Agency Information Collection Activities: Proposed Collection Comment Request, 5444-5445 [E7-1824]
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5444
Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices
guidance documents on quality systems
auditing practices. As a result of its
efforts, this group has developed
document SG4(PD)N33R13:2006.
SG4(PD)N33R13:2006 (proposed
document), entitled ‘‘Guidelines for
Regulatory Auditing of Quality
Management Systems of Medical Device
Manufacturers—Part 3: Regulatory
Audit Reports,’’ suggests a structure for
audit reports used in multiple
jurisdictions, promoting consistency
and uniformity and should assist the
auditor in preparing a report for use by
multiple regulators and/or auditing
organizations. Having reports that are
consistent in content should facilitate
the review and exchange of audit
reports. Acceptance of audit reports by
multiple regulators should eventually
reduce the number of audits for
manufacturers.
Study Group 2 was initially tasked
with the responsibility of developing
guidance documents that will be used
for the exchange of adverse event
reports. As a result of its efforts, this
group developed SG2N54R8:2006.
SG2N54R8:2006 (final document),
entitled ‘‘Medical Devices Post Market
Surveillance: Global Guidance for
Adverse Event Reporting for Medical
Devices,’’ provides guidance on the type
of adverse events associated with
medical devices that should be reported
by manufacturers to a National
Competent Authority. It elaborates on
the regulatory requirements existing in
the participating member countries.
sroberts on PROD1PC70 with NOTICES
II. Significance of Guidance
These documents represent
recommendations from the GHTF study
groups and do not describe regulatory
requirements. FDA is making these
documents available so that industry
and other members of the public may
express their views and opinions.
III. Electronic Access
Persons interested in obtaining a copy
of the documents may also do so by
using the Internet. The Center for
Devices and Radiological Health (CDRH)
maintains an entry on the Internet for
easy access to information including
text, graphics, and files that may be
downloaded to a personal computer
with Internet access. Updated on a
regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
VerDate Aug<31>2005
16:03 Feb 05, 2007
Jkt 211001
submissions, Mammography Matters,
and other device-oriented information.
Information on the GHTF may be
accessed at https://www.ghtf.org. The
CDRH web site may be accessed at
https://www.fda.gov/cdrh.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding these documents.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Comments
received may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: January 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–1864 Filed 2–5–07; 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) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) will publish 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, call the
HRSA Reports Clearance Officer on
(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
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Sfmt 4703
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: Reporting Form for
the MCHB National Hemophilia
Program Grantees and Hemophilia
Treatment Center (HTC) Affiliates
Having Factor Replacement Product
(FRP) Programs—NEW
The Maternal and Child Health
Bureau (MCHB) of the Health Resources
and Services Administration (HRSA) is
planning to implement an annual
reporting form required of grantees of
the MCHB National Hemophilia
Program and their HTC affiliates having
a factor replacement product (FRP)
program. The purpose of the form is to
provide systematic information and data
comprising a financial overview of the
FRP programs of the HTCs receiving
funding through grantees of the MCHB
National Hemophilia Program. The
proposed form will constitute a
reporting requirement for the MCHB
National Hemophilia Program grantees
and their affiliate HTCs having FRP
programs.
Data from the form will provide
quantitative information on the
financial and services provision aspects
of each of the HTC FRP programs under
each of the MCHB National Hemophilia
Program grantees, specifically: (a)
Patient FRP program participation, (b)
FRP program revenue, (c) FRP program
costs, (d) FRP program net income, and
(e) use of FRP program net income. This
form will provide data useful to grantees
and their affiliate HTCs having FRP
programs. Useful data will also be
provided to the MCHB National
Hemophilia Program in order to assess
FRP program performance including
FRP program operational costs
appropriateness, FRP program cost
efficiency, and FRP program services
benefits-information that is essential to
evaluating HTCs having FRP programs,
grantees, and the MCHB National
Hemophilia Program.
Each HTC having an FRP program is
to submit its report to the grantee and
each grantee is to submit the individual
reports of each of their affiliate HTCs
having an FRP program to the MCHB
National Hemophilia Program as a part
of their annual grant application.
The burden estimate for this project is
as follows:
E:\FR\FM\06FEN1.SGM
06FEN1
5445
Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices
Form
Number of
respondents
Average number of responses per
respondent
Total
responses
Hours per
response
Total burden
hours
Factor Replacement Product (FRP) Data Sheet .................
68
1
68
30
2040
Agency Information Collection
Activities: Proposed Collection:
Comment Request
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, call the HRSA Reports
Clearance Officer on (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.
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,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to the Office of
Proposed Project: ‘‘Health Care and
Other Facilities’’ Construction Program:
Web-Based Status Reporting Form:
NEW
The Health Resources and Services
Administration’s Health Care and Other
Facilities (HCOF) construction program
provides earmarked funds to healthrelated facilities for construction-related
activities and/or capital equipment
purchases. Awarded facilities are
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33 Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857. Written comments should be
received within 60 days of this notice.
Dated: January 29, 2007.
Caroline Lewis,
Acting Associate Administrator for
Administration and Financial Management.
[FR Doc. E7–1824 Filed 2–5–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Project type
(current)
Responses
per
respondent
Number of
respondents
required to provide a periodic (quarterly
for construction-related projects,
annually for equipment only projects)
update of the status of the funded
project until it is completed. The
monitoring period averages about 3
years, although some projects take up to
5 years to complete. The information
collected from these updates is vital to
program management staff to determine
whether projects are progressing
according to the established timeframes,
meeting deadlines established in the
Notice of Grant Award (NGA), and
funds are drawn down appropriately.
The data collected from the updates is
also shared with both the Division of
Grants Management Operations (DGMO)
and the Division of Engineering Services
(DES), so that they can assist in the
overall evaluation of each project’s
progress.
A Web-based form has been
developed for progress reporting for the
HCOF program. This form will provide
awardees access to directly input the
required status update information in a
timely, consistent, and uniform manner.
The Web-based form will minimize
burden to respondents and will inform
respondents when there are missing
data elements prior to submission.
The estimate of burden for the forms
is as follows:
Total
responses
Hours per
response
Total burden
hours
Construction-Related .........................................................
Equipment Only .................................................................
325
357
4
1
1,300
357
.5
.5
650
178.5
Total ............................................................................
682
........................
1,657
........................
828.5
Project type
(FY 07–09 projection)
Responses
per
espondent
Number of
respondents
Total
responses
Hours per response
498
925
4
1
1,992
925
.5
.5
Total ............................................................................
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Construction-Related* ........................................................
Equipment Only** ...............................................................
1,423
........................
2,917
........................
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06FEN1
Total burden
hours
996
462.5
1,458
]]>Agencies
[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Notices]
[Pages 5444-5445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1824]
-----------------------------------------------------------------------
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) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Public Law 104-13), the Health Resources and Services
Administration (HRSA) will publish 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, call the HRSA Reports Clearance Officer on (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: Reporting Form for the MCHB National Hemophilia
Program Grantees and Hemophilia Treatment Center (HTC) Affiliates
Having Factor Replacement Product (FRP) Programs--NEW
The Maternal and Child Health Bureau (MCHB) of the Health Resources
and Services Administration (HRSA) is planning to implement an annual
reporting form required of grantees of the MCHB National Hemophilia
Program and their HTC affiliates having a factor replacement product
(FRP) program. The purpose of the form is to provide systematic
information and data comprising a financial overview of the FRP
programs of the HTCs receiving funding through grantees of the MCHB
National Hemophilia Program. The proposed form will constitute a
reporting requirement for the MCHB National Hemophilia Program grantees
and their affiliate HTCs having FRP programs.
Data from the form will provide quantitative information on the
financial and services provision aspects of each of the HTC FRP
programs under each of the MCHB National Hemophilia Program grantees,
specifically: (a) Patient FRP program participation, (b) FRP program
revenue, (c) FRP program costs, (d) FRP program net income, and (e) use
of FRP program net income. This form will provide data useful to
grantees and their affiliate HTCs having FRP programs. Useful data will
also be provided to the MCHB National Hemophilia Program in order to
assess FRP program performance including FRP program operational costs
appropriateness, FRP program cost efficiency, and FRP program services
benefits-information that is essential to evaluating HTCs having FRP
programs, grantees, and the MCHB National Hemophilia Program.
Each HTC having an FRP program is to submit its report to the
grantee and each grantee is to submit the individual reports of each of
their affiliate HTCs having an FRP program to the MCHB National
Hemophilia Program as a part of their annual grant application.
The burden estimate for this project is as follows:
[[Page 5445]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average number
Form Number of of responses Total Hours per Total burden
respondents per respondent responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Factor Replacement Product (FRP) Data Sheet........................ 68 1 68 30 2040
--------------------------------------------------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville,
Maryland 20857. Written comments should be received within 60 days of
this notice.
Dated: January 29, 2007.
Caroline Lewis,
Acting Associate Administrator for Administration and Financial
Management.
[FR Doc. E7-1824 Filed 2-5-07; 8:45 am]
BILLING CODE 4165-15-P
