February 2007 – Federal Register Recent Federal Regulation Documents
Results 551 - 600 of 2,390
Determination of Regulatory Review Period for Purposes of Patent Extension; BARACLUDE
The Food and Drug Administration (FDA) has determined the regulatory review period for BARACLUDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; EXJADE
The Food and Drug Administration (FDA) has determined the regulatory review period for EXJADE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Medicare Program; Announcement of New Members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups
This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Proposed Collection; Comment Request
In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Title and purpose of information collection: Investigation of Claim for Possible Days of Employment; OMB 3220-0196. Under Section 1(k) of the Railroad Unemployment Insurance Act (RUIA), unemployment and sickness benefits are not payable for any day with respect to which remuneration is payable or accrues to the claimant. Also Section 4(a-1) of the RUIA provides that unemployment or sickness benefits are not payable for any day the claimant receives the same benefits under any law other than the RUIA. Under Railroad Retirement Board (RRB) regulations, 20 CFR 322.4(a), a claimant's certification or statement on an RRB provided claim form that he or she did not work on any day claimed and did not receive income such as vacation pay or pay for time lost shall constitute sufficient evidence unless there is conflicting evidence. Further, under 20 CFR 322.4(b), when there is a question raised as to whether or not remuneration is payable or has accrued to a claimant with respect to a claimed day or days, investigation shall be made with a view to obtaining information sufficient for a finding. Form ID-5S(SUP), Report of Cases for Which All Days Were Claimed During a Month Credited Per an Adjustment Report, collects required information about compensation credited to an employee during a period when the employee claimed either unemployment or sickness benefits from a railroad employer. The request is generated as a result of a computer match that compares data which is maintained in the RRB's RUIA Benefit Payment file with data maintained in the RRB's records of service. The ID-5S(SUP) is generated annually when the computer match indicates that an employee(s) of the railroad employer was paid unemployment or sickness benefits for every day in one or more months for which creditable compensation was adjusted due to the receipt of a report of creditable compensation adjustment (RRB FORM BA-4, OMB Approved 3220- 0008) from their railroad employer. The computer generated Form ID-5S(SUP) includes pertinent identifying information, the BA-4 adjustment process date and the claimed months in question. Space is provided on the report for the employer's use in supplying the information requested in the computer generated transmittal letter, Form ID-5S, which accompanies the report. To our knowledge no other agency uses forms similar to Form ID-5S(SUP). Completion is voluntary. One response is requested of each respondent. The RRB estimates that 80 responses are received annually. The RRB proposes non-burden impacting editorial changes to Form ID-5S(SUP) and Form ID-5S. Additional Information or Comments: To request more information or to obtain a copy of the information collection justification, forms, and/or supporting material, please call the RRB Clearance Officer at (312) 751-3363 or send an e-mail request to Charles.Mierzwa@RRB.GOV. Comments regarding the information collection should be addressed to Ronald J. Hodapp, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-2092 or send an e-mail to Ronald.Hodapp@RRB.GOV. Written comments should be received within 60 days of this notice.
Solicitation for Grant Applications (SGA); Women in Apprenticeship and Nontraditional Occupations (WANTO) Grants
The Employment and Training Administration published a document in the Federal Register on February 13, 2007 announcing the availability of funds and solicitation for grant applications (SGA) for the Women in Apprenticeship and Nontraditional Occupations (WANTO) grant programs. This notice is an amendment to the SGA and it amends the Supplementary Information section to correct the number of sections in this SGA.
Medicare Program; Notice of Supplemental Election Period for Provider Participation in the Calendar Year (CY) 2007 Competitive Acquisition Plan for Part B Drugs
This notice announces an additional physician election period for physicians who are not currently participating in the competitive acquisition program (CAP) for Medicare Part B drugs for calendar year (CY) 2007. The additional physician election period begins on May 1, 2007 and ends on June 15, 2007. Physicians who elect to join the CAP during this additional election period will enter into a physician election agreement effective August 1, 2007 through December 31, 2007.
Program; Public Meetings in Calendar Year 2007 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2007 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Medicare, Medicaid, and CLIA Programs; Approval of the Joint Commission (Formerly the Joint Commission on Accreditation of Healthcare Organizations) as a CLIA Accreditation Organization
This notice announces CMS' grant of deeming authority to the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the Joint Commission accreditation process are equal to or more stringent than the CLIA condition level requirements, and that the Joint Commission has met the requirements of subpart E of 42 CFR part 493. Consequently, laboratories that are voluntarily accredited by the Joint Commission and continue to meet the Joint Commission requirements will be deemed to meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.
Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly the Commission on Office Laboratory Accreditation) as a CLIA Accreditation Organization
In this notice, we grant COLA (formerly the Commission on Office Laboratory Accreditation) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the COLA accreditation process are equal to or more stringent than the CLIA condition level requirements, and that COLA has met the requirements of subpart E of 42 CFR Part 493. Consequently, laboratories that are voluntarily accredited by COLA and continue to meet COLA requirements will be deemed to meet the CLIA condition-level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.
Airworthiness Directives; Superior Air Parts, Inc. (SAP), Cast Cylinder Assemblies Part Numbers Series: SA47000L, SA47000S, SA52000, SA55000, SL32000W, SL32000WH, SL32006W, SL36000TW, SL36000W, and SL36006W
The FAA is adopting a new airworthiness directive (AD) for certain SAP cast cylinder assemblies installed in Teledyne Continental Motors (TCM) 470, 520, and 550 series reciprocating engines, Lycoming Engines (LE) 320, 360, and 540 series reciprocating engines, Avco Lycoming (AL) 540 series reciprocating engines, and Superior Air Parts, Inc. (SAP) 360 series reciprocating engines. This AD requires removing from service certain SAP part numbered (P/N) cast cylinder assemblies installed in TCM, LE, and AL reciprocating engines. This AD also requires removing from service certain cast cylinder assemblies installed as original equipment in SAP reciprocating engines, or in certain overhauled or repaired SAP reciprocating engines. This AD results from nine separated SAP cylinder assemblies in TCM reciprocating engines and one in LE reciprocating engines. We are issuing this AD to prevent cylinder separation that can lead to engine failure, a possible engine compartment fire, and damage to the airplane.
Drawbridge Operation Regulations; Cheesequake Creek, Morgan, NJ
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the New Jersey Transit Rail Operation (NJTRO) Railroad Bridge across Cheesequake Creek, mile 0.2, at Morgan, New Jersey. Under this temporary deviation, the bridge may remain in the closed position for two 24-hour time periods between February 20, 2007 and February 24, 2007. The exact two 24-hour closure dates will be determined based upon favorable weather necessary to perform the scheduled repairs. This deviation is necessary to facilitate scheduled bridge maintenance.
Advance Electronic Presentation of Cargo Information for Truck Carriers Required To Be Transmitted Through ACE Truck Manifest at Ports in the States of Michigan and New York
Pursuant to section 343(a) of the Trade Act of 2002 and implementing regulations, truck carriers and other eligible parties are required to transmit advance electronic truck cargo information to the Bureau of Customs and Border Protection (CBP) through a CBP-approved electronic data interchange. In a previous notice, CBP designated the Automated Commercial Environment (ACE) Truck Manifest System as the approved interchange and announced that the requirement that advance electronic cargo information be transmitted through ACE would be phased in by groups of ports of entry. This notice announces that at all land border ports in Michigan and New York, truck carriers will be required to file electronic manifests through the ACE Truck Manifest System.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Processor Vessels Using Pot Gear in the Bering Sea and Aleutian Islands Management Area
NMFS is prohibiting directed fishing for Pacific cod by catcher processor vessels using pot gear in the Bering Sea and Aleutian Islands (BSAI) management area. This action is necessary to prevent exceeding the A season allowance of the 2007 Pacific cod total allowable catch (TAC) specified for catcher processor vessels using pot gear in the BSAI.
Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 630 of the Gulf of Alaska
NMFS is reopening directed fishing for pollock in Statistical Area 630 of the Gulf of Alaska (GOA) for 48 hours. This action is necessary to allow full harvest of the A season allowance of the 2007 total allowable catch (TAC) of pollock specified for Statistical Area 630 of the GOA.
Federal Implementation Plan Under the Clean Air Act for Certain Trust Lands of the Forest Country Potawatomi Community Reservation if Designated as a PSD Class I Area; State of Wisconsin
The EPA is announcing two public hearings on our proposed ``Federal Implementation Plan Under the Clean Air Act for Certain Trust Lands of the Forest Country Potawatomi Community Reservation if Designated as a PSD Class I Area; State of Wisconsin.'' We are also extending the comment period from January 17, 2007, until April 27, 2007, 30 days from the second public hearing. This proposed rulemaking was published in the Federal Register on December 18, 2006 (71 FR 75694), and proposes to promulgate a Federal Implementation Plan (FIP) if it approves the Forest County Potawatomi (FCP) Community's request to redesignate certain trust lands as a Class I area under the Prevention of Significant Deterioration (PSD) program.
Connecticut Marine Sanitation Device Standard-Receipt of Petition
Notice is hereby given that a petition has been received from the state of Connecticut requesting a determination by the Regional Administrator, U.S. Environmental Protection Agency, that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the state waters of Branford, East Haven, New Haven, West Haven, Orange, Milford, Stratford, Bridgeport, Fairfield, Westport, Norwalk, Darien, Stamford, and Greenwich. The proposed area also includes the Housatonic River from the Derby Dam and the Quinnipiac River from the southern border of North Haven.
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly BioSurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. no. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 3rd meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 93-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 6th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Notice of Opportunity for Public Comment on Surplus Property Release at Douglas Municipal Airport, Douglas, GA
Under the provisions of Title 49, U.S.C. Section 47153(c), notice is being given that the FAA is considering a request from the City of Douglas to waive the requirement that approximately .76 acres of surplus property, located at the Douglas Municipal Airport, be used for aeronautical purposes.
Noise Exposure Map Notice; Austin-Bergstrom International Airport, Austin, TX
The Federal Aviation Administration (FAA) announces its determination that the noise exposure maps submitted by the city of Austin, Texas for Austin-Bergstrom International Airport under the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise Abatement Act) and 14 CFR part 150 are in compliance with applicable requirements.
Public Notice for Waiver of Aeronautical Land-Use Assurance Rickenbacker International Airport, Columbus, OH
The Federal Aviation Administration (FAA) is considering a proposal to change a potion of the airport from aeronautical use to non-aeronautical use and to authorize the release of 68.277 acres of vacant airport property for the proposed development bulk warehouse/ distribution facilities as a component of the Rickenbacker Global Logistics Park. The land was acquired by the Rickenbacker Port authority through two Quitclaim Deeds dated March 30, 1984 from the Administrator of General Services for the United States of America and May 11, 1999 from the United States of America, acting by and through the Secretary of the Air Force. There are no impacts to the airport by allowing the airport to dispose of the property. Approval does not constitute a commitment by the FAA to financially assist in the disposal of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA. The CRAA will receive $1,468,000 for the parcel. In accordance with section 47107(h) of title 49, United States Code, this notice is required to be published in the Federal register 30 days before modifying the land-use assurance that requires the property to be used for an aeronautical purpose.
Notice of Intent To Rule on Request To Release Airport Property at the Waterloo Regional Airport, Waterloo, IA
The FAA proposes to rule and invites public comment on the release of land at the Waterloo Regional Airport under the provisions of section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).
Substances Approved for Use in the Preparation of Meat and Poultry Products; Announcement of Effective Date
The Food and Drug Administration (FDA) is announcing the effective date for the information collection requirements contained in a final rule published in the Federal Register of August 25, 2000 (65 FR 51758). The rule amended FDA's regulations on food additive and color additive petitions to permit an efficient joint review by both FDA and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. An information collection requirement cannot be instituted unless it is reviewed by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA), approved by OMB, and assigned an OMB control number. OMB's approval of the information collection requirements of the August 25, 2000, final rule was announced in the Federal Register of March 1, 2001 (66 FR 12938), and these requirements are currently approved under OMB control number 0910-0016. Accordingly, FDA is announcing that the information collection requirements of the August 25, 2000, final rule will go into effect on March 26, 2007.
Federal Property Suitable as Facilities To Assist the Homeless
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Syngenta; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance
We are reopening the comment period for a draft environmental assessment prepared with respect to a petition from Syngenta Seeds, Inc., seeking a determination of nonregulated status for corn rootworm- resistant corn derived from a transformation event designated as MIR604. This action will allow interested persons additional time to prepare and submit comments on the draft environmental assessment.
Organization; Definitions; Disclosure to Shareholders; Accounting and Reporting Requirements; Regulatory Accounting Practices; Title IV Conservators, Receivers, and Voluntary Liquidations; and Disclosure to Investors in System-Wide and Consolidated Bank Debt Obligations of the Farm Credit System; Effective Date
The Farm Credit Administration (FCA) published a final rule under parts 611, 619, 620, 621, 624, 627, and 630 on December 20, 2006 (71 FR 76111). This final rule amends our disclosure and reporting regulations for Farm Credit System (System) institutions by clarifying and enhancing existing disclosures and reporting to System shareholders and investors. In accordance with 12 U.S.C. 2252, the effective date of the final rule is 30 days from the date of publication in the Federal Register during which either or both Houses of Congress are in session. Based on the records of the sessions of Congress, the effective date of the regulations is February 16, 2007.
Fund Availability Under VA Homeless Providers Grant and Per Diem Program
The Department of Veterans Affairs (VA) is announcing the availability of funds for currently operational VA Grant and Per Diem Special Need Grant Recipients in conjunction with their collaborative VA Special Need partners to make re-applications for assistance under the Special Need grant component of VA's Homeless Providers Grant and Per Diem (GPD) Program. The focus of this Notice of Fund Availability (NOFA) is to encourage applicants to continue to deliver services to the homeless Special Need veteran population. This Notice contains information concerning the program, application process, and amount of funding available.
Fund Availability Under VA Homeless Providers Grant and Per Diem Program
The Department of Veterans Affairs (VA) is announcing the availability of funds for currently operational VA Homeless Providers Grant and Per Diem (GPD) providers to make applications for assistance under the Special Need Grant Component of VA's GPD Program. The focus of this Notice of Fund Availability (NOFA) is to encourage new applicants to create new projects that will deliver services to the homeless Special Need veteran population. This Notice contains information concerning the program, application process, and amount of funding available. Note: Current Special Need providers should not respond to this NOFA. Renewal funding is being offered under a separate NOFA.
Fund Availability Under the VA Homeless Providers Grant and Per Diem Program
The Department of Veterans Affairs is announcing the availability of funds for applications for assistance under the ``Per Diem Only'' component of VA's Homeless Providers Grant and Per Diem Program. This Notice contains information concerning the program, funding priorities, application process and amount of funding available.
Record of Decision and Floodplain Statement of Findings: Site Selection for the Expansion of the Strategic Petroleum Reserve
DOE has prepared an environmental impact statement (EIS) (DOE/ EIS-0385), pursuant to the National Environmental Policy Act of 1969 (NEPA), to assess the environmental impacts associated with a proposal to expand the crude oil storage capacity of the Strategic Petroleum Reserve (SPR) from 727 million barrels (MMB) to 1 billion barrels, and to fill the Reserve to the full authorized volume of 1 billion barrels. The proposal was to develop one new storage facility and expand the capacity of two or three existing SPR storage facilities. After careful consideration of the environmental impacts of the alternatives, along with an evaluation of SPR distribution capabilities, geological technical assessments, projected costs, and operational impacts associated with existing commercial operations, DOE has decided to develop a new 160 MMB SPR storage facility at Richton (Mississippi), expand the storage capacity at the existing Bayou Choctaw (Louisiana) SPR facility by 33 MMB, expand the storage capacity at the existing Big Hill (Texas) SPR facility by 80 MMB, and fill the Reserve to 1 billion barrels of oil as authorized by Congress. This ROD has been prepared in accordance with the regulations of the Council on Environmental Quality (40 CFR Parts 1500-1508) for implementing NEPA and DOE's NEPA Implementing Procedures (10 CFR Part 1021). The accompanying Floodplain Statement of Findings has been prepared in accordance with DOE's regulations ``Compliance with Floodplain and Wetland Environmental Review Requirements'' (10 CFR Part 1022). Because the decision differs somewhat from the alternatives evaluated in the EIS, DOE has prepared a Supplement Analysis (SA) (DOE/ EIS-0385-SA-1) to determine whether a supplement to the final EIS is required. DOE has determined that the minor modification to the Bayou Choctaw expansion site, i.e., an increase in capacity of 33 MMB compared to 20 MMB as described in the final EIS, is not a substantial change to the proposed action that is relevant to environmental concerns, and there are no significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts, within the meaning of 40 CFR 1502.9(c)(1) and 10 CFR 1021.314(c). Therefore, a supplement to the SPR final EIS is not needed.
Fund Availability Under VA Homeless Providers Grant and Per Diem Program
The Department of Veterans Affairs (VA) is announcing the availability of funds for applications for assistance under the Technical Assistance Grant component of VA's Homeless Providers Grant and Per Diem Program. This notice contains information concerning the program, application process, and amount of funding available.
Fisheries of the Exclusive Economic Zone Off Alaska; Groundfish Observer Program
NMFS issues a proposed rule to amend regulations implementing the North Pacific Groundfish Observer Program (Observer Program). This action is necessary to avoid expiration of these regulations on December 31, 2007, and ensure uninterrupted observer coverage in North Pacific groundfish fisheries. The proposed rule is intended to promote the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area and the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMPs).
Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Automobile and Light Duty Truck Surface Coating Operations (Renewal), EPA ICR Number 1064.15, OMB Control Number 2060-0034.
In compliance with the Paperwork Reduction Act (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 to renew an existing approved collection. The ICR that is abstracted below describes the nature of the collection and the estimated burden and cost.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NSPS and NESHAP for Wool Fiberglass Manufacturing Plants (Renewal), EPA ICR Number 1160.08, OMB Control Number 2060-0114
In compliance with the Paperwork Reduction Act (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 to renew an existing approved collection. The ICR which is abstracted below describes the nature of the collection and the estimated burden and cost.
Agency Information Collection Activities; Submission to OMB for Review and Approval; NSPS for Pressure Sensitive Tape and Label Surface Coating Operations, EPA ICR Number 0658.09, OMB Control Number 2060-0004
In compliance with the Paperwork Reduction Act (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 to renew an existing approved collection. The ICR that is abstracted below describes the nature of the collection and the estimated burden and cost.
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