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
17562 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Dosage and 

Administration Section of Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ This 

draft guidance is one of a series of 

guidance documents intended to assist 

applicants in drafting prescription drug 

labeling in which prescribing 

information is clear and accessible and 

complying with the new requirements 

in the final rule on the content and 

format of labeling for prescription drug 

and biological products (71 FR 3922, 

January 24, 2006). This draft guidance is 

intended to help applicants select 

information for inclusion in the ‘‘Dosage 

and Administration’’ section of labeling 

and to help them organize that 

information. 

DATES: Submit written or electronic 

comments on the draft guidance by July 

9, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857; or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835–

4709 or 301–827–1800. Send two selfaddressed adhesive labels to assist the 

office in processing your requests. 

Submit written comments on the draft 

guidance 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.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Joseph P. Griffin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4204, 

Silver Spring, MD 20993–0002, 

301–796–1077; 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 draft guidance for industry entitled 

‘‘Dosage and Administration Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ The draft guidance provides 

recommendations on how to select 

information for inclusion in the ‘‘Dosage 

and Administration’’ section of labeling 

and how to organize information within 

the section. This draft guidance is one 

of a series guidances FDA is developing, 

or has developed, to assist applicants 

and reviewers with the format and 

content of certain sections of the 

labeling for prescription drugs. In the 

Federal Register of January 24, 2006 (71 

FR 3998 and 3999), FDA issued final 

guidances on the format and content of 

the ‘‘Adverse Reactions’’ and ‘‘Clinical 

Studies’’ sections of labeling and draft 

guidances on implementing the new 

labeling requirements for prescription 

drugs and the format and content of the 

‘‘Warnings and Precautions,’’

‘‘Contraindications,’’ and ‘‘Boxed 

Warning’’ sections of labeling. The new 

labeling requirements (71 FR 3922) and 

these guidances are intended to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’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 requirement 

of the applicable statutes and 

regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft guidance. 

Submit a single copy of electronic 

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. 

III. Paperwork Reduction Act of 1995 

This draft 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 collections 

of information in 21 CFR 201.57 have 

been approved under OMB control 

number 0910–0572. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/guidelines.htm. 

Dated: March 30, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6508 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–0106] 

Draft Guidance for Clinical 

Investigators, Sponsors, and 

Investigational Review Boards on 

Adverse Event Reporting—Improving 

Human Subject Protection; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Guidance for Clinical 

Investigators, Sponsors, and IRBs; 

Adverse Event Reporting—Improving 

Human Subject Protection.’’ This 

guidance is intended to assist the 

research community in interpreting 

requirements for submitting reports of 

unanticipated problems, including 

certain adverse events reports, to the 

Institutional Review Board (IRB). FDA 

developed this draft guidance in 

response to concerns raised by the IRB 

community that increasingly large 

volumes of individual adverse event 

reports are inhibiting rather than 

enhancing IRBs’ ability to adequately 

protect human subjects. The guidance 

provides recommendations to IRBs, 

sponsors, and investigators on 

improving the usefulness of the adverse 

event information submitted to IRBs. 

DATES: Submit written or electronic 

comments on the draft guidance by June 

8, 2007. General comments on agency 

guidance documents are welcome at any 

time. 


sroberts on PROD1PC70 with NOTICES