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.

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. Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding labeling requirements for nonprescription human drugs marketed without an approved application has been submitted to OMB for review.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-sixth meeting; the primary focus of discussion will be the future of public bioethics and national bioethics commissions in the United States. The full agenda will be posted on the Council's Web site at https://www.bioethics.gov prior to the meeting. Subjects discussed at past Council meetings (although not on the agenda for the March 2009 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, standards for the determination of death, children and bioethics, and lifespan-extension, among others. 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); Taking Care: Ethical Caregiving in Our Aging Society (September 2005); Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008); The Changing Moral Focus of Newborn Screening: An Ethical Analysis by The President's Council on Bioethics (December 2008); and Controversies in the Determination of Death: A White Paper by The President's Council on Bioethics (December 2008). Reports are forthcoming on organ transplantation and health care reform.

Notice is hereby given that the Administration for Children and Families (ACF), Educational Development and Partnership Division (EDPD) will award a non-competitive successor award to Southwestern Indian Polytechnic Institute (SIPI) a Tribal College federally charted and operated by the Bureau of Indian Education, Department of the Interior located in Albuquerque, NM. Southwestern Indian Polytechnic Institute (SIPI) will assume a grant award under the Head Start Career Advancement Partnership Program for the remainder of the project period January 22, 2009 to September 29, 2009. The Board of Regents, Southwestern Indian Polytechnic Institute, has relinquished the grant to its Federal entity to ensure greater internal controls.

The Food and Drug Administration (FDA) is confirming the effective date of March 27, 2009, for the direct final rule that appeared in the Federal Register of November 12, 2008 (73 FR 66750). The direct final rule amends the agency's regulations to update the statutory citations regarding the new civil monetary penalties prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), amends the regulations to include the new FDAAA penalties, and adjusts the preceding maximum civil penalty amounts for inflation as prescribed by the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). This document confirms the effective date of the direct final rule.

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 National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention, has provided statistics on the health of the American people for almost 50 years. Two of its preeminent surveys, the National Health Interview Survey and the National Health and Nutrition Examination Survey are at the half century mark. The quality of NCHS' statistical program is of critical concern to the Center. Data on sample design, data quality and estimation techniques are discussed in detail in NCHS reports and in the proposed data collections that are published in the Federal Register and submitted to the Office of Management and Budget (OMB) for review and approval. The timelines for preparing and submitting requests for OMB approval under the Paperwork Reduction Act and for the Federal Government's budget process often are not synchronized. Thus it is possible that a survey may receive OMB approval for collection of data from a certain number of respondents before the necessary resources have been appropriated in the federal budget. In all cases, the design of the survey allows for changes to the number of respondents without jeopardizing the representativeness of the weighted survey results. In addition, information on final sample sizes is included with each data release. Over the last decade NCHS has made a number of program changes to stay within existing resources, including changes to survey design and sample size, in order to continue carrying out its mission and maintain its program quality. Three surveys have had or may have sample size reductions take place in FY 2009 and FY 2010. They are the National Health Interview Survey, the National Hospital Discharge Survey and the National Health and Nutrition Examination Survey.

The Administration on Aging (AoA) 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 State Annual Long-Term Care Ombudsman Report and Instructions for Older Americans Act Title VII.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the seventh annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the eighth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

This notice announces the cancellation of the March 18, 2009 public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the January 16, 2009 Federal Register (74 FR 3051 through 3053). This notice also announces a public meeting on Wednesday, June 17, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide some examples of using Bayesian techniques for meta-analyses. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

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 Novartis Animal Health US, Inc. The supplemental NADA provides for removal of a 250-pound weight restriction and the addition of a reproductive caution statement to labeling of tiamulin concentrate solution used in drinking water for the treatment of certain bacterial respiratory and enteric diseases in swine.

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 provisions of FDA's requirements for food irradiation processors. This notice also notifies the public of and solicits comments on FDA's proposal to transfer the collection of information and associated burden hours from the Office of Management and Budget (OMB) control number 0910-0549 to the subject collection of information (OMB control number 0910-0186).

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. Date and Time: The meeting will be held on March 19, 2009, from 8 a.m. to 5 p.m. Location: Marriott Conference Centers, UMUC Inn and Conference Center by Marriott, 3501 University Blvd., East, Adelphi, MD. The hotel telephone number is 301-985-7385. Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug application (NDA) 22- 406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 5, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 25, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 26, 2009. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Elaine Ferguson at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

HRSA is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2009-02), to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project. The PIN, ``Specialty Services and Health Centers'' Scope of Project,'' and the Agency's ``Response to Public Comments'' are available on the Internet at http:/ /bphc.hrsa.gov.

The Department of Health and Human Services published a notice in the Federal Register of February 4, 2009 announcing a February 24, 2009 meeting of the Advisory Committee on Minority Health. It was announced that this meeting would be held at The Westin National Harbor, 171 Waterfront Street, Oxon Hill, MD. Due to unforseen circumstances the location of the meeting has been changed.

The Food and Drug Administration (FDA) has determined the regulatory review period for MACROPLASTIQUE IMPLANTS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.

The Food and Drug Administration (FDA) is withdrawing approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) construct in a lineage of genetically engineered (GE) goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a biologics license application (BLA) has been approved by FDA for use of this antithrombin in humans.

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 provisions of the Notification Procedure for Substances Generally Recognized as Safe.

The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The NTP invites public comment on the recommendation from an expert panel on the listing status for cobalt-tungsten carbide powders and hard metals in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for cobalt-tungsten carbide powders and hard metals are available electronically in Part B of the Expert Panel Report (https:// ntp.niehs.nih.gov/go/29682, see Expert Panel Report Part B) or in printed text from the RoC Center (see FOR FURTHER INFORMATION CONTACT below). The RoC Center convened a seven-member expert panel of scientists, plus one technical scientific expert, from the public and private sectors on December 9-10, 2008. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for cobalt-tungsten carbide powders and hard metals in the 12th RoC and (2) to provide the scientific justification for the recommendation.

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

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.'' The revised guidance only changes the date on which FDA intends to stop issuing export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). The date FDA now intends to stop issuing EU Export Certificates is June 17, 2009.