Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 22903 

including occupational history and 

smoking history. The data collected are 

used by scientists for research purposes 

in defining the diagnostic criteria for 

pneumoconiosis and in correlating 

pathologic changes with exposures and 

x-ray findings. 

There are no costs of the NCWAS to 

respondents other than their time. The 

total estimated burden hours are 4,470. 

Type of respondent Form name Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Physicians B Readers ............ Roentgenographic Interpretation Form—CDC/NIOSH (M) 

2.8.

10,000 1 3/60 

Interpreting Physician Certification Document—CDC/NIOSH 

(M) 2.12.

300 1 10/60 

Miners ..................................... Miner Identification Document—CDC/NIOSH (M) 2.9 ........... 5,000 1 20/60 

No form—X-ray ...................................................................... 5,000 1 15/60 

No form—Spirometry .............................................................. 2,500 1 20/60 

Coal Mine Operators .............. Coal Mine Operator’s Plan—CDC/NIOSH (M) 2.10 .............. 200 1 30/60 

Supervisor at X-ray Facilities .. Facility Certification Document—CDC/NIOSH (M) 2.11 ........ 100 1 30/60 

Pathologist .............................. No form—Invoice .................................................................... 50 1 5/60 

No form—Final Diagnosis Report .......................................... 50 1 5/60 

Next-of-Kin .............................. Consent, Release, and History Form—CDC/NIOSH (M) 2.6 50 1 15/60 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–9922 Filed 4–22–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0125] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007.’’ 

This draft guidance provides 

information on how a manufacturer may 

demonstrate that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. In this 

draft guidance, FDA provides 

recommendations on the evidence that 

a manufacturer may use to demonstrate 

that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. This 

draft guidance is not final nor is it in 

effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 24, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007’’ to the Center for 

Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Annette Marthaler, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

e-mail: annette.marthaler@fda.hhs.gov. 

With regard to the proposed 

collection of information: Jonna 

Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, e-mail: Jonnalynn.Capezzuto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance provides 

information on how a manufacturer may 

establish that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. In this 

draft guidance, FDA provides 

recommendations on the information 

that a manufacturer may use to establish 

that a tobacco product was 

commercially marketed in the United 

States on February 15, 2007, and is, 

therefore, a grandfathered product not 

subject to premarket review 

requirements. In the draft guidance 

document, FDA recommends that this 

information may include, among other 

things, dated copies of advertisements, 

dated catalog pages, and dated 

promotional material. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on ‘‘Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007.’’ 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

An electronic version of the draft 

guidance document is available on the 

Internet at http://www.regulations.gov 


jdjones on DSKHWCL6B1PROD with NOTICES
22904 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 

and http://www.fda.gov/ 

TobaccoProducts/GuidanceCompliance

RegulatoryInformation/default.htm. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(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 

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. 

Draft Guidance on Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007—(OMB Control 

Number 0910–NEW) 

This draft guidance provides 

information on how a manufacturer may 

establish that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007, and is, 

therefore, a grandfathered product not 

subject to premarket review. The draft 

guidance recommends that the 

manufacturer provide evidence that may 

include, among other things, dated 

copies of advertisements, dated catalog 

pages, dated promotional material, and 

dated bills of lading. FDA recommends 

that the manufacturer submit as much 

information as possible to demonstrate 

that the tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. FDA’s 

estimate of the number of respondents 

is based on the fact that requesting an 

agency determination of the 

grandfathered status of a tobacco 

product under the draft guidance is not 

required and also on indications of 

interest in making such request. The 

number of hours is FDA’s estimate of 

how long it might take one to review, 

gather, and submit dated information if 

making a request for an agency 

determination. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ONE TIME REPORTING BURDEN 1

Activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Submit evidence of commercial marketing in the United 

States as of February 15, 2007 ....................................... 150 1 150 10 1,500 

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

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9939 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–F–0225] 

Ferm Solutions, Inc.; Filing of Food 

Additive Petition (Animal Use); 

Erythromycin Thiocyanate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Ferm Solutions, Inc., has filed a 

petition proposing that the food additive 

regulations be amended to provide for 

the safe use of erythromycin thiocyanate 

as an antimicrobial processing aid in 

fuel-ethanol fermentations with respect 

to its consequent presence in byproduct 

distiller grains used as an animal feed 

or feed ingredient. 

DATES: Submit either electronic or 

written comments on the petitioner’s 

environmental assessment by May 25, 

2011. 

ADDRESSES: Submit electronic 

comments to: http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Isabel W. Pocurull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6853, email: isabel.pocurull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(section 409(b)(5) (21 U.S.C. 348(b)(5)), 

notice is given that a food additive 

petition (FAP 2271) has been filed by 

Ferm Solutions, Inc., P.O. Box 203, 445 

Roy Arnold Ave., Danville, KY 40423. 

The petition proposes to amend the food 

additive regulations in part 573 Food 

Additives Permitted in Feed and 

Drinking Water of Animals (21 CFR part 

573) to provide for the safe use of 

erythromycin thiocyanate as an 

antimicrobial processing aid in fuelethanol fermentations with respect to its 


jdjones on DSKHWCL6B1PROD with NOTICES