Agency Information Collection Activities: Proposed Collection: Comment Request, 72064-72065 [E8-28048]

Download as PDF 72064 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 http://www.AdvaMed.org and http://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 ........................................ mstockstill on PROD1PC66 with NOTICES 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. VerDate Aug<31>2005 17:30 Nov 25, 2008 Jkt 217001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\26NON1.SGM 26NON1 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: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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. E:\FR\FM\26NON1.SGM 26NON1

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]


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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