17558 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 

hydrochloride suppository product that 

is not the subject of an approved NDA 

will then be unlawful. 

We note that under enforcement 

policies regarding drugs marketed 

without required applications described 

in the agency’s guidance entitled 

Marketed Unapproved Drugs—

Compliance Policy Guide, it is a high 

priority for the agency to take 

enforcement action against those 

unapproved drug products that lack 

evidence of effectiveness. Firms should 

be aware that we intend to take 

enforcement action without further 

notice against any firm that 

manufactures or ships in interstate 

commerce any unapproved product 

covered by this notice after May 9, 2007. 

Firms that discontinue or have already 

discontinued manufacturing products 

covered by this notice may want to 

notify us that they are no longer 

manufacturing those products. A firm 

that wishes to notify us of product 

discontinuation should send a letter, 

signed by the firm’s chief executive 

officer, fully identifying the 

discontinued product, including its 

National Drug Code (NDC) number. The 

firm should send the letter to the 

Division of New Drugs and Labeling 

Compliance, New Drugs and Labeling 

Team (see ADDRESSES). Firms should 

also update the listing of their products 

under section 510(j) of the act (21 U.S.C. 

360(j)) to reflect discontinuation of 

unapproved or otherwise discontinued 

products. We plan to rely on our 

existing records, the results of a 

subsequent inspection, or other 

available information when we evaluate 

whether to take enforcement action. 

Dated: March 14, 2007. 

Douglas C. Throckmorton, 

Deputy Director, Center for Drug Evaluation 

and Research. 

[FR Doc. E7–6593 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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: Blood Products 

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 April 26, 2007, from 2 p.m. to 

6 p.m. and on April 27, 2007, from 8 

a.m. to 3:30 p.m. 

Location: Hilton Hotel, Washington, 

DC North/Gaithersburg, 620 Perry 

Pkwy., Gaithersburg, MD 20877. 

Contact Person: Donald W. Jehn or 

Pearline K. Muckelvene, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike (HFM–71), 

Rockville, MD 20852, 301–827–0314, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014519516. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On April 26, 2007, the 

committee will hear an update on a 

summary of August 30 and 31, 2006, 

meeting of the Department of Health 

and Human Services Advisory 

Committee on Blood Safety and 

Availability. The committee will then 

discuss issues related to implementation 

of blood donor screening for infection 

with Trypanosoma cruzi and issues 

related to transmissibility of 

Trypanosoma cruzi in donors of human 

cells, tissue, and cellular and tissuebased products. On April 27, 2007, the 

committee will hear updates on 

summary of December 15, 2006, meeting 

of the Transmissible Spongiform 

Encephelopathies Advisory Committee, 

FDA’s risk communication on plasmaderived Factor VIII and Factor XI, and 

summary of September 25 and 26, 2006, 

FDA Workshop on Molecular Methods 

in Immunohematology. The committee 

will then discuss transfusion related 

acute lung injury, and discuss issues 

related to implementation of blood 

donor screening for infection with West 

Nile Virus. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

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 18, 2007. Oral 

presentations from the public will be 

scheduled between approximately 4:30 

p.m. and 5 p.m. on April 26, 2007, and 

between approximately 10:45 a.m. and 

11:15 a.m. on April 27, 2007. 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 10, 

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 11, 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 Donald W. 

Jehn or Pearline K. Muckelvene 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. E7–6594 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

General Hospital and Personal Use 

Devices Panel of the Medical Devices 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


sroberts on PROD1PC70 with NOTICES