50036 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

determine appropriate dosing of cough 

and cold ingredients in the pediatric 

population? How should these studies 

be designed and powered? 

2. Should cough and cold products for 

the pediatric population continue to be 

available OTC, or should they be made 

available only by prescription? 

3. If the pediatric indications and 

dosing for cough and cold products 

were no longer available OTC, would 

the public use the adult formulations of 

the OTC monograph products for 

children, and thus create a greater risk 

of misuse or overdose? 

4. Do the answers to the previous 

questions depend on the age of the 

pediatric patients? If so, how should age 

be considered in making regulatory 

decisions for these products? 

5. At the time the monograph was 

established, FDA routinely extrapolated 

safety and efficacy data from adults to 

children age 12 and over. Current PREA 

standards permit extrapolation of 

pediatric efficacy -- but not safety-- 

based upon sufficient adult data. Does it 

remain appropriate to recommend in the 

cough and cold monograph that 

children 12 and over should receive the 

same dose of medication as adults, 

without requiring any additional studies 

in children in this age group? What 

additional safety and/or efficacy studies 

should be required in this age group? 

6. What is the most appropriate 

method for determining pediatric doses 

that could be used as an alternative to 

the quarter- and half-dose assumptions 

used in the monograph? Should 

products be dosed by age, by weight, or 

both? 

7. There are monographs for topical 

and intranasal ingredients to treat the 

common cold. Should these 

monographs be considered in a similar 

fashion to the oral cough and cold 

products? Are the answers to the 

previous questions different for any 

subcategories of cough and cold 

medicines (e.g., topical or intranasal 

products)? 

8. The CCABADP monograph allows 

for the combination of ingredients to 

treat colds and/or coughs. Should 

combination products be permitted for 

all pediatric age groups? Should data be 

provided to support each unique 

combination? 

9. Can measurement errors in dosing 

be reduced using more standardized 

measuring devices or alternative dosage 

forms and, if so, what is the best way 

to effect this change? 

III. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner is announcing that 

the public hearing will be held in 

accordance with part 15 (21 CFR part 

15). The hearing will be conducted by 

a presiding officer, accompanied by 

FDA senior management from the Office 

of the Commissioner and the Center for 

Drug Evaluation and Research. 

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10 (21 CFR part 10), 

subpart C)). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). To the extent that the 

conditions for the hearing, as described 

in this document, conflict with any 

provisions set out in part 15, this 

document acts as a waiver of those 

provisions as specified in 21 CFR 

15.30(h). 

IV. Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

written or electronic comments to the 

Division of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments should be identified 

with the docket number found in 

brackets in the heading of this 

document. To ensure consideration, 

submit comments by (see DATES). 

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 through FDMS only. 

V. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript will also 

be available in either hard copy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of participation and comments for 

consideration. 

Dated: August 20, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19657 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60-Day 

Proposed Information Collection: 

Indian Health Service; HIV Knowledge/ 

Attitudes/Practice Customer Survey 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

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

Reduction Act of 1995 which requires 

60 days for public comment on 

proposed information collection 

projects, the Indian Health Service (IHS) 

is publishing for comment a summary of 

a proposed information collection to be 

submitted to the Office of Management 

and Budget (OMB) for review. 

Proposed Collection: Title: 0917–

NEW, ‘‘Indian Health Service HIV 

Knowledge/Attitudes/Practice Customer 

Survey.’’ Type of Information Collection 

Request: This is a one time survey to 

deliver the mission of the IHS and 

Centers for Disease Control (CDC) 

national guidelines collection, 0917–

NEW, ‘‘Indian Health Service HIV 

Knowledge/Attitudes/Practice Customer 

Survey.’’ Form(s): The Indian Health 

Service Customer Survey. Need and Use 

of Information Collection: 

The IHS goal is to raise the health 

status of the American Indian and 

Alaska Native (AI/AN) people to the 

highest possible level by providing 

comprehensive health care and 

preventive health services. To support 

the IHS mission, the Division of 

Epidemiology and Disease Prevention 

(DEDP) and the Human 

Immunodeficiency Virus (HIV) Program 

collaborate to provide programmatic, 

technical, and financial assistance to 


ebenthall on PRODPC60 with NOTICES
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50037 

IHS Areas and Service Units for 

improving prevention, detection, and 

treatment of infectious and chronic 

disease, specifically in this case, HIV 

and Sexually Transmitted Disease 

(STD). 

The ‘‘HIV Knowledge/Attitudes/ 

Practice Customer Survey’’ (hereto 

referred to as Customer Survey), will 

provide the information needed to 

understand the most effective and 

appropriate methods to complete these 

goals. With the information collected 

from patients, we will be able to offer 

recommendations to Service Units on 

how to best scale up screening for 

sensitive topics such as HIV and STDs 

in AI/AN communities. Also, the 

information will give IHS the tools to 

assist our Service Units with 

implementation of current national 

recommendations by CDC. At the 

moment, we are encouraging uptake of 

current CDC national recommendations; 

however, without this information, we 

are unable to maximize effectiveness, 

dispel myths, and identify 

misinformation. 

Voluntary customer surveys will be 

conducted through self-administered 

questionnaires, face-to-face interviews, 

and potentially electronic media. The 

information gathered will be used by 

DEDP and the HIV Program to identify 

how patients would prefer to be offered 

expanded testing in a way that is 

respectful, confidential, and effective. 

Affected Public: Individuals. Type of 

Respondents: IHS customers. 

The table below provides: Types of 

data collection instruments, Estimated 

number of respondents, Number of 

responses per respondent, Average 

burden hour per response, and Total 

annual burden hour(s). 

ESTIMATED BURDEN HOURS

Data collection instrument 

Estimated 

number of 

respondents 

Responses 

per 

respondent 

Average 

burden hour 

per response 

Total annual 

burden hours 

Customer survey .............................................................................................. 1000 1 10/60 166 

Total .......................................................................................................... 1000 ........................ ........................ 166 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of the public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimates are logical; (e) ways to 

enhance the quality, utility, and clarity 

of the information being collected; and 

(f) ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Send Comments and Requests for 

Further Information: Send your written 

comments, requests for more 

information on the proposed collection, 

or requests to obtain a copy of the data 

collection instrument(s) and 

instructions to: Ms. Janet Ingersoll, 

Acting IHS Reports Clearance Officer, 

801 Thompson Avenue, TMP 450, 

Rockville, MD 20852–1627; call non-toll 

free (301) 443–6177; send via facsimile 

to (301) 443–2316; or send your E-mail 

requests, comments, and return address 

to: janet.ingersoll@ihs.gov. 

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having full effect if 

received within 60 days of the date of 

this publication. 

Dated: August 18, 2008. 

Robert G. McSwain, 

Director, Indian Health Service. 

[FR Doc. E8–19479 Filed 8–22–08; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60-Day 

Proposed Information Collection: 

Indian Health Service; Health 

Promotion/Disease Prevention Grantee 

Survey 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

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

Reduction Act of 1995 which requires 

60 days for public comment on 

proposed information collection 

projects, the Indian Health Service (IHS) 

is publishing for comment a summary of 

a proposed information collection to be 

submitted to the Office of Management 

and Budget (OMB) for review. 

Proposed Collection: Title: 0917–

NEW, ‘‘Indian Health Service Health 

Promotion/Disease Prevention Grantee 

Survey.’’ Type of Information Collection 

Request: This is a one time survey to 

fulfill an OMB request for an 

independent external evaluation 

collection, 0917–NEW, ‘‘Indian Health 

Service Health Promotion/Disease 

Prevention (HP/DP) Grantee Survey.’’

Form(s): The Indian Health Service HP/ 

DP Interview Survey. Need and Use of 

Information Collection: The IHS goal is 

to raise the health status of the 

American Indian and Alaska Native (AI/ 

AN) people to the highest possible level 

by providing comprehensive health care 

and preventive health services. HP/DP 

is one of the three IHS Director’s 

Initiatives to reduce health disparities 

among AI/AN populations through a 

coordinated and systematic approach to 

enhance health promotion and chronic 

disease prevention approaches at the 

local, regional, and national levels. 

The HP/DP competitive grant was 

established in 2005 to encourage Tribal 

and urban Indian programs to fully 

engage their local schools, communities, 

health care providers, health centers, 

faith-based/spiritual communities, 

senior centers, youth programs, local 

governments, academia, non-profit 

organizations, and many other 

community sectors to work together to 

enhance and promote health and 

prevent chronic disease in their 

communities. Thirty-three Tribal/urban 

Indian organizations and programs were 

awarded competitive grants to expand 

and enhance health promotion and 

disease prevention to address health 

disparities among AI/AN populations. 

To conduct a thorough evaluation of 

the grant program, 29 telephone and 

four face-to-face interviews will be 

conducted to collect information to 

complete a quantitative and qualitative 

evaluation of the HP/DP grant program. 

The teleconference interviews may 

include one staff member per site. Each 

of the Tribal/urban organization/ 


ebenthall on PRODPC60 with NOTICES