January 5, 2011 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2011-01-05-ReaderAids
Type: Reader Aids
Date: 2011-01-05
Board of Governors; Sunshine Act Meeting
Document Number: 2010-33358
Type: Notice
Date: 2011-01-05
Agency: Postal Service, Agencies and Commissions
Ocean Transportation Intermediary License Applicants
Document Number: 2010-33353
Type: Notice
Date: 2011-01-05
Agency: Federal Maritime Commission, Agencies and Commissions
Ocean Transportation Intermediary License; Reissuance
Document Number: 2010-33352
Type: Notice
Date: 2011-01-05
Agency: Federal Maritime Commission, Agencies and Commissions
Ocean Transportation Intermediary License; Rescission of Order of Revocation
Document Number: 2010-33351
Type: Notice
Date: 2011-01-05
Agency: Federal Maritime Commission, Agencies and Commissions
Harmonization of Airworthiness Standards for Transport Category Airplanes-Landing Gear Retracting Mechanisms and Pilot Compartment View
Document Number: 2010-33347
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration proposes to amend the airworthiness standards for transport category airplanes on landing gear retracting mechanisms and the pilot compartment view. This proposal would adopt the 1-g stall speed as a reference stall speed instead of the minimum speed obtained in a stalling maneuver, and would add an additional requirement to keep the landing gear and doors in the correct retracted position in flight. This proposal would also revise the requirements for pilot compartment view in precipitation conditions. Adopting these proposals would eliminate regulatory differences between the airworthiness standards of the U.S. and the European Aviation Safety Agency (EASA), without affecting current industry design practices.
Ocean Transportation Intermediary License Revocation
Document Number: 2010-33346
Type: Notice
Date: 2011-01-05
Agency: Federal Maritime Commission, Agencies and Commissions
Notice of Agreements Filed
Document Number: 2010-33343
Type: Notice
Date: 2011-01-05
Agency: Federal Maritime Commission, Agencies and Commissions
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2010-33342
Type: Notice
Date: 2011-01-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Mine Safety and Health Research Advisory Committee: Notice of Charter Renewal
Document Number: 2010-33341
Type: Notice
Date: 2011-01-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Elizabeth Hartwell Mason Neck National Wildlife Refuge, Fairfax County, VA, and Featherstone National Wildlife Refuge, Prince William County, VA; Draft Comprehensive Conservation Plan and Environmental Assessment
Document Number: 2010-33340
Type: Notice
Date: 2011-01-05
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the draft comprehensive conservation plan and the environmental assessment (CCP/EA) for Elizabeth Hartwell Mason Neck (Mason Neck) National Wildlife Refuge (NWR) and Featherstone NWR for a 45-day public review and comment period. The draft CCP/EA describes three alternatives for managing Mason Neck NWR and two alternatives for managing Featherstone NWR for the next 15 years. Alternative B is identified for both refuges as the Service-preferred alternative. Also available for public review and comment are the draft compatibility determinations, which are included as appendix B in the draft CCP/EA.
State of Arizona Resource Advisory Council Meeting
Document Number: 2010-33339
Type: Notice
Date: 2011-01-05
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM), Arizona Resource Advisory Council (RAC), will meet on February 3, 2011, at the BLM National Training Center located at 9828 North 31st Avenue in Phoenix from 8 a.m. until 4:30 p.m. Agenda items include: BLM State Director's update on statewide programs and issues; presentation on water; updates on the Renewable Energy Strategy, Restoration Design Energy Project Programmatic Environmental Impact Statement (EIS), and Northern Arizona Proposed Mineral Withdrawal Draft EIS; RAC questions on BLM District Managers' Reports; and reports by the RAC working groups. A public comment period will be provided at 11:30 a.m. on February 3, 2011, for any interested members of the public who wish to address the Council on BLM programs and business. Under the Federal Lands Recreation Enhancement Act, the RAC has been designated as the Recreation Resource Advisory Council (RRAC), and has the authority to review all BLM and Forest Service (FS) recreation fee proposals in Arizona. The RRAC will not review any recreation fee proposals at this meeting.
Glen Canyon Dam Adaptive Management Program Work Group (AMWG)
Document Number: 2010-33338
Type: Notice
Date: 2011-01-05
Agency: Department of the Interior, Bureau of Reclamation, Reclamation Bureau
The Glen Canyon Dam Adaptive Management Program (AMP) was implemented as a result of the Record of Decision on the Operation of Glen Canyon Dam Final Environmental Impact Statement to comply with consultation requirements of the Grand Canyon Protection Act (Pub. L. 102-575) of 1992. The AMP includes a Federal advisory committee, the Adaptive Management Work Group (AMWG), a technical work group (TWG), a Grand Canyon Monitoring and Research Center, and independent review panels. The AMWG makes recommendations to the Secretary of the Interior concerning Glen Canyon Dam operations and other management actions to protect resources downstream of Glen Canyon Dam consistent with the Grand Canyon Protection Act. The TWG is a subcommittee of the AMWG and provides technical advice and recommendations to the AMWG.
Airworthiness Directives; Fokker Services B.V. Model F.28 Mark 1000, 2000, 3000, and 4000 Airplanes
Document Number: 2010-33337
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Airworthiness Directives; Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G Airplanes
Document Number: 2010-33335
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to supersede an existing airworthiness directive (AD) that applies to all Model 382, 382B, 382E, 382F, and 382G airplanes. The existing AD currently requires revising the FAA- approved maintenance program by incorporating new airworthiness limitations for fuel tank systems to satisfy Special Federal Aviation Regulation No. 88 requirements. That AD also requires the accomplishment of certain fuel system modifications, the initial inspections of certain repetitive fuel system limitations to phase in those inspections, and repair if necessary. This proposed AD would correct certain part number references, add an additional inspection area, and for certain airplanes, require certain actions to be re- accomplished according to revised service information. This proposed AD results from a report of incorrect accomplishment information in the service information cited by the existing AD. We are proposing this AD to prevent the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
Airworthiness Directives; Dassault-Aviation Model FALCON 7X Airplanes
Document Number: 2010-33334
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
National Institute of Nursing Research; Notice of Meeting
Document Number: 2010-33331
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2010-33330
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
Airworthiness Directives; Bombardier, Inc. Model CL-600-2A12 (CL-601) and CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) Airplanes
Document Number: 2010-33329
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2010-33325
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2010-33323
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2010-33322
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2010-33321
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2010-33320
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2010-33319
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, National Institutes of Health
New Postal Product
Document Number: 2010-33317
Type: Notice
Date: 2011-01-05
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recently-filed Postal Service request to add a Global Expedited Package Services 3 contract to the competitive product list. This notice addresses procedural steps associated with the filing.
Hazardous Materials Transportation: Revisions of Special Permits Procedures
Document Number: 2010-33316
Type: Rule
Date: 2011-01-05
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
PHMSA is revising its procedures for applying for a special permit to require an applicant to provide sufficient information about its operations to enable the agency to evaluate the applicant's fitness and the safety impact of operations that would be authorized in the special permit. In addition, PHMSA is providing an on-line application option.
New Postal Product
Document Number: 2010-33315
Type: Notice
Date: 2011-01-05
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recently-filed Postal Service request to add an additional Global Reseller Expedited Package contract to the competitive product list. This notice addresses procedural steps associated with the filing.
Endangered and Threatened Species, Designation of Critical Habitat for Southern Distinct Population Segment of Eulachon
Document Number: 2010-33314
Type: Proposed Rule
Date: 2011-01-05
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
We, the National Marine Fisheries Service (NMFS), propose to designate critical habitat for the southern Distinct Population Segment (DPS) of Pacific eulachon (Thaleichthys pacificus), which was recently listed as threatened under the Endangered Species Act (ESA). We have proposed 12 specific areas for designation as critical habitat within the states of California, Oregon, and Washington. The proposed areas are a combination of freshwater creeks and rivers and their associated estuaries which comprise approximately 470 km (292 mi) of habitat. Three particular areas are proposed for exclusion after evaluating the impacts and benefits associated with tribal land ownership and management by Indian tribes, but no areas are proposed for exclusion based on economic impacts. We are soliciting comments from the public on all aspects of the proposal, including information on the economic, national security, and other relevant impacts of the proposed designation, as well as the benefits to the southern DPS of eulachon from designation. We will consider additional information received prior to making a final designation.
Notification of U.S. Fish Quotas and an Effort Allocation in the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area
Document Number: 2010-33312
Type: Rule
Date: 2011-01-05
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces that fish quotas are available for harvest by U.S. fishermen in the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area. This action is necessary to make available to U.S. fishermen a fishing privilege on an equitable basis.
Notice of Submission for OMB Review
Document Number: 2010-33311
Type: Notice
Date: 2011-01-05
Agency: Department of Education
The Acting Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Marking Meteorological Evaluation Towers
Document Number: 2010-33310
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
The FAA is considering revising its current Advisory Circular on Obstruction Marking and Lighting to include guidance for Meteorological Evaluation Towers (METs). These towers are erected in remote and rural areas, often are less than 200 feet above ground level (AGL), and fall outside of FAA regulations governing tall structures and their impact on navigable airspace. The proposed marking guidance would enhance the conspicuity of the towers and address the safety related concerns of low level agricultural operations. The FAA seeks comment on the proposed guidance.
Marine Mammals; File No. 15616
Document Number: 2010-33309
Type: Notice
Date: 2011-01-05
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Craig Matkin, North Gulf Oceanic Society, Homer, AK, has applied in due form for a permit to conduct research on marine mammals.
Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2011 Gulf of Alaska Pollock and Pacific Cod Total Allowable Catch Amounts
Document Number: 2010-33308
Type: Rule
Date: 2011-01-05
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is adjusting the 2011 total allowable catch (TAC) amounts for the Gulf of Alaska (GOA) pollock and Pacific cod fisheries. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the GOA pollock and Pacific cod TACs are the appropriate amounts based on the best available scientific information for pollock and Pacific cod in the GOA. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.
Alternative Personnel Management System (APMS) at the National Institute of Standards and Technology
Document Number: 2010-33307
Type: Notice
Date: 2011-01-05
Agency: Department of Commerce, National Institute of Standards and Technology
This notice announces changes to existing provisions of the National Institute of Standards and Technology's (NIST) Alternative Personnel Management System (APMS), primarily to expedite hiring and align APMS Direct-Hire procedures with the Office of Personnel Management (OPM) Direct-Hire Authority (5 CFR part 337 and 69 FR 114). NIST will pilot direct-hire authority under 5 CFR part 337, subpart B, for a period of one year from the issuance date of this notice, for all positions within NIST in the Scientific and Engineering (ZP) career path at the Pay Band III and above, for Nuclear Reactor Operator positions in the Scientific and Engineering Technician (ZT) career path at Pay Band III and above, and for all occupations for which there is a special rate under the General Schedule pay system.
Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2011 Bering Sea and Aleutian Islands Pacific Cod Total Allowable Catch Amount
Document Number: 2010-33306
Type: Rule
Date: 2011-01-05
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is adjusting the 2011 total allowable catch (TAC) amount for the Bering Sea and Aleutian Islands (BSAI) Pacific cod fishery. This action is necessary because NMFS has determined this TAC is incorrectly specified. This action will ensure the BSAI Pacific cod TAC is the appropriate amount, based on the best available scientific information for Pacific cod in the BSAI. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.
Proposed Modification of the Minneapolis, MN, Class B Airspace Area; Public Meetings
Document Number: 2010-33305
Type: Proposed Rule
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
This notice announces four fact-finding informal airspace meetings to solicit information from airspace users and others concerning a proposal to revise the Class B airspace area at Minneapolis, MN. The purpose of these meetings is to provide interested parties an opportunity to present views, recommendations, and comments on the proposal. All comments received during these meetings will be considered prior to any revision or issuance of a notice of proposed rulemaking.
Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2011 Bering Sea Pollock Total Allowable Catch Amount
Document Number: 2010-33303
Type: Rule
Date: 2011-01-05
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is adjusting the 2011 total allowable catch (TAC) amount for the Bering Sea pollock fishery. This action is necessary because NMFS has determined this TAC is incorrectly specified. This action will ensure the Bering Sea pollock TAC is the appropriate amount based on the best available scientific information for pollock in the Bering Sea subarea. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.
Notice of Funding Availability (NOFA) for HUD's Fiscal Year 2010; Resident Opportunity and Self-Sufficiency (ROSS)-Service Coordinators Program; Extension of Application Due Date
Document Number: 2010-33302
Type: Notice
Date: 2011-01-05
Agency: Department of Housing and Urban Development
On October 21, 2010, HUD posted on https://www.Grants.gov, its Notice of Funding Availability (NOFA) for the FY2010 Resident Opportunity and Self-Sufficiency (ROSS) Service Coordinators Program. The NOFA establishes an application due date of Monday, February 21, 2011, which inadvertently falls on the federal holiday of Washington's Birthday (commonly referred to as Presidents Day). To help ensure that applicants have sufficient time to submit their applications, are not deprived, this notice announces that HUD has posted an extension of the application due date on https://www.Grants.gov. The new deadline for submission of applications is Wednesday, February 23, 2011. Applicants do not need to download a new application or resubmit their applications as a result of this notice.
Commercial Space Transportation Advisory Committee-Public Teleconference
Document Number: 2010-33301
Type: Notice
Date: 2011-01-05
Agency: Federal Aviation Administration, Department of Transportation
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. 2), notice is hereby given of a teleconference of the Commercial Space Transportation Advisory Committee (COMSTAC). The teleconference will take place on Thursday, January 20, 2011, starting at 1:30 p.m. Eastern Standard Time. Individuals who plan to participate should contact Susan Lender, DFO, (the Contact Person listed below) by phone or e-mail for the teleconference call in number. The proposed agenda for this teleconference is to review the structure of the COMSTAC Working Groups. The Committee will examine the current Working Groups and discuss whether it should make changes to the current structure. If changes are necessary, what should they be? Interested members of the public may submit relevant written statements for the COMSTAC members to consider under the advisory process. Statements may concern the issues and agenda items mentioned above or additional issues that may be relevant for the U.S. commercial space transportation industry. Interested parties wishing to submit written statements should contact Susan Lender, DFO, (the Contact Person listed below) in writing (mail or e-mail) by January 14, 2011, so that the information can be made available to COMSTAC members for their review and consideration before the January 20, 2011, teleconference. Written statements should be supplied in the following formats: one hard copy with original signature or one electronic copy via e-mail. An agenda will be posted on the FAA Web site at https://www.faa.gov/ go/ast. Individuals who plan to participate and need special assistance should inform the Contact Person listed below in advance of the meeting.
National Conference on Weights and Measures 2011 Interim Meeting
Document Number: 2010-33300
Type: Notice
Date: 2011-01-05
Agency: Department of Commerce, National Institute of Standards and Technology
The National Conference on Weights and Measures (NCWM) 2011 Interim Meeting will be held January 23 to 26, 2011. Publication of this notice on the NCWM's behalf is undertaken as a public service. The meetings are open to the public but a paid registration is required. Please see registration information in the SUPPLEMENTARY INFORMATION section below.
Notice of Funding Availability (NOFA) for Fiscal Year 2010; Rural Innovation Fund Program; Correction
Document Number: 2010-33299
Type: Notice
Date: 2011-01-05
Agency: Department of Housing and Urban Development
On December 22, 2010, HUD posted on https://www.Grants.gov its Notice of Funding Availability (NOFA) for HUD's FY 2010 Rural Innovation Fund Program, ``Rural Fund.'' Today's Federal Register publication announces that HUD has posted on https://www.Grants.gov a technical correction that, most significantly, corrects the application due date and corrects the maximum funding amounts for Category 1 proposals. HUD has also corrected an incorrect reference to a ``Revolving Fund grant'' rather than a ``Rural Fund grant.'' The revised NOFA can be found and downloaded from https://www.Grants.gov, using the CFDA number for that program, 14.263.
Privacy Act of 1974; Computer Matching Program Between the Department of Housing and Urban Development (HUD) and the Department of Health and Human Services (HHS): Matching Tenant Data in Assisted Housing Programs
Document Number: 2010-33298
Type: Notice
Date: 2011-01-05
Agency: Department of Housing and Urban Development
Pursuant to the Computer Matching and Privacy Protection Act of 1988, as amended, HUD is providing notice of its intent to execute a new computer matching agreement with HHS for a recurring matching program with HUD's Office of Public and Indian Housing (PIH) and Office of Housing, involving comparisons of information provided by participants in any authorized HUD rental housing assistance program with the independent sources of income information available through the National Directory of New Hires (NDNH) maintained by HHS. Specifically, the HUD-HHS computer matching program will now include program participants of HUD's new Disaster Housing Assistance Program (DHAP), in addition to participants of previously authorized HUD rental housing assistance programs and conditions requiring HUD's annual Quality Control for Rental Assistance Subsidy Determinations (``QC'') study to provide a statistical measurement of subsidy error within HUD rental housing assistance programs. The most recent renewal of the current matching agreement expires on January 5, 2011.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2010-33296
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: January 10, 2011, 9 a.m. to 6 p.m. and January 28, 2011, 9:30 a.m.-5 p.m. e.t.
Office of Child Support Enforcement Privacy Act of 1974; System of Records
Document Number: 2010-33295
Type: Notice
Date: 2011-01-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Office of Child Support Enforcement (OCSE) is publishing notice that it will rescind a notice of a system of records entitled ``Location and Collection System,'' 09-90-0074, establish two new systems of records entitled ``OCSE National Directory of New Hires'' and ``OCSE Debtor File,'' and amend an existing system of records entitled ``OCSE Federal Case Registry of Child Support Orders.''
Agency Information Collection Activities: Request for Comments for a New Information Collection
Document Number: 2010-33294
Type: Notice
Date: 2011-01-05
Agency: Federal Highway Administration, Department of Transportation
The FHWA has forwarded the information collection request described in this notice to the Office of Management and Budget (OMB) for approval of a new information collection. We published a Federal Register Notice with a 60-day public comment period on this information collection on September 7, 2010. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi; Availability
Document Number: 2010-33293
Type: Notice
Date: 2011-01-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. This draft guidance is not final nor is it in effect at this time.
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