Department of Health and Human Services February 2009 – Federal Register Recent Federal Regulation Documents

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), announces a second meeting of an independent scientific peer review panel (hereafter, Panel) to evaluate three non-radioactive modified versions and new applications for the Murine Local Lymph Node Assay (LLNA). The LLNA is an alternative test method that can be used to determine the allergic contact dermatitis potential of chemicals and products. The Panel will consider additional data and information for the three non-radioactive modified versions and new applications of the LLNA obtained by NICEATM subsequent to the original Panel meeting in March 2008. Based on this new information, the Panel will review the following: The validation status of three modified LLNA test methods. The proposed applicability domain of the LLNA. The Panel will peer review revised draft BRDs for each topic and evaluate the extent that established validation and acceptance criteria have been appropriately addressed. The Panel also will be asked to comment on the extent to which draft ICCVAM test method recommendations are supported by the data analyses provided in the BRDs. NICEATM invites public comments on the draft BRDs and draft ICCVAM test recommendations. All documents will be available on the NICEATM- ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/immunotox/llna PeerPanel.htm by March 3, 2009.

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 Metallurgical Laboratory in Chicago, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 16, 2009, 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:

This notice announces the continuation of effectiveness of a Medicare interim final rule with comment period and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act (the ``regular timeline'') or, if applicable, at the end of each succeeding 1-year extension to the regular timeline, if prior to the expiration of the timeline, the Secretary publishes in the Federal Register a notice of continuation and explains why the regular timeline or any subsequent extension was not complied with.

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 Extramural Research, 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: Ruth L. Kirschstein NRSA Individual Fellowship Application and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0002, Expiration Date 9/30/11. Form Numbers: PHS 416-1, 416-9, 416-5, 416-7, 6031, 6031-1. Need and Use of Information Collection: The PHS 416-1and 416-9 are used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The other related forms (PHS 416-5, 416-7, 6031, 6031-1) are used by these individuals to activate, terminate, and provide for payback of a National Research Service Award. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or households; businesses or other for profit; not-for-profit institutions; Federal Government; and State, Local or Tribal Governments. Type of Respondents: Adult scientific trainees and Respondents: 34,454; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 3.9; and Estimated Total Annual Burden Hours Requested: 132,501. The annualized cost to respondents is estimated at: $4,637,535. 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. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Mikia Currie, Project Clearance Branch, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-0941, or e-mail your request, including your address to: [curriem@od.nih.gov]. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.

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

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Colorado Regional Health Information Exchange (CORHIO) Point of Care Exchange System Evaluation: Point of Care Questionnaires and Focus Groups.'' 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 December 1st, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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 medical device reporting (MDR); manufacturer, importer, user facility, and distributor reporting.

The Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. The event will be webcast live and audio conferencing will be available.