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 

Federal Register / Vol. 74, No. 82 / Thursday, April 30, 2009 / Notices 19975 

authorizes the funding for IRR. While 

the list is long, those data elements can 

also be helpful to tribes who coordinate 

projects and transportation activities 

with other public authorities. It is not 

all required to be provided in order to 

participate in the program; that is the 

reason for default values in the CFR 

tables. The commenter stated that there 

is a difference in requested items from 

region to region because of politics and 

physical roadway characteristics, and 

questioned the practical utility of some 

requested information, suggesting a 

committee evaluate the need further 

since not all requested information is 

listed in the CFR. The BIA participated 

in many meetings of committees and 

public hearings when the requirements 

were developed—the result was a list of 

requirements that covered all situations, 

but not necessarily all requirements are 

needed for each situation. The 

commenter also stated that too much 

information is required in certain 

instances. The BIA has determined that, 

in those instances, the additional data 

are beneficial in supporting more 

accurate decisions rather than using 

default tables and that it is beneficial to 

the tribe to include this information. 

The commenter stated that they believe 

that the time and cost of submitting 

certain information far exceeds their 

estimated amount. The time and cost 

associated with data collection and 

submission has been consistently 

decreasing in the three years prior to 

this request for comment as improved 

methods of collection are developed. 

The estimated time and cost of 

submitting data indicates that the 

commenters are increasingly successful 

in assuring that data are provided for 

purposes identified. Finally, the 

commenter stated that use of automated 

techniques does not abrogate the 

physical collection of data and that a 

technological solution may be available 

with funds for equipment and staff to 

maintain the automated equipment. In 

response, the BIA notes that no special 

equipment is necessary for this 

information collection, and that more 

advanced techniques are available but 

this collection process does not require 

their use. The BIA did not make any 

changes to the information collection 

request for approval in response to these 

comments. 

III. Request for Comments 

The BIA requests your comments on 

this collection concerning: (a) The 

necessity of this information collection 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden (hours 

and cost) of the collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) ways we could enhance the quality, 

utility and clarity of the information to 

be collected; and (d) ways we could 

minimize the burden of the collection of 

the information on the commenters, 

such as through the use of automated 

collection techniques or other forms of 

information technology. 

Please note that an agency may not 

sponsor or request, and an individual 

need not respond to, a collection of 

information unless it has a valid OMB 

Control Number. OMB has up to 60 days 

to make a decision on the submission 

for renewal, but may make the decision 

after 30 days. Therefore, to receive the 

best consideration of your comments, 

you should submit them closer to 30 

days than 60 days. 

It is our policy to make all comments 

available to the public for review at the 

location listed in the ADDRESSES section, 

room 4516 MIB, during the hours of 8 

a.m.–4:30 p.m., EST Monday through 

Friday except for legal holidays. Before 

including your address, phone number, 

e-mail address or other personally 

identifiable information, be advised that 

your entire comment—including your 

personally identifiable information— 

may be made public at any time. While 

you may request that we withhold your 

personally identifiable information, we 

cannot guarantee that we will be able to 

do so. All comments from organizations 

or representatives will be available for 

review. We may withhold comments 

from review for other reasons. 

IV. Data 

OMB Approval Number: 1076–0161. 

Title: 25 CFR 170, Indian Reservation 

Roads. 

Brief Description of Collection: Some 

of the information such as the 

application of Indian Reservation Roads 

High Priority Projects (IRRHPP) (25 CFR 

170.210), the road inventory updates (25 

CFR 170.443), the development of a long 

range transportation plan (25 CFR 

170.411 and 170.412), the development 

of a tribal transportation improvement 

program and priority list (25 CFR 

170.420 and 170.421) are required to 

maintain or obtain a benefit 

(consideration of projects and for 

program funding from the formula). 

Some of the information such as public 

hearing requirements are also required 

to maintain or obtain a benefit and 

provides public notification and the 

opportunity for public involvement (25 

CFR 170.437 and 170.439). While others 

such as data appeals (25 CFR 170.231) 

and requests for design exceptions (25 

CFR 170.456) are voluntary information. 

Type of Review: Renewal. 

Respondents: Respondents include 

Federally recognized Indian tribal 

governments who have transportation 

needs associated with the IRR Program 

as described in 25 CFR 170. 

Number of Respondents: Varies from 

10 to 281. 

Estimated Time per Response: The 

reports require from 30 minutes to 40 

hours to complete. An average would be 

16 hours. 

Frequency of Response: Annually or 

on an as needed basis. 

Total Annual Burden to Respondents: 

19,628 hours. 

Total Annual Cost to Respondents: 

$0. 

Dated: April 24, 2009. 

Sanjeev ‘‘Sonny’’ Bhagowalia, 

Chief Information Officer—DOI. 

[FR Doc. E9–9921 Filed 4–29–09; 8:45 am] 

BILLING CODE 4310–4J–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–NWRS–2009–N0016;1265–0000– 

10137–S3] 

McNary and Umatilla National Wildlife 

Refuges, Benton, Walla Walla, and 

Franklin Counties, WA, and Morrow 

and Umatilla Counties, OR 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability of the final 

comprehensive conservation plan, 

environmental assessment, and finding 

of no significant impact. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), have 

completed a comprehensive 

conservation plan, environmental 

assessment (CCP/EA), and finding of no 

significant impact (FONSI) for the 

McNary and Umatilla National Wildlife 

Refuges (Refuges), which are part of the 

Mid-Columbia River National Wildlife 

Refuge Complex (Complex). The CCP/ 

EA was developed to provide a 

foundation for the management and use 

of the Refuges. We are furnishing this 

notice to advise other agencies and the 

public of the availability of the CCP/EA 

and FONSI, and the decision to 

implement Alternative 2 as described in 

the CCP/EA. The Service’s Regional 

Director for the Pacific Region selected 

Alternative 2 for managing the Refuges 

for the next 15 years. The Refuges are 

located along the Columbia River in the 

states of Oregon and Washington.