Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Notices 53695 

requests for proposals, bid solicitations, 

and other documents describing projects 

or programs funded in whole or in part 

with Federal money, the issuance shall 

clearly state the percentage and dollar 

amount of the total costs of the program 

or project to be financed with Federal 

money and the percentage and dollar 

amount of the total costs of the project 

or program to be financed by nongovernmental sources. 

3. Reporting Requirements 

The applicant must provide HHS with 

an original, plus two hard copies, as 

well as an electronic copy of the 

following reports in English: 

1. A quarterly progress report, due no 

less than 30 days after the end of each 

quarter of the budget period. The 

quarterly progress report must contain 

the following elements: 

a. Activities and Objectives for the 

Current Budget Period; 

b. Financial Progress for the Current 

Budget Period; 

c. Proposed Activity Objectives for the 

New Budget Period; 

d. Budget; 

e. Measures of Effectiveness; and 

f. Additional Requested Information. 

2. A progress report, due 90 days after 

the end of the budget period, which 

must contain a detailed summary of the 

elements required in the quarterly 

progress report; 

3. A final performance report, due no 

more than 90 days after the end of the 

project period; and 

4. A Financial Status Report (FSR) 

SF–269 is due 90 days after the close of 

the 12-month budget period. 

Recipients must mail the reports to 

the Grants Management Specialist listed 

in the ‘‘Agency Contacts’’ section of this 

announcement. 

VII. Agency Contacts 

For program technical assistance, 

contact: Craig Carlson, MPH, Office of 

Public Health Emergency Preparedness, 

Department of Health and Human 

Services, Telephone: 202–205–5228, Email: craig.carlson@hhs.gov. 

For financial, grants management, or 

budget assistance, contact: DeWayne 

Wynn, Grants Management Specialist, 

Office of Grants Management, Office of 

Public Health and Science, Department 

of Health and Human Services, 1101 

Wootten Parkway, Suite 550, Rockville, 

MD 20857, Telephone: (240) 453–8822, 

E-Mail Address: 

DeWayne.Wynn.os@hhs.gov. 

Dated: September 6, 2006. 

W. Craig Vanderwagen, 

Assistant Secretary for Public Health 

Emergency Preparedness, Department of 

Health and Human Services. 

[FR Doc. E6–15018 Filed 9–11–06; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) allow the proposed 

information collection project: 

‘‘Eisenberg Center Voluntary Customer 

Survey Generic Clearance for the 

Agency for Healthcare Research and 

Quality.’’ In accordance with the 

Paperwork Reduction Act of 1995, 

Public Law 104–13 (44 U.S.C. 

3506(c)(2)(A)), AHRQ invites the public 

to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 

Register on July 5, 2006 and allowed 60 

days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

DATES: Comments on this notice must be 

received by October 12, 2006. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, 540 

Gaither Road, Room #5036, Rockville, 

MD 20850. Copies of the proposed 

collection plans, data collection 

instruments, and specific details on the 

estimated burden can be obtained from 

AHRQ’s Reports Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ, Reports 

Clearance Officer, (301) 427–1477. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Eisenberg Center Voluntary 

Customer Survey Generic Clearance for 

the Agency for Healthcare Research and 

Quality’’. 

AHRQ’s newly-established Eisenberg 

Center is an innovative effort aimed at 

improving communication of findings to 

a variety of audiences (‘‘customers’’), 

including consumers, clinicians, payers, 

and health care policy makers. The 

Eisenberg Center, one of three 

components of AHRQ’s Effective Health 

Care Program announced in September 

2005, is directed through a contract by 

the Oregon Health and Science 

University, Department of Medicine, 

located in Portland, Oregon. The 

Eisenberg Center intends to employ the 

latest survey research techniques to (1) 

determine how well its products and 

services are meeting customers’ current 

and anticipated needs; (2) identify 

problem areas with existing products 

and services and determine what 

improvements should be made to 

improve these products and services; 

and (3) identify and develop new 

products and services. 

To address customer requirements 

and to evaluate current and future 

AHRQ products and services, the 

Eisenberg Center must periodically 

determine how well the Eisenberg 

Center products and services are 

meeting customers’ current and 

anticipated needs. Work conducted 

under this clearance will improve the 

products and services the Center 

develops for AHRQ for a three year 

period. The health care environment 

changes rapidly and requires a quick 

response from AHRQ to provide 

appropriately refined products and 

services. A generic clearance for this 

work will facilitate AHRQ’s timely 

response to customers’ needs. 

Methods of Collection 

Participation in survey testing will be 

fully voluntary and non-participation 

will have no affect on eligibility for, or 

receipt of, future AHRQ health services 

research support, on future 

opportunities to participate in research 

or to obtain informative research results. 

Specific estimation procedures, when 

used, will be described when we notify 

OMB as to actual studies conducted 

under the clearance. 

Estimated Annual Respondent Burden 

Type of survey Number of respondents 

Average hours 

per response Total hours 

Focus groups for needs assessment ...................................................................................... 30 1 30 

Individual interviews for needs assessment ............................................................................ 50 .75 37.5 


sroberts on PROD1PC70 with NOTICES
53696 Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Notices 

Type of survey Number of respondents 

Average hours 

per response Total hours 

Formative focus groups for information tools .......................................................................... 120 1 120

Cognitive testing of information tools ...................................................................................... 500 1 500 

Clinician interviews for information tools ................................................................................. 160 .75 120 

Decision aid laboratory testing ................................................................................................ 100 1 100 

Formative focus groups for decision aids ............................................................................... 60 1 60 

Automated/web-based surveys for product evaluation ........................................................... 600 .163 98 

Telephone interviews for product evaluation ........................................................................... 100 1 100

Focus groups for product evaluation ....................................................................................... 20 1 20 

Totals ................................................................................................................................ 1,740 NA 1,186 

Estimated Costs to the Federal 

Government 

The maximum cost to the Federal 

Government is $750,000 annually for FY 

2007, FY 2008, and FY 2009. Most of 

the work will be carried out through 

contracts. The costs were estimated at 

$200 for each face-to-face interview, 

$100 for each telephone interview, 

$5,000 for each focus group, $10,000 for 

Web-based surveys, and $20,000 for 

each laboratory testing module. Any 

deviation from these limits will be 

noted in reports made to OMB with 

respect to a particular study or studies 

conducted under the clearance. 

Request for Comments 

In accordance with the above-cited 

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 health care information 

dissemination functions of AHRQ, 

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 request for OMB 

approval of the proposed information 

collection. All comments will become a 

matter of public record. 

Dated: August 31, 2006. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 06–7585 Filed 9–11–06; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0344] 

Draft Guidance for Industry on Drug 

Interaction Studies—Study Design, 

Data Analysis, and Implications for 

Dosing and Labeling; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Drug Interaction 

Studies—Study Design, Data Analysis, 

and Implications for Dosing and 

Labeling.’’ This document is intended to 

provide recommendations to sponsors 

of new drug applications (NDAs), and 

biologic license applications (BLAs) for 

therapeutic biologics (drugs) on carrying 

out in vitro or in vivo drug-drug 

interaction studies. The draft guidance 

reflects the current view that the 

metabolism and transport of a new drug 

should be defined during drug 

development and that its interactions 

with other drugs should be explored as 

part of an adequate assessment of the 

safety and effectiveness of the drug. 

DATES: Submit written or electronic 

comments on the draft guidance by 

November 13, 2006. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857; or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the draft 

guidance 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.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Shiew-Mei Huang, Center for Drug 

Evaluation and Research (HFD–

850), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4550, 

Silver Spring, MD 20993–0002, 

301–796–1541, or 

Toni Stifano, Center for Biologics 

Evaluation and Research (HFM–

600), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–6190. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Drug Interaction Studies—Study 

Design, Data Analysis, and Implications 

for Dosing and Labeling.’’ FDA 

previously published two guidance 

documents on the use of in vitro and in 

vivo approaches to study metabolism 

and metabolic drug-drug interactions 

entitled ‘‘Drug Metabolism/Drug 

Interaction Studies in the Drug 

Development Process: Studies in Vitro’’

and ‘‘In Vivo Drug Metabolism/Drug 

Interaction Studies—Study Design, Data 

Analysis, and Recommendations for 

Dosing and Labeling.’’ The draft 

guidance, when finalized, will replace 

these guidance documents. This draft 

guidance discusses study design, choice 

of interacting drugs, data analysis, and 

provides recommendations for dosing 

and labeling. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 


sroberts on PROD1PC70 with NOTICES