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59374 Federal Register / Vol. 71, No.

195 / Tuesday, October 10, 2006 / Rules and Regulations

PART 135—OPERATING SUPPLEMENTARY INFORMATION: Merial Dated: September 27, 2006.


REQUIREMENTS: COMMUTER AND Ltd., 3239 Satellite Blvd., Bldg. 500, Steven D. Vaughn,
ON-DEMAND OPERATIONS AND Duluth, GA 30096–4640, filed a Director, Office of New Animal Drug
RULES GOVERNING PERSONS ON supplement to NADA 141–227 for Evaluation, Center for Veterinary Medicine.
BOARD SUCH AIRCRAFT ULCERGARD (omeprazole) Paste. The [FR Doc. E6–16604 Filed 10–6–06; 8:45 am]
supplemental application provides for BILLING CODE 4160–01–S
■ 3. The authority citation for part 135 administration of omeprazole paste to
continues to read as follows: horses for 8 or 28 days for the
Authority: 49 U.S.C. 106(g), 44113, 44701– prevention of gastric ulcers. The DEPARTMENT OF DEFENSE
44702, 44705, 44709, 44711–44713, 44715– supplemental NADA is approved as of
44717, 44722. September 15, 2006, and 21 CFR Office of the Secretary
4. In § 135.128, amend paragraph 520.1615 is amended to reflect the
approval. The basis of approval is [DOD–2006–OS–0134; RIN 0790–AG91]
(a)(2)(ii)(D) to read as follows:
discussed in the freedom of information 32 CFR Part 284
§ 135.128 Use of safety belts and child summary.
restraint systems In accordance with the freedom of Waiver Procedures for Debts Resulting
(a) * * * information provisions of 21 CFR part from Erroneous Payments of Pay and
(2) * * * 20 and 21 CFR 514.11(e)(2)(ii), a Allowances
(ii) * * * summary of safety and effectiveness
(D) Except as provided in data and information submitted to AGENCY: Department of Defense.
§ 135.128(a)(2)(ii)(C)(3) and support approval of this application ACTION: Final rule.
§ 135.128(a)(2)(ii)(C)(4), booster-type may be seen in the Division of Dockets
child restraint systems (as defined in Management (HFA–305), Food and Drug SUMMARY: This rule implements policy
Federal Motor Vehicle Safety Standard Administration, 5630 Fishers Lane, rm. and prescribes procedures for
No. 213 (49 CFR 571.213)), vest- and 1061, Rockville, MD 20852, between 9 considering applications for the waiver
harness-type child restraint systems, a.m. and 4 p.m., Monday through of debts resulting from erroneous
and lap held child restraints are not Friday. payments of pay and allowances
approved for use in aircraft; and Under section 512(c)(2)(F)(iii) of the (including travel and transportation
* * * * * Federal Food, Drug, and Cosmetic Act allowances) to or on behalf of members
(21 U.S.C. 360b(c)(2)(F)(iii)), this of the Uniformed Services and civilian
Issued in Washington, DC on September
approval qualifies for 3 years of Department of Defense (DoD)
29, 2006.
marketing exclusivity beginning employees. The Legislative Branch
Brenda D. Courtney,
September 15, 2006. Appropriations Act of 1996 transferred
Acting Director, Office of Rulemaking. The agency has determined under 21 to the Director of the Office of
[FR Doc. E6–16622 Filed 10–6–06; 8:45 am] CFR 25.33(d)(1) that this action is of a Management and Budget (OMB) the
BILLING CODE 4910–13–P type that does not individually or Comptroller General’s authority to settle
cumulatively have a significant effect on claims. The OMB Director subsequently
the human environment. Therefore, delegated some of these authorities to
DEPARTMENT OF HEALTH AND neither an environmental assessment the Department of Defense. Later, the
HUMAN SERVICES nor an environmental impact statement General Accounting Office Act of 1996
is required. codified many of these delegations to
Food and Drug Administration This rule does not meet the definition the Secretary of Defense and others and
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because transferred to the OMB Director the
21 CFR Part 520 it is a rule of ‘‘particular applicability.’’ authority of the Comptroller General to
Therefore, it is not subject to the waive uniformed service member and
Oral Dosage Form New Animal Drugs; congressional review requirements in 5 employee debts arising out of the
Omeprazole U.S.C. 801–808. erroneous payment of pay or allowances
AGENCY: Food and Drug Administration, List of Subjects in 21 CFR Part 520 exceeding $1,500. The OMB Director
HHS. subsequently delegated the authority to
Animal drugs. waive such debts of uniformed service
ACTION: Final rule.
■ Therefore, under the Federal Food, members and DoD employees to the
SUMMARY: The Food and Drug Drug, and Cosmetic Act and under Secretary of Defense. The Secretary of
Administration (FDA) is amending the authority delegated to the Commissioner Defense further delegated his claims
animal drug regulations to reflect of Food and Drugs and redelegated to settlement and waiver authorities to the
approval of a supplemental new animal the Center for Veterinary Medicine, 21 General Counsel. This rule implements
drug application (NADA) filed by Merial CFR part 520 is amended as follows: the reassignment of the Comptroller
Ltd. The supplemental NADA provides General’s former duties within the
PART 520—ORAL DOSAGE FORM Department of Defense with little
for administration of omeprazole paste
NEW ANIMAL DRUGS impact on the public.
to horses for 8 or 28 days for the
prevention of gastric ulcers. ■ 1. The authority citation for 21 CFR DATES: Effective Date: October 10, 2006.
DATES: This rule is effective October 10, part 520 continues to read as follows: FOR FURTHER INFORMATION CONTACT:
2006. Authority: 21 U.S.C. 360b. Michael Hipple, 703–696–8510.
FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: On
Melanie R. Berson, Center for Veterinary § 520.1615 Omeprazole. Thursday, November 14, 2002 (67 FR
jlentini on PROD1PC65 with RULES

Medicine (HFV–110), Food and Drug ■ 2. In paragraph (d)(1)(ii) of § 520.1615, 68964), the Department of Defense
Administration, 7500 Standish Pl., at the end of the first sentence remove published 32 CFR part 284 along with
Rockville, MD 20855, 301–827–7540, e- ‘‘for up to 28 days’’ and add in its place parts 281, 282, and 283 as proposed
mail: melanie.berson@.fda.hhs.gov. ‘‘for 8 or 28 days’’. rules with request for public comments.

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