46486 Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices 

have been made to the guidance. The 

guidance announced in this notice 

finalizes the draft guidance dated 

October 2005. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirement of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

§ 601.12(d) and (f)(2) have been 

approved under OMB control number 

0910–0338. 

III. Comments 

Interested persons may, at any time, 

submit written or electronic comments 

to the Division of Dockets Management 

(see ADDRESSES) regarding this 

guidance. Submit a single copy of 

electronic comments 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 the 

brackets in the heading of this 

document. A copy of the 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/cber/guidelines.htm or 

http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: August 1, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–13233 Filed 8–11–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection: Comment 

Request; National Institute of Diabetes 

and Digestive and Kidney Diseases 

Information Clearinghouses Customer 

Satisfaction Survey 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995 to 

provide opportunity for public comment 

on proposed data collection projects, the 

National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

the National Institutes of Health (NIH), 

is giving public notice that the agency 

proposes to request reinstatement of an 

information collection activity for 

which approval has expired. 

Proposed Collection: Title: NIDDK 

Information Clearinghouses Customer 

Satisfaction Survey. Type of Information 

Requested: Reinstatement, with change, 

of a previously approved collection for 

which approval has expired. The OMB 

control number 0925–0480 expired on 

July 31, 2003. Need and Use of 

Information Collection: NIDDK is 

conducting a survey to access the 

efficiency and effectiveness of services 

provided by NIDDK’s three 

clearinghouses: the National Diabetes 

Information Clearinghouse (NDIC); the 

National Digestive Diseases Information 

Clearinghouse (NDDIC); and the 

National Kidney and Urologic Diseases 

Information Clearinghouse (NKUDRIC). 

The survey responds to Executive Order 

12821, ‘‘Setting Customer Service 

Standards,’’ which requires agencies 

and departments to identify and survey 

their ‘‘customers to determine the kind 

and quality of service they want and 

their level of satisfaction with existing 

services.’’ Frequency of Response: On 

occasion. Affected Public: Individuals or 

households; business and for profit 

organizations; not-for-profit agencies, 

Type of Respondents: Physicians, 

healthcare professionals, patients, 

family and friends of patients. 

The annual reporting burden is as 

follows: estimated number of 

respondents: 5,112; estimated number of 

responses per respondent: 1; estimated 

average burden hours per response: 

0.025; and estimated total annual 

burden hours requested: 128. The 

annualized costs to respondents are 

estimated at $6,400. There are no capital 

costs to report. There are no operating 

or maintenance costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of the 

information on those who are to 

respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection reports and 

instrument, contact Kathy Kranzfelder, 

Project Officer, NIDDK Information 

Clearinghouses, NIH, Building 31, Room 

9A06, MSC2560, Behtesda, MD 20892. 

You may also submit comment and data 

by electronic mail (e-mail) at 

KranzfelderK@mail.nih.gov. 

Dated: July 11, 2006. 

Barbara Merchant, 

NIDDK Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 06–6878 Filed 8–11–06; 8:45am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Pre-Testing of NCI 

Communication Messages 

SUMMARY: In compliance with the 

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

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Pretesting 

of NCI Communication Messages. Type 

of Information Collection Request: 

EXTENSION (OMB# 0925–0046, expires 

10/31/06). Need and Use of Information 

Collection: In order to carry out NCI’s 

legislative mandate to educate and 

disseminate information about cancer 

prevention, detection, diagnosis, and 

treatment to a wide variety of audiences 


jlentini on PROD1PC65 with NOTICES