Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Notices 7441 

The number of respondents in Table 

1 of this document are the number of 

sponsors registered to make electronic 

submissions (25). The number of total 

annual responses is based on a review 

of the actual number of such 

submissions made between July 1, 2005, 

and June 30, 2006. (156 x hours per 

response (.08) = 12.5 total hours.) 

Dated: February 8, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–2579 Filed 2–14–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0016] 

Sentinel Network To Promote Medical 

Product Safety; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of registration 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

February 28, 2007, registration for the 

public meeting that will be held on 

March 7 and 8, 2007, regarding FDA’s 

exploration and development of an 

integrated national network to link 

private sector and public sector 

postmarket safety efforts, creating a 

virtual, integrated, electronic ‘‘Sentinel 

Network’’. Such a network would 

integrate existing and planned efforts to 

collect, analyze, and disseminate 

medical product safety information to 

health care practitioners and patients at 

the point-of-care. It would be 

established through multiple, broadbased, public-private partnerships. 

Dates and Times: The public meeting 

will be held on March 7 and 8, 2007, 

from 8 a.m. to 5 p.m. 

Location: The public meeting will be 

held at the University System of 

Maryland Shady Grove Center, 8630 

Gudelsky Dr., Rockville, MD 20850. 

ADDRESSES: Submit written registration 

to Erik Mettler, Office of Policy (HF–11), 

Food and Drug Administration, 5600 

Fishers Lane, rm. 14–101, Rockville, MD 

20852, 301–827–3360, FAX: 301–594–

6777. Submit electronic registration to 

Erik.Mettler@fda.hhs.gov. 

For Registration to Attend and/or 

Participate in the Meeting: Seating at the 

meeting is limited. People interested in 

attending should e-mail or submit 

written registration to Erik Mettler (see 

ADDRESSES) by close of business on 

February 28, 2007. Registration is free 

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

basis. All individuals wishing to speak 

during the open session of the meeting 

must indicate their intent, the question 

to be addressed, and provide an abstract 

of the presentation by February 28, 

2007. 

We have set aside a portion of the 

agenda (http://www.fda.gov/oc/op/ 

sentinel/) for individuals who would 

like to make presentations at the 

meeting. If you wish to make an oral 

presentation during the open session of 

the meeting, you must state your 

intention on your registration 

submission (see ADDRESSES). To speak, 

submit your name, title, business 

affiliation, address, telephone number, 

fax number, and e-mail address. FDA 

will do its best to accommodate requests 

to speak. 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. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. 

If you require special 

accommodations due to a disability, 

please inform Erik Mettler (see 

ADDRESSES) when you register. 

For Information On the Meeting 

Contact: Erik Mettler (see ADDRESSES). 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 18, 2007 (72 

FR 2284), FDA announced a public 

meeting to explore opportunities to link 

private sector and public sector 

postmarket safety efforts to create a 

virtual, integrated, electronic ‘‘Sentinel 

Network’’. Such a network would 

integrate existing and planned efforts to 

collect, analyze, and disseminate 

medical product safety information to 

health care practitioners and patients at 

the point-of-care. It would be 

established through multiple, broadbased, public-private partnerships. We 

are seeking input on a number of 

specific questions, included in the 

original Federal Register notice, 

regarding opportunities for 

collaboration, the efficient use of 

information technology, and the 

collection and analysis of medical 

product safety information. A tentative 

agenda for the 2-day meeting has been 

posted on FDA’s Web site and can be 

viewed at http://www.fda.gov/oc/op/ 

sentinel/. We will post a final agenda by 

March 1, 2007, at the same Web site. 

During the course of the registration 

period, FDA became aware that some 

registrations were not properly 

recorded. Because of this and because of 

the strong interest being expressed in 

this meeting, the agency has decided to 

reopen and extend the registration 

period to February 28, 2007. 

In light of the fact that we have 

experienced some registration 

difficulties, individuals who have 

already registered can contact Erik 

Mettler (see ADDRESSES) if they wish to 

receive confirmation that their 

registration has been recorded. 

Interested parties who have not yet 

registered may, on or before February 

28, 2007, submit to Erik Mettler (see 

ADDRESSES) an electronic or written 

registration. Please include your name, 

title, business affiliation, address, 

telephone number, fax number, and email address. Please also indicate if you 

wish to speak during the open public 

session or if you would like to register 

to make a presentation. 

Dated: February 12, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–710 Filed 2–12–07; 2:59 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0040] 

Draft Guidance for Industry on 

Developing Products for Weight 

Management; 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 ‘‘Developing Products 

for Weight Management.’’ FDA is 

interested in updating the September 

1996 draft guidance entitled ‘‘Guidance 

for the Clinical Evaluation of WeightControl Drugs’’ by incorporating the 

latest scientific and clinical advances in 

the drug development field of obesity, 

including recommendations on the 

development of products for weight 

management in pediatric patients and in 

patients with medication-induced 

weight gain, and recommendations on 

the development of combinations of 

weight-management products. This 

action is expected to provide clear and 

consistent advice to those in industry 

who are interested in developing 

weight-management products. 

DATES: Submit written or electronic 

comments on the draft guidance by 


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