Office of Community Services; Notice To Award a Single Source Program Expansion Supplement Under the American Recovery and Reinvestment Act (ARRA) to Technical Assistance by Community Action Program Legal Services, Inc., 37230-37231 [E9-17890]
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Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Notices
Proposed Project
Voluntary Product Satisfaction and
Usability Assessment—New—National
Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Executive Order 12862 directs Federal
agencies that provide services directly
to the public to survey customers to
determine the kind and quality of
services they need and their level of
satisfaction with existing services.
CDC releases a number of new
products each year to its customers, a
diverse group that includes health care
providers, researchers, public health
practitioners, policy makers, and the
general public. The term product is
broadly defined to include publications,
Web pages, podcasts, e-cards, CD–
ROMs, and videos. At present, there is
no mechanism for evaluating whether
1. Response cards via mail: Each
product that is sent out will include a
one-page response card along with a
self-addressed and stamped envelope.
Customers can then voluntarily choose
whether to return the response card.
2. E-mail announcements: Products
are released to customers via an e-mail
announcement that includes a link to
the electronic version of the product
plus a link to a Web-based evaluation.
Customers can then voluntarily choose
whether to complete the evaluation.
3. Web-based assessments: Products
are available on-line in an electronic
format. Each product Web page will
include a link to a Web-based
evaluation. Customers can then
voluntarily choose whether to complete
the evaluation.
The information being collected will
not impose a cost burden on the
respondents beyond that associated
with their time to provide the required
data.
these products are meeting customer
needs.
CDC is requesting a 3-year generic
clearance in order to better evaluate its
products. Obtaining feedback from
customers on a regular, on-going basis
will help ensure that customers find
CDC products to be useful. This type of
evaluation will allow CDC to maximize
the impact of its products which will
ultimately benefit the public’s health.
The target audience will be limited to
customers who request and receive CDC
products. Customer participation in the
evaluation is completely voluntary.
Names of customers will not be
collected. The only personal
information collected will relate to
professional discipline, job duties, and
experience working with public health
topics. No sensitive data (e.g., age, race,
or gender) will be collected. The
evaluation data will be collected using
a combination of methodologies
including:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Evaluation
method
Customers .....................
Response cards ...................................................
E-mail Assessments ............................................
Web-Based Assessments ...................................
50,000
60,000
432,000
1
1
1
10/60
10/60
10/60
8,333
10,000
72,000
Total ........................
..............................................................................
........................
........................
........................
90,333
Dated: July 22, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–17898 Filed 7–27–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
mstockstill on DSKH9S0YB1PROD with NOTICES
Office of Community Services; Notice
To Award a Single Source Program
Expansion Supplement Under the
American Recovery and Reinvestment
Act (ARRA) to Technical Assistance by
Community Action Program Legal
Services, Inc.
AGENCY: Office of Community Services,
ACF, HHS.
ACTION: Notice to award a Single Source
Program Expansion Supplement under
the American Recovery and
Reinvestment Act (ARRA) to Technical
Assistance by Community Action
Program Legal Services, Inc.
VerDate Nov<24>2008
19:36 Jul 27, 2009
Jkt 217001
Number of
respondents
Average
burden per
response
(in hours)
Type of respondent
CFDA#: 93.710.
Legislative Authority: The legislative
authority for this award is provided in the
American Recovery and Reinvestment Act of
2009 (Pub. L. 111–5). Additional legislative
authority and requirements are provided in
Section 674(b)(2)(B) of the CSBG Act, as
amended, by the Community Opportunity
Accountability, and Training and
Educational Services (Coats Human Services
Reauthorization Act of 1998) (Pub. L. 105–
285).
Amount of Supplemental Award:
$96,952.
Project Period: September 30, 2006
through September 30, 2009.
SUMMARY: The Office of Community
Services (OCS) announces the awarding
of a $96,952 single source program
expansion supplement to the
Community Action Legal Services, Inc.
(CAPLAW), located in Boston, MA, to
support training and technical
assistance on legal issues faced by
Community Action Agencies (CAAs)
related to the American Recovery and
Reinvestment Act of 2009 (ARRA). The
project activities are designed to support
and strengthen the ability of the CAA
network to comply with, and carry out,
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Total burden
(in hours)
Community Services Block Grant
(CSBG) activities funded by ARRA. The
training projects and resources
developed under the award will include
analysis and explanation of the practical
impact of ARRA for States and CSBGeligible entities so that they can work
more effectively to reach the ARRA
goals and document how they have in
fact reached those goals and used the
ARRA funds. The project’s overall
approach is based on the following five
key elements: (1) Technical assistance
and issue-specific consultation; (2)
Publications, including online postings
on the CAPLAW Web site, e-Bulletins,
and a print newsletter, which is also
available on CAPLAW’s Web site; (3)
Online toolkit; (4) Presentations at CAA
conferences, including CAPLAW’s 2009
national training conference, and
CAPLAW audio conferences.
The training and technical assistance
CAPLAW will provide is particularly
critical at this time due to the large
temporary increase in funding of CSBG
awards to eligible entities and the need
for both rapid implementation of these
programs and adherence to high
E:\FR\FM\28JYN1.SGM
28JYN1
Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Notices
standards of accountability and tracking
of awards and results.
Contact for Further Information:
Danielle Williams, U.S. Department of
Health and Human Services, Office of
Community Services, Administration
for Children and Families, 370 L’Enfant
Promenade, SW., Washington, DC
20047.
Telephone: (202) 205–4717. E-mail:
Danielle.Williams@acf.hhs.gov.
Dated: July 15, 2009.
Yolanda J. Butler,
Acting Director, Office of Community
Services.
[FR Doc. E9–17890 Filed 7–27–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0379]
Guidance for Industry: Nucleic Acid
Testing To Reduce the Possible Risk
of Human Parvovirus B19
Transmission by Plasma-Derived
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Nucleic Acid
Testing (NAT) to Reduce the Possible
Risk of Human Parvovirus B19
Transmission by Plasma-Derived
Products,’’ dated July 2009. The
guidance document provides to
manufacturers of plasma-derived
products recommendations for
performing parvovirus B19 NAT as an
in-process test for Source Plasma and
recovered plasma to identify and help to
prevent the use of plasma units
containing high levels of parvovirus
B19. The guidance also recommends
how to report to FDA implementation of
parvovirus B19 NAT. The guidance
announced in this notice finalizes the
draft guidance of the same title, dated
July 2008.
DATES: Submit written or electronic
comments on agency guidances at any
time.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
ADDRESSES:
VerDate Nov<24>2008
19:36 Jul 27, 2009
Jkt 217001
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Jr., Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Nucleic Acid Testing (NAT) to
Reduce the Possible Risk of Human
Parvovirus B19 Transmission by
Plasma-Derived Products,’’ dated July
2009. Parvovirus B19 is a small, nonenveloped single stranded DNA virus.
Virus clearance studies, using nonhuman parvoviruses as models for
parvovirus B19, have indicated that this
virus is highly resistant to all commonly
used inactivation methods, including
heat and solvent/detergent (S/D)
treatment, and is also difficult to remove
by filtration because of its small size.
More recent studies have demonstrated
that human parvovirus B19 may be
more readily cleared than certain model
animal parvoviruses. The parvovirus
B19 can be transmitted by blood
components and certain plasma
derivatives and may cause morbidity to
susceptible recipients such as pregnant
women, persons with underlying
hemolytic disorders, and immune
compromised individuals. The disease
transmission from transfusion of blood
components is rare. However, extremely
high levels of parvovirus B19 in plasma
of acutely infected but asymptomatic
donors may present a greater risk in
plasma derivatives due to pooling of
large numbers of units of these products
in the manufacturing process.
The guidance provides
recommendations for performing
parvovirus B19 NAT as an in-process
test for Source Plasma and recovered
plasma used in the further
manufacturing of plasma-derived
products to identify and help to prevent
the use of plasma units containing high
levels of parvovirus B19. The guidance
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
37231
also recommends how to report to FDA
implementation of parvovirus B19 NAT.
In the Federal Register of July 30,
2008 (73 FR 44272), FDA announced the
availability of the draft guidance of the
same title, dated July 2008. FDA
received a few comments on the draft
guidance and those comments were
considered as the guidance was
finalized. In addition to minor editorial
changes made to improve clarity,
changes to the draft guidance include
the addition of 4 references to reflect
recent studies that show B19 may be
less resistant to inactivation than
animal-derived parvoviruses that have
been used as models; and removal of the
recommendation on the acceptable limit
for B19 DNA titer in individual plasma
units. The guidance announced in this
notice finalizes the draft guidance dated
July 2008.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’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
requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This 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 the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 601.12(a)(2) and 601.12(c)(5),
have been approved under OMB No.
0910–0338.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
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. A copy of the 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 guidance at either https://
E:\FR\FM\28JYN1.SGM
28JYN1
Agencies
[Federal Register Volume 74, Number 143 (Tuesday, July 28, 2009)]
[Notices]
[Pages 37230-37231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Office of Community Services; Notice To Award a Single Source
Program Expansion Supplement Under the American Recovery and
Reinvestment Act (ARRA) to Technical Assistance by Community Action
Program Legal Services, Inc.
AGENCY: Office of Community Services, ACF, HHS.
ACTION: Notice to award a Single Source Program Expansion Supplement
under the American Recovery and Reinvestment Act (ARRA) to Technical
Assistance by Community Action Program Legal Services, Inc.
-----------------------------------------------------------------------
CFDA#: 93.710.
Legislative Authority: The legislative authority for this award
is provided in the American Recovery and Reinvestment Act of 2009
(Pub. L. 111-5). Additional legislative authority and requirements
are provided in Section 674(b)(2)(B) of the CSBG Act, as amended, by
the Community Opportunity Accountability, and Training and
Educational Services (Coats Human Services Reauthorization Act of
1998) (Pub. L. 105-285).
Amount of Supplemental Award: $96,952.
Project Period: September 30, 2006 through September 30, 2009.
SUMMARY: The Office of Community Services (OCS) announces the awarding
of a $96,952 single source program expansion supplement to the
Community Action Legal Services, Inc. (CAPLAW), located in Boston, MA,
to support training and technical assistance on legal issues faced by
Community Action Agencies (CAAs) related to the American Recovery and
Reinvestment Act of 2009 (ARRA). The project activities are designed to
support and strengthen the ability of the CAA network to comply with,
and carry out, Community Services Block Grant (CSBG) activities funded
by ARRA. The training projects and resources developed under the award
will include analysis and explanation of the practical impact of ARRA
for States and CSBG-eligible entities so that they can work more
effectively to reach the ARRA goals and document how they have in fact
reached those goals and used the ARRA funds. The project's overall
approach is based on the following five key elements: (1) Technical
assistance and issue-specific consultation; (2) Publications, including
online postings on the CAPLAW Web site, e-Bulletins, and a print
newsletter, which is also available on CAPLAW's Web site; (3) Online
toolkit; (4) Presentations at CAA conferences, including CAPLAW's 2009
national training conference, and CAPLAW audio conferences.
The training and technical assistance CAPLAW will provide is
particularly critical at this time due to the large temporary increase
in funding of CSBG awards to eligible entities and the need for both
rapid implementation of these programs and adherence to high
[[Page 37231]]
standards of accountability and tracking of awards and results.
Contact for Further Information: Danielle Williams, U.S. Department
of Health and Human Services, Office of Community Services,
Administration for Children and Families, 370 L'Enfant Promenade, SW.,
Washington, DC 20047.
Telephone: (202) 205-4717. E-mail: Danielle.Williams@acf.hhs.gov.
Dated: July 15, 2009.
Yolanda J. Butler,
Acting Director, Office of Community Services.
[FR Doc. E9-17890 Filed 7-27-09; 8:45 am]
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