32620 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Blood Products Advisory Committee; 

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: Blood Products 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on July 20, 2009, from 8 a.m. to 6 

p.m. and on July 21, 2009, from 9 a.m. 

to 12 noon. 

Location: Hilton Washington DC 

North/Gaithersburg, Grand Ballroom, 

620 Perry Pkwy., Gaithersburg, MD 

20877, 301–977–8900. 

Contact Person: William Freas or 

Pearline K. Muckelvene, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike (HFM–71), 

Rockville, MD 20852, 301–827–0314, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014519516. 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: On July 20, 2009, in the 

morning, the committee will review 

proposed strategies to demonstrate the 

effectiveness of new coral snake 

antivenoms. In the afternoon, the 

committee will discuss alternative 

clinical and surrogate endpoints for 

evaluating efficacy of Alpha-1 

Proteinase Inhibitor (Human) 

augmentation therapy in Alpha-1 

antitrypsin deficiency. Alpha-1 

antitrypsin deficiency is a genetic 

condition associated with decreased 

circulating levels of alpha-1 antitrypsin 

that significantly increases the risk of 

serious lung disease (i.e. emphysemia) 

in adults. On July 21, 2009, the 

committee will hear updates on the 

following topics: The April 30 to May 1, 

2009, meeting of the Department of 

Health and Human Services Advisory 

Committee on Blood Safety and 

Availability (http://www.hhs.gov/ophs/ 

bloodsafety/index.html); the June 12, 

2009, meeting of the FDA Transmissible 

Spongiform Encephalopathies Advisory 

Committee (http://www.fda.gov/ 

AdvisoryCommittees/Committees

MeetingMaterials/BloodVaccinesand

OtherBiologics/Transmissible

SpongiformEncephalopathiesAdvisory

Committee/ucm129559.htm); and an 

overview of the epidemiology and 

virology of the 2009 A/H1N1 influenza 

virus and its impact on the U.S. blood 

system. The committee will also hear 

informational presentations on recent 

public and private hemovigilance 

efforts, including the pilot 

hemovigilance module in the National 

Healthcare Safety Network. 

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, 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 July 15, 2009. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. and 11 a.m. and between 

approximately 3:45 p.m. and 5 p.m. on 

July 20, 2009, and between 

approximately 11:30 a.m. and 12 noon 

on July 21, 2009. 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 July 13, 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 July 8, 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 William 

Freas or Pearline K. Muckelvene 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/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

FDA regrets that it was unable to 

publish this notice 15 days prior to the 

July 20, 2009, Blood Advisory 

Committee meeting. Because the agency 

believes there is some urgency to bring 

these issues to public discussion and 

qualified members of the Blood 

Advisory Committee were available at 

this time, the Commissioner of Food 

and Drugs concluded that it was in the 

public interest to hold this meeting even 

if there was not sufficient time for the 

customary 15-day public notice. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: June 29, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–16101 Filed 7–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; 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. 

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