Agency Information Collection Activities; Proposed Collection; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V, 37240-37242 [E7-13195]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37240-37242]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13195]



[[Page 37240]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0236]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Presubmission Conferences, New Animal Drug 
Applications and Supporting Regulations and Guidance 152, and Form FDA 
356V

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 extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on paperwork associated with 
applications for new animal drugs.

DATES: Submit written or electronic comments on the collection of 
information by September 7, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 extension 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Presubmission Conferences, New Animal Drug Applications and Supporting 
Regulations and Guidance 152, and Form FDA 356V--21 CFR 514.5, 514.1, 
514.4, 514.8, (OMB Control Numbers 0910-0555, 0910-0032, 0910-0356, 
0910-0522, and 0910-0600)--Extension

    Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360b(b)(3)), any person intending to file a New 
Animal Drug Application (NADA) or supplemental NADA or a request for an 
investigational exemption under section 512(j) of the act is entitled 
to one or more conferences with FDA to reach an agreement acceptable to 
FDA establishing a submission or investigational requirement. FDA and 
industry have found that these meetings increased the efficiency of the 
drug development and drug review processes.
    Section 514.5 (21 CFR 514.5), describes the procedures for 
requesting, conducting, and documenting presubmission conferences. 
Section 514.5(b) describes the information that must be included in a 
letter submitted by a potential applicant requesting a presubmission 
conference, including a proposed agenda and a list of expected 
participants. Section 514.5(d) describes the information that must be 
provided by the potential applicant to FDA at least 30 days prior to a 
presubmission conference. This information includes a detailed agenda, 
a copy of any materials to be presented at the conference, a list of 
proposed indications and, if available, a copy of the proposed labeling 
for the product under consideration, and a copy of any background 
material that provides scientific rationale to support the potential 
applicant's position on issues listed in the agenda for the conference. 
Section 514.5(f) discusses the content of the memorandum of conference 
that will be prepared by FDA and gives the potential applicant an 
opportunity to seek correction to or clarification of the memorandum. 
The OMB control number for the collection of presubmission conference 
information is 0910-0555.
    Under section 512(b)(1) of the act, any person may file an NADA 
seeking approval to legally market a new animal drug. Section 512(b)(1) 
sets forth the information required to be submitted in an NADA. FDA 
allows applicants to submit a complete NADA or to submit information in 
support of an NADA for phased review followed by submission of an 
administrative NADA when FDA finds all the applicable technical 
sections are complete.
    Section 514.1 (21 CFR 514.1) interprets section 512(b)(1) of the 
act and further describes the information that must be submitted as 
part of a NADA and the manner and form in which the NADA must be 
assembled and submitted. The application must include safety and 
effectiveness data, proposed labeling, product manufacturing 
information, and where necessary, complete information on food safety 
(including microbial food safety) and any methods used to determine 
residues of drug chemicals in edible tissue from food producing 
animals. Guidance 152 outlines a risk assessment approach for 
evaluating the microbial food safety of antimicrobial new animal drugs. 
FDA requests that an applicant accompany NADAs, supplemental NADAs, and 
requests for phased review of data to support NADAs, with the Form FDA 
356V to ensure efficient and accurate processing of information to 
support new animal drug approval. The OMB control number for the NADA 
and the form 356V is 0910-0032, and the control number for Guidance 152 
``Evaluating the Safety of Antimicrobial New Animal Drugs With Regard 
to Their Microbiological Effects on Bacteria of Human Health Concern'' 
is 0910-0522. This information collection also combines several other 
OMB control numbers: OMB control number 0910-0356 and OMB control 
number 0910-

[[Page 37241]]

0600 that will be assigned to the collection of information under 
revised Sec.  514.8, effective February 12, 2007. The Animal Drug 
Availability Act of 1996 required FDA to further define the term 
``substantial evidence'' of effectiveness. Following notice and comment 
rulemaking, FDA further defined substantial evidence at Sec.  514.4 (21 
CFR 514.4) (OMB control number 0910-0356). Because Sec.  514.4 is only 
a definition, it should not be viewed as creating an additional 
collection burden; the collection of substantial evidence occurs as 
part of an NADA under Sec.  514.1. FDA also recently revised Sec.  
514.8 (21 CFR 514.8) to implement the provisions of section 116 of the 
Food and Drug Administration Modernization Act of 1997 (71 FR 74766, 
December 13, 2006; OMB control number pending). Section 514.8 describes 
the information that must be submitted as part of a supplemental 
application to support proposed changes to an approved NADA. An 
applicant may reference existing information from the NADA in the 
supplemental NADA, but must submit some subset of information required 
in Sec.  514.1 to support the proposed changes. The total burden hours 
for each of these CFR sections are found in table 1 of this document.
    FDA estimates the burden of the collections of information 
described in this notice as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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 21 CFR Section/         No. of        Annual Frequency     Total Annual        Hours per
   FDA Form No.       Respondents       per Respondent       Responses           Response         Total Hours
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514.5(b), (d),                   134                .7                93                   50              4,650
 (f)
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514.1 and 514.6                  134                .1                19                  212              4,028
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514.4                            134               0                   0                    0                  0
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514.8(b)                         134               3.2               425                   35             14,875
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514.8(c)(1)                      134               0.1                14                   71                994
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514.8(c)(2) and                  134                .4                53                   20              1,060
 (c)(3)
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514.11                           134                .1                19                    1                 19
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558.5(i)                         134                .01                1.0                  5                  5
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514.1(b)(8) and                  134                .1                10                   90                900
 514.8(c)(1)\2\
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FDA Form 356V                    134               5.8               778                    5              3,890
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Total Hours        .................  .................  .................  .................             30,421
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
  antimicrobial concerns as part of the overall preapproval safety evaluation.

    Number of respondents. Based on the number of sponsors subject to 
animal drug user fees, FDA estimates that there are 134 respondents. We 
use this estimate consistently throughout the table and calculate the 
``annual frequency per respondent'' by dividing the total annual 
responses by number of respondents. Following is a description of how 
we estimated the total annual responses and calculated total paperwork 
burden hours by type of submission.
    Presubmission conferences (Sec.  514.5). Over the past 5 fiscal 
years, from October 1, 2001, through September 30, 2006, FDA estimates 
it has conducted an average of 93 presubmission conferences per year. 
FDA estimates that preparing the paperwork to request the meeting, 
providing the advance materials, and commenting on the memorandum of 
conference will take approximately 50 hours. Thus, the total burden 
hours for presubmission conferences is estimated to be 4,650 hours.
    NADA (Sec.  514.1 and 21 CFR 514.6). Over the past 5 fiscal years, 
FDA has received an average of 19 NADAs per year. FDA estimates that 
preparing the paperwork required for an NADA under Sec.  514.1, whether 
all of the information is submitted with the NADA or the applicant 
submits information for phased review followed by an Administrative 
NADA that references that information, will take approximately 212 
hours. Thus, the total burden hours for the submission of an NADA with 
any amendments are estimated to be 4,028 hours.
    Substantial evidence (Sec.  514.4). Because Sec.  514.4 only 
defines substantial evidence, it should not be viewed as creating an 
additional collection burden. The collection of information to 
demonstrate substantial evidence occurs as part of an NADA under Sec.  
514.1. There is no additional paperwork burden under Sec.  514.4.
    Supplements fall into one of three categories:
     Manufacturing supplements described at Sec.  514.8(b);
     Section 514.8(b)(1) supplements (i.e., supplements seeking 
changes, other than in manufacturing or labeling, in an established 
condition of an approval beyond the variations already provided for in 
the approved application) described at Sec.  514.8(c)(1); and
     Labeling supplements described at 514.8(c)(2) and (c)(3).
An applicant may rely on information and data already filed to support 
those aspects of the NADA for which there are no changes. Thus, an 
applicant submitting a supplement should only have to prepare 
supporting information for those aspects of the application for which 
there are changes and the paperwork burden will be a percentage of the 
burden of preparing an NADA.
    Manufacturing supplements (Sec.  514.8(b)). Over the past 5 fiscal 
years, FDA has received an average of 425 manufacturing supplements 
annually. FDA estimates that it takes on average 35 hours (1/6 of the 
time it takes to prepare the paperwork to support a full NADA) to 
prepare the paperwork to

[[Page 37242]]

support approval of manufacturing changes. This results in total of 
14,875 burden hours.
    Supplements seeking approval of changes in intended uses or 
conditions of use (Sec.  514.8(c)(1)). Over the past 3 fiscal years, 
October 1, 2003, through September 2006, FDA has received an average of 
14 supplements annually seeking approval for changes in intended uses 
or conditions of use. FDA used a 3-year average for this calculation 
because data for the previous 2 years for this category of supplements 
was not tracked as an independent number. FDA estimates that it takes 
an average of 71 hours (approximately 1/3 of the time it takes to 
prepare the paperwork to support a full NADA) to prepare the paperwork 
to support approval for such changes. This results in a total of 994 
burden hours.
    Labeling Supplements (Sec.  514.8(c)(2) and (c)(3)). Over the past 
5 fiscal years, FDA has received an average of 53 labeling supplements 
annually. FDA estimates that it takes an average of 20 hours 
(approximately 1 percent of the time it takes to prepare the paperwork 
to support a full NADA) to prepare the paperwork to support approval of 
a labeling change. This results in a total of 1,060 burden hours.
    Freedom of Information Summary (Sec.  514.11 (21 CFR 514.11)). 
Regulations under Sec.  514.11 require the preparation of a summary of 
the safety and effectiveness data and information submitted with or 
incorporated by reference in an approved NADA and that the summary be 
publicly released when the approval is published in the Federal 
Register. This summary, generally referred to as the Freedom of 
Information (FOI) Summary, may be prepared by FDA or FDA may require 
the applicant to prepare the summary (Sec.  514.11(e)(ii)). In the 
past, FDA has required the applicant to prepare the FOI Summary. 
Currently, FDA generally takes responsibility for preparing the FOI 
Summary. Thus, the paperwork burden on applicants to prepare an FOI 
Summary has significantly decreased. Based on the estimate of 19 NADAs 
received annually and an estimate that applicants now spend little or 
no time preparing the FOI summary, the estimated burden hours are 19 
hours.
    Requirements for liquid medicated feeds (Sec.  558.5(i) (21 CFR 
558.5(i)). Generally, specific labeling is required to make sure that 
certain drugs, approved for use in animal feed or drinking water but 
not in liquid medicated feed, are not diverted to use in liquid feeds. 
Section 558.5(i) permits an applicant to seek a waiver from this 
requirement (Sec.  558.5(h)) if there is evidence that it is unlikely a 
new animal drug would be used in the manufacture of a liquid medicated 
feed. If FDA receives one NADA per year seeking approval of the use of 
a liquid medicated feed and on average it takes 5 hours to prepare the 
request for waiver, the estimated paperwork burden is 5 hours.
    Risk assessment of antimicrobial new animal drugs with regard to 
their microbiological effects on bacteria of human health concern. 
(Sec. Sec.  514.1(b)(8) and 514.8(c)(1)). FDA estimates that it 
receives 10 risk assessments evaluating the microbial food safety of 
antimicrobial new animal drugs per year. FDA estimates that it takes on 
average 90 hours to put together the references and other materials in 
the format recommended by Guidance 152 and to summarize the hazards and 
associated risk(s). Thus, the total burden hours for preparing such 
risk assessments for submission to FDA are estimated to be 900 hours.
    Form FDA 356V. FDA requests that an applicant fill out and send in 
with NADAs and supplemental NADAs, and requests for phased review of 
data to support NADAs, a Form FDA 356V to ensure efficient and accurate 
processing of information to support new animal drug approval. Over the 
past 5 fiscal years, FDA has received an average of 511 NADAs and 
supplements and 267 submissions of data to support NADAs. FDA estimates 
that it takes an average of 5 hours to read the instructions and fill 
out Form FDA 356V and organize the information that it will accompany. 
This results in a total of 3,890 burden hours.

    Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13195 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S