Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices 19973 

FDA is issuing this SECG as level 2 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c) (2)). The SECG represents the 

agency’s current thinking on this topic. 

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. 

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. The SECG 

and received comments may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: April 24, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9870 Filed 4–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0198] 

Small Entity Compliance Guide: 

Cochineal Extract and Carmine: 

Declaration by Name on the Label of 

All Foods and Cosmetic Products That 

Contain These Color Additives; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Cochineal Extract and 

Carmine: Declaration by Name on the 

Label of All Foods and Cosmetic 

Products That Contain These Color 

Additives—Small Entity Compliance 

Guide.’’ The small entity compliance 

guide (SECG) is being issued for a final 

rule published in the Federal Register 

of January 5, 2009, and it is intended to 

set forth in plain language the 

requirements of the regulation and to 

help small businesses understand the 

regulation. 

DATES: Submit written or electronic 

comments on the SECG at any time. 

ADDRESSES: Submit written requests for 

single copies of the SECG to the 

Division of Petition Review, Office of 

Food Additive Safety (HFS–265), Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740, or FAX your request to 301–436– 

2972. Send one self-addressed adhesive 

label to assist that office in processing 

your request. Submit written comments 

on the SECG to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the SECG to 

http://www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

James C. Wallwork, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1303. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 5, 

2009 (74 FR 207), FDA issued a final 

rule requiring the declaration of 

cochineal extract and carmine by name 

on the label of all foods and cosmetic 

products that contain these color 

additives. This final rule becomes 

effective January 5, 2011. 

FDA examined the economic 

implications of the final rule as required 

by the Regulatory Flexibility Act (5 

U.S.C. 601–612) and determined that 

the final rule may have a significant 

economic impact on a substantial 

number of small entities. In compliance 

with section 212 of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121), FDA is making 

available this SECG stating in plain 

language the legal requirements of the 

January 5, 2009, final rule set forth in 21 

CFR parts 73 and 101 concerning 

cochineal extract and carmine. 

FDA is issuing this SECG as level 2 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c)(2)). The SECG represents the 

agency’s current thinking on this topic. 

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. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this SECG. 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. The SECG and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: April 24, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9868 Filed 4–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Statement of Delegation of Authority 

Notice is hereby given that I have 

delegated to the Director, National 

Institutes of Health (NIH), the 

authorities added to the Public Health 

Service Act by Section 801 of Public 

Law 110–85, the Food and Drug 

Administration Amendments Act of 

2007, 42 U.S.C. 282(j), as amended, 

pertaining to the expansion of the 

Clinical Trial Registry and Results Data 

Bank described therein. Specifically, the 

Director is delegated the following 

authorities: 

1. 402(j)(2)(A)(ii)(IV), 42 U.S.C. 

282(j)(2)(A)(ii)(IV): The Secretary may 

make publicly available certain 

administrative data collected for the 

registry, as necessary. 

2. 402(j)(3)(A)(i), 42 U.S.C. 

282(j)(3)(A)(i): To ensure that the Data 

Bank includes links to results 

information for those trials that form the 

primary basis for an efficacy claim or 

are performed after clearance or 

approval of the drug or device, under 42 

U.S.C. 282(j)(3)(A)(i). 

3. 402(j)(3)(A)(ii)(I), 42 U.S.C. 

282(j)(3)(A)(ii)(I): To ensure that the 

Data Bank includes links to specified 

FDA information. 

19974 Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices 

4. 402(j)(3)(A)(ii)(II), 42 U.S.C. 

282(j)(3)(A)(ii)(II): To ensure that the 

Data Bank includes links to specified 

NIH information. 

5. 402(j)(3)(A)(ii)(iii), 42 U.S.C. 

282(j)(3)(A)(ii)(iii): To include links to 

the FDA and NIH information described 

above for Data Bank entries for clinical 

trials submitted to the Data Bank prior 

to the enactment of FDAAA. 

6. 402(j)(3)(C), 42 U.S.C. 282(j)(3)(C): 

To include in the Data Bank the 

specified ‘‘basic results’’ information for 

drugs that are approved under section 

505 of the Federal Food, Drug and 

Cosmetic Act or licensed under section 

351 of the Public Health Service Act, 

and for devices that are cleared under 

section 510(k) of the Federal Food, Drug 

and Cosmetic Act, or approved under 

section 515 or 520(m) of the Federal 

Food, Drug, and Cosmetic Act. 

7. 402(j)(3)(D)(vi), 42 U.S.C. 

282(j)(3)(D)(vi): To consider the status of 

World Health Organization consensus 

data elements for reporting clinical trial 

results when issuing regulations. 

8. 402(j)(3)(D)(vii), 42 U.S.C. 

282(j)(3)(D)(vii): To hold a public 

meeting to provide an opportunity for 

input from interested parties with 

regard to the regulations to be issued 

pursuant to 42 U.S.C. 282(j)(3)(D)(i). 

9. 402(j)(3)(I)(iii), 42 U.S.C. 

282(j)(3)(I)(iii): To include in the Data 

Bank tables of information of 

anticipated and unanticipated serious 

adverse events and anticipated and 

unanticipated frequent adverse events, 

upon the application of 42 U.S.C. 

282(j)(3)(I)(ii). 

10. 402(j)(3)(I)(iv), 42 U.S.C. 

282(j)(I)(iv): To consult with experts in 

risk communication and post, with the 

tables described in 42 U.S.C. 

282(j)(3)(I)(iii), information to enhance 

patient understanding and to ensure 

such tables do not mislead patients or 

the lay public. 

11. 402(j)(4)(B)(i), 42 U.S.C. 

282(j)(B)(i): To determine for a specified 

clinical trial, that posting in the Data 

Bank of clinical trial information for 

such clinical trial is necessary to protect 

the public health, and further, to require 

by notification that such information be 

submitted to, and accepted on behalf of 

the Secretary by, the Director of the 

National Institutes of Health, in accord 

with 42 U.S.C. 282(j)(4)(B)(i)(I). 

12. 402(j)(5)(A)(iv), 42 U.S.C. 

282(j)(5)(A)(iv): To consult with other 

agencies that conduct human subjects 

research in accordance with any section 

of part 46 of title 45, Code of Federal 

Regulations (or any successor 

regulation), to determine if such 

research is an applicable clinical trial 

and develop, with such agencies, 

procedures to ensure the submission of 

clinical trial information. 

13. 402(j)(5)(C)(i), 42 U.S.C. 

282(j)(5)(C)(i): To use the publicly 

available information and any other 

information available to the Secretary 

about applicable clinical trials to verify 

the accuracy of submitted results 

information for the Pilot Quality Control 

Study. 

This delegation will be exercised in 

accordance with the Department’s 

applicable policies, procedures, 

guidelines and regulations. 

I ratify and affirm any actions taken 

by you or your subordinates that 

involved the exercise of the authorities 

delegated herein prior to the effective 

date of this delegation. This delegation 

is effective upon date of signature. 

Dated: April 21, 2009. 

Charles E. Johnson, 

Acting Secretary. 

[FR Doc. E9–9699 Filed 4–29–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

Indian Reservation Roads 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Notice of submission of 

information collection to the Office of 

Management and Budget. 

SUMMARY: The Bureau of Indian Affairs 

(BIA) is submitting the information 

collection for the Indian Reservation 

Roads (IRR) Program, OMB Control No. 

1076–0161, to the Office of Management 

and Budget for renewal. The current 

approval period is approaching 

expiration; this renewal will allow us to 

continue to operate the IRR program. 

This renewal is necessary for tribal 

participation in the IRR Program and for 

the allocation of funding for the IRR 

Program to federally recognized tribal 

governments for transportation 

assistance. 

DATE: Submit comments on or before 

June 1, 2009. 

ADDRESSES: Submit comments on the 

information collection to the Desk 

Officer for the Department of the 

Interior at the Office of Management and 

Budget, by fax at (202) 395–5806 or email at OIRA_DOCKET@omb.eop.gov. 

Please send copy of your comments to: 

LeRoy Gishi, Chief, Division of 

Transportation, 1849 C Street, NW. MS 

4512 MIB, Washington, DC 20240, fax: 

(202) 208–4696. 

FOR FURTHER INFORMATION CONTACT: You 

may request further information or 

obtain copies of the proposed 

information collection request from 

LeRoy Gishi, Chief, Division of 

Transportation, telephone (202) 513– 

7711. 

SUPPLEMENTARY INFORMATION: 

I. Abstract 

This information collection is 

necessary to allow Federally recognized 

tribal governments to participate in the 

IRR Program as defined in 23 U.S.C. 

204(a)(1). Some of the information 

collected determines the allocation of 

IRR program funds to Indian tribes as 

described in 23 U.S.C. 202(d)(2)(A). 

II. Summary of Public Comments 

Received 

The BIA received comments from one 

commenter in response to the notice 

published January 12, 2009 (74 FR 

1244), which announced that we would 

submit this renewal to OMB for 

approval and provided the 60-day 

public comment period. The commenter 

had a number of suggestions that would 

be appropriate for consideration upon 

amending the rule; however, because 

the scope of this public comment period 

is limited to the information collections, 

the BIA was not able to accommodate 

these requests. Comments specific to the 

information collection included the 

following. The commenter expressed 

concern that the word ‘‘some’’ in the 

Brief Description indicated that there 

were other information collections that 

BIA did not address. The Brief 

Description addresses all the 

information collections associated with 

Indian Reservation Roads—the word 

‘‘some’’ indicates that some of these 

information collections are required to 

obtain or maintain a benefit (program 

participation and funding) and others 

are voluntary. Another comment asked 

why an applicant must provide 

documentation that the project meets 

the definition of an IRR transportation 

facility and is on the IRR inventory 

when the information already exists. 

The BIA requires this information as 

part of the IRR High Priority Project 

application because the application is a 

collection of all information necessary 

for the Department to make an approval 

determination based upon criteria 

established by law. The commenter also 

stated that they believe that the amount 

of information could be reduced. The 

information collection was developed 

by meetings between tribal members 

and the BIA. What emerged was a list 

that met the various needs of the tribe 

and the requirements of the law which