69086 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 

organization or other affiliation, full 

address and phone, fax, and e-mail 

information or e-mail this information 

to FindYouthInfo@air.org. Additional 

identification documents may be 

required. 

Dated: November 4, 2010. 

Sherry Glied, 

Assistant Secretary for Planning and 

Evaluation. 

Authority: Division F, Pub. L. 111–8; E.O. 

13459, 73 FR 8003, February 12, 2008. 

[FR Doc. 2010–28396 Filed 11–9–10; 8:45 am] 

BILLING CODE 4154–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–10–10DE] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC), Agency for Toxic 

Substances and Disease Registry 

(ATSDR) publishes a list of information 

collection requests under review by the 

Office of management and Budget 

(OMB) in compliance with the 

Paperwork Reduction Act (33 U.S.C. 

chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer, at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to ATSDR Desk Officer, 

Office of Management and Budget, 

Washington, DC 20503 or by fax to (202) 

395–5806. Written comments should be 

received within 30 days of this notice. 

Proposed Project 

Creation of State and Metropolitan 

Area-based Surveillance Projects for 

Amyotrophic Lateral Sclerosis (ALS)— 

New—Agency for Toxic Substances and 

Disease Registry (ATSDR). 

Background and Brief Description 

On October 10, 2008, President Bush 

signed S. 1382: ALS Registry Act which 

amended the Public Health Service Act 

to provide for the establishment of an 

Amyotrophic Lateral Sclerosis (ALS) 

Registry. The activities described are 

part of the effort to create the National 

ALS Registry. The purpose of the 

registry is to: (1) Better describe the 

incidence and prevalence of ALS in the 

United States; (2) examine appropriate 

factors, such as environmental and 

occupational, that might be associated 

with the disease; (3) better outline key 

demographic factors (such as age, race 

or ethnicity, gender, and family history 

of individuals diagnosed with the 

disease); and (4) better examine the 

connection between ALS and other 

motor neuron disorders that can be 

confused with ALS, misdiagnosed as 

ALS, and in some cases progress to ALS. 

The registry will collect personal health 

information that may provide a basis for 

further scientific studies of potential 

risks for developing ALS. 

This project purposes to collect 

information-specific data related to 

ALS. The objective of this project is to 

develop state-based and metropolitan 

area-based surveillance projects for 

ALS. The primary goal of the state-based 

and metropolitan area-based 

surveillance project is to use these data 

to evaluate the completeness of the 

National ALS Registry. The secondary 

goal of the surveillance project is to 

obtain reliable and timely information 

on the incidence and prevalence of ALS 

and to better describe the demographic 

characteristics (e.g., age, race, sex, and 

geographic location) of those with ALS. 

Neurologists or their staff will 

complete an ALS Case Reporting Form 

on each of their ALS patients. This will 

be transmitted to the state or 

metropolitan health department. The 

contract surveillance staff assigned to 

the state and metropolitan area health 

departments will train medical 

personnel how to complete the ALS 

Case Reporting Form (Attachment 3) 

and assist with abstracting records as 

requested. An ALS Medical Record 

Verification Form will be collected on a 

subset of cases reported. Each medical 

provider reporting source should keep a 

line listing of individuals diagnosed 

with or thought to have ALS along with 

information on whether or not the case 

was reported and if not, the reason. 

Surveillance items to be collected 

include information to make sure that 

there are no duplicates. There are no 

costs to the respondents other than their 

time. The estimated annualized burden 

hours are 703. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of data collection instrument Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Training ........................................................... Medical Personnel/Neurologist ...................... 243 1 30/60 

ALS Case Reporting Form ............................. Medical Personnel/Neurologist ...................... 2,250 1 5/60 

ALS Medical Record Verification Form .......... Neurologist ..................................................... 450 1 20/60 

Line Listing (record keeping) .......................... Medical Personnel .......................................... 243 1 1 

Dated: November 4, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention/Agency for 

Toxic Substances and Disease Registry. 

[FR Doc. 2010–28337 Filed 11–9–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB review; comment 

request; NCCAM Office of 

Communications and Public Liaison 

Communications Program Planning 

and Evaluation Research 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Center for Complementary and 

Alternative Medicine (NCCAM), the 

National Institutes of Health (NIH), has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on August 25, 2010 

(Vol. 75, No. 164, p. 52349) and allowed 

60-days for public comment. There was 

one public comments received during 

this time. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 69087 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: NCCAM 

Office of Communications and Public 

Liaison Communications Program 

Planning and Evaluation Research. Type 

of Information Collection Request: 

Extension. Need and Use of Information 

Collection: To carry out NCCAM’s 

legislative mandate to educate and 

disseminate information about 

complementary and alternative 

medicine (CAM) to a wide variety of 

audiences and organizations, the 

NCCAM Office of Communications and 

Public Liaison (OCPL) requests 

clearance to carry out (1) formative and 

(2) evaluative research of a variety of 

print and online materials, outreach 

activities, and messages to maximize 

their impact and usefulness. 

OCPL wishes to continue to carry out 

formative research to further understand 

the knowledge, attitudes, and behaviors 

of its core constituent groups: members 

of the general public, researchers, and 

providers of both conventional and 

CAM health care. In addition, it seeks to 

test newly formulated messages and 

identify barriers and impediments to the 

effective communication of those 

messages. With this formative audience 

research, OCPL test audience responses 

to NCCAM’s fact sheets, Web content, 

and other materials and messages. 

Clearance is also requested to 

continue evaluative research on existing 

materials and messages, as part of 

OCPL’s ongoing effort to develop a 

comprehensive program of testing and 

evaluation of all of its communications 

strategies. This evaluative research will 

include pilot testing of recently 

developed messages and information 

products such as consumer fact sheets 

and brochures. It will address the need 

to evaluate the processes by which new 

materials and messages were developed, 

the effectiveness of an outreach activity 

or the extent to which behaviors were 

changed by the message, and the impact 

of a message on health knowledge and 

behaviors. 

The tools to collect this information 

have been selected to minimize burden 

on NCCAM’s audiences, produce or 

refine messages that have the greatest 

potential to influence target audience 

attitudes and behavior in a positive 

manner, and to use Government 

resources efficiently. They may include 

individual in-depth interviews, focus 

group interviews, intercept interviews, 

self-administered questionnaires, 

gatekeeper reviews, and omnibus 

surveys. 

The data will enhance OCPL’s 

understanding of the unique 

information needs and distinct healthinformation-seeking behaviors of its 

core constituencies, and the segments 

within these constituencies with special 

information needs (for example, among 

the general public these segments 

include cancer patients, the chronically 

ill, minority and ethnic populations, the 

elderly, users of dietary supplements, 

and patients integrating complementary 

therapies with conventional medical 

treatments). 

Frequency of Response: On occasion. 

Affected Public: Individuals and 

households; non-profit institutions; 

Federal Government; State, Local, or 

Tribal Government. Type of 

Respondents: Adult patients; members 

of the public; health care professionals; 

organizational representatives. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

2,500; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours per Response: 0.58; and 

Estimated Total Burden Hours 

Requested: 2,109 for the 3-year 

clearance period (approximately 703 

hours annually). The annualized cost to 

respondents is estimated at $18,123. 

There are no Capital Costs, Operating 

Costs, or Maintenance Costs to report. 

TABLE 1—ANNUAL BURDEN HOURS

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

In-depth interviews with general public ........................................................... 30 1 .75 23 

Focus groups ................................................................................................... 20 1 1.5 30 

Omnibus surveys ............................................................................................. 1,900 1 0.25 475 

Intercept interviews with public and healthcare professionals ........................ 300 1 .25 75 

In-depth interviews health professionals ......................................................... 50 1 .50 25 

Self-administered questionnaires with health professionals ............................ 200 1 .25 50 

Total .......................................................................................................... 2,500 ........................ ........................ 678 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Christy 

Thomsen, Director, Office of 

Communications and Public Liaison, 

NCCAM, 31 Center Drive, Room 2B11, 

Bethesda, MD 20892, or fax your request 

to 301–402–4741, or e-mail 

thomsenc@mail.nih.gov. Ms. Thomsen 

can be contacted by telephone at 301– 

451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 


emcdonald on DSK2BSOYB1PROD with NOTICES
69088 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 

Dated: November 1, 2010. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. 2010–28290 Filed 11–9–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Strengthening Communities 

Fund (SCF) Evaluation. 

OMB No.: New Collection. 

Description: This proposed 

information collection activity is to 

obtain information from participants in 

two Strengthening Communities Fund 

(SCF) programs: The Nonprofit Capacity 

Building Program and the State, Local, 

and Tribal Government Capacity 

Building Program. Both programs are 

designed to contribute to the economic 

recovery as authorized in the American 

Recovery and Reinvestment Act of 2009 

(ARRA). The SCF evaluation is an 

important opportunity to examine 

outcomes achieved by the Strengthening 

Communities Fund and progress toward 

the objective of improving the capacity 

of organizations served by program 

grantees to address broad economic 

recovery issues in their communities. 

The evaluation will be designed to 

assess progress and measure increased 

organizational capacity of each 

participating organization. The purpose 

of this request is to receive approval of 

the data collection instruments that will 

be used in this study. 

A significant amount of information is 

already being collected through 

program-specific OMB-approved PPR 

forms or is available through secondary 

sources. Proposed surveys and phone 

interviews are very brief to reduce the 

burden on respondents. 

Respondents: SCF grantees,and faithbased and Community Organizations 

(FBCOs). 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

An on-line survey of SCF grantees ................................................................. 84 1 0.25 21 

Telephone interview of SCF grantees ............................................................. 84 1 1.50 126 

On-line survey of faith-based and community organizations (FBCOs) that 

received capacity building services from the SCF grantees ....................... 1,000 1 0.50 500 

Estimated Total Annual Burden 

Hours: 647 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: November 4, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–28304 Filed 11–9–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–P–0273] 

Determination That Amphetamine 

Sulfate, 5 and 10 Milligram Tablets, 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that Amphetamine sulfate, 5 and 10 

milligram (mg) tablets, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for Amphetamine 

sulfate, 5 mg and 10 mg tablets, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Raulerson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6368, 

Silver Spring, MD 20993–0002, 301– 

796–3522. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 


emcdonald on DSK2BSOYB1PROD with NOTICES