Agency Information Collection Activities: Submission for OMB Review; Comment Request, 27067-27068 [2011-11396]
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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.
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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
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18:02 May 09, 2011
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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 https://
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
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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 https://
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 https://
edocket.access.gpo.gov/2010/pdf/
2010-30713.pdf.
• Additional information regarding
implementation of the BPCI Act is
available at https://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]
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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
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
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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.
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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
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]]>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]
-----------------------------------------------------------------------
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
