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comments or two paper copies of any limited only by the available meeting evaluations of the potential mailed comments, except that room space. Following the expert panel developmental and reproductive individuals may submit one paper copy. meeting and completion of the expert toxicities of soy formula and its Comments are to be identified with the panel report, the CERHR will post the predominant constituent docket number found in brackets in the final report on its Web site and solicit . CERHR selected soy formula heading of this document. Received public comment on it through a Federal and genistein for expert panel comments may be seen in the Division Register notice. evaluation because of (1) the availability of Dockets Management between 9 a.m. DATES: The expert panel meeting for soy of numerous reproductive and and 4 p.m., Monday through Friday. formula will be held on December 16– developmental toxicity studies in laboratory animals and humans, (2) the IV. Electronic Access 18, 2009. Chapters 1–4 of the draft expert panel report will be available for availability of information on exposures Persons with access to the Internet public comment on October 19, 2009. in infants and women of reproductive may obtain the document at http:// Written public comments on the draft age, and (3) public concern for effects on www.fda.gov/Drugs/Guidance report must be received by December 2, infant or child development. The expert ComplianceRegulatoryInformation/ 2009. Time is set aside at the expert panel reports were released for public Guidances/default.htm, http:// panel meeting on December 16, 2009, comment on May 5, 2006 (71 FR 28368). www.fda.gov/BiologicsBloodVaccines/ for oral public comments. Individuals On November 8, 2006 (71 FR 65537), GuidanceComplianceRegulatory wishing to make oral public comments CERHR staff released draft NTP Briefs Information/Guidances/default.htm, or are asked to register online (http:// on Genistein and Soy Formula that http://www.regulations.gov. cerhr.niehs.nih.gov) or contact Dr. provided the NTP’s interpretation of the Dated: October 13, 2009. Kristina A. Thayer, CERHR Acting potential for genistein and soy formula David Horowitz, Director, by December 9, 2009, and if to cause adverse reproductive and/or Assistant Commissioner for Policy. possible, send a copy of the statement developmental effects in exposed and/or slide presentation at that time. [FR Doc. E9–24991 Filed 10–16–09; 8:45 am] humans. CERHR has not completed Persons wishing to attend are asked to these evaluations, finalized the briefs, or BILLING CODE 4160–01–S register by December 9, 2009 via the issued NTP–CERHR monographs on CERHR Web site (http:// these substances. Since 2006, a DEPARTMENT OF HEALTH AND cerhr.niehs.nih.gov). substantial number of new publications HUMAN SERVICES ADDRESSES: Public comments and any related to human exposure or other correspondence should be reproductive and/or developmental National Institutes of Health submitted to Dr. Kristina A. Thayer, toxicity have been published for these CERHR Acting Director, NIEHS, P.O. substances. CERHR has determined that Availability of the Draft Expert Panel Box 12233, Mail Drop K2–04, Research updated evaluations of genistein and Report on Soy Formula; Request for Triangle Park, NC 27709 (mail), 919– soy formula are needed. However, the Public Comment on the Draft Report; 541–5021 (telephone), or current evaluation will focus on soy Announcement of the Soy Formula [email protected] (e-mail). Courier formula and the potential Expert Panel Meeting address: NIEHS, 530 Davis Drive, Room developmental toxicity of its major isoflavone components, e.g., genistein, AGENCY: National Institute of K2154, Morrisville, NC 27560. , and . This evaluation Environmental Health Sciences FOR FURTHER INFORMATION CONTACT: Dr. (NIEHS), National Institutes of Health Kristina A. Thayer (telephone: 919–541– will not include an assessment on the (NIH). 5021 or e-mail: [email protected]). potential reproductive toxicity of genistein following exposures during ACTION: Availability of draft report, Persons needing interpreting services in order to attend should contact (301) adulthood as was done in the 2006 request for public comment, and evaluation. CERHR is narrowing the announcement of a meeting. 402–8180 (voice) or (301) 435–1908 (TTY). Requests should be made at least scope of the evaluation because the SUMMARY: The CERHR announces the seven business days in advance of the assessment of reproductive effects of availability of the draft expert panel meeting. genistein following exposure to adults was not considered relevant in the report on soy formula on October 19, SUPPLEMENTARY INFORMATION: 2009, on the CERHR Web site (http:// consideration of soy formula use in cerhr.niehs.nih.gov) or in printed text Background infants during the initial evaluation in from CERHR (see FOR FURTHER Soy formula is fed to infants as a 2006. INFORMATION CONTACT below). The supplement or replacement for human At the meeting, the expert panel will CERHR invites the submission of public milk or cow milk. Soy formula contains review and revise the draft expert panel comments on chapters 1–4 of the draft such as genistein (CAS RN: report and reach conclusions regarding expert panel report (see SUPPLEMENTARY 446–72–0), daidzein (CAS RN: 486–66– whether exposure to soy formula is a INFORMATION below). The expert panel 8), and glycitein (CAS RN: 40957–83–3). hazard to human development. The will meet on December 16–18, 2009, at Genistein, daidzein, glycitein, and the draft expert panel report has the the Hilton Alexandria Old Town, 1767 daidzein metabolite are non- following chapters: King Street, Alexandria, VA 22314 (Tel: steroidal, estrogenic compounds that 1.0 Chemistry, Use, and Human 1–703–837–0440) to review and revise occur naturally in some plants and are Exposure the draft expert panel report and reach often referred to as ‘‘.’’ In 2.0 General Toxicological and conclusions regarding whether exposure plants, nearly all genistein, daidzein, Biological Effects to soy formula is a hazard to human and glycitein is linked to a sugar 3.0 Developmental Toxicity Data development. The expert panel will also molecule and these isoflavone-sugar a. Developmental Toxicity Data for identify data gaps and research needs. complexes are called , , Genistein, Daidzein, Equol, and CERHR expert panel meetings are open or . Glycitein to the public with time scheduled for On March 15–17, 2006, CERHR b. Developmental Toxicity Data for oral public comment. Attendance is convened an expert panel to conduct Soy Formula and Other Soy

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Products expert panel to complete its work. DEPARTMENT OF HEALTH AND 4.0 Reproductive Toxicity Data Anticipated agenda topics for each day HUMAN SERVICES 5.0 Summary, Conclusions, and are listed below. Critical Data Needs (to be Food and Drug Administration developed at the expert panel December 16, 2009 [Docket No. FDA–2009–N–0143] meeting). • Opening remarks; • Request for Comments Oral public comments (7 minutes Risk Evaluation and Mitigation per speaker; one representative per Strategies for Certain Opioid Drugs; CERHR invites written public group); Notice of Public Meeting; Reopening of comments on chapters 1–4 of the draft • Review of chapters 1–4 of the draft Comment Period expert panel report on soy formula. Any expert panel report on soy formula; comments received will be posted on • Discussion of Chapter 5.0 AGENCY: Food and Drug Administration, the CERHR Web site prior to the Summary, Conclusions, and Critical HHS. meeting and distributed to the expert Data Needs. ACTION: Notice; reopening of comment panel and CERHR staff for their period. consideration in revising the draft report December 17, 2009 and/or preparing for the expert panel • Discussion of Chapter 5.0 SUMMARY: The Food and Drug meeting. Persons submitting written Summary, Conclusions, and Critical Administration (FDA) is reopening until comments are asked to include their Data Needs; October 19, 2010, the comment period name and contact information • Preparation of draft summaries and for the notice of public meeting (affiliation, mailing address, telephone conclusion statements. published in the Federal Register of number, e-mail, and sponsoring April 20, 2009 (74 FR 17967). In that organization, if any) and send them to December 18, 2009 notice, FDA announced a public Dr. Thayer (see ADDRESSES above) for • Presentation, discussion of, and meeting that took place on May 27 and receipt by December 2, 2009. Comments agreement on summaries, conclusions, 28, 2009, to solicit input on developing will be identified on the Web site by the and data needs; Risk Evaluation and Mitigation submitter’s name, affiliation, and/or • Closing comments. Strategies (REMS) for certain opioid sponsoring organization. drugs. FDA is reopening the comment Time is set aside on December 16, Background Information on the CERHR period in light of continued public 2009 for the presentation of oral public The NTP established CERHR in 1998 interest in this topic and to provide an comments at the expert panel meeting. (63 FR 68782). CERHR is a publicly opportunity for all interested parties to Seven minutes will be available for each accessible resource for information provide information and share views on speaker (one speaker per organization). about adverse reproductive and/or the matter. Online registration is available on the developmental health effects associated DATES: Submit written or electronic CERHR website or persons wishing to with exposure to environmental and/or comments by October 19, 2010. make oral remarks can contact Dr. occupational exposures. CERHR follows ADDRESSES: Submit written comments Thayer. If possible, send a copy of the a formal process for the evaluation of to the Division of Dockets Management statement, talking points, and/or slide selected substances that includes (HFA–305), Food and Drug presentation to Dr. Thayer by December opportunities for public input. Administration, 5630 Fishers Lane, rm. 2. This statement will be provided to the CERHR invites the nomination of 1061, Rockville, MD 20852. Submit expert panel to assist them in substances for review or scientists for its electronic comments to http:// identifying issues for discussion and expert registry. Information about www.regulations.gov. noted in the meeting record. CERHR and the nomination process can FOR FURTHER INFORMATION CONTACT: Registration for presentation of oral be obtained from its homepage (http:// comments will also be available at the cerhr.niehs.nih.gov) or by contacting Dr. Theresa (Terry) Martin, Center for Drug Evaluation and Research, Food and meeting on December 16, 2009, from Thayer (see ADDRESSES above). CERHR 7:30–8:30 a.m. Persons registering at the selects substances for evaluation based Drug Administration, 10903 New meeting are asked to bring 30 copies of upon several factors including Hampshire Ave., Bldg. 51, rm. 6196, their statement, talking points, and/or production volume, potential for human Silver Spring, MD 20993–0002, 301– slide presentation for distribution to the exposure from use and occurrence in 796–3448; FAX: 301–847–8752, e-mail: expert panel and for the record. the environment, extent of public [email protected]. concern, and extent of data from SUPPLEMENTARY INFORMATION: Attendance and Registration reproductive and developmental I. Background In order to facilitate planning for this toxicity studies. Expert panels conduct meeting, persons wishing to attend are scientific evaluations of substances In the Federal Register of April 20, asked to register by December 9, 2009, selected by CERHR in public forums. 2009 (74 FR 17967), FDA published a via the CERHR Web site (http:// Following these evaluations, CERHR notice of a public meeting on cerhr.niehs.nih.gov). prepares the NTP–CERHR monograph developing REMS for certain opioid drugs. The affected opioid drugs include Preliminary Agenda on the substance evaluated. The monograph is transmitted to appropriate long acting and extended release brand The meeting begins each day at 8:30 Federal and State agencies and made name and generic products that are a.m. On December 16 and 17, it is available to the public. formulated with the following active anticipated that a lunch break will occur ingredients: Fentanyl, hydromorphone, from noon–1 p.m. and the meeting will Dated: October 8, 2009. methadone, morphine, oxycodone, and adjourn at 5–6 p.m. The meeting is John R. Bucher, oxymorphone. The REMS would be expected to adjourn by noon on Associate Director, National Toxicology intended to ensure that the benefits of December 18, 2009; however, Program. these drugs continue to outweigh risks adjournment may occur earlier or later [FR Doc. E9–25122 Filed 10–16–09; 8:45 am] associated with: (1) Use of high doses of depending upon the time needed by the BILLING CODE 4140–01–P long acting opioid and extended release

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