August 24, 2011 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2011-08-24-ReaderAids
Type: Reader Aids
Date: 2011-08-24
Changes in Flood Elevation Determinations
Document Number: C1-2011-20963
Type: Rule
Date: 2011-08-24
Agency: Federal Emergency Management Agency, Department of Homeland Security
Sunshine Act; Notice of Agency Meeting
Document Number: 2011-21760
Type: Notice
Date: 2011-08-24
Agency: National Credit Union Administration, Agencies and Commissions
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-21718
Type: Notice
Date: 2011-08-24
Agency: National Archives and Records Administration, Agencies and Commissions
NARA is giving public notice that the agency proposes to request extension of a currently approved information collection used when veterans or other authorized individuals request information from or copies of documents in military service records. The public is invited to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.
Renewal of Advisory Committee on Electronic Records Archives
Document Number: 2011-21717
Type: Notice
Date: 2011-08-24
Agency: National Archives and Records Administration, Agencies and Commissions
This notice is published in accordance with the provisions of section 9(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) and advises of the renewal of the National Archives and Records Administration's (NARA) Advisory Committee on Electronic Records Archives. In accordance with Office of Management and Budget (OMB) Circular A-135, OMB approved the inclusion of the Advisory Committee on Electronic Records Archives in NARA's ceiling of discretionary advisory committees.
Clean Water Act Section 303(d): Final Agency Action on 16 Total Maximum Daily Loads (TMDLs) in Arkansas
Document Number: 2011-21711
Type: Notice
Date: 2011-08-24
Agency: Environmental Protection Agency
This notice announces the final agency action on 16 TMDLs established by EPA Region 6 for waters listed in the State of Arkansas, under section 303(d) of the Clean Water Act (CWA). Documents from the administrative record files for the final 16 TMDLs, including TMDL calculations may be viewed at https://www.epa.gov/region6/water/npdes/ tmdl/index.htm.
Workshop: Advancing Research on Mixtures; New Perspectives and Approaches for Predicting Adverse Human Health Effects
Document Number: 2011-21688
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services
The NIEHS is hosting a workshop entitled ``Advancing Research on Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects'' on September 26-27, 2011 at the Sheraton Chapel Hill, Chapel Hill, NC. This workshop is organized to include plenary sessions and small group breakout sessions on specific topics. It is open to the public to attend as observers. For more information and to register for this workshop, please visit https://tools.niehs.nih.gov/ conferences/dert/mixtures/. The deadline to register for this workshop is Monday, September 12, 2011. Registration is limited to 85 observers based on available space.
Prospective Grant of Exclusive License: Devices for Clearing Mucus From Endotracheal Tubes
Document Number: 2011-21685
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
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 a worldwide exclusive license, to practice the invention embodied in: HHS Ref. No. E-061-2004/0 ``Mucus Shaving Apparatus for Endotracheal Tubes''; U.S. Patent 7,051,737 to EndOclear, LLC, a company incorporated under the laws of the State of Michigan having its headquarters in Petoskey, Michigan. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices for clearing mucus from endotracheal tubes.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-21683
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2011-21682
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-21681
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority and Health Disparities; Notice of Closed Meetings
Document Number: 2011-21680
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Notice of Meeting
Document Number: 2011-21679
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-21678
Type: Notice
Date: 2011-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Chlorpyrifos Registration Review; Preliminary Human Health Risk Assessment; Extension of Comment Period
Document Number: 2011-21677
Type: Notice
Date: 2011-08-24
Agency: Environmental Protection Agency
EPA issued a notice in the Federal Register of Wednesday, July 6, 2011, concerning the availability of the chlorpyrifos registration review; preliminary human health risk assessment. This document extends the comment period for 30 days, from Tuesday, September 6, 2011 to Thursday, October 6, 2011.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Financial Responsibility for Licensed Launch Activities
Document Number: 2011-21672
Type: Notice
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. Information is used to determine if licensees have complied with financial responsibility requirements (including maximum probable loss determination) as set forth in FAA regulations.
Withdrawal of Application for Duty-Free Entry of Scientific Instruments
Document Number: 2011-21671
Type: Notice
Date: 2011-08-24
Agency: Department of Commerce, International Trade Administration
Ball Bearings and Parts Thereof From France, Germany, and Italy: Final Results of Antidumping Administrative and Changed Circumstances Reviews
Document Number: 2011-21669
Type: Notice
Date: 2011-08-24
Agency: Department of Commerce, International Trade Administration
On April 21, 2011, the Department of Commerce (the Department) published the preliminary results of the administrative reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy. The period of review is May 1, 2009, through April 30, 2010. Based on our analysis of the comments received, we have made changes, including corrections of certain programming and other errors in the margin calculations. Therefore, the final results are different from the preliminary results for certain respondents. The final weighted-average dumping margins for the reviewed respondents are listed below in the section entitled ``Final Results of the Reviews.'' We have also determined that Schaeffler Technologies GmbH & Co. KG (Schaeffler Technologies) is the successor-in-interest to Schaeffler KG with respect to the order on ball bearings and parts thereof from Germany.
Airworthiness Directives; The Boeing Company Model 757-200, -200PF, and -200CB Series Airplanes
Document Number: 2011-21668
Type: Proposed Rule
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
We propose to supersede an existing airworthiness directive (AD) that applies to the products listed above. The existing AD currently requires repetitive inspections of the shim installation between the engine strut vertical flange and bulkhead, and repair if necessary. The existing AD also requires, for certain airplanes, an inspection for cracking of the four critical fastener holes in the horizontal flange, and repair if necessary. Additionally, the existing AD requires that the existing action be performed on airplanes without conclusive records of previous inspections. Since we issued that AD, we have received reports of loose fasteners and cracks at the joint common to the aft torque bulkhead and strut-to-diagonal brace fitting and one report of such damage occurring less than 3,000 flight cycles after the last inspection. This proposed AD would reduce the repetitive inspection interval, and add repetitive detailed inspections for cracking of the bulkhead, and repair if necessary. This proposed AD would also provide an option, for certain airplanes, to extend the repetitive intervals by also doing repetitive ultrasonic inspections for cracking of the bulkhead, and repair if necessary. This proposed AD would also add an option for the high frequency eddy current inspection for cracking of the critical fastener holes, and repair if necessary. We are proposing this AD to detect and correct cracks, loose and broken bolts, and shim migration in the joint between the aft torque bulkhead and the strut-to-diagonal brace fitting, which could result in damage to the strut and consequent separation of the strut and engine from the airplane.
Airworthiness Directives; The Boeing Company Model 767-200, -300, and -300F Series Airplanes
Document Number: 2011-21667
Type: Proposed Rule
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain model 767-200, -300, and -300F series airplanes. This proposed AD would require doing certain wiring changes, installing a new relay and necessary wiring in the cabin air conditioning and temperature control system (CACTCS), and performing an operational test of the cooling pack fire suppression system. This AD results from reports of loss of avionics cooling due to an unserviceable relay installed on a panel as part of the CACTCS. We are proposing this AD to prevent loss of electrical equipment bay cooling and the overheating of flight deck instruments, which would result in the eventual loss of primary flight displays, an unusually high pilot workload, and depressurization of the cabin.
Federal Motor Vehicle Safety Standards; Side Impact Protection
Document Number: 2011-21666
Type: Rule
Date: 2011-08-24
Agency: National Highway Traffic Safety Administration, Department of Transportation
This document responds to a petition for reconsideration from the Alliance of Automobile Manufacturers regarding a March 2010 final rule on the Federal motor vehicle safety standard for side impact protection. Today's rule makes minor changes to the standard's testing requirements and clarifies some aspects of the standard.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Hazardous Materials Training Requirements
Document Number: 2011-21665
Type: Notice
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The collection involves requirements for certain repair stations to provide documentation showing that persons handling hazmat for transportation have been trained following DOT guidelines.
Certain Polyester Staple Fiber From Korea: Rescission of Antidumping Duty Administrative Review
Document Number: 2011-21664
Type: Notice
Date: 2011-08-24
Agency: Department of Commerce, International Trade Administration
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Organization Designation Authorization
Document Number: 2011-21662
Type: Notice
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. This information collection involves certain organizations applying to perform certification functions on behalf of the FAA. These function may include approving data, issuing various kinds of aircraft and organization certificates, and other functions.
Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of Information Collection: Activation of Ice Protection Rule-Flight Manual Requirements
Document Number: 2011-21660
Type: Notice
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for a new information collection. This Paperwork Reduction Act collection is a recordkeeping requirement imposed by the new rule ``Part 121 Activation of Ice Protection''. The NPRM for that rule was published in the Federal Register on November 23, 2009 (74 FR 61055).
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: FAA Airport Master Record
Document Number: 2011-21658
Type: Notice
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Airport Safety Data Program involves the collection and dissemination of civil aeronautics information.
Western Pacific Pelagic Fisheries; American Samoa Longline Gear Modifications To Reduce Turtle Interactions
Document Number: 2011-21655
Type: Rule
Date: 2011-08-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This rule requires specific gear configuration for pelagic longline fishing in the South Pacific. The requirements apply to U.S. vessels longer than 40 ft (12.2 m) while fishing south of the Equator, and include minimum float line and branch line lengths, number of hooks between floats, and distance between floats and adjacent hooks. The rule also limits the number of swordfish taken. The action is intended to ensure that longline hooks fish deeper than 100 meters (m) to reduce interactions with Pacific green sea turtles. This final rule also makes administrative clarifications to the names of several tunas and marlins.
Draft 2011 Marine Mammal Stock Assessment Reports
Document Number: 2011-21654
Type: Notice
Date: 2011-08-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS reviewed the Alaska, Atlantic, and Pacific regional marine mammal stock assessment reports (SARs) in accordance with the Marine Mammal Protection Act. SARs for marine mammals in the Alaska, Atlantic, and Pacific regions were revised according to new information. NMFS solicits public comments on draft 2011 SARs.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aviation Insurance
Document Number: 2011-21653
Type: Notice
Date: 2011-08-24
Agency: Federal Aviation Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The requested information is included in air carriers applications for insurance when insurance is not available from private sources.
Indian Gaming
Document Number: 2011-21652
Type: Notice
Date: 2011-08-24
Agency: Department of the Interior, Bureau of Indian Affairs, Indian Affairs Bureau
This notice publishes an extension of Gaming between the Rosebud Sioux Tribe and the State of South Dakota.
Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries
Document Number: 2011-21651
Type: Rule
Date: 2011-08-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has determined that the Atlantic tunas General category daily Atlantic bluefin tuna (BFT) retention limit should be adjusted from one to three large medium or giant BFT for the September, October- November, and December time periods of the 2011 fishing year, based on consideration of the regulatory determination criteria regarding inseason adjustments. This action applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels (when fishing commercially for BFT).
Endangered Species; Receipt of Applications for Permit
Document Number: 2011-21650
Type: Notice
Date: 2011-08-24
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless a Federal permit is issued that allows such activities. The ESA law requires that we invite public comment before issuing these permits.
President's Export Council, Subcommittee on Export Administration; Notice of Open Meeting
Document Number: 2011-21649
Type: Notice
Date: 2011-08-24
Agency: Department of Commerce, Bureau of Industry and Security, Industry and Security Bureau
Urban Area Criteria for the 2010 Census
Document Number: 2011-21647
Type: Notice
Date: 2011-08-24
Agency: Department of Commerce, Bureau of the Census, Census Bureau
This notice announces the Bureau of the Census' (hereafter, Census Bureau's) final criteria for defining urban areas based on the results of the 2010 Decennial Census (the term ``urban area'' as used throughout this notice refers generically to urbanized areas of 50,000 or more population and urban clusters of at least 2,500 and less than 50,000 population). This notice also provides a summary of comments received in response to proposed criteria published in the August 24, 2010, Federal Register (75 FR 52174), as well as the Census Bureau's response to those comments. The Census Bureau's urban-rural classification is fundamentally a delineation of geographic areas, identifying both individual urban areas and the rural areas of the nation. The Census Bureau's urban areas represent densely developed territory, and encompass residential, commercial, and other nonresidential urban land uses. The Census Bureau delineates urban areas after each decennial census by applying specified criteria to decennial census and other data. Since the 1950 Census, the Census Bureau has reviewed and revised these criteria, as necessary, for each decennial census. The revisions over the years reflect the Census Bureau's desire to improve the classification of urban and rural territory to take advantage of newly available data, as well as advancements in geographic information processing technology.
Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2011-21642
Type: Notice
Date: 2011-08-24
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 short- term (10 year) projection methods and assumptions in projecting Medicare health spending for Parts C and D and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. They will also discuss the long term (75 year) projection methods and assumptions in projecting the National Health Expenditures and Medicare expenditures. 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.
Notice of an Open Meeting of the Advisory Committee on Apprenticeship (ACA)
Document Number: 2011-21641
Type: Notice
Date: 2011-08-24
Agency: Employment and Training Administration, Department of Labor
Pursuant to section 10 of the Federal Advisory Committee Act (Pub. L. 92-463; as amended 5 U.S.C., App. 2), notice is hereby given to announce an open meeting of the Advisory Committee on Apprenticeship (ACA) being held on September 22-23, 2011, in Hanover, Maryland. The ACA, an advisory board to the Secretary of Labor, is a discretionary Committee established by the Secretary of Labor, in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended 5 U.S.C., App. 2, and it's implementing regulations (41 CFR parts 101-6 and 102-3). All meetings of the ACA are open to the public. Time and Date: The meeting will begin at approximately 8:30 a.m. Eastern Time on Thursday, September 22, 2011, and continue until approximately 5 p.m. The meeting will reconvene on Friday, September 23, 2011, at approximately 8:30 a.m. Eastern Time and adjourn at approximately 12 noon. Place: The meeting location is the International Finishing Trades Institute, 7230 Parkway Drive, Hanover, Maryland 21076.
Energy Conservation Program: Energy Conservation Standards for Residential Clothes Dryers and Room Air Conditioners
Document Number: 2011-21640
Type: Rule
Date: 2011-08-24
Agency: Department of Energy
DOE published a direct final rule to establish amended energy conservation standards for residential clothes dryers and room air conditioners in the Federal Register on April 21, 2011. DOE has determined that the adverse comments received in response to the direct final rule do not provide a reasonable basis for withdrawing the direct final rule. Therefore, DOE provides this document confirming adoption of the energy conservation standards established in the direct final rule and announcing the effective date of those standards. DOE also published a proposed rule to amend the compliance dates set forth in the direct final rule on May 9, 2011. Elsewhere in today's Federal Register, DOE publishes a final rule which adopts the compliance dates set forth in its proposed rule published on May 9, 2011.
Energy Conservation Program: Energy Conservation Standards for Residential Clothes Dryers and Room Air Conditioners
Document Number: 2011-21639
Type: Rule
Date: 2011-08-24
Agency: Department of Energy
In a direct final rule published on April 21, 2011, the U.S. Department of Energy (DOE) adopted amended energy conservation standards for residential clothes dryers and room air conditioners. As required by the Energy Policy and Conservation Act (EPCA), DOE also published simultaneously a notice of proposed rulemaking (NOPR) that proposed identical energy efficiency standards. The standards set forth in the direct final rule and NOPR were identical to the standards provided in the consensus agreement that served as the basis for those rulemaking actions. The consensus agreement also provided specific compliance dates for both products. In the direct final rule and NOPR, however, DOE provided for a compliance date 3 years after the date of publication in the Federal Register, or April 21, 2014. As such, the compliance date of the direct final rule and NOPR did not correspond with the consensus agreement. DOE now amends the compliance dates set forth in the direct final rule and corresponding NOPR to be consistent with the compliance dates set out in the consensus agreement. Elsewhere in today's Federal Register, DOE also published a document confirming adoption of the standards set forth in the direct final rule and confirming the effective date of the direct final rule.
Environmental Management Site-Specific Advisory Board, Nevada
Document Number: 2011-21638
Type: Notice
Date: 2011-08-24
Agency: Department of Energy
This notice announces a meeting of the Site-Wide Environmental Impact Statement (EIS) Committee of the Environmental Management Site- Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation
Document Number: 2011-21637
Type: Notice
Date: 2011-08-24
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Energy Conservation Program: Energy Conservation Standards for Fluorescent Lamp Ballasts
Document Number: 2011-21636
Type: Proposed Rule
Date: 2011-08-24
Agency: Department of Energy
On April 11, 2011, the U.S. Department of Energy (DOE) published a notice of proposed rulemaking (NOPR) proposing new and amended standards for fluorescent lamp ballasts (ballasts) pursuant to the Energy Policy and Conservation Act of 1975 (EPCA). During the subsequent public meeting and in written comments, stakeholders provided additional data and raised concerns regarding the test data DOE used in support of the NOPR and DOE's approach to accounting for measurement variation and compliance certification requirements. In response to several of those comments, DOE conducted additional testing and is publishing this notice to: announce the availability of additional data provided by the National Electrical Manufacturers Association (NEMA) and additional DOE test data; address the differences between the DOE test data and the data submitted by NEMA; describe the methodological changes DOE is considering based on the additional data and present efficiency levels developed using the revised methodology and all available test data; and request public comment on the updated analyses, as well as the submission of data and other relevant information.
Notice of Supplemental Filing; International Transmission Company, d/b/a ITC Transmission.
Document Number: 2011-21635
Type: Notice
Date: 2011-08-24
Agency: Department of Energy
International Transmission Company, d/b/a ITCTransmission (ITC), filed supplemental documents in an ongoing Presidential permit proceeding regarding the ITC application to amend Presidential Permit No. PP-230-3.
Proposed Agency Information Collection
Document Number: 2011-21634
Type: Notice
Date: 2011-08-24
Agency: Department of Energy
The Department of Energy (DOE) has submitted to the Office of Management and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the Paperwork Reduction Act of 1995. The proposed collection will allow DOE to comply with a reporting requirement placed on all Federal agencies administering programs subject to Davis-Bacon wage provisions. 29 CFR part 5, Section 5.7(b) requires all Federal agencies administering programs subject to Davis- Bacon wage provisions to submit to the Department of Labor (DOL) a semi-annual compliance and enforcement report. In order for the Department of Energy (DOE) to comply with this reporting requirement, it must collect information from Recipients of Recovery Act funded grants, including state and local agencies; Recovery Act funded Loan and Loan Guarantee Borrowers, DOE direct contractors, and other prime contractors and subcontractors that administer DOE programs subject to Davis-Bacon requirements. DOE Recipients will be asked each six months to report to DOE the same items that DOE must ultimately report to DOL, including information on the number Davis-Bacon Act compliance and enforcement investigations conducted and violations found.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2011-21632
Type: Notice
Date: 2011-08-24
Agency: Federal Reserve System, Agencies and Commissions
Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention; Availability
Document Number: 2011-21630
Type: Notice
Date: 2011-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.
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