[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Pages 66632-66633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0503]


Agency Information Collection Activities: Proposed Collection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements for submission of 
a new animal drug application (NADA).

DATES: Submit written comments on the collection of information by 
February 17, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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, 301-827-1686.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed reinstatement of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

New Animal Drug Application (NADA), Form FDA 356 V, 21 CFR Part 
514, (OMB Control number 0910-0032--Reinstatement)

    Description: FDA has the responsibility under the Federal Food, 
Drug, and Cosmetic Act (the act), 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 an 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 of this collection of information as 
follows:

                                  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                                                                                      282,038       
 hours                                                                                                          
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


[[Page 66633]]

    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 amendents to unapproved applications.

    Dated: December 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33098 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F