Notices. Notice

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BILLING CODE 6210-01-P OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of members of the updated OGE Senior Executive Service

(SES)Performance Review Board. EFFECTIVE DATE: September 20, 2007. FOR FURTHER INFORMATION CONTACT: Daniel D. Dunning, Deputy Director for Administration and Information Management, Office of Government Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917; Telephone: 202-482-9300; TDD: 202-208-9293; FAX: 202-482-9237. SUPPLEMENTARY INFORMATION: 5 U.S.C. 4314(c) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management at 5 CFR part 430, subpart C and § 430.310 thereof in particular, one or more Senior Executive Service performance review boards. As a small executive branch agency, OGE has just one board. In order to ensure an adequate level of staffing and to avoid a constant series of recusals, the designated members of OGE's SES Performance Review Board are being drawn, as in the past, in large measure from the ranks of other agencies. The board shall review and evaluate the initial appraisal of each OGE senior executive's performance by his or her supervisor, along with any recommendations in each instance to the appointing authority relative to the performance of the senior executive. This notice updates the membership of OGE's SES Performance Review Board as it was last published at 71 FR 71548-71549 (December 11, 2006). Approved: September 12, 2007. Robert I. Cusick, Director, Office of Government Ethics. The following officials have been selected as regular members of the SES Performance Review Board of the Office of Government Ethics: Marilyn L. Glynn [Chair], General Counsel, Office of Government Ethics; Daniel D. Dunning [Alternate Chair], Deputy Director for Administration and Information Management, Office of Government Ethics; Rosalind A. Knapp, Deputy General Counsel, Department of Transportation; Daniel L. Koffsky, Special Counsel, Office of Legal Counsel, Department of Justice; and David Maggi, Chief, Ethics Law and Programs Division, Office of the Assistant General Counsel for Administration, Department of Commerce. [FR Doc. E7-18518 Filed 9-19-07; 8:45 am] BILLING CODE 6345-02-P GOVERNMENT PRINTING OFFICE Depository Library Council to the Public Printer; Meeting The Depository Library Council to the Public Printer

(DLC)will meet on Monday, October 15, 2007, through Wednesday, October 17, 2007, at Doubletree Hotel Crystal City, located at Arlington, Virginia. The sessions will take place from 8 a.m. to 5 p.m. Monday through Wednesday. The meeting will be held at the Doubletree Hotel Crystal City, 300 Army Navy Drive, Arlington, Virginia. The purpose of this meeting is to discuss the Federal Depository Library Program. All sessions are open to the public. The sleeping rooms available at the Doubletree Hotel Crystal City will be at the Government rate of $ 201.00 (plus applicable state and local taxes, currently 10.25%) a night for a single or double. The Doubletree Hotel Crystal City is in compliance with the requirements of Title III of the Americans With Disabilities Act and meets all Fire Safety Act regulations. William H. Turri, Acting, Public Printer of the United States. [FR Doc. E7-18505 Filed 9-19-07; 8:45 am] BILLING CODE 1520-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Re-allotment of FY 2006 Funds for the Low Income Home Energy Assistance Program (LIHEAP) AGENCY: Office of Community Services, ACF, HHS. ACTION: Notice of determination concerning funds available for reallotment. *C.F.D.A. Number:* 93.568. SUMMARY: In accordance with Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), Title XXVI of the Omnibus Budget Reconciliation Act of 1981 (42 U.S.C. 8621, *et seq.* ), as amended, a notice was published in the **Federal Register** on August 1, 2007 announcing the Secretary's preliminary determination that $326,894 in Fiscal Year

(FY)2006 funds may be available for re-allotment. After a 30-day comment period, this amount has not changed. This notice announces that $326,894 will be re-allotted to current Low Income Home Energy Assistance Program (LIHEAP) grantees. Pursuant to the statute cited above, funds will be re-allotted to LIHEAP grantees based upon the normal allocation formula as if the funds had been appropriated for FY 2007. No subgrantees or other entities may apply for these funds. FOR FURTHER INFORMATION CONTACT: Nick St. Angelo, Director, Division of Energy Assistance, Office of Community Services, 370 L'Enfant Promenade, SW., Washington, DC 20447; telephone

(202)401-9351. Dated: September 13, 2007. Josephine B. Robinson, Director, Office of Community Services. [FR Doc. E7-18580 Filed 9-19-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0229] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 22, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0073. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance: Medical Devices: Current Good Manufacturing Practice Quality System Regulations—21 CFR Part 820 (OMB Control Number 0910-0073)—Extension Under section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), the Secretary of the Department of Health and Human Services (the Secretary) has the authority to prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety and effectiveness of a device), packing, storage, and installation of a device conform to current good manufacturing practices (CGMPs), as described in such regulations, to assure that the device will be safe and effective and otherwise in compliance with the act. The CGMP/Quality System (CGMP/QS) regulation implementing authority provided by this statutory provision is found under part 820 (21 CFR part 820) and sets forth basic CGMP requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all finished medical devices intended for human use. The authority for this regulation is covered under the act , i.e. 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383. The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process or product changes, and clarifies requirements for product acceptance activities quality data evaluations and corrections of nonconforming product/quality problems. Requirements are compatible with specifications in International Standards, “ISO 9001: “Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.” The CGMP/QS information collections will assist FDA inspections of manufacturers for compliance with QS requirements encompassing design, production, installation, and servicing processes. Section 820.20(a) through

(e)requires management with executive responsibility to establish, maintain, and/or review the following topics:

(1)The quality policy,

(2)the organizational structure,

(3)the quality plan, and

(4)the QS procedures of the organization. Section 820.22 requires the conduct and documentation of QS audits and re-audits. Section 820.25(b) requires the establishment of procedures to identify training needs and documentation of such training. Section 820.30(a)(1) and

(b)through (j), requires in respective order, the establishment, maintenance, and/or documentation of the following topics:

(1)Procedures to control design of class III and class II devices, and certain class I devices as listed therein;

(2)plans for design and development activities and updates;

(3)procedures identifying, documenting, and approving design input requirements;

(4)procedures defining design output, including acceptance criteria, and documentation of approved records;

(5)procedures for formal review of design results and documentation of results in the design history file (DHF);

(6)procedures for verifying device design and documentation of results and approvals in the DHF;

(7)procedures for validating device design, including documentation of results in the DHF;

(8)procedures for translating device design into production specifications;

(9)procedures for documenting, verifying, validating approved design changes before implementation of changes; and

(10)the records and references constituting the DHF for each type of device. Section 820.40 requires manufacturers to establish and maintain procedures controlling approval and distribution of required documents and document changes. Section 820.40(a) and

(b)requires the establishment and maintenance of procedures for the review, approval, issuance and documentation of required records (documents) and changes to those records. Section 820.50(a)(1), (a)(2), (a)(3), and

(b)requires the establishment and maintenance of procedures and requirements to ensure service and product quality, records of acceptable suppliers, and purchasing data describing specified requirements for products and services. Sections 820.60 and 820.65 require, respectively, the establishment and maintenance of procedures for identifying all products from receipt to distribution and for using control numbers to track surgical implants and life-sustaining or supporting devices and their components. Section 820.70(a)(1) through (a)(5),

(b)through (e), (g)(1) through (g)(3), (h), and

(i)requires the establishment, maintenance, and/or documentation of the following topics:

(1)Process control procedures;

(2)procedures for verifying or validating changes to specification, method, process, or procedure;

(3)procedures to control environmental conditions and inspection result records;

(4)requirements for personnel hygiene;

(5)procedures for preventing contamination of equipment and products;

(6)equipment adjustment, cleaning, and maintenance schedules;

(7)equipment inspection records;

(8)equipment tolerance postings; procedures for utilizing manufacturing materials expected to have an adverse effect on product quality; and

(9)validation protocols and validation records for computer software and software changes. Sections 820.72(a), (b)(1), and (b)(2) and 820.75(a) through

(c)require, respectively, the establishment, maintenance, and/or documentation of the following topics:

(1)Equipment calibration and inspection procedures;

(2)national, international or in-house calibration standards;

(3)records that identify calibrated equipment and next calibration dates;

(4)validation procedures and validation results for processes not verifiable by inspections and tests;

(5)procedures for keeping validated processes within specified limits;

(6)records for monitoring and controlling validated processes; and

(7)records of the results of revalidation where necessitated by process changes or deviations. Sections 820.80(a) through

(e)and 820.86 require, respectively, the establishment, maintenance, and/or documentation of the following topics:

(1)Procedures for incoming acceptance by inspection, test or other verification;

(2)procedures for ensuring that in-process products meet specified requirements and the control of product until inspection and tests are completed;

(3)procedures for, and records that show, incoming acceptance or rejection is conducted by inspections, tests or other verifications;

(4)procedures for, and records that show, finished devices meet acceptance criteria and are not distributed until device master record

(DMR)activities are completed;

(5)records in the device history record

(DHR)showing acceptance dates, results and equipment used; and

(6)the acceptance/rejection identification of products from receipt to installation and servicing. Sections 820.90(a), (b)(1), (b)(2), and 820.100 require, respectively, the establishment, maintenance and/or documentation of the following topics:

(1)Procedures for identifying, recording, evaluating, and disposing of nonconforming product;

(2)procedures for reviewing and recording concessions made for, and disposition of, nonconforming product;

(3)procedures for reworking products, evaluating possible adverse rework effect and recording results in the DHR;

(4)procedures and requirements for corrective and preventive actions, including analysis, investigation, identification and review of data, records, causes and results; and

(5)records for all corrective and preventive action activities. Section 820.100(a)(1) through (a)(7) states that procedures and requirements shall be established and maintained for corrective/preventive actions, including the following:

(1)Analysis of data from process, work, quality, servicing records; investigation of nonconformance causes;

(2)identification of corrections and their effectiveness;

(3)recording of changes made; and

(4)appropriate distribution and managerial review of corrective and preventive action information. Section 820.120 states that manufacturers shall establish/maintain procedures to control labeling storage/application; and examination/release for storage and use, and document those procedures. Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b), 820.160(a) and (b), and 820.170(a) and (b), respectively, require the establishment, maintenance, and/or documentation of the following topics:

(1)Procedures for controlling and recording the storage, examination, release and use of labeling;

(2)the filing of labels/labeling used in the DHR;

(3)procedures for controlling product storage areas and receipt/dispatch authorizations;

(4)procedures controlling the release of products for distribution;

(5)distribution records that identify consignee, product, date, and control numbers; and

(6)instructions, inspection and test procedures that are made available, and the recording of results for devices requiring installation. Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a) through (f), and 820.186 require, respectively, the maintenance of records that are:

(1)Retained at prescribed site(s), made readily available and accessible to FDA and retained for the device's life expectancy or for 2 years;

(2)contained or referenced in a DMR consisting of device, process, quality assurance, packaging and labeling, and installation, maintenance, and servicing specifications and procedures;

(3)contained in a DHR and demonstrate the manufacture of each unit, lot or batch of product in conformance with DMR and regulatory requirements, include manufacturing and distribution dates, quantities, acceptance documents, labels and labeling, control numbers; and

(4)contained in a quality system record (QSR), consisting of references, documents, procedures and activities not specific to particular devices. Sections 820.198(a) through

(c)and 820.200(a) through (d), respectively, requires the establishment, maintenance and/or documentation of the following topics:

(1)Complaint files and procedures for receiving, reviewing, and evaluating complaints;

(2)complaint investigation records identifying the device, complainant, and relationship of the device to the incident;

(3)complaint records that are reasonably accessible to the manufacturing site or at prescribed sites;

(4)procedures for performing and verifying that device servicing requirements are met and that service reports involving complaints are processed as complaints; and

(5)service reports that record the device, service activity, and test and inspection data. Section 820.250 requires the establishment and maintenance of procedures to identify valid statistical techniques necessary to verify process and product acceptability; and sampling plans, when used, that are written and based on valid statistical rationale, and procedures for ensuring adequate sampling methods. The CGMP/QS regulation amends and revises the CGMP requirements for medical devices set out under part 820. The regulation adds design and purchasing controls; modifies previous critical device requirements; revises previous validation and other requirements; and harmonizes device CGMP requirements with QS specifications in the international standard, “ISO 9001: Quality Systems Model for Quality Assurance in Design/Development Production, Installation and Servicing.” The rule does not apply to manufacturers of components or parts of finished devices, nor to manufacturers of human blood and blood components subject to 21 CFR part 606. With respect to devices classified in class I, design control requirements, apply only to class I devices listed in § 820.30(a)(2) of the regulation. The rule imposes burden upon:

(1)Finished device manufacturer firms which are subject to all recordkeeping requirements;

(2)finished device contract manufacturers; specification developers; and

(3)repacker, relabelers and contract sterilizer firms, which are subject only to requirements applicable to their activities. In addition, re-manufacturers of hospital single-use devices

(SUDs)will now be considered to have the same requirements as manufacturers in regard to this regulation. The establishment, maintenance and/or documentation of procedures, records and data required by this regulation will assist FDA in determining whether firms are in compliance with CGMP requirements, which are intended to ensure that devices meet their design, production, labeling, installation, and servicing specifications and, thus are safe, effective and suitable for their intended purpose. In particular, compliance with CGMP design control requirements should decrease the number of design-related device failures that have resulted in deaths and serious injuries. The CGMP/QS regulation applies to approximately 8,963 respondents. These recordkeepers consist of 8,945 original respondents and an estimated 18 hospitals which remanufacture or reuse SUDs. They include manufacturers, subject to all requirements and contract manufacturers, specification developers, repackers, relabelers and contract sterilizers, subject only to requirements applicable to their activities. Hospital remanufacturers of SUDs are now defined to be manufacturers under guidelines issued by FDA's Center for Devices and Radiological Health's (CDRH), Office of Surveillance and Biometrics. Respondents to this collection have no reporting activities, but must make required records available for review or copying during FDA inspection. The regulation contains additional recordkeeping requirements in such areas as design control, purchasing, installation, and information relating to the remanufacture of SUDs. The estimates for this burden are derived from those incremental tasks that were determined when the new CGMP/QS regulation became final as well as those carryover requirements. The carryover requirements are based on decisions made by the agency on July 16, 1992, under OMB clearance submission 0910-0073, which still provides valid baseline data. FDA estimates respondents will have a total annual recordkeeping burden of approximately 3,076,370 hours. This figure also consists of approximately 143,052 hours spent on a startup basis by 650 new firms. In the **Federal Register** of Monday, July 9, 2007, FDA published a 60-day notice soliciting public comments on the information collection requirements for the proposed extension of this collection of information. In response to that notice, no comments were received. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Hours Hours Per Recordkeeper Total Hours 820.20(a) 8,963 1 8,963 6.58 58,977 820.20(b) 8,963 1 8,963 4.43 39,706 820.20(c) 8,963 1 8,963 6.17 55,302 820.20(d) 8,963 1 8,963 9.89 88,644 820.20(e) 8,963 1 8,963 9.89 88,644 820.22 8,963 1 8,963 32.72 293,269 820.25(b) 8,963 1 8,963 12.68 113,651 820.30(a)(1) 8,963 1 8,963 1.75 15,685 820.30(b) 8,963 1 8,963 5.95 53,330 820.30(c) and

(d)8,963 1 8,963 1.75 15,685 820.30(e) 8,963 1 8,963 23.39 209,645 820.30(f) and

(g)8,963 1 8,963 37.42 335,395 820.30(h) 8,963 1 8,963 3.34 29,936 820.30(i) 8,963 1 8,963 17.26 154,701 820.30(j) 8,963 1 8,963 2.64 23,662 820.40 8,963 1 8,963 8.91 79,860 820.40(a)and

(b)8,963 1 8,963 2.04 18,285 820.50(a)(1) through (a)(3) 8,963 1 8,963 21.90 196,290 820.50(b) 8,963 1 8,963 6.02 53,957 820.6 8,963 1 8,963 0.32 2,868 820.65 8,963 1 8,963 0.67 6,005 820.70(a)(1) through (a)(5), (b), and

(c)8,963 1 8,963 1.85 16,582 820.70(d) 8,963 1 8,963 2.87 25,724 820.70(e) 8,963 1 8,963 1.85 16,582 820.70(g)(1) through (g)(3) 8,963 1 8,963 1.43 12,817 820.70(h) 8,963 1 8,963 1.85 16,582 820.70(i) 8,963 1 8,963 7.50 67,223 820.72(a) 8,963 1 8,963 4.92 44,098 820.72(b)(1) and (b)(2) 8,963 1 8,963 1.43 12,817 820.75(a) 8,963 1 8,963 2.69 24,110 820.75(b) 8,963 1 8,963 1.02 9,142 820.75(c) 8,963 1 8,963 1.11 9,949 820.80(a) through

(e)8,963 1 8,963 4.80 43,022 820.86 8,963 1 8,963 0.79 7,081 820.90(a), (b)(1), and (b)(2) 8,963 1 8,963 4.95 44,367 820.100 (a)(1) through (a)(7) 8,963 1 8,963 12.48 111,858 820.100(b) 8,963 1 8,963 1.28 11,473 820.120(b) and

(d)8,963 1 8,963 0.45 4,033 820.130 8,963 1 8,963 0.45 4,033 820.140 8,963 1 8,963 6.34 56,825 820.150(a) and

(b)8,963 1 8,963 5.67 50,820 820.160(a) and

(b)8,963 1 8,963 0.67 6,005 820.170(a) and

(b)8,963 1 8,963 1.50 13,445 820.180(b) and

(e)8,963 1 8,963 1.21 10,845 820.184(a) through

(f)8,963 1 8,963 1.41 12,638 820.186 8,963 1 8,963 0.40 3,585 820.198(a) through

(d)8,963 1 8,963 2.61 23,393 820.25 8,963 1 8,963 0.67 6,005 Totals 3,072,337 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Burden (labor) hour and cost estimates were originally developed under FDA contract by Eastern Research Group, Inc. (ERG), in 1996 when the CGMP/QS regulation became final. These figures are still accurate. Additional factors considered in deriving estimates included: • Establishment Type: Query has been made of CDRH's registration/listing databank and has counted 8,963 domestic firms subject to CGMPs. In addition, hospitals which reuse or remanufacture devices are now considered manufacturers under new FDA guidance. After investigations of many hospitals and the changes in enforcements of FDA's requirements for hospitals, the number of reuse or remanufactures of SUDs have decreased from the estimated 66 to an estimated 18 hospitals. Because the total number of registered firms is not static, the number of respondents will fluctuate from year to year resulting in slight changes to the overall burden. Currently, there are 8,963 firms subject to the CGMPs; an increase from the last renewal of 8,254. • Potentially Affected Establishments: Except for manufacturers, not every type of firm is subject to every CGMP/QS requirement. For example, all are subject to FDA's quality policy regulations (§ 820.20(a)), document control regulations (§ 820.40), and other requirements, whereas only manufacturers and specification developers are subject to FDA's design controls regulations (§ 820.30). The type of firm subject to each requirement was identified by ERG. FDA estimates the burden hours (and costs) based on the last approved renewal for this information collection. FDA estimates that some 650 “new” establishments (marketing devices for the first time) will expend some 143,052 “development” hours on a one-time startup basis to develop records and procedures for the CGMP/QS regulation. FDA estimates that annual labor hours are apportioned as follows: 40 percent goes to requirements dealing with manufacturing specifications, process controls and the DHR; 20 percent goes to requirements dealing with components and acceptance activities; 25 percent goes to requirements dealing with equipment, records (the DMR and QSR), complaint investigations, labeling/packaging and reprocessing/investigating product nonconformance; and 15 percent goes to quality audit, traceability, handling, distribution, statistical, and other requirements. Dated: September 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18582 Filed 9-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Educational Workshops on Current Good Manufacturing Practices; Public Workshops AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshops. SUMMARY: The Food and Drug Administration

(FDA)is announcing a series of educational workshops on quality pharmaceutical production under current good manufacturing practice (CGMP). The workshops, which will be held in collaboration with the Parenteral Drug Association (PDA), are intended to educate participants on current methods for compliance with good manufacturing practices (GMP). The workshops are being offered to help ensure effective CGMP programs and to further the common goals of FDA and providers of quality pharmaceutical products. DATES: See table 1 in the SUPPLEMENTARY INFORMATION section of this document. ADDRESSES: See table 1 in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Erik N. Henrikson, Center for Drug Evaluation and Research (HF-18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-9190, *erik.henrikson@fda.hhs.gov* , or Wanda Neal, Parenteral Drug Association, 4350 East West Hwy., suite 200, Bethesda, MD 20814, 301-656-5900, FAX: 301-986-0296, *neal@pda.org* . SUPPLEMENTARY INFORMATION: I. General Information A. Who Should Attend? This announcement is directed towards professionals involved in the manufacture, control, and regulation of pharmaceutical products who will benefit from these workshops, including process/production engineers, manufacturing personnel, quality assurance/quality control and regulatory affairs professionals, consultants, regulatory investigators, and CGMP compliance officials. Other entities or individuals may also be interested in attending. B. Where and When Will These Workshops Be Held? We have scheduled four workshops. The locations and times are listed in table 1 of this document. **Table 1.—Workshop Locations and Schedules** Workshop Address Dates and Local Times Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814 November 1 and 2, 2007, from 9 a.m. to 5 p.m. each day The Gresham Hotels, 23 Upper O'Connell St., Dublin 1, Ireland December 10 and 11, 2007, from 9 a.m. to 5 p.m. each day Peking University, Beijing, China 100871 April 21 and 22, 2008, from 9 a.m. to 5 p.m. each day Grand Hyatt Shanghai, Jin Mao Tower, 88 Century Blvd., Pudong, Shanghai, China 200121 April 24 and 25, 2008, from 9 a.m. to 5 p.m. each day C. How Can I Participate? You can participate in person. Anyone interested in the GMP workshops can register through the contact person (see FOR FURTHER INFORMATION CONTACT ). D. Is There a Registration Fee for This Workshop? Yes, a registration fee is required for this workshop. The registration fee includes workshop reference materials and meals. Registration fees for the Bethesda, MD and Dublin, Ireland workshops are listed in table 2 of this document. The registration fee for both China locations (Beijing and Shanghai) is $550 with no discounts. All fees are given in U.S. dollars. **Table 2.—Registration Fees for the Bethesda, MD and Dublin, Ireland Workshops** Date of Registration PDA Member Nonmember Government Employee or Health Authority Academic Student Through October 1, 2007 $1,295 $1,695 $350 $350 1 $150 After October 1, 2007 $1,495 $1,895 $405 $405 1 $180 1 Must be PDA member to receive this rate. E. How Can I Get Additional Information? The notice of participation form, information about the workshops, and other related documents are available from the contact person (see FOR FURTHER INFORMATION CONTACT ) and on the Internet at *http://www.fda.gov/cder/workshop.htm* . II. Background Information A. Why Is FDA Cosponsoring These Workshops? FDA is cosponsoring these 2-day workshops to provide information and training opportunities for industry as well as CGMP compliance officials. B. What Will Be Covered? The workshops will provide information on specific topics designed to educate and guide participants on methodologies and implementation of CGMP as applied to quality drug manufacturing. Presentations by both FDA and industry will provide a regulatory and practical perspective on the current relevant critical topics. Dated: September 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18556 Filed 9-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Children's Hospital Graduate Medical Education (CHGME) Payment Program Annual Report: NEW The CHGME Payment Program was enacted by Public Law 106-129 to provide Federal support for graduate medical education

(GME)to freestanding children's hospitals, similar to Medicare GME support received by other non-children's hospitals. The legislation mandates that eligible children's hospitals will receive payments for both direct and indirect medical education. Direct payments are designed to offset the expenses associated with operating approved graduate medical residency training programs and indirect payments are designed to compensate hospitals for expenses associated with the treatment of more severely ill patients and the additional costs relating to teaching residents in such programs. The CHGME Payment Program was reauthorized for a period of five years in October 2006 by Public Law 109-307. The reauthorizing legislation requires that children's hospitals participating and receiving funds from the CHGME Payment Program provide information about their residency training programs in an annual report that will be an addendum to the hospitals' annual applications for funds. Specifically, data are required to be collected on:

(1)The types of training programs that the hospital provided for residents such as general pediatrics, internal medicine/pediatrics, and pediatric subspecialties including both American Board of Pediatrics certified medical subspecialties and non-medical subspecialties approved by other medical certification boards;

(2)the number of training positions for residents, the number of such positions recruited to fill, and the number of positions filled;

(3)the types of training that the hospital provided for residents related to the health care needs of difference populations such as children who are underserved for reasons of family income or geographic location, including rural and urban areas;

(4)changes in residency training the hospital made during an academic year, including changes in curricula, training experiences, and types of training programs, and benefits that have resulted from such changes and changes for purposed of training residents in the measurement and improvement and the quality and safety of patient care; and

(5)the numbers of residents (disaggregated by specialty and subspecialty) who completed training in the academic year and provide care within the borders of the service area of the hospital or within the borders of the State in which the children's hospital is located. For purposes of the annual report data collection, “residents” are those who are

(1)in full-time equivalent resident training positions in any training program sponsored by the hospital; or

(2)in a training program sponsored by an entity other than the hospital who spend more than 75 percent of their time training at the hospital. The annual report data collection instruments consist of Excel workbooks with several pages (worksheets) each. These data collection instruments for the annual report were pre-tested by nine participating CHGME Payment Program hospitals. Each hospital provided an estimate of the number of hours required to complete each part of the annual report. Following the pre-test, the data collection instruments were significantly reduced by collapsing certain categories, shifting several questions from the individual GME training program level to the hospital level instrument, and by omitting several questions. As a result, the estimated burden to each respondent was significantly reduced. The estimated annual burden is as follows: Form name Number of respondents Responses per respondent Total number of responses Hours per response Total burden hours Screening Instrument 57 1 57 10.0 570.0 Annual Report, Hospital and Program-Level Information 57 1 57 74.8 4263.6 Total 57 57 84.8 4833.6 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: September 14, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-18561 Filed 9-19-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Final Policy Guidance AGENCY: Health Resources and Services Administration, HHS. ACTION: Final Agency Guidance and Response to Public Comments. SUMMARY: The Health Resources and Services Administration

(HRSA)is publishing a final Agency Guidance (“Policy Information Notice”

(PIN)2007-16) to describe and clarify the circumstances under which Federal Tort Claims Act (FTCA)—deemed Health Center Program grantees are covered under the FTCA as they respond to emergencies. The PIN, “Federal Tort Claims Act Coverage for Health Center Program Grantees Responding to Emergencies,” and the Agency's “Response to Public Comments” are available on the Internet at *http://bphc.hrsa.gov/policy/pin0716.* DATES: The effective date of this final Agency guidance is August 22, 2007. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver comprehensive, culturally competent, quality primary health care services to patients regardless of their ability to pay. Charges for health care services are set according to income. On March 15, 2007, HRSA made the draft PIN, “Federal Tort Claims Act Coverage for Health Center Program Grantees Responding to Emergencies,” available for public comment on HRSA's Web site. Comments were due to HRSA by May 31, 2007. Comments were received from 14 organizations and/or individuals. After review and careful consideration of all comments received, HRSA has amended the PIN to incorporate certain recommendations from the public. The final PIN reflects these changes. In addition to making the final PIN available on HRSA's Web site, HRSA is also posting the Agency's “Response to Public Comments.” The purpose of that document is to summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments did not result in a revision to the PIN, explanations are provided. FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, please contact the Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, at 301-594-4300. Dated: September 14, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-18562 Filed 9-19-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Final Policy Guidance AGENCY: Health Resources and Services Administration, HHS. ACTION: Final Agency Guidance and Response to Public Comments. DATES: The effective date of this final Agency guidance is August 22, 2007. SUMMARY: The Health Resources and Services Administration

(HRSA)is publishing a final Agency Guidance (“Policy Information Notice”

(PIN)2007-15) to provide guidance on emergency management expectations for health centers to assist them in planning and preparing for future emergencies through the development and maintenance of an effective and appropriate emergency management strategy. The PIN, “Health Center Emergency Management Program Expectations,” and the Agency's “Response to Public Comments” are available on the Internet at *http://bphc.hrsa.gov/policy/pin0715.* *Background:* HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver comprehensive, culturally competent, quality primary health care services to patients regardless of their ability to pay. Charges for health care services are set according to income. On February 27, 2007, HRSA made the draft PIN available for public comment on HRSA's Web site. The purpose of the PIN was to provide guidance on emergency management expectations for health centers to assist them in planning and preparing for future emergencies. Comments were due to HRSA by April 13, 2007. Comments were received from 31 organizations and/or individuals. After review and careful consideration of all comments received, HRSA amended the PIN to incorporate certain recommendations from the public. The final PIN reflects these changes. In addition to making the final PIN available on HRSA's Web site, HRSA is also posting the Agency's “Response to Public Comments.” The purpose of the document is to summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments did not result in a revision to the PIN, explanations are provided. FOR FURTHER INFORMATION CONTACT: Please contact the Office of Policy and Program Development at

(301)594-4300 for any questions regarding this PIN. Dated: September 14, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-18560 Filed 9-19-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on

(240)276-1243. Project: Independent Evaluation of the Substance Abuse Prevention and Treatment Block Grant Program—NEW The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT), Division of State and Community Assistance administers the Substance Abuse Prevention and Treatment Block Grant (SAPT BG) in collaboration with the Center for Substance Abuse Prevention (CSAP), Division of State Programs. The Substance Abuse Prevention and Treatment Block Grant is funded by Congress to provide monies to States, Territories, and one Native American Tribe for the purpose of planning, carrying out, and evaluating activities to prevent and treat substance abuse and other allowable activities. The SAPT BG constitutes approximately 40 percent of all States budgets for substance abuse prevention and treatment services and activities, and is the primary Federal source of funding. States have flexibility in determining how funds should be allocated, but there are specific set-aside and maintenance of effort requirements that must be met in order to receive funding. These requirements, introduced by both the ADAMHA Reorganization Act of 1992 and the Children's Health Act of 2000, are listed below: Table 1.—SAPT BG Set-Aside Provisions a Category Set-aside provision Prevention and treatment activities regarding alcohol Not less than 35 percent of SAPT BG funding*. Prevention and treatment activities regarding other drugs Not less than 35 percent of SAPT BG funding*. Primary prevention programs Not less than 20 percent of SAPT BG funding. Pregnant women and women with dependent children Not less than amount equal to expenditure in FY 1994. Tuberculosis services No set amount but services must be provided to receive SAPT BG funds. HIV services b No more than 5 percent increase over State allotment for HIV services in FY 1991. Prohibition of sale of tobacco to individuals under age of 18 (Synar amendment) State must enforce law against sale of tobacco to underage individuals to receive SAPT BG funds—noncompliance leads to a 10 percent reduction in funds the first applicable fiscal year; 20 percent, the second year; 30 percent, the third year; and 40 percent, the fourth year. Maintenance of effort

(MOE)for State expenditures State will maintain funding at no less than the average level of expenditures for the 2 years preceding the fiscal year for which the State is applying. Administrative expenses Limited to 5 percent of SAPT BG funding. a These set-asides shown in this table were included in the 1992 SAPT BG authorizing legislation 42 U.S.C. 300x-21 to 42 U.S.C. 300x-62). In the Children's Health Act of 2000 (Pub. L. 106-310) Sec. 3303(a)(1)), however, the set-asides marked with asterisks were removed. b For designated States whose rate of AIDS cases is 10 or more per 100,000 individuals as confirmed by the Centers for Disease Control and Prevention. In addition to the set-asides, the SAPT BG Program has identified 17 goals which must be met by States in order to receive this Federal funding: Table 2.—Federal Goals for the Substance Abuse Prevention and Treatment Block Grant GOAL #1: Continuum of substance abuse treatment services The State shall expend block grant funds to maintain a continuum of substance abuse treatment services that meet these needs for the services identified by the state (see 42 U.S.C. 300x-21(b) and 45 CFR 96.122(f)(g)). GOAL #2: Spending on primary prevention programs The State agrees to spend not less than 20 percent on primary prevention programs for individuals who do not require treatment for substance abuse, specifying the activities proposed for each of the six strategies (see 42 U.S.C. 300x-22(b)(1) and 45 CFR 96.124(b)(1)). GOAL #3: Spending on services for pregnant women and children The State agrees to expend not less than an amount equal to the amount expended by the State for FY 1994 to establish new programs or expand the capacity of existing programs to make available treatment services designed for pregnant women and children with dependent children; and, directly or through arrangements with other public or nonprofit entities, to make available prenatal care to women receiving such treatment services, and, while the women are receiving services, child care (see 42 U.S.C. 300x-22(c)(1) and 45 CFR 96.124(c)(e)). GOAL #4: Treatment for intravenous drug abusers The State agrees to provide treatment to intravenous drug abusers that fulfills the 90 percent capacity reporting, 14-120 day performance requirement, interim services, outreach activities and monitoring requirements (see 42 U.S.C. 300x-23 and 45 CFR 96.126). GOAL #5: Tuberculosis services for people in substance abuse treatment The State agrees, directly or through arrangements with other public or nonprofit private entities, to routinely make available tuberculosis services to each individual receiving treatment for substance abuse and to monitor such service delivery (see 42 U.S.C. 300x-24 and 45 CFR 96.127). GOAL #6: Early intervention services for HIV for people in substance abuse treatment Designated States agree to provide treatment for persons with substance abuse problems with an emphasis on making available within existing programs early intervention services for HIV in areas of the state that have the greatest need for such services and to monitor such service delivery (see 42 U.S.C. 300x-24(b) and 45 CFR 96.128). GOAL #7: Group homes for recovering substance abusers Designated States agree to provide for and encourage the development of group homes for recovering substance abusers through the operation of a revolving loan fund (see 42 U.S.C. 300x-25 and 45 CFR 96.129). GOAL #8: State efforts to reduce the availability of tobacco products The State agrees to continue to have in effect a State law that makes it unlawful for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18; and, to enforce such laws in a manner than can reasonably be expected to reduce the extent to which tobacco products are available to individuals under age 18 (see 42 U.S.C. 300x-26 and 45 CFR 96.130). GOAL #9: Preferential admission of pregnant women to substance abuse treatment The State agrees to ensure that each pregnant woman be given preference in admission to treatment facilities; and, when the facility has insufficient capacity, to ensure that the pregnant woman be referred to the State, which will refer the woman to a facility that does have the capacity to admit the woman, or if no such facility has the capacity to admit the woman, will make available interim services within 48 hours (see 42 U.S.C. 300x-27 and 45 CFR 96.131). GOAL #10: Improved process for referring individuals to substance abuse treatment The State agrees to improve the process in the State for referring individuals to the treatment modality that is most appropriate for the individual (see 42 U.S.C. 300x-28 and 45 CFR 96.132(a)). GOAL #11: Continuing education for employees at substance abuse prevention and/or treatment facilities The State agrees to provide continuing education for the employees of facilities which provide prevention activities or treatment services (or both) (see 42 U.S.C. 300x-28(b) and 45 CFR 96.132(b)). GOAL #12: Coordination of services The State agrees to coordinate prevention activities and treatment services with the provision of other appropriate services (see 42 U.S.C. 300x-28(c) and 45 CFR 96.132(c)). GOAL #13: Needs assessment by State and locality The State agrees to submit an assessment of the need for both treatment and prevention in the State for authorized activities, both by locality and by the State in general (see 42 U.S.C. 300x-29 and 45 CFR 96.133). GOAL #14: Ensuring that needles and syringes are not provided for illegal drug use The State agrees to ensure that no program funded through the block grant will use funds to provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs (see 42 U.S.C. 300x-31(a)(1)(F) and 45 CFR 96.135(a)(6)). GOAL #15: Improving the quality and appropriateness of treatment services The State agrees to assess and improve, through independent peer review, the quality and appropriateness of treatment services delivered by provider that receive funds from the block grant (see 42 U.S.C. 300x-53(a) and 45 CFR 96.136). GOAL #16: Protecting patient records from inappropriate disclosure The State agrees to ensure that the State has in effect a system to protect patient records from inappropriate disclosure (see 42 U.S.C. 300x-53(b), 45 CFR 6.132(e), and 42 CFR part 2). GOAL #17: Compliance with 42 CFR part 54 Charitable Choice Provisions and Regulations The State agrees to ensure that the State has in effect a system to comply with 42 CFR part 54 (see 42 CFR 54.8(c)(4) and 54.8(b)) Charitable Choice Provisions and Regulations). Source: Performance Partnership Grant Branch, Division of State and Community Assistance, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, “Uniform Application, FY 2007, Substance Abuse Prevention and Treatment Block Grant (42 U.S.C. 300x-21 through 300x-64),” Rockville, MD, 2004. The FY 2003 Office of Management and Budget

(OMB)Program Assessment Rating Tool

(PART)assessment of the SAPT BG Program rated the program as “Ineffective.” The SAPT BG received high scores on three of four PART areas rated, including Program Purpose and Design, Strategic Planning, and Program Management. However, the scores could have been even higher in these areas if data were available to document that the resources were reaching the intended beneficiaries or the program had ambitious targets and long-term measures. In the fourth area, Program Results/Accountability, where a low rating was achieved, it was found that “no independent evaluation of the program has been completed” to establish that the SAPT BG Program is effective and fulfilling its legislative mandates. In direct response to this OMB finding, a contract was developed and awarded in FY 2003 to conduct an Evaluability Assessment

(EA)to determine the feasibility of conducting an independent evaluation of the SAPT BG Program, and subsequently, to fund such an evaluation effort. EA is a recognized program evaluation methodology which involves collaboration with multiple stakeholders and development of a program logic model used to plan formal evaluations of large and/or complex programs, such as the SAPT BG Program. The findings of the EA were used as a foundation in the development and awarding of a multi-year contract in FY 2004 to conduct an independent, comprehensive evaluation of the SAPT BG Program. As noted in the OMB PART Assessment, the legislative intent of the SAPT BG is to provide funding to States by formula to plan, carry out, and evaluate activities to prevent and treat substance abuse. Therefore, the evaluation is designed to examine the system-level activities, outputs, and outcomes associated with the program in relation to its goals. In this evaluation, a multi-method evaluation approach is being used to examine Federal and State performance with regard to the SAPT BG and its identified goals. This approach emphasizes a qualitative and quantitative examination of both the SAPT BG process (e.g., activities and outputs in the logic model) and system-level outcomes whereby Federal and State stakeholder perspectives on the SAPT BG, as captured through semi-structured interviews and surveys, are corroborated and compared to the considerable amount of already-collected source documents and data provided by States, CSAT, and CSAP (e.g., Web Block Grant Application System (BGAS), Treatment Episode Data Set (TEDS), National Survey on Drug Use and Health (NSDUH), the Minimum Data Set (MDS), Technical Review Reports, State Prevention and Synar System Reports). The purpose of the evaluation is to determine the extent to which States and the Federal Government are implementing the SAPT BG according to the authorizing legislation and implementing regulations. The evaluation will cover the following domains: The State SAPT BG planning process, Federal review of SAPT BG applications including annual reports, progress reports and intended use plans, Federal technical assistance, State SAPT BG implementation, Federal oversight and management, State SAPT BG reporting, and State-level outcomes. The results of this evaluation will not only document the effectiveness of the SAPT BG Program in supporting the Substance Abuse Prevention and Treatment system, they will also help guide CSAT and CSAP and the States to improve the methods by which they implement the SAPT BG, including the capacity to collect, analyze, and interpret the National Outcome Measures (NOMs). As a separate, parallel SAMHSA initiative, the NOMs project began after the SAPT BG Evaluation contract inception and was not used in the SAPT BG EA or the development of the evaluation framework and logic model. However, selected NOMs items that relate to the evaluation framework and logic model will be examined in the independent evaluation. These selected NOMs items include: • Increase in number of persons reporting a reduction in 30-day drug/alcohol use • Increase in number of persons employed or in school • Reduction in number of drug or alcohol-related arrests • Increase in number of persons in stable housing situations (reduction in homelessness) • Increase in access to services measured by unduplicated counts of persons served and numbers served compared to those in need • Increase in number of persons receiving evidence-based services. In addition, the evaluators will attempt to collect information on system-wide client perception of care. Statistical tests for association between outcome measures and a number of independent variables will be conducted. Examples of independent variables include, but are not limited to, level of funding, level of the Single State Agency

(SSA)for substance abuse services within State government, degree of SSA partnership with other State agencies and community organizations, and amount of State-funded support available for research and training activities. In addition to information about the selected NOMs domains, the evaluation will also examine systemic measures related to infrastructure. Infrastructure refers to the resources, systems, and policies that support the nation's public substance abuse prevention and treatment system, and is a potential contributor to significant State behavioral health system outcomes. Examples of infrastructure include staff training, policy changes, and service availability. Because this is the first-ever comprehensive evaluation of the SAPT BG Program, the data collection activities are more extensive (and time intensive) than would be expected of a program that has been regularly evaluated. These data will serve as a baseline for future evaluations. The two primary data collection strategies will include open-ended interviews and web-based surveys. Interviews will be conducted with Federal staff involved in the administration of the SAPT BG and State staff from all States and Territories involved in their State's implementation of the SAPT BG Program. Two web-based surveys will be administered to all individuals who formally participate in monitoring the SAPT BG as part of the Technical Review or State Prevention and Synar System Review Teams. The interview protocol for Federal staff includes 80 questions (mostly open-ended), and, on average, should take 90 minutes to complete. The interview protocol for the State staff includes 99 questions (again, mostly open-ended), and should take, on average, 3 hours to complete. Both the Federal staff interviews and the State staff interviews will be conducted as in-person interviews. While the Federal staff will each be interviewed individually, a single group State staff interview will be conducted for all relevant State staff. The SSA Directors will be asked to select those State staff who they believe are most knowledgeable about the SAPT BG for participation in the interviews. It is anticipated that, at a minimum, the State Planner, the State Data Analyst, the State Prevention Lead, the State Treatment Lead, one additional State staff member, and the State SSA Director will participate. The two web-based surveys will be distributed to the two current sets of formal reviewers for the SAPT BG: Technical Reviewers and State Prevention and Synar System Reviewers. The web-based surveys are designed so that each stakeholder group receives survey questions designed to capture their specific knowledge of and experience with the SAPT BG. The Technical Reviewer survey contains 47 questions and the State Prevention and Synar System Reviewer survey has 27 questions. Each survey should take approximately 1 hour or less to complete. Reviewers will submit their responses to the survey online over a 3-week period. Table 3 summarizes the estimated annual total burden hours for the in-person and web-based surveys for the Federal and State staff stakeholders and Technical Reviewers, Synar Reviewers. Table 3.—Estimated Reporting Burden of Interviews and Web-Based Surveys Respondents Number of respondents Average hours per interview/survey Estimated total burden (hours) In-person Interviews: State Substance Abuse Prevention and Treatment Agency Commissioner 60 3 180 State Planners 60 3 180 State Data Analysts 60 3 180 State Prevention Lead 60 3 180 State Treatment Lead 60 3 180 Additional State Staff 60 3 180 Federal SAPT Block Grant Staff 35 1.5 52.5 Subtotal 395 1,132 Web-based Interviews: Technical Reviewers 15 1 15 State Prevention and Synar System Reviewers 30 1 30 Subtotal 45 45 Total 440 1,177 This **Federal Register** Notice is focused on the interviews and surveys that will be administered to the SAPT BG stakeholders as those methods of data collection require OMB approval. It is anticipated that in future independent evaluations of the SAPT BG Program focus will be given to the NOMs and their implications for program performance and goals. Written comments and recommendations concerning the proposed information collection should be sent by October 22, 2007 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: September 12, 2007. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E7-18555 Filed 9-19-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration [Docket No. TSA-2006-24191; USCG-2007-27415] Transportation Worker Identity Credential

(TWIC)Biometric Reader Specification and TWIC Contactless Smart Card Application AGENCY: Transportation Security Administration; United States Coast Guard; DHS. ACTION: Notice of availability. SUMMARY: The Department of Homeland Security, through the U.S. Coast Guard (Coast Guard) and the Transportation Security Administration (TSA), announces the availability of the working specification for Transportation Worker Identification Credential

(TWIC)biometric readers and the TWIC contactless smart card application. This specification is based on recommendations to the Coast Guard and TSA from the National Maritime Security Advisory Committee (NMSAC); comments from the public following publication of the NMSAC recommendations and request for comment; and, the government's review of the NMSAC recommendations and comments received. The working specification is available to review at *www.tsa.gov/twic* and at *http://dms.dot.gov* in docket USCG-2007-27415. DATES: The reader specifications and card application are available September 20, 2007. FOR FURTHER INFORMATION CONTACT: John Schwartz, Office of Transportation Threat Assessment and Credentialing (TSA-19), Transportation Worker Identification Credential Program Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202-4220; telephone

(571)227-2177; facsimile

(703)603-0409; e-mail *john.schwartz@dhs.gov.* Reviewing Comments and the TWIC Working Technology Specification in the Docket Please be aware that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the applicable Privacy Act Statement published in the **Federal Register** on April 11, 2000 (65 FR 19477), or you may visit *http://dms.dot.gov.* You may review the comments in the public docket by visiting the Dockets Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Dockets Office is located in the West Building Ground Floor, Room W12-140, at the Department of Transportation address, previously provided under ADDRESSES. Also, you may review public dockets on the Internet at *http://dms.dot.gov.* Availability of Document You can get an electronic copy of this Notice and the actual working specifications using the Internet by—

(1)Searching the Department of Transportation's electronic Docket Management System

(DMS)Web page ( *http://dms.dot.gov/search* );

(2)Accessing the Government Printing Office's Web page at *http://www.gpoaccess.gov/fr/index.html* (Notice only); or

(3)Visiting TSA's Security Regulations Web page at *http://www.tsa.gov* and accessing the link for “Research Center” at the top of the page. In addition, copies are available by writing or calling the individual in the FOR FURTHER INFORMATION CONTACT section. Make sure to identify the docket number of this action. I. Background The National Maritime Security Advisory Council (NMSAC) was created pursuant to the Federal Advisory Committee Act, 5 U.S.C., App. 2

(FACA)in 2003. The membership of NMSAC, which includes 21 voting members, was selected to represent a broad range of viewpoints regarding maritime security challenges and to advise the Secretary of Homeland Security through the Commandant of the Coast Guard of relevant maritime security issues. At the NMSAC meeting of November 14, 2006, the Coast Guard and TSA asked NMSAC to provide advice on a contactless biometric smart card application and reader specification for TWIC by February 28, 2007, taking into account expertise from the biometric credentialing industry and maritime/TWIC industry stakeholders. The specification is necessary for biometric readers and the TWICs that will be issued to individuals in the initial rollout of the TWIC program, beginning in the fall of 2007, and that will be used in pilot programs required by the Security and Accountability for Every Port Act of 2006 (SAFE Port Act). 1 1 Pub. L. 109-347; October 13, 2006. TSA and Coast Guard provided NMSAC the following baseline requirements for the specification: 1. Be non-proprietary; 2. Incorporate appropriate security and privacy controls; 3. Be interoperable with FIPS 201-1 credential specifications; 4. Be capable of serving as a platform for future capabilities; 5. Be capable of supporting maritime operations; and 6. Be suitable for manufacturing. TSA and Coast Guard recommended that the task be addressed by dividing responsibilities to construct operational maritime requirements and technology specifications. We recommended that members of the maritime industry develop operational maritime requirements and address credential authentication ( *e.g.* authentication time and process, and alternate authentication procedures) requirements; durability requirements; and credential management procedures, including key management. We recommended that the biometric credentialing experts develop technology specifications, including a smart card, reader, and keying specifications. In the course of our discussions with NMSAC, members of the committee stated that they did not wish to recommend a specification that included encryption of the biometric and corresponding processes to decrypt the biometric when the card engages the reader. Many of the NMSAC members asserted that encryption was not necessary because the biometric—a fingerprint minutiae template, rather than an actual fingerprint—should not require the added protection that encryption provides. Also, members of NMSAC did not want to take on the additional responsibility of key management, which would be necessary if the recommended specification included encryption. However, TSA and Coast Guard disagreed with NMSAC's suggestion that the fingerprint template does not need to be encrypted and therefore asked NMSAC to provide one specification with encryption of the biometric and a corresponding process to decrypt the biometric when the card engages the reader. The formal request from the TWIC program to NMSAC is available at the following URL: *http://homeport.uscg.mil,* and in the docket for this notice. On March 1, 2007, the Coast Guard received NMSAC's report, entitled “Recommendations on Developing a Contactless Biometric Specification for the TWIC.” The report included two specifications. The first recommended specification, preferred by NMSAC for the reasons discussed in the paragraph above, does not provide for encryption of the TWIC cardholder's biometric fingerprint minutiae template. Without encryption, the template is transmitted in the clear and could be read by a third party whenever the card is energized by a contactless reader. Therefore, there is a risk that the template on the TWIC could be read without the knowledge or overt action of the cardholder. NMSAC's second specification includes encryption of the biometric fingerprint minutiae template, which will protect the template from being decrypted unless information on the card's magnetic stripe or contact integrated circuit chip (ICC), is also provided to the reader. The information on the card's magnetic strip (or ICC) is needed to decrypt the template, which is obtained contactlessly from the card. This method of encryption protects the template from being read even if it is obtained covertly since the information on the card's magnetic stripe (or ICC) cannot be obtained without physical possession of the card. If a TWIC is physically obtained by someone other than the rightful owner, the information necessary to obtain and decrypt the template would be available to them. Note that each TWIC will contain three magnetic stripes and the first is reserved exclusively for TSA's use to store encryption information. Owner/operators may use the remaining two magnetic stripes for information that facilitates the use of local access control systems so long as doing so does not interfere with the information encoded by TSA on the first magnetic stripe that allows contactless operation of the TWIC. Technical specifications for the magnetic stripe and areas reserved for TSA use are contained in the TWIC contactless card and reader working specification. In March 2007, the Coast Guard published a Notice of Availability of the NMSAC Recommendations and requested comments from all interested parties. (72 FR 12626, March 16, 2007.) In addition to requesting general comments, Coast Guard asked the public to respond to specific questions, including:

(1)Whether the use of a Personal Identification Number

(PIN)is justified to further minimize the chance that a fingerprint template from a lost or stolen credential could be obtained by an unauthorized individual;

(2)what, if any, privacy concerns exist if the fingerprint template is obtained by an unauthorized individual;

(3)how the recommended specifications impact maritime security and operations;

(4)how the recommended specifications impact existing physical access control systems (PACS);

(5)whether TSA and Coast Guard should consider alternative designs;

(6)how the recommended specifications impact product, system, and operational costs;

(7)how quickly the recommended specifications could be incorporated into the design and manufacture of access control equipment; and

(8)whether there should be a qualified products list

(QPL)or equivalent regime. Over thirty separate entities submitted comments to these questions. The majority of commenters represented the maritime industry, but several technology companies and trade associations also responded. Generally, the commenters praised the work of the NMSAC TWIC Contactless Specification Workgroup. TSA and Coast Guard agree that NMSAC delivered excellent recommendations in a very short time-frame, and we greatly appreciate NMSAC's efforts in this important security endeavor. In the following section, we summarize all comments received. II. Summary of Comments Question 1—Additional Security Features Commenters generally agreed that the additional security feature mentioned, a PIN, was not a good idea for general use due to operational concerns. Others stated that a PIN should be considered only if it could be used in a way that does not adversely impact maritime operations. Many commenters stated that TWIC holders would likely forget their PINs, which would become burdensome to TWIC users and maritime operations. As for PIN length, the few who commented prefer a 4-digit PIN over a longer PIN. Only one commenter discussed an alternative security feature—the use of a smart card holder that protects information stored on the card's integrated circuit chip until the holder is activated by the card holder's live biometric. At least one commenter suggested that to help deter fraudulent use of the TWIC, fingerprint scanners associated with card readers should be able to confirm that the fingerprint being presented is that of a live person rather than an artificial replica of a fingerprint or fingerprint template. This capability is called “liveness” detection. Question 2—Privacy Concerns Most commenters from the maritime industry stated that maintaining the privacy of the information stored on the card is important, but they do not believe additional measures are necessary to protect the privacy of biometric fingerprint templates. However, commenters from the technology industry generally asserted that biometric fingerprint templates should be protected, and that the TWIC Privacy Key

(TPK)scheme provided in NMSAC's alternative recommended specification is sufficient to protect the template. Question 3—Vessel and Facility Security Operations A number of maritime commenters stated that use of a PIN and TPK card swipe scheme, and, encryption of the fingerprint biometric template have the potential to adversely impact port and facility operations. Specifically, commenters expressed concern about error rates that might impact gate throughput, particularly during times of high-volume access; and, the effect of requiring the use of both PINs and biometrics at certain Maritime Security (MARSEC) levels. Commenters also mentioned that the upcoming TWIC pilot program that TSA and Coast Guard are implementing to test card and reader interaction will be helpful in identifying impacts on facility and vessel operations. Question 4—Impacts on Existing Physical Access Control Systems Commenters generally agreed that the TWIC program will have a significant impact on existing PACS if the two are integrated and will be duplicative if they are not. They cited the need for replacing or enhancing existing systems; additional trenching and related construction activities; and, installing or upgrading electrical power supplies and wiring to readers as examples of the impacts TWIC will have on existing PACS. Some commenters mentioned that the use of TPK would impact legacy PACS by requiring the modification or replacement of existing readers to include a magnetic stripe reading capability. Some commenters expressed concern that multiple credentials may be required of certain workers at certain locations and that multiple credentials would have to be processed to allow entry. Several commenters asserted that the cost of integration should be supported by Federal grant funding. One commenter suggested that TWIC PACS requirements should have a long phase-in period to allow facilities to use legacy equipment through the end of its useful life. Question 5—Alternative Designs Commenters mentioned that any alternative designs should be evaluated in the context of the maritime operating requirements established by the NMSAC working group. Several commenters suggested that the short time period allotted for development of the technical specification may have prevented alternative designs from emerging. However, a technology industry commenter stated that alternatives were considered and rejected by the technology team during their deliberations. The commenter stated that the following alternative designs were considered and rejected: 1. Shared Symmetric Keys Key management is operationally complex and exposure of the key would have a negative impact on the entire TWIC system. Shared symmetric keys rely on one secret key to be distributed among all readers and cards to establish secure communications between card and reader. Keys must be changed regularly, and securely distributed and stored to maintain system security. Secure key management would be difficult to accomplish due to the number and dispersion of TWIC readers. 2. Public Key Infrastructure

(PKI)In a PKI system, secure communication and authentication are done using public key certificates which require online communication. The fragmented TWIC PACS would lack the real-time network access required of a PKI system. 3. Biometric Match-on-Card

(MOC)MOC involves matching a biometric sample against a reference biometric template stored inside the secure environment of a smart card. The reference template cannot be read outside of the card, but is only used internally by the matching process inside the smart card. MOC is a relatively new approach within the smart card and biometrics industries and provides a good level of security and privacy. This is because the user's biometric information is protected by the smart card and is never released from the card. Internal to the smart card, MOC matches the user's live biometric template provided by an external biometric reader with the user's stored reference template. A major advantage to MOC over other approaches is that the card never releases personally identifying information (the biometric template) to the reader. Thus, the biometric could not be lifted or “skimmed” by an unauthorized individual. Also, under the MOC process, the need for reader authentication and associated reader key management is minimized because the reader only stores public keys that do not need to be protected from disclosure by using a Secure Access Module

(SAM)to store secret keys to identify a particular smart card. With MOC, the transmission of the biometric template from the reader to the card is done using the public key and can only be decrypted using the private key that is stored securely on the smart card. For all of these reasons, MOC is a very promising technology to pursue. However, it has not been fully tested in a variety of laboratory or field settings and currently, there are no approved MOC standards. Therefore, we have determined that it would not be advisable to implement MOC for the upcoming TWIC rollout. We will continue to follow the development of MOC and if it matures for operational use, we will again consider its use in the maritime environment. One commenter requested that the distance between the card reader and the card be increased from four to 18 inches to allow truck drivers to remain in their cabs while their TWICs are read. Some commenters reiterated their view that the specification should not include encryption in any form. Question 6—Cost Impacts A number of commenters reiterated their endorsement of NMSAC's non-encryption recommendation to minimize costs. Commenters who operate existing PACS expressed concern about integrating TWIC into their operation, particularly if encryption of the biometric is required and if wiring upgrades are necessary to support TWIC readers. Commenters who do not have PACS now expressed concern about how much it will cost to purchase, install, and maintain TWIC systems. Question 7—Incorporation of TWIC Into Existing Access Control Equipment Maritime industry commenters generally deferred this question to the technical experts. Technical commenters stated that the specifications TSA and Coast Guard choose for the TWIC program will determine the ease of design, manufacture, and integration. They also stated that knowledge gained through experience with designs for other PACS that share common attributes with TWIC will lessen the time needed to create TWIC PACS products. Conversely, features that are unique to TWIC will have to be created, but some commenters believe TWIC-unique features can be accommodated through software or firmware ( *i.e.* , computer programming instructions that are stored in a read-only memory unit rather than being implemented through software) applications for existing readers. The commenters estimate that it may take from only a few months up to 36 months to integrate TWIC with certain PACS designs. Question 8—Quality Products List Process & Creation Almost universally, commenters agreed that TSA and Coast Guard should use a QPL process to help stakeholders know what equipment is best for use in the maritime environment. Many commented that the process the U.S. General Services Administration uses should be considered as a starting point for development of a TWIC QPL. Commenters also stated that product testing should include harsh maritime conditions. III. Working Specification Selected A. Summary of Selection TSA and the Coast Guard have selected the NMSAC alternate recommendation that requires encryption and use of the TWIC Privacy Key

(TPK)as the working specification for readers that will be used during the pilot programs. If the readers that meet this working specification perform as planned during the pilot testing, we will finalize the specification as we complete the rulemaking that requires the use of readers. Also, it is important to note that the TWICs that will be issued this fall in the initial rollout of the TWIC program will operate as designed when engaged in readers that are built to this working specification. We are choosing to adopt this specification to protect the personally identifiable information

(PII)contained in the TWIC from unintended disclosure while the TWIC is in the possession of the credential's rightful owner. Even assuming individuals suffer no real injury today if their template is taken or lifted through an unauthorized process, the template is personal information connected to that individual. Using a fingerprint template in lieu of a fingerprint image does not necessarily prevent the long-term potential for unauthorized use of personally identifying fingerprint information, if intercepted by unauthorized persons. Even assuming the fingerprint template cannot be reverse-engineered to produce an accurate duplicate fingerprint today, we cannot be certain that such a capability will not arise in the future. With the use of the TPK model, security and privacy protection are provided without the burden that other encryption models would place on PACS owners and operators. TSA and Coast Guard take the industry's concerns about adverse operational impacts very seriously. Consequently, as the card and readers are envisioned to operate when TWIC is fully implemented, use of a PIN will not be necessary to release the biometric unless the owner/operator chooses to use contact readers and the contact side of the credential. In addition, we are in the process of finalizing plans for the pilot tests required by the SAFE Port Act and we are working with experts within DHS to establish a very thorough test plan to evaluate the card-reader interface under a variety of conditions and assess its impact on operations. Through the pilot tests, we will investigate the impacts of requiring biometric identity verification on business processes, technology, and operations on facilities and vessels of various size, type, and location. As detailed below, while the government has removed any specific language about MARSEC levels from the specifications, the pilot testing process will be used to evaluate various use case scenarios that will influence the upcoming TWIC reader rulemaking process, including TWIC card and reader use requirements at various MARSEC levels. We understand that the decision to implement the TPK model for contactless biometric identity verification will have impacts on the installed base of PACS systems. However, the TPK model allows facilities to integrate the model with their local PACS in several different ways. The TPK model allows use of:

(1)The magnetic stripe to transfer TPK information by swiping the card through a magnetic strip reader and then presenting the card to a contactless reader to securely transmit the biometric template;

(2)pre-registration of the information on the magnetic stripe into the local PACS and then presenting the card to a contactless reader; or

(3)pre-registering the biometric minutiae templates into the local PACS until retrieved upon presentation of the TWIC to a contactless reader. The TPK model also allows several options for handheld readers. Handheld reader options include the use of either the contact or contactless portion of the TWIC to enable biometric identity verification. We do not wish to implement any alternative designs at this time. However, we may add additional security features to the card or card reader with due notice to the industry and regard for operational impacts. One alternative technology of particular interest to the government is match-on-card

(MOC)technology. The TWIC program and Coast Guard remain in close contact with the National Institute of Standards and Technology

(NIST)in their consideration of MOC technology for various Federal smart card and personal identification initiatives. We are mindful that cost is a strong consideration in the operational implementation of TWIC and we are working to minimize costs on the operational users of TWIC where possible. Also, we are working closely with other DHS components to continue to make available Port Security Grant funds to mitigate some of the costs to vessel and facility operators and owners of implementing the TWIC program. We have worked closely with the NMSAC working group to understand the impacts of the TWIC program on the maritime sector. Our choice of the TPK model is grounded in the specific recommendation of smart card, PACS, and biometrics industry experts involved in the NMSAC working group process and a thorough review of technology choices and impacts by government experts. These experts leveraged other similar technologies from contactless identification regimes in their deliberations. While implementation of the TWIC program should be as timely as possible, we understand that technical implementation timelines must incorporate engineering and manufacturing time, field testing, facility adaptation, and final field installation. We are encouraged by the positive responses we received regarding the creation of a QPL. However, unlike other government smart card programs, TWIC card readers, in most cases, will not be procured by the government. This lessens the ability of the government to leverage existing QPL-type programs already in existence, such as those supporting the Homeland Security Presidential Directive (HSPD)—12 Personal Identity Verification

(PIV)Program. B. Technical Changes to the TPK Working Specification TSA and Coast Guard are making some technical modifications to the TPK working specification recommended by NMSAC. We believe these changes are necessary to further protect privacy and security for the TWIC program. There are four important changes involving verification of the cardholder unique identifier (CHUID) data, MARSEC level operations, biometric liveness detection, and contactless transmission speed that are discussed in detail below. In addition, we made minor changes to the specification that is discussed below. B.1. Signature Verification of CHUID Data The NMSAC specification recommends that verification of the signature on the CHUID be optional. However, regardless of whether the credential is digitally signed, CHUID data can be copied or “cloned” to another card. Signature verification mitigates counterfeited CHUID data from being accepted as authentic. For this reason, verification of the digital signature on any CHUID unknown to a PACS is mandatory and is included in the final specification. Signature verification will have minimal performance impact to the contactless transaction and minimal impact on reader implementation. B.2. Authentication Methods Used at MARSEC Levels: NMSAC recommended that CHUID authentication should be used at MARSEC 1 and biometric authentication should be used at MARSEC 2. Specifying authentication methods for various threat or risk levels is outside of the scope of a technical specification for contactless cards and readers, and is more appropriately addressed separately in the risk management and security requirements for maritime operators. Therefore, we have removed the MARSEC guidance relating to use of specific authentication levels at different MARSEC levels from the working specification. B.3. Biometric Liveness Detection NMSAC recommended that biometric liveness detection *may* be employed in TWIC readers, making liveness detection optional. Liveness detection is an important means to prevent spoofing of a biometric sensor and is generally something that is strongly recommended by the reader industry. Because standards for liveness detection are currently not available, and there is no conformance testing protocol to validate its effectiveness, it is difficult to specify liveness detection as a mandatory requirement. However, we have changed the language for liveness detection from *may* to *should,* to stress that liveness detection (or attended verification) in TWIC readers is a highly desirable feature. This change will have no operational impact on TWIC contactless transactions. B.4. Contactless Transmission Speed The contactless reader performance requirements in the NMSAC specification are based upon transaction completion time. We have determined that specific requirements for contactless transmission speed should be specified so that the reader will support negotiation of a contactless speed with the card that achieves at least 400K bits per second. This will minimize transaction timings based on transmission capabilities of both current and future TWIC card versions. This change will not adversely impact TWIC contactless transactions. C. List of All Changes to the TPK Specification Listed below is a complete list of the changes TSA and Coast Guard have made to the TPK specification that NMSAC recommended. The changes of interest are discussed in detail above in Section III.B. 1. Section 4, TWIC Modes of Operation. Requirement for specific authentication modes to be used at specific MARSEC levels has been removed and available authentication modes have been clarified. 2. Section 4, TWIC Modes of Operation. Ability to configure specific authentication modes depending on a given perimeter security requirement and to be used at differing MARSEC levels has been added. 3. Section 4, TWIC Modes of Operation. Verification of CHUID signature changed to mandatory. CHUID signature is either verified once, either when the card holder's CHUID is registered in a local PACS, or read by the TWIC reader each time the card is presented for access. 4. Section 5.1.1, Device Dimensions. Note added to stress contactless reader sensitivity to location and electromagnetic conditions of their environment. 5. Section 6, Portable Reader Requirements. Requirements for confidentiality and authentication added for wireless devices used in physical access systems. 6. Section 7, Operational Requirements. Contactless transmission speed requirement changed to support 106kbit/s, 212kbit/s or 424kbit/s, based on the card's capabilities. 7. Section 7, Operational Requirements. Requirement added to reject transaction if multiple cards are simultaneously detected in the reader's contactless field. 8. Section 8, Performance Requirements. Support for biometric liveness detection strengthened from “may” to “should” indicating a strong preference for liveness detection. 9. Appendix A.1, CHUID Authentication. CHUID authentication clarified. 10. Appendix A.2, TWIC Biometric Authentication. Biometric authentication clarified. 11. Appendix A.3, Card Authentication Key Authentication. Card Authentication data object reference corrected. 12. Appendix A.3, Card Authentication Key Authentication. Card Authentication Key usage clarified to indicate that it is only available via the PIV application, and is not shared with the TWIC application. 13. Appendix D, TWIC Reader Compatibility with Other Card Types. Reader compatibility and default card support clarified and modified to allow configuration of default AID. 14. Appendix E.4, Alternate Implementations. Minor clarifications to PACS enrollment. 15. Appendix F, Proposed TWIC AID Structure. TSA RID added, AID structure clarified. D. Future Changes to Specification TSA and Coast Guard will continue to evaluate and test the working specification as we implement the TWIC Pilot Program. We anticipate that, as with any testing program, we will encounter technical issues that can be corrected by making minor changes to the working specification. We will make such changes available to the public as they occur, through use of the following link/Web site: *www.tsa.gov/twic.* In addition, we will address any necessary changes to the working specification prior to finalizing the regulations requiring TWIC readers. Issued in Arlington, Virginia, on September 14, 2007. Stephanie Rowe, Assistant Administrator, Transportation Threat Assessment and Credentialing, Transportation Security Administration. [FR Doc. 07-4649 Filed 9-19-07; 8:45 am]

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