74056 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 

Dated: November 24, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–30105 Filed 11–29–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Request for Public Comment on the 

Proposed Adoption of Administration 

for Native Americans (ANA) Program 

Policies and Procedures 

AGENCY: Administration for Native 

Americans, ACF, HHS. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 814 of the 

Native American Programs Act of 1974 

(NAPA), as amended, the 

Administration for Native Americans 

(ANA) is required to provide members 

of the public an opportunity to 

comment on proposed changes in 

interpretive rules, general statements of 

policy, and rules of agency procedure or 

practice, and to give notice of the final 

adoption of such changes at least 30 

days before the changes become 

effective. In accordance with notice 

requirements of NAPA, ANA herein 

describes its proposed interpretive 

rules, general statements of policy, and 

rules of agency procedure or practice as 

they relate to the Fiscal Year (FY) 2011 

Funding Opportunity Announcements 

(FOA) for the following programs: 

Social and Economic Development 

Strategies (SEDS), Social and Economic 

Development Strategies—Tribal 

Governance (SEDS—TG), Social and 

Economic Development Strategies— 

Assets for Independence (SEDS—AFI), 

Native Language Preservation and 

Maintenance (Language P&M), Native 

Language Preservation and 

Maintenance—Esther Martinez Initiative 

(Language—EMI), and Environmental 

Regulatory Enhancement (ERE). This 

notice also provides additional 

information about ANA’s plan for 

administering the programs. 

DATES: The deadline for receipt of 

comments is 30 days from the date of 

publication in the Federal Register. 

ADDRESSES: Comments in response to 

this notice should be addressed to 

Lillian Sparks, Commissioner, 

Administration for Native Americans, 

370 L’Enfant Promenade, SW., Mail 

Stop: Aerospace 2—West, Washington, 

DC 20447. Delays may occur in mail 

delivery to Federal offices; therefore, a 

copy of comments should be faxed to 

(202) 690–7441. Comments will be 

available for inspection by members of 

the public at the Administration for 

Native Americans, 901 D Street, SW., 

Washington, DC 20447. 

FOR FURTHER INFORMATION CONTACT: 

Kathy Killian, Program Specialist, (877) 

922–9262. 

SUPPLEMENTARY INFORMATION: Section 

814 of NAPA, as amended, requires 

ANA to provide notice of its proposed 

interpretive rules, general statements of 

policy, and rules of agency organization, 

procedure, or practice. The proposed 

clarifications, modifications, and new 

text will appear in the FY 2011 FOAs: 

SEDS, SEDS—TG, SEDS—AFI, 

Language P&M, Language—EMI, and 

ERE. This notice serves to fulfill this 

requirement. 

A. Funding Opportunity 

Announcements 

1. Social and Economic Development 

Strategies (SEDS) 

In FY 2011, ANA will combine the 

SEDS and SEDS—Special Initiative 

(SEDS—SI) FOAs from FY 2010 into one 

SEDS FOA. The SEDS FOA will include 

all program areas of interest from the 

previous FOAs which address Social 

Development, Economic Development, 

and Strengthening Families. Governance 

projects will be addressed in a separate 

FOA (see SEDS—TG, below). The SEDS 

FOA will include two funding ranges 

with the higher funding amount being 

the disqualification factor for 

applications (see Section C of this 

Notice for more information on funding 

ranges). Furthermore, through the SEDS 

FOA, ANA will fund project proposals 

from Tribes to prepare applications for 

Federal recognition. Tribes will only be 

allowed to receive funding for this 

priority area once, as per the funding 

restriction which states, ‘‘ANA does not 

fund projects that are essentially 

identical or similar in whole or in part 

to previously funded projects proposed 

by the same applicant or activities or 

projects proposed by a consortium that 

duplicate activities for which any 

consortium member also receives 

funding from ANA.’’ This is a return to 

the ANA priority of the 1990s. (Legal 

authority: Section 803(a) of NAPA, as 

amended.) 

2. SEDS—Tribal Governance (TG) 

In FY 2011 ANA will introduce 

SEDS—TG to fund tribal governance 

projects. These types of projects were 

formerly funded under SEDS. ANA will 

expand the governance priority to 

emphasize projects that strengthen the 

internal capacity and infrastructure of 

tribal governments to increase services 

provided to children and families. The 

FOA will also emphasize increasing the 

tribal government’s ability to exercise 

local control and decision making over 

their resources. ANA is particularly 

interested in projects designed to 

develop strong linkages between social 

services, health programs, and schools 

serving Native children. Program areas 

of interest will be expanded to include: 

(1) Interoperability: Promote program 

coordination among human and social 

service programs for tribal communities 

to strengthen the programs they provide 

to their children, youth, and families. 

(2) Comprehensive Strategies: 

Develop comprehensive 

intergovernmental strategies involving 

tribal, State and Federal governments to 

meet the needs of tribal children and 

youth. 

(3) Self-Governance: Build the 

capacity and infrastructure of tribal 

governments to enter into selfgovernance compacts. 

ANA believes this FOA will 

encourage Tribes and Native 

communities to look at new 

opportunities and methods for 

providing services to their communities. 

Applicants eligible for this FOA are the 

same as those identified for SEDS. 

(Legal authority: Section 803(a) of 

NAPA, as amended.) 

3. SEDS—Assets for Independence (AFI) 

ANA is partnering with the Office of 

Community Services’ (OCS) AFI 

program to support Tribes and Native 

organizations in planning and 

implementing comprehensive assetbuilding projects. ANA and OCS are 

providing this support through funding 

opportunities, training, and technical 

assistance. The AFI program is an 

assets-based approach for assisting lowincome families out of poverty. The 

program assists individuals and families 

to save earned income in specialpurpose, matched savings accounts 

called Individual Development 

Accounts (IDAs). Every dollar in savings 

deposited into an IDA by a participant 

will be combined with non-participant 

funds (from $1 to $8 combined Federal 

(AFI) and non-Federal funds). The 

program promotes savings and enables a 

participant to acquire a lasting asset. An 

AFI participant can use the IDA savings 

to achieve any of three objectives: 

acquire a first home, capitalize a small 

business, or enroll in postsecondary 

education or training. 

ANA, through its SEDS program, and 

OCS, through its AFI program, are 

offering Tribes and Native organizations 

a joint funding initiative. The purpose 

of the joint SEDS–AFI funding is to 

support Tribes and Native organizations 


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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74057 

implement asset building projects with 

an AFI-funded IDA component. The 

ANA–SEDS portion of the funding will 

focus on the operational and staffing 

costs necessary to implement the 

project, financial literacy training, 

capacity building, and other activities. 

The OCS–AFI portion will be used to 

provide funding for IDAs and limited 

administrative costs. This FOA will 

request one application with two project 

budgets to complete the project. The 

two project budgets will separately 

identify the SEDS portion of the funding 

and corresponding match and the AFI 

portion of the funding and 

corresponding match. These two project 

budgets will be the basis for two awards 

needed to complete the project. The 

project will be monitored by a team 

representing both ANA and OCS. ANA 

will provide a funding opportunity for 

applicants to apply for a 5-year (five 12- 

month budget periods) grant to 

accompany award of a standard 5-year 

AFI grant. 

Eligible applicants include non-profit 

organizations that serve Native 

American populations, or Tribes, and 

Alaska Native villages if they are joint 

applicants with a non-profit 

organization serving Native American 

populations. The eligibility reflects the 

overlap between ANA’s target 

populations and the AFI program’s 

legislative eligibility requirements. 

Individual participants who open IDAs 

under this program must meet AFI 

participant guidelines, which are: 

Members of a household that is eligible 

for assistance under Temporary 

Assistance for Needy Families (TANF), 

or whose adjusted gross income is either 

equal to or less than 200 percent of the 

Federal poverty line, or is eligible for 

Federal Earned Income Tax Credit and 

has less than $10,000 in assets 

(excluding the value of a primary 

dwelling unit and one motor vehicle). 

The partnership includes a training 

and technical assistance (T/TA) 

component, through which ANA’s T/TA 

providers will conduct pre-application 

trainings and provide one-on-one 

technical assistance to potential SEDS— 

AFI applicants. 

This partnership between OCS and 

ANA will allow these two programs to 

provide enhanced funding opportunities 

to our common target communities and 

maximize the impact of grant dollars. 

Interoperability between programs 

within ACF is an ACF priority. (Legal 

authority: Section 803(a) of NAPA, as 

amended.) 

4. Native Language Preservation and 

Maintenance (Language P&M) and 

Esther Martinez Initiative (Language— 

EMI) 

All Language P&M and Language— 

EMI projects funded in FY2011 will 

have a start date of August 1, 2011. The 

revision to the start date will allow 

projects to better align with most school 

schedules throughout ANA’s target 

communities. To accommodate this 

revision, the Language FOAs will be 

published and application due dates 

will be earlier in the year than all other 

FOAs. (Legal authority: Section 803(a) 

and 803C of NAPA, as amended, 42 

U.S.C. 2991b and § 2991b-3 and Pub. L. 

109–394.) 

B. Administrative Policies: In FY 

2011, ANA will add five administrative 

policies. 

1. Grantees can have only one active 

grant per Catalog of Federal Domestic 

Assistance (CFDA) number. 

2. ANA will increase the reach of its 

limited funding. Therefore, applicants 

that have received funding from ANA 

for at least two projects consecutively 

and within one CFDA number may not 

be funded for a third consecutive project 

within the same CFDA number if other 

applicants who have not received ANA 

funding in the past 3 years are within 

the scoring range to be funded. 

3. Applicants are requested to identify 

a target amount of leveraged resources 

(target of zero is acceptable) and a target 

number of partnerships. The value of 

the targets will not be evaluated and 

scored; however, the indicators’ 

contribution within the overall strategy 

of project implementation and its 

sustainability is included in the 

evaluation criteria. Grantees will be 

required to track these indicators 

quarterly throughout the project period. 

Leveraged resources are in addition to 

the statutory matching requirement of 

20 percent and are not a requirement of 

this grant. 

4. Business plans should be submitted 

for all SEDS applications requesting an 

equity investment on behalf of the 

Federal government. 

The first two administrative policies 

will allow ANA to maximize its limited 

funding to benefit the most 

communities. The intent of the first 

policy, to restrict funding to one grant 

per entity per CFDA number, will also 

be stated in the eligibility and funding 

restriction sections of all FOAs. Due to 

the change in the project period start 

date for language projects, ANA will 

waive this restriction if a language 

project is ending within 2 months of a 

new project start date (i.e., organizations 

or Tribes with projects ending 9/29/ 

2011 can receive new awards with a 8/ 

1/2011 start date). In addition to 

maximizing the benefit of ANA’s 

limited funds, the first administrative 

policy will encourage current grantees 

to successfully complete project 

objectives within the originally defined 

project periods and avoid requests for 

No Cost Extensions (NCEs). Past 

experience has shown that project 

success is increased when a grantee can 

complete one project prior to starting a 

second project. Overlapping projects, 

specifically a new award and an 

extension, can result in delays or 

significant challenges to one or both 

projects because of limited financial and 

personnel resources. 

The second administrative policy 

allows the ANA commissioner to limit 

the frequency of the same organizations 

receiving funding, thus allowing it to 

address more communities. (Legal 

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

803C of NAPA, as amended, 42 U.S.C. 

2991b and 2991b–3 and Pub. L. 109– 

394.) 

The third administrative policy 

allows ANA to continue to measure 

leveraged resources and partnerships for 

all funded projects, but removes the 

target numbers for these indicators from 

being evaluated and scored by panel 

reviewers. ANA is required to measure 

these important indicators, as per the 

Government Performance Reporting Act 

(GPRA) for all negotiated awards. (Legal 

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

803C of NAPA, as amended, 42 U.S.C. 

2991b and 2991b–3 and Pub. L. 109– 

394.) 

The last administrative policy is 

specific to SEDS FOA. The business 

plan will not be evaluated for the merit 

of the plan itself; however, the business 

plan will be reviewed to ensure that the 

project strategy is in line with the 

business plan. (Legal authority: Section 

803(a) of NAPA, as amended.) 

C. Award Information: In all FOAs, 

ANA identifies funding floors and 

funding ceilings, as well as project 

periods. In FY 2011, the thresholds and 

project periods for SEDS, SEDS—TG, 

and SEDS—AFI are new or have 

changed. 

The funding ranges and project 

periods for the combined and new FOAs 

(see Section A of this Notice) will be as 

follows: 

SEDS 

$50,000 to $149,999 per budget period, 

and 

$150,000 to $400,000 per budget period. 

12-month project and budget period, or 

24-month project period with two 12- 

month budget periods, or 


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74058 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 

36-month project period with three 12- 

month budget periods. 

The SEDS FOA will identify how 

many applications will be funded in 

each of the two funding ranges. Only the 

upper limit of the two ranges ($400,000) 

will be used as a disqualification factor. 

SEDS—TG 

$50,000 to $375,000 per budget period. 

12-month project and budget period, or 

24-month project period with two 12- 

month budget periods, or 

36-month project period with three 12- 

month budget periods. 

SEDS—AFI 

$50,000 to $250,000 per budget period. 

60-month project period with five 12- 

month budget periods. 

The SEDS—AFI range reflects the 

ANA portion of the funding only. OCS 

will provide up to $1 million for a 5- 

year budget and project period. (Legal 

authority: Section 803(a) of NAPA, as 

amended.) 

Disqualification Factors: ANA will 

revise for clarification two factors that 

are specific to applications submitted 

for ANA funding. Applications that are 

submitted without this documentation 

will be considered non-responsive to 

the FOA and will not be considered for 

competition. 

The first ANA-specific 

disqualification factor applies to all 

applicants. The documentation required 

from the Tribe, Alaska Native village or 

organization stating approval of the 

proposed project must come in the form 

of a Board Resolution. 

The second ANA-specific 

disqualification factor applies only to 

applicants that are not Tribes or Native 

Alaska villages. Organizations applying 

for funding must show that a majority 

of board members approving the project 

proposal are representative of the 

community to be served. ANA will 

revise the categories of representatives 

of the community to be served to 

include: (1) Members of Federally or 

State recognized Tribes; (2) persons 

eligible to be a participant or beneficiary 

to the project to be funded; (3) persons 

who are recognized by the eligible 

community to be served as having a 

cultural relationship with the 

community to be served; or (4) persons 

considered to be Native American as 

defined in title 45, part 1336, section 10 

of the Code of Federal Regulations 

(CFR), and Native American Pacific 

Islander as defined in the Native 

American Programs Act. 

These disqualification factors will be 

revised to better establish board support 

for a project and to demonstrate a 

stronger link between an organization’s 

board and the community to be served. 

(Legal authority: Section 803(a) and 814 

of NAPA, as amended.) 

D. Definitions: ANA will revise and 

add definitions for terms used in the 

FOA. 

Leveraged Resources—Any resource, 

not including the Federal share, nonFederal contribution, and program 

income, acquired or utilized during the 

project period that supports the project. 

Leveraged resources are expressed as a 

dollar amount and may include natural, 

financial, personnel, and physical 

resources provided to assist in the 

successful completion of the project. 

Interoperability—Collaborative 

administration or information sharing 

that integrates the efforts of individual 

programs, projects, departments, etc. in 

order to strengthen programs and 

provide comprehensive service. 

Program Income—Gross income 

earned by a recipient and/or 

subrecipient that was directly generated 

by the grant-supported activity or 

earned as a result of the award. Program 

income includes (but is not limited to) 

fees for services performed, the use or 

rental of real or personal property 

acquired under the grant, the sale of 

commodities or items fabricated under 

an award, license fees and royalties on 

patents and copyrights, and payments of 

interest on loans made with grant funds. 

Except as otherwise provided in statute, 

regulation, or the terms and conditions 

of the award, program income does not 

include rebates, credits, discounts, or 

interest earned in relation to program 

income; the receipt of principal on loans 

or interest the recipient earns on those 

amounts after receiving them from the 

borrower; taxes, special assessments, 

levies, fines, or similar revenues raised 

by a governmental recipient or 

subrecipient. The term also does not 

include interest earned on advances of 

Federal funds and proceeds from the 

sale of equipment or real property 

acquired under an award, which have 

distinct accountability requirements. 

The leveraged resources definition 

will be revised to state that program 

income cannot be included. 

Interoperability is defined because the 

evaluation criteria will include a 

reference to the integration of the 

proposed project into other programs, if 

appropriate for the proposed project. 

Interoperability is an ACF priority, both 

within ACF and in the entities it funds. 

Program income is defined to clarify the 

definition of leveraged resources. (Legal 

authority: Section 803(b) and 814 of 

NAPA, as amended and 42 U.S.C. 

2991b-3(b)(7)(C).) 

E. Cost Sharing or Matching: The 

matching requirement waiver for Insular 

Areas will no longer be available for 

nongovernmental entities. 

1. All matching is waived for 

consolidated grants to governments of 

the Insular Areas; 

2. The first $200,000 of matching is 

waived for non-consolidated grants to 

governments of American Samoa, 

Guam, the Virgin Islands, or the 

Northern Mariana Islands; however, 

matching over the first $200,000 is not 

waived; 

3. Matching is not waived for grants 

to nongovernmental entities of the 

Insular Areas. 

Although there is not an automatic 

waiver for all applicants from the 

Insular Areas, any applicant may 

request an individual match 

requirement waiver, in accordance with 

NAPA. (Legal authority: 48 U.S.C. 

1469(a)(d) and 45 CFR 1336.50(b)(3).) 

F. Funding Restrictions: The 

restriction that prevents ANA from 

funding ‘‘counseling or therapeutic 

activities that are medically-based’’ will 

not be included in the following FOAs: 

Language—P&M, Language—EMI, 

SEDS—AFI, SEDS—TG, and ERE. In the 

SEDS FOA, the restriction will be 

revised to state: 

ANA does not fund couples or family 

counseling activities that are medically 

based. 

ANA will revise this restriction in 

SEDS in order to fund medically based 

activities in projects that address such 

health issues as diabetes prevention and 

care projects, elder health care, or other 

similar types of health issues. This 

funding restriction will not appear in 

other FOAs. (Legal authority: Sections 

803(a) and 814 of NAPA, as amended.) 

G. ANA Application Evaluation 

Criteria: ANA will revise the evaluation 

criteria throughout the Language—P&M, 

Language—EMI, SEDS, SEDS—TG, and 

ERE FOAs to clarify how reviewers will 

evaluate and score applications. The 

content of evaluation criteria will mirror 

the content of the project description 

section of the FOAs, which instructs 

applicants on what to include in an 

application. 

i. Titles and Assigned Weight: In FY 

2011, ANA will rename the criteria and 

adjust the weighted scores. 

For FY 2011, the criteria will be titled 

and weighted as follows: 

—Objectives and Need for Assistance 20 

points; 

—Outcomes Expected 15 points; 

—Approach 50 points; 

—Sub-criterion—Project Strategy 30 

points; 

—Sub-criterion—Objective Work Plan 

(OWP) 20 points and 


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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74059 

—Budget and Budget Justification 15 

points. 

For FY 2011, the two criteria for the 

SEDS–AFI FOA will be titled and 

weighted as follows: 

—Approach 90 points and 

—Budget and Budget Justification 

10 points. 

The criteria titles will match the titles 

found in the project description section 

of the FOAs. Matching titles will help 

applicants to better understand the 

connection between the two sections of 

the FOAs. The assigned weights better 

reflect what ANA considers to be the 

most important elements of the project 

application. (Legal authority: Section 

803(c) of NAPA, as amended.) 

ii. ANA Evaluation Criteria: Included 

here is a summary of each criterion. The 

FOAs will include a more detailed 

description of the evaluation criteria 

and the associated project description. 

(a) Objectives and Need for 

Assistance: Under this criterion, 

applications will be evaluated on the 

applicant’s community and applicant 

identification, connection to the 

community, community participation in 

the project development, the problem 

statement, and the briefly stated 

objectives. 

(b) Outcomes Expected: Under this 

criterion, applications will be evaluated 

on the strength of the project outcomes 

expected, which include the project 

goal, the results and benefits expected, 

and one project-specific impact 

indicator. For language applications that 

are designed to teach a Native language, 

applicants must include an impact 

indicator that shows advancement of 

language fluency. All other language 

projects should provide an impact 

indicator that measures an increase in 

community interest to preserve the 

language. 

(c) Approach: Under this criterion, 

the application will be evaluated on the 

strength of the project approach. This 

criterion includes two sub-criteria: The 

project strategy and the OWP. The 

project strategy sub-criterion includes a 

detailed description of the 

implementation plan, community 

involvement and outreach during 

implementation, and contingency 

planning to support project 

implementation. In addition, 

partnerships and leveraged resources 

will be evaluated as to their 

contribution within the overall strategy 

of project implementation and its 

sustainability; however, the target 

numbers will not be evaluated or 

scored. In this section reviewers will 

also consider organizational capacity 

and project sustainability. The OWP 

sub-criterion includes a review of the 

OWP form and its strength as an 

effective implementation tool. 

(d) Budget: Under this criterion, the 

application will be evaluated on the 

strength of the budget and how well it 

supports successful completion of the 

project objectives. This criterion 

includes a line-item budget and budget 

justification for each line item for each 

budget period. 

The changes to the content of 

evaluation criteria, and the 

complementary changes to the project 

description section of the FOA, will 

more effectively guide panel reviewers 

and applicants on what ANA believes 

are critical components of a project 

application. (Legal authority: Section 

803(c) of NAPA, as amended.) 

Dated: November 22, 2010. 

Lillian Sparks, 

Commissioner, Administration for Native 

Americans. 

[FR Doc. 2010–29976 Filed 11–29–10; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0583] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Radioactive Drug 

Research Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection contained in 

regulations governing the use of 

radioactive drugs for basic informational 

research (21 CFR 361.1). 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 31, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane., rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Radioactive Drug Research 

Committees—(OMB Control Number 

0910–0053) 

Under sections 201, 505, and 701 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 321, 355, and 371), FDA 

has the authority to issue regulations 

governing the use of radioactive drugs 


jdjones on DSK8KYBLC1PROD with NOTICES