TASK DEFINITION: In this task, you are given a summary for US Congressional and California state bill, your task is to generate a Title for this bill. The preferred titles are under forty words and mention the purpose of the bill.
PROBLEM: Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage.Permits extrapolation from adult studies where the course of the disease and the effects of the drug are sufficiently similar in all populations.Permits deferral of such assessments if adult studies are completed earlier and the applicant submits a plan for or a description of planned or ongoing pediatric studies.Permits full waiver of such assessments if: (1) studies are highly impractical or impossible; (2) the evidence strongly suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; (3) there is no meaningful therapeutic advantage or benefit in the pediatric population; or (4) the drug or product is not likely to be used in a substantial number of pediatric patients.Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed.Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations.Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if: (1) the drug or biological product would represent a meaningful therapeutic benefit for pediatric patients for one or more claimed indications and the absence of adequate labeling could pose significant risks to pediatric patients; or (2) it is used for a number of pediatric patients for the labeled indications and the absence of adequate labeling could pose significant risks to pediatric patients. Sets forth criteria for full waiver and partial waivers of such requirement. Requires labels to provide indication in cases in which a waiver has been granted due to evidence a product would be unsafe or ineffective in pediatric populations.Requires the Secretary to issue a written request for related pediatric studies under the Public Health Service Act before requiring an assessment for a drug.States that drugs or products with delayed assessments may be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties.

SOLUTION: To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients.

PROBLEM: 13th Regional Corporation Land Entitlement Act - Amends the Alaska Native Claims Settlement Act to set forth land selection rights of the 13th Regional Corporation.

Authorizes the Corporation, within five years, to select up to 1,453,388 acres from specified public lands and directs the Secretary of the Interior to convey to the Corporation the surface and subsurface estate of no more than 1,162,710 acres of the lands selected. Prohibits any selection within the geographical region of any other Alaska Native Regional Corporation without such Regional Corporation's written approval.

Sets forth: (1) limitations on lands that may be selected; (2) restrictions on rights, use, management, and sale of lands conveyed; and (3) requirements for timber and subsurface estate revenue sharing by the 13th Regional Corporation and the other 12 Regional Corporations.

SOLUTION: To amend the Alaska Native Claims Settlement Act to provide an equitable distribution of land to the 13th Alaska Native Regional Corporation.

PROBLEM: Hydrographic Services Amendments of 2004 - Title I: NOAA Hydrographic Services Improvement - (Sec. 102) Amends the Hydrographic Services Improvement Act of 1998 (HSIA) to require the Administrator of the National Oceanic and Atmospheric Administration (NOAA) (Administrator) to establish, equip, and maintain up to four Regional Navigation Response teams in priority coastal areas to conduct activities related to navigational safety and the validation of hydrographic data.

Authorizes the Administrator to: (1) establish and implement a volunteer program and accept volunteer services; and (2) participate in a joint institute that develops new hydrographic technology and conducts academic, educational, and outreach activities that assist the Administrator. (Sec. 103) Designates as Koss Cove a cove on the southern coast of Elrington Island in Alaska, in honor of the late Able Bodied Seaman Eric Steiner Koss who served on the NOAA vessel RAINIER and died in the performance of a nautical charting mission off the Alaskan coast. (Sec. 104) Requires the Secretary of Commerce (Secretary) and the Secretary of the Interior to provide to specified congressional committees a plan to depict the same shorelines on NOAA nautical charts and U.S. Geological Survey mapping products. (Sec. 105) Revises HSIA requirements relating to the Hydrographic Services Advisory Panel and certain duties of the Secretary and the NOAA Administrator. (Sec. 106) Authorizes specified funds under HSIA in each fiscal year for the Great Lakes Water Level Observation Network. Title II: Fishery Survey Vessels - (Sec. 201) Amends the Fisheries Survey Vessel Authorization Act of 2000 to revise and extend for FY 2005 and 2006 the authorization of appropriations for certain fishery survey vessels. (Sec. 202) Directs the Secretary to report to specified committees on the acquisition of a new hydrographic survey vessel having specified capabilities, the retirement of any current vessel(s), and operation and maintenance cost comparisons between the two.

SOLUTION:
To authorize certain hydrographic services programs, to name a cove in Alaska in honor of the late Able Bodied Seaman Eric Steiner Koss, and for other purposes.