Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices 60705 

ESTIMATED ANNUALIZED BURDEN HOURS

Forms Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Recruit Letters ................................................................................................. 10,754 1 15/60 2,689 

Web Survey ..................................................................................................... 10,754 1 20/60 3,585 

Total .......................................................................................................... ........................ ........................ ........................ 6,274 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E8–24297 Filed 10–10–08; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality (AHRQ), Office for Civil Rights 

(OCR) 

Implementing the Patient Safety and 

Quality Improvement Act of 2005 

Including How to Become a Patient 

Safety Organization: Interim Guidance 

Availability 

October 14, 2008. 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), Office for Civil 

Rights (OCR), HHS. 

ACTION: Notice of Availability. 

SUMMARY: AHRQ and OCR are 

announcing the availability of the 

guidance entitled ‘‘Implementing the 

Patient Safety and Quality Improvement 

Act of 2005 Including How to Become 

a Patient Safety Organization.’’ The 

Interim Guidance document explains 

how the Department of Health and 

Human Services (HHS) will begin 

implementing the Patient Safety and 

Quality Improvement Act of 2005 

(Patient Safety Act), how an entity can 

become a Patient Safety Organization 

(PSO), and how information may be 

protected as Patient Safety Work 

Product (PSWP) in the interim period 

prior to the promulgation of a final 

regulation. To access the Interim 

Guidance, visit AHRQ’s PSO Web site at 

http://www.pso.ahrq.gov. 

DATES: The Interim Guidance is effective 

immediately with the publication of this 

notice. The Interim Guidance will 

remain effective until the effective date 

of the final regulation, which is 

expected to be promulgated before the 

end of 2008. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Interim Guidance document is 

intended to inform private, public and 

nonprofit health care communities, the 

legal community and others of HHS’s 

policies and procedures for 

implementing the Patient Safety Act, 

prior to the promulgation of a final 

regulation. This Interim Guidance 

interprets the Patient Safety Act. The 

Patient Safety Act (Pub. L. 109–41) 

amended the Public Health Service Act 

(42 U.S.C. 299 et seq.) by renumbering 

existing sections and inserting new 

sections 921 through 926 (42 U.S.C. 

299b–21 through 299b–26). The Patient 

Safety Act authorizes the listing by the 

Secretary of statutorily defined PSOs. 

PSOs are to carry out statutorily defined 

patient safety activities on behalf of 

providers in order to assist them to 

improve patient safety. To encourage 

providers to submit information to PSOs 

and PSOs to conduct analyses regarding 

patient safety, the statute establishes 

privilege and confidentiality protections 

to protect certain information, including 

information collected by providers for 

sharing with PSOs for analysis, analyses 

performed by the providers and/or the 

PSOs, and information shared between 

the PSOs and the health care providers 

they serve. This information is defined 

in the statute as PSWP. 

II. Significance of the Interim Guidance 

The Interim Guidance establishes the 

process by which the Secretary will list 

PSOs. Once PSOs are listed by the 

Secretary, providers can: (1) Voluntarily 

submit information to PSOs, and (2) 

seek PSOs’ analysis of patient safety 

events. These activities should lead to 

improvements in patient safety. The 

protections established by the Patient 

Safety Act will permit and encourage 

numerous providers to submit pertinent 

data to PSOs so that the PSOs will be 

able to aggregate and analyze the data 

from multiple providers, thus enabling 

the identification of patterns that could 

suggest underlying or systemic causes of 

patient risks and hazards that then can 

be addressed to improve patient safety 

and quality. 

III. Paperwork Reduction Act of 1995 

The listing of PSOs under the Interim 

Guidance involves collecting of 

information that is subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

These collections of information have 

been approved under OMB control 

number 0935–0143. 

Dated: October 7, 2008. 

Ann C. Agnew, 

Executive Secretary to the Department. 

[FR Doc. E8–24267 Filed 10–8–08; 4:15 pm] 

BILLING CODE 4153–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0448] 

International Drug Scheduling; 

Convention of Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; Gammahydroxybutyric acid; Ketamine; 

Dextromethorphan; Nbenzylpiperazine; 1-(3- 

trifluoromethylphenyl) piperazine; 1-(3- 

chlorophenyl) piperazine; 1-(4- 

Methoxyphenyl) piperazine; 1-(3,4- 

methylenedioxybenzyl) piperazine; 

Gamma-butyrolactone; 1,4-Butanediol; 

Reopening of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

October 20, 2008, the comment period 

for the notice on ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs,’’ 

published in the Federal Register of 

September 5, 2008 (73 FR 51823), 

requesting comments on abuse 

potential, actual abuse, medical 

usefulness, trafficking, and impact of 

scheduling changes on availability for 

medical use of 10 drug substances. FDA 

is taking this action in response to a 

request for a reopening of the comment 

period to allow interested persons 

additional time to review the notice and 

submit comments. 


jlentini on PROD1PC65 with NOTICES
60706 Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices 

DATES: Submit written or electronic 

comments by October 20, 2008. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5146, 

Silver Spring, MD 20993–0002, 301– 

796–3156, e-mail: 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (the Psychotropic 

Convention). Article 2 of the 

Psychotropic Convention provides that 

if a party to the convention or the World 

Health Organization (WHO) has 

information about a substance, which in 

its opinion may require international 

control or changes in such control, it 

should notify the Secretary-General of 

the United Nations (the SecretaryGeneral) and provide the SecretaryGeneral with information in support of 

its opinion. 

The Controlled Substances Act (21 

U.S.C. 811 et seq.) (Title II of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970) provides that 

when WHO notifies the United States 

under Article 2 of the Psychotropic 

Convention that it has information that 

may justify: (1) Adding a drug or other 

substance to one of the schedules of the 

convention, (2) transferring a drug or 

substance from one schedule to another, 

or (3) deleting it from the schedules, the 

Secretary of State must transmit the 

notice to the Secretary of Health and 

Human Services (the Secretary of HHS). 

The Secretary of HHS must then publish 

the notice in the Federal Register and 

provide opportunity for interested 

persons to submit comments that HHS 

will consider in its preparation of the 

scientific and medical evaluations of the 

drug or substance. 

In the Federal Register of September 

5, 2008 (73 FR 51823), FDA published 

a notice requesting comments on the 

abuse potential, actual abuse, medical 

usefulness, trafficking, and impact of 

scheduling changes on availability for 

medical use of 10 drug substances. 

These comments will be considered in 

preparing the United States’ response to 

WHO regarding the abuse liability and 

diversion of these drugs. WHO will use 

this information to consider whether to 

recommend that certain international 

restrictions be placed on these drugs. 

Interested persons were originally 

given until October 6, 2008, to comment 

on the 10 named drug substances. 

II. Request for Comments 

Following publication of the 

September 5, 2008, notice, FDA 

received a request to allow interested 

persons additional time to comment. 

The requester asserted that the time 

period for comments was insufficient to 

respond fully to FDA’s specific request 

for comments and to allow potential 

respondents to thoroughly evaluate and 

address pertinent issues. Therefore, 

FDA has decided to reopen the 

comment period on the notice until 

October 20, 2008, to allow the public 

more time to review and comment on its 

contents. 

III. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the ten drug 

substances. Submit a single copy of 

electronic comments to http:// 

www.regulations.gov or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: October 7, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–24264 Filed 10–10–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Joint Meeting of the Anesthetic and 

Life Support Drugs Advisory 

Committee and the Drug Safety and 

Risk Management 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committees: Anesthetic and 

Life Support Drugs Advisory Committee 

and the Drug Safety and Risk 

Management Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on November 13 and 14, 2008, 

from 8 a.m. to 4:30 p.m. 

Location: Holiday Inn, The Ballrooms, 

Two Montgomery Village Ave., 

Gaithersburg, MD. The hotel phone 

number is 301–948–8900. 

Contact Person: Kalyani Bhatt, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane, (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

Kalyani.Bhatt@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in 

Washington, DC area), codes 

3014512529 or 3014512535. Please call 

the Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact 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 hot line/phone 

line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On November 13 and 14, 

2008, the committees will begin with a 

closed session, from 8 a.m. to 9:15 a.m. 

Following the closed session, from 9:15 

a.m. to 4:30 p.m., the meeting will be 

open to the public. On November 13, 

2008, the committees will discuss new 

drug application (NDA) 22–324, 


jlentini on PROD1PC65 with NOTICES