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Federal Register / Vol. 71, No.

118 / Tuesday, June 20, 2006 / Rules and Regulations 35389

is estimated to vary from 0.5 hour to 4 Comp., p. 173); E.O. 12518 (3 CFR, 1985 contingent upon the Secretary of
hours per response, with an average of Comp., p. 348). Defense’s determination that a waiver
1.25 hours per response, including time § 806.14 [Amended]
will promote access to promising new
for reviewing instructions, searching treatments and contribute to the
existing data sources, gathering and ■ 2. Section 806.14 (e) is amended by development of such treatments. Based
maintaining the data needed, and removing ‘‘$30,000,000’’ and adding on the improved beneficiary access to
completing and reviewing the collection ‘‘$40,000,000’’ in its place. these trials, and the contributions to the
of information. Because reports are filed [FR Doc. E6–9608 Filed 6–19–06; 8:45 am] development of such treatments, it is in
4 times per year, 54,000 responses BILLING CODE 3510–06–P the best interest of the Department and
annually are expected. Thus, the total its beneficiaries to continue to provide
annual respondent burden of the survey access through an authorized waiver as
is estimated at 67,500 hours (13,500 DEPARTMENT OF DEFENSE outlined in the proposed rule.
respondents times 4 times 1.25 hours Clinical trials are the major avenue for
average burden). This estimate is the Office of the Secretary discovering, developing, and evaluating
same as the burden hours currently new cancer therapies, and clinical trial
carried for this collection in the OMB 32 CFR Part 199 participants are among the first to
inventory. receive new cancer prevention or
[Docket No. DoD–2006–HA–0143]
Comments regarding the burden treatment methods before they are
estimate or any other aspect of this RIN 0720–0057 widely available. Many significant
collection of information should be medical discoveries in this field have
addressed to: Director, Bureau of Civilian Health and Medical Program of occurred as a direct result of clinical
Economic Analysis (BE–1), U.S. the Uniformed Services (CHAMPUS)/ trial participation. For example, because
Department of Commerce, Washington, TRICARE; Coverage of Phase II and of survival improvements seen in an
DC 20230, fax: 202–606–5311; and the Phase III Clinical Trials Sponsored by NCI-sponsored clinical trial, early
Office of Management and Budget, the National Institutes of Health initiation of hormonal therapy has
O.I.R.A., Paperwork Reduction Project National Cancer Institute become the standard of care in node-
0608–0004, Attention PRA Desk Officer positive prostrate cancer patients. Even
AGENCY: Office of the Secretary, DoD.
for BEA, via the Internet at when they do not lead to new therapies,
ACTION: Final rule. clinical trials often answer important
pbugg@omb.eop.gov, or by fax at 202–
395–7245. questions and help move research
SUMMARY: The final rule allows the
forward so that others may prevent or
Regulatory Flexibility Act Department of Defense to waive normal
survive this disease.
requirements so that covered Cancer treatment trials may include
The Chief Counsel for Regulation, beneficiaries can participate in Phase II
Department of Commerce, has certified testing new drugs, new approaches to
and Phase III clinical trials sponsored or surgery or radiation therapy, new
to the Chief Counsel for Advocacy, approved by the National Institutes of
Small Business Administration, under combinations of treatments, or new
Health National Cancer Institute (NIH methods such as gene therapy. Studies
the provisions of the Regulatory NCI). This waiver authority is expected
Flexibility Act (5 U.S.C. 605(b)), that that involve drugs or invasive
to promote beneficiary access to procedures are categorized by phase.
this rule will not have a significant promising new treatments and Phase I trials evaluate new cancer drugs
economic impact on a substantial contribute to the development of such to determine what dose is safe, how a
number of small entities. The factual treatments. new agent should be administered (by
basis for the certification was published
DATES: This rule is effective July 20, mouth, injected into a vein, or injected
in the proposed rule and is not repeated
2006. into the muscle), and how frequently
here. No comments were received
the treatment should be given. After
regarding the economic impact of the ADDRESSES: TRICARE Management
safety parameters have been established,
rule. As a result, no final regulatory Activity (TMA), Medical Benefits and
Phase II trials are conducted to assess
flexibility analysis was prepared. Reimbursement System, 16301 East
the effectiveness of an agent or
Centretech Parkway, Aurora, CO 80011–
List of Subjects in 15 CFR Part 806 intervention against a specific type of
cancer. Phase III trials compare effective
International transactions, Economic FOR FURTHER INFORMATION CONTACT: treatments from Phase II studies to
statistics, U.S. investment abroad, Debra Hatzel, Medical Benefits and conventional cancer treatments. Clinical
Penalties, Reporting and recordkeeping Reimbursement Systems, TMA, trials offer high quality care for cancer
requirements. telephone (303) 676-3572. Questions prevention and treatment, and no
Dated: May 26, 2006. regarding payment of specific claims patient ever receives a placebo
J. Steven Landefeld, under TRICARE should be addressed to (substance with active ingredients)
Director, Bureau of Economic Analysis. the appropriate TRICARE contractor. when effective care exists.
SUPPLEMENTARY INFORMATION: The Department of Defense (DoD) and
■ For the reasons set forth in the
the National Cancer Institute (NCI)
preamble, BEA is amending 15 CFR part I. Background established a partnership in 1994 to
806 as follows:
This final rule implements Title 10, conduct a demonstration project that
PART 806—DIRECT INVESTMENT United States Code, section 1079(a)(13) allowed patients with breast cancer to
SURVEYS which provides for a waiver of the participate in NCI-sponsored bone
general prohibition on coverage of marrow transplant clinical trials. This
■ 1. The authority citation for 15 CFR unproven medical treatments or demonstration project expanded in 1996
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part 806 continues to read as follows: procedures in connection with clinical to include all cancers and NCI-
Authority: 5 U.S.C. 301; 22 U.S.C. 3101– trials sponsored or approved by the sponsored Phase II and III cancer
3108; E.O. 11961 (3 CFR, 1977 Comp., p. 86), National Institutes of Health National treatment clinical trials. The DoD–NCI
as amended by E.O. 12318 (3 CFR, 1981 Cancer Institute. This waiver is demonstration partnership was further

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35390 Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Rules and Regulations

expanded on June 21, 1999 to include II. Public Comments covered beneficiaries to promising new
clinical trials related to prevention, The proposed rule was published in treatments and contribute to the
screening and early detection of cancer. the Federal Register on May 31, 2000 development of such treatments. A
Because of the inherent safety risks and (65 FR 34627). No public comments waiver shall only be exercised as
unproven clinical benefits associated were received. The final rule is authorized under this paragraph.
with toxicology studies, Phase I clinical (i) Demonstration waiver. A waiver
consistent with the proposed rule.
trials were not included in this may be granted through a demonstration
demonstration. III. Regulatory Procedures project established in accordance with
Executive Order (EO) 12866 requires Sec. 199.1(o) of this part.
Between January 1996 and July 2004, (ii) Continuous waiver. (A) General.
approximately 350 TRICARE that a comprehensive regulatory impact
As a result of a demonstration project
beneficiaries have participated in NCI- analysis be performed on any
under which a waiver has been granted
approved clinical trials conducted in economically significant regulatory
in connection with a National Institutes
doctors’ offices, community hospitals action, defined as one which would
of Health National Cancer Institute
and clinics, cancer centers, other result in an annual effect of $100
clinical trial, a determination may be
medical centers, and veterans’ and million or more on the national
made that it is in the best interest of the
military hospitals across the United economy or which would have other
government and CHAMPUS
States. Healthcare costs for the DoD–NCI substantial impacts. This is not a
beneficiaries to end the demonstration
demonstration have ranged from $5.8 significant regulatory action under EO
and continue to provide a waiver for
million to $16 million per year, and 12866 and has been reviewed by the
CHAMPUS cost-sharing of the specific
Office of Manpower and Budget.
research has indicated that patient-care clinical trial. Only those specified
The Regulatory Flexibility Act (RFA)
costs associated with cancer clinical clinical trials identified under
requires that each Federal agency
trials are only slightly higher than the paragraph (e)(26)(ii) of this section have
prepare, and make available for public
costs associated with treating similar comment, a regulatory flexibility been authorized a continuous waiver
patients outside of trials. analysis when the agency issues a under CHAMPUS.
The Department of Defense hopes that (B) National Cancer Institute (NCI)
regulation which would have a
his permanent benefit will heighten the sponsored cancer prevention, screening,
significant impact on a substantial
awareness among our cancer patients and early detection clinical trials. A
number of small entities. We certify that
continuous waiver under paragraph
that clinical trials are a promising this final rule will not significantly
(e)(26) of this regulation has been
treatment option and encourage them to affect a substantial number of small
granted for CHAMPUS cost-sharing for
consider Phase II and Phase III clinical entities.
those CHAMPUS-eligible patients
trial participation. Participation in This final rule will not impose
selected to participate in NCI sponsored
clinical trials related to prevention, additional information collection
Phase II and Phase III studies for the
screening, and early detection of cancer requirements on the public under the
prevention and treatment of cancer.
will contribute to the growing base of Paperwork Reduction Act of 1995 (44
(1) TRICARE will cost-share all
medical knowledge in these areas and U.S.C. chapter 55).
medical care and testing required to
may lead to more effective treatments in List of Subjects in 32 CFR Part 199 determine eligibility for an NCI-
the future. Phase I trials will continue sponsored trial, including the
to be excluded from coverage; also, Administrative practice and
procedure, Claims, Fraud, Healthcare, evaluation for eligibility at the
TRICARE will continue to deny institution conducting the NCI-
coverage for any items or services that Health insurance, Military personnel.
sponsored study. TRICARE will cost-
are already covered under the ■Accordingly, 32 CFR part 199 is share all medical care required as a
investigational protocol. Only those amended as follows: result of participation in NCI-sponsored
supplies and services that TRICARE studies. This includes purchasing and
otherwise would have covered during PART 199—[AMENDED] administering all approved
the normal course of treatment (to ■ 1. The authority citation for part 199 chemotherapy agents (except for NCI-
include costs for screening tests to continues to read as follows: funded investigational drugs), all
determine clinical trial eligibility) will inpatient and outpatient care, including
Authority: 5 U.S.C. 301; 10 U.S.C. chapter
be eligible for cost-sharing. This 55. diagnostic and laboratory services not
continues the coverage policy which otherwise reimbursed under an NCI
was previously established for the DoD– ■ 2. Section 199.4 is amended by adding grant program if the following
NCI cancer trials demonstration. new paragraph (e)(26) and revising conditions are met:
This final rule was previously paragraph (g)(15) introductory text to (i) The provider seeking treatment for
read as follows: a CHAMPUS-eligible patient in an NCI
published in the Federal Register on
January 31, 2001 (66 FR 8365–8366). approved protocol has obtained pre-
§ 199.4 Basic program benefits.
authorization for the proposed treatment
The rule was withdrawn on February 7, * * * * * before initial evaluation; and,
2001 (66 FR 9199) because it was (e) * * * (ii) Such treatments are NCI
determined that it should not have been (26) National Institutes of Health sponsored Phase II or Phase III
published in accordance with the clinical trials. By law, the general protocols; and,
Regulatory Review Plan. We are prohibition against CHAMPUS cost- (iii) The patient continues to meet
reissuing this final rule with only minor sharing of unproven drugs, devices, and entry criteria for said protocol; and,
changes (‘‘CHAMPUS’’ changed to medical treatments or procedures may (iv) The institutional and individual
‘‘TRICARE’’ where appropriate; minor be waived in connection with clinical
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providers are CHAMPUS authorized

changes to paragraph numbers to reflect trials sponsored or approved by the providers.
current regulations); however, we are National Institutes of Health National (2) TRICARE will not provide
repeating the entire final rule here for Cancer Institute if it is determined that reimbursement for care rendered in the
the benefit of the public. such a waiver will promote access by National Institutes of Health Clinical

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Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Rules and Regulations 35391

Center or costs associated with non- DATES: This rule is effective from June Discussion of Rule
treatment research activities associated 20, 2006 until October 29, 2006. The regulation was requested by
with the clinical trials. ADDRESSES: Documents indicated in this Florida Representative Rice’s office on
(3) Cost-shares and deductibles preamble as being available in the behalf of the residents of Madeira Beach
applicable to CHAMPUS will also apply docket are part of docket CGD07–06– and will provide temporary relief for
under the NCI-sponsored clinical trials. 074 and are available for inspection or vehicular traffic while other bridge
(4) The Director, TRICARE (or copying at Commander (dpb), Seventh construction projects are underway,
designee), shall issue procedures and Coast Guard District, 909 S.E. 1st while continuing to provide for the
guidelines establishing NCI-sponsorship Avenue, Room 432, Miami, FL 33131, reasonable needs of navigation. The
of clinical trials and the administrative between 7:30 a.m. and 4 p.m., Monday bridge will be required to only open on
process by which individual patients through Friday, except Federal holidays. the hour and half-hour on Fridays from
apply for and receive cost-sharing under 2 p.m. until 6 p.m. and on Saturdays,
NCI-sponsored cancer clinical trials. Sundays and Federal holidays from 10
(g) * * * Barry Dragon, Project Officer, Seventh
Coast Guard District, Bridge Branch, at a.m. until 6 p.m. The draw shall open
(15) Unproven drugs, devices, and
(305) 415–6743. as necessary for the passage of tugs with
medical treatments or procedures. By
SUPPLEMENTARY INFORMATION: tows, public vessels of the United States
law, CHAMPUS can only cost-share
and vessels in distress.
medically necessary supplies and Regulatory Information
services. Any drug, device, or medical Regulatory Evaluation
treatment or procedure, the safety and We did not publish a notice of
proposed rulemaking (NRPM) for this This rule is not a ‘‘significant
efficacy of which have not been regulatory action’’ under section 3(f) of
established, as described in this regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists Executive Order 12866, Regulatory
paragraph (g)(15), is unproved and Planning and Review, and does not
cannot be cost-shared by CHAMPUS for not publishing an NPRM. Publishing
require an assessment of potential costs
except as authorized under paragraph an NPRM was impracticable and
and benefits under section 6(a)(3) of that
199.4(e)(26) of this part. contrary to the public interest, because
Order. The Office of Management and
the rule is needed to provide for
* * * * * Budget has not reviewed it under that
vehicular traffic relief during
Dated: June 9, 2006. Order. It is not ‘‘significant’’ under the
construction of bridges and provides
L.M. Bynum, regulatory policies and procedures of
provisions for vessels to transit through
Alternate OSD Federal Register Liaison
the Department of Homeland Security
the area on a twice an hour schedule
Officer, Department of Defense. (DHS). The Coast Guard expects the
during heavy vehicular traffic periods.
economic impact of this rule to be so
[FR Doc. 06–5432 Filed 6–19–06; 8:45 am] Under 5 U.S.C. 553(d)(3), the Coast
minimal that a full Regulatory
BILLING CODE 5001–06–M Guard finds that good cause exists for
Evaluation is unnecessary, because the
making this rule effective less than 30
rule will allow for bridge openings
days after Federal Register publication.
during the construction of nearby
DEPARTMENT OF HOMELAND This rule provides for scheduled bridge bridges.
SECURITY openings for vessels to transit through
the bridge. Small Entities
Coast Guard Under the Regulatory Flexibility Act
Background and Purpose
(5 U.S.C. 601–612), we considered
33 CFR Part 117 The Welch Causeway (SR 699) bridge, whether this rule would have a
Gulf Intracoastal Waterway mile 122.8, significant economic impact on a
Madeira Beach, Pinellas County, Florida substantial number of small entities.
RIN 1625–AA09 currently opens on signal; except that, The term ‘‘small entities’’ comprises
from 9:30 a.m. to 6 p.m. on Saturdays, small businesses, not-for-profit
Drawbridge Operation Regulations; Sundays, and Federal holidays, the
Welch Causeway (SR 699) Bridge, Gulf organizations that are independently
draw need be opened only on the hour, owned and operated and are not
Intracoastal Waterway, Mile 122.8, 20 minutes after the hour, and 40
Madeira Beach, Pinellas County, FL dominant in their fields, and
minutes after the hour. This bridge is in governmental jurisdictions with
AGENCY: Coast Guard, DHS. close proximity to other bridges populations of less than 50,000.
ACTION: Temporary final rule. currently under construction. The The Coast Guard certifies under 5
bridge provides vehicular access on and U.S.C. 605(b) that this rule would not
SUMMARY: The Coast Guard is off the coastal barrier islands. have a significant economic impact on
temporarily changing the regulations Florida State Representative Rice’s a substantial number of small entities,
governing the operation of the Welch office, on behalf of the citizens of because the regulations provide for
Causeway (SR 699) Bridge, Gulf Madeira Beach, requested the Coast bridge openings, and for the reasonable
Intracoastal Waterway mile 122.8, Guard change the current operation of needs of navigation.
Madeira Beach, Pinellas County, the bridge to two openings per hour
Florida. This rule is needed to provide during certain periods, while other Assistance for Small Entities
vehicular traffic relief during heavy bridge construction projects were Under section 213(a) of the Small
vehicular traffic periods as well as underway. The bridge will be required Business Regulatory Enforcement
meeting the reasonable needs of to only open on the hour and half-hour Fairness Act of 1996 (Pub. L. 104–121),
mariners during the construction of Fridays from 2 p.m. until 6 p.m. and we want to assist small entities in
nearby bridges. This bridge will open on Saturdays, Sundays and Federal understanding this rule so that they can
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the hour and half hour, Friday, 2 p.m. holidays from 10 a.m. until 6 p.m. better evaluate its effects on them and
until 6 p.m., Saturday, Sunday and Public vessels of the United States, tugs participate in the rulemaking process. If
Federal holidays from 10 a.m. until 6 with tows and vessels in distress shall this rule would affect your small
p.m. until October 29, 2006. be passed as necessary. business, organization, or governmental

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