Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations, 37859 [05-12907]
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Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Notices
Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden, to the Regulatory Secretariat
(VIR), General Services Administration,
Room 4035, 1800 F Street, NW.,
Washington, DC 20405. Please cite OMB
Control No. 3090–0248, Solicitation
provisions and contract clauses,
Placement of Orders clause, and
Ordering Information clause, in all
correspondence.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Device Labeling Regulations’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 1, 2005 (70 FR
16824), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0485. The
approval expires on June 30, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
ADDRESSES:
A. Purpose
The General Services Administration
(GSA) has various mission
responsibilities related to the
acquisition and provision of Federal
Supply Service’s (FSS’s) Stock, Special
Order, and Schedules Programs. These
mission responsibilities generate
requirements that are realized through
the solicitation and award of various
types of FSS contracts. Individual
solicitations and resulting contracts may
impose unique information collection
and reporting requirements on
contractors, not required by regulation,
but necessary to evaluate particular
program accomplishments and measure
success in meeting program objectives.
B. Annual Reporting Burden
Respondents: 6,493.
Hours Per Response: .25.
Total Burden Hours: 1,623.
OBTAINING COPIES OF
PROPOSALS: Requesters may obtain a
copy of the information collection
documents from the General Services
Administration, Regulatory Secretariat
(VIR), 1800 F Street, NW., Room 4035,
Washington, DC 20405, telephone (202)
208–7312. Please cite OMB Control No.
3090–0248, Solicitation provisions and
contract clauses, Placement of Orders
clause, and Ordering Information
clause, in all correspondence.
Dated: June 24, 2005.
Julia Wise,
Director, Contract Policy Division.
[FR Doc. 05–12899 Filed 6–29–05; 8:45 am]
BILLING CODE 6820–61–S
Food and Drug Administration
[Docket No. 2004N–0515]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Device Labeling Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: June 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12907 Filed 6–29–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0558]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluating the
Safety of Antimicrobial New Animal
Drugs With Regard to Their
Microbiological Effects on Bacteria of
Human Health Concerns
AGENCY:
Food and Drug Administration,
HHS.
VerDate jul<14>2003
16:26 Jun 29, 2005
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ACTION:
37859
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that the 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 August 1,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, rm.
4B–41, Rockville, MD 20857, 301–827–
1472.
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.
Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to
Their Microbiological Effects on
Bacteria of Human Health Concern
(OMB Control Number 0910–0522)
In the Federal Register of January 6,
2005 (70 FR 1253), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received
on this information collection.
Description: This guidance discusses
an approach for assessing the safety of
antimicrobial new animal drugs with
regard to their microbiological effects on
bacteria of human health concern. In
particular, the guidance describes
methodology that sponsors of
antimicrobial new animal drug
applications for food-producing animals
may use to complete a qualitative
antimicrobial resistance risk assessment.
This risk assessment should be
submitted to FDA for the purposes of
evaluating the safety of the new animal
drug to human health. The guidance
document outlines a process for
integrating relevant information into an
overall estimate of risk and discusses
possible risk management strategies.
Table 1 of this document represents
the estimated burden of meeting the
reporting requirements. The burden
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Page 37859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0515]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Medical Device Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Medical Device Labeling
Regulations'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 1, 2005 (70
FR 16824), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0485.
The approval expires on June 30, 2008. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.fda.gov/ohrms/dockets.
Dated: June 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12907 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S
