790 Federal Register / Vol. 76, No. 4 / Thursday, January 6, 2011 / Notices 

information on electronic access to the 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Annette Marthaler, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

annette.marthaler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance that provides 

recommendations related to reports 

under section 905(j) of the FD&C Act (21 

U.S.C. 387e(j)), as amended by the 

Family Smoking Prevention and 

Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31). Section 

905(j) authorizes FDA to establish the 

form for the submission of information 

related to substantial equivalence. The 

guidance is intended to assist persons 

submitting reports under section 905(j) 

of the FD&C Act. It explains, among 

other things, FDA’s interpretation of the 

statutory sections related to substantial 

equivalence, and provides 

recommendations on the form and 

content of section 905(j) reports. The 

guidance also provides information on 

FDA’s review of 905(j) reports. 

II. Significance of Guidance 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s GGPs (§ 10.115 

(21 CFR 10.115)). The guidance 

discusses premarket statutory 

requirements that include certain 

submissions to be made to FDA no later 

than March 22, 2011. This guidance 

document is being implemented 

immediately without prior public 

comment under § 10.115(g)(2) because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate, as interested parties need 

clarity as to FDA’s expectations 

regarding 905(j) reports and sufficient 

time to prepare submissions in advance 

of the statutory deadline. 

Manufacturers of tobacco products 

first introduced or delivered for 

introduction into interstate commerce 

for commercial distribution after 

February 15, 2007, and prior to March 

22, 2011, must submit the report no 

later than March 22, 2011, or the 

tobacco product can no longer be legally 

marketed. If a 905(j) report is submitted 

prior to March 23, 2011, the tobacco 

product may continue to be marketed 

unless FDA issues an order that the 

tobacco product is not substantially 

equivalent to the predicate tobacco 

product (section 910(a)(2)(B) of the 

FD&C Act (21 U.S.C. 387j(a)(2)(B)), as 

amended by the Tobacco Control Act). 

It is important that this guidance be 

available in advance of March 23, 2011, 

to assist manufacturers in preparing 

905(j) reports. 

For 905(j) reports for tobacco products 

first marketed between February 15, 

2007, and March 22, 2011 (many of 

which are from small manufacturers) 

that are submitted prior to March 23, 

2011, FDA intends to allow 

manufacturers who have acted 

diligently in preparing their 

submissions a reasonable amount of 

time to supplement their initial 

submissions, provided these 

manufacturers submit a 905(j) report by 

the statutory deadline. FDA intends to 

determine what constitutes a reasonable 

period of time on a case-by-case basis. 

This guidance 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. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control number 0910–0673. 

IV. Comments 

This guidance document is being 

implemented immediately without prior 

public comment under § 10.115(g)(2) 

because the Agency has determined that 

prior public participation is not feasible 

or appropriate, as interested parties 

need clarity as to FDA’s expectations 

regarding 905(j) reports and sufficient 

time to prepare submissions in advance 

of the statutory deadline. You may 

submit written comments to FDA on 

this guidance at any time for Agency 

consideration; in addition, we request 

that you submit any comments 

regarding any significant oversight in 

this guidance within 30 days of the 

issuance of this guidance (refer to the 

title page of the guidance for the issue 

date). 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. 

FDA will review any comments we 

receive and revise the guidance 

document when appropriate. 

V. Electronic Access 

An electronic version of the guidance 

document is available on the Internet at 

http://www.regulations.gov and http:// 

www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–35 Filed 1–5–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1950– 

DR; Docket ID FEMA–2010–0002] 

Arizona; Major Disaster and Related 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This is a notice of the 

Presidential declaration of a major 

disaster for the State of Arizona (FEMA– 

1950–DR), dated December 21, 2010, 

and related determinations. 

DATES: Effective Date: December 21, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Office of Response and 

Recovery, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that, in a letter dated 

December 21, 2010, the President issued 

a major disaster declaration under the 

authority of the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121 et seq. 

(the ‘‘Stafford Act’’), as follows: 

I have determined that the damage in 

certain areas of the State of Arizona resulting 

from severe storms and flooding during the 

period of October 3–6, 2010, is of sufficient 

severity and magnitude to warrant a major 

disaster declaration under the Robert T. 

Stafford Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121 et seq. (the 

‘‘Stafford Act’’). Therefore, I declare that such 

a major disaster exists in the State of Arizona. 

In order to provide Federal assistance, you 

are hereby authorized to allocate from funds 

available for these purposes such amounts as 

you find necessary for Federal disaster 

assistance and administrative expenses. 


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Federal Register / Vol. 76, No. 4 / Thursday, January 6, 2011 / Notices 791 

You are authorized to provide Public 

Assistance and Hazard Mitigation in the 

designated area. Consistent with the 

requirement that Federal assistance is 

supplemental, any Federal funds provided 

under the Stafford Act for Public Assistance 

and Hazard Mitigation will be limited to 75 

percent of the total eligible costs. 

Further, you are authorized to make 

changes to this declaration for the approved 

assistance to the extent allowable under the 

Stafford Act. 

The Federal Emergency Management 

Agency (FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Administrator, under Executive Order 

12148, as amended, Michael L. Karl, of 

FEMA is appointed to act as the Federal 

Coordinating Officer for this major 

disaster. 

The following areas of the State of 

Arizona have been designated as 

adversely affected by this major disaster: 

The Sovereign Tribal Nation of the 

Havasupai Tribe for Public Assistance. 

The Sovereign Tribal Nation of the 

Havasupai Tribe is eligible to apply for 

assistance under the Hazard Mitigation Grant 

Program. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2010–33360 Filed 1–5–11; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1951– 

DR; Docket ID FEMA–2010–0002] 

Vermont; Major Disaster and Related 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This is a notice of the 

Presidential declaration of a major 

disaster for the State of Vermont 

(FEMA–1951–DR), dated December 22, 

2010, and related determinations. 

DATES: Effective Date: December 22, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Office of Response and 

Recovery, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that, in a letter dated 

December 22, 2010, the President issued 

a major disaster declaration under the 

authority of the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121 et seq. 

(the ‘‘Stafford Act’’), as follows: 

I have determined that the damage in 

certain areas of the State of Vermont resulting 

from a severe storm during the period of 

December 1–5, 2010, is of sufficient severity 

and magnitude to warrant a major disaster 

declaration under the Robert T. Stafford 

Disaster Relief and Emergency Assistance 

Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford 

Act’’). Therefore, I declare that such a major 

disaster exists in the State of Vermont. In 

order to provide Federal assistance, you are 

hereby authorized to allocate from funds 

available for these purposes such amounts as 

you find necessary for Federal disaster 

assistance and administrative expenses. 

You are authorized to provide Public 

Assistance in the designated areas and 

Hazard Mitigation throughout the State. 

Consistent with the requirement that Federal 

assistance is supplemental, any Federal 

funds provided under the Stafford Act for 

Public Assistance and Hazard Mitigation will 

be limited to 75 percent of the total eligible 

costs. 

Further, you are authorized to make 

changes to this declaration for the approved 

assistance to the extent allowable under the 

Stafford Act. 

The Federal Emergency Management 

Agency (FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Administrator, under Executive Order 

12148, as amended, Albert Lewis, of 

FEMA is appointed to act as the Federal 

Coordinating Officer for this major 

disaster. 

The following areas of the State of 

Vermont have been designated as 

adversely affected by this major disaster: 

Chittenden, Franklin, and Lamoille 

Counties for Public Assistance. 

All counties within the State of Vermont 

are eligible to apply for assistance under the 

Hazard Mitigation Grant Program. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2010–33359 Filed 1–5–11; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1951– 

DR; Docket ID FEMA–2010–0002] 

Vermont; Amendment No. 1 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

State of Vermont (FEMA–1951–DR), 

dated December 22, 2010, and related 

determinations. 

DATES: Effective Date: December 23, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Office of Response and 

Recovery, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Administrator, under Executive Order 

12148, as amended, Craig A. Gilbert, of 

FEMA is appointed to act as the Federal 

Coordinating Officer for this disaster. 

This action terminates the 

appointment of Albert Lewis as Federal 

Coordinating Officer for this disaster. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 


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