April 14, 2009 – Federal Register Recent Federal Regulation Documents

Initiation of Section 302 Investigation, Determination of Action Under Section 301, and Request for Comments: Canada-Compliance With Softwood Lumber Agreement
Document Number: Z9-8232
Type: Notice
Date: 2009-04-14
Agency: Office of the United States Trade Representative, Trade Representative, Office of United States, Executive Office of the President
Reader Aids
Document Number: FR-2009-04-14-ReaderAids
Type: Reader Aids
Date: 2009-04-14
National Former Prisoner of War Recognition Day, 2009
Document Number: E9-8703
Type: Proclamation
Date: 2009-04-14
Agency: Executive Office of the President, Presidential Documents
Certain Steel Threaded Rod from the People's Republic of China: Notice of Antidumping Duty Order
Document Number: E9-8630
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, International Trade Administration
Based on affirmative final determinations by the Department of Commerce (``Department'') and the International Trade Commission (``ITC''), the Department is issuing an antidumping duty order on certain steel threaded rod (``STR'') from the People's Republic of China (``PRC''). On April 6, 2009, the ITC notified the Department of its affirmative determination of material injury to a U.S. industry. See Steel Threaded Rod from China (Investigation No. 731-TA-1145 (Final), USITC Publication 4070, April 2009).
Public Land Order No. 7731; Withdrawal of Public Lands for Gold Point and Ione Townsites; Nevada
Document Number: E9-8604
Type: Notice
Date: 2009-04-14
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
This order withdraws approximately 672 acres of public lands from location and entry under the United States mining laws for a period of 5 years to protect historic and cultural resources within the Gold Point and Ione Townsites pending special legislation that would resolve land ownership conflicts.
Sunshine Federal Register Notice
Document Number: E9-8575
Type: Notice
Date: 2009-04-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Sunshine Act Meeting Notice
Document Number: E9-8565
Type: Notice
Date: 2009-04-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Funding Availability for the Beginning Farmer and Rancher Development Program for Fiscal Year (FY) 2009
Document Number: E9-8543
Type: Notice
Date: 2009-04-14
Agency: Department of Agriculture, Cooperative State Research, Education, and Extension Service
The Cooperative State Research, Education, and Extension Service (CSREES) is announcing the release of the FY 2009 Beginning Farmer and Rancher Development Program (BFRDP) Request for Applications (RFA) via Grants.gov.
The National Infrastructure Advisory Council
Document Number: E9-8541
Type: Notice
Date: 2009-04-14
Agency: Department of Homeland Security
The meeting of the National Infrastructure Advisory Council (NIAC) scheduled for Tuesday April 14, 2009 at the J.W. Marriott, 1331 Pennsylvania Avenue, Washington, DC announced in the Federal Register on February 17, 2009 (73 FR 7456), will not be held.
Action Affecting Export Privileges; Islamic Republic of Iran Shipping Lines et al
Document Number: E9-8533
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, Bureau of Industry and Security, Industry and Security Bureau
Express Mail Refunds for Shipments of Live Animals
Document Number: E9-8531
Type: Proposed Rule
Date: 2009-04-14
Agency: Postal Service, Agencies and Commissions
The Postal Service proposes to revise its refund guarantees for Express Mail[supreg] shipments of live animals in an effort to maintain the economic viability of shipping animals as a service.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Resources of the South Atlantic; Trip Limit Reduction
Document Number: E9-8530
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS reduces the commercial trip limit for golden tilefish in the South Atlantic to 300 lb (136 kg) per trip in or from the exclusive economic zone (EEZ). This trip limit reduction is necessary to protect the South Atlantic golden tilefish resource.
Fisheries of the Exclusive Economic Zone Off Alaska; Revision of Single Geographic Location Requirement in the Bering Sea Subarea
Document Number: E9-8528
Type: Proposed Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes regulations to increase the number of times per year that a stationary floating processor (SFP) that is qualified under the American Fisheries Act (AFA) may move within State of Alaska waters in the Bering Sea (BS) subarea to process pollock harvested in the BS subarea directed pollock fishery. This action also would require AFA SFPs to process all Gulf of Alaska (GOA) pollock and GOA Pacific cod where they processed these species in 2002. This action is necessary to increase operational flexibility for AFA SFPs that process pollock caught in the BS subarea directed fishery while continuing to limit the competitive advantage of AFA SFPs in the GOA pollock and GOA Pacific cod fisheries. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plans for Groundfish of the GOA and for Groundfish of the Bering Sea and Aleutian Islands Management Area, and other applicable laws.
Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; State Waters Exemption
Document Number: E9-8526
Type: Proposed Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes regulations to allow an exemption from the minimum twine-top mesh size for vessels issued Federal scallop permits and fishing exclusively in State of Maine (ME) waters. In addition, the state waters exemption would provide an exemption from scallop days-at- sea (DAS) for limited access DAS scallop vessels, provided the vessel owner declares that the vessel will fish exclusively in ME state waters. The scallop fishery regulations specify that a state may be eligible for a state waters exemption if it has a scallop fishery and a scallop conservation program that does not jeopardize the biomass and fishing mortality/effort limit objectives of the Atlantic Sea Scallop Fishery Management Plan (FMP). The regulations further state that the Regional Administrator, Northeast Region, NMFS (RA), shall determine which states meet those criteria and shall authorize the exemption for such states by publishing a rule in the Federal Register.
Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E9-8524
Type: Notice
Date: 2009-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial.
Submission for OMB Review; Comment Request for Revised Information Collection: Fingerprint Charts: Standard Form (SF) 87 AND SF 87A
Document Number: E9-8523
Type: Notice
Date: 2009-04-14
Agency: Office of Personnel Management, Personnel Management Office, Agencies and Commissions
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) this notice announces that the U.S. Office of Personnel Management (OPM) has submitted to the Office of Management and Budget (OMB) a request for review and clearance of the revised collection of information collection (Fingerprint Charts SF 87 and SF 87A; OMB No. 3206-0150). The Fingerprint Charts are used in processing fingerprint checks submitted to the Federal Bureau of Investigation (FBI) to assist in determining whether an applicant is suitable for Federal employment or should be granted a security clearance.
Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; 2009 Georges Bank Cod Hook Sector Operations Plan and Agreement, and Allocation of Georges Bank Cod Total Allowable Catch
Document Number: E9-8521
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule implements the Georges Bank (GB) Cod Hook Sector (Hook Sector) Fishing Year (FY) 2009 Operations Plan and Agreement, approved by the Administrator, Northeast (NE) Region, NMFS (Regional Administrator), and allocates a hard total allowable catch (TAC) of GB cod to the Hook Sector. Amendment 13 to the Northeast (NE) Multispecies Fishery Management Plan (FMP) implemented the Hook Sector and authorized annual allocation of up to 20 percent of the GB cod TAC to the Hook Sector. Pursuant to that authorization, the Hook Sector submitted an Operations Plan and Sector Contract entitled, ``Georges Bank Cod Hook Sector Fishing Year 2009-2010 Operations Plan and Agreement'' (together referred to as the Sector Agreement) and an Environmental Assessment (EA), and requested an allocation of GB cod, consistent with the FMP. This action results in authorization of the Sector Operations Plan for FY 2009 and allocation of 350.1 mt of GB cod to the Hook Sector.
Pennsylvania Disaster #PA-00022
Document Number: E9-8520
Type: Notice
Date: 2009-04-14
Agency: Small Business Administration, Agencies and Commissions
This is a notice of an Administrative declaration of a disaster for the State of Pennsylvania.
Endangered and Threatened Species: Advance Notice of Proposed Rulemaking to Designate Critical Habitat for Cook Inlet Beluga Whales
Document Number: E9-8519
Type: Proposed Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
We, the National Marine Fisheries Service (NMFS), will be designating critical habitat for the endangered Cook Inlet beluga whale (Delphinapterus leucas) under the Endangered Species Act (ESA). The designation will involve areas within Cook Inlet, Alaska. This advance notice of proposed rulemaking (ANPR) identifies issues for consideration and evaluation and solicits comments regarding these issues.
Fisheries of the Exclusive Economic Zone Off Alaska, Groundfish of the Gulf of Alaska; Correction
Document Number: E9-8517
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is correcting the preamble to a final rule published in the Federal Register on January 21, 2009 (74 FR 3446). The final rule implemented a regulatory amendment to exempt fishermen using dinglebar fishing gear in federal waters of the Gulf of Alaska from the requirement to carry a vessel monitoring system (VMS). This correction is necessary to summarize and respond to public comments received on the proposed rule. No changes to the requirements of the final rule result from this correction.
Marine Mammals; File No. 775-1875
Document Number: E9-8515
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that the NMFS Northeast Fisheries Science Center (NEFSC), Woods Hole, MA, has applied for an amendment to Scientific Research Permit No. 775-1875.
International Whaling Commission; 61st Annual Meeting; Nominations
Document Number: E9-8514
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This notice is a call for nominees for the U.S. Delegation to the June 2009 International Whaling Commission (IWC) annual meeting. The non-federal representative(s) selected as a result of this nomination process is(are) responsible for providing input and recommendations to the U.S. IWC Commissioner representing the positions of non-governmental organizations. Generally, only one non-governmental position is selected for the U.S. Delegation.
Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in the West Yakutat District of the Gulf of Alaska
Document Number: E9-8513
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for pollock in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2009 total allowable catch (TAC) of pollock in the West Yakutat District of the GOA.
Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in the West Yakutat District of the Gulf of Alaska
Document Number: E9-8511
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is reopening directed fishing for pollock in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to fully use the 2009 total allowable catch (TAC) of pollock specified for the West Yakutat District of the GOA.
Fisheries of the Exclusive Economic Zone Off Alaska; Directed Fishing With Trawl Gear by American Fisheries Act Catcher Processors in Bycatch Limitation Zone 1 of the Bering Sea and Aleutian Islands Management Area
Document Number: E9-8510
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing with trawl gear, other than pelagic trawl gear for walleye pollock, by American Fisheries Act (AFA) trawl catcher processors in Bycatch Limitation Zone 1 of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the sideboard limit of the 2009 bycatch allowance of red king crab in Zone 1 specified for AFA trawl catcher processors in the BSAI.
Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; 2009 Georges Bank Cod Fixed Gear Sector Operations Plan and Agreement, and Allocation of Georges Bank Cod Total Allowable Catch
Document Number: E9-8508
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule implements the Georges Bank (GB) Cod Fixed Gear Sector (Fixed Gear Sector) Fishing Year (FY) 2009 Operations Plan and Agreement, approved by the Administrator, Northeast (NE) Region, NMFS (Regional Administrator), and allocates a hard total allowable catch (TAC) of GB cod to the Fixed Gear Sector. Framework Adjustment 42 (FW 42) to the NE Multispecies Fishery Management Plan (FMP) authorized allocation of up to 20 percent of the annual GB cod TAC to the Fixed Gear Sector. Pursuant to that authorization, the Fixed Gear Sector submitted an Operations Plan and Sector Contract, entitled ``Georges Bank Cod Fixed Gear Sector Fishing Year 2009-2010 Operations Plan and Agreement'' (together referred to as the Sector Agreement), and an Environmental Assessment (EA), and requested an allocation of GB cod, consistent with the FMP. This action results in authorization of the Sector Operations Plan for FY 2009 and allocation of 503.8 mt of GB cod to the Fixed Gear Sector.
Advisory Committee on the Records of Congress; Meeting
Document Number: E9-8506
Type: Notice
Date: 2009-04-14
Agency: National Archives and Records Administration, Agencies and Commissions
In accordance with the Federal Advisory Committee Act, the National Archives and Records Administration (NARA) announces a meeting of the Advisory Committee on the Records of Congress. The committee advises NARA on the full range of programs, policies, and plans for the Center for Legislative Archives in the Office of Records Services.
Submission for OMB Review; Comment Request
Document Number: E9-8503
Type: Notice
Date: 2009-04-14
Agency: Department of Education
The 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.
Notice of Proposed Information Collection Requests
Document Number: E9-8502
Type: Notice
Date: 2009-04-14
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.
Certain Pasta from Turkey: Notice of Preliminary Results of Antidumping Duty Changed Circumstances Review
Document Number: E9-8498
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, International Trade Administration
On January 7, 2009, the Department of Commerce (``the Department'') published a notice of initiation of a changed circumstances review of the antidumping duty order of certain pasta from Turkey as requested by Marsan Gida Sanayi ve Ticret A.S. (``Marsan''). After receiving additional information on the operations of Marsan, we preliminarily determine that Marsan is the successor-in- interest to Gidasa Sabanci Gida Sanayi ve Ticaret A.S. (``Gidasa''), and should be accorded the same antidumping duty treatment accorded Gidasa with respect to the antidumping duty order on certain pasta from Turkey. Interested parties are invited to comment on these preliminary results.
Certain Corrosion-Resistant Carbon Steel Flat Products from the Republic of Korea: Notice of Intent to Rescind Antidumping Duty Administrative Review, In Part
Document Number: E9-8497
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, Internatioinal Trade Administration, International Trade Administration
On September 30, 2008, we published the notice of initiation of this antidumping duty administrative review with respect to Dongbu Steel Co., Ltd., Dongkuk Industries Co., Ltd. (Dongkuk), Haewon MSC Co., Ltd., Hyundai HYSCO, LG Chem, Ltd., Pohang Iron and Steel Co., Ltd/Pohang Coated Steel Co., Ltd., and Union Steel Manufacturing Co., Ltd, for the period August 1, 2007, through July 31, 2008. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part, 73 FR 56795 (September 30, 2008) (Notice of Initiation). Dongkuk submitted a letter to the Department that it had no shipments of subject merchandise to the U.S. during the period of review (POR). See Letter from Dongkuk to the Secretary of Commerce dated October 20, 2008. The Department corroborated the claim of no shipments by Dongkuk. See memo from Christopher Hargett, International Trade Compliance Analyst, Office 3, through James Terpstra, Program Manager, Office 3, to Melissa Skinner, Office Director, Office 3, Import Administration, dated March 27, 2009 (No Shipment Analysis). We have preliminarily determined that the review of Dongkuk should be rescinded. This review will remain in effect for all other companies initiated upon.
Fisheries of the Northeastern United States; Atlantic Herring Fishery; Total Allowable Catch Harvested for Management Area 2
Document Number: E9-8496
Type: Rule
Date: 2009-04-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces that, effective 0001 hours, April 15, 2009, federally permitted vessels may not fish for, catch, possess, transfer, or land more than 2,000 lb (907.2 kg) of Atlantic herring in or from Management Area 2 (Area 2) per trip or calendar day until January 1, 2010, when the 2010 total allowable catch (TAC) becomes available, except for transiting purposes as described in this notice. This action is based on the determination that 95 percent of the Atlantic herring TAC allocated to Area 2 for 2009 is projected to be harvested by April 14, 2009. Regulations governing the Atlantic herring fishery require publication of this notification to advise vessel and dealer permit holders that no TAC is available for the directed fishery for Atlantic herring harvested from Area 2.
Certain Lined Paper Products from India: Notice of Final Results of the First Antidumping Duty Administrative Review
Document Number: E9-8495
Type: Notice
Date: 2009-04-14
Agency: Department of Commerce, International Trade Administration
On October 7, 2008, the Department of Commerce (the Department) published the preliminary results of the antidumping duty administrative review for certain lined paper products (CLPP) from the India.\1\ This review covers two mandatory respondents, Kejriwal Exports and Kejriwal Paper Limited (Kejriwal), and Ria ImpEx Pvt. Ltd. (Ria), and 17 other manufacturers and exporters of the subject merchandise (collectively, respondents).\2\ The period of review (POR) is April 17, 2006, through August 31, 2007.
Change in Disease Status of the Republic of Korea With Regard to Foot-and-Mouth Disease and Rinderpest; Availability of an Environmental Assessment
Document Number: E9-8494
Type: Proposed Rule
Date: 2009-04-14
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that an environmental assessment has been prepared by the Animal and Plant Health Inspection Service relative to a proposed rule that would add the Republic of Korea to the list of regions considered free of rinderpest and foot-and-mouth disease. The environmental assessment documents our review and analysis of environmental impacts associated with adding the Republic of Korea to the list of regions considered free of rinderpest and foot-and-mouth disease. We are making this environmental assessment available to the public for review and comment.
Drawbridge Operation Regulation; Intracoastal Waterway (ICW), Beach Thorofare, Atlantic City, NJ
Document Number: E9-8493
Type: Rule
Date: 2009-04-14
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is changing the drawbridge operation regulations of the Route 30 Bridge, at ICW mile 67.2, across Beach Thorofare at Atlantic City, NJ. This will allow the drawbridge to open on signal every hour during high transit periods during summer months and operate on an advance notice basis at all other times. The change will result in more efficient use of the bridge.
Safety Zone; San Diego Bay, San Diego, CA
Document Number: E9-8492
Type: Rule
Date: 2009-04-14
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a safety zone on the navigable waters of San Diego Bay in support of the Fireworks Display. 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.
Application To Export Electric Energy; ENMAX Energy Marketing, Inc.
Document Number: E9-8489
Type: Notice
Date: 2009-04-14
Agency: Department of Energy
ENMAX Energy Marketing, Inc. (ENMAX) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Approval and Promulgation of Implementation Plans and Operating Permits Program; State of Missouri
Document Number: E9-8487
Type: Rule
Date: 2009-04-14
Agency: Environmental Protection Agency
EPA is taking direct final action to approve a revision to the State Implementation Plan (SIP) and Operating Permits Program to amend the definitions provisions of the rules by adding definitions for stage I/II vapor recovery systems and outstate area, updating the lists of volatile organic compounds and hazardous air pollutants for consistency with the Environmental Protection Agency (EPA) lists, removing unnecessary definitions, and making typographical corrections and clarifications. Approval of this revision will ensure consistency between the state and the Federally-approved rules.
Approval and Promulgation of Implementation Plans and Operating Permits Program; State of Missouri
Document Number: E9-8486
Type: Proposed Rule
Date: 2009-04-14
Agency: Environmental Protection Agency
EPA proposes to approve the State Implementation Plan (SIP) and Operating Permits Program to amend the definitions provisions of the rules by adding definitions for stage I/II vapor recovery systems and outstate area, updating the lists of volatile organic compounds and hazardous air pollutants for consistency with the Environmental Protection Agency (EPA) lists, removing unnecessary definitions, and making typographical corrections and clarifications. This revision will ensure consistency between the State and the Federally-approved rules.
Proposed Consent Decree, Clean Air Act Citizen Suit
Document Number: E9-8485
Type: Notice
Date: 2009-04-14
Agency: Environmental Protection Agency
In accordance with section 113(g) of the Clean Air Act, as amended (``Act''), 42 U.S.C. 7413(g), notice is hereby given of a
National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines
Document Number: E9-8483
Type: Proposed Rule
Date: 2009-04-14
Agency: Environmental Protection Agency
On March 5, 2009, EPA proposed national emission standards for existing stationary reciprocating internal combustion engines that either: are located at area sources of hazardous air pollutant emissions; or are located at major sources of hazardous air pollutants and are either non-emergency compression-ignition engines, or are other engines that have a site rating of less than or equal to 500 brake horsepower. In this notice, we are announcing a 30-day extension of the public comment period for the proposal.
Announcement of the Third Dietary Guidelines Advisory Committee Meeting and Solicitation of Written Comments
Document Number: E9-8482
Type: Notice
Date: 2009-04-14
Agency: Department of Health and Human Services, Department of Agriculture
The Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) provide notice of the third meeting of the Dietary Guidelines Advisory Committee, and (b) solicit written comments pertinent to a review of the Dietary Guidelines for Americans.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: E9-8481
Type: Notice
Date: 2009-04-14
Agency: Department of Health and Human Services, National Institutes of Health
Sunshine Act Meeting
Document Number: E9-8480
Type: Notice
Date: 2009-04-14
Agency: Securities and Exchange Commission, Agencies and Commissions
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E9-8479
Type: Notice
Date: 2009-04-14
Agency: Department of Health and Human Services, National Institutes of Health
The Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
Document Number: E9-8477
Type: Notice
Date: 2009-04-14
Agency: Department of Health and Human Services, National Institutes of Health
For many decades, the pediatric medical community, the public health community, and government agencies have recognized a range of questions regarding the use of therapeutics in children, including the shortage of clinical studies of drugs in children resulting in inadequate labeling for pediatric use. The lack of appropriate labeling results in off-label use of prescription drugs in many children and for many conditions. Contributing factors to this frequent off-label use of drugs in pediatrics include the rarity of some conditions in children with limited patient availability, the ethical concerns regarding the conduct of clinical trials in children, the lack of accurate information about which drugs are used by children, and the lack of long-term data on the medications that are frequently used.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.