April 27, 2009 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2009-04-27-ReaderAids
Type: Reader Aids
Date: 2009-04-27
Board of Governors; Sunshine Act Meeting
Document Number: E9-9595
Type: Notice
Date: 2009-04-27
Agency: Postal Service, Agencies and Commissions
Ball Bearings and Parts Thereof From France, Germany, Italy, Japan, and the United Kingdom: Preliminary Results of Antidumping Duty Administrative Reviews and Intent To Revoke Order In Part
Document Number: E9-9588
Type: Notice
Date: 2009-04-27
Agency: Department of Commerce, International Trade Administration
In response to requests from interested parties, the Department of Commerce (the Department) is conducting administrative reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom. The reviews cover 15 manufacturers/exporters. The period of review is May 1, 2007, through April 30, 2008. We have preliminarily determined that sales have been made below normal value by certain companies subject to these reviews. If these preliminary results are adopted in our final results of administrative reviews, we will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries.
Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part
Document Number: E9-9587
Type: Notice
Date: 2009-04-27
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with March anniversary dates. We received a timely request to revoke one antidumping duty order in part. In accordance with the Department's regulations, we are initiating those administrative reviews.
Safety Zone; Coronado Fourth of July Fireworks; San Diego Bay, San Diego, CA
Document Number: E9-9583
Type: Proposed Rule
Date: 2009-04-27
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes establishing a temporary safety zone on the navigable waters of the San Diego Bay in support of the Coronado Fourth of July Fireworks. This temporary safety zone is necessary to provide for the safety of crew, spectators, and other users and vessels of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this temporary safety zone unless authorized by the Captain of the Port or his designated representative.
Cross-Media Electronic Reporting Rule State Authorized/Approved Program Modification/Revision Approval: State of Texas
Document Number: E9-9582
Type: Notice
Date: 2009-04-27
Agency: Environmental Protection Agency
This notice announces EPA's approval, under regulations for Cross-Media Electronic Reporting, of the State of Texas' request to modify/revise their program to allow electronic reporting for certain of their EPA-authorized programs. This notice also announces an opportunity to request a public hearing on EPA's approval of the State of Texas' request to revise their EPA-authorized National Primary Drinking Water Regulations Implementation program to allow electronic reporting.
Draft Toxicological Review of Halogenated Platinum Salts and Platinum Compounds: In Support of the Summary Information in the Integrated Risk Information System (IRIS)
Document Number: E9-9580
Type: Notice
Date: 2009-04-27
Agency: Environmental Protection Agency
EPA is announcing that Eastern Research Group, Inc. (ERG), an EPA contractor for external scientific peer review, will convene an independent panel of experts and organize and conduct an external peer review workshop to review the external review draft document titled, ``Toxicological Review of Halogenated Platinum Salts and Platinum Compounds: In Support of Summary Information on the Integrated Risk Information System (IRIS)'' (EPA/635/R-08/018). EPA previously announced the 60-day public comment period (ending April 6, 2009) for the draft document in the Federal Register on February 5, 2009 (74 FR 6154). EPA will consider public comments and recommendations from the expert panel workshop as EPA finalizes the draft document.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Environmental and Economic Effects of Environmental Conflict Resolution at EPA; EPA ICR No. 2306.01 OMB Control No. 2090-NEW
Document Number: E9-9579
Type: Notice
Date: 2009-04-27
Agency: Environmental Protection Agency
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request for a new collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.
Cross-Media Electronic Reporting Rule State Approved Program Revision/Modification Approval: State of Louisiana
Document Number: E9-9578
Type: Notice
Date: 2009-04-27
Agency: Environmental Protection Agency
This notice announces EPA's approval, under regulations for Cross-Media Electronic Reporting, of the State of Louisiana's request to revise/modify their EPA-authorized National Pollutant Discharge Elimination System (NPDES) State Program Requirements and General Pretreatment Regulations for Existing and New Sources of Pollution programs to allow electronic reporting for those programs.
Notice of Availability of Draft NPDES General Permits MAG640000 and NHG640000 for Discharges From Potable Water Treatment Facilities in the Commonwealth of Massachusetts (Including Both Commonwealth and Indian Country Lands) and the State of New Hampshire: the Potable Water Treatment Facility General Permit (PWTF GP)
Document Number: E9-9577
Type: Notice
Date: 2009-04-27
Agency: Environmental Protection Agency
The Director of the Office of Ecosystem Protection, EPANew England, is issuing a notice of availability of the draft National Pollutant Discharge Elimination System (NPDES) general permits for potable water treatment facility (PWTF) discharges to certain waters of the Commonwealth of Massachusetts (included both Commonwealth and Indian country lands) and the State of New Hampshire. These General Permits replace the previous PWTF GP, which expired on November 15, 2005.
Safety Zone; BWRC `300' Enduro; Lake Moolvalya, Parker, AZ
Document Number: E9-9575
Type: Proposed Rule
Date: 2009-04-27
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes a safety zone, on the navigable waters of the Lake Moolvalya region on the lower Colorado River in support of the Bluewater Resort and Casino `300' Enduro. This safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod in the Bering Sea and Aleutian Islands
Document Number: E9-9574
Type: Rule
Date: 2009-04-27
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is opening directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 meters (m)) length overall (LOA) using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to fully use the 2009 total allowable catch (TAC) of Pacific cod specified for catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI.
Annual Assessment of the Status of Competition in the Market for the Delivery of Video Programming
Document Number: E9-9571
Type: Notice
Date: 2009-04-27
Agency: Federal Communications Commission, Agencies and Commissions
The Commission is required to report annually to Congress on the status of competition in markets for the delivery of video programming. This document further extends the deadlines for filing comments and reply comments in response to the notice of inquiry for the 14th Annual Report to Congress, which requested data as of June 2007. The Commission needs to bring its reporting up to date and will issue a single report for 2007, 2008, and 2009. The Commission previously announced that it would establish concurrent comment and reply deadlines for 2007 and 2008 data. On April 8, 2009 the Commission adopted a supplemental notice of inquiry to request information for 2008 and 2009. The supplemental notice established May 20, 2009 as the comment deadline for the filing of 2008 information, and June 20, 2009 as the reply comment deadline. This document adopts comment and reply comment deadlines for 2007 information that are concurrent with those filing dates. A single set of deadlines for 2007 and 2008 will avoid duplication of effort by commenters and streamline Commission review of the submitted information.
Science Advisory Board Staff Office; Request for Nominations of Experts for the Review of Technical Guidance on Nutrient Criteria Development
Document Number: E9-9570
Type: Notice
Date: 2009-04-27
Agency: Environmental Protection Agency
The EPA Science Advisory Board (SAB) Staff Office is requesting nominations of non-EPA experts to augment the SAB Ecological Processes and Effects Committee (EPEC) for the review of EPA's draft Technical Guidance on Empirical Approaches for Numeric Nutrient Criteria Development.
Agency Information Collection Activities: Application for Overflight Program/Advance Notice for Aircraft Landings
Document Number: E9-9569
Type: Notice
Date: 2009-04-27
Agency: Department of Homeland Security, U.S. Customs and Border Protection
As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Application for Overflight Program/Advance Notice for Aircraft Landings. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)).
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area
Document Number: E9-9566
Type: Rule
Date: 2009-04-27
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is reallocating the projected unused amount of Pacific cod from vessels using jig gear to catcher vessels less than 60 feet (< 18.3 meters (m)) length overall (LOA) using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to allow the B season apportionment of the 2009 total allowable catch (TAC) of Pacific cod to be harvested.
Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Biennial Specifications and Management Measures; Inseason Adjustments
Document Number: E9-9564
Type: Rule
Date: 2009-04-27
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule announces inseason changes to management measures in the commercial Pacific Coast groundfish fisheries. These actions, which are authorized by the Pacific Coast Groundfish Fishery Management Plan (FMP), are intended to allow fisheries to access more abundant groundfish stocks while protecting overfished and depleted stocks. The rule also implements changes to the incidental retention allowance for halibut in the primary sablefish fishery under the authority of the Northern Pacific Halibut Act.
Marine Mammals; File No. 14497
Document Number: E9-9563
Type: Notice
Date: 2009-04-27
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that The Mirage Casino-Hotel, 3400 Las Vegas Blvd. South, Las Vegas, Nevada 89109, has applied in due form for a permit to import two bottlenose dolphins (Tursiops truncatus) for the purposes of public display.
Certain Cut-to-Length Carbon-Quality Steel Plate Products From the Republic of Korea: Final Results of Antidumping Duty Administrative Review
Document Number: E9-9553
Type: Notice
Date: 2009-04-27
Agency: Department of Commerce, International Trade Administration
On December 19, 2008, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain cut-to-length carbon- quality steel plate products (steel plate) from the Republic of Korea (Korea). The period of review is February 1, 2007, through January 31, 2008. We gave interested parties an opportunity to comment on the preliminary results. Based on our analysis of the comments received and an examination of our calculations, we have made changes for the final results. The final weighted-average dumping margin is listed below in the ``Final Results of the Review'' section of this notice.
Broker Self-Assessment Outreach Pilot
Document Number: E9-9551
Type: Notice
Date: 2009-04-27
Agency: Department of Homeland Security, U.S. Customs and Border Protection
This document announces the commencement of the Broker Self- Assessment (BSA) Outreach Pilot (BSA Pilot). The BSA pilot is voluntary and is intended to be a partnership between U.S. Customs and Border Protection (CBP) and participating customs brokers. The primary goal of the pilot is to facilitate a higher level of broker compliance with CBP laws and regulations. In this regard, the BSA Pilot will allow for customs brokers to ascertain voluntarily with CBP how well they comply with their broker requirements, provide recognition and support to participating brokers, and facilitate legitimate trade so that CBP can focus on higher-risk trade enforcement issues. Under this program test, participating customs brokers will update and improve internal controls, perform periodic testing of these internal controls, and disclose to CBP deficiencies discovered through the testing. Any licensed customs broker, who is a member of the Customs-Trade Partnership Against Terrorism (C-TPAT) and who meets the other eligibility requirements of the pilot, may apply to participate. After closure of the application period and review of the applications received, CBP will select a limited number of customs brokers to participate in the BSA Pilot. This document sets forth information on the application process and the requirements for participation in the program test.
Annual Assessment of the Status of Competition in the Market for the Delivery of Video Programming
Document Number: E9-9550
Type: Notice
Date: 2009-04-27
Agency: Federal Communications Commission, Agencies and Commissions
The Commission is required to report annually to Congress on the status of competition in markets for the delivery of video programming. On January 16, 2009, the Commission released a Notice of Inquiry requesting data as of June 30, 2007. This document is a Supplemental Notice of Inquiry that solicits additional information from the public to ensure that the next report to Congress includes information as of June 30, 2008, and June 30, 2009. The Commission intends to bring its reporting up to date and submit a single report to Congress covering 2007, 2008, and 2009. We will use comments and data submitted by parties in conjunction with publicly available information and filings submitted in relevant Commission proceedings.
Notice of Proposed Information Collection Requests
Document Number: E9-9549
Type: Notice
Date: 2009-04-27
Agency: Department of Education
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Montana: Final Authorization of State Hazardous Waste Management Program Revision
Document Number: E9-9544
Type: Rule
Date: 2009-04-27
Agency: Environmental Protection Agency
The Solid Waste Disposal Act, as amended, commonly referred to as the Resource Conservation and Recovery Act (RCRA), allows the Environmental Protection Agency (EPA) to authorize States to operate their hazardous waste management programs in lieu of the federal program. Montana has applied to EPA for Final authorization of the changes to its hazardous waste program under the RCRA. EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this immediate final action.
Notice of Proposed Information Collection Requests
Document Number: E9-9542
Type: Notice
Date: 2009-04-27
Agency: Department of Education
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Montana: Final Authorization of State Hazardous Waste Management Program Revisions
Document Number: E9-9541
Type: Proposed Rule
Date: 2009-04-27
Agency: Environmental Protection Agency
The State of Montana has applied to EPA for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to the hazardous waste program changes submitted by the State of Montana. In the ``Rules and Regulations'' section of this Federal Register, EPA is authorizing the changes in an immediate final rule. EPA did not propose the rule prior to issuing the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written comments that oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we receive comments that oppose this action, we will publish a document in the Federal Register
Safety Zone; Red Bull Air Races; San Diego Bay, San Diego, CA
Document Number: E9-9537
Type: Rule
Date: 2009-04-27
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone on the navigable waters of the San Diego Bay in support of the Red Bull Air Races. The safety zone is necessary to provide for the safety of the crew, spectators, participants and other vessels and users of the waterway. Persons and vessels will be prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized to do so by the Captain of the Port or his designated representative.
Delaware River and Bay Oil Spill Advisory Committee; Meeting
Document Number: E9-9536
Type: Notice
Date: 2009-04-27
Agency: Coast Guard, Department of Homeland Security
The Delaware River and Bay Oil Spill Advisory Committee (DRBOSAC) will meet in Philadelphia, PA to discuss various issues to improve oil spill prevention and response strategies for the Delaware River and Bay. This meeting will be open to the public.
Collection of Information Under Review by Office of Management and Budget: OMB Control Numbers: 1625-0101, 1625-0102, and 1625-0103
Document Number: E9-9535
Type: Notice
Date: 2009-04-27
Agency: Coast Guard, Department of Homeland Security
In compliance with the Paperwork Reduction Act of 1995, this request for comments announces that the U.S. Coast Guard is forwarding three Information Collection Requests (ICRs), abstracted below, to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) requesting an extension of its approval for the following collections of information: (1) 1625-0101, Periodic Gauging and Engineering Analyses for Certain Tank Vessels Over 30 Years Old; (2) 1625-0102, National Response Resource Inventory; and (3) 1625- 0103, Mandatory Ship Reporting System for the Northeast and Southeast Coasts of the United States. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Navigation Safety Advisory Council; Vacancies
Document Number: E9-9534
Type: Notice
Date: 2009-04-27
Agency: Coast Guard, Department of Homeland Security
The Coast Guard seeks applications for membership on the Navigation Safety Advisory Council (NAVSAC). NAVSAC provides advice and makes recommendations to the Secretary on a wide range of issues related to the prevention of collisions, rammings, and groundings. This includes, but is not limited to: Inland and International Rules of the Road, navigation regulations and equipment, routing measures, marine information, diving safety, and aids to navigation systems.
RTCA Government/Industry Air Traffic Management Advisory Committee
Document Number: E9-9533
Type: Notice
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public of a meeting of RTCA Government/Industry Air Traffic Management Advisory Committee.
Seventh Plenary Meeting, NextGen Mid-Term Implementation Task Force
Document Number: E9-9532
Type: Notice
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public of a meeting of the NextGen Mid-Term Implementation Task Force.
Proposed Amendment of Class E Airspace; Ankeny, IA
Document Number: E9-9531
Type: Proposed Rule
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to amend Class E airspace at Ankeny, IA. Cancellation of NDB approaches at Ankeny Regional Airport has made it necessary to reconfigure Class E airspace. Controlled airspace is necessary to accommodate Standard Instrument Approach Procedures (SIAPs) at Ankeny Regional Airport, Ankeny, IA. This action also would update the geographic coordinates of the airport to coincide with the FAA's National Aeronautical Charting Office. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) aircraft operations at Ankeny Regional Airport.
Toxics Release Inventory Form A Eligibility Revisions Implementing the 2009 Omnibus Appropriations Act
Document Number: E9-9530
Type: Rule
Date: 2009-04-27
Agency: Environmental Protection Agency
EPA is amending its regulations on the eligibility criteria for submitting a Form A Certification Statement in lieu of the more detailed Form R submitted by facilities subject to TRI reporting under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA). This action is being taken to comply with the ``Omnibus Appropriations Act of 2009'' enacted on March 11, 2009. As this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary, and this rule is effective immediately. Upon publication to the Federal Register, the provisions of the Toxics Release Inventory Burden Reduction Final Rule will be removed and the regulations in place prior to its implementation will be restored as described below.
Special Conditions: Boeing Model 747-8/-8F Airplanes, Structural Design Requirements for Four-Post Main Landing Gear System
Document Number: E9-9529
Type: Proposed Rule
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
This action proposes special conditions for the Boeing Model 747-8/-8F airplane. This airplane will have novel or unusual design features associated with a four-post main landing gear system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Intramammary Dosage Forms; Change of Sponsor
Document Number: E9-9527
Type: Rule
Date: 2009-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Merial Ltd. to Cross Vetpharm Group Ltd.
Notice of Inquiry and Request for Comments on the Topic of Facilitating Access to Copyrighted Works for the Blind or Persons With Other Disabilities; Notice of Public Meeting
Document Number: E9-9526
Type: Notice
Date: 2009-04-27
Agency: Library of Congress, Agencies and Commissions, Copyright Office, Copyright Office, Library of Congress
The United States Copyright Office (Copyright Office) and the United States Patent and Trademark Office (USPTO) are extending the time in which comments and reply comments may be filed on the topic of facilitating access to copyrighted works for ``blind or other persons with disabilities'' \1\ in connection with a forthcoming meeting of the Standing Committee on Copyright and Related Rights of the World Intellectual Property Organization.
Ninth Meeting, RTCA Special Committee 216: Aeronautical System Security
Document Number: E9-9525
Type: Notice
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 216: Aeronautical Systems Security.
Ball Bearings and Parts Thereof From Germany: Amended Final Results of Antidumping Duty Administrative Review Pursuant to a Court Decision
Document Number: E9-9524
Type: Notice
Date: 2009-04-27
Agency: Department of Commerce, International Trade Administration
On June 29, 2007, the United States Court of International Trade (CIT) affirmed the redetermination of the Department of Commerce (the Department) on voluntary remand of the final results of the administrative review of the antidumping duty order on ball bearings and parts thereof from Germany. See Paul M[uuml]ller Industrie GmbH & Co. v. United States, 502 F. Supp. 2d 1271 (CIT 2007). The Department is amending the final results of the administrative review of the antidumping duty order on ball bearings and parts thereof from Germany covering the period of review May 1, 2002, through April 30, 2003, to reflect the CIT's order.
Sixth Plenary Meeting, NextGen Mid-Term Implementation Task Force
Document Number: E9-9523
Type: Notice
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public of a meeting of the NextGen Mid-Term Implementation Task Force.
Proposed Amendment of Class E Airspace; Mansfield, OH
Document Number: E9-9522
Type: Proposed Rule
Date: 2009-04-27
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to amend Class E airspace at Mansfield, OH. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAPs) at Mansfield/Lahm Regional Airport, Mansfield, OH. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) aircraft operations at Mansfield/Lahm Regional Airport. This action also would update the airport name to Mansfield/Lahm Regional Airport and update the geographic coordinates of Shelby Community Airport and Willard Airport.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on “Target Animal Safety for Veterinary Pharmaceutical Products,” VICH GL43; Availability
Document Number: E9-9521
Type: Notice
Date: 2009-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (185) entitled ``Target Animal Safety for Veterinary Pharmaceutical Products,'' VICH GL43. The purpose of this harmonized guidance is to provide recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. The guidance includes recommendations on including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies.
Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies
Document Number: E9-9520
Type: Notice
Date: 2009-04-27
Agency: Federal Reserve System, Agencies and Commissions
Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products; Availability
Document Number: E9-9519
Type: Notice
Date: 2009-04-27
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 document entitled ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.'' The draft guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. For a combination product that includes the injector, the marketing application would typically be a new drug application (NDA) or a biological licensing application (BLA).
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