May 9, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 146
Labor Management Cooperation Act of 1978 (Pub. L. 95-524)
The Federal Mediation and Conciliation Service (FMCS) is publishing a final Fiscal Year 2007 Program Guidelines/Application Solicitation for the Labor-Management Cooperation Program. The program is supported by Federal funds authorized by the Labor-Management Cooperation Act of 1978, subject to annual appropriations. This solicitation contains a change in the deadline for accepting applications. Comments: There were no comments received on the draft Fiscal Year 2007 Program Guidelines/Application Solicitation.
Fenpyroximate; Pesticide Tolerances for Emergency Exemptions
This regulation establishes a time-limited tolerance for combined residues of fenpyroximate in or on honey. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide in managed beehives. This regulation establishes a maximum permissible level for residues of fenpyroximate in this food commodity. The tolerance expires and is revoked on December 31, 2010.
Notice of Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Commodities
This notice announces the initial filing of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Bacillus thuringiensis Vip3Aa19 Protein in Cotton; Exemption from the Requirement of a Tolerance
This regulation establishes an extension of the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied/used as a plant-incorporated protectant (PIP). Syngenta Seeds, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied/used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2008.
Notice of Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Commodities
This notice announces the initial filing of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Agency Information Collection Activities; Proposed Collection; Comment Request; Safer Detergent Stewardship Initiative (SDSI) Program; EPA ICR No. 2261.01, OMB Control No. 2070-new
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request for a new Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR, entitled: ``Safer Detergent Stewardship Initiative (SDSI) Program'' is identified by EPA ICR No. 2261.01 and OMB Control No. 2070-new. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection.
Agency Information Collection Activities; Proposed Collection; Comment Request; Asbestos-Containing Materials in Schools Rule and Revised Asbestos Model Accreditation Plan Rule; EPA ICR No. 1365.08, OMB Control No. 2070-0091
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR, entitled: ``Asbestos-Containing Materials in Schools Rule and Revised Asbestos Model Accreditation Plan Rule'' and identified by EPA ICR No. 1365.08 and OMB Control No. 2070-0091, is scheduled to expire on January 31, 2008. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection.
Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances; EPA ICR No. 0574.13, OMB Control No. 2070-0012
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR, entitled: ``Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances'' and identified by EPA ICR No. 0574.13 and OMB Control No. 2070-0012, is scheduled to expire on December 31, 2007. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection.
Clethodim; Pesticide Tolerance
This regulation establishes tolerances for combined residues of clethodim and certain of its metabolites in or on asparagus; flax, seed; herb, subgroup 19A; hop, dried cones; leafy greens subgroup 4A; safflower, meal; safflower, seed; sesame, seed; and vegetable, legume, group 6, except soybean. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Flufenacet; Pesticide Tolerance
This regulation establishes pesticide tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) for combined residues of flufenacet and its metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in or on grass (forage, hay), sweet corn (forage, kernel plus cob with husk removed, stover), wheat (bran, forage, grain, hay, straw), cattle kidney, goat kidney, hog kidney, horse kidney, and sheep kidney. Bayer Cropscience petitioned EPA to establish these tolerances.
Radio Broadcasting Services; Dinosaur, CO
This document requests comments on a petition for rule making filed by Cumulus Licensing LLC (``Petitioner'') proposing the allotment of Channel 262C0 at Dinosaur, Colorado. The proposed coordinates are 40-03-26 NL and 108-39-46 WL with a site restriction of 36.4 km (22.6 miles) southeast of city reference.
Polyethylene Retail Carrier Bags from the People's Republic of China: Amended Final Results of Antidumping Duty Administrative Review
On March 19, 2007, the Department of Commerce (the ``Department'') published Polyethylene Retail Carrier Bags from the People's Republic of China: Final Results of Antidumping Duty Administrative Review, 72 FR 12762 (March 19, 2007) (``Final Results''), covering the period of review (``POR'') January 26, 2004, through July 31, 2005. We are amending the Final Results to correct ministerial errors made in the calculation of the dumping margins for Crown Polyethylene Products (International) Ltd. (``Crown'') and High Den Enterprises Ltd. (``High Den''), pursuant to section 751(h) of the Tariff Act of 1930, as amended (``the Act'').
Radio Broadcasting Services; Christine, TX
This document requests comments on a petition for rule making filed by Katherine Pyeatt (``Petitioner'') proposing the allotment of Channel 245C3 at Christine, Texas, as a first local service. The proposed coordinates are 28-40-00 NL and 98-30-15 WL with a site restriction of 13.6 km (8.4 miles) south of city reference.
Notice of Public Information Collection(s) being Reviewed by the Federal Communications Commission, Comments Requested
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, Public Law No. 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Foramsulfuron; Exemption from the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of foramsulfuron on corn, sweet (K+CWHR); corn, sweet, forage; corn, sweet, stover; corn, pop grain; and corn, pop, stover when applied/used as a herbicide. The Interregional Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of foramsulfuron.
Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Proposals to conduct research involving the deliberate transfer of a tetracycline resistance trait to Chlamydia Trachomatis have been submitted to the NIH Office of Biotechnology Activities (OBA). The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Chlamydia infections in humans. Under the NIH Guidelines, these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approval by the NIH Director as Major Actions. These proposals will be discussed at the June 19-21, 2007 meeting of NIH Recombinant DNA Advisory Committee.
National Toxicology Program (NTP); Report on Carcinogens; Request for Nominations of Scientific Experts for Review of Candidate Substances for the 12th Report on Carcinogens
On April 16, 2007, NTP released the final review process for preparation of the 12th Report on Carcinogens (RoC, 72FR18999, available at https://ntp.niehs.nih.gov/go/9732). This notice invites the public to nominate scientists to serve on expert panels. These scientists should have expertise and/or knowledge relevant to evaluation of the potential carcinogenic hazard of the candidate substances that will undergo review for the 12th RoC.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM request the submission of data and information on the use of topical anesthetics and systemic analgesics for alleviating pain and distress in rabbits during eye irritation testing. They also request the submission of information about other procedures and strategies that may reduce or eliminate pain and distress associated with in vivo eye irritation methods.
Notice of Intent To Grant Exclusive Patent License; Neurovel, Inc.
The Department of the Navy hereby gives notice of its intent to grant to Neurovel, Inc., a revocable, nonassignable, exclusive license in the field of nerve stimulation and the recording of such nerve stimulation in humans and animals including, but not limited to, applications such as a retinal prosthesis and a cortical implant in the United States and certain foreign countries, the Government-owned inventions described in U.S. Patent No. 5,264,722: Nanochannel Glass Matrix Used In Making Mesoscopic Structures, Navy Case No. 74,224.// U.S. Patent No. 6,393,327: Microelectronic Stimulator Array, Navy Case No. 82,449.//U.S. Patent No. 6,647,297: Permanent Retinal Implant Device, Navy Case No. 83,839.//U.S. Patent No. 6,970,745: Microelectronic Stimulator Array for Stimulating Nerve Tissue, Navy Case No. 83,682.//U.S. Patent Application Serial No. 10/ 446,257: Fabrication of Microelectrode Arrays Having High Aspect Ratio Microwires, Navy Case No. 83,713 and any continuations, divisions or re-issues thereof.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on Five In Vitro Pyrogen Test Methods: Availability and Request for Public Comments
NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) convened an independent scientific peer review panel meeting on February 6, 2007, to evaluate the validation status of five in vitro pyrogen test methods proposed as replacements for the Rabbit Pyrogen Test (RPT). The peer review panel (``the Panel'') report from this meeting is now available. The report contains (1) the Panel's evaluation of the validation status of the methods and (2) the Panel's comments and conclusions on draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM/ICCVAM Web site at (https://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below).
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.
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: Treatment of Inflammatory Bowel Disease (IBD) Using IL-13 Modulators and Inhibitors
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 invention embodied in:
Notice with Respect to List of Countries Denying Fair Market Opportunities for Government-Funded Airport Construction Projects
Pursuant to section 533 of the Airport and Airway Improvement Act of 1982, as amended (49 U.S.C. 50104), the United States Trade Representative (USTR) has determined not to include any countries on the list of countries that deny fair market opportunities for U.S. products, suppliers, or bidders in foreign government-funded airport construction projects.
Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Rheumatoid Arthritis (RA)
This notice, in accordance with 35 U.S.C. Sec. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in PCT Application No. PCT/US01/04125, filed February 9, 2001, entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-PCT-02]; U.S. Patent No. 7,148,061, issued December 12, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-US-03]; U.S. Patent Application No. 11/637,272, filed December 12, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E- 095-2000/0-US-08]; PCT Application No. PCT/US06/24909, filed June 26, 2006, entitled ``A Potential Novel Therapeutic Protein Molecule of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptor Type 1'' [E-095-2000/4-PCT-01]; European Patent Application No. 01910476.9, filed February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-EP-06]; Australian Patent Application No. 2001238076, filed on February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-AU-04]; Australian Patent Application No. 2006203490, filed on August 11, 2006, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' [E-095-2000/0-AU-07]; and Canadian Patent Application No. 2399388, filed February 9, 2001, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre- ligand Receptor Assembly and Function'' [E-095-2000/0-CA-05] to Welson Pharmaceuticals, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for rheumatoid arthritis (RA) using Welson's proprietary platform.
Prospective Grant of Exclusive License: Use of Licensee's proprietary delivery formulation containing synthetic peptides of the CEA antigen (or modifications, derivatives, fragments, or immunogenic epitopes thereof) as claimed in the Licensed Patent Rights, alone or in combination with at least one other synthetic peptide for use in the prevention and/or treatment of adenocarcinomas in humans. For the avoidance of doubt, said delivery formulation specifically excludes all poxviruses, eukaryotic expression vectors, and recombinant yeast
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent 6,756,038 and PCT Application Serial No. PCT/US98/19794 and foreign equivalents thereof, entitled ``Agonist and Antagonist Peptides of Carcinoembryonic Antigen (CEA)'' (E-099-1996/0), to Immatics Biotechnologies, GmbH, which is located in Tuebingen, Germany. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensee's proprietary delivery formulation containing synthetic peptides of the CEA antigen (or modifications, derivatives, fragments, or immunogenic epitopes thereof) as claimed in the Licensed Patent Rights, alone or in combination with at least one other synthetic peptide for use in the prevention and/or treatment of adenocarcinomas in humans. For the avoidance of doubt, said delivery formulation specifically excludes all poxviruses, eukaryotic expression vectors, and recombinant yeast.
Guide Concerning Fuel Economy Advertising for New Automobiles
As part of the Commission's systematic review of all current FTC rules and guides, the Commission requests public comment on the overall costs, benefits, necessity, and regulatory and economic impact of the FTC's Guide Concerning Fuel Economy Advertising for New Automobiles (``Fuel Economy Guide'' or ``Guide''). The Commission is also seeking comments on whether the Guide should be amended in light of recent amendments to the Environmental Protection Agency's (``EPA'') fuel economy labeling rules for new automobiles.
Proposed Collection; Comment Request; Customer and Other Partners Satisfaction Surveys
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for the opportunity for pubic comment on the proposed data collection projects, the Warren Grant Magnuson Clinical Center (CC), 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: Customer and Other Partners Satisfaction Surveys. Type of Information Collection Request: New request/waiver. Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; and (4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center's operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer's needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households; businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center's major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: Clinical Center patients, family members of Clinical Center patients, visitors to the Clinical Center, National Institutes of Health investigators, NIH intramural collaborators, private physicians or organizations who refer patients to the Clinical Center, volunteers, vendors and collaborating commercial enterprises, small businesses, regulators, and other organizations. The annual reporting burden is as follows:
Proposed Information Collection Request Submitted for Public Comment and Recommendations; Safety Defects, Examination, Correction, and Records
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance 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.
Submission for OMB Review; Comment Request
The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Notice of Proposed Information Collection Requests
On April 27, 2007, the Department of Education published a notice in the Federal Register (Page 20998, Column 1) for the information collection, ``The Effect of Connected Mathematics 2 (CM2) on the Math Achievement of Middle School Students''. This notice hereby corrects the reporting and recordkeeping hour burden to 15,383 responses and 6,407 hours. The IC Clearance Official, Regulatory Information Management Services, Office of Management, hereby issues a correction notice as required by the Paperwork Reduction Act of 1995.
National Center for Complementary and Alternative Medicine Announcement of Stakeholder Dialogue
The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to a Stakeholder Dialogue. Attendees will meet the NCCAM Acting Director and discuss the Center's activities and priorities. The Dialogue will take place on June 20, 2007 in Bethesda, Maryland. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. To date, NCCAM's efforts to rigorously study CAM, to train CAM researchers, to conduct outreach, and to facilitate integration have been guided by NCCAM's strategic plans located on the NCCAM Web site at https://nccam.nih.gov/about/plans/fiveyear/index.htm. Request for Participation: The public is invited to provide input into the NCCAM's priorities and activities at a Stakeholder Dialogue. This event will give NCCAM stakeholders an opportunity to voice their opinions regarding future directions for research, training, outreach, and integration in complementary and alternative medicine (CAM). The Dialogue will be held: June 20, 2007, 9 a.m. to 3 p.m., Natcher Conference Center, National Institutes of Health,Bethesda, Maryland 20892. NCCAM's acting director will provide an overview of NCCAM's history and current activities, followed by a discussion with attendees. Dialogue attendees are welcome to participate in one of three afternoon breakout sessions (research, training, and communications) wherein there will be an opportunity to interact with NCCAM senior staff and discuss how NCCAM and the CAM community can work together in the future. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. Those wishing to attend should register by June 15, 2007. To register, please visit https://nccam.nih.gov/dialogue. For Further Information: To request more information, visit the NCCAM Web site at https://nccam.nih.gov/dialogue, call 1-888-644-6226, or e-mail info@nccam.gov.
Construction of an Industrial Facility in Brevard County, FL
We, the Fish and Wildlife Service (Service), announce the availability of an incidental take permit (ITP) application and Habitat Conservation Plan (HCP). Michael Richardson (applicant) requests an incidental take permit (ITP) for a duration of 5 years pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act). The applicant anticipates taking approximately 2.2 acre (ac) of Florida scrub-jay (Alphelocoma coerulescens)occupied habitat incidental to constructing an industrial facility in Brevard County, Florida (project). The applicant's HCP describes the mitigation and minimization measures the applicant proposes to address the effects of the project to the scrub-jay.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.'' This guidance document describes a means by which gene expression profiling test systems for breast cancer prognosis 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 gene expression profiling test systems for breast cancer prognosis into class II (special controls). This guidance document is immediately in effect as the special control for gene expression profiling test systems for breast cancer prognosis, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis
The Food and Drug Administration (FDA) is classifying gene expression profiling test systems for breast cancer prognosis 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: Gene Expression Profiling Test System for Breast Cancer Prognosis.'' 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.
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