Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 15701 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 5 years of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by June 1, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

October 1, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

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. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: March 12, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–6061 Filed 3–30–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

The 10th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 10th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

Drug, Device, and Biologics industries 

with an opportunity to interact with 

FDA reviewers and compliance officers 

from the Centers and District Offices, as 

well as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the three medical 

product areas. Industry speakers, 

interactive questions and answers, and 

workshop sessions will also be included 

to assure open exchange and dialogue 

on the relevant regulatory issues. 

Date and Time: The conference will 

be held on June 11 and 12, 2007, from 

7:30 a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, 949–608–4413, FAX: 

949–608–4417, or OCRA, Attention to 

Detail (ATD), 5319 University Dr., suite 

641, Irvine, CA 92612, 949–387–9046, 

FAX: 949–387–9047, Web site: 

www.ocra-dg.org. 

Registration and Meeting Information: 

See OCRA Web site, www.ocra-dg.org. 

Contact ATD at 949–387–9046. 

Before May 11, 2007, registrations fees 

are as follows: $575.00 for members, 

$625.00 for non-members and $400.00 

for FDA/Govt/Students. After May 11, 

2007, $625.00 for members, $725.00 for 

non-members, and $400.00 for FDA/ 

Govt/Students. 

OCRA student rate applies to those 

individuals enrolled in a Regulatory or 

Quality related academic program at an 

accredited institution. Proof of 

enrollment required. 

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking and speaker 

expenses. If you need special 

accommodations due to a disability, 

please contact Linda Hartley at least 10 

days in advance. 

Dated: March 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6052 Filed 3–30–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0114] 

Electronic Distribution of Prescribing 

Information for Prescription Drug 

Products; Public Hearing; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing to solicit views and 

information from interested parties 

concerning the concept of electronic 

distribution of FDA-approved 

prescribing information currently 

contained in the package insert (or PIs) 

for human prescription drug and 

biological products. In particular, FDA 

is seeking views and information on the 

feasibility of establishing a modern and 

efficient process for industry to 

electronically distribute prescribing 

information to dispensers. We are 

seeking input on a number of questions 

regarding the current use of package 

inserts and those logistical issues 

associated with electronic distribution 

of such prescribing information. 

DATES: Public Hearing: The public 

hearing will be held on April 27, 2007, 

from 9 a.m. to 5 p.m. However, 

depending on the level of public 

participation, the public hearing may be 

extended later or may end early. If you 

need special accommodations due to a 

disability, please contact Erik Mettler 

(see FOR FURTHER INFORMATION CONTACT) 

by April 20, 2007. 

Registration: Seating at the public 

hearing is limited. Registration is free 

and will be on a first-come, first-serve 

basis. Persons interested in attending 

the public hearing should register by 

close of business on April 20, 2007. 

Notice of Oral Presentation: Persons 

interested in presenting responses to the 

questions should submit a notice of oral 

presentation by close of business on 

April 17, 2007. See section I of this 

document for information on how to 

participate in the public hearing. 

Comments: Submit written or 

electronic comments by June 22, 2007. 

ADDRESSES: Public Hearing: The public 

hearing will be held at 5600 Fishers 

Lane, third Fl., conference rooms D & E, 

Rockville, MD 20857. 

Registration: Submit written 

registration to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic registration to http:// 

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

dockets/meetings/meetingdocket.cfm. 

Notice of Oral Presentation and 

Comments: Submit written notices of 

oral presentation and comments to the 

Division of Dockets Management (see 

previous paragraph). Submit electronic 

notices of oral presentation and 

comments to http:// 

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

dockets/comments/commentdocket.cfm. 

Identify all submissions to the docket 

with the docket number found in 


hsrobinson on PROD1PC76 with NOTICES
15702 Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Erik 

Mettler, Office of Policy (HF–11), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, Erik.Mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. How to Participate in the Public 

Hearing 

The procedures governing the hearing 

are set forth in part 15 (21 CFR part 15) 

of FDA’s regulations. If you wish to 

make an oral presentation during the 

hearing, you must submit a written 

notice of oral presentation with the 

Division of Dockets Management (see 

ADDRESSES) by April 13, 2007. In the 

written notice, submit your name, title, 

business affiliation, address, telephone 

number, fax number, and e-mail 

address. You should also submit a 

written statement for each discussion 

topic in section IV of this document that 

you intend to address, or other pertinent 

information related to the topic in your 

presentation, the names and addresses 

of all individuals that plan to 

participate, and the approximate time 

requested for your presentation. We 

encourage individuals and organizations 

with common interests to consolidate or 

coordinate their presentations to allow 

adequate time for each request for 

presentation. Participants should submit 

to the docket a copy of each 

presentation. 

We will file the hearing schedule 

indicating the order of presentation and 

the time allotted to each person with the 

Division of Dockets Management (see 

ADDRESSES). We will also mail or 

telephone the schedule to each 

participant before the hearing. In 

anticipation of the hearing presentations 

moving ahead of schedule, participants 

are encouraged to arrive early to ensure 

their designated order of presentation. 

Participants who are not present when 

called, risk forfeiting their scheduled 

time. 

II. Background 

The PIs with prescribing information 

accompany prescription drugs to meet 

the requirement that ‘‘labeling on or 

within the package from which the drug 

is to be dispensed bears adequate 

information for its use***.’’ (21 

CFR 201.100(c)(1). FDA approves the 

prescribing information as part of the 

drug’s labeling in the drug application. 

Currently, the PI containing the 

prescribing information for the safe and 

effective use of the product is a paper 

leaflet. PIs are used in numerous ways 

by various healthcare entities, including 

pharmacies that receive and dispense 

the drug, and provide important drug 

information for the safe and effective 

use of the product. Such information 

includes, among other things, 

indications, adverse events, warnings 

and precautions, and dosing 

instructions. Although the information 

in the PI is a valuable resource, it is 

often not readily accessible when a 

healthcare provider who has not 

physically received the drug makes a 

treatment decision or discusses 

treatments with a patient. Additionally, 

the PI may not contain the most current 

information, because the PI 

accompanying the drug’s distribution 

may have been printed and distributed 

prior to more recent labeling changes. 

As the healthcare system advances into 

the 21st century, we are considering 

how dissemination of the prescribing 

information contained in the PI can take 

advantage of technological advances in 

the electronic transmission of 

information. 

III. Purpose and Scope of the Hearing 

The purpose of the public hearing is 

to gain a better understanding of how 

the prescribing information in a PI is 

currently used by healthcare entities 

and what the information needs are as 

we consider new approaches to 

disseminating labeling information. We 

are also interested in getting a better 

understanding of the logistical processes 

that are currently in place or that might 

need to be established in order to 

electronically disseminate the 

prescribing information, including the 

costs of these efforts. 

In particular, we would like to hear 

from manufacturers of drug and 

biological products, pharmacists and 

pharmacies, other healthcare providers, 

wholesalers, consumers, and 

information providers. 

IV. Issues for Discussion 

To help achieve the objectives 

discussed in section III of this 

document, we are specifically interested 

in hearing comments on the following 

questions and any other pertinent 

information related to the electronic 

distribution of the prescribing 

information. 

A. General 

(1) Currently, who uses, and benefits 

from the prescribing information? 

(2) How can electronic distribution 

and access of the prescribing 

information be accomplished? 

(3) Would electronic distribution and 

access of the prescribing information 

improve the public health? 

(4) Would electronic distribution and 

access of prescribing information 

improve prescribing habits? If so, how? 

(5) How might we ensure that changes 

in the distribution and access of the 

prescribing information will not 

negatively affect the current users? 

(6) Would an increase in electronic 

access to prescribing information affect 

prescribers, pharmacists, and patients? 

If so, how? 

B. Logistics 

(1) Generally and without focusing on 

vendor-specific methods, how can 

electronic distribution of prescribing 

information be accomplished? 

(2) What are the costs associated with 

the successful implementation of 

electronic distribution and access to 

prescribing information, including startup and maintenance expenses? Please 

breakdown costs per healthcare sector. 

(3) Is the technology and 

infrastructure currently available to 

accomplish electronic distribution and 

access? If so, what is available? If not, 

what is needed? 

(4) What are other potential barriers to 

accomplishing the electronic 

prescribing information? 

(5) How can we ensure that electronic 

prescribing information is accessible to 

those who need the information? 

(6) How do we meet the needs of 

those who do not have electronic 

capability? 

(7) In case of emergency or when a 

computer system is down, what might 

be the backup? 

(8) How should electronically 

disseminated prescribing information be 

regularly updated and remain current? 

(9) What are the roles for the involved 

parties (manufacturers, third-parties, 

health professionals, FDA, and 

consumers)? 

(10) Should all products have 

electronic prescribing information or are 

there some products or classes of 

products that should continue to have a 

paper prescribing information 

accompany the product? 

(11) If electronic prescribing 

information were to be used instead of 

paper inserts, then how should 

electronic prescribing information be 

implemented? Should electronic 

prescribing information be phased in? If 

so, over what time period? Which 

products should use electronic 

prescribing information first? 

V. Notice of Hearing Under Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15. 

The hearing will be conducted by a 

presiding officer, who will be 


hsrobinson on PROD1PC76 with NOTICES
Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 15703 

accompanied by FDA senior 

management from the Office of the 

Commissioner, the Office of Policy and 

Planning, the Office of the Chief 

Counsel, the Center for Drug Evaluation 

and Research, and the Center for 

Biologics Evaluation and Research. 

Persons who wish to participate in the 

part 15 hearing must file a written or 

electronic notice of oral presentation 

with the Division of Dockets 

Management (see ADDRESSES and 

DATES). To ensure timely handling of 

written submissions, any outer envelope 

should be clearly marked with the 

docket number found in brackets in the 

heading of this document, along with 

the statement ‘‘Electronic Distribution of 

Package Inserts for Prescription Drug 

Products.’’ Requests to make an oral 

presentation should contain the 

potential presenter’s name and title; 

address; telephone and fax number; email address; affiliation, if any; the 

sponsor of the presentation (e.g., the 

organization paying travel expenses or 

fees), if any; and a brief summary of the 

presentation (including the discussion 

topic(s) that will be addressed). 

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. 

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 those provisions as specified 

in § 15.30(h). 

VI. Requests for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of oral presentation and comments for 

consideration. 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 June 22, 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 identified by topic to which 

they refer (see section IV of this 

document). Two paper 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 at the 

heading of this document. Received 

comments may be seen in Division of 

Dockets Management (see ADDRESSES) 

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

through Friday. 

VII. Transcripts 

The hearing will be transcribed as 

stipulated in § 15.30(b). Transcripts of 

the hearing will be available for review 

at the Division of Dockets Management 

(see ADDRESSES) and on the Internet at 

http://www.fda.gov/ohrms/dockets 

approximately 21 days after the hearing. 

You may place orders for copies of the 

transcript 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: March 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1604 Filed 3–28–07; 1:02 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Health Information National 

Trends Survey 2007 (HINTS 2007) 

Summary: In compliance with the 

requirement of Section 3507(a)(1)(D) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) 

request a review and approval of the 

information listed below. The proposed 

information collection was previously 

published in the Federal Register on 

October 26, 2006 on page 62597 and 

allowed 60 days for public comment. 

One public comment was received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised or implemented 

on or after October 1, 1995 unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: Health 

Information National Trends Survey 

2007 (HINTS 2007). Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: Building on 

the first two rounds of HINTS data 

collection (HINTS 2003: OMB #0925–

0507, Exp. Date: 8/31/03; and HINTS 

2005: OMB # 0925–0538, Exp. Date 11/ 

30/2007), HINTS 2007 will continue to 

provide NCI with a comprehensive 

assessment of the American public’s 

current access to, and use of, 

information about cancer, including 

cancer prevention, early detection, 

diagnosis, treatment, and prognosis. The 

content of the survey will focus on 

understanding the degree to which 

members of the general population 

understand vital cancer prevention 

messages. More importantly, this NCI 

survey will couple knowledge-related 

questions with inquiries into the 

communication channels through which 

understanding is being obtained. HINTS 

is intended to be the foundation of NCI’s 

effort to build on the opportunities 

presented by a national shift in 

communication context (for example, 

the increase in information available on 

the Internet and the use of email as a 

method of communication), and by so 

doing, improve the nation’s ability to 

reduce the national cancer burden. Data 

will be used (1) to understand 

individuals sources of and access to 

cancer-related information; (2) to 

measure progress in improving cancer 

knowledge and communication to the 

general public; (3) to develop 

appropriate messages for the public 

about cancer prevention, detection, 

diagnosis, treatment, and survivorship; 

and (4) to identify research gaps and 

guide decisions about NCI’s research 

efforts in health promotion and health 

communication. Frequency of Response: 

One time. Affected Public: Individuals. 

Type of Respondents: U.S. Adults. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

11,670; Estimated Number of Responses 

per Respondent: 1.36; Average Burden 

Hours per Response: .24; and Estimated 

Total Annual Burden Hours Requested: 

3,739. The annualized cost to 

respondents is estimated at: $59,824. 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 


hsrobinson on PROD1PC76 with NOTICES