Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Notices 82031 

Data to Support Food and Nutrition 

Product Communications, as Used by 

the Food and Drug Administration—21 

U.S.C. 393(d)(2)(D) (OMB Control 

Number 0910–NEW) 

FDA plans to use the data collected 

under this generic clearance to inform 

its nutrition and foods communications 

campaigns. FDA expects the data to 

guide the formulation of its food and 

nutrition communication objectives. 

FDA also plans to use the data to help 

tailor print, broadcast, and use 

electronic media communications in 

order for them to have powerful and 

desired impacts on target audiences. 

The data will not be used for the 

purposes of making policy or regulatory 

decisions. 

The information collected will serve 

two major purposes. First, as formative 

research, it will provide the critical 

knowledge needed about target 

audiences. FDA must explore 

audiences’ beliefs, perceptions, and 

decisionmaking processes about 

nutrition and food consumption in 

order to formulate the basic objectives of 

its risk communication campaigns. Such 

knowledge will provide the needed 

target audience understanding to design 

effective communication strategies, 

messages, and product labels. These 

communications will aim to improve 

public understanding of the risks and 

benefits of consuming certain foods or 

nutritional products by providing users 

with a better context in which to place 

risk information more completely. 

Second, as initial testing, it will give 

FDA some information about the 

potential effectiveness of messages and 

materials in reaching and successfully 

communicating with their intended 

audiences. Testing messages with a 

sample of the target audience will allow 

FDA to refine messages while still in the 

developmental stage. Respondents may 

be asked to give their reaction to the 

messages in individual or group 

settings. 

FDA’s Center of Food Safety and 

Applied Nutrition, Office of the 

Commissioner, and other Centers or 

Offices will use this mechanism to test 

messages about regulated food and 

nutrition products on a variety of 

subjects related to consumer, patient, or 

health care professional perceptions and 

use of foods and related materials, 

including but not limited to, food 

advertising, food and nutrition labeling, 

emerging risk communications, online 

sales of food products, and consumer 

and professional education. The data 

will not be used for the purposes of 

making policy or regulatory decisions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Annual 

frequency 

per response 

Total 

annual 

responses 

Hours per 

response 

Total 

hours 

Individual indepth interviews ............................................................ 360 1 360 0.75 270 

General public focus group interviews ............................................ 144 1 144 1.5 216 

Intercept interviews: central location ............................................... 600 1 600 0.25 150 

Intercept interviews: telephone ........................................................ 10,000 2 1 10,000 0.08 800 

Self-administered surveys ................................................................ 2,400 1 2,400 0.25 600 

Gatekeeper reviews ......................................................................... 400 1 400 0.50 200 

Omnibus surveys ............................................................................. 2,400 1 2,400 0.17 408 

Total (general public) ................................................................ 16,304 ........................ 16,304 ........................ 2,644 

Total physician focus group interviews .................................... 144 1 144 1.5 216 

Total (overall) ............................................................................ ........................ ........................ ........................ ........................ 2,860 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Brief interviews with callers to test messages, concepts and strategies following their call-in request to an FDA Center 1–800 number. 

Annually, FDA projects about 30 

communication studies using the 

variety of test methods listed in table 1. 

FDA is requesting this burden so as not 

to restrict the Agency’s ability to gather 

information on public sentiment for its 

proposals in its regulatory and 

communications programs. 

Dated: December 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32739 Filed 12–28–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: PulmonaryAllergy Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 8, 2011, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room, 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings.’’ 

Please note that visitors to the White 

Oak Campus must enter through Bldg 1. 

Contact Person: Kristine T. Khuc, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave, Bldg. 31, rm. 2417, Silver Spring, 


srobinson on DSKHWCL6B1PROD with NOTICES
82032 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Notices 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: 

kristine.khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On March 8, 2011, the 

committee will discuss new drug 

application (NDA) 022–383, indacaterol 

maleate (ARCAPTA NEOHALER), by 

Novartis Pharmaceuticals Corp., for the 

long-term once daily maintenance 

bronchodilator treatment of airflow 

obstruction in patients with chronic 

obstructive pulmonary disease, 

including chronic bronchitis and/or 

emphysema. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 22, 2011. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

11, 2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 14, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Kristine T. 

Khuc at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: December 21, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–32735 Filed 12–28–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to OMB for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Ryan White HIV/ 

AIDS Program Allocation and 

Expenditure Forms (OMB No. 0915– 

0318)—[Extension] 

The Ryan White HIV/AIDS Program 

Allocation and Expenditure Reports will 

enable the Health Resources and 

Services Administration’s HIV/AIDS 

Bureau to track spending requirements 

for each program as outlined in the 

legislation. Grantees funded under Parts 

A, B, C, and D of the Ryan White HIV/ 

AIDS Program (codified under Title 

XXVI of the Public Health Service Act) 

would be required to report financial 

data to HRSA at the beginning and end 

of their grant cycle. 

All parts of the Ryan White HIV/AIDS 

Program specify HRSA’s responsibilities 

in the administration of grant funds. 

Accurate allocation and expenditure 

records of the grantees receiving Ryan 

White HIV/AIDS Program funding are 

critical to the implementation of the 

legislation and thus are necessary for 

HRSA to fulfill its responsibilities. 

The forms would require grantees to 

report on how funds are allocated and 

spent on core and non-core services, 

and on various program components, 

such as administration, planning, 

evaluation, and quality management. 

The two forms are identical in the types 

of information that are collected. 

However, the first report would track 

the allocation of the award at the 

beginning of the grant cycle and the 

second report would track actual 

expenditures (including carryover 

dollars) at the end of the grant cycle. 

The primary purposes of these forms 

are to (1) provide information on the 

number of grant dollars spent on various 

services and program components, and 

(2) oversee compliance with the intent 

of Congressional appropriations in a 

timely manner. In addition to meeting 

the goal of accountability to the 

Congress, clients, advocacy groups, and 

the general public, information 

collected on these reports is critical for 

HRSA, state and local grantees, and 

individual providers for the evaluation 

of the effectiveness of these programs. 

The response burden for grantees is 

estimated as: 


srobinson on DSKHWCL6B1PROD with NOTICES