Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 10599 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written requests for single 

copies of the guidance to the Office of 

Food Safety, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Michael E. Kashtock,Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2022. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Guidance for 

Industry: Measures to Address the Risk 

for Contamination by Salmonella 

Species in Food Containing a PeanutDerived Product as an Ingredient.’’ This 

guidance is intended to clarify for 

manufacturers who produce foods 

containing a peanut-derived product as 

an ingredient that there is a risk that 

Salmonella species (spp.) may be 

present in the incoming peanut-derived 

product, and to recommend measures to 

address that risk. Peanut-derived 

products include peanuts, peanut 

butter, peanut paste, peanut meal, and 

peanut granules. 

In the recent past, products made 

from peanuts have been associated with 

two large, multi-state Salmonella 

outbreaks. The first of these, an outbreak 

of Salmonella Tennessee in 2007 linked 

to peanut butter, resulted in more than 

600 illnesses in 47 states (Ref. 1). More 

recently, peanut butter and peanut paste 

have been confirmed as the source of a 

large multi-state outbreak caused by 

Salmonella Typhimurium (Ref. 2). 

Peanut-derived products that have been 

recalled have been used as ingredients 

in other products such as cookies, 

crackers, cereal, candy, and ice cream. 

This had led to additional recalls. 

FDA is issuing this guidance as a level 

1 guidance consistent with FDA’s good 

guidance practices regulation § 10.115 

(21 CFR 10.115). Consistent with FDA’s 

good guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately in accordance with 

§ 10.115(g)(2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the current 

circumstances. The guidance represents 

the agency’s current thinking on 

measures to address the risk for 

contamination by Salmonella spp. in 

foods containing a peanut-derived 

product as an ingredient. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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 brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.cfsan.fda.gov/guidance.html. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. FDA, FDA Warns Consumers Not to 

Eat Certain Jars of Peter Pan Peanut 

Butter and Great Value Peanut Butter; 

Product May be Contaminated With 

Salmonella, FDA News, P07–21, 

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

topics/NEWS/2007/NEW01563.html, 

February 14, 2007. 

2. FDA, Recall of Products Containing 

Peanut Butter; Salmonella 

Typhimurium, available at http:// 

www.fda.gov/oc/opacom/hottopics/ 

salmonellatyph.html, updated February 

4, 2009. 

Dated: March 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5367 Filed 3–9–09; 4:15 pm] 

BILLING CODE 4160–01–S 

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 the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Patient Navigator 

Outreach and Chronic Disease 

Prevention Demonstration Program 

Patient Data Collection Form—[New] 

The purpose of the Patient Navigator 

Outreach and Chronic Disease 

Prevention (PN) Demonstration Program 

is to promote model ‘‘patient navigator’’ 

programs to improve health care 

outcomes for individuals with cancer 

and/or other chronic diseases, with a 

specific emphasis on health disparity 

populations. This program aims to 

coordinate comprehensive health 

services for patients in need of chronic 

disease care and management through 

enhanced chronic disease management 

provided by patient navigators. 

In order to describe successful PN 

program models and make 

recommendations on the ability of such 

programs to improve patient outcomes, 

data is needed at the individual patient, 

patient navigator, and PN program 

levels. This information includes: 

fi Sociodemographics of patients 

(e.g., insurance status, income, 

education level, gender, age, race and 

ethnicity, primary language, number of 

family dependents) served; 

fi Patient access barriers to standard 

chronic disease care (e.g., access to 

pharmaceuticals, distance of patient’s 

home from health care facilities utilized, 

primary mode of transportation to 

health care facilities utilized, cultural 

and linguistic barriers as well as literacy 

levels); 

fi Health care service utilization 

(e.g., screening rates, compliance rate 

for appointments and follow-up exams, 


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10600 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 

time interval between diagnosis or 

referral and resolution date); 

fi Patient health status (e.g., type and 

stage of diagnosis, chronic disease 

status, final outcome or result); and 

fi Patient navigation data (e.g., type 

of navigator, patient navigation training 

plans and outcomes, point at which 

patient navigator was brought into the 

process, number of patients referred, 

how patient barriers were resolved, 

patient satisfaction, follow-up 

outcomes—such as number of 

uninsured who get health coverage). 

This information will be collected from 

patients or their designated caregiver, 

patient navigators, and PN program 

administrators. Maintaining 

confidentiality of patient medical 

information is a concern and thus all 

personal information will be deidentified to protect the confidentiality 

of all patients. Data collection and 

disclosure processes will abide by 

Health Insurance Portability and 

Accountability Act (HIPPA) Privacy 

Rule provisions and procedures. 

The annual estimate of burden is as 

follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total 

burden hours 

Navigated Patient 1 Data Intake Form ............................. 6000 1 6000 0 .5 3000 

SubTotal—Patient Burden ........................................ 6000 1 6000 0 .5 3000 

Patient Navigator Survey ................................................. 30 1 30 0 .25 7 .5 

Patient Navigator Encounter/Tracking Log 2 .................... 30 750 22,500 0 .25 5625 

SubTotal—Patient Navigator Burden ....................... 30 751 22530 0 .5 5632 .5 

Grantee PN Administrative Records 3 ............................. 6 1 6 0 .5 3 

Medical Record and Clinic Data 4 (Baseline Measures) 6 2000 12000 2 24000 

Quarterly Report .............................................................. 6 4 24 1 24 

SubTotal—Grantee Burden ...................................... 18 2005 12030 3 .5 24027 

Total Average Annual Burden ........................... 6048 2757 40560 4 .5 32659 .5 

1Estimated number of navigated patients per year based on applications was rounded to 6000. See table below for projected numbers navigated by Grantee. 2Assumes 5 log entries of PN activities per patient. 

3 Includes administrative data related to PN recruitment, hiring, and training. 

4 Includes medical record abstraction and clinic database abstraction on individual patients (note: Decreased to 2 hours per patient). 

Over 2 yrs Annual 

Goodwin ............ 400 200 

Lutheran ............ 650 325 

Northeast .......... 6000 3000 

Palmetto ............ 3000 1500 

South Broward .. 2200 1100 

Texas Tech ....... 500 250 

Total ........... 12750 6375 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: February 27, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–5102 Filed 3–10–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Revision of OMB 

No. 0925–0001/exp. 11/30/10, Research 

and Research Training Grant 

Applications and Related Forms 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on December 10, 

2008, page 75121 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. The 

National Institutes of Health may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after November 30, 2010, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: Research 

and Research Training Grant 

Applications and Related Forms. Type 

of Information Collection Request: 

Revision, OMB 0925–0001, Expiration 

Date 11/30/2010. Form Numbers: PHS 

398, 2590, 2271, 3734 and HHS 568. 

Need and Use of Information Collection: 

The application is used by applicants to 

request Federal assistance for research 

and research-related training. The other 

related forms are used for trainee 

appointment, final invention reporting, 

and to relinquish rights to a research 

grant. Frequency of response: 

Applicants may submit applications for 

published receipt dates. If awarded, 

annual progress is reported and trainees 

may be appointed or reappointed. 

Affected Public: Individuals or 

Households; Business or other for-profit; 

Not-for-profit institutions; Federal 

Government; and State, Local or Tribal 

Government. Type of Respondents: 

Adult scientific professionals. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

160,135; Estimated Number of 

Responses per Respondent: 1; Average 

Burden Hours Per Response: 14; and 

Estimated Total Annual Burden Hours 

Requested: 2,251,500. The estimated 

annualized cost to respondents is 

$78,802,500. 

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; 


rwilkins on PROD1PC63 with NOTICES