Notices. Notice

8,268 words·~38 min read·/register/2007/04/02/07-1604

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 Institute of Environmental Health Sciences Announcement of Meeting To Discuss Soy Estrogens and Development AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, Department of Health and Human Services. ACTION: Notice. SUMMARY: Beginning on Thursday, April 12, 2007 (9 a.m. to 4:30 p.m.) and continuing through Friday, April 13, 2007 (9 a.m.-12:30 p.m.), Dr. Walter Rogan of the National Institute of Environmental Health Sciences will sponsor a meeting with experts in pediatric endocrinology, psychology, epidemiology, and nutrition to discuss soy estrogens and infant development.

The meeting will be held at the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina. During 2004-05, NIEHS conducted pilot studies to test innovative ethods for studying estrogenic isoflavones in soy formula and their potential ability to act as pharmacologic estrogens in infants by prolonging anatomical and biochemical markers in infants. The results of these studies are becoming available. While the investigators are at the early stage of planning what, if any, steps to take next, they have convened experts in pediatric endocrinology, psychology, epidemiology, nutrition, etc., to offer their individual opinions.

This meeting is open to the public, but is limited by space. Registration is free but required. Please also note that the following security procedures must be followed when visiting the NIEHS: • The purpose of a visit must be official (registered); • The visit should be expected and approved by a “host” employee; • Visitors must show an ID (Driver's license plus one of the following: company ID; government ID or university ID) at the entrance; • Vehicles may be searched. Those interested in attending the meeting, or who have questions should contact:

Kerry James by e-mail at *james4@niehs.nih.gov* or by telephone at 919-287-4339; or Janet Archer by e-mail at *archer2@niehs.nih.gov* or by phone at 919-287-4334. Dated: March 26, 2007. Walter J Rogan, Senior Investigator, Epidemiology Branch, National Institutes of Environmental Health Sciences, National Institutes of Health. [FR Doc. E7-6065 Filed 3-30-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (Ntp); Center for the Evaluation of Risks to Human Reproduction (CERHR);

Announcement of the Second Bisphenol A Expert Panel Meeting and Availability of Interim Draft Expert Panel Report AGENCY: National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health. ACTION: Announcement of a meeting and request for public comment. SUMMARY: CERHR announces the second meeting of the expert panel on bisphenol A on May 21-23, 2007, tentatively planned for the Washington, DC area. The interim draft expert panel report will be posted on the CERHR Web site ( *http://cerhr.niehs.nih.gov* ) and available in printed text from CERHR (see “ FOR FURTHER INFORMATION CONTACT ” below) by April 20.

CERHR invites submission of written public comments on the interim draft expert panel report (see “ SUPPLEMENTARY INFORMATION ” below). The expert panel meeting is open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. CERHR also announces that the working groups for sections 3 and 4 of the expert panel report will meet April 5-6, 2007, in Durham, NC to continue discussions not completed at the March meeting.

DATES: The second CERHR expert panel meeting on bisphenol A will be held May 21-23, 2007. The interim draft expert panel report containing sections 1-4 will be available for public comment by April 20, 2007. Written public comments on the interim draft report must be received by May 14. Time will be set-aside at the expert panel meeting on May 21 for oral public comments. Individuals wishing to make oral public comments are asked to contact Dr. Michael D. Shelby, CERHR Director, by May 14, 2007, and if possible, send a copy of their PowerPoint slides, statement, or talking points at that time.

Persons needing special assistance, such as sign language interpretation or other reasonable accommodation in order to attend, should contact 919-541-2475 (voice), 919-541-4644 TTY (text telephone), through the Federal TTY Relay System at 800-877-8339, or by e-mail to *niehsoeeo@niehs.nih.gov* . Requests should be made at least seven business days in advance of the event. ADDRESSES: The location of the second expert panel meeting on bisphenol A is not yet set. Comments on the interim draft expert panel report should be sent to Dr.

Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail),

(919)316-4511 (fax), or *shelby@niehs.nih.gov* (e-mail). *Courier address:* CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. The working groups will meet in Durham, NC. FOR FURTHER INFORMATION CONTACT: Dr. Michael D. Shelby, CERHR Director, 919-541-3455, *shelby@niehs.nih.gov* . SUPPLEMENTARY INFORMATION: Background CERHR convened the first expert panel meeting on March 5-7 in Alexandria, VA to assess the potential reproductive and developmental hazards of bisphenol A. The panel discussed the scientific evidence and made revisions to the draft expert panel report on bisphenol A, but because of the length and complexity of this evaluation, the panel was unable to complete its task (a meeting summary is available at *http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.html* ). The expert panel will reconvene on May 21-23, 2007, for a second meeting. The meeting location, which is not yet set, will be posted on the CERHR Web site when finalized along with a schedule for the meeting. The meeting will begin each day at 8:30 a.m. and continue until adjournment. It is expected to adjourn by noon on May 23, although adjournment may occur earlier or later depending upon the time needed for the expert panel to complete its work. The expert panel will

(1)continue its review,

(2)finalize sections 1-4 of the draft report,

(3)reach conclusions regarding whether exposure to bisphenol A is a hazard to human reproduction or development, and

(4)write Section 5 Summary, Conclusions, and Critical Data Needs. At the March meeting, working groups for sections 1-4 of the draft report met periodically to discuss their sections and prepare materials for deliberation by the panel during public plenary sessions. The working groups for Section 3 Developmental Toxicity Data and Section 4 Reproductive Toxicity Data will meet on April 5-6 in Durham, NC to continue discussions not completed at the March meeting. Their edits will be included in the interim draft expert panel report, which will be posted on the CERHR Web site and available for public comment by April 20, and brought before the expert panel during the public plenary sessions at the May 21-23 meeting. The interim draft report, which will show all edits to date, will be posted on the CERHR Web site by April 20 and serve as the starting point for the panel's discussions at its May meeting. Bisphenol A (CAS RN: 80-5-07) is a high production volume chemical used in the production of epoxy resins, polyester resins, polysulfone resins, polyacrylate resins, polycarbonate plastics, and flame retardants. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact to bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected this chemical for evaluation because of

(1)high production volume,

(2)widespread human exposure,

(3)evidence of reproductive toxicity in laboratory animal studies, and

(4)public concern. Request for Comments The CERHR invites written public comments on the interim draft expert panel report on bisphenol A. Any comments received will be posted on the CERHR Web site prior to the second meeting and distributed to the expert panel and CERHR staff for their consideration in revising the draft report and/or preparing for the second meeting. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, e-mail, and sponsoring organization, if any) and send them to Dr. Shelby (see ADDRESSES above) for receipt by May 14, 2007. Time will be set-aside on May 21, 2007, for the presentation of oral public comments at the expert panel meeting. Seven minutes will be available for each speaker (one speaker per organization). When registering to comment orally, please provide your name, affiliation, mailing address, telephone and facsimile numbers, e-mail and sponsoring organization (if any). If possible, send a copy of the PowerPoint slides, statement, or talking points to Dr. Shelby by May 14. This statement will be provided to the expert panel to assist them in identifying issues for discussion and will be noted in the meeting record. Registration for presentation of oral comments will also be available at the meeting on May 21, 2007, from 7:30-8:30 a.m. Persons registering at the meeting are asked to bring 20 copies of their statement or talking points for distribution to the expert panel and for the record. Background Information on CERHR NTP established CERHR in June 1998 [ **Federal Register** , December 14, 1998 (Volume 63, Number 239, page 68782)]. CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. Expert panels conduct scientific evaluations of agents selected by the CERHR in public forums. CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its homepage ( *http://cerhr.niehs.nih.gov* ) or by contacting Dr. Shelby (see FOR FURTHER INFORMATION CONTACT above). CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. The formal evaluation process was published in the **Federal Register** on July 16, 2001 (Volume 66, Number 136, pages 37047-37048) and is available on the CERHR Web site under “About CERHR” or in printed copy from CERHR. Dated: March 21, 2007. David A. Schwartz, Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-6080 Filed 3-30-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Interagency Committee on Smoking and Health: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the charter for the Interagency Committee on Smoking and Health

(ICSH)of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services, has been renewed for a 2-year period through March 20, 2009. For further information, contact Dana Shelton, Executive Secretary, Interagency Committee on Smoking and Health, Centers for Disease Control Prevention, of the Department of Health and Human Services, CDC, 4770 Buford Highway, NE., M/S K-50, Atlanta, Georgia 30341-3717, telephone 770-488-5709 or fax 770-488-5767. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7-6020 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Council for the Elimination of Tuberculosis: Notice of Charter Renewal. This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Advisory Council for the Elimination of Tuberculosis, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 15, 2009. For information, contact Kenneth Castro, M.D., Executive Secretary, Advisory Council for the Elimination of Tuberculosis, Centers for Disease Control and Prevention, Department of Health and Human Services, 1600 Clifton Road, NE., Mailstop E10, Atlanta, Georgia 30333, telephone 404/639-8000 or fax 404/639-8604. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7-6016 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Peer Review of Division of HIV/AIDS Prevention Intramural International Biomedical Interventional Research in Thailand, Kenya, Botswana and Cameroon In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting. *Times and Dates:* 8 a.m.-5 p.m., May 2, 2007 (Closed) 8 a.m.-5 p.m., May 3, 2007 (Closed). *Place:* Corporate Square, 9 Corporate Boulevard, Suite 100, Atlanta, GA 30329, telephone 404-679-7900. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of the “Division of HIV/AIDS Prevention Intramural International Biomedical Interventional Research in Thailand, Kenya, Botswana and Cameroon.” *Contact Person for More Information:* Elise M. Beltrami, M.D., M.P.H., Designated Federal Official, National Center for Preparedness, Detection and Control of Infectious Diseases, Division of Healthcare Quality Promotion, CDC, 1600 Clifton Road N.E., Mailstop A-31, Atlanta, GA 30333, Telephone 404-639-4271. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6009 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Provider and Public Health Input for Vaccine Policy Decisions, Potential Extramural Project (PEP), 2007-R-04 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting. *Time and Date:* 12 p.m.-4 p.m., May 8, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to PEP 2007-R-04, “Provider and Public Health Input for Vaccine Policy Decisions.” *Contact Person for More Information:* Christine J. Morrison, PhD Scientific Review Administrator, Office of the Chief Science Officer, CDC, 1600 Clifton Road NE, Mailstop D-72, Atlanta, GA 30333, Telephone (404)639-3098. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6010 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Evaluation of the Immune Response to a Modified Dosing Schedule of the Quadrivalent HPV Vaccine, Potential Extramural Project

(PEP)2007-R-03 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting. *Time and Date:* 12 p.m.-4 p.m., May 17, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “The Immune Response to a Modified Dosing Schedule of the Quadrivalent HPV Vaccine,” PEP 2007-R-03. *Contact Person for More Information:* Christine J. Morrison, PhD, Scientific Review Administrator, Office of the Chief Science Officer, CDC, 1600 Clifton Road NE, Mailstop D-72, Atlanta, GA 30333, Telephone

(404)639-3098. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6036 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention

(CDC)Meetings of the Advisory Committee for Injury Prevention and Control (ACIPC), and Its Subcommittee, the Science and Program Review Subcommittee (SPRS or the Subcommittee) In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention announces the following meetings of the aforementioned subcommittee and committee. *Name:* Science and Program Review Subcommittee. *Times and Date:* 10:30 a.m.-10:45 a.m., April 30, 2007 (Open). 10:45 a.m.-2 p.m., April 30, 2007 (Closed). *Place:* Koger Center, Vanderbilt Building, Room 1004 A/B, 2939 Flowers Road, South, Atlanta, GA 30341. *Purpose:* The SPRS provides advice on the needs, structure, progress and performance of programs of the National Center for Injury Prevention and Control (NCIPC). *Matters to be Discussed:* The subcommittee will meet April 30, 2007, to provide a secondary review of, discuss, and evaluate grant applications and cooperative agreements received in response to three Request for Applications

(RFAs)related to the following individual research grant and cooperative agreement applications: 07001, Grants for Injury Control Research Centers; 07009, Dissertation Grant Awards for Doctoral Candidates for Violence-Related Injury Prevention Research in Minority Communities; and 07010, Research for Preventing Violence-Related Injury. In addition, the ACIPC will meet via teleconference on April 30, 2007, to vote on the recommendations of the SPRS regarding the RFAs. Agenda items are subject to change as priorities dictate. *Name:* Advisory Committee for Injury Prevention and Control. *Times and Date:* 3 p.m.-3:15 p.m., April 30, 2007 (Open). 3:15 p.m.-4:30 p.m., April 30, 2007 (Closed). *Place:* Koger Center, Vanderbilt Building, Room 1004 A/B, 2939. *Purpose:* The committee advises and makes recommendations to the Secretary, Department of Health and Human Services, the Director, CDC, and the Director, NCIPC, regarding feasible goals for the prevention and control of injury. The committee makes recommendations regarding policies, strategies, objectives, and priorities, and reviews progress toward injury prevention and control. *Matters to be Discussed:* Agenda items for the open portion include the call to order and introductions and request for public comments. Beginning at 3:15 p.m., April 30, 2007, through 4:30 p.m, during the closed portion, the Committee will vote on the results of the secondary review. This portion of the meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and (b), title 5 U.S.C., and the Determination of the Acting Director, Management Analysis and Services Office, CDC pursuant to Pub L. 92-463. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Ms. Amy Harris, Executive Secretary, ACIPC, NCIPC, CDC, 4770 Buford Highway, NE., M/S K61, Atlanta, Georgia 30341-3724, telephone

(770)488-4936. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6037 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting of the aforementioned committee. *Times and Dates:* 8:45 a.m.-5:15 p.m., May 2, 2007. 8:30 a.m.-12:15 p.m., May 3, 2007. *Place:* Pittsburgh Airport Marriott, 777 Aten Road, Coraopolis, PA, 15108, telephone

(412)788-8800, fax

(412)788-6299. *Status:* Open to the public, limited only by the space available. The meeting room accommodates approximately 50 people. *Purpose:* This committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, National Institute for Occupational Safety and Health (NIOSH), on priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C. 812(b)(2), Section 102(b)(2). *Matters to be Discussed:* The meeting will focus on Communications and Tracking, update on Refuge Chamber Activities, Mine Seals Research, other Research Projects Related to Disaster Prevention and Response and Behavioral Research on Mine Escape. The agenda will also include an update report from the Associate Director for Mining. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Jeffery L. Kohler, PhD, Executive Secretary, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, telephone

(412)386-5301, fax

(412)386-5300. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E7-6008 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Center for Health Statistics In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics

(NCHS)announces the following meeting of the aforementioned committee. *Times and Dates:* 2 p.m.-5:30 p.m., April 26, 2007. 8:30 a.m.-2 p.m., April 27, 2007. *Place:* NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782. *Status:* Open to the public, and limited only to the space available. The meeting room accommodates approximately 100 people. *Purpose:* This committee is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS. *Matters to be Discussed:* The agenda will include welcome remarks by the Director, NCHS; introduction of members and key NCHS staff; scientific presentations and discussions; continued discussion of the review of the natality program; discussion of upcoming program reviews and an open session for comments from the public. Requests to make oral presentations should be submitted in writing to the contact person listed below. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by April 13, 2007. The agenda items are subject to change as priorities dictate. *Contact Person For More Information:* Virginia S. Cain, Ph.D., Director of Extramural Research, NCHS/CDC, 3311 Toledo Road, Room 7211, Hyattsville, Maryland 20782, telephone

(301)458-4500, fax

(301)458-4020. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7-6022 Filed 3-30-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005E-0245] Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for KEPIVANCE 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 human biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial complete submission of an application to market the human biological product and continues until FDA grants permission to market the drug 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 recently approved for marketing the human biological product KEPIVANCE (palifermin). KEPIVANCE is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for KEPIVANCE (U.S. Patent No. 5,677,278) from Chiron Corp., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated June 14, 2006, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of KEPIVANCE represented the first permitted commercial marketing or use of the product. Shortly 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 KEPIVANCE is 3,303 days. Of this time, 3,119 days occurred during the testing phase of the regulatory review period, while 184 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* : December 2, 1995. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 2, 1995. 2. * The date the application was initially submitted with respect to the human biological product under section 505(b) of the act * : June 15, 2004. The applicant claims May 14, 2004, as the date the biologics license application

(BLA)for KEPIVANCE (BLA 125103) was initially submitted. However, FDA records indicate that the final reviewable unit of BLA 125103 was submitted on June 15, 2004. 3. *The date the application was approved* : December 15, 2004. FDA has verified the applicant's claim that BLA 125103 was approved on December 15, 2004. 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 1,417 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 June 1, 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 October 1, 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: February 26, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-6053 Filed 3-30-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003E-0256] Determination of Regulatory Review Period for Purposes of Patent Extension; RANEXA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for RANEXA 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 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 drug 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 RANEXA (ranolazine). RANEXA is indicated for treatment of chronic angina. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for RANEXA (U.S. Patent No. 4,567,264) from Roche Palo Alto, L.L.C., 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 RANEXA represented the first permitted commercial marketing or use of the product. Shortly 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 RANEXA is 6,770 days. Of this time, 5,645 days occurred during the testing phase of the regulatory review period, while 1,125 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* : July 18, 1987. The applicant claims July 10, 1987, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was July 18, 1987, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : December 30, 2002. FDA has verified the applicant's claim that the new drug application

(NDA)for RANEXA (NDA 21-526) was initially submitted on December 30, 2002. 3. *The date the application was approved* : January 27, 2006. FDA has verified the applicant's claim that NDA 21-526 was approved on January 27, 2006. 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 5 years 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 June 1, 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 October 1, 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. E7-6061 Filed 3-30-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The 10th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration

(FDA)is announcing the following conference: 10th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive questions and answers, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues. *Date and Time* : The conference will be held on June 11 and 12, 2007, from 7:30 a.m. to 5 p.m. *Location* : The conference will be held at the Irvine Marriott, 18000 Von Karman Ave., Irvine, CA 92612. *Contact* : Linda Hartley, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949-608-4413, FAX: 949-608-4417, or OCRA, Attention to Detail (ATD), 5319 University Dr., suite 641, Irvine, CA 92612, 949-387-9046, FAX: 949-387-9047, Web site: *www.ocra-dg.org* . *Registration and Meeting Information* : See OCRA Web site, *www.ocra-dg.org* . Contact ATD at 949-387-9046. Before May 11, 2007, registrations fees are as follows: $575.00 for members, $625.00 for non-members and $400.00 for FDA/Govt/Students. After May 11, 2007, $625.00 for members, $725.00 for non-members, and $400.00 for FDA/Govt/Students. OCRA student rate applies to those individuals enrolled in a Regulatory or Quality related academic program at an accredited institution. Proof of enrollment required. The registration fee will cover actual expenses including refreshments, lunch, materials, parking and speaker expenses. If you need special accommodations due to a disability, please contact Linda Hartley at least 10 days in advance. Dated: March 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6052 Filed 3-30-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0114] Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration

(FDA)is announcing a public hearing to solicit views and information from interested parties concerning the concept of electronic distribution of FDA-approved prescribing information currently contained in the package insert (or PIs) for human prescription drug and biological products. In particular, FDA is seeking views and information on the feasibility of establishing a modern and efficient process for industry to electronically distribute prescribing information to dispensers. We are seeking input on a number of questions regarding the current use of package inserts and those logistical issues associated with electronic distribution of such prescribing information. DATES: *Public Hearing* : The public hearing will be held on April 27, 2007, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the public hearing may be extended later or may end early. If you need special accommodations due to a disability, please contact Erik Mettler (see FOR FURTHER INFORMATION CONTACT ) by April 20, 2007. *Registration* : Seating at the public hearing is limited. Registration is free and will be on a first-come, first-serve basis. Persons interested in attending the public hearing should register by close of business on April 20, 2007. *Notice of Oral Presentation* : Persons interested in presenting responses to the questions should submit a notice of oral presentation by close of business on April 17, 2007. See section I of this document for information on how to participate in the public hearing. *Comments* : Submit written or electronic comments by June 22, 2007. ADDRESSES: *Public Hearing* : The public hearing will be held at 5600 Fishers Lane, third Fl., conference rooms D & E, Rockville, MD 20857. *Registration* : Submit written registration to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic registration to *http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm* . *Notice of Oral Presentation and Comments* : Submit written notices of oral presentation and comments to the Division of Dockets Management (see previous paragraph). Submit electronic notices of oral presentation and comments to *http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm* . Identify all submissions to the docket with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, *Erik.Mettler@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. How to Participate in the Public Hearing The procedures governing the hearing are set forth in part 15 (21 CFR part 15) of FDA's regulations. If you wish to make an oral presentation during the hearing, you must submit a written notice of oral presentation with the Division of Dockets Management (see ADDRESSES ) by April 13, 2007. In the written notice, submit your name, title, business affiliation, address, telephone number, fax number, and e-mail address. You should also submit a written statement for each discussion topic in section IV of this document that you intend to address, or other pertinent information related to the topic in your presentation, the names and addresses of all individuals that plan to participate, and the approximate time requested for your presentation. We encourage individuals and organizations with common interests to consolidate or coordinate their presentations to allow adequate time for each request for presentation. Participants should submit to the docket a copy of each presentation. We will file the hearing schedule indicating the order of presentation and the time allotted to each person with the Division of Dockets Management (see ADDRESSES ). We will also mail or telephone the schedule to each participant before the hearing. In anticipation of the hearing presentations moving ahead of schedule, participants are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called, risk forfeiting their scheduled time. II. Background The PIs with prescribing information accompany prescription drugs to meet the requirement that “labeling on or within the package from which the drug is to be dispensed bears adequate information for its use * * * .” (21 CFR 201.100(c)(1). FDA approves the prescribing information as part of the drug's labeling in the drug application. Currently, the PI containing the prescribing information for the safe and effective use of the product is a paper leaflet. PIs are used in numerous ways by various healthcare entities, including pharmacies that receive and dispense the drug, and provide important drug information for the safe and effective use of the product. Such information includes, among other things, indications, adverse events, warnings and precautions, and dosing instructions. Although the information in the PI is a valuable resource, it is often not readily accessible when a healthcare provider who has not physically received the drug makes a treatment decision or discusses treatments with a patient. Additionally, the PI may not contain the most current information, because the PI accompanying the drug's distribution may have been printed and distributed prior to more recent labeling changes. As the healthcare system advances into the 21st century, we are considering how dissemination of the prescribing information contained in the PI can take advantage of technological advances in the electronic transmission of information. III. Purpose and Scope of the Hearing The purpose of the public hearing is to gain a better understanding of how the prescribing information in a PI is currently used by healthcare entities and what the information needs are as we consider new approaches to disseminating labeling information. We are also interested in getting a better understanding of the logistical processes that are currently in place or that might need to be established in order to electronically disseminate the prescribing information, including the costs of these efforts. In particular, we would like to hear from manufacturers of drug and biological products, pharmacists and pharmacies, other healthcare providers, wholesalers, consumers, and information providers. IV. Issues for Discussion To help achieve the objectives discussed in section III of this document, we are specifically interested in hearing comments on the following questions and any other pertinent information related to the electronic distribution of the prescribing information. A. General

(1)Currently, who uses, and benefits from the prescribing information?

(2)How can electronic distribution and access of the prescribing information be accomplished?

(3)Would electronic distribution and access of the prescribing information improve the public health?

(4)Would electronic distribution and access of prescribing information improve prescribing habits? If so, how?

(5)How might we ensure that changes in the distribution and access of the prescribing information will not negatively affect the current users?

(6)Would an increase in electronic access to prescribing information affect prescribers, pharmacists, and patients? If so, how? B. Logistics

(1)Generally and without focusing on vendor-specific methods, how can electronic distribution of prescribing information be accomplished?

(2)What are the costs associated with the successful implementation of electronic distribution and access to prescribing information, including start-up and maintenance expenses? Please breakdown costs per healthcare sector.

(3)Is the technology and infrastructure currently available to accomplish electronic distribution and access? If so, what is available? If not, what is needed?

(4)What are other potential barriers to accomplishing the electronic prescribing information?

(5)How can we ensure that electronic prescribing information is accessible to those who need the information?

(6)How do we meet the needs of those who do not have electronic capability?

(7)In case of emergency or when a computer system is down, what might be the backup?

(8)How should electronically disseminated prescribing information be regularly updated and remain current?

(9)What are the roles for the involved parties (manufacturers, third-parties, health professionals, FDA, and consumers)?

(10)Should all products have electronic prescribing information or are there some products or classes of products that should continue to have a paper prescribing information accompany the product?

(11)If electronic prescribing information were to be used instead of paper inserts, then how should electronic prescribing information be implemented? Should electronic prescribing information be phased in? If so, over what time period? Which products should use electronic prescribing information first? V. Notice of Hearing Under Part 15 The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15. The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner, the Office of Policy and Planning, the Office of the Chief Counsel, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. Persons who wish to participate in the part 15 hearing must file a written or electronic notice of oral presentation with the Division of Dockets Management (see ADDRESSES and DATES ). To ensure timely handling of written submissions, any outer envelope should be clearly marked with the docket number found in brackets in the heading of this document, along with the statement “Electronic Distribution of Package Inserts for Prescription Drug Products.” Requests to make an oral presentation should contain the potential presenter's name and title; address; telephone and fax number; e-mail address; affiliation, if any; the sponsor of the presentation (e.g., the organization paying travel expenses or fees), if any; and a brief summary of the presentation (including the discussion topic(s) that will be addressed). Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in § 15.30(h). VI. Requests for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic notices of oral presentation and comments for consideration. To permit time for all interested persons to submit data, information, or views on this subject, the administrative record of the hearing will remain open until June 22, 2007. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management (see ADDRESSES ). You should annotate and organize your comments to identify the specific questions identified by topic to which they refer (see section IV of this document). Two paper copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number at the heading of this document. Received comments may be seen in Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday. VII. Transcripts The hearing will be transcribed as stipulated in § 15.30(b). Transcripts of the hearing will be available for review at the Division of Dockets Management (see ADDRESSES ) and on the Internet at *http://www.fda.gov/ohrms/dockets* approximately 21 days after the hearing. You may place orders for copies of the transcript through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents per page. Dated: March 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-1604 Filed 3-28-07; 1:02 pm]

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