Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Notices 58603 

through community-based 

organizations, Tribes and Village 

governments. The purpose of ANA is to 

promote the goal of economic and social 

self-sufficiency for American Indians, 

Native Hawaiians, Alaskan Natives and 

other Native American Pacific Islanders, 

including American Samoa Natives. 

2. Priority Area Description for 

Economic Development 

The FY2009 PA Priority Area 

Description for Economic Development 

Projects adds the following bullet: 

• Projects to promote traditional 

energy activities and practices that 

support conservation and help to 

mitigate the high costs associated with 

the purchase, transportation, and 

storage of fuel in remote Alaskan 

Villages. 

3. Priority Area Description for Social 

Development 

The FY 2009 PA Priority Area 

Description for Social Development 

Projects removes the following bullets: 

• Projects to reduce child/infant 

abuse and neglect and family domestic 

violence. 

• Projects that address the needs of 

grandparents raising grandchildren. 

• Projects to recruit, train and certify 

new Native American foster parents or 

promote appropriate extended family 

placements or to assist abused, 

neglected and abandoned Native 

American children, youth and their 

families. 

(D) ANA ERE: The FY 2009 PA 

includes an additional instruction in the 

Approach evaluation criterion, Project 

Strategy sub-criterion. This change 

reflects the need for additional 

information related to the land area and 

natural resources over which the 

applicant has jurisdiction. (Legal 

authority: Section 803(a) and (d) and 

803C of the Native American Programs 

Act of 1974, as amended, 42 U.S.C. 

2991b and 2991b–3 and Pub. L. 109– 

394.) 

The FY 2009 PA Approach evaluation 

criterion, Project Strategy sub-criterion 

will have the following statement 

added: 

Applicants are required to describe a 

land base or other resources, e.g., river 

or body of water, over which they 

exercise jurisdiction to implement 

Tribal regulation of environmental 

quality. Maps and photos of the area are 

encouraged. 

Dated: September 30, 2008. 

Quanah Crossland Stamps, 

Commissioner, Administration for Native 

Americans. 

[FR Doc. E8–23662 Filed 10–6–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–F–0518] 

Anitox; Filing of Food Additive Petition 

(Animal Use); Formaldehyde 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Anitox has filed a petition 

proposing that the food additive 

regulations be amended to provide for 

the safe use of formaldehyde to retard 

the growth of Clostridium perfringens in 

animal feeds. 

DATES: Submit written or electronic 

comments on the petitioner’s 

environmental assessment December 8, 

2008. 

ADDRESSES: Submit written comments 

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: 

Isabel W. Pocurull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6853, 

e-mail: isabel.pocurull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(section 409(b)(5) (21 U.S.C. 348(b)(5)), 

notice is given that a food additive 

petition (FAP 2259) has been filed by 

Anitox, 1055 Progress Circle, 

Lawrenceville, GA 30043. The petition 

proposes to amend the food additive 

regulations in part 573—Food Additives 

Permitted in Feed and Drinking Water 

of Animals (21 CFR part 573) to provide 

for the safe use of formaldehyde to 

retard the growth of Clostridium 

perfringens in animal feeds. 

The potential environmental impact 

of this action is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 29, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–23723 Filed 10–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of 

Meeting; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

that appeared in the Federal Register of 

September 24, 2008 (73 FR 55114). The 

document announced a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). A portion of the meeting will be 

closed to the public. This document 

corrects the error. 

FOR FURTHER INFORMATION CONTACT: 

Theresa Green, Office of the 

Commissioner, Food and Drug 

mstockstill on PROD1PC66 with NOTICES

58604 Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Notices 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1220. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E8–22437, appearing on page 55114 in 

the Federal Register of Wednesday, 

September 24, 2008, the following 

correction is made: 

1. On page 55114, in the third 

column, in the Procedure section, the 

fourth sentence is corrected to read 

‘‘Oral presentations from the public will 

be scheduled between approximately 2 

p.m. and 3 p.m.’’ 

There are no other changes to the 

document. 

Dated: October 1, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–23718 Filed 10–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0525] 

Draft Guidance for Industry on New 

Contrast Imaging Indication 

Considerations for Devices and 

Approved Drug and Biological 

Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘New Contrast 

Imaging Indication Considerations for 

Devices and Approved Drug and 

Biological Products.’’ As part of the 

Medical Device User Fee Amendments 

of 2007 (MDUFA) Commitment for the 

Performance Goals and Procedures, FDA 

agreed to publish draft guidance by 

September 30, 2008, for medical 

imaging devices with ‘‘contrast agents or 

radiopharmaceuticals.’’ FDA intends 

this draft guidance to assist developers 

of medical imaging devices and imaging 

drug/biological products that provide 

image contrast enhancement. 

Particularly this guidance focuses on 

approaches in developing new contrast 

indications for imaging devices for use 

with already approved imaging 

products. FDA intends for the 

recommendations in this guidance to 

promote timely and effective review of, 

and consistent and appropriate 

regulation and labeling for imaging 

drugs and devices. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by January 5, 2009. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Y. Love, Office of Combination 

Products (HFG–3), Office of the 

Commissioner, Food and Drug 

Administration, 15800 Crabbs Branch 

Way, Rockville, MD 20855, 301–427– 

1934. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘New Contrast Imaging Indication 

Considerations for Devices and 

Approved Drug and Biological 

Products.’’ This draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance represents 

the agency’s current thinking on New 

Contrast Imaging Indication 

Considerations for Devices and 

Approved Drug and Biological Products. 

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 

requirements of the applicable statutes 

and regulations. 

This draft 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 part 807 have 

been approved under 0910–0120. The 

collections of information in 21 CFR 

part 814 have been approved under 

0910–0231. The collections of 

information in 21 CFR part 314 have 

been approved under 0910–0001. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, the 

FDA Division of Dockets Management 

Web site transitioned to the Federal 

Dockets Management System (FDMS). 

FDMS is a Government-wide, electronic 

docket management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: September 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23712 Filed 10–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0281] 

Pilot Program To Evaluate Proposed 

Name Submissions; Concept Paper 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a concept paper entitled 

‘‘PDUFA Pilot Project Proprietary Name 

Review.’’ The concept paper provides 

information to pharmaceutical firms 

about how to evaluate proposed 

propriety names and submit the data 

generated from those evaluations to 

FDA for review under an anticipated 

pilot program. FDA plans to begin 

enrollment in the pilot program in fiscal 

year (FY) 2009. 

mstockstill on PROD1PC66 with NOTICES