Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

This 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 (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT- 01], to Hope Medical Enterprises, Inc., dba Hope PharmaceuticalsTM, an Arizona S-Corporation having a principle place of business in Scottsdale, Arizona. The field of use may be limited to the use of nitrite salts for the treatment of cerebral vasospasm following subarachnoid hemorrhage and/or cardiovascular conditions. The United States of America is an assignee of the patent rights in these inventions.

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in United States Patent No. 4,892,827, issued on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxin: Construction Of An Active Immunotoxin With Low Side Effects'' [E-385-1986/0-US-01]; U.S. Patent No. 5,635,599, issued on June 3, 1997, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-US-01]; PCT Patent Application No. PCT/US95/04468, filed April 6, 1995, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/ 0-PCT-02]; Switzerland Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E- 047-1994/0-CH-03]; Spain Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-ES-04]; United Kingdom Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-GB-05]; Italy Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-IT-06]; Luxembourg Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/ 0-LU-07]; Netherlands Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E- 047-1994/0-NL-09]; German Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-DE-10]; Austria Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-AT-11]; Australia Patent No. 694211, issued on November 5, 1998, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-AU-12]; Belgium Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-BE-13]; Canada Patent No. 2187283, filed on April 6, 1995, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-CA-14]; European Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-EP-15]; France Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/ 0-FR-16]; Ireland Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E- 047-1994/0-IE-17]; Liechtenstein Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-LI-18]; and U.S. Patent No. 6,011,002, issued on January 4, 2000, entitled ``Circularly Permutated Ligands And Circularly Permuted Chimeric Molecules'' [E-047-1994/1-US-01] to Protox Therapeutics, Inc., which has offices in Vancouver, British Columbia, Canada. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of Interleukin-4/cytotoxin fusion proteins for the treatment of cancer.

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 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 collection of information entitled ``Cosmetic Product Voluntary Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Humanitarian Use Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this notice is to invite pharmaceutical companies interested in participating in this program to contact CDER.

The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA) to seek public comments relative to the program's overall performance and reauthorization as directed by Congress. Date and Time: The public meeting will be held on February 24, 2006, from 9 a.m. to 5 p.m. Requests to make a presentation at the meeting must be received by February 10, 2006. Written comments regarding this meeting may be made by March 26, 2006, to the Division of Dockets Management (see Addresses). Location: The meeting will be held at the DoubleTree Hotel, Plaza II and III, 1750 Rockville Pike, Rockville, MD 20852. Registration is not required to attend the meeting. Parking is limited, so we recommend arriving by subway (Metro rail) if possible. The DoubleTree Hotel is accessible from the Metro rail's red line at the Twinbrook station.

The Food and Drug Administration (FDA) is reopening until January 27, 2006, the comment period for the proposed rule published in the Federal Register of September 27, 2005 (70 FR 56394), proposing implementing regulations for designation of new animal drugs for minor uses and minor species under section 573 of the Federal Food, Drug, and Cosmetic Act (the act). FDA is reopening the comment period to update comments and to receive any new information.

The Department of Health and Human Services (HHS) gives notice of a 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, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) gives notice of a decision that a class of employees at the National Bureau of Standards, Van Ness Street, Washington, DC, do not meet the statutory criteria for addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). On December 8, 2005, the Secretary of HHS determined, based on the decision by the Department of Energy to remove the site from the list of covered facilities, that the following class of employees do not meet the statutory requirements for covered employees under EEOICPA and thus do not meet the statutory requirements for the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2).'' The guidance explains, using a question and answer format, FDA's current thinking on a number of issues related to the regulation of food allergens, including implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy.'' This draft guidance provides a recommended maximum lead level in candy likely to be consumed frequently by small children. FDA considers the recommended maximum level to be protective of human health and to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients. The agency is also announcing the availability of a draft supporting document entitled ``Supporting Document for Recommended Maximum Level for Lead in Candy Likely To Be Consumed Frequently by Small Children.'' These two documents are intended to assist candy manufacturers in achieving reduced lead levels in their products consistent with the agency's policy of reducing lead levels in the food supply to reduce consumers' lead exposure to the lowest level that practicably can be obtained.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for oral use of furosemide syrup for the treatment of edema in dogs.

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: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting.

This document corrects technical errors that appeared in the final rule published in the Federal Register on January 28, 2005 entitled ``Establishment of the Medicare Advantage Program.''

The Department of Health and Human Services (HHS) is amending regulations to remove the Health Resources and Services Administration (HRSA) from the list of agencies which require grantees to utilize an informal appeals procedure for grant related disputes subject to the departmental appeal procedures. In doing so, HRSA will simplify the appeals procedure for aggrieved HRSA grantees by permitting them direct access to the Departmental Grant Appeals Board.

The Food and Drug Administration (FDA) is amending the regulation authorizing a health claim on the relationship between oat beta-glucan soluble fiber and reduced risk of coronary heart disease (CHD). The amendment adds barley as an additional eligible source of beta-glucan soluble fiber. We (FDA) are taking this action in response to a petition that the National Barley Foods Council submitted. We have concluded, based on the totality of publicly available scientific evidence that, in addition to certain oat products, whole grain barley and certain dry milled barley grain products are appropriate sources of beta-glucan soluble fiber for the health claim.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the first biannual meeting of the Ambulatory Payment Classification (APC) Panel (the Panel) for 2006. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking.

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2005, entitled ``Hospice Wage Index for Fiscal Year 2006.''

This notice, in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act), announces a Town Hall meeting to discuss fiscal year (FY) 2007 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their individual comments, recommendations, and data regarding whether the FY 2007 new medical services and technologies applications meet the substantial clinical improvement criteria.

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2006. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

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.

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) as amended by 42 U.S.C. 2991 et seq., ANA herein describes its issuance of final interpretive rules, general statements of policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. The notice also provides additional information about ANA's plan for administering the programs.

The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients. Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005. Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850. Contact: Eric Chen, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 301-443- 8262, ext. 146, e-mail: eac@cdrh.fda.gov, or Michael Berman (HFZ-170), 12725 Twinbrook Pkwy., 301-827-4744, e-mail: mrb@cdrh.fda.gov. If you need special accommodations due to a disability, please contact Eric Chen, at least 7 days in advance of the meeting. Registration: There is no fee to attend the workshop; however, because space is limited, registration is required. Please submit registration information (including name, title, firm name, address, e- mail address, telephone number, and fax number) by December 30, 2005 (see Contact). Background information for the workshop will be available to the public on the Internet at https://www.fda.gov/cdrh/ meetings/012006workshop/.

The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The approved NADA provides for the veterinary prescription use of an injectable solution of tilmicosin phosphate for respiratory disease in cattle and sheep. This supplemental NADA adds user safety information to product labeling.

Notice is hereby given that on November 23, 2005, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the scientific misconduct findings of the U.S. Public Health Service (PHS) in the following case: Jessica Lee Grol, University of Pittsburgh: Based on the report of an investigation conducted by the University of Pittsburgh (UP) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, HHS found on October 17, 2005, that Ms. Grol, former Research Project Coordinator, Department of Neurological Surgery, UP, engaged in scientific misconduct by fabricating study research records for 15 subjects, including the patient interview data, the forms tracking data, and the medical record extraction data in a study on the management of cerebral aneurysms. The research was supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), career development award K23 NS02159. In a final decision dated November 23, 2005, the HHS Debarring Official, on behalf of the Secretary of HHS, issued the final debarment notice based on the PHS findings of scientific misconduct finding. The following actions have been implemented for a period of three (3) years, beginning on November 23, 2005: (1) Ms. Grol has been debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR part 76; and (2) Ms. Grol is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Food and Drug Administration (FDA) proposed, among other things, to classify Anthrax Vaccine Adsorbed (AVA) on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the United States District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004. The purpose of this final order is to categorize AVA according to the evidence of its safety and effectiveness, thereby determining if it may remain licensed and on the market; issue a final response to recommendations made in the Panel's report, and; respond to comments on the previously published proposed order. The final rule and final order concerning bacterial vaccines and toxoids other than AVA is published elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs provide for oral use of moxidectin gel or moxidectin and praziquantel gel in horses and ponies for the treatment and control of two additional species of small strongyles.

The Center for the Evaluation of Risks to Human Reproduction (CERHR) announces availability of the two draft expert panel reports on genistein and soy formula on January 16, 2006, from the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from CERHR (see ADDRESSES below). CERHR invites public comments on sections 1-4 of both draft expert panel reports (see SUPPLEMENTARY INFORMATION below). An expert panel will meet on March 15-17, 2006, at the Radisson Hotel Old Town in Alexandria, Virginia to review and revise each draft expert panel report and reach conclusions regarding whether exposure to genistein or soy formula is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available space in the meeting room. Following the expert panel meeting and completion of the expert panel reports, CERHR will post the final reports on its website and solicit public comment on them through a Federal Register notice.

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), is considering convening an independent peer review panel (hereafter, ``Panel'') to evaluate the validation status of five in vitro pyrogenicity test methods: (1) Human PBMC/IL-6 in vitro pyrogen test (PBMC/IL-6), (2) human whole blood/IL-1 in vitro pyrogen test (WB/IL- 1), (3) human whole blood/IL-1 in vitro pyrogen test: application of cryopreserved human whole blood cryo (WB/IL-1), (4) the human whole blood/IL-6 in vitro pyrogen test (WB/IL-6), and (5) an alternative in vitro pyrogen test using the human monocytoid cell line MONO MAC-6 (MM6/IL6). NICEATM requests public comments as to the appropriateness and relative priority of this activity. In addition, NICEAM requests the nomination of expert scientists for consideration as potential Panel members in the event a Panel meeting occurs. Finally, NICEATM requests the submission of data from the rabbit pyrogenicity test, the bacterial endotoxin test (BET), and in vitro pyrogenicity testing with the methods listed above.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.

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 providing notice of a memorandum of understanding (MOU) between the United States Food and Drug Administration and the C-Path Institute. The specific purpose of this MOU is to establish an overarching framework for collaboration between the parties. This framework will be based on mutually agreed upon programs and activities in the areas of applied scientific research and training/education to foster the development of new evaluation tools to inform medical product development. The parties shall each leverage its own expertise and resources to facilitate programs of shared interests across the diverse disciplines of therapeutics, biological sciences, engineering and medical devices in building applied research and training/education programs. The appropriate formal agreements will be executed as required by law for any activities that result from this collaboration.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``FDA Recall Regulations (Guidelines)'' has been approved by the Office of Management and Budget (OMB) 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 CERHR announces a 30-day extension of the public comment period on the DEHP update expert panel report. The CERHR previously announced a public comment period on the DEHP update expert panel report in a prior Federal Register Notice [November 16, 2005 (Vol. 70, No. 220, pg. 69567)]. The DEHP update expert panel report was released by CERHR on November 21, 2005 and public comments will now be accepted by CERHR through Friday, February 3, 2006 instead of the original deadline of January 4, 2006. The DEHP update expert panel report is available from the CERHR Web site (https://cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below).

This Notice provides the status of ATSDR's Superfund-mandated Substance-Specific Applied Research Program (SSARP) which was last updated in a Federal Register notice in 2002 (67 FR 4836). Authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA, also known as the Superfund statute), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604 (i)], this research program was initiated on October 17, 1991. At that time, a list of priority data needs for 38 priority hazardous substances frequently found at waste sites was announced in the Federal Register (56 FR 52178). The list was subsequently revised based on public comments and published in final form on November 16, 1992 (57 FR 54150). The 38 substances, each of which is found on ATSDR's Priority List of Hazardous Substances (68 FR 63098, November 7, 2003), are aldrin/ dieldrin, arsenic, benzene, beryllium, cadmium, carbon tetrachloride, chloroethane, chloroform, chromium, cyanide, p,p'-DDT,DDE,DDD, di(2- ethylhexyl) phthalate, lead, mercury, methylene chloride, nickel, polychlorinated biphenyl compounds (PCBs), polycyclic aromatic hydrocarbons (PAHsincludes 15 substances), selenium, tetrachloroethylene, toluene, trichloroethylene, vinyl chloride, and zinc. On July 30, 1997, priority data needs for 12 additional hazardous substances frequently found at waste sites were determined and announced in the Federal Register (62 FR 40820). The 12 substances, each of which is included in ATSDR's Priority List of Hazardous Substances, are chlordane, 1,2-dibromo-3-chloropropane, di-n-butyl phthalate, disulfoton, endrin (includes endrin aldehyde), endosulfan (alpha-, beta-, and endosulfan sulfate), heptachlor (includes heptachlor epoxide), hexachlorobutadiene, hexachlorocyclohexane (alpha- , beta-, delta- and gamma-), manganese, methoxychlor, and toxaphene. More recently, priority data needs for 10 additional hazardous substances frequently found at waste sites were determined and announced in the Federal Register (68 FR 22704). The ten substances, each of which is included in ATSDR's Priority List of Hazardous Substances, are asbestos, benzidine, chlorinated dibenzo-p-dioxins, 1,2-dibromoethane, 1,2-dichloroethane, 1,1-dichloroethene, ethylbenzene, pentachlorophenol, 1,1,2,2-tetrachloroethane, and total xylenes. Currently, the priority data needs for acrolein and barium are being identified and will be reported in a future Federal Register notice. To date, 270 priority data needs have been identified for the 60 hazardous substances, and 86 priority data needs have been filled (Table 1). ATSDR fills these research needs through U.S. Environmental Protection Agency (EPA) regulatory mechanisms (test rules), private- sector voluntarism, and the direct use of CERCLA funds. Additional priority data needs are being addressed through collaboration with the National Toxicology Program (NTP), by ATSDR's Great Lakes Human Health Effects Research Program, and other Agency programs. Priority data needs documents describing ATSDR's rationale for prioritizing research needs for each substance are available. See ADDRESSES section of this Notice. This Notice also serves as a continuous call for voluntary research proposals. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this Notice by indicating their interest through submission of a letter of intent to ATSDR (see ADDRESSES section of this Notice). A Tri-Agency Superfund Applied Research Committee (TASARC) composed of scientists from ATSDR, National Institute of Environmental Health Sciences (NIEHS)/NTP, and the EPA, will review all proposed voluntary research studies.

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 requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of nine drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).

The Food and Drug Administration (FDA) is issuing a proposed rule to amend the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA is issuing this proposed rule after considering information submitted in a citizen petition. This proposal is part of FDA's ongoing review of OTC drug products.

The Food and Drug Administration (FDA) is announcing that Food Ingredient Solutions, LLC, has filed a petition proposing that the color additive regulations be amended to expand the use of sodium copper chlorophyllin to include foods generally (with the exception of meat, poultry, fish, and standardized foods) and to include fescue grass as a permitted source.

On November 28, 2005, we published a notice and comment period seeking comments from interested parties on draft compliance program guidance (CPG) developed by the Office of Inspector General (OIG) for recipients of extramural research awards from the National Institutes of Health and other agencies of the U.S. Public Health Service (PHS) (70 FR 71312). To facilitate public comment, we are extending the comment period.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Department of Health and Human Services routinely publishes a list of laboratories in the Federal Register that are currently certified to meet standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (69 FR 19644) dated April 13, 2004. This notice informs the public that effective November 15, 2005, the following laboratory's certification is suspended: Sciteck Clinical Laboratories, Inc., 317 Rutledge Rd., Fletcher, NC 28732.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens.'' This draft guidance document is being issued to provide guidance on the types of information and data to consider when preparing or reviewing premarket submissions for nucleic acid based in vitro diagnostic devices for the detection of microbial pathogens.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Enforcement Notifications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) revise the Priority List of Hazardous Substances. This list includes substances most commonly found at facilities on the CERCLA National Priorities List (NPL) which have been determined to be of greatest concern to public health at or around these NPL hazardous waste sites. This announcement provides notice that the agencies have developed and are making available a revised CERCLA Priority List of 275 Hazardous Substances, based on the most recent information available. Each substance on the priority list is a candidate to become the subject of a toxicological profile prepared by ATSDR and subsequently a candidate for the identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events with ATSDR activities where a substance has been found in a completed exposure pathway (CEP). This report is included in the Support Document of the Priority List.