Agency Information Collection Activities: Submission for OMB Review; Comment Request, 27067-27068 [2011-11396]

Download as PDF Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices • Review and discussion of FDA’s proposed 351(k) user fee program structure and any alternative structures submitted to the public docket in response to this document that would also meet the key design principles and criteria. • Review and discussion of FDA’s proposed performance goals for 351(k) applications. FDA will review and analyze the industry stakeholder input obtained through this process. FDA will take this information into account, as well as information obtained from public stakeholder consultation meetings, in developing the proposed set of recommendations that will be presented to Congressional Committee staff, published in the Federal Register for public review and comment, and presented at a public meeting to obtain public input. After the public meeting, the proposed recommendations would be revised as necessary before transmittal to Congress by January 15, 2012. jlentini on DSKJ8SOYB1PROD with NOTICES VI. Next Steps A. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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. FDA encourages members of the public to submit comments to the docket on the following topics: Question VI.1: FDA-proposed principles for a fair and adequate 351(k) user fee program (section II of this document), Question VI.2: FDA-proposed structure for a 351(k) user fee program that aligns with these principles (section III of this document), and Question VI.3: FDA-proposed performance goals for a 351(k) user fee program for FYs 2013 through 2017 (section IV of this document). FDA also encourages the public to submit comments to the docket concerning any potential alternative 351(k) user fee structures that would align with the proposed principles. When you submit comments to the docket, identify the section of this document and the number of each question you address. FDA plans to review the comments submitted to the docket, hold consultation meetings with VerDate Mar<15>2010 18:02 May 09, 2011 Jkt 223001 public stakeholder groups, and hold industry stakeholder meetings, to refine the proposed recommendations for a 351(k) user fee program for FYs 2013 through 2017. B. Public Stakeholder Identification Public stakeholders who have not yet notified FDA that they wish to participate in these consultation meetings should notify FDA by e-mail to BiosimilarsUserFeeProgram@ fda.hhs.gov on or before June 3, 2011. Your e-mail should contain complete contact information, including name, title, organization affiliation, address, email address, telephone number, and notice of any special accommodations required because of disability. Stakeholders will receive confirmation and additional information about the first meeting once FDA receives their notification. C. Industry Stakeholder Identification FDA is requesting that industry stakeholders, including industry associations with relevant interests and individual companies with ongoing efforts or interest in developing biosimilar and interchangeable biological products, identify their interest in participating in industry stakeholder meetings. The purpose of these industry stakeholder meetings is to hold a series of discussions to develop proposed recommendations for a user fee program for biosimilar and interchangeable biological product applications for FYs 2013 through 2017. If you have not yet notified FDA that you are a company or trade association that would be affected by a 351(k) user fee program, please provide notification by e-mail to BiosimilarsUserFeeProgram@ fda.hhs.gov on or before June 3, 2011. Your e-mail should contain complete contact information, including name, title, organization affiliation, address, email address, telephone number, and notice of any special accommodations required because of disability. VII. Additional Information on the BPCI Act There are several sources of information on FDA’s Web site that may serve as useful resources for stakeholders intending to participate in consultation meetings: • The Federal Register document that announced the November 2010, public hearing and requested public comments is available at http:// edocket.access.gpo.gov/2010/pdf/ 2010-24853.pdf. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 27067 to the Web site after this document publishes in the Federal Register.) • Comments submitted in response to the November 2010 public hearing document can be found at http:// www.regulations.gov using Docket No. FDA–2010–N–0477. • The Federal Register notice that requested notification of stakeholder intention to participate in consultation meetings is available at http:// edocket.access.gpo.gov/2010/pdf/ 2010-30713.pdf. • Additional information regarding implementation of the BPCI Act is available at http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/UCM215031. Dated: May 4, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–11348 Filed 5–9–11; 8:45 am] BILLING CODE 4160–01–P 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: Title (OMB No. 0915– NEW)—[NEW] Authorized through the Patient Navigator Outreach and Chronic Disease Prevention Act of 2005 (Pub. L. 109–18), as amended by the Patient Protection and Affordable Care Act (Pub. L. 111– 148), the Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program (PNDP) supports the development and operation of projects to provide patient navigator services to improve health outcomes for individuals, including individuals with cancer and other chronic diseases, and health disparities populations. Award E:\FR\FM\10MYN1.SGM 10MYN1 27068 Federal Register / Vol. 76, No. 90 / Tuesday, May 10, 2011 / Notices recipients are to use grant funds to recruit, assign, train, and employ patient navigators who have direct knowledge of the communities they serve to facilitate care for those who are at risk for or who have cancer or other chronic diseases and for outreach to health disparities populations. As authorized by the statute, a report on the outcomes of the program must be submitted to Congress. The statute requires that the Report to Congress include a quantitative analysis of baseline and benchmark measures; aggregate information about the patients served and program activities; and recommendations on whether patient Number of respondents Form Responses per respondent navigator programs could be used to improve patient outcomes in other public health areas. The data collection instruments (see table) are intended to provide the data needed to produce the Report to Congress. The annual estimate of burden is as follows: Total responses Hours per response Total burden hours Navigated Patient Data Intake Form ................................... VR–12 Health Status Form .................................................. 4,827 4,827 1 2 4,827 9,654 0.5 .12 2,413.5 1,158.5 SubTotal-Patient Burden .............................................. Patient Navigator Survey ..................................................... Patient Navigator Encounter/Target Services Log .............. Patient Navigator Focus Group ........................................... 4,827 46 46 46 ........................ 1 629.6 1 ........................ 46 28,961.6 46 ........................ 0.2 0.25 1 3,572 9.2 7,240.4 46 SubTotal-Patient Navigator Burden .............................. Patient Medical Record and Clinic Data (no personally identifiable information) .................................................... Annual Clinic-Wide Clinical Performance Measures Report Patient Navigator Cultural Competency Checklist ............... Patient Navigator/Health System Administrator Focus Group ................................................................................ Grantee Health Care Provider Focus Group ....................... Social Service Provider Focus Group ................................. Quarterly Report .................................................................. 46 ........................ ........................ ........................ 7,295.6 10 5 10 482.7 1 4.6 4,827 5 46 .17 8 1.17 820.6 40 53.8 50 30 50 10 1 1 1 4 50 30 50 40 1 1 1 1 50 30 50 40 SubTotal-Grantee Burden ............................................. Totals ..................................................................... 165 5,038 ........................ ........................ ........................ 48,582.6 ........................ ........................ 1084.4 11,952 Total Average Annual Burden ........................ ........................ ........................ ........................ ........................ 11,952 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: May 5, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–11396 Filed 5–9–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health jlentini on DSKJ8SOYB1PROD with NOTICES National Heart, Lung, and Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections VerDate Mar<15>2010 18:02 May 09, 2011 Jkt 223001 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, SBIR Contract Review. Date: June 2, 2011. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: YingYing Li-Smerin, PhD, MD, Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892– 7924. 301–435–0277. lismerin@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, Resource Related Research Project in National Biological Sample Data Repository. Date: June 8, 2011. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00068 Fmt 4703 Sfmt 9990 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: Giuseppe Pintucci, PhD, Scientific Review Officer, Review Branch/ DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7192, Bethesda, MD 20892. 301–435–0287. Pintuccig@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: May 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–11398 Filed 5–9–11; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 76, Number 90 (Tuesday, May 10, 2011)]
[Notices]
[Pages 27067-27068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11396]


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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: Title (OMB No. 0915-NEW)--[NEW]

    Authorized through the Patient Navigator Outreach and Chronic 
Disease Prevention Act of 2005 (Pub. L. 109-18), as amended by the 
Patient Protection and Affordable Care Act (Pub. L. 111-148), the 
Patient Navigator Outreach and Chronic Disease Prevention Demonstration 
Program (PNDP) supports the development and operation of projects to 
provide patient navigator services to improve health outcomes for 
individuals, including individuals with cancer and other chronic 
diseases, and health disparities populations. Award

[[Page 27068]]

recipients are to use grant funds to recruit, assign, train, and employ 
patient navigators who have direct knowledge of the communities they 
serve to facilitate care for those who are at risk for or who have 
cancer or other chronic diseases and for outreach to health disparities 
populations.
    As authorized by the statute, a report on the outcomes of the 
program must be submitted to Congress. The statute requires that the 
Report to Congress include a quantitative analysis of baseline and 
benchmark measures; aggregate information about the patients served and 
program activities; and recommendations on whether patient navigator 
programs could be used to improve patient outcomes in other public 
health areas. The data collection instruments (see table) are intended 
to provide the data needed to produce the Report to Congress.
    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 Data Intake              4,827               1           4,827             0.5         2,413.5
 Form...........................
VR-12 Health Status Form........           4,827               2           9,654             .12         1,158.5
                                 -------------------------------------------------------------------------------
    SubTotal-Patient Burden.....           4,827  ..............  ..............  ..............           3,572
Patient Navigator Survey........              46               1              46             0.2             9.2
Patient Navigator Encounter/                  46           629.6        28,961.6            0.25         7,240.4
 Target Services Log............
Patient Navigator Focus Group...              46               1              46               1              46
                                 -------------------------------------------------------------------------------
    SubTotal-Patient Navigator                46  ..............  ..............  ..............         7,295.6
     Burden.....................
Patient Medical Record and                    10           482.7           4,827             .17           820.6
 Clinic Data (no personally
 identifiable information)......
Annual Clinic-Wide Clinical                    5               1               5               8              40
 Performance Measures Report....
Patient Navigator Cultural                    10             4.6              46            1.17            53.8
 Competency Checklist...........
Patient Navigator/Health System               50               1              50               1              50
 Administrator Focus Group......
Grantee Health Care Provider                  30               1              30               1              30
 Focus Group....................
Social Service Provider Focus                 50               1              50               1              50
 Group..........................
Quarterly Report................              10               4              40               1              40
                                 -------------------------------------------------------------------------------
    SubTotal-Grantee Burden.....             165  ..............  ..............  ..............          1084.4
        Totals..................           5,038  ..............        48,582.6  ..............          11,952
                                 -------------------------------------------------------------------------------
            Total Average Annual  ..............  ..............  ..............  ..............          11,952
             Burden.............
----------------------------------------------------------------------------------------------------------------

    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: May 5, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-11396 Filed 5-9-11; 8:45 am]
BILLING CODE 4165-15-P