Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 51163 

FDA’s Web site at http://www.fda.gov/ 

transparency along with the agenda for 

this meeting. The complete case studies 

will be available in the same locations 

after the public meeting. 

III. Issues for Discussion 

The discussion of the three issues 

described in the following section of 

this document should not be limited by 

current statutes or regulations, as the 

proposals the Task Force develops may 

include recommendations for changes to 

current law. 

A. Emerging Safety Issues Concerning 

FDA-Regulated Products 

When FDA receives safety 

information associated with a marketed 

FDA-regulated product, e.g., medical 

device, drug, biologic, dietary 

supplement, cosmetic, or food 

(including ingredients and food 

additives), FDA evaluates the 

information in deciding whether and 

what actions to take, such as regulatory 

action regarding the product. FDA will 

continue to receive, gather, and evaluate 

additional information to further inform 

its decisions. 

During this process, while still 

evaluating the situation, FDA may 

communicate with the public based on 

the agency’s current analysis of the 

available information about the 

situation. For example, the agency may 

issue an early communication about its 

ongoing safety review of a drug, device, 

or biologic, or may issue an early 

communication advising consumers not 

to eat a certain type of food that may be 

linked to a foodborne illness or to stop 

using a certain dietary supplement that 

may be associated with adverse events. 

The Task Force is interested in 

discussing the principles the agency 

should use when deciding whether to 

issue an early communication about a 

potential problem with an FDAregulated product. For example, when is 

it appropriate, or not appropriate for the 

agency to advise the public about a 

possible, but unconfirmed foodborne 

illness outbreak or to issue an early 

communication about an emerging 

safety issue with a medical product, 

dietary supplement, or cosmetic? If 

appropriate, how should this 

information be conveyed to the public 

so that it is useful and does not cause 

unfounded or unnecessary concern 

about the product? And what 

mechanisms (e.g., Internet, mass media, 

cell phones, direct outreach to health 

professional and patient organizations) 

should FDA use to effectively reach the 

target audiences in a timely manner? 

B. Product Applications That Are 

Abandoned (Which Means That No 

Work is Being Done or Will Be 

Undertaken to Have the Application 

Approved) or Withdrawn By the 

Applicant Before Approval 

The Task Force is interested in 

discussing the principles and 

considerations the agency should apply 

to disclosure of data contained in 

product applications that are abandoned 

during the approval process or 

withdrawn before approval by the 

applicant. The Task Force would also 

like to receive comments on whether the 

considerations governing treatment of 

these data should depend on the reason 

the product application was abandoned 

or withdrawn. 

C. Communicating Agency Decisions 

About Pending Product Applications 

The Task Force is interested in 

discussing what information about 

pending product applications should be 

disclosed. Should the agency inform the 

public when: 

• A marketing application seeking 

approval of a drug or biologic is 

submitted to the agency for review? 

• A marketing application seeking 

approval or clearance of a medical 

device is submitted to the agency for 

review? 

When the agency does not approve a 

marketing application for a drug or 

biologic, it issues a letter that informs 

the applicant of FDA’s determination 

not to approve the application in its 

current form, identifying all apparent 

deficiencies in the application. Should 

the agency disclose to the public a 

determination not to approve a 

marketing application for a drug or 

biologic? What, if any, information 

should the agency disclose about the 

determination not to approve the 

application? What, if any, information 

contained in the response letter should 

the agency disclose? What principles 

should the agency apply in making 

these determinations? 

When the agency does not approve a 

premarket application (PMA) for a 

medical device, it may issue a ‘‘not 

approvable’’ letter that informs the 

applicant of FDA’s determination not to 

approve the application in its current 

form. When the agency does not clear a 

device submitted through the 510(k) 

process, a ‘‘not substantially equivalent’’ 

(NSE) letter is issued to the applicant. 

Should the agency disclose to the public 

a determination not to approve or clear 

a marketing application for a medical 

device? What, if any, information 

should the agency disclose about the 

determination not to approve or clear 

the application? What, if any, 

information contained in the not 

approvable letter or the NSE letter 

should the agency disclose? What 

principles should the agency apply in 

making these determinations? 

IV. Request for Comments 

Regardless of attendance at the public 

meeting, interested persons may submit 

written or electronic comments (see 

ADDRESSES). Submit a single copy of 

electronic comments to http:// 

www.regulations.gov or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

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. 

V. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.regulations.

gov. It may be viewed at the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD. A 

transcript will also be available in either 

hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: September 29, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23916 Filed 10–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Customs and Border Protection 

Agency Information Collection 

Activities: Delivery Ticket 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 60-Day Notice and request for 

comments; Extension of an existing 

collection of information: 1651–0081. 

SUMMARY: As part of its continuing effort 

to reduce paperwork and respondent 

burden, CBP invites the general public 

and other Federal agencies to comment 

on an information collection 

requirement concerning the Delivery 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
51164 Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 

Ticket. This request for comment is 

being made pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). 

DATES: Written comments should be 

received on or before December 4, 2009, 

to be assured of consideration. 

ADDRESSES: Direct all written comments 

to U.S. Customs and Border Protection, 

Attn: Tracey Denning, Office of 

Regulations and Rulings, 799 9th Street, 

NW., 7th Floor, Washington, DC 20229– 

1177. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Office of Regulations and Rulings, 799 

9th Street, NW., 7th Floor, Washington, 

DC 20229–1177, at 202–325–0265. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) the 

annual costs burden to respondents or 

record keepers from the collection of 

information (a total capital/startup costs 

and operations and maintenance costs). 

The comments that are submitted will 

be summarized and included in the CBP 

request for Office of Management and 

Budget (OMB) approval. All comments 

will become a matter of public record. 

In this document CBP is soliciting 

comments concerning the following 

information collection: 

Title: Delivery Ticket. 

OMB Number: 1651–0081. 

Form Number: Form 6043. 

Abstract: This collection of 

information requires warehouse 

proprietors, carriers, Foreign Trade 

Zone operators and others to prepare a 

CBP Form 6043 (Delivery Ticket) to 

cover the receipt of the merchandise 

and its transport from the custody of the 

arriving carrier. The information is to be 

used by CBP officers to document 

transfers of imported merchandise 

between parties. 

Current Actions: There are no changes 

to the information collection. This 

submission is being made to extend the 

expiration date. 

Type of Review: Extension (without 

change). 

Affected Public: Businesses. 

Estimated Number of Respondents: 

1000. 

Estimated Number of Annual 

Responses per Respondent: 200. 

Estimated Number of Total Annual 

Responses: 200,000. 

Estimated Time per Response: 20 

minutes. 

Estimated Total Annual Burden 

Hours: 66,000. 

Dated: September 29, 2009. 

Tracey Denning, 

Agency Clearance Officer, Customs and 

Border Protection. 

[FR Doc. E9–23820 Filed 10–2–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1858– 

DR; Docket ID FEMA–2008–0018] 

Georgia; 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 Georgia (FEMA– 

1858–DR), dated September 24, 2009, 

and related determinations. 

DATES: Effective Date: September 24, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Disaster Assistance 

Directorate, 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 

September 24, 2009, 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 Georgia resulting 

from severe storms and flooding beginning 

on September 18, 2009, and continuing, 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 Georgia. 

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 Individual 

Assistance in the designated areas, Hazard 

Mitigation throughout the State, and any 

other forms of assistance under the Stafford 

Act that you deem appropriate. Consistent 

with the requirement that Federal assistance 

is supplemental, any Federal funds provided 

under the Stafford Act for Hazard Mitigation 

and Other Needs Assistance will be limited 

to 75 percent of the total eligible costs. If 

Public Assistance is later requested and 

warranted, Federal funds provided under 

that program will also be limited to 75 

percent of the total eligible costs. 

Further, you are authorized to make 

changes to this declaration to the extent 

allowable under the Stafford Act. 

The time period prescribed for the 

implementation of section 310(a), 

Priority to Certain Applications for 

Public Facility and Public Housing 

Assistance, 42 U.S.C. 5153, shall be for 

a period not to exceed six months after 

the date of this declaration. 

The Federal Emergency Management 

Agency (FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Administrator, under Executive Order 

12148, as amended, Gracia B. Szczech, 

of FEMA is appointed to act as the 

Federal Coordinating Officer for this 

major disaster. 

The following areas of the State of 

Georgia have been designated as 

adversely affected by this major disaster: 

Cherokee, Cobb, Douglas, and Paulding 

Counties for Individual Assistance. 

All counties within the State of Georgia 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. E9–23957 Filed 10–2–09; 8:45 am] 

BILLING CODE 9111–23–P 


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