Federal Register / Vol. 74, No. 78 / Friday, April 24, 2009 / Notices 18733 

8Letter from Steven Galson to State Boards of 

Pharmacy, Acetaminophen Hepatotoxicity and 

Nonsteroidal Anti-Inflammatory Drug (NSAID)- 

Related Gastrointestinal and Renal Toxicity 

(January 22, 2004), available on FDA’s Web site at 

http://www.fda.gov/cder/drug/analgesics/ 

letter.htm.) 

9 Internal Analgesic, Antipyretic, and 

Antirheumatic Drug Products for Over-the Counter 

Human Use: Proposed Amendment of the Tentative 

Final Monograph: Required Warnings and Other 

Labeling, 71 FR 77314–52 (December 26, 2006) 

(Docket No.1977N–0094L) (amending 21 CFR 

201.66, 201.322, 201.325, 343.50). 

alcohol during prescription use.8 FDA 

was informed by the National 

Association of Boards of Pharmacy that, 

as of February 2008, no states had 

implemented regulations related to the 

request. 

In December 2006, FDA issued 

proposed regulations for OTC labeling 

for acetaminophen containing products 

to require inclusion of new safety 

information and that the container and 

outer carton identify acetaminophen 

when it is an ingredient.9 The final 

version of the regulation is currently 

under review. 

In 2007, the Director of FDA’s Center 

for Drug Evaluation and Research 

(CDER) convened a multidisciplinary 

working group in CDER to continue to 

evaluate the issues associated with 

acetaminophen-related liver injury and 

consider additional steps FDA could 

take to decrease the number of cases of 

acetaminophen-related liver injury. The 

working group considered detailed 

reviews of the issues from the Office of 

Nonprescription Products, the Office of 

Surveillance and Epidemiology and the 

Division of Anesthesia and Analgesic 

and Rheumatology Drug Products as 

part of its deliberations. The working 

group considered the full range of 

options proposed and made 

recommendations to the Center Director 

regarding which should be considered 

for implementation. Given the complex 

nature of the underlying problem of 

acetaminophen liver toxicity, the Center 

Director and the Working Group agreed 

that the options should be presented for 

public discussion prior to taking further 

action. The report of the Working Group 

will be available by or around May 22, 

2009, at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2009 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons and 

Sponsors (representatives from 

industry) may present data, information, 

or views, orally or in writing, on issues 

pending before the committee. 

All electronic and written 

submissions submitted to the Docket 

(see above section: Addresses) on or 

before June 8, 2009, will be provided to 

the committees. 

Oral presentations from the public 

(excluding Sponsors) will be scheduled 

between approximately 1 p.m. to 2 p.m. 

on both days. Persons desiring to make 

formal oral presentations during this 

time 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 June 1, 

2009. 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 at the open public 

hearing session by June 3, 2009. 

FDA will work with sponsors of 

acetaminophen products who wish to 

make presentations to ensure that 

adequate time, separate from the 1 p.m. 

to 2 p.m. time slots for the general Open 

Public Hearing, is provided. Sponsors 

interested in making formal 

presentations to the committees should 

notify the contact person on or before 

June 1, 2009. Sponsors with common 

interest are urged to coordinate their 

oral presentations. 

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 Elaine 

Ferguson 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.). 

Dated: April 16, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–9380 Filed 4–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Injury Prevention 

and Control, Initial Review Group, 

(NCIPC, IRG) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC announces the 

following meeting of the 

aforementioned review group: 

Times and Dates: 

10 a.m.–10:10 a.m., May 18, 2009 (Open). 

10:10 a.m.–4 p.m., May 18, 2009 (Closed). 

Place: Teleconference, Toll Free: (877) 

468–4185, Participant Passcode: 4475689. 

Status: Portions of the meetings will be 

closed to the public in accordance with 

provisions set forth in Section 552b(c)(4) and 

(6), Title 5, U.S.C., and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Section 

10(d) of Public Law 92–463. 

Purpose: This group is charged with 

providing advice and guidance to the 

Secretary, Department of Health and Human 

Services, and the Director, CDC, concerning 

the scientific and technical merit of grant and 

cooperative agreement applications received 

from academic institutions and other public 

and private profit and nonprofit 

organizations, including State and local 

government agencies, to conduct specific 

research that focuses on prevention and 

control. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications submitted in 

response to Fiscal Year 2009 Requests for 

Applications related to the following 

individual research announcement: TS09001, 

Libbey Montana Amphibole Epidemiology 

Research Program (R01) and TS09002, 

Disease Progression in persons Exposed to 

Asbestos Contaminated Vermiculite Ore in 

Marysville, Ohio (R01). 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Lisa 

T. Garbarino, B.S., NCIPC, Division of Injury 

Response, CDC, 4770 Buford Highway, NE., 

M/S F62, Atlanta, Georgia 30341, Telephone 

(440) 723–1527. The Director, Management 

Analysis and Services Office has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities for both 

CDC and the Agency for Toxic Substances 

and Disease Registry. 

Dated: April 16, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–9470 Filed 4–23–09; 8:45 am] 

BILLING CODE 4163–18–P 

mstockstill on PROD1PC66 with NOTICES