Agency Information Collection Activities: Proposed Collection; Comment Request, 56925-56926 [05-19432]
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56925
Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices
Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued
Medical
Specialty
Regulation
Number
Device Type
Class
Product
Code
RiskA
Critical/
Semicritical/Noncritical
Premarket
Exempt
226
Surgery
Surgical Cutting Accessories
878.4800,
874.4420
I
GDZ, GDX,
GES,
KBQ,
KAS
2
C
Y
227
Surgery
Electrosurgical Electrodes/
Handles/Pencils
876.4300
878.4400
II
HAM, GEI,
FAS
2
C
N
228
Surgery
Scissor Tips
878.4800,
884.4520,
874.4420
I
LRW, HDK,
HDJ,
JZB,
KBD
2
C
Y
229
Surgery
Laser Fiber Delivery Systems
878.4810
874.4500
886.4390
884.4550
886.4690
II
GEX EWG
LLW
HQF
HHR
HQB
1
C
N
ARisk
categorization may be either:
1 = low risk according to RPS
2 = moderate risk according to RPS
3 = high risk according to RPS
3* = high risk due to neurological use
See section II of this document, ‘‘FDA’s Implementation of New Section 510(o) of the Act’’ for methodology and criteria used to identify the
risk.
Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–19510 Filed 9–28–05; 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 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, call the HRSA Reports
Clearance Officer at (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
VerDate Aug<31>2005
13:52 Sep 28, 2005
Jkt 205001
practical utility; (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: Maternal and Child
Health Services Title V Block Grant
Program—Guidance and Forms for the
Title V Application/Annual Report,
OMB No.0915–0172: Revision
The Health Resources and Services
Administration (HRSA) proposes to
revise the Maternal and Child Health
Services Title V Block Grant Program—
Guidance and Forms for the
Application/Annual Report. The
guidance is used annually by the 50
States and 9 jurisdictions in making
application for Block Grants under Title
V of the Social Security Act, and in
preparing the required annual report.
The proposed revisions follow and
build on extensive consultation received
from a workgroup convened to provide
suggestions to improve the guidance
and forms. The proposed revisions are
editorial and technical revisions based
on the experience of the states and
jurisdictions in using the guidance and
forms since 2003.
Two new performance measures were
developed (obesity in children aged 2 to
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
5 years; and smoking in the last
trimester of pregnancy) and two existing
performance measures were either
removed entirely (low birth weight) or
incorporated into an existing health
status capacity indicator (eligible
children receiving services under
Medicaid). This will result in no net
increase in the number of performance
measures. In addition, the directions in
the guidance for the Health Systems
Capacity Indicators (HSCI) were
expanded to enhance clarification. This
proposed change will make it easier for
the states to report on these indicators.
The existing electronic system used
by the states to submit their Block Grant
Application and Annual Report has also
been enhanced. First, using the
electronic system, the narrative from the
prior year’s submission is available
online in the system so that the
applicant need only edit those sections
that have changed. This reduces burden
by avoiding duplicating material. For
national performance measures 2–6, the
data obtained from the National Survey
of Children with Special Health Care
Needs are pre-populated which
eliminates the need to retrieve and enter
data from this survey, unless the states
choose to use another data source. Also,
notes from the prior year’s submission
are available to the states allowing for
more efficient updating through edits
rather then recreating them. Data are
entered once (in a data entry field on a
given form), and where those data are
referenced elsewhere, the value is
E:\FR\FM\29SEN1.SGM
29SEN1
56926
Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices
copied and displayed. The electronic
system includes an automatic character
counter that tells the user how many
characters the states have left. This
eliminates the need to independently
track entries against the Maternal and
Child Health Bureau’s limits for each
section and ensures compliance. The
electronic system includes forms status
checker and data alerts, which conduct
automated checks on data validity, data
consistency, and application
completeness, as well as value tolerance
checks. This facilitates application
review and eliminates much of
previously required data cleaning
activity. Also, this allows the user to
obtain an immediate update at any point
in time on the completeness and
compliance of the application, reducing
the need to conduct a review of the
application. Data are saved directly to
Number of respondents
Type of respondent
the HRSA server so that no manual
transmission is required. Finally, the
automatic commitment of data to the
HRSA server eliminates the need for
version control or data migration.
The estimated average annual burden
per year is as follows for the Annual
Report and Application without the
Needs Assessment:
Responses
per
respondent
Burden hours
per response
Total burden
hours
States ...............................................................................................................
Jurisdictions .....................................................................................................
50
9
1
1
297
120
14,868
1,077
Total ..........................................................................................................
........................
........................
59
15,945
Burden in the 3 Year Reporting Cycle
for the Annual Report and Application
with Needs Assessment is:
Number of respondents
Burden hours per
responses
States/Jurisdictions ..................................................................................
59
378.5
1
22,303
Total Average Burden for 3 year cycle ............................................
........................
............................
............................
18,064
Needs assessment
Send comments to Susan G. Queen,
PhD., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of notice.
Dated: September 23, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–19432 Filed 9–28–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Ricky Ray Hemophilia Relief Fund
Program Administrative Close-Out
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice.
SUMMARY: This Notice announces the
administrative close-out of the Ricky
Ray Hemophilia Relief Fund Program
(the Program). All business concerning
petitions and related payment
documentation associated with the
Program will conclude on October 31,
2005.
VerDate Aug<31>2005
13:52 Sep 28, 2005
Jkt 205001
As of that date, the Program will cease
to accept or process any additional
documentation submitted by
individuals (or their representatives)
relating to the eligibility or payment of
petitions still pending. Remaining funds
will be returned to the United States
Treasury, and the Program will archive
all outstanding documentation at the
Washington National Records Center in
Suitland, Maryland, in accordance with
the requirements of the National
Archives and Records Administration.
DATES: Effective Date: October 31, 2005.
ADDRESSES: Ricky Ray Hemophilia
Relief Fund Program, Healthcare
Systems Bureau, Health Resources and
Services Administration, U.S.
Department of Health and Human
Services, 5600 Fishers Lane, Room 11C–
06, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Paul
T. Clark, Director, Ricky Ray
Hemophilia Relief Fund Program, 5600
Fishers Lane, Room 11C–06, Rockville,
MD 20857; (301) 443–2330.
SUPPLEMENTARY INFORMATION: The
Program implemented the Ricky Ray
Hemophilia Relief Fund Act of 1998
(the Act), Pub. Law 105–369. The Act
established a Trust Fund to provide
compassionate payments to individuals
with blood-clotting disorders, such as
hemophilia, who were treated with
antihemophilic factor between July 1,
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Responses per
respondent
Total burden
hours
1982 and December 31, 1987, and
contracted human immunodeficiency
virus (HIV), as well as to certain persons
who contracted HIV from these
individuals. In the event individuals
eligible for payment were deceased, the
Act also provided for payments to
certain survivors of these individuals.
Under section 101(d) of the Act, the
Trust Fund terminated on November 12,
2003. The Act requires all remaining
funds to be deposited in the
miscellaneous receipts account in the
Treasury of the United States.
The Program has made compassionate
payments totaling in excess of $559
million to more than 7,171 eligible
individuals and survivors.
Dated: September 22, 2005.
Dennis P. Williams,
Deputy Administrator.
[FR Doc. 05–19430 Filed 9–28–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meetings: Organ Transplantation
Advisory Committee
Health Resources and Services
Administration, HHS.
AGENCY:
E:\FR\FM\29SEN1.SGM
29SEN1
Agencies
[Federal Register Volume 70, Number 188 (Thursday, September 29, 2005)]
[Notices]
[Pages 56925-56926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19432]
-----------------------------------------------------------------------
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 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, call
the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (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: Maternal and Child Health Services Title V Block
Grant Program--Guidance and Forms for the Title V Application/Annual
Report, OMB No.0915-0172: Revision
The Health Resources and Services Administration (HRSA) proposes to
revise the Maternal and Child Health Services Title V Block Grant
Program--Guidance and Forms for the Application/Annual Report. The
guidance is used annually by the 50 States and 9 jurisdictions in
making application for Block Grants under Title V of the Social
Security Act, and in preparing the required annual report. The proposed
revisions follow and build on extensive consultation received from a
workgroup convened to provide suggestions to improve the guidance and
forms. The proposed revisions are editorial and technical revisions
based on the experience of the states and jurisdictions in using the
guidance and forms since 2003.
Two new performance measures were developed (obesity in children
aged 2 to 5 years; and smoking in the last trimester of pregnancy) and
two existing performance measures were either removed entirely (low
birth weight) or incorporated into an existing health status capacity
indicator (eligible children receiving services under Medicaid). This
will result in no net increase in the number of performance measures.
In addition, the directions in the guidance for the Health Systems
Capacity Indicators (HSCI) were expanded to enhance clarification. This
proposed change will make it easier for the states to report on these
indicators.
The existing electronic system used by the states to submit their
Block Grant Application and Annual Report has also been enhanced.
First, using the electronic system, the narrative from the prior year's
submission is available online in the system so that the applicant need
only edit those sections that have changed. This reduces burden by
avoiding duplicating material. For national performance measures 2-6,
the data obtained from the National Survey of Children with Special
Health Care Needs are pre-populated which eliminates the need to
retrieve and enter data from this survey, unless the states choose to
use another data source. Also, notes from the prior year's submission
are available to the states allowing for more efficient updating
through edits rather then recreating them. Data are entered once (in a
data entry field on a given form), and where those data are referenced
elsewhere, the value is
[[Page 56926]]
copied and displayed. The electronic system includes an automatic
character counter that tells the user how many characters the states
have left. This eliminates the need to independently track entries
against the Maternal and Child Health Bureau's limits for each section
and ensures compliance. The electronic system includes forms status
checker and data alerts, which conduct automated checks on data
validity, data consistency, and application completeness, as well as
value tolerance checks. This facilitates application review and
eliminates much of previously required data cleaning activity. Also,
this allows the user to obtain an immediate update at any point in time
on the completeness and compliance of the application, reducing the
need to conduct a review of the application. Data are saved directly to
the HRSA server so that no manual transmission is required. Finally,
the automatic commitment of data to the HRSA server eliminates the need
for version control or data migration.
The estimated average annual burden per year is as follows for the
Annual Report and Application without the Needs Assessment:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Burden hours Total burden
Type of respondent respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
States.......................................... 50 1 297 14,868
Jurisdictions................................... 9 1 120 1,077
-----------------
Total....................................... .............. .............. 59 15,945
----------------------------------------------------------------------------------------------------------------
Burden in the 3 Year Reporting Cycle for the Annual Report and
Application with Needs Assessment is:
----------------------------------------------------------------------------------------------------------------
Number of Burden hours per Responses per Total burden
Needs assessment respondents responses respondent hours
----------------------------------------------------------------------------------------------------------------
States/Jurisdictions........................ 59 378.5 1 22,303
-----------------
Total Average Burden for 3 year cycle... .............. ................ ................ 18,064
----------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, PhD., HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of notice.
Dated: September 23, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-19432 Filed 9-28-05; 8:45 am]
BILLING CODE 4165-15-P