Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7269 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms 

(if necessary) 

Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Self-administered questionnaire ....... Medicare beneficiaries ..................... 500 1 25/60 208 

Total ........................................... 500 ........................ ........................ 208 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–3071 Filed 2–17–10; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0074] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed extension of an existing 

collection of information pertaining to 

registration and product listing for 

owners and operators of domestic 

tobacco product establishments and to 

listing of ingredients in tobacco 

products under the Family Smoking 

Prevention and Tobacco Control Act 

(the Tobacco Control Act). 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 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) must be 

submitted to FDA by December 22, 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

7270 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

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. 

On September 1, 2009 (74 FR 45219), 

FDA published notice in the Federal 

Register announcing that a proposed 

collection of information had been 

submitted to OMB for emergency 

processing under the Paperwork 

Reduction Act of 1995. On September 

15, 2009 (74 FR 47257), FDA published 

a notice correcting the length of the 

comment period, keeping it open until 

October 1, 2009. On 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 

the number of respondents for listing of 

ingredients under section 904 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. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. 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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3031 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0434] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Humanitarian Device Exemption 

Holders, Institutional Review Boards, 

Clinical Investigators, and Food and 

Drug Administration Staff: 

Humanitarian Device Exemption 

Regulation: Questions and Answers; 

Availability 

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. 

DATES: Fax written comments on the 

collection of information by March 22, 

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–NEW and 

title Guidance for Humanitarian Device 

Exemption Holders, Institutional 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES