Agency Information Collection Activities: Submission for OMB Review; Comment Request, 10599-10600 [E9-5102]
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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 https://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
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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 https://
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 https://www.fda.gov/bbs/
topics/NEWS/2007/NEW01563.html,
February 14, 2007.
2. FDA, Recall of Products Containing
Peanut Butter; Salmonella
Typhimurium, available at https://
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]
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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,
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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]
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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.’’
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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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
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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;
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[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]
-----------------------------------------------------------------------
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]
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