37230 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 

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: 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Evaluation 

method 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Customers ..................... Response cards ................................................... 50,000 1 10/60 8,333 

E-mail Assessments ............................................ 60,000 1 10/60 10,000 

Web-Based Assessments ................................... 432,000 1 10/60 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 

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 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 

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Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Notices 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] 

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. 

SUMMARY: 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. 

ADDRESSES: 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 

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 http:// 

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 

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 http:// 

mstockstill on DSKH9S0YB1PROD with NOTICES