Agency Information Collection Activities; Proposed Collection; Comment Request, 37247-37248 [E7-13167]
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Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices
On December 20, 2002, the agency
announced its intention to extend
Pearson to health claims for
conventional foods (67 FR 78002).
Recognizing the need for an approach
for scientific evaluations for qualified
health claims, the task force on
‘‘Consumer Health Information for
Better Nutrition’’ was formed. As part of
the task force’s final report,1 FDA
developed an interim evidence-based
review system that the agency intended
to use to evaluate the substance/disease
relationships that are subjects of
qualified health claims.
In reviewing both the December 22,
1999, guidance document and the 2003
task force report, it became apparent to
the agency that the components of the
scientific review process for an SSA
health claim and qualified health claim
are very similar. Because of the
similarity between the scientific reviews
for SSA and qualified health claims,
FDA intends to generally use the
approach set out in this draft guidance
for evaluating the scientific evidence in
petitions that are submitted for an SSA
health claim or qualified health claim.
The primary purpose of this
document is to set out FDA’s current
thinking on the process for evaluating
the scientific evidence for a health
claim, the meaning of the SSA standard
in section 403(r)(3) of the act and
§ 101.14(c), and credible scientific
evidence to support a qualified health
claim.
This draft guidance is being issued
consistent with FDA’s good guidance
practice regulations (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the scientific review process for SSA
and qualified health claims. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
rwilkins on PROD1PC63 with NOTICES
1See guidance entitled ‘‘Interim Evidence-based
Ranking System for Scientific Data,’’ July 10, 2003
(https://www.cfsan.fda.gov/~dms/hclmgui4.html).
VerDate Aug<31>2005
16:59 Jul 06, 2007
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the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in §§ 101.14 and 101.70
have been approved under OMB control
number 0910–0381.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the draft guidance
document. 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. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.cfsan.fda.gov/guidance.html.
Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–13274 Filed 7–6–07; 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)(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, call the HRSA Reports
Clearance Officer at (301) 443–1129.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
37247
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 estimated 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: Office of Health
Information Technology, Health Center
Controlled Networks Progress
Reports—New
The Office of Health Information
Technology (OHIT), Division of State
and Community Assistance (DSCA)
plans to collect network outcome
measures, conduct evaluation of those
measures, and create an electronic
reporting system for the following new
2007 grant opportunities: Health
Information Technology Planning
Grants, Electronic Health Record
Implementation Health Center
Controlled Networks, Health
Information Technology Innovations for
Health Center Controlled Networks, and
High Impact Electronic Health Records
Implementation for Health Center
Controlled Networks and Large Multi
Site Health Centers.
In order to help carry out its mission,
DSCA has created a set of performance
measures that grantees will use to
evaluate the effectiveness of their
service programs and monitor their
progress through the use of performance
reporting data.
OHIT will develop an electronic
performance measurement reporting
instrument with HRSA’s Office of
Information Technology. The
instrument will be developed to
accomplish the following goals: To
monitor improved access to needed
services, to evaluate the productivity
and efficiency of the networks, and to
monitor patient outcome measures.
Grantees will submit their Progress
Reports in a mid-year report and an
accumulative annual progress report
each fiscal year of the grant.
The estimates of burden are as
follows:
E:\FR\FM\09JYN1.SGM
09JYN1
37248
Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices
Number of respondents
Application
Responses
per respondent
Total responses
Hours per response
Total burden
hours
Planning ...............................................................................
Electronic Health Records Implementation .........................
Innovations Category 1 ........................................................
Innovations Category 2 ........................................................
High Impact ..........................................................................
12
8
7
5
8
2
2
2
2
2
24
16
14
10
16
18
18
18
18
18
432
288
252
180
288
Totals ............................................................................
40
........................
80
........................
1,440
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
OMB for review, 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:
Dated: June 28, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–13167 Filed 7–6–07; 8:45 am]
Proposed Project: Reporting Form for
the MCHB National Hemophilia
Program Grantees and Hemophilia
Treatment Center (HTC) Affiliates
Having Factor Replacement Product
(FRP) Programs
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.
BILLING CODE 4165–15–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
Number of
respondents
Form
Factor Replacement Product (FRP) Data Sheet .................
rwilkins on PROD1PC63 with NOTICES
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
Karen Matsuoka, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: June 28, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–13168 Filed 7–6–07; 8:45 am]
BILLING CODE 4165–15–P
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16:59 Jul 06, 2007
Jkt 211001
Average
number of responses per
respondent
68
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
Frm 00067
Fmt 4703
Sfmt 4703
Total
responses
1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
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 as well as to the MCHB
National Hemophilia Program. The data
will be used 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 estimated response burden for
grantees is as follows:
68
Hours per
response
Total burden
hours
30
2,040
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, 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: ‘‘Health Care and
Other Facilities’’ Project Status Update
Form: NEW
The Health Resources and Services
Administration’s Health Care and Other
Facilities (HCOF) program provides
earmarked funds to health-related
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37247-37248]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13167]
-----------------------------------------------------------------------
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 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, 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 estimated 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: Office of Health Information Technology, Health
Center Controlled Networks Progress Reports--New
The Office of Health Information Technology (OHIT), Division of
State and Community Assistance (DSCA) plans to collect network outcome
measures, conduct evaluation of those measures, and create an
electronic reporting system for the following new 2007 grant
opportunities: Health Information Technology Planning Grants,
Electronic Health Record Implementation Health Center Controlled
Networks, Health Information Technology Innovations for Health Center
Controlled Networks, and High Impact Electronic Health Records
Implementation for Health Center Controlled Networks and Large Multi
Site Health Centers.
In order to help carry out its mission, DSCA has created a set of
performance measures that grantees will use to evaluate the
effectiveness of their service programs and monitor their progress
through the use of performance reporting data.
OHIT will develop an electronic performance measurement reporting
instrument with HRSA's Office of Information Technology. The instrument
will be developed to accomplish the following goals: To monitor
improved access to needed services, to evaluate the productivity and
efficiency of the networks, and to monitor patient outcome measures.
Grantees will submit their Progress Reports in a mid-year report and an
accumulative annual progress report each fiscal year of the grant.
The estimates of burden are as follows:
[[Page 37248]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Application respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Planning........................ 12 2 24 18 432
Electronic Health Records 8 2 16 18 288
Implementation.................
Innovations Category 1.......... 7 2 14 18 252
Innovations Category 2.......... 5 2 10 18 180
High Impact..................... 8 2 16 18 288
-------------------------------------------------------------------------------
Totals...................... 40 .............. 80 .............. 1,440
----------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: June 28, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7-13167 Filed 7-6-07; 8:45 am]
BILLING CODE 4165-15-P
