Department of Health and Human Services January 2006 – Federal Register Recent Federal Regulation Documents
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Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration
The Food and Drug Administration (FDA, we) is proposing to revise its requirements for cochineal extract and carmine by requiring their declaration on the label of all food and cosmetic products that contain these color additives. The proposed rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract and carmine-containing food and cosmetics and would allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This proposed action also responds, in part, to a citizen petition submitted by the Center for Science in the Public Interest (CSPI). With regard to drug products, FDA plans to initiate rulemaking to implement the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.105-115) provisions that require declaration of inactive ingredients for drugs. The FDAMA provisions have already been implemented for over-the-counter (OTC) drugs.
Determination of Regulatory Review Period for Purposes of Patent Extension; XOLAIR
The Food and Drug Administration (FDA) has determined the regulatory review period for XOLAIR 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 human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ENABLEX
The Food and Drug Administration (FDA) has determined the regulatory review period for ENABLEX 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 human drug product.
Proposed Collection; Comment Request Evaluation of the Impact of the New Conflicts of Interest Regulations on the National Institutes of Health's Ability To Recruit and Retain Staff
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Human Resources (OHR) of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the office of Management and Budget (OMB) for review and approval.
American Health Information Community Electronic Health Record Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
American Health Information Community Meeting
This notice announces the fourth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the first 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.)
American Health Information Community Chronic Care Workgroup Meeting
This notice announces the first 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.).
Amendment To Extend the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures, as Amended on January 24, 2004 and January 24, 2005
Concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and United States Government facilities abroad continues to exist. The January 24, 2003, declaration regarding administration of smallpox countermeasures is revised to incorporate statutory definitions from the Smallpox Emergency Personnel Protection Act of 2003 and extended for one year until and including January 23, 2007.
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-March 30, 2006
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. The charter also permits the MCAC to develop recommendations about other specific issues of Medicare coverage. This meeting concerns authoritative drug compendia that may be used in determining the medically accepted indications of drugs and biologicals used in an anti-cancer chemotherapeutic regimen under Part B of the Medicare program. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 6, 2006
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Determination of Regulatory Review Period for Purposes of Patent Extension; SPIRIVA HANDIHALER
The Food and Drug Administration (FDA) has determined the regulatory review period for SPIRIVA HANDIHALER 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.
Medicare Program; Approval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
In this final notice we respond to public comments on our September 30, 2005 notice with comment period and announce our decision concerning an application submitted by Advanced Medical Optics (AMO) to adjust the Medicare payment amounts for certain intraocular lenses (IOLs) on the basis that they are new technology intraocular lenses (NTIOLs). This is the third of three statutorily required Federal Register documents. On May 27, 2005, we published a notice in the Federal Register entitled ``Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70 FR 30731) that solicited interested parties to submit requests for review of the appropriateness of the payment amount for an IOL furnished by an ambulatory surgical center. On September 30, 2005, we published a notice with comment period entitled ``Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs)'' (70 FR 57297) acknowledging timely receipt of one application. In this final notice, we announce our decision to approve the NTIOL application submitted by Advanced Medical Optics (AMO) for Tecnis[supreg] (model numbers Z9000, Z9001, and Z9003).
Control of Communicable Diseases
On November 30, 2005, at 70 FR 71892, CDC published a proposed rule, ``Control of Communicable Diseases,'' to revise existing regulations related to preventing the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. and from one state or possession into another. CDC provided a 60 day public comment period. Written comments were to be received on or before January 30, 2006. We have received requests asking for an extension of the comment period. In consideration of these requests, CDC is extending the comment period by 30 days to March 1, 2006.
Proposed Collection; Comment Request-National Network of Tobacco Cessation Quitlines Evaluation
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Nomination To Hold a Workshop on Alternative Methods To Replace the Mouse LD50
In October 2005, the Humane Society of the United States (HSUS) submitted a nomination to NICEATM requesting that alternative test methods to the mouse LD50 assay for botulinum toxin potency testing be assessed and prioritized for prevalidation and validation efforts. The nomination proposed that an initial key step in this process would be for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to organize a workshop on this topic. ICCVAM considered the nomination and supports with a high priority the concept of a workshop to discuss alternative methods and approaches that might reduce, refine, or replace the use of animals for botulinum potency testing. The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) considered the nomination and the ICCVAM proposal at its meeting on December 12, 2005, and agreed that the proposed activity should have a high priority. At this time, NICEATM requests (1) information on development and/or validation activities relevant to reduction, refinement (less pain and distress), and/or replacement alternatives for botulinum toxin potency testing, (2) public comments on the appropriateness and relative priority of proceeding with a workshop on this topic, (3) the nomination of scientific experts who might participate if a workshop occurs, and (4) the submission of data from mouse LD50 botulinum potency testing and ex vivo and in vitro test methods used for botulinum toxin potency testing. The HSUS nomination is available at https:// iccvam.niehs.nih.gov/ see ``Nominations and Submissions.''
Medicare Program; Payment for Respiratory Assist Devices With Bi-Level Capability and a Backup Rate
This final rule clarifies that respiratory assist devices with bi-level capability and a backup rate must be paid as capped rental items of durable medical equipment (DME) under the Medicare program and not paid as items requiring frequent and substantial servicing (FSS), as defined in section 1834(a)(3) of the Social Security Act. Before 1999, respiratory assist devices with bi-level capability (with or without a backup rate feature) were referred to as ``intermittent assist devices with continuous positive airway pressure devices'' under the Medicare program and in the Healthcare Common Procedure Coding System (HCPCS). This final rule responds to public comments received on a proposed rule published in the Federal Register on August 22, 2003, and finalizes the policy in that proposed rule. The rule will ensure that respiratory assist devices are consistently and properly paid under Medicare as capped rental items.
Proposed Collection; Comment Request; Request for Generic Clearance To Conduct Voluntary Customer/Partner Surveys
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Medicare and Medicaid Programs; Application by the TU
This proposed notice acknowledges the receipt of an application from the TUV Healthcare Specialists for deeming authority for hospitals that wish to participate in the Medicare and Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; February 15, 2006 Town Hall Meeting on the Practice Expense Methodology Including the Proposal From the Physician Fee Schedule Proposed Rule for Calendar Year 2006
This notice announces a Town Hall meeting on our methodology for establishing practice expense (PE) values for services paid under the physician fee schedule (PFS). The purpose of this meeting is to: (1) Clarify our proposed revisions to the PE methodology contained in the PFS calendar year (CY) 2006 proposed rule; and (2) receive comments and opinions from individuals of the medical community regarding ideas for the CY 2007 PFS proposed rule. This meeting is open to the public, but attendance is limited to space available.
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2007: Proposed Annual Payment Rate Updates, Policy Changes, and Clarification
This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed payment amounts and factors used to determine the updated Federal rates that are described in this proposed rule were determined based on the LTCH PPS rate year July 1, 2006 through June 30, 2007. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and would continue to be effective each October 1. The proposed outlier threshold for July 1, 2006, through June 30, 2007, would also be derived from the LTCH PPS rate year calculations. We are also proposing to make policy changes and clarifications.
Use of Federal Real Property To Assist the Homeless
Title V of the McKinney-Vento Homeless Assistance Act, 42 U.S.C. 11411 (Title V) authorizes the Secretary of Health and Human Services (the Secretary) to make suitable Federal properties categorized as excess or surplus available to representatives of persons experiencing homelessness as a permissible use in the protection of public health. The Department of Health and Human Services (HHS) is requesting comment on its proposal to revise its current policy under Title V to include permanent supportive housing as an allowable use of surplus real property to assist persons experiencing homelessness. The purpose of this proposed change is to increase the housing and service opportunities available to communities as they respond to homelessness, and is consistent with efforts within the Federal, state, and local governments, and communities themselves, to end chronic homelessness.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and Final Documents; Availability
The Food and Drug Administration (FDA) is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1, 2, 3, and 4 of the Global Harmonization Task Force (GHTF). These documents are intended to provide information only and represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for FDA Regulated Products
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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.
Proposed Collection; Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Survey of Estimated GFR Reporting Practices of Clinical Laboratories: Type of Information Collection Request: New. Need and Use of Information Collection: This study will assess the level of U.S. clinical laboratory reporting of estimated GFR as a measure of kidney function. This will be accomplished through baseline and follow-up surveys of a representative sample of clinical laboratories in the U.S. Information will be used to establish baseline data necessary to measure an anticipated increased in use of estimated GFR, following the implementation of the NKDEP's communications and Lab Working Group (LWG) activities promoting use of estimated GFR for patients at risk for kidney disease. The LWG, whose members are experts in their field, strongly believes that routine reporting of estimated GFR will result in a significant increase in early detection of chronic kidney disease, therefore enabling treatment that can slow or prevent patients' progression to kidney failure. Frequency of Response: Baseline survey only. Affected Public: Clinical laboratory community. Type of Respondents: Laboratory directors. The annual reporting burden is as follow: Estimated Number of Respondents: Anticipate 4,126 completed surveys; Estimated Number of Responses per Respondent: Respondents will complete one paper-and-pencil or online survey; Average Burden Hours Per Response: .083 hours [5 minutes]; and Estimated Total Annual Burden Hours Requested: 342.46 hours. The annualized total cost to respondents is estimated at $11,759.10. (Note: Completing this survey is similar to other data reporting carried out by lab directors. Since lab directors will be able to responded to the survey within their usual workday, this collection of information will not cost labs.employers additional time and money.) There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Notice of Hearing: Reconsideration of Disapproval of Ohio State Plan Amendments 05-07 and 05-020
This notice announces an administrative hearing to be held on February 28, 2006, in Suite 500, 233 N. Michigan Avenue, Minnesota Conference Room, Chicago, IL 60202, to reconsider CMS' decision to disapprove Ohio State plan amendments 05-07 and 05-020. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by February 8, 2006.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Good Laboratory Practice Regulations for Nonclinical Studies
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Good Laboratory Practice Regulations for Nonclinical Studies'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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 information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the agency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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.
Annual Update of the HHS Poverty Guidelines
This notice provides an update of the HHS poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Solicitation for Nominations for New Primary and Secondary Health Topics To Be Considered for Review by the United States Preventive Services Task Force
The Agency for Healthcare Research and Quality (AHRQ) invites individuals and organizations to nominate primary and secondary prevention topics pertaining to clinical preventive services that they would like the United States Preventive Services Task Force (USPSTF) to consider for review. A list of topics that have been recently reviewed or are currently under review by the USPSTF is listed below in the supplementary information section. The USPSTF is an independent panel of experts that makes evidence- based recommendations regarding the provision of clinical preventive services. Clinical preventive services include screening, counseling and preventive medications. The USPSTF makes recommendations about preventive services for asymptomatic peoplepeople without recognized signs or symptoms of the specific conditions targeted by the preventive service. Topics can be nominated by individuals, organizations, evidence- based practice centers (EPC) and USPSTF members. The USPSTF will consider nominations and prioritize topics for review based on the following set of criteria: Public health importance (burden of suffering, potential of preventive service to reduce the burden); new evidence that has the potential to change prior recommendations including inactive ones; and, potential for greatest Task Force impact (e.g., clinical controversy, practice does not reflect evidence, inappropriate timing in delivery of services). The USPSTF will prioritize topics for which there is a performance gap and the potential to significantly improve clinical practice. Individuals and organizations may nominate new topics or topics previously reviewed by the USPSTF. Basic Topic Nomination Requirements: Nominations must be no more than 500 words in length and must include the following information. Nominations may include an appendix that contains references and supporting documents (not included in word count). 1. Name of topic. 2. Rationale for consideration by the USPSTF, to include: a. Primary or secondary prevention topic (screening, counseling or preventive medication). b. Primary care relevance (aplicable clinical preventive service must be initiated in the primary care setting which can be defined as family practice, internal medicine, pediatrics or obstetrics/gynecology and provided by a primary care provider). c. Description of public health importance (burden of disease/ suffering, potential of preventive service to reduce burden, including effective interventions). Citations and supporting documents are recommended. d. Summary of new evidence, if any, that has potential to affect the Task Force's recommendation on a previously reviewed topic. Please refer to https://preventiveservices.ahrg.gov for USPSTF recommendations. Citations and supporting documents are recommended. e. Description of potential impact of USPSTF's review of the topic, i.e., change in clinical practice, research focus, etc.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Linde Ceramics Plant, in Tonawanda, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 8, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners.
Two Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry entitled ``Clinical Studies Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format'' and ``Adverse Reactions Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' These guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for human prescription drug and biological products published elsewhere in this issue of the Federal Register.
Draft Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Labeling for Human Prescription Drug and Biological ProductsImplementing the New Content and Format Requirements'' and ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' These draft guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products published elsewhere in this issue of the Federal Register. Elsewhere in this issue of the Federal Register, the agency is announcing the availability of two guidances on the content and format of the ``Clinical Studies'' and ``Adverse Reactions'' sections of labeling.
Health Resources and Services Administration; Organ Procurement and Transplantation Network Status of Living Donor Guidelines
The purpose of this solicitation of comments is to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System Payment Update for Rate Year Beginning July 1, 2006 (RY 2007)
This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the rate year beginning July 1, 2006 through June 30, 2007. We are proposing to adopt the new Office of Management and Budget (OMB) labor market area definitions for the purpose of geographic classification and the wage index. In addition, we are proposing other new polices and making changes to existing policies.
National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, U.S. Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as voting representative members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/ her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
Proposed Collection; Comment Request; Collection of Demographic and Smoking/Tobacco Use Information From NCI Cancer Information Service Clients
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Collection of Demographic and Smoking/ Tobacco Use Information from NCI Cancer Information Service Clients. Type of Information Collection Request: Revision of OMB no. 0925-0208 expiration date 11/30/2006. Need and Use of Information Collection: The NCI's Cancer Information Service (CIS) provides accurate and up-to-date cancer information to the public through a toll-free telephone number (1-800-4-CANCER) and LiveHelp, an online instant messaging service. In addition, CIS provides smoking cessation assistance through a telephone quitline (accessed through 1-800-44U-QUIT or 1-800-QUITNOW). Characterizing CIS clients is essential to customer service, program planning, and promotion. Currently CIS conducts a brief survey of a sample of telephone and LiveHelp clients at the end of usual service (OMB no. 0925-0208 expiration date 11/30/2006); the survey includes three customer service and five demographic questions (age, sex, race, ethnicity, education). This request is to supplement the current data collection activity by adding (1) four demographic questions related to income, health insurance coverage, and regular source of health care; and (2) a set of 20 smoking/tobacco use questions for individuals seeking smoking cessation assistance. The demographic questions will allow CIS to better measure the program's reach to underserved populations and program impacts on these populations. The smoking/ tobacco use questions are necessary as part of the intake and needs assessment process for smoking cessation clients. The information collected about clients' smoking history, previous quit attempts, and motivations to quit smoking will enable Information Specialists to provide effective individualized counseling. Consistent with the current data collection, the proposed demographic and smoking intake questions will be asked of clients who are cancer patients, family members and friends of patients, and the general public. Also consistent with the current data collection, 25% of telephone and quitline clients will be sampled for the proposed demographic questions. If the call is the result of a special promotion, 50% of callers will be surveyed. Overall, it is estimated that 36% of telephone and quitline clients will be sampled for the demographic questions for an estimated annual total of 40,700 telephone clients and 2,400 quitline clients. Also consistent with the current data collection, the demographic questions will be asked of 50% of LiveHelp clients for an estimated annual total of 2,000 online clients. The higher sampling rate for LiveHelp clients is necessary due to the lower response rate among online clients. The proposed smoking intake questions will be asked of 100% of quitline clients for an annual total of approximately 6,700 clients. The combined total to be surveyed each year is approximately 49,400 CIS clients for a total of 2,478 annual burden hours. Frequency of Response: Single time. Affected Public: Individuals or households. Type of Respondents: Cancer patients, family members and friends of cancer patients, and general public who contact CIS via telephone or online. The annual reporting burden is as follows:
Proposed Collection; Comment Request; ActiGraph Accelerometer Validation Study
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Actigraph Accelerometer Validation Study. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI is collaborating with other NIH Institutes on a proposed longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study. The Hispanic population is now the largest minority population in the U.S. with a projected three-fold growth by 2050. Hispanic subgroups are influenced by a number of chronic disease risk factors associated with immigration from different cultural settings and environments. These factors include diet, physical activity, community support, working conditions, and access to health care. Hispanic groups have higher rates of obesity and diabetes than non-Hispanic groups, but have lower coronary disease and cancer (all sites) mortality. There are also observed differences in health outcomes between Hispanic subgroups. For example, Puerto Ricans have a four-fold higher asthma prevalence than Mexican-Americans. Hispanic populations are understudied with respect to many diseases and risk factors. Their projected population growth underscores the need for accurate evaluation of their disease burden and risk. A vast amount of research suggests that the level of physical activity influences many of the chronic diseases and conditions of interest, including obesity, diabetes, cardiovascular disease, and cancer. To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, it is necessary to be able to accurately assess levels and types of activity. In particular, better methods are needed to improve the validity and reliability of physical activity assessment instruments to better assess the frequency, duration, and intensity of physical activity. For that reason, NCI plans to evaluate the use of a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time. This new accelerometer will be used in the Hispanic Community Health Study and will allow examination of levels as well as patterns of activity. Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES) (OMB: 0920- 0237, October 15, 2004, Vol 69, pp. 61253-61254). NHANES provides estimates for Mexican-American, but not other Hispanic subgroups. Between the time of the NHANES and the Hispanic Community Health Study, there has been a change in the technology of the accelerometer used in NHANES. To allow comparison of the physical activity data that will be collected from the four Hispanic subgroups in the Hispanic Community Study to the data collected with the previous technology used in NHANES, a cross-validation study is needed. The proposed study, the ActiGraph Accelerometer Validation Study, will serve this purpose. It is a cross-validation study comparing the two ActiGraph accelerometer models under different circumstances of walking or jogging in differing age groups and for both genders. Frequency of response: One-time study. Affected Public: Individuals. Type of Respondents: Healthy adults between the ages of 18-74 years. The annual reporting burden is as follows: Estimated Number of Respondents: 144; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.5; and Estimated Total Annual Burden Hours Requested: 186. The annualized cost to respondents is estimated at: $3,288.
Proposed Collection; Comment Request; Survey of Non-Federal Funding Sources for Cancer CAM Research
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Survey of Non-Federal Funding Sources for Cancer Complementary and Alternative Medicine (CAM) Research. Type of Information Collection Request: NEW. Need and Use of Information Collection: The goal of this study is to collect information that will allow the NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) to develop a directory of organizations external to the Federal Government that offer funding for cancer CAM research. This study will assist OCCAM in its mission to increase the quality of cancer CAM research supported by the NCI. One of the hurdles that many cancer CAM researchers encounter is the difficulty of obtaining research funding and in particular, the difficulty of obtaining Federal funding for foundational or exploratory research. Often, researchers must obtain their initial funding through non-Federal sources, so that they can demonstrate proof of concept, which can be a pre-condition of obtaining Federal funds. The funding directory that is developed through this study will provide cancer CAM researchers with a resource that they can use to identify non-Federal funding sources, and target the funding sources that are most closely aligned with their research objectives. Frequency of Response: Semiannual. Affected Public: Nonprofit organizations; Businesses or other for-profit organizations; Type of Respondents: Organizations (other than Federal Government) that offer funding for cancer CAM research and have an open grant application process. The annual reporting burden is as follows: Estimated Number of Respondents: 200; Estimated Number of Responses per Respondent: 2 per year; Average Burden Hours Per Response: .25; and Estimated Total Annual Burden Hours Requested: 100. The annualized cost to respondents is estimated at: $2000 (assumes $20 hourly rate x 100 hours). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Prospective Grant of Exclusive License: FDA Approvable Human Diagnostic for Osteoarthritis
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 U.S. Patent Application Number 60/602,334 filed August 18, 2005, entitled ``Biomarkers for Osteoarthritis,'' to PeptiFarma, Inc., having a place of business in San Diego, CA 92191. The contemplated exclusive license may be limited to an FDA approvable human diagnostic for osteoarthritis. The United States of America is an assignee of the patent rights in this invention.
Proposed Collection; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Environmental Factors in the Development of Polycystic Ovary Syndrome. Type of Information Collection Request: Revision of OMB No. 0925-0483 and expiration date 3/31/2006. Need and Use of Information Collection: The purpose of this study is to identify a cohort of living female twin pairs in which at least one member is likely to have Polycystic Ovary Syndrome (PCOS) for future study. Potential participants (~3,700) will come from the Mid-Atlantic Twin Registry (MATR) and were chosen based on their answers to several questions (in a preliminary MATR survey) concerning irregular periods and a history of cystic ovaries. The instrument to be used here will be administered by telephone by professional interviewers at the MATR. It contains 17 simple and direct questions and will take about 10 minutes to complete. Its contents deal with the frequency of menstrual periods, a history of polycystic ovaries, obesity, excess facial hair and other evidence of hyperandrogenism. Since this is such a short telephone survey, participants will receive no prior notification. Informed consent will be asked for verbally over the phone at the time of the interview. All participants will be asked about their willingness to participate in future studies if their answers meet certain criteria. The major objectives of future studies using this cohort are to determine more reliable concordance rates for PCOS in monozygotic and dizygotic twins, establish baseline heritability estimates, and develop hypotheses concerning possible pathogenetic and/or environmental factors. The findings from this study will aid in developing: (1) Genetic tests to identify high risk women; (2) preventative strategies; and (3) more effective therapies for PCOS and related syndromes such as type 2 diabetes, obesity, idiopathic hyperandrogenism, and male pattern baldness. Frequency of Response: One time. Affected Public: Individuals or households. Type of Respondents: Adult women. The annual reporting burden is as follows: Estimated Number of Respondents: 3,700; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated Total Annual Burden Hours Requested: 206 per year for 3 years. The annualized cost to respondents is estimated at $6,179.00. There are no Capital Costs to report. There are no Operating 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 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Laboratory of Pulmonary Pathobiology; Submission for OMB Review; Comment Request; Use of In-Home Test Kits in Dust Mite Allergen Reduction
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 October 21, 2004, pages 61853-61854, and allowed 60 days for public comment. No public comments were received although one person sent an e-mail expressing interest in the study and asking if she could participate. She was told this was a pilot study to be carried out in a specific location in North Carolina. 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: Use of In-home Test Kits in Dust Mite Allergen Reduction. Type of Information Collection Request: New. 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). Asthmatics and others with dust mite allergies often implement strategies to avoid dust mite exposure, but have little objective evidence that their interventions are successful in reducing dust mite populations. Recently developed in-home test kits have introduced the capability to monitor the effectiveness of allergen reduction strategies by providing an affordable, simple way to measure dust mite allergens on a regular basis. The primary objective of this study is to determine if use of in-home test kits results in decreased dust mite allergen levels in home of children sensitive or allergic to dust mites. A secondary objective is to determine if use of in-home test kits result in additudinal and behavioral changes related to implementing and maintaining dust mite reduction strategies. This study is a randomized intervention trial designed to test the efficacy of an in-home test kit in influencing behaviors to reduce dust mite allergen levels. Households will be recruited through flyers and will be screened for eligibility through a recruitment call line and a home visit to determine baseline dust mite levels in the household. Study participants will be randomly assigned to a treatment or control group. The treatment group will receive educational materials and an in-home test kit at set intervals, while the control group will receive educational materials alone. Vacuumed dust samples will be collected and delivered to the NIEHS laboratory for ELISA-based measurements of the dust mite allergens Der f2 and Der p 2. A questionnaire will be used to collect information on home characteristics and on dust mite reduction attitudes and behaviors. Data will be collected at baseline, 6 months and 12 months. The results from this study will be used by NIEHS to plan future primary and secondary asthma prevention trials. Frequency of Response: After the two stages of eligibility screening, data will be collected at baseline, 6-months, and 12-months. Type of Respondents: Parents of children with dust-mite allergies. The annual reporting burden is as follows: Estimated Number of Respondents: See table below; Estimated Number of Responses per Respondent: See table below; Average Burden Hours Per Response: 0.25 hour for initial screening, 0.5 hour for dust mite eligibility screening, 1.5 hours for each baseline visit, and 1 hour for each follow-up home visit (6- and 12-month); and Estimated Total Annual Burden Hours Requested: 690.5. The annualized cost to respondents is estimated at: $13,810 (assuming $20 hourly wage x 690.5 hours). There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.
Proposed Data Collection; Comment Request; National Survey of Primary Care Physicians' Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening
In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: National Survey of Primary Care Physicians' Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening. Type of Information Collection Request: New. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians' knowledge, attitudes, recommendations, and practices related to screening for breast, cervical, colorectal, and lung cancer. There have been substantial changes in guidelines and/or technologies for these types of cancer screening in recent years. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer control knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Two questionnaires, one covering breast and cervical cancer screening and the other colorectal and lung cancer screening, will be administered by mail or telephone to a randomly-selected national sample of primary care physicians. Frequency of Response: One Time. Affected Public: Medical practices, clinics, or other health care organizations. Type of Respondents: Primary Care Physicians. Burden estimates are as follows:
National Institute for Occupational Safety and Health; Proposed Changes to the Dose Reconstruction Target Organ Selection for Lymphoma Under the Energy Employees Occupational Illness Compensation Program Act of 2000
The National Institute for Occupational Safety and Health (NIOSH) proposes to change the selection of target organs used in dose reconstructions NIOSH produces under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) for energy employees with lymphoma cancers. This proposed change is in response to an evaluation by NIOSH of current scientific data on lymphoma, which revealed that the site of the radiation injury can differ from the site of the tumor or cancer origin documented in the medical files of a lymphoma cancer patient. The new process for selecting dose reconstruction target organs for energy employees with lymphoma cancers would include selecting the target organ that would have received the highest radiation dose from among relevant, possibly irradiated organs, as determined through the dose reconstruction process, when the identity of the target organ is in question. This change would result in the Department of Labor calculating higher probability of causation determinations for select lymphoma cases among previously decided and current EEOICPA cancer claims.
Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 43 abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. The drug products are no longer marketed, and Able Labs has requested that the approval of the applications be withdrawn.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Submission for OMB Review; Comment Request; Field Test of the Discovering the Science of Alcohol Curriculum
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), 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 August 15, 2005, page 47840 and allowed 60 days for public comment. One public comment was received from the New York State Office of Alcoholism and Substance Abuse Services (OASAS) and was responded to on August 31, 2005. 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.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Chief Executive Officer Retention Survey
The Department of Health and Human Services, 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 Indian Health Service (IHS) is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review.
Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
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 collections of information in current rules, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions in FDA's cosmetic labeling regulations. FDA's cosmetic labeling regulations, as published in the Federal Register on March 15, 1974 (39 FR 10054 at 10056) and subsequently amended, most recently on March 17, 1999 (64 FR 13254 at 13297), remain unchanged by this notice. FDA is publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative.
HHS Managing Partner Grants.gov E-Government Initiative; Governmentwide Notice of Opportunity to Register Early for Electronic Submission of Grant Applications for Federal Funding Opportunities; Early Registration With Grants.gov
Federal grant applicants must complete a three-step registration process before applying for a federal grant opportunity through Grants.gov. Grants.gov is the federal government's free, single, and secure site for finding and submitting applications electronically for federal grant funding. It is part of the ongoing implementation of Electronic Government (E-Government) and a key component of the President's Management Agenda. Expanding electronic government makes it simpler for the public to receive high-quality services from the federal government in addition to improving the federal government's efficiency in the delivery of its services. To protect the applicant and the applicant's information, and to assure federal agencies that they are interacting with officials authorized to submit applications for funding on behalf of applicant entities, an applicant must register with Grants.gov. In fiscal year 2005, 20 out of 26 federal grant making departments and agencies achieved their goals, set through OMB guidance, of making 25 percent of their discretionary funding opportunities available for the electronic submission of applications on Grants.gov and over 15,000 applications were received. Per OMB milestones, in fiscal year 2006 the percentage of discretionary funding opportunities available for electronic submission will increase to 75 percent and then to 100 percent in fiscal year 2007. This planned increase in utilization of the Grants.gov system is indicative of a governmentwide transition to electronic grant processes. The twenty-six federal grant making departments and agencies participating in Grants.gov are: The Departments of Health and Human Services, Housing and Urban Development, Transportation, Education, Agriculture, Justice, Labor, Homeland Security, Defense, Commerce, Veterans Affairs, State, Treasury, Interior, and Energy, and the National Science Foundation, Environmental Protection Agency, National Aeronautics and Space Administration, National Endowment of the Arts, National Endowment of Humanities, Corporation for National & Community Service, U.S. Agency for International Development, National Archives and Records Administration, Small Business Administration, Institute of Museum and Library Services, and Social Security Administration. Each of the federal grant-making departments and agencies listed above are posting funding opportunities and grant application materials on Grants.gov. To facilitate the federal grant application process, this notice encourages prospective applicants to register early. Registering in advance of agencies posting their grant opportunities will eliminate many of the issues that applicants have faced by not meeting registration requirements in time to meet application deadlines. Registering early will allow the Federal agencies and Grants.gov sufficient time to address questions applicants may have in completing the registration process.
Institutional Review Boards: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Board Reviews; Withdrawal
The Food and Drug Administration (FDA) is announcing the withdrawal of an advance notice of proposed rulemaking (ANPRM) entitled ``Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews'' that published in the Federal Register of March 6, 2002 (67 FR 10115).
Guidance for Industry on Exploratory Investigational New Drug Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Exploratory IND Studies.'' This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing, and controls information that should be considered when planning exploratory studies, including studies of closely related drugs or biologics, under an investigational new drug (IND) application.
Current Good Manufacturing Practice Regulation and Investigational New Drugs
The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDs Approaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.
Draft Guidance for Industry on Investigational New Drugs; Approaches to Complying with Current Good Manufacturing Practice During Phase 1; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``INDs Approaches to Complying with CGMP During Phase 1.'' This draft guidance is intended to assist persons producing drug and biological products (investigational drugs) for use during phase 1 development in complying with relevant current good manufacturing practice (CGMP) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Controls for producing an investigational new drug (IND) for use in a phase 1 study are primarily aimed at ensuring subject safety. This guidance is being issued concurrently with a direct final rule and companion proposed rule published elsewhere in this issue of the Federal Register, which, if finalized, will specify that the particular requirements in the regulations need not be met for most investigational drugs manufactured for use during phase 1 development. Instead, the agency recommends the approaches outlined in this guidance for complying with the FD&C Act.
Current Good Manufacturing Practice Regulation and Investigational New Drugs; Companion Document to Direct Final Rule
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ``Phase 1'' drugs from complying with the regulatory requirements. We will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled ``INDsApproaches to Complying With CGMP During Phase 1'' to provide further guidance on the subject.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces 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: ``Security Checkpoints and Patients with Radiopharmaceuticals.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 2, 2005 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.
University of Arkansas/Food and Drug Administration Food Labeling; Public Workshop; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 4, 2006 (71 FR 349). The document announced a public workshop entitled ``UA/FDA Food Labeling Workshop.'' The document was published with a typographical error in the SUPPLEMENTARY INFORMATION section. This document corrects that error.
National Health and Nutrition Examination Survey III (NHANES) DNA Specimens: Guidelines for Proposals To Use Samples and Cost Schedule
The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population, blood lymphocytes were collected in NHANES III in anticipation of advances in genetic research. The lymphocytes have been stored and maintained at the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH), CDC. The collection of lymphocytes was begun in the second phase of the survey (1991-1994) because of the significant advances in the rapidly evolving field of molecular biology that were occurring during the planning phase of this survey. CDC is making DNA samples from these specimens available to the research community for genetic analyses. Specimens are available from approximately 7,159 participants in the second phase of NHANES III. No cell lines will be made available. This program has been previously announced (Tuesday, June 1, 1999 [64 FR 29321]; Thursday, August 8, 2002 [67 FR 51585]). The purpose of this notice is to announce a fourth category for proposals for use of these specimens, add an additional secondary review of approved applications and provide a new proposal schedule. For final proposal guidelines and requests or letters of intent, please contact Ms. Oraegbu or go to https://www.cdc.gov/nchs/about/major/nhanes/ dnafnlgm2.htm. All interested researchers are encouraged to submit letters of intent. No funding is provided as part of this solicitation. Proposals will be reviewed by a technical panel and approved applications will be reviewed by an internal Secondary Review Committee, which will perform a programmatic review based on the results of the peer review for technical merit. The primary purpose of the Secondary Review Committee is to factor in the scientific and technical results from the first level of review, important programmatic considerations such as program priorities, program relevance, and other criteria germane to this announcement and to CDC. The secondary review panel will be comprised of senior CDC scientists, who will advise the Director, NCHS, on the approved applications. Projects approved by both reviews will be submitted to the NCHS Ethics Review Board for final approval. Approved projects that do not obtain funding on their own will be canceled. A more complete description of this program follows.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2006
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for administrative law judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustments to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2006. The 2006 AIC threshold amounts are $110 for ALJ hearings and $1090 for judicial review.
Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.'' The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers.
Determination That Celestone Soluspan (Betamethasone Sodium Phosphate and Betamethasone Acetate) Injection and Celestone (Betamethasone Sodium Phosphate) Injection Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that two drug productsCelestone Soluspan (betamethasone sodium phosphate and betamethasone acetate) injection and Celestone (betamethasone sodium phosphate) injectionwere not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for betamethasone sodium phosphate and betamethasone acetate injection and betamethasone sodium phosphate injection if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for betamethasone sodium phosphate and betamethasone acetate injection, future applicants are advised that Celestone Soluspan injection may not be commercially available because, under a consent decree between FDA and the manufacturer, it is being made available in certain instances of medical necessity only. The reasons for its unavailability are not safety or effectiveness considerations associated with the drug product in general, but specific to the manufacturer. An ANDA applicant who is unable to obtain Celestone Soluspan injection for bioequivalence testing must contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect. If the reference listed drug (RLD) product becomes commercially available prior to ANDA approval, the ANDA applicant will need to show bioequivalence to the RLD product.
Public Meeting of the President's Council on Bioethics
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-third meeting, at which, among other things, it will continue the discussion on ethical issues relating to children. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Protocol Regarding the Sharing of the Phonetic and Orthographic Computer Analysis Tool to Support Review and Evaluate Proprietary Names of Therapeutic Products Between the Food and Drug Administration Department of Health and Human Services of the United States of America and Health Products and Food Branch, Health Canada of Canada
The Food and Drug Administration (FDA) is providing notice of a protocol regarding the sharing of the Phonetic and Orthographic Computer Analysis Tool to support review and evaluate proprietary names of therapeutic products between FDA and the Health Products and Food Branch, Health Canada of Canada (the Protocol). This Protocol is intended to enable, enhance, and strengthen the exchange of information about computerized software programs developed by FDA to minimize medication errors due to similar proprietary names of therapeutic products (Phonetic and Orthographic Computer Analysis).
Memorandum of Understanding Between the United States Food and Drug Administration Department of Health and Human Services and the Australian Pesticides and Veterinary Medicines Authority, Australia
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the United States Food and Drug Administration, Department of Health and Human Services and the Australian Pesticides and Veterinary Medicines Authority (APVMA), Australia. This MOU is intended to establish an information-sharing arrangement between APVMA and FDA. The Participants intend to strengthen the exchange of knowledge and expertise to enhance the efficiency and effectiveness of their respective roles. This MOU focuses on cooperation in relations to the operational aspects of animal drug regulation and is not intended to cover broader government regulatory policy or to cover areas not falling under the common jurisdictional purview of the Participants.
Anti-Counterfeit Drug Initiative Workshop and Vendor Display
The Food and Drug Administration (FDA) is announcing a public workshop and vendor display on the use of electronic track and trace technology to combat counterfeit drugs. The purpose of the meeting is as follows: To identify incentives for widespread adoption of radio- frequency identification (RFID), as well as obstacles to the adoption of RFID across the U.S. drug supply chain and possible solutions to those obstacles; to solicit comment on the implementation of the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and the use of an electronic pedigree (e-pedigree); and to learn the state of technology development related to electronic track and trace and e- pedigree technology solutions. To address these issues, we are inviting interested individuals, organizations, and other stakeholders to present information to FDA's Counterfeit Drug Task Force. We are also inviting vendors of track and trace technologies and e-pedigree solutions relevant to the drug distribution system to display their products for the educational benefit of FDA and attendees. (For this meeting, we are only interested in displays from vendors of track and trace technology and e-pedigree solutions for the PDMA requirement, as opposed to covert or overt counterfeiting technologies, such as holograms or color-shifting inks.)
Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium Injection
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 Bayer HealthCare LLC. The supplemental NADA provides for veterinary prescription use of a hyaluronate sodium solution, formulated with a benzyl alcohol preservative, for intravenous administration to horses for the treatment of osteoarthritis.
New Animal Drugs For Use in Animal Feeds; Monensin
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 Elanco Animal Health. The supplemental NADA provides for use of monensin Type C medicated feeds in component feeding systems (including top dress) for increased milk production efficiency in dairy cows.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Carbohydrate Content Claims on Food Labels
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Carbohydrate Content Claims on Food Labels'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Contact Substances Notification
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Contact Substances Notification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised); Request for Comments; Availability
The Food and Drug Administration (FDA) is announcing the availability for comments of a draft revised guidance for industry (93) entitled ``Impurities in New Veterinary Medicinal Products (Revised)'' VICH GL11(R). This draft revised guidance, which updates a final guidance on the same topic for which a notice of availability was published in the Federal Register of July 7, 2000 (the 2000 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products.
Prospective Grant of Exclusive License: Anthrax Lethal Factor Is a MAPK Kinase Protease
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 to practice the inventions embodied in U.S. Patent Nos. 6,485,925 B1, issued November 26, 2002, 6,893,835 B2, issued May 17, 2005, and 6,911,203 B1, issued June 28, 2005, and U.S. Patent App. No. 11/112,137, filed April 22, 2005 and published on September 8, 2005 as U.S. Pat. Pub. No. 2005/0196822 A1, all titled ``Lethal Factor is a MAPK Kinase Protease'' (HHS Ref. Nos. E-066-1998/0-US-06, -07, -08, and -10) to Van Andel Research Institute, of Grand Rapids, Michigan. The patent rights in these inventions have been assigned to the Government of the United States. The prospective exclusive license territory will be worldwide. The field of use may be limited to the development and sale of Anthrax lethal factor, a MAPK kinase protease, as a therapeutic agent for the treatment of cancer.
Government-Owned Inventions; Availability for Licensing
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.
Medical Device Reporting
The Food and Drug Administration (FDA) is amending its medical device reporting regulations to reflect a change in address for agency contacts for reporting a public health emergency. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Agency Emergency Processing Under Office of Management and Budget Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA believes, and is preparing a guidance document explaining, that it is possible in certain circumstances for In Vitro Diagnostic (IVD) device studies to be conducted using leftover specimens obtained without informed consent while protecting the human subjects who are the source of such specimens. This notice solicits comments on the proposed collection of information associated with the guidance document entitled ``Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding Their Preferences for Public Health Notifications
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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of healthcare practitioners' preferences regarding public health notifications (PHNs).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
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.
International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Final Guidance for Industry on Environmental Impact Assessments for Veterinary Medicinal Products-Phase II; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (166) entitled ``Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)Phase II'' (VICH GL38). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document provides recommendations for internationally harmonized test methods used to generate environmental fate and toxicity data.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This draft guidance document describes a means by which herpes simplex virus types 1 and/or 2 (HSV 1 and/or 2) serological assays may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these devices from class III into class II (special controls).
Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays
The Food and Drug Administration (FDA) is proposing to reclassify herpes simplex virus (HSV) (types 1 and/or 2) serological assays from class III (premarket approval) to class II (special controls). HSV serological assays (types 1 and/or 2) are intended for testing specimens from individuals who have signs and symptoms of infection consistent with HSV 1 and/or 2 or for determining if an individual has been previously infected with HSV 1 and/or 2, as well as for providing epidemiological information about these infections. The detection of HSV antibodies, in conjunction with other clinical laboratory findings, aids in the clinical laboratory diagnosis of an infection by HSV 1 and/or 2. FDA is proposing this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control, if FDA reclassifies this device.
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