[Federal Register Volume 66, Number 170 (Friday, August 31, 2001)]
[Notices]
[Page 46016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0231]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Veterinary Adverse Drug Reaction, Lack of 
Effectiveness, Product Defect Report; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period on a proposed collection of certain information by the 
agency until October 15, 2001. Under the Paperwork Reduction Act of 
1995, Federal agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
is reopening the comment period for a data collection effort to solicit 
comments on reporting and recordkeeping requirements obligating holders 
of approved new animal drug applications (NADAs) and abbreviated new 
animal drug applications (ANADAs) to submit information on adverse drug 
reactions, lack of effectiveness, and product defects.

DATES: Submit written or electronic comments on the collection of 
information by October 15, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
via the internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 29, 2001 (66 
FR 29141), FDA published a notice soliciting comments on reporting and 
recordkeeping requirements associated with 21 CFR part 510. To give 
interested persons additional time to submit comments on the proposed 
data collection, the agency is reopening the comment period until 
October 15, 2001.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments by October 15, 2001. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: August 24, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21967 Filed 8-30-01; 8:45 am]
BILLING CODE 4160-01-S