Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice, 52141 [E7-18031]
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52141
Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices
detention and possible refusal at the
port. FDA requests the following
information from each processor seeking
to be included on the lists:
1. Business name and address;
2. Name and telephone number of
person designated as business contact;
3. Lists of products presently being
shipped to the EC and those intended to
be shipped in the next 6 months;
4. Name and address of
manufacturing plants for each product;
and
5. Names and affiliations of any
Federal, State, or local governmental
agencies that inspect the plant,
government-assigned plant identifier
such as plant number, and last date of
inspection.
In the Federal Register of June 21,
2007 (72 FR 34256), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Products
No. of
Respondents
Shell Eggs
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
10
1
10
.25
3
120
1
120
.25
30
Game Meat and Meat Products
5
1
5
.25
1
Animal Casings
5
1
5
.25
1
Gelatin
3
1
3
.25
1
Collagen
3
1
3
.25
1
Dairy
Total
1There
37
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the
responses received over the past 3 years.
We estimate that the annual reporting
burden would be approximately 37
hours. The time to respond to the
questions should take approximately 15
minutes using any of the technologies
available to transmit the information.
All of the information asked for should
be readily available. No record retention
is required. In previous years, FDA
estimated that the agency’s
communication with trade associations
and states resulted in a reporting burden
of 520 hours. FDA no longer receives
information from trade associations and
states under this program. Accordingly,
the proposed annual burden for this
information collection has been reduced
by 520 hours. Therefore, the proposed
annual burden for this information
collection is 37 hours.
Dated: September 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18033 Filed 9–11–07; 8:45 am]
jlentini on PROD1PC65 with NOTICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of a meeting of the
Cardiovascular and Renal Drugs
Advisory Committee. This meeting was
announced in the Federal Register of
August 14, 2007 (72 FR 45435). The
amendment is being made to reflect a
change in the Date and Time and
Agenda portions of the meeting. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
Cathy A. Miller, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5630
Fishers Lane (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–7001, FAX: 301–827–
6776, e-mail:
Cathy.Miller1@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
Line for up-to-date information on this
meeting.
PO 00000
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In the
Federal Register of August 14, 2007,
FDA announced that a meeting of the
Cardiovascular and Renal Drugs
Advisory Committee would be held on
October 16 and 17, 2007.
On page 45435, in the second column,
the Date and Time portion of the
document is amended to read as
follows:
Date and Time: The meeting will be
held on October 16, 2007, from 8 a.m.
to 5 p.m.
On page 45435, in the third column,
the Agenda portion of the document is
amended to read as follows:
Agenda: On October 16, 2007, the
committee will discuss regulatory
considerations for extending the use of
phosphate binders from the dialysis
population (where they are approved) to
the pre-dialysis population (where no
products are approved). The committee
will hear presentations on this topic
from Shire Development, Genzyme
Corp., and Fresenius Medical Care.
SUPPLEMENTARY INFORMATION:
Dated: September 5, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–18031 Filed 9–11–07; 8:45 am]
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[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Page 52141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs Advisory Committee; Amendment of
Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of a meeting of the Cardiovascular and Renal Drugs
Advisory Committee. This meeting was announced in the Federal Register
of August 14, 2007 (72 FR 45435). The amendment is being made to
reflect a change in the Date and Time and Agenda portions of the
meeting. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Cathy A. Miller, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5630
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
Cathy.Miller1@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512533. Please call the Information Line for up-to-date information
on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 14, 2007,
FDA announced that a meeting of the Cardiovascular and Renal Drugs
Advisory Committee would be held on October 16 and 17, 2007.
On page 45435, in the second column, the Date and Time portion of
the document is amended to read as follows:
Date and Time: The meeting will be held on October 16, 2007, from 8
a.m. to 5 p.m.
On page 45435, in the third column, the Agenda portion of the
document is amended to read as follows:
Agenda: On October 16, 2007, the committee will discuss regulatory
considerations for extending the use of phosphate binders from the
dialysis population (where they are approved) to the pre-dialysis
population (where no products are approved). The committee will hear
presentations on this topic from Shire Development, Genzyme Corp., and
Fresenius Medical Care.
Dated: September 5, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-18031 Filed 9-11-07; 8:45 am]
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