[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