Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 12969 

to revoke, suspend, or modify their 

tolerances, will remain in the channels 

of trade after the applicable tolerance is 

revoked, suspended, or modified. If 

FDA encounters food bearing a residue 

of a pesticide chemical for which the 

tolerance has been revoked, suspended, 

or modified, it intends to address the 

situation in accordance with provisions 

of the guidance. In general, FDA 

anticipates that the party responsible for 

food found to contain pesticide 

chemical residues (within the former 

tolerance) after the tolerance for the 

pesticide chemical has been revoked, 

suspended, or modified will be able to 

demonstrate that such food was 

handled, e.g., packed or processed, 

during the acceptable timeframes cited 

in the guidance by providing 

appropriate documentation to the 

Agency as discussed in the guidance 

document. FDA is not suggesting that 

firms maintain an inflexible set of 

documents where anything less or 

different would likely be considered 

unacceptable. Rather, the Agency is 

leaving it to each firm’s discretion to 

maintain appropriate documentation to 

demonstrate that the food was so 

handled during the acceptable 

timeframes. 

Examples of documentation which 

FDA anticipates will serve this purpose 

consist of documentation associated 

with packing codes, batch records, and 

inventory records. These are types of 

documents that many food processors 

routinely generate as part of their basic 

food-production operations. 

FDA is requesting the extension of 

OMB approval for the information 

collection provisions in the guidance. 

Description of Respondents: The 

likely respondents to this collection of 

information are firms in the produce 

and food-processing industries that 

handle food products that may contain 

residues of pesticide chemicals after the 

tolerances for the pesticide chemicals 

have been revoked, suspended, or 

modified. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity No. of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Documentation Submission ................................................. 1 1 1 3 3 

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

FDA expects the total number of 

pesticide tolerances that are revoked, 

suspended, or modified by EPA 

pursuant to dietary risk considerations 

in the next 3 years to remain at a low 

level, as there have been no changes to 

the safety standard for pesticide 

residues in food since 1996. Thus, FDA 

expects the number of submissions it 

will receive pursuant to the guidance 

document will also remain at a low 

level. However, to avoid counting this 

burden as zero, FDA has estimated the 

burden at one respondent making one 

submission a year for a total of one 

annual submission. 

FDA based its estimate of the hours 

per response on the assumption that the 

information requested in the guidance is 

readily available to the submitter. We 

expect that the submitter will need to 

gather information from appropriate 

persons in the submitter’s company and 

to prepare this information for 

submission to FDA. The submitter will 

almost always merely need to copy 

existing documentation. We believe that 

this effort should take no longer than 3 

hours per submission. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity No. of recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

Documentation Recordkeeping ............................................ 1 1 1 16 16 

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

In determining the estimated annual 

recordkeeping burden, FDA estimated 

that at least 90 percent of firms maintain 

documentation, such as packing codes, 

batch records, and inventory records, as 

part of their basic food production or 

import operations. Therefore, the 

recordkeeping burden was calculated as 

the time required for the 10 percent of 

firms that may not be currently 

maintaining this documentation to 

develop and maintain documentation, 

such as batch records and inventory 

records. In previous information 

collection requests, this recordkeeping 

burden was estimated to be 16 hours per 

record. FDA has retained its prior 

estimate of 16 hours per record for the 

recordkeeping burden. As shown in 

table 1 of this document, FDA estimates 

that one respondent will make one 

submission per year. Although FDA 

estimates that only 1 out of 10 firms will 

not be currently maintaining the 

necessary documentation, to avoid 

counting the recordkeeping burden for 

the 1 submission per year as 1/10 of a 

recordkeeper, FDA estimates that 1 

recordkeeper will take 16 hours to 

develop and maintain documentation 

recommended by the guidance. 

Dated: March 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5286 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0012] 

Campaign To Improve Poor Medication 

Adherence (U18) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the Center for Drug 

Evaluation and Research. A goal of the 

Center for Drug Evaluation and Research 

is to raise consumers’ awareness of the 


Emcdonald on DSK2BSOYB1PROD with NOTICES
12970 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices 

importance of good medication 

adherence, a vital first step toward 

improved adherence behavior and better 

public health outcomes. 

DATES: Important dates are as follows: 

1. The application due date is April 

15, 2011. 

2. The anticipated start date is April 

16, 2011. 

3. The opening date is March 15, 

2011. 

4. The expiration date is April 15, 

2011. 

For Further Information and 

Additional Requirements Contact: 

Programmatic Contact: Tamara Ford, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, Office of Executive 

Programs, 10903 New Hampshire Ave., 

rm. 6114, Silver Spring, MD 20993, 

301–796–5226, FAX: 301–847–8737, email: Tamara.Ford@fda.hhs.gov; Grants 

Management Contact: Oluyemisi 

Akinneye, Division of Acquisition 

Support and Grants (HFA–500), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 2129, Rockville, MD 20857, 

301–827–0079, FAX: 301–827–7101, email: Oluyemisi.Akinneye@fda.hhs.gov. 

For more information on the funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

grants2.nih.gov/grants/guide/ and/or 

http://www.fda.gov/Drugs/DrugSafety/ 

ucm187806.htm. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

A. Background 

This funding opportunity is a single 

source application for the award of a 

cooperative agreement to the National 

Consumers League (NCL) to develop 

and lead a groundbreaking national 

campaign to raise consumers’ awareness 

of the importance of good medication 

adherence and provide tools to 

prescribers to help their patients use 

their medications in the most safe and 

efficacious manner. This campaign is a 

vital first step toward improved 

adherence behavior and better health 

outcomes. 

Relevance 

Inadequate medication adherence is a 

$290 billion dollar problem that touches 

everyone. Nearly three out of four 

Americans report that they do not take 

their medications as directed. One in 

three people never fill their 

prescriptions. Americans with chronic 

conditions account for nearly 45 percent 

of the population, and they are at greater 

risk for health complications and 

negative health outcomes because of 

medication adherence problems. 

Understanding the root causes for 

inadequate medication adherence, and 

effecting changes in knowledge and 

behaviors to increase appropriate 

medication adherence and thus enhance 

health outcomes is an important goal for 

all Americans. 

B. Research Objectives 

The goal of this broad campaign is to 

increase consumer awareness of the 

importance of medication adherence; 

targeting both consumers with chronic 

conditions and health care practitioners 

as well as to provide tools and support 

for both health care practitioners and 

consumers in managing and adhering to 

their medications and medication 

regimens. To plan and facilitate the 

campaign the NCL has brought together 

a public-private coalition of more than 

110 stakeholder organizations from 

within and outside the health care 

arena, including businesses, chain drug 

stores, health care professionals, 

insurance companies, labor, researchers, 

pharmaceutical companies, health 

information technology companies, and 

government agencies. The NCL has the 

expertise, background, and motivation 

necessary to successfully lead this 

campaign. In addition, the campaign 

complements FDA’s mission, protecting 

the public health by assuring the safety, 

efficacy, and security of human drugs 

and helping the public obtain accurate, 

science-based information that they 

need to use medicines and foods to 

maintain and improve their health. 

C. Eligibility Information 

Competition is limited to the NCL 

because it has unique expertise and 

capacity found nowhere else. As part of 

the implementation of their campaign, 

the NCL is building on extensive 

research and lessons learned from 

earlier adherence promotion efforts, and 

with the active involvement of more 

than 110 leading nonprofit 

organizations, professional associations, 

businesses, and Federal Agencies, 

including FDA, the NCL will: (1) 

Leverage partnerships with public and 

private stakeholders to raise awareness 

and disseminate campaign messages 

through their networks, (2) reach out to 

people suffering from common chronic 

conditions and their caregivers, and (3) 

conduct more intensive targeted 

outreach in six strategic markets. 

II. Award Information/Funds Available 

A. Award Amount 

The estimated amount of support in 

fiscal year (FY) 2011 will be up to 

($40,000) total costs (direct plus indirect 

cost) with a possibility of 2 additional 

years at $40,000 each for FY 2012 and 

FY 2013. 

B. Length of Support 

The award will provide 1 year of 

support, with the possibility of 2 

additional years of support, contingent 

upon satisfactory performance in the 

achievement of project and program 

report objectives during the preceding 

year and the availability of Federal FY 

appropriations. 

III. Paper Application, Registration, 

and Submission Information 

To submit a paper application in 

response to this FOA, applicants should 

first review the full announcement 

located at http://grants2.nih.gov/grants/ 

guide/ and/or http://www.fda.gov/ 

Drugs/DrugSafety/ucm187806.htm. 

(FDA has verified the Web site 

addresses throughout this document, 

but FDA is not responsible for any 

subsequent changes to the Web sites 

after this document publishes in the 

Federal Register.) Persons interested in 

applying for a grant may obtain an 

application from the PHS 398 

application instructions available at 

http://grants.nih.gov/grants/forms.htm, 

or http://www.fda.gov/Drugs/ 

DrugSafety/ucm187806.htm. For all 

paper application submissions, the 

following steps are required: 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number. 

• Step 2: Register With Central 

Contractor Registration. 

• Step 3: Register With Electronic 

Research Administration (eRA) 

Commons 

Steps 1 and 2, in detail, can be found 

at http://www07.grants.gov/applicants/ 

organization_registration.jsp. Step 3, in 

detail, can be found at https:// 

commons.era.nih.gov/commons/ 

registration/registrationInstructions.jsp. 

After you have followed these steps, 

submit paper applications to: http:// 

www.fda.gov/Drugs/DrugSafety/ 

ucm187806.htm; Tamara Ford, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, Office of 

Executive Programs, 10903 New 

Hampshire Ave., rm. 6114, Silver 

Spring, MD 20993; Oluyemisi Akinneye, 

Division of Acquisition Support and 

Grants (HFA–500), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

2129, Rockville, MD 20857. 

Dated: March 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5287 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 


Emcdonald on DSK2BSOYB1PROD with NOTICES