[Federal Register Volume 68, Number 86 (Monday, May 5, 2003)]
[Notices]
[Pages 23726-23728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10932]


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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]]

[email protected] 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\
----------------------------------------------------------------------------------------------------------------
 21 CFR Section/Title/FDA                         Annual Frequency   Total Annual     Hours per
         Form No.            No. of Respondents     per Response       Responses      Response      Total Hours
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
                                                  Annual Frequency   Total Annual     Hours per
      21 CFR Section         No. of Respondents      of Response       Responses      Response      Total Hours
----------------------------------------------------------------------------------------------------------------
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