Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 25267 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on June 7, 2010. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–10622 Filed 5–6–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0074] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco 

Product Establishments and Listing of 

Ingredients in Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by June 7, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0650. Also 

include the FDA 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, 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments and 

Listing of Ingredients in Tobacco 

Products—(OMB Control Number 0910– 

0650)—Extension 

On June 22, 2009, the President 

signed The Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Public Law 111–31) into 

law. The Tobacco Control Act amended 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et seq.) by, 

among other things, adding a new 

chapter granting FDA important new 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

generally and to reduce tobacco use by 

minors. Section 905(b) of the act (21 

U.S.C. 395(b)), as amended by the 

Tobacco Control Act, requires that 

‘‘every person who owns or operates any 

establishment in any State engaged in 

the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products 

***’’ register with FDA the name, 

places of business, and all 

establishments owned or operated by 

that person. Every person must register 

by December 31 of each year. Section 

905(i)(1) of the act, as amended by the 

Tobacco Control Act, requires that all 

registrants ‘‘shall, at the time of 

registration under any such subsection, 

file with [FDA] a list of all tobacco 

products which are being manufactured, 

prepared, compounded, or processed by 

that person for commercial 

distribution,’’ along with certain 

accompanying consumer information, 

such as all labeling and a representative 

sampling of advertisements. Section 

904(a)(1) of the act, as amended by the 

Tobacco Control Act, requires each 

tobacco product manufacturer or 

importer, or agent thereof, to submit ‘‘a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are * * * added by the 

manufacturer to the tobacco, paper, 

filter, or other part of each tobacco 

product by brand and by quantity in 

each brand and subbrand.’’ Since the 

Tobacco Control Act was enacted on 

June 22, 2009, the information required 

under section 904(a)(1) of the act must 

be submitted to FDA by December 22, 

2009, and include the ingredients added 

as of the date of submission. Section 

904(c) of the act also requires 

submission of information whenever 

additives, or the quantities of additives, 

are changed. 

FDA issued guidance documents on 

both (1) Registration and Product Listing 

for Owners and Operators of Domestic 

Tobacco Product Establishments 

(November 12, 2009, 74 FR 58298) and 

(2) Listing of Ingredients in Tobacco 

Products (December 1, 2009, 74 FR 

62795) to assist persons making such 

submissions to FDA under the Tobacco 

Control Act. While electronic 

submission of registration and product 

listing information and ingredient 

listing information are not required, 

FDA is strongly encouraging electronic 

submission to facilitate efficiency and 

timeliness of data management and 

collection. To that end, FDA designed 

the eSubmitter application to streamline 

the data entry process for registration 

and product listing and for ingredient 

listing. This tool allows for importation 

of large quantities of structured data, 

attachments of files (e.g., in portable 

document format (PDFs) and certain 

media files), and automatic 

acknowledgement of FDA’s receipt of 

submissions. FDA also developed paper 

forms (FDA Form 3742—Registration 

and Listing for Owners and Operators of 

Domestic Tobacco Product 

Establishments and FDA Form 3743— 

Listing of Ingredients in Tobacco 

Products) as an alternative submission 

tool. Both the eSubmitter application 

and the paper forms can be accessed at 

http://www.fda.gov/tobacco. 

In the Federal Register of September 

1, 2009 (74 FR 45219), FDA published 

a notice announcing that a proposed 

collection of information had been 

submitted to OMB for emergency 

processing under the PRA. In the 

Federal Register of September 15, 2009 

(74 FR 47257), FDA published a notice 

correcting the length of the comment 

period, keeping it open until October 1, 

2009. In the Federal Register of October 

13, 2009 (74 FR 52495), FDA published 

a notice reopening the comment period 

until October 26, 2009. Based on 

comments indicating that the burden 

estimates were too low, FDA has 

adjusted its original burden estimates. 

FDA has adjusted its burden estimate 

for registration and product listing for 

owners and operators of domestic 

establishments under section 905 of the 

act from 0.75 hours per response to 3.75 

hours per response. FDA has adjusted 

its burden estimate for listing of 

ingredients under section 904 of the act 

from 0.75 hours per response to 3.0 

hours per response. FDA also decreased 


jlentini on DSKJ8SOYB1PROD with NOTICES
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 


jlentini on DSKJ8SOYB1PROD with NOTICES