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Federal Register / Vol. 72, No.

206 / Thursday, October 25, 2007 / Rules and Regulations 60547

Rulemaking to amend section regulatory flexibility analysis is not TENNESSEE VALLEY AUTHORITY
344.9(a)(3) to extend the time period for required.
reporting quarterly personal securities 18 CFR Part 1301
transactions to 30-calendar days after C. Paperwork Reduction Act
the end of the calendar quarter.5 The Testimony by TVA Employees,
The recordkeeping and reporting Production of Official Records, and
comment period was 60 days, and requirements for securities transactions
expired on August 27, 2007. The FDIC Disclosure of Official Information in
in Part 344 constitute a collection of Legal Proceedings
received one comment on this proposal.
information as defined by the
The commenter supported the proposed AGENCY: Tennessee Valley Authority
amendment and agreed that the purpose Paperwork Reduction Act. The
information collection has been (TVA).
of extending the reporting deadline was
approved by the Office of Management ACTION: Final rule.
to align the FDIC’s requirements with
the SEC’s, and to promote practical and and Budget under control number 3064– SUMMARY: The Tennessee Valley
uniform recordkeeping requirements. 0028. The reporting requirements and Authority (‘‘TVA’’) is publishing as a
burden associated with that collection final rule a regulation governing access
III. Final Rule would not be affected by this rule. to TVA information and records in
As explained above, the FDIC connection with legal proceedings in
received one industry comment on its List of Subjects in 12 CFR Part 344
which neither the United States nor
proposal to extend the personal Reporting and recordkeeping TVA is a party. This final rule
securities transactions reporting requirements. establishes guidelines for use in
requirement to 30-calendar days after determining whether TVA employees
the end of the calendar quarter, which ■ For the reasons set forth in the will provide testimony or records
comment endorsed the FDIC’s reasoning preamble, title 12, chapter III, part 344, relating to their official duties. It also
for its proposal. Accordingly, the FDIC is amended as follows: establishes procedures for requesters to
is adopting the rule as proposed with no follow when making demands on or
requests to a TVA employee for official
CONFIRMATION REQUIREMENTS FOR documents or to provide testimony.
IV. Regulatory Analysis and Procedure
SECURITIES TRANSACTIONS This final rule standardizes TVA’s past
A. Plain Language
practices, promotes uniformity in
Section 722 of the Gramm-Leach- ■ 1. The authority citation for Part 344 decisions, conserves the ability of TVA
Bliley Act (12 U.S.C. 4809) requires the continues to read as follows: to conduct official business, preserves
FDIC to use ‘‘plain language’’ in all Authority: 12 U.S.C. 1817, 1818, and 1819. its employee resources, protects
proposed and final rules published after confidential information, provides
January 1, 2000. The proposed rule ■ 2. In § 344.9, paragraph (a)(3) is guidance to requestors, minimizes
requested comments on how the rule revised to read as follows: involvement in matters unrelated to
might be changed to reflect the TVA’s mission and programs, avoids
requirements of GLBA. No comments § 344.9 Personal securities trading
reporting by bank officers and employees. wasteful allocation of agency resources,
were received. and avoids spending public time and
B. Regulatory Flexibility Act (a) * * * money for private purpose.
(3) In connection with their duties, DATES: The effective date of the
Under section 605(b) of the
Regulatory Flexibility Act (‘‘RFA’’) (5 obtain information concerning which regulation is October 25, 2007.
U.S.C. 605(b)) the regulatory flexibility securities are being purchased or sold or FOR FURTHER INFORMATION CONTACT:
analysis otherwise required under recommend such action, must report to Nicholas P. Goschy, Assistant General
section 603 of the RFA (5 U.S.C. 603) is the bank, within 30-calendar days after Counsel, Tennessee Valley Authority,
not required if the head of the agency the end of the calendar quarter, all 400 W. Summit Hill Drive, Knoxville,
certifies that the rule will not have a transactions in securities made by them Tennessee 37902, (865) 632–8960.
significant economic impact on a or on their behalf, either at the bank or SUPPLEMENTARY INFORMATION:
substantial number of small entities and elsewhere in which they have a Background
the agency publishes such certification beneficial interest. The report shall
and a statement explaining the factual identify the securities purchased or sold TVA regularly receives subpoenas and
basis for such a certification in the and indicate the dates of the other informal requests for documents
Federal Register along with its rule. transactions and whether the and requests for TVA employees to
Pursuant to section 605(b) of the RFA, provide testimony or evidence in cases
transactions were purchases or sales.
the FDIC certifies that this final rule will in which TVA is not a party. Sometimes
not have a significant impact on a * * * * * these subpoenas or requests are for TVA
substantial number of small entities. By Order of the Board of Directors. records that are not available to the
The FDIC does not expect that this rule Dated at Washington, DC, the 16th day of public under the Freedom of
will create any additional burden on October, 2007. Information Act. TVA also receives
small entities. In effect, the rule extends requests for TVA employees to appear
Federal Deposit Insurance Corporation
to 30-calendar days the reporting period as witnesses in litigation and to provide
Robert E. Feldman, testimony relating to materials
within which officers and certain
employees of state nonmember banks Executive Secretary. contained in TVA’s official records or
have to report their personal securities [FR Doc. E7–20998 Filed 10–24–07; 8:45 am] provide testimony or information
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transactions and gives these individuals BILLING CODE 6714–01–P acquired during the performance of the
more latitude to report their quarterly employees’ official duties.
securities transactions. Accordingly, a Although many other federal agencies
currently have regulations in place to
5 72 FR 35204 (June 27, 2007). address these types of requests, and

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60548 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations

TVA itself has rules implementing the which TVA is not a named party. Subpart D—Testimony by TVA
Freedom of Information Act that govern Current and former TVA employees will Employees, Production of Official
requests for information from the not provide testimony about specific Records, and Disclosure of Official
general public, TVA has not had official matters involving information which Information in Legal Proceedings
regulations governing subpoenas and they acquired during the performance of
other information requests for document their official duties unless permitted to § 1301.51 Purpose and scope.
production and testimony of TVA testify as provided in the rule. They are (a) Purpose. This part sets forth the
employees in legal proceedings. Issues not restricted from providing testimony procedures to be followed when TVA or
about such requests that have arisen in on their own time about general matters a TVA employee is served with a
recent years warrant adoption of unconnected with the specific TVA demand to provide testimony and/or
regulations governing their submission, matters. produce or disclose official information
evaluation, and processing. Responding or records in a legal proceeding in
This final rule will ensure a more
to these requests is not only which TVA or the United States is not
efficient use of TVA’s resources,
burdensome, but may also result in a a party, and where such appearance
minimize the possibility of involving
significant disruption of a TVA arises out of, or is related to, the
TVA in issues unrelated to its
employee’s work schedule and possibly individual’s employment with TVA.
responsibilities, promote uniformity in
involve TVA in issues unrelated to its (b) Scope. This part applies when, in
responding to such subpoenas and like
responsibilities. In order to resolve these a judicial, administrative, legislative, or
requests, and maintain the impartiality
issues, many agencies have issued other legal proceeding, a TVA employee
of TVA in matters that are in dispute
regulations, similar to this final is served with a demand to provide
between other parties. It will also serve
regulation, governing the circumstances testimony concerning information
TVA’s interest in protecting sensitive,
and manner in which an employee may acquired in the course of performing
confidential, and privileged information
respond to demands for testimony or for official duties or because of official
and records that are generated in
the production of documents. status and/or to produce official
Establishing uniform procedures for fulfillment of TVA’s statutory
information and/or records.
legal processes will ensure timely notice responsibilities.
and promote centralized decision The final rule is internal and § 1301.52 Definitions.
making. The United States Supreme procedural rather than substantive. It The following definitions apply to
Court upheld this type of regulation in does not create a right to obtain official this part:
United States ex rel. Touhy v. Ragen, records or the official testimony of a (a) Appearance means testimony or
340 U.S. 462 (1951). TVA employee nor does it create any production of documents or other
On September 10, 2007, TVA additional right or privilege not already material, including an affidavit,
published in the Federal Register its available to TVA to deny any demand deposition, interrogatory, declaration, or
own proposed Touhy regulation, for or request for testimony or documents. other required written submission.
codification in part 1301 of 18 CFR. See Failure to comply with the procedures (b) Demand means a subpoena, order,
72 FR 51572–51574, which provided for set out in these regulations would be a or other demand of a court of competent
a 30 day comment period. TVA did not basis for denying a demand or request jurisdiction, or other specific authority
receive any comments on the proposed submitted to TVA. (e.g. an administrative or State
rule, and is issuing the final rule with legislative body), for the production,
no substantive changes from the List of Subjects in 18 CFR Part 1301 disclosure, or release of TVA records or
proposed rule. information or for the appearance of
Administrative practice and
The final rule will formalize past TVA personnel as witnesses in their
practices already utilized by TVA in official capacities.
responding to requests for disclosure of ■ For the reasons stated in the preamble, (c) Employee means any members of
official records or testimony by TVA TVA amends 18 CFR Chapter XIII, as the Board of Directors, officials, officers,
employees when TVA is not a party to follows: directors, employees or agents of TVA,
the litigation. Briefly summarized, the except as TVA may otherwise determine
final rule will prohibit disclosure of PART 1301—PROCEDURES in a particular case, and includes former
official records or testimony by TVA’s TVA employees to the extent that the
employees, as defined in section ■ 1. The authority citation for part 1301 information sought was acquired in the
1301.52, unless there is compliance continues to read as follows: performance of official duties for TVA.
with the rule. The final rule sets out the Authority: 16 U.S.C. 831–831ee, 5 U.S.C. (d) General Counsel means the
information that requesters must 552. General Counsel of TVA or a person to
provide and the factors that TVA will whom the General Counsel has
consider in making determinations in ■ 2. Part 1301 is amended by adding delegated authority under this part.
response to requests for testimony or the subpart D to read as follows: (e) Legal proceeding means any and
production of documents. The final rule Subpart D—Testimony by TVA Employees,
all pre-trial, trial, and post-trial stages of
sets forth TVA’s standard practice of Production of Official Records, and all judicial or administrative actions,
providing employee testimony by Disclosure of Official Information in Legal hearings, investigations, or similar
affidavit only and clarifies those steps Proceedings proceedings before courts, commissions,
requesters must follow in order to Sec. boards, or other judicial or quasi-
obtain official TVA documents, 1301.51 Purpose and scope. judicial bodies or tribunals, whether
including how to accomplish service of 1301.52 Definitions. criminal, civil, or administrative in
process on TVA. The final rule also 1301.53 General. nature.
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establishes a new practice that service 1301.54 Requirements for a demand for (f) Records or official records and
can now be accomplished by United records or testimony. information means all information in
States mail. 1301.55 Responding to demands. the custody and control of TVA, relating
This final rule applies to a range of 1301.56 Final determination. to information in the custody and
matters in any legal proceeding in 1301.57 Waiver. control of TVA, or acquired by a TVA

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Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations 60549

employee in performance of his or her categories of records sought, a detailed following factors, among others, in
official duties or because of his or her description of how the information deciding whether requested testimony
official status while the individual was sought is relevant to the issues in the or materials must be withheld:
employed by TVA. legal proceeding, and a specific (1) Whether production is appropriate
(g) Testimony means any written or description of the substance of the in light of any relevant privilege;
oral statements, including depositions, records sought. (2) Whether production is appropriate
answers to interrogatories, affidavits, (iii) If testimony is sought, a under the applicable rules of discovery
declarations, interviews, and statements description of the intended use of the or the procedures governing the case or
made by an individual in connection testimony, a detailed description of how matter in which the demand arose;
with a legal proceeding. the testimony sought is relevant to the (3) Whether the material requested is
issues in the legal proceeding, and a relevant to the matter at issue;
§ 1301.53 General. (4) Whether allowing such testimony
specific description of the substance of
(a) No employee shall appear, in the testimony sought. or production of records would be
response to a demand for official (iv) A statement as to how the need necessary to prevent a miscarriage of
records or information, in any for the information outweighs any need justice;
proceeding to which this part applies to to maintain the confidentiality of the (5) Whether disclosure would violate
provide testimony and/or produce information and outweighs the burden a statute, Executive Order, or regulation,
records or other official information on TVA to produce the documents or including, but not limited to, the
without prior authorization as set forth testimony. Privacy Act of 1974, as amended, 5
in this part. (v) A statement indicating that the U.S.C. 552a;
(b) This part is intended only to information sought is not available from (6) Whether disclosure would impede
provide procedures for responding to another source, from other persons or or interfere with an ongoing law
demands for testimony or production of entities, or from the testimony of enforcement investigation or
records or other official information, someone other than a TVA employee, proceeding, or compromise
and is not intended to, does not, and such as a retained expert. constitutional rights or national security
may not be relied upon to, create any (vi) The name, address, and telephone interests;
right or benefit, substantive or (7) Whether disclosure would
number of counsel to each party in the
procedural, enforceable by any party improperly reveal trade secrets or
against TVA and the United States. (d) Additional information. TVA proprietary confidential information
reserves the right to require additional without the owner’s consent;
§ 1301.54 Requirements for a demand for (8) Whether disclosure would unduly
records or testimony. information to complete the request
interfere with the orderly conduct of
(a) Service of demands. Only TVA’s where appropriate or to waive any of the
TVA’s functions;
General Counsel or his/her designee is requirements of this section at its sole (9) Whether the records or testimony
authorized to receive and accept discretion. can be obtained from other sources;
demands sought to be served upon TVA § 1301.55 Responding to demands. (10) Whether disclosure would result
or its employees. All such documents in TVA appearing to favor one litigant
Generally, authorization to provide
should be delivered in person or by over another;
the requested material or testimony
United States mail to the Office of the (11) Whether the demand or request is
shall not be withheld unless their
General Counsel, Tennessee Valley within the authority of the party making
Authority, 400 W. Summit Hill Drive, disclosure is prohibited by law or for it; and
Knoxville, Tennessee 37902. other compelling reasons, provided the (12) Whether a substantial
(b) Time limit for serving demands. request is reasonable and in compliance Government interest is implicated.
The demand must be served at least 30 with the requirements of this part, and (d) Restrictions on testimony or
days prior to the scheduled date of subject to the following conditions: production of records or official
testimony or disclosure of records, in (a) Demands for testimony. TVA’s information. When necessary or
order to ensure that the General Counsel practice is to provide requested appropriate, the General Counsel may
has adequate time to consider the testimony of TVA employees by impose restrictions or conditions on the
demand and prepare a response, except affidavit only. TVA will provide production of testimony or records or
in cases of routine requests for affidavit testimony in response to official information. These restrictions
personnel and payroll records located demands for such testimony, provided may include, but are not limited to:
on-site in Knoxville, where service 15 all requirements of this part are met and (1) Limiting the area of testimony;
days prior will normally be considered there is no compelling factor under (2) Requiring that the requester and
sufficient. The General Counsel may, paragraph (c) of this section that other parties to the legal proceeding
upon request and for good cause shown, requires the testimony to be withheld. agree to keep the testimony under seal;
waive the requirement of this paragraph. The General Counsel may waive this (3) Requiring that the testimony be
(c) Form of Demand. A demand for restriction when necessary. used or made available only in the legal
testimony or production of records or (b) Demands for production of records proceeding for which it was requested;
other official information must comply or official information. TVA’s practice is (4) Requiring that the parties to the
with the following requirements: to provide requested records or official legal proceeding obtain a protective
(1) The demand must be in writing information, provided all requirements order or execute a confidentiality
and submitted to the General Counsel. of this part are met and there is no agreement to limit access and any
(2) The demand must include the compelling factor under paragraph (c) of further disclosure of produced records
following information: this section that requires the records or or official information.
(i) The caption of the legal official information to be withheld. (e) Fees for Production. Fees will be
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proceeding, docket number, and name (c) Factors to be considered in charged for production of TVA records
and address of the court or other determining whether requested and information. The fees will be the
authority involved. testimony or records or official same as those charged by TVA pursuant
(ii) If production or records or other information must be withheld. The to its Freedom of Information Act
official information is sought, a list of General Counsel shall consider the regulations, 16 CFR 1301.10.

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60550 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations

§ 1301.56 Final determination. supplement to NADA 140–958 that DEPARTMENT OF HEALTH AND
The General Counsel makes the final provides for use of EQUIPHEN HUMAN SERVICES
determination whether a demand for (phenylbutazone) Paste in horses for
testimony or production of records or relief of inflammatory conditions Food and Drug Administration
official testimony in a legal proceeding associated with the musculoskeletal
in which TVA is not a party shall be system. The supplemental NADA 21 CFR Part 520
granted. All final determinations are provides for a revised human food
within the sole discretion of the General Oral Dosage Form New Animal Drugs;
safety warning on product labeling. The Spinosad
Counsel. The General Counsel will supplemental NADA is approved as of
notify the requesting party and, when September 26, 2007, and the regulations AGENCY: Food and Drug Administration,
necessary, the court or other authority of are amended in 21 CFR 520.1720c to HHS.
the final determination, the reasons for reflect the approval. ACTION: Final rule.
the grant or denial of the request, and
any conditions that the General Counsel Approval of this supplemental NADA SUMMARY: The Food and Drug
may impose on the production of did not require review of additional Administration (FDA) is amending the
testimony or records or official safety or effectiveness data or animal drug regulations to reflect
information. information. Therefore, a freedom of approval of a new animal drug
information summary is not required. application (NADA) filed by Elanco
§ 1301.57 Waiver. Animal Health. The NADA provides for
FDA has determined under 21 CFR
The General Counsel may grant a veterinary prescription use of spinosad
25.33(a)(1) that this action is of a type
waiver of any procedure described by chewable tablets to kill fleas and for the
this part where a waiver is considered that does not individually or
cumulatively have a significant effect on prevention and treatment of flea
necessary to promote a significant infestations on dogs for 1 month.
interest of TVA or the United States, or the human environment. Therefore,
neither an environmental assessment DATES: This rule is effective October 25,
for other good cause. 2007.
nor an environmental impact statement
Maureen H. Dunn, is required. FOR FURTHER INFORMATION CONTACT:
General Counsel. Melanie R. Berson, Center for Veterinary
This rule does not meet the definition Medicine (HFV–110), Food and Drug
[FR Doc. E7–20907 Filed 10–24–07; 8:45 am]
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Administration, 7500 Standish Pl.,
it is a rule of ‘‘particular applicability.’’ Rockville, MD 20855, 301–827–7540, e-
Therefore, it is not subject to the mail:
congressional review requirements in 5 SUPPLEMENTARY INFORMATION: Elanco
HUMAN SERVICES Animal Health, A Division of Eli Lilly
List of Subjects in 21 CFR Part 520 & Co., Lilly Corporate Center,
Food and Drug Administration Indianapolis, IN 46285, filed NADA
Animal drugs. 141–277 that provides for veterinary
21 CFR Part 520 prescription use of COMFORTIS
■ Therefore, under the Federal Food,
(spinosad) Chewable Tablets to kill fleas
Oral Dosage Form New Animal Drugs; Drug, and Cosmetic Act and under
and for the prevention and treatment of
Phenylbutazone Paste authority delegated to the Commissioner
flea infestations (Ctenocephalides felis)
of Food and Drugs and redelegated to on dogs for 1 month. The NADA is
AGENCY: Food and Drug Administration, the Center for Veterinary Medicine, 21
HHS. approved as of September 25, 2007, and
CFR part 520 is amended as follows: the regulations in 21 CFR part 520 are
ACTION: Final rule.
amended by adding § 520.2130 to reflect
SUMMARY: The Food and Drug the approval.
NEW ANIMAL DRUGS In accordance with the freedom of
Administration (FDA) is amending the
animal drug regulations to reflect information provisions of 21 CFR part
■ 1. The authority citation for 21 CFR 20 and 21 CFR 514.11(e)(2)(ii), a
approval of a supplemental new animal
drug application (NADA) filed by part 520 continues to read as follows: summary of safety and effectiveness
Luitpold Pharmaceuticals, Inc. The Authority: 21 U.S.C. 360b. data and information submitted to
supplemental NADA provides for a support approval of this application
revised human food safety warning for § 520.1720c [Amended] may be seen in the Division of Dockets
phenylbutazone paste, used in horses Management (HFA–305), Food and Drug
■ 2. In § 520.1720c, in paragraph (c)(3), Administration, 5630 Fishers Lane, rm.
for relief of inflammatory conditions remove ‘‘Not for use in horses intended
associated with the musculoskeletal 1061, Rockville, MD 20852, between 9
for food.’’ and add in its place ‘‘Do not a.m. and 4 p.m., Monday through
use in horses intended for human Friday.
DATES: This rule is effective October 25, consumption.’’ Under section 512(c)(2)(F)(i) of the
2007. Federal Food, Drug, and Cosmetic Act
Dated: October 17, 2007.
FOR FURTHER INFORMATION CONTACT: (21 U.S.C. 360b(c)(2)(F)(i)), this
Bernadette Dunham,
Melanie R. Berson, Center for Veterinary approval qualifies for 5 years of
Medicine (HFV–110), Food and Drug Deputy Director, Center for Veterinary
marketing exclusivity beginning on the
Administration, 7500 Standish Pl., Medicine.
date of approval.
Rockville, MD 20855, 301–827–7540, e- [FR Doc. E7–21054 Filed 10–24–07; 8:45 am]
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FDA has determined under 21 CFR

mail: BILLING CODE 4160–01–S 25.33(d)(1) that this action is of a type
SUPPLEMENTARY INFORMATION: Luitpold that does not individually or
Pharmaceuticals, Inc., Animal Health cumulatively have a significant effect on
Division, Shirley, NY 11967, filed a the human environment. Therefore,

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