Agency Information Collection Activities: Proposed Collection: Comment Request, 38605-38606 [E7-13626]
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38605
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on this topic. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. 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. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/reading.htm.
Dated: July 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–13667 Filed 7–12–07; 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 on
(301) 443–1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (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: Uniform Progress
Reports (OMB No. 0915–0061)—
Revision
The HRSA Uniform Progress Report
(UPR) is used for the preparation and
submission of continuation applications
Number of
respondents
Report
Responses
per
respondent
for Title VII and VIII health professions
and nursing education and training
programs. The UPR measures grantee
success in meeting (1) The objectives of
the grant project, and (2) the crosscutting outcomes developed for the
Bureau of Health Professions’ education
and training programs. Part I of the
progress report is designed to collect
information to determine whether
sufficient progress has been made on the
approved project objectives, as grantees
must demonstrate satisfactory progress
to warrant continuation of funding. Part
II collects information on activities
specific to a given program. Part III, the
Comprehensive Performance
Management System (CPMS), collects
data on overall project performance
related to the Bureau’s strategic goals,
objectives, outcomes, and indicators.
Progress will be measured based on the
objectives of the grant project, and
outcome measures and indicators
developed by the Bureau to meet
requirements of the Government
Performance and Results Act (GPRA).
The Bureau has simplified several
tables in UPR II and added the ability
for grantees to provide better race and
ethnicity data. In addition, to respond to
the requirements of GPRA, the Bureau
has revised its cross-cutting goals,
expected outcomes, and indicators in
UPR III CPMS that provide the
framework for collection of outcome
data for its Title VII and VIII programs.
An outcome based performance system
is critical for measuring whether
program support is meeting national
health workforce objectives. At the core
of the performance measurement system
are found cross-cutting goals with
respect to workforce quality, supply,
diversity, and distribution of the health
professions workforce.
The estimated annual burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
1,550
1
1,550
24
37,200
Total ..............................................................................
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Uniform progress report .......................................................
1,550
........................
1,550
........................
37,200
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38606
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices
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 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: July 5, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–13626 Filed 7–12–07; 8:45 am]
Proposed Project: Healthcare Integrity
and Protection Data Bank for Final
Adverse Information on Health Care
Providers, Suppliers, and Practitioners
(OMB No. 0915–0239)—Extension
BILLING CODE 4165–15–P
Section 221(a) of the Health Insurance
Portability and Accountability Act
(HIPAA) of 1996 specifically directs the
Secretary to establish a national health
care fraud and abuse data collection
program for the reporting and disclosure
of certain final adverse actions taken
against health care providers, suppliers,
and practitioners. A final rule was
published October 26, 1999, in the
Federal Register to implement the
statutory requirements of section 1128E
of the Social Security Act (The Act) as
added by Section 221(a) of HIPAA. The
Act requires the Secretary to implement
the national health care fraud and abuse
data collection program. This Data Bank
is known as the Healthcare Integrity and
Protection Data Bank (HIPDB). It
contains the following types of
information: (1) Civil judgments against
a health care provider, supplier, or
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
Regulatory citation
61.6(a),(b) Errors & Omissions .........................................
61.6 Revisions/Appeal Status ...........................................
61.7 Reporting by State Licensure Boards .......................
61.8 Reporting of State Criminal Convictions ...................
61.9 Reporting of Civil Judgments ....................................
61.10(b) Reporting Exclusions from participating in Federal and State Health Care Programs .............................
61.11 Reporting of adjudicated actions/decisions .............
61.12 Request for Information—State & Federal Agencies ...................................................................................
61.12 Request for Information—Health Plans, etc. ..........
61.12 Request for Information—Health Care Providers,
Suppliers, Practitioners (Self-query) ................................
61.12(a)(4) Request by Researchers for Aggregate Data
61.15 Place Report in Dispute ..........................................
61.15 Add a Subject Statement ........................................
61.15 Request for Secretarial Review ..............................
Total ..............................................................................
Frequency of
responses
practitioner in Federal or State court
related to the delivery of a health care
item or service; (2) Federal or State
criminal convictions against a health
care provider, supplier, or practitioner
related to the delivery of a health care
item or service; (3) Actions by Federal
or State agencies responsible for the
licensing and certification of health care
providers, suppliers, or practitioners; (4)
Exclusion of a health care provider,
practitioner or supplier from
participation in Federal or State health
care programs; and (5) Any other
adjudicated actions or decisions that the
Secretary shall establish by regulations.
Access to this Data Bank is limited to
Federal and State Government agencies
and health plans. The final regulations
governing the HIPDB are codified at 45
CFR part 61.
The reporting forms and the request
for information forms (query forms)
must be accessed, completed, and
submitted to the HIPDB electronically
through the HIPDB Web site at https://
www.npdb-hipdb.hrsa.gov. All reporting
and querying is performed through this
secure Web site. Due to overlap in
requirements for the HIPDB, some of the
National Practitioner Data Bank’s
burden has been subsumed under the
HIPDB.
Estimates of burden are as follows:
Total
responses
pwalker on PROD1PC71 with NOTICES
19:05 Jul 12, 2007
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Total burden
hours
188
130
305
45
4
4.4
26.9
80.8
56.0
2.5
817
3,492
24,640
2,518
10
15
30
45
45
45
204.25
1,746
18,480
1,888.5
7.5
9
92
320.3
17
2,883
1,562
20
45
961
1,171.5
855
1,239
279.3
532.4
238,814
659,617
5
5
19,901.26
54,968.1
50,416
1
300
669
15
1
1
1
1
1
50,416
1
300
669
15
25
30
5
45
480
21,006.7
.5
25
501.8
120
54,268
........................
985,754
........................
120,982.11
Note: Numbers in the table may not add up exactly due to rounding.
VerDate Aug<31>2005
Hours per
response
(min.)
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Agencies
[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38605-38606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13626]
-----------------------------------------------------------------------
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 on (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (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: Uniform Progress Reports (OMB No. 0915-0061)--
Revision
The HRSA Uniform Progress Report (UPR) is used for the preparation
and submission of continuation applications for Title VII and VIII
health professions and nursing education and training programs. The UPR
measures grantee success in meeting (1) The objectives of the grant
project, and (2) the cross-cutting outcomes developed for the Bureau of
Health Professions' education and training programs. Part I of the
progress report is designed to collect information to determine whether
sufficient progress has been made on the approved project objectives,
as grantees must demonstrate satisfactory progress to warrant
continuation of funding. Part II collects information on activities
specific to a given program. Part III, the Comprehensive Performance
Management System (CPMS), collects data on overall project performance
related to the Bureau's strategic goals, objectives, outcomes, and
indicators. Progress will be measured based on the objectives of the
grant project, and outcome measures and indicators developed by the
Bureau to meet requirements of the Government Performance and Results
Act (GPRA).
The Bureau has simplified several tables in UPR II and added the
ability for grantees to provide better race and ethnicity data. In
addition, to respond to the requirements of GPRA, the Bureau has
revised its cross-cutting goals, expected outcomes, and indicators in
UPR III CPMS that provide the framework for collection of outcome data
for its Title VII and VIII programs. An outcome based performance
system is critical for measuring whether program support is meeting
national health workforce objectives. At the core of the performance
measurement system are found cross-cutting goals with respect to
workforce quality, supply, diversity, and distribution of the health
professions workforce.
The estimated annual burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Report respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Uniform progress report......... 1,550 1 1,550 24 37,200
-------------------------------------------------------------------------------
Total....................... 1,550 .............. 1,550 .............. 37,200
----------------------------------------------------------------------------------------------------------------
[[Page 38606]]
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 this
notice.
Dated: July 5, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-13626 Filed 7-12-07; 8:45 am]
BILLING CODE 4165-15-P