1076-0161 30-day notice

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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,

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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.

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 [email protected].
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.
DATE:

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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

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

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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)

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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.

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