[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Notices]
[Page 70331-70334]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de07-52]
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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 baguilar@omb.eop.gov. 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 < greek- No. of Annual Frequency Total Annual Hours per Total Hours
i> 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)).
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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