[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70331-70334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0236]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
10, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments

[[Page 70332]]

should be identified with the OMB control number 0910-0032. Also 
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance:

Presubmission Conferences, New Animal Drug Applications and Supporting 
Regulations and Guidance 152, and Form FDA 356V--(OMB Control Number 
0910-0032)--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) 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) 
of the act 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 an 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 revised 
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 revised Form FDA 356V is 0910-0032, and the OMB 
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 consolidates several other OMB control 
numbers: OMB control number 0910-0356 and OMB control number 0910-0600, 
for which the collection of information requirements under the new 
revised Sec.  514.8 (21 CFR 514.8) has been approved for a final rule 
that became 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. As previously stated, FDA also 
recently revised Sec.  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). Revised Sec.  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 
under 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.
    In the Federal Register of July 9, 2007 (72 FR 37240), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received in response to that 
notice.
    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/
 FDA Form             Respondents        per Response        Responses           Response
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514.5(b), (d),                   134                 .7                 93                 50              4,650
 and (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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[[Page 70333]]

 
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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Form FDA 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 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. Sec.  514.1 and 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 is 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 21 CFR 
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 Sec.  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 support approval of manufacturing changes. 
This results in a 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 30, 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)).

[[Page 70334]]

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 ten 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 is 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: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23998 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S