Agency Information Collection Activities; Proposed Collection; Comment Request, 27972-27973 [2013-11256]
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
20877. The hotel phone number is 301–
977–8900.
Contact Person: Sara J. Anderson,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg 66,
Rm. 1611, Silver Spring, MD,
Sara.Anderson@fda.hhs.gov, 301–796–
7047, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On July 18, 2013, the
committee will discuss and make
recommendations on the proposed
regulatory classification for dental
devices known as Endosseous Dental
Implants (Blade-form), one of the
remaining preamendments Class III
devices. The Class III blade-form
endosseous dental implant is a device
placed into the maxilla or mandible and
composed of biocompatible material,
such as commercially pure titanium,
with sufficient strength to support a
dental restoration, such as a crown,
bridge, or denture, intended for the
purpose of replacing tooth (or teeth)
roots and extending a support post
through the gingival tissue into the oral
cavity to restore chewing function. The
blade-form implant is generally a
rectangular shape or rounded corner
rectangle shape (in the mesio-distal
plane) with a narrow tapered (narrow at
the apical edge) edge (in the buccolingual plane) similar in shape to a razor
blade. Other blade designs, such as
square, V-shaped, and triangles have
also been used. The blade-form implants
are either one-piece or two-piece
implants designed with one to three
cylindrical abutment posts extending
from the coronal aspect of the blade
through the soft tissue and into the oral
cavity.
On January 4, 2013 (FDA–2012–N–
0677), FDA issued a proposed order
which, if made final, would reclassify
the blade-form endosseous dental
implant into class II (special controls).
The committee’s discussion will involve
making recommendations regarding
regulatory classification to either
reaffirm Class III or reclassify these
devices into Class II and comment on
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whether the proposed Special Controls
are adequate to reasonably ensure the
safety and effectiveness of blade-form
endosseous dental implants. The
regulatory history of blade-form
endosseous dental implant has been
discussed as part of the proposed order
(FDA–2012–N–0677).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 9, 2013. On July
18, 2013, oral presentations will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 28,
2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 1, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at
Annmarie.Williams@fda.hhs.gov or 301
796–5966 at least 7 days in advance of
the meeting.
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FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–11286 Filed 5–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
ACTION:
Notice.
SUMMARY: 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, email
paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
Information Collection Request Title:
Information and Referral and
Professional Training Impact Surveys
in Health Resources and Services
Administration (HRSA)—Funded
Traumatic Brain Injury Grants (OMB
No. 0915–xxxx)—New
Abstract: This survey is designed to
collect information from HRSA-funded
Traumatic Brain Injury (TBI) State
Implementation Partnership Grants and
Protection and Advocacy for Traumatic
Brain Injury (TBI) Grants regarding the
impact of grant activities on individuals
with traumatic brain injury and their
family members. The authority for this
program is the Public Health Service
Act, Title XII, Section 1252 (42 U.S.C.
300d–52) as amended by the Children’s
Health Act of 2000, sec. 1304, Public
Law 106–310, as further amended by the
Traumatic Brain Injury Act of 2008, sec.
6, Public Law 110–206.
Individuals with TBI present with a
host of different symptoms, which exist
with varying levels of severity.
Comprehensive appropriate care often
requires a variety of services such as
physical rehabilitation, speech
rehabilitation, cognitive rehabilitation,
special education accommodations,
vocational skills coaching, and
independent living skills training,
which are located across many state and
local agencies. For this reason,
individuals with TBI and their family
members often have difficulty
identifying local providers with the
skills and expertise to deliver services
that will promote recovery and
maximize independence.
Per the authorizing legislation, the
intent of these programs is to improve
access to rehabilitation and other
services regarding traumatic brain
injury. The HRSA State Implementation
Partnership Grants and State Protection
and Advocacy Grants support this
charge by providing information to
individuals with TBI and their families
about TBI and making referrals to local
providers equipped to meet the unique
needs of each survivor. Additionally,
these grant programs train providers in
various settings to identify and
effectively serve individuals with TBI
and their families.
To date, a number of grantees have
collected data independently to
determine the impact of their work on
individuals with TBI and their families.
HRSA proposes uniform data collection
surveys for these two categories of
activities—information and referral
Number of
respondents
Form name
Number of
responses per
respondent
services, and professional training—to
assess the extent to which these
activities are increasing access to
rehabilitation and other services. In
addition to providing uniform data
across these grant programs, the data
will help determine what efforts might
improve outreach and provision of
services for future projects.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Feedback Form for Individuals with TBI and/or their Family
Members receiving Information and Referral Services ....
Feedback Form for Training Session Participants ..............
21,000
10,500
1
1
21,000
10,500
0.25
0.25
5250
2,625
Total ..............................................................................
31,500
11
31,500
0.50
7,875
1 Respondents
for these two survey forms will be distinct; individuals will not complete both surveys. Therefore, there will be only one response
per respondent.
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this ICR must
be received within 60 days of this
notice.
ADDRESSES:
Dated: May 7, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2013–11256 Filed 5–10–13; 8:45 am]
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Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
ACTION:
Notice.
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
Comments submitted during the first
public review of this ICR will be
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provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Information Collection Clearance
Officer at (301) 443–1984.
Information Collection Request Title:
Organ Donation/Transplant Life Stories
(OMB No. 0915–xxxx)—NEW
Abstract: HRSA’s Division of
Transplantation (DoT) is the primary
entity in the Department of Health and
Human Services (HHS) responsible for
the Organ Transplant Program
established under the National Organ
Transplant Act (Pub. L. 98–507, codified
at sections 371–377D of the Public
Health Service (PHS) Act). Section 377A
of the PHS Act authorizes the Secretary
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[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27972-27973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11256]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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, email paperwork@hrsa.gov or
call the HRSA Information Collection Clearance Officer at (301) 443-
1984.
HRSA especially requests comments on: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions, (2) the accuracy of the estimated burden, (3)
ways to enhance the quality, utility, and clarity of the information to
be collected, and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
[[Page 27973]]
Information Collection Request Title: Information and Referral and
Professional Training Impact Surveys in Health Resources and Services
Administration (HRSA)--Funded Traumatic Brain Injury Grants (OMB No.
0915-xxxx)--New
Abstract: This survey is designed to collect information from HRSA-
funded Traumatic Brain Injury (TBI) State Implementation Partnership
Grants and Protection and Advocacy for Traumatic Brain Injury (TBI)
Grants regarding the impact of grant activities on individuals with
traumatic brain injury and their family members. The authority for this
program is the Public Health Service Act, Title XII, Section 1252 (42
U.S.C. 300d-52) as amended by the Children's Health Act of 2000, sec.
1304, Public Law 106-310, as further amended by the Traumatic Brain
Injury Act of 2008, sec. 6, Public Law 110-206.
Individuals with TBI present with a host of different symptoms,
which exist with varying levels of severity. Comprehensive appropriate
care often requires a variety of services such as physical
rehabilitation, speech rehabilitation, cognitive rehabilitation,
special education accommodations, vocational skills coaching, and
independent living skills training, which are located across many state
and local agencies. For this reason, individuals with TBI and their
family members often have difficulty identifying local providers with
the skills and expertise to deliver services that will promote recovery
and maximize independence.
Per the authorizing legislation, the intent of these programs is to
improve access to rehabilitation and other services regarding traumatic
brain injury. The HRSA State Implementation Partnership Grants and
State Protection and Advocacy Grants support this charge by providing
information to individuals with TBI and their families about TBI and
making referrals to local providers equipped to meet the unique needs
of each survivor. Additionally, these grant programs train providers in
various settings to identify and effectively serve individuals with TBI
and their families.
To date, a number of grantees have collected data independently to
determine the impact of their work on individuals with TBI and their
families. HRSA proposes uniform data collection surveys for these two
categories of activities--information and referral services, and
professional training--to assess the extent to which these activities
are increasing access to rehabilitation and other services. In addition
to providing uniform data across these grant programs, the data will
help determine what efforts might improve outreach and provision of
services for future projects.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Feedback Form for Individuals 21,000 1 21,000 0.25 5250
with TBI and/or their Family
Members receiving Information
and Referral Services..........
Feedback Form for Training 10,500 1 10,500 0.25 2,625
Session Participants...........
-------------------------------------------------------------------------------
Total....................... 31,500 1\1\ 31,500 0.50 7,875
----------------------------------------------------------------------------------------------------------------
\1\ Respondents for these two survey forms will be distinct; individuals will not complete both surveys.
Therefore, there will be only one response per respondent.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this ICR must be received within 60 days of
this notice.
Dated: May 7, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-11256 Filed 5-10-13; 8:45 am]
BILLING CODE 4165-15-P
