Proposed Rules. Notice of proposed special condition

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BILLING CODE 4910-13-M DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. NM358; Notice No. 25-06-12-SC] Special Conditions: Gulfstream Aerospace Corporation, Model GV, GV-SP, and GIV-X Airplanes; Windshield Coating in Lieu of Wipers AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed special condition. SUMMARY: This action proposes a special condition for the Gulfstream Aerospace Corporation Model GV, GV-SP, and GIV-X airplanes.

These airplanes will have a novel or unusual design feature(s) associated with use of a hydrophobic windshield coating, rather than windshield wipers, as the means to maintain a clear portion of the windshield during precipitation conditions, as required by the airworthiness standards for transport category airplanes. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. This proposed special condition contains the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES: We must receive your comments by November 20, 2006. ADDRESSES: You must mail two copies of your comments to: Federal Aviation Administration, Transport Airplane Directorate, Attn: Rules Docket (ANM-113), Docket No. NM358, 1601 Lind Avenue SW., Renton, Washington, 98057-3356. You may deliver two copies to the Transport Airplane Directorate at the above address. You must mark your comments: Docket No. NM358. You can inspect comments in the Rules Docket weekdays, except Federal holidays, between 7:30 a.m. and 4 p.m.

FOR FURTHER INFORMATION CONTACT: John McConnell, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356; telephone

(425)227-1365; facsimile

(425)227-1320, e-mail *john.mcconnell@faa.gov* . SUPPLEMENTARY INFORMATION: Comments Invited We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special condition, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments. We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this special condition. You can inspect the docket before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays. We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change this special condition based on the comments we receive. If you want the FAA to acknowledge receipt of your comments on this proposal, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you. Background On December 19, 2005, Gulfstream Aerospace Corporation applied for a change to Type Certificate No. A12EA to use a hydrophobic windshield coating as the sole means of providing adequate pilot compartment view in the presence of precipitation for Gulfstream Model GV, GV-SP and GIV-X airplanes. The Gulfstream Model GV, GV-SP and GIV-X airplanes are currently approved under Type Certificate No. A12EA. The Model GV airplane is powered by two BMW-Rolls Royce Deutschland BR700-710A1-10 engines, operates with a two person flightcrew, and has the capacity to carry 19 passengers. The Model GV-SP airplane is powered by two BMW-Rolls Royce Deutschland BR700-710C4-11 engines, operates with a two person flightcrew, and has the capacity to carry 19 passengers. The Model GIV-X airplane is powered by two Rolls Royce Tay Mark 611-8C engines, operates with a two person flightcrew, and has the capacity to carry 19 passengers. Type Certification Basis Under the provisions of § 21.101, Gulfstream Aerospace Corporation must show that the Model GV, GV-SP and GIV-X airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A12EA, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in Type Certificate No. A12EA include: • For Model GV airplanes—part 25, effective February 1, 1965, Amendment 25-1 through Amendment 25-81, with exceptions. • For Model GV-SP airplanes—part 25, effective February 1, 1965, Amendment 25-1 through Amendment 25-98. • For Model GIV-X airplanes—part 25, effective February 1, 1965, Amendment 25-1 through Amendment 25-101, with exceptions. In addition, the certification basis includes other regulations, special conditions and exemptions that are not relevant to this proposed special condition. If the Administrator finds that the applicable airworthiness regulations ( *i.e.* , 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model GV, GV-SP and GIV-X airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16. In addition to the applicable airworthiness regulations and special conditions, the Model GV, GV-SP and GIV-X airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36. The FAA issues special conditions, as defined in § 11.19, under § 11.38, and they become part of the type certification basis under § 21.101. Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101. Novel or Unusual Design Features The Gulfstream Model G-V, GV-SP and GIV-X flightdeck designs incorporate a hydrophobic windshield coating to provide adequate pilot compartment view in the presence of precipitation. Sole reliance on such a coating, without windshield wipers or a windshield blower, constitutes a novel or unusual design feature for which the applicable airworthiness regulations do not contain adequate or appropriate safety standards. Therefore, special conditions are required that provide the level of safety equivalent to that established by the regulations. Discussion Section 25.773(b)(1) requires that both pilots of a transport category airplane be provided a means to maintain a sufficiently clear portion of the windshield during precipitation conditions, and that this clear portion of the windshield must have a sufficiently extensive view along the flight path. The regulations require this means to maintain such an area during precipitation in heavy rain at speeds up to 1.5 V SR1 . This requirement has existed in principle since 1953 in Part 4b of the Civil Air Regulations (CAR). Section 4b.351(b)(1) of CAR 4b required that “Means shall be provided for maintaining a sufficient portion of the windshield clear so that both pilots are afforded a sufficiently extensive view along the flight path in all normal flight attitudes of the airplane. Such means shall be designed to function under the following conditions without continuous attention on the part of the crew:

(i)In heavy rain at speeds up to 1.6 V S1 , flaps retracted.” Effective December 26, 1990, Amendment 25-108 changed the criterion for effectiveness of the means to maintain an area of clear vision from 1.6 V S1 to 1.5 V SR1 to accommodate the redefinition of the reference stall speed as the 1-g stall speed. As noted in the preamble to the final rule for that amendment, the 7 percent decrease in the speed value offsets a corresponding increase in the reference stall speed associated with the use of V SR1 rather than V S1 . The requirement that the means to maintain a clear area of forward vision must function at high speeds and high precipitation rates is based on the use of windshield wipers as the means to maintain an adequate area of clear vision in precipitation conditions. The requirement in 14 CFR 121.313(b), and in 14 CFR 125.213(b), to provide “a windshield wiper or equivalent for each pilot station” has remained unchanged since at least 1953. The effectiveness of windshield wipers to maintain an area of clear vision normally degrades as airflow and precipitation rates increase. It is assumed that because high speeds and high precipitation rates represent limiting conditions for windshield wipers, they will also be effective at lower speeds and precipitation levels. Accordingly, § 25.773(b)(1)(i) does not require maintenance of a clear area of forward vision at lower speeds or lower precipitation rates. A forced air stream blown over the windshield has also been used to maintain an area of clear vision in precipitation. The limiting conditions for this technology are comparable to those for windshield wipers. Accordingly, introduction of this technology did not present a need for special conditions to maintain the level of safety embodied in the existing regulations. Hydrophobic windshield coatings may depend to some degree on airflow to maintain a clear vision area. The heavy rain and high-speed conditions specified in the current rule do not necessarily represent the limiting conditions for this new technology. For example, airflow over the windshield, which may be necessary to remove moisture from the windshield, may not be adequate to maintain a sufficiently clear area of the windshield in low speed flight or during surface operations. Alternatively, airflow over the windshield may be disturbed during such critical times as the approach to land, where the airplane is at a higher than normal pitch attitude. In these cases, areas of airflow disturbance or separation on the windshield could cause failure to maintain a clear vision area on the windshield. In addition to potentially depending on airflow to function effectively, hydrophobic coatings may also be dependent on water droplet size for effective precipitation removal. For example, precipitation in the form of a light mist may not be sufficient for the coating's properties to result in maintaining a clear area of vision. In summary, the current regulations identify speed and precipitation rate requirements that represent limiting conditions for windshield wipers and blowers, but not for hydrophobic coatings, so it is necessary to issue special conditions to maintain the level of safety represented by the current regulations. These special conditions provide an appropriate safety standard for the hydrophobic coating technology as the sole means to maintain a clear area of vision by requiring it to be effective at low speeds and precipitation rates as well as the higher speeds and precipitation rates identified in the current regulation. These are the only new or changed requirements relative to those in § 25.773(b)(1) at Amendment 25-108. Applicability As discussed above, this special condition is applicable to Gulfstream Model GV, GV-SP and GIV-X airplanes. Should Gulfstream Aerospace Corporation apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special condition would apply to that model as well. The substance of this special condition has been subject to the notice and public comment procedure in several prior instances. Therefore, because a delay would significantly affect scheduled airplane deliveries, we are shortening the public comment period to 20 days. Conclusion This action affects only certain novel or unusual design features on Gulfstream Model GV, GV-SP, and GIV-X airplanes. It is not a rule of general applicability. List of Subjects in 14 CFR Part 25 Aircraft, Aviation safety, Reporting and recordkeeping requirements. The authority citation for these special conditions is as follows: Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704. The Proposed Special Condition Accordingly, the Federal Aviation Administration

(FAA)proposes the following special condition as part of the type certification basis for Gulfstream Aerospace Corporation Model GV, GV-SP, and GIV-X airplanes. Pilot Compartment View—Hydrophobic Coatings in Lieu of Windshield Wipers The airplane must have a means to maintain a clear portion of the windshield, during precipitation conditions, enough for both pilots to have a sufficiently extensive view along the ground or flight path in normal taxi and flight attitudes of the airplane. This means must be designed to function, without continuous attention on the part of the crew, in conditions from light misting precipitation to heavy rain at speeds from fully stopped in still air, to 1.5 V SR1 with lift and drag devices retracted. Issued in Renton, Washington, on October 23, 2006. Kalene C. Yanamura, Acting Manager,Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-18288 Filed 10-30-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2006-25947; Airspace Docket No. 06-AAL-31] Proposed Revision of Class D/E Airspace; Big Delta, Allen Army Airfield, Fort Greely, AK AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking. SUMMARY: This action proposes to revise the controlled airspace at Allen Army Airfield (AAF), AK. The current Class D airspace is continuous. The United States Army has decided to staff the Allen AAF air traffic control tower

(ATCT)part time. The Class D and E airspace will need to be revised in order to align Class D airspace effective times to match ATCT hours of operation. The current title of the airspace described in FAA Order 7400.9P will also change to reflect current guidance in FAA Order 7400.2E. Adoption of this proposal would result in reconfiguring the controlled airspace at Allen AAF, Delta Junction, AK. DATES: Comments must be received on or before December 15, 2006. ADDRESSES: Send comments on the proposal to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590-0001. You must identify the docket number FAA-2006-25947/Airspace Docket No. 06-AAL-31, at the beginning of your comments. You may also submit comments on the Internet at *http://dms.dot.gov.* You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527) is on the plaza level of the Department of Transportation NASSIF Building at the above address. An informal docket may also be examined during normal business hours at the office of the Manager, Safety, Alaska Flight Service Operations, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587. FOR FURTHER INFORMATION CONTACT: Gary Rolf, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number

(907)271-5898; fax:

(907)271-2850; e-mail: *gary.ctr.rolf@faa.gov.* Internet address: *http://www.alaska.faa.gov/at.* SUPPLEMENTARY INFORMATION: Comments Invited Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2006-25947/Airspace Docket No. 06-AAL-31.” The postcard will be date/time stamped and returned to the commenter. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. Availability of Notice of Proposed Rulemaking's (NPRM's) An electronic copy of this document may be downloaded through the Internet at *http://dms.dot.gov.* Recently published rulemaking documents can also be accessed through the FAA's Web page at *http://www.faa.gov* or the Superintendent of Document's Web page at *http://www.access.gpo.gov/nara.* Additionally, any person may obtain a copy of this notice by submitting a request to the Federal Aviation Administration, Office of Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW., Washington, DC 20591 or by calling

(202)267-8783. Communications must identify both docket numbers for this notice. Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking,

(202)267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure. The Proposal The FAA is considering an amendment to the Code of Federal Regulations (14 CFR Part 71), which would revise the Class D and E airspace descriptions at Allen AAF, AK resulting from a change in the hours of activation at the Allen AAF Control Tower. The intended effect of this proposal is to adjust the Class D airspace activation time to align with the Allen AAF tower hours of operation. The class D airspace would only be in place while the tower is manned. The Class D airspace area will be effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. The Army does not need to operate the control tower 24 hours per day. Class D airspace is only in effect when a tower is open. When the tower is not open, the airspace would revert to Class E. Additionally, the title of each airspace description in FAA Order 7400.9P associated with Allen AAF would be changed. By convention, these titles are associated with the nearest city or town. In this case, “Delta Junction” should be referenced (not “Big Delta”). For example, the Class E5 airspace should be titled: “AAL AK E5 Delta Junction, AK”. There is a smaller town named Big Delta about 10 miles further north of Delta Junction. It has been mistakenly listed in the description since 1995. This action would correct that error. The proposed airspace changes are sufficient in size to contain aircraft executing instrument procedures at Allen AAF, AK. The area would be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class D airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 in FAA Order 7400.9P, *Airspace Designations and Reporting Points,* dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document would be published subsequently in the Order. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it proposes changes to Class D and E airspace that remain sufficient in size to contain aircraft executing instrument procedures at Allen AAF and represents the FAA's continuing effort to safely and efficiently use the navigable airspace. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS D AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9P, *Airspace Designations and Reporting Points* , dated September 1, 2006, and effective September 15, 2006, is to be amended as follows: Paragraph 5000 General. AAL AK D Delta Junction, AK [Revised] Allen AAF, AK (Lat. 63°59″40′ N., long. 145°43″18′ W.) Big Delta VORTAC (Lat. 64°00″16′ N., long. 145°43″02′ W.) Delta Junction Airport (D66), AK (Lat. 64°03″02′ N., long. 145°43″02′ W.) That airspace extending upward from the surface to and including 3,800 feet MSL within a 6.3-mile radius from Allen AAF; excluding the portion within the boundary of restricted areas R2202A and R2202C, and excluding that airspace below 700 feet above the surface contained within an area from an East/West line 1/2-mile south of the Delta Junction Airport (D66), extending from 1 mile east of the Richardson Highway to 1 mile west of the Delta River, thence northwest and parallel to the Richardson Highway and the Delta River, to the 6.3-mile radius from Allen AAF. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Paragraph 6000 General. AAL AK E2 Delta Junction, AK [Revised] Allen AAF, AK (Lat. 63°59″40′ N., long. 145°43″18′ W.) Within an area from an East/West line 1/2 -mile south of the Delta Junction Airport (D66), extending from 1 mile east of the Richardson Highway to 1 mile west of the Delta River, thence northwest and parallel to the Richardson Highway and the Delta River, to the 6.3-mile radius from Allen AAF. This Class E2 airspace area is effective only when Class D airspace is activated. Paragraph 6004 Class E airspace areas designated as an extension to a Class D surface area. AAL AK E4 Delta Junction, AK [Revised] Allen AAF, AK (Lat. 63°59″40′ N., long. 145°43″18′ W.) Big Delta VORTAC (Lat. 64°00″16′ N., long. 145°43″02′ W.) The airspace extending upward from the surface within 3 miles north and 2.6 miles south of the 039° radial of the Big Delta VORTAC extending from the 6.3-mile radius from Allen AAF to 10.3 miles northeast of Allen AAF. Paragraph 6005 Class D airspace extending upward from 700 feet or more above the surface of the earth. AAL AK E5 Delta Junction, AK [Revised] Allen AAF, AK (Lat. 63°59″40′ N., long. 145°43″18′ W.) Big Delta VORTAC (Lat. 64°00″16′ N., long. 145°43″02′ W.) That airspace extending upward from 700 feet above the surface within an 8.6-mile radius of Allen AAF, and within 3 miles north and 2.6 miles south of the 039° radial of the Big Delta VORTAC extending from the 8.6-mile radius from Allen AAF, to 10.3 miles northeast of Allen AAF; excluding the portion within restricted areas 2202A and R2202C. Issued in Anchorage, AK, on October 23, 2006. Anthony M. Wylie, Director, Alaska Flight Service Information Office. [FR Doc. E6-18264 Filed 10-30-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 20, 201, 207, 314, 330, 514, 515, 601, 607, 610, and 1271 [Docket No. 2005N-0403] RIN 0910-AA49 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Public Meeting; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; notice of public meeting and extension of comment period. SUMMARY: The Food and Drug Administration

(FDA)is announcing a public meeting to discuss the proposed changes to the National Drug Code

(NDC)system contained in the agency's proposed rule governing drug establishment registration and drug listing. The proposed rule appeared in the **Federal Register** of August 29, 2006 (71 FR 51276). In addition, in response to requests for an extension, FDA is extending to January 26, 2007, the comment period for the proposed rule to provide interested parties additional time to submit comments. DATES: The public meeting will be held on December 11, 2006, from 9 a.m. to 4 p.m. Register to attend the meeting by November 24, 2006. Submit written or electronic comments for consideration at the meeting and requests to speak by November 24, 2006. Submit written or electronic comments on the proposed rule and this notice by January 26, 2007. ADDRESSES: The public meeting will be held at FDA, Center for Drug Evaluation and Research Advisory Committee Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD 20852. You may submit comments, identified by Docket No. 2005N-0403 and RIN number 0910-AA49, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number

(RIN)for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lakshmi Cherukuri, Center for Drug Evaluation and Research (HFD-330), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8924, E-mail: *Lakshmi.Cherukuri@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of August 29, 2006 (71 FR 51276), FDA published a proposed rule entitled “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs” (proposed rule). The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/or human cells, tissues, and cellular and tissue-based products, and animal drugs. The proposed rule would make certain changes to the NDC system and add a requirement that the appropriate NDC number appear on the labels of all drugs subject to the listing requirements. The NDC number is a widely used identifier for drugs. It is a unique 10-digit number consisting of 3 segments: The labeler code, the product code, and the package code. NDC numbers are an important, standardized identification system for drug products used in data or claims processing and for a variety of other purposes where identification of drug products is essential. For more information regarding the NDC number, how it originated, and how it is used, see the preamble of the proposed rule (71 FR 51276 at 51295 to 51296). In the proposed rule, FDA is not proposing to change the format of the NDC number (although comments are welcome on this topic), but is proposing to change the processes for assigning and displaying the NDC number. FDA's proposed changes to the NDC number are described in detail in section IV.C of the preamble of the proposed rule (71 FR 51276 at 51295 through 51306). II. The Public Meeting A. Request for a Public Meeting on NDC-Related Issues In a letter dated October 20, 2005, the Healthcare Distribution Management Association (HDMA), a trade association representing drug distributors, requested that before publishing the proposed rule, FDA hold a public meeting on issues related to changes to the NDC system. FDA responded by letter dated December 14, 2005, that we planned to hold a public meeting on NDC changes during the comment period following publication of the proposed rule. We stated that doing so after the proposal was published would give interested parties the benefit of reviewing the agency's proposal prior to the meeting, which would facilitate more focused comments during the meeting on issues raised in the proposed rule. B. Scope of the Public Meeting As requested, we are holding a public meeting to discuss changes to the NDC system contained in the proposed rule. We emphasize that discussion at this public meeting will be limited to NDC-related issues and will not include any other registration or listing issues. Persons wishing to comment on other aspects of the proposed rule should do so by submitting their comments, in writing, as directed in the proposal. We anticipate that discussions will include presentations from FDA personnel, invited speakers, and members of the public. We invite discussion of NDC-related topics raised in the proposed rule, including the following: 1. The proposed requirement that human-readable NDC numbers appear on the labels of drugs subject to the drug listing requirements (see 71 FR 51276 at 51297). 2. The proposed requirement that the “appropriate NDC number” that must appear on the labels of drugs is the NDC number of the last manufacturer, repacker or relabeler (including a drug product salvager who repacks or relabels the drug), or private label distributor responsible for the drug immediately before it is received by the wholesaler or retailer (see 71 FR 51276 at 51297 to 51298). 3. The proposed requirement that the human-readable NDC number be immediately preceded by the prefix “NDC” (see 71 FR 51276 at 51298). 4. The proposal to designate the responsibility of assigning the NDC number to FDA (see 71 FR 51276 at 51299). 5. The proposed prohibitions against using an NDC number to represent a different drug than the drug to which the NDC number was assigned, and against using a different NDC number if marketing is resumed for a drug that was discontinued earlier (see 71 FR 51276 at 51305). 6. The proposal to exempt from public disclosure the NDC number assigned to the drug immediately before the drug is received by the repacker or relabeler. The reason for the proposed exemption is that this information may disclose a business relationship between the manufacturer, repacker, relabeler, or drug product salvager and the business from which they obtained the drug, and may constitute commercial or financial information that is exempt from public disclosure (see 71 FR 51276 at 51320). 7. The possibility of adding one or more digits to the NDC code in the future (see 71 FR 51276 at 51300). C. Registration, Agenda, and Transcript There is no fee to register for the meeting, but registration is required and space is limited. Interested parties are therefore encouraged to register early. Limited visitor parking is available for a fee, and the Twinbrook Metro Stop is within walking distance of the meeting site. Early arrival is encouraged, as there will be security screening. You will be asked for government-issued picture identification by the security officers. If you need special accommodations due to a disability, please include this information when registering. *Registration for General Attendees* . Registration is required to attend the public meeting. If you wish to attend the meeting, you must register by November 24, 2006, via e-mail to: *CDER_330CATS@cder.fda.gov* . Please indicate “National Drug Code

(NDC)system” in the SUBJECT line and provide complete contact information for each attendee (including name, title, affiliation, e-mail address, and phone number(s)). Upon receipt and review for adequacy of information, an e-mail will be sent to confirm registration. *Registration for Speaking Attendees* . If you wish to speak at the meeting, you must register by November 24, 2006, via e-mail to: *CDER_330CATS@cder.fda.gov* . Please indicate “Speaker-National Drug Code

(NDC)system” in the SUBJECT line. When registering, speakers must provide the following information:

(1)The NDC-related topic or issue to be addressed;

(2)the speaker's name, title, company or organization, address, phone number, and e-mail address; and

(3)the approximate length of time requested to speak. We encourage consolidation of like minded presentations to enable a broad range of views to be presented. *Agenda and Transcript* . The agenda for the public meeting will be available on FDA's Center for Drug Evaluation and Research

(CDER)Web site at: *www.fda.gov/cder/ndc/database/default.htm* . After the meeting, the agenda, presentations, and transcript will be placed on file in the Division of Dockets Management under Docket No. 2005N-0403 and on CDER's Web site identified previously. Copies of the transcript may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 20 working days after the meeting at a cost of 10 cents per page, or on compact disc at a cost of $14.25 each. You may also examine the transcript at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and on the Internet at *http://www.fda.gov/ohrms/dockets/default.htm* . III. Extension of the Comment Period for the Proposed Rule By letter dated September 25, 2006, the Compressed Gas Association and the Gases and Welding Distributors Association requested an extension of 60 days to comment on the proposed rule because their member companies do not have sufficient time to evaluate the economic impact of the proposal and report their findings to FDA. By letter dated September 26, 2006, the Animal Health Institute

(AHI)also requested a 60-day extension of the comment period to provide AHI additional time to review the proposed rule, analyze the impact on its industry, and provide comments to FDA. In addition, by letter dated October 12, 2006, the Consumer Healthcare Products Association

(CHPA)requested a 60-day extension of the comment period to provide CHPA additional time to obtain and review opinions and responses from its member companies. FDA has considered these extension requests and is extending the comment period to January 26, 2007. We believe that extending the comment period is reasonable in light of the complexity and scope of the issues in the proposed rule and that it will not significantly delay resolution of this rulemaking. IV. Request for Comments We are interested in obtaining public comment on the NDC-related issues identified in this document. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on this document and the proposed rule (see DATES ). Submit two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with Docket No. 2005N-0403. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18310 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. 2006N-0362] General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration

(FDA)is proposing to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device. DATES: Submit written comments by January 29, 2007. See section X of this document for the proposed effective date of a final rule based on this proposed rule. ADDRESSES: You may submit comments, identified by Docket No. 2006N-0362, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and Docket No. for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141. SUPPLEMENTARY INFORMATION: I. Regulatory Authorities The act, as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990

(SMDA)(Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). The 1976 amendments broadened the definition of “device” in section 201(h) of the act (21 U.S.C. 321(h)) to include certain articles that were once regulated as drugs. Under the 1976 amendments, Congress classified all transitional devices, i.e., those devices previously regulated as new drugs, including the absorbable hemostatic device, into class III. SMDA amended section 520(l) of the act (21 U.S.C. 360j(l)) to direct FDA to collect certain safety and effectiveness information from the manufacturers of transitional devices still remaining in class III to determine whether the devices should be reclassified into class II (special controls) or class I (general controls). The legislative history of the SMDA reflects congressional concern that many transitional devices were being overregulated in class III (H. Rept. 808, 101st Cong., 2d sess. 26-27 (1990); S. Rept. 513, 101st Cong., 2d sess. 27 (1990)). Accordingly, in the **Federal Register** of November 14, 1991 (56 FR 57960), FDA issued an order under section 520(l)(5)(A) of the act, requiring manufacturers of transitional devices, including the absorbable hemostatic device (21 CFR 878.4490), to submit to FDA a summary of and a citation to any information known or otherwise available to them respecting the devices, including adverse safety or effectiveness information, which had not been submitted under section 519 of the act (21 U.S.C. 360i). Manufacturers were to submit the summaries and citations to FDA by January 13, 1992. However, because of misunderstandings and uncertainties regarding the information required by the order, and whether the order applied to certain manufacturers' devices, many transitional class III device manufacturers failed to comply with the reporting requirement by January 13, 1992. Consequently, in the **Federal Register** of March 10, 1992 (57 FR 8462), FDA extended the reporting period to March 31, 1992. Section 520(l)(5)(B) of the act provides that, after the issuance of an order requiring manufacturers to submit any information known or otherwise available respecting the devices, but before December 1, 1992, FDA was to publish regulations either leaving transitional class III devices in class III or reclassifying them into class I or II. Subsequently, as permitted by section 520(l)(5)(C) of the act, in the **Federal Register** of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations until December 1, 1993. Due to limited resources, FDA was unable to publish the regulations before the December 1, 1993, deadline. II. Regulatory Background of the Device In the **Federal Register** of December 16, 1977 (42 FR 63472), FDA identified the absorbable hemostatic agent and dressing as a transitional device that is a class III device that FDA previously regulated as a drug and for which premarket approval was immediately required. Since enactment of the 1976 amendments, FDA has approved numerous premarket approval

(PMA)applications and PMA supplements authorizing the commercial distribution of new absorbable hemostatic agents and dressings in the United States. Absorbable hemostatic products that include biological products or drug components are combination products as defined in 21 CFR 3.2(e). When the device component is responsible for the primary mode of action of the absorbable hemostatic product, it is assigned to CDRH for premarket review and regulation. If the absorbable hemostatic device is reclassified, these combination products will be subject to premarket notification [510(k)] requirements. III. Description of the Device The current identification of the device states that an “absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.” Absorbable hemostatic devices are primarily applied during surgical procedures in order to control bleeding that is not readily controlled via conventional means, such as cautery or ligation. At other times, an absorbable hemostatic device may be applied due to the inaccessibility of a site to conventional hemostatic methods. FDA is proposing the following device name and identification based on the agency's review to more accurately identify the device: An absorbable hemostatic device is an absorbable device that is placed in the body during surgery to produce hemostasis by accelerating the clotting process of blood. IV. Recommendation of the Panel At a July 8, 2002, public meeting of FDA's General and Plastic Surgery Devices Panel (the Panel), the Panel requested that the agency provide information on the potential content of a class II special controls guidance document for the absorbable hemostatic device. The Panel requested this information to enable them to make an appropriate recommendation on possible reclassification of the device (Ref. 1). At a July 24, 2003, public meeting of the Panel, the agency presented the possible content of a class II special controls guidance for the absorbable hemostatic device (Ref. 2). The Panel unanimously recommended that the absorbable hemostatic device be reclassified from class III into class II and recommended that a class II guidance document be the special control for the device. The Panel based the recommendations on the information provided by FDA, the presentations to the panel by manufacturers and FDA, the Panel's deliberations at the meeting, and their personal experience with the device. V. Risks to Health After considering the information in the panel's recommendation, as well as the published literature and Medical Device Reports, FDA has evaluated the risks to health associated with use of the absorbable hemostatic device and determined that the following risks to health are associated with its use. A. Uncontrolled Bleeding The absorbable hemostatic device is intended for use during surgical procedures as an adjunct to hemostasis when conventional means fail to produce hemostasis or are impractical. Patients receiving antiplatelet/anticoagulation therapy have increased blood clotting times. This increase in blood clotting time occurs even when an absorbable hemostatic device is used during the surgical procedure to control bleeding. Failure to completely control bleeding can lead to death or severe injury. B. Hematoma If small amounts of bleeding persist following the application of an absorbable hemostatic device, the accumulation of blood behind the device will form a hematoma. The hematoma may press on soft tissue and cause soft tissue or nerve damage. A hematoma may also result in infection (see section V.C of this document). C. Infection An absorbable hemostatic device may serve as a nidus for infection and abscess formation. Absorbable hemostatic devices are manufactured from collagen, gelatin, or oxidized regenerated cellulose; some collagen and gelatin hemostatic devices may contain FDA-licensed bovine thrombin. Bacteria can grow on these device materials. For example, the use of absorbable hemostatic devices in nasal surgery has caused toxic shock syndrome. D. Wound Dehiscence The use of an absorbable hemostatic device near sites of skin incision closures has interfered with the healing of the incision. This interference is due to mechanical interposition of the device and is not due to intrinsic interference with the wound healing process. E. Foreign Body Reactions The absorbable hemostatic device has been associated with foreign body reactions involving fluid accumulation due to encapsulation of the device. Such encapsulated devices have resulted in granuloma formation, inflammation, and edema, which may require surgical removal. F. Immunologic Reactions Absorbable hemostatic devices are composed of animal or plant derived proteins and/or polysaccharides. These devices are made of bovine collagen, porcine and bovine gelatin, and regenerated oxidized cellulose; some may also include FDA-licensed bovine thrombin as a combination product component. Some patients are allergic to these animal or plant-derived materials. Patients allergic to bovine thrombin containing hemostatic devices may form antibodies to bovine Factor V a that may cross react with human Factor V a resulting in a potentially fatal coagulopathy. G. Adhesion Formation An absorbable hemostatic device, in the presence of coagulated blood and tissue fluid, often leads to scarring and adhesion formation in the weeks and months following the surgical procedure. The surgical procedure itself may result in scarring and adhesion formation. H. Failure to be Absorbed Absorbable hemostatic devices are readily degraded by enzymatic and hydrolytic action. Occasionally, an absorbable hemostatic device may lodge in an area with low enzymatic and hydrolytic activity. In such instances, it may not be efficiently absorbed. Subsequently, it may become encapsulated and exert pressure on soft tissue requiring surgical removal. I. Interference With Methylmethacrylate Adhesives Some types of absorbable hemostatic devices have been reported to reduce the strength of methylmethacrylate adhesives used to fixate orthopedic prosthetic devices to bone. J. Aspiration Into Blood Salvage System Filters Fragments of an absorbable hemostatic device may pass through blood salvage system filters and occlude the systems or the patient's vasculature. K. Embolization Absorbable hemostatic devices used near moderate to large blood vessels may result in embolization of the blood vessel. Such embolization has been associated with severe adverse effects, including fever, duodenal and pancreatic infarct, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis, asterixis, and death. L. Paralysis/Nerve Damage/Tissue Necrosis Absorbable hemostatic devices absorb liquid and swell to varying degrees, up to 35 to 40 times their weight in liquid. This absorption of liquid is accompanied by a concomitant swelling of the device. VI. Summary of the Reasons for the Reclassification FDA believes that the absorbable hemostatic device should be reclassified into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device and because there is sufficient information to establish special controls to provide such assurance. In addition to the potential risks to health associated with use of the absorbable hemostatic device described in section V of this document, there is reasonable knowledge of the benefits of the device. Specifically, the absorbable hemostatic device may prevent extended bleeding, reduce surgical morbidity due to blood loss, and reduce the need for transfusions. VII. Special Controls In addition to general controls, FDA believes that the draft guidance document entitled “Class II Special Controls Guidance: Absorbable Hemostatic Device” (the class II special controls guidance document) is an adequate special control to address the risks to health associated with the use of the device described in section V of this document. FDA believes that the class II special controls guidance document, which incorporates voluntary consensus standards and describes labeling recommendations, addresses the Panel's concerns. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice of availability of the draft class II special controls guidance document that the agency would use as the special control for this device. The draft class II special controls guidance document sets forth the information FDA believes should be included in premarket notification submissions (510(k)s) for the absorbable hemostatic device. FDA has identified the risks to health associated with the use of the device in the first column of table 1 of this document and the recommended mitigation measures identified in the class II special controls guidance document in the second column of table 1. FDA believes that addressing these risks to health in a 510(k) in the manner identified in the class II special controls guidance document, or in an acceptable alternative manner, is necessary to provide reasonable assurance of the safety and effectiveness of the device. **Table 1.** Identified Risk Recommended Mitigation Measures Uncontrolled Bleeding Material and performance characteristics, Animal testing, Clinical testing, Labeling Hematoma Animal testing, Clinical testing, Labeling Infection Animal testing, Sterility, Labeling Wound Dehiscence Labeling Foreign Body Reactions Animal testing, Biocompatibility, and Labeling Immunological Reactions Animal testing, Biocompatibility, Labeling Adhesion Formation Animal testing, Clinical testing Failure to be Absorbed Material and performance characteristics, Animal testing, Biocompatibility Interference with Methylmethacrylate Adhesives Animal testing, Labeling Aspiration Into Blood Salvage System Filters Labeling Embolization Labeling Paralysis/Nerve Damage/Tissue Necrosis Labeling VIII. FDA's Findings As discussed previously in this document, FDA believes the absorbable hemostatic device should be reclassified into class II because special controls, in addition to general controls, provide reasonable assurance of the safety and effectiveness of the device and because there is sufficient information to establish special controls to provide such assurance. FDA, therefore, is proposing to reclassify the device into class II and establish the draft class II special controls guidance document as a special control for the device. Section 510(m) of the act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the act, if the agency determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes that premarket notification is necessary to provide reasonable assurance of safety and effectiveness and, therefore, does not intend to exempt the device from the premarket notification requirements. IX. Effective Date FDA proposes that any final regulation based on this proposal become effective 30 days after its date of publication in the **Federal Register** . X. Environmental Impact The agency has determined under 21 CFR 25.34(b) that this proposed reclassification action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. XI. Analysis of Impacts FDA has examined the impacts of the proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-602), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of this device from class III to class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device, the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $118 million, using the most current

(2004)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount. XII. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement has not been prepared. XIII. Paperwork Reduction Act of 1995 FDA tentatively concludes that this proposed rule contains no collections of information. Therefore, clearance by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) is not required. FDA also tentatively concludes that the draft special control guidance document does not contain new information collection provisions that are subject to review and clearance by OMB under the PRA. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice announcing the availability of the draft guidance document entitled ”Class II Special Controls Guidance Document: Absorbable Hemostatic Device”; the notice contains an analysis of the paperwork burden for the draft guidance. XIV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. XV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. General and Plastic Surgery Devices Panel, Transcript, pp. 80-177, July 8, 2002. 2. General and Plastic Surgery Devices Panel, Transcript, July 24, 2003. List of Subjects in 21 CFR Part 878 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 878 be amended as follows: PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for 21 CFR Part 878 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Section 878.4490 is revised to read as follows: § 878.4490 Absorbable hemostatic device.

(a)*Identification* . An absorbable hemostatic device is an absorbable device that is placed in the body during surgery to produce hemostasis by accelerating the clotting process of blood.

(b)*Classification* . Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Absorbable Hemostatic Device.” See § 878.1(e) for the availability of this guidance document. Dated: October 19, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-18324 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-124152-06] RIN 1545-BF73 Definition of Taxpayer for Purposes of Section 901 and Related Matters; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking and notice of public hearing; Correction. SUMMARY: This document contains corrections to notice of proposed rulemaking and notice of public hearing that was published in the **Federal Register** on Friday, August 4, 2006 (71 FR 44240) relating to the determination of who is considered to pay a foreign tax for purposes of sections 901 and 903. FOR FURTHER INFORMATION CONTACT: Bethany A. Ingwalson,

(202)622-3850 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The notice of proposed rulemaking and notice of public hearing (REG-124152-06) that is the subject of these corrections are under sections 901 and 903 of the Internal Revenue Code. Need for Correction As published, the notice of proposed rulemaking and notice of public hearing (REG-124152-06) contains errors that may prove to be misleading and are in need of clarification. Correction of Publication Accordingly, the notice of proposed rulemaking and notice of public hearing (REG-124152-06) that was the subject of FR Doc. E6-12358 is corrected as follows: § 1.901-2 [Corrected] 1. On page 44246, column 1, § 1.901-2(f)(6), paragraph

(i)of *Example 4.* , line 4, the language “county Y. A accrues interest income on the” is corrected to read “country Y. A accrues interest income on the”. 2. On page 44246, column 2, § 1.901-2(f)(6), paragraph

(i)of *Example 4.* , first paragraph of the column, line 1, the language “pay over to country X 10 percent of the” is corrected to read “pay over to country Y 10 percent of the”. 3. On page 44247, column 1, § 1.901-2(f)(6), paragraph

(i)of *Example 8.* , the language “tax purposes. New D also has a short U.S.” is corrected to read “tax purposes. “New” D also has a short U.S.”. 4. On page 44247, column 1, § 1.901-2(f)(6), paragraph

(ii)of *Example 8.* , line 11, the language “years of terminating D and new D. See” is corrected to read “years of old D and new D. See”. 5. On page 44247, column 1, § 1.901-2(f)(6), paragraph

(ii)of *Example 8.* , line 13, the language “allocation of terminating D's country M taxes” is corrected to read “allocation of old D's country M taxes”. 6. On page 44247, column 1, § 1.901-2(h), the language “(h) *Effective Date* . Paragraphs (a)” is corrected to read “(h) *Effective date* . Paragraphs (a)”. LaNita Van Dyke, Federal Register Liaison, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration). [FR Doc. E6-18205 Filed 10-30-06; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900-AM17 Notice and Assistance Requirements AGENCY: Department of Veterans Affairs. ACTION: Proposed rule. SUMMARY: The Department of Veterans Affairs

(VA)proposes to amend its regulation governing VA's duty to provide a claimant with notice of the information and evidence necessary to substantiate a claim and VA's duty to assist a claimant in obtaining the evidence necessary to substantiate the claim. The purpose of these proposed changes is to clarify when VA has no duty to notify a claimant of how to substantiate a claim for benefits, to make the regulation comply with statutory changes, and to streamline the development of claims. DATES: Comments must be received by VA on or before January 2, 2007. ADDRESSES: Written comments may be submitted through *http://www.Regulations.gov;* by: mail or hand-delivery to the Director, Regulations Management (00REG), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; or by fax to

(202)273-9026. Comments should indicate that they are submitted in response to “RIN 2900-AM17—Notice and Assistance Requirements.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call

(202)273-9515 for an appointment. In addition, during the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Maya Ferrandino, Consultant, Compensation and Pension Service, Policy and Regulations Staff, Veterans Benefits Administration, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)273-7211. SUPPLEMENTARY INFORMATION: Section 3(a) of the Veterans Claims Assistance Act of 2000 (VCAA), Public Law 106-475, 114 Stat. 2096, amended 38 U.S.C. 5103 to impose on VA a duty to provide certain notice to certain claimants applying for veterans' benefits. *See* 38 U.S.C. 5103(a). Under section 5103(a), upon receipt of a substantially complete application for benefits, VA must “notify the claimant and the claimant's representative, if any, of any information, and any medical or lay evidence, not previously provided to the Secretary that is necessary to substantiate the claim” (section 5103(a) notice). 38 U.S.C. 5103(a). VA implemented section 5103(a) in 38 CFR 3.159, which reflects section 5103(a)'s requirement that VA give the notice upon receipt of a substantially complete application. *See* 38 CFR 3.159(b)(1). In addition, VA defined “substantially complete application” for purposes of section 5103(a) notice. *See* 38 CFR 3.159(a)(3). The purpose of this rulemaking is, in part, to clarify when VA has no duty to give section 5103(a) notice. Long before enactment of the VCAA, VA had defined “application” in 38 CFR 3.1(p). An “application” is “a formal or informal communication in writing requesting a determination of entitlement or evidencing a belief in entitlement, to a benefit.” 38 CFR 3.1(p). Because that definition pre-dated the VCAA, it is apparent that it was not issued in implementation of the VCAA. However, experience implementing section 5103(a) has disclosed a potential ambiguity in the regulations, which this rulemaking will clarify. That ambiguity is whether VA's receipt of a notice of disagreement

(NOD)also triggers VA's duty to give section 5103(a) notice because the NOD can be viewed as satisfying the § 3.1(p) definition of “application.” We propose to clarify that it does not. An NOD is the means by which a claimant initiates an appeal of a decision on a claim to the Board of Veterans' Appeals (Board). 38 U.S.C. 7105(a); 38 CFR 20.200. “A written communication from a claimant or his or her representative expressing dissatisfaction or disagreement with an adjudicative determination by the agency of original jurisdiction and a desire to contest the result will constitute [an NOD].” 38 CFR 20.201. The ambiguity we propose to clarify is whether VA's receipt of an NOD triggers VA's duty to issue section 5103(a) notice. It appears from these regulatory definitions that a single written communication expressing disagreement with a decision of the agency of original jurisdiction could be viewed as constituting both an NOD under § 20.201 and an application under § 3.1(p). (If a single written communication contains language expressing disagreement with a decision of the agency of original jurisdiction as well as language raising a new claim for benefits, section 5103(a) notice would be required in response to the new claim for benefits.) Because the definition in § 3.1(p) is a holdover from before the VCAA and was not intended to govern when VA must give section 5103(a) notice, VA does not view it as dispositive of the question. Furthermore, section 5103(a) does not specify whether VA must issue section 5103(a) notice upon receipt of an NOD. For the reasons we explain below, VA believes that Congress did not intend to require section 5103(a) notice upon VA's receipt of an NOD. 1. Congress intended VA to give section 5103(a) notice at the beginning of the claim process, but an NOD is filed after VA has decided a claim. VA's claim process begins with the filing of an application. 38 U.S.C. 5101(a); 38 CFR 3.151(a), 3.152(a); *Hensley* v. *West,* 212 F.3d 1255, 1259 (Fed. Cir. 2000) (discussing claims process before VCAA's enactment). As stated, upon VA's receipt of a complete or substantially complete application, VA provides section 5103(a) notice. The claimant has a year from the date the notice is sent to respond. 38 U.S.C. 5103(b)(1). As we will further discuss, VA may decide the claim within that one-year period, but if the claimant subsequently submits relevant evidence within that one-year period, VA must readjudicate the claim. 38 CFR 3.159(b)(1). After notice of a decision on a claim is sent to the claimant, the claimant has up to one year to file an NOD with that decision. 38 U.S.C. 7105(b)(1); 38 CFR 20.302. Following receipt of an NOD, unless VA can resolve the disagreement through development or review action, VA will issue a statement of the case. 38 U.S.C. 7105(d)(1); 38 CFR 19.26. To perfect the appeal, the appellant has to file a substantive appeal in response to the statement of the case. 38 U.S.C. 7105(a), (d)(3); 38 CFR 20.200, 20.302(b)(1). Following VA's receipt of a substantive appeal, the appeal is certified to the Board. From the above description of the claim process, it is apparent that, typically, an application starts the claim process and an NOD starts the appeal process after VA has decided a claim. However, the legislative history of the VCAA indicates that Congress intended VA to issue section 5103(a) notice early in the claim process. See S. Rep. No. 106-397, at 22

(2000)(“The Committee bill, in summary, modifies the pertinent statutes to reinstate VA's traditional practice of assisting veterans at the beginning of the claims process.”). The VCAA's legislative history indicates that Congress intended the new law to improve the efficiency of the adjudication process and the process by which subsequent claims for rating increases or service connection for additional conditions are handled, by ensuring proper development of the record when the claimant first submits an application for benefits. 146 Cong. Rec. S9211, S9212 (daily ed. Sept. 25, 2000) (statement of Sen. Rockefeller). The drafters wanted claimants to know early in the claim process what was necessary to substantiate their claims. Therefore, the VCAA was drafted to impose on VA the duty to issue section 5103(a) notice early in the claim process. However, an NOD, which, as stated, is received in response to a decision on a claim and begins the appeal process for a decision on a claim, may fall within the § 3.1(p) definition of claim/application. We find nothing in section 5103(a)'s language or in the legislative history indicating Congressional intent to require VA to give another section 5103(a) notice upon receipt of an NOD. 2. Congress requires VA to issue a statement of the case in response to an NOD, so additional section 5103(a) notice would be redundant. Upon receipt of an NOD, applicable law requires VA to review and, if necessary, further develop the evidence on the claim for which an NOD was filed. If such development or review does not resolve the disagreement, VA is required to prepare a statement of the case. The statement of the case in effect provides the claimant and any representative with notice similar to the notice required by section 5103(a). A statement of the case must include a summary of the evidence in the case pertinent to the issue or issues with which disagreement has been expressed and a citation of pertinent laws and regulations that controlled the decision. It also must include a discussion of how these laws and regulations affected the decision on the claim and a summary of the reasons for the decision made on each claim. 38 U.S.C. 7105(d)(1); 38 CFR 19.29. A statement of the case notifies a claimant of the evidence that VA received from the claimant and from other sources, and explains why that evidence dictated the result on that claim. A statement of the case therefore informs a claimant of the evidence needed to substantiate a claim for benefits addressed in the NOD. The requirement to issue a statement of the case could be viewed as being largely superfluous if section 5103(a) were interpreted to require VA to also provide notice under this section upon receipt of an NOD. 3. Giving section 5103(a) notice at the appeal stage of the claim process results in logical inconsistencies in the claim process. Furthermore, interpreting section 5103(a) to require notice upon receipt of an NOD could result in the VA claim decision becoming final while the claimant still has time to submit the information and evidence necessary to substantiate a claim for benefits addressed in the NOD. Section 5103(b) of title 38, United States Code, provides a claimant one year to submit information or evidence requested in VA's section 5103(a) notice; however, an appellant has sixty days from the date VA mails a statement of the case, or the remainder of the one-year period beginning on the date notification of the determination being appealed is mailed, whichever period ends later, to file a formal or substantive appeal. 38 U.S.C. 7105(d)(3); 38 CFR 20.302(b). Thus, if the claimant does not complete the appeal initiated by the NOD or the Board decides the appeal before one year has elapsed from the date VA gave notice, VA's claim decision could become final while there is still time remaining to submit information and evidence necessary to substantiate a claim for benefits addressed in the NOD. Congress could not have intended such a result in this circumstance. 4. Not requiring section 5103(a) notice upon VA's receipt of an NOD would be consistent with case law governing such notice. Besides the reasons given above regarding the intent of Congress, developing case law also supports not requiring section 5103(a) notice upon VA's receipt of an NOD. In *Pelegrini* v. *Principi,* 18 Vet. App. 112, 120 (2004), the United States Court of Appeals for Veterans Claims

(CAVC)concluded that VA must provide section 5103(a) notice to a claimant seeking service connection before an initial unfavorable RO decision is made on the claim. The Court of Appeals for the Federal Circuit has agreed. *Mayfield* v. *Nicholson,* 444 F.3d 1328, 1334 (Fed. Cir. 2006). In *Dingess* v. *Nicholson,* 19 Vet. App. 473, 489 (2006), the CAVC added that VA must provide section 5103(a) notice to a claimant on the initial-disability rating and effective-date elements of a claim before the initial adjudication on them. Requiring section 5103(a) notice upon VA's receipt of an NOD would not satisfy these requirements because notice given following receipt of an NOD necessarily implies notice given after VA had already decided the claim. Furthermore, because the law requires that VA address the initial disability-rating and effective-date elements of a claim in the notice it gives upon receipt of an application, requiring notice on such elements upon VA's receipt of an NOD would be redundant. Therefore, for the reasons stated above, we propose to state in a new paragraph, § 3.159(b)(3), that VA does not have a duty to provide the section 5103(a) notice upon receipt of an NOD. Additionally, we propose to state that the section 5103(a) notice duty does not arise when the claimant is not eligible for the claimed benefit as a matter of law. In such circumstances, for example, in a claim for nonservice-connected disability pension when the claimant has no wartime service, there is no additional information or evidence the claimant could provide or VA could obtain that could substantiate the claim. This regulation would be consistent with the intent of Congress expressed in 38 U.S.C. 5103A(a)(2), which provides that “[t]he Secretary is not required to provide assistance to a claimant under this section if no reasonable possibility exists that such assistance would aid in substantiating the claim.” The legislative history of sections 5103(a) and 5103A(a) supports a conclusion that VA action under section 5103(a) is not required if there is no relevant information or evidence to obtain because the claim is barred as a matter of law. The House Committee on Veterans' Affairs' report on legislation that became the VCAA stated with regard to the provision that became 38 U.S.C. 5103A(a): This language * * * recognizes that certain claims, including those that on their face seek benefits for ineligible claimants (such as a veteran who seeks pension benefits but lacks wartime service), or claims which have been previously decided on the same evidence can be decided without providing any assistance or obtaining any additional evidence, and authorizes the Secretary to decide those claims without providing any assistance under this subsection. H.R. Rep. No. 106-781, at 10 (2000), *reprinted in* 2000 U.S.C.C.A.N. 2006, 2012-13. Accordingly, Congress clearly contemplated that evidentiary development should not be required for claims that are barred as a matter of law. Our analysis is also supported by the case law of the CAVC. In *Mason* v. *Principi,* 16 Vet. App. 129, 132 (2002), the CAVC rejected the claimant's contention that service during the 1980 Iran hostage situation constitutes wartime service for purposes of nonservice-connected disability pension pursuant to 38 U.S.C. 1521. The CAVC noted that there was no dispute as to the facts concerning the claimant's service and held that the claimant did not serve on active duty during a “period of war” as defined by 38 U.S.C. 101(11). *Id.* The CAVC further held that the VCAA was not applicable to the claim because the statute, and not the evidence, was dispositive of the claim. *Id.* ; *see also Smith* v. *Gober,* 14 Vet. App. 227, 231-32

(2000)(VCAA does not affect issue of whether interest on past due benefits is payable pursuant to Federal statutes), *aff'd,* 281 F.3d 1384 (Fed. Cir. 2002); *Valiao* v. *Principi,* 17 Vet. App. 229, 232

(2003)(“[w]here the facts averred by a claimant cannot conceivably result in any disposition of the appeal other than affirmance of the Board decision, the case should not be remanded for development [under the VCAA] that could not possibly change the outcome of the decision”). Thus, if a claim cannot be granted because, under undisputed facts, the claimant as a matter of law is not entitled to the benefit sought, it is reasonable to conclude that no section 5103(a) notice to the claimant is required. Therefore, VA proposes to state in § 3.159(b)(3) that no section 5103(a) notice duty arises “[w]hen, as a matter of law, entitlement to the benefit claimed cannot be established, including, but not limited to, when the claimant is ineligible for the benefit sought due to lack of qualifying service, lack of veteran status, or other lack of legal eligibility.” In addition to revising § 3.159 to ensure that the regulation is clear for users and consistent with statutory requirements, we propose to amend 38 CFR 3.159(b)(1). First, we propose to remove the third sentence of current § 3.159(b)(1), which states that VA will request the claimant to provide any evidence in the claimant's possession that pertains to the claim. Section 3.159 generally implements the notice and development requirements of sections 5103(a) and 5103A. The three notice requirements in section 5103(a) are currently prescribed in § 3.159(b)(1) as follows: VA will notify the claimant

(1)of the information and medical or lay evidence required to substantiate the claim,

(2)of which information and evidence, if any, that the claimant is to provide to VA, and

(3)of which information and evidence, if any, VA will attempt to obtain on behalf of the claimant. However, the third sentence of current § 3.159(b)(1) is not required by statute and is redundant of the three statutory requirements from the perspective of what the claimant needs to submit to support the claim. As such, it is unnecessary as part of the regulation. In *Paralyzed Veterans of America* v. *Secretary of Veterans Affairs,* 345 F.3d 1334 (Fed. Cir. 2003), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) addressed a specific challenge to the additional regulatory provision in § 3.159 that states that VA will request that the claimant provide any evidence in the claimant's possession that pertains to the claim. The Federal Circuit expressly agreed with VA's rationale that the additional provision merely assists “the claimant by inviting any additional evidence that might help substantiate the claim.” *Id.* at 1347. The Federal Circuit found that the additional provision was reasonable and “effectively aimed at ensuring that the claimant makes the best showing possible to support his or her claim.” *Id.* at 1348. However, the Federal Circuit stopped short of finding this “additional regulatory provision” to be necessary, especially in light of the other three requirements. In *Pelegrini* v. *Principi,* 18 Vet. App. 112 (2004), although the content of the section 5103(a) notice was not expressly at issue, the CAVC commented that the regulatory provision stating that VA will request that the claimant provide any evidence in the claimant's possession that pertains to the claim “can be considered a fourth element of the requisite notice” under section 5103(a). *Id.* at 121. However, because a request that the claimant provide any evidence that pertains to the claim is redundant of the notice required by statute from the perspective of what the claimant needs to submit to support the claim, a claimant will not be prejudiced by deleting this regulatory provision. A claimant who receives a section 5103(a) notice containing the three statutory elements will have received the same information regarding what the claimant needs to submit to support the claim as the claimant would have received had the claimant received a letter containing the three statutory elements and an additional request that the claimant provide any evidence in the claimant's possession that pertains to the claim. We wish to avoid the possibility that this regulatory provision, intended only to perpetuate VA's long-standing practice to invite a claimant to submit any evidence he or she wants VA to consider, may be misconstrued as a statutory requirement to include specific language in the notices parroting the sentence in the regulation. Therefore, we propose to delete the statement in current § 3.159(b)(1) that VA will also request that the claimant provide any evidence in the claimant's possession that pertains to the claim. To avoid the possibility of similar misunderstandings regarding the nature of this provision and to ensure consistency between the manual and regulatory provisions, we further propose to rescind the provision of paragraph I.1.B.3.b of the Veterans Benefits Administration Adjudication Procedures Manual M21-1MR (VBA Manual M21-1MR), which currently requires ROs to send a letter to the claimant in response to a substantially complete application that “asks the claimant to submit any evidence in his/her possession that pertains to the claim.” Second, for ease of use, we propose to add at the end of the second sentence of current § 3.159(b)(1) the term “notice” in parentheses, to use as a term of art within § 3.159(b)(1). The first two sentences of § 3.159(b)(1) describe the content of the section 5103(a) notice, and rather than repeating the language describing the content of the notice in the rest of § 3.159(b)(1), we propose to use the term “notice” to refer to the notice described in the first two sentences of § 3.159(b)(1). Third, we propose to remove the fourth sentence of current § 3.159(b)(1). This sentence states: “If VA does not receive the necessary information and evidence requested from the claimant within one year of the date of the notice, VA cannot pay or provide any benefits based on that application.” This provision implemented language from section 5103 that was repealed by the Veterans Benefits Act of 2003, Public Law 108-183, section 701(b), 117 Stat. 2670. To ensure consistency with current law and the intent of Congress, we propose to replace this sentence with the following: “The information and evidence that the claimant is informed that the claimant is to provide must be provided within one year of the date of the notice.” Fourth, we propose to amend the fifth sentence of current § 3.159(b)(1), which states that VA may decide the claim if the claimant has not responded to the section 5103(a) notice within 30 days. We propose to provide 45 days as a reasonable period after which VA may decide a claim if no response to the section 5103(a) notice has been received. Therefore, we propose to change the 30-day period in § 3.159(b)(1) to a 45-day period. To ensure consistency between the manual and regulatory provisions, we further propose to rescind the provision of paragraph I.1.B.3.c of the VBA Manual M21-1MR, which currently advises ROs to “inform the claimant that if he/she does not respond to the request for information within 60 days, VA may decide the claim based on all the information and evidence in the file.” The 45-day period will provide a claimant with more time to respond to the section 5103(a) notice compared to the 30-day period in § 3.159(b)(1) and, at the same time, will allow VA to adjudicate the claim more expeditiously compared to the 60-day period in the manual provision. It is important to note that, regardless of whether VA decides a claim after the 45-day period, the claimant still has one year from the date of the section 5103(a) notice to submit the requested information and evidence. Additionally, 38 U.S.C. 5103A(g), “Other assistance not precluded,” states, “Nothing in this section shall be construed as precluding the Secretary from providing such other assistance under subsection

(a)to a claimant in substantiating a claim as the Secretary considers appropriate.” In accordance with section 5103A(g), VA promulgated § 3.159(c), obligating itself to give the assistance described in paragraphs (c)(1), (c)(2), and (c)(3) of § 3.159, relating to assistance with obtaining records, to an individual attempting to reopen a finally decided claim. *See* Duty to Assist, 66 FR 45,620, 45,628 (Aug. 29, 2001). In accordance with VA's intention to issue regulations when the Secretary deems it appropriate to provide the additional assistance in substantiating a claim contemplated in section 5103A(g), *see id.* at 45,629, we propose to add to § 3.159 a new paragraph (g), which states that the authority recognized in subsection

(g)of 38 U.S.C. 5103A is reserved to the sole discretion of the Secretary and will be implemented, when deemed appropriate by the Secretary, through the promulgation of regulations. The main purpose of this provision is to avoid the potential disparate treatment of similarly situated claimants that could arise from inconsistent use in various parts of the agency of open-ended authority to provide “extra” development assistance. Also, this provision is consistent with the Secretary's determination, in the prior rulemaking for § 3.159, of the appropriate level of assistance to be provided individuals based on VA's finite resources and the need to process claims in an efficient manner for the benefit of all veterans. Last, we propose to clarify another aspect of § 3.159 to state that a medical examination or medical opinion is not necessary to establish a nexus between a current disability and service when a claimant satisfies the chronicity or continuity requirements in 38 CFR 3.303(b). Section 3.303(b) states, in pertinent part, as follows: “With chronic disease shown as such in service (or within the presumptive period under § 3.307) so as to permit a finding of service connection, subsequent manifestations of the same chronic disease at any later date, however remote, are service connected, unless clearly attributable to intercurrent causes * * *. For the showing of chronic disease in service there is required a combination of manifestations sufficient to identify the disease entity, and sufficient observation to establish chronicity at the time, as distinguished from merely isolated findings or a diagnosis including the word `Chronic.' When the disease identity is established * * *, there is no requirement of evidentiary showing of continuity. Continuity of symptomatology is required only where the condition noted during service (or in the presumptive period) is not, in fact, shown to be chronic or where the diagnosis of chronicity may be legitimately questioned. When the fact of chronicity in service is not adequately supported, then a showing of continuity after discharge is required to support the claim.” If the chronicity or continuity requirements are met, there is no need for VA to provide a medical examination or medical opinion to determine whether there is a nexus between a veteran's current disability or death and some disease or symptoms during service. (Of course, a medical examination might be needed for some other reason, such as to determine the current level of disability in a claim for service connection.) We believe that it would be helpful to claimants, their representatives, and VA staff to explicitly state this within § 3.159(c)(4)(i), which covers medical examinations and medical opinions. We therefore propose to add the following sentence after the first sentence in § 3.159(c)(4)(i): “A medical examination or medical opinion is not necessary to show a link between a veteran's current disability or death and some disease or symptoms during service when the evidence of record already satisfies the chronicity or continuity requirements in § 3.303(b).” Paperwork Reduction Act This document contains no provisions constituting a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Regulatory Flexibility Act The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Executive Order 12866 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million or more; creating a serious inconsistency or interfering with an action of another agency; materially altering the budgetary impact of entitlements or the rights of entitlement recipients; or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this proposed rule and has concluded that it is a significant regulatory action because it raises novel legal or policy issues. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance Numbers The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.103, Life Insurance for Veterans; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses, and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death; 64.114, Veterans Housing—Guaranteed and Insured Loans; 64.115, Veterans Information and Assistance; 64.116,Vocational Rehabilitation for Disabled Veterans; 64.117, Survivors and Dependents Educational Assistance; 64.118, Veterans Housing—Direct Loans for Certain Disabled Veterans; 64.119, Veterans Housing—Manufactured Home Loans; 64.120, Post-Vietnam Era Veterans' Educational Assistance; 64.124, All-Volunteer Force Educational Assistance; 64.125, Vocational and Educational Counseling for Servicemembers and Veterans; 64.126, Native American Veteran Direct Loan Program; 64.127, Monthly Allowance for Children of Vietnam Veterans Born with Spina Bifida; and 64.128, Vocational Training and Rehabilitation for Vietnam Veterans' Children with Spina Bifida or Other Covered Birth Defects. List of Subjects in 38 CFR Part 3 Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam. Approved: July 25, 2006. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. For the reasons set out in the preamble, VA proposes to amend 38 CFR part 3 (subpart A) as follows: PART 3—ADJUDICATION Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation 1. The authority citation for part 3, subpart A, continues to read as follows: Authority: 38 U.S.C. 501(a), unless otherwise noted. 2. Amend § 3.159 as follows: a. In paragraph (b)(1), at the end of the first sentence after the word “claim”, add the following parenthetical “(hereafter in this paragraph referred to as the “notice”)”. b. In paragraph (b)(1), at the beginning of the second sentence, add “In the notice,”. c. In paragraph (b)(1), remove the third sentence. d. In paragraph (b)(1), remove the fourth sentence and add a new sentence in its place as set forth below. e. In paragraph (b)(1), remove “request” each place it appears and add, in its place, “notice”. f. In paragraph (b)(1), remove “30 days” and add, in its place, “45 days”. g. Add paragraphs (b)(3), and (g). h. In paragraph (c)(4)(i), at the end of the first sentence, a new sentence is added. The revisions read as follows: § 3.159 Department of Veterans Affairs assistance in developing claims.

(b)* * *

(1)* * * The information and evidence that the claimant is informed that the claimant is to provide must be provided within one year of the date of the notice. * * *

(3)VA has no duty to provide the notice described in paragraph (b)(1) of this section at times other than upon its receipt of a complete or substantially complete application. No such duty arises:

(i)Upon receipt of a Notice of Disagreement.

(ii)When, as a matter of law, entitlement to the benefit claimed cannot be established, including, but not limited to, when the claimant is ineligible for the benefit sought due to lack of qualifying service, lack of veteran status, or other lack of legal eligibility. (Authority: 38 U.S.C. 5103(a), 5103A(a)(2))

(c)* * *

(4)* * *

(i)* * * A medical examination or medical opinion is not necessary to show a link between a veteran's current disability or death and some disease or symptoms during service when the evidence of record already satisfies the chronicity or continuity requirements in § 3.303(b). * * *

(g)The authority recognized in subsection

(g)of 38 U.S.C. 5103A is reserved to the sole discretion of the Secretary and will be implemented, when deemed appropriate by the Secretary, through the promulgation of regulations. (Authority: 38 U.S.C. 5103A(g)) [FR Doc. E6-18180 Filed 10-30-06; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2006-0539, EPA-R05-OAR-2006-0610; FRL-8224-4] Approval and Promulgation of Air Quality Implementation Plans; Indiana AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve requests submitted by the Indiana Department of Environmental Management on December 21, 2005 and June 27, 2006 to revise the Indiana State Implementation Plan

(SIP)in two areas:

(1)To amend 326 IAC 1-3-4, ambient air quality standards, to provide consistency between state and federal reference conditions for measurements of particulate matter air quality; and

(2)to update the references to the Code of Federal Regulations

(CFR)from the 2002 edition to the 2004 edition. In the final rules section of this **Federal Register** , EPA is approving the SIP revision as a direct final rule without prior proposal, because EPA views this as a noncontroversial revision and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If we do not receive any adverse comments in response to these direct final and proposed rules, we do not contemplate taking any further action in relation to this proposed rule. If EPA receives adverse comments, we will withdraw the direct final rule and will respond to all public comments in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. DATES: Comments must be received on or before November 30, 2006. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2006-0539, EPA-R05-OAR-2006-0610 by one of the following methods: • *www.regulations.gov* : Follow the on-line instructions for submitting comments. • *E-mail:* *mooney.john@epa.gov* . • *Fax:* (312)886-5824. • *Mail:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch(AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. • *Hand Delivery:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch(AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Jonathan Nichols, Life Scientist, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,

(312)353-7942, *nichols.jonathan@epa.gov* . SUPPLEMENTARY INFORMATION: In the Final Rules section of this **Federal Register** , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this **Federal Register** . Dated: September 14, 2006. Norman Niedergang, Acting Regional Administrator, Region 5. [FR Doc. E6-18168 Filed 10-30-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2006-0747, FRL-8231-6] Revisions to the California State Implementation Plan, Antelope Valley Air Quality Management District AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the Antelope Valley Air Quality Management District (AVAQMD) portion of the California State Implementation Plan (SIP). Under authority of the Clean Air Act as amended in 1990 (CAA or the Act), we are proposing to approve local rules that address permitting requirements. DATES: Any comments on this proposal must arrive by November 30, 2006. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2006-0747, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov.* Follow the on-line instructions. • E-mail: *R9airpermits@epa.gov* . • Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105. *Instructions:* All comments will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or e-mail. www.regulations.gov is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at *http://www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location ( *e.g.* , copyrighted material), and some may not be publicly available in either location ( *e.g.* , CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Al Petersen, Rulemaking Office (AIR-4), U.S. Environmental Protection Agency, Region IX,

(415)947-4118, *petersen.alfred@epa.gov* . SUPPLEMENTARY INFORMATION: This proposal addresses the approval of local AVAQMD Rule 442. In the Rules and Regulations section of this **Federal Register** , we are approving this local rule in a direct final action without prior proposal because we believe this SIP revision is not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule. We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action. Dated: September 1, 2006. Laura Yoshii, Acting Regional Administrator, Region IX. [FR Doc. E6-18172 Filed 10-30-06; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 512 Docket No. NHTSA-06-26140; Notice 1 RIN 2127-AJ95 Confidential Business Information AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION: Notice of Proposed Rulemaking. SUMMARY: This notice addresses the confidentiality of certain information that manufacturers of motor vehicles and motor vehicle equipment submit to NHTSA pursuant to the Early Warning Reporting

(EWR)rule. The agency is proposing to create class determinations, based on Exemption 4 of the Freedom of Information Act (FOIA), treating certain categories of EWR information as confidential, namely production numbers (excluding light vehicles), consumer complaints, paid warranty claims, and field reports. In addition, for EWR reports on deaths and injuries, NHTSA is proposing to create a class determination based on FOIA Exemption 6 that the last six

(6)characters of the vehicle identification number

(VIN)are confidential. Finally, the agency is also proposing to clarify its Confidential Business Information rule with regard to confidentiality markings in submissions in electronic media. DATES: Comments on the proposal are due January 2, 2007. See the SUPPLEMENTARY INFORMATION portion of this document for DOT's Privacy Act Statement regarding documents submitted to the agency's dockets. ADDRESSES: You may submit comments by any of the following methods: • *Web site: <http://dms.dot.gov>* . Follow the instructions for submitting comments on the DOT electronic docket site. • *Fax:* 1-202-493-2251. • *Mail:* Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590. • *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Federal eRulemaking Portal:* Go to *<http://www.regulations.gov>* . Follow the online instructions for submitting comments. *Instructions:* All submissions must include the agency name and docket number or Regulatory Identification Number

(RIN)for this rulemaking. For detailed instructions on submitting comments and additional information on the rulemaking process, see the Request for Comments heading of the Supplementary Information section of this document. Note that all comments received will be posted without change to *<http://dms.dot.gov>* , including any personal information provided. Please see the Privacy Act heading under Rulemaking Analyses and Notices. *Docket:* For access to the docket to read background documents or comments received, go to *<http://dms.dot.gov>* at any time or to Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Michael Kido, Office of Chief Counsel, NHTSA, telephone

(202)366-5263, facsimile

(202)366-3820, 400 Seventh Street, SW., Washington, DC 20590. SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Information Submissions Before and After the EWR Rule Became Effective A. Pre-TREAD Act Transmissions of Information to NHTSA B. The Early Warning Reporting Requirements C. Manufacturer Submissions of EWR Information III. The Proposed Rule on the Confidentiality of EWR Information A. Class Determinations Based on FOIA Exemption 4 1. Basis for Exemptions 2. Proposed Class Determinations on the Confidentiality of EWR Data a. Production Numbers b. Consumer Complaints c. Warranty Claims d. Field Reports e. Common Green Tire Identifiers f. Other Issues To Be Considered B. EWR Class Determination Based on FOIA Exemption 6 IV. Exemption 3 V. Other EWR Data VI. Identifying Confidential Information Located in Electronic Files VII. Request for Comments VIII. Privacy Act Statement IX. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures B. Regulatory Flexibility Act C. National Environmental Policy Act D. Executive Order 13132 (Federalism) E. Unfunded Mandate Reform Act F. Executive Order 12988 (Civil Justice Reform) G. Paperwork Reduction Act H. Executive Order 13045 I. Regulation Identifier Number

(RIN)I. Background In 1966, the Congress enacted the National Traffic and Motor Vehicle Safety Act (Safety Act), for the purpose of reducing traffic accidents and deaths and injuries to persons resulting from traffic accidents. 49 U.S.C. 30101. 1 Since it was amended in 1974, 2 the Safety Act has contained a series of provisions that address motor vehicles and motor vehicle equipment that contain a potential or actual defect that is related to motor vehicle safety. 1 Pub. L. No. 89-563, 80 Stat. 718. This preamble will use the current citations to the United States Code. In 1994, the Safety Act, as amended, was repealed, reenacted, and recodified without material change as part of the recodification of Title 49 of the United States Code. *See* Pub. L. No. 103-272, 108 Stat. 745, 1379, 1385

(1994)(repealing); *id.* at 745, 941-73

(1994)(reenacting and recodifying without substantive changes). 2 Pub. L. No. 93-492, 88 Stat. 1470 (1974). First, the Act requires a manufacturer to notify NHTSA and the vehicle or equipment owners if it learns of a defect and decides in good faith that the defect is related to motor vehicle safety. 49 U.S.C. 30118(c). This duty is independent of any action by NHTSA. 3 Ordinarily, a manufacturer's notice is followed by the manufacturer's provision of a free remedy to owners of defective vehicles and equipment. *See* 49 U.S.C. 30120. Collectively, the manufacturer's notice and remedy are known as a recall. 3 *United States* v. *General Motors Corp.,* 574 F. Supp. 1047, 1049 (D.D.C. 1983). Second, Congress provided NHTSA with considerable investigative and enforcement authority. The Safety Act authorizes NHTSA to conduct investigations and to require manufacturers to submit reports to enable the agency to determine compliance with the statute. 49 U.S.C. 30166(b), (e). In addition, NHTSA may initiate administrative enforcement proceedings to decide whether a motor vehicle or motor vehicle equipment contains a safety-related defect or does not comply with applicable standards. An investigation may culminate in NHTSA's order to the manufacturer to provide notification of a safety-related defect or a noncompliance to owners of the vehicle or equipment. 49 U.S.C. 30118(a)-(b). As a practical matter, if a manufacturer has not submitted a notice of a safety-related defect to NHTSA and if the agency has not received information that provides a sufficient basis for the opening of an investigation, it has been unlikely that NHTSA would investigate a potential problem. This practical limitation on NHTSA's investigations manifested itself in 2000. Under the limited level of reporting then required, the agency lacked sufficient information to identify defects in Firestone tires mounted on Ford Explorers. 4 Numerous fatalities occurred before NHTSA opened an investigation and Firestone conducted recalls. 4 Background information on this matter is available through NHTSA's defects investigation Web site at *http://www-odi.nhtsa.dot.gov/cars/problems/defect/defectsearch.cfm* . Enter “EA00023” in the “NHTSA Action Number” box and click on “search”. On November 1, 2000, Congress enacted the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act. Pub. L. No. 106-414, 114 Stat. 1800. The TREAD Act added provisions to the Safety Act that expanded the scope of the information manufacturers submit to NHTSA prior to a manufacturer-initiated recall. In relevant part, the TREAD Act required the Secretary of Transportation to publish a rule setting out the early warning reporting

(EWR)requirements to enhance the agency's ability to carry out the Act. 49 U.S.C. 30166(m). In general, the TREAD Act authorized the agency to require manufacturers to submit information that may assist in the early identification of defects related to motor vehicle safety. *Id.* In July 2002, NHTSA promulgated the EWR rule. 67 FR 45822 (July 10, 2002). 5 Generally, the EWR rule required certain manufacturers of motor vehicles ( *e.g.* , automobiles and other light vehicles, trucks, buses, motorcycles, and trailers) and motor vehicle equipment ( *e.g.* , tires and child restraints) to submit data regarding production numbers (cumulative total vehicles or equipment manufactured annually), incidents involving death or injury based on claims and notices, property damage claims, consumer complaints, warranty claims paid, and field reports (collectively “early warning data”) on a quarterly basis. *See* 49 CFR 579.21-26. The information is submitted electronically to the agency in a standardized format. 6 5 Thereafter, NHTSA published amendments to the EWR rule. As used herein, the references to the EWR rule are to the rule as amended. The reader should note that the discussion of the EWR rule in this notice is a summary. The full text of the rule and associated **Federal Register** notices should be consulted for a full description. 6 Subsequently, in response to petitions for reconsideration, the rule was amended but these amendments are not germane to the rulemaking at hand. The EWR rule did not address the confidentiality of EWR data, but noted that this issue would be considered as part of the proposed amendments to NHTSA's confidential business information rule. *See* 67 FR at 45866, n.6. The agency addressed the confidentiality of EWR data in its July 2003 final rule on Confidential Business Information

(CBI)rule. 49 CFR part 512, 68 FR 44209 (July 28, 2003). In addition to establishing revised general requirements governing claims of confidentiality and NHTSA rulings on these claims, the CBI rule addressed the confidentiality of EWR data. The CBI rule established a new Appendix C setting forth class determinations treating EWR information on production numbers (excluding light vehicles), consumer complaints, warranty claims, and field reports as confidential. 49 CFR part 512 App. C. Other EWR data were not specifically covered by the CBI rule. The agency based these class determinations on the substantial competitive harm and impairment standards of Freedom of Information Act

(FOIA)Exemption 4. *See* 5 U.S.C. 552(b)(4); 49 CFR part 512 App. C. In April 2004, NHTSA responded to petitions for reconsideration of the July 2003 CBI rule. 69 FR 21409 (April 21, 2004). The agency amended the rule by adding two class determinations to Appendix C based on FOIA Exemptions 4 and 6. One class determination, based on Exemption 4, covered common green tire identifiers submitted by tire manufacturers under 49 CFR 579.26(d). 7 The Exemption 6 class determination covered the last six

(6)characters of vehicle identification numbers

(VINs)contained in EWR death and injury reports submitted to NHTSA. *See* *e.g.* , 49 CFR 579.21(b)(2). 7 The term “common green tires” refers to “tires that are produced to the same internal specifications but that have, or may have, different external characteristics and may be sold under different tire line names.” 49 CFR § 579.4. Public Citizen challenged the legality of Appendix C to 49 CFR part 512. In a March 31, 2006 decision, the United States District Court for the District of Columbia ruled that NHTSA had the authority to promulgate the rule making categorical confidentiality determinations for classes of EWR data. *Public Citizen, Inc.* v. *Mineta,* 427 F. Supp. 2d 7, 12-14 (D.D.C. 2006). The District Court also concluded, however, that NHTSA had not provided adequate notice and opportunity to comment on those determinations at the time of the proposed rule, *id* . at 14-17. The Court remanded the matter to NHTSA but did not address the parties' other claims. *Id.* Thereafter, intervenor Rubber Manufacturers Association

(RMA)filed a motion to amend the judgment to address its claim that the disclosure of EWR data was precluded by a specific disclosure provision in the TREAD Act, 49 U.S.C. 30166(m)(4)(C). 8 RMA asserted that this provision met the requirements of FOIA Exemption 3, which allows the withholding of information prohibited from disclosure by another statute. 5 U.S.C. 552(b)(3). 8 In reference to information provided by manufacturers pursuant to the EWR rule, 49 U.S.C. § 30166(m)(4)(C) states: “Disclosure. None of the information collected pursuant to the final rule promulgated under paragraph

(1)[the EWR rule] shall be disclosed pursuant to section 30167(b) unless the Secretary determines the disclosure of such information will assist in carrying out sections 30117(b) and 30118 through 30121.” In a supplemental memorandum opinion filed on July 31, 2006, the Court accepted RMA's argument that it should consider the Exemption 3 claim, but held that the TREAD Act's disclosure provision was not an Exemption 3 statute. *See Public Citizen, Inc.* v. *Mineta,* 444 F. Supp. 2d 12 (D.D.C. 2006). On August 24, 2006, RMA filed a motion seeking either a judgment under Federal Rule of Civil Procedure 54(b) or certification of interlocutory appeal under 28 U.S.C. 1292(b) of the District Court's decision regarding Exemption 3. On September 5, 2006, the District Court granted RMA's motion. On September 28, 2006, RMA filed a Notice of Appeal of the Judgment of July 31, 2006 and associated orders. In light of the District Court's decisions, NHTSA is proposing a rule to address the confidentiality of EWR information through specific class determinations based on FOIA Exemptions 4 and 6. Our proposal, which sets forth determinations largely similar to our prior determinations, addresses the District Court's notice and comment concerns. II. Information Submissions Before and After the EWR Rule Became Effective A. Pre-TREAD Act Transmissions of Information to NHTSA Prior to the enactment of the TREAD Act, NHTSA received information on potential and actual safety-related defects in motor vehicles through several primary mechanisms. First, vehicle owners submitted complaints (also known as vehicle owner questionnaires (VOQs)) 9 to NHTSA's Office of Defects Investigation (ODI). These complaints tended to identify problems consumers had experienced in their vehicles. Second, manufacturers provided copies of technical service bulletins and other communications transmitted to more than one manufacturer, dealer or owner. *See* 49 U.S.C. 30166(f); 49 CFR 579.5 (2002-2005), 573.8 (1995-2001). Third, manufacturers submitted information to the agency during investigations of particular vehicles and equipment (such as tires) undertaken by ODI. Finally, manufacturers submitted reports that certain motor vehicles and equipment contained safety-related defects pursuant to 49 CFR part 573 (Defect and Non-Compliance Responsibility and Reports) after determining that such a defect exists. *See* 49 U.S.C. 30118(c). 9 *See http://www-odi.nhtsa.dot.gov/ivoq/.* On average, during the five years preceding the TREAD Act, ODI conducted approximately 83 investigations of potential safety related defects per year. On average, 64 of these were first stage investigations known as Preliminary Evaluations (PEs). The remaining ones were second-stage investigations—Engineering Analyses (EAs). During the five

(5)years following enactment of the TREAD Act, these numbers have remained roughly the same, with the agency conducting approximately 84 investigations annually (66 PEs, 28 EAs). In most of these investigations, ODI issued information requests to manufacturers. A review of the submissions received from manufacturers over a recent one-year period revealed that nearly every PE or EA submission to the agency involved a request for confidential treatment. 10 10 Out of 276 requests for confidential treatment we received from July 1, 2005 through June 30, 2006, approximately 30%

(83)involved requests related to a PE

(52)or EA (31). These numbers do not include requests related to other enforcement-related activities, such as compliance investigations or recall-related queries. B. The Early Warning Reporting Requirements The TREAD Act dramatically changed the nature and amount of information manufacturers submit to NHTSA. The EWR rule requires specified manufacturers to submit a broad array of information on each make and model of vehicle and child seat, and substantial tire line that they manufacture. The EWR requirements apply mainly to larger manufacturers of motor vehicles and tires, and all manufacturers of child restraint systems ( *see* 49 CFR part 579). In general, vehicle manufacturers who annually produce 500 or more vehicles in a category must submit quarterly reports with regard to the following categories of vehicles: light vehicles, medium-heavy vehicles and buses, trailers, and motorcycles. The reporting information required of these manufacturers is summarized below: • *Production.* These manufacturers must report the number of vehicles, child restraint systems, and tires, by make, model, and model (or production) year, during the reporting period and the prior nine model years (prior four years for child restraint systems and tires). • *Consumer complaints.* These manufacturers (other than tire manufacturers) must report the numbers of consumer complaints they receive that are related to problems with certain specified components and systems. Manufacturers of child restraint systems must report the combined number of such consumer complaints and warranty claims, as discussed below. • *Property damage.* These manufacturers (other than child restraint system manufacturers) must report the numbers of claims for property damage that are related to alleged problems with certain specified components and systems, regardless of the amount of such claims. • *Warranty claims information.* These manufacturers must report the number of warranty claims (adjustments for tire manufacturers), including extended warranty and good will, they pay that are related to problems with certain specified components and systems. As noted above, manufacturers of child restraint systems must combine these with the number of reportable consumer complaints. • *Field reports.* These manufacturers (other than tire manufacturers) must report the total number of field reports they receive from the manufacturer's employees, representatives, and dealers, and from fleets, that are related to problems with certain specified components and systems. In addition, manufacturers must provide copies of certain field reports received from their employees, representatives, and fleets, but are not required to provide copies of reports received from dealers. • *Deaths.* These manufacturers must report certain specified information about each incident involving a death that occurred in the United States that is identified in a claim (as defined) against and received by the manufacturer. They must also report information about incidents involving a death in the United States that is identified in a notice received by the manufacturer alleging or proving that the death was caused by a possible defect in the manufacturer's product. Finally, they must report on each death occurring in a foreign country that is identified in a claim against the manufacturer involving the manufacturer's product, or one that is identical or substantially similar to a product that the manufacturer has offered for sale in the United States. • *Injuries.* These manufacturers must report certain specified information about each incident involving an injury that is identified in a claim against and received by the manufacturer, or that is identified in a notice received by the manufacturer which notice alleges or proves that the injury was caused by a possible defect in the manufacturer's product. C. Manufacturer Submissions of EWR Information EWR reporting was phased-in, with the first quarterly EWR reports submitted on or about December 1, 2003. Field reports (copies of non-dealer reports) were first submitted on or about July 1, 2004. 68 FR 35145, 35148 (June 11, 2003) (specifying deadline submissions for EWR reports). Since the EWR rule's data submission requirements began in December 2003, manufacturers have submitted large amounts of information. Over 500 manufacturers have regularly submitted reports and collectively submitted thousands of reports, making the volume of the incoming data extensive. NHTSA has received reports on more than 8 million consumer complaints, 138 million warranty claims, and nearly 5 million field reports (all aggregated) from light vehicle manufacturers. Other manufacturers have also provided a large volume of aggregated data for the agency to analyze: heavy and medium bus manufacturers—over 246,000 consumer complaints, nearly 7 million warranty claims, and nearly 245,000 field reports; trailer manufacturers—nearly 66,000 consumer complaints, over 1.2 million warranty claims, and over 18,000 field reports; motorcycle manufacturers—over 35,000 consumer complaints, over 687,000 warranty claims, and over 91,000 field reports; tire manufacturers—over 1 million warranty claims; and child restraint manufacturers—nearly 43,000 warranty claims and over 7,000 field reports. III. The Proposed Rule on the Confidentiality of EWR Information A. Class Determinations Based on FOIA Exemption 4 In view of the Court's decision in *Public Citizen, Inc.* v. *Mineta,* NHTSA is initiating a new rulemaking proceeding and proposing to adopt class determinations that address the confidential treatment of certain EWR information. In general, NHTSA is proposing to adopt the class determinations promulgated in 2003 and 2004. 11 The new class determinations we are proposing for EWR data are based on FOIA Exemption 4 and would be set out in a new Appendix C to 49 CFR part 512, which would read as follows: 11 Minor changes from the 2003 rule, as amended in 2004, are reflected in this proposed new Appendix C. One change parallels proposed changes to the EWR rule involving the identification of product evaluation reports. The proposed changes to the EWR regulation were published on September 1, 2006. 71 FR 52040. Another change to Part 512 is the relocation of Appendix C's subparagraph addressing common green tires. Appendix C—Early Warning Reporting Class Determinations

(a)The Chief Counsel has determined that the following information required to be submitted to the agency under 49 CFR 579 subpart C, will cause substantial competitive harm and will impair the government's ability to obtain this information in the future if released:

(1)Reports and data relating to warranty claim information;

(2)Reports and data relating to field reports, including dealer reports, product evaluation reports, and hard copies of field reports; and

(3)Reports and data relating to consumer complaints.

(b)In addition, the Chief Counsel has determined that the following information required to be submitted to the agency under 49 CFR 579, subpart C, will cause substantial competitive harm if released:

(1)Reports of production numbers for child restraint systems, tires, and vehicles other than light vehicles, as defined in 49 CFR 579.4(c); and

(2)Lists of common green tire identifiers. 1. Basis for Exemptions Consistent with our prior approach, the agency proposes creating categories based on Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4). Under Exemption 4, the standard for assessing the confidentiality of required submissions of information is whether disclosure is likely either to cause substantial competitive harm to the originating entity or to impair the government's ability to obtain necessary information in the future. *National Parks & Conservation Ass'n* v. *Morton,* 498 F.2d 765, 770 (D.C. Cir. 1974). Meeting the competitive harm standard requires that there be “actual competition and a likelihood of substantial competitive injury” from disclosure of the information. *CNA* v. *Donovan,* 830 F.2d 1132, 1152 (D.C. Cir. 1987). Assessing the effect of disclosure under the impairment prong requires a “rough balancing” of the extent of impairment and the information's importance against the public's interest in disclosure. *Washington Post* v. *Dep't of Health and Human Services,* 690 F.2d 252, 269 (D.C. Cir. 1982). We note that motor vehicle and motor vehicle equipment manufacturers who are required to submit EWR data operate in a highly competitive business environment. *See http://stats.bls.gov/oco/cg/cgs012.htm* (generally describing the nature of the motor vehicle and parts industry). In light of the highly competitive environment in which these manufacturers operate, the comprehensive EWR data that they submit possess commercial value to the submitting manufacturers, competitors, and others such as suppliers who are interested in these types of data. These data are standardized and, as discussed above, the EWR reports contain identical informational elements for each regulated manufacturer category under the EWR rule. *See* 49 CFR part 579 subpart C. These reports are submitted pursuant to standardized electronic reporting templates that are used repeatedly from reporting period to reporting period. Each manufacturer in a regulatory category reports on the same systems and components and provides a snapshot of that manufacturer's experience for each of the standard informational elements. Further, as we explain below, under the TREAD Act, manufacturers need only produce that information which they already collect. In light of this fact, on balance, the disclosure of certain categories of EWR information (consumer complaints, warranty claims, and field reports) is more likely to cause manufacturers to scale back their collection efforts, which would impair the agency's ability to obtain EWR data in future submissions, than if the information were not disclosed. Without the collection of comprehensive data by manufacturers, the effectiveness of the EWR program would be adversely impacted. Additionally, as reflected by the number of EWR submissions when compared to the number of confidentiality requests that manufacturers submit to the agency in the course of defect investigations noted above, if NHTSA were to attempt to process individualized requests for confidentiality of individual EWR submissions, the agency would be overwhelmed. A huge backlog would develop and grow. During the time that NHTSA was processing these requests for confidentiality, nothing would be released. The situation would be similar to the substantial FOIA request backlog experienced at some agencies. Moreover, submissions would not be released until the individual processing was completed. The net effect would be to hamper agency efforts to address these claims for confidential treatment expeditiously and likely divert resources from other efforts, including pursuing other enforcement activities. The District Court recognized this possibility when it ruled that categorical rules that address the confidentiality of EWR data are necessary “to allow the agency to administer the EWR program effectively,” *Public Citizen,* 427 F. Supp. 2d at 13, and that the agency was “justified in making categorical rules to manage the tasks assigned to it by Congress under the TREAD Act.” *Id.* In the recent *Public Citizen* case, the parties submitted briefs on NHTSA's authority to issue categorical determinations. The court accepted NHTSA's position that the agency had the authority to do so. *Id.* 2. Proposed Class Determinations on the Confidentiality of EWR Data Based on NHTSA's authority, as recently confirmed in the District Court's decision, to make categorical class determinations, we are proposing to create such classes based on Exemption 4 for the EWR data categories listed below. a. Production Numbers The EWR rule requires certain manufacturers to submit the number of vehicles, tires and child restraint systems, by make, model, and model (or production) year, produced during the model year of the reporting period and the prior nine model years (prior four years for child restraint systems and tires). *See* 49 CFR 579.21-26. Production figures for models of motor vehicles, other than light vehicles, and for tires and child restraints are not publicly available. 12 As noted above, NHTSA proposes to include EWR production figures, other than for light vehicles, in a class determination of confidentiality based on the competitive harm prong of *National Parks.* EWR production data reveal a variety of valuable information, including a company's production capacity, the sales and market performance of its individual products, 13 and the success of its marketing strategies. This market-related information would be valuable to the reporting manufacturer's competitors, who commonly want to know how well products sell, including how well their competitors' products have been and are selling. The competitors would use the production information in their own product planning and marketing. For example, the release of this EWR production information would likely have the following impacts:

(1)Medium-heavy vehicle manufacturers would use a rival's production information to monitor the competitor's production capacity (which would reveal that competitor's capacity to manufacture certain products) and, separately, suppliers would use the information to gain a competitive advantage over a submitter during pricing negotiations, in instances such as when they could determine that they are the sole supplier;

(2)bus manufacturers would use production information to chart the overall market and the strengths and weaknesses of the reporting entity's business within specific makes and models;

(3)because product plans are based upon an evolution of production direction and experience, disclosure of motorcycle production information would expose manufacturers' future plans to competitors;

(4)child restraint manufacturers would use production data to assess their competitors' production capabilities, sales and market performance through means otherwise unavailable without considerable market research expense; and

(5)the disclosure of tire production numbers by brand and size would result in competitive harm to the manufacturers by revealing specific and critical information about those companies' sales and marketing strategies. We note that in the context of individual investigations, the agency has generally granted confidential treatment to production data on child restraints and tires submitted to NHTSA but released past light vehicle production numbers, which, as noted above, are generally available to the public and have generally not been granted confidential status. 12 The basis for excluding EWR production data on light vehicles (“any motor vehicle, except a bus, motorcycle, or trailer, with a gross vehicle weight rating of 10,000 lbs or less,” 49 CFR § 579.4) from the proposed class determination on confidentiality is that those data are publicly available. Information that is already publicly available cannot be withheld by an agency under Exemption 4. *Niagara Mohawk Power Corp.* v. *Dep't of Energy,* 169 F.3d 16, 19 (D.C. Cir. 1999). We note that more detailed production data on light vehicles, such as detailed production information by engine and transmission combination, is not publicly available and has been granted confidentiality. 13 *See, e.g. http://www.claritas.com/claritas/Default.jsp?ci=2&pn=cs_bmwusa.* b. Consumer Complaints The EWR rule requires larger volume vehicle manufacturers and all child restraint manufacturers to submit the number of consumer complaints received broken out, for each make and model, by specific categories such as system component, fire and rollover—all of which are binned by code. 49 CFR 579.4, 579.21-26. Consumer complaints are defined by the regulation as: [A] communication of any kind made by a consumer (or other person) to or with a manufacturer addressed to the company, an officer thereof or an entity thereof that handles consumer matters, a manufacturer Web site that receives consumer complaints, a manufacturer electronic mail system that receives such information at the corporate level, or that are otherwise received by a unit within the manufacturer that receives consumer inquiries or complaints, including telephonic complaints, expressing dissatisfaction with a product, or relating the unsatisfactory performance of a product, or any actual or potential defect in a product, or any event that allegedly was caused by any actual or potential defect in a product, but not including a claim of any kind or a notice involving a fatality or injury. 14 14 49 CFR § 579.4(c). NHTSA proposes to include EWR consumer complaint data in a class determination of confidentiality based on both the competitive harm and impairment prongs of *National Parks* . The commercial value of consumer complaint data is well-recognized. Complaint data are a valuable data source used by companies to help them identify areas of concern, including product performance, to consumers and provide guidance on where to allocate their limited resources. 15 The disclosure of EWR complaint numbers would provide competitors with aggregated data on the performance of entire product lines and key, individual systems and/or components. In view of the competitive value of these data, NHTSA has tentatively concluded that the release of EWR consumer complaint data would cause substantial harm to the competitive position of the manufacturer that collected and reported them. 15 *See e.g.* , John Goodman & Steve Newman, Six Steps to Integrating Complaint Data into QA Decisions, 36 Quality Progress, Issue 2 (Feb. 1, 2003) (stressing the importance of complaint data in helping to identify issues with products and the data's effectiveness in assisting companies with resource allocation decisions to address quality assurance issues) and Edward Bond & Ross Fink, Meeting the Customer Satisfaction Challenge, 43 Industrial Management, Issue 4 (July 1, 2001) (noting the importance of measuring customer satisfaction, describing customer complaints as a data source to a company that can create a “big benefit” from small changes, and emphasizing the need for companies to make it convenient for consumers to complain). Both articles are available in Docket No. NHTSA-2002-12150, Item No. 65. Companies may receive customer input and feedback on product performance in a variety of ways and establish differing practices for the receipt of customer complaints, which are taken into account by the definition of consumer complaint. To obtain these data, companies may, for example, increase the staff available at their toll-free telephone numbers or create web-based systems through which consumers can make complaints instantly by electronic mail. More consumer input channels increase the robustness of the available data. In addition to providing valuable information to the company, consumer complaints provide feedback on product performance that can be valuable to NHTSA in identifying problems, including potential defects that may point to the presence (or absence) of a safety problem. The agency seeks to ensure that it receives as much information as possible to identify possible defect trends. Under the early warning reporting provisions of the Safety Act, however, NHTSA may not require a manufacturer of a motor vehicle or motor vehicle equipment to maintain or submit records respecting information not in the possession of the manufacturer. 49 U.S.C. 30166(m)(4)(B). In other words, NHTSA may require manufacturers to submit reports based on information that they have collected but may not require manufacturers to collect information not otherwise collected. In view of the fact that the quantity and comprehensiveness of the EWR consumer complaint data depend in substantial part on the willingness of manufacturers to collect this information through a broad and multi-input approach, NHTSA does not want to take steps that discourage the collection efforts. NHTSA is concerned that the routine disclosure of EWR consumer complaint information would discourage these efforts, and ultimately reduce the amount of information manufacturers collect. This would impair our ability to obtain this information in the future for analysis. It would adversely impact not only the EWR program as a whole, but a reduction in complaint data would also significantly impact individual investigations in which ODI routinely considers and follows up on such data. The disclosure of these data, however, would be of limited value to the public. Complaint data frequently involves issues that are not safety-related. On balance, the importance of the information to the agency's ability to help it identify potential safety defects and the associated impairment outweigh the smaller interest in its public disclosure. Thus, the agency proposes to withhold these data under Exemption 4. c. Warranty Claims Under the EWR rule, manufacturers of more than 500 vehicles per year and tire manufacturers must report warranty claims (warranty adjustments for tire manufacturers) they paid for specified components and systems broken down by component, make, model and model year. 49 CFR 579.21-26. Repairs made outside of warranties that are covered by “good will” are also reported under warranty claims and warranty adjustments. 16 49 CFR 579.4. Manufacturers of child restraint systems must combine these data with the number of reportable consumer complaints. The warranty information is reported on a detailed make/model basis and categorized with reference to the twenty-two categories defined in the EWR regulation. 16 These data include “good will” repairs that are conducted and paid for by the manufacturer outside of the warranty. “Good will” means “the repair or replacement of a motor vehicle or item of motor vehicle equipment, including labor, paid for by the manufacturer, at least in part, when the repair or replacement is not covered under warranty, or under a safety recall reported to NHTSA under part 573 of this chapter.” 49 CFR § 579.4. NHTSA proposes to include EWR warranty data in a class determination of confidentiality based on both the competitive harm and impairment prongs of *National Parks* . Warranty claims data generally reflect a repair paid for by a manufacturer under a warranty. The commercial value of warranty complaint data is well known. Warranty data are a valuable data source used by companies in identifying problem trends early in the life of a vehicle or equipment, before the expiration of the warranty. The EWR warranty data provide comprehensive, competitively valuable information about the field experience of components and systems across all makes and models. Many components and systems are updated over time to incorporate new technologies or to achieve cost savings. They may be provided by different suppliers. The manufacturer's warranty experience with various components and systems is a valuable dataset. 17 The disclosure of EWR warranty numbers would provide competitors with aggregated data on the performance of entire product lines and key, individual systems and/or components. Competitors would use this information to assess the in-use performance of parts and systems. It would be used in purchasing, pricing, and sourcing decisions, all of which would be likely to have competitive impacts. Accordingly, NHTSA has tentatively concluded that the release of the EWR warranty data would cause substantial harm to the competitive position of the manufacturer that collected and reported them. 17 Published reports illustrate the extent to which the industry as a whole relies on and uses sensitive warranty information. For example, GM uses its warranty data to help it pinpoint problem areas and to help it reduce its warranty costs. *See, e.g.* , Gregory L. White, GM Takes Tips from CDC to Debug its Fleet of Cars, Wall St. J., April 8, 1999, at B1 (noting GM's adaptation of the epidemiological system used by the Centers for Disease Control and Prevention to warranty issues) and A Message to Dealers Regarding the Ford Recall of Firestone Wilderness AT Tires and General Motors Continued Use of Firestone Tires on its Vehicles, (May 25, 2001) (stating that GM and Firestone tire engineers “are on site at GM's tire and wheel laboratory two days a week” to “monitor tire warranty data”). Both of these documents are available in Docket No. NHTSA-2002-12150, Item No. 65. Warranties vary in length ( *e.g.* , years, miles) and scope ( *e.g.* , 3 years/36,000 miles vs. 4 years/50,000 miles). Other things being equal, we believe that companies with more generous warranty and good will programs will have a higher number of warranty claims than those with more limited policies. The more generous the warranty policies (such as longer warranty coverage), the more warranty data that will be subject to disclosure to NHTSA. Because of the data's commercial value and the manner in which they can be used, the disclosure of this information would reduce the willingness of manufacturers to maintain extensive warranty programs including extended warranties and good will, which could ultimately reduce the availability of robust warranty information in the future. ODI would have substantially less information to analyze in investigating potential defects. 18 Also consumers would receive fewer free repairs under warranty programs, which in addition to being economically disadvantageous, would in some instances adversely affect motor vehicle safety because vehicles would not be repaired. However, the EWR information would not be useful to the public in comparing vehicles or equipment because of the differences in warranty terms and corporate warranty practices—which would could cause the public to derive incorrect conclusions from the information. The rough balancing under the impairment prong weighs in favor of withholding this information, as the public interest favoring disclosure is small and the adverse effects accompanying disclosure are substantial. Thus, the agency proposes to withhold EWR warranty information under Exemption 4. 18 Manufacturers may choose to make available to their customers warranties of longer duration and broader mileage ( *e.g.* , a company may offer a 5-year/50,000 mile warranty or a 3-year/36,000 mile warranty), making more warranty claims information subject to disclosure to the agency. DaimlerChrysler, for example, lengthened its engine warranty period to gain in the competitive market. *See, e.g.* , Jeff Green, DC Emphasizes Warranty, Bloomberg, Sept. 6, 2002, available at *http://www.theautochannel.com* . Not only do warranties differ by manufacturer, they also differ based on the targeted market ( *e.g.* luxury v. non-luxury) and on system components and 2003 Manufacturers' Warranties, available at *www.enterprise.com* . Both items are docketed in Docket No. NHTSA-2002-12150, Item No. 65. d. Field Reports Field reports are communications from a manufacturer's representative or dealer about a malfunction or performance problem. 49 CFR 579.4. The EWR rule requires manufacturers of specified vehicles and child restraints to provide information on field reports and copies of non-dealer field reports. In general, as in other categories of EWR data, the field report data are provided by make, model and model year and, further, by numerous specified systems and components. 49 CFR 579.21-25. Field reports reflect the in-use experience of a manufacturer's product, collected by the company at its expense and with the intent of identifying problems with its products. The nature, quality and quantity of field reports vary, with reports from some companies reflecting their pursuit of detailed feedback, and those from others yielding less information. For others, a field report is more akin to a technical investigation into a problem detected through warranty, consumer complaint or other information available to the company. NHTSA proposes to include EWR field report information in a class determination of confidentiality based on both the competitive harm and impairment prongs of *National Parks* . Field report information would identify systems and components that have experienced malfunction or performance issues, in quantitative terms in all products. More particularly, the field reports would reveal specific problems associated with particular components and systems. Overall, the information would reveal aspects of a vehicle's performance (whether potentially safety-related or not) that a manufacturer deems important in its commercial efforts. If EWR field report information were disclosed, the reporting manufacturer's competitors would have access to comprehensive data involving malfunction or performance issues covering all products. Such information, if publicly released, would be of substantial value to competitors, who could avert similar issues or improve their products without the need to invest in market research, engineering development, or actual market experience. NHTSA has tentatively concluded that their release would cause substantial harm to the competitive position of the manufacturer that collected and reported them. Manufacturers' decisions to obtain field reports are discretionary and practices vary among manufacturers. The disclosure of field report data would discourage manufacturers from initiating field reports. This would lead to fewer and less reliable field reports available to the agency in the future to identify potential safety defects promptly. Field reports are particularly valuable in identifying areas of potential concern to manufacturers. Some of these reports have also been indicative of potential defect trends. Since the agency can require only that manufacturers submit information about, and copies of, those field reports that companies choose to prepare and/or obtain, there is a substantial risk that the agency's ability to obtain this information in the future would be impaired, which would adversely affect the program's effectiveness. *See* 49 U.S.C. 30166(m)(4)(B). By contrast, the value of these data would be limited to the public. The technical data and reports of the number of field reports would not readily identify safety-related issues. As such, the agency does not believe that these data and numbers would contain information that would be informative to the public with regard to vehicle safety. In balancing the interests in disclosure, the agency has tentatively concluded that the impacts to the agency's ability to identify safety defects from these technically-rich reports—as well as the competitive impacts to submitters—outweigh the interest the public has in disclosure of this information. Consequently, the agency proposes to withhold this information under Exemption 4. e. Common Green Tire Identifiers The EWR rule requires certain tire manufacturers to provide a list of common green tire data. 49 CFR § 579.26(d). “Common greens” are tires “that are produced to the same internal specifications but that have, or may have, different external characteristics and may be sold under different tire line names.” 49 CFR 579.4(c). NHTSA proposes to include EWR common green tire data in a class determination of confidentiality based on the competitive harm prong of *National Parks* . The common green tire information reveals the identities of tires that share the same internal specifications and relationships between manufacturers and private brand name owners. Tire manufacturers previously indicated that these data are particularly valuable because they permit competitors to assess individual manufacturer capabilities and marketing strategies. 69 FR at 21417. f. Other Issues To Be Considered In addition to comments on the above, we seek comments on the proposed approach. This includes whether the proposed categories for certain EWR data ( *i.e.* , those data covering non-light vehicle production, consumer complaints, warranty claims, field reports, and common green tires) should be held confidential by class determinations based on Exemption 4. For example, we invite commenters to provide information relating to whether the release of this information would provide competitors with valuable information relating to the business of the reporting entity, such as marketing, performance problems and/or costs, to the extent that the disclosure would cause or be likely to cause the data submitter substantial competitive harm. We are also interested in whether the disclosure of the information covered by our proposed classes would significantly discourage manufacturers from continuing to obtain and manage this information as they do now. Commenters may also address different approaches. We invite comments that address the practical concerns of such potential approaches. For example, if NHTSA were to adopt presumptive class determinations for each of the EWR data categories, what are the relative merits of each proposed class within the context of the large volume of information generated by EWR requirements, and the manner in which the agency can address the confidentiality of these materials in an efficient and consistent manner. 19 19 “Binding” determinations would alleviate the need for submitters to provide a formal written request for confidentiality and supporting justification, whereas “presumptive” determinations would require submitters to provide a written request and supporting justification pursuant to 49 CFR Part 512. Commenters should also, where appropriate, indicate and demonstrate how the restrictions imposed by Congress in 49 U.S.C. 30166(m)(4)(B) would affect the agency's ability to continue collecting EWR data if they are subject to routine disclosure. Supporting facts in favor or against each class should be included as appropriate. B. EWR Class Determination Based on FOIA Exemption 6 NHTSA receives VIN information under the EWR rule in reports on incidents involving deaths and injuries. *See e.g.* 49 CFR 579.21(b)(2). NHTSA is proposing to create a class determination that would apply to the last six

(6)characters of the unique seventeen

(17)character vehicle identification number

(VIN)contained in EWR death and injury reports. This proposal is grounded on Exemption 6 of the FOIA, which protects information that would result in a clearly unwarranted invasion of privacy if disclosed. *See* 5 U.S.C. 552(b)(6). *See also Center for Auto Safety* v. *NHTSA* , 809 F. Supp. 148 (D.D.C. 1993). Factually, this proposed exemption is based on the risk that the disclosure of a full VIN could enable an individual to discern personal information involving a vehicle owner that could result in an unwarranted invasion of his or her privacy. With respect to EWR submissions, NHTSA had previously issued a determination that the last six

(6)characters in the seventeen-character VIN should be protected, as a class, from public disclosure under FOIA Exemption 6, 5 U.S.C. 552(b)(6). 69 FR at 21416. When coupled with publicly-available data bases, the disclosure of a complete VIN can lead to the discovery of personal information (e.g., name and address) about the owner of a vehicle associated with a death or injury. 20 The first 11 characters of the VIN reveal the make, model, model year, and engine of the vehicle, but the last six identify the specific vehicle. We are concerned that release of VINs where there has been a death or an injury reported under the EWR program would result in communications and inquiries from third parties that would invade personal privacy. 20 NHTSA has previously documented that full VINs can be used to ascertain personal information on individual vehicle owners. *See* Docket No. NHTSA-2002-12150, Item No. 64 (listing various publicly available Web sites by which VIN information can be used to reveal personal information). Since the public can still determine a vehicle's make and model using the first 11 characters of the VIN, which would be released, members of the public with an interest in motor vehicle safety can still ascertain whether a particular type of vehicle may be involved in a potential vehicle safety issue. As discussed above, however, the revelation of the complete VIN is accompanied by the risk of an invasion of privacy. On balance, the agency tentatively believes that that interest in protecting the risk of invading individuals' privacy outweighs the public's interest in this information and the agency has tentatively concluded that this information merits withholding under FOIA Exemption 6. 21 21 *See generally Horowitz* v. *Peace Corps* , 428 F.3d 271, 278-79 (D.C. Cir. 2005) (discussing balancing required under Exemption 6 and indicating that “seemingly innocuous information” can be subject to the Exemption's protection). This new class determination would be set out in a new Appendix D, which would read as follows: Appendix D—Vehicle Identification Number Information The Chief Counsel has determined that the disclosure of the last six

(6)characters, when disclosed along with the first eleven

(11)characters, of vehicle identification numbers reported in information on incidents involving death or injury pursuant to the early warning information requirements of 49 CFR Part 579 will constitute a clearly unwarranted invasion of personal privacy within the meaning of 5 U.S.C. 552(b)(6). This proposal would apply as a rule to only those VINs that are provided in EWR submissions and would not apply as a rule to the agency's treatment of VINs in other instances. We seek comment on the appropriateness of our proposal, as well as variations on this proposal related to the confidentiality of all or parts of VINs. IV. Exemption 3 In its comments in the course of the earlier EWR CBI rulemaking, and the memoranda it filed with the District Court in the *Public Citizen* case, the RMA asserted that Exemption 3 of the FOIA covered all EWR submissions, including requests for the confidentiality of EWR information not within the scope of Appendix C to Part 512 as promulgated in 2003 and amended in 2004 and individual requests for confidentiality. The District Court rejected the contention that Exemption 3 applies to the EWR data, concluding that the disclosure provision affecting EWR data, 49 U.S.C. 30166(m)(4)(C), 22 did not qualify as an Exemption 3 statute because the provision does not prescribe a formula to enable the agency to determine precisely whether the disclosure of the data would be helpful in carrying out the recall notification and remedy provisions of the Safety Act. It also noted that the provision did not refer to particular matters that must be withheld. *See Public Citizen* , 444 F. Supp. 2d at 12. 22 The provision, 49 U.S.C. § 30166(m)(4)(C), provides as follows: *Disclosure.* None of the information collected pursuant to the final rule promulgated under paragraph

(1)[i.e. early warning reporting rule] shall be disclosed pursuant to section 30167(b) unless the Secretary determines the disclosure of such information will assist in carrying out sections 30117(b) and 30118 through 30121. RMA filed a notice of appeal of the District Court's Judgment. The contention that NHTSA is precluded by statute from releasing the early warning data is within the scope of this notice. Should the Court of Appeals reverse the District Court on this issue and decide that Exemption 3 does apply to EWR data, the agency may proceed to issue a final rule exempting EWR data from disclosure in a manner consistent with the Court of Appeal's decision or terminate the EWR Appendix C portion of this rulemaking as unnecessary. V. Other EWR Data We are not proposing to include property damage claims and notices of death, personal injury or property damage as part of our class determinations based on Exemption 4. These items involve a collection of information, many pieces of which are publicly available. In the particular circumstances of these data, we do not believe that the disclosure of this collected information would likely provide information that would be used competitively and result in substantial competitive harm. These kinds of claims tend to be more historical, rather than predictive, when compared to the other types of information required by the EWR regulation, with any apparent trends arising over longer periods of time. We consider it unlikely that information about claims of death, personal injury or property damage will be valuable to competitors such as in cross-company comparisons. We note also that manufacturers receive claims based on incidents occurring in the field, not as the result of proactive efforts to obtain data or customer feedback. They are required under 49 CFR Part 576 to retain this information and do not have the option to refuse to amass it. Therefore, other than within the context of the Exemption 3 discussion above and except to the extent that the EWR submissions contain personal information covered by Exemption 6, these data categories lie outside the scope of this rulemaking. VI. Identifying Confidential Information Located in Electronic Files We are also proposing to clarify NHTSA's Confidential Business Information rule, 49 CFR 512.6, regarding data claimed as confidential that are submitted in electronic form. The current regulation states requirements for paper submissions. *See* 49 CFR 512.6(a), (b)(1) and (2); *see also* 49 CFR § 512.8. It then states that if submitted in electronic format, a comparable method to of identifying the information claimed to be confidential may be used. If submitted on CD-ROM or other format, the item containing the information shall be labeled as containing confidential information. 49 CFR 512.6(c). Some CD-ROMs that are submitted to us are not labeled or indelibly marked as confidential on the disk itself. We propose to require that the medium (e.g., the disk itself and not the plastic enclosure for the disk) be permanently labeled with the submitter's name, the subject of the information and the word “Confidential.” This is already the routine practice with some manufacturers. In addition, during our reviews of claims for confidential treatment, we often find that CD-ROMs do not properly designate the information that the submitters claim to be confidential. More particularly, individual files submitted electronically (e.g., pdf format) on CD-ROMs often contain documents in which each page claimed to be confidential is not labeled as confidential. Also, while a page may contain some information that is not confidential (e.g., identical information is publicly available) and some information that is within the claim for confidentiality under section 512.8, the submitter does not enclose each item of information that is claimed to be confidential within brackets. Today's proposal would require that the CD-ROM be marked permanently as confidential and that each page that contains confidential material be so marked. Also, the proposal would require that where only part of the information is within the scope of the claim, that part of the information be separately enclosed within brackets. Our proposed clarification seeks to minimize inadvertent disclosure of materials that are subject to a claim of confidentiality and eliminate any ambiguity on the scope of the claim in our review of these types of submitted documents. During our reviews of claims for confidential treatment, we also find that files within CD-ROMs do not contain page numbers. Electronic submissions sometimes contain large numbers of files and folders. Not infrequently, these files contain numerous pages. When we deny a request for confidentiality for a particular page, we need to identify it with particularity. Individual pages within individual electronic files that lack page numbers ordinarily cannot be readily identified. In these instances, there are substantial implementation problems in identifying what page(s) are within the scope of the agency's grant of a request for confidentiality and what page(s) that are within the scope of the agency's denial. To eliminate these problems, we are proposing to add a provision requiring the inclusion of a sequential numeric or alpha-numeric system that would identify each page contained in an electronic submission. This may be added to the pages before they are scanned or in the course of the preparation of the CD-ROM. We note that the courts require page numbers in appendices. *See e.g.* , Federal Rule of Appellate Procedure 30. The proposal also provides that electronic media may be submitted only in commonly available and used formats. This would include formats such as pdf, Word documents and Excel spreadsheets. From time-to-time, manufacturers submit information in proprietary or uncommon data bases. We have been unable to open and review these items and accordingly have denied the associated requests for confidentiality. Finally, we would clarify that requests for confidential treatment for information submitted to the agency must provide the information claimed as confidential in a physical medium such as a CD-ROM. There have been occasions where manufacturers have attempted to submit information claimed as confidential via e-mail. Not only was this not allowed under the existing regulations, but tracking requests for confidential treatment submitted in this manner is very difficult and far more prone to error than a physical submission. This affects the agency's ability to provide timely responses to these requests and the Chief Counsel's office's ability to transmit the information to the relevant office within NHTSA. In addition, the Department of Transportation limits the overall amount of e-mail information that an individual may maintain, and this presents problems. It also creates storage issues. To ensure our ability to properly track and handle this information, our proposal would require that the information be placed on appropriate physical media, such as CDs, when requesting confidential treatment. These changes would be included in a new § 512.6(c) which would replace § 512.6(b)(3). The proposed § 512.6(c) would read as follows:

(c)Submissions in electronic format

(1)Persons submitting information under this Part may submit the information in electronic format. Except for early warning reporting data submitted to the agency under 49 CFR part 579, the information shall be submitted in a physical medium such as a CD-ROM. The exterior of the medium (e.g., the disk itself) shall be permanently labeled with the submitter's name, the subject of the information and the word “CONFIDENTIAL”.

(2)Pages and materials claimed to be confidential must be designated as provided in paragraphs (b)(1) and (b)(2) of this section. Files and materials that cannot be marked internally, such as video clips or executable files, shall be renamed prior to submission so the characters “Conf” or the word “Confidential” appear in the file name.

(3)Each page within an electronic file that is submitted for confidential treatment must be individually numbered in the order presented with a sequential numeric or alpha-numeric system that separately identifies each page contained in that submission.

(4)Electronic media may be submitted only in commonly available and used formats. VII. Request for Comments How Do I Prepare and Submit Comments? Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments. Your comments must not be more than 15 pages long (49 CFR 553.21). We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments. Please submit two copies of your comments, including the attachments, to Docket Management at the beginning of this document, under ADDRESSES . You may also submit your comments electronically to the docket following the steps outlined under ADDRESSES . How Can I Be Sure That My Comments Were Received? If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail. How Do I Submit Confidential Business Information? If you wish to submit any information under a claim of confidentiality, you should submit the following to the Chief Counsel (NCC-110) at the address given at the beginning of this document under the heading FOR FURTHER INFORMATION CONTACT :

(1)A complete copy of the submission;

(2)a redacted copy of the submission with the confidential information removed; and

(3)either a second complete copy or those portions of the submission containing the material for which confidential treatment is claimed and any additional information that you deem important to the Chief Counsel's consideration of your confidentiality claim. A request for confidential treatment that complies with 49 CFR part 512 must accompany the complete submission provided to the Chief Counsel. For further information, submitters who plan to request confidential treatment for any portion of their submissions are advised to review 49 CFR part 512, particularly those sections relating to document submission requirements. Failure to adhere to the requirements of part 512 may result in the release of confidential information to the public docket. In addition, you should submit two copies from which you have deleted the claimed confidential business information, to Docket Management at the address given at the beginning of this document under ADDRESSES . Will the Agency Consider Late Comments? We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated at the beginning of this notice under DATES . In accordance with our policies, to the extent possible, we will also consider comments that Docket Management receives after the specified comment closing date. If Docket Management receives a comment too late for us to consider in developing the proposed rule, we will consider that comment as an informal suggestion for future rulemaking action. How Can I Read the Comments Submitted by Other People? You may read the comments received by Docket Management at the address and times given near the beginning of this document under ADDRESSES . You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:

(1)Go to the Docket Management System

(DMS)Web page of the Department of Transportation ( *http://dms.dot.gov/* ).

(2)On that page, click on “search.”

(3)On the next page ( *http://dms.dot.gov/search/* ), type in the four-digit docket number shown at the heading of this document. Example: if the docket number were “NHTSA-2001-1234,” you would type “1234.”

(4)After typing the docket number, click on “search.”

(5)The next page contains docket summary information for the docket you selected. Click on the comments you wish to see. You may download the comments. The comments are imaged documents, in either TIFF or PDF format. Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically search the Docket for new material. VIII. Privacy Act Statement Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477) or you may visit *http://dms.dot.gov.* IX. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735 (Oct. 4, 1993)), provides for making determinations whether a regulatory action is “significant” and therefore subject to review by the Office of Management and Budget

(OMB)and to the requirements of the Executive Order. The Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities;

(2)Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3)Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4)Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. NHTSA has considered the impact of this rulemaking action under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures (44 FR 11034 (Feb. 26, 1979)). This rulemaking action is not significant under E.O. 12866, “Regulatory Planning and Review” or the Department's regulatory policies and procedures. There are no new significant burdens on information submitters or related costs that would require the development of a full cost/benefit evaluation. As indicated in the preamble, this document proposes primarily to remedy a technical deficiency identified by a Federal court and does not raise any new legal or policy issues. This proposed rule does not present novel policy issues. Instead, it involves issues that have been subject to past notice and comment and have also been previously addressed in prior court proceedings. B. Regulatory Flexibility Act We have considered the effects of this rulemaking action under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) This proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would impose no additional reporting obligations on small entities beyond those otherwise required by the Safety Act and the early warning reporting regulation. This proposed rule addresses the agency's treatment of early warning reporting data and would clarify procedures for all submitters, including small entities, with regard to confidentiality. The rule would protect certain categories of early warning reporting information from disclosure. In addition, small entities, which generally submit items in hard copy format, are expected to and may continue to do so. Those wishing to submit information in electronic format would be able to do so using the procedures that we are clarifying in this proposal. Therefore, a regulatory flexibility analysis is not required for this proposed action. C. National Environmental Policy Act NHTSA has analyzed this proposed rule for the purposes of the National Environmental Policy Act and determined that it will not have any significant impact on the quality of the human environment. D. Executive Order 13132 (Federalism) NHTSA has examined today's proposed rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999). This action would not have “federalism implications” because it would not have “substantial direct effects on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government,” as specified in section 1 of the Executive Order. E. Unfunded Mandate Reform Act The Unfunded Mandate Reform Act of 1995 requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). This proposal would not result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. F. Executive Order 12988 (Civil Justice Reform) With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729, February 7, 1996) requires that Executive agencies make every reasonable effort to ensure that the regulation:

(1)Clearly specifies the preemptive effect, if any;

(2)clearly specifies any effect on existing Federal law or regulation;

(3)provides a clear legal standard for affected conduct while promoting simplification and burden reduction;

(4)specifies the retroactive effect, if any;

(5)adequately defines key terms; and

(6)addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement. NHTSA notes that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court. G. Paperwork Reduction Act The existing requirements of Part 512 are considered to be information collection requirements as that term is defined by the Office of Budget and Management

(OMB)in 5 CFR part 1320. Accordingly, the existing part 512 regulation was submitted to and approved by OMB pursuant to the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ). At the time that we submitted the prior requirements of part 512, these requirements were approved through January 31, 2008. This proposal does not revise the existing currently approved information collection under part 512. Instead, the proposal contains the same requirements as before and only clarifies procedures as to electronically-submitted items to the agency for which confidentiality is sought. It does not require electronic submissions. H. Executive Order 13045 Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that:

(1)Is determined to be “economically significant” as defined under E.O. 12866, and

(2)concerns an environmental, health or safety risk that NHTSA has reason to believe may have a disproportionate effect on children. This proposed action does not meet either of these criteria. I. Regulation Identifier Number

(RIN)The Department of Transportation assigns a regulation identifier number

(RIN)to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda. List of Subjects in 49 CFR Part 512 Administrative procedure and practice, Confidential business information, Freedom of information, Motor vehicle safety, Reporting and record keeping requirements. In consideration of the foregoing, the National Highway Traffic Safety Administration proposes to amend 49 CFR Chapter V, Code of Federal Regulations, by amending part 512 as set forth below. PART 512—CONFIDENTIAL BUSINESS INFORMATION 1. The authority citation for part 512 continues to read as follows: Authority: 49 U.S.C. 322; 5 U.S.C. 552; 49 U.S.C. 30166, 49 U.S.C. 30167; 49 U.S.C. 32307; 49 U.S.C. 32505; 49 U.S.C. 32708; 49 U.S.C. 32910; 49 U.S.C. 33116; delegation of authority at 49 CFR 1.50. 2. Section 512.6 is amended by removing paragraph (b)(3) and adding a new paragraph

(c)to read as follows: § 512.6 How should I prepare documents when submitting a claim for confidentiality?

(c)*Submissions in electronic format.*

(1)Persons submitting information under this Part may submit the information in electronic format. Except for early warning reporting data submitted to the agency under 49 CFR part 579, the information shall be submitted in a physical medium such as a CD-ROM. The exterior of the medium ( *e.g.* , the disk itself) shall be permanently labeled with the submitter's name, the subject of the information and the word “Confidential”.

(4)Electronic media may be submitted only in commonly available and used formats. 3. Appendix C to part 512 is revised to read as follows: Appendix C to Part 512—Early Warning Reporting Class Determinations

(a)The Chief Counsel has determined that the following information required to be submitted to the agency under 49 CFR part 579, subpart C, will cause substantial competitive harm and will impair the government's ability to obtain this information in the future if released:

(1)Reports and data relating to warranty claim information;

(2)Reports and data relating to field reports, including dealer reports, product evaluation reports, and hard copies of field reports; and

(3)Reports and data relating to consumer complaints.

(1)Reports of production numbers for child restraint systems, tires, and vehicles other than light vehicles, as defined in 49 CFR § 579.4(c); and

(2)Lists of common green tire identifiers. 4. Appendix D to part 512 is redesignated as Appendix E to part 512 and a new Appendix D to part 512 is added to read as follows: Appendix D to Part 512—Vehicle Identification Number Information The Chief Counsel has determined that the disclosure of the last six

(6)characters, when disclosed along with the first eleven

(FMPs)under their purview. The omnibus amendment would establish standardized bycatch reporting methodology

(SBRM)for each FMP, as required under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). DATES: The public hearings will be on November 14, 2006, in Gloucester, MA, and December 12, 2006, in New York City, NY. Written comments must be received at the appropriate address, e-mail address, or fax number (see ADDRESSES ) by 5 p.m., local time, on December 29, 2006. ADDRESSES: NMFS and the Councils will accept comments at two public hearings. For specific locations, see SUPPLEMENTARY INFORMATION . You may submit comments on the draft amendment by any of the following methods: • E-mail: *SBRMcomment@noaa.gov* • Through the Federal eRulemaking portal: *http://www.regulations.gov* . Reference I.D. 102006A. • Mail: Patricia A. Kurkul, Regional Administrator, NOAA Fisheries Service, Northeast Regional Office, 1 Blackburn Drive, Gloucester MA 01930. Mark the outside of the envelope: “Comments on SBRM Amendment.” • Fax:

(978)281-9135, Attention: Patricia A. Kurkul. Copies of the draft SBRM amendment and the public hearing document may be obtained by contacting the NMFS Northeast Regional Office at the above address. The documents are also available via the internet at: *http://www.nero.noaa.gov/nero/regs/com.html* . FOR FURTHER INFORMATION CONTACT: Michael Pentony, Senior Fishery Policy Analyst,

(978)281-6283. SUPPLEMENTARY INFORMATION: Section 303(a)(11) of the Magnuson-Stevens Act requires each FMP to include provisions establishing “a standardized reporting methodology to assess the amount and type of bycatch occurring in the fishery.” The Councils and NMFS are considering an omnibus amendment to establish an SBRM or modify existing SBRMs under every Northeast Region FMP. The purpose of the amendment is to explain the methods and processes by which bycatch is currently monitored and assessed for Northeast Region fisheries, to determine whether these methods and processes need to be modified and/or supplemented, to establish standards of precision for bycatch estimation for all Northeast Region fisheries and, thereby, to document the SBRM established for all fisheries managed through the FMPs of the Northeast Region. The scope of the omnibus amendment is limited to those fisheries prosecuted in the Federal waters of the Northeast Region and managed through an FMP developed by either the Mid-Atlantic or New England Council. Alternatives under consideration in the omnibus SBRM amendment address bycatch reporting and monitoring mechanisms, analytical techniques and allocation of at-sea fishery observers, establishment of a target level for precision of bycatch estimates, and requirements for reviewing and reporting on the efficacy of the SBRM. NMFS and the Councils will consider all comments received on the draft SBRM amendment and the alternatives for incorporation into the final document until the end of the comment period on December 29, 2006. The public will have several additional opportunities to comment on the SBRM. The final amendment will be considered for approval by the Councils at public meetings in February of 2007. Once submitted to NMFS, the final SBRM Amendment will be made available for public review and comment, and regulations will be proposed for review and comment in March 2007. Meeting Dates, Times, and Locations The public hearings have been scheduled to coincide with the date and location of New England and Mid-Atlantic Fishery Management Council meetings. Tuesday, November 14, 2006, at 5:30 p.m. - Tavern on the Harbor, 30 Western Ave., Gloucester, MA 01930, telephone:

(978)283-4200. Tuesday, December 12, 2006, at 7 p.m. - Skyline Hotel, 725 10th Ave, New York, NY 10019, telephone:

(212)586-3400. Special Accommodations These hearings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids at the Gloucester, MA, meeting should be directed to Paul J. Howard, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. Requests for such services at the New York, NY, meeting should be directed to M. Jan Saunders,

(302)674 2331 extension 18. Requests for accessibility accommodations must be received at least at least 5 days prior to the meeting dates. Authority: 16 U.S.C. 1801 *et seq.* Dated: October 25, 2006. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. E6-18286 Filed 10-30-06; 8:45 am] BILLING CODE 3510-22-S 71 210 Tuesday, October 31, 2006 Notices DEPARTMENT OF AGRICULTURE Forest Service Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of Meeting. SUMMARY: The Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee meeting that had been set for November 8, 2006 has been cancelled. The new date that the Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee will meet is Tuesday, December 12, 2006 at the Okanogan and Wenatchee National Forests Headquarters office, 215 Melody Lane, Wenatchee, WA. This meeting will begin at 9:30 a.m. and continue until 4 p.m. During this meeting Provincial Advisory Committee members will continue the collaboration process on forest plan issues relating to the preparation of a revised forest plan for the Okanogan and Wenatchee National Forests. All Eastern Washington Cascades and Yakima Province Advisory Committee meetings are open to the public. FOR FURTHER INFORMATION CONTACT: Direct questions regarding this meeting to Paul Hart, Designated Federal Official, USDA, Wenatchee National Forest, 215 Melody Lane, Wenatchee, Washington 98801, 509-664-9200. Dated: October 25, 2006. Paul Hart, Designated Federal Official, Okanogan and Wenatchee National Forests. [FR Doc. 06-8976 Filed 10-30-06; 8:45 am]

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