[Federal Register Volume 62, Number 146 (Wednesday, July 30, 1997)]
[Proposed Rules]
[Pages 40765-40773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19820]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 207, 225, 510, 514, 515, and 558
[Docket No. 97N-0276]
Animal Drug Availability Act; Medicated Feed Mill Licenses
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the animal drug regulations to provide for feed mill licensing in
accordance with the Animal Drug Availability Act (ADAA) of 1996. The
ADAA amends the Federal Food, Drug, and Cosmetic Act (the act) to
require a single facility license for the manufacture of feeds
containing approved new animal drugs, rather than multiple medicated
feed applications (MFA's) for each feed mill, as previously required by
the act. The proposed regulation implements the requirements for feed
mill licensing set forth in the ADAA.
DATES: Submit written comments on the proposed rule by October 28,
1997. Submit written comments on the information collection provisions
by August 29, 1997. The agency proposes that any final rule that may
issue based on this proposal become effective 30 days after date of
publication of the final rule.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Submit written comments on information collection
requirements to the Office of Information and Regulatory Affairs, OMB,
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC
20503, Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: William D. Price, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1724.
SUPPLEMENTARY INFORMATION:
I. Background
The ADAA (Pub. L. 104-250), which amended section 512(a) and (m) of
the act (21 U.S.C. 360b(a) and (m)), replaces the system for the
approval of specific medicated feeds with a general licensing system.
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 to submit a separate MFA for each medicated feed to be
manufactured by the firm. The ADAA eliminates the requirement that a
feed mill submit a separate MFA for the manufacture of each type of
medicated feed and instead provides for feed mills to be licensed and
allows a licensed facility 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 a
medicated feed mill license. The ADAA sets forth the requirements for
such licensing.
The proposed regulation will 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
exempted from the MFA requirement under Sec. 558.4 (21 CFR 558.4) will
also be exempt from the requirement of a medicated feed mill license
under this proposal. Thus, the regulation, in implementing the statute,
would reduce the overall costs of regulatory compliance for industry.
Additionally, because of the reduction in the number of applications
that FDA would process annually, the proposed regulation, in
implementing the statute, would reduce costs for the Federal
Government.
The ADAA contains a transitional provision that provides that any
person currently engaged in the manufacture of a medicated feed under
an approved MFA shall be deemed to hold a medicated feed mill license
for the manufacturing site identified in the application. Such
transitional license
[[Page 40766]]
expires April 9, 1998, 18 months after the date of enactment of the
ADAA, unless the person has obtained a medicated feed mill license by
that date.
II. Description of the Proposed Rule
The proposed regulation implements the requirements of section
512(m) of the act for medicated feed mill licensing. The proposed rule
would add a new part 515 to provide the requirements for feed mill
licensing. The proposed rule would amend part 514 (21 CFR part 514) to
remove the provisions regarding MFA's.
Section 515.10 sets forth the criteria for medicated feed mill
license applications. Section 515.10(b)(1) requires the applicant to
provide the full business name and address of the feed manufacturing
facility and the facility's FDA registration number. Section
515.10(b)(2) requires the applicant to provide the name, title, and
original signature of the responsible individual or individuals for
that facility. Section 515.10(b)(3) requires the applicant to certify
that the feed manufacturing facility is manufacturing and labeling the
animal feed bearing or containing new animal drugs in accordance with
applicable regulations published under section 512(i) of the act.
Section 515.10(b)(4) requires the applicant to certify that the feed
manufacturing facility is in conformity with current good manufacturing
practice (CGMP) requirements. All of these requirements are set forth
in section 512(m)(1) of the act, as amended by the ADAA.
Section 515.10(b)(5) requires the applicant to certify that the
feed manufacturing facility will comply with applicable regulations or
orders issued under sections 512(m)(5)(A) or 504(a)(3)(A) (21 U.S.C.
354(a)(3)(A)) of the act for record and reporting requirements. This
certification requirement is based on section 512(m)(5)(A) of the act,
which sets forth the agency's authority to issue record and reporting
requirements applicable to medicated feed mill licensees, and section
512(m)(4)(B)(i) of the act, which sets forth the agency's authority to
revoke a license for the licensee's failure to comply with such
requirements.
Section 515.10(b)(6) requires the applicant to commit to the
possession of current approved Type B and/or Type C medicated feed
labeling for each animal feed containing an approved new animal drug.
The labeling is submitted in the new animal drug application (NADA)
under Sec. 514.1(b)(3)(v)(b). This commitment to possess the approved
labeling is based on section 512(a)(1)(B) of the act, which requires
that at the time of removal of the Type A medicated article from a
manufacturing, packing, or distributing establishment, such
establishment must possess an unrevoked written statement from the feed
manufacturing facility that such facility possesses a medicated feed
mill license and current approved medicated feed labeling for the use
of the Type A medicated article in animal feed. The facility can
provide such a statement to the manufacturing, packing, or distributing
establishment only if that facility is currently in possession of the
approved labeling, which is the labeling approved in the NADA for the
new animal drug in animal feed.
Section 515.10(b)(7) requires the applicant to commit to renew
registration with FDA every year, in accordance with Secs. 207.20 and
207.21 (21 CFR 207.20 and 207.21). Section 207.20(a) requires owners or
operators of all drug establishments, not exempt under Sec. 207.10 (21
CFR 207.10), that engage in the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs to register with FDA; and
Sec. 207.21 requires the yearly renewal of such registration. Section
207.10(f) exempts domestic establishments that manufacture only certain
types of medicated feed from the registration requirement. If a feed
mill manufactures any type of medicated feed that is not exempt under
Sec. 207.10(f), then the feed mill must register the establishment with
FDA under Sec. 207.20. The types of feed that would require
registration of the establishment under Sec. 207.20 would also require
a medicated feed mill license under Sec. 558.4. Thus, under
Secs. 207.10(f) and 558.4, each medicated feed mill that must possess a
license must also register the establishment with FDA. Medicated feed
mill licensees, however, are exempt from any drug listing requirement
under Sec. 207.20(a).
Section 515.10(d) provides for the return of applications that are
``facially deficient.'' The agency would apply this provision to those
applications that fail to provide sufficient information for the agency
to make a determination regarding approvability, such as if the
application is unsigned or undated. Thus, the provision is intended to
allow the agency to respond quickly to facially deficient applications
so that the applicant may have an opportunity to correct the
deficiencies and resubmit the application.
Section 515.11 sets forth the criteria for supplemental medicated
feed mill license applications. Section 515.11(a) requires a licensee
to supplement an application for a change in ownership and/or mailing
address of the facility site. The relocation of the feed manufacturing
facility to a new site would require the submission of a new medicated
feed mill license application, because an approved license is site
specific.
Section 515.11(c) requires the agency to approve a supplemental
medicated feed mill license application within 30 days after the filing
of such an application if the Commissioner of Food and Drugs (the
Commissioner) determines that the application provides ``adequate
information'' respecting the change in ownership and/or mailing address
of the facility site. The agency views supplemental applications as a
means to ensure the accuracy of agency records regarding a licensed
site. Thus, under this provision, the supplemental application would be
approved if the application provided the agency with a complete and
accurate description of the change in ownership and/or mailing address
of the facility site.
Section 515.11(c) also requires the agency to return supplemental
applications that fail to provide adequate information respecting a
change in ownership and/or mailing address of the facility site.
Because of the limited nature of the changes requiring an approved
supplemental application, the agency believes it would be inefficient
to deny applications that do not provide adequate information regarding
such a change. Therefore, a supplemental application that does not
provide a complete and accurate description of a change would be
returned to the applicant to complete.
Section 515.20 sets forth the requirements for the approval of
medicated feed mill license applications, and Sec. 515.21 sets forth
the requirements for the refusal to approve a medicated feed mill
license application. Section 515.22 sets forth the requirements for the
suspension and/or revocation of a medicated feed mill license and
Sec. 515.23 provides for the voluntary revocation of a medicated feed
mill license. Section 515.24 provides for the notice of revocation of
medicated feed mill licenses, Sec. 515.25 provides for the revocation
of an order refusing to approve an application or suspending or
revoking a license, and Sec. 515.26 provides for the service of notices
and orders.
Section 515.30 sets forth the provisions for a notice of
opportunity for a hearing concerning a refusal to approve a medicated
feed mill license application or a revocation of approval of a
medicated feed mill license. Section 515.31 describes the procedures
for hearings, and Sec. 515.40 provides for the
[[Page 40767]]
judicial review of an order entered by the Commissioner.
The proposed regulation also provides conforming amendments to the
Code of Federal Regulations by removing references to MFA's and
inserting appropriate references to medicated feed mill licenses. In
particular, the references to ``medicated feed application'' in other
sections have been eliminated and replaced, where appropriate, with the
new term ``medicated feed mill license.''
The proposed rule would amend Sec. 207.10(f) in order to clarify
the exemption from the requirement of establishment registration, as
set forth in Sec. 207.20. Section 207.10(f), as amended, clarifies the
types of feed manufactured exclusively by a facility that would not
require the registration of that facility. This clarification would
make the scope of this exemption from the requirement of establishment
registration identical to the scope of the exemption from the
requirement of a medicated feed mill license in Sec. 558.4(b).
The general scheme for categories and types of medicated feeds set
forth in Sec. 558.3 (21 CFR 558.3) would remain under medicated feed
mill licensing. Those medicated feeds exempted from the MFA requirement
under Sec. 558.4 also would be exempt from the requirement of a
medicated feed mill license under this proposal. Thus, the manufacture
of a Type B or Type C medicated feed from a Category I Type A medicated
article or from a Category II Type B or Type C medicated feed would be
exempt from the required license, unless otherwise specified.
Section 512(m)(6) of the act, as amended by the ADAA, provides the
agency with the authority, consistent with the public health, to
establish such an exemption. Category I Type A medicated articles, as
defined in Sec. 558.3(b)(1), require no withdrawal period at the lowest
use level in each species for which they are approved. Because Category
I Type A medicated articles do not require a withdrawal period, the
agency has determined that the exemption from the licensing requirement
for facilities that manufacture only Type B and Type C medicated feed
from Category I Type A articles, with the exception of certain types of
liquid and free choice medicated feed, would be consistent with the
protection of the public health. Furthermore, because Category II, Type
B and Type C medicated feeds are much more dilute than the Type A
medicated articles, Type B and Type C medicated feeds manufactured from
Category II Type B and Type C medicated feeds are unlikely to produce
unsafe (above tolerance) residues when such feed is fed to animals.
Thus, the agency has determined that the exemption from the licensing
requirement for facilities that manufacture only Type B or Type C
medicated feeds from Category II Type B or Type C medicated feeds would
be consistent with the protection of the public health.
The references to ``medicated feed application'' in the sections
for liquid medicated feed (21 CFR 558.5), and free-choice medicated
feed (21 CFR 510.455), will be amended in a future proposal that may
incorporate substantive changes to these provisions. The agency is
reviewing a citizen petition filed by the American Feed Industry
Association (AFIA) on April 30, 1993, as amended on March 3, 1994, and
December 6, 1996, concerning liquid medicated feed. Additionally, the
references to ``medicated feed application'' in 21 CFR 558.311 and
558.355 for lasalocid and monensin, respectively, will be amended in
the future proposal.
Finally, the reference to ``medicated feed application'' in the
section for records and reports (21 CFR 510.301), has been changed in
this proposal to ``medicated feed mill license.'' The agency intends to
propose other changes to this section in a future proposal in response
to a citizen petition filed by AFIA and the Animal Health Institute on
November 13, 1995, as amended on December 6, 1996, concerning the
records and reports requirements for medicated feed manufacturing
facilities.
III. Proposed Effective Date
The agency proposes that any final rule that may issue based on
this proposal become effective 30 days after date of publication of the
final rule.
IV. Environmental Impact
FDA has carefully considered the potential environmental impacts of
this proposed rule.
The agency has determined under 21 CFR 25.24(a)(8) 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.
Feed mill licensing is a procedure established by the ADAA as a
replacement for FDA's previous MFA system. The proposed action
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 a MFA for each applicable feed containing an
approved new animal drug.
This paperwork streamlining in no way reduces the responsibility of
each facility to manufacture medicated feeds in full compliance with
CGMP's regulations. Nor does the proposed action prevent the 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.
V. Analysis of Impacts
FDA has examined the impact of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),
and under the Unfunded Mandates Reform Act (Pub. L. 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 million.
The agency has reviewed this proposed rule and has determined that
the rule is consistent with the principles set forth in the Executive
Order and in these two statutes. FDA finds that the proposed rule will
not be a significant regulatory action under the Executive
[[Page 40768]]
Order. Further, the agency finds that the proposed rule will not have a
significant effect on a substantial number of small entities. Also,
because the expenditures required by the proposed rule are under $100
million, FDA is not required to perform a cost/benefit analysis
according to the Unfunded Mandates Reform Act.
As provided in this proposed rule, FDA would amend the process for
obtaining approval to manufacture medicated feeds. Instead of requiring
an approved MFA for each applicable medicated feed, this proposed
regulation requires only a single facility license per feed mill, as
appropriate. The ADAA grants a transitional license to all feed
manufacturing facilities currently holding an approved MFA. This
transitional license is valid for 18 months. During this time, the
facilities can obtain a permanent license by submitting a license
application and a copy of an approved MFA to FDA. One goal of this
proposed rule is to streamline paperwork requirements for facilities
and FDA. Despite this switch from MFA's to facility licenses, all other
existing reporting responsibilities for each drug remain unchanged.
The only costs that will be incurred are the paperwork costs
associated with applying for a facility license. FDA estimates that
approximately 2,000 feed mills will be affected by this proposed rule,
and that it will take approximately 15 minutes for each facility to
complete its application. Taking 1,995 median weekly earnings of
$684\1\ for the executives, administrators, and managers who will
complete the applications, and adding 40 percent for fringe benefits,
yields average hourly earnings of $23.94. Thus, the combined paperwork
costs for all facilities total $11,970 for the first year, and $599 for
the estimated 100 mills expected to apply for licensing or license
supplements in each subsequent year. This total cost translates into
approximately $6 per mill.
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\1\ Employment and Earnings, U.S. Department of Labor Bureau and
Labor Statistics, vol. 43, No. 1, p. 205, January 1996.
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Eliminating the MFA requirement provides industry with a large
savings in paperwork burden. Over the past 5 years, the agency has
received approximately 3,300 MFA's 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. Therefore, FDA estimates
this proposed rule will save industry over $158,000 per year, or
approximately $79 per mill per year, on average. The mills that have
routinely submitted a larger number of MFA's will realize a larger
total savings than those mills that routinely submit fewer MFA's.
FDA will also experience a cost savings in response to the feed
mill licensing requirement. Since 1994, the agency spent approximately
$180,000 per year for a contractor to process the MFA's. In contrast,
FDA estimates that it will take 40 minutes to process each feed mill
license application at a cost of $25 per hour for a GS-13 Government
employee. In the first year, it will cost the agency $33,500 to process
the expected 2,000 applications, and a startup cost of $10,000 for a
tracking and indexing computerized database. It is expected to cost
only $1,700 to process the 100 applications for each year thereafter.
The Small Business Administration (SBA) defines all manufacturers
of prepared feeds and feed ingredients for animals and fowls having 500
employees or fewer as a small business. FDA estimates that
approximately 20 percent of the affected feed mills belong to large
conglomerates that have an overall employee count of higher than 500.
Therefore, the remaining 80 percent of the affected facilities would be
considered small businesses by SBA's standards. However, the agency
concludes that these altered paperwork burdens will constitute an
insignificant percentage of gross revenue. FDA finds the proposed rule
will provide a net economic savings for all facilities, as well as the
Federal Government. Therefore, in accordance with the Regulatory
Flexibility Act, FDA certifies that this proposed rule will not have a
significant economic effect on a substantial number of small entities.
VI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown below with an estimate of the annual
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Medicated Feed Mill License Application.
Description: This proposed rule implements the ADAA's medicated
feed mill licensing provisions. It would require that any medicated
feed manufacturing facility seeking a license submit an application to
FDA. In Sec. 515.10 of the proposed regulations, FDA is proposing that
the medicated feed mill license application form include:
(1) Manufacturing site legal business name,
(2) Address,
(3) Phone number,
(4) Fax number,
(5) Type of application,
(6) FDA registration number, and
(7) Date and signature.
The information on the form will be used to issue medicated feed
mill licenses. The information requested on the form is specifically
mandated by the ADAA, except for the phone number and fax number. These
numbers are needed so that FDA can contact the firm quickly when
necessary. The additional burden of supplying this information is
minimal.
Section 515.11 of the proposed regulations also specifies that
supplemental applications must be submitted for a change in ownership
and/or a change in mailing address. A medicated feed mill licensee
would submit such information to FDA on the medicated feed mill license
application form. Furthermore, Sec. 515.23 of the proposed regulations
also provides for voluntary revocation of the license. A medicated feed
mill licensee would submit in writing to FDA a request for voluntary
revocation of a license. Finally, Sec. 515.30 of the proposed
regulations provides procedures for 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 for a hearing
[[Page 40769]]
in writing to FDA in response to the agency's proposal to refuse to
approve a medicated feed mill license application.
Description of Respondents: Medicated feed manufacturing
facilities.
Table 1.--Estimated Annual Reporting Burden: First Year
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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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
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There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Reporting Burden: Each Succeeding Year
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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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
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There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates 2,000 respondents for the submission of a medicated
feed mill license application within the first year based on the number
of current MFA holders (approximately 2,000). Furthermore, FDA
estimates 100 respondents for the submission of a medicated feed mill
license application during each succeeding year based on the average
number of new firms that began to manufacture medicated feed in past
years. FDA estimates 25 respondents per year for the submission of
supplements based on the average number of supplements that FDA
received for MFA's in past years. FDA estimates 50 respondents per year
for the submission of voluntary revocation requests based on the
average number of cancellation requests that FDA received for feed mill
registration in past years. Finally, FDA estimates 0.15 respondents per
year for the submission of hearing requests based on the fact that FDA
received only approximately five such requests for MFA's in the past 33
years.
FDA has already begun accepting and acting on feed mill license
applications in accordance with its statutory authority to do so under
the ADAA. This proposed rule would not significantly change the
application form that is now being used for such applications. To allow
FDA to begin implementing the ADAA promptly, the OMB approved this
collection of information, including the use of the application Form
FDA 3448, on a temporary basis under the emergency processing
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(j)).
The approval is under OMB control number 0910-0337 and it was announced
in a notice published in the Federal Register of March 31, 1997 (62 FR
15186). The March 31, 1997, Federal Register notice solicited public
comment on the collection of information and provided 60 days for such
comments. FDA received no comments in response to this notice.
In compliance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information
collection provisions of this proposed rule to OMB for review.
Interested persons are requested to send comments regarding information
collection by August 29, 1997, to (address above).
VII. Request for Comments
Interested persons may, on or before, October 28, 1997, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Interested persons may, on or before August 29, 1997, submit
written comments on the information collection provisions to the Office
of Information and Regulatory Affairs, OMB (address above).
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.
21 CFR Part 514
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Part 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, it is
proposed that title 21 of the Code of Federal Regulations be amended as
follows:
[[Page 40770]]
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: Secs. 301, 501, 502, 505, 506, 507, 510, 512, 701,
704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351,
352, 355, 356, 357, 360, 360b, 371, 374); sec. 351 of the Public
Health Service Act (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
phrase ``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: Secs. 501, 502, 512, 701, 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360b, 371, 374).
6. Section 225.1 is amended by revising paragraph (b)(2) and by
adding a new paragraph (c) to read as follows:
Sec. 225.1 Current good manufacturing practice.
* * * * *
(b) * * *
(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 new animal drug applications and a medicated feed
mill license are subject to the requirements of Sec. 510.301 of this
chapter.
Sec. 225.58 [Amended]
7. Section 225.58 Laboratory controls is amended in paragraph
(b)(1) by revising the first sentence to read ``For feeds requiring a
medicated feed mill license (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 is amended by revising paragraph (b)(2) to read
as follow:
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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 376e).
10. Section 510.301 is amended by revising 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.
* * * * *
11. Section 510.305 is revised in its entirety 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 on
the premises of each establishment:
(a) A copy of the approved medicated feed mill license (Form FDA
3448); and
(b) Approved labeling for Type B and/or Type C feeds being
manufactured.
PART 514--NEW ANIMAL DRUG APPLICATIONS
12. The authority citation for 21 CFR part 514 continues to read as
follows:
Authority: Secs. 501, 502, 512, 701, 721, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360b, 371, 379e,
381).
Sec. 514.2 [Removed]
13. Section 514.2 Applications for animal feeds bearing or
containing new animal drugs is removed.
Sec. 514.9 [Removed]
14. Section 514.9 Supplemental applications for animal feeds
bearing or containing new animal drugs is removed.
Sec. 514.105 [Amended]
15. Section 514.105 Approval of applications is amended by removing
paragraph (b) and by redesignating paragraphs (a)(1) and (a)(2) as
paragraphs (a) and (b) and by removing the designation ``(a)'' from the
first paragraph.
Sec. 514.111 [Amended]
16. Section 514.111 Refusal to approve an application is amended by
removing paragraph (b) and redesignating paragraph (c) as paragraph
(b).
Sec. 514.112 [Removed]
17. Section 514.112 Return of applications for animal feeds bearing
or containing new animal drugs is removed.
Sec. 514.115 [Amended]
18. 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.
[[Page 40771]]
19. 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.
20. Part 515 is added to read as follows:
PART 515--MEDICATED FEED MILL LICENSE
Subpart A--Applications
Sec.
515.10 Applications for licenses to manufacture animal feeds
bearing or containing new animal drugs (medicated feed mill
license).
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 Service 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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Subpart A--Applications
Sec. 515.10 Applications for licenses to manufacture animal feeds
bearing or containing new animal drugs (medicated feed mill license).
(a) Applications (Form FDA 3448) to be filed under section 512(m)
of the Federal Food, Drug, and Cosmetic Act (the act) shall be
completed, signed, and submitted in the form described in paragraph (b)
of this section to the Division of Animal Feeds (HFV-220), Center for
Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.
(b) Each application for a license to manufacture animal feeds
bearing or containing new animal drugs shall include the following
information:
(1) A full statement of the business name and address of the
specific facility at which the manufacturing is to take place and the
facility's FDA registration number assigned under section 510 of the
act.
(2) The name, title, and original signature of the responsible
individual or individuals for that facility.
(3) 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.
(4) A certification that the methods used in, and the facilities
and controls used for, manufacturing, processing, packaging, and
holding such animal feeds are in conformity with current good
manufacturing practice as described in section 501(a)(2)(B) of the act
and part 225 of this chapter.
(5) A certification that the facility will establish and maintain
all records required by regulation or order issued under section
512(m)(5)(A) or 504(a)(3)(A) of the act, as published in Sec. 515.30,
and will permit access to, or copying or verification of such records.
(6) A commitment that current approved Type B and/or Type C
medicated feed labeling for each animal drug in animal feed will be in
the possession of the feed manufacturing facility prior to receiving
the Type A medicated article containing such drug.
(7) A commitment to renew registration every year with FDA as
required in Secs. 207.20 and 207.21 of this chapter.
(c) Upon approval, the original copy of the application will be
signed by an authorized employee of the Food and Drug Administration
designated by the Commissioner of Food and Drugs, and a copy will be
returned to the applicant.
(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) Applications (Form 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.
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 he shall
notify the applicant that it is approvable 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 determines that none
of the grounds for denying approval specified in section 512(m)(3) of
the Federal Food, Drugs, and Cosmetic Act applies, he 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 shall within 90 days, or
such additional period as may be agreed upon by the Commissioner and
the applicant, after the filing of an application under Sec. 515.10,
inform the applicant in writing of his 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 animals feeds bearing or
containing new animal drugs in a manner that does not accord with the
conditions or indications of use that are
[[Page 40772]]
published under section 512(i) of the Federal Food, Drug, and Cosmetic
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 a medicated feed mill
license application.
(a) The Secretary may suspend a medicated feed mill license
approved under section 512(m)(2) of the Federal Food, Drug, and
Cosmetic Act and give the person holding the medicated feed mill
license application prompt notice of his 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 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 he 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 he 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 section 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 section 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 ensure 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 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 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 is revoked by the Commissioner, he 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, upon his own initiative or upon
request of an applicant stating reasonable grounds therefor and if he
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 Service of notices and orders.
All notices and orders under this part and section 512 of the
Federal Food, Drug, and Cosmetic 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 his last known address in the records of the
Food and Drug Administration.
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 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 he
proposes to issue his order. On request of the applicant, the
Commissioner will explain the reasons for his 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 he 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, his 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, he is required to file a written appearance requesting the
hearing
[[Page 40773]]
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 he 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 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 he 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 his 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 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. 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
21. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.3 [Amended]
22. Section 558.3 Definitions and general considerations applicable
to this part is amended in paragraphs (b)(2) and (b)(5) by removing the
phrase ``an application approved under 514.105(a) of this chapter'' and
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 their
places ``a medicated feed mill license application approved under
Sec. 515.20 of this chapter''.
23. 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 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: July 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-19820 Filed 7-29-97; 8:45 am]
BILLING CODE 4160-01-F
