[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)]
[Notices]
[Pages 31505-31506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15271]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0503]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below 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: Submit written comments on the collection of information by July
9, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503,
Attention: Desk Officer for FDA.
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 compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
New Animal Drug Application (NADA), Form FDA 356 V, 21 CFR Part
514--(OMB Control Number 0910-0032--Reinstatement)
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has
the responsibility for the approval of new animal drugs that are safe
and effective. Section 512(b) of the act (21 U.S.C. 360b(b)), requires
that a sponsor submit and receive approval of a NADA before interstate
marketing is allowed. The regulations implementing statutory
requirements for NADA approval have been codified under 21 CFR part
514. NADA applicants generally use a single form, FDA 356 V. The NADA
must contain, among other things, safety and effectiveness data for the
drug, labeling, a list of components, manufacturing and controls
information, and complete information on any methods used to determine
residues of drug chemicals in edible tissues. While the NADA is
pending, an amended application may be submitted for proposed changes.
After a NADA has been approved, a supplemental application must be
submitted for certain proposed changes, including changes beyond the
variations provided for in the NADA and other labeling changes. An
amended application and a supplemental application may omit statements
concerning which no change is proposed. This information is reviewed by
FDA scientific personnel to ensure that the intended use of an animal
drug, whether as a pharmaceutical dosage form, in drinking water, or in
medicated feed is safe and effective. The respondents are
pharmaceutical firms that produce veterinary products and commercial
feed mills.
FDA estimates the burden for this collection of information as
follows:
[[Page 31506]]
Table 1.--Estimated Annual Reporting Burden1
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Annual
Form No. 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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Form FDA
356 V 514.1 and 514.6 190 6.76 1,824 211.6 271,694
514.8 and 514.9 30 8,520
514.11 1 1,824
Total
burden
hours 282,038
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the burden hours required for reporting are based
on fiscal year 1996 data. The burden estimate includes original NADA's,
supplemental NADA`s, and amendments to unapproved applications.
Dated: June 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15271 Filed 6-8-98; 8:45 am]
BILLING CODE 4160-01-F
