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
74060 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 

for basic scientific research. Section 

361.1 (21 CFR 361.1) sets forth specific 

regulations regarding the establishment 

and composition of Radioactive Drug 

Research Committees and their role in 

approving and monitoring basic 

research studies utilizing 

radiopharmaceuticals. No basic research 

study involving any administration of a 

radioactive drug to research subjects is 

permitted without the authorization of 

an FDA approved Radioactive Drug 

Research Committee (§ 361.1(d)(7)). The 

type of research that may be undertaken 

with a radiopharmaceutical drug must 

be intended to obtain basic information 

and not to carry out a clinical trial for 

safety or efficacy. The types of basic 

research permitted are specified in the 

regulation, and include studies of 

metabolism, human physiology, 

pathophysiology, or biochemistry. 

Section 361.1(c)(2) requires that each 

Radioactive Drug Research Committee 

shall select a chairman, who shall sign 

all applications, minutes, and reports of 

the committee. Each committee shall 

meet at least once each quarter in which 

research activity has been authorized or 

conducted. Minutes shall be kept and 

shall include the numerical results of 

votes on protocols involving use in 

human subjects. Under § 361.1(c)(3), 

each Radioactive Drug Research 

Committee shall submit an annual 

report to FDA. The annual report shall 

include the names and qualifications of 

the members of, and of any consultants 

used by, the Radioactive Drug Research 

Committee, using FDA Form 2914, and 

a summary of each study conducted 

during the proceeding year, using FDA 

Form 2915. 

Under § 361.1(d)(5), each investigator 

shall obtain the proper consent required 

under the regulations. Each female 

research subject of childbearing 

potential must state in writing that she 

is not pregnant, or on the basis of a 

pregnancy test be confirmed as not 

pregnant. 

Under § 361.1(d)(8), the investigator 

shall immediately report to the 

Radioactive Drug Research Committee 

all adverse effects associated with use of 

the drug, and the committee shall then 

report to FDA all adverse reactions 

probably attributed to the use of the 

radioactive drug. 

Section 361.1(f) sets forth labeling 

requirements for radioactive drugs. 

These requirements are not in the 

reporting burden estimate because they 

are information supplied by the Federal 

Government to the recipient for the 

purposes of disclosure to the public (5 

CFR 1320.3(c)(2)). 

Types of research studies not 

permitted under this regulation are also 

specified, and include those intended 

for immediate therapeutic, diagnostic, 

or similar purposes or to determine the 

safety or effectiveness of the drug in 

humans for such purposes (i.e., to carry 

out a clinical trial for safety or efficacy). 

These studies require filing of an 

investigational new drug application 

(IND) under 21 CFR part 312, and the 

associated information collections are 

covered in OMB Control Number 0910– 

0014. 

The primary purpose of this 

collection of information is to determine 

whether the research studies are being 

conducted in accordance with required 

regulations and that human subject 

safety is assured. If these studies were 

not reviewed, human subjects could be 

subjected to inappropriate radiation or 

pharmacologic risks. 

Respondents to this information 

collection are the chairperson(s) of each 

individual Radioactive Drug Research 

Committee, investigators, and 

participants in the studies. 

The burden estimates are based on 

FDA’s experience with these reporting 

and recordkeeping requirements over 

the past few years and the number of 

submissions received by FDA under the 

regulations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Forms Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

361.1(c)(3) & (4) ................. FDA 2914 ........................... 80 1 80 1 80 

361.1(c)(3) ........................... FDA 2915 ........................... 50 6.8 340 3.5 1,190 

361.1(d)(8) .......................... ............................................. 50 6.8 340 0.1 34 

Total ............................. ............................................. ........................ ........................ ........................ ........................ 1,304 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

361.1(c)(2) ............................................................................ 80 4 320 10 3,200 

361.1(d)(5) ........................................................................... 50 6.8 340 .75 255 

Total .............................................................................. ........................ ........................ ........................ ........................ 3,455 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices 74061 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30038 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0594] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Focus Groups as 

Used by the Food and Drug 

Administration (All Food and Drug 

Administration Regulated Products) 

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 

focus groups as used by FDA to gauge 

public opinion on all FDA-regulated 

products. 

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: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, e-mail: 

Jonnalynn.capezzuto@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. 

Focus Groups as Used by the Food and 

Drug Administration (All FDARegulated Products)—(OMB Control 

Number 0910–0497)—Extension 

FDA conducts focus group interviews 

on a variety of topics involving FDAregulated products, including drugs, 

biologics, devices, food, tobacco, and 

veterinary medicine. 

Focus groups provide an important 

role in gathering information because 

they allow for a more indepth 

understanding of consumers’ attitudes, 

beliefs, motivations, and feelings than 

do quantitative studies. Focus groups 

serve the narrowly defined need for 

direct and informal opinion on a 

specific topic and as a qualitative 

research tool have three major purposes: 

• To obtain consumer information 

that is useful for developing variables 

and measures for quantitative studies, 

• To better understand consumers’ 

attitudes and emotions in response to 

topics and concepts, and 

• To further explore findings 

obtained from quantitative studies. 

FDA will use focus group findings to 

test and refine their ideas but will 

generally conduct further research 

before making important decisions, such 

as adopting new policies and allocating 

or redirecting significant resources to 

support these policies. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Focus Group Interviews ....................................................... 1,440 1 1,440 1.75 2,520 

1There are no capital or operating and maintenance costs associated with this collection of information. 


jdjones on DSK8KYBLC1PROD with NOTICES