24706 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices 

Superbowls (football) and World Series 

(baseball); the political conventions of 

both major US political parties; and the 

Presidential Inauguration (2009). 

Today, EARS is a highly successful 

and sustainable system and has over 200 

users at the Federal, State, local, and 

international levels. These users include 

international Ministries of Health and 

domestic state and local public health 

departments. Additionally, EARS 

detection methods have been integrated 

in well-known surveillance platforms 

such as BioSense at CDC, ESSENSE at 

Johns Hopkins, NAMRD at US 

Department of Defense, and Emergint at 

Northrop Grumman. 

EARS is widely-accepted and easily 

sustainable due to its being free to all 

end users, the capacity to use multiple 

forms of data, flexibility and user-driven 

design and maintenance. EARS is a 

service provided by CDC as share-ware 

and is available by download at no cost 

from the CDC Web site http:// 

www.bt.cdc.gov/surveillance/EARS. 

In an effort to continue to improve 

and enhance EARS, the collection of 

registration information is needed to 

track users and organizations to assist in 

future needs assessments. Requiring the 

users to register will provide CDC with 

contact information (i.e., e-mail 

addresses) to use for broadcast e-mails 

regarding new releases for upgrades and 

enhancements; track the number of 

users, the download frequency, and the 

type of data that users will monitor with 

EARS; and solicit users for feedback for 

future upgrades and enhancements. 

CDC estimates that there will be 150 

respondents registered for EARS. Each 

respondent will need an average of 10 

minutes to complete the EARS 

registration form which leads to a total 

public burden of 25 hours. 

There is no cost to respondents to 

participate in this program. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Users ................................................................................................................ 150 1 10/60 25 

Dated: April 21, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–10586 Filed 5–4–10; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–10–0741] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call Maryam I. Daneshvar, the 

CDC Reports Clearance Officer, at (404) 

639–5960 or send an e-mail to 

omb@cdc.gov. Send written comments 

to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

The Study to Explore Early 

Development (SEED) (OMB No. 0920– 

0741 exp. 6/30/2010)—Revision— 

National Center on Birth Defects and 

Developmental Disabilities (NCBDDD), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

This data collection is based on the 

following components of the Public 

Health Service Act: (1) Act 42 U.S.C. 

241, Section 301, which authorizes 

‘‘research, investigations, experiments, 

demonstrations, and studies relating to 

the causes, diagnosis, treatment, control, 

and prevention of physical and mental 

diseases and impairments of man.’’ (2) 

42 U.S.C. 247b–4, Section 317 C, which 

authorizes the activities of the National 

Center on Birth Defects and 

Developmental Disabilities. This section 

was created by Public Law 106–310, 

also known as ‘‘the Children’s Health 

Act of 2000.’’ This portion of the code 

has also been amended by Public Law 

108–154, which is also known as the 

‘‘Birth Defects and Developmental 

Disabilities Prevention Act of 2003.’’ 

The Children’s Health Act of 2000 

mandated CDC to establish autism 

surveillance and research programs to 

address the number, incidence, 

correlates, and causes of autism and 

related disabilities. Under the 

provisions of this act, CDC funded five 

Centers for Autism and Developmental 

Disabilities Research and Epidemiology 

(CADDRE) including the California 

Department of Health and Human 

Services, Colorado Department of Public 

Health and Environment, Johns Hopkins 

University, the University of 

Pennsylvania, and the University of 

North Carolina at Chapel Hill. CDC 

National Center on Birth Defects and 

Developmental Disabilities participates 

as the sixth CADDRE site. The SEED 

multi-site, collaborative project is an 

epidemiological investigation of 

possible causes for the autism spectrum 

disorders. 

Study participants are to be selected 

from children born in and residing in 

the following six areas: Atlanta 

metropolitan area, San Francisco Bay 

area, Denver metropolitan area, 

Baltimore metropolitan area, 

Philadelphia metropolitan area, and 

Central North Carolina. Children with 

autism spectrum disorders are 

compared to children with other 

developmental problems, referred to as 

the neurodevelopmentally impaired 

group (NIC), as well as children who do 

not have developmental problems, 

referred to as the sub-cohort. 

Data collection methods consist of the 

following: (1) Medical record review of 

the child participant; (2) medical record 

review of the biological mother of the 

child participant; (3) packets sent to the 

participants with self-administered 

questionnaires and a buccal swab kit; (4) 

a telephone interview focusing on 

pregnancy-related events and early life 

history (biological mother and/or 

primary caregiver interview); (5) a child 

development evaluation (more 

comprehensive for case participants 

than for the control group participants); 

(6) parent-child development interview 

(for case participants only) administered 

over the telephone or in-person; (7) a 

physical exam of the child participant; 

(8) biological sampling of the child 

participant (blood and hair); and, (9) 


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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices 24707 

biological sampling of the biological 

parents of the child participant (blood 

only). Minor changes to some of the self 

administered questionnaires and the 

telephone interview include 

clarification of instructions to the 

respondent and clarifying specific 

questions to make the instruments 

easier to complete and further improve 

data quality. The only study design 

change that is being proposed is to 

expand the eligible study participant 

birth date range from September 1, 

2003–August 31, 2005 to September 1, 

2003–August 31, 2006. 

There is no cost to respondents other 

than their time. The total estimated 

annualized burden is 4,948 hours. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Responses 

per 

respondent 

Avg. burden 

per response 

(in hours) 

Parent .............................................................. Response Card .............................................. 2,458 1 10/60 

Parent .............................................................. Invitation packet ............................................. 1,008 1 30/60 

Parent .............................................................. Questionnaire packet ..................................... 347 1 3.5 

Parent .............................................................. Caregiver Interview packet ............................ 402 1 1.5 

Parent .............................................................. Follow-up telephone call packet .................... 347 3 20/60 

Parent and Child ............................................. Biosample packet ........................................... 1,041 1 40/60 

Parent and Child ............................................. Blood Draw ..................................................... 966 1 15/60 

Child ................................................................ Clinic Visit—control children packet ............... 214 1 1

Parent .............................................................. Clinic Visit—control parent ............................. 80 1 45/60 

Parent .............................................................. Control parent consent form .......................... 214 1 10/60 

Child ................................................................ Clinic Visit—Case children packet ................. 107 1 1.5 

Parent .............................................................. Clinic Visit—Case parent packet ................... 107 1 3.5

Parent .............................................................. Medical Record Abstraction ........................... 347 5 3/60 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–10585 Filed 5–4–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0483] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Medical Device User Fee Cover 

Sheet—Form FDA 3601 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Medical Device User Fee Cover Sheet— 

Form FDA 3601’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 19, 2010 (75 

FR 2866), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0511. The 

approval expires on February 28, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: April 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10579 Filed 5–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0486] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry, Food and Drug 

Administration, and Foreign 

Governments: Fiscal Year 2010 

Medical Device User Fee Small 

Business Qualification and 

Certification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry, FDA, and 

Foreign Governments: Fiscal Year 2010 

Medical Device User Fee Small Business 

Qualification and Certification’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 19, 2010 (75 

FR 2874), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0508. The 

approval expires on February 28, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: April 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10581 Filed 5–4–10; 8:45 am] 

BILLING CODE 4160–01–S 


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