200 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: December 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–6266 Filed 12–27–07; 3:08 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276–

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Opioid Treatment 

Programs (OTPs) Mortality Reporting 

Form—NEW 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Center for Substance Abuse 

Treatment (CSAT), has developed a 

voluntary reporting form for Opioid 

Treatment Programs (OTPs) to report 

mortality data on patients who at the 

time of death, were enrolled in the 

Programs that were certified to operate 

by SAMHSA. 

Methadone is a Schedule II controlled 

substance approved by the Food and 

Drug Administration for the treatment of 

opioid dependence and pain. Although 

it has proven safe and effective, it must 

be carefully administered and for that 

reason, treatment of opioid dependence 

with methadone is provided only 

through specialized and Federally 

regulated and accredited clinics, the 

OTPs. Buprenorphine, a Schedule III 

controlled ssubstance, is also used in 

the treatment of opioid addiction by 

OTPs and office-based physicians. 

In recent years, methadone has been 

associated with an increasing number of 

deaths around the country. 

Simultaneously, the use of methadone 

for pain has increased significantly over 

the last 5 to 10 years. While the Food 

and Drug Administration (FDA) 

maintains oversight of methadone for 

use in pain, SAMHSA provides 

oversight of methadone for use in opioid 

addiction treatment. Currently, there is 

no national database that tracks 

mortality among patients receiving 

methadone in OTPs and as a result, it 

is not clear whether and to what extent 

the increase in methadone-associated 

deaths may be related to treatment in 

OTPs. MedWatch, a voluntary reporting 

system maintained by FDA, provides 

information relevant to its role in its 

more general oversight of medication 

and device safety. A similar system is 

needed within SAMHSA to gather 

information directly relevant to the 

agency’s mission of overseeing and 

ensuring safe and effective treatment for 

patients with opioid dependence. 

In order to more accurately 

understand potential methadoneassociated deaths at the OTP level, it is 

necessary to examine all patient deaths, 

including those related to 

buprenorphine. Understanding the 

actual cause of death of patients 

enrolled in OTPs can be a challenging 

task for many reasons, including 

inconsistencies in methods of reporting 

causes of deaths across different 

localities and officials; patients’ use of 

other drugs, including illicit, over-thecounter, and prescription products; and 

other aspects of the patient’s physical 

and mental condition. The standardized 

terminology to be used for reporting in 

the proposed system will contribute to 

a more precise and relevant analysis of 

individual cases and higher-level 

trends. The data will be used by 

SAMHSA to increase understanding of 

the factors contributing to these deaths, 

identify preventable causes of deaths, 

and ultimately, take appropriate action 

to minimize risk and help improve the 

quality of care. Importantly, better data 

will enable the agency to more 

proactively manage the oversight of 

treatment. 

The information requested from OTPs 

should be readily available to any OTP 

that has met accreditation standards. 

The OTP should not find any need to 

otherwise analyze or synthesize new 

data in order to complete this form. 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS

Form 

Number of 

facilities 

(OTPs) 

Responses 

per facility 

Burden 

responses 

(hours) 

Annual 

burden 

(hours) 

SAMHSA OTP Mortality Report ....................................................................... 1,150 2 0.5 1,150 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: December 31, 2007. 

Elaine Parry, 

Acting Director, Office of Program Services. 

[FR Doc. 07–6254 Filed 12–31–07; 8:45 am] 

BILLING CODE 4162–20–M 


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