[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
