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Food and Drug Administration, HHS § 516.

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§ 516.36 Insufficient quantities of prior to final FDA action on the re-


MUMS-designated drugs. quest unless the existence of the re-
(a) Under section 573 of the act, quest has been previously publicly dis-
whenever FDA has reason to believe closed or acknowledged.
that sufficient quantities of a condi- (b) Whether or not the existence of a
tionally-approved or approved, MUMS- pending request for designation has
designated drug to meet the needs for been publicly disclosed or acknowl-
which the drug was designated cannot edged, no data or information in the re-
be assured by the sponsor, FDA will so quest are available for public disclo-
notify the sponsor of this possible in- sure prior to final FDA action on the
sufficiency and will offer the sponsor request.
the following options, one of which (c) Except as provided in paragraph
must be exercised by a time that FDA (d) of this section, upon final FDA ac-
specifies: tion on a request for designation, the
(1) Provide FDA information and public availability of data and informa-
data regarding how the sponsor can as- tion in the request will be determined
sure the availability of sufficient quan- in accordance with part 20 of this chap-
tities of the MUMS-designated drug ter and other applicable statutes and
within a reasonable time to meet the regulations.
needs for which the drug was des- (d) In accordance with § 516.28, FDA
will make a cumulative list of all
ignated; or
MUMS-drug designations available to
(2) Provide FDA in writing the spon-
the public and update such list periodi-
sor’s consent for the conditional ap-
cally. In accordance with § 516.29, FDA
proval or approval of other applica-
will give public notice of the termi-
tions for the same drug before the expi-
nation of all MUMS-drug designations.
ration of the 7-year period of exclusive
marketing rights.
(b) If, within the time that FDA Subpart C—Index of Legally Mar-
specifies, the sponsor fails to consent keted Unapproved New Ani-
to the conditional approval or approval mal Drugs for Minor Species
of other applications and if FDA finds
that the sponsor has not shown that it SOURCE: 72 FR 69121, Dec. 6, 2007, unless
can assure the availability of sufficient otherwise noted.
quantities of the MUMS-designated
drug to meet the needs for which the § 516.111 Scope of this subpart.
drug was designated, FDA will issue a This subpart implements section 572
written order terminating designation of the act and provides standards and
of the MUMS drug and the associated procedures to establish an index of le-
exclusive marketing rights. This order gally marketed unapproved new animal
will state FDA’s findings and conclu- drugs. This subpart applies only to
sions and will constitute final agency minor species and not to minor use in
action. An order terminating designa- major species. This index is only avail-
tion and associated exclusive mar- able for new animal drugs intended for
keting rights may issue whether or not use in a minor species for which there
there are other sponsors that can as- is a reasonable certainty that the ani-
sure the availability of alternative mal or edible products from the animal
sources of supply. Such an order will will not be consumed by humans or
not withdraw the conditional approval food-producing animals and for new
or approval of an application. Once ter- animal drugs intended for use only in a
minated under this section, neither hatchery, tank, pond, or other similar
designation, nor exclusive marketing contained man-made structure in an
rights may be reinstated. early, nonfood life stage of a food-pro-
ducing minor species, where safety for
§ 516.52 Availability for public disclo- humans is demonstrated in accordance
sure of data and information in re- with the standard of section 512(d) of
quests. the act (including, for an antimicrobial
(a) FDA will not publicly disclose the new animal drug, with respect to anti-
existence of a request for MUMS-drug microbial resistance). The index shall
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designation under section 573 of the act not include a new animal drug that is

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§ 516.115 21 CFR Ch. I (4–1–08 Edition)

contained in, or a product of, a Product defect/manufacturing defect.


transgenic animal. Among its topics, Serious adverse drug experience.
this subpart sets forth the standards Unexpected adverse drug experience.
and procedures for: (c) The definitions of the following
(a) Investigational exemptions for in- terms are given in § 516.3 of this chap-
dexing purposes; ter:
(b) Submissions to FDA of requests Same dosage form.
for determination of eligibility of a Same drug.
new animal drug for indexing; Same intended use.
(c) Establishment and operation of
expert panels; § 516.117 Submission of correspond-
(d) Submissions to FDA of requests ence under this subpart.
for addition of a new animal drug to Unless directed otherwise by FDA,
the index; all correspondence relating to any as-
(e) Modifications to index listings; pect of the new animal drug indexing
(f) Publication of the index; and process described in this subpart must
(g) Records and reports. be addressed to the Director, OMUMS.
The initial correspondence for a par-
§ 516.115 Definitions. ticular index listing should include the
(a) The following definitions of terms name and address of the authorized
apply only in the context of subpart C contact person. Notifications of
of this part: changes in such person or changes of
Director OMUMS means the Director address of such person should be pro-
of the Office of Minor Use and Minor vided in a timely manner.
Species Animal Drug Development of
the FDA Center for Veterinary Medi- § 516.119 Permanent-resident U.S.
cine. agent for foreign requestors and
holders.
Holder means the requestor of an
index listing after the request is grant- Every foreign requestor and holder
ed and the new animal drug is added to shall name a permanent resident of the
the index. United States as their agent upon
Index means FDA’s list of legally whom service of all processes, notices,
marketed unapproved new animal orders, decisions, requirements, and
drugs for minor species. other communications may be made on
Intended use has the same meaning as behalf of the requestor or holder. Noti-
that given in § 516.13 of this chapter. fications of changes in such agents or
Qualified expert panel means a panel changes of address of agents should
that is composed of experts qualified preferably be provided in advance, but
by scientific training and experience to not later than 60 days after the effec-
evaluate the target animal safety and tive date of such changes. The perma-
effectiveness of a new animal drug nent resident U.S. agent may be an in-
under consideration for indexing. dividual, firm, or domestic corporation
Requestor means the person making a and may represent any number of re-
request for determination of eligibility questors or holders. The name and ad-
for indexing or a request for addition dress of the permanent-resident U.S.
to the index. agent shall be submitted to the Direc-
Transgenic animal means an animal tor, OMUMS, and included in the index
whose genome contains a nucleotide se- file.
quence that has been intentionally
modified in vitro, and the progeny of § 516.121 Meetings.
such an animal, provided that the term (a) A requestor or potential requestor
‘transgenic animal’ does not include an is entitled to one or more meetings to
animal of which the nucleotide se- discuss the requirements for indexing a
quence of the genome has been modi- new animal drug.
fied solely by selective breeding. (b) Requests for such meetings should
(b) The definitions of the following be in writing, be addressed to the Di-
terms are given in § 514.3 of this chap- rector, OMUMS, specify the partici-
ter: pants attending on behalf of the re-
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Adverse drug experience. questor or potential requestor, and

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Food and Drug Administration, HHS § 516.123

contain a proposed agenda for the (f) The purpose of an informal con-
meeting. ference is to discuss scientific and fac-
(c) Within 30 days of receiving a re- tual issues. It will involve a discussion
quest for a meeting, FDA will attempt of FDA’s initial decision and any writ-
to schedule the meeting at a time ten response to that decision.
agreeable to both FDA and the person (g) Internal agency review of a deci-
making the request. sion must be based on the information
in the administrative file. If the person
§ 516.123 Informal conferences regard- requesting an informal conference pre-
ing agency administrative actions. sents new information not in the file,
(a) Should FDA make an initial deci- the matter will be returned to the ap-
sion denying a request for determina- propriate lower level in the agency for
tion of eligibility for indexing, termi- reevaluation based on the new informa-
nating an investigational exemption, tion.
determining that a qualified expert (h) Informal conferences under this
panel does not meet the selection cri- part are not subject to the separation
teria, denying a request for addition to of functions rules in § 10.55 of this chap-
the index, or removing a new animal ter.
drug from the index, FDA will give (i) The rules of evidence do not apply
written notice that specifies the to informal conferences. No motions or
grounds for the initial decision and objections relating to the admissibility
provides an opportunity for an infor- of information and views will be made
mal conference for review of the deci- or considered, but any party to the
sion. conference may comment upon or
(b) The written notice will include in- rebut all such data, information and
formation for scheduling the informal views.
conference and state that a written re- (j) [Reserved]
quest for a conference must be made (k) The presiding officer will prepare
within 60 days of the date FDA sends a written report regarding the subject
its notice. of the informal conference that states
(c) Within 45 days of receiving a re- and describes the basis for his or her
quest for an informal conference, FDA findings. Whenever time permits, the
will schedule and hold the informal parties to the informal conference will
conference at a time agreeable to both have 30 days to review and comment on
FDA and the person making the re- the report.
quest.
(l) The administrative record of the
(d) Such an informal conference will
informal conference will consist of:
be conducted by a presiding officer who
will be the Director of the Center for (1) The notice providing an oppor-
Veterinary Medicine or his or her des- tunity for an informal conference and
ignee, excluding the Director of the Of- the written response to the notice.
fice of Minor Use and Minor Species (2) All written information and views
Animal Drug Development and other submitted to the presiding officer at
persons significantly involved in the the conference or, at the discretion of
initial decision. the presiding officer, thereafter.
(e) The person requesting an informal (3) The presiding officer’s written re-
conference must provide a written re- port.
sponse to FDA’s initial decision at (4) All correspondence and memo-
least 2 weeks prior to the date of the randa of any and all meetings between
scheduled meeting. Generally, this the participants and the presiding offi-
written response would be attached to cer.
the request for an informal conference. (m) The administrative record of the
At the option of the person requesting informal conference is closed to the
an informal conference, such written submission of information at the close
response to FDA’s initial decision may of the conference, unless the presiding
act in lieu of a face-to-face meeting. In officer specifically permits additional
this case, the informal conference will time for further submission.
consist of a review by the presiding of- (n) The administrative record of the
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ficer of the submitted written response. informal conference specified herein

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§ 516.125 21 CFR Ch. I (4–1–08 Edition)

constitutes the exclusive record for de- mals are not to be used for food for hu-
cision. mans or other animals unless author-
ization has been granted by the U.S.
§ 516.125 Investigational use of minor Food and Drug Administration or by
species new animal drugs to sup- the U.S. Department of Agriculture.’’
port indexing.
(3) Under § 511.1(b)(4) of this chapter,
(a) The investigational use of a new the notice is titled ‘‘Notice of Claimed
animal drug or animal feed bearing or Investigational Exemption for a New
containing a new animal drug intended Animal Drug for Index Listing’’ and is
solely for investigational use in minor submitted in duplicate to the Director,
species shall meet the requirements of OMUMS.
part 511 of this chapter if the investiga- (4) Under § 511.1(c)(3) of this chapter,
tional use is for the purpose of: if an investigator is determined to be
(1) Demonstrating human food safety ineligible to receive new animal drugs,
under section 572(a)(1)(B) of the act; each ‘‘Notice of Claimed Investiga-
(2) Demonstrating safety with re- tional Exemption for a New Animal
spect to individuals exposed to the new Drug for Index Listing’’ and each re-
animal drug through its manufacture quest for indexing shall be examined
and use under section 572(c)(1)(F) of the with respect to the reliability of infor-
act; mation submitted by the investigator.
(3) Conducting an environmental as-
(5) Under § 511.1(c)(4) and (d)(2) of this
sessment under section 572(c)(1)(E) of
chapter, with respect to termination of
the act; or
exemptions, the sponsor of an inves-
(4) Obtaining approval of a new ani-
tigation shall not be granted an oppor-
mal drug application or abbreviated
tunity for a regulatory hearing before
new animal drug application under sec-
FDA pursuant to part 16 of this chap-
tion 512(b) of the act.
ter. Instead, the sponsor shall have an
(b) Correspondence and information
associated with investigations de- opportunity for an informal conference
scribed in paragraph (a) of this section as described in § 516.123.
shall not be sent to the Director, (6) Under § 511.1(c)(5) of this chapter,
OMUMS, but shall be submitted to if the Commissioner of Food and Drugs
FDA in accordance with the provisions determines, after the unreliable data
of part 511 of this chapter. submitted by the investigator are
(c) The investigational use of a new eliminated from consideration, that
animal drug or animal feed bearing or the data remaining are such that a re-
containing a new animal drug intended quest for addition to the index would
solely for investigational use in minor have been denied, FDA will remove the
species, other than for an investiga- new animal drug from the index in ac-
tional use described in paragraph (a) of cordance with § 516.167.
this section, shall meet the require- (d) The investigational use of a new
ments of this section. For such inves- animal drug or animal feed bearing or
tigations, all provisions of part 511 of containing a new animal drug subject
this chapter apply with the following to paragraph (c) of this section shall
modifications: not be subject to the good laboratory
(1) Under § 511.1(a)(1) of this chapter, practice requirements in part 58 of this
the label statement is as follows: chapter.
‘‘Caution. Contains a new animal (e) Correspondence and information
drug for investigational use only in associated with investigations de-
laboratory animals or for tests in vitro scribed in paragraph (c) of this section
in support of index listing. Not for use shall be sent to the Director, OMUMS,
in humans.’’ in accordance with the provisions of
(2) Under § 511.1(b)(1) of this chapter, this section.
the label statement is as follows:
‘‘Caution. Contains a new animal § 516.129 Content and format of a re-
drug for use only in investigational quest for determination of eligi-
animals in clinical trials in support of bility for indexing.
index listing. Not for use in humans. (a) Each request for determination of
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Edible products of investigational ani- eligibility:

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Food and Drug Administration, HHS § 516.133

(1) May involve only one drug (or one early, non-food life stage of a food-pro-
combination of drugs) in one dosage ducing minor species, and information
form; to demonstrate food safety in accord-
(2) May not involve a new animal ance with the standards of section
drug that is contained in or a product 512(d) of the act and § 514.111 of this
of a transgenic animal; chapter (including, for an anti-
(3) May not involve the same drug in microbial new animal drug, with re-
the same dosage form for the same in- spect to antimicrobial resistance);
tended use as a drug that is already ap- (8) A description of the methods used
proved or conditionally approved; and in, and the facilities and controls used
(4) Must be submitted separately. for, the manufacture, processing and
(b) A request for determination of eli- packing of the new animal drug suffi-
gibility for indexing may involve mul- cient to demonstrate that the re-
tiple intended uses and/or multiple questor has established appropriate
minor species. However, if a request for specifications for the manufacture and
determination of eligibility for index- control of the new animal drug and
ing that contains multiple intended that the requestor has an under-
uses and/or multiple minor species can- standing of current good manufac-
not be granted in any part, the entire turing practices;
request will be denied. (9) Either a claim for categorical ex-
(c) A requestor must submit two cop- clusion under § 25.30 or § 25.33 of this
ies of a dated request signed by the au- chapter or an environmental assess-
thorized contact person for determina- ment under § 25.40 of this chapter;
tion of eligibility for indexing that
(10) Information sufficient to support
contains the following:
the conclusion that the new animal
(1) Identification of the minor species
drug is safe under section 512(d) of the
or groups of minor species for which
act with respect to individuals exposed
the new animal drug is intended;
to the new animal drug through its
(2) Information regarding drug com-
manufacture and use; and
ponents and composition;
(3) A statement of the intended use(s) (11) The name and address of the con-
of the new animal drug in the identi- tact person or permanent-resident U.S.
fied minor species or groups of minor agent.
species;
§ 516.131 Refuse to file a request for
(4) A statement of the proposed con- determination of eligibility for in-
ditions of use associated with the stat- dexing.
ed intended use(s) of the new animal
drug, including the proposed dosage, (a) If a request for determination of
route of administration, contraindica- eligibility for indexing contains all of
tions, warnings, and any other signifi- the information required by § 516.129,
cant limitations associated with the FDA shall file it, and the filing date
intended use(s) of the new animal drug; shall be the date FDA receives the re-
(5) A brief discussion of the need for quest.
the new animal drug for the intended (b) If a request for a determination of
use(s); eligibility lacks any of the information
(6) An estimate of the anticipated an- required by § 516.129, FDA will not file
nual distribution of the new animal it, but will inform the requestor in
drug, in terms of the total quantity of writing within 30 days of receiving the
active ingredient, after indexing; request as to what information is lack-
(7) Information to establish that the ing.
new animal drug is intended for use:
(i) In a minor species for which there § 516.133 Denying a request for deter-
is a reasonable certainty that the ani- mination of eligibility for indexing.
mal or edible products from the animal (a) FDA will deny a request for deter-
will not be consumed by humans or mination of eligibility for indexing if it
food-producing animals; or determines upon the basis of the re-
(ii) In a hatchery, tank, pond, or quest evaluated together with any
other similar contained man-made other information before it with re-
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structure in (which includes on) an spect to the new animal drug that:

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§ 516.135 21 CFR Ch. I (4–1–08 Edition)

(1) The same drug in the same dosage § 516.135 Granting a request for deter-
form for the same intended use is al- mination of eligibility for indexing.
ready approved or conditionally ap- (a) FDA will grant the request for de-
proved; termination of eligibility for indexing
(2) There is insufficient information if none of the reasons described in
to demonstrate that the new animal § 516.133 for denying such a request ap-
drug is intended for use: plies.
(i) In a minor species for which there (b) When a request for determination
is a reasonable certainty that the ani- of eligibility for indexing is granted,
mal or edible products from the animal FDA will notify the requestor in ac-
will not be consumed by humans or cordance with § 516.137.
food-producing animals, or
(ii) In a hatchery, tank, pond, or § 516.137 Notification of decision re-
other similar contained man-made garding eligibility for indexing.
structure in (which includes on) an (a) Within 90 days after the filing of
early, non-food life stage of a food-pro- a request for a determination of eligi-
ducing minor species, and there is in- bility for indexing based on
sufficient evidence to demonstrate § 516.129(c)(7)(i), or 180 days for a re-
safety for humans in accordance with quest based on § 516.129(c)(7)(ii), FDA
the standard of section 512(d) of the act shall grant or deny the request, and no-
and § 514.111 of this chapter (including, tify the requestor of FDA’s decision in
for an antimicrobial new animal drug, writing.
with respect to antimicrobial resist- (b) If FDA denies the request, FDA
ance); shall provide due notice and an oppor-
(3) The new animal drug is contained tunity for an informal conference as
in or is a product of a transgenic ani- described in § 516.123 regarding its deci-
mal; sion. A decision of FDA to deny a re-
(4) There is insufficient information quest for determination of eligibility
to demonstrate that the requestor has for indexing following an informal con-
established appropriate specifications ference shall constitute final agency
for the manufacture and control of the action subject to judicial review.
new animal drug and that the re-
questor has an understanding of cur- § 516.141 Qualified expert panels.
rent good manufacturing practices; (a) Establishment of a qualified expert
(5) The requester fails to submit an panel. Establishing a qualified expert
adequate environmental assessment panel is the first step in the process of
under § 25.40 of this chapter or fails to requesting the addition of a new ani-
provide sufficient information to estab- mal drug to the index. A qualified ex-
lish that the requested action is sub- pert panel may not be established until
ject to categorical exclusion under FDA has determined that the new ani-
§ 25.30 or § 25.33 of this chapter; mal drug is eligible for indexing. The
(6) There is insufficient information requestor must choose members for the
to determine that the new animal drug qualified expert panel in accordance
is safe with respect to individuals ex- with selection criteria listed in para-
posed to the new animal drug through graph (b) of this section and submit in-
its manufacture or use; or formation about these proposed mem-
(7) The request for determination of bers to FDA. FDA must determine
eligibility for indexing fails to contain whether the proposed qualified expert
any other information required under panel meets the selection criteria prior
the provisions of § 516.129. to the panel beginning its work. Quali-
(b) FDA may deny a request for de- fied expert panels operate external to
termination of eligibility for indexing FDA and are not subject to the Federal
if it contains any untrue statement of Advisory Committee Act, as amended,
a material fact or omits material infor- 5 U.S.C. App.
mation. (b) Criteria for the selection of a quali-
(c) When a request for determination fied expert panel. (1) A qualified expert
of eligibility for indexing is denied, panel member must be an expert quali-
FDA will notify the requestor in ac- fied by training and experience to
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cordance with § 516.137. evaluate a significant aspect of target

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Food and Drug Administration, HHS § 516.141

animal safety or effectiveness of the onstrating that he or she is qualified


new animal drug under consideration. by training and experience to evaluate
(2) A qualified expert panel member the target animal safety and effective-
must certify that he or she has a work- ness of the new animal drug under con-
ing knowledge of section 572 of the act sideration. This information can be ob-
(the indexing provisions of the statute) tained from a comprehensive cur-
and this subpart, and that he or she has riculum vitae or similar document.
also read and understood a clear writ- (v) Notify each potential expert panel
ten statement provided by the re- member that he or she must submit in-
questor stating his or her duties and formation relating to potential conflict
responsibilities with respect to review- of interest directly to FDA in a timely
ing the new animal drug proposed for manner, as required in paragraph (e)(6)
addition to the index. of this section.
(3) A qualified expert panel member (2) The requestor must submit, in
may not be an FDA employee. writing, the names and addresses of the
(4) A qualified expert panel must proposed qualified expert panel mem-
have at least three members. bers and sufficient information about
(5) A qualified expert panel must each proposed member for FDA to de-
have members with a range of expertise termine whether the panel meets the
such that the panel, as a whole, is selection criteria listed in paragraphs
qualified by training and experience to (b)(1) through (b)(5) of this section.
evaluate the target animal safety and
(3) After FDA has determined that
effectiveness of the new animal drug
the qualified expert panel meets the se-
under consideration.
lection criteria, the requestor must
(6) Unless FDA makes a determina-
provide to the panel all information
tion to allow participation notwith-
known by the requestor that is rel-
standing an otherwise disqualifying fi-
evant to a determination of the target
nancial interest, a qualified expert
animal safety and the effectiveness of
panel member must not have a conflict
the new animal drug at issue. In addi-
of interest or the appearance of a con-
tion, the requestor must notify FDA of
flict of interest, as described in para-
graph (g) of this section. the name of the qualified expert panel
(c) Requestor responsibilities. (1) The leader.
requestor must: (4) The requestor must immediately
(i) Choose members for the qualified notify FDA if it believes a qualified ex-
expert panel in accordance with selec- pert panel member no longer meets the
tion criteria listed in paragraph (b) of selection criteria listed in paragraph
this section. (b) of this section or is otherwise not in
(ii) Provide each potential expert compliance with the requirements of
panel member a copy of section 572 of this section.
the act (the indexing provisions of the (5) If a qualified expert panel member
statute) and this subpart and obtain cannot complete the review for which
certification that he or she has a work- he or she was selected, the requestor
ing knowledge of the information. must either choose a replacement or
(iii) Provide each potential expert justify the continued work of the panel
panel member a written statement de- in the absence of the lost panelist. In
scribing the purpose and scope of his or either case, the requestor must submit
her participation on the qualified ex- sufficient information for FDA to de-
pert panel and obtain certification that termine whether the proposed revised
he or she has read and understood the qualified expert panel meets the selec-
information. The written statement tion criteria listed in paragraphs (b)(1)
should describe the duties and respon- through (b)(5) of this section.
sibilities of qualified expert panels and (6) The requestor must keep copies of
their members established by para- all information provided to, or received
graphs (e) and (f) of this section, in- from, qualified expert panel members,
cluding the need to prepare a written including the written report, for 2
report under § 516.143. years after the completion of the re-
(iv) Obtain information from each po- port, or the product is added to the
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tential expert panel member dem- index, whichever occurs later, and

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§ 516.141 21 CFR Ch. I (4–1–08 Edition)

make them available to a duly author- the qualified expert panel, described in
ized employee of the agency at all rea- § 516.143.
sonable times. (5) Sign, or otherwise approve in
(d) FDA responsibilities. (1) FDA will writing, the written report. Such sig-
determine whether the requestor’s pro- nature or other written approval will
posed qualified expert panel meets the serve as certification that the written
selection criteria listed in paragraph report meets the requirements of the
(b) of this section. FDA will expedi- written report in § 516.143.
tiously inform the requestor, in writ- (6) Provide the information relating
ing, of its determination. If FDA deter- to potential conflict of interest de-
mines that the qualified expert panel scribed in paragraph (g) of this section
does not meet the selection criteria, to FDA for its consideration. Such in-
FDA will provide due notice and an op- formation should be submitted directly
portunity for an informal conference as to the Director, OMUMS, when notified
described in § 516.123. A determination by the requestor.
by FDA that a proposed qualified ex- (7) Immediately notify the requestor
pert panel does not meet the selection and FDA of any change in conflict of
criteria following an informal con- interest status.
ference shall constitute final agency
(8) Certify at the time of submission
action subject to judicial review.
of the written report that there has
(2) If FDA determines that a qualified
been no change in conflict of interest
expert panel no longer meets the selec-
status, or identify and document to
tion criteria listed in paragraph (b) of
FDA any such change.
this section or that the panel or its
members are not in compliance with (f) Additional responsibilities of a quali-
the requirements of this section, the fied expert panel leader. (1) The qualified
agency will expeditiously inform the expert panel leader must ensure that
requestor, in writing, of this deter- the activities of the panel are per-
mination and provide due notice and an formed efficiently and in accordance
opportunity for an informal conference with generally accepted professional
as described in § 516.123. A determina- and ethical business practices.
tion by FDA, following an informal (2) The qualified expert panel leader
conference, that a qualified expert serves as the principal point of contact
panel no longer meets the selection cri- between representatives of the agency
teria listed in paragraph (b) of this sec- and the panel.
tion or that the panel or its members (3) The qualified expert panel leader
are not in compliance with the require- is responsible for submitting the writ-
ments of this section shall constitute ten report and all notes or minutes re-
final agency action subject to judicial lating to panel deliberations to the re-
review. questor.
(e) Responsibilities of a qualified expert (4) The qualified expert panel leader
panel member. A qualified expert panel must maintain a copy of the written
member must do the following: report and all notes or minutes relat-
(1) Continue to meet all selection cri- ing to panel deliberations that are sub-
teria described in paragraph (b) of this mitted to the requestor for 2 years
section. after the report is submitted. Such
(2) Act in accordance with generally records must be made available to a
accepted professional and ethical busi- duly authorized employee of the agen-
ness practices. cy for inspection at all reasonable
(3) Review all information relevant times.
to a determination of the target ani- (g) Prevention of conflicts of interest.
mal safety and effectiveness of the new (1) For the purposes of this subpart,
animal drug provided by the requestor. FDA will consider a conflict of interest
The panel should also consider all rel- to be any financial or other interest
evant information otherwise known by that could impair a person’s objec-
the panel members, including anec- tivity in serving on the qualified expert
dotal information. panel or could create an unfair com-
(4) Participate in the preparation of petitive advantage for a person or orga-
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the written report of the findings of nization.

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Food and Drug Administration, HHS § 516.141

(2) Factors relevant to whether there evant to the subject of the review of
is a conflict of interest or the appear- the qualified expert panel:
ance of a conflict of interest include (i) Investments (for example, stocks,
whether the qualified expert panel bonds, retirement plans, trusts, part-
member, their spouse, their minor chil- nerships, sector funds, etc.), including
dren, their general partners, or any or- for each the following: Name of the
ganizations in which they serve as an firm, type of investment, owner (self,
officer, director, trustee, general part- spouse, etc.), number of shares / cur-
ner or employee: rent value.
(i) Is currently receiving or seeking (ii) Employment (full or part time,
funding from the requestor through a current or under negotiation), includ-
contract or research grant (either di- ing for each the following: Name of the
rectly or indirectly through another firm, relationship (self, spouse, etc.),
entity, such as a university). position in firm, date employment or
(ii) Has any employment, contrac- negotiation began.
tual, or other financial arrangement (iii) Consultant/advisor (current or
with the requestor other than receiving under negotiation), including for each
a reasonable fee for serving as a mem- the following: Name of the firm, topic/
ber of the qualified expert panel. issue, amount received, date initiated.
(iii) Has any ownership or financial (iv) Contracts, grants, Cooperation
interest in any drug, drug manufac- Research and Development Agreement
turer, or drug distributor which will (CRADAs) (current or under negotia-
benefit from either a favorable or unfa- tion), including for each the following:
vorable evaluation or opinion. Type of agreement, product under
(iv) Has any ownership or financial study and indications, amount of remu-
interest in the new animal drug being neration (institution/self), time period,
reviewed by the qualified expert panel. sponsor (government, firm, institution,
(v) Has participated in the design, individual), role of the person (site in-
manufacture, or distribution of any vestigator, principal investigator, co-
drug that will benefit from either a fa- investigator, partner, no involvement,
vorable or unfavorable opinion of the other), awardee.
qualified expert panel. (v) Patents/royalties/trademarks, in-
(vi) Has provided within 1 year any cluding for each the following: Descrip-
consultative services regarding the new tion, name of firm involved, income re-
animal drug being reviewed by the ceived.
qualified expert panel. (vi) Expert witness (last 12 months or
(vii) Has entered into an agreement under negotiation), including for each
in which fees charged or accepted are the following: For or against, name of
contingent upon the panel member firm, issue, amount received.
making a favorable evaluation or opin- (vii) Speaking/writing (last 12 months
ion. or under negotiation), including for
(viii) Receives payment for services each the following: Firm, topic/issue,
related to preparing information the amount received (honorarium/travel),
requestor presents to the qualified ex- date.
pert panel, other than for services re- (viii) Whether the potential qualified
lated to the written report described in expert panel member, their spouse,
§ 516.143. their minor children, their general
(3) To permit FDA to make a decision partners or any organizations in which
regarding potential conflict of interest, they serve as an officer, director, trust-
a potential qualified expert panel mem- ee, general partner or employee, have
ber must submit to the Director, had, at any time in the past, involve-
OMUMS, the following information re- ment of the kind noted in paragraph
lating to themselves, their spouse, (g)(3)(i) through (g)(3)(vii) of this sec-
their minor children, their general tion with respect to the animal drug
partners, or any organizations in which that is the subject of the qualified ex-
they serve as an officer, director, trust- pert panel review.
ee, general partner or employee, re- (ix) Whether there are any other in-
garding the following issues to the ex- volvements (other kinds of relation-
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§ 516.143 21 CFR Ch. I (4–1–08 Edition)

of a conflict of interest which have not the target animal, taking into account
been described in paragraph (g)(3)(i) the harm being caused by the absence
through (g)(3)(viii) of this section. of an approved or conditionally-ap-
(x) In all cases, a response of ‘‘no,’’ proved new animal drug for the minor
‘‘none,’’ or ‘‘not applicable’’ is satisfac- species in question, the written report
tory when there is no relevant informa- shall:
tion to submit. (1) Provide draft labeling that in-
(xi) A certification statement signed cludes all conditions of use and limita-
by the potential qualified expert panel tions of use of the new animal drug
member to the effect that all informa- deemed necessary by the panel to as-
tion submitted is true and complete to sure that the benefits of use of the new
the best of their knowledge, that they animal drug outweigh the risks, or pro-
have read and understood their obliga- vide narrative information from which
tions as an expert panel member, and such labeling can be written by the re-
that they will notify FDA and the re- questor; and
questor of any change in their conflict
(2) Include a recommendation regard-
of interest status.
ing whether the new animal drug
(4) The fact that a qualified expert
should be limited to use under the pro-
panel member receives a reasonable fee
for services as a member of the quali- fessional supervision of a licensed vet-
fied expert panel, provided that the fee erinarian.
is no more than commensurate with
§ 516.145 Content and format of a re-
the value of the time that the member quest for addition to the index.
devotes to the review process, does not
constitute a conflict of interest or the (a) A requestor may request addition
appearance of a conflict of interest. of a new animal drug to the index only
after the new animal drug has been
§ 516.143 Written report. granted eligibility for indexing.
The written report required in (b) A requestor shall submit two cop-
§ 516.145(b)(3) shall: ies of a dated request signed by the au-
(a) Be written in English by a quali- thorized contact for addition of a new
fied expert panel meeting the require- animal drug to the index that contains
ments of § 516.141; the following:
(b) Describe the panel’s evaluation of (1) A copy of FDA’s determination of
all available target animal safety and eligibility issued under § 516.137;
effectiveness information relevant to (2) A copy of FDA’s written deter-
the proposed use of the new animal mination that the proposed qualified
drug, including anecdotal information; expert panel meets the selection cri-
(c) For all information considered, teria provided for in § 516.141(b);
including anecdotal information, in- (3) A written report that meets the
clude either a citation to published lit- requirements of § 516.143;
erature or a summary of the informa- (4) A proposed index entry that con-
tion;
tains the information described in
(d) State the panel’s opinion regard-
§ 516.157;
ing whether the benefits of using the
new animal drug for the proposed use (5) Proposed labeling, including rep-
in a minor species outweigh its risks to resentative labeling proposed to be
the target animal, taking into account used for Type B and Type C medicated
the harm being caused by the absence feeds if the drug is intended for use in
of an approved or conditionally-ap- the manufacture of medicated feeds;
proved new animal drug for the minor (6) Anticipated annual distribution of
species in question; the new animal drug, in terms of the
(e) Be signed, or otherwise approved total quantity of active ingredient,
in writing, by all panel members, in ac- after indexing;
cordance with § 516.141; and (7) A written commitment to manu-
(f) If the panel unanimously con- facture the new animal drug and ani-
cludes that the benefits of using the mal feeds bearing or containing such
new animal drug for the proposed use new animal drug according to current
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in a minor species outweigh its risks to good manufacturing practices;

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Food and Drug Administration, HHS § 516.153

(8) A written commitment to label, ready approved or conditionally ap-


distribute, and promote the new ani- proved;
mal drug only in accordance with the (2) On the basis of new information,
index entry; the new animal drug no longer meets
(9) The name and address of the con- the conditions for eligibility for index-
tact person or permanent-resident U.S. ing;
agent; and (3) The request for indexing fails to
(10) A draft Freedom of Information contain information required under the
summary which includes the following provisions of § 516.145;
information: (4) The qualified expert panel fails to
(i) A general information section meet any of the selection criteria list-
that contains the name and address of ed in § 516.141(b);
the requestor and a description of the (5) The written report of the qualified
drug, route of administration, indica- expert panel and other information
tions, and recommended dosage. available to FDA is insufficient to per-
(ii) A list of the names and affili- mit FDA to determine that the bene-
ations of the members of the qualified fits of using the new animal drug for
expert panel, not including their ad- the proposed use in a minor species
dresses or other contact information. outweigh its risks to the target ani-
(iii) A summary of the findings of the mal, taking into account the harm
qualified expert panel concerning the caused by the absence of an approved
target animal safety and effectiveness or conditionally-approved new animal
of the drug. drug for the minor species in question;
(iv) Citations of all publicly-available (6) On the basis of the report of the
literature considered by the qualified qualified expert panel and other infor-
expert panel. mation available to FDA, the benefits
(v) For an early life stage of a food- of using the new animal drug for the
producing minor species animal, a proposed use in a minor species do not
human food safety summary. outweigh its risks to the target ani-
(c) Upon specific request by FDA, the mal, taking into account the harm
requestor shall submit the information caused by the absence of an approved
described in § 516.141 that it submitted or conditionally-approved new animal
to the qualified expert panel. Any such drug for the minor species in question;
information not in English should be or
accompanied by an English trans-
(7) The request contains any untrue
lation.
statement of a material fact or omits
§ 516.147 Refuse to file a request for material information.
addition to the index. (b) When a request for addition to the
(a) If a request for addition to the index is denied, FDA will notify the re-
index contains all of the information questor in accordance with § 516.153.
required by § 516.145(b), FDA shall file
§ 516.151 Granting a request for addi-
it, and the filing date shall be the date tion to the index.
FDA receives the request.
(b) If a request for addition to the (a) FDA will grant the request for ad-
index lacks any of the information re- dition of a new animal drug to the
quired by § 516.145, FDA will not file it, index if none of the reasons described
but will inform the requestor in writ- in § 516.149 for denying such a request
ing within 30 days of receiving the re- applies.
quest as to what information is lack- (b) When a request for addition of a
ing. new animal drug to the index is grant-
ed, FDA will notify the requestor in ac-
§ 516.149 Denying a request for addi- cordance with § 516.153.
tion to the index.
(a) FDA will deny a request for addi- § 516.153 Notification of decision re-
tion to the index if it finds the fol- garding index listing.
lowing: (a) Within 180 days after the filing of
(1) The same drug in the same dosage a request for addition of a new animal
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form for the same intended use is al- drug to the index, FDA shall grant or

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§ 516.155 21 CFR Ch. I (4–1–08 Edition)

deny the request and notify the re- § 516.161 Modifications to indexed
questor of FDA’s decision in writing. drugs.
(b) If FDA denies the request for ad- (a) After a drug is listed in the index,
dition of a new animal drug to the certain modifications to the index list-
index, FDA shall provide due notice ing may be requested. Any modifica-
and an opportunity for an informal tion of an index listing may not cause
conference as described in § 516.123. A an indexed drug to be a different drug
decision of FDA to deny a request to (or different combination of drugs) or a
index a new animal drug following an different dosage form. If such modifica-
informal conference shall constitute tion is requested, FDA will notify the
final agency action subject to judicial holder that a new index listing is re-
review. quired for the new drug or dosage form.
(b) Modifications to the indexed drug
§ 516.155 Labeling of indexed drugs. will fall under one of three categories
and must be submitted as follows:
(a) The labeling of an indexed drug (1) Urgent changes. (i) The following
that is found to be eligible for indexing modifications to an indexed drug or its
under § 516.129(c)(7)(i) shall state, labeling should be made as soon as pos-
prominently and conspicuously: ‘‘NOT sible, and a request to modify the in-
APPROVED BY FDA.—Legally marketed dexed drug should be concurrently sub-
as an FDA indexed product. Extra-label mitted:
use is prohibited.’’ ‘‘This product is not to (A) The addition to package labeling,
be used in animals intended for use as promotional labeling, or prescription
food for humans or other animals.’’ drug advertising of additional warning,
(b) The labeling of an indexed drug contraindication, side effect, or cau-
that was found to be eligible for index- tionary information.
ing for use in an early, non-food life (B) The deletion from package label-
stage of a food-producing minor species ing, promotional labeling, and drug ad-
animal, under § 516.129(c)(7)(ii), shall vertising of false, misleading, or unsup-
state, prominently and conspicuously: ported indications for use or claims for
effectiveness.
‘‘NOT APPROVED BY FDA.—Legally
(C) Changes in manufacturing meth-
marketed as an FDA indexed product.
ods or controls required to correct
Extra-label use is prohibited.’’ product or manufacturing defects that
(c) The labeling of an indexed drug may result in serious adverse drug
shall contain such other information as events.
may be prescribed in the index listing. (ii) The modifications described in
paragraph (b)(1)(i) of this section must
§ 516.157 Publication of the index and be submitted to the Director, OMUMS,
content of an index listing. in the form of a request for modifica-
(a) FDA will make the list of indexed tion of an indexed drug, and must con-
drugs available through the FDA Web tain sufficient information to permit
site. A printed copy can be obtained by FDA to determine the need for the
writing to the FDA Freedom of Infor- modification and whether the modi-
mation Staff or by visiting the FDA fication appropriately addresses the
Freedom of Information Public Read- need.
ing Room. (iii) FDA will take no action against
(b) The list will contain the following an indexed drug or index holder solely
information for each indexed drug: because modifications of the kinds de-
scribed in paragraph (b)(1)(i) of this
(1) The name and address of the per-
section are placed into effect by the
son who holds the index listing;
holder prior to receipt of a written no-
(2) The name of the drug and the in- tice granting the request if all the fol-
tended use and conditions of use for lowing conditions are met:
which it is indexed; (A) A request to modify the indexed
(3) Product labeling; and drug providing a full explanation of the
(4) Conditions and any limitations basis for the modifications has been
that FDA deems necessary regarding submitted, plainly marked on the mail-
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use of the drug. ing cover and on the request as follows:

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Food and Drug Administration, HHS § 516.163

‘‘Special indexing request— modifica- (c) When changes affect the index
tions being effected;’’ listing, it will be updated accordingly.
(B) The holder specifically informs
FDA of the date on which such modi- § 516.163 Change in ownership of an
fications are to be effected and submits index file.
two printed copies of any revised label- (a) A holder may transfer ownership
ing to be placed in use, and of a drug’s index file to another person.
(C) All promotional labeling and all (1) The former owner shall submit in
drug advertising are promptly revised writing to FDA a statement that all
consistent with modifications made in
rights in the index file have been trans-
the labeling on or within the indexed
ferred, giving the name and address of
drug package.
(2) Significant changes. (i) The fol- the new owner and the date of the
lowing modifications to an indexed transfer. The former owner shall also
drug or its labeling may be made only certify that a complete copy of the fol-
after a request has been submitted to lowing, to the extent that they exist at
and subsequently granted by FDA: the time of the transfer of ownership,
(A) Addition of an intended use. has been provided to the new owner:
(B) Addition of a species. (i) The request for determination of
(C) Addition or alteration of an ac- eligibility;
tive ingredient. (ii) The request for addition to the
(D) Alteration of the concentration index;
of an active ingredient. (iii) Any modifications to the index
(E) Alteration of dose or dosage regi- listing;
men. (iv) Any records and reports under
(F) Alteration of prescription or § 516.165; and
over-the-counter status. (v) All correspondence with FDA rel-
(ii) Each modification described in
evant to the indexed drug and its index
paragraph (b)(2)(i) of this section must
listing.
go through the same review process as
an original index listing and is subject (2) The new owner shall submit the
to the same standards for review. following information in writing to
(iii) Each submission of a request for FDA:
a modification described in paragraph (i) The date that the change in own-
(b)(2)(i) of this section should contain ership is effective;
only one type of modification unless (ii) A statement that the new owner
one modification is actually neces- has a complete copy of all documents
sitated by another, such as a modifica- listed in paragraph (a)(1) of this section
tion of dose necessitated by a modifica- to the extent that they exist at the
tion of the concentration of an active time of the transfer of ownership;
ingredient. Submissions relating to ad- (iii) A statement that the new owner
dition of an intended use for an exist- understands and accepts the respon-
ing species or addition of a species sibilities of a holder of an indexed drug;
should be submitted separately, but (iv) The name and address of a new
each such submission may include mul- primary contact person or permanent-
tiple additional intended uses and/or resident U.S. agent; and
multiple additional species.
(v) A list of labeling changes associ-
(3) Minor changes. All modifications
other than those described in para- ated with the change of ownership
graphs (b)(1) and (b)(2) of this section (e.g., a new trade name) as draft label-
including, but not limited to, formula- ing, with complete final printed label-
tion, labeling, and manufacturing ing to be submitted in the indexed drug
methods and controls (at the same annual report in accordance with
level of detail that these were de- §§ 516.161 and 516.165.
scribed in the request for determina- (b) Upon receiving the necessary in-
tion of eligibility for indexing) must be formation to support a change of own-
submitted as part of the annual in- ership of a drug’s index file, FDA will
dexed drug experience report or as oth- update its publicly-available listing in
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§ 516.165 21 CFR Ch. I (4–1–08 Edition)

§ 516.165 Records and reports. (3) Annual indexed drug experience re-
(a) Scope and purpose. (1) The record- port. The holder must submit this re-
keeping and reporting requirements of port every year on the anniversary
this section apply to all holders of in- date of the letter granting the request
dexed drugs, including indexed drugs for addition of the new animal drug to
intended for use in medicated feeds. the index, or within 60 days thereafter.
(2) A holder is not required to report The report must contain data and in-
information under this section if the formation for the full reporting period.
holder has reported the same informa- Any previously submitted information
tion under § 514.80 of this chapter. contained in the report must be identi-
(3) The records and reports referred fied as such. The holder may ask FDA
to in this section are in addition to to change the date of submission and,
those required by the current good after approval of such request, file such
manufacturing practice regulations in reports by the new filing date. The re-
parts 211, 225, and 226 of this chapter. port must contain the following:
(4) FDA will review the records and (i) The number of distributed units of
reports required in this section to de- each size, strength, or potency (e.g.,
termine, or facilitate a determination, 100,000 bottles of 100 5-milligram tab-
whether there may be grounds for re- lets; 50,000 10-milliliter vials of 5- per-
moving a drug from the index under cent solution) distributed during the
section 572(f) of the act. reporting period. This information
(b) Recordkeeping requirements. (1) must be presented in two categories:
Each holder of an indexed drug must Quantities distributed domestically
establish and maintain complete files and quantities exported. This informa-
containing full records of all informa- tion must include any distributor-la-
tion pertinent to the safety or effec- beled product.
tiveness of the indexed drug. Such (ii) If the labeling has changed since
records must include information from the last report, include a summary of
foreign and domestic sources. those changes and the holder’s and dis-
(2) The holder must, upon request tributor’s current package labeling, in-
from any authorized FDA officer or cluding any package inserts. For large-
employee, at all reasonable times, per- size package labeling or large shipping
mit such officer or employee to have cartons, submit a representative copy
access to copy and to verify all such (e.g., a photocopy of pertinent areas of
records. large feed bags). If the labeling has not
(c) Reporting requirements. (1) Three- changed since the last report, include a
day indexed drug field alert report. The statement of such fact.
holder must inform the appropriate (iii) A summary of any changes made
FDA District Office or local FDA resi- during the reporting period in the
dent post of any product or manufac- methods used in, and facilities and con-
turing defects that may result in seri- trols used for, manufacture, processing,
ous adverse drug events within 3 work- and packing. This information must be
ing days of first becoming aware that presented in the same level of detail
such a defect may exist. The holder that it was presented in the request for
may initially provide this information determination of eligibility for index-
by telephone or other electronic com- ing. Do not include changes that have
munication means, with prompt writ- already been submitted under § 516.161.
ten followup. The mailing cover must (iv) Nonclinical laboratory studies
be plainly marked ‘‘3–Day Indexed and clinical data not previously re-
Drug Field Alert Report.’’ ported under this section.
(2) Fifteen-day indexed drug alert re- (v) Adverse drug experiences not pre-
port. The holder must submit a report viously reported under this section.
on each serious, unexpected adverse (vi) Any other information pertinent
drug event, regardless of the source of to safety or effectiveness of the in-
the information. The holder must sub- dexed drug not previously reported
mit the report within 15 working days under this section.
of first receiving the information. The (4) Distributor’s statement. At the time
mailing cover must be plainly marked of initial distribution of an indexed
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‘‘15–Day Indexed Drug Alert Report.’’ drug by a distributor, the holder must

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Food and Drug Administration, HHS § 516.171

submit a report containing the fol- (4) Any of the conditions in


lowing: § 516.133(a)(2), (5), or (6) are present;
(i) The distributor’s current product (5) The manufacture of the new ani-
labeling. This must be identical to that mal drug is not in accordance with cur-
in the index listing except for a dif- rent good manufacturing practices;
ferent and suitable proprietary name (6) The labeling, distribution, or pro-
(if used) and the name and address of motion of the new animal drug is not
the distributor. The name and address in accordance with the index listing;
of the distributor must be preceded by (7) The conditions and limitations of
an appropriate qualifying phrase such
use associated with the index listing
as ‘‘manufactured for’’ or ‘‘distributed
have not been followed; or
by.’’
(ii) A signed statement by the dis- (8) Any information used to support
tributor stating: the request for addition to the index
(A) The category of the distributor’s contains any untrue statement of ma-
operations (e.g., wholesale or retail); terial fact.
(B) That the distributor will dis- (b) The agency may partially remove
tribute the drug only under the indexed an indexing listing if, in the opinion of
drug labeling; the agency, such partial removal would
(C) That the distributor will promote satisfactorily resolve a safety or effec-
the indexed drug only for use under the tiveness issue otherwise warranting re-
conditions stated in the index listing; moval of the listing under section
and 572(f)(1)(B) of the act.
(D) If the indexed drug is a prescrip- (c) FDA may immediately suspend a
tion new animal drug, that the dis- new animal drug from the index if FDA
tributor is regularly and lawfully en- determines that there is a reasonable
gaged in the distribution or dispensing probability that the use of the drug
of prescription products. would present a risk to the health of
(5) Other reporting. FDA may by order humans or other animals. The agency
require that a holder submit informa- will subsequently provide due notice
tion in addition to that required by and an opportunity for an informal
this section or that the holder submit conference as described in § 516.123.
the same information but at different (d) A decision of FDA to remove a
times or reporting periods. new animal drug from the index fol-
§ 516.167 Removal from the index. lowing an informal conference, if any,
shall constitute final agency action
(a) After due notice to the holder of subject to judicial review.
the index listing and an opportunity
for an informal conference as described § 516.171 Confidentiality of data and
in § 516.123, FDA shall remove a new information in an index file.
animal drug from the index if FDA
(a) For purposes of this section, the
finds that:
(1) The same drug in the same dosage index file includes all data and infor-
form for the same intended use has mation submitted to or incorporated
been approved or conditionally ap- by reference into the index file, such as
proved; data and information related to inves-
(2) The expert panel failed to meet tigational use exemptions under
the requirements in § 516.141; § 516.125, requests for determination of
(3) On the basis of new information eligibility for indexing, requests for ad-
before FDA, evaluated together with dition to the index, modifications to
the evidence available to FDA when indexed drugs, changes in ownership,
the new animal drug was listed in the reports submitted under § 516.165, and
index, the benefits of using the new master files. The availability for public
animal drug for the indexed use do not disclosure of any record in the index
outweigh its risks to the target ani- file shall be handled in accordance with
mal, taking into account the harm the provisions of this section.
caused by the absence of an approved (b) The existence of an index file will
or conditionally-approved new animal not be disclosed by FDA before an
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§ 516.171 21 CFR Ch. I (4–1–08 Edition)

FDA, unless it has previously been pub- (i) Names and any information that
licly disclosed or acknowledged by the would identify the person using the
requestor. product.
(c) If the existence of an index file (ii) Names and any information that
has not been publicly disclosed or ac- would identify any third party involved
knowledged, no data or information in with the report, such as a veterinarian.
the index file are available for public (5) A list of all active ingredients and
disclosure. any inactive ingredients previously
(d) If the existence of an index file disclosed to the public as defined in
has been publicly disclosed or acknowl- § 20.81 of this chapter.
edged before an index listing has been (6) An assay method or other analyt-
made public by FDA, no data or infor- ical method, unless it serves no regu-
mation contained in the file will be latory or compliance purpose and is
available for public disclosure before shown to fall within the exemption es-
such index listing is made public, but tablished in § 20.61 of this chapter.
the agency may, at its discretion, dis- (7) All correspondence and written
close a brief summary of such selected summaries of oral discussions relating
portions of the safety and effectiveness to the index file, in accordance with
data as are appropriate for public con- the provisions of part 20 of this chap-
sideration of a specific pending issue, ter.
e.g., at an open session of a Food and (f) The following data and informa-
Drug Administration advisory com- tion in an index file are not available
mittee or pursuant to an exchange of for public disclosure unless they have
important regulatory information with been previously disclosed to the public
a foreign government. as defined in § 20.81 of this chapter, or
(e) After FDA sends a written notice they relate to a product or ingredient
to the requestor granting a request for that has been abandoned and they no
addition to the index, the following longer represent a trade secret or con-
data and information in the index file fidential commercial or financial infor-
are available for public disclosure un- mation as defined in § 20.61 of this chap-
less extraordinary circumstances are ter:
shown: (1) Manufacturing methods or proc-
(1) All safety and effectiveness data esses, including quality control proce-
and information previously disclosed to dures.
the public, as defined in § 20.81 of this (2) Production, sales, distribution,
chapter. and similar data and information, ex-
(2) A summary or summaries of the cept that any compilation of such data
safety and effectiveness data and infor- and information aggregated and pre-
mation submitted with or incorporated pared in a way that does not reveal
by reference in the index file. Such data or information which is not avail-
summaries do not constitute the full able for public disclosure under this
information described under section provision is available for public disclo-
572(c) and (d) of the act on which the sure.
safety or effectiveness of the drug may (3) Quantitative or semiquantitative
be determined. Such summaries will be formulas.
based on the draft Freedom of Informa- (g) Subject to the disclosure provi-
tion summary submitted under sions of this section, the agency shall
§ 516.145, which will be reviewed and, regard the contents of an index file as
where appropriate, revised by FDA. confidential information unless specifi-
(3) A protocol for a test or study, un- cally notified in writing by the holder
less it is shown to fall within the ex- of the right to disclose, to reference, or
emption established for trade secrets otherwise utilize such information on
and confidential commercial informa- behalf of another named person.
tion in § 20.61 of this chapter. (h) For purposes of this regulation,
(4) Adverse reaction reports, product safety and effectiveness data include
experience reports, consumer com- all studies and tests of an animal drug
plaints, and other similar data and in- on animals and all studies and tests on
formation, after deletion of the fol- the animal drug for identity, stability,
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Food and Drug Administration, HHS Pt. 520

(i) Safety and effectiveness data and initiating a further course of therapy.
information that have not been pre- A dose-related decrease in
viously disclosed to the public are hematopoietic/lymphopoietic tissue
available for public disclosure at the may occur. The time required for
time any of the following events occurs hematopoietic/lymphopoietic tissues to
unless extraordinary circumstances are regenerate was not evaluated. The ef-
shown: fects of florfenicol on reproductive per-
(1) No work is being or will be under- formance have not been determined.
taken to have the drug indexed in ac- Feeds containing florfenicol must be
cordance with the request. withdrawn 12 days prior to slaughter.
(2) A final determination is made Federal law limits this drug to use
that the drug cannot be indexed and all under the professional supervision of a
legal appeals have been exhausted. licensed veterinarian. The expiration
(3) The drug has been removed from date of veterinary feed directives
the index and all legal appeals have (VFDs) for florfenicol must not exceed
been exhausted. 15 days from the date of prescribing.
(4) A final determination has been VFDs for florfenicol shall not be re-
made that the animal drug is not a new filled. See § 558.6 of this chapter for ad-
animal drug. ditional requirements.
(2) [Reserved]
Subpart D [Reserved]
PART 520—ORAL DOSAGE FORM
Subpart E—Conditionally Appr. NEW ANIMAL DRUGS
New Animal Drugs For Minor
Use and Minor Species Sec.
520.23 Acepromazine maleate tablets.
SOURCE: 72 FR 57200, Oct. 9, 2007, unless 520.44 Acetazolamide sodium soluble pow-
otherwise noted. der.
520.45 Albendazole oral dosage forms.
§ 516.1215 Florfenicol. 520.45a Albendazole suspension.
520.45b Albendazole paste.
(a) Specifications. Type A medicated
520.48 Altrenogest.
article containing 500 grams (g)
520.62 Aminopentamide hydrogen sulphate
florfenicol per kilogram.
tablets.
(b) Sponsor. See No. 000061 in 520.82 Aminopropazine fumarate oral dosage
§ 510.600(c) of this chapter. forms.
(c) Special considerations. Labeling 520.82a Aminopropazine fumarate tablets.
shall bear the following: ‘‘Condi- 520.82b Aminopropazine fumarate, neomy-
tionally approved by FDA pending a cin sulfate tablets.
full demonstration of effectiveness 520.88 Amoxicillin oral dosage forms.
under application number 141–259. 520.88a Amoxicillin trihydrate film-coated
Extra-label use of this drug in or on tablets.
animal feed is strictly prohibited.’’ 520.88b Amoxicillin trihydrate for oral sus-
(d) Related tolerances. See § 556.283 of pension.
this chapter. 520.88c Amoxicillin trihydrate oral suspen-
(e) Conditions of use—(1) Catfish—(i) sion.
Amount. Feed 182 to 1816 g florfenicol 520.88d Amoxicillin trihydrate soluble pow-
per ton of feed as a sole ration for 10 der.
520.88e Amoxicillin trihydrate boluses.
consecutive days to deliver 10 milli-
520.88f Amoxicillin trihydrate tablets.
grams florfenicol per kilogram of fish.
520.88g Amoxicillin trihydrate and
(ii) Indications for use. For the control clavulanate potassium film-coated tab-
of mortality due to columnaris disease lets.
associated with Flavobacterium 520.88h Amoxicillin trihydrate and
columnare. clavulanate potassium for oral suspen-
(iii) Limitations. Feed containing sion.
florfenicol shall not be fed to catfish 520.90 Ampicillin oral dosage forms.
for more than 10 days. Following ad- 520.90a Ampicillin capsules.
ministration, fish should be reevalu- 520.90b Ampicillin trihydrate tablets.
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