Federal Register / Vol. 73, No. 187 / Thursday, September 25, 2008 / Notices 55517 

meet the criteria for notifications that 

are established in section 403(r)(2)(G) 

and (r)(3)(C) of the act. In addition to the 

information specifically required by the 

act to be in such notifications, the 

guidance states that the notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. FDA intends 

to review the notifications the agency 

receives to ensure that they comply with 

the criteria established by the act. 

In the Federal Register of May 7, 2008 

(73 FR 25749), FDA published a 60-day 

notice requesting public comment on 

the information collection provisions. 

FDA received one letter of comment that 

was not related to the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act/Basis of 

Burden 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

403(r)(2)(G) (nutrient content claims) 1 1 1 250 250 

403(r)(2)(C) (health claims) 2 1 2 450 900 

Guidance for notifications 3 1 3 1 3 

Total 1,153 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

These estimates are based on FDA’s 

experience with health claims, nutrient 

content claims, and other similar 

notification procedures that fall under 

the agency’s jurisdiction. FDA estimates 

that it will receive one nutrient content 

claim notification and two health claim 

notifications per year. 

Section 403(r)(2)(G) and 403(r)(3)(C) 

of the act requires that the notification 

include the exact words of the claim, a 

copy of the authoritative statement, a 

concise description of the basis upon 

which such person relied for 

determining that this is an authoritative 

statement as outlined in the act, and a 

balanced representation of the scientific 

literature relating to the relationship 

between a nutrient and a disease or 

health-related condition to which a 

health claim refers or to the nutrient 

level to which the nutrient content 

claim refers. This balanced 

representation of the scientific literature 

is expected to include a bibliography of 

the scientific literature on the topic of 

the claim and a brief, balanced account 

or analysis of how this literature either 

supports or fails to support the 

authoritative statement. 

Since the claims are based on 

authoritative statements of a scientific 

body of the Federal Government or 

NAS, FDA believes that the information 

that is required by the act to be 

submitted with a notification will be 

readily available to a respondent. 

However, the respondent will have to 

collect and assemble that information. 

Based on communications with firms 

that have submitted notifications, FDA 

estimates that it will take a respondent 

250 hours to collect and assemble the 

information required by the statute for 

nutrient content claim notifications and 

450 hours to collect and assemble the 

information required by the statute for 

health claim notifications. 

Under the guidance, notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. The 

guidance applies to both nutrient 

content claim and health claim 

notifications. FDA has determined that 

this information should be readily 

available to a respondent and, thus, the 

agency estimates that it will take a 

respondent 1 hour to incorporate the 

information into the notification. 

Dated: September 17, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22636 Filed 9–25–08; 8:45 am] 

BILLING CODE 4160–01–S 

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(cX4) and 552b(cX6), 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 giant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Integrative 

Signaling. 

Date: October 9, 2008. 

Time: 1:30 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: Russell T. Dowell, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4128, 

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

1850, dowellr@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: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Musculoskeletal Tissue Engineering Study 

Section. 

Date: October 13–14, 2008. 

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: Jean D. Sipe, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4106, 

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

1743, sipej@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: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Skeletal Biology Development and Disease 

Study Section. 

Date: October 13–14, 2008. 

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

mstockstill on PROD1PC66 with NOTICES

55518 Federal Register / Vol. 73, No. 187 / Thursday, September 25, 2008 / Notices 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Alexandria Old Town, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Priscilla B. Chen, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4104, 

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

1787, chenp@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; Topics and 

Parasites. 

Date: October 13–14, 2008. 

Time: 9 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: Robert Freund, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3200, 

MSC 7848, Bethesda, MD 20892, (301) 435– 

1050, freundr@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; Member 

Conflicts (PBKD and UKGD) and Small 

Business Grant Applications. 

Date: October 15, 2008. 

Time: 11 a.m. to 1:30 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: Shirley Hilden, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4222, 

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

1198, hildens@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Drug 

Discovery for the Nervous System. 

Date: October 16–17, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Allerton Hotel, 701 North 

Michigan Avenue, Chicago, IL 60611. 

Contact Person: Mary Custer, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4148, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1164, custerm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; F07 

Immunology Fellowships and Area. 

Date: October 16, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Marina del Rey Hotel, 4100 

Admiralty Way, Marina del Rey, CA 90290. 

Contact Person: Calbert A. Laing, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4210, 

MSC 7812, Bethesda, MD 20892, 301–435– 

1221, laingc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Thrombosis 

and Erythrocyte Biology. 

Date: October 20–21, 2008. 

Time: 9 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: Manjit Hanspal, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7804, Bethesda, MD 20892, 301–435– 

1195, hanspalm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts 2: Cell Biology. 

Date: October 20–21, 2008. 

Time: 11 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: Noni Bymes, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5130, 

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

1023, byrnesn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Neurodevelopment, Synaptic Plasticity and 

Neurodegeneration. 

Date: October 23–24, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Westin St. Francis, 335 Powell 

Street, San Francisco, CA 94102. 

Contact Person: Vilen A. Movsesyan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040M, 

MSC 7806, Bethesda, MD 20892, 301–402– 

7278, movsesyanv@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Imaging 

Agents and Technologies. 

Date: October 23, 2008. 

Time: 2 p.m. to 4 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. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Sensory, 

Motor and Cognitive Neuroscience 

Fellowship Study Section. 

Date: October 24, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: One Washington Circle Hotel, One 

Washington Circle, NW., Washington, DC 

20037. 

Contact Person: John Bishop, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5180, 

MSC 7844, Bethesda, MD 20892, (301) 435– 

1250, bishopjcsr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Aging 

Program Project Review. 

Date: October 27–28, 2008. 

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: Seetha Bhagavan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1126, 

MSC 7846, Bethesda, MD 20892 (301) 435– 

1121, bhagavas@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Fellowship: 

Brain Disorders and Related Neuroscience. 

Date: October 27–28, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott— 

Washingtonian Center, 204 Boardwalk Place, 

Gaithersburg, MD 20878. 

Contact Person: Toby Behar, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4136, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

4433, behart@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Cardiovascular Sciences Small Business 

Activities. 

Date: October 27, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza National Airport, 1480 

Crystal Drive, Arlington, VA 22202. 

Contact Person: Lawrence E. Boerboom, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5156, 

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

8367, boerboom@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Cardiac 

Hypertrophy, lschemia and Regeneration. 

Date: October 27–28, 2008. 

Time: 8 p.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: Rajiv Kumar, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

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

1212, kumarra@csr.nih.gov. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 187 / Thursday, September 25, 2008 / Notices 55519 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Interactions 

Among Genetic and Behavioral/Social 

Factors Influencing Health and Disease. 

Date: October 28–29, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Jose Fernando Arena, PhD, 

MD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3135, 

MSC 7770, Bethesda, MD 20892, 301–435– 

1735, arenajmail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Bioinformatics and Software Development. 

Date: October 28, 2008. 

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: Ping Fan, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5154, 

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

1740, fanp@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Experimental Cancer Therapeutics SBIR/ 

STTR. 

Date: October 28–29, 2008. 

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: Denise R. Shaw, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6158, 

MSC 7804, Bethesda, MD 20892, 301–435– 

0198, shawkath@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business and Innovative Ultrasound Imaging. 

Date: October 28, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Alexandria Old Town, 1767 

King Steet, Alexandria, VA 22314. 

Contact Person: Xiang-Ning Li, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5112, 

MSC 7854, Bethesda, MD 20892, 301–435– 

1744, lixiang@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Radiation 

Therapy and Biology SBIR/STTR. 

Date: October 28–29, 2008. 

Time: 10 a.m. to 7 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Bo Hong, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 6194, MSC 7804, Bethesda, MD 

20892, 301–435–5879, hongb@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 17, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–22297 Filed 9–24–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

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 

meeting. 

The meeting 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: Heart, Lung, and 

Blood Initial Review Group; Clinical Trials 

Review Committee. 

Date: October 27, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Intercontinental Harbor Court, 550 

Light Street, Baltimore, MD 21202. 

Contact Person: Keary A. Cope, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7190, 

Bethesda, MD 20892–7924, 301–435–2222, 

copeka@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 17, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–22294 Filed 9–24–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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: National Heart, Lung, 

and Blood Institute, Special Emphasis Panel, 

Echocardiogram Analysis Program Review. 

Date: October 2, 2008. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue Bethesda, MD 20814. 

Contact Person: Holly K Krull, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7188, 

Bethesda, MD 20892–7924, 301–435–0280, 

krullh@nhlbi.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: National Heart, Lung, 

and Blood Institute, Special Emphasis Panel, 

Coagulation Program Project. 

Date: October 3. 2008. 

Time: 1 p.m.to 4 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: Charles Joyce, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7196, 

Bethesda, MD 20892–7924, 301–435–0288, 

cjoyce@nhlbi.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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

mstockstill on PROD1PC66 with NOTICES