Agency Information Collection Activities: Proposed Collection: Comment Request, 72064-72065 [E8-28048]
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Federal Register / Vol. 73, No. 229 / Wednesday, November 26, 2008 / Notices
facility is spacious, registration will be
on a first-come, first-served basis. NonU.S. citizens are subject to additional
security screening, and should register
as soon as possible.
If you need special accommodations
because of a disability, please contact
Kathryn O’Callaghan at least 7 days
before the public workshop.
IV. Where Can I Find Out More About
This Public Workshop?
Background information on the public
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://www.AdvaMed.org and
https://www.fda.gov/cdrh/dsma/
workshop.html.
Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28169 Filed 11–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
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,
Responses
per
respondent
Number of
respondents
Form
patient navigator, and PN program
levels. This information includes:
• Sociodemographics of patients (e.g.,
insurance status, income, education
level, gender, age, race and ethnicity,
primary language, number of family
dependents) served;
• 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);
• Health care service utilization (e.g.,
screening rates, compliance rate for
appointments and follow-up exams,
time interval between diagnosis or
referral and resolution date);
• Patient health status (e.g., type and
stage of diagnosis, chronic disease
status, final outcome or result); and
• 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
estimated annual burden is as follows:
Total
responses
Hours per
response
Total burden
hours
6,000
6,000
1
1
6,000
6,000
0.5
0.25
3,000
1,500
SubTotal—Patient Burden ............................................
6,000
2
1,2000
0.75
4,500
Patient Navigator Survey .....................................................
Patient Navigator Encounter/Tracking Log 2 ........................
30
30
1
750
30
22,500
0.25
0.25
7.5
5,625
SubTotal—Patient Navigator Burden ...........................
30
751
22,530
0.5
5,632.5
Grantee PN Administrative Records 3 .................................
Medical Record and Clinic Data 4 ........................................
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Navigated Patient 1 Data Intake Form .................................
Navigated Patient Satisfaction Survey ................................
6
6
1
2,000
6
12,000
0.5
2
3
24,000
SubTotal—Grantee Burden ..........................................
12
2,001
12,012
2.5
24,006
Total Average Annual Burden ...............................
6,052
2,754
54,052
3.75
36,016
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.
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Federal Register / Vol. 73, No. 229 / Wednesday, November 26, 2008 / Notices
3 Includes
4 Includes
administrative data related to PN recruitment, hiring, and training.
medical record abstraction and clinic database abstraction on individual patients (note: decreased to 2 hours per patient).
Over 2
yrs
Annual
Goodwin ..............................
Lutheran ..............................
Northeast .............................
Palmetto ..............................
South Broward ....................
Texas Tech .........................
400
650
6,000
3,000
2,200
500
200
325
3,000
1,500
1,100
250
Total .............................
12,750
6,375
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: November 20, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–28048 Filed 11–25–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
mstockstill on PROD1PC66 with NOTICES
72065
SUMMARY: The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (‘‘the
Program’’), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place, NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
VerDate Aug<31>2005
17:30 Nov 25, 2008
Jkt 217001
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated his
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions which may lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
if the petitioner shows that the
condition was caused by one of the
listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that the
Secretary publish in the Federal
Register a notice of each petition filed.
Set forth below is a list of petitions
received by HRSA on January 2, 2008,
through June 30, 2008.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
(a) ‘‘Sustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
SUPPLEMENTARY INFORMATION:
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Table but which was caused by’’ one of
the vaccines referred to in the Table, or
(b) ‘‘Sustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
This notice will also serve as the
special master’s invitation to all
interested persons to submit written
information relevant to the issues
described above in the case of the
petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the U.S. Court of
Federal Claims at the address listed
above (under the heading ‘‘For Further
Information Contact’’), with a copy to
HRSA addressed to Director, Division of
Vaccine Injury Compensation Program,
Healthcare Systems Bureau, 5600
Fishers Lane, Room 11C–26, Rockville,
MD 20857. The Court’s caption
(Petitioner’s Name v. Secretary of Health
and Human Services) and the docket
number assigned to the petition should
be used as the caption for the written
submission. Chapter 35 of title 44,
United States Code, related to
paperwork reduction, does not apply to
information required for purposes of
carrying out the Program.
List of Petitions
1. Alex and Steven Padula on behalf
of William Padula, Miami, Florida,
Court of Federal Claims Number 08–
0001V.
2. Gary Moraga, Santa Rosa,
California, Court of Federal Claims
Number 08–0002V.
3. Shayna Tatum and Donnell Villa on
behalf of Michael Villa, Hawthorne,
California, Court of Federal Claims
Number 08–0008V.
4. Matt Daniels, Broderline, New
Hampshire, Court of Federal Claims
Number 08–0009V.
5. Rhonda Kay Rossi, Glendale,
Arizona, Court of Federal Claims
Number 08–0010V.
6. December and Danny Ledet on
behalf of Dane Paul Ledet, Baton Rouge,
Louisiana, Court of Federal Claims
Number 08–0013V.
7. Megan and Shawn Brewer on
behalf of Renee Brewer, Ft. Sill,
Oklahoma, Court of Federal Claims
Number 08–0014V.
8. Peter J. Dawson, Clifton Springs,
New York, Court of Federal Claims
Number 08–0016V.
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]]>Agencies
[Federal Register Volume 73, Number 229 (Wednesday, November 26, 2008)]
[Notices]
[Pages 72064-72065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28048]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer on (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
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:
Sociodemographics of patients (e.g., insurance status,
income, education level, gender, age, race and ethnicity, primary
language, number of family dependents) served;
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);
Health care service utilization (e.g., screening rates,
compliance rate for appointments and follow-up exams, time interval
between diagnosis or referral and resolution date);
Patient health status (e.g., type and stage of diagnosis,
chronic disease status, final outcome or result); and
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 estimated annual burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Navigated Patient \1\ Data 6,000 1 6,000 0.5 3,000
Intake Form....................
Navigated Patient Satisfaction 6,000 1 6,000 0.25 1,500
Survey.........................
-------------------------------------------------------------------------------
SubTotal--Patient Burden.... 6,000 2 1,2000 0.75 4,500
-------------------------------------------------------------------------------
Patient Navigator Survey........ 30 1 30 0.25 7.5
Patient Navigator Encounter/ 30 750 22,500 0.25 5,625
Tracking Log \2\...............
-------------------------------------------------------------------------------
SubTotal--Patient Navigator 30 751 22,530 0.5 5,632.5
Burden.....................
-------------------------------------------------------------------------------
Grantee PN Administrative 6 1 6 0.5 3
Records \3\....................
Medical Record and Clinic Data 6 2,000 12,000 2 24,000
\4\............................
-------------------------------------------------------------------------------
SubTotal--Grantee Burden.... 12 2,001 12,012 2.5 24,006
===============================================================================
Total Average Annual 6,052 2,754 54,052 3.75 36,016
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.
[[Page 72065]]
\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......................................... 6,000 3,000
Palmetto.......................................... 3,000 1,500
South Broward..................................... 2,200 1,100
Texas Tech........................................ 500 250
---------------------
Total......................................... 12,750 6,375
------------------------------------------------------------------------
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: November 20, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-28048 Filed 11-25-08; 8:45 am]
BILLING CODE 4165-15-P
