Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Notices 53507 

1See ‘‘Requirements on Content and Format of 

Labeling for Human Prescription Drug and 

Biological Products’’ (71 FR 3922, January 24, 2006; 

21 CFR parts 201, 314, 601). 2See § 201.57(a)(6). 

Committee will be required to disclose 

information regarding financial 

holdings, consultancies, and research 

grants and/or contracts. 

Dated: October 6, 2009. 

Bruce Gellin, 

Director, National Vaccine Program Office, 

Executive Secretary, National Vaccine 

Advisory Committee. 

[FR Doc. E9–25079 Filed 10–16–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0302] (formerly 

Docket No. 2007D–0185) 

Guidance for Industry and Review Staff 

on Labeling for Human Prescription 

Drug and Biological Products— 

Determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

and review staff entitled ‘‘Labeling for 

Human Prescription Drug and Biological 

Products—Determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information.’’ 

This guidance is intended to provide 

applicants and review staff with a 

definition of established pharmacologic 

class and to help them identify the most 

appropriate word (term) or phrase that 

describes the established pharmacologic 

class for a drug or biological product for 

inclusion in the Indications and Usage 

section of Highlights of Prescribing 

Information (Highlights) of approved 

labeling. This guidance finalizes the 

draft guidance published in the Federal 

Register on May 16, 2007. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Laurie B. Burke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6462, 

Silver Spring, MD 20993–0002, 

301–796–0136; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration,1401 

Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and review staff 

entitled ‘‘Labeling for Human 

Prescription Drug and Biological 

Products—determining Established 

Pharmacologic Class for Use in the 

Highlights of Prescribing Information.’’ 

This guidance is intended to provide 

applicants and review staff with a 

definition of established pharmacologic 

class and to help them identify the most 

appropriate word (term) or phrase that 

describes the established pharmacologic 

class for a drug or biological product for 

inclusion in the Indications and Usage 

section of Highlights of approved 

labeling, as required under 21 CFR 

201.57(a)(6). 

In January 2006, FDA published a 

final rule that amended the 

requirements for the content and format 

of labeling for human prescription drug 

and biological products.1

The new labeling format is intended 

to make it easier for health care 

professionals to access, read, and use 

the information in prescription drug 

labeling, thereby facilitating 

professionals’ use of labeling to make 

prescribing decisions. 

The rule requires that the following 

statement appear under the Indications 

and Usage section of Highlights if a drug 

is a member of an established 

pharmacologic class:2

‘‘(Drug) is a (name of class) indicated 

for (indication(s)).’’ 

If the drug is not a member of an 

established pharmacologic class, the 

name of class component of this 

statement should be omitted. 

Knowing the established 

pharmacologic class can provide health 

care professionals with important 

information about what to expect from 

a drug and how it relates to other 

therapeutic options. Such information 

can also help reduce the risk of 

duplicative therapy and drug 

interactions. This guidance provides 

recommendations for identifying the 

established pharmacologic class and its 

appropriate term for inclusion in the 

Indications and Usage section of 

Highlights. 

A draft version of this guidance was 

made available for public comment in 

2007 (72 FR 27576, May 16, 2007). All 

of the public comments we received 

have been considered and the guidance 

has been revised as appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The information collection 

associated with the final rule entitled 

‘‘Requirements on Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products’’ is 

approved by OMB under Control 

Number 0910–0572. The submission of 

prior-approval labeling supplements, as 

described in section VI of the guidance, 

is approved by OMB under Control 

Numbers 0910–0001 and 0910–0338. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. 

Submit a single copy of electronic 


sroberts on DSKD5P82C1PROD with NOTICES
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 


sroberts on DSKD5P82C1PROD with NOTICES