Notices. Notice; request for comments and additional information

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Office of Chemical Nomination and Selection; Announcement of and Request for Public Comment on Toxicological Study Nominations to the NTP AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health. ACTION: Notice; request for comments and additional information. SUMMARY: The NTP continuously solicits and accepts nominations for toxicological studies to be undertaken by the program.

Nominations of substances of potential human health concern are received from federal agencies, the public, and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. This notice

(1)Provides brief background information and preliminary study recommendations regarding nine nominations for study by the NTP (Table 1),

(2)solicits public comment on the nominations and study recommendations, and

(3)requests the submission of additional relevant information for consideration by the NTP in its continued review of these nominations. An electronic copy of this announcement, supporting documents for each nomination, and further information on the NTP and the NTP Study Nomination and Review Process can be accessed through the NTP Web site ( *http://ntp.niehs.nih.gov/* ; select “Nominations to the Testing Program”). DATES: Comments or information should be submitted by May 10, 2007. ADDRESSES: Correspondence should be addressed to Dr. Scott A. Masten, Director, Office of Chemical Nomination and Selection, NIEHS/NTP, 111 T.W. Alexander Drive, P.O. Box 12233, Research Triangle Park, North Carolina 27709; telephone: 919-541-5710; FAX: 919-541-3647; e-mail: *masten@niehs.nih.gov* . SUPPLEMENTARY INFORMATION: Background Information The NTP actively seeks to identify and select for study chemicals and other substances for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal open nomination and selection process. Nominations can be submitted to the NTP at *http://ntp.niehs.nih.gov/* ; select “Nominations to the Testing Program” or by contacting Dr. Scott Masten (see ADDRESSES above). Substances considered appropriate for study generally fall into two broad yet overlapping categories:

(1)Substances judged to have high concern as possible public health hazards based on the extent of human exposure and/or suspicion of toxicity and

(2)substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g., by facilitating cross-species extrapolation or evaluating dose-response relationships. Nominations are also solicited for studies that permit the testing of hypotheses to enhance the predictive ability of future NTP studies, address mechanisms of toxicity, or fill significant gaps in the knowledge of the toxicity of classes of chemical, biological, or physical agents. Study nominations may entail the evaluation of a variety of health-related effects including, but not limited to, reproductive and developmental toxicity, genetic toxicity, immunotoxicity, neurotoxicity, metabolism and disposition, and carcinogenicity in appropriate experimental models. In reviewing and selecting nominations for study, the NTP also considers legislative mandates that require responsible private sector organizations to evaluate their products for health and environmental effects. The possible human health consequences of anticipated or known human exposure, however, remain the over-riding factor in the NTP's decision to study a particular substance. Nominations undergo a multi-step, formal process of review. Briefly, during the entire nomination review and selection process, the NTP works with staff at other federal agencies and interested parties to supplement information about nominated substances and ensure that regulatory and public health needs are addressed. The nomination review and selection process is accomplished through the participation of representatives from the NIEHS, other federal agencies represented on the Interagency Committee for Chemical Evaluation and Coordination (ICCEC), the NTP Board of Scientific Counselors (BSC)—an external scientific advisory body, the NTP Executive Committee—the NTP federal interagency policy body, and the public. Preliminary study recommendations for each nomination are developed and refined by the nominator, NTP staff, and the ICCEC and may be further refined as the formal review process continues. The NTP considers recommendations from the BSC and the NTP Executive Committee, public comments received on the nominations, and other available information in selecting candidate substances for study. The NTP initiates appropriate toxicology and carcinogenicity studies as time and resources permit. The nomination review and selection process is described in further detail on the NTP Web site ( *http://ntp.niehs.nih.gov/* ; select “Nominations to the Testing Program”). Request for Comments and Additional Information The NTP invites interested parties to submit written comments or supplementary information on the nominated substances and study recommendations that appear in Table 1. The NTP welcomes toxicology study information from completed, ongoing, or anticipated studies, as well as information on current U.S. production levels, use or consumption patterns, human exposure, environmental occurrence, or public health concerns for any of the nominated substances. The NTP is interested in identifying appropriate animal and non-animal experimental models for mechanistic-based research, including genetically modified rodents and high-throughput *in vitro* test methods, and as such, solicits comments regarding the use of specific *in vivo* and *in vitro* experimental approaches to address questions relevant to the nominated substances and issues under consideration. Comments should be submitted by May 10, 2007; however, the NTP welcomes comments or additional information on these study nominations at any time. The NTP will not respond to submitted comments; however, all information received will become part of the official record that the NTP considers in its ongoing review of these nominations. Persons submitting comments should include their name, affiliation, mailing address, phone, fax, e-mail address, and sponsoring organization (if any) with the submission. Written submissions will be made publicly available electronically on the NTP Web site as they are received ( *http://ntp.niehs.nih.gov/* ; select “Nominations to the Testing Program”). Background Information on the NTP Office of Chemical Nomination and Selection The NTP Office of Chemical Nomination and Selection

(OCNS)manages the solicitation, receipt, and review of NTP toxicology study nominations. The OCNS conducts an initial review of each study nomination received to determine whether the substance or issue has been adequately studied or has been previously considered by the NTP. For nominations not eliminated from consideration or deferred at this stage, the OCNS initiates a formal review process, as described above. The OCNS also ensures adequate background information is available to support the review for each nomination and corresponds with interested parties regarding the status of NTP study nominations. For further information on the OCNS visit the NTP Web site ( *http://ntp.niehs.nih.gov* ; select “Nominations to the Testing Program”) or contact Dr. Masten (see ADDRESSES above). Dated: March 21, 2007. David A. Schwartz, Director, National Institute of Environmental Health Sciences and National Toxicology Program. Table 1.—Testing Recommendations for Substances Nominated to the NTP for Toxicological Studies Substance [CAS No.] Nominated by 1 Nomination rationale Preliminary study recommendations 2 Aminopyridines: 2-Aminopyridine [504-29-0], 3-Aminopyridine [462-08-8], 4-Aminopyridine [504-24-5] NCI Moderate production and use; acutely toxic; lack of adequate toxicological data; suspicion of toxicity and carcinogenicity based on structure —Toxicological characterization including chronic toxicity and carcinogenicity studies for 2-aminopyridine. —Short-term mechanistic studies for 3- and 4-aminopyridine. —Comparative neurotoxicity studies for 2-, 3-, and 4-aminopyridine. Artificial butter flavoring mixture and certain components: Acetoin [513-86-0], Diacetyl [431-03-8] United Food and Commercial Workers International Union Evidence of lung disease in exposed workers and respiratory toxicity in short-term animal toxicity studies —Chronic toxicity and carcinogenicity studies via inhalation in rats. —Mechanistic studies. Asbestos, naturally occurring and atypical forms [1332-21-4] National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, U.S. Environmental Protection Agency Widespread community exposure in certain geographic locales; insufficient dose-response data to characterize risk from exposure to “unregulated” asbestiform mineral fibers and naturally occurring fibrous mineral “mixtures” —Mineral characterization. — *In vitro* durability and toxicity studies. —Subchronic and chronic toxicity/carcinogenicity studies via inhalation. —Studies should utilize test materials representative of minerals identified in Libby, MT and at other Naturally Occurring Asbestos

(NOA)sites. Diethyl phthalate [84-66-2] National Institute of Environmental Health Sciences Widespread consumer exposure through use in cosmetics and personal care products; insufficient toxicity data to assess potential reproductive hazard —Multigeneration oral reproductive and developmental toxicity studies —Toxicokinetic studies (oral and dermal routes). 2′,2″-Dithiobisbenzanilide [135-57-9] NCI High production volume; potential worker and consumer exposures; lack of adequate toxicological data; suspicion of toxicity based on structure —Genotoxicity studies. —Metabolism studies. 2-Methoxy-4-nitroaniline [97-52-9] NCI High production volume; potential worker exposures; lack of adequate toxicological data; positive mutagenicity data; strong suspicion of toxicity and carcinogenicity based on structure —Toxicological characterization. —Short-term mechanistic studies to predict carcinogenic potential. Nanoscale materials Nanoscale gold [7440-57-5] Nanoscale silver [7440-22-4] U.S. Food and Drug Administration Widespread and increasing use in drug, food and cosmetic products; lack of adequate toxicological and pharmacokinetic data; need to evaluate whether the current required tests are adequate to detect adverse biological and toxicological events —Nanoscale materials characterization. —Metabolism and pharmacokinetic studies. —Acute, subacute and subchronic toxicity studies. —Mechanistic studies to assess the role of size and surface coating on biological disposition and toxicity. Pentaethylenehexamine [4067-16-7] NCI High production volume; potential worker exposures; lack of adequate toxicological data; positive mutagenicity data No studies at this time due to the irritant and corrosive nature of this compound. *o* -Phthalaldehyde [643-79-8] National Institute for Occupational Safety and Health Widespread and increasing use as a disinfectant in health care settings; lack of adequate and publicly available toxicological data; potential skin and respiratory sensitizer —Toxicological characterization including studies to assess dermal irritation, dermal toxicity, and sensitization and asthmagenic potential. 1 National Cancer Institute (NCI). 2 The term “toxicological characterization” in this table includes studies for genotoxicity, subchronic toxicity, and chronic toxicity/carcinogenicity as determined to be appropriate during the conceptualization and design of a research program to address toxicological data needs. Other types of studies (e.g., metabolism and disposition, immunotoxicity, and reproductive and developmental toxicity) may be conducted as part of a complete toxicological characterization; however, these types of studies are not listed unless they are specifically recommended. [FR Doc. E7-5831 Filed 3-28-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1997E-0013] Determination of Regulatory Review Period for Purposes of Patent Extension; RETEVASE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for RETEVASE 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. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA approved for marketing the human biological product RETEVASE (reteplase). RETEVASE is indicated in the management of acute myocardial infarction

(AMI)in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for RETEVASE (U.S. Patent No. 5,223,256) from Boehringer Mannheim GmbH, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 6, 1997, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of RETEVASE represented the first permitted commercial marketing or use of the product. On September 14, 2006, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for RETEVASE is 1,919 days. Of this time, 1,430 days occurred during the testing phase of the regulatory review period, while 489 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective* : August 1, 1991. The applicant claims July 1, 1991, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was August 1, 1991, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262)* : June 30, 1995. FDA has verified the applicant's claim that the product license application

(PLA)for Retevase (PLA 95-1167) was initially submitted on June 30, 1995. The PLA was renumbered as biologics license application

(BLA)103632/0. 3. *The date the application was approved* : October 30, 1996. The applicant claims October 29, 1996, as the date the PLA was approved. However, FDA records indicate that PLA 95-1167 (BLA 103632/0) was approved on October 30, 1996. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 123 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by May 29, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 25, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-5736 Filed 3-28-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0354] Determination of Regulatory Review Period for Purposes of Patent Extension; VAPRISOL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for VAPRISOL 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. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product VAPRISOL (conivaptan hydrochloride). VAPRISOL is indicated for treatment of euvolemic hyponatremia in hospitalized patients. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for VAPRISOL (U.S. Patent No. 5,723,606) from Astellas Pharma, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 5, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of VAPRISOL represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for VAPRISOL is 2,796 days. Of this time, 2,096 days occurred during the testing phase of the regulatory review period, while 700 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : May 6, 1998. FDA has verified the applicant's claim that the date the Investigational New Drug application became effective was on May 6, 1998. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : January 30, 2004. FDA has verified the applicant's claim that the new drug application

(NDA)for VAPRISOL (NDA 21-697) was initially submitted on January 30, 2004. 3. *The date the application was approved* : December 29, 2005. FDA has verified the applicant's claim that NDA 21-697 was approved on December 29, 2005. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,745 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by May 29, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 25, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-5737 Filed 3-28-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N-0312] Meeting to Present Work-in-Progress on a Method for Ranking Feed Contaminants According to the Relative Risks They Pose to Animal and Public Health; Part 2: Exposure Scoring for Feed Contaminants; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. The Food and Drug Administration

(FDA)is announcing the following public meeting: “Meeting to Present Work-in-Progress on a Method for Ranking Feed Contaminants According to the Relative Risks They Pose to Animal and Public Health; Part 2: Exposure Scoring for Feed Contaminants.” The topic to be discussed will present work-in-progress on a method for ranking animal feed contaminants by their relative risks to animal and human health. The relative risk posed by feed contaminants to animal and human health consists of two components, namely, health consequence scoring and exposure scoring. At a meeting held in September 2006, the agency presented its current thinking on health consequence scoring. At this public meeting, the agency will describe the methods it plans to use to develop animal and human exposure scoring for chemical, physical, and microbiological feed contaminants. At a subsequent public meeting, FDA will present information on its relative risk-ranking model and how the health consequence scoring and exposure scoring will be combined to determine the relative risks of contaminants in feed. *Date and Time* : The public meeting will be held on May 22, 2007, from 9 a.m. to 4 p.m. *Location* : The public meeting will be held at the Holiday Inn, 2 Mongomery Village Ave., Gaithersburg, MD 20879. *Contact* : *For general information* : Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6867, FAX: 240-453-6882, or e-mail: *zoe.gill@fda.hhs.gov* . *For registration* : Nanette Milton, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6840, FAX: 240-453-6880, or e-mail: *nanette.milton@fda.hhs.gov* . *Registration* : Send registration information (including name, title, firm name, address, telephone, and fax number) to the contact person (see *Contact* ). To obtain the registration form via the Web site, go to *http://www.fda.gov/cvm/AFSS052007PM.htm* . Due to limited meeting space, registration will be required. We strongly encourage early registration. If you need special accommodations due to a disability, please contact Nanette Milton (see *Contact* ) no later than May 15, 2007. *Comments* : Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to the docket at the following Web site: *http://www.fda.gov/dockets/ecomments* . Submit a single copy of electronic comments or two paper copies of any written comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. The docket will remain open for written or electronic comments through June 21, 2007, 30 days following the meeting. SUPPLEMENTARY INFORMATION: I. Background The Animal Feed Safety System

(AFSS)is FDA's program for animal feed aimed at protecting human and animal health by ensuring animal feed is safe. It covers the entire spectrum of agency activities from preapproval of food additives and drugs for use in feed, to establishing limits for feed contaminants, providing education and training, conducting inspections, and taking enforcement actions for ensuring compliance with agency regulations. The AFSS includes oversight of all feed ingredients and mixed feed at all stages of manufacture, production, distribution and use, whether at commercial or non-commercial establishments. During the past several years, FDA has been considering changes that need to be made to the AFSS to ensure that it is comprehensive, preventive and risk-based. As part of this effort, the agency is developing a model for ranking the relative risks to human and animal health from contaminants in animal feed. An effective model will permit the agency to systematically distinguish among feed hazards based on the relative risks they pose to animals or humans. Such a model will consider the risks of hazards present in incoming materials or feed ingredients and will also consider how activities at feed manufacturing, storage, distribution, and transportation facilities may modify such risks. For the purpose of the AFSS, FDA defines a feed hazard as a biological, chemical, or physical agent in, or condition of, feed with the potential to cause an adverse health effect in animals or humans. Previously, FDA held three public meetings to discuss the AFSS. The first two meetings were held on September 23 and 24, 2003, in Herndon, VA and on April 5 and 6, 2005, in Omaha, NE. These public meetings included active participation by consumers, animal feed processors, animal producers, and State and other Federal government agencies. Following the meetings, we placed a number of documents in FDA's docket for the AFSS project (see docket number found in brackets in the heading of this document). These documents included transcripts of the meetings, summaries of break-out discussion groups, presentations of invited speakers and meeting summaries. We also placed in FDA's docket a number of other documents relating to the AFSS, including a framework for the AFSS that lists the principal components of the AFSS and the gaps the agency has identified which are being addressed by the agency team working on the AFSS project. These documents provided general background material on the AFSS for the third public meeting that was held on September 12, 2006, in Rockville, MD. The September 2006 meeting was the first of several planned by FDA to discuss aspects of the AFSS relative risk ranking model during the model's development by the agency. In this model, information about the health consequences posed by the hazardous contaminants will be combined with information about exposures to the contaminants in animal feed. At the September 2006 meeting, the agency presented its current thinking on the development of a health consequences scoring system to represent the animal and human health consequences associated with the feed contaminants. The meeting also afforded the opportunity for attendees and agency presenters to have an open discussion concerning the health consequences approach being considered by the agency. The presentations and the transcript of the meeting have been added to the AFSS docket. At the May 22, 2007, meeting, which will be held in Gaithersburg, MD, FDA will continue its discussions on the development of the AFSS relative risk ranking model by focusing on the exposure component of the model. The exposure scoring system under development intends to address the presence of contaminants in source materials for feed ingredients and those factors in manufacturing and/or processing that may affect the levels of contaminants in final feed formulations. At the May 2007 meeting, the agency will use the production of swine feed as an example exposure scenario to illustrate its approach to exposure assessment. At one or more subsequent meetings, the agency will present information about how health consequences and exposure are combined to determine the relative risks of contaminants in animal feed and various aspects of the relative risk model developed by the agency. II. Meeting We are holding the public meeting in an effort to gather further information from you, our stakeholders, on changes to the AFSS that will help minimize risks to animal and human health associated with animal feed. Prior to the public meeting, FDA will place a document entitled “Exposure Scoring for Feed Contaminants—A Swine Feed Example” in the docket found in brackets in the heading of this notice. The document will summarize the agency's methods for determining exposures to physical, chemical, and microbiological contaminants that may be present in swine feed. Details of these methods will be discussed at the meeting. A draft agenda for the meeting will also be placed in the docket prior to the meeting. Dated: March 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5820 Filed 2-28-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Workshop to Discuss Development of a Women's Health Information Sharing Network AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA's) Office of Women's Health is announcing the following meeting: “Workshop to Develop a Women's Health Information Sharing Network” to discuss opportunities for national organizations to share information about their women's health education activities. There will be two meetings. One will focus on Hispanic/Latina populations, and the other will focus on all other communities. Representatives of national community-based organizations are invited. A continental breakfast will be provided. *Date and Time* : The meetings will be held on April 12 and 13, 2007, from 8:30 am to 11:30 am. *Location* : The meetings will be held at AARP, 601 East St., NW., Washington, DC 20049. *Contact* : Susana Perry, FDA Office of Women's Health (HF-8), Food and Drug Administration, 5600 Fishers Lane, rm. 16-65, Rockville, MD 20857, 301-827-0350, FAX: 301-827-9194, e-mail: *susana.perry@fda.hhs.gov* . *Registration* : There is no fee, but pre-registration is required for security purposes by AARP. Seating is limited to 20 participants for each meeting. If you need special accommodations due to a disability, please contact Susana Perry at least 7 days in advance (by April 6, 2007). Dated: March 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-1546 Filed 3-27-07; 8:50 am]

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