Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Notices 9407 

Name of Committee: 

Psychopharmacologic Drugs 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 April 7 and 8, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd, Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, fax: 301– 

827–6776, e-mail: 

yvette.waples@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512544. 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 hotline/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On April 7, 2009, the 

committee will discuss safety and 

efficacy issues of new drug application 

(NDA) 20–644, sertindole (Serdolect) 

tablets, Lundbeck USA, proposed for the 

treatment of schizophrenia. On April 8, 

2009, the committee will discuss safety 

and efficacy issues of supplemental new 

drug applications (sNDAs) 22–047/S– 

010/S–011/S–012, quetiapine b6 

maleate (Seroquel XR), Astra Zeneca 

Pharmaceuticals LP, proposed for the 

treatment of major depressive disorder 

and 22–047/S–014/S–015, Seroquel XR 

(quetiapine maleate), Astra Zeneca 

Pharmaceuticals LP, proposed for the 

treatment of generalized anxiety 

disorder. Particular safety issues for 

discussion on April 8, 2009, regarding 

the Seroquel XR applications are 

concerns regarding exposing a greatly 

expanded population to a drug with 

known metabolic side effects and a 

possible risk of tardive dyskinesia. 

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/ohrms/ 

dockets/ac/acmenu.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 March 27, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on both days. 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 March 

18, 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 March 23, 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 John 

Lauttman 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/oc/advisory/ 

default.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: February 26, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–4523 Filed 3–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Reimbursement of Travel and 

Subsistence Expenses Toward Living 

Organ Donation Eligibility Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Request for comments on 

proposed change to the Reimbursement 

of Travel and Subsistence Expenses 

Program Eligibility criteria. 

SUMMARY: HRSA published the final 

eligibility guidelines for the 

Reimbursement of Travel and 

Subsistence Expenses Program in the 

Federal Register on October 5, 2007 (72 

FR 57049). A subsequent amendment to 

the Program guidelines was published 

in the Federal Register on June 20, 2008 

(73 FR 35143). HRSA is requesting 

public comments concerning 

recommended changes to a specific 

section of the reimbursement program 

eligibility guidelines. On page 35145, 

under the Qualifying Expenses Section, 

the first paragraph states: 

For the purposes of the Reimbursement of 

Travel and Subsistence Expenses toward 

Living Organ Donation Program, qualifying 

expenses presently include only travel, 

lodging, and meals and incidental expenses 

incurred by the donor and/or his/her 

accompanying person(s) as part of: 

(1) Donor evaluation, clinic visit or 

hospitalization, 

(2) Hospitalization for the living donor 

surgical procedure, and/or 

(3) Medical or surgical follow-up clinic 

visit or hospitalization within 90 days 

following the living donation procedure. 

HRSA wishes to amend the first item 

of this paragraph to read: ‘‘(1) Donor 

evaluation (including, if applicable, 

clinic visits or hospitalization) and/or’’. 

This is a technical change to clarify that 

the expenses referred to are all related 

to the donor evaluation. In addition, 

HRSA wishes to amend the third item 

of this paragraph to read: ‘‘(3) Medical 

or surgical follow-up, clinic visits, or 

hospitalization within 2 calendar years 

following the living donation procedure 

(or beyond the 2-year period if 

exceptional circumstances exist).’’ This 

change in the follow-up period would 

bring the National Living Donor 

Assistance Center follow-up period in 

line with the Organ Procurement and 

Transplantation Network policy 

requiring follow-up of living organ 

donors for a period of 2 years. Adding 

the exceptional circumstances language 

at the end of this item would allow 

reimbursement for post-surgical followVerDate Nov<24>2008 15:08 Mar 03, 2009 Jkt 217001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1
9408 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Notices 

up beyond the anticipated 2-year period 

in unusual circumstances. 

HRSA is requesting your comments 

on this specific section. 

DATES: Written comments must be 

submitted to the office in the address 

section below by mail or e-mail on or 

before April 3, 2009. 

ADDRESSES: Please send all written 

comments to Richard Durbin, Acting 

Director, Division of Transplantation, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Room 12C–06, Parklawn Building, 5600 

Fishers Lane, Rockville, Maryland 

20857; telephone (301) 443–7577; fax 

(301) 594–6095; or e-mail: 

rdurbin@hrsa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Richard Durbin, Acting Director, 

Division of Transplantation, Healthcare 

Systems Bureau, Health Resources and 

Services Administration, Parklawn 

Building, Room 12C–06, 5600 Fishers 

Lane, Rockville, Maryland 20857; 

telephone (301) 443–7577; fax (301) 

594–6095; or e-mail: rdurbin@hrsa.gov. 

Dated: February 12, 2009. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E9–4519 Filed 3–3–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Special: 

Biomaterials and Biointerfaces. 

Date: March 9, 2009. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Ross D. Shonat, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5156, 

MSC 7849, Bethesda, MD 20892, 301–435– 

2786, shonatr@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Growth 

Factors, Cell Migration and Mechanosensors. 

Date: March 10, 2009. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Joseph D. Mosca, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5158, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

2344. moscajos@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; DIG Member 

Conflicts. 

Date: March 11, 2009. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Ryan G. Morris, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4205, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1501, morrisr@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; ZRG1 CB P 

40 P: Program Project: WNT Signaling. 

Date: March 16–17, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Elena Smirnova, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5187, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1236, smirnove@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Review of 

Fellowships for Training in HIV Research. 

Date: March 18–19, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Mary Clare Walker, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5208, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1165, walkermc@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Nature’s 

Solutions. 

Date: March 18, 2009. 

Time: 2 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Anshumali Chaudhari, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4124, 

MSC 7802, Bethesda, MD 20892, (301) 435– 

1210, chaudhaa@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA/PA # 

RMO8–019 Membrane Protein Production 

Centers. 

Date: March 23–24, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Nuria E. Assa-Munt, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4164, 

MSC 7806, Bethesda, MD 20892, (301) 451– 

1323, assamunu@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Biobehavior and Addiction. 

Date: March 24, 2009. 

Time: 9 a.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Biao Tian, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 3089B, MSC 7848, Bethesda, 

MD 20892, (301) 402–4411, 

tianbi@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Epidemiology and Genetics Member Conflict 

Reviews. 

Date: March 31, 2009.