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, 37859-37860 [05-12910]
Download as PDF
<![CDATA[
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
Jkt 205001
PO 00000
Frm 00115
Fmt 4703
Sfmt 4703
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
37860
Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Notices
estimates for these information
collection requirements are based on
information provided by the Office of
New Animal Drug Evaluation, Center for
Veterinary Medicine. The guidance
document describes the type of
information that should be collected by
the drug sponsor when completing the
antimicrobial resistance risk assessment.
FDA will use the risk assessment and
supporting information to evaluate the
safety of original (21 CFR 514.1) or
supplemental (21 CFR 514.8) NADAs for
antimicrobial drugs intended for use in
food-producing animals.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Antimicrobial Risk Assessments
No. of Respondents
Annual Frequency
of Response
Hours per
Response
Total Annual
Responses
Total Hours
Hazard Identification (initial
scoping of issues; relevant
bacteria, resistance determinants, food products;
preliminary data gathering)
15
1
15
30
450
Release Assessment (literature review; review of
research reports; data development; compilation,
and presentation)
10
1
10
1,000
10,000
Exposure Assessment (identifying and extracting consumption data; estimating
probability of contamination on food product)
10
1
10
8
80
Consequence Assessment
(review ranking of human
drug importance table)
10
1
10
4
40
Risk Estimation (integration
of risk components; development of potential arguments as basis for overall
risk estimate)
10
1
10
12
120
Risk Management (discussion of appropriate risk
management activities)
10
1
10
30
300
Total Burden
1There
10,990
are no capital costs and operating and maintenance costs associated with this collection of information.
FDA estimates that on an annual basis
an average of 15 NADAs (including
original applications and major
supplements) would be subject to
information collection under this
guidance. This estimate is based on the
number of reviews completed between
October 2003 and October 2004. During
that period, microbial food safety for
approximately 15 antimicrobial NADAs
(including original and major
supplements) was evaluated. This
estimate excludes NADAs for
antimicrobial drug combinations,
generic drug applications (ANADAs),
and certain supplemental NADAs.
Dated: June 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12910 Filed 6–29–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate jul<14>2003
16:26 Jun 29, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001N–0275 (formerly Docket
No. 01N–0275)]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Performance Standard for Diagnostic
X-Ray Systems and Their Major
Components
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Performance Standard for Diagnostic
X-Ray Systems and Their Major
Components’’ has been approved by the
PO 00000
Frm 00116
Fmt 4703
Sfmt 4703
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 June 10, 2005 (70 FR
33998 at 34012), 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 0910–0564. The
approval expires on December 31, 2006.
A copy of the supporting statement for
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Pages 37859-37860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12910]
-----------------------------------------------------------------------
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.
ACTION: 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 60-day 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
[[Page 37860]]
estimates for these information collection requirements are based on
information provided by the Office of New Animal Drug Evaluation,
Center for Veterinary Medicine. The guidance document describes the
type of information that should be collected by the drug sponsor when
completing the antimicrobial resistance risk assessment. FDA will use
the risk assessment and supporting information to evaluate the safety
of original (21 CFR 514.1) or supplemental (21 CFR 514.8) NADAs for
antimicrobial drugs intended for use in food-producing animals.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Hours per
Antimicrobial Risk Assessments No. of Respondents of Response Total Annual Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hazard Identification (initial scoping of 15 1 15 30 450
issues; relevant bacteria, resistance
determinants, food products; preliminary data
gathering)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Release Assessment (literature review; review 10 1 10 1,000 10,000
of research reports; data development;
compilation, and presentation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure Assessment (identifying and extracting 10 1 10 8 80
consumption data; estimating probability of
contamination on food product)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consequence Assessment (review ranking of human 10 1 10 4 40
drug importance table)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk Estimation (integration of risk 10 1 10 12 120
components; development of potential arguments
as basis for overall risk estimate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk Management (discussion of appropriate risk 10 1 10 30 300
management activities)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden .................. .................. ....................... .................. 10,990
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs and operating and maintenance costs associated with this collection of information.
FDA estimates that on an annual basis an average of 15 NADAs
(including original applications and major supplements) would be
subject to information collection under this guidance. This estimate is
based on the number of reviews completed between October 2003 and
October 2004. During that period, microbial food safety for
approximately 15 antimicrobial NADAs (including original and major
supplements) was evaluated. This estimate excludes NADAs for
antimicrobial drug combinations, generic drug applications (ANADAs),
and certain supplemental NADAs.
Dated: June 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12910 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S
