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 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 http://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]


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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