At the Board meeting scheduled on Wednesday, January 13, the Access Board will consider the following agenda items:

• Approval of the draft September 11, 2009 meeting minutes.

• Budget Committee Report.

• Planning and Evaluation Committee Report.

• Technical Programs Committee Report.

• Committee of the Whole Report.

• Ad Hoc Committee Reports.

• Executive Director's Report.

• ADA and ABA Guidelines; Federal Agency Updates.

All meetings are accessible to persons with disabilities. An assistive listening system, computer assisted real-time transcription (CART), and sign language interpreters will be available at the Board meeting. Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see http://www.access-board.gov/about/policies/fragrance.htm for more information).

HOPE provides for duty-free treatment for certain apparel articles imported directly from Haiti. Section 213A (b)(1)(B) of HOPE outlines the requirements for certain apparel articles to qualify for duty-free treatment under a “value-added” program. In order to qualify for duty-free treatment, apparel articles must be wholly assembled, or knit-to-shape, in Haiti from any combination of fabrics, fabric components, components knit-to-shape, and yarns, as long as the sum of the cost or value of materials produced in Haiti or one or more countries, as described in HOPE, or any combination thereof, plus the direct costs of processing operations performed in Haiti or one or more countries, as described in HOPE, or any combination thereof, is not less than an applicable percentage of the declared customs value of such apparel articles. For the period December 20, 2009 through December 19, 2010, the applicable percentage is 55 percent.

For every twelve month period following the effective date of HOPE, duty-free treatment under the value-added program is subject to a quantitative limitation. HOPE provides that the quantitative limitation will be recalculated for each subsequent 12-month period. Section 213A (b)(1)(C) of HOPE, as amended by HOPE II, requires that, for the twelve-month period beginning on December 20, 2009, the quantitative limitation for qualifying apparel imported from Haiti under the value-added program will be an amount equivalent to 1.25 percent of the aggregate square meter equivalent of all apparel articles imported into the United States in the most recent 12-month period for which data are available.

For purposes of this notice, the most recent 12-month period for which data are available as of December 20, 2009 is the 12-month period ending on October 31, 2009. Therefore, for the one-year period beginning on December 20, 2009 and extending through December 19, 2010, the quantity of imports eligible for preferential treatment under the value-added program is 284,904,116 square meters equivalent. Apparel articles entered in excess of these quantities will be subject to otherwise applicable tariffs.

These quantities are calculated using the aggregate square meters equivalent of all apparel articles imported into the United States, derived from the set of Harmonized System lines listed in the Annex to the World Trade Organization Agreement on Textiles and Clothing (“ATC”), and the conversion factors for units of measure into square meter equivalents used by the United States in implementing the ATC.

In accordance with sections 751(h) and 777(i)(1) of the Tariff Act of 1930, as amended, (“Act”), on November 10, 2009, the Department of Commerce (“Department”) published1 the final results of the administrative review of the antidumping duty order on certain activated carbon from the People's Republic of China (“PRC”) covering the period October 11, 2006, through March 31, 2008. See First Administrative Review of Certain Activated Carbon from the People's Republic of China: Final Results of Antidumping Duty Administrative Review, 74 FR 57995 (November 10, 2009) (“Final Results”).

On November 12, 2009, Petitioner Norit Americas, voluntary respondent Ningxia Guanghua Activated Carbon Co., Ltd. (“Cherishmet”),2 mandatory respondent Jacobi,3 importer Albemarle,4 and separate rate company Hebei Foreign Trade & Advertising Corp. (“Hebei Foreign”) filed timely ministerial allegations pursuant to 19 CFR 351.224(c)(1) that the Department made various ministerial errors in the Final Results and requested, pursuant to 19 CFR 351.224, that the Department correct the alleged ministerial errors in the Final Results and the “Administrative Review of Certain Activated Carbon from the People's Republic of China: Issues and Decisions Memorandum for the Final Results,” dated November 10, 2009 (“Decision Memo”). On November 17, 2009, Petitioners5 filed timely rebuttal comments with respect to certain ministerial errors alleged by Cherishmet and Hebei Foreign. No other party in this proceeding submitted ministerial error comments or rebuttals on the Department's Final Results.

A ministerial error is defined as “an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which the {Secretary} considers ministerial.” See section 751(h) of the Act; see also 19 CFR 351.224(f).

After analyzing all interested party comments and rebuttals, we have determined, in accordance with section 751(h) of the Act and 19 CFR 351.224(e), that we made certain ministerial errors in the Final Results. With regard to Jacobi, Calgon Carbon (Tianjin) Co., Ltd. (“CCT”), and Cherishmet, we transposed digits in the surrogate value for bituminous coal used in valuing coking coal. With regard to Cherishmet, the Department made ministerial errors pertaining to the calculation of international freight and copying of surrogate values. For a detailed discussion of these ministerial errors, as well as the Department's analysis of these errors and other allegations raised, see Memorandum to James C. Doyle, Director, Office 9, through Catherine Bertrand, Program Manager, Office 9, from Robert Palmer, Case Analyst, Office 9: Certain Activated Carbon From the People's Republic of China: Allegation of Ministerial Errors in the Final Results of the First Administrative Review, (December 3, 2009) (“Ministerial Error Memo”).

Additionally, in the Final Results, we determined that several companies qualified for a separate rate. See Final Results, 74 FR at 57998. The separate rate was based on the calculated margins for CCT and Jacobi, the two mandatory respondents in this review. The margins for CCT and Jacobi changed following the correction of the ministerial errors and subsequent revisions made to the Final Results. Accordingly, the Department revised the calculated all others rate for the companies that qualified for a separate rate. We note that the errors did not affect the PRC-wide entity rate, and thus that rate will not be revised. Additionally, the margin for Cherishmet, the voluntary respondent, changed following the revisions made to the Final Results.

Therefore, in accordance with section 751(h) of the Act, we are amending the Final Results in the antidumping duty administrative review of certain activated carbon from the PRC.

After correcting these ministerial errors, the final weight-averaged dumping margins results are as follows:

The Department will determine, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries based on the amended final results. For details on the assessment of antidumping duties on all appropriate entries, see Final Results. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after the date of publication of the amended final results of the administrative review.

The following deposit rates will be effective retroactively on any entries made on or after November 10, 2009, the date of publication of the Final Results, for all shipments of certain activated carbon from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be established in these amended final results of review (except, if the rate is zero or de minimis, i.e., less than 0.5 percent, a zero cash deposit rate will be required for that company); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 228.11 percent; and (4) for all non-PRC exporters of the subject merchandise which have not received their own rate, the cash deposit rate will be at the rate applicable to the PRC exporters that supplied that non-PRC exporter. The deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the review period. Pursuant to 19 CFR 351.402(f)(3), failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO as explained in the administrative protective order itself. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

We are issuing and publishing these results and notice in accordance with sections 751(a)(1), 751(h) and 777(i)(1) of the Act.

On August 7, 2008, the Department of Commerce (the “Department”) published in the Federal Register the antidumping duty order on laminated woven sacks (“LWS”) from the People's Republic of China (“PRC”). See Notice of Antidumping Duty Order: Laminated Woven Sacks From the People's Republic of China, 73 FR 45941 (August 7, 2008) (“LWS Order”). On August 3, 2009, the Department published a notice of opportunity to request an administrative review of the LWS Order. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review, 74 FR 38397 (August 3, 2009).

The Department received a timely request for an administrative review of the LWS Order from Zibo Aifudi Plastic Packaging Co., Ltd. (“Zibo Aifudi”) and Changshu Xinsheng Bags Producing Company, Ltd. (“Changshu Xinsheng Bags”) on August 26, 2009 and August 31, 2009, respectively, in accordance with section 751(a) of Tariff Act of 1930, as amended (the “Act”). On September 22, 2009, the Department published in the Federal Register a notice of the initiation of an administrative review of the LWS Order. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part, 74 FR 48224 (September 22, 2009) (“Initiation Notice”). The review was initiated with respect to both companies and covers the period from January 31, 2008, through July 31, 2009. On November 6, 2009, Changshu Xinsheng Bags submitted to the Department a timely letter requesting a withdrawal from the ongoing administrative review.

Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. Because Changshu Xinsheng Bags withdrew its request for an administrative review within 90 days of the date of publication of the notice of initiation, and no other interested party requested a review of this company, the Department is rescinding this review with respect to Changshu Xinsheng Bags, in accordance with 19 CFR 351.213(d)(1). The review will continue with respect to Zibo Aifudi which is identified in the Initiation Notice.

The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries. Since the company for which this review has been rescinded does not have a separate rate at this time, the Department will issue assessment instructions for this company upon completion of the instant administrative review.

This notice serves as a final reminder to importers whose entries will be liquidated as a result of this rescission notice, of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's assumption that reimbursement of antidumping duties occurred and subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to APOs of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This notice is issued and published in accordance with section 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

On August 18, 2009, the Department of Commerce (the Department) initiated the antidumping investigations of Certain Magnesia Carbon Bricks from the People's Republic of China and Mexico. See Certain Magnesia Carbon Bricks from the People's Republic of China and Mexico: Initiation of Antidumping Duty Investigations, 74 FR 42852 (August 25, 2009).

The notice of initiation stated that unless postponed the Department would issue the preliminary determinations for these investigations no later than 140 days after the date of initiation, in accordance with section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act). The preliminary determinations are currently due no later than January 5, 2010.

On December 8, 2009, the petitioner, Resco Products Inc., made a timely request pursuant to section 733(c)(1)(A) of the Act and 19 CFR 351.205(e) for a 50-day postponement of the preliminary determinations. The petitioner requested postponement of the preliminary determinations in order to ensure that the Department has ample time to thoroughly analyze the complex issues involved in these investigations.

Because there are no compelling reasons to deny the request, the Department is postponing the deadline for the preliminary determinations pursuant to section 733(c)(1)(A) of the Act to February 24, 2010, the 190th day from the date of initiation. The deadline for the final determinations will continue to be 75 days after the date of the preliminary determinations, unless postponed.

This notice is issued and published pursuant to sections 733(c)(2) of the Act and 19 CFR 351.205(f)(1).

Since October of 2000, the USPTO has been providing users of the USPTO electronic systems with PKI certificates free of charge to pro se inventors, registered patent practitioners and limited recognition practitioners who signed an agreement with the USPTO and have been approved for use of the systems. A PKI certificate holder enjoys many benefits including having the ability to file patent applications and follow-on documents in applications electronically via EFS-Web as a registered user, and retrieving e-Office actions and checking the status of an application electronically via Private PAIR. The USPTO published a notice on the Legal Framework for EFS-Web to set forth the current policy and procedure for using EFS-Web and to permit a holder of a PKI certificate to designate a single employee of the holder's organization, or a single employee of a contractor, who may use the PKI certificate under the direction and control of the holder. See Legal Framework for Electronic Filing System-Web (EFS-Web), 74 FR 55200 (October 27, 2009) (notice). The USPTO received many suggestions and inquiries from users of EFS-Web and PAIR on the usage of PKI certificates. In response to the suggestions, the USPTO is expanding the procedure for PKI certificates to permit a holder of a PKI certificate to designate more than one employee to use the PKI certificate under the direction and control of the holder in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web. The designated employees should be paralegals or support staff of the certificate holder. Each designated employee must be either an employee of the holder's organization or an employee of a contractor. The PKI certificate holder and the designated employees may use the holder's PKI certificate concurrently. For example, a registered patent practitioner may file a patent application electronically via EFS-Web using his or her PKI certificate at the same time when one of the practitioner's paralegals files a follow-on document in another application electronically via EFS-Web, and another paralegal of the practitioner retrieves an e-Office action via Private PAIR, using the practitioner's PKI certificate under the direction and control of the practitioner. The revised procedure for PKI certificates will provide users more flexibility and meet users' needs for multiple concurrent usage of the USPTO electronic systems.

The revised procedure for PKI certificates is effective immediately upon the publication of this notice. The PKI subscriber agreement has been revised to permit a holder of a PKI certificate to designate more than one employee to use the PKI certificate under the direction and control of the holder in accordance with the PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web. The revised PKI subscriber agreement (provided in section II of this notice and to be posted on the USPTO Web site) will apply to new PKI certificate holders who receive their PKI certificates on or after the publication date of this notice and current PKI certificate holders that continue to use their PKI certificates (includes any PKI certificate usage by their designated employees). The Legal Framework for EFS-Web published in the Federal Register (74 FR 55200) on October 27, 2009, will be revised in accordance with this notice and the revised version will also be posted on the USPTO Web site.

I. New Frequently Asked Questions Regarding PKI Certificates: The following are provided for further clarification of the procedure for PKI certificates and to address the inquiries that the USPTO has received:

1. Can current PKI certificate holders designate more than one employee without applying for a new PKI certificate or filing a newly signed certificate action form (PTO-2042)?

Answer: Yes, a new request for PKI certificate is not needed. Continued use of a PKI certificate after the publication of this notice will constitute agreement to the revised PKI subscriber agreement by the current PKI certificate holder. See section 9 of the PKI subscriber agreement. Therefore, a current PKI certificate holder may designate more than one employee immediately to use the holder's PKI certificate under the direction and control of the holder in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web.

2. What is the maximum number of employees that a PKI certificate holder may designate?

Answer: PKI certificate holders may only designate a reasonable number of employees for which he or she can maintain proper control. The PKI certificate holder is responsible for the usage by the designated employees who can only use the PKI certificate under the direction and control of the holder in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web. The holder must take reasonable steps to ensure compliance with the requirements in the revised PKI subscriber agreement and the rules and policies of the USPTO. When a PKI certificate holder or one of the holder's designated employees electronically transmits a submission to the USPTO via EFS-Web using the holder's PKI certificate, the PKI certificate holder is presenting the information in the submission to the USPTO and making the certification under 37 CFR 11.18(b). Furthermore, the PKI certificate holder is not permitted to designate a person who is not an employee, and designated employees are not permitted to share the certificate with anyone else (e.g., a designated employee cannot designate another employee).

3. Can a PKI certificate holder designate employees of more than one contractor?

Answer: Yes, a PKI certificate holder may designate employees of more than one contractor as long as the PKI certificate holder maintains control of the PKI certificate usage and can ensure that the employees of the contractors are using the PKI certificate in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web.

4. Can multiple PKI certificate holders designate the same employee to use their certificates?

Answer: Yes, multiple PKI certificate holders may designate the same employee if the PKI certificate holders and the designated employee take reasonable steps to ensure that the designated employee uses the proper PKI certificate for each task in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web. For example, if Holder Smith asked the designated employee to electronically submit a patent application via EFS-Web, the designated employee must use the PKI certificate of Holder Smith to submit the patent application, rather than a certificate of another holder who did not give the designated employee the direction to file the patent application.

5. Can a PKI certificate holder designate an employee that is not located in the same location?

Answer: Yes, a PKI certificate holder may designate an employee that is not located in the same location as long as the designated employee uses the PKI certificate under the direction and control of the holder in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web.

6. What should a PKI certificate holder do if one of his or her designated employees is leaving the holder's organization or the contractor's organization?

Answer: The PKI certificate holder must take reasonable steps to ensure that the employee does not continue to use the PKI certificate when the employee leaves the holder's organization or the contractor's organization or when the contractor is no longer a contractor to the holder.

7. Can a pro se inventor use his or her PKI certificate to file an application or document for another person or retrieve information regarding another person's application?

Answer: No, a pro se inventor cannot use (or permit someone else to use) his or her PKI certificate to file an application or document for another person, or retrieve information (e.g., an e-Office action or the status) regarding another person's application. A pro se inventor may use his or her PKI certificate to file his or her application or follow-on documents in his or her application that does not contain a power of attorney.

8. Can a PKI certificate holder designate a company that offers paralegal services to use the PKI certificate?

Answer: No, a PKI certificate holder cannot designate a company. A PKI certificate holder may only designate more than one employee of a contractor (or the organization of the holder) to use his or her certificate under the holder's direction and control in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web.

9. Can a PKI certificate holder designate an invention promotion company or an invention promoter to use the PKI certificate?

Answer: No, a PKI certificate holder is not permitted to designate an invention promotion company or an invention promoter to use the PKI certificate. A PKI certificate holder may only designate more than one employee of a contractor (or the organization of the holder) to use his or her certificate under the holder's direction and control in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web. The designated employees should be paralegals or support staff of the holder's organization (or a contractor's organization). A PKI certificate holder must take reasonable steps to ensure that the PKI certificate is not being used in connection with the unauthorized practice before the USPTO in patent matters. See section 3 of the PKI subscriber agreement.

10. Can a registered patent practitioner who is a PKI certificate holder designate his or her client or a “foreign associate” (e.g., an attorney in another law firm) to use the PKI certificate?

Answer: No, a PKI certificate holder cannot designate his or her client, and cannot designate a “foreign associate” (e.g., an attorney in another law firm) who is not an employee of the certificate holder's organization and is not an employee of a contractor. A PKI certificate holder may only designate more than one employee of a contractor (or the organization of the holder) to use his or her certificate under the holder's direction and control in accordance with the revised PKI subscriber agreement and the rules and policies of the USPTO including the Legal Framework for EFS-Web. The designated employees should be paralegals or support staff of the certificate holder. Furthermore, if the “foreign associate” is located outside of the United States, it would be difficult for the holder to maintain control of the PKI certificate usage and ensure compliance with the rules and policies of the USPTO by a person located outside of the United States. In addition, accessing an application before the applicant has received a foreign filing license by a person located outside of the United States, or by a foreign national inside the United States, constitutes an export. The holder cannot permit the use of the PKI certificate in a manner that would violate or circumvent the Export Administration Regulations. See section 6 of the PKI subscriber agreement for more information.

11. Can a PKI certificate holder or a designated employee file a third party submission or a protest via EFS-Web using the PKI certificate?

Answer: No, the EFS-Web Legal Framework (section B2) specifically prohibits the filing of third party submissions and protests in patent applications via EFS-Web. The USPTO has a special screening procedure to ensure such documents are filed in compliance with 37 CFR 1.99 or 1.291 (in paper) before being entered into the application. See also 35 U.S.C. 122(c) and Manual of Patent Examining Procedure (MPEP) §§ 1134, 1134.01 and 1901.05. Filing such documents electronically via EFS-Web would be circumventing these rules and procedures and be a violation of the Legal Framework for EFS-Web and the revised PKI subscriber agreement. Such violation may cause the USPTO to revoke the PKI certificate and/or refer the PKI certificate holder to the Office of Enrollment and Discipline for appropriate action. Therefore, PKI certificate holders should take reasonable steps to ensure that their designated employees do not file third party submissions and protests via EFS-Web.

12. Can a designated employee continue to use the PKI certificate of a deceased holder?

Answer: No, all of the designated employees must stop using the PKI certificate of a deceased holder because designated employees only have the authority to use the PKI certificate under the direction and control of the holder. The USPTO will revoke the PKI certificate once the USPTO becomes aware that the holder is deceased.

13. Can a PKI certificate holder or his or her designated employees continue to use the PKI certificate after the holder is suspended from practice before the USPTO?

Answer: No, the PKI certificate holder and all of his or her designated employees must stop using the PKI certificate once the holder is suspended from practice before the USPTO. The USPTO will revoke the PKI certificate once the appropriate official in the USPTO becomes aware of the suspension.

II. Revised PKI Subscriber Agreement (November 2009): The following is the PKI Subscriber Agreement in effect as of December 17, 2009:

III. Additional Information: The USPTO appreciates the suggestions and inquiries from users. The USPTO will continue to provide clarifications, answers to frequently asked questions, and other helpful information on the USPTO Web site. Users are encouraged to check the USPTO Web site for more information and contact the Patent Electronic Business Center for questions related to the usage of PKI certificates or USPTO electronic systems.

The commissioners of the MLDC will meet to continue their efforts to address congressional concerns as outlined in the commission charter.

Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, the meeting will be open to the public. Please note that the availability of seating is on a first-come basis.

Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the MLDC about its mission and functions. Written statements may be submitted at any time or in response to the stated agenda of a planned meeting of the Commission.

All written statements shall be submitted to the Designated Federal Officer for the Military Leadership Diversity Commission, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Designated Federal Officer can be obtained from the GSA's FACA Database—https://www.fido.gov/facadatabase/public.asp.

Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT) at least five calendar days prior the meeting which is the subject of this notice. Written statements received after this date may not be provided to or considered by the Commission until its next meeting.

The Designated Federal Officer will review all timely submissions with the MLDC Chairperson and ensure they are provided to all members of the Commission before the meeting that is the subject of this notice.

The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from (see FOR FURTHER INFORMATION CONTACT).

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on December 10, 2009, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The U.S. Marine Corps system of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from (see FOR FURTHER INFORMATION CONTACT).

The proposed system report, as required by 5 U.S.C. 552a(r), of the Privacy Act of 1974, as amended, was submitted on December 10, 2009, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Acting Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review: New.

Title: Evaluation of the Helen Keller National Center for Deaf-Blind Youths and Adults.

Frequency: One time.

Affected Public: Businesses or other for-profit; Individuals or households; Not-for-profit institutions; State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden:

Abstract: The Helen Keller National Center for Deaf-Blind Youths and Adults (HKNC) provides services designed to equip clients to live independently in their communities and/or to enhance their ability to secure meaningful employment. The HKNC evaluation will provide RSA with independent and objective information by which to draw conclusions about the effectiveness, including cost effectiveness, of the Center. The evaluation will identify characteristics of the populations served by HKNC and the extent to which HKNC effectively serves clients with different needs. The evaluation will also examine the relationship between HKNC and vocational rehabilitation (VR) agencies and how well HKNC meets the needs of the agencies. Finally, this evaluation will include recommendations to improve HKNC programs and service delivery, including measures that could be used to assess ongoing performance of the Center, its regional staff and functions, and its national training program.

The evaluation scope of work is identified in the following objectives:

* Provide RSA with reliable and valid information on program effectiveness, including cost effectiveness.

* Identify both the characteristics of the populations served by HKNC and the strengths and weaknesses of the program that have an impact on its effectiveness in serving these populations.

* Examine the relationship between HKNC and VR agencies and the effectiveness of direct services, technical assistance, and training activities provided by the Center's headquarters and regional programs in meeting the needs of VR agencies.

* Make recommendations for program adjustments or improvements based on study findings, including measures that could be implemented to assess ongoing performance.

Requests for copies of the information collection submission for OMB review may be accessed from http://edicsweb.ed.gov, by selecting the “Browse Pending Collections” link and by clicking on link number 4157. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Washington, DC 20202-4537. Requests may also be electronically mailed to the Internet address ICDocketMgr@ed.gov or faxed to 202-401-0920. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be electronically mailed to ICDocketMgr@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA.

Today's notice is simply an announcement of a finding that we have already made. EPA Region IX sent a letter to the California Air Resources Board on November 20, 2009 stating that the 2002 and 2020 motor vehicle emissions budgets for NO2 in the submitted 2007 AQMP are adequate. The budgets correspond to the South Coast NO2 maintenance area, which generally includes Orange County, the southwestern two-thirds of Los Angeles County, southwestern San Bernardino County, and western Riverside County. Receipt of these motor vehicle emissions budgets was announced on EPA's transportation conformity Web site, and no comments were submitted. The finding is available at EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm.

The adequate 2002 and 2020 motor vehicle emissions budgets (calculated for a winter season day) are provided in the following table:

Transportation conformity is required by Clean Air Act section 176(c). EPA's conformity rule requires that transportation plans, transportation improvement programs, and projects conform to state air quality implementation plans (SIPs) and establishes the criteria and procedures for determining whether or not they do conform. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.

The criteria by which we determine whether a SIP's motor vehicle emissions budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4). We have described our process for determining the adequacy of submitted SIP budgets in our July 1, 2004, preamble starting at 69 FR 40038, and we used the information in these resources while making our adequacy determination. Please note that an adequacy review is separate from EPA's completeness review, and should not be used to prejudge EPA's ultimate approval action for the SIP. Even if we find a budget adequate, the SIP could later be disapproved.

I. Information About IRIS

IRIS is a database that contains potential adverse human health effects information that may result from chronic (or lifetime) exposure to specific chemical substances found in the environment. The database (available on the Internet at http://www.epa.gov/iris) contains qualitative and quantitative health effects information for more than 540 chemical substances that may be used to support the first two steps (hazard identification and dose-response evaluation) of a risk assessment process. When supported by available data, the database provides oral reference doses (RfDs) and inhalation reference concentrations (RfCs) for chronic health effects, and oral slope factors and inhalation unit risks for carcinogenic effects. Combined with specific exposure information, government and private entities can use IRIS data to help characterize public health risks of chemical substances in a site-specific situation and thereby support risk management decisions designed to protect public health.

In accordance with ARRA Section 1605(c), EPA hereby provides notice that it is granting a project waiver of the requirements of Section 1605(b)(2) of Public Law 111-5, Buy American requirements to Taos for the acquisition of a GE/Zenon Zeeweed 500D MBR system's (MBR system) membrane filtration cassettes, manufactured by GE Water and Process Technologies, Canada. Taos has been unable to find an American made membrane filtration cassette manufacturer to meet its specific wastewater requirements.

Section 1605 of the ARRA requires that none of the appropriated funds may be used for the construction, alteration, maintenance, or repair of a public building or public work unless all of the iron, steel, and manufactured goods used in the project are produced in the United States unless a waiver is provided to the recipient by EPA. A waiver may be provided if EPA determines that (1) Applying these requirements would be inconsistent with public interest; (2) iron, steel, and the relevant manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality; or (3) inclusion of iron, steel, and the relevant manufactured goods produced in the United States will increase the cost of the overall project by more than 25 percent.

Taos' waiver request is to allow the purchase of sixteen membrane filtration cassettes for use in improvements to its existing WWTP in Taos, New Mexico. This project will replace its existing secondary wastewater treatment processes with a new MBR system to meet the effluent requirements of the NPDES permit. The membrane filtration cassette is an integral component of the MBR system because it separates the treated wastewater from the mixed liquor which comes from the biological reactors, before the treated wastewater is disinfected and discharged. Taos chose the MBR system after an engineering analysis of treatment alternatives. Taos determined this to be the most environmentally sound and cost effective solution because it meets the strict NPDES tertiary treatment standards for Total Suspended Solids, Biological Oxygen Demand, and turbidity, when compared to other considered solutions. In addition, in anticipation of procuring the MBR system, Taos has already incorporated specific technical design requirements for installation of membrane filter cassettes with the MBR system at its WWTP, including specific tank footprint, geometry and configuration.

Taos has provided information to the EPA demonstrating that there are no membrane filtration cassettes manufactured in the United States in sufficient and reasonable quantity and of a satisfactory quality to meet the required technical specification. Six companies were considered for the membrane filtration cassettes, none based in the United States. Taos has performed market research but was unsuccessful in its effort to locate any domestic manufacturers of membrane filtration cassettes for its WWTP.

Based on additional research conducted by EPA Region 6, there does not appear to be any domestic MBR cassette manufacturers that would meet Taos' technical specifications. EPA's national contractor prepared a technical assessment report dated November 19, 2009 based on the waiver request submittal. The report determined that the waiver request submittal was complete, that adequate technical information was provided, and that there were no significant weaknesses in the justification provided. The report confirmed the waiver applicant's claim that there are no American-made MBR cassettes available for use in the proposed MBR system. Taos included a performance guarantee in the request for proposal (RFP) as well as the original specification. GE's performance guarantee applies to the entire MBR system, including all components supplied by GE. The existence of the performance guarantee supports treating the entire MBR system as a unitary whole, rather than a collection of individual components. Therefore, EPA Region 6 concludes that the “GE/Zenon Zeeweed 500D MBR System—as a whole” meets the “specifications in project plans and design.”

The April 28, 2009 EPA HQ Memorandum, Implementation of Buy American provisions of P.L. 111-5, the “American Recovery and Reinvestment Act of 2009”, defines reasonably available quantity as “the quantity of iron, steel, or relevant manufactured good is available or will be available at the time needed and place needed, and in the proper form or specification as specified in the project plans and design.” Taos has incorporated specific technical design requirements for installation of membrane filtration cassettes at its WWTP.

The purpose of the ARRA is to stimulate economic recovery in part by funding current infrastructure construction, not to delay projects that are “shovel ready” by requiring utilities, such as Taos, to revise their standards and specifications, institute a new bidding process, and potentially choose a more costly, less efficient project. The imposition of ARRA Buy American requirements on such projects otherwise eligible for State Revolving Fund assistance would result in unreasonable delay and thus displace the “shovel ready” status for this project. To further delay construction is in direct conflict with a fundamental economic purpose of the ARRA, which is to create or retain jobs.

The Region 6 Water Quality Protection Division has reviewed this waiver request, and to the best of my knowledge at the time of review, has determined that the supporting documentation provided by Taos is sufficient to meet the criteria listed under ARRA, Section 1605(b), Office of Management and Budget (OMB) regulations at 2 CFR 176.60-176.170, and in the April 28, 2009, “Implementation of Buy American Provisions of Public Law 111-5, the ‘American Recovery and Reinvestment Act of 2009’ Memorandum:” Iron, steel, and the manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality. The basis for this project waiver is the authorization provided in ARRA, Section 1605(b)(2). Due to the lack of production of this product in the United States in sufficient and reasonably available quantities and of a satisfactory quality in order to meet Taos' technical specifications, a waiver from the Buy American requirement is justified.

EPA headquarters' March 31, 2009 Delegation of Authority Memorandum provided Regional Administrators with the authority to issue exceptions to Section 1605 of ARRA within the geographic boundaries of their respective regions and with respect to requests by individual grant recipients. Having established both a proper basis to specify the particular good required for this project, and that this manufactured good was not available from a producer in the United States, Taos is hereby granted a waiver from the Buy American requirements of ARRA, Section 1605(a) of Public Law 111-5 for the purchase of “GE/Zenon Zeeweed 500D MBR system” using ARRA funds, as specified in Taos' request of October 23, 2009. This supplementary information constitutes the detailed written justification required by ARRA, Section 1605(c), for waivers “based on a finding under subsection (b).”

I. Additional Information About the Proposed Consent Decree

Under sections 111(b)(1)(B), 112(d)(6) and 112(f)(2) of the CAA, EPA has a mandatory duty to take actions relative to the review/revision of new source performance standards (“NSPS”) and national emission standards for hazardous air pollutants (“NESHAP”) within eight years of the issuance of the standards. The proposed consent decree would resolve a deadline suit filed by Plaintiffs for EPA's failure to take the above actions within eight years of issuing NSPS and NESHAP for the Oil and Natural Gas production source category. The proposed Consent Decree requires that EPA sign by January 31, 2011 proposed standards and/or determinations not to issue standards pursuant to sections 111(b)(1)(B), 112(d)(6) and 112(f)(2), and that EPA finalize its proposals by November 30, 2011. The proposed Consent Decree authorizes EPA to sign by January 31, 2011 a final determination not to review the NSPS pursuant to section 111(b)(1)(B) without issuing a proposal for such determination. The approach of determining not to review is not available for actions under section 112. The proposed Consent Decree further requires that, within 15 business days following signature, EPA shall deliver a notice of such action to the Office of the Federal Register for prompt publication. The proposed consent decree states that, after EPA fulfills its obligations under the decree, the case shall be dismissed with prejudice.

For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who were not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines, based on any comment submitted, that consent to this consent decree should be withdrawn, the terms of the decree will be affirmed.

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2009-0918) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

An electronic version of the public docket is available through http://www.regulations.gov. You may use http://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search”.

It is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing online at http://www.regulations.gov without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute is not included in the official public docket or in the electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

You may submit comments as provided in the ADDRESSES section. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment and with any disk or CD-ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. 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.

Use of the http://www.regulations.gov Web site to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. In contrast to EPA's electronic public docket, EPA's electronic mail (e-mail) system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

The Superfund Amendments and Reauthorization Act (SARA) (Pub. L. 99-499) amends the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) (42 U.S.C. 9601 et seq.) by establishing certain responsibilities for ATSDR and the U.S. Environmental Protection Agency (U.S. EPA) with regard to hazardous substances most commonly found at facilities on the CERCLA National Priorities List (NPL). As part of these responsibilities, the ATSDR Administrator must prepare toxicological profiles for substances enumerated on the priority list of hazardous substances. This list identifies 275 hazardous substances which, according to ATSDR and U.S. EPA, pose the most significant potential threat to human health. The availability of the revised priority list of 275 hazardous substances was announced in the Federal Register on March 6, 2008 (73 FR 12178). In addition, ATSDR has the authority to prepare toxicological profiles for substances not found at sites on the National Priorities List, in an effort to “* * * establish and maintain inventory of literature, research, and studies on the health effects of toxic substances” under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and as otherwise necessary to support the site-specific response actions conducted by ATSDR.

For previous versions of the list of substances, see Federal Register notices dated April 17, 1987 (52 FR 12866); October 20, 1988 (53 FR 41280); October 26, 1989 (54 FR 43619); October 17, 1990 (55 FR 42067); October 17, 1991 (56 FR 52166); October 28, 1992 (57 FR 48801); February 28, 1994 (59 FR 9486); April 29, 1996 (61 FR 18744); November 17, 1997 (62 FR 61332); October 21, 1999 (64 FR 56792); October 25, 2001 (66 FR 54014); November 7, 2003 (68 FR 63098); and December 7, 2005 (70 FR 72840). [CERCLA also requires that ATSDR initiate a research program to fill data needs associated with the substances.] Section 104(i)(3) of CERCLA [42 U.S.C. 9604(i)(3)] outlines the content of these profiles. Each profile will include an examination, a summary, and an interpretation of available toxicological information and epidemiological evaluations. This information and these data identify the levels of significant human exposure for the substance and for the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of each substance is available or is in the process of development. If adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of research to determine such health effects.

Although during the profile development process ATSDR considered key studies for each of the substances, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data and ongoing studies. ATSDR will evaluate such data or studies for possible addition to the profiles, now or in the future.

The following draft toxicological profiles have been made available to the public:

All profiles issued as “Drafts for Public Comment” represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We seek public comment and additional information that may supplement these profiles. ATSDR remains committed to providing a public comment period for these documents as the best means to serve public health and our clients.

Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 9A4779) has been filed by Lallemand, Inc., c/o Dennis T. Gordon, 117 N. Welcome Slough Rd., Puget Island, Cathlamet, WA 98612. The petition proposes to amend the food additive regulations in part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172) to provide for the safe use of vitamin D2 bakers yeast as a dual purpose nutrient supplement and leavening agent or dough relaxer in yeast-containing baked products.

The agency has determined under 21 CFR 25.32(k) that this 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.

Former Grantee of Record: Trover Health System.

Original Period of Grant Support: March 1, 2009 to February 28, 2011 (NAP) and March 27, 2009 to March 26, 2011 (IDS).

Replacement Awardee: Regional Health Care Affiliates.

Amount of Replacement Awards: $1,300,000 (NAP) and $101,000 (IDS).

Period of Replacement Awards: The period of support for the replacement awards is March 1, 2009, to February 28, 2011 (NAP) and March 27, 2009, to March 26, 2009 (IDS).

CFDA Number: 93.703.

Under the original grant applications approved by HRSA, Regional Health Care Affiliates (RHCA) was identified as the provider of health care services on behalf of the Trover Health System, while Trover Health System was to serve in an administrative capacity for the grants. After the awards were issued, Trover Health System and RHCA notified HRSA that RHCA's organizational structure had changed to enable it to carry out both administrative and programmatic requirements. The two parties requested that full responsibility for the grants be transferred from Trover Health System to RHCA. RHCA provided documentation that it meets Section 330 statutory and regulatory requirements as well as applicable grant management requirements.

Regional Health Care Affiliates will directly initiate primary health care services in Webster and McLean Counties to the more than 5,250 low income, underserved and uninsured individuals in the original service area, Webster and McLean Counties, KY, as had been proposed in funded grant applications.

Regional Health Care Affiliates can provide primary health care services immediately, is located in the same geographical area where the Trover Health System's primary health care services have been provided, and will be able to provide continuity of care to patients of the former grantee.

This underserved target population has an immediate need for vital primary health care services and would be negatively impacted by any delay caused by a competition. As a result, in order to ensure that critical primary health care services are available to the original target population in a timely manner, these replacement awards will not be competed.

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

In October 2009, the ICH Steering Committee agreed that a draft guidance entitled “Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)” should be made available for public comment. The draft guidance is the product of the Safety (S6) Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the ICH S6 Safety Expert Working Group.

The draft document provides guidance on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. Biotechnology-derived pharmaceuticals include protein therapeutic, diagnostic, and prophylactic products derived from cell-culture systems such as bacteria, yeast, and eukaryotic cells, including organisms produced by recombinant DNA technology. The draft guidance specifically provides clarification of and greater detail to the nonclinical recommendations in ICH S6 regarding the topics of species selection, study design, and recommendations for immunogenicity, carcinogenicity, and reproductive and developmental toxicity testing of biotechnology-derived pharmaceuticals. ICH S6 was published more than 10 years ago and much knowledge relevant to the safety evaluation of biopharmaceuticals has been gained since that original publication. This draft guidance seeks to incorporate this new knowledge within the established framework of ICH S6 and is intended to enable the development of safe and effective biopharmaceuticals. In addition, this draft guidance harmonizes approaches given in both ICH S6 and the ICH guidance “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.”

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments on the draft guidance. 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.

Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

In October 2009, the ICH Steering Committee agreed that a draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 11: Capillary Electrophoresis General Chapter” should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group.

The draft guidance provides the specific evaluation results from the ICH Q4B process for the Capillary Electrophoresis General Chapter harmonization proposal originating from the three-party PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. 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.

Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

In October 2009, the ICH Steering Committee agreed that a draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving General Chapter” should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group.

The draft guidance provides the specific evaluation results from the ICH Q4B process for the Analytical Sieving General Chapter harmonization proposal originating from the three-party PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. 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.

Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the Federal Register a notice of each petition filed. Set forth below is a list of petitions received by HRSA on January 5, 2009, through March 30, 2009.

Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

2. Any allegation in a petition that the petitioner either:

(a) “Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or

(b) “Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT), with a copy to HRSA addressed to Director, Division of Vaccine Injury Compensation Program, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.

1. Tracy and Edward Roman on behalf of Chase Roman, Philadelphia, Pennsylvania. Court of Federal Claims Number: 09-0001V.

2. Michelle and Waleed Moujaes on behalf of Dimitri Moujaes, Dublin, Ohio. Court of Federal Claims Number: 09-0002V.

3. Annette and Matt Flynn on behalf of Nathan Flynn, Kenosha, Washington. Court of Federal Claims Number: 09-0009V.

4. Brenda and Daniel Klein on behalf of Kara Quinn Klein, McMurray, Pennsylvania. Court of Federal Claims Number: 09-0010V.

5. Nelly and Leon Huppert on behalf of Zachary Huppert, Garden City, New York. Court of Federal Claims Number: 09-0011V.

6. James Burghardt, Staten Island, New York. Court of Federal Claims Number: 09-0012V.

7. Benjamin Jahanbani, Riverside, California. Court of Federal Claims Number: 09-0019V.

8. Glinda Morse on behalf of Kaden Morse, Crawfordville, Florida. Court of Federal Claims Number: 09-0023V.

9. Amy and Evan and Tyler Frey on behalf of Frederick Frey, Jr., Deceased, Baton Rouge, Louisiana. Court of Federal Claims Number: 09-0026V.

10. Kimberly Hicks on behalf of Chasen Hicks, Baytown, Texas. Court of Federal Claims Number: 09-0028V.

11. Deborah and Jack Breard on behalf of Reneau Breard, Garden City, New York. Court of Federal Claims Number: 09-0029V.

12. Cynthia Lilley on behalf of Robert Lilley, Nashville, Tennessee. Court of Federal Claims Number: 09-0031V.

13. Jacqueline and Mark Smith on behalf of Kyler J. Smith, Palm Harbor, Florida. Court of Federal Claims Number: 09-0032V.

14. Ronald R. Leyland, Greensburg, Pennsylvania. Court of Federal Claims Number: 09-0033V.

15. Elliott M. Leake, Raleigh, North Carolina. Court of Federal Claims Number: 09-0034V.

16. Amy Crutchfield, New York, New York. Court of Federal Claims Number: 09-0039V.

17. Theresa and Mark Eichinger on behalf of Samantha Eichinger, Cedar Rapids, Iowa. Court of Federal Claims Number: 09-0040V.

18. Cheri A. Johnson, Coon Rapids, Minnesota. Court of Federal Claims Number: 09-0041V.

19. Helaine and William Searle on behalf of Cody James Searle, Prescott, Arizona. Court of Federal Claims Number: 09-0043V.

20. Dayna and Mike Relstab on behalf of Michael Relstab, Memphis, Tennessee. Court of Federal Claims Number: 09-0047V.

21. Lee Keffer, Kosovo, Serbia. Court of Federal Claims Number: 09-0050V.

22. Sharon Goldman, Somerville, Massachusetts. Court of Federal Claims Number: 09-0051V.

23. Shauna Ammendola, Ridgewood, New Jersey. Court of Federal Claims Number: 09-0056V.

24. Ziva Fink, St. Louis Park, Minnesota. Court of Federal Claims Number: 09-0057V.

25. Patricia Blow on behalf of Kenn Blow, Deceased, Faribault, Minnesota. Court of Federal Claims Number: 09-0058V.

26. Lauren Caro, Sunrise, Florida. Court of Federal Claims Number: 09-0061V.

27. Donna and John Guerra on behalf of Michael Guerra, San Antonio, Texas. Court of Federal Claims Number: 09-0062V.

28. Melissa and John Mark Wallace on behalf of Melodi Mae Wallace, Sandy, Utah. Court of Federal Claims Number: 09-0065V.

29. Julia and Thomas Canny on behalf of Christian Canny, Garden City, New York. Court of Federal Claims Number: 09-0068V.

30. Tserendulam and Daniel Wagner on behalf of Sarnai Wagner, Pooler, Georgia. Court of Federal Claims Number: 09-0069V.

31. Angela and Andrew Rewolinski on behalf of Alexander Rewolinksi, West Allis, Wisconsin. Court of Federal Claims Number: 09-0070V.

32. Angela and Andrew Rewolinski on behalf of Ethan Rewolinski, West Allis, Wisconsin. Court of Federal Claims Number: 09-0071V.

33. Catherine Guidry on behalf of Hayden Guidry, St. Francisville, Louisiana. Court of Federal Claims Number: 09-0072V.

34. Shannon Nelson, Schaumburg, Illinois. Court of Federal Claims Number: 09-0073V.

35. Dolores Holzem, Dells, Wisconsin. Court of Federal Claims Number: 09-0076V.

36. Jessica and R. Blake Schmutz on behalf of Dallin Blake Schmutz, Dallas, Texas. Court of Federal Claims Number: 09-0077V.

37. Hodan Hassan on behalf of Geni-Fadumo Farah, New Hope, Minnesota. Court of Federal Claims Number: 09-0079V.

38. Cheryl and Ernest Graves on behalf of Garrett Lee Graves, Fernandina Beach, Florida. Court of Federal Claims Number: 09-0080V.

39. Neeru Arora, Vernon Hills, Illinois. Court of Federal Claims Number: 09-0083V.

40. Ben D. Schultz, Sauk City, Wisconsin. Court of Federal Claims Number: 09-0084V.

41. Tiffany and Rodrigo Magalhaes on behalf of Christopher Magalhaes, Camp Legune, North Carolina. Court of Federal Claims Number: 09-0085V.

42. Sou Sou Awad on behalf of Christopher L. Varga, Phoenix, Arizona. Court of Federal Claims Number: 09-0087V.

43. Helen and Lloyd Barnes on behalf of Helen Therese Barnes, Omaha, Nebraska. Court of Federal Claims Number: 09-0088V.

44. Usuamayak Danesi on behalf of Sean Danesi, Reseda, California. Court of Federal Claims Number: 09-0090V.

45. Rachel Campos on behalf of Alexis Campos, Bountiful, Utah. Court of Federal Claims Number: 09-0091V.

46. Elizabeth Pace Laderer, Glenn Cove, New York. Court of Federal Claims Number: 09-0097V.

47. April and Scott Sanders on behalf of Mathew Dylan Sanders, Ada, Oklahoma. Court of Federal Claims Number: 09-0098V.

48. Carlis James DeWese, Gambrills, Maryland. Court of Federal Claims Number: 09-0101V.

49. Chistina Blackfox on behalf of Victoria Nicole Blackfox, Deceased, Miami, Oklahoma. Court of Federal Claims Number: 09-0102V.

50. Katie and Mark Eleccion on behalf of Mark Eleccion, Napa, California. Court of Federal Claims Number: 09-0105V.

51. Michelle Broussard-Pacot on behalf of Cole Pacot, Rowlett, Texas. Court of Federal Claims Number: 09-0107V.

52. Harry Selph, Greenville, South Carolina. Court of Federal Claims Number: 09-0110V.

53. Radhakrishna Kukkillaya on behalf of Manorama A. Kukkillaya, Logan, West Virginia. Court of Federal Claims Number: 09-0115V.

54. Katie and Dan Dittman on behalf of Jolie Tess Dittman, Omaha, Nebraska. Court of Federal Claims Number: 09-0117V.

55. Sonya and Erik Mercado on behalf of Erik Mercado, Jr., Deceased, Austin, Texas. Court of Federal Claims Number: 09-0120V.

56. Kimberly Totzkay on behalf of Shelby Whale, Taylor, Michigan. Court of Federal Claims Number: 09-0123V.

57. Susan Johnson, Winston-Salem, North Carolina. Court of Federal Claims Number: 09-0124V.

58. Yin H. Mendive-Garcia and Julio Garcia on behalf of Julian A. Garcia, Richardson, Texas. Court of Federal Claims Number: 09-0126V.

59. Elizabeth Medina and George Barahona on behalf of Brandon Barahona, Wenonah, New Jersey. Court of Federal Claims Number: 09-0127V.

60. Trinity and Johnny Montgomery on behalf of Trace Montgomery, Ardmore, Oklahoma. Court of Federal Claims Number: 09-0128V.

61. Brianna Samsal on behalf of Michael Thomas Martin, Deceased, Newport Beach, California. Court of Federal Claims Number: 09-0132V.

62. Yin H. Mendive-Garcia and Julio Garcia on behalf of Julian A. Garcia, Richardson, Texas. Court of Federal Claims Number: 09-0134V.

63. Eura Dell Franklin, Dallas, Texas. Court of Federal Claims Number: 09-0135V.

64. Joseph John Dushel, Baltimore, Maryland. Court of Federal Claims Number: 09-0138V.

65. Jamie and Joseph Uhelsky on behalf of Caitlin Uhelsky, Middletown, New York. Court of Federal Claims Number: 09-0140V.

66. Limya Elshazli on behalf of Mohamed Mohamed, Dallas, Texas. Court of Federal Claims Number: 09-0141V.

67. Jody and James Rettig on behalf of Tristan James Rettig, Cumming, Georgia. Court of Federal Claims Number: 09-0143V.

68. Santhamma George, Dallas, Texas. Court of Federal Claims Number: 09-0144V.

69. Michelle and William Sasser on behalf of Katherine Elizabeth Sasser, Santa Rosa, California. Court of Federal Claims Number: 09-0145V.

70. Susan Lawson on behalf of Julia Grimes, Boca Raton, Florida. Court of Federal Claims Number: 09-0148V.

71. Thomas Lamb, San Francisco, California. Court of Federal Claims Number: 09-0149V.

72. Valerie Soto on behalf of Yvette Diaz, Las Vegas, Nevada. Court of Federal Claims Number: 09-0150V.

73. Ronie Fearon, South Euclid, Ohio. Court of Federal Claims Number: 09-0151V.

74. Lu Marie Guzman-Diaz and Hector Orellano-Diaz on behalf of Jeshua Orellano-Guzman, Napa, California. Court of Federal Claims Number: 09-0157V.

75. Bridget and Dusty Golden on behalf of Hailey Golden, Miami, Oklahoma. Court of Federal Claims Number: 09-0161V.

76. Jeremy Coe, Columbus, Nebraska. Court of Federal Claims Number: 09-0169V.

77. Lynn and Scott O'Brien on behalf of Davis William O'Brien, Woodstock, Georgia. Court of Federal Claims Number: 09-0170V.

78. Zenoria Phillips-Deloatch on behalf of Moshella F. Roberts, Deceased, Fayetteville, North Carolina. Court of Federal Claims Number: 09-0171V.

79. Andrea Cortez on behalf of Renaldo Cortez, Deceased, Baycliff, Texas. Court of Federal Claims Number: 09-0176V.

80. Judy A. Jourden, Bradford, Pennsylvania. Court of Federal Claims Number: 09-0177V.

81. Jeremy Coe, Columbus, Nebraska. Court of Federal Claims Number: 09-0178V.

82. Debby and Dalibor Hradek on behalf of Federico Hradek, Lima, Ohio. Court of Federal Claims Number: 09-0179V.

83. Justin W. Gerhardt, Quantico, Virginia. Court of Federal Claims Number: 09-0180V.

84. Calista and Sam Bussard on behalf of James Bussard, Deceased, Spokane Valley, Washington. Court of Federal Claims Number: 09-0191V.

85. Dana Ionescu on behalf of Emma Ionescu, Cooper City, Florida. Court of Federal Claims Number: 09-0192V.

The public workshop helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The public workshop will provide those engaged in FDA-regulated (human) clinical trials with information on a number of topics concerning FDA requirements related to informed consent, clinical investigation requirements, institutional review board investigations, electronic record requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial, (2) Adverse Event Reporting, (3) Part 11 Compliance—electronic signatures, (4) Informed Consent Regulations, (5) IRB Regulations and FDA Inspections, (6) Keeping Informed and Working Together, (7) FDA Conduct of Clinical Investigator Inspections, (8) Meetings with the FDA, (9) Investigator Initiated Research, (10) Medical Device Aspects of Clinical Research, (11) Working with FDA's Center for Biologics Evaluation and Research, (12) Ethical Issues in Subject Enrollment, (13) The Inspection is Over—What Happens Next? Possible FDA Compliance Actions.

FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The public workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The public workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as outreach activities by Government agencies to small businesses.

OMB regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8 (d)]. This notice identifies an information collection that OSM will be submitting to OMB for approval. This collection is contained in 30 CFR part 702—Exemption for Coal Extraction Incidental to the Extraction of Other Minerals. The information submitted by respondents is required to obtain a benefit. OSM will request a 3-year term of approval for this information collection activity.

Comments are invited on: (1) The need for the collection of information for the performance of the functions of the agency; (2) the accuracy of the agency's burden estimates; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information. A summary of the public comments will accompany OSM's submission of the information collection request to OMB.

Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Title: 30 CFR Part 702 Exemption for Coal Extraction Incidental to the Extraction of Other Minerals.

OMB Control Number: 1029-0089.

Summary: This part implements the requirement in Section 701(28) of the Surface Mining Control and Reclamation Act of 1977 (SMCRA), which grants an exemption from the requirements of SMCRA to operators extracting not more than 162/3 percentage tonnage of coal incidental to the extraction of other minerals. This information will be used by the regulatory authorities to make that determination.

Bureau Form Number: None.

Frequency of Collection: Once and annually thereafter.

Description of Respondents: Producers of coal and other minerals and State regulatory authorities.

Total Annual Responses: 120.

Total Annual Burden Hours: 535.

Total Non-wage Costs: $200.

Bureau of Land Management, Colorado State Office, Lakewood, Colorado, hereby gives notice that a public hearing will be held on 6 p.m., March 25, 2010, at the La Quinta Inn at the address given above.

An application for coal lease was filed by New Elk Coal Company, LLC. requesting the Bureau of Land Management offer for competitive lease Federal coal in the lands outside established coal production regions described as:

The coal resource to be offered is limited to coal recoverable by underground mining methods.

The purpose of the hearing is to obtain public comments on the environmental assessment and on the following items:

1. The method of mining to be employed to obtain maximum economic recovery of the coal,

2. The impact that mining the coal in the proposed leasehold may have on the area, and

3. The methods of determining the fair market value of the coal to be offered.

Written requests to testify orally at the March 25, 2010, public hearing should be received at the Bureau of Land Management Office in Canon City by 12 p.m., March 25, 2010. Those who indicate they wish to testify when they register at the hearing may have an opportunity if time is available.

In addition, the public is invited to submit written comments concerning the fair market value and maximum economic recovery of the coal resource. Public comments will be utilized in establishing fair market value for the coal resource in the described lands. Comments should address specific factors related to fair market value including, but not limited to:

1. The quality and quantity of the coal resource.

2. The price that the mined coal would bring in the market place.

3. The cost of producing the coal.

4. The interest rate at which anticipated income streams would be discounted.

5. Depreciation and other accounting factors.

6. The mining method or methods which would achieve maximum economic recovery of the coal.

7. Documented information on the terms and conditions of recent and similar coal land transactions in the lease area, and

8. Any comparable sales data of similar coal lands.

Should any information submitted as comments be considered proprietary by the commenter, the information should be labeled as such and stated in the first page of the submission. Written comments on the environmental assessment, maximum economic recovery, and fair market value should be sent to Melissa Smeins at the above address prior to close of business on March 05, 2010. Substantive comments, whether written or oral, will receive equal consideration prior to any lease offering.

The environmental assessment, maximum economic recovery report, and comments submitted by the public will be available from the Bureau of Land Management Field Office in Canon City (see above) upon request.

A copy of the environmental assessment, the maximum economic recovery report, the case file, and the comments submitted by the public, except those portions identified as proprietary by the commenter and meeting exemptions stated in the Freedom of Information Act, will be available for public inspection at the Colorado State Office, 2850 Youngfield, Lakewood, Colorado 80215.

In accordance with Section 7 of the Taylor Grazing Act (43 U.S.C. 315f), the following public land in Dona Ana County, New Mexico, has been examined and found suitable for classification for lease and conveyance to the New Mexico General Services Department under the provisions of the R&PP Act, as amended (43 U.S.C. 869 et seq.):

In accordance with the R&PP Act, the Property Control Division of the New Mexico General Services Department proposes to construct buildings for the Department of Public Safety, New Mexico State Police District 4 Headquarters, which will include offices for the District 4 Uniform Bureau, the Investigations Bureau, and the Special Investigations Bureau, a communication center for District 4 and District 12, and a full service automobile repair garage. This will consolidate the three offices currently leased for officers and agents. Additional detailed information pertaining to this application, plan of development, and site plans are contained in case file NMNM 122512 located in the BLM Las Cruces District Office. The above-described land is not needed for any Federal purpose. Lease and conveyance of the land to the Property Control Division of the New Mexico General Services Department is consistent with the BLM Mimbres Resource Management Plan, dated December 1993, and would be in the public interest. The Property Control Division of the New Mexico General Services Department has not applied for more than the 640-acre annual limitation for public purposes other than recreation use and has submitted a statement in compliance with the regulations at 43 CFR 2741.4(b).

The lease and conveyance, if issued, will be subject to the following terms, conditions, and reservations:

1. Provisions of the R&PP Act and to all applicable regulations of the Secretary of the Interior, including, but not limited to, the terms required by 43 CFR 2741.9;

2. A right-of-way for ditches and canals constructed by the authority of the United States, Act of August 30, 1890, 26 Statute (stat.) 391 (43 U.S.C. 945);

3. Lease or patent of the public land shall be subject to valid existing rights. Subject to limitations prescribed by law and regulation, prior to patent issuance, a holder of any right-of-way within the lease area may be given the opportunity to amend the right-of-way for conversion to a new term, including perpetuity, if applicable;

4. All minerals shall be reserved to the United States, together with the right to prospect for, mine, and remove the same;

5. An appropriate indemnification clause protecting the United States from claims arising out of the lessee's/patentee's use, occupancy, or operations on the leased/patented lands;

6. Any other reservations that the authorized officer determines appropriate to ensure public access and proper management of Federal land and interests therein.

Detailed information concerning this proposed project, including, but not limited to, documentation relating to compliance with applicable environmental and cultural resource laws, is available for review at the address above.

On December 17, 2009, the land described above will be segregated from all other forms of appropriation under the public land laws, including the general mining laws, except for lease and conveyance under the R&PP Act, and leasing under the mineral leasing laws.

Classification Comments: Interested parties may submit comments involving the suitability of the land for the proposed use. Comments on the classification are restricted to whether: (1) The land is physically suited for the proposal; (2) The use will maximize the future use or uses of the land; (3) The use is consistent with local planning and zoning; and (4) The use is consistent with state and Federal programs.

Application Comments: Interested parties may submit comments regarding the specific use proposed in the application and plan of development, whether the BLM followed proper administrative procedures in reaching the decision, or any other factor not directly related to the suitability of the land for R&PP use.

Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Any adverse comments will be reviewed by the BLM State Director who may sustain, vacate, or modify this realty action. In the absence of any adverse comments, the classification will become effective February 16, 2010. The land will not be available for lease or conveyance until after the classification becomes effective.

Background.—On October 6, 2009, the Commission determined that responses to its notice of institution of the subject five-year review were such that a full review pursuant to section 751(c)(5) of the Act should proceed (74 FR 54068, October 21, 2009). A record of the Commissioners' votes, the Commission's statement on adequacy, and any individual Commissioner's statements are available from the Office of the Secretary and at the Commission's Web site.

Participation in the review and public service list.—Persons, including industrial users of the subject merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in this review as parties must file an entry of appearance with the Secretary to the Commission, as provided in section 201.11 of the Commission's rules, by 45 days after publication of this notice. A party that filed a notice of appearance following publication of the Commission's notice of institution of the review need not file an additional notice of appearance. The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the review.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in this review available to authorized applicants under the APO issued in the review, provided that the application is made by 45 days after publication of this notice. Authorized applicants must represent interested parties, as defined by 19 U.S.C. 1677(9), who are parties to the review. A party granted access to BPI following publication of the Commission's notice of institution of the review need not reapply for such access. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Staff report.—The prehearing staff report in the review will be placed in the nonpublic record on April 14, 2010, and a public version will be issued thereafter, pursuant to section 207.64 of the Commission's rules.

Hearing.—The Commission will hold a hearing in connection with the review beginning at 9:30 a.m. on May 4, 2010, at the U.S. International Trade Commission Building. Requests to appear at the hearing should be filed in writing with the Secretary to the Commission on or before April 28, 2010. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference to be held at 9:30 a.m. on April 30, 2010, at the U.S. International Trade Commission Building. Oral testimony and written materials to be submitted at the public hearing are governed by sections 201.6(b)(2), 201.13(f), 207.24, and 207.66 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony in camera no later than 7 business days prior to the date of the hearing.

Written submissions.—Each party to the review may submit a prehearing brief to the Commission. Prehearing briefs must conform with the provisions of section 207.65 of the Commission's rules; the deadline for filing is April 23, 2010. Parties may also file written testimony in connection with their presentation at the hearing, as provided in section 207.24 of the Commission's rules, and posthearing briefs, which must conform with the provisions of section 207.67 of the Commission's rules. The deadline for filing posthearing briefs is May 13, 2010; witness testimony must be filed no later than three days before the hearing. In addition, any person who has not entered an appearance as a party to the review may submit a written statement of information pertinent to the subject of the review on or before May 13, 2010. On June 3, 2010, the Commission will make available to parties all information on which they have not had an opportunity to comment. Parties may submit final comments on this information on or before June 7, 2010, but such final comments must not contain new factual information and must otherwise comply with section 207.68 of the Commission's rules. All written submissions must conform with the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002). Even where electronic filing of a document is permitted, certain documents must also be filed in paper form, as specified in II (C) of the Commission's Handbook on Electronic Filing Procedures, 67 FR 68168, 68173 (November 8, 2002).

Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.

In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

The Commission instituted this investigation on April 6, 2009, based on a complaint filed on March 2, 2009, by Gertrude Neumark Rothschild of Hartsdale, New York. 74 FR 15520-21 (April 6, 2009). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain light emitting diode chips, laser diode chips, and products containing same by reason of infringement of certain claims of U.S. Patent No. 5,252,499. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complaint names numerous respondents.

On October 30, 2009, complainant Rothschild and respondent Dalian Lumei jointly moved to terminate the investigation as to Dalian Lumei based on a settlement agreement. In the same motion, complainant moved for the termination of the investigation in its entirety. The Commission investigative attorney supported the motion.

On November 13, 2009, the ALJ issued an ID (Order No. 29) granting the motion. No party petitioned for review of the ID, and the Commission has determined not to review it.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in sections 210.21 and 210.42(h) of the Commission's Rules of Practice and Procedure, 19 CFR 210.21, 210.42(h).

The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.

Description of Permit Modification Requested: The Foundation issued a permit (2009-014) to Dr. Douglas P. Nowacek, Duke University on January 7, 2009. The issued permit allows the applicant to tag up to 100 Humpback and Minke whales each.

The applicant requests to collect skin and blubber samples from an additional 100 Humpback and Minke whales each. Samples will be used to determine genetic stock structure of the animals sampled as well as individual genetic identification and sex determination. Skin samples will also be collected to stable isotope analysis that provides information on the diet composition of individual whales.

Location: Antarctic Peninsula waters.

Dates: January 1, 2010 to July 31, 2010.

Appearing in the listing below are the individual authorities established under Schedules A, B, and C between March 1, 2009, and March 31, 2009. Future notices will be published on the fourth Tuesday of each month, or as soon as possible thereafter. A consolidated listing of all authorities as of September 30 is published each year. The following Schedules are not codified in the code of Federal Regulations. These are agency specific exceptions.

No Schedule A appointments in the month of March 2009.

No Schedule B appointments were approved for March 2009.

The following Schedule C appointments were approved during March 2009:

Notice is hereby given that as a result of the President's major disaster declaration on 12/10/2009, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.

The following areas have been determined to be adversely affected by the disaster:

The Interest Rates are:

The number assigned to this disaster for physical damage is 11964B and for economic injury is 11965B.

The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Arkansas, dated 12/03/2009, is hereby amended to establish the incident period for this disaster as beginning 10/29/2009 and continuing through 11/08/2009.

All other information in the original declaration remains unchanged.

Notice is hereby given that as a result of the President's major disaster declaration on 12/09/2009, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.

The following areas have been determined to be adversely affected by the disaster:

The Interest Rates are:

The number assigned to this disaster for physical damage is 119626 and for economic injury is 119636.

Title: Transportation, Community, and System Preservation Program Grant Application. Delta Region Transportation Development Program Grant Application. Transportation Planning Excellence Awards Nomination Form.

OMB Control #: 2125-0615.

Background: Transportation, Community, and System Preservation Program Grant Application: Section 1117 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) provides funding for the Transportation, Community, and System Preservation (TCSP) Program. The TCSP Program is a comprehensive initiative of research and grants to investigate the relationships between transportation, community, and system preservation plans and practices and identify sector-based initiatives to improve such relationships. States, metropolitan planning organizations, local governments, and tribal governments are eligible for discretionary grants to carry out eligible projects to integrate transportation, community, and system preservation plans and practices that:

• Improve the efficiency of the transportation system of the United States.

• Reduce environmental impacts of transportation.

• Reduce the need for costly future public infrastructure investments.

• Ensure efficient access to jobs, services, and centers of trade.

• Examine community development patterns and identify strategies to encourage private sector development patterns and investments that support these goals.

The 2-page TCSP grant application is the tool used to collect the necessary information needed to successfully submit eligible TCSP Program projects to the Secretary of Transportation for approval and for the distribution of TCSP funds. The TCSP grant application includes four parts: (A) Project Information—General contact and funding information, (B) Project Abstract—Overview of the purpose and intent of project, (C) Project Narrative—Description of the project and the expected results, and (D) Project Eligibility—Discussion of how the project meets statutory eligibility.

The TCSP Program is a discretionary program. However in some years, the projects awarded TCSP Program funding have been designated by Congress. In order to comply with Congressional designation, the FHWA Division offices will continue to be asked to identify the intended recipient of the TCSP designated grant. The specified grant recipient would then be asked to complete the grant application each fiscal year that they receive TCSP funding and submit it electronically.

Section 1117 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) provides funding for the Delta Region Transportation Development Program (DRTDP). The DRTDP supports and encourages multistate transportation planning and corridor development, provides for transportation project development, facilitates transportation decision making and supports transportation construction in the eight States comprising the Delta Region (Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee). A State transportation department or metropolitan planning organization in a Delta Region State may receive and administer funds provided under the program.

The 2-page DRTDP grant application is the tool used to collect the necessary information needed to successfully submit eligible DRTDP projects to the Secretary of Transportation for approval and for the distribution of DRTDP funds. The DRTDP grant application collects project information including general contact and funding information, a narrative project description, and information regarding statutory eligibility.

The DRTDP Program is a discretionary program. However in some years, the projects awarded DRTDP Program funding have been designated by Congress. In order to comply with Congressional designation, the FHWA Division offices will continue to be asked to identify the intended recipient of the DRTDP designated grant. The specified grant recipient would then be asked to complete the grant application each fiscal year that they receive DRTDP funding and submit it electronically.

The Transportation Planning Excellence Awards (TPEA) Program is a biennial awards program developed by the FHWA and the Federal Transit Administration (FTA) to recognize outstanding initiatives across the country to develop, plan and implement innovative transportation planning practices. The program is co-sponsored by the American Planning Association.

The on-line TPEA nomination form is the tool for submitters to nominate a process, group, or individual involved in a project or process that has used the FHWA and/or the FTA funding sources to make an outstanding contribution to the field of transportation planning. The information about the process, group or individual provided by the submitter may be shared and published if that submission is selected for an award.

The TPEA Program is a biennial awards program and individuals will be asked to submit nominations via the online form every two years. The participants will provide their information by means of the Internet.

Respondents: For the TCSP Program, 200 participants annually. For the DRTDP Program, 20 participants annually. For the TPEA, 150 participants biennially.

Frequency: For the TCSP Program, grant applications are solicited on an annual basis. For the DRTDP, grant applications are solicited on an annual basis. For the TPEA, nominations are solicited every two years.

Estimated Average Burden per Response: For the TCSP Program, approximately 120 minutes. For the DRTDP, approximately 90 minutes. For the TPEA Program, approximately 90 minutes.

Estimated Total Annual Burden Hours: For the TCSP Program, 400 hours annually. For the DRTDP, 30 hours annually. TPEA, 225 hours in the first year and 225 hours in the third year.