Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 923

Dated: December 29, 2003. 

John P. Burke III, 

CMS Reports Clearance Officer, Office of 

Strategic Operations and Regulatory Affairs, 

Division of Regulations Development and 

Issuances.

[FR Doc. 04–382 Filed 1–5–04; 3:11 pm] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N–0424]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substantial 

Evidence of Effectiveness of New 

Animal Drugs

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 

(the PRA).

DATES: Fax written comments on the 

collection of information by February 6, 

2004.

ADDRESSES: The Office of Management 

and Budget 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, 

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

Substantial Evidence of Effectiveness of 

New Animal Drugs—21 CFR Part 514 

(OMB Control Number 0910–0356)—

Extension

Congress enacted the Animal Drug 

Availability Act of 1996 (ADAA) (Public 

Law 104–250) on October 9, 1996. As 

directed by ADAA, FDA published a 

regulation under § 514.4(a) (21 CFR 

514.4(a)), to further define substantial 

evidence in a manner that encourages 

the submission of new animal drug 

applications (NADAs) and supplemental 

NADAs and encourages dose range 

labeling. Under ADAA, substantial 

evidence is the standard that a sponsor 

must meet to demonstrate the 

effectiveness of a new animal drug for 

its intended use under the conditions 

suggested in its proposed labeling. 

Section 514.4(a) gives FDA greater 

flexibility to make case-specific 

scientific determinations regarding the 

number and types of adequate and wellcontrolled studies that will provide, in 

an efficient manner, substantial 

evidence that a new animal drug is 

effective. FDA believes this regulation 

will reduce the number of adequate and 

well-controlled studies necessary to 

demonstrate the effectiveness of certain 

combination new animal drugs, will 

eliminate the need for an adequate and 

well-controlled dose titration study, and 

may, in limited instances, reduce or 

eliminate the number of adequate and 

well-controlled field investigations 

necessary to demonstrate by substantial 

evidence the effectiveness of a new 

animal drug. Table 1 of this document 

represents the estimated burden of 

meeting the substantial evidence 

standard.

In the Federal Register of September 

19, 2003 (68 FR 54905), 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

21 CFR Section No. of Respondents Annual Frequency 

per Response Total Annual Responses Hours per Response Total Hours 

514.4(a) 190 4.5 860 632.6 544,036

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 30, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–256 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N–0565]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Food and 

Drug Administration Rapid Response 

Surveys

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the use of rapid response surveys to 

obtain data on safety information to 

support quick-turnaround decision 

making about potential safety problems 

or risk management solutions from 

health care professionals, hospitals and 

other user-facilities (e.g., nursing homes, 

etc.), consumers, manufacturers of 

biologics, drugs and medical devices, 

distributors, and importers when FDA 

must quickly determine whether or not 

a problem with a biologic, drug, or 

medical device impacts the public 

health.

DATES: Submit written or electronic 

comments on the collection of 

information by March 8, 2004.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the