Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices 5687

SUMMARY: The Food and Drug 

Administration (FDA) Center for Drug 

Evaluation and Research (CDER), in 

collaboration with FDA’s Office of 

Regulatory Affairs (ORA), Southwest 

Regional Office (SWRO), is announcing 

a public workshop entitled ‘‘FDA Drug 

Educational Forum.’’ This public 

workshop is intended to provide 

information about FDA’s premarket 

requirements to the drug industry, 

particularly small businesses, startups, 

and entrepreneurs.

Date and Time: The public workshop 

will be held on May 11, 2005, from 8 

a.m. to 5 p.m.

Location: The public workshop will 

be held at the Kansas City Health 

Department Auditorium, 2400 Troost 

Ave., Kansas City, MO 64108–2666. For 

directions to the facility, please call 

816–513–6008, e-mail: 

health@kcmo.org, or visit http://

www.kcmo.org/health.nsf/web/

healthmap?opendocument. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.)

Contact: David Arvelo or Cassandra 

Davis, Food and Drug Administration, 

4040 N. Central Expressway, suite 900, 

Dallas, TX 75204–3128, 214–253–4952 

or 214–253–4951, FAX: 214–253–4970, 

e-mail: oraswrsbr@ora.fda.gov.

Registration: Registration begins on 

April 6, 2005, and ends May 6, 2005. 

Registration is free. Seats are limited, 

please register as soon as possible. 

Space will be filled in order of receipt 

of registration. Those registered will 

receive confirmation. Registration will 

close after available space fills. 

Registration at the site will be based on 

space availability on the day of the 

event starting at 8 a.m.

If you need special accommodations 

due to disability, please contact David 

Arvelo or Cassandra Davis (see 

CONTACT) at least 7 days in advance.

Registration Form Instructions: To 

register, complete the following 

registration form and submit via: 

• E-mail: oraswrsbr@ora.fda.gov,

• FAX: 214–253–4970, or

• Mail to: Food and Drug 

Administration, Southwest Regional 

Office, Small Business Representative, 

4040 N. Central Expressway, suite 900, 

Dallas, TX 75204–3128.

Name: 

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Company Name: 

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Mailing Address: 

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City: llllll State:llll

Zip Code: 

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Phone: ( ) lllllll

Fax: ( ) 

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Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Course 

handouts may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at cost of 10 cents per 

page.

SUPPLEMENTARY INFORMATION: The 

public workshop is being held in 

response to the interest in the topics 

discussed from small drug 

manufacturers, startups, and 

entrepreneurs in the FDA Southwest 

Region area. FDA, CDER, and ORA 

present this public workshop to help 

achieve objectives set forth in section 

406 of the Food and Drug 

Administration Modernization Act of 

1997 (21 U.S.C. 393), which include 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. This is also consistent with the 

purposes of FDA’s Regional Small 

Business Program, which are in part to 

respond to industry inquiries, develop 

educational materials, sponsor 

workshops and conferences to provide 

firms, particularly small businesses, 

with firsthand working knowledge of 

FDA’s requirements and compliance 

policies. This public workshop is also 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121), as outreach 

activities by Government agencies to 

small businesses.

The goal of the public workshop is to 

present information that will enable 

manufacturers and regulated industry to 

better comply with the new drug 

approval process (21 CFR part 314). 

Information presented will be based on 

agency position as articulated through 

regulation, compliance policy guides, 

and information previously made 

available to the public. Topics to be 

discussed at the public workshop 

include the following: (1) Planning for 

successful, efficient, pharmaceutical 

product approval; (2) current challenges 

and concerns for generic abbreviated 

new animal drug applications (ANDAs); 

(3) regulatory aspects and challenges in 

the development of over-the-counter 

(OTC) Drugs; (4) the basics of chemistry, 

manufacturing and control; (5) FDA 483 

issues; (6) mastering regulatory 

compliance; and (7) incentives for small 

businesses.

Dated: January 28, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2098 Filed 2–2–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0036]

Use of Color on Pharmaceutical 

Product Labels, Labeling and 

Packaging; Public Hearing

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public hearing; request 

for comments.

SUMMARY: The Center for Drug 

Evaluation and Research (CDER) of the 

Food and Drug Administration (FDA) is 

announcing a public hearing on the 

current practice of applying color to 

pharmaceutical product packaging and 

labeling to help identify, classify, and 

differentiate those drug products. To 

date, there is little scientific evidence 

that applying color is effective in 

reducing medication errors. 

Furthermore, there is no validated 

scientific method to corroborate the 

benefits of using colors on 

pharmaceuticals in this fashion. FDA 

does not have a policy pertaining to the 

use of colors on drug product packaging. 

The purpose of the hearing is to obtain 

public input on the benefits and 

potential drawbacks of applying color to 

drug packaging and labeling to help 

identify, classify, or differentiate those 

products.

DATES: The public hearing will be held 

on March 7, 2005, from 8 a.m. to 4:30 

p.m. Submit written or electronic 

notices of participation and comments 

for consideration at the hearing by 

February 11, 2005. Written or electronic 

comments will be accepted after the 

hearing until April 7, 2005. The 

administrative record of the hearing will 

remain open until April 7, 2005.

ADDRESSES: The public hearing will be 

held at Lister Hill Auditorium, Building 

38A, on the campus of the National 

Institutes of Health, Bethesda, MD 

(Metro stop: Medical Center Station on 

the Red Line). Submit written or 

electronic notices of participation and 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

5688 Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices 

1Citations regarding the role of color coding and 

medication error reduction may be accessed at 

Report 5 of the Council on Scientific Affairs (A–04) 

Full Text—The Role of Color Coding in Medication 

Error Reduction. The article is accessible at: http:/

/www.ama-assn.org/ama/pub/category/13662.html

(FDA has verified the Web site address but is not 

responsible for subsequent changes to the Web site 

after this document publishes in the Federal 

Register.)

1061, Rockville, MD 20852; e-mail 

FDADockets@oc.fda.gov; or on the 

Internet at http://

frwebgate.access.gpo.gov/cgi-bin. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://frwebgate.access.gpo, 

approximately 30 days after the hearing.

FOR FURTHER INFORMATION CONTACT:

Mary C. Gross, Center for Drug 

Evaluation and Research (HFD–400), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3216, grossm@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The following color techniques are 

used on pharmaceutical products and 

medical devices:

• Color Coding—Color coding is the 

systematic standard application of color 

to aid in the classification and 

identification of drug products. A color 

coding system allows people to 

memorize a color and match it to its 

function.

• Color Differentiation—Color 

differentiation involves the use of color 

to make certain features on the package 

stand out or to help distinguish one 

item from another. The color itself is not 

a standard code that is applied 

systematically to classify and identify 

the product, as with color coding.

• Color Branding—Color branding is a 

newly applied concept introduced by a 

single manufacturer of insulin products. 

Color branding is used to differentiate 

one drug product from another and is 

managed by the individual sponsor. The 

sponsor recommended this tool in an 

effort to minimize error between an 

insulin analogue and another product 

containing a mix of insulin analogues.

• Color Matching—Color matching is 

sometimes applied in an effort to reduce 

the risk of errors. For example, a 

medical device may have a blue plug 

that attaches to a blue receptacle and a 

yellow plug that attaches to a yellow 

receptacle. However, the colors have no 

special meaning beyond matching one 

item with another.

In the Federal Register of May 13, 

1998 (63 FR 26694), FDA published a 

direct final rule entitled ‘‘Removal of 

Regulations Regarding Certification of 

Drugs Composed Wholly or Partly of 

Insulin.’’ Included in the rule was the 

removal of § 429.12 (21 CFR 429.12) that 

contained a distinguishing color scheme 

for insulin products. At that time, the 

agency was favorably impressed with 

the cooperative effort between the 

insulin manufacturers and the 

International Diabetes Foundation (IDF) 

that resulted in a new color coding 

system in which each insulin product 

would be identified with a distinctive 

color. Although some insulin products 

have been approved with the IDF colors, 

the agency has not taken a position on 

whether to fully implement the IDF 

color scheme for insulin products, nor 

has FDA taken a public position on the 

acceptability of adopting any other color 

scheme currently in use.

A number of drug product and device 

manufacturers use color schemes as 

described previously in this document 

in an effort to facilitate the selection and 

dispensing of drugs. For example, 

ophthalmic, anesthetic, dental, and 

insulin drug products, as well as 

medical devices, all use color to 

classify, identify, or differentiate drugs 

among the same class or facilitate the 

correct use of medical devices. 

Individual practitioner groups often 

endorse the use of colors to help 

differentiate among drugs. Many drugs 

are marketed with similar labeling and 

labels which contributes to an already 

complex prescribing and dispensing 

environment. Sight challenged 

ophthalmic patients count on color 

coding to identify their products. 

Patient safety groups, however, argue 

that broad application of color 

techniques is unproven, controversial, 

and could be a contributing factor in 

medication errors.1

II. Scope of the Hearing

FDA is interested in obtaining public 

comment on the following issues:

• How and under what circumstances 

has the use of color on pharmaceutical 

packaging and/or labeling demonstrated 

an improvement in patient care? If there 

is no discernible improvement, please 

describe what you consider to be 

deficiencies in the program. 

• Are there specific classes of drugs 

where use of color has demonstrated 

value? Are there classes where use of 

color is a hindrance to public safety?

• Are there drug products currently 

marketed that do not use color but 

should use color to aid in identification 

of the drug? If so, how should color be 

used?

• How should the effectiveness of 

application of color on drug products be 

scientifically validated?

III. Notice of Hearing Under 21 CFR 

Part 15

The Commissioner of Food and Drugs 

(the Commissioner) is announcing that 

the public hearing will be held in 

accordance with part 15 (21 CFR part 

15). The presiding officer will be the 

Commissioner or his designee. The 

presiding officer will be accompanied 

by a panel of FDA employees with 

relevant expertise.

Persons who wish to participate in the 

part 15 hearing must file a written or 

electronic notice of participation with 

the Division of Dockets Management 

(see ADDRESSES and DATES). To ensure 

timely handling, any outer envelope 

should be clearly marked with the 

docket number listed in brackets in the 

heading of this notice along with the 

statement ‘‘Use of Color on Drug 

Product Packaging Hearing.’’ Groups 

should submit two written copies. The 

notice of participation should contain 

the potential presenter’s name; address; 

telephone number; affiliation, if any; the 

sponsor of the presentation (e.g., the 

organization paying travel expenses or 

fees), if any; a brief summary of the 

presentation; and the approximate 

amount of time requested for the 

presentation. The agency requests that 

interested persons and groups having 

similar interests consolidate their 

comments and present them through a 

single representative. After reviewing 

the notices of participation and 

accompanying information, FDA will 

schedule each appearance and notify 

each participant of the time allotted to 

the presenter and the approximate time 

that presenter’s oral testimony is 

scheduled to begin. If time permits, FDA 

may allow interested persons attending 

the hearing who did not submit a 

written or electronic notice of 

participation in advance to make an oral 

presentation at the conclusion of the 

hearing. The hearing schedule will be 

available at the hearing. After the 

hearing, the schedule will be placed on 

file in the Division of Dockets 

Management (see ADDRESSES) under the 

docket number listed in brackets in the 

heading of this notice.

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 (21 

CFR part 10, subpart C). Under§ 10.205 

Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices 5689

(21 CFR 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. The hearing will be 

transcribed as stipulated in § 15.30(b). 

The transcript will be available on the 

Internet at http://www.fda.gov/ohrms/

dockets, and orders for copies of the 

transcript can be placed at the meeting 

or through the Division of Dockets 

Management (see ADDRESSES).

Any handicapped persons requiring 

special accommodations to attend the 

hearing should direct those needs to the 

contact person (see FOR FURTHER

INFORMATION CONTACT).

To the extent that the conditions for 

the hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

these provisions as specified in 

§ 15.30(h).

IV. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of participation and comments for 

consideration at the hearing (see DATES). 

Submit a single copy of written or 

electronic notices of participation and 

comments, or two paper copies of any 

mailed notices of participation and 

comments, 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. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday.

Dated: January 28, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2094 Filed 1–31–05; 3:37 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Infant 

Mortality; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Infant 

Mortality (ACIM). 

Dates and Times: March 1, 2005, 9 

a.m.–5 p.m. March 2, 2005, 8:30 a.m.–

3 p.m. 

Place: Sheraton National Hotel, 900 

South Orme Street, Arlington, Virginia 

22204, (703) 521–1900. 

Status: The meeting is open to the 

public with attendance limited to space 

availability. 

Purpose: The Committee provides 

advice and recommendations to the 

Secretary of Health and Human Services 

on the following: Department programs 

that are directed at reducing infant 

mortality and improving the health 

status of pregnant women and infants; 

factors affecting the continuum of care 

with respect to maternal and child 

health care, including outcomes 

following childbirth; strategies to 

coordinate the variety of Federal, State, 

local and private programs and efforts 

that are designed to deal with the health 

and social problems impacting on infant 

mortality; and the implementation of 

the Healthy Start program and Healthy 

People 2010 infant mortality objectives. 

Agenda: Topics that will be discussed 

include the following: Improving 

Perinatal Data; Neonatal Intensive Care 

and Ethical Issues; and Provider 

Reimbursement Issues. Substantial time 

will be spent in small group and full 

Committee discussions aimed at 

formulating the ACIM issues agenda. 

Proposed agenda items are subject to 

change as priorities indicate. 

Time will be provided for public 

comments limited to five minutes each; 

comments are to be submitted no later 

than February 15, 2005.

FOR FURTHER INFORMATION CONTACT:

Anyone requiring information regarding 

the Committee should contact Peter C. 

van Dyck, M.D., M.P.H., Executive 

Secretary, ACIM, Health Resources and 

Services Administration (HRSA), Room 

18–05, Parklawn Building, 5600 Fishers 

Lane, Rockville, MD 20857, Telephone: 

(301) 443–2170. 

Individuals who are submitting public 

comments or who have questions 

regarding the meeting should contact 

Ann M. Koontz, C.N.M., Dr. P.H., HRSA, 

Maternal and Child Health Bureau, 

telephone: (301) 443–6327, e-mail: 

akoontz@hrsa.gov.

Dated: January 31, 2005. 

Steven A. Pelovitz, 

Associate Administrator for Administration 

and Financial Management.

[FR Doc. 05–2102 Filed 2–2–05; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS.

ACTION: Notice.

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 

This notice is also available on the 

Internet at http://workplace.samhsa.gov

and http://www.drugfreeworkplace.gov.

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh or Dr. Walter Vogl, 

Division of Workplace Programs, 

SAMHSA/CSAP, Room 2–1035, 1 Choke 

Cherry Road, Rockville, Maryland 

20857; (240) 276–2600 (voice), (240) 

276–2610 (fax).

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were developed 

in accordance with Executive Order 

12564 and section 503 of Pub. L. 100–

71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

Testing for Federal Agencies,’’ sets strict 

standards that laboratories must meet in 

order to conduct drug and specimen 

validity tests on urine specimens for 

Federal agencies. To become certified, 

an applicant laboratory must undergo 

three rounds of performance testing plus 

an on-site inspection. To maintain that