Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 5, 2006, page 17119, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Hazardous Waste Worker Training42 CFR Part 65. Type of Information Collection Request: Revision of OMB No. 0925-0348, expiration date August 31, 2006. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) has been given major responsibility for initiating a worker safety and health training program under section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting workers and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In seventeen years (FY 1987-2004), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 1.3 million workers across the country and presented over 69,000 classroom and hands-on training courses, which have accounted for nearly 18 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4(a), (b), (c) and 65.6(b) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Type of Respondents: Grantees. The annual reporting burden is as follows: Estimated Number of Respondents: 18; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 10; and Estimated Total Annual Burden Hours Requested: 360. The annualized cost to respondents is estimated at: $10,764. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumption use; (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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Joseph T. Hughes, Jr., Director, Worker Education and Training Program, Division of Extramural Research and Training, NIEHS, P.O. Box 12333, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-0217 or E-mail your request, including your address to wetp@niehs.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 13, 2006, page 12703-12704 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 25, 2006, page 4151-4152 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. This 30-day submission is modified in order to reflect an increase in sample size. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice announces the seventh meeting of the American Health Information Community (``Community'') Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of various internal parasites or parasitic conditions.

This notice announces the seventh meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the seventh meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied: HHS. Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic Agents,'' Provisional Patent Application, 60/413,673; International Patent Application PCT/US03/30155, U.S. Patent Application Serial No. 10/528,310; European Patent Applications Serial No. 03756863.1; Australian Patent Application No. 2003299140; Canadian Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and/1 ``Method for Increasing the Distribution of Therapeutic Agents;'' and ``Method for Increasing the Distribution of Nucleic Acids;'' Provisional, Patent Application 60/250,286; Provisional Patent Application No. 60/286,308; U.S. Patent Application No. 09/999,203; U.S. Patent Application No. 10/132,681; and Canadian Patent Application No. 2327208, to MedGenesis Therapeutix, Inc. a Canadian company having its headquarters in Victoria, British Columbia. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in a field of use limited to the convection enhanced delivery and tracking of gadolinium conjugated peptides, polypeptides or lipid-based therapeutic agents within the central nervous system of subjects with cancer, Parkinson's disease, Dementia with Lewy bodies or Alzheimer's disease.

The Administration for Children and Families (ACF) is proposing to add regulations at 45 CFR part 1356 to require States to collect and report data to ACF on youth who are receiving independent living services and the outcomes of certain youth who are in foster care or who age out of foster care. This proposed rule implements the data collection requirements of the Foster Care Independence Act of 1999 (Public Law 106-169) as incorporated into the Social Security Act at section 477.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), 42 U.S.C. 300aa-1 et seq., and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Pacific Proving Grounds, Enewetak Atoll, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for the revision of a food safety warning on labeling of furosemide injectable solution for use in horses.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co. The supplemental NADA provides for use of ceftiofur crystalline free acid suspension via a new injection site in beef and nonlactating dairy cattle, for use in lactating dairy cattle for the treatment of respiratory disease, and for the establishment of a 13-day pre-slaughter withdrawal period in cattle. FDA is also amending the regulations to revise the tolerance for residues of ceftiofur in bovine kidney to accommodate these new conditions of use.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia.

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: 0917-0002, `` Indian Health Service Contract Health Service Report''. Type of Information Collection Request: Extension, without revision, of currently approved information collection 0917-0002, ``Indian Health Service Contract Health Service Report''. Form Number: IHS 843-1A. Need and Use of Information Collection: The purpose for the collection is to authorize contract health care providers to provide health care services to eligible IHS patients. The IHS form 843-1A ``Order for Health Services'' was developed specifically for this collection of information. Other than revising the title ``Purchase- Delivery Order for Health Services'' to read ``Order for Health Services'', acquisition terms on the front of the form, the contract clauses contained on the back of copy 3 of the form, the form has not been revised and there is no change in the substance or in the use of the form. A copy of the form is at Attachment 2. The majority of the information contained in this form is completed by IHS staff from existing IHS automated patient and vendor data files. Contract health care providers complete and sign the streamlined form and submit it, along with a completed standard Centers for Medicare & Medicaid Services (CMS) health claim form (CMS 1450 (UB 92) and CMS 1500), to the IHS for verification and payment. The CMS forms are used and accepted nation-wide by the health care industry and IHS is an approved user. The information collection is needed to administer and manage the contract health care services provided to eligible American Indian and Alaska Native patients. The form is used to: Authorize contract health care services for eligible patients; certify that the health care services requested and authorized have been performed by the contract provider(s); process payments for health care services performed by such providers; obtain program data; and, serve as a legal document for health and medical care authorized by the IHS and rendered by health care providers under contract with the IHS. The information collected is also used for: Planning for further care of the patient; for keeping an accurate record of the patient's health status and health services received and recommended; for planning future health care programs; for communicating among members of the health care team; for evaluating the health care rendered; for research and continuing education; and, for the provision of program health statistics. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides the estimated burden hours for this information collection:

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nevada Test Site (NTS), Mercury, Nevada, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, lasalocid, and tylosin to make three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.

This interim final rule with comment period amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's declaration of citizenship. It also gives States guidance on the processes that may be used to help minimize the administrative burden on both States and applicants and recipients.

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a teleconference meeting of the SACATM on August 3, 2006. The teleconference is scheduled from 1 p.m. to 4 p.m. and is open to the public. At the teleconference, SACATM will discuss the conclusions of a peer review panel that met on May 23, 2006 to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods (see ``Background'' for more detail). The public is invited to participate in the teleconference and will be provided with an opportunity to make oral comments during the public comment period. Participation is limited only by the number of phone lines available.

This notice announces the first meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in: International Patent Application PCT/US2005/031678 filed September 2, 2005 entitled, ``(N)-Methanocarba Adenosine Derivative as A3 Receptor Agonists'', to Can-Fite BioPharma, Ltd. having a place of business in Petach-Tikva, Israel. The contemplated exclusive license may be limited to an FDA approvable human therapeutic for cancer, autoimmune and other inflammatory diseases. The United States of America is the assignee of the patent rights in this invention.

This notice announces the first meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ``Sec. 616.100 Streptomycin Residues in Cattle Tissues (CPG 7125.22).'' This CPG is obsolete.

The Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) is providing public notice to clarify a requirement contained in the Federalwide Assurance (FWA) form for international (non-U.S.) institutions, approved by the Office for Human Research Protections (OHRP) under the HHS protection of human subjects regulations. HHS clarifies that the requirements of HHS regulations must be satisfied for all HHS-conducted or -supported research covered by an FWA, regardless of whether the research is conducted domestically or internationally. To date, HHS has not deemed any other procedural standards equivalent to the protection of human subjects.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Altana Inc. The ANADA provides for veterinary prescription use of gentamicin sulfate, betamethasone valerate, clotrimazole ointment for the treatment of canine otitis externa.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by V[eacute]toquinol NA, Inc. The ANADA provides for use of oxytetracycline soluble powder to prepare medicated drinking water for the treatment of various bacterial diseases of livestock.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Lingjie Zhao, University of Iowa: Based on the investigation reports drafted by the University of Iowa (UI) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Lingjie Zhao, former Doctoral Student, UI, engaged in research misconduct. The research was supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant P01 CA66081. PHS found that Ms. Zhao engaged in research misconduct by falsifying research records included in: (a) A manuscript submitted for publication in Cancer Research, (b) drafts of her work reported in the laboratory, and (c) drafts of her work reported to her dissertation committee. Specifically, PHS found: 1. That Ms. Zhao darkened with a marking device the thioredoxin (Trx) band of Lanes 1 and 2 on the autoradiographic film that was to become part of Figure 9 of the manuscript. 2. That Ms. Zhao (a) falsified this same original film of the western blot by darkening Lanes 1, 2, 4, and 5 with a marking device at the origin of the gel and (b) further falsified Figure 9 of the Cancer Research manuscript by claiming falsely that these marked bands were thioredoxin reductase (TR) untreated and with mismatch oligodeoxynucleotide in the presence and absence of tumor necrosis factor alpha. 3. That Ms. Zhao falsified the glutathione reductase (GR) activity data in either Figure 4 or Figure 9 of the Cancer Research manuscript (the data are identical but stated to be from entirely different experimental conditions). 4. That Ms. Zhao falsified the actin data in either Figure 4 or Figure 9 of the Cancer Research manuscript or in the experiments simultaneously using Prx III-As and Phospholipid hydroperoxide glutathione peroxidase-As reported in slide presentations (the actin data are identical under 3 entirely different experimental conditions). 5. That Ms. Zhao falsified the manganese superoxide dismutase (MnSOD) data in either Figure 1A or Figure 4 of the Cancer Research manuscript (these MnSOD data are identical while being clearly described as coming from different experiments). 6. That Ms. Zhao falsified the MnSOD data in Figure 2 of the Cancer Research manuscript by enhancing with a marking device Lanes 6 and 7, mismatch and antisense Prx oligos at 3 days of incubation (unmarked, Prx III-As decreased the expression of MnSOD). Ms. Zhao has entered into a Voluntary Exclusion Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on June 3, 2006: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR part 76; (2) To exclude herself from serving in any advisory capacity to PHS including, but not limited, to service on any PHS advisory committee, board, and/or peer review committee, or as consultant.

The Food and Drug Administration (FDA) has determined the regulatory review period for TAXUS EXPRESS Paclitaxel-Eluting Coronary Stent System 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 which claims that medical device.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of griseofulvin powder orally as a systemic antifungal agent in horses.

This notice announced the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

In accordance with the requirements of the Privacy Act, the Office of Public Health and Science (OPHS) is publishing notice of a proposal to add a new system of records, 09-90-0160, ``Medical Reserve Corps Unit Information, HHS/OPHS/OSG.''

The Office of Population Affairs (OPA), Office of Family Planning (OFP), announces the anticipated availability of funds for Fiscal Year (FY) 2007 family planning services grants under the authority of Title X of the Public Health Service Act. This notice solicits applications for competing grant awards to serve the areas and/or populations listed in Table I. Only applications which propose to serve the populations and/or areas listed in Table I will be accepted for review and possible funding.

This correcting amendment corrects a technical error identified in the final rule that appeared in the April 21, 2006 Federal Register entitled ``Requirements for Providers and Suppliers to Establish and Maintain Medicare Enrollment.'' In that final rule, we require all providers and suppliers (other than physicians or practitioners who have elected to ``opt-out'' of the Medicare program) to: (1) Complete an enrollment form and submit specific information to us; and (2) periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. The final rule also implements statutory provisions requiring us to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. The effective date of the final rule was June 20, 2006.

This document corrects errors in the final rule that appeared in the May 9, 2006 Federal Register entitled ``Inpatient Psychiatric Facilities Prospective Payment System Update for Rate Year Beginning July 1, 2006 (RY 2007).''

The Office on Women's Health (OWH) in the Department of Health and Human Services (DHHS) is the government's focal point for women's health issues, and works to redress inequities in research, health care services, and education that have historically placed the health of women at risk. The OWH coordinates women's health efforts within DHHS to eliminate disparities in health status and supports culturally sensitive educational programs that encourage women to take personal responsibility for their own health and wellness. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These partnerships are with non-profit community-based, faith-based, and women's service organizations (CBOs, FBOs, WSOs) innovating intergenerational approaches for HIV/AIDS prevention education targeting women disproportionately impacted by HIV/AIDS across the lifespan. African American and Latino women constituted 25 percent of the U.S. female population in 2002, but 81.5 percent of the reported female AIDS cases (65 percent were among African Americans and 16.5 percent were among Hispanics). (1) The number of Asian/Pacific Islanders and American Indian/Alaskan Native women living with AIDS continues to rise, with an approximately 10 percent increase each year over the past 5 years. (2) Women disproportionately impacted by HIV/AIDS are vulnerable for the disease because they lack accurate information about the virus; are impacted by cultural factors that decrease their abilities to protect themselves against HIV; have low to no condom negotiation skills; are faced with low socioeconomic circumstances; suffer from sexual abuse; struggle with violence and other traumas perpetrated against women, and lack information and skills to share sexual health information with other female members in the family. To this end, the Intergenerational Approaches to HIV/AIDS Prevention Education with Women Across the Lifespan Pilot Program intends to: (1) Develop a cross-generational HIV/AIDS prevention education program to establish effective and/or increase communication about sexual health between African American, Native American/American Indian, Hispanic/Latino, and Asian/Pacific Islander women at risk for or living with HIV/AIDS with other female family and/or kinship network members 12+ years old; (2) provide opportunities for African American, Native American/American Indian, Hispanic/Latino, and Asian/Pacific Islander women and other female members of the family 12+ years old to know their serostatus; and (3) address the age-, gender-, cultural-, spiritual-, and language-specific needs of African American, Native American/American Indian, Hispanic/ Latino, and Asian/Pacific Islander women and other female members of the family 12+ years old regarding their sexual health issues, particularly HIV/AIDS prevention so they may decrease their risks for disease. This program builds on Minority AIDS Initiative- and Office on Women's Health-funded Women and HIV/AIDS Programs (e.g., Model Mentorship Program; HIV Prevention Education for Young Women Attending Minority Academic Institutions) by addressing HIV/AIDS issues using the strength of familial and kinship networks, as well as women-specific vulnerabilities to acquiring the virus.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Fogarty International Center (FIC), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 14, 2006, page 7780-7781, and allowed 60-days for public comment. No comments were received from this notification regarding the cost and hour burden estimates. One comment was received suggesting that the Federal Government should not be funding international work until all Amercians are cared for. We note that through partnerships in training and research with scientists from around the world, including those in developing countries, we are able to identify new strategies and new understandings of disease processes, including for AIDS, TB, and chronic diseases such as heart disease, that affect all Americans. The purpose of this announcement is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Questions and Answers Regarding Establishment and Maintenance of Records (Edition 3).'' The guidance responds to various questions raised about section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation who employ 500 or more full-time equivalent employees (FTEs) had to be in compliance by December 9, 2005, and those who employ 11-499 FTEs had to be in compliance by June 9, 2006. Persons who employ 10 or fewer FTEs have until December 11, 2006 to be in compliance. ``Person'' includes an individual, partnership, corporation, and association.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This interim final rule implements the statutory changes enacted in the reauthorization of the Temporary Assistance for Needy Families (TANF) program in the Deficit Reduction Act of 2005. This legislation reauthorizes the TANF program through fiscal year (FY) 2010 with a renewed focus on work, program integrity and strengthening families through healthy marriage promotion and responsible fatherhood. The interim final rule addresses the work and program integrity changes of the new law.

CDC began charging fees to conduct sanitation inspections of cruise vessels in 1988. The purpose of these charges is to recover full costs of operating the Vessel Sanitation Program. CDC is requesting comments to the modified fee schedule; the modified fee schedule includes an additional vessel size, the ``mega-sized'' vessel, for any vessel that is greater than 120,000 Gross Registered Tons (GRT). A modified fee schedule would go into effect in the beginning of the next fiscal year, October 2007.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry (137) entitled ``Analytical Methods Description for Type C Medicated Feeds.'' This draft guidance provides our recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA revises labeling of oxytetracycline soluble powder with the current genus for the causative bacteria for American foul brood of honeybees.