60-Day FRN

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

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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?

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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 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?

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.

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.

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

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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

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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.

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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

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‘‘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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