31800 Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 

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 materials, 

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 Institute of 

Mental Health Special Emphasis Panel; 

Fellowships and Dissertations. 

Date: July 13, 2010. 

Time: 1 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Serena P. Chu, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6154, MSC 9609, 

Bethesda, MD 20892–9609, 301–443–0004, 

sechu@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: May 27, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13413 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Race-Based Social 

Stress and Health in the MADICS 

Longitudinal Study, University of Michigan 

at Ann Arbor. 

Date: June 25, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Michele C. HindiAlexander, PhD, Division of Scientific 

Review, National Institutes of Health, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, 1600 

Executive Boulevard, Rm. 5B01, Bethesda, 

MD 20892, (301) 435–8382, 

hindialm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: May 27, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13414 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0215] 

Substances Generally Recognized as 

Safe Added to Food for Animals; 

Notice of Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is seeking 

participants for a voluntary pilot 

program whereby persons submit to 

FDA notices of claims that a particular 

use of a substance in food for animals 

is exempt from the statutory premarket 

approval requirements based on the 

notifier’s determination that such use is 

generally recognized as safe (GRAS). 

FDA intends to evaluate these notices 

and will inform each participant 

(notifier) in writing either that the 

notice provides a sufficient basis for the 

GRAS determination or that FDA has 

identified questions as to whether the 

intended use of the substance is GRAS. 

DATES: Submit written requests to 

participate in the pilot program 

beginning June 4, 2010. 

ADDRESSES: Submit written requests to 

participate in the pilot program to the 

Division of Animal Feeds (HFV–224), 

Center for Veterinary Medicine, Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855. 

FOR FURTHER INFORMATION CONTACT: 

Geoffrey K. Wong, Center for Veterinary 

Medicine (HFV–224), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6879, 

Geoffrey.wong@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The 1958 Amendment 

In 1958, in response to public concern 

about the increased use of chemicals in 

foods and food processing, Congress 

enacted the Food Additives Amendment 

(the 1958 amendment) to the Federal 

Food, Drug, and Cosmetic Act (the act). 

The 1958 amendment required that, 

before a new additive could be used in 

food, its producer must demonstrate the 

safety of the additive to FDA. The 1958 

amendment defined the terms ‘‘food 

additive’’ (section 201(s) of the act (21 

U.S.C. 321(s))) and ‘‘unsafe food 

additive’’ (section 409(a) of the act (21 

U.S.C. 348(a))), established a premarket 

approval process for food additives 

(section 409(b) through (h)), and 

amended the food adulteration 

provisions of the act to deem 

adulterated any food that is, or bears or 

contains, any food additive that is 

unsafe within the meaning of section 

409 (section 402(a)(2)(C) of the act (21 

U.S.C. 342(a)(2)(C))). 

In enacting the 1958 amendment, 

Congress recognized that many 

substances intentionally added to food 

would not require formal premarket 

review by FDA to assure their safety. 

Congress thus adopted, in section 201(s) 

of the act, a two-step definition of ‘‘food 

additive.’’ The first step broadly 

includes any substance, the intended 

use of which results or may reasonably 

be expected to result, directly or 

indirectly, in its becoming a component 

or otherwise affecting the characteristics 

of food. The second step, however, 

excludes from the definition of ‘‘food 

additive’’ substances that are generally 

recognized, among experts qualified by 

scientific training and experience to 

evaluate their safety (‘‘qualified 

experts’’), as having been adequately 

shown through scientific procedures (or, 

in the case of a substance used in food 

prior to January 1, 1958, through either 

scientific procedures or through 


srobinson on DSKHWCL6B1PROD with NOTICES