Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information From United States Processors That Export to the European Community, 52140-52141 [E7-18033]
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52140
Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices
in a DB2 relational database
management environment (DASD data
storage media).
RETRIEVABILITY:
Information is most frequently
retrieved by HICN, provider number
(facility, physician, IDs), service dates,
and beneficiary state code.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against unauthorized
use. Personnel having access to the
system have been trained in the Privacy
Act and information security
requirements. Employees who maintain
records in this system are instructed not
to release data until the intended
recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
jlentini on PROD1PC65 with NOTICES
RETENTION AND DISPOSAL:
Records are maintained with
identifiers for all transactions after they
are entered into the system for a period
of 20 years. Records are housed in both
active and archival files. All claimsrelated records are encompassed by the
document preservation order and will
be retained until notification is received
from the Department of Justice.
SYSTEM MANAGER AND ADDRESS:
Director, Quality Measurement and
Health Assessment Group, Office of
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18:43 Sep 11, 2007
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Clinical Standards and Quality, CMS,
Room C1–23–14, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
NOTIFICATION PROCEDURE:
For purpose of notification, the
subject individual should write to the
system manager who will require the
system name, and the retrieval selection
criteria (e.g., HICN, Provider number,
etc.).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORD SOURCE CATEGORIES:
Medicare Beneficiary Database (09–
70–0536), National Claims History File
(09–70–0558), and private physicians,
private providers, laboratories, other
providers and suppliers who are
participating in health care transparency
projects sponsored by the Agency.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–17907 Filed 9–11–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0230]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information From
United States Processors That Export
to the European Community
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
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information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 12,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0320. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Information From U.S. Processors That
Export to the European Community—
(OMB Control Number 0910–0320)—
Extension
The European Community (EC) is a
group of 27 European countries that
have agreed to harmonize their
commodity requirements to facilitate
commerce among member states. EC
legislation for intra-EC trade has been
extended to trade with non-EC
countries, including the United States.
For certain food products, including
those listed in this document, EC
legislation requires assurances from the
responsible authority of the country of
origin that the processor of the food is
in compliance with applicable
regulatory requirements.
FDA requests information from
processors that export certain animalderived products (e.g., shell eggs, dairy
products, game meat, game meat
products, animal casings, and gelatin) to
the EC. FDA uses the information to
maintain lists of processors that have
demonstrated current compliance with
U.S. requirements and provides the lists
to the EC quarterly. Inclusion on the list
is voluntary. EC member countries refer
to the lists at ports of entry to verify that
products offered for importation to the
EC from the United States are from
processors that meet U.S. regulatory
requirements. Products processed by
firms not on the lists are subject to
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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.
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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]
BILLING CODE 4160–01–S
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[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52140-52141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18033]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0230]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Information From
United States Processors That Export to the European Community
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
12, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0320. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Information From U.S. Processors That Export to the European
Community--(OMB Control Number 0910-0320)--Extension
The European Community (EC) is a group of 27 European countries
that have agreed to harmonize their commodity requirements to
facilitate commerce among member states. EC legislation for intra-EC
trade has been extended to trade with non-EC countries, including the
United States. For certain food products, including those listed in
this document, EC legislation requires assurances from the responsible
authority of the country of origin that the processor of the food is in
compliance with applicable regulatory requirements.
FDA requests information from processors that export certain
animal-derived products (e.g., shell eggs, dairy products, game meat,
game meat products, animal casings, and gelatin) to the EC. FDA uses
the information to maintain lists of processors that have demonstrated
current compliance with U.S. requirements and provides the lists to the
EC quarterly. Inclusion on the list is voluntary. EC member countries
refer to the lists at ports of entry to verify that products offered
for importation to the EC from the United States are from processors
that meet U.S. regulatory requirements. Products processed by firms not
on the lists are subject to
[[Page 52141]]
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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Products Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shell Eggs 10 1 10 .25 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dairy 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 37
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There 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]
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