Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
44
DECLARATION of Amy A. Barcelo in Support re: 40 MOTION for Summary Judgment.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P Part 1 of 5, # 17 Exhibit P Part 2 of 5, # 18 Exhibit P Part 3 of 5, # 19 Exhibit P Part 4 of 5, # 20 Exhibit P Part 5 of 5)(Barcelo, Amy)
Federal Register / Vol. 75, No. 59 / Monday, March 29, 2010 / Proposed Rules
connection with the broadcast
presentation, must contain a brief
summary of all necessary information
related to side effects and
contraindications.
(ii) Clear, conspicuous, and neutral
manner. Advertisements for
prescription drugs intended for use by
humans presented directly to consumers
in television or radio format must
present the major statement in a clear,
conspicuous, and neutral manner. A
major statement is clear, conspicuous,
and neutral if:
(A) Information is presented in
language that is readily understandable
by consumers;
(B) Audio information is
understandable in terms of the volume,
articulation, and pacing used;
(C) Textual information is placed
appropriately and is presented against a
contrasting background for sufficient
duration and in a size and style of font
that allows the information to be read
easily; and
(D) The advertisement does not
include distracting representations
(including statements, text, images, or
sounds or any combination thereof) that
detract from the communication of the
major statement.
*
*
*
*
*
Dated: March 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6996 Filed 3–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 514, and 558
[Docket No. FDA–2010–N–0155]
Veterinary Feed Directive
AGENCY:
Food and Drug Administration,
HHS.
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ACTION: Advance notice of proposed
rulemaking.
SUMMARY: The Food and Drug
Administration (FDA or the agency) is
announcing an advance notice of
proposed rulemaking (ANPRM) to
solicit comments from the public
regarding potential changes to its
current regulation relating to veterinary
feed directive (VFD) drugs. FDA’s VFD
regulation, which became effective on
January 8, 2001, established
requirements relating to the distribution
and use of VFD drugs and animal feeds
containing such drugs. FDA is
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undertaking a review of these
requirements in an effort to identify
possible changes to improve efficiency.
Therefore, the agency is requesting
public comment on all aspects of the
VFD regulation, particularly suggestions
relating to improving efficiency. This
information may be used to help draft
a proposed rule in the near future.
DATES: Submit electronic or written
comments by June 28, 2010.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2010–N–
0155, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received may be posted
without change to http://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Neal
Bataller, Center for Veterinary Medicine
(HFV–230), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9201, email: Neal.Bataller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
15387
I. Background
approval and marketing of new animal
drugs and medicated feeds. As part of
the ADAA, Congress determined that
certain new animal drugs should be
approved for use in animal feed but
only if these medicated feeds were
administered under a veterinarian’s
order and professional supervision.
Therefore, the ADAA created a new
category of products called veterinary
feed directive drugs (or VFD drugs).
VFD drugs are new animal drugs
intended for use in or on animal feed
which are limited to use under the
professional supervision of a licensed
veterinarian in the course of the
veterinarian’s professional practice.
In the Federal Register of December 8,
2000 (65 FR 76924), FDA issued a final
rule amending the new animal drug
regulations to implement the VFDrelated provisions of the ADAA. FDA
reaffirmed that certain new animal
drugs should be approved for use in
animal feed only if these medicated
feeds are administered under a
veterinarian’s order and professional
supervision. Veterinarian oversight is
important for assuring the safe and
appropriate use of certain new animal
drugs. For example, safety concerns
relating to the difficulty of disease
diagnosis, drug toxicity, drug residues,
antimicrobial resistance, or other
reasons may dictate that the use of a
medicated feed be limited to use by
order and under the supervision of a
licensed veterinarian.
It has been 9 years since FDA began
implementing the final rule regulating
VFDs. Although, currently there are few
approved VFD animal drug products,
FDA has received a number of informal
general comments that characterize the
current VFD process as being overly
burdensome. In addition, there are
concerns that the process in its current
form will become particularly
problematic to administer in the future
as the number of approved VFD animal
drugs increases. When veterinary
oversight of a medicated feed is
determined to be necessary, it is
critically important that such oversight
be facilitated through an efficient VFD
process. In response to these concerns,
the agency is undertaking a review of
the VFD regulations to determine
whether changes are warranted to
improve the program’s efficiency.
Before 1996, two options existed for
regulating the distribution of animal
drugs, including drugs in animal feed:
(1) Over-the-counter (OTC) and (2)
prescription. In 1996, Congress passed
and the President signed into law the
Animal Drug Availability Act (ADAA)
(Public Law 104–250), to facilitate the
II. Agency Request for Comments
The purpose of this document is to
solicit public comment on whether such
efficiency improvements are needed
and, if so, on possible revisions to the
VFD regulations. Such comments are
welcome on all aspects of the VFD
regulation. To facilitate FDA’s review of
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Federal Register / Vol. 75, No. 59 / Monday, March 29, 2010 / Proposed Rules
submitted comments, please organize
your comments based on the major
categories of requirements included in
the current VFD regulation at 21 CFR
558.6. These categories of requirements
are listed following this paragraph. (See
A through F.) If your comment
addresses an issue outside of one of
these categories, please categorize your
comment as G. ‘‘Other:’’
A. Conditions that must be met by
veterinarians issuing a VFD;
B. What veterinarians must do with a
VFD (e.g., disposition of original VFD
and copies);
C. Records that must be kept related
to the VFDs;
D. Notification requirements for
distributors of animal feeds containing a
VFD drug;
E. Additional recordkeeping
requirements that apply to distributors;
F. Cautionary statements required for
VFD drugs and animal feeds containing
VFD drugs; and
G. Other.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper 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 Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6872 Filed 3–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Parts 124, 126, and 129
[Public Notice: 6931]
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RIN 1400–AC62
Amendment to the International Traffic
in Arms Regulations: Removing
Requirement for Prior Approval for
Certain Proposals to Foreign Persons
Relating to Significant Military
Equipment
Department of State.
Proposed rule.
AGENCY:
ACTION:
The Department of State is
amending the International Traffic in
Arms Regulations (ITAR) to remove the
SUMMARY:
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16:34 Mar 26, 2010
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requirements for prior approval or prior
notification for certain proposals to
foreign persons relating to significant
military equipment at section 126.8 of
the ITAR.
DATES: Effective Date: The Department
of State will accept comments on this
proposed rule until May 28, 2010.
ADDRESSES: Interested parties may
submit comments within 60 days of the
date of the publication by any of the
following methods:
• E-mail:
DDTCResponseTeam@state.gov with an
appropriate subject line.
• Mail: Department of State,
Directorate of Defense Trade Controls,
Office of Defense Trade Controls Policy,
ATTN: Regulatory Change, Section
126.8, SA–1, 12th Floor, Washington,
DC 20522–0112.
• Persons with access to the Internet
may also view this notice by going to
the U.S. Government regulations.gov
Web site at http://regulations.gov/
index.cfm.
FOR FURTHER INFORMATION CONTACT:
Director Charles B. Shotwell, Office of
Defense Trade Controls Policy,
Department of State, Telephone (202)
663–2803 or Fax (202) 261–8199; E-mail
DDTCResponseTeam@state.gov. ATTN:
Regulatory Change, Section 126.8.
Effective
September 1, 1977, the Department of
State amended the International Traffic
in Arms Regulations (ITAR) at 22 CFR
123.16, to require Department of State
approval before a proposal or
presentation is made that is designed to
constitute the basis for a decision to
purchase significant combat equipment,
involving the export of an item on the
U.S. Munitions List, valued at
$7,000,000 or more for use by the armed
forces of a foreign country (42 FR 41631,
dated August 18, 1977). Also, 22 CFR
124.06, entitled ‘‘Approval of proposals
for technical assistance and
manufacturing license agreements,’’ was
amended to require similar prior
approval requirements with respect to
proposals and presentations for
technical assistance and manufacturing
license agreements involving the
production or assembly of significant
combat equipment.
‘‘Proposals to foreign persons relating
to significant military equipment’’
became section 126.8 in a final rule
effective January 1, 1985 (49 FR 47682,
dated December 6, 1984). Section 126.8
did not require prior approval of the
Department of State when the proposed
sale was to the armed forces of a
member of the North Atlantic Treaty
Organization (NATO), Australia, Japan,
SUPPLEMENTARY INFORMATION:
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or New Zealand, except with respect to
manufacturing license agreements or
technical assistance agreements.
A prior notification requirement,
instead of prior approval, was added to
section 126.8 in a final rule effective
March 31, 1985 (50 FR 12787, dated
April 1, 1985). Prior notification to the
Department of State was required 30
days in advance of a proposal or
presentation to any foreign person
where such proposals or presentations
concern equipment previously approved
for export.
The current section 126.8 requires
prior approval or prior notification for
certain proposals and presentations to
make a determination whether to
purchase significant military equipment
valued at $14,000,000 or more (other
than a member of NATO, Australia,
New Zealand, Japan, or South Korea), or
whether to enter into a manufacturing
license agreement or technical
assistance agreement for the production
or assembly of significant military
equipment, regardless of dollar value.
These types of proposals and
presentations usually involve large
dollar amounts. Before the defense
industry undertakes the effort involved
in formulating its proposals and
presentations, if there is any doubt that
the corresponding license application or
proposed agreement would not be
authorized by the Department of State,
the industry may request an advisory
opinion (See 22 CFR 126.9). The written
advisory opinion, though not binding on
the Department, helps inform the
defense industry whether the
Department would likely grant a license
application or proposed agreement.
Currently, the time between submitting
a license application or proposed
agreement and obtaining a decision
from the Department of State whether to
authorize such transactions has been
decreased sufficiently that requiring
prior approval or prior notification for
proposals is unnecessary and imposes
an administrative burden on industry.
References to § 126.8 have been
removed at §§ 124.1(a), 126.13, and
129.8(c).
Regulatory Analysis and Notices
Administrative Procedure Act
This proposed amendment involves a
foreign affairs function of the United
States and, therefore, is not subject to
the procedures contained in 5 U.S.C.
553 and 554.
Regulatory Flexibility Act
Since this proposed amendment
involves a foreign affairs function of the
United States, it does not require
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