Rules and Regulations. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0239] Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(PHS)guideline entitled “PHS Guideline on Infectious Disease Issues in Xenotransplantation” dated January 19, 2001. DATES: Submit written or electronic comments on the collection of information by August 21, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Infectious Disease Issues in Xenotransplantation (OMB Control Number 0910-0456)—Extension The statutory authority to collect this information is provided under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 *et seq.* ). The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance to sponsors in the following ways:

(1)The development of xenotransplantation clinical protocols,

(2)the preparation of submissions to FDA, and

(3)the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The guideline also describes a public health need for a national xenotransplantation database, which is currently under development by PHS. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation. The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include the following information, as recommended by the specific PHS guideline sections:

(1)Records linking each xenotransplantation product recipient with relevant health records of the source animal, herd or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (3.2.7.1);

(2)aliquots of serum samples from randomly selected animal and specific disease investigations (3.4.3.1);

(3)source animal biological specimens designated for PHS use (3.7.1); animal health records (3.7.2), including necropsy results (3.6.4); and

(4)recipients' biological specimens (4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation. The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses that have presented problems in human to human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus

(HIV)and Human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid that is reverse-transcribed into deoxyribonucleic acid

(DNA)using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease, 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for Hepatitis C. In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and nosocomial exposures. Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications

(INDs)and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated 12 respondents who are sponsors of INDs that include protocols for xenotransplantation in humans. Other respondents for this collection of information are an estimated 18 source animal facilities which provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These 18 source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The total annual reporting and recordkeeping burden is estimated to be approximately 156 hours. The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting and recordkeeping tasks described in the guideline. FDA does not expect the level of clinical studies using xenotransplantation to increase significantly in the next few years. FDA is requesting an extension of OMB approval for the following reporting and recordkeeping recommendations in the PHS guideline: **Table 1.—Reporting Recommendations** PHS Guideline Section Description 3.2.7.2 Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations 3.4 Standard operating procedures

(SOPs)of source animal facility should be available to review bodies 3.5.1 Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened 3.5.4 Sponsor to make linked records described in section 3.2.7 available for review 3.5.5 Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after xenotransplantation product procurement **Table 2.—Recordkeeping Recommendations** PHS Guideline Section Description 3.2.7 Establish records linking each xenotransplantation product recipient with relevant records 4.3 Sponsor to maintain cross-referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures) 3.4.2 Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically 3.4.3.2 Document full necropsy investigations including evaluation for infectious etiologies 3.5.1 Justify shortening a source animal's quarantine period of 3 weeks prior to xenotransplantation product procurement 3.5.2 Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal does not preclude using it 3.5.4 Add summary of individual source animal record to permanent medical record of the xenotransplantation product recipient 3.6.4 Document complete necropsy results on source animals (50-year record retention) 3.7 Link xenotransplantation product recipients to individual source animal records and archived biologic specimens 4.2.3.2 Record base-line sera of xenotransplantation health care workers and specific nosocomial exposure 4.2.3.3 and 4.3.2 Keep a log of health care workers' significant nosocomial exposure(s) 4.3.1 Document each xenotransplant procedure 5.2 Document location and nature of archived PHS specimens in health care records of xenotransplantation product recipient and source animal FDA estimates the burden for this collection of information as follows: **Table 3.—Estimated Annual Reporting Burden** 1 PHS Guideline Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3.2.7.2 2 1 1 1 0.5 0.5 3.4 3 12 0.33 4 0.08 0.32 3.5.1 4 12 0.08 (0-1) 1 0.25 0.25 3.5.4 5 12 1 12 0.5 6.0 3.5.5 4 18 0.06 (0-1) 1 0.2 0.2 Total 7.27 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 No animal facility or sponsor has ceased operations in the last 3 years, however, we are using 1 respondent for estimation purposes. 3 FDA's records indicate that an average of 4 INDs are expected to be submitted per year. 4 To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 5 Based on an estimate of 36 patients treated over a 3 year period, the average number of xenotransplantation product recipients per year is estimated to be 12. **Table 4.—Estimated Annual Recordkeeping Burden** 1 PHS Guideline Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 3.2.7 2 1 1 1 16 16.0 4.3 3 12 1 12 0.83 9.96 3.4.2 4 12 11 132 0.25 33.0 3.4.3.2 5 18 4 72 0.3 21.6 3.5.1 6 12 0.08 (0-1) 1 0.5 0.5 3.5.2 6 12 0.08 (0-1) 1 0.25 0.25 3.5.4 12 1 12 0.17 2.04 3.6.4 7 12 2 24 0.25 6.0 3.7 7 18 1.33 24 0.08 1.92 4.2.3.2 8 12 25 300 0.17 51.0 4.2.3.2 6 12 0.08 (0-1) 1 0.17 0.17 4.2.3.3 and 4.3.2 6 12 0.08 (0-1) 1 0.17 0.17 4.3.1 12 1 12 0.25 3.0 5.2 9 12 3 36 0.08 2.88 Total 148.49 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA estimates 1 new sponsor annually. 3 FDA estimates there is minimal recordkeeping burden associated with maintaining the record system. 4 Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are approximately 6 sentinel animals per herd x 1 herd per facility x 18 facilities = 108 sentinel animals. There are approximately 24 source animals per year (see footnote 7 of this table); 108 + 24 = 132 monitoring records to document. 5 Necropsy for animal deaths of unknown cause estimated to be approximately 4 per herd per year x 1 herd per facility x 18 facilities = 72. 6 Has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 7 On average 2 source animals are used for preparing xenotransplantation product material for one recipient. The average number of source animals is 2 source animals per recipient x 12 recipients annually = 24 source animals per year (see footnote 5 of table 3 of this document). 8 FDA estimates there are approximately 12 clinical centers doing xenotransplantation procedures x approximately 25 health care workers involved per center = 300 health care workers. 9 24 source animal records + 12 recipient records = 36 total records. Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Since these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 through 4 can be found under existing regulations and approved under the OMB control numbers as follows:

(1)“Current Good Manufacturing Practice for Finished Pharmaceuticals,” 21 CFR 211.1 through 211.208, approved through 9/30/2008 under OMB control number 0910-0139;

(2)“Investigational New Drug Application,” 21 CFR 312.1 through 312.160, approved through 5/31/2009 under OMB control number 0910-0014; and

(3)information included in a license application, 21 CFR 601.2, approved through 9/30/2008 under OMB control number 0910-0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product (e.g., it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.) However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 4. In table 5 of this document, FDA identifies those information collection activities that are already encompassed by existing regulations or are consistent with voluntary standards which reflect industry's usual and customary business practice. Table 5.—Collection of Information Required by Current Regulations and Standards PHS Guideline Section Description of Collection of Information Activity 21 CFR Section (Unless Otherwise Stated) 2.2.1 Document off-site collaborations 312.52 2.5 Sponsor ensure counseling patient, family, and contacts 312.62(c) 3.1.1 and 3.1.6 Document well-characterized health history and lineage of source animals 312.23(a)(7)(a) and 211.84 3.1.8 Registration with and import permit from the Centers for Disease Control and Prevention 42 CFR 71.53 3.2.2 Document collaboration with accredited microbiology labs 312.52 3.2.3 Procedures to ensure the humane care of animals 9 CFR parts 1, 2, and 3 and PHS Policy 1 3.2.4 Procedures consistent for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and consistent with the National Research Council's (NRC's) guide AAALAC international rules of accreditation 2 and NRC guide 3 3.2.5, 3.4, and 3.4.1 Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record standard veterinary care 211.100 and 211.122 3.2.6 Animal facility SOPs PHS Policy 1 3.3.3 Validate assay methods 211.160(a) 3.6.1 Procurement and processing of xenografts using documented aseptic conditions 211.100 and 211.122 3.6.2 Develop, implement, and enforce SOPs for procurement and screening processes 211.84(d) and 211.122(c) 3.6.4 Communicate to FDA animal necropsy findings pertinent to health of recipient 312.32(c) 3.7.1 PHS specimens to be linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected 312.23(a)(6) 4.1.1 Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program lifelong (justify > 2 years (yrs.)); investigator case histories (2 yrs. after investigation is discontinued) 312.23(a)(6)(iii)(f) and (g), and 312.62(b) and

(c)4.1.2 Sponsor to justify amount and type of reserve samples 211.122 4.1.2.2 System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal) 312.57(a) 4.1.2.3 Notify FDA of a clinical episode potentially representing a xenogeneic infection 312.32 4.2.2.1 Document collaborations (transfer of obligation) 312.52 4.2.3.1 Develop educational materials (sponsor provides investigators with information needed to conduct investigation properly) 312.50 4.3 Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories 312.57 and 312.62(b) 1 The “Public Health Service Policy on Humane Care and Use of Laboratory Animals” ( *http://www.grants.nih.gov/grants/olaw/references/phspol.htm* ). 2 AAALAC international rules of accreditation ( *http://www.aaalac.org/accreditation/rules.cfm* ). (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site address after this document publishes in the Federal Register .) 3 NRC's “Guide for the Care and Use of Laboratory Animals” (1996). Dated: June 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9816 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0343] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006,” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of April 10, 2006 (71 FR 18105), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0571. The approval expires on May 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: June 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9824 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0369] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of February 10, 2006 (71 FR 7048), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0583. The approval expires on April 30, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: June 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9826 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0457] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Generally Recognized as Safe: Notification Procedure AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Substances Generally Recognized as Safe: Notification Procedure” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of April 7, 2006 (67 FR 17892), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0342. The approval expires on May 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: June 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9827 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0237] Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which an applicant may obtain an assignment or designation determination. DATES: Submit written or electronic comments on the collection of information by August 21, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications—21 CFR Part 3 (OMB Control Number 0910-0523)—Extension This regulation relates to agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Public Law 101-629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any of the following combinations:

(1)A drug and a device;

(2)a device and a biological;

(3)a biological and a drug; or

(4)a drug, a device, and a biological. The second purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for classifying and determining which agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biologicals, and combination products. The respondents will be businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Part 3 43 1 43 24 1,032 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9900 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006O-0232] Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient AGENCY: Food and Drug Administration, HHS. ACTION: Notice of eligibility; request for data and information. SUMMARY: The Food and Drug Administration

(FDA)is announcing a call-for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter

(OTC)drug products: Sodium picosulfate, up to 10 milligrams (mg), as a laxative single active ingredient. FDA reviewed a time and extent application

(TEA)for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/E) for its proposed OTC use. DATES: Submit data, information, and comments by September 20, 2006. ADDRESSES: Submit comments, data, and information to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments, data, and information to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., WO Bldg. 22, Mail Stop 5411, Silver Spring, MD 20993, 301-796-2090. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 23, 2002 (67 FR 3060), FDA published a final rule establishing criteria and procedures for additional conditions to become eligible for consideration in the OTC drug monograph system. These criteria and procedures, codified in § 330.14 (21 CFR 330.14), permit OTC drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any marketing experience in the United States to become eligible for FDA's OTC drug monograph system. The term “condition” means an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration, marketed for a specific OTC use (§ 330.14 (a)). The criteria and procedures also permit conditions that are regulated as cosmetics or dietary supplements in foreign countries but that would be regulated as OTC drugs in the United States to become eligible for the OTC drug monograph system. Sponsors must provide specific data and information in a TEA to demonstrate that the condition has been marketed for a material time and to a material extent to become eligible for consideration in the OTC drug monograph system. When the condition is found eligible, FDA publishes a notice of eligibility and request for safety and effectiveness data for the proposed OTC use. The TEA that FDA reviewed (Ref. 1) and FDA's evaluation of the TEA (Ref. 2) have been placed on public display in the Division of Dockets Management (see ADDRESSES ) under the docket number found in brackets in the heading of this document. Information deemed confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j) was deleted from the TEA before it was placed on public display. II. Request for Data and Information FDA determined that the information submitted in this TEA satisfies the criteria of § 330.14. FDA will evaluate sodium picosulfate, up to 10 mg, as a laxative single active ingredient for inclusion in the monograph for OTC laxative drug products (21 CFR part 334). Accordingly, FDA invites all interested persons to submit data and information, as described in § 330.14(f), on the safety and effectiveness of this active ingredient for this use so that FDA can determine whether it can be GRAS/E and not misbranded under recommended conditions of OTC use. The TEA does not include an official or proposed United States Pharmacopeia-National Formulary (USP-NF) drug monograph. According to § 330.14(i) sponsors must include, an official or proposed USP-NF monograph for this ingredient as part of the safety and effectiveness data for this ingredient. III. Comments Interested persons should submit comments, data, and information to the Division of Dockets Management (see ADDRESSES ). Submit three copies of all comments, data, and information. Individuals submitting written information or anyone submitting electronic comments may submit one copy. Submissions are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by supporting information. Received submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Information submitted after the closing date will not be considered except by petition under (21 CFR 10.30). IV. Marketing Policy Under § 330.14(h), any product containing the condition for which data and information are requested may not be marketed as an OTC drug in the United States at this time unless it is the subject of an approved new drug application or abbreviated new drug application. V. References The following references are on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. TEA for sodium picosulfate submitted by Ropes and Gray LLP on behalf of Boehringer Ingelheim on June 24, 2005. 2. FDA's evaluation and comments on the TEA for sodium picosulfate. Dated: June 16, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-9896 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0444] Determination of Regulatory Review Period for Purposes of Patent Extension; BONIVA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for BONIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions 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* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug application becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product BONIVA (ibandronate sodium). BONIVA is indicated for treatment and prevention of osteoporosis in postmenopausal women. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BONIVA (U.S. Patent No. 4,927,814) from Hoffmann-La Roche Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of BONIVA represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for BONIVA is 2,559 days. Of this time, 2,254 days occurred during the testing phase of the regulatory review period, while 305 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: May 15, 1996. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on May 15, 1996. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: July 16, 2002. The applicant claims July 15, 2002, as the date the new drug application

(NDA)for BONIVA (NDA 21-455) was initially submitted. However, FDA records indicate that NDA 21-455 was initially submitted on July 16, 2002. 3. The date the application was approved: May 16, 2003. FDA has verified the applicant's claim that NDA 21-455 was approved on May 16, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 337 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by August 21, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 19, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 17, 2006. Jane Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-9817 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0413] Determination of Regulatory Review Period for Purposes of Patent Extension; CIALIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for CIALIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions 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* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product CIALIS (tadalafil). CIALIS is indicated for treatment of erectile dysfunction. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CIALIS (U.S. Patent No. 5,859,006) from ICOS Corporation, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of CIALIS represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for CIALIS is 1,943 days. Of this time, 1,067 days occurred during the testing phase of the regulatory review period, while 876 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective* : July 29, 1998. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on July 29, 1998. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : June 29, 2001. FDA has verified the applicant's claim that the new drug application

(NDA)for CIALIS (NDA 21-368) was initially submitted on June 29, 2001. 3. *The date the application was approved* : November 21, 2003. FDA has verified the applicant's claim that NDA 21-368 was approved on November 21, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 679 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by August 21, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 19, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 17, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-9899 Filed 6-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2006M-0075, 2006M-0009, 2006M-0014, 2006M-0015, 2006M-0163] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is publishing a list of premarket approval applications

(PMAs)that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the **Federal Register** . Instead, the agency now posts this information on the Internet on FDA's home page at *http://www.fda.gov* . FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the **Federal Register** , and FDA believes that the Internet is accessible to more people than the **Federal Register** . In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from January 1, 2006, through March 31, 2006. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date. **Table 1.—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2006, through March 31, 2006** PMA No./Docket No. Applicant Trade Name Approval Date P020024/2006M-0075 AGA Medical Corp. AMPLATZER DUCT OCCULUDER AND 180 DELIVERY SYSTEM May 14, 2003 P020001/2006M-0009 Neoventa Medical AB STAN S31 FETAL HEART MONITOR November 1, 2005 P040001/2006M-0014 St. Francis Medical Technologies, Inc. X STOP INTERSPINOUS PROCESS DECROMPRESSION SYSTEM November 21, 2005 P050009/2006M-0015 Biomet, Inc. C2 A-TAPER ACETABULAR SYSTEM December 16, 2005 P050007/2006M-0016 Abbott Vascular Devices

(AVD)STARCLOSE VASCULAR CLOSURE SYSTEM December 21, 2005 H040005/2006M-0163 Karl Storz Endoscopy-America, Inc. KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENT SET WITH 0 AND 12 DEGREE SCOPE, KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENT SET WITH 30 DEGREE SCOPE, AND KARL STORZ SEMI-RIGID TTTS F ETOSCOPY INSTRUMENT SET March 31, 2006 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cdrh/pmapage.html* . Dated: June 13, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-9898 Filed 6-21-06; 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: Indian Health Service Medical Staff Credentials and Privileges Files AGENCY: Indian Health Service, HHS. 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 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:* 0917-0009, “Indian Health Service Medical Staff” *Typed of Information Collection Request:* Extension, without revision, of currently approved information collection, 0917-0009, “Indian Health Service Medical Staff Credentials and Privileges Files.” *Form Numbers(s):* None. *Need and Use of Information Collection:* This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. The HHS operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these services, the IHS employs (directly and under contract) several categories of health care providers including: Physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physician assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives. The IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility's capabilities and medical staff bylaws. There are three types of IHS medical staff applicants:

(1)Health care providers applying for direct employment with IHS;

(2)contractors who will not seek to become IHS employees; and

(3)employed IHS health care providers who seek to transfer between IHS health care facilities. National health care standards developed by the Center for Medicare and Medicaid Services (formerly the Health Care Financing Administration), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and other accrediting organizations required health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. To meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. In addition to the initial granting of medical staff membership and clinical privileges, JCAHO standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty. The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is not optional; such records must be established and maintained at all health care facilities in the United States that are accredited by JCAHO. Prior to the establishment of this JCAHO requirement, the degree to which medical staff applications were verified for completeness and accuracy varied greatly across America. *Affected Public:* Individuals and households. *Type of Respondents:* Individuals. *Burden Hours:* The table below provides the estimated burden hours for this information collection: Data collection Est. number of respondents Responses per respondent Burden per response * Total annual burden hrs. Application to Medical Staff 600 1 1.00 (60 mins) 600.0 Reference Letter 1800 1 0.33 (20 mins) 594.0 Reappointment Request 200 1 1.00 (60 mins) 200.0 Ob-Gyn Privileges 25 1 1.00 (60 mins) 25.0 Internal Medicine 387 1 1.00 (60 mins) 387.0 Surgery Privileges 23 1 1.00 (60 mins) 23.0 Psychiatry Privileges 18 1 1.00 (60 mins) 18.0 Anesthesia Privileges 16 1 1.00 (60 mins) 16.0 Dental Privileges 128 1 0.33 (20 mins) 42.2 Optometry Privileges 21 1 0.33 (20 mins) 6.9 Psychology Privileges 23 1 0.17 (10 mins) 3.9 Audiology Privileges 6 1 0.08 (5 mins) 0.48 Podiatry Privileges 6 1 0.08 (5 mins) 0.48 Radiology Privileges 9 1 0.33 (20 mins) 2.9 Pathology Privileges 3 1 0.33 (20 mins) .99 Total 3,265 1,920.85 * For ease of understanding, burden hours are provided in actual minutes. 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:* For the proposed collection or requests to obtain a copy of the data collection instrument(s) and instructions to: Mrs. Christina Rouleau, IHS Reports Clearance Officer, 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: June 15, 2006. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. 06-5574 Filed 6-21-06; 8:45 am]

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