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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