53508 Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 

comments or two paper copies of any 

mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: October 13, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24991 Filed 10–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Availability of the Draft Expert Panel 

Report on Soy Formula; Request for 

Public Comment on the Draft Report; 

Announcement of the Soy Formula 

Expert Panel Meeting 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: Availability of draft report, 

request for public comment, and 

announcement of a meeting. 

SUMMARY: The CERHR announces the 

availability of the draft expert panel 

report on soy formula on October 19, 

2009, on the CERHR Web site (http:// 

cerhr.niehs.nih.gov) or in printed text 

from CERHR (see FOR FURTHER

INFORMATION CONTACT below). The 

CERHR invites the submission of public 

comments on chapters 1–4 of the draft 

expert panel report (see SUPPLEMENTARY

INFORMATION below). The expert panel 

will meet on December 16–18, 2009, at 

the Hilton Alexandria Old Town, 1767 

King Street, Alexandria, VA 22314 (Tel: 

1–703–837–0440) to review and revise 

the draft expert panel report and reach 

conclusions regarding whether exposure 

to soy formula is a hazard to human 

development. The expert panel will also 

identify data gaps and research needs. 

CERHR expert panel meetings are open 

to the public with time scheduled for 

oral public comment. Attendance is 

limited only by the available meeting 

room space. Following the expert panel 

meeting and completion of the expert 

panel report, the CERHR will post the 

final report on its Web site and solicit 

public comment on it through a Federal 

Register notice. 

DATES: The expert panel meeting for soy 

formula will be held on December 16– 

18, 2009. Chapters 1–4 of the draft 

expert panel report will be available for 

public comment on October 19, 2009. 

Written public comments on the draft 

report must be received by December 2, 

2009. Time is set aside at the expert 

panel meeting on December 16, 2009, 

for oral public comments. Individuals 

wishing to make oral public comments 

are asked to register online (http:// 

cerhr.niehs.nih.gov) or contact Dr. 

Kristina A. Thayer, CERHR Acting 

Director, by December 9, 2009, and if 

possible, send a copy of the statement 

and/or slide presentation at that time. 

Persons wishing to attend are asked to 

register by December 9, 2009 via the 

CERHR Web site (http:// 

cerhr.niehs.nih.gov). 

ADDRESSES: Public comments and any 

other correspondence should be 

submitted to Dr. Kristina A. Thayer, 

CERHR Acting Director, NIEHS, P.O. 

Box 12233, Mail Drop K2–04, Research 

Triangle Park, NC 27709 (mail), 919– 

541–5021 (telephone), or 

thayer@niehs.nih.gov (e-mail). Courier 

address: NIEHS, 530 Davis Drive, Room 

K2154, Morrisville, NC 27560. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Kristina A. Thayer (telephone: 919–541– 

5021 or e-mail: thayer@niehs.nih.gov). 

Persons needing interpreting services in 

order to attend should contact (301) 

402–8180 (voice) or (301) 435–1908 

(TTY). Requests should be made at least 

seven business days in advance of the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Background 

Soy formula is fed to infants as a 

supplement or replacement for human 

milk or cow milk. Soy formula contains 

isoflavones such as genistein (CAS RN: 

446–72–0), daidzein (CAS RN: 486–66– 

8), and glycitein (CAS RN: 40957–83–3). 

Genistein, daidzein, glycitein, and the 

daidzein metabolite equol are nonsteroidal, estrogenic compounds that 

occur naturally in some plants and are 

often referred to as ‘‘phytoestrogens.’’ In 

plants, nearly all genistein, daidzein, 

and glycitein is linked to a sugar 

molecule and these isoflavone-sugar 

complexes are called genistin, daidzin, 

or glycitin. 

On March 15–17, 2006, CERHR 

convened an expert panel to conduct 

evaluations of the potential 

developmental and reproductive 

toxicities of soy formula and its 

predominant isoflavone constituent 

genistein. CERHR selected soy formula 

and genistein for expert panel 

evaluation because of (1) the availability 

of numerous reproductive and 

developmental toxicity studies in 

laboratory animals and humans, (2) the 

availability of information on exposures 

in infants and women of reproductive 

age, and (3) public concern for effects on 

infant or child development. The expert 

panel reports were released for public 

comment on May 5, 2006 (71 FR 28368). 

On November 8, 2006 (71 FR 65537), 

CERHR staff released draft NTP Briefs 

on Genistein and Soy Formula that 

provided the NTP’s interpretation of the 

potential for genistein and soy formula 

to cause adverse reproductive and/or 

developmental effects in exposed 

humans. CERHR has not completed 

these evaluations, finalized the briefs, or 

issued NTP–CERHR monographs on 

these substances. Since 2006, a 

substantial number of new publications 

related to human exposure or 

reproductive and/or developmental 

toxicity have been published for these 

substances. CERHR has determined that 

updated evaluations of genistein and 

soy formula are needed. However, the 

current evaluation will focus on soy 

formula and the potential 

developmental toxicity of its major 

isoflavone components, e.g., genistein, 

daidzein, and glycitein. This evaluation 

will not include an assessment on the 

potential reproductive toxicity of 

genistein following exposures during 

adulthood as was done in the 2006 

evaluation. CERHR is narrowing the 

scope of the evaluation because the 

assessment of reproductive effects of 

genistein following exposure to adults 

was not considered relevant in the 

consideration of soy formula use in 

infants during the initial evaluation in 

2006. 

At the meeting, the expert panel will 

review and revise the draft expert panel 

report and reach conclusions regarding 

whether exposure to soy formula is a 

hazard to human development. The 

draft expert panel report has the 

following chapters: 

1.0 Chemistry, Use, and Human 

Exposure 

2.0 General Toxicological and 

Biological Effects 

3.0 Developmental Toxicity Data 

a. Developmental Toxicity Data for 

Genistein, Daidzein, Equol, and 

Glycitein 

b. Developmental Toxicity Data for 

Soy Formula and Other Soy 


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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 53509 

Products 

4.0 Reproductive Toxicity Data 

5.0 Summary, Conclusions, and 

Critical Data Needs (to be 

developed at the expert panel 

meeting). 

Request for Comments 

CERHR invites written public 

comments on chapters 1–4 of the draft 

expert panel report on soy formula. Any 

comments received will be posted on 

the CERHR Web site prior to the 

meeting and distributed to the expert 

panel and CERHR staff for their 

consideration in revising the draft report 

and/or preparing for the expert panel 

meeting. Persons submitting written 

comments are asked to include their 

name and contact information 

(affiliation, mailing address, telephone 

number, e-mail, and sponsoring 

organization, if any) and send them to 

Dr. Thayer (see ADDRESSES above) for 

receipt by December 2, 2009. Comments 

will be identified on the Web site by the 

submitter’s name, affiliation, and/or 

sponsoring organization. 

Time is set aside on December 16, 

2009 for the presentation of oral public 

comments at the expert panel meeting. 

Seven minutes will be available for each 

speaker (one speaker per organization). 

Online registration is available on the 

CERHR website or persons wishing to 

make oral remarks can contact Dr. 

Thayer. If possible, send a copy of the 

statement, talking points, and/or slide 

presentation to Dr. Thayer by December 

2. This statement will be provided to the 

expert panel to assist them in 

identifying issues for discussion and 

noted in the meeting record. 

Registration for presentation of oral 

comments will also be available at the 

meeting on December 16, 2009, from 

7:30–8:30 a.m. Persons registering at the 

meeting are asked to bring 30 copies of 

their statement, talking points, and/or 

slide presentation for distribution to the 

expert panel and for the record. 

Attendance and Registration 

In order to facilitate planning for this 

meeting, persons wishing to attend are 

asked to register by December 9, 2009, 

via the CERHR Web site (http:// 

cerhr.niehs.nih.gov). 

Preliminary Agenda 

The meeting begins each day at 8:30 

a.m. On December 16 and 17, it is 

anticipated that a lunch break will occur 

from noon–1 p.m. and the meeting will 

adjourn at 5–6 p.m. The meeting is 

expected to adjourn by noon on 

December 18, 2009; however, 

adjournment may occur earlier or later 

depending upon the time needed by the 

expert panel to complete its work. 

Anticipated agenda topics for each day 

are listed below. 

December 16, 2009 

• Opening remarks; 

• Oral public comments (7 minutes 

per speaker; one representative per 

group); 

• Review of chapters 1–4 of the draft 

expert panel report on soy formula; 

• Discussion of Chapter 5.0 

Summary, Conclusions, and Critical 

Data Needs. 

December 17, 2009 

• Discussion of Chapter 5.0 

Summary, Conclusions, and Critical 

Data Needs; 

• Preparation of draft summaries and 

conclusion statements. 

December 18, 2009 

• Presentation, discussion of, and 

agreement on summaries, conclusions, 

and data needs; 

• Closing comments. 

Background Information on the CERHR 

The NTP established CERHR in 1998 

(63 FR 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. CERHR follows 

a formal process for the evaluation of 

selected substances that includes 

opportunities for public input. 

CERHR invites the nomination of 

substances 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. 

Thayer (see ADDRESSES above). CERHR 

selects substances 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. Expert panels conduct 

scientific evaluations of substances 

selected by CERHR in public forums. 

Following these evaluations, CERHR 

prepares the NTP–CERHR monograph 

on the substance evaluated. The 

monograph is transmitted to appropriate 

Federal and State agencies and made 

available to the public. 

Dated: October 8, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–25122 Filed 10–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0143] 

Risk Evaluation and Mitigation 

Strategies for Certain Opioid Drugs; 

Notice of Public Meeting; Reopening of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

October 19, 2010, the comment period 

for the notice of public meeting 

published in the Federal Register of 

April 20, 2009 (74 FR 17967). In that 

notice, FDA announced a public 

meeting that took place on May 27 and 

28, 2009, to solicit input on developing 

Risk Evaluation and Mitigation 

Strategies (REMS) for certain opioid 

drugs. FDA is reopening the comment 

period in light of continued public 

interest in this topic and to provide an 

opportunity for all interested parties to 

provide information and share views on 

the matter. 

DATES: Submit written or electronic 

comments by October 19, 2010. 

ADDRESSES: Submit written comments 

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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Theresa (Terry) Martin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6196, 

Silver Spring, MD 20993–0002, 301– 

796–3448; FAX: 301–847–8752, e-mail: 

OpioidREMS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 20, 

2009 (74 FR 17967), FDA published a 

notice of a public meeting on 

developing REMS for certain opioid 

drugs. The affected opioid drugs include 

long acting and extended release brand 

name and generic products that are 

formulated with the following active 

ingredients: Fentanyl, hydromorphone, 

methadone, morphine, oxycodone, and 

oxymorphone. The REMS would be 

intended to ensure that the benefits of 

these drugs continue to outweigh risks 

associated with: (1) Use of high doses of 

long acting opioid and extended release 


sroberts on DSKD5P82C1PROD with NOTICES