Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 17559 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: General Hospital 

and Personal Use Devices Panel of the 

Medical Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 4, 2007, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, and C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: Scott Colburn, Center 

for Devices and Radiological Health 

(HFZ–480), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville MD, 20850, 240–276–3707, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512520. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

and make recommendations on the 

scientific and clinical issues raised by 

the addition of antimicrobial agents to 

personal protective equipment (PPE). 

The PPE to be discussed are surgical 

masks/respirators, medical gloves, and 

surgical/isolation gowns. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 20, 2007. Oral 

presentations from the public will be 

scheduled for approximately 30 minutes 

during the morning deliberations and 

for approximately 30 minutes during the 

afternoon deliberations. Those desiring 

to make formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before April 12, 2007. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 13, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, Committee Management Staff, 

at 301–827–7291 at least 7 days in 

advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 3, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–6645 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0121] 

Use of Medication Guides to Distribute 

Drug Risk Information to Patients; 

Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for Drug 

Evaluation and Research (CDER), is 

announcing a public hearing to obtain 

feedback on FDA’s Medication Guide 

program, which provides for the 

distribution of FDA-approved written 

patient information for certain drug and 

biological products that pose serious 

and significant public health concerns. 

FDA is interested in obtaining public 

comment on ways to improve 

communication to patients who receive 

Medication Guides. The purpose of the 

public hearing is to solicit information 

and views from interested persons on 

specific issues associated with the 

development, distribution, 

comprehensibility, and accessibility of 

Medication Guides, which are required 

to convey risk information to patients. 

Dates and Times: The public hearing 

will be held on June 12 and 13, 2007, 

from 8:30 a.m. to 4:30 p.m. on both 

days. Submit written or electronic 

notices of participation by 4:30 p.m. on 

May 12, 2007. Written and electronic 

comments will be accepted until July 

12, 2007. 

Location: The public hearing will be 

held at the National Transportation and 

Safety Board Boardroom and Conference 

Center, 429 L’Enfant Plaza SW., 

Washington, DC 20594 (Metro: L’Enfant 

Plaza Station on the Green, Yellow, 

Blue, and Orange Lines). 

Addresses: Submit written or 

electronic notices of participation to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852, or on the Internet at http:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/meetings/meetingdocket.cfm. 

Submit written or electronic comments 

to http://www.accessdata.fda.gov/ 

scripts/oc/dockets/commentdocket.cfm 

or to the Division of Dockets 

Management. Transcripts of the hearing 

will be available for review at the 

Division of Dockets Management and on 

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

ohrms/dockets approximately 21 days 

after the hearing. 

For Registration to Attend and/or to 

Participate in the Meeting: Seating at the 

meeting is limited. People interested in 

attending should register at http:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/meetings/meetingdocket.cfm or 

submit a written request for registration 

to the Division of Dockets Management 

(see Addresses) by 4:30 p.m. on May 12, 

2007. Registration is free and will be on 

a first-come, first-served basis. 

If you wish to make an oral 

presentation during the open session of 

the meeting, you must state this 

intention on your notice of participation 

(see Addresses) and provide an abstract 

of your presentation by May 12, 2007. 

In the notice, submit your name, title, 

business affiliation, address, telephone 

and fax numbers, and e-mail address. 

FDA has identified questions and 

subject matter of special interest in 

section II of this document. You should 

also identify the subject matter and 

question number you wish to address in 

your presentation, and the approximate 

time requested for your presentation. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations and to request time for a 

joint presentation. FDA may require 

joint presentations by persons with 

common interests. We will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. You must submit final electronic 

presentations, if any, to Mary Gross (see 

Contacts) by no later than June 6, 2007. 

Contacts: Mary C. Gross, Safety Policy 

and Communication Staff (HFD–001), 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 


sroberts on PROD1PC70 with NOTICES
17560 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 

Rockville, MD 20857, 301–443–5421, email: mary.gross@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is committed to ensuring that 

prescribers, patients, and their families 

have the information needed to support 

the safe and effective use of prescription 

medications. In the Federal Register of 

December 1, 1998 (63 FR 66378), FDA 

published its final rule entitled 

‘‘Prescription Drug Product Labeling; 

Medication Guide Requirements’’

(effective June 1, 1999). The final rule 

included provisions that require the 

distribution of FDA-approved written 

patient information, Medication Guides, 

for certain prescription drug and 

biological products that pose a serious 

and significant public health concern 

(see part 208 (21 CFR part 208)). 

Medication Guides are intended to 

provide information that FDA has 

determined is necessary to patients’ safe 

and effective use of drug products. 

Under § 208.24, manufacturers who ship 

drug products for which Medication 

Guides are required are responsible for 

ensuring that Medication Guides are 

provided in sufficient numbers to allow 

distributors, packers, or authorized 

dispensers to provide the guides to all 

patients who receive the drug product. 

Alternatively, manufacturers may 

provide the means for distributors, 

packers, or authorized dispensers to 

produce and provide Medication Guides 

to patients. 

Section 208.24 also requires each 

authorized dispenser of a prescription 

drug for which a Medication Guide is 

required to provide the guide to the 

patient, or to the patient’s agent, when 

the product is dispensed, unless exempt 

from this requirement under § 208.26. 

The failure to provide a Medication 

Guide when such a product is 

dispensed would cause the product to 

be misbranded in violation of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (see sections 502(a), 201(n), and 

503(b)(2) of the act (21 U.S.C. 352(a), 

321(n), and 353(b)(2)). 

Consumers may receive prescription 

drug information through sources other 

than Medication Guides. For example, 

patient package inserts (PPIs) are FDAapproved patient information required 

to be dispensed with certain drugs such 

as estrogens (21 CFR 310.515) and oral 

contraceptives (21 CFR 310.501) to 

ensure the safe and effective use of these 

products. PPIs are considered part of the 

product labeling. Products with 

Medication Guides do not have PPIs; a 

required Medication Guide would 

replace an existing PPI for a product. 

Consumer medication information 

(CMI) is another source of prescription 

drug information. CMI, which is not 

FDA-approved, is a private sector 

initiative based on Public Law 104–180. 

This law sets specific distribution and 

quality goals and timeframes for the 

private sector distribution of written 

prescription drug information to 

consumers. The law requires that the 

Secretary of the Department of Health 

and Human Services evaluate the 

private sector progress toward meeting 

these goals, including that, by 2006, 95 

percent of people receiving new 

prescriptions would receive useful 

written patient information with their 

prescriptions. For this public hearing, 

FDA is not soliciting comments on PPIs 

or the CMI initiative. Comments should 

be limited to the Medication Guide 

program, including the questions listed 

in section II of this document. 

A list of drug products with 

Medication Guides is available on 

FDA’s Web site at http://www.fda.gov/ 

cder/offices/ods/ 

medication_guides.htm. 

II. Scope of Hearing 

FDA is interested in obtaining public 

comment on ways to improve 

communication to patients consistent 

with the requirement that Medication 

Guides, FDA-approved patient 

information, be distributed for selected 

prescription drugs that pose a serious 

and significant public health concern. 

As stated in § 208.1, patient labeling in 

the form of a Medication Guide is 

required if one or more of the following 

circumstances exist: 

1. The drug product is one for which 

patient labeling could help prevent 

serious adverse effects. 

2. The drug product is one that has 

serious risk(s) (relative to benefits) of 

which patients should be made aware 

because information concerning the 

risk(s) could affect the patients’ decision 

to use, or continue to use, the product. 

3. The drug product is important to 

health and patient adherence to 

directions for use is crucial to the 

effectiveness of the drug. 

The following questions are organized 

according to consumers, pharmacies/ 

mail order pharmacies, manufacturers, 

information vendors/wholesalers, and 

academicians/researchers. Specifically, 

we are seeking input on the following 

issues: 

Consumers 

1. What is the best way for consumers 

to be informed about the serious risks of 

a drug product or other important 

prescribing information? Do Medication 

Guides have a unique or important role 

in educating consumers about these 

risks compared to other written 

medication information distributed at 

the pharmacy? Should the information 

be combined or simplified into fewer or 

one communication vehicle(s)? 

2. How do consumers prefer to receive 

Medication Guide information (e.g., 

paper, e-mail, Internet)? When should 

they receive Medication Guide 

information (e.g., when prescribed, 

when dispensed, when they download 

it from a Web site or e-mail message)? 

3. Are Medication Guides easy to read 

and understand? How can Medication 

Guides be improved? Do they serve as 

useful adjuncts to counseling by 

physicians or pharmacists? 

Pharmacies/Mail Order Pharmacies 

1. Currently, how are you informed 

that a Medication Guide is required to 

be distributed with a specific 

medication? 

2. How do you receive Medication 

Guides from the manufacturers (e.g., in 

what format)? Should the way you 

receive these be changed? If so, how? 

3. What are the challenges in 

complying with the Medication Guide 

regulation, maintaining an adequate 

supply of Medication Guides, and 

distributing Medication Guides to 

consumers? What changes should be 

made to the Medication Guide program 

to address these challenges? 

4. What steps would you need to take 

to facilitate electronic distribution of 

Medication Guides (e.g., e-mailed to 

patients)? 

5. Do you consider the Medication 

Guide to be a valuable tool in 

counseling patients about drugs with 

serious risks? 

6. Do Medication Guides have a 

unique role compared to other 

communication vehicles that patients 

receive at the pharmacy? Should the 

information be combined or simplified 

into fewer communication vehicles? 

7. What process improvements could 

be made to ensure that patients receive 

appropriate drug risk information at the 

pharmacy? 

8. What are the advantages and 

disadvantages of having Medication 

Guides to cover a class of drugs versus 

Medication Guides for each individual 

product in a class? 

Manufacturers 

1. What steps do you take to ensure 

compliance with the Medication Guide 

requirements? What challenges do you 

encounter in complying with the 

requirement to distribute Medication 

Guides with the product to pharmacies 

and others? How do you ensure that 

pharmacies are receiving a sufficient 

supply of Medication Guides? 

2. Have means other than paper, such 

as electronic files, been used to supply 

Medication Guides to pharmacies or 


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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 17561 

third-party vendors? If so, please 

describe your experience. If not, please 

explain why not. 

3. How do you instruct pharmacies 

that Medication Guides must be 

dispensed with certain prescription 

drugs per § 208.24(d)? 

4. Should standardized language and/ 

or a uniform symbol on the container 

label be used for the required 

instruction to dispensers? If so, please 

propose standardized language and 

suggest a uniform symbol that might be 

appropriate. 

5. What can be done by means of 

packaging, such as ‘‘unit-of-use,’’ to 

ensure that a Medication Guide is 

shipped with the drug product so that 

it is distributed with each prescription? 

What are the advantages and 

disadvantages of using unit-of-use 

packaging for any product that requires 

a Medication Guide? 

6. What are the advantages and 

disadvantages of developing Medication 

Guides to cover a class of drugs rather 

than having a separate Medication 

Guide for each product in a class? 

Information Vendors/Wholesalers 

1. What challenges or issues regarding 

distribution of Medication Guides have 

you encountered? What changes should 

be made to the Medication Guide 

program to address these challenges? 

2. What challenges do information 

vendors face when offering electronic 

versions of Medication Guides in the 

FDA-approved format? What ideas do 

you have regarding how Medication 

Guides could be integrated into other 

consumer information? 

Academicians/Researchers 

1. Please describe any research that is 

available regarding how often patients 

receive, read, and/or understand 

Medication Guides. 

2. What research is available about 

Medication Guide comprehensibility 

and understandability for the diverse 

range of health literacy levels or special 

populations (e.g., elderly, adolescents, 

non-English speaking)? Please describe 

your recommendations as to how FDA 

should modify Medication Guides to 

more effectively inform a broader 

audience about drug risk information. 

III. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of the FDA 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). To ensure timely 

handling, any outer envelope should be 

clearly marked with the docket number 

listed in brackets in the heading of this 

document along with the statement 

‘‘FDA Public Hearing: Use of 

Medication Guides to Distribute Drug 

Risk Information to Patients.’’ Groups 

should submit two written copies. 

Requests to make a presentation 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 under the docket number 

listed in brackets in the heading of this 

document. 

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. 

Any handicapped persons requiring 

special accommodations to attend the 

hearing should direct those needs to the 

contact person (see Contacts). 

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 these provisions as specified 

in § 15.30(h). 

IV. Request for 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 

and Times). 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 July 12, 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 to which they refer (see 

section II of this document). Two 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 

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. 

V. Transcripts 

The hearing will be transcribed as 

stipulated in § 15.30(b). The transcript 

of the hearing will be available 30 days 

after the hearing 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 

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: April 2, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6506 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0118] 

Draft Guidance for Industry on the 

Content and Format of the Dosage and 

Administration Section of Labeling for 

Human Prescription Drug and 

Biological Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


sroberts on PROD1PC70 with NOTICES