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draft guidance of the same title, dated 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:// 

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37232 Federal Register / Vol. 74, No. 143 / Tuesday, July 28, 2009 / Notices 

www.fda.gov/cber/guidelines.htm or 

http://www.regulations.gov. 

Dated: July 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–17965 Filed 7–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Science Board to the Food and Drug 

Administration; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Science Board to 

the Food and Drug Administration 

(Science Board). 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex and 

technical issues, as well as emerging 

issues within the scientific community 

in industry and academia. Additionally, 

the Science Board provides advice to 

the agency on keeping pace with 

technical and scientific evolutions in 

the fields of regulatory science, on 

formulating an appropriate research 

agenda, and on upgrading its scientific 

and research facilities to keep pace with 

these changes. It will also provide the 

means for critical review of agency 

sponsored intramural and extramural 

scientific research programs. 

Date and Time: The meeting will be 

held on Monday, August 17, 2009, from 

8 a.m. to 4 p.m. 

Addresses: Hilton Washington DC/ 

Rockville Hilton, 1750 Rockville Pike, 

Rockville, MD 20852. 

Contact Person: Carlos Pen ̃ a, Office of 

the Commissioner, Food and Drug 

Administration (HF–33), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

6687, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512603. Please call the 

Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

agency’s Web site and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The Science Board will hear 

about and discuss reports from its 

subcommittees on the following: (1) The 

review of research at the Center for 

Veterinary Medicine, and (2) the review 

of FDA’s scientific information 

technology infrastructure modernization 

initiatives. The Science Board will hear 

about plans to establish an additional 

subcommittee for the review of research 

at the Center for Food Safety and 

Applied Nutrition. The Science board 

will also hear about and discuss updates 

from the agency regarding the continued 

assessment of Bisphenol-A (BPA) in 

FDA-regulated products. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm, click on the year 2009 and 

scroll down to the appropriate advisory 

committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before August 10, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before August 3, 2009. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 4, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Carlos Pen ̃ a 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: July 22, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–17961 Filed 7–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, July 27, 

2009, 11 a.m. to July 27, 2009, 7 p.m., 

National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

which was published in the Federal 

Register on July 16, 2009, 74 FR 34583– 

34585. 

The meeting will be held July 31, 

2009. The meeting time and location 

remain the same. The meeting is closed 

to the public. 

Dated: July 22, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–17974 Filed 7–27–09; 8:45 am] 

BILLING CODE 4140–01–P 

mstockstill on DSKH9S0YB1PROD with NOTICES