Proposed Data Collections Submitted for Public Comment and Recommendations, 52492-52493 [E9-24522]
Download as PDF
<![CDATA[
52492
Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices
that strive to augment the informed
consent document and increase a
subject’s understanding of research
participation. The meeting will
conclude with a panel of speakers
focusing on the regulatory barriers that
may be associated with Community
Based and Participatory Research.
Public comment will be heard on both
days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
Thursday, October 22, 2009.
Information about SACHRP and the
draft meeting agenda will be posted on
the SACHRP Web site at: https://
www.hhs.gov/ohrp/sachrp/.
Dated: October 6, 2009.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. E9–24482 Filed 10–9–09; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood Safety and Availability
erowe on DSK5CLS3C1PROD with NOTICES
AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Blood Safety
and Availability (ACBSA) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will take place
Thursday, November 19 and Friday,
November 20, 2009 from 8:30 a.m. to 5
p.m.
ADDRESSES: The Universities at Shady
Grove, 9630 Gudelsky Drive, Rockville,
MD 20850, Phone: 301–738–6000.
FOR FURTHER INFORMATION CONTACT: Jerry
A. Holmberg, PhD, Executive Secretary,
VerDate Nov<24>2008
15:29 Oct 09, 2009
Jkt 220001
Advisory Committee on Blood Safety
and Availability, Office of Public Health
and Science, Department of Health and
Human Services, 1101 Wootton
Parkway, Suite 250, Rockville, MD
20852, (240) 453–8803, FAX (240) 453–
8456, e-mail ACBSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Advisory Committee on Blood Safety
and Availability provides advice to the
Secretary and the Assistant Secretary for
Health on a range of policy issues that
impact (1) Definition of public health
parameters around safety and
availability of the blood supply and
blood products, (2) broad public health,
ethical and legal issues related to
transfusion and transplantation safety,
and (3) the implications for safety and
the availability of various economic
factors affecting product cost and
supply.
In keeping with its established
mission, the ACBSA has been asked to
review and comment on the current
processes and parameters which should
be used in the decision-making process
for transplantation safety policy. At the
November 19 and 20, 2009 meeting, the
Committee will be asked to comment
and make recommendations on current
safety decision making processes within
the Department of Health and Human
Services while considering those same
processes within the Private Sector.
During the meeting, the ACBSA will
be provided a briefing on Biovigilance
(surveillance of blood, organs, and
tissues safety). Specifically, the
committee will be asked to comment on
the white paper entitled, ‘‘Biovigilance
in the United States: Efforts to Bridge a
Critical Gap in Patient Safety and Donor
Health.’’
The public will have opportunity to
present their views to the Committee on
both meeting days. A public comment
session has been scheduled for
November 19 and 20, 2009. Comments
will be limited to five minutes per
speaker and must be pertinent to the
discussion. Pre-registration is required
for participation in the public comment
session. Any member of the public who
would like to participate in this session
is encouraged to contact the Executive
Secretary at his/her earliest
convenience. It is requested that those
who wish to have printed material
distributed to the Committee provide
thirty (30) copies of the document to be
distributed to the Executive Secretary,
ACBSA, prior to close of business
November 16, 2009. If it is not possible
to provide 30 copies of the material to
be distributed, then individuals are
requested to provide at a minimum one
(1) copy of the document(s) to be
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
distributed prior to the close of business
November 16, 2009. It also is requested
that any member of the public who
wishes to provide comments to the
Committee utilizing electronic data
projection submit the necessary material
to the Executive Secretary prior to close
of business November 16, 2009.
Dated: September 25, 2009.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on
Blood Safety and Availability.
[FR Doc. E9–24483 Filed 10–9–09; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–0612]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Well-Integrated Screening and
Evaluation for Women Across the
Nation (WISEWOMAN) Reporting
System (OMB #0920–0612, exp.
1/31/2010)—Revision—National Center
E:\FR\FM\13OCN1.SGM
13OCN1
52493
Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices
for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Cardiovascular disease (CVD), which
includes heart disease, myocardial
infarction, and stroke, is the leading
cause of death for women in the United
States, and is largely preventable. The
WISEWOMAN program (Well-Integrated
Screening and Evaluation for Women
Across the Nation), administered by the
Centers for Disease Control and
Prevention (CDC), was established to
examine ways to improve the delivery
of services for women who have limited
access to health care and elevated risk
factors for CVD. The program focuses on
reducing CVD risk factors and provides
screening services for select risk factors
such as elevated blood cholesterol,
hypertension and abnormal blood
glucose levels. The program also
provides lifestyle interventions and
medical referrals. On an annual basis,
15 grantees funded through the
WISEWOMAN program have provided
services to approximately 30,000
women who are already participating in
the National Breast and Cervical Cancer
Early Detection Program (NBCCEDP),
also administered by CDC. CDC plans to
WISEWOMAN program is at reducing
the burden of cardiovascular disease
risk factors among women who utilize
program services. The information
collected from grantees is also used to
assess the cost-effectiveness and impact
of the program. The overall program
evaluation is designed to demonstrate
how WISEWOMAN can obtain more
complete health data on vulnerable
populations, promote public education
about disease incidence and risk-factors,
improve the availability of screening
and diagnostic services for under-served
women, ensure the quality of services
provided to under-served women, and
develop strategies for improved
interventions. The information reported
to CDC also includes programmatic
information related to grantee
management, public education and
outreach, professional education,
service delivery, cost, and progress
toward meeting stated programmatic
objectives.
All MDE information will be
submitted to CDC electronically.
Progress reports will be submitted in
hardcopy format. Because certain
demographic information has already
been collected as part of NBCCEDP, the
additional burden on grantees will be
modest. There is no cost to the
respondents other than their time.
increase the reach of the WISEWOMAN
program by increasing the number of
grantees from 15 to 21.
CDC currently collects information
from WISEWOMAN grantees to support
continuous program monitoring and
improvement activities. CDC seeks to
extend OMB approval for three
additional years. The total estimated
annualized burden will increase due to
the increase in the number of funded
grantees. However, the burden to each
respondent will decrease due to a
reduction in the frequency of data
collection for items that were previously
collected on a quarterly basis. During
the next OMB approval period, all
information will be collected twice per
year.
Information reported to CDC includes
baseline and follow-up data (12 months
post enrollment) for all women served
through the WISEWOMAN program.
These data, called the minimum data
elements (MDE), include data elements
that describe risk factors for the women
served in each program and data
elements that describe the number and
type of intervention sessions attended.
Funded grantees compile the data from
their existing databases and report the
MDE to CDC in April and October of
each year. The MDE data provide an
assessment of how effective the
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response (in
hours)
Form name
WISEWOMAN Grantees ...................
WISEWOMAN MDEs .......................
Progress Report ...............................
21
21
2
2
40
16
1,680
672
Total ...........................................
...........................................................
........................
........................
........................
2,352
Dated: October 5, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–24522 Filed 10–9–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
erowe on DSK5CLS3C1PROD with NOTICES
[Docket No. FDA–2009–N–0484]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
15:29 Oct 09, 2009
Jkt 220001
ACTION:
Number of
respondents
Number of
responses per
respondent
Type of
respondent
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
guidance on reagents for detection of
specific novel influenza A viruses.
DATES: Submit written or electronic
comments on the collection of
information by December 14, 2009.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Total burden
(in hours)
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
E:\FR\FM\13OCN1.SGM
13OCN1
]]>Agencies
[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52492-52493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-10-0612]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
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. Written comments should be received
within 60 days of this notice.
Proposed Project
Well-Integrated Screening and Evaluation for Women Across the
Nation (WISEWOMAN) Reporting System (OMB 0920-0612, exp. 1/31/
2010)--Revision--National Center
[[Page 52493]]
for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Cardiovascular disease (CVD), which includes heart disease,
myocardial infarction, and stroke, is the leading cause of death for
women in the United States, and is largely preventable. The WISEWOMAN
program (Well-Integrated Screening and Evaluation for Women Across the
Nation), administered by the Centers for Disease Control and Prevention
(CDC), was established to examine ways to improve the delivery of
services for women who have limited access to health care and elevated
risk factors for CVD. The program focuses on reducing CVD risk factors
and provides screening services for select risk factors such as
elevated blood cholesterol, hypertension and abnormal blood glucose
levels. The program also provides lifestyle interventions and medical
referrals. On an annual basis, 15 grantees funded through the WISEWOMAN
program have provided services to approximately 30,000 women who are
already participating in the National Breast and Cervical Cancer Early
Detection Program (NBCCEDP), also administered by CDC. CDC plans to
increase the reach of the WISEWOMAN program by increasing the number of
grantees from 15 to 21.
CDC currently collects information from WISEWOMAN grantees to
support continuous program monitoring and improvement activities. CDC
seeks to extend OMB approval for three additional years. The total
estimated annualized burden will increase due to the increase in the
number of funded grantees. However, the burden to each respondent will
decrease due to a reduction in the frequency of data collection for
items that were previously collected on a quarterly basis. During the
next OMB approval period, all information will be collected twice per
year.
Information reported to CDC includes baseline and follow-up data
(12 months post enrollment) for all women served through the WISEWOMAN
program. These data, called the minimum data elements (MDE), include
data elements that describe risk factors for the women served in each
program and data elements that describe the number and type of
intervention sessions attended. Funded grantees compile the data from
their existing databases and report the MDE to CDC in April and October
of each year. The MDE data provide an assessment of how effective the
WISEWOMAN program is at reducing the burden of cardiovascular disease
risk factors among women who utilize program services. The information
collected from grantees is also used to assess the cost-effectiveness
and impact of the program. The overall program evaluation is designed
to demonstrate how WISEWOMAN can obtain more complete health data on
vulnerable populations, promote public education about disease
incidence and risk-factors, improve the availability of screening and
diagnostic services for under-served women, ensure the quality of
services provided to under-served women, and develop strategies for
improved interventions. The information reported to CDC also includes
programmatic information related to grantee management, public
education and outreach, professional education, service delivery, cost,
and progress toward meeting stated programmatic objectives.
All MDE information will be submitted to CDC electronically.
Progress reports will be submitted in hardcopy format. Because certain
demographic information has already been collected as part of NBCCEDP,
the additional burden on grantees will be modest. There is no cost to
the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
WISEWOMAN Grantees............ WISEWOMAN MDEs.. 21 2 40 1,680
Progress Report. 21 2 16 672
----------------------------------------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 2,352
----------------------------------------------------------------------------------------------------------------
Dated: October 5, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-24522 Filed 10-9-09; 8:45 am]
BILLING CODE 4163-18-P
