on March 29, 2006 in USA (E-316-2003/0-US-03), in Canada (E-316- 2003/0-CA-04), in Europe (E-316-2003/0-EP-05), and in Australia (E-316- 2003/0-AU-06), entitled: ``Immunoglobulins With Potent and Broad Antiviral Activity''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei- Yun Zhang (SAIC) to Virosys Pharmaceuticals Inc. (hereafter Virosys) having a place of business in Los Altos Hills, California, and Profectus Biosciences, Inc. (hereafter Profectus) having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.
Proposed Collection; Comment Request; NCCAM Customer Service Data Collection
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), will submit to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. A notice of this proposed information collection was previously published in the Federal Register on February 22, 2006, pages 9135- 9136. To date, no public comments have been received. The purpose of this notice is to announce a final 30 days for public comment. NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NCCAM Customer Service Data Collection. Type of Information Collection Request: Renewal. Need and Use of Information Collection: NCCAM provides the public, patients, families, health care providers, complementary and alternative medicine (CAM) practitioners, and others with the latest scientifically based information on CAM and information about NCCAM's programs through a variety of channels, including its toll-free telephone information service and its quarterly newsletter. NCCAM wishes to continue to measure customer satisfaction with NCCAM telephone interactions and the NCCAM newsletter and to assess which audiences are being reached through these channels. This effort involves a telephone survey consisting of 10 questions, which 25 percent of all callers are asked to answer, for an annual total of approximately 1,210 respondents, and a newsletter survey consisting of 10 questions, which is sent to all U.S.-based print newsletter subscribers and which Web users have the option of completing when they exit the page where the latest issue of the newsletter is posted, for an annual total of approximately 839 respondents. NCCAM uses the data collected from the surveys to help program staff measure the impact of their communication efforts, tailor services to the public and health care providers, measure service use among special populations, and assess the most effective media and messages to reach these audiences. Frequency of Response: Once for the telephone survey and periodically for the newsletter survey (to measure any changes in customer satisfaction). Affected Public: Individuals and households. Type of Respondents: For the telephone survey, patients, spouses/family/friends of patients, health care providers, physicians, CAM practitioners, or other individuals contacting the NCCAM Clearinghouse; for the newsletter survey, subscribers to the print NCCAM newsletter and visitors to the newsletter page on NCCAM's Web site. The annual reporting burden is as follows:
Prospective Grant of Exclusive License: GLP-1 Exendin-4 Peptide Analogs and Uses Thereof
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Patent Application Number 10/485,140 filed January 27, 2004, entitled ``GLP-1 Exendrin-4 Peptide Analogs and Uses Thereof,'' to Amylin Pharmaceuticals, Inc., having a place of business in San Diego, CA 92121. The contemplated exclusive license may be limited to use to human therapeutics for diabetes, obesity and cardiovascular disease, as well as neurological and neurodegenerative diseases, disorders and injuries. The United States of America is the assignee of the patent rights in this invention.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Brief on Di-(2-ethylhexyl) phthalate; Request for Public Comments
CERHR invites the submission of public comments on the draft NTP Brief for di-(2-ethylhexyl)phthalate (DEHP). The draft NTP Brief is available from the CERHR Web site (https://cerhr.niehs.nih.gov see ``CERHR Reports & Monographs'') or in hardcopy from CERHR (see ADDRESSES below). Public comments will be considered during the peer review and finalization of the NTP Brief.
Notice of Public Input Opportunity
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to Provide Input on a proposed Web based document:
Notice of Public Input Opportunity
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to provide input on a proposed document:
Guidance for Industry on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency.'' The purpose of this guidance is to assist sponsors in developing and submitting nonclinical and clinical virology data, which are important to support clinical trials of antiviral products. Nonclinical and clinical virology reports are essential components in the review of investigational antiviral products. The information in this guidance will facilitate the development of antiviral products.
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.
Prospective Grant of Exclusive License: Human Monoclonal Antibodies, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in: U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002 (E-144-2002/0-US-01), PCT Application, PCT/US03/14292, filed May 6, 2003, (E-144-2002/0-PCT-02), converted into 03736557.4 (E-144-2002/0- EP-04) filed in Europe on December 3, 2004, and 2003237187 (E-144-2002/ 0-AU-05) filed in Australia on November 3, 2004, 10/513,725 (E-144- 2002/0-US-03) filed in USA on November 5, 2004, as well as 2,484,930 (E-144-2002/0-CA-06) filed in Canada on November 5, 2004, entitled ``Novel broadly cross-reactive HIV neutralizing human monoclonal antibodies selected from Fab phage display libraries using a novel strategy based on alternative antigen panning,'' Inventors: Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences, Inc., having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.
Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of titanium dioxide coated mica-based pearlescent pigments as color additives in food. This action is in partial response to a petition filed by EM Industries, Inc.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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 the information collection provisions of the agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
International Conference on Harmonisation; Guidance on Q9 Quality Risk Management; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q9 Quality Risk Management.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk- based decisions.
Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Chronic Cutaneous Ulcer and Burn WoundsDeveloping Products for Treatment.'' This document provides recommendations on developing products for the treatment of chronic cutaneous ulcer and burn wounds. It includes general guidance on clinical trial design as well as preclinical and manufacturing considerations. This guidance finalizes the draft guidance published on June 28, 2000.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed
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 the reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987
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 (the PRA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Investigational New Drug Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Notice of Participation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information That They Provide to Pregnant Women
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary survey of health care professional on the food safety and nutrition information that they provide to pregnant women.
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:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
First-Generation Guidelines for NCI-Supported Biorepositories
The public comment period for the First Generation Guidelines for NCI-Supported Biorepositories (Federal Register, Vol. 71, Number 82, Page 25814, April 28, 2006) will be extended an additional 30 days beyond publication of this notice.
Agency Information Collection Activities; Proposed Collection: Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project ``Continuance of the Medical Expenditure Panel SurveyHousehold and Medical Provider Component through 2009''. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed collection.
Announcement of Availability of Funds for One Family Planning Clinical Training Cooperative Agreement
This announcement seeks applications from public and nonprofit private entities for one cooperative agreement grant to establish and operate one family planning clinical training project to serve Title X service delivery projects nationally. The project will include two components: (1) Training of clinical preceptors to work in Title X family planning service projects; and (2) conducting a national clinical training meeting every other year of the project. In close collaboration with the Office of Family Planning (OFP) project officer, the successful applicant will be responsible for the development and overall management of all components of the clinical training program. The successful applicant should anticipate substantial involvement of the OFP project officer in the conduct of this cooperative agreement.
New Animal Drugs for Use in Animal Feeds; Melengestrol, Ractopamine, Monensin, and Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, ractopamine, monensin, and tylosin to make four-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Withdrawal and Revision of Seven Guidances
The Food and Drug Administration (FDA) is announcing the withdrawal of five and the revision of two guidances for industry, because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative). Several of the guidances listed in this notice are cross-Center guidances relating to products regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM).
Request for Public Comment: 60-Day Proposed Information Collection
The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review.
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