60704 Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices 

for the proper performance of the 

functions of the FTC, including whether 

the information will have practical 

utility; (2) the accuracy of the FTC’s 

estimate of the burden of the proposed 

collection of information; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) ways to minimize the burden of 

collecting information on those who are 

to respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. All 

comments should be filed as prescribed 

in the ADDRESSES section above, and 

must be received on or before December 

15, 2008. 

IV. FTC’s Proposed Study of Consumer 

Perception 

The FTC proposes to collect 

information from up to 7,000 consumers 

in order to gather data on consumer 

perception of environmental marketing 

claims. All information will be collected 

on a voluntary basis. The FTC plans to 

contract with a consumer research firm 

to identify consumers and conduct the 

study via the Internet. Among other 

things, the research firm will be 

expected to study a stratified sample of 

the adult United States population 

broadly representative of consumer 

group characteristics (e.g., geographic 

location, housing characteristics, 

gender, age, education, and race/ 

ethnicity), relative to the most recent 

Census Bureau Current Population 

Survey. 

The FTC expects that selected 

respondents will be asked questions 

about a number of express or implied 

environmental marketing claim 

concepts, such as ‘‘renewable’’ and 

‘‘sustainable.’’ Each concept may be 

featured in a separate module of 

questions. Such questions may explore 

perceptions about the unqualified 

general concept and variations on the 

concept. The results will assist the FTC 

in its review of the Green Guides by 

helping to ensure that the Green Guides 

are consistent with consumer 

perception of environmental marketing 

claims. 

The FTC is considering pre-testing the 

consumer questionnaires on 

approximately 100 respondents to 

ensure that all questions are easily 

understood. The FTC expects that the 

pre-test would take approximately 25 

minutes on average per person, 

approximately 42 hours total (100 

respondents x 25 minutes each). Once 

the pretest is completed, the FTC plans 

to seek information from up to 7,000 

respondents for approximately 25 

minutes each. Thus, answering the 

FTC’s information requests will require 

up to 2,917 hours total (7,000 

respondents x 25 minutes each). 

Accordingly, cumulative total burden 

hours for the survey will be 

approximately 3,000 hours. 

The cost per respondent should be 

negligible. Participation is voluntary 

and will not require start-up, capital, or 

labor expenditures by respondents. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E8–24339 Filed 10–10–08: 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New; 30-day 

notice] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–5683. Send written comments and 

recommendations for the proposed 

information collections within 30 days 

of this notice directly to the OS OMB 

Desk Officer; faxed to OMB at 202–395– 

6974. 

Proposed Project: Evaluating 

Institutions Research Misconduct 

Education Efforts—OMB No. 0990– 

NEW–Office of Research Integrity. 

Abstract: The Office of Research 

Integrity (ORI) is conducting this study 

of Research Misconduct Education in 

medical schools because these 

institutions are responsible for 

dissemination of information and 

guidelines to their faculty, staff, and 

students concerning the U.S. Public 

Health Service (PHS) Policies on 

Research Misconduct (42 CFR Part 93). 

The ORI review of institutional research 

misconduct policies, investigation 

reports, requests for technical assistance 

in handling allegations, and analyses of 

filings of the Annual Report on Possible 

Research Misconduct (PHS 6349) have 

raised questions about the level of 

knowledge of medical school faculty 

conducting research and responding to 

allegations, and the faculty’s perception 

of their institution’s commitment to 

dealing with research misconduct. This 

study is designed to evaluate the 

knowledge of medical school faculty 

members about their institution’s 

policies and procedures and identify 

best practices and approaches used by 

medical institutions to produce the most 

positive perceptions of commitment and 

the best understanding of research 

misconduct. Also, the study will 

identify the areas of responsibility and 

specify the activities that institutions 

perform in the process of educating 

their employees to the meaning of 

scientific misconduct at their 

institutions. 

This will involve a one-time data 

collection effort. These researchers have 

been identified from a list of medical 

school principal investigators (PIs) that 

we obtained from the National Institutes 

of Health (NIH). All received NIH 

research projects awards in 2005 or 

2006. 


jlentini on PROD1PC65 with NOTICES
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