Notices. Notice; withdrawal and revision

4,538 words·~21 min read·/register/2006/06/01/06-5021

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BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-06-0242x] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* 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 or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Estimating the Cost of Sigmoidoscopy and Colonoscopy for Colorectal Cancer Screening in U.S. Healthcare Facilities—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Colorectal cancer

(CRC)is the second leading cause of cancer-related deaths in the United States. In 2005, it was estimated that approximately 56,300 Americans died from CRC and about 145,300 new cases were diagnosed. The risk of developing CRC increases with advancing age. More than 90% of newly diagnosed CRCs occur in persons 50 years of age and older. Several scientific studies have demonstrated that regular screening for CRC reduces the incidence and mortality cases stemming from this disease. Other studies have shown that regular screening for CRC is also cost-effective in terms of years of life saved. Despite strong scientific evidence and evidence-based clinical guidelines recommending screening, current screening rates remain low. A recent CDC study reported that more than 40 million Americans who are 50 years of age or older and at average risk for CRC have not been screened in accordance with current guidelines. The study also reported that screening this population with current endoscopic ( *i.e.* , flexible sigmoidoscopy and colonoscopy) capacity in the health care system could require as much as ten years to complete. An effective national effort to promote CRC screening could increase the demand for endoscopic procedures. It has been reported that reimbursements for endoscopic procedures in publicly-funded programs may not be adequate to cover the costs of performing these procedures. This may be a disincentive for providers to perform endoscopy procedures. Currently, there is little information available about the resources required or the cost of providing these procedures in different types of healthcare facilities in the United States. The purpose of this project is to conduct a survey of a nationally representative sample of healthcare facilities in order to estimate the average variable costs of providing colonoscopy and flexible sigmoidoscopy for CRC screening and follow-up services. Over time, payments need to cover fixed costs in addition to variable costs. If some facilities have the ability to provide more procedures without additional investment in space or equipment, then recovering fixed costs is not necessary at least in the short run. The estimated average variable cost by procedure will be compared to the reimbursement rates for both screening procedures in order to determine whether the payments to facilities exceed this minimum threshold. Otherwise, facilities will find reimbursement a potential barrier to expansion of CRC screening to uninsured or underinsured populations even if there is underutilized capacity. The study will also determine whether there are factors that affect average variable costs across facilities such as the number of procedures performed, specialization in types of procedures or other characteristics of the facility. Results of this study will be used to better understand the economics of colorectal cancer screening. Respondents include medical facility receptionists, hospital operators, and office/business managers. There is no cost to the respondent, other than their time. Estimated Annualized Burden Hours Form type Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Telephone script to medical facility receptionists 4,160 1 5/60 347 Mail Survey to hospital-based outpatient department managers 1,000 1 1 1,000 Mail Survey to ambulatory surgery center managers 725 1 1 725 Total 2,072 Dated: May 24, 2006. Joan F. Karr, Acting Report Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-8453 Filed 5-31-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Surveillance and Epidemiologic Research of Duchenne and Becker Muscular Dystrophy and Other Single Gene Disorders, Request for Applications

(RFA)Number DD06-002 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Surveillance and Epidemiologic Research of Duchenne and Becker Muscular Dystrophy and Other Single Gene Disorders, Request for Applications

(RFA)Number DD06-002. *Time and Date:* 12 p.m.-5 p.m., June 27, 2006 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* To conduct expert review of scientific merit of research applications: Surveillance and Epidemiologic Research of Duchenne and Becker Muscular Dystrophy and Other Single Gene Disorders, RFA Number DD06-002. FOR FURTHER INFORMATION CONTACT: Juliana Cyril, PhD., Scientific Review Administrator, Centers for Disease Control, 1600 Clifton Road, NE., Mail Stop D-72, Atlanta, GA 30333, Telephone 404.639.4639. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8443 Filed 5-31-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Research and Development Contract Attention Deficit Hyperactivity Disorder Surveillance, Contract Solicitation Number

(CSN)2006-N-08468 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Research and Development Contract Attention Deficit Hyperactivity Disorder Surveillance, CSN 2006-N-08468. *Time and Date:* 12 p.m.-4 p.m., June 22, 2006 (Closed). *Place:* Centers for Disease Control, 1600 Clifton Road NE., Building 19, Room 8123, Atlanta, GA 30333. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to “Research and Development Contract Attention Deficit Hyperactivity Disorder Surveillance,” CSN 2006-N-08468. *Contact Person for More Information:* Christine Morrison, Ph.D., Scientific Review Administrator, Office of Extramural Research, CDC, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404-639-3098. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8444 Filed 5-31-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee on Immunization Practices: Teleconference In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announce the following Federal Committee meeting. *Name:* Advisory Committee on Immunization Practices

(ACIP)teleconference. *Time and Date:* 10 a.m.—11 a.m., June 8, 2006. *Place:* The conference call will originate at the National Immunization Program (NIP), in Atlanta. Georgia. Please see SUPPLEMENTARY INFORMATION for details on accessing the conference call. *Status:* Open to the public, limited only by the availability of telephone ports. *Purpose:* The Committee is charged with advising the Director, CDC, on the appropriate uses of immunizing agents. In addition, under 42 U.S.C. 1396s, the Committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children

(VFC)program, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. *Matters to Be Discussed:* To discuss background for decisions about the use of tetanus, reduced diphtheria and acellular

(Tdap)vaccine in pregnant women. *Supplementary Information:* This conference call is scheduled to begin at 10 a.m., Eastern Standard Time. To participate in the conference call, please dial 1-888-710-9649 and reference passcode 4003357. As provided under 41 CFR 102-3.150(b), the public health urgency of this agency business requires that the meeting be held prior to the first available date for publication of this notice in the **Federal Register** . *For Further Information Contact:* Demetria Gardner, Epidemiology and Surveillance Division, National Immunization Program, CDC, 1600 Clifton Road, NE, (E-05), Atlanta, Georgia 30333, telephone 404/639-8836, fax 404/639-8616. The Acting Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 26, 2006. Diane Allen, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8590 Filed 5-31-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH); Advisory Board on Radiation and Worker Health (ABRWH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention announces the following committee meeting: *Name:* Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health and Subcommittee for Dose Reconstruction and Site Profile Reviews (SDRSPR). *Subcommittee Meeting Time and Date:* 9 a.m.-12 p.m., June 14, 2006. *Committee Meeting Times and Dates:* 1 p.m.-5:45 p.m., June 14, 2006. 8:30 a.m.-6:15 p.m., June 15, 2006. 8:30 a.m.-5 p.m., June 16, 2006. *Public Comment Times and Dates:* 4:15 p.m.-5:45 p.m., June 14, 2006. 1 p.m.-1:30 p.m., June 15, 2006. 5 p.m.-6:15 p.m., June 15, 2006. *Place:* Marriott Metro Center, 775 12th Street, Washington, DC 20005. Phone 202.737.2200, Fax 202.347.5886. *Status:* Open to the public, limited only by the space available. The meeting space accommodates approximately 75 people. *Background:* The ABRWH was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services

(HHS)as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2007. *Purpose:* This board is charged with

(a)Providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179;

(b)providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and

(c)upon request by the Secretary, HHS, advise the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. *Matters To Be Discussed:* The agenda for the Subcommittee meeting includes Selection of 6th Round of Individual Dose Reconstruction

(DR)Cases; Completion of Review of 2nd and 3rd Round of DR Cases; and Completion of Procedures Review. The agenda for the Board meeting includes NIOSH and DOL Program Status Updates; Conflict of Interest; Ames SEC Petition; NIOSH Presentation on Partial Dose Reconstructions for Non-Presumtive Cancers Added to the SEC; Status and Planning for Upcoming SEC Petitions: Allied Chemical, S-50, LANL, and Harshaw; Discussion of Board's Use of Subcommittees and Working Groups; SC&A Report of SEC Review Procedures; SEC Petition Updates for Y-12, Rocky Flats, Nevada Test Site and Pacific Proving Ground; Site Profile Updates for: Savannah River Site, Hanford, and Nevada Test Site; Second Year Site Profiles; Finalization of Selection of 6th Round of Individual DR Cases; SC&A Initial Presentation of 4th Round of DR Cases; Finalization of Review of the 2nd and 3rd Rounds of Individual DR Cases; and Finalization of Report on Procedures Review; NIOSH Update on Program Issues: Bethlehem Steel Site Profile, Construction Workers, Site Profile Revision Activities, Quality Assurance/Quality Control, and Communications Initiative; Future Plans and Schedules. The agenda is subject to change as priorities dictate. In the event an individual cannot attend, written comments may be submitted. Any written comments received will be provided at the meeting and should be submitted to the contact person below well in advance of the meeting. *For More Information Contact:* Dr. Lewis V. Wade, Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513.533.6825, fax 513.533.6826. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 24, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. FR Doc. E6-8586 Filed 5-31-06; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 1985D-0243 (formerly 85D-0243), 1984D-0115 (formerly 84D-0115), 1998D-0362 (formerly 98D-0362), 2003D-0061 (formerly 03D-0061), 2006D-0198, 1998D-0994 (formerly 98D-0994), 2003D-0571, 2000D-0186 (formerly 00D-0186), 1993D-0139 (formerly 93D-0139), 1996D-0010 (formerly 96D-0010), 1996D-0028 (formerly 96D-0028), 2001D-0361 (formerly 01D-0361), 2002D-0237 (formerly 02D-0237), 2002D-0231 (formerly 02D-0231), 1997D-0448 (formerly 97D-0448), 1998D-0374 (formerly 98D-0374), 2000D-1418 (formerly 00D-1418), 2005D-0021] Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Withdrawal and Revision of Seven Guidances AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal and revision. SUMMARY: The Food and Drug Administration

(FDA)is announcing the withdrawal of five and the revision of two guidances for industry, because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative). Several of the guidances listed in this notice are cross-Center guidances relating to products regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM). FOR FURTHER INFORMATION CONTACT: *For products regulated by CDER* : Jon Clark, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3550, Silver Spring, MD 20993-0002, 301-796-2020. *For products regulated by CBER* : Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food and Drug Administration 1401 Rockville Pike, suite 200N Rockville, MD 20852-1448, 301-435-5681. *For products regulated by CVM* : Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., MPN II, Rockville, MD 20855, 301-827-6956. SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of five and the revision of two guidances for industry because of inconsistencies with the agency's CGMP Initiative, announced by FDA on August 21, 2002. FDA introduced the Initiative for a number of reasons:

(1)To enhance the CGMP,

(2)to focus our resources and regulatory attention on those aspects of manufacturing that pose the greatest risk to the quality of the product,

(3)to ensure that our work does not impede innovation in manufacturing, and

(4)to promote consistency in our regulatory approach. A report on the outcome of the initiative and the recommended steps for implementing a pharmaceutical quality regulatory system for the future can be found on the FDA Web site at *http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm* . Many of FDA's previously published guidances relating to chemistry, manufacturing, and controls information were drafted prior to the CGMP Initiative. FDA has begun a review of its guidances for their consistency with the CGMP Initiative and is withdrawing five guidances and revising two guidances as listed below. Several of the guidances are cross-Center guidances. **CDER—Only Guidance for Withdrawal** • *Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application* , February 1987. **CDER/CBER Guidances for Withdrawal** • *Submitting Documentation for the Stability of Human Drugs and Biologics* , February 1987. • *Stability Testing of Drug Substances and Drug Products* (Draft), June 1998. • *Drug Product: Chemistry, Manufacturing, and Controls Information* (Draft), January 2003. • *Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptides* , November 1994. **CDER/CBER Guidances for Withdrawal; CVM Guidances for Revision** CDER and CBER are withdrawing the following two guidances from their Web sites: • *BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation* , February 2001. • *Drug Substance: Chemistry, Manufacturing, and Controls Information* (draft), January 2004. CVM made Level II revisions to the above two guidances to support their continued use in CVM for the approval of new animal drugs (e.g., removed references to human drug and biological products). The revised guidances are available on *http://www.fda.gov/cvm* . CVM is committed to and supports the CGMP Initiative and may draft additional guidance that supports the CGMP Initiative as it relates to new animal drugs. We will continue to review our guidances for their consistency with the CGMP Initiative and may withdraw or revise other guidances if they do not reflect our current thinking or to align them with the concepts of the CGMP Initiative, the Quality by Design Initiative, or Question-based Reviews. We also plan to develop new guidances to support these agency initiatives and to communicate guidance on submission of new drug applications and abbreviated new drug applications. In the meantime, we recommend that the human drug pharmaceutical industry refer to the following International Conference on Harmonisation's

(ICH)documents, which are available on FDA's Web sites, as alternate resources. • *M4: Common Technical Document

(CTD)for the Registration of Pharmaceuticals for Human Use* (CTD), October 2001. • *M4: The CTD—Quality* , August 2001. • *Q1A(R2) Stability Testing of New Drug Substances and Products* , November 2003. • *Q1B Photostability Testing of New Drug Substances and Products* , November 1996. • *Q1C Stability Testing for New Dosage Forms* , May 1997. • *Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products* , January 2003. • *Q1E Evaluation of Stability Data* , June 2004. • *Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV* , Revision 1, July 2004. • *Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances* , December 2000. • *Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products* , August 1999. • *Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients* , August 2001. • *Q8 Pharmaceutical Development* (Draft), February 2005. The above list is not intended to be exhaustive. If questions arise that are not covered in the ICH guidances, we recommend that pharmaceutical manufacturers contact the appropriate review division. Dated: May 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8417 Filed 5-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 60-Day Proposed Information Collection AGENCY: Indian Health Service, HHS. ACTION: Request for public comment: 60-day proposed information collection: Indian Health Service forms to implement the privacy rule (45 CFR parts 160 & 164). SUMMARY: The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review. Proposed Collection *Title:* 0917-0030, “IHS Forms to Implement the Privacy Rule (45 CFR Parts 160 & 164).” *Type of Information Collection Request:* Extension, without revision, of currently approved information collection, 0917-0030, “IHS Forms to Implement the Privacy Rule (45 CFR Parts 160 & 164)”. *Form Number(s):* IHS-810, IHS-917, IHS-912-1, IHS-912-2, and IHS-913. *Need and Use of Information Collection:* This collection of information is made necessary by the Department of Health and Human Services Rule entitled “Standards for Privacy of Individually Identifiable Health Information” (“Privacy Rule”) (45 CFR Parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Information Portability and Accountability Act of 1996 and creates national standards to protect individual's personal health information and gives patients increased access to their medical records. 45 CFR 164.508, 522, 526 and 528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will use the following data collection instruments to implement the information collection requirements contained in the Rule. *45 CFR 164.508:* This provision requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information for other than for treatment, payment and healthcare operations. Under the provision individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The IHS-810 will be used to document an individual's authorization to use or disclose their protected health information. *45 CFR 164.522:* Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction. The form IHS-912-1 “Request for Restrictions(s)” will be used to document an individual's request for restriction of their protected health information and whether IHS agreed or disagreed with the restriction. Section 164.522(a)(2)(1) permits a covered entity to terminate its agreement to a restriction if the individual agrees to or requests the termination in writing. The form IHS-912-2 “Request for Revocation of Restriction(s)” will be used to document the agency or individual request to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. *45 CFR 164.526:* This provision requires covered entities to permit an individual to request that the covered entity amend protected health information. If the covered entity accepts the requested amendment, in whole or in part, the covered entity must inform the individual that the amendment is accepted and obtain the individual's identification of an agreement to have the covered entity notify the relevant persons with which the amendment needs to be shared. If the covered entity denies the requested amendment, in whole or in part, the covered entity must provide the individual with a written denial. The form IHS-917 “Request for Correction/Amendment of Protected Health Information” will be used to document an individual's request to amend their protected health information and the agency's decision to accept or deny the request. *45 CFR 164.528:* This provision requires covered entities to permit and individual to request that the covered entity provide an accounting of disclosures of protected health information made by the covered entity. The form IHS-913 “Request for an Accounting of Disclosures” will be used to document an individual's request for an Accounting of Disclosures of their protected health information and the agency's handling of the request. Completed forms used in this collection of information are filed in the medical record. *Affected Public:* Individuals and households. *Type of Respondents:* Individuals. *Burden Hours:* The table below provides the estimated burden hours for this information collection: 45 CFR section/IHS form Number of respondents Responses per respondent Burden per response*

(mins)Total annual burden 164.506 IHS-810 500,000 1 20 166,667 164.522(a)(1) IHS-912-1 15,000 1 10 2,500 164.522(a)(2) IHS-912-2 5,000 1 10 833 164.526 IHS-917 7,500 1 15 1,875 164.528 IHS-913 15,000 1 10 2,500 Total Annual Burden 5 174,375 * For ease of understanding, burden hours are provided in actual minutes. The total estimated burden for this collection of information is 174,375 hours. There are no capital costs, operating costs and/or maintenance costs to respondents. *Request for Comments:* Your written comments and/or suggestions are invited on one or more of the following points:

(a)Whether the information collection activity is necessary to carry out an agency function;

(b)whether the agency processes the information collected in a useful and timely fashion;

(c)the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information);

(d)whether the methodology and assumptions used to determine the estimate are logical;

(e)ways to enhance the quality, utility, and clarity of the information being collected; and

(f)ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Send Comments and Requests for Further Information:* Send your written comments and requests for more information on the proposed collection or requests to obtain a copy of the data collection instrument(s) and instructions to: Mrs. Christina Rouleau, IHS Reports Clearance Office, 801 Thompson Avenue, TMP, Suite 450, Rockville, MD 20852, call non-toll free

(301)443-5938, send via facsimile to

(301)443-2316, or send your e-mail requests, comments, and return address to: *crouleau@hqe.ihs.gov.* *Comment Due Date:* Your comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: May 23, 2006. Charles W. Grim, Assistant Surgeon General, Director, Indian Health Service. [FR Doc. 06-5021 Filed 5-31-06; 8:45 am]

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