Department of Health and Human Services November 2007 – Federal Register Recent Federal Regulation Documents

NICEATM announces availability of the ICCVAM Test Method Evaluation Report: In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives (NIH Publication 07-4517). The report describes four ocular toxicity test methods evaluated by ICCVAM: (1) The Bovine Corneal Opacity and Permeability [BCOP] test, (2) the Isolated Chicken Eye [ICE] test, (3) the Isolated Rabbit Eye [IRE] test, and (4) the Hen's Egg TestChorioallantoic Membrane [HET- CAM]. The report includes ICCVAM's (a) final test method recommendations on the use of these four in vitro test methods, (b) recommended test method protocols for future testing, (c) recommendations for further optimization and validation studies for these test methods, and (d) recommended reference substances for validation studies. The report recommends that the BCOP and ICE methods, with specific limitations for certain chemical classes and/or physical properties, can be used in a tiered testing strategy to determine ocular hazards, and substances that test positive can be classified as ocular corrosives or severe irritants without further testing in animals. The report also recommends that these in vitro test methods should be considered before using animals for ocular testing and used when determined appropriate. NICEATM also announces availability of the final Background Review Documents (BRDs) for the BCOP, ICE, IRE, and HET-CAM test methods (NIH Publications 06-4512, 06-4513, 06-4514, and 06-4515, respectively). These BRDs provide the data and analyses used to assess the current validation status of these four test methods for identifying ocular corrosives and severe irritants. Electronic copies of the ICCVAM Test Method Evaluation Report and the four BRDs are available from the NICEATM/ICCVAM Web site at https:// iccvam.niehs.nih.gov or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT). The ICCVAM Test Method Evaluation Report and the final BRDs have been forwarded to U.S. Federal agencies for regulatory and other acceptance considerations where applicable. Responses will be posted on the ICCVAM/NICEATM Web site as they are received.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (93) entitled ``Impurities in New Veterinary Medicinal Products (Revision)'' VICH GL11(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention.'' In this draft guidance, FDA provides recommendations on the development of drugs to be used to treat or prevent smallpox (variola) infection. This guidance is intended to help sponsors plan and design appropriate studies during the development of these drugs.

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 extending the expiration date of the compliance policy guide (CPG) entitled ``Sec. 400.210Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2008.

This proposed rule would permit a waiver of nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173, enacted December 8, 2003.) In addition, this proposed rule would codify an additional statutory provision enacted by section 4755 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) that requires the State to establish a procedure to permit a nurse aide to petition the State to have a single finding of neglect removed from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a single occurrence.

This notice announces a listening session being conducted as part of the selection of Hospital-Acquired Conditions (HAC) and implementation of Present on Admission (POA) Indicator Reporting, as authorized by section 5001(c) of the Deficit Reduction Act of 2005 (DRA). The purpose of this listening session is to solicit informal comments in preparation for the fiscal year 2009 inpatient prospective payment system (IPPS) rulemaking process. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and all interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. However, because of time constraints, telephone participants will not be able to make verbal comments. Informal written comments will be accepted. This meeting is open to the public, but registration is required due to limited space and security requirements to enter the meeting location. This Listening Session is being held as a joint partnership between the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention.

This notice announces the new date for the Bidder's Conference for the Medicare Clinical Laboratory Services Competitive Bidding Demonstration project.

This notice announces the 18th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 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).

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.

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 Child Health and Human Development (NICHD), 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: Pilot Study for the National Children's Study, Type of Information Collection Request: NEW, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18-49 years of age, their husbands or partners, and their children who live in selected areas within the seven (7) National Children's Study Vanguard sites enumerated below. A small number of health care professionals, community leaders, and child care personnel are also potential respondents. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of this Study is to pilot test protocols, policies, and procedures for the National Children's Study (NCS) with the goal of improving the efficiency of study procedures and enhancing the subsequent implementation of the NCS. The NCS is a long- term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. The Act specifies a broad definition of environment, including biologic, chemical, physical, and psycho-social factors and authorizes NICHD to plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of those exposures on child health and human development. This data collection will test procedures for population-based sampling and recruitment of pregnant women and women of child-bearing age, test study logistics, and estimates of subject burden, and evaluate data collection strategies including interviews and acquisition of biologic and environmental samples. In addition, participants will also be asked to provide qualitative and quantitative input on their feelings regarding participation in this Study, to enhance the lessons that can be learned and applied to improve the efficiency of the full NCS. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: https://nationalchildrensstudy.gov. This Pilot Study will be carried out in the seven NCS ``Vanguard'' locations previously selected as the initial study sites. These sites are Orange County, CA; Duplin County, NC; Queens County, NY; Montgomery County, PA; Salt Lake County, UT; Waukesha County, WI; and the aggregate of Lincoln, Pipestone, and Yellow Medicine Counties, MN and Brookings County, SD. This data collection is intended to begin with household enumeration and enrollment of women, proceed through pregnancy and birth, and continue with follow-up of children for up to 21 years. This application is for the first three years of data collection, which includes data collection through the visits at which some of the children will be 24 months old. Details of data collections beyond this period will be addressed at the time of renewal or in future applications. Women who are pregnant will be eligible for participation if, at the time of household enumeration and screening, they are within the first trimester of pregnancy. Women who are not pregnant will be eligible if, at the time of household enumeration and screening, they are 18-49 years of age, are neither surgically nor medically sterile, and can participate in the consent process. A subset of age-eligible women with a high likelihood of pregnancy (e.g., planning to become pregnant) will be enrolled to enable assessment of peri-conceptional exposures, should they become pregnant. The remainder of the study population will comprise women enrolled early in pregnancy. The seven centers combined will follow approximately 1000 infants born to women enrolled in the first year of this Pilot Study. Infants born to women enrolled in this Pilot Study but born after the eligibility period for the Pilot will be eligible for enrollment in the full NCS. The schedule of participant contacts for this data collection includes home visits, clinic visits, and phone contacts, and is described in the NCS Research Plan: https://nationalchildrensstudy.gov. Home visits before and during pregnancy will include collection of interview data, environmental specimens such as air and dust samples, maternal and paternal biospecimens such as blood and hair samples, and a brief physical examination including anthropometric measures and blood pressure. During pregnancy, women will receive up to three fetal ultrasounds to assess fetal growth. At birth, cord blood and placental samples will be collected and the infant will receive a brief developmental assessment. During infancy, home visits will include collection of interview data, environmental specimens, biospecimens from the infant and parents, a brief physical examination of the infant, and assessment of infant development and parental-infant interactions. Burden statement: The public burden for this Study will vary depending on the eligibility and pregnancy status of potential participants at the time of household screening. Women who are not pregnant at the time of screening will have varying burden depending on their likelihood of pregnancy and, should they become pregnant, the time to pregnancy. The burden for women enrolled during pregnancy will depend on when during pregnancy they are identified and enrolled in the Study. The table provides an annualized average burden per person for each stage of the Pilot Study over the three year period of the Study.

Under the provision 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 for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 9, 2007, page 26399 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: Program Assessment and Evaluations for NIEHSAsthma Research. Type of Information Collection Request: NEW. New and Use of Information Collection: National Institute of Environmental Health Sciences, Division of Extramural Research and Training (DERT). DERT, with contract support from Battelle Centers for Public Health Research and Evaluation, is examining the impact of its research portfolio. Focusing specifically on one portion of the research portfolioasthma researchDERT proposes to supplement extant data sources with a primary data collection activity. The purpose of the proposed primary data collection is to obtain information from grantees regarding the impact of their funded asthma research in the short-, intermediate-, and long-term. This will be done through a survey of grantees that includes questions about the impact of funding on career development, the field of asthma research, public attitudes, commercial product development, clinical practice, business and industry practices, and long-term human and environmental health. Frequency of Response: One time. Affected Public: Individuals. Type of Respondents: Individuals receiving asthma funding. A 15-minute, close- ended, multi-mode (web and paper) survey will be administered to the universe of NIEHS-funded asthma researchers (N=179) and comparison agency asthma researchers (N=1371). Comparison agencies include other NIH institutes (NICHD, NIAID, NIA, NHLBI), the CDC, AHRQ, and the EPA. The survey development process included formative interviews with a small sample of NIEHS asthma researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1550; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 15 minutes; and Estimated Total Annual Burden Hours Requested: 387.5. The annualized cost to respondents is estimated at $13,039.38. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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.

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.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Kellex/Pierpont, Jersey City, New Jersey, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Kellex/Pierpont. Location: Jersey City, New Jersey. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1943 through December 31, 1953.