Agency Information Collection Activities: Submission for OMB Review; Comment Request, 46638-46639 [E7-16368]
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Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices
Dated: August 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16470 Filed 8–20–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Medical Devices 101: An Educational
Forum; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC64 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Office (SWRO), in
cosponsorship with the FDA Medical
Device Industry Coalition (FMDIC), is
announcing a public workshop entitled
‘‘Medical Devices 101: An Educational
Forum.’’ This public workshop,
presented previously on February 9,
2007, is intended to provide an
overview on FDA’s medical device
requirements to entrepreneurs, startup
companies, and small businesses.
Date and Time: The public workshop
will be held on October 26, 2007, from
8 a.m. to 5 p.m.
Location: The public workshop will
be held at the FDA SWRO, 4040 North
Central Expressway, 9th floor
conference room, Dallas, TX.
Contact Person: David Arvelo, Food
and Drug Administration, 4040 North
Central Expressway, suite 900, Dallas,
TX 75204, 214–253–4952, FAX: 214–
253–4970, e-mail:
oraswrsbr@fda.hhs.gov.
Registration: FMDIC has a $75 early
registration fee. The early registration
fee for government officials is $50 and
for students is $25 with positive
identification. Early registration ends
October 12, 2007. After October 12,
2007, registration is $100 for the public
at large, $75 for government officials,
and $50 for students with positive
identification. To register online, please
visit https://www.fmdic.org/. As an
alternative, you may mail your
registration information including
name, title, organization or company
name, physical address, telephone and
fax numbers, and e-mail address, along
with a check or money order for the
appropriate amount payable to the
FMDIC, to William Hyman, Texas A&M
University, Department of Biomedical
Engineering, 3120 TAMU, College
Station, TX 75843–3120. The available
space will be filled in order of receipt
VerDate Aug<31>2005
15:08 Aug 20, 2007
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of registration with appropriate fees.
Seats are very limited; please submit
registration as soon as possible. Those
accepted into the course will receive
confirmation. Registration will close
after the course is filled. Registration at
the site may be available based on space
availability on the day of the public
workshop beginning at 8 a.m. The cost
of registration at the site is $99 payable
to FMDIC. The registration fee will be
used to offset expenses associated with
this event including lunch,
refreshments, and course materials.
If you require special
accommodations due to a disability,
please contact David Arvelo (see
Contact Person) at least 21 days in
advance.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at an estimated cost of
10 cents per page.
SUPPLEMENTARY INFORMATION: The
workshop, previously presented on
February 9, 2007 (72 FR 968, January 9,
2007), is being held in response to the
interest in the topics discussed from
small medical device entrepreneurs and
startup manufacturers in the Dallas
District area. FDA presents this
workshop in cosponsorship with FMDIC
to help achieve objectives set forth in
section 406 of the Food and Drug
Administration Modernization Act of
1997 (21 U.S.C. 393), which include
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. This is also consistent with the
purposes of FDA’s Regional Small
Business Program, which are in part to
respond to industry inquiries, develop
educational materials, and sponsor
workshops and conferences to provide
firms, particularly small businesses,
with firsthand working knowledge of
FDA’s requirements and compliance
policies. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as an
outreach activity by Government
agencies to small businesses.
The goal of the workshop is to present
information that will enable
manufacturers and regulated industry to
better comply with the Medical Device
Quality System Regulation. The
following topics will be broadly covered
at the workshop: (1) Medical device
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classification; (2) establishment
registration; (3) device listing; (4)
premarket notification; (5) premarket
approval; (6) quality system regulation;
(7) labeling; (8) recalls, removals, and
corrections; (9) medical device
reporting; (10) tracking; and (11)
postmarket surveillance.
Dated: August 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16375 Filed 8–20–07; 8:45 am]
BILLING CODE 4160–01–S
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, in
compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). 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: Data Collection Tool
for the Black Lung Clinics Program:
(OMB No. 0915–0292) Revision
The Office of Rural Health Policy
(ORHP), Health Resources and Services
Administration, conducts an annual
data collection of user information for
the Black Lung Clinics Program. The
purpose of the Black Lung Clinics
Program is to improve the health status
of coal workers by providing services to
minimize the effects of respiratory and
pulmonary impairments of coal miners.
Grantees provide specific diagnostic and
treatment procedures required in the
management of problems associated
with black lung disease which improves
the quality of life of the miner and
reduces economic costs associated with
morbidity and mortality arising from
pulmonary diseases. The purpose of
collecting this data is to provide HRSA
with information on how well each
grantee is meeting the needs of active
and retired miners in the funded
communities.
Data from the annual report will
provide quantitative information about
E:\FR\FM\21AUN1.SGM
21AUN1
46639
Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices
the programs, specifically: (a) The
characteristics of the patients they serve
(gender, age, disability level, occupation
type); (b) the characteristics of services
provided (medical, non-medical, or
counseling); (c) number of patients
served and visits conducted
(encounters); and (d) the improvement
in pulmonary function of patients
(pulmonary rehabilitation). This
assessment will provide data useful to
the program and will enable HRSA to
provide data required by Congress
under the Government Performance and
Results Act of 1993. It will also ensure
that the organizations funded have
demonstrated a need for services in
their communities and that funds are
being effectively used to provide
services to meet those needs.
The estimated burden is as follows:
Form name
Number of
respondents
Hours per
response
Total burden
hours
Database ......................................................................................................................................
15
20
300
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: August 15, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–16368 Filed 8–20–07; 8:45 am]
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
Health Resources and Services
Administration, HHS.
ACTION: Correction of total burden
hours.
AGENCY:
SUMMARY: The Health Resources and
Services Administration published an
Agency Information Collection
document in the Federal Register of
July 31, 2007 (FR Doc. E7–14680), on
page 41759, regarding Bureau of
Primary Health Care (BPHC) Uniform
Data System (OMB No. 0915–0193). In
the burden table, the total burden hours
published are incorrect.
Correction
In the Federal Register issue of July
31, 2007, FR Doc. E7–14680), on page
41759, correct the Total Burden Hours
as follows:
The purpose of these surveys is to
conduct a follow-up study to the
National Practitioner Data Bank (NPDB)
Total ...............................
60,804 User and Non-User Surveys of 2001. In
addition, Healthcare Integrity and
Protection Data Bank (HIPDB) users and
Dated: August 15, 2007.
non-sers will be included in this study.
Alexandra Huttinger,
The study will evaluate the
Acting Director, Division of Policy Review
effectiveness of the NPDB and the
and Coordination.
HIPDB as flagging systems, sources of
[FR Doc. E7–16370 Filed 8–20–07; 8:45 am]
information, and decisionmaking tools.
BILLING CODE 4165–15–P
It will also determine user satisfaction
with the process, use, and information
provided by the NPDB and HIPDB.
DEPARTMENT OF HEALTH AND
Surveys will be administered to
HUMAN SERVICES
entities that report to and/or query the
NPDB and HIPDB, including users who
Health Resources and Services
query either the NPDB and/or HIPDB
Administration
and who receive a ‘‘match’’, i.e. copies
of adverse actions concerning a queried
Agency Information Collection
practitioner. A sample of Queriers who
Activities: Submission for OMB
received a matched response will be
Review; Comment Request
surveyed about the information
received. NPDB and HIPDB non-users
Periodically, the Health Resources
will also be surveyed. Eligible NPDB
and Services Administration (HRSA)
and HIPDB users will be asked to
publishes abstracts of information
complete a Web-based Internet survey
collection requests under review by the
or a computer-assisted telephone
Office of Management and Budget
interview (CATI). NPDB and HIPDB
(OMB), in compliance with the
non-users will complete either a Web or
Paperwork Reduction Act of 1995 (44
CATI, or will be transferred to an
U.S.C. Chapter 35). To request a copy of interactive voice response (IVR) system
the clearance requests submitted to
during the CATI to complete the survey.
Data gathered from the survey will be
OMB for review, call the HRSA Reports
compared with similar information from
Clearance Office on (301) 443–1129.
previous surveys of users and non-users
The following request has been
and will provide HRSA with the
submitted to the Office of Management
information necessary to improve the
and Budget for review under the
usability of the NPDB and HIPDB.
Paperwork Reduction Act of 1995:
The estimate of burden is as follows:
Universal report ....................
Grant report ..........................
rmajette on PROD1PC64 with NOTICES
Respondents
Respondent description
NPDB Users Group Survey
15:08 Aug 20, 2007
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PO 00000
Frm 00041
58,104
2,700
Responses
per
respondent
Number of
respondents
Malpractice Payers ............
Licensing Boards ...............
Hospitals (Reporting) .........
Hospitals (Querying) ..........
MCOs ................................
VerDate Aug<31>2005
Total burden
hours
Type of report
Proposed Project: National Practitioner
Data Bank and Healthcare Integrity and
Protection Data Bank Market Surveys
and Survey of Use of Data Bank
Information by Queriers: NEW
228
90
466
994
900
Fmt 4703
Sfmt 4703
Total
responses
1
1
1
1
1
E:\FR\FM\21AUN1.SGM
228
90
466
994
900
21AUN1
Hours per
response
Total burden
(hours)
.25
.25
.25
.25
.25
57
22.5
116.5
248.5
225
]]>Agencies
[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Notices]
[Pages 46638-46639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16368]
-----------------------------------------------------------------------
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, in compliance with the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 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: Data Collection Tool for the Black Lung Clinics
Program: (OMB No. 0915-0292) Revision
The Office of Rural Health Policy (ORHP), Health Resources and
Services Administration, conducts an annual data collection of user
information for the Black Lung Clinics Program. The purpose of the
Black Lung Clinics Program is to improve the health status of coal
workers by providing services to minimize the effects of respiratory
and pulmonary impairments of coal miners. Grantees provide specific
diagnostic and treatment procedures required in the management of
problems associated with black lung disease which improves the quality
of life of the miner and reduces economic costs associated with
morbidity and mortality arising from pulmonary diseases. The purpose of
collecting this data is to provide HRSA with information on how well
each grantee is meeting the needs of active and retired miners in the
funded communities.
Data from the annual report will provide quantitative information
about
[[Page 46639]]
the programs, specifically: (a) The characteristics of the patients
they serve (gender, age, disability level, occupation type); (b) the
characteristics of services provided (medical, non-medical, or
counseling); (c) number of patients served and visits conducted
(encounters); and (d) the improvement in pulmonary function of patients
(pulmonary rehabilitation). This assessment will provide data useful to
the program and will enable HRSA to provide data required by Congress
under the Government Performance and Results Act of 1993. It will also
ensure that the organizations funded have demonstrated a need for
services in their communities and that funds are being effectively used
to provide services to meet those needs.
The estimated burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Hours per Total burden
Form name respondents response hours
----------------------------------------------------------------------------------------------------------------
Database..................................................... 15 20 300
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: August 15, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-16368 Filed 8-20-07; 8:45 am]
BILLING CODE 4165-15-P
