25268 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 

the number of respondents for listing of 

ingredients under section 904 of the act 

from 100,000 to 11,000 in response to 

comments that this estimate was too 

high. FDA also added the activity of 

applying for a Dun and Bradstreet D-UN-S number to the burden of this 

information collection for those who 

chose to use eSubmitter. 

In the Federal Register of February 

18, 2010 (75 FR 7269), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

but was outside the scope of the PRA 

requirements. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

Activity Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Respondents 

Hours per 

Response Total Hours 

Registration and Product 

Listing for Owners and 

Operators of Domestic 

Establishments 100,000 1 100,000 3 .75 375,000 

Listing of Ingredients 11,000 1 11,000 3 .0 33,000 

Obtaining a Dun and 

Bradstreet D-U-N-S 

Number 1,550 1 1,550 0 .5 775 

Total 112,550 112,550 408,775 

Dated: May 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10781 Filed 5–6–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0487] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance on Informed Consent for In 

Vitro Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Individually Identifiable 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance on Informed Consent For In 

Vitro Diagnostic Device Studies Using 

Leftover Human Specimens That Are 

Not Individually Identifiable’’ 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, email: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 19, 2010 (75 

FR 2868), 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 0910–0582. 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: May 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10782 Filed 5–6–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; REDS–II—Does 

Pre-Donation Behavioral Deferral 

Increase the Safety of the Blood 

Supply? 

SUMMARY: Under the provisions of 

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

Reduction Act of 1995, the National 

Heart, Lung and Blood Institute 

(NHLBI), the National Institutes of 

Health has submitted to the Office of 

Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on February 24, 2010 in 

Volume 75, No. 36, pages 8367–8368 

and allowed 60-days for public 

comment. (No public comments were 

received.) 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 

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: REDS–II 

Does Pre-Donation Behavioral Deferral 

Increase the Safety of the Blood Supply? 

Type of Information Collection 

Request: New. Need and Use of 

Information Collection: While it is wellaccepted that deferrals, as part of the 

‘‘layers of safety’’ concept, increase the 

safety of the blood supply, studies with 

sufficiently large sample size to quantify 

HIV infection and other infectious 

marker rates in deferred donors are 

lacking. Evidence in support of 

increased safety is frequently inferred 

from studies conducted in other health 

care settings. For example, a small 

hospital-based case control study 

conducted in Brazil examined the 

association between infectious markers 

and body tattoos. Even though tattoos 

are not used as a criteria to determine 

blood donor eligibility in Brazil, having 

a tattoo was associated with HCV and 

also with having at least one positive 

infectious marker.(1) Significant 

associations were not independently 

observed for HIV, HBV, syphilis or 

Chagas. The authors reported an overall 

sensitivity of 11% and specificity of 


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