[Federal Register: August 25, 2000 (Volume 65, Number 166)]
[Proposed Rules]
[Page 51782-51787]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au00-19]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. 00N-1399]
Presubmission Conferences
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its new animal drug regulations to describe the procedures to be
followed for requesting, conducting, and documenting presubmission
conferences. Under the Federal Food, Drug, and Cosmetic Act (the act),
as amended by the Animal Drug Availability Act of 1996 (ADAA), any
person intending to file a new animal drug application (NADA) or
supplemental (NADA) or to investigate a new animal drug is entitled to
one or more conferences with FDA to reach an agreement establishing a
submission or investigational requirement. This proposed regulation
describes how a person would request a presubmission conference and
describes the procedures for the conduct of the presubmission
conference.
DATES: Submit written comments on the proposed rule by November 8,
2000. Submit written comments on the information collection provisions
by September 25, 2000.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit written comments on the
information collection requirements to the Office of Information and
Regulatory Affairs, Office of Management and Budget, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Gail L. Schmerfeld, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1620.
SUPPLEMENTARY INFORMATION:
I. Background
The ADAA (Public Law 104-250) was enacted on October 9, 1996.
Section 512(b)(3) of the act (21 U.S.C. 360b(b)(3)), as amended by
section 2(d) of the ADAA, provides that any person intending to file an
NADA or supplemental NADA or to investigate a new animal drug is
entitled to one or more conferences with FDA prior to such submission
or during the investigation of a new animal drug. The purpose of such a
conference is to reach an agreement establishing a submission or
investigational requirement. A decision establishing a submission or
investigational requirement can be changed only if: (1) FDA and the
potential applicant mutually agree to modify the requirement, or (2)
FDA by written order determines that a substantiated scientific
requirement essential to the determination of safety or effectiveness
of the animal drug involved has appeared after the conference. If FDA
determines that more than one field study is required to establish by
substantial evidence that an intended use of a new animal drug is
effective, FDA will provide written scientific justification for that
decision within 25 calendar days of the conference. While section
512(b)(3) of the act does not entitle persons who intend to file an
abbreviated new animal drug application (ANADA) to request a
presubmission conference, such potential applicants are entitled to
request presubmission conferences under this proposed rule.
Although the ADAA added a statutory entitlement to a presubmission
conference, FDA's Center for Veterinary Medicine (CVM) had already been
encouraging sponsors of NADA's to participate in conferences with FDA
to discuss in detail what studies are necessary to demonstrate the
safety and effectiveness of a new animal drug. In its experience with
these presubmission conferences, FDA found that, as a result of this
direct and detailed communication during the development and review of
new animal drugs, fewer unusable studies were conducted and there were
fewer delays in the review process. Consequently, companies saved
resources and the marketing of new animal drugs became more
expeditious. FDA's success with the use of presubmission conferences to
establish submission requirements for new animal drugs was also
reflected in its commitment to implement broad use of presubmission
conferences as part of the President's reinventing government
initiatives (e.g., ``Reinventing the Regulation of Animal Drugs,'' May
1996). The ADAA codifies FDA's use of presubmission conferences.
II. Description of Proposed Rule
The regulations being proposed by FDA would establish the
procedures for requesting, conducting, and documenting presubmission
conferences. Presubmission conferences will continue to be like those
that were held between applicants and FDA prior to the enactment of the
ADAA. The purpose of presubmission conferences is to allow FDA and a
potential applicant, i.e., a person intending to investigate a new
animal drug or to file an NADA, supplemental NADA, or ANADA, to discuss
and reach agreement regarding a submission or investigational
requirement. A submission or investigational requirement includes,
among other things, identification of the number and types of studies
that are necessary to demonstrate the safety and effectiveness of a new
animal drug for the intended uses and conditions of use prescribed,
recommended, or suggested in the proposed labeling for the new animal
drug. Presubmission conferences give FDA and a potential applicant a
means to identify the least burdensome appropriate requirements that
have a reasonable likelihood of resulting in approval.
Meetings other than presubmission conferences may be necessary
during the development and review of new animal drugs. Meetings in
which the focus is other than to establish the safety and effectiveness
data requirements for new animal drugs (e.g., meetings relating to
administrative processes, protocol development, or label development)
are not specifically covered by this proposed rule.
A. Definitions (Proposed Sec. 514.3)
Proposed Sec. 514.3 defines the terms ``potential applicant,''
``presubmission conference,'' and ``presubmission conference
agreement'' as those terms are used in 21 CFR part 514. ``Potential
applicant'' means any person intending to investigate a new animal
drug, file an NADA or supplement, or file an ANADA. One or more
``presubmission conferences'' may be needed to establish agreement
regarding part or all of a submission or investigational requirement.
Agreement on a submission or investigational requirement reached by a
potential applicant and FDA in a presubmission conference(s) will be
recorded in the ``presubmission conference agreement'' section of the
memorandum of conference prepared by FDA and will be
[[Page 51783]]
binding upon both FDA and the potential applicant.
B. Presubmission Conferences (Proposed Sec. 514.4)
Proposed Sec. 514.4 describes procedures for requesting,
conducting, and documenting a presubmission conference.
1. Requesting a Presubmission Conference
Under the proposed rule, a potential applicant could request a
presubmission conference any time prior to filing an NADA, supplemental
NADA, or ANADA, including before a potential applicant submits a notice
of claimed investigational exemption for a new animal drug. In order to
request a presubmission conference, a potential applicant would be
required to submit to FDA a letter requesting a presubmission
conference. FDA would have to receive the request for a presubmission
conference at least 30 calendar days prior to the requested conference
date. The potential applicant would identify the request as a request
for a presubmission conference and would have to include a proposed
agenda and a list of the expected attendees. FDA would, to the extent
agency resources permit, make every effort to schedule the
presubmission conference at the earliest time agreeable to both FDA and
the potential applicant. In order to ensure a productive exchange of
views and efficient use of FDA resources, a potential applicant would
also be required to forward to FDA, at least 30 calendar days in
advance of the scheduled conference date the following: A copy of any
materials to be presented at the conference; a list of proposed
indications for the new animal drug or, if available, a copy of the
proposed labeling; and a copy of any relevant background material that
provides the scientific rationale to support the potential applicant's
position on an issue to be discussed during the conference. If such
materials are not provided or are not sufficient to provide the basis
for a meaningful discussion, FDA may elect to postpone the meeting
until it receives sufficient materials.
2. Conducting a Presubmission Conference
A presubmission conference (or series of such conferences) would be
directed primarily at establishing agreement between FDA and the
potential applicant regarding part or all of a submission or
investigational requirement. The potential applicant and FDA could each
bring consultants to the presubmission conference.
3. Documenting a Presubmission Conference
Under the proposed rule, FDA would prepare a memorandum of
conference summarizing the substance of each presubmission conference,
including all key discussion points, decisions, recommendations,
agreements reached regarding all or part of a submission or
investigational requirement, disagreements, and action items. That
portion of the memorandum of conference that documents any agreements
reached regarding all or part of a submission or investigational
requirement would be the ``presubmission conference agreement'' and
would be denoted as such by a heading as such. FDA would provide a copy
of this memorandum to the potential applicant and give the potential
applicant 30 calendar days to request changes to or seek clarification
of the substance of the memorandum. The potential applicant could elect
to have the copy of the memorandum provided by mail, by facsimile, and/
or by some electronic media. For purposes of calculating the 30 days,
FDA would use the date the memorandum is mailed, facsimiled, or
electronically transmitted from the Documents Control Unit, whichever
is earlier. If a potential applicant were to request changes or
clarification, such a request should be directed to the appropriate
Division Director in CVM. A copy of FDA's original memorandum of
conference and a copy of the memorandum with changes or clarification,
as appropriate, would be made part of the administrative file. If a
memorandum is silent on an issue, including one that was discussed
during the conference or addressed by materials provided by the
potential applicant for the conference, such silence cannot be
construed as agreement between FDA and the potential applicant on the
issue. A copy of the final memorandum would be provided to the
potential applicant. FDA would file in the administrative record, but
not review or consider binding in any way, a memorandum of conference
prepared by a potential applicant.
If FDA determines that more than one field study is necessary to
demonstrate effectiveness, in accordance with section 512(b)(3) of the
act, it would provide, either separately or as part of a memorandum of
conference, written scientific justification for its decision within 25
calendar days of the date such decision is made. FDA would not,
however, provide such written scientific justification if the potential
applicant voluntarily proposes to conduct more than one field study but
FDA does not believe multiple studies are necessary. The potential
applicant's proposal to conduct more than one field study would be
documented in the memorandum of conference.
One study can be a study at a single location or a study in which
data are collected from multiple locations. Results obtained in a
single location study may be dependent on site specific factors (e.g.,
disease definition, concomitant treatment, diet, management practices,
climate, field conditions, etc.). In such cases, the results, although
significant with respect to that site, may not permit inferences to be
made to the intended target animal population. If FDA requires one
field study to be conducted at multiple locations, at the request of
the potential applicant, FDA would provide verbal or written
justification for requiring multiple locations. Written justification
could be provided separately or as part of a memorandum of conference.
FDA intends to issue guidance to industry regarding the use of field
studies to provide substantial evidence of effectiveness.
Presubmission conference agreements would generally include
timeframes for completion. The agreements would assume that the
potential applicant would use due diligence to complete the drug
development process within those timeframes and FDA would use due
diligence to complete its reviews within reasonable timeframes. If a
potential applicant were to fail to meet the terms of an agreement, the
agreement would have no precedential value for subsequent agreements
relating to the same new animal drug because standards may change over
time. Similarly, agreements relating to one new animal drug would have
no precedential value with respect to other new animal drugs because
requirements may vary from drug to drug or intended use to intended
use.
Agreements reached through a presubmission conference could be
modified under the limited circumstances described in proposed
Sec. 514.4(g). Proposed Sec. 514.4(h) describes how a potential
applicant may breach an agreement. The act provides that FDA breaches
an agreement if it unilaterally modifies the agreement without a
written order determining that a substantiated scientific requirement
essential to the determination of safety or effectiveness appeared
after the conference. Proposed Sec. 514.4(i) describes procedures for
resolving disputes that may arise between a
[[Page 51784]]
potential applicant and FDA during the presubmission conference
process.
FDA encourages potential applicants to meet with FDA at any time to
discuss submission requirements.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Analysis of Impacts
FDA has examined the impact of the proposed rule under Executive
Order 12866 and under Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities unless the rule is not expected to have a significant
economic impact on a substantial number of small entities. As this
proposed rule will not impose significant new costs on any firms, under
the Regulatory Flexibility Act (5 U.S.C. 605(b)), the agency certifies
that the proposed rule will not have a significant impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
Under section 512(b)(3) of the act, as amended by the ADAA, any
person intending to file an NADA or supplemental NADA or to investigate
a new animal drug is entitled to one or more conferences prior to such
submission to reach an agreement establishing a submission or
investigational requirement. The purpose of a presubmission conference
is to allow a potential applicant and FDA to discuss and to reach
agreement regarding a submission or investigational requirement,
including the number and types of studies that are necessary to
demonstrate that a new animal drug is safe and effective for its
intended uses.
Prior to the enactment of the ADAA, CVM had already been
encouraging sponsors of NADA's to participate in conferences with FDA
to discuss in detail what studies are necessary to demonstrate the
safety and effectiveness of the particular new animal drug being
investigated. FDA found that, as a result of this direct communication
during the development and review of new animal drugs, both the drug
development and review processes became more efficient. This proposed
rule would implement the statutory entitlement to a presubmission
conference and, thus, ensure that this benefit will continue where
applicants request a presubmission conference. To the extent that this
proposed rule would educate those in the industry that were not
familiar with presubmission conferences, there will be further benefits
as additional potential applicants realize efficiencies gained in the
animal drug development and application process if they request a
presubmission conference.
FDA is not able to make a precise estimate of the savings that
industry has realized through the presubmission conferences up to this
point, or of any increase in the number of presubmission conferences
that may be requested as a result of this rule. There are many factors
that determine the type and number of studies necessary to demonstrate
the safety and effectiveness of new animal drugs. This proposed rule
seeks to secure an avenue of communication between the agency and
potential applicants through which both can agree on the studies needed
for a certain drug, thereby reducing unnecessary studies and review
periods.
It is possible, however, to forecast a range of savings that may be
expected to result from any decrease in approval time resulting from
the use of a presubmission conference. For this purpose, FDA estimated
a straight-line increase of a prospective drug's sales revenues from
the application's approval up to $5 million in the 10th year and then
decreasing again to zero in the 20th year. Since many drugs attain
sales much greater than $5 million, the agency estimate results in a
rather conservative benefit. Assuming a pretax profit of 20 percent of
sales revenue, FDA estimates the present value of the profits from a 1-
to 6-month decrease in approval time at $20,000 to $120,000 using a 7
percent discount rate. Research costs saved by the firm from not
conducting unnecessary studies would be added to this amount.
Regardless of the exact reduction in the drug review period, since the
presubmission conferences are voluntary, applicants would only be
expected to request a conference if they expected the net benefit of
the conference to be positive. The proposed rule would not impose any
mandatory compliance costs.
V. Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement of
anticipated costs and benefits before proposing any rule that may
result in an expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million in any one
year (adjusted annually for inflation).
The Unfunded Mandates Reform Act does not require FDA to prepare a
statement of costs and benefits for the proposed rule, because the
proposed rule is not expected to result in any 1-year expenditure that
would exceed $100 million adjusted for inflation. The current
inflation-adjusted statutory threshold is $110 million.
VI. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency has concluded that the rule does not contain policies that
have federalism implications as defined in the order and, consequently,
a federalism summary impact statement is not required.
VII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). A description of these provisions is given below with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
[[Page 51785]]
With respect to the following collection of information, FDA
invites comments on: (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.
Title: Presubmission Conferences
Description: The proposed regulation is intended to implement
section 512(b)(3) of the act which entitles any person intending to
file an NADA or supplemental NADA or to investigate a new animal drug
to request one or more conferences with FDA to reach an agreement
establishing a submission or investigational requirement. Prior to the
enactment of section 512(b)(3) of the act, FDA encouraged sponsors to
meet with FDA to discuss the number and types of studies necessary to
demonstrate that a new animal drug is safe and effective. FDA found
that these informal presubmission conferences increased the efficiency
of the drug development and drug review processes. FDA is publishing
this proposed regulation to describe how to request, conduct, and
document a presubmission conference.
Proposed section 514.4(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. Proposed section 514.4(d) lists the information
that must be provided by the potential applicant to FDA prior to a
presubmission conference. This information includes a copy of any
materials to be presented at the conference, a list of proposed
indications or a copy of the proposed labeling for the product under
consideration, and any background material that provides an adequate
scientific rationale to support the potential applicant's position on
issues listed on the proposed agenda for the conference. Proposed
section 514.4(f) discusses the content of the memorandum of meeting
that will be prepared by FDA and proposes to allow the potential
applicant to seek clarification or correction of the memorandum.
Table 1 of this document provides, by relevant section, the
estimated burden of requesting, preparing for, and participating in
presubmission conferences. The numbers in the chart are based on recent
consultation with several of the major research and development firms
that are responsible for the development of new animal drugs. While FDA
estimates that the proposed regulation would increase the annual
paperwork burden associated with the submission of NADA's, supplemental
NADA's, and abbreviated NADA's, and requests for guidance on
investigational requirements, FDA believes this increase will be offset
by the resulting efficiencies (e.g., eliminating the conduct of studies
that are not needed to demonstrate safety and effectiveness, decreasing
the requests from reviewers for additional or clarifying information
during the review process).
Description of Respondents: Potential applicants
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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514.4(b) 190 1 190 7 1,330
514.4(d) 190 1 190 123 23,370
514.4(f) 190 1 190 16 3,040
Total 27,740
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\1\ There are no capital cost or operating and maintenance costs associated with this collection of information.
In compliance with section 3507(d) of the PRA, the agency has
submitted the information collection provisions of this proposed rule
to OMB for review. Interested persons may submit to OMB (address above)
written comments regarding the information collection by September 25,
2000.
Lists of Subjects in 21 CFR Part 514
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 514 be amended as follows:
PART 514--NEW ANIMAL DRUG APPLICATIONS
1. The authority citation for 21 CFR part 514 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.
2. Section 514.2 is added to subpart A to read as follows:
Sec. 514.2 Definitions.
(a) Potential applicant means any person intending to:
(1) Investigate a new animal drug under section 512(j) of the
Federal Food, Drug, and Cosmetic Act (the act),
(2) File a new animal drug application (NADA) or supplemental NADA
under 512(b)(1) of the act, or
(3) File an abbreviated new animal drug application (ANADA) under
section 512(b)(2) of the act.
(b) Presubmission conference means one or more conferences between
a potential applicant and FDA, requested by the potential applicant, to
reach a binding agreement establishing a submission or investigational
requirement.
(c) Presubmission conference agreement means that section of the
memorandum of conference headed ``Presubmission Conference Agreement''
that records any agreement on the submission or investigational
requirement reached by a potential applicant and FDA during the
presubmission conference. The presubmission conference agreement will
be binding on the potential applicant and FDA unless it is modified as
described in Sec. 514.5(g).
3. Section 514.5 is added to subpart A to read as follows:
Sec. 514.5 Presubmission conferences.
(a) General. Presubmission conferences provide a forum for a
[[Page 51786]]
potential applicant and FDA to reach agreement regarding the overall
plan for conducting investigations of new animal drugs or obtaining
approval of a new animal drug, including to discuss what studies are
required to support approval of a new animal drug application (NADA), a
supplemental NADA, or an abbreviated new animal drug application
(ANADA), and to discuss the objectives and general design of particular
studies. Presubmission conferences, as a project management tool, can
enhance the animal drug development and evaluation process. The general
principle underlying the conduct of any such conference is that there
must be candid, full, and open communication about scientific or
medical issues pertaining to the safety and effectiveness of an
investigational new animal drug.
(b) Requesting a presubmission conference. A potential applicant is
entitled to one or more conferences prior to the submission of an NADA,
supplemental NADA, or an ANADA to reach an agreement establishing part
or all of a submission or investigational requirement. Potential
applicants must request a presubmission conference by submitting their
request to the appropriate Center for Veterinary Medicine (CVM)
Division Director in a signed letter. The letter must include a
proposed agenda that clearly outlines the scope, purpose, and
objectives of the presubmission conference and must list the names and
positions of the representatives who are expected to attend the
presubmission conference on behalf of the potential applicant.
(c) Timing. A potential applicant may request one or more
presubmission conferences at any time prior to the filing of a NADA,
supplemental NADA, or an ANADA. A request for a presubmission
conference must be received by FDA at least 30 calendar days in advance
of the requested conference date. FDA will schedule the presubmission
conference at a time agreeable to both FDA and the potential applicant.
(d) Advance information. The potential applicant must provide to
FDA, at least 30 calendar days in advance of a scheduled presubmission
conference, a copy of any materials to be presented at the conference,
a list of proposed indications or a copy of the proposed labeling for
the product under consideration, and any background material that
provides an adequate scientific rationale to support the potential
applicant's position on issues listed on the proposed agenda for the
conference. If the materials are not provided or are not sufficient to
provide the basis for meaningful discussion, FDA may elect to postpone
the meeting until sufficient materials are provided to FDA.
(e) Conduct of a presubmission conference. The potential applicant
and FDA may each bring consultants to the presubmission conference. The
presubmission conference(s) will be directed primarily at establishing
agreement between FDA and the potential applicant regarding a
submission or investigational requirement. The submission or
investigational requirement will include the number and types of
studies that are necessary to demonstrate the safety and effectiveness
of a new animal drug for the intended uses and conditions of use
prescribed, recommended, or suggested in the proposed labeling for the
new animal drug.
(f) Documentation of a presubmission conference--(1) Memorandum of
conference. FDA will prepare a memorandum of each conference
summarizing the substance of the conference: Key discussion points,
decisions, recommendations, agreements reached regarding all or part of
a submission or investigational requirement, disagreements, and action
items. That portion of the memorandum of conference that documents any
agreements reached regarding all or part of a submission or
investigational requirement will be included under the heading
``Presubmission Conference Agreement.'' FDA will provide a copy of the
memorandum to the potential applicant for review. The potential
applicant will have 30 calendar days from the date a copy of the final
draft of the memorandum is provided to the applicant to request changes
to or clarification of the substance of the memorandum. For purposes of
calculating the 30 days, FDA will use the date the memorandum is
mailed, facsimiled, or electronically transmitted to the potential
applicant from the Document Control Unit, whichever is earlier. If a
potential applicant requests changes or clarification, such request
should be directed to the appropriate CVM Division Director. A copy of
FDA's original memorandum of conference and a copy of the memorandum
with changes or clarification, as appropriate, will be made part of the
administrative file. If a memorandum is silent on an issue, including
one that was discussed in the conference or addressed by materials
provided for the conference, such silence cannot be construed as
agreement between FDA and the potential applicant on the issue. FDA
will provide the potential applicant with a copy of the final
memorandum.
(2) Field studies. If FDA requires more than one field study to
establish by substantial evidence that the new animal drug is effective
for its intended uses under the conditions of use prescribed,
recommended, or suggested in the proposed labeling, FDA will provide
written scientific justification for requiring more than one field
study. Such justification must be provided no later than 25 calendar
days after the date of the conference at which the requirement for more
than one field study is established. If FDA does not believe more than
one field study is required but the potential applicant voluntarily
proposes to conduct more than one field study, FDA will not provide
such written justification. If FDA requires one field study to be
conducted at multiple locations, FDA will, at the request of the
potential applicant, provide written or verbal justification for
requiring multiple locations.
(g) Modification of presubmission conference agreements. An
agreement made under a presubmission conference requested under section
512(b)(3) of the Federal Food, Drug, and Cosmetic Act and documented in
a memorandum of conference is binding on the potential applicant and
FDA and may only be modified if:
(1) FDA and the potential applicant mutually agree to modify, in
part or in whole, the agreement and such modification is documented and
provided to the potential applicant as described in paragraph (f)(1) of
this section; or
(2) FDA by written order determines that a substantiated scientific
requirement essential to the determination of safety or effectiveness
of the new animal drug appeared after the conference.
(h) When the terms of a presubmission conference agreement are no
longer binding. (1) A presubmission conference agreement will no longer
be binding if:
(i) The potential applicant makes to FDA, before, during, or after
the presubmission conference, any untrue statement of material fact; or
(ii) The potential applicant fails to follow any term of the
agreement; and
(2) A presubmission conference agreement may no longer be binding
if the potential applicant submits false or misleading data relating to
a new animal drug to FDA.
(i) Dispute resolution. FDA is committed to resolving differences
between a potential applicant and FDA reviewing divisions with respect
to requirements for the investigation of new animal drugs and for
NADA's,
[[Page 51787]]
supplemental NADA's, and ANADA's as quickly and amicably as possible
through a cooperative exchange of information and views. When
administrative or procedural disputes arise, a potential applicant
should first attempt to resolve the matter within the appropriate
review division beginning with the individual(s) most directly assigned
to review of the application or investigational exemption. If the
dispute cannot be resolved after such attempts, the dispute shall be
evaluated and administered in accordance with applicable regulations
(21 CFR 10.75). Dispute resolution procedures may be further explained
by guidance available from CVM.
Dated: August 17, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21692 Filed 8-24-00; 8:45 am]
BILLING CODE 4160-01-F