[Federal Register: May 5, 2003 (Volume 68, Number 86)]
[Notices]
[Page 23726-23728]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my03-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88N-0038]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Records and Reports Concerning Experience With
Approved New Animal Drugs
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.
DATES: Submit written or electronic comments on the collection of
information by June 4, 2003.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. To ensure that comments on the information collection are
received, OMB recommends that written comments be electronically mailed
to
[[Page 23727]]
sshapiro@omb.eop.gov or faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA,
FAX 202-395-6974.
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 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Records and Reports Concerning Experience With Approved New Animal
Drugs-- (OMB Control Number 0910-0284)
Description: This final rule amends the provisions of the animal
drug regulations concerning requirements for recordkeeping and reports
concerning experience with approved new animal drugs. The information
contained in the reports required by this rule enables FDA to monitor
the use of new animal drugs after approval and to ensure their
continued safety and efficacy. The reporting requirements include: (1)
A report that provides information on product and manufacturing defects
that may result in serious adverse drug events within 3 days of
becoming aware the defect exists (Sec. 514.80(b)(1) (21 CFR
514.80(b)(1))); (2) a report that provides information on serious and
unexpected adverse drug events and a followup report on such events
(Sec. 514.80(b)(2)); (3) a summary report of increased frequency of
adverse drug experiences (Sec. 514.80(b)(4)(v)); (4) a report from
nonapplicants, such as distributors, to applicants providing
information on adverse drug experiences (Sec. 514.80(b)(3)); (5) a
periodic report with information on distribution, labeling,
manufacturing or controls changes, new laboratory studies, and all
adverse events in the reporting period (Sec. 514.80(b)(4)); (6) other
reports that include special drug experience reports; and (7) reports
for advertising and promotional labeling, and reports for distributor
statements (Sec. 514.80(b)(5)). These reports must be kept for 5 years
(Sec. 514.80(e)).
The final rule strengthens the current reporting system by
requiring periodic reports every 6 months for the first 2 years
following initial approval of an application rather than just for the
first year following initial approval. The increased burden on
applicants amounts to one additional periodic report. While greater
than the reporting burden in the previous rule, this burden is less
than that of the proposed rule which would have required quarterly
periodic reports for 3 years following initial approval.
All periodic reports must be submitted with Form FDA 2301,
``Transmittal of Periodic Reports and Promotional Materials for New
Animal Drugs'' (OMB control number 0910-0012). Adverse drug experience
reports must be submitted on Form FDA 1932, ``Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product Defect Report'' (OMB control
number 0910-0012).
In the Federal Register of February 4, 2002 (67 FR 5046), FDA
invited comments on the interim final rule and the information
collection requirements. Only one comment received pertained to
information collection. That comment stated that the requirements under
``Multiple Applications'' do not appear to decrease but may increase
the burden on the applicant. In particular, the comment questioned the
requirement under Sec. 514.80(c)(4) and requested clarification. The
comment also voiced concern about an increased reporting burden due to
the increasing number of approved applications for combinations of
drugs for use in feeds since the implementation of the Animal Drug
Availability Act of 1996. Further complicating the reporting issue is
that frequently there are nonapplicants involved in the marketing of
these combinations. The comment stated that with the exception of
``promotion literature,'' there is rarely any other information to be
reported, suggesting that the ``promotion literature'' be submitted to
the application held by either party, i.e., the nonapplicants or
applicant, and not the application approved for the use of the
combination of drugs.
In response, FDA notes that the provision of the regulation in
question is currently codified under Sec. 510.300(b)(4)(ii). The
current regulation and the proposal in the interim final rule are
similar. There is no increase of the reporting burden. It is not the
intention of FDA for the implementation of Sec. 514.80(c) to be
different from the current requirement under Sec. 510.300(b)(4)(ii).
There is no additional reporting burden than that already covered under
Sec. 514.80(b)(4). Section 514.80(c) is not an additional information
collection, i.e., in addition to Sec. 514.80(b)(4); it is an
administrative tool for industry to use to submit common information
only once to FDA. Only information specific to a particular new animal
drug application (NADA)/abbrieviated new animal drug application
(ANADA) that is not common to all the applications must be included in
the report for that particular NADA/ANADA; for example, labeling. With
regard to the comment that there is an increased reporting burden due
to the Animal Drug Availability Act of 1996, increased reporting is due
to the increased number of approved applications. FDA consequently
believes that this is a reasonable reporting requirement.
Description of Respondents: Applicant respondents are sponsors of
approved NADAs and ANADAs. Nonapplicant respondents are those, other
than the applicant, involved in manufacturing, processing, packing,
labeling, or distributing new animal drugs.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Section/Title/FDA Annual Frequency Total Annual Hours per
Form No. No. of Respondents per Response Responses Response Total Hours
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514.80(b)(2)(i)/Original 190 55.26 12,283 1 12,283
15-day Alert Report/Form
FDA 1932
514.80(b)(1)/3-day Field 190 0.32 95 1 95
Alert Report/Form FDA
1932
514.80(b)(2)(ii)/Followup 190 17.90 6,007 1 6,007
15-day Alert Report/Form
FDA 1932
514.80(b)(3)/Nonapplicant 340 2.94 1,000 1 1,000
Report/Form FDA 1932
514.80(b)(4)/Periodic Drug 190 7.11 1,226 11 13,486
Experience Report/Form
FDA 2301, and 514.80(c)
Multiple Applications\2\
[[Page 23728]]
514.80(b)(4)(v)/Summary 190 1.58 300 2 600
Report of Increased
Frequency of Adverse Drug
Experience
514.80(b)(5)(i)/Special 190 0.13 25 2 50
Drug Experience Report/
Form FDA 2301
514.80(b)(5)(ii)/ 190 2.11 772 2 1,544
Advertising and
Promotional Materials
Report/Form FDA 2301
514.80(b)(5)(iii)/ 530 0.14 56 2 112
Distributor's Statement
Report/Form FDA 2301
Total .................... ................ .............. ............ 35,177
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The reporting burden for Sec. 514.80(b)(4)(iv)(A) is included in the reporting burden for Sec.
514.80(b)(2)(i).
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency Total Annual Hours per
21 CFR Section No. of Respondents of Response Responses Response Total Hours
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514.80(e)\2\ 530 28.22 19,385 0.5 9,693
514.80(e)\3\ 530 4.06 2,379 10.35 24,623
Total .................... ................ .............. ............ 34,316
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\1\ Burden estimates were separated between Form FDA 1932 and Form FDA 2301 to reflect the difference in
estimates for ``Hours per Respondent'' required.
\2\ Recordkeeping estimates for Sec. 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932.
\3\ Recordkeeping estimates for Sec. 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301.
Forms FDA 1932 and FDA 2301 for this collection of information are
currently approved under OMB control number 0910-0012 and will not
change due to implementation of this regulation. The reporting and
recordkeeping burden estimates in this document are based on the
submission of reports to the Division of Surveillance, Center for
Veterinary Medicine. The total annual response numbers are based on the
2000 fiscal year submission of reports to the Division of Surveillance,
Center for Veterinary Medicine. The numbers in
tables 1 and 2 of this document are total burden associated with this
regulation. Section 514.80(b)(3) and (b)(4)(v) are new information
collection requirements over the current requirements.
Dated: April 28, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10932 Filed 5-2-03; 8:45 am]
BILLING CODE 4160-01-S