Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Notices 7567 

4If FDA finds it necessary to take enforcement 

action against a product covered by this notice, the 

agency may take action relating to all of the 

defendent’s other violations of the act at the same 

time. For example, if a firm continues to 

manufacture or market a product covered by this 

notice after the applicable enforement date has 

passed, to preserve limited agency resources, FDA 

may take enforcement action relating to all of the 

firm’s unapproved drugs that require applications at 

the same time (see e.g. United States v. Sage 

Phamaceuticals, 210 F3d 475, 479-480 (5th Cir. 

2000) (permitting the agency to combine all 

violations of the act in one proceeding, rather than 

taking action against multiple violations of the act 

in ‘‘piecemeal fashion’’)). 

manufactured, shipped, or otherwise 

introduced or delivered for introduction 

into interstate commerce by any person 

on or after February 8, 2008, or is not 

currently marketed but is subsequently 

manufactured, shipped, or otherwise 

introduced or delivered for introduction 

into interstate commerce by any person 

on or after February 8, 2008. 

However, for currently marketed and 

listed unapproved colchicine for 

injection products, the agency intends 

to exercise its enforcement discretion 

after February 8, 2008, as identified 

elsewhere in this document. FDA 

intends to initiate enforcement action 

against any currently marketed and 

listed colchicine for injection product 

that is manufactured on or after March 

10, 2008, or that is shipped on or after 

August 6, 20084. Further, FDA intends 

to take enforcement action against any 

person who manufactures or ships such 

products after the dates set forth 

previously. Any person who submits an 

NDA for a colchicine for injection 

product but has not received approval 

must comply with this notice. 

The agency, however, does not intend 

to exercise its enforcement discretion as 

outlined previously if the following 

apply: (1) A manufacturer or distributor 

of an unapproved injectable colchicine 

product covered by this notice is 

violating other provisions of the act, 

including but not limited to, violations 

related to FDA’s current good 

manufacturing practices, adverse drug 

event reporting, misbranding, or other 

violations, or (2) it appears that a firm, 

in response to this notice, increases its 

manufacture or interstate shipment of 

injectable colchicine drug products 

above its usual volume during these 

periods. 

Nothing in this notice, including 

FDA’s intent to exercise its enforcement 

discretion, alters any person’s liability 

or obligations in any other enforcement 

action, or precludes the agency from 

initiating or proceeding with 

enforcement action in connection with 

any other alleged violation of the act, 

whether or not related to an unapproved 

drug product covered by this notice. 

Similarly, a person who is or becomes 

enjoined from marketing unapproved 

drugs may not resume marketing of 

unapproved injectable colchicine 

products based on FDA’s exercise of 

enforcement discretion as set forth in 

this notice. 

Drug manufacturers and distributors 

should be aware that the agency is 

exercising its enforcement discretion as 

described previously only in regard to 

colchicine for injection products that 

are marketed under an NDC number 

listed with the agency before February 

6, 2008. As previously stated, 

unapproved colchicine for injection 

products that are currently marketed 

and not listed with the agency on the 

date of this notice must, as of the 

effective date of this notice, have 

approved applications prior to their 

shipment in interstate commerce. 

Moreover, any person or firm that 

submits an NDA but has yet to receive 

approval for such products is still 

responsible for full compliance with 

this notice. 

C. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

NDC number(s), and stating that the 

product(s) has (have) been discontinued 

and will not be marketed again without 

FDA approval. The letter should be sent 

to Jennifer Devine, (see ADDRESSES). 

Firms should also update the listing of 

their products under section 510(j) of 

the act to reflect discontinuation of 

unapproved colchicine for injection 

products. FDA plans to rely on its 

existing records, the results of a 

subsequent inspection, or other 

available information when it initiates 

enforcement action. 

This notice is issued under the act 

(sections 502 (21 U.S.C. 352)) and 505 

and under authority delegated to the 

Deputy Commissioner for Policy under 

section 1410.10 of the FDA Staff Manual 

Guide. 

Dated: January 29, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 08–564 Filed 2–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Risk Communication 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: Risk 

Communication Advisory Committee 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

effective risk communication. 

Date and Time: The meeting will be 

held on February 28, 2008, from 8 a.m. 

to 5 p.m. and February 29, 2008, from 

8 a.m. to 4 p.m. 

Location: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD 20877, Salons A, B, C, 

and D. 

Contact Person: Lee L. Zwanziger, 

Office of the Commissioner, Office of 

Planning (HFP–60), Food and Drug 

Administration, 5600 Fishers Lane, 

rm.15–22, Rockville, MD, 20857, 301–

827–2895, Fax: 301–827–5340, Food 

and Drug Administration, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732112560. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that affect a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On February 28, 2008, the 

committee will meet for the first time, 

for presentations and discussion of the 

relation of FDA’s risk communication 

programs and FDA’s responsibilities. On 

February 29, 2008, the meeting will 

continue with presentations and 

discussion of FDA’s proposed template 

for press releases announcing product 

recalls with a view to incorporating best 

practices of risk communication. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 


pwalker on PROD1PC71 with NOTICES
7568 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Notices 

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 2008 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 February 20, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on February 28th and 

11:15 to 12:15 on February 29th. 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 February 

11, 2008. 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 February 12, 2008. 

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 Lee L. 

Zwanziger at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 3, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 08–588 Filed 2–5–08; 3:58 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Office of Inspector General 

Statement of Organization, Functions, 

and Delegations of Authority 

This notice amends Part A (Office of 

the Secretary), chapter AF of the 

Statement of Organization, Functions, 

and Delegations of Authority for the 

Department of Health and Human 

Services (HHS) to reflect title changes 

and responsibilities within the Office of 

Inspector General’s (OIG) Office of 

Investigations (OI). The statement of 

organization, functions, and delegations 

of authority conforms to and carries out 

the statutory requirements for operating 

OIG. These organizational changes are 

primarily to balance investigative 

operations and investigative support 

functions within OI, more clearly 

delineate responsibilities for the 

activities within this office, and 

facilitate the most efficient and effective 

health care fraud investigations. Chapter 

AF was last amended on December 21, 

2006 (71 FR 76676). 

As amended, sections AFJ.00, AFJ.10, 

and AFJ.20 of Chapter AF now read as 

follows: 

* * * * * 

Section AFJ.00, Office of 

Investigations—Mission 

The Office of Investigations (OI) is 

responsible for conducting and 

coordinating investigative activities 

related to fraud, waste, abuse, and 

mismanagement in HHS programs and 

operations, including wrongdoing by 

applicants, grantees, and contractors, or 

by HHS employees in the performance 

of their official duties. The office serves 

as OIG liaison to Department of Justice 

on all matters relating to investigations 

of HHS programs and personnel, and 

reports to the Attorney General when 

OIG has reasonable grounds to believe 

Federal criminal law has been violated. 

The office serves as a liaison to CMS, 

State licensing boards, and other outside 

organizations and entities with regard to 

exclusion, compliance, and enforcement 

activities. OI works with other 

investigative agencies and organizations 

on special projects and assignments. In 

support of its mission, the office carries 

out and maintains an internal quality 

assurance system. The system includes 

quality assessment studies and quality 

control reviews of OI processes and 

products to ensure that policies and 

procedures are followed effectively, and 

are functioning as intended. 

Section AFJ.10, Office of 

Investigations—Organization 

This office is comprised of the 

following components: 

A. Immediate Office 

B. Investigations Division 1 

C. Investigations Division 2 

Section AFJ.20, Office of 

Investigations—Functions 

A. Immediate Office of the Deputy 

Inspector General for Investigations 

This office is directed by the Deputy 

Inspector General for Investigations 

(DIGI), who is responsible for the 

functions designated in the law for the 

position Assistant Inspector General for 

Investigations. The DIGI supervises the 

Assistant Inspector General for 

Investigations Division 1, the Assistant 

Inspector General for Investigations 

Division 2, and the Special Advisor who 

heads the offices described below. 

The DIGI is responsible to the 

Inspector General for carrying out the 

investigative mission of OIG and for 

providing and leading general 

supervision to the OIG investigative 

component. The Immediate Office 

provides broad guidance and instruction 

to staff and serves as the focal point for 

interaction within OIG. The Immediate 

Office handles all investigative and 

management advisory services for the 

DIGI, ensuring that the DIGI is briefed 

on all complex, sensitive, and precedent 

setting program and administrative 

issues that may significantly impact on 

OI management and the investigative 

program nationwide. The Special 

Advisor to the DIGI will supervise the 

Special Investigations Unit (SIU) 

Director and a group of inspectors. The 

SIU will conduct investigations 

concerning alleged electronic and 

computer-related violations, as well as 

conduct sensitive and complex 

investigations concerning alleged 

misconduct by OIG and some 

Department employees. Separately, the 

inspectors who report directly to the 

Special Advisor will conduct the most 

sensitive investigations involving senior 

officials, political appointees, national 

security issues, and subjects of high 

media interest. Additionally, those 

inspectors will coordinate special 

projects as assigned by the Special 

Advisor and investigations involving 

Congress and top echelon Executive 

Branch Officials. 


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