Federal Register / Vol. 71, No. 205 / Tuesday, October 24, 2006 / Notices 62267 

payers and providers regarding the 

value and challenges of P4Q programs 

in safety net settings. The P4Q 

evaluation is designed to assess whether 

P4Q programs in such settings appear to 

improve quality on the measures that 

are the focus of the programs and also 

whether the programs lead to 

unintended consequences. the P4Q 

evaluation will also seek to identify 

design and implementation practices 

that are likely to increase as well as 

decrease the risks of negative outcomes 

resulting from the implementation of 

P4Q programs in safety net settings. 

Data collection in the P4Q evaluation 

will be approved by the Boston 

University’s Medical Campus 

Institutional Review Board. It will be 

conducted in accordance with the 

Health Insurance Protection and 

Portability Act (HIPAA) Privacy Rule 

and with the Protection of Human 

Subjects regulations, 45 CFR part 46. In 

addition, the identifiable data collected 

in this study about provider 

organizations and individuals will only 

be used for the above-stated purposes 

and will be protected in accordance 

with the AHRQ confidentiality statute, 

section 934(c) of the Public Health 

Service Act (42 U.S.C. 299c–3(c)). 

Methods of Collection 

The evaluation will use several 

methods to examine P4Q programs in 

safety net settings, including a survey 

and key informant interviews. Survey 

data will be obtained from physicians 

participating in P4Q programs using a 

confidential mailed questionnaire. The 

key informant interviews will consist of 

35-minute semi-structured interviews 

with physician organization executives, 

practice leaders, physicians, and other 

senior managers in each study setting 

regarding program design, 

implementation, and impact. The 

research project investigators will 

interview up to six informants at each 

site. 

Estimated Annual Respondent Burden 

The table below indicates that total 

time burden required to obtain all of the 

data required to meet the study’s 

objectives. It does not include time 

required to analyze the data and prepare 

it for reporting and publication. 

Type of respondent Number of 

respondents 

Number of responses per 

respondent 

Estimated time per 

respondent 

(hours) 

Estimated total 

burden 

(hours) 

Estimated annual cost to the 

government 

Physicians ............................. 216 1 0.25 hours (15 minutes) ....... 54 $5,322.12 to cover costs of 

responding to survey. 

Practice executives and other 

senior managers.

24 1 0.58 hours (35 minutes) ....... 14 $841.35 to cover costs of 

participating in in-person 

interviews. 

Total ............................... ........................ ........................ ............................................... 68 $6,163.47 

Estimated Costs to the Federal 

Government 

The total cost to the government for 

this activity is estimated to be $193,941. 

This funding will be used to support 

survey administration costs, salary and 

fringe benefits for the research team 

relating to the design and 

administration of the survey and 

informant interviews, and costs for two 

members of the research team to travel 

to each site for the informant interviews. 

The project will attempt to minimize 

burden to physician survey respondents 

by distributing surveys at medical staff 

meetings. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) 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 upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: October 10, 2006. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 06–8831 Filed 10–23–06; 8:45am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–72, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 71 FR 50065, dated 

August 24, 2006) is amended to reflect 

the establishment of the Statistical 

Support Most Efficient Organization 

within the Division of Surveillance, 

Hazard Evaluation, and Field Studies, 

National Institute for Occupational 

Safety and Health. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete in its entirety the functional 

statement for the Division of 

Surveillance, Hazard Evaluation, and 

Field Studies (CCK) and insert the 

following: (1) Develops and maintains a 

surveillance system of the Nation’s work 

force and its environs to make an early 

detection and continuous assessment of 

the magnitude and extent of job-related 

illness, exposures, and hazardous 

agents; (2) conducts the legislatively 

mandated health hazard evaluation and 

industry-wide epidemiological research 

programs through longitudinal record 

studies and clinical/environmental field 

studies and surveys to identify the 

occupational causes of disease in the 

working population and their offspring, 

and to determine the incidence and 

prevalence of acute and chronic effects 

from work-related exposures to toxic 

and hazardous substances; (3) conducts 

epidemiological research for input to 

criteria for standards for the control of 

occupational health hazards; (4) 


rmajette on PROD1PC67 with NOTICES1
62268 Federal Register / Vol. 71, No. 205 / Tuesday, October 24, 2006 / Notices 

provides statistical support including 

the collection, processing, compilation, 

computation, analysis, editing, and/or 

presentation of statistical data to CDC; 

and provides, upon request and on a 

self-initiated basis, technical assistance, 

demonstrations, and consultation on 

technical matters pertaining to 

occupational safety and health to other 

Federal agencies, state, and local 

agencies, other agencies, other technical 

groups, unions, employers, and 

employees. 

Statistical Support Most Efficient 

Organization (CCKE). (1) Provides 

statistical support including the 

collection, processing, compilation, 

computation, analysis, editing and/or 

presentation of statistical data; (2) 

provides technical statistical support to 

professionals as they analyze and 

prepare reports on statistical studies and 

surveys; (3) provides information, 

reference, and research services; and (4) 

provided administrative services related 

to statistical support. 

Delete item (5) of the functional 

statement of the Community Health and 

Program Services Branch (CUCEG), 

Division of Adult and Community 

Health (CUCE), National Center for 

Chronic Disease Prevention and Health 

Promotion (CUC), Coordinating Center 

for Health Promotion (CU), and insert 

the following: (5) provides professional 

statistical and programming services to 

the division, including assistance in 

design of data collection instruments, 

computer programming, and statistical 

analysis. 

Delete item (1) of the functional 

statement for the Information 

Technology, Statistics, and Surveillance 

Branch (CUCJD), Division of 

Reproductive Health (CUCJ), and insert 

the following: (1) Provides professional 

statistical and computer services to the 

division including statistical 

consultation, systems analysis, technical 

assistance, and resource identification. 

Delete item (6) of the functional 

statement for the Statistics and Data 

Management Branch (CVBCG), Division 

of Sexually Transmitted Disease 

Prevention (CVBC), National Center for 

HIV, STD, and TB Prevention (CVB), 

Coordinating Center for Infectious 

Diseases (CV), and insert the following: 

(6) provides data management and 

professional statistical services for STD 

surveillance and epidemiologic studies. 

Delete item (3) of the functional 

statement for the Statistics and Data 

Management Branch (CVBED), Division 

of HIV/AIDS Prevention-Surveillance 

and Epidemiology (CVBE), and insert 

the following: (3) provides data 

management and statistical services for 

HIV/AIDS surveillance, HIV 

serosurveys, epidemiologic studies and 

other studies conducted within the 

division and DHAP/IRS. 

Dated: October 4, 2006. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC). 

[FR Doc. 06–8839 Filed 10–23–06; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0333] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry: Emergency Use 

Authorization of Medical Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry: Emergency Use 

Authorization of Medical Products’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 18, 2006 (71 FR 

40722), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0595. The 

approval expires on October 31, 2009. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: October 18, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–17718 Filed 10–23–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0021] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Request for Samples and Protocols 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Request for Samples and Protocols’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 29, 2006 (71 FR 

37080), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0206. The 

approval expires on September 30, 

2009. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

Dated: October 18, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–17720 Filed 10–23–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006P–0085] 

Medical Devices; Exemptions From 

Premarket Notification; Class II 

Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 


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