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37240 Federal Register / Vol. 72, No.

130 / Monday, July 9, 2007 / Notices

DEPARTMENT OF HEALTH AND U.S.C. 3506(c)(2)(A)) requires Federal conference. This information includes a
HUMAN SERVICES agencies to provide a 60-day notice in detailed agenda, a copy of any materials
the Federal Register concerning each to be presented at the conference, a list
Food and Drug Administration proposed collection of information, of proposed indications and, if
[Docket No. 2007N–0236] including each proposed extension of an available, a copy of the proposed
existing collection of information, labeling for the product under
Agency Information Collection before submitting the collection to OMB consideration, and a copy of any
Activities; Proposed Collection; for approval. To comply with this background material that provides
Comment Request; Presubmission requirement, FDA is publishing notice scientific rationale to support the
Conferences, New Animal Drug of the proposed collection of potential applicant’s position on issues
Applications and Supporting information set forth in this document. listed in the agenda for the conference.
Regulations and Guidance 152, and With respect to the following Section 514.5(f) discusses the content of
Form FDA 356V collection of information, FDA invites the memorandum of conference that
comments on these topics: (1) Whether will be prepared by FDA and gives the
AGENCY: Food and Drug Administration, the proposed collection of information potential applicant an opportunity to
HHS. is necessary for the proper performance seek correction to or clarification of the
ACTION: Notice. of FDA’s functions, including whether memorandum. The OMB control
the information will have practical number for the collection of
SUMMARY: The Food and Drug utility; (2) the accuracy of FDA’s presubmission conference information
Administration (FDA) is announcing an estimate of the burden of the proposed is 0910–0555.
opportunity for public comment on the collection of information, including the Under section 512(b)(1) of the act, any
proposed collection of certain validity of the methodology and person may file an NADA seeking
information by the agency. Under the assumptions used; (3) ways to enhance approval to legally market a new animal
Paperwork Reduction Act of 1995 (the the quality, utility, and clarity of the drug. Section 512(b)(1) sets forth the
PRA), Federal agencies are required to information to be collected; and (4) information required to be submitted in
publish notice in the Federal Register ways to minimize the burden of the an NADA. FDA allows applicants to
concerning each proposed collection of collection of information on submit a complete NADA or to submit
information, including each proposed respondents, including through the use information in support of an NADA for
extension of an existing collection of of automated collection techniques, phased review followed by submission
information, and to allow 60 days for when appropriate, and other forms of of an administrative NADA when FDA
public comment in response to the information technology. finds all the applicable technical
notice. This notice solicits comments on sections are complete.
paperwork associated with applications Presubmission Conferences, New Section 514.1 (21 CFR 514.1)
for new animal drugs. Animal Drug Applications and interprets section 512(b)(1) of the act
Supporting Regulations and Guidance and further describes the information
DATES: Submit written or electronic
152, and Form FDA 356V—21 CFR that must be submitted as part of a
comments on the collection of
514.5, 514.1, 514.4, 514.8, (OMB NADA and the manner and form in
information by September 7, 2007.
Control Numbers 0910–0555, 0910– which the NADA must be assembled
ADDRESSES: Submit electronic 0032, 0910–0356, 0910–0522, and 0910–
comments on the collection of and submitted. The application must
0600)—Extension include safety and effectiveness data,
information to: http://www.fda.gov/
dockets/ecomments. Submit written Under section 512(b)(3) of the Federal proposed labeling, product
comments on the collection of Food, Drug, and Cosmetic Act (the act) manufacturing information, and where
information to the Division of Dockets (21 U.S.C. 360b(b)(3)), any person necessary, complete information on
Management (HFA–305), Food and Drug intending to file a New Animal Drug food safety (including microbial food
Administration, 5630 Fishers Lane, Rm. Application (NADA) or supplemental safety) and any methods used to
1061, Rockville, MD 20852. All NADA or a request for an investigational determine residues of drug chemicals in
comments should be identified with the exemption under section 512(j) of the edible tissue from food producing
docket number found in brackets in the act is entitled to one or more animals. Guidance 152 outlines a risk
heading of this document. conferences with FDA to reach an assessment approach for evaluating the
agreement acceptable to FDA microbial food safety of antimicrobial
FOR FURTHER INFORMATION CONTACT:
establishing a submission or new animal drugs. FDA requests that an
Denver Presley, Jr., Office of the Chief investigational requirement. FDA and applicant accompany NADAs,
Information Officer (HFA–250), Food industry have found that these meetings supplemental NADAs, and requests for
and Drug Administration, 5600 Fishers increased the efficiency of the drug phased review of data to support
Lane, Rockville, MD 20857, 301–827– development and drug review NADAs, with the Form FDA 356V to
1472. processes. ensure efficient and accurate processing
SUPPLEMENTARY INFORMATION: Under the Section 514.5 (21 CFR 514.5), of information to support new animal
PRA (44 U.S.C. 3501–3520), Federal describes the procedures for requesting, drug approval. The OMB control
agencies must obtain approval from the conducting, and documenting number for the NADA and the form
Office of Management and Budget presubmission conferences. Section 356V is 0910–0032, and the control
(OMB) for each collection of 514.5(b) describes the information that number for Guidance 152 ‘‘Evaluating
information they conduct or sponsor. must be included in a letter submitted the Safety of Antimicrobial New Animal
‘‘Collection of information’’ is defined by a potential applicant requesting a Drugs With Regard to Their
in 44 U.S.C. 3502(3) and 5 CFR presubmission conference, including a Microbiological Effects on Bacteria of
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1320.3(c) and includes agency requests proposed agenda and a list of expected Human Health Concern’’ is 0910–0522.
or requirements that members of the participants. Section 514.5(d) describes This information collection also
public submit reports, keep records, or the information that must be provided combines several other OMB control
provide information to a third party. by the potential applicant to FDA at numbers: OMB control number 0910–
Section 3506(c)(2)(A) of the PRA (44 least 30 days prior to a presubmission 0356 and OMB control number 0910–

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Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices 37241

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

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section/FDA Form No. Total Hours
Respondents per Respondent Responses Response

514.5(b), (d), (f) 134 .7 93 50 4,650

514.1 and 514.6 134 .1 19 212 4,028

514.4 134 0 0 0 0

514.8(b) 134 3.2 425 35 14,875

514.8(c)(1) 134 0.1 14 71 994

514.8(c)(2) and (c)(3) 134 .4 53 20 1,060

514.11 134 .1 19 1 19

558.5(i) 134 .01 1.0 5 5

514.1(b)(8) and 514.8(c)(1)2 134 .1 10 90 900

FDA Form 356V 134 5.8 778 5 3,890

Total Hours 30,421


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


approximately 50 hours. Thus, the total Supplements fall into one of three FDA estimates that it takes on average
burden hours for presubmission categories: 35 hours (1/6 of the time it takes to
conferences is estimated to be 4,650 • Manufacturing supplements prepare the paperwork to support a full
hours. described at § 514.8(b); NADA) to prepare the paperwork to

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37242 Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices

support approval of manufacturing evidence that it is unlikely a new opportunity for public comment on the
changes. This results in total of 14,875 animal drug would be used in the proposed collection of certain
burden hours. manufacture of a liquid medicated feed. information by the agency. Under the
Supplements seeking approval of If FDA receives one NADA per year Paperwork Reduction Act of 1995 (the
changes in intended uses or conditions seeking approval of the use of a liquid PRA), Federal agencies are required to
of use (§ 514.8(c)(1)). Over the past 3 medicated feed and on average it takes publish notice in the Federal Register
fiscal years, October 1, 2003, through 5 hours to prepare the request for concerning each proposed collection of
September 2006, FDA has received an waiver, the estimated paperwork burden information, including each proposed
average of 14 supplements annually is 5 hours. extension of an existing collection of
seeking approval for changes in Risk assessment of antimicrobial new information, and to allow 60 days for
intended uses or conditions of use. FDA animal drugs with regard to their public comment in response to the
used a 3-year average for this microbiological effects on bacteria of notice. This notice solicits comments on
calculation because data for the human health concern. (§§ 514.1(b)(8) FDA’s patent term restoration
previous 2 years for this category of and 514.8(c)(1)). FDA estimates that it regulations on due diligence petitions
supplements was not tracked as an receives 10 risk assessments evaluating for regulatory review period revision.
independent number. FDA estimates the microbial food safety of Where a patented product must receive
that it takes an average of 71 hours antimicrobial new animal drugs per FDA approval before marketing is
(approximately 1/3 of the time it takes year. FDA estimates that it takes on permitted, the Office of Patents and
to prepare the paperwork to support a average 90 hours to put together the Trademarks may add a portion of the
full NADA) to prepare the paperwork to references and other materials in the FDA review time to the term of a patent.
support approval for such changes. This format recommended by Guidance 152 Petitioners may request reductions in
results in a total of 994 burden hours. and to summarize the hazards and the regulatory review time if FDA
Labeling Supplements (§ 514.8(c)(2) associated risk(s). Thus, the total burden marketing approval was not pursued
and (c)(3)). Over the past 5 fiscal years, hours for preparing such risk with ‘‘due diligence.’’
FDA has received an average of 53 assessments for submission to FDA are
labeling supplements annually. FDA DATES: Submit written comments on the
estimated to be 900 hours.
estimates that it takes an average of 20 Form FDA 356V. FDA requests that an collection of information by September
hours (approximately 1 percent of the applicant fill out and send in with 7, 2007.
time it takes to prepare the paperwork NADAs and supplemental NADAs, and ADDRESSES: Submit electronic
to support a full NADA) to prepare the requests for phased review of data to comments on the collection of
paperwork to support approval of a support NADAs, a Form FDA 356V to information to: http://www.fda.gov/
labeling change. This results in a total ensure efficient and accurate processing dockets/ecomments. Submit written
of 1,060 burden hours. of information to support new animal comments on the collection of
Freedom of Information Summary drug approval. Over the past 5 fiscal information to the Division of Dockets
(§ 514.11 (21 CFR 514.11)). Regulations years, FDA has received an average of Management (HFA–305), Food and Drug
under § 514.11 require the preparation 511 NADAs and supplements and 267 Administration, 5630 Fishers Lane, rm.
of a summary of the safety and submissions of data to support NADAs. 1061, Rockville, MD 20852. All
effectiveness data and information FDA estimates that it takes an average comments should be identified with the
submitted with or incorporated by of 5 hours to read the instructions and docket number found in brackets in the
reference in an approved NADA and fill out Form FDA 356V and organize heading of this document.
that the summary be publicly released the information that it will accompany. FOR FURTHER INFORMATION CONTACT:
when the approval is published in the This results in a total of 3,890 burden Elizabeth Berbakos, Office of the Chief
Federal Register. This summary, hours. Information Officer (HFA–250), Food
generally referred to as the Freedom of Dated: June 28, 2007. and Drug Administration, 5600 Fishers
Information (FOI) Summary, may be Lane, Rockville, MD 20857, 301–827–
Jeffrey Shuren,
prepared by FDA or FDA may require 1482.
the applicant to prepare the summary Assistant Commissioner for Policy.
(§ 514.11(e)(ii)). In the past, FDA has [FR Doc. E7–13195 Filed 7–6–07; 8:45 am] SUPPLEMENTARY INFORMATION: Under the
required the applicant to prepare the BILLING CODE 4160–01–S PRA (44 U.S.C. 3501–3520), Federal
FOI Summary. Currently, FDA generally agencies must obtain approval from the
takes responsibility for preparing the Office of Management and Budget
FOI Summary. Thus, the paperwork DEPARTMENT OF HEALTH AND (OMB) for each collection of
burden on applicants to prepare an FOI HUMAN SERVICES information they conduct or sponsor.
Summary has significantly decreased. ‘‘Collection of information’’ is defined
Food and Drug Administration
Based on the estimate of 19 NADAs in 44 U.S.C. 3502(3) and 5 CFR
received annually and an estimate that [Docket No. 2007N–0240] 1320.3(c) and includes agency requests
applicants now spend little or no time or requirements that members of the
preparing the FOI summary, the Agency Information Collection public submit reports, keep records, or
estimated burden hours are 19 hours. Activities; Proposed Collection; provide information to a third party.
Requirements for liquid medicated Comment Request, Patent Term Section 3506(c)(2)(A) of the PRA (44
feeds (§ 558.5(i) (21 CFR 558.5(i)). Restoration, Due Diligence Petitions, U.S.C. 3506(c)(2)(A)) requires Federal
Generally, specific labeling is required Filing, Format, and Content of agencies to provide a 60-day notice in
to make sure that certain drugs, Petitions the Federal Register concerning each
approved for use in animal feed or AGENCY: Food and Drug Administration, proposed collection of information,
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drinking water but not in liquid HHS. including each proposed extension of an
medicated feed, are not diverted to use ACTION: Notice. existing collection of information,
in liquid feeds. Section 558.5(i) permits before submitting the collection to OMB
an applicant to seek a waiver from this SUMMARY: The Food and Drug for approval. To comply with this
requirement (§ 558.5(h)) if there is Administration (FDA) is announcing an requirement, FDA is publishing notice

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