[Federal Register Volume 64, Number 223 (Friday, November 19, 1999)]
[Rules and Regulations]
[Pages 63195-63206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29856]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 207, 225, 510, 514, 515, and 558
[Docket No. 97N-0276]
RIN 0910-AB18
Animal Drug Availability Act; Medicated Feed Mill Licenses
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a final
rule amending the new animal drug regulations to implement the
medicated feed mill licensing requirements of the Animal Drug
Availability Act of 1996 (ADAA). The ADAA amended the Federal Food,
Drug, and Cosmetic Act (the act) to require that each facility that
manufactures feeds containing approved new animal drugs possess a
medicated feed mill license for the facility, rather than a separate
medicated feed application
[[Page 63196]]
(MFA) for each medicated feed manufactured by the facility, as
previously required by the act. The final rule implements the feed mill
licensing provisions of the ADAA.
EFFECTIVE DATE: December 20, 1999
FOR FURTHER INFORMATION CONTACT: William D. Price, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6652.
SUPPLEMENTARY INFORMATION:
I. Background
The ADAA (Public Law 104-250), which amended sections 512(a) and
(m) of the act (21 U.S.C. 360b(a) and (m)), replaces the system that
required the agency's approval for the manufacture of specific
medicated feeds with a site licensing system for the manufacture of
such feeds.
Prior to the passage of the ADAA, an approved MFA was required by
the act for the manufacture of medicated feed. The act required a feed
mill (referred to also as ``feed manufacturer,'' ``feed firm,'' or
``feed manufacturing facility'') to submit a separate MFA for each
medicated feed manufactured by the firm. The ADAA eliminates this
requirement and provides for feed mills to be licensed and allows
licensed facilities to manufacture any feed containing an approved new
animal drug. Additionally, section 512(m)(6) of the act, as added by
the ADAA, provides the agency with the authority, to the extent
consistent with the public health, to exempt facilities that
manufacture certain types of medicated feed from the requirement of
obtaining a medicated feed mill license.
These final regulations implementing section 512(m) of the act as
amended by the ADAA require only one facility license for the
manufacture of animal feeds containing approved new animal drugs,
instead of multiple approved MFA's. Furthermore, those medicated feeds
previously exempted from the MFA requirement under Sec. 558.4 (21 CFR
558.4) will also be exempt from the requirement of being manufactured
in a licensed feed mill under this regulation.
The ADAA also provided for a transitional license for any feed
manufacturing facility that, at the time of enactment of the ADAA, held
an approved MFA for the manufacture of a medicated feed . Transitional
licenses expired April 9, 1998. The Office of Management and Budget
(OMB) approved the paperwork requirements for licensing for a 3-year
period on October 31, 1997 (OMB control number 0910-0337).
II. Summary of the Proposed Rule
In the Federal Register of July 30, 1997 (62 FR 40765), FDA
published a proposed rule to implement the feed mill licensing
provisions of the ADAA. The proposed rule would add a new part 515 to
provide the requirements for medicated feed mill licensing. The
proposed rule also would amend part 514 (21 CFR part 514) to remove the
provisions regarding MFA's.
The proposed rule set forth the information to be included in
medicated feed mill license applications and supplemental applications.
The proposed rule also set forth the criteria for, among other things,
the approval and refusal to approve a medicated feed mill license
application, as well as the criteria for the revocation and/or
suspension of a license.
The proposed rule provided conforming amendments to the Code of
Federal Regulations (CFR) by removing references to ``MFA's'' and
inserting appropriate references to ``medicated feed mill licenses.''
Furthermore, the proposed rule clarified that the scope of the
exemption from the requirement of establishment registration is
identical to the scope of the exemption from the requirement of a
medicated feed mill license. Finally, the proposed rule maintained the
general scheme for categories and types of medicated feeds, and
provided that those feeds exempted from the MFA requirement now would
be exempt from being required to be manufactured in a licensed feed
mill.
III. Discussion of Comments
A total of six parties submitted comments to the proposed rule. A
discussion of the comments and FDA's responses follows:
A. Possession of Current Approved Labeling
1. Four comments objected to the requirement in proposed
Sec. 515.10(b)(6) that the license applicant commit to possess current
approved Type B and/or Type C medicated feed labeling for each animal
feed containing an approved new animal drug prior to receiving the Type
A medicated article containing such drug. Furthermore, these comments
objected to the related requirement in proposed Sec. 510.305(b) (21 CFR
510.305(b)) that the medicated feed mill licensee maintain copies of
approved labeling at the feed manufacturing facility for those Type B
and/or Type C medicated feeds being manufactured. Two comments
maintained that the possession by the feed manufacturer of labeling for
the Type A medicated article, instead of the Type B and Type C
medicated feed labeling, would satisfy the feed labeling requirements
of the statute.
These four comments argued that the two proposed provisions,
Secs. 515.10(b)(6) and 510.305(b), would impose impractical
requirements on feed mills, because the mills would be required to
possess multiple feed labels for the use of each Type A medicated
article before receipt of the Type A medicated article. These comments
explained that because many Type A medicated articles may be used in
multiple types of approved feeds, feed manufacturers typically do not
know at the time of shipment of the Type A medicated article which
feeds will be manufactured with the drug. Thus, these comments argued
that the only way to satisfy the proposed rule's labeling requirement
would be for the drug sponsor to ship in advance to the feed
manufacturer the current approved labeling for all possible feeds that
could be manufactured with each drug, and then for the feed
manufacturer to maintain all of this labeling. The comments concluded
that such a practice would pose a significant burden for both the drug
sponsor and the feed manufacturer.
FDA has evaluated the comments and has concluded that the act, as
amended by the ADAA, requires the licensed feed manufacturing facility
to possess and maintain the current approved labeling for those Type B
and/or Type C medicated feeds that will be manufactured at that
facility prior to receiving the Type A medicated article(s) for these
feeds. Section 512(a)(1) of the act, explicitly provides that at the
time of removal of a Type A medicated article from a manufacturing,
packing, or distributing establishment that the establishment have an
unrevoked written statement from the licensed feed manufacturing
facility, or a notice from the Secretary of Health and Human Services
(the Secretary), that the facility has a medicated feed mill license
and current approved labeling for the use of the Type A medicated
article in animal feed. Section 512(a)(1) of the act provides that, in
the absence of meeting these requirements, the new animal drug is
deemed unsafe. A new animal drug deemed unsafe under section 512(a)(1)
of the act is adulterated under section 501(a)(5) of the act (21 U.S.C.
351(a)(5)). Thus, the requirement in these regulations that the feed
mill possess the current approved labeling is mandated by section
512(a)(1) of the act as amended by the ADAA.
Furthermore, FDA has concluded that the ``approved labeling''
required by the
[[Page 63197]]
act and these regulations is that labeling submitted with and approved
in the new animal drug application (NADA) for use of the feed
containing the new animal drug (the ``Blue Bird'' label), not the
labeling for the Type A medicated article as maintained by some
comments.
Section 512(b)(1)(F) of the act requires an NADA for a new animal
drug intended for use in animal feed to include ``proposed labeling
appropriate for such use'' in animal feed as well as specimens of
labeling for the drug itself. The regulations at Sec. 514.1(b)(3)(v)(a)
and (b)(3)(v)(b), which implement this provision, specifically require
two sets of labels for new animal drugs for use in medicated feeds:
``labeling to be used for such new animal drug with adequate directions
for the manufacture and use of finished feeds'' and ``representative
labeling proposed to be used for Type B and Type C medicated feeds
containing the new animal drug.'' FDA refers to the representative
labeling for the Type B and Type C medicated feeds as the ``Blue Bird''
label. This labeling is approved as part of the NADA. FDA believes that
Congress intended feed mills to possess and maintain the labeling for
use of the feed approved as part of the NADA since this provides the
same level of public health protection that existed under the pre-ADAA
system under which FDA approved the feed use labeling as part of the
MFA and required such labeling to be maintained at the facility. Both
systems ensure that each facility has the pertinent information to
generate an actual feed label that is consistent with representative
medicated feed labeling already approved by the agency.
The agency has concluded that the requirement that licensed feed
manufacturers possess Blue Bird labeling for each medicated feed to be
manufactured will not add a significant regulatory burden for industry.
First, feed manufacturers have possessed and maintained feed labeling
approved by FDA since the implementation of the new animal drug
regulations in 1971 (36 FR 18375, September 14, 1971). Section
512(m)(1)(d) of the act and the regulations at Sec. 514.2(b)(11)
previously required feed manufacturers to submit for FDA's approval the
proposed feed labeling with the MFA. Section 512(a)(1) of the act and
the regulations at Sec. 510.7 (21 CFR 510.7) also required the feed
manufacturer to possess the approved MFA, with the feed labeling, prior
to shipment of the Type A medicated article for each feed. Furthermore,
the regulations at Sec. 510.305 previously required feed manufacturers
to maintain the MFA, with the approved labeling, on site at the
facility. Thus, this final rule's requirement that feed mill licensees
possess and maintain feed labeling approved by FDA in the NADA (the
Blue Bird label), as required by section 512(a) (1) of the act, is in
essence the same as the feed manufacturer's previous legal obligation
under the act to possess and maintain feed labeling approved by FDA.
Second, drug sponsors have submitted Blue Bird labels with the NADA
as required by Sec. 514.1(b)(3)(v)(b) (formerly Sec. 135.4a(b)(3)(v)(b)
(21 CFR 135.4a(b)(3)(v)(b))) since the implementation of the new animal
drug regulations in 1971 (36 FR 18375, September 14, 1971.) The
requirement for the submission and approval of such labels with the
NADA has ensured that these labels are available for distribution to
feed manufacturers. Type A manufacturers, in turn, have been supplying
approved Blue Bird labels to feed manufacturers since the development
of these labels.
Third, feed manufacturers have been using Blue Bird labels as a
model to generate actual feed labels and previously used such labels to
satisfy the requirement for the submission of representative feed
labeling with the MFA. Prior to this final rule, the new animal drug
regulations required feed manufacturers to submit an MFA for each
medicated feed with ``a copy of the final printed labeling,'' for
approval by the agency (Sec. 135.4b(d); 36 FR 18375, September 14,
1971). Initially, FDA had accepted from the feed manufacturer only the
actual feed label to satisfy this requirement. However, an FDA
medicated feed task force, after consulting with the Animal Health
Institute (AHI), the American Feed Industry Association (AFIA), and the
Association of American Feed Control Officials (AAFCO), issued a report
in December 1978 that recommended, among other things, that FDA accept
``generic'' labels with the MFA (Ref. 1). Soon after issuance of the
task force's report, FDA allowed feed manufacturers to submit the Blue
Bird label, rather than the actual feed label, with the MFA. The agency
amended Sec. 514.2(b)(11) to allow ``labeling representative of each
intended use as stated in the claim'' to be submitted with the MFA (51
FR 7382, March 3, 1986).
FDA has found that since approximately 1980, feed manufacturers
have generally relied on the Blue Bird label in submitting the required
labeling with the MFA. Feed manufacturers typically submitted with the
MFA either a copy of the Blue Bird label or a label derived from the
Blue Bird label (an equivalent Blue Bird label). An equivalent Blue
Bird label listed the same active drug(s), claim(s), caution and/or
warning statements, and mixing and feeding directions as listed in the
Blue Bird label. The facility could then generate the actual feed label
based on that labeling approved in the MFA. Since the equivalent Blue
Bird label was approved as part of the MFA, the agency was assured that
the labeling upon which the actual feed label was based correctly
reflected the approval conditions of use for the feed.
As noted previously, Type A medicated article manufacturers
frequently supplied the appropriate Blue Bird labels to the feed
manufacturer for submission with the MFA. Thus, the requirement that
the licensed feed manufacturer possess Blue Bird labeling for the feed
being manufactured is consistent with industry practice.
FDA agrees with the comments that proposed Sec. 515.10(b)(6)
appeared to require a licensed feed mill to commit to possess approved
labeling for all possible feeds that could be manufactured from the
Type A medicated article. FDA does not intend that a licensed feed
manufacturing facility must possess current approved labeling for Type
B and/or Type C medicated feeds that the facility does not actually
manufacture from the Type A medicated article. Thus, FDA is amending
proposed Sec. 515.10(b)(6) (in the final rule, Sec. 515.10(b)(7)) to
read, ``A commitment that current approved Type B and/or Type C
medicated feed labeling for each Type B and/or Type C medicated feed to
be manufactured will be in the possession of the feed manufacturing
facility prior to receiving the Type A medicated article containing
such drug.''
FDA notes that a feed manufacturer can satisfy the requirement to
possess the current approved labeling by maintaining the Blue Bird
labeling for each feed to be manufactured at the facility in either
paper or electronic format. To assist drug sponsors and feed
manufacturers in the distribution of Blue Bird labels and to allow
parties to determine more easily whether a feed mill is licensed, FDA
has created a data base of medicated feed mill licensing information,
available to the public on the Center for Veterinary Medicine's (CVM's)
web site at ``http://www.fda.gov/cvm''.
2. One comment argued that proposed Secs. 510.305(b) and
515.10(b)(6) should not apply to medicated feed mill licensees because
the majority of such licensees are firms with multiple
[[Page 63198]]
facilities, where labeling is not created at the feed facility but in
the home office. The comment claimed that these firms use the published
regulation of approval as the source of required information for the
label. Furthermore, the comment argued that the proposed regulation
would require such multiple facility firms to distribute Blue Bird
labels from the home office to all of the facilities before obtaining
the drug, which would serve no purpose. The comment noted that the
proposed rule does not apply to nonlicensed facilities and stated that
most of these facilities are single mill firms that may not have access
to the labeling information in the Federal Register, CFR, Feed Additive
Compendium, or to a computer with the capability to obtain this
information free from the various information sources on the Internet.
The comment concluded that the proposed rule's requirement for the
possession of Blue Bird labeling should be eliminated, because ``[t]he
present system of label development has worked well for the feed
industry.''
FDA has considered the previous comment and has concluded that the
requirement that licensed feed mills possess Blue Bird labels will not
add to the legal obligations with respect to feed labeling that existed
for these mills prior to the enactment of ADAA. As discussed
previously, before enactment of the ADAA, in accordance with section
512(m)(1)(D) of the act, feed firms submitted with the MFA the specimen
of labeling to be approved for that feed. To satisfy this requirement
firms typically chose to submit the Blue Bird label as the labeling
specimen. Once FDA approved the MFA, the feed mill maintained a copy of
the approved MFA, which included the approved labeling, under
Sec. 510.305. To comply with the conditions set forth in the MFA for
the manufacture of feed, the facility could then generate the actual
feed label based on the approved labeling.
Under this rule implementing medicated feed mill licensing, firms
that were previously required to have an approved MFA are now required
to have a medicated feed mill license and the approved labeling for the
manufacture of such feed. Just as the previous regulatory scheme
required firms to possess labeling approved by FDA with the MFA for
each feed to be manufactured, Sec. 515.10(b)(7) of this rule requires
firms to possess the approved labeling for such feed. The only
distinction is that instead of the firm maintaining labeling for the
feed that is approved by FDA in the medicated feed application process
in addition to the NADA approval process, the firm will maintain the
Blue Bird medicated feed labeling approved in the NADA. Additionally,
Sec. 510.305(b), as revised by this rule, requires that licensed firms
maintain the approved labeling on the premises, which is consistent
with the previous requirement for maintaining the MFA with a sample of
the approved labeling. Thus, the requirements of this rule do not
change the previous legal obligations of feed mills to possess and
maintain approved labeling for the feed. Furthermore, as also discussed
earlier in this preamble, since feed mills previously submitted the
Blue Bird label or its equivalent for approval of an MFA, the
requirements of this rule are consistent with the industry's method of
feed label development.
For those firms where labeling is created based on the CFR or other
sources, FDA has concluded that a firm must possess and maintain the
Blue Bird label to satisfy the requirements of section 512(a)(1) of the
act, and Secs. 515.10(b)(6) and 510.305(b) of this final rule. As
discussed earlier in the preamble, the statutory requirement that
licensed feed mills possess and maintain approved labeling for the feed
ensures that these facilities rely on approved labeling to develop the
actual feed labels. FDA is revising Sec. 510.305 to clarify that if the
home office of a multiple facility firm generates the actual feed
labels and maintains the Blue Bird labels for all the feed the multiple
facilities manufactures, then only the home office will be required to
maintain the Blue Bird labels.
Finally, as for nonlicensed feed mills, such firms are not the
subject of this regulation. Feed mills previously exempted from MFA's
are also exempt from the licensing requirements set forth in this
regulation. FDA previously exempted firms from the requirement that an
MFA be approved for the manufacture of Type B and/or Type C medicated
feed from Category I Type A medicated articles or from Category II Type
B and/or Type C medicated feed, unless otherwise required by
regulation. FDA exempted the manufacture of these feeds from the MFA
requirements, including the submission of the labeling specimen,
because any errors in the manufacture or labeling of such feeds would
be unlikely to produce unsafe residues (Sec. 558.4(a); 51 FR 7382,
March 3, 1986). Because nonlicensed facilities can manufacture only
exempt feeds, FDA is not proposing that the requirements of
Secs. 510.305(b) and 515.10(b)(7) in the final rule apply to
nonlicensed feed mills.
3. One comment argued that proposed Sec. 510.305 should be amended
so that a feed manufacturing firm with multiple establishments can
maintain each license at its home office, while the firm simply
maintains a ``single readable document with relevant licensing
information at each facility.'' Under Sec. 510.305(d), as proposed, the
home office of a multiple facility establishment can maintain the
original licenses, but each facility must maintain a copy of the
license. The license lists the requirements and commitments for the
establishment, and it is very important that the people at the
manufacturing site understand these requirements. Hence, it is very
important that a copy of the license is maintained at each
manufacturing facility. Thus, FDA has not changed Sec. 510.305 as
requested by the comment.
4. One comment requested that the agency hold a public meeting to
discuss alternatives to the proposed rule regarding medicated feed
labeling. The comment reasoned that such a meeting would give the
agency the opportunity to hear and consider current industry methods
and sources for developing labeling for medicated feeds. The comment
stated that alternatively, interested members of the public could hold
a round table for agency officials to provide the agency with input
from industry compliance directors on the development of labeling.
In response to this comment, FDA participated in a meeting with
representatives of AFIA and AHI on March 17, 1998. AFIA and AHI
presented their views, previously expressed in their written comments,
regarding the feed labeling provisions of the medicated feed mill
licensing proposed rule. The meeting helped the agency to understand
the concerns of industry. Minutes of the meeting are included in Docket
No. 97N-0276, and may be viewed at the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
B. Establishment Registration
5. One comment proposed that feed manufacturing facilities be
exempt from the annual establishment registration requirement set forth
in Sec. 207.20 (21 CFR 207.20), so that all feed mills would be listed
as exempt from this requirement under Sec. 207.10 (21 CFR 207.10). The
comment argued that establishment registration serves no purpose. The
comment stated that one argument for establishment registration is that
such registration is required yearly, and provides the agency with a
list of who is registered and their locations. However, according to
the comment, establishment registration has
[[Page 63199]]
not achieved this goal in practice because neither CVM nor field
enforcement offices have been provided numbers or locations of
establishment registration facilities. The comment argued that, in any
case, such information could be updated based on the agency's
inspections of firms and the requests by firms for the withdrawal of
medicated feed mill licenses.
The comment requests amendments to the registration requirements
that are beyond the scope of this rulemaking. FDA is issuing these
regulations to provide for medicated feed mill licensing in accordance
with the ADAA. Therefore, FDA is not making any substantive changes to
the scope of the registration exemption. With regard to the exemptions
in Sec. 207.10, FDA is amending the regulation merely to clarify, but
not change, the scope of the registration exemption for medicated feed
mill licensees. Furthermore, FDA is amending Secs. 207.20 and 207.21
(21 CFR 207.21) in the regulations only to replace the phrase
``medicated feed application'' with the term ``medicated feed mill
license application.''
Additionally, contrary to the comment's assertion, registration
provides beneficial information to the agency that is not available
from medicated feed mill licensing. Registration, unlike medicated feed
mill licensing, is required annually by 21 CFR 207.22. FDA has found
that firms comply with this requirement and provide annually the
numbers and locations of registered facilities. This requirement allows
FDA to determine which feed mills are still doing or intend to do
business. Therefore, the agency believes the exemptions from
registration should not be expanded.
C. Ninety-Day Approval Period
6. One comment noted that proposed Sec. 515.20 provides the agency
90 days to act upon a medicated feed mill license application. The
comment further noted that the agency did not require the 90 days set
forth by regulation to process medicated feed applications, but instead
the agency provided the industry timely approvals that ensured that
facilities were not placed at a competitive disadvantage. Thus, the
comment concluded that 30 days would better reflect the time
requirements for acting on a medicated feed mill license application,
particularly because a medicated feed mill license approval does not
involve the agency's review of the medicated feed labeling.
FDA rejects the suggestion that proposed Sec. 515.20 be changed to
allow the agency only 30 days to act on a medicated feed mill license
application. First, section 512(m)(2) of the act sets forth explicitly
the time limit of 90 days for agency action. Second, almost all feed
mills applying for a license will require a preapproval inspection by
FDA conducted after filing of the medicated feed mill license
application, and it would not be feasible for FDA, in all cases, to
conduct the preapproval inspection within 30 days of filing of the
application. Of course, as with MFA's, FDA will continue to act as
expeditiously as possible in processing license applications.
D. Requirements for Drug Sponsors
7. Three comments noted that the agency accidentally omitted a
revision of Sec. 510.7 (21 CFR 510.7) (consignees of new animal drugs
for use in the manufacture of animal feeds) in the licensing proposal.
The comments suggested that the reference in Sec. 510.7(a)(1) to
``Sec. 514.2'' should be changed to ``Sec. 515.10.'' The comments
stated that such a change would be consistent with the deletion of
Sec. 514.2 (applications for animal feeds bearing or containing new
animal drugs) and the establishment of Sec. 515.10 (applications for
licenses to manufacture animal feeds bearing or containing new animal
drugs).
FDA agrees that in order to be consistent with Sec. 515.10 of these
regulations, the reference should be changed as noted in the comments.
Furthermore, in order to be consistent with the language of the ADAA,
FDA has concluded that Sec. 510.7 must also clarify that at the time of
a new animal drug's removal from the establishment of a manufacturer,
packer, or distributor of a Type A medicated article, such
manufacturer, packer, or distributor must possess an unrevoked written
statement from the consignee, or notice from the Secretary, that the
consignee holds a medicated feed mill license and has in its possession
current approved labeling for the drug in animal feed. Thus,
Sec. 510.7(a)(1) has been amended to read as follows: ``Holds a license
issued under Sec. 515.20''.
A drug sponsor can satisfy this requirement by receiving written
confirmation from the facility as to its feed mill license number or by
verifying the feed mill's license status on CVM's web site. The
confirmation and/or identification of a feed manufacturing facility's
license number indicates that the firm should possess current approved
labeling, because the firm must commit to the possession of such
labeling in the medicated feed mill license application. The drug
sponsor's verification from the FDA web site of an approved facility's
license number would constitute ``notice from the Secretary'' that the
feed mill possesses a license and the current approved feed labeling.
Section 510.7(a)(2) has also been amended to reference the new
Sec. 515.10 regulation. As provided in section 512(a)(1)(B)(ii) of the
act, if the consignee is not the user of the drug the shipper must
obtain an unrevoked written statement from the consignee that the
consignee will ship such drug only to a holder of an approved
application under Sec. 515.10 of this chapter.
E. Status of Related Citizen Petitions
8. One comment expressed disappointment and concern that the agency
was unable to resolve pending issues in order to publish proposed rules
for two citizen petitions on drug assays (Docket No. 95P-0373) and on
medicated liquid feeds (Docket No. 93P-0174) as part of this
rulemaking. The comment further stated that these two petitions suggest
significant and appropriate changes to the current good manufacturing
practices (CGMP's) and would have saved the agency much time and
resources if the agency had published responses concurrently or
incorporated such responses in the published proposal on medicated feed
mill licenses. The comment stated that the medicated liquid feed
petition is long overdue for rulemaking as the agency provided a letter
to AFIA on April 19, 1995, that essentially agreed with the substance
of AFIA's petition and indicated that a proposal to amend 21 CFR 558.5
was being prepared at that time. The comment urged the agency to act on
these two petitions and publish proposed rules to resolve these
impasses on serious issues related to the regulation of medicated feed.
FDA is well aware of the two citizen petitions and is actively
reviewing these petitions. In preparing this proposal, FDA concluded
that incorporating any amendments to the regulations based on these
petitions would have unduly delayed the publication of this final rule.
The agency plans to develop proposed rules related to these citizen
petitions following publication of this final rule.
FDA notes that in a March 30, 1998, amendment to the AFIA and AHI
1995 Citizen Petition (Docket No. 95P-0373) AFIA and AHI withdrew their
request to amend Sec. 510.301 (21 CFR 510.301). However, following
publication of this final rule FDA intends to develop a proposed rule
to amend Sec. 510.301 to be consistent with the requirements of the
ADAA.
[[Page 63200]]
F. Enforcement Policy
9. One comment requested that the agency take swift and positive
compliance action against those firms found to be in violation of
CGMP's. FDA recognizes that a visible and firm regulatory posture is
essential so that medicated feeds are manufactured, labeled, and
distributed in a safe manner. FDA is prepared to take the necessary
steps to ensure the safe and effective use of animal drugs in animal
feeds.
IV. Additional Changes
FDA has reordered and rewritten subpart A of part 15 to make it
more logical and consistent.
V. Environmental Impact
FDA has carefully considered the potential environmental impacts of
this rule. 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.
Medicated feed mill licensing is a procedure established by the
ADAA as a replacement for FDA's previous MFA system. The final rule
substitutes a facility licensing program for a system of feed-by-feed
approval to manufacture feeds containing approved new animal drugs,
thereby substantially reducing the number of approval requests required
from facilities manufacturing feeds containing new animal drugs. A
medicated feed mill license authorizes a feed mill to manufacture any
feed containing an approved new animal drug. Previously, a feed mill
was required to submit an MFA to manufacture each applicable feed
containing an approved new animal drug.
This streamlining does not reduce the responsibility of each
facility to manufacture medicated feeds in full compliance with CGMP's
regulations. Additionally, the final rule does not prevent FDA from
inspecting facilities and their records or taking actions to bring
facilities into compliance.
The licensing of a feed mill by FDA does not reduce or change the
responsibilities of the mill management to comply with requirements of
other Federal, State, or local workplace waste management and emissions
laws and regulations. Consistent failure of a facility to comply with
hazard communication requirements, to provide necessary worker
protection, or to adequately manage wastes could be regarded by FDA as
an indication that the facility has a systemic problem that calls into
question the ability of the feed mill to comply with FDA CGMP's
regulations.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),
and under the Unfunded Mandates Reform Act (Public Law 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity).
Under the Regulatory Flexibility Act, unless an agency certifies
that a rule will not have a significant impact on a substantial number
of small entities, the agency must analyze regulatory options that
would minimize any significant impact of a rule on small entities. The
Unfunded Mandates Reform Act requires (in section 202) that agencies
prepare an assessment of anticipated costs and benefits before
proposing any expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector of $100 or more (adjusted
annually for inflation) million in any one year.
The agency has reviewed this final rule and has determined that the
rule is consistent with the principles set forth in the Executive Order
and in these two statutes. FDA believes that the rule is consistent
with the regulatory philosophy and principles identified in the
Executive Order and will not have a significant effect on a substantial
number of small entities. The Office of Management and Budget has
determined that this final rule is a significant regulatory action
subject to review under the Executive Order. Also, since the
expenditures required by the rule are under $100 million, FDA is not
required to perform a cost/benefit analysis according to the Unfunded
Mandates Reform Act.
With this rule, FDA is streamlining existing paperwork requirements
by amending the process for obtaining approval to manufacture medicated
feeds. Instead of requiring an MFA for each applicable medicated feed,
this final regulation requires only a single facility license per feed
mill, as appropriate. The ADAA granted a transitional license, valid
for 18 months, to all feed manufacturing facilities that held an
approved MFA. During this time, the facilities could obtain a permanent
license by submitting a license application and a copy of an approved
MFA to FDA. All other existing reporting responsibilities for each drug
remain unchanged.
In its analysis for the proposed rule, the agency had assumed that
the only costs to be incurred by industry would be the paperwork costs
associated with applying for a facility license. FDA estimated that
approximately 2,000 feed mills would be affected by this rule, and that
it would take approximately 15 minutes for each facility to complete
its application. Taking 1995 median weekly earnings of $684 (Ref. 2)
for the executives, administrators, and managers who would complete the
applications, and adding 40 percent for fringe benefits, yielded
average hourly earnings of $23.94. Thus, the agency estimated a
combined paperwork cost for all facilities totaling $11,970 for the
first year, and $600 for the estimated 100 mills expected to apply for
licensing in each subsequent year. In addition, FDA estimated annual
costs of $530 for all of those facilities completing paperwork in
reference to license supplements, the voluntary revocation of their
license, or hearing procedures. The total cost equaled approximately $6
per mill.
FDA has inflated these costs in the final rule to account for the
increase in employment costs from 1995 to 1999. Using the average
annual increase of 3.35 percent from 1995 to 1998 over the 4 years from
1995 to 1999, FDA estimates that the combined paperwork costs would
total $13,735 in the first year and about $700 in each subsequent year
(Ref. 3). Further, paperwork costs in reference to license supplements,
voluntary revocation of licenses and hearing procedures would amount to
about $600 annually.
Several comments to the proposed rule indicated that additional
costs would be incurred due to the labeling requirements of the rule.
The agency acknowledges that the costs for feed mills maintaining and
retrieving Blue Bird labels was not estimated in the proposal. In Table
3 of section VIII of this document, a total cost to the industry of 500
hours is estimated for a total of 2,000 licensees. At the inflation-
adjusted $27.47 per hour, the agency estimates that maintaining and
retrieving the labels will cost the industry an additional $13,735
annually. Total industry costs would amount to only about $14 per mill.
For the proposed rule, the agency had estimated a large savings in
the paperwork burden due to the elimination of the MFA requirements.
Over the past 5 years, the agency has received approximately 3,300
MFA's
[[Page 63201]]
per year including both original applications and MFA supplements. In
the past, FDA surveyed several feed mills and animal drug
manufacturers, and determined that it took industry about 2 hours to
complete an MFA application. Therefore, FDA estimated that the rule
would save industry over $158,000 per year, or approximately $79 per
mill per year, on average. FDA has adjusted this saving for wage
inflation to approximately $181,000 per year, or about $91 per mill
each year. The mills that have routinely submitted a larger number of
MFA's would realize a larger savings than those mills that routinely
submit few MFA's. The agency did not receive comments on this estimate
and retains the inflation-adjusted amount for the final rule.
FDA also predicted that it would experience an administrative cost
saving in response to the medicated feed mill licensing requirement.
Since 1994, the agency has spent approximately $180,000 per year for a
contractor to process the MFA's. In contrast, it would take FDA only
about 40 minutes to process each medicated feed mill license
application, at a cost of $25 per hour for a GS-13 government employee.
The first year, the agency estimated that it would cost $33,500 to
process the expected 2,000 applications, and $10,000 for starting up a
tracking and indexing computerized data base. Further, it would cost
only about $1,700 to process the 100 applications for each year
thereafter.
Adjusting for wage inflation for the final rule, the agency expects
the first year cost to process the applications to be about $37,200,
and $11,500 for the tracking and indexing computerized data base.
Application processing for subsequent years is expected to cost about
$1,850 per year. The agency did not receive comments on these estimates
of government cost savings and retains the inflation-adjusted amounts
for the final rule.
The Small Business Administration (SBA) defines all manufacturers
of prepared feeds and feed ingredients for animals and fowls having 500
employees or less as a small business. The agency previously estimated
that approximately 20 percent of the affected feed mills belong to
large conglomerates that have an overall employee count higher than
500. Therefore, the remaining 80 percent of the affected facilities
would be considered small feed mills by SBA's standards. However, as
described previously, the agency has determined that the rule will
provide a net economic savings for all facilities. Therefore, in
accordance with the Regulatory Flexibility Act, FDA certifies that this
rule will not have a significant effect on a substantial number of
small entities.
VII. Federalism
FDA has analyzed the final rule in accordance with the principles
and criteria set forth in Executive Order 13132 and has determined that
this final rule does not have sufficient federalism implications to
warrant the preparation of a federalism assessment.
VIII. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520). A description of these provisions is given as
follows. 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.
Title: Medicated Feed Mill License Application.
Description: This final rule implements the ADAA's medicated feed
mill licensing provisions. It requires that any medicated feed
manufacturing facility seeking a license submit an application to FDA.
In Sec. 515.10 of the final regulations, FDA proposed that medicated
feed mill license applications be submitted on FDA Form 3448,
``Medicated Feed Mill License Application.''
Section 515.11 of the final regulation specifies that supplemental
applications must be submitted for a change in ownership and/or change
in mailing address, which also would be submitted on FDA Form 3448.
Furthermore, Sec. 515.23 of the regulations provides for voluntary
revocation of a license. A medicated feed licensee would submit, in
writing to FDA, a request for voluntary revocation of a license.
Finally, Sec. 515.30 of the regulation provides procedures refusing
to approve license applications when, among other reasons, the
application is incomplete, false or misleading or the manufacturing,
processing, and packaging of the animal feed do not comply with
applicable provisions of the act. A medicated feed manufacturing
facility would have the option to submit a request in writing for a
hearing in response to the agency's proposal to refuse to approve a
medicated feed mill application.
Description of Respondents: Medicated Feed Manufacturing
Facilities.
In the Federal Register of July 30, 1997 (62 FR 40765), interested
persons were requested to send comments regarding this collection of
information to OMB by August 29, 1997. In response to this notice OMB
received one comment regarding the paperwork aspect of this collection
of information. The comment argued that the agency's estimate of the
burden of the proposed collection of information was inaccurate in the
following two instances: (1) In assuming that the only costs that will
be incurred are the paperwork costs associated with applying for a
facility license, and (2) in the estimate of $10,000 for tracking and
indexing a computerized data base.
Regarding instance (1), the comment stated that the agency's
assumption is inaccurate in that no consideration has been given to the
capital and operating costs for the retrieval and maintenance of
approved labeling for medicated feeds. The comment stated that this
burden applies to sponsors under section 512(a)(1)(B) of the act and to
licensed feed mills under proposed Sec. 510.305.
CVM has evaluated this part of the comment and agrees that the
agency did not address the cost for the licensed feed mill to maintain
and retrieve approved Blue Bird labels as required under Sec. 510.305.
Table 3 of this document provides an estimate of that cost at a total
of 500 hours annually for an estimated 2,000 licensees. This covers the
cost of obtaining the label from either the drug sponsor or FDA and
keeping it in a file. CVM estimates that most licensed feed
establishments would only have 1 to 10 Blue Bird labels to maintain and
retrieve. A few, primarily the multiple facilities, may have many more,
but would only maintain and retrieve these labels at their home office.
Thus the average estimate of 15 minutes per licensee takes these
factors into account.
The agency has concluded that it did not err in excluding this
burden for drug sponsors because the provision the comment cited, which
requires retrieval and maintenance of approved labeling, applies only
to feed mills, not to sponsors. The burden is on feed mills to retrieve
the approved labeling either from the sponsor or FDA.
Regarding instance (2), the comment maintained that unless access
to this data base is made available to sponsors and consignees, it
would be logical to assume that similar expenses would be incurred by
each sponsor and consignee maintaining a parallel data base in order to
ensure their compliance with section 512(a)(1)(B) of the act. The
comment argued that the most effective approach to eliminate this
unnecessary burden would be for CVM to provide public
[[Page 63202]]
access to its data base through the CVM home page. FDA has evaluated
this comment, and CVM has put a list of approved licensees on the
Internet, and public access has been granted.
FDA had estimated that 2,000 respondents would apply for feed mill
licenses under Sec. 515.10 during the first year and that a total of
500 hours would be required for them to respond. During the first 18
months (by the transition provisions, respondents had 18 months to
obtain a license), only 1,250 respondents applied for licenses. FDA
estimated that during each succeeding year, 100 new respondents would
request feed mill licenses. Based on current information, that number
appears to be a reasonable estimate of the number of respondents. The
agency has received approximately 70 requests for licenses in the year
following the first 18 months. FDA also estimated that there would be
25 respondents for supplemental applications (Sec. 515.11), 50 for
voluntary revocations (Sec. 515.23), and 0.15 for notices of
opportunity for hearing (Sec. 515.30). Those numbers also appear to
have been reasonable estimates.
This final rule contains the original provisions of part 515, as
proposed, and amends these provisions only for further clarity. As a
result of the comment(s) received, an estimate of an annual
recordkeeping burden (Table 3) has been added to the burden chart,
under Sec. 510.305. Thus, the original annual reporting burden estimate
has been changed to include annual recordkeeping requirements.
Table 1.--Estimated Annual Reporting Burden: First Year\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
515.10 2,000 1 2,000 0.25 500
515.11 25 1 25 0.25 6.25
515.23 50 1 50 0.25 12.25
515.30 0.15 1 0.15 24 3.6
Total 522.1
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Reporting Burden: Each Succeeding Year1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
515.10 100 1 100 0.25 25
515.11 25 1 25 0.25 6.25
515.23 50 1 50 0.25 12.25
515.30 0.15 1 0.15 24 3.6
Total 47.1
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
510.305 2,000 1 2,000 0.25 500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital cost or operating and maintenance cost associated with this collection of information.
Individuals or organizations may submit comments on this burden
estimate or any other aspect of these collection of information
provisions, including suggestions for reducing the burden, and direct
them to William Price (address above).
The information collection provisions in this final rule have been
approved under OMB control number 0910-0356. This approval expires
October 31, 2000. An agency may not conduct or sponsor, and a person is
not required to provide, a collection of information unless the
collection of information displays a currently valid OMB control
number.
IX. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA Medicated Feed Task Force, ``Medicated Feed Task Force
Report,'' December 1978.
2. Employment and Earnings, U.S. Department of Labor Bureau and
Labor Statistics, vol. 43, No. 1, p. 205, January 1996.
3. U.S. Department of Labor Bureau of Labor Statistics; ``ftp://
ftp.bls.gov/pub/special.requests/lf/aat39.txt''.
List of Subjects
21 CFR Part 207
Drugs, Reporting and recordkeeping requirements.
21 CFR Part 225
Animal drugs, Animal feeds, Labeling, Packaging and containers,
Reporting and recordkeeping requirements.
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
[[Page 63203]]
21 CFR Parts 514 and 515
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
Chapter I is amended to read as follows:
PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS
IN COMMERCIAL DISTRIBUTION
1. The authority citation for 21 CFR part 207 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 355, 360, 360b, 371, 374; 42
U.S.C. 262.
2. Section 207.10 is amended by revising paragraph (f) to read as
follows:
Sec. 207.10 Exemptions for domestic establishments.
* * * * *
(f) Persons who only manufacture the following:
(1) Type B or Type C medicated feed using Category I, Type A
medicated articles or Category I, Type B or Type C medicated feeds,
and/or;
(2) Type B or Type C medicated feed using Category II, Type B or
Type C medicated feeds.
(3) Persons who manufacture free-choice feeds, as defined in
Sec. 510.455 of this chapter, or medicated liquid feeds, as defined in
Sec. 558.5 of this chapter, where a medicated feed mill license is
required are not exempt.
* * * * *
Sec. 207.20 [Amended]
3. Section 207.20 Who must register and submit a drug list is
amended in paragraph (c) by removing the words ``medicated feed
application,'' and adding in its place ``medicated feed mill license
application,''.
Sec. 207.21 [Amended]
4. Section 207.21 Times for registration and drug listing is
amended in paragraph (a) in the second sentence, by removing the words
``medicated feed application,'' and adding in its place ``medicated
feed mill license application,''.
PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
5. The authority citation for 21 CFR part 225 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
6. Section 225.1 is amended by revising paragraph (b)(2) and by
adding paragraph (c) to read as follows:
Sec. 225.1 Current good manufacturing practice.
* * * * *
(b)(1) * * *
(2) The regulations in Secs. 225.10 through 225.115 apply to
facilities manufacturing one or more medicated feeds for which an
approved medicated feed mill license is required. The regulations in
Secs. 225.120 through 225.202 apply to facilities manufacturing solely
medicated feeds for which an approved license is not required.
(c) In addition to the recordkeeping requirements in this part,
Type B and Type C medicated feeds made from Type A articles or Type B
feeds under approved NADA's and a medicated feed mill license are
subject to the requirements of Sec. 510.301 of this chapter.
7. Section 225.58 is amended in paragraph (b)(1) by revising the
first sentence to read as follows:
Sec. 225.58 Laboratory controls.
* * * * *
(b) * * *
(1) For feeds requiring a medicated feed mill licence (Form FDA
3448) for their manufacture and marketing, at least three
representative samples of medicated feed containing each drug or drug
combination used in the establishment shall be collected and assayed by
approved official methods, at periodic intervals during the calendar
year, unless otherwise specified in this chapter. * * *
* * * * *
8. Section 225.115 Complaint files is amended by revising paragraph
(b)(2) to read as follows:
Sec. 225.115 Complaint files.
* * * * *
(b) * * *
(2) For medicated feeds whose manufacture require a medicated feed
mill license (Form FDA 3448), records and reports of clinical and other
experience with the drug shall be maintained and reported, under
Sec. 510.301 of this chapter.
PART 510--NEW ANIMAL DRUGS
9. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
10. Section 510.7 is amended by revising paragraphs (a)(1) and
(a)(2) to read as follows:
Sec. 510.7 Consignees of new animal drugs for use in the manufacture
of animal feed.
(a) * * *
(1) Holds a license issued under Sec. 515.20 of this chapter; or
(2) Will, if the consignee is not the user of the drug, ship such
drug only to a holder of an approved application under Sec. 515.10 of
this chapter.
* * * * *
11. Section 510.301 is amended to revise the section heading to
read as follows:
Sec. 510.301 Records and reports concerning experience with animal
feeds bearing or containing new animal drugs for which an approved
medicated feed mill license application is in effect.
* * * * *
12. Section 510.305 is revised to read as follows:
Sec. 510.305 Maintenance of copies of approved medicated feed mill
licenses to manufacture animal feed bearing or containing new animal
drugs.
Each applicant shall maintain in a single accessible location:
(a) A copy of the approved medicated feed mill license (Form FDA
3448) on the premises of the manufacturing establishment; and
(b) Approved labeling for each Type B and/or Type C feed being
manufactured on the premises of the manufacturing establishment or the
facility where the feed labels are generated.
PART 514--NEW ANIMAL DRUG APPLICATIONS
13. The authority citation for 21 CFR part 514 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.
Sec. 514.2 [Removed]
14. Section 514.2 Applications for animal feeds bearing or
containing new animal drugs is removed.
Sec. 514.9 [Removed]
15. Section 514.9 Supplemental applications for animal feeds
bearing or containing new animal drugs is removed.
Sec. 514.105 [Amended]
16. Section 514.105 Approval of applications is amended by removing
the introductory text of paragraph (a) and by removing paragraph (b),
and by redesignating paragraphs (a)(1) and (a)(2) as paragraphs (a) and
(b), and by amending newly redesignated paragraph
[[Page 63204]]
(a) by removing the first word ``He'' and adding in its place ``The
Commissioner ''.
Sec. 514.111 [Amended]
17. Section 514.111 Refusal to approve an application is amended by
removing paragraph (b) and by redesignating paragraph (c) as paragraph
(b).
Sec. 514.112 [Removed]
18. Section 514.112 Return of applications for animal feeds bearing
or containing new animal drugs is removed.
Sec. 514.115 [Amended]
19. Section 514.115 Withdrawal of approval of applications is
amended in paragraphs (a), (b), (c), and (d) by removing the phrase
``or (m)(2)''; in paragraph (c)(1) by removing the phrases ``or
(m)(5)(A)'' and ``or (m)(5)(B)''; in paragraph (c)(3) by removing the
phrase ``or animal feed', and in paragraph (e) by removing the second
sentence.
20. Section 514.201 is revised to read as follows:
Sec. 514.201 Procedures for hearings.
Hearings relating to new animal drugs under section 512(d) and (e)
of the act shall be governed by part 12 of this chapter.
21. Part 515 is added to read as follows:
PART 515--MEDICATED FEED MILL LICENSE
Subpart A--Applications
Sec.
515.10 Medicated feed mill license applications.
515.11 Supplemental medicated feed mill license applications.
Subpart B--Administrative Actions on Licenses
515.20 Approval of medicated feed mill license applications.
515.21 Refusal to approve a medicated feed mill license
application.
515.22 Suspension and/or revocation of approval of a medicated
feed mill license.
515.23 Voluntary revocation of medicated feed mill license.
515.24 Notice of revocation of a medicated feed mill license.
515.25 Revocation of order refusing to approve a medicated feed
mill license application or suspending or revoking a license.
515.26 Services of notices and orders.
Subpart C--Hearing Procedures
515.30 Contents of notice of opportunity for a hearing.
515.31 Procedures for hearings.
Subpart D--Judicial Review
515.40 Judicial review.
Authority: 21 U.S.C. 360b, 371.
Subpart A--Applications
Sec. 515.10 Medicated feed mill license applications.
(a) Medicated feed mill license applications (Forms FDA 3448) may
be obtained from the Public Health Service, Consolidated Forms and
Publications Distribution Center, Washington Commerce Center, 3222
Hubbard Rd., Landover, MD 20785, or electronically from the Center for
Veterinary Medicine home page at ``http://www.fda.gov/cvm''.
(b) A completed medicated feed mill license must contain the
following information:
(1) The full business name and address of the facility at which the
manufacturing is to take place.
(2) The facility's FDA registration number as required by section
510 of the Federal Food, Drug, and Cosmetic Act (the act).
(3) The name, title, and signature of the responsible individual or
individuals for that facility.
(4) A certification that the animal feeds bearing or containing new
animal drugs are manufactured and labeled in accordance with the
applicable regulations published under section 512(i) of the act.
(5) A certification that the methods used in, and the facilities
and controls used for, manufacturing, processing, packaging, and
holding such animal feeds conform to current good manufacturing
practice as described in section 501(a)(2)(B) of the act and in part
225 of this chapter.
(6) A certification that the facility will establish and maintain
all records required by regulation or order issued under sections
512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or
copying or verification of such records.
(7) A commitment that current approved Type B and/or Type C
medicated feed labeling for each Type B and/or Type C medicated feed to
be manufactured will be in the possession of the feed manufacturing
facility prior to receiving the Type A medicated article containing
such drug.
(8) A commitment to renew registration every year with FDA as
required in Secs. 207.20 and 207.21 of this chapter.
(c) Applications must be completed, signed, and submitted to the
Division of Animal Feeds (HFV-220), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
(d) Applications that are facially deficient will be returned to
the applicant. All reasons for the return of the application will be
made known to the applicant.
(e) Upon approval, the original copy of the application will be
signed by an authorized employee of FDA designated by the Commissioner
of Food and Drugs, and a copy will be returned to the applicant.
Sec. 515.11 Supplemental medicated feed mill license applications.
(a) After approval of a medicated feed mill license application to
manufacture animal feed, a supplemental application shall be submitted
for a change in ownership and/or a change in mailing address of the
facility site.
(b) Each supplemental application should be accompanied by a fully
completed Form FDA 3448 and include an explanation of the change.
(c) Within 30 working days after a supplemental application has
been filed, if the Commissioner of Food and Drugs determines that the
application provides adequate information respecting the change in
ownership and/or postal address of the facility site, then an
authorized employee of the Food and Drug Administration designated by
the Commissioner shall notify the applicant that it is approved by
signing and mailing to the applicant a copy of the Form FDA 3448.
Supplemental applications that do not provide adequate information
shall be returned to the applicant and all reasons for the return of
the application shall be made known to the applicant.
Subpart B--Administrative Actions on Licenses
Sec. 515.20 Approval of medicated feed mill license applications.
Within 90 days after an application has been filed under
Sec. 515.10, if the Commissioner of Food and Drugs (the Commissioner)
determines that none of the grounds for denying approval specified in
section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act)
applies, an authorized employee of the Food and Drug Administration
designated by the Commissioner shall notify the applicant that it is
approved by signing and mailing to the applicant a copy of the Form FDA
3448.
Sec. 515.21 Refusal to approve a medicated feed mill license
application.
(a) The Commissioner of Food and Drugs (the Commissioner) shall
within 90 days, or such additional period as may be agreed upon by the
Commissioner and the applicant, after
[[Page 63205]]
the filing of an application under Sec. 515.10, inform the applicant in
writing of his/her intention to issue a notice of opportunity for a
hearing on a proposal to refuse to approve the application, if the
Commissioner determines upon the basis of the application, on the basis
of a preapproval inspection, or upon the basis of any other information
before him that:
(1) The application is incomplete, false, or misleading in any
particular; or
(2) The methods used in and the facilities and controls used for
the manufacturing, processing, and packaging of such animal feed are
not adequate to preserve the identity, strength, quality, and purity of
the new animal drug therein; or
(3) The facility manufactures animal feeds bearing or containing
new animal drugs in a manner that does not accord with the
specifications for manufacture or labels animal feeds bearing or
containing new animal drugs in a manner that does not accord with the
conditions or indications of use that are published under section
512(i) of the act.
(b) The Commissioner, as provided in Sec. 515.30, shall
expeditiously notify the applicant of an opportunity for a hearing on
the question of whether such application is approvable, unless by the
30th day following the date of issuance of the letter informing the
applicant of the intention to issue a notice of opportunity for a
hearing the applicant:
(1) Withdraws the application; or
(2) Waives the opportunity for a hearing; or
(3) Agrees with the Commissioner on an additional period to precede
issuance of such notice of hearing.
Sec. 515.22 Suspension and/or revocation of approval of a medicated
feed mill license.
(a) The Secretary of Health and Human Services may suspend a
medicated feed mill license approved under section 512(m)(2) of the
Federal Food, Drug, and Cosmetic Act (the act) and give the person
holding the medicated feed mill license application prompt notice of
this action and afford the applicant the opportunity for an expedited
hearing on a finding that there is an imminent hazard to the health of
man or of the animals for which such animal feed is intended.
(b) The Commissioner of Food and Drugs (the Commissioner ) shall
notify in writing the person holding an application approved under
section 512(m)(2) of the act and afford an opportunity for a hearing on
a proposal to revoke approval of such application if the Commissioner
finds:
(1) That the application contains any untrue statement of a
material fact; or
(2) That the applicant has made any changes that would cause the
application to contain any untrue statements of material fact or that
would affect the safety or effectiveness of the animal feeds
manufactured at the facility unless the applicant has supplemented the
application by filing a supplemental application under Sec. 515.11.
(c) The Commissioner may notify in writing the person holding an
application approved under section 512(m)(2) of the act and afford an
opportunity for a hearing on a proposal to revoke approval of such
application if the Commissioner finds:
(1) That the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports in accordance with
a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of
the act, or the applicant has refused to permit access to, or copying,
or verification of, such records as required by sections 512(m)(5)(B)
or 504(a)(3)(B) of the act; or
(2) That on the basis of new information before him, evaluated
together with the evidence before him when such license was issued, the
methods used in, or the facilities and controls used for, the
manufacture, processing, packing, and holding of such animal feed are
inadequate to assure and preserve the identity, strength, quality, and
purity of the new animal drug therein, and were not made adequate
within a reasonable time after receipt of written notice from the
Commissioner specifying the matter complained of; or
(3) That on the basis of new information before him, evaluated
together with the evidence before him when such license was issued, the
labeling of any animal feeds, based on a fair evaluation of all
material facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written notice from
the Commissioner specifying the matter complained of; or
(4) That on the basis of new information before him, evaluated
together with the evidence before him when such license was issued, the
facility has manufactured, processed, packed, or held animal feed
bearing or containing a new animal drug adulterated under section
501(a)(6) of the act, and the facility did not discontinue the
manufacture, processing, packing, or holding of such animal feed within
a reasonable time after receipt of written notice from the Commissioner
specifying the matter complained of.
Sec. 515.23 Voluntary revocation of medicated feed mill license.
A license issued under section 512(m)(2) of the Federal Food, Drug,
and Cosmetic Act (the act) will be revoked on the basis of a request
for its revocation submitted in writing by a responsible individual
holding such license on the grounds that the facility no longer
manufactures any animal feed covered under Sec. 558.4(b) of this
chapter. A written request for such revocation shall be construed as a
waiver of the opportunity for a hearing as otherwise provided for in
this section. Revocation of approval of a medicated feed mill license
under the provisions of this paragraph shall be without prejudice.
Sec. 515.24 Notice of revocation of a medicated feed mill license.
When a license approved under section 512 of the Federal Food,
Drug, and Cosmetic Act (the act) is revoked by the Commissioner of Food
and Drugs (the Commissioner), the Commissioner will give appropriate
public notice of such action by publication in the Federal Register.
Sec. 515.25 Revocation of order refusing to approve a medicated feed
mill license application or suspending or revoking a license.
The Commissioner of Food and Drugs (the Commissioner), upon his/her
own initiative or upon request of an applicant stating reasonable
grounds therefor and if the Commissioner finds that the facts so
require, may issue an order approving a medicated feed mill license
application that previously has had its approval refused, suspended, or
revoked.
Sec. 515.26 Services of notices and orders.
All notices and orders under this part 515 and section 512 of the
Federal Food, Drug, and Cosmetic Act (the act) pertaining to medicated
feed mill licenses shall be served:
(a) In person by any officer or employee of the Department of
Health and Human Services designated by the Commissioner of Food and
Drugs; or
(b) By mailing the order by certified mail addressed to the
applicant or respondent at the applicant or respondent's last known
address in the records of the Food and Drug Administration.
[[Page 63206]]
Subpart C--Hearing Procedures
Sec. 515.30 Contents of notice of opportunity for a hearing.
(a) The notice to the applicant of opportunity for a hearing on a
proposal by the Commissioner of Food and Drugs (the Commissioner) to
refuse to approve a medicated feed mill license application or to
revoke the approval of a medicated feed mill license will specify the
grounds upon which the Commissioner proposes to issue this order. On
request of the applicant, the Commissioner will explain the reasons for
the action. The notice of opportunity for a hearing will be published
in the Federal Register and will specify that the applicant has 30 days
after issuance of the notice within which the Commissioner is required
to file a written appearance electing whether:
(1) To avail himself of the opportunity for a hearing; or
(2) Not to avail himself of the opportunity for a hearing.
(b) If the applicant fails to file a written appearance in answer
to the notice of opportunity for hearing, this failure will be
construed as an election not to avail himself of the opportunity for
the hearing, and the Commissioner without further notice may enter a
final order.
(c) If the applicant elects to avail himself of the opportunity for
a hearing, the applicant is required to file a written appearance
requesting the hearing within 30 days after the publication of the
notice, giving the reason why the application should not be refused or
the medicated feed mill license should not be revoked, together with a
well-organized and full-factual analysis of the information the
applicant is prepared to prove in support of his opposition to the
Commissioner's proposal. A request for a hearing may not rest upon mere
allegations or denials, but must set forth specific facts showing there
is a genuine and substantial issue of fact that requires a hearing.
When it clearly appears from the information in the application and
from the reasons and factual analysis in the request for the hearing
that no genuine and substantial issue of fact precludes the refusal to
approve the application or the revocation of approval of the
application, the Commissioner will enter an order on this information,
stating his/her findings and conclusions. If a hearing is requested and
is justified by the applicant's response to the notice of opportunity
for a hearing, the issues will be defined, an Administrative Law Judge
will be named, and the Judge shall issue a written notice of the time
and place at which the hearing will commence. In the case of denial of
approval, such time shall be not more than 90 days after the expiration
of such 30 days unless the Administrative Law Judge and the applicant
otherwise agree; and, in the case of withdrawal of approval, such time
shall be as soon as practicable.
(d) The hearing will be open to the public; however, if the
Commissioner finds that portions of the application which serve as a
basis for the hearing contain information concerning a method or
process entitled to protection as a trade secret, the part of the
hearing involving such portions will not be public, unless the
respondent so specifies in the appearance.
Sec. 515.31 Procedures for hearings.
Hearings relating to new animal drugs under section 512(m)(3) and
(m)(4) of the Federal Food, Drug, and Cosmetic Act (the act) shall be
governed by part 12 of this chapter.
Subpart D--Judicial Review
Sec. 515.40 Judicial review.
The transcript and record shall be certified by the Commissioner of
Food and Drugs (the Commissioner). In any case in which the
Commissioner enters an order without a hearing under Sec. 314.200(g) of
this chapter, the request(s) for hearing together with the data and
information submitted and the Commissioner's findings and conclusions
shall be included in the record certified by the Commissioner.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
22. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: U.S.C. 360b, 371.
Sec. 558.3 [Amended]
23. Section 558.3 Definitions and general considerations applicable
to this part is amended in paragraphs (b)(3) and (b)(4) by removing the
phrase ``an application approved under Sec. 514.105(b) of this
chapter'' and adding in its place ``a medicated feed mill license
application approved under Sec. 515.20 of this chapter''; and in
paragraphs (b)(2) and (b)(5) by removing ``Sec. 514.105(a)'' and adding
in its place ``Sec. 514.105''.
24. Section 558.4 is amended by revising the section heading and
paragraphs (a), (b), and (c) to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
(a) A feed manufacturing facility must possess a medicated feed
mill license in order to manufacture a Type B or Type C medicated feed
from a Category II, Type A medicated article.
(b) The manufacture of the following types of feed are exempt from
the required license, unless otherwise specified:
(1) Type B or Type C medicated feed using Category I, Type A
medicated articles or Category I, Type B or Type C medicated feeds; and
(2) Type B or Type C medicated feed using Category II, Type B or
Type C medicated feeds.
(c) The use of Type B and Type C medicated feeds shall also conform
to the conditions of use provided for in subpart B of this part and in
Secs. 510.515 and 558.15 of this chapter.
* * * * *
Dated: August 12, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-29856 Filed 11-18-99; 8:45 am]
BILLING CODE 4160-01-F
