Agency Information Collection Activities: Submission for OMB Review; Comment Request, 10599-10600 [E9-5102]

Download as PDF Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 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: rwilkins on PROD1PC63 with NOTICES 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 VerDate Nov<24>2008 17:01 Mar 10, 2009 Jkt 217001 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 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 10599 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, E:\FR\FM\11MRN1.SGM 11MRN1 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, 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: 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 Number of respondents Form Responses per respondent Total responses Hours per response Total burden hours Navigated Patient 1 Data Intake Form ............................. SubTotal—Patient Burden ........................................ Patient Navigator Survey ................................................. Patient Navigator Encounter/Tracking Log 2 .................... SubTotal—Patient Navigator Burden ....................... Grantee PN Administrative Records 3 ............................. Medical Record and Clinic Data 4 (Baseline Measures) Quarterly Report .............................................................. SubTotal—Grantee Burden ...................................... 6000 6000 30 30 30 6 6 6 18 1 1 1 750 751 1 2000 4 2005 6000 6000 30 22,500 22530 6 12000 24 12030 0.5 0.5 0.25 0.25 0.5 0.5 2 1 3.5 3000 3000 7.5 5625 5632.5 3 24000 24 24027 Total Average Annual Burden ........................... 6048 2757 40560 4.5 32659.5 1 Estimated number of navigated patients per year based on applications was rounded to 6000. See table below for projected numbers navigated by Grantee. 2 Assumes 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 Goodwin ............ Lutheran ............ Northeast .......... Palmetto ............ South Broward .. Texas Tech ....... 400 650 6000 3000 2200 500 Total ........... 12750 Annual 200 325 3000 1500 1100 250 Dated: February 27, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–5102 Filed 3–10–09; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 4165–15–P 17:01 Mar 10, 2009 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 6375 Applications and Related Forms 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.’’ VerDate Nov<24>2008 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 217001 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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; E:\FR\FM\11MRN1.SGM 11MRN1

Agencies

[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Notices]
[Pages 10599-10600]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5102]


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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:
    [dec222] Sociodemographics of patients (e.g., insurance status, 
income, education level, gender, age, race and ethnicity, primary 
language, number of family dependents) served;
    [dec222] 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);
    [dec222] Health care service utilization (e.g., screening rates, 
compliance rate for appointments and follow-up exams,

[[Page 10600]]

time interval between diagnosis or referral and resolution date);
    [dec222] Patient health status (e.g., type and stage of diagnosis, 
chronic disease status, final outcome or result); and
    [dec222] 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 de-identified 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:

----------------------------------------------------------------------------------------------------------------
                                    Number of     Responses per       Total         Hours per     Total  burden
              Form                 respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
Navigated Patient \1\ Data                 6000               1            6000            0.5            3000
 Intake Form...................
    SubTotal--Patient Burden...            6000               1            6000            0.5            3000
Patient Navigator Survey.......              30               1              30            0.25              7.5
Patient Navigator Encounter/                 30             750          22,500            0.25           5625
 Tracking Log \2\..............
    SubTotal--Patient Navigator              30             751           22530            0.5            5632.5
     Burden....................
Grantee PN Administrative                     6               1               6            0.5               3
 Records \3\...................
Medical Record and Clinic Data                6            2000           12000            2             24000
 \4\ (Baseline Measures).......
Quarterly Report...............               6               4              24            1                24
    SubTotal--Grantee Burden...              18            2005           12030            3.5           24027
                                --------------------------------------------------------------------------------
        Total Average Annual               6048            2757           40560            4.5           32659.5
         Burden................
----------------------------------------------------------------------------------------------------------------
\1\ Estimated number of navigated patients per year based on applications was rounded to 6000. See table below
  for projected numbers navigated by Grantee.
\2\ Assumes 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 e-mail 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