Agency Information Collection Activities: Submission for OMB Review; Comment Request, 14928-14929 [E6-4217]
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14928
Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices
situations involving imminent danger to
health or gross deception of the
consumer.
Section 903(d)(2) of the act (21 U.S.C.
393(d)(2)) authorizes the Commissioner
of Food and Drugs to implement general
powers (including conducting research)
to carry out effectively the mission of
FDA. These sections of the act enable
FDA to enhance consumer protection
from risks associated with medical
products usage that are not foreseen or
apparent during the premarket
notification and review process. FDA’s
regulations governing application for
agency approval to market a new drug
(21 CFR part 314) and regulations
governing biological products (21 CFR
part 600) implement these statutory
care professionals, patients, consumers,
and risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to obtain
quickly vital information about medical
product risks and interventions to
reduce risks so the agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
In theFederal Register of October 25,
2005 (70 FR 61624), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of the
collection of information as follows:
provisions. Currently FDA monitors
medical product related postmarket
adverse events via both the mandatory
and voluntary MedWatch reporting
systems using FDA Forms 3500 and
3500A (OMB control number 0910–
0291) and the vaccine adverse event
reporting system. FDA is seeking OMB
clearance to collect vital information via
a series of rapid response surveys.
Participation in these surveys will be
voluntary. This request covers rapid
response surveys for community based
health care professionals, general type
medical facilities, specialized medical
facilities (those known for cardiac
surgery, obstetrics/gynecology services,
pediatric services, etc.), other health
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per
Response
No. of
Respondents
200
1There
Total Annual
Responses
30 (maximum)
6,000
Total Hours
0.5
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA projects 30 emergency risk
related surveys per year with a sample
of between 50 and 200 respondents per
survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
can analyze in a timely manner. The
annual frequency of response was
determined by the maximum number of
questionnaires that will be sent to any
individual respondent. Some
respondents may be contacted only one
time per year, while other respondents
may be contacted several times
annually, depending on the human
drug, biologic, or medical device under
evaluation. It is estimated that, given the
expected type of issues that will be
addressed by the surveys, it will take 0.5
hours for a respondent to gather the
requested information and fill in the
answers.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4262 Filed 3–23–06; 8:45 am]
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
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: Voluntary Partner
Surveys in the Health Resources and
Services Administration—(OMB No.
0915–0212)—Extension
In response to Executive Order 12862,
the Health Resources and Services
BILLING CODE 4160–01–S
In-class evaluations .........................................................................................................
Surveys ............................................................................................................................
Focus groups ...................................................................................................................
VerDate Aug<31>2005
18:26 Mar 23, 2006
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Administration (HRSA) conducts
voluntary customer surveys of its
‘‘partners’’ to assess strengths and
weaknesses in program services. An
extension of a generic approval is being
requested from OMB to conduct these
customer or partner satisfaction surveys.
HRSA partners are typically State or
local governments, health care facilities,
health care consortia, health care
providers, and researchers.
Partner surveys to be conducted by
HRSA might include, for example, brief
surveys of grantees to determine
satisfaction with a technical assistance
contractor, or in-class evaluation forms
completed by providers who receive
training from HRSA grantees, to
measure satisfaction with the training
experience. Results of these surveys will
be used to plan and redirect resources
and efforts as needed to improve
service. Focus groups may also be used
to potential method to obtain input on
services and training. Focus groups, inclass evaluation forms, mail surveys,
and telephone surveys are expected to
be the preferred methodologies.
The estimated response burden is as
follows:
Number of
respondents
Instrument
wwhite on PROD1PC61 with NOTICES
Hours per
Response
Frm 00097
Fmt 4703
Sfmt 4703
Responses
per
respondent
40,000
12,000
50
1
1
1
E:\FR\FM\24MRN1.SGM
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Hours per
response
.05
.25
1.5
Total hour
burden
2,000
3,000
75
14929
Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices
Number of
respondents
Instrument
Responses
per
respondent
52,050
1
Total ..........................................................................................................................
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
John Kraemer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: March 20, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–4217 Filed 3–23–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research
Resources; Notice of Meeting
wwhite on PROD1PC61 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting at the
National Advisory Research Resources
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Research Resources Council.
Date: May 18, 2006.
Open: 8 a.m. to 12 p.m.
Agenda: NCRR’s Director’s report and
other business of the Council.
VerDate Aug<31>2005
18:26 Mar 23, 2006
Jkt 208001
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Louise E. Ramm, PhD,
Deputy Director, National Center for
Research Resources, National Institutes of
Health, Building 31, Room 3B11, Bethesda,
MD 20892, 301–496–6023.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.ncrr.nih.gov/newspub/minutes.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333, National Institutes of Health,
HHS)
Dated: March 20, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–2885 Filed 3–23–06; 8:45 am]
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Hours per
response
Total hour
burden
.10
5,075
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development, Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetingsn will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, SLLP Medicated
Regulations of Sperm Oolemma Binding.
Date: April 18, 2006.
Time: 10 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852. (Telephone Conference Call).
Contact Person: Jon M. Ranhand, PhD,
Scientist Review Administrator, Division of
Scientific Review, National Institute of Child
Health, and Human Development, NIH, 6100
Executive Boulevard, Room 5B01, Bethesda,
MD 20892. (301) 435–6884.
ranhandj@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Mentored Research
Career Development Award.
Date: April 18, 2006.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852. (Telephone Conference Call).
Contact Person: Kishena C. Wadhwani,
PhD, MPH, Scientific Review Administrator,
Division of Scientific Review, 9000 Rockville
Pike, MSC 7510, 6100 Building, Room 5B01,
Bethesda, MD 20892–7510. (301) 496–1485.
wadhwank@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
E:\FR\FM\24MRN1.SGM
24MRN1
]]>Agencies
[Federal Register Volume 71, Number 57 (Friday, March 24, 2006)]
[Notices]
[Pages 14928-14929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4217]
-----------------------------------------------------------------------
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 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: Voluntary Partner Surveys in the Health Resources and
Services Administration--(OMB No. 0915-0212)--Extension
In response to Executive Order 12862, the Health Resources and
Services Administration (HRSA) conducts voluntary customer surveys of
its ``partners'' to assess strengths and weaknesses in program
services. An extension of a generic approval is being requested from
OMB to conduct these customer or partner satisfaction surveys. HRSA
partners are typically State or local governments, health care
facilities, health care consortia, health care providers, and
researchers.
Partner surveys to be conducted by HRSA might include, for example,
brief surveys of grantees to determine satisfaction with a technical
assistance contractor, or in-class evaluation forms completed by
providers who receive training from HRSA grantees, to measure
satisfaction with the training experience. Results of these surveys
will be used to plan and redirect resources and efforts as needed to
improve service. Focus groups may also be used to potential method to
obtain input on services and training. Focus groups, in-class
evaluation forms, mail surveys, and telephone surveys are expected to
be the preferred methodologies.
The estimated response burden is as follows:
----------------------------------------------------------------------------------------------------------------
Responses
Instrument Number of per Hours per Total hour
respondents respondent response burden
----------------------------------------------------------------------------------------------------------------
In-class evaluations........................................ 40,000 1 .05 2,000
Surveys..................................................... 12,000 1 .25 3,000
Focus groups................................................ 50 1 1.5 75
---------------------------------------------------
[[Page 14929]]
Total................................................... 52,050 1 .10 5,075
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
John Kraemer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503.
Dated: March 20, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-4217 Filed 3-23-06; 8:45 am]
BILLING CODE 4165-15-P
