Notices. Notice

10,449 words·~47 min read·/register/2006/03/31/06-3091

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS 250-254 and CMS 10171] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Secondary Payer Information Collection and Supporting Regulations in 42 CFR 411.25, 489.2, and 489.20; *Form Number:* CMS 250-254 (OMB#: 0938-0214); *Use:* Medicare Secondary Payer Information

(MSP)is essentially the same concept known in the private insurance industry as coordination of benefits, and refers to those situations where Medicare does not have primary responsibility for paying the medical expenses of a Medicare beneficiary. Medicare Fiscal Intermediaries, Carriers, and now Part D plans, need information about primary payers in order to perform various tasks to detect and process MSP cases and make recoveries. MSP information is collected at various times and from numerous parties during a beneficiary's membership in the Medicare Program. Collecting MSP information in a timely manner means that claims are processed correctly the first time, decreasing the costs associated with adjusting claims and recovering mistaken payments.; *Frequency:* Reporting—On Occasion; *Affected Public:* Individuals or Households, Business or other for-profit, Not-for-profit institutions; *Number of Respondents:* 134,553,682; *Total Annual Responses:* 134,553,682; *Total Annual Hours:* 1,611,303. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Coordination of Benefits between Part D Plans and Other Prescription Coverage Providers; *Form Number:* CMS 10171 (OMB#: 0938-0978); *Use:* Section 1860D-23 and 1860D-24 of the Social Security Act requires the Secretary to establish requirements for prescription drug plans to ensure effective coordination between Part D plans, State pharmaceutical assistance programs and other payers. The requirements must relate to the following elements:

(1)Enrollment file sharing;

(2)claims processing and payment;

(3)claims reconciliation reports;

(4)application of the protections against high out-of-pocket expenditures by tracking true out-of-pocket (TrOOP) expenditures; and

(5)other processes that the Secretary determines. This information will be used by Part D plans, other health insurers or payers, pharmacies and CMS to coordinate prescription drug benefits provided to the Medicare beneficiary.; *Frequency:* Reporting—Monthly; *Affected Public:* Business or other for-profit, Federal, State, local and or tribal government; *Number of Respondents:* 56,320; *Total Annual Responses:* 2,153,767,270; *Total Annual Hours:* 1,017,914. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503. Fax Number:

(202)395-6974. Dated: March 24, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-4631 Filed 3-30-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-30, CMS-10117,10118,10119,10135,10136 and CMS-R-206 Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Information Collection Requirements in the Hospice Conditions for Coverage and Supporting Regulations at 42 CFR 418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.83, 418.96, and 418.100; *Use:* The information collection requirements contained in the Hospice Conditions for Coverage information collection request

(ICR)serve to ensure compliance with the hospice conditions of participation. The State survey agencies utilize the furnished information during the certification and re-certification periods to assist in determining compliance with the statute and regulations. In addition, data collected will be used to produce statistical reports to the Congress, to establish reimbursement rates, and to provide increased information on the hospice industry.; *Form Number:* CMS-R-30 (OMB#: 0938-0302); *Frequency:* Reporting—Other—depending on program areas and data requirements; *Affected Public:* Business or other for-profit, Not-for-profit institutions, Federal government; *Number of Respondents:* 2,874; *Total Annual Responses:* 2,874; *Total Annual Hours:* 9,930,912. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Qualification—Medicare Advantage Application For Coordinated Care, Private Fee-For-Service, Regional Preferred Provider Organization, Service Area Expansion For Coordinated Care and Private Fee-For-Service Plans, Medical Savings Account Plans; *Use:* An entity seeking a contract as an MA organization must be able to provide Medicare's basic benefits plus meet the organizational requirements set out under 42 CFR part 422. An applicant must demonstrate that it can meet the benefit and other requirements within the specific geographic area it is requesting. The application forms are designed to provide the information needed to determine the health plan's compliance. The regulatory requirements are incorporated into the MA applications. The MA application forms will be used to determine if an entity is eligible to enter into a contract to provide services to Medicare beneficiaries; *Form Number:* CMS-10117, 10118, 10119, 10135, 10136 (OMB#: 0938-0935); *Frequency:* Reporting: One time submission; *Affected Public:* Business or other for-profit, Not-for-profit institutions and State, local or tribal government; *Number of Respondents:* 80; *Total Annual Responses:* 110; *Total Annual Hours:* 3,400. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Information Collection Requirements Referenced in HIPAA, Title 1, for the Group Market, Supporting Regulations at 45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, and 146.180, and forms/instructions; *Use:* The requirements of this information collection will ensure that group health plans and issuers in the group market comply with Health Insurance Portability and Accountability Act of 1996 (HIPAA). These requirements include providing individuals with certificates of creditable coverage, notifying individuals about their status with respect to preexisting condition exclusions, and giving individuals the special enrollment rights to which they are entitled. In addition, this collection gives states and the Federal government the flexibility necessary to enforce these HIPAA requirements.; *Form Number:* CMS-R-206 (OMB#: 0938-0702); *Frequency:* Recordkeeping, Third party disclosure and Reporting: On occasion; *Affected Public:* Individuals or Households, Business or other for-profit, Not-for-profit institutions and Federal, State, Local or Tribal Government; *Number of Respondents:* 2,800; *Total Annual Responses:* 37,002,217; *Total Annual Hours:* 446,679. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on May 30, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attention: William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: March 24, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-4633 Filed 3-30-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0226] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 014 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 014” (Recognition List Number: 014), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 014” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT ). Submit electronic comments by e-mail: *standards@cdrh.fda.hhs.gov* . This document may also be accessed on FDA's Web site at *http://www.fda.gov/cdrh/fedregin.html* . See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 014 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 12720 Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the **Federal Register** of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. In **Federal Register** notices published on October 16, 1998 (63 FR 55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022), May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2, 2002 (67 FR 61893), April 28, 2003 (68 FR 22391), March 8, 2004 (69 FR 10712), June 18, 2004 (69 FR 34176), October 4, 2004 (69 FR 59240), May 27, 2005 (70 FR 30756), and November 8, 2005 (70 FR 67713), FDA modified its initial list of FDA recognized consensus standards. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language”

(HTML)and “portable document format”

(PDF)versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Web site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 014 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 014” to identify these current modifications. In table 1 of this document, FDA describes the following modifications:

(1)The withdrawal of standards and their replacement by others,

(2)the correction of errors made by FDA in listing previously recognized standards, and

(3)the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1. Old Item No. Standard Change Replacement Item No. A. Anesthesia 32 ISO 7767: 1997: Oxygen Monitors for Monitoring Patient Breathing Mixtures—Safety Requirements Withdrawn 33 ISO 9918: 1993: Capnometers for Use with Humans—Requirements Withdrawn 41 NFPA 99: 2005: Standard for Health Care Facilities Chapter 20—Hyperbaric Facilities Withdrawn and replaced with newer version 67 B. Dental/Ear, Nose, and Throat 52 ANSI/ADA Specification No. 27: 1997, Resin-Based Filling Materials Date 60 ANSI/ADA Specification No. 96: 2000, Dental-Water-Based Cements—Adoption of ISO 9917: 1991 Date and title 114 ANSI/ADA Specification No. 48: 2004, Ultraviolet Activator and Disclosing Lights Date C. General Hospital/General Plastic Surgery 47 ASTM D5712-05 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method Withdrawn and replaced with newer version 144 77 ASTM F1862-00a Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) Contact person 86 ASTM D3578-05 Standard Specification for Rubber Examination Gloves Withdrawn and replaced with newer version 145 96 ASTM F2101-01 Standard Test Method for Evaluating the Bacterial Filtration Efficiency

(BFE)of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus Contact person 112 AAMI/ANSI PB70: 2003 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities Contact person 113 ASTM F2100-04 Standard Specification for Performance of Materials Used in Medical Face Masks Contact person 120 ASTM F1054-01 Standard Specification for Conical Fittings Withdrawn 128 ASTM F1670-03 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Contact person D. Materials 14 ASTM F688-05: Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) Withdrawn and replaced with newer version 119 38 ASTM F2005-00: Standard Terminology for Nickel-Titanium Shape Memory Alloys Withdrawn 78 ASTM F560-05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Withdrawn and replaced with newer version 120 100 ASTM F2005-05: Standard Terminology for Nickel-Titanium Shape Memory Alloys Withdrawn and replaced with newer version 121 E. OB-GYN/Gastroenterology 19 ISO 8600-1: 2005 Optics and photonics—Medical endoscopes and endotherapy devices—Part 1: General requirements Withdrawn and replaced with newer version 37 F. Orthopedic/Physical Medicine 162 ASTM F564-02: Standard Specification and Test Methods for Metallic Bone Staples Extent of recognition, type of standard, contact person and related Code of Federal Regulations citation and product codes 164 ASTM F1541-02: Standard Specification and Test Methods for External Skeletal Fixation Devices Devices affected, processes affected, extent of recognition, type of standard, and contact person 182 ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements Processes affected and relevant guidance G. Radiology 1 ISO 9236-1: 2004 Photography—Sensitometry of screen/film systems for medical radiography—Part 1: Determination of sensitometric curve shape, speed and Average Gradient Withdrawn and replaced with newer version 136 2 ISO 4090: 2001 Photography—Medical radiographic cassettes/screens/films and hard-copy imaging films—Dimensions and specifications Withdrawn and replaced with newer version 137 5 ISO 5799: 1991 Photography—Direct-exposing medical and dental radiographic film/process systems—Determination of ISO Speed and ISO average gradient Withdrawn and replaced with newer version 138 37 IEC 60601-2-11-2004 Amendment 1—Medical electrical equipment—Part 2-11: Particular requirements for the safety of gamma beam therapy equipment Withdrawn and replaced with newer version 133 44 AOMS-2005 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Withdrawn and replaced with newer version 139 46 RTD1-2005 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1 Withdrawn and replaced with newer version 140 101 ANSI/IESNA RP-27.1-1996 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements Title 102 ANSI/IESNA RP-27.2-2000 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement Techniques Title 103 ANSI/IESNA RP-27.3-1996 Recommended Practice for Photobiological Safety Lamps—Risk Group Classification and Labeling Title 128 IEEE N42.13-2004 Calibration and Usage of “Dose Calibrator” Ionization Chambers for the Assay of Radionuclides Withdrawn and replaced with newer version 141 H. Sterility 53 ANSI/AAMI ST66, Sterilization of health care products—Chemical indicators—Part 2: Indicators for Air Removal Test Sheets and Packs Relevant guidance 74 ANSI/AAMI ST60, Sterilization of health care products—Chemical indicators—Part 1: General requirements Extent of recognition and relevant guidance 92 ASTM F2097-05, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products Withdrawn and replaced with newer version 167 151 ASTM F2338-05, Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method Withdrawn and replaced with newer version 168 III. Listing of New Entries The listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 014, follows: Table 2. Item No. Title of Standard Reference No. and Date A. Cardiovascular/Neurology 58 Cardiovascular implants—Cardiac valve prostheses ANSI/AAMI/ISO 5840: 2005 B. General Hospital/General Plastic Surgery 146 Medical electrical equipment—Part 2: Particular requirements for safety of infant radiant warmers ANSI/AAMI/IEC 60601-2-21 and 60601-2-21 amendment 1: 2000 147 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs ASTM D6978-05 148 Sterile hypodermic syringes for single use—Part 3: Auto-disable syringes for fixed-dose immunization ISO 7886-3: 2005 149 Standard Practice for Determination of Expiration Dating for Medical Gloves ASTM D7160-05 150 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions ASTM D7161-05 C. Orthopedic/Physical Medicine 183 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface ASTM F1875-98

(2004)184 Implants for Surgery—Staples with parallel legs for orthopaedic use—General requirements ISO 8827: 1988 185 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression ASTM F2267-04 186 Test Methods for Intervertebral Body Fusion Devices ASTM F2077-03 187 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System ASTM F2193-02 188 Implants for surgery—Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test ISO 14243-1: 2002 189 Implants for surgery—wear of total knee-joint prostheses—Part 2: Methods of measurement ISO 14243-2: 2000 190 Implants for surgery—wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test ISO 14243-3: 2004 191 Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial trays ISO 14879-1: 2000 192 Standard Test Method for Determination of Total Knee Replacement Constraint ASTM F1223-05 193 Standard Specification for Total Knee Prosthesis ASTM F2083-04 D. Radiology 142 Lasers and laser-related equipment—Test methods for laser beam widths, Divergence angles, and beam propagation ratios—Part 2: General astigmatic beams ISO 11146-2: 2005 143 Lasers and laser-related equipment—Test methods for determination of the shape of a laser beam wavefront—Part 2: Shack-Hartmann sensors ISO 15367-2: 2005 E. Sterility 169 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas ASTM F2391-05 170 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials ASTM F2475-05 171 Chemical Indicators—Guidance on the selection, use, and interpretation of results ANSI/AAMI/ISO 15882: 2003 IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Web site at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm* . FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the **Federal Register** , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the **Federal Register** once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT ). To be properly considered such recommendations should contain, at a minimum, the following information:

(1)Title of the standard,

(2)any reference number and date,

(3)name and address of the national or international standards development organization,

(4)a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and

(5)a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access In order to receive “Guidance on the Recognition and Use of Consensus Standards” on your fax machine, call the Center for Devices and Radiological Health

(CDRH)Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign. Follow the remaining voice prompts to complete your request. You may also obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the **Federal Register** , this notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 014” will be available on the CDRH home page. You may access the CDRH home page at *http://www.fda.gov/cdrh* . You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at *http://www.fda.gov/cdrh/stdsprog.html* . This **Federal Register** document on modifications in FDA's recognition of consensus standards is available at *http://www.fda.gov/cdrh/fedregin.html* . VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 014. These modifications to the list of recognized standards are effective upon publication of this notice in the **Federal Register** . Dated: March 23, 2006 Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-4695 Filed 3-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0128] Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions.” This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of orphan-drug and humanitarian use device

(HUD)designation requests and related submissions to the Office of Orphan Products Development (OPD). The submission of these documents in electronic format should improve the agency's efficiency in processing, archiving, and reviewing them. DATES: Submit written or electronic comments on the draft guidance by May 30, 2006. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Electronic Submissions Coordinator, Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6A-55, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: James D. Bona, Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3666. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions.” This draft document provides guidance to industry regarding submissions of designation requests and related submissions to OPD in electronic format. It describes the two methods by which submissions can be made electronically to OPD. The first is totally electronic through use of FDA's electronic submission gateway pathway and the second is directly to OPD through the use of physical media (e.g., CD-ROMs). Recommendations are described for the formatting and organization of these submissions. A listing of agency contacts for assistance is also provided. 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 providing designation requests and related submissions in electronic format. 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. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic 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. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Paperwork Reduction Act of 1995 This notice contains no new collections of information. The information requested for designation requests and related submissions is already covered by the regulations for orphan-drugs under 21 CFR 316.20 and for HUDs under 21 CFR 814.102. This notice announces the availability of a guidance that provides applicants with an alternative mechanism for submitting designation requests and related submissions to the agency. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. IV. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/orphan/esub/esub.htm* or at *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: March 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-4709 Filed 3-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration

(HRSA)will publish periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques of other forms of information technology. Proposed Project: Loan Information System Records for the DHHS and DHUD Hospital Mortgage Insurance, Guarantee, and Direct Loan Programs (OMB No. 0915-0174)—Extension The Division of Facilities and Loans within the Health Resources and Services Administration monitors outstanding direct and guaranteed loans made under section 621 of Title VI and section 1601 of Title XVI of the Public Health Service Act, as well as loans insured under the section 242 Hospital Mortgage Insurance Program of the National Housing Act. These programs were designed to aid construction and modernization of health care facilities by increasing the access of facilities to capital through the assumption of the mortgage credit risk by the Federal Government. Operating statistics and financial information are collected annually from hospitals with mortgages that are insured under these programs. The information is used to monitor the financial stability of the hospitals to protect the Federal investment in these facilities. The form used for the data collection is the Hospital Facility Data Abstract. No changes in the form are proposed. The estimated response burden is as follows: Form Number of respondents Responses per respondent Hours per response Total hour burden Hospital Facility Data Abstract 80 1 1 80 Send comments to Susan G. Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received with 60 days of this notice. Dated: March 27, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-4689 Filed 3-30-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Cancellation of Previously Announced Grant Opportunities AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of Cancellation. SUMMARY: The Health Resources and Services Administration

(HRSA)announces the cancellation of the following grant opportunities that were initially published on Grants.gov Find, in the HRSA *Preview,* and on the HRSA Web site ( *http://www.hrsa.gov/grants/preview/* ). DATES: *Effective Date:* March 31, 2006. FOR FURTHER INFORMATION CONTACT: Gail Lipton, Director, Division of Grants Policy, Office of Federal Assistance Management, Telephone

(301)443-6509. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: Based on funds made available through the final fiscal year

(FY)2006 appropriation and a redirection of priorities, HRSA hereby withdraws the following programs and announcements from FY 2006 competition: HRSA-06-002 Mental Health/Substance Abuse, Oral Health and Comprehensive Pharmacy Services in Section 330-funded Health Centers. *Applications Due:* January 13, 2006. HRSA-06-004 New Access Points. *Applications Due:* February 10, 2006. HRSA-06-014 Residency Training in Primary Care. *Applications Due:* February 17, 2006. HRSA-06-015 Academic Administrative Units in Primary Care. *Applications Due:* February 17, 2006. HRSA-06-016 Physician Assistant Training in Primary Care. *Applications Due:* February 17, 2006. HRSA-06-017 Residency Training in General and Pediatric Dentistry. *Applications Due:* February 17, 2006. HRSA-06-018 Pre-Doctoral Training in Primary Care. *Applications Due:* February 17, 2006. HRSA-06-019 Faculty Development in Primary Care. *Applications Due:* February 17, 2006. HRSA-06-022 Health Careers Opportunity Program. *Applications Due:* February 21, 2006. HRSA-06-024 Center for Health Workforce. *Applications Due:* August 1, 2006. HRSA-06-025 Quentin N. Burdick Program For Rural Interdisciplinary Training. *Applications Due:* January 13, 2006. HRSA-06-029 Geriatric Education Centers. *Applications Due:* February 1, 2006. HRSA-06-031 Allied Health Projects. *Applications Due:* January 13, 2006. HRSA-06-036 Pathways to Health Professions. *Applications Due:* October 3, 2005. HRSA-06-052 New Access Points in High Poverty Counties. *Applications Due:* March 15, 2006. HRSA-06-053 Planning Grants in High Poverty Counties. *Applications Due:* March 30, 2006. HRSA-06-055 Health Center Consortia. *Applications Due:* April 3, 2006. HRSA-06-056 Healthy Communities Access Program. *Applications Due:* February 2, 2006. HRSA-06-057 Health Center Controlled Networks (HCCN). *Applications Due:* February 17, 2006. HRSA-06-058 Operational Network Grants (OPN). *Applications Due:* March 1, 2006. HRSA-06-068 Trauma-EMS Systems Program. *Applications Due:* April 11, 2006. HRSA-06-073 State Planning Grants Program (SPGP). *Applications Due:* March 31, 2006. HRSA-06-106 Rural Emergency Medical Services Training and Assistance Cooperative Agreement. *Applications Due:* April 15, 2006. HRSA-06-111 Graduate Geropsychology Education Program. *Applications Due:* March 1, 2006. These cancellations are effective immediately upon publication of this **Federal Register** notice, and the appropriate changes have already been made to Grants.gov Find and the HRSA Web site. HRSA will not accept any FY 2006 competitive applications for these funding opportunities, and any applications previously submitted will not be considered. Further information about HRSA programs will be provided both through the HRSA Web site at *http://www.hrsa.gov/grants/preview* and through *http://www.grants.gov,* the official E-Grants Web site where applicants can find and apply for Federal funding opportunities. Dated: March 27, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-4690 Filed 3-30-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Privacy Act of 1974; Report of Modified or Altered System—Medical Staff Credentials and Privileges Records AGENCY: Indian Health Service (IHS). ACTION: Notice of proposed modification or alteration to a System or Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, the Indian Health Service

(IHS)is proposing to modify or alter an SOR, “Medical Staff Credentials and Privileges Records,” System No. 09-17-0003. We propose to modify the SOR to reflect current program changes, technology changes, statutory and implementation changes. Under the system name, we propose to change to the current program office name. We are proposing to update the categories of individuals covered by the system with minor edits to the Active, Temporary and Courtesy or Associate. We are proposing to update the Authority for maintenance by including the Federal Records Act and the Privacy Act. We are proposing to update the Purposes to reflect the new program title of the National Practitioner Data Bank to include the Healthcare Integrity and Protection Data Bank and the inclusion of authorizing statute. We are proposing to update the Routine Uses to reflect the new program title of the National Practitioner Data Bank to include the Healthcare Integrity and Protection Data Bank and the inclusion of authorizing statute for routine use numbers 2 and 3. We will also take the opportunity to update any sections of the system notice to provide clarity on the changing environment to include for digital records and the initiative of transitioning from a paper-based record to a computerized-based or electronic medical record. DATES: The Report of Intent to Amend a System of Records Notice and an advance copy of the system notice have been sent to the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure that all parties have adequate time in which to comment, the modified system of records, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, whichever is later, unless IHS receives comments that require alterations to this notice. ADDRESSES: The public should address comments to: Mr. William Tibbitts, IHS Privacy Act Officer, Division of Regulatory, Records Access and Policy Liaison, 801 Thompson Avenue, TMP Suite 450, Rockville, MD 20852-1627; call non-toll free

(301)443-1116; send via facsimile to

(301)443-2316, or send your email requests, comments, and return address to: *wtibbitt@hqe.ihs.gov* . FOR FURTHER INFORMATION CONTACT: Stephen Heath, IHS Risk Management Consultant, Headquarters East

(HQE)Office of Clinical and Preventative Services, 801 Vassar Drive, NE., Albuquerque, New Mexico 87106, Telephone

(505)248-4047. SUPPLEMENTARY INFORMATION: A. Major Modification of 09-17-0003, is to reflect the statutory change in routine use numbers 2 and 3 of the National Practitioner Data Bank and the Healthcare and Integrity Protection Data Bank. In addition to updating and making editorial corrections to improve the clarify of the system notice, this alteration requires the updating of the system manager listing, and revisions of the Categories of Records, Purposes, Authority, Safeguard, Retention and Disposal, Notification and Access Procedures sections. Dated: March 23, 2006. Charles W. Grim, Assistant Surgeon General, Director, Indian Health Service, Department of Health and Human Services. 09-17-0003 System name: Indian Health Service Medical Staff Credentials and Privileges Records, HHS/IHS/OCPS. Security classification: None. System location: Each Indian Health Service

(IHS)Area Office and each IHS Service Unit (Appendix 1). Records may also be located at hospitals and offices of health care providers who are under contract with IHS. A current list of contractor sites is available by writing to the appropriate System Manager (Area or Service Unit Director) at the address shown in Appendix I. Categories of individuals covered by the system: Prospective, current and former IHS medical staff members. The term IHS medical staff includes fully licensed individuals permitted by law to provide patient care services independently and without concurrent professional direction or supervision, within the scope of his/her license and in accordance with individually granted clinical privileges. The IHS medical staff includes physicians (M.D. and D.O.) and dentists and may include other health care practitioners such as psychologists, optometrists, podiatrists, audiologists, and, in some states, certified nurse midwives. Types of assignment categories of current and former IHS medical staff members include the following: Provisional—Those new members of the medical staff who are serving a required initial probationary period, as specified in the local medical staff bylaws. During this time, their qualifications for membership on the active or courtesy IHS medical staff are assessed. Active—Those members who are Federal employees and/or spend at least fifty percent of their professional time providing patient care related services in the facility. Temporary—Those members who provide services on a short-term basis or have applied for active medical staff membership and are awaiting a full credential review. Courtesy or Associate—Those members who generally provide services on a periodic or episodic basis (e.g., consultants for specialty clinics). Categories of records in the system: Contains name, Social Security number, IHS medical staff membership and privileges applications and associated forms, employment data, liability insurance coverage, credentialing history of licensed health professionals, personal, educational, and demographic background information, professional performance information consisting of continuing education, performance awards, and adverse or disciplinary actions, and evaluations and approvals completed by IHS medical staff reviewers. Authority for maintenance of the system: Federal Records Act (44 U.S.C. 2901), Privacy Act of 1974, as amended (5 U.S.C. 552a), Indian Self Determination and Education and Assistance Act (25 U.S.C. 450), Snyder Act (25 U.S.C. 13), Indian Health Care Improvement Act (25 U.S.C. 1601 *et seq* .), Indian Health Service Transfer Act ((42 U.S.C. 2001-2004). Purpose(s): The purposes of this system are: 1. To ensure that IHS medical staff members are qualified, competent and capable of delivering quality health services consistent with those of the medical community at large and that they are granted privileges commensurate with their training and competence and with the ability of the facility to provide adequate support equipment, services, and staff. 2. To inform health care practitioner(s) and staff of health care facilities, state or county health professional societies or licensing boards to whom the subject individual may apply for clinical privileges, membership or licensure, of the subject individual's professional competence, character and ethical qualifications. This may include information regarding drug or alcohol abuse or dependency. Within the Department such releases may be made to personnel staffs of DHHS Regional Offices. 3. To provide adverse health care practice information to the National Practitioner Data Bank-Healthcare Integrity and Protection Data Bank (NPDB-HIPDB) established under Title IV of Public Law 99-660, the Health Care Quality Improvement Act of 1986, as amended, and Section 221(a) of Public Law 104-191, the Heath Insurance Portability and Accountability Act of 1996. The purpose of such a release is to provide information concerning a current or former IHS medical staff member whose professional health care activity failed to conform to generally accepted standards of professional medical practice. 4. To provide health care practice information concerning current or former members of the IHS medical staff with Commissioned Corps status to the Division of Commissioned Personnel, U.S. Public Health Service, so that an informed decision may be made concerning the promotion, retention, or reassignment of the subject individual. Routine uses of records maintained in the system, including categories of users and the purposes of such uses: 1. Records may be disclosed to organizations authorized to conduct evaluation studies concerning the delivery of health care services by the IHS ( *e.g.* , Joint Commission on the Accreditation of Healthcare Organizations). 2. IHS may disclose records consisting of name, Social Security number, employment history and any professional qualification information concerning medical staff membership and privileges, professional competence, clinical judgment and personal character to a state or local government health professional licensing board, to the Federation of State Medical Boards, to the NPDB-HIPDB, and/or to a similar entity which has the authority to maintain records concerning the issuance, retention or revocation of licenses or registrations necessary to practice a health professional occupation or specialty. The purpose of this disclosure is to inform medical profession licensing boards and appropriate entities about the health care practices of a current, terminated, resigned, or retired IHS medical staff member whose professional health care activity significantly failed to conform to generally accepted standards of professional medical practice. This will be done within the guidelines for notice, hearing, and review as delineated in the medical staff bylaws for the IHS facility and/or within other HHS or IHS regulations or policies. 3. IHS may disclose biographic data and information supplied by potential applicants to

(a)references listed on the IHS medical staff and/or privileges application and associated forms for the purpose of evaluating the applicant's professional qualifications, experience, and suitability, and

(b)a state or local government health profession licensing board, to a health-related professional organization, to the Federation of State Medical Boards, and to the NPDB-HIPDB or a similar entity for the purpose of verifying that all claimed background and employment data are valid and all claimed credentials are current and in good standing. 4. Records may be disclosed to other Federal agencies (including the Office of Personnel Management for subject individuals applying for or maintaining Civil Service appointments), to state and local governmental agencies, and to organizations in the private sector to which the subject individual applies for clinical privileges, membership or licensure for the purpose of documenting the qualifications and competency of the subject individual to provide health services in his/her health profession based on the individual's professional performance while employed by the IHS. 5. The Department may disclose information from this system of records to the Department of Justice, or to a court or other tribunal, when

(a)HHS, or any component thereof, or

(b)any HHS employee in his or her official capacity; or

(c)any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or

(d)the United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components, is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the court or other tribunal is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected. 6. Records may be disclosed to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual. 7. In the event that a system of records maintained by the IHS to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, state, or local, charged with enforcing or implementing the statute or rule, regulation or order issued pursuant thereto. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: File folders and computer-based or electronic files. Retrievability: Indexed and retrieved by name, Social Security number, and any other identifying numbers necessary to establish the identity of an individual whose record is maintained in the system of records. Safeguards: 1. Authorized Users: Access is limited to authorized personnel for use in the performance of their official duties. Authorized personnel include: Physician Recruitment and other Health Professions Branch Staff and Area Governing Board Members at IHS Area Offices, and Service Unit Directors, Clinical Directors and members of the Credentials and Privilege Committee of each IHS Service Unit. At each location where records in this system will be maintained, a list of personnel or categories of personnel having an official need-to-know has been developed and is maintained. 2. Physical Safeguards: Records are kept in locked metal filing cabinets or in locked desk drawers in secured rooms at all times when not actually in use during working hours and at all times during non-working hours. Record storage areas, including file cabinets and desks, are not left unattended or unlocked during office hours, including lunch hours. Computer-based or electronic records are password protected security and any additional internal security for database (linked or unlinked). 3. Procedural Safeguards: Persons who have an official need-to-know are entrusted with records from this system of records and are instructed to safeguard the confidentiality of these records and to destroy all copies or to return such records when the need to know has expired. Instructions include the statutory penalties for noncompliance. Proper charge-out procedures are followed for the removal of records from the area in which they are maintained. Before an employee who will control disclosure of records can work with the records (i.e., employees who report to the system manager) the system manager or designee ensures that the employee has received training in the safeguards applicable to the records and is aware of the actions to take to restrict disclosure. When copying records for authorized purposes, care is taken to ensure that any imperfect pages are not left in the reproduction room where they can be read but are destroyed or obliterated. 4. Implementation Guidelines: DHHS Chapter 45-13 and supplementary Chapter PHS.hf:45-13 of the General Administration Manual; DHHS, “Automated Information System Security Program Handbook,” as amended; DHHS IRM Policy HHS-IRM-2000-0005, “IRM Policy for IT Security for Remove Access; OMB Circular A-130 “Management of Federal Information Resources”; and E-Government Act of 2002 (Pub. L. 107-347, 44 U.S.C. Ch. 36). Retention and disposal: Records are maintained by IHS for at least ten years after the individual's termination of employment or association with IHS. Records of unsuccessful applicants for medical staff membership will be retained for three years after his/her rejection. After these periods of retention expire, records are destroyed by shredding or burning. System manager(s) and address: See Appendix 1. Policy Coordinating Official: Director, Office of Clinical and Preventive Services, IHS, 801 Thompson Avenue, Suite 300, Rockville, Maryland 20852. The IHS Clinical Directors at all IHS Service Units listed in Appendix 1 are System Managers. IHS medical staff credentials and privileges files are stored at these locations. Other addresses listed in Appendix 1 are locations at which all or parts of these records may also be stored (Physician Recruiter at IHS Area Offices). Post Office Box designations appearing in Appendix 1 should be specified when making requests by mail. Notification procedure: Requests must be made to the appropriate System Manager (Clinical Director for the appropriate Service Unit) listed in Appendix 1. Requests by mail: Requests for information and/or access to records received by mail must contain information providing the identity of the writer and a reasonable description of the record desired. Written requests must contain, at a minimum, the name, signature, Social Security number, and address of the requester, and for unsuccessful applicants the date when the application was submitted, and for current or former IHS health care providers the dates and locations of service. We may request additional identification when we hold records for different persons with the same name or where an apparent discrepancy exists between information contained in the record and that provided by the individual requesting access to the record. Other names used: Where an individual is seeking to obtain information about himself/herself which may be retrieved by a different name than his/her current name, he/she shall be required to produce evidence to verify that he/she is the person whose record he/she seeks. Requests in person: A subject individual who appears in person at a specific location (where he or she currently works or formerly worked) seeking access or disclosure of records contained in this system of records relating to him/her shall provide the information described in “Requests by mail” (above) and at least one piece of tangible identification such as a driver's license or passport. Requests by telephone: Since positive identification of the caller cannot be established, telephone requests are not honored. Record access procedures: Same as Notification procedure: Requesters should also provide a reasonable description of the record being sought. Requesters may also request an accounting of disclosures that have been made of their records, if any. Contesting record procedures: Write to the appropriate Service Unit Clinical Director at the address specified in Appendix 1 and reasonably identify the record, specify the information being contested, and state the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. Record source categories: Subject individual, IHS health care personnel, references supplied by the subject individual, professional societies or associations, specialty boards, colleges and universities attended by the subject individual, former employers, health facilities or health providers with which the subject individual was associated, liability insurance carriers, organizations providing cardiopulmonary resuscitation

(CPR)training to the subject individual, state and local health and health care licensing or certifying organizations, and organizations which serve as repositories of information on health care professionals. Systems exempted from certain provisions of the act: None. Appendix 1: System Managers and IHS Locations Under Their Jurisdiction Where Records are Maintained Director, Aberdeen Area Indian Health Service, Room 309, Federal Building, 115 Fourth Avenue, SE., Aberdeen, South Dakota 57401 Director, Cheyenne River Service Unit, Eagle Butte Indian Hospital, P.O. Box 1012, Eagle Butte, South Dakota 57625 Director, Crow Creek Service Unit, Ft. Thompson Indian Health Center, P.O. Box 200, Ft. Thompson, South Dakota 57339 Director, Fort Berthold Service Unit, Fort Berthold Indian Health Center, P.O. Box 400, New Town, North Dakota 58763 Director, Carl T. Curtis Health Center, P.O. Box 250, Macy, Nebraska 68039 Director, Fort Totten Service Unit, Fort Totten Indian Health Center, P.O. Box 200, Fort Totten, North Dakota 58335 Director, Kyle Indian Health Center, P.O. Box 540, Kyle, South Dakota 57752 Director, Lower Brule Indian Health Center, P.O. Box 191, Lower Brule, South Dakota 57548 Director, McLaughlin Indian Health Center, P.O. Box 879, McLaughlin, South Dakota 57642 Director, Omaha-Winnebago Service Unit, Winnebago Indian Hospital, Winnebago, Nebraska 68071 Director, Pine Ridge Service Unit, Pine Ridge Indian Hospital, Pine Ridge, South Dakota 57770 Director, Rapid City Service Unit, Rapid City Indian Hospital, 3200 Canyon Lake Drive, Rapid City, South Dakota 57701 Director, Rosebud Service Unit, Rosebud Indian Hospital, Rosebud, South Dakota 57570 Director, Sisseton-Wahpeton Service Unit, Sisseton Indian Hospital, P.O. Box 189, Sisseton, South Dakota 57262 Director, Standing Rock Service Unit, Fort Yates Indian Hospital, P.O. Box J, Fort Yates, North Dakota 58538 Director, Trenton-Williston Indian Health Center, P.O. Box 210, Trenton, North Dakota 58853 Director, Turtle Mountain Service Unit, Belcourt Indian Hospital, P.O. Box 160, Belcourt, North Dakota 58316 Director, Wanblee Indian Health Center, 100 Clinic Drive, Wanblee, South Dakota 57577 Director, Yankton-Wagner Service Unit, Wagner Indian Hospital, 110 Washington Street, Wagner, South Dakota 57380 Director, Youth Regional Treatment Center, P.O. Box #68, Mobridge, South Dakota 57601 Director, Sac & Fox Health Center, 307 Meskwaki Road, Tama, Iowa 52339 Director, Santee Health Center, 425 Frazier Avenue, Main Street #2, Niobrara, Nebraska 68760 Director, Alaska Area Native Health Service, 4141 Ambassador Drive, Suite 300, Anchorage, Alaska 99508-5928 Director, Albuquerque Area Health Service, 5300 Homestead Road, NE., Albuquerque, New Mexico 87110 Director, Acoma-Canoncito-Laguna Service Unit, Acoma-Canoncito-Laguna Indian Hospital, P.O. Box 130, San Fidel, New Mexico 87049 Director, To-Hajille Health Center, P.O. Box 3528, Canoncito, New Mexico 87026 Director, New Sunrise Treatment Center, P.O. Box 219, San Fidel, New Mexico 87049 Director, Albuquerque Service Unit, Albuquerque Indian Hospital, 801 Vassar Drive, NE., Albuquerque, New Mexico 87049 Director, Albuquerque Indian Dental Clinic, P.O. Box 67830, Albuquerque, New Mexico 87193 Director, Alamo Navajo Health Center, P.O. Box 907, Magdalena, New Mexico 87825 Director, Jemez PHS Health Center, P.O. Box 279, Jemez, New Mexico 87024 Director, Santa Ana PHS Health Center, P.O. Box 37, Bernalillo, New Mexico 87004 Director, Sandia PHS Health Center, P.O. Box 6008, Bernalillo, New Mexico 87004 Director, Zia PHS Health Center, 155 Capital Square, Zia, New Mexico 87053 Director, Santa Fe Service Unit, Santa Fe Indian Hospital, 1700 Cerrillos Road, Santa Fe, New Mexico 87501 Director, Santa Clara Health Center, RR5, Box 446, Espanola, New Mexico 87532 Director, San Felipe Health Center, P.O. Box 4344, San Felipe, New Mexico 87001 Director, Cochiti Health Center, P.O. Box 105, 255 Cochiti Street, Cochiti, New Mexico 87072 Director, Santo Domingo Health Center, P.O. Box 340, Santo Domingo, New Mexico 87052 Director, Southern Colorado-Ute Service Unit, P.O. Box 778, Ignacio, Colorado 81137 Director, Ignacio Indian Health Center, P.O. Box 889, Ignacio, Colorado 81137 Director, Towaoc Ute Health Center, Towaoc, Colorado 81334 Director, Jicarilla Indian Health Center, P.O. Box 187, Dulce, New Mexico 87528 Director, Mescalero Service Unit, Mescalero Indian Hospital, P.O. Box 210, Mescalero, New Mexico 88340 Director, Taos/Picuris Indian Health Center, P.O. Box 1956, 1090 Goat Springs Road, Taos, New Mexico 87571 Director, Zuni Service Unit, Zuni Indian Hospital, Zuni, New Mexico 87327 Director, Pine Hill Health Center, P.O. Box 310, Pine Hill, New Mexico 87357 Director, Bemidji Area Indian Health Service, 522 Minnesota Avenue, NW., Bemidji, Minnesota 56601 Director, Red Lake Service Unit, PHS Indian Hospital, Highway 1, Red Lake, Minnesota 56671 Director, Leech Lake Service Unit, PHS Indian Hospital, 425 7th Street, NW., Cass Lake, Minnesota 56633 Director, White Earth Service Unit, PHS Indian Hospital, P.O. Box 358, White Earth, Minnesota 56591 Director, Billings Area Indian Health Service, P.O. Box 36600, 2900 4th Avenue North, Billings, Montana 59101 Director, Blackfeet Service Unit, Browning Indian Hospital, P.O. Box 760, Browning, Montana 59417 Director, Heart Butte PHS Indian Health Clinic, Heart Butte, Montana 59448 Director, Crow Service Unit, Crow Indian Hospital, Crow Agency, Montana 59022 Director, Lodge Grass PHS Indian Health Center, Lodge Grass, Montana 59090 Director, Pryor PHS Indian Health Clinic, P.O. Box 9, Pryor, Montana 59066 Director, Fort Peck Service Unit, Poplar Indian Hospital, Poplar, Montana 59255 Director, Fort Belknap Service Unit, Harlem Indian Hospital, Harlem, Montana 59526 Director, Hays PHS Indian Health Clinic, Hays, Montana 59526 Director, Northern Cheyenne Service Unit, Lame Dear Indian Health Center, Lame Deer, Montana 59043 Director, Wind River Service Unit, Fort Washakie Indian Health Center, Fort Washakie, Wyoming 82514 Director, Arapahoe Indian Health Center, Arapahoe, Wyoming 82510 Director, Chief Redstone Indian Health Center, Wolf Point, Montana 59201 Director, California Area Indian Health Service, John E. Moss Federal Building, 650 Capitol Mall, Suite 7-100, Sacramento, California 95814 Director, Nashville Area Indian Health Service, 711 Stewarts Ferry Pike, Nashville, Tennessee 37214-2634 Director, Catawba PHS Indian Nation of South Carolina, P.O. Box 188, Catawba, South Carolina 29704 Director, Unity Regional Youth Treatment Center, P.O. Box C-201, Cherokee, North Carolina 28719 Director, Navajo Area Indian Health Service, P.O. Box 9020, Highway 264, Window Rock, Arizona 86515-9020 Director, Chinle Service Unit, Chinle Comprehensive Health Care Facility, P.O. Drawer PH, Chinle, Arizona 86503 Director, Tsaile Health Center, P.O. Box 467, Navajo Routes 64 & 12, Tsaile, Arizona 86556 Director, Rock Point Field Clinic, c/o Tsaile Health Center, P.O. Box 647, Tsaile, Arizona 86557 Director, Pinon Health Station, Pinon, Arizona 86510 Director, Crownpoint Service Unit, Crownpoint Comprehensive Health Care Facility, P.O. Box 358, Crownpoint, New Mexico 87313 Director, Pueblo Pintado Health Station, c/o Crownpoint Comprehensive Health Care Facility, P.O. Box 358, Crownpoint, New Mexico 87313 Director, Fort Definance Service Unit, Fort Definance Indian Hospital, P.O. Box 649, Intersection of Navajo Routes N12 & N7, Fort Defiance, Arizona 86515 Director, Nahata Dziil Health Center, P.O. Box 125, Sanders, Arizona 86512 Director, Gallup Service Unit, Gallup Indian Medical Center, P.O. Box 1337, Nizhoni Boulevard, Gallup, New Mexico 87305 Director, Tohatchi Indian Health Center, P.O. Box 142, Tohatchi, New Mexico 87325 Director, Ft. Wingate Health Station, c/o Gallup Indian Medical Center, P.O. Box 1337, Gallup, New Mexico 87305 Director, Kayenta Service Unit, Kayenta Indian Health Center, P.O. Box 368, Kayenta, Arizona 86033 Director, Inscription House Health Center, P.O. Box 7397, Shonto, Arizona 86054 Director, Dennhotso Clinic, c/o Kayenta Health Center, P.O. Box 368, Kayenta, Arizona 86033 Director, Shiprock Service Unit, Northern Navajo Medical Center, P.O. Box 160, U.S. Hwy 491 North, Shiprock, New Mexico 87420 Director, Dzilth-Na-O-Dith-Hle Indian Health Center, 6 Road 7586, Bloomfield, New Mexico 87413 Director, Teecnospos Health Center, P.O. Box 103, N5114 BIA School Road, Teecnospos, Arizona 86514 Director, Sanostee Health Station, c/o Northern Navajo Medical Center, P.O. Box 160, Shiprock, New Mexico 87420 Director, Toadlena Health Station, c/o Northern Navajo Medical Center, P.O. Box 160, Shiprock, New Mexico 87420 Director, Teen Life Center, c/o Northern Navajo Medical Center, P.O. Box 160, Shiprock, New Mexico 87420 Director, Oklahoma City Area Indian Health Service, Five Corporation Plaza, 3625 NW. 56th Street, Oklahoma City, Oklahoma 73112 Director, Claremore Service Unit, Claremore Comprehensive Indian Health Facility, West Will Rogers Boulevard and Moore, Claremore, Oklahoma 74017 Director, Clinton Service Unit, Clinton Indian Hospital, Route 1, Box 3060, Clinton, Oklahoma 73601-9303 Director, El Reno PHS Indian Health Clinic, 1631A E. Highway 66, El Reno, Oklahoma 73036 Director, Watonga Indian Health Center, Route 1, Box 34-A, Watonga, Oklahoma 73772 Director, Haskell Service Unit, PHS Indian Health Center, 2415 Massachusetts Avenue, Lawrence, Kansas 66044 Director, Lawton Service Unit, Lawton Indian Hospital, 1515 Lawrie Tatum Road, Lawton, Oklahoma 73501 Director, Anadarko Indian Health Center, P.O. Box 828, Anadarko, Oklahoma 73005 Director, Carnegie Indian Health Center, P.O. Box 1120, Carnegie, Oklahoma 73150 Director, Holton Service Unit, PHS Indian Health Center, 100 West 6th Street, Holton, Kansas 66436 Director, Pawnee Service Unit, Pawnee Indian Service Center, RR2, Box 1, Pawnee, Oklahoma 74058-9247 Director, Pawhuska Indian Health Center, 715 Grandview, Pawhuska, Oklahoma 74056 Director, Tahlequah Service Unit, W.W. Hastings Indian Hospital, 100 S. Bliss, Tahlequah, Oklahoma 74464 Director, Wewoka Indian Health Center, P.O. Box 1475, Wewoka, Oklahoma 74884 Director, Phoenix Area Indian Health Service, Two Renaissance Square, 40 North Central Avenue, Phoenix, Arizona 85004 Director, Colorado River Service Unit, Chemehuevi Indian Health Clinic, P.O. Box 1858, Havasu Landing, California 92363 Director, Colorado River Service Unit, Havasupai Indian Health Station, P.O. Box 129, Supai, Arizona 86435 Director, Colorado River Service Unit, Parker Indian Health Center, 12033 Agency Road, Parker, Arizona 85344 Director, Colorado River Service Unit, Peach Springs Indian Health Center, P.O. Box 190, Peach Springs, Arizona 86434 Director, Colorado River Service Unit, Sherman Indian High School, 9010 Magnolia Avenue, Riverside, California 92503 Director, Elko Service Unit, Newe Medical Clinic, 400 “A” Newe View, Ely, Nevada 89301 Director, Elko Service Unit, Southern Bands Health Center, 515 Shoshone Circle, Elko, Nevada 89801 Director, Fort Yuma Service Unit, Fort Yuma Indian Hospital, P.O. Box 1368, Fort Yuma, Arizona 85366 Director, Keams Canyon Service Unit, Hopi Health Care Center, P.O. Box 4000, Polacca, Arizona 86042 Director, Phoenix Service Unit, Phoenix Indian Medical Center, 4212 North 16th Street, Phoenix, Arizona 85016 Director, Phoenix Service Unit, Salt River Health Center, 10005 East Osborn Road, Scottsdale, Arizona 85256 Director, San Carlos Service Unit, Bylas Indian Health Center, P.O. Box 208, Bylas, Arizona 85550 Director, San Carlos Service Unit, San Carlos Indian Hospital, P.O. Box 208, San Carlos, Arizona 85550 Director, Schurz Service Unit, Schurz Service Unit Administration, Drawer A, Schurz, Nevada 89427 Director, Fort McDermitt Clinic, P.O. Box 315, McDermitt, Nevada 89421 Director, Unitah and Ouray Service Unit, Fort Duchesne Indian Health Center, P.O. Box 160, Fort Duchesne, Utah 84026 Director, Whiteriver Service Unit, Cibecue Health Center, P.O. Box 37, Cibecue, Arizona 85941 Director, Whiteriver Service Unit, Whiteriver Indian Hospital, P.O. Box 860, Whiteriver, Arizona 85941 Director, Desert Vision Youth Wellness Center/RTC, P.O. Box 458, Sacaton, AZ 85247 Director, Portland Area Indian Health Service, Room 476, Federal Building, 1220 Southwest Third Avenue, Portland, Oregon 97204-2829 Director, Colville Service Unit, Colville Indian Health Center, P.O. Box 71-Agency Campus, Nespelem, Washington 99155 Director, Fort Hall Service Unit, Not-Tsoo Gah-Nee Health Center, P.O. Box 717, Fort Hall, Idaho 83203 Director, Neah Bay Service Unit, Sophie Trettevick Indian Health Center, P.O. Box 410, Neah Bay, Washington 98357 Director, Warm Springs Service Unit, Warm Springs Indian Health Center, P.O. Box 1209, Warm Springs, Oregon 97761 Director, Wellpinit Service Unit, David C. Wynecoop Memorial Clinic, P.O. Box 357, Wellpinit, Washington 99040 Director, Western Oregon Service Unit, Chemawa Indian Health Center, 3750 Chemawa Road, NE., Salem, Oregon 97305-1198 Director, Yakama Service Unit, Yakama Indian Health Center, 401 Buster Road, Toppenish, Washington 98948 Director, Tucson Area Indian Health Service, 7900 South “J” Stock Road, Tucson, Arizona 85746-9352 Director, Pascua Yaqui Service Unit, Division of Public Health, 7900 South “J” Stock Road, Tucson, Arizona 85746 Director, San Xavier Indian Health Center, 7900 South “J” Stock Road, Tucson, Arizona 85746 Director, Sells Service Unit, Santa Rosa Indian Health Center, HCO1, Box 8700, Sells, Arizona 85634 Director, Sells Service Unit, Sells Indian Hospital, P.O. Box 548, Sells, Arizona 85634 Director, Sells Service Unit, West Side Health Station, P.O. Box 548, Sells, Arizona 85634 [FR Doc. 06-3091 Filed 3-30-06; 8:45 am]

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