[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Pages 66992-66995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33110]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR 199

[DoD 6010.8-R]
RIN 0720-AA44


Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS); TRICARE Retiree Dental Program (TRDP)

AGENCY: Office of the Secretary, DoD.

ACTION: Final rule.

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SUMMARY: This final rule establishes the TRICARE Retiree Dental Program 
(TRDP), a premium based indemnity dental insurance coverage program, 
that will be available to retired members of the Uniformed Services, 
their dependents, and certain other beneficiaries.

EFFECTIVE DATE: This final rule is effective January 22, 1998.

ADDRESSES: Office of Health Services Financing Policy, Department of 
Defense, Room 1B657 Pentagon, Washington, DC 20301-1200.

FOR FURTHER INFORMATION CONTACT:
Cynthia P. Speight, Office of the Assistant Secretary of Defense 
(Health Affairs), (703) 697-8975.

SUPPLEMENTARY INFORMATION:

I. Overview of the Final Rule

    Implementation of the TRICARE Retiree Dental Program (TRDP) was 
directed by Congress in section 703 of the National Defense 
Authorization Act for Fiscal Year 1997, Pub. L. 104-201, which amended 
title 10, United States Code, by adding section 1076c. This final rule 
also incorporates the minor changes in the National Defense 
Authorization Act for Fiscal Year 1998 which expand eligibility to 
retirees of the Public Health Service and the National Oceanic and 
Atmospheric Administration, and active duty survivors and their 
dependents. The law directs the implementation of a dental program for: 
(1) Members of the Uniformed Services who are entitled to retired pay, 
(2) Members of the Retired Reserve under the age of 60, (3) Eligible 
dependents of (1) or (2) who are covered by the enrollment of the 
member, and (4) The unremarried surviving spouse and eligible child 
dependents of a deceased member who died while in status described in 
(1) or (2); the unremarried surviving spouse and eligible child 
dependents who receive a surviving spouse annuity; or the unremarried 
surviving spouse and eligible child dependents of a deceased member who 
died while on active duty for a period of more than 30 days and whose 
eligible dependents are not eligible or no longer eligible for the 
Active Duty Dependents Dental Plan.
    Included in the program are the 50 United States and the District 
of Columbia, Canada, Puerto Rico, Guam, American Samoa, the 
Commonwealth of the Northern Mariana Islands, and the U.S. Virgin 
Islands. The final rule expands the coverage of the program to include 
all U.S. Territories. Enrollment in the program is voluntary and 
members enrolled in the dental plan will be responsible for paying the 
full cost of the premiums. Under the final rule, the initial enrollment 
period has been extended from 12 months to 24 months (similar to the 
Active Duty Dependents Dental Program) in order to reduce the risk of 
adverse selection. The premium payment may be collected pursuant to 
procedures established by the Assistant Secretary of Defense (Health 
Affairs). Dental coverage under the TRDP will provide basic dental 
care, to include diagnostic services, preventive services, basic 
restorative services (including endodontics), surgical services, and 
emergency oral examinations. Minor administrative changes have been 
made in the plan benefits section in order to correct outdated codes 
and to include codes that were inadvertently excluded from the list.
    Under this rule, where possible, members entitled to retired pay 
and eligible family members and their dependents may make use of 
participating dental providers in their areas and may benefit from 
reduced out-of-pocket and provider submission of claims and acceptance 
of contractor allowances and arrangements. Enrollees using non-network 
providers may be balance billed amounts in excess of allowable charges. 
Under the final rule, the maximum payment allowable by the TRDP (minus 
the appropriate cost-share) will be the lesser of the billed charges or 
the Usual, Customary and Reasonable rates, in which the customary rate 
is calculated at the 50th percentile of billed charges in that 
geographic area, as measured in an undiscounted charge profile in 1995 
or later for that geographic area (as defined by three-digit zip code). 
TRDP eligibles will obtain information concerning the program and the 
application process from the contractor.
    This final rule adopts the statutory preemption authority of 10 
U.S.C., section 1103. This statute broadly authorizes preemption of 
state laws in connection with DoD contracts for medical and dental 
care. The Assistant Secretary of Defense (Health Affairs) has made the 
judgment that preemption is necessary and appropriate to assure the 
operation of a consistent, effective, and efficient federal program. 
Absent preemption of certain State and local laws on insurance 
regulation and other matters, competition would be severely limited and 
the process substantially delayed. The final rule incorporates language 
to clarify that the preemption of State laws section includes 
preemption of State and local laws imposing premium taxes on health or 
dental insurance carriers or underwriters or other plan managers, or 
similar taxes on such entities.

II. Public Comments

    The proposed rule was published on June 24, 1997 (62 FR 34032-
34035). We received one public comment. We thank the commenter; 
significant items raised by the commenter and our analysis of the 
comments are summarized below in the appropriate sections of the 
preamble.
    1. Benefits: We received a comment that an error exists in the 
description of procedure code 00120, 00140, and 00150.
    Response: We appreciate the comment and we have replaced 
``examination'' with ``evaluation'' in the description of the procedure 
codes 00120, 00140, and 00150.
    2. Benefits: The commenter pointed out an oversight in that two 
procedures, Amalgam-one surface, permanent (02140) and Amalgam (two-
surface), permanent (02150) were not included in the benefits of the 
program.
    Response: We concur with the comment and procedures codes 02140 and 
02150 have been added under the restorative benefits under the program.
    3. Benefits: Another comment we received pointed out that several 
periodontic (04261, 04262, 04268) codes are outdated and have been 
changed.
    Response: We appreciate the comment. These periodontic codes have 
been changed in the final rule as follows: code 04261 has been replaced 
by Bone replacement graft-first site in quadrant (04263); code 04262 
has been replaced by Bone replacement-each additional site in quadrant; 
code 04268 has been replaced by Guided tissue regeneration-resorbable 
barrier, per site, per tooth (04266) and Guided tissue

[[Page 66993]]

regeneration-nonresorbable barrier, per site, per tooth (includes 
membrane removal) (04267).
    4. Benefits: We received a comment that the benefits need to be 
expanded to include prosthetic services.
    Response: Under the law, 10 U.S.C. 1076c, the TRICARE Retiree 
Dental Program shall provide benefits for basic dental care and 
treatment, including diagnostic services, preventive services, basic 
restorative services (including endodontics), surgical services, and 
emergency services; prosthetic services are not included.
    5. Maximum Annual Cap: The commenter expressed concern about the 
$1,000 maximum annual cap and recommended a higher annual maximum 
benefit.
    Response: As the government does not share in the cost of the 
premium, the maximum annual cap is necessary to ensure that the monthly 
premium is a reasonable/affordable amount for the enrollee. It is 
important to note that the maximum annual cap does not apply to all of 
the diagnostic services and some of the preventive services covered 
under the program.
    6. Benefit Payment: The commenter pointed out a mistake in the 
Benefit payment section. The section states, ``For enrollees who do not 
use these network providers, however, providers shall not balance bill 
any amount in excess of the maximum payment allowable by the TRDP.''
    Response: The commenter is correct and the sentence has been 
corrected to state, ``For enrollees who do use these network providers, 
however, providers shall not balance bill any amount in excess of the 
maximum payment allowable by the TRDP.''
    7. Balance Billing: A commenter asked if balance billing is limited 
to 115% of the CHAMPUS allowable charge for a service.
    Response: As this is not a CHAMPUS program, DoD's statutory 
authority to limit balance billing to 115% of the CHAMPUS allowable 
charge does not apply. Non-network providers are not limited in the 
amount they may balance bill an enrollee.

III. Rulemaking Procedures

    Executive Order 12866 requires certain regulatory assessments for 
any ``significant regulatory action,'' defined as one which would 
result in an annual effect on the economy of $100 million or more, or 
have other substantial impacts.
    The Regulatory Flexibility Act (RFA) requires that each Federal 
agency prepare, and make available for public comment, a regulatory 
flexibility analysis when the agency issues a regulation which would 
have a significant impact on a substantial number of small entities.
    This rule will impose additional information collection 
requirements on the public, associated with beneficiary enrollment, 
under the Paperwork Reduction Act of 1995. OMB approval number 0720-
0015 pending a development of a contractor-designed enrollment form 
which has now been accomplished. The form will be submitted to OMB 
concurrently with publication of this notice. The collection instrument 
serves as an application form for military members entitled to retired 
pay and eligible dependents to enroll in the TRICARE Retiree Dental 
Program. The application will allow the Department of Defense to 
identify enrollment applicants, evaluate their eligibility for the 
enrollment, and determine other health insurance coverage which an 
applicant may have.
    Affected Public: Eligible family members and their dependents.
    Annual Burden Hours: 71,640.
    Number of Respondents: 286,570.
    Responses per Respondent: 1.
    Average Burden per Response: 15 minutes.
    Frequency: Once, at time of initial application.
    Respondents are retirees of the Uniformed Services entitled to 
retired pay and eligible family members and their dependents who are 
seeking enrollment in the TRICARE Retiree Dental Program. The 
enrollment application will allow the Department to collect the 
information necessary to properly identify the program's applicants and 
to determine their eligibility for enrollment in the TRICARE Retiree 
Dental Program. In completing and signing a TRICARE Retiree Dental 
Program enrollment form, applicants will acknowledge that they 
understand the benefits offered under the program and the rules they 
must follow to continue their participation in the program. Further, 
applicants will acknowledge that the premium will be withheld from 
retired pay when such pay is available. Initial enrollment will be for 
a period of 24 months followed by month-to-month enrollment as long as 
the enrollee chooses to continue enrollment.

List of Subjects in 32 CFR Part 199

    Claims, Health insurance, Individuals with disabilities, Military 
personnel, Reporting and recordkeeping requirements.

    Accordingly, 32 CFR part 199 amended as follows:

PART 199--[AMENDED]

    1. The authority citation for part 199 continues to read as 
follows:

    Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.

    2. Part 199 is amended by adding Sec. 199.22 to read as follows:


Sec. 199.22  TRICARE Retiree Dental Program (TRDP).

    (a) Purpose. The TRDP is a premium based indemnity dental insurance 
coverage program that will be available to retired members of the 
Uniformed Services, their dependents, and certain other beneficiaries, 
as specified in paragraph (d) of this section. The TRDP is authorized 
by 10 U.S.C. 1076c.
    (b) General provisions. (1) Benefits are limited to diagnostic 
services, preventive services, basic restorative services (including 
endodontics), surgical services, and emergency oral examinations, as 
specified in paragraph (f) of this section.
    (2) Premium costs for this coverage will be paid by the enrollee.
    (3) The program is applicable to authorized providers in the 50 
United States and the District of Columbia, Canada, Puerto Rico, Guam, 
American Samoa, the Commonwealth of the Northern Mariana Islands, and 
the U.S. Virgin Islands.
    (4) Except as otherwise provided in this section or by the 
Assistant Secretary of Defense (Human Affairs) or designee, the TRDP is 
administered in a manner similar to the Active Duty Dependents Dental 
Plan under Sec. 199.13 of this part.
    (5) The TRDP shall be administered through a contract.
    (c) Definitions. Except as may be specifically provided in this 
section, to the extent terms defined in Secs. 199.2 and 199.13(b) of 
this part are relevant to the administration of the TRICARE Retiree 
Dental Program, the definitions contained in Secs. 199.2 and 199.13(b) 
of this part shall apply to the TRDP as they do to CHAMPUS and the 
TRICARE Active Duty Dependents Dental Plan.
    (d) Eligibility and enrollment.--(1) Eligibility. Enrollment in the 
TRICARE Retiree Dental Program is open to:
    (i) Members of the Uniformed Services who are entitled to retired 
pay;
    (ii) Members of the Retired Reserve under the age of 60;
    (iii) Eligible dependents of paragraph (d)(1)(i) or paragraph 
(d)(1)(ii) of this section who are covered by the enrollment of the 
member; and
    (iv) The unremarried surviving spouse and eligible child dependents 
of a deceased member who died while in status described in paragraph 
(d)(1)(i) or paragraph (d)(1)(ii) of this section; the

[[Page 66994]]

unremarried surviving spouse and eligible child dependents who receive 
a surviving spouse annuity; or the unremarried surviving spouse and 
eligible child dependents of a deceased member who died while on active 
duty for a period of more than 30 days and whose eligible dependents 
are not eligible or no longer eligible for the Active Duty Dependents 
Dental Plan.
    (2) Notification of eligibility. The contractor will notify persons 
eligible to receive dental benefits under the TRICARE Retiree Dental 
Program.
    (3) Election of coverage. Following this notification, interested 
members entitled to retired pay and eligible family members and their 
dependents may elect to enroll. In order to obtain dental coverage, 
written election by the eligible beneficiary must be made.
    (4) Enrollment. Enrollment in the TRICARE Retiree Dental Program is 
voluntary and will be accomplished by submission of an application to 
the TRDP contractor. Initial enrollment shall be for a period of 24 
months followed by month-to-month enrollment as long as the enrollee 
chooses to continue enrollment.
    (5) Period of coverage. TRICARE Retiree Dental Program coverage is 
terminated when the member's entitlement to retired pay is terminated, 
the member's status as a member of the Retired Reserve is terminated, a 
dependent child loses eligible child dependent status, or in the case 
of remarriage of the surviving spouse.
    (6) Continuation of dependents' enrollment upon death of enrollee. 
Coverage of a dependent in the TRDP under an enrollment of a member or 
surviving spouse who dies during the period of enrollment shall 
continue until the end of that period and may be renewed by (or for) 
the dependent, so long as the premium paid is sufficient to cover 
continuation of the dependent's enrollment. Coverage may be terminated 
when the premiums paid are no longer sufficient to cover continuation 
of the enrollment.
    (e) Premium payments. Persons enrolled in the dental plan will be 
responsible for paying the full cost of the premiums in order to obtain 
the dental insurance.
    (1) Premium payment method. The premium payment may be collected 
pursuant to procedures established by the Assistant Secretary of 
Defense (Health Affairs) or designee.
    (2) Effects of failure to make premium payments. Failure to make 
monthly renewal premium payments will result in the enrollee's 
disenrollment from the TRDP and subject to a lock-out period of 12 
months. Following this period of time, persons eligible will be able to 
reenroll if they so choose.
    (3) Member's payment of premiums. The cost of the TRDP monthly 
premium will be paid by the enrollee. Interested beneficiaries may 
contact the dental contractor-insurer to obtain the enrollee premium 
cost.
    (f) Plan benefits. (1) The TRDP will provide basic dental care, to 
include diagnostic services, preventive services, basic restorative 
services (including endodontics), surgical services, and emergency oral 
examinations. The following is the TRDP covered dental benefit (using 
the American Dental Association, The Council on Dental Care Program's 
Code On Dental Procedures and Nomenclature):
    (i) Diagnostic Periodic oral evaluation (00120); Comprehensive oral 
evaluation (limited to one exam per year in the same dental office) 
(00150), Intraoral-complete series (including bitewings) (00210); 
Intraoral-periapical-first film (00220); Intraoral-periapical-each 
additional film (00230); Intraoral-occlusal film (00240); Bitewings-
single film (00270); Bitewings-two films (00272); Bitewings-four films 
(00274); Panoramic film (00330); Caries susceptibility tests, by report 
(00425); Pulp vitality tests (00460).
    (ii) Preventive: Prophaylaxis-adult (limit-once per year) (01110); 
Prophylaxis-child (01120); Topical application of fluoride (excluding 
prophylaxis)-child (01203); Topical application of fluoride (excluding 
prophylaxis)-adult, by report, once per year (01204); Sealant-per tooth 
(01351); Space maintainer-fixed-unilateral (01510); Space maintainer-
fixed-bilateral (01515); Space maintainer-removable-unilateral (01520); 
Space maintainer-removable-bilateral (01525); Recementation of space 
maintainer (01550).
    (iii) Restorative: Amalgam-one surface, primary (02110); Amalgam-
two surfaces, primary (02120); Amalgam-three surfaces, primary (02130); 
Amalgam-four or more surfaces, primary (02131); Amalgam-one surface, 
permanent (02140); Amalgam-two surfaces, permanent (02150); Amalgam-
three surfaces, permanent (02160); Amalgam-four or more surfaces, 
permanent (02161); Resin-one surface, anterior (02330); Resin-two 
surfaces, anterior (02331); Resin-three surfaces, anterior (02332); 
Resin-four or more surfaces or involving incisal angle (anterior) 
(02335); Recement inlay (02910); Recement crown (02920); Prefabricated 
stainless steel crown-primary tooth (02930); Prefabricated stainless 
crown-permanent tooth (02931); Prefabricated resin crown (02932); 
Prefabricated stainless steel crown with resin window (02933); Pin 
retention-per tooth, in addition to restoration (02951); Temporary 
crown (fractured tooth) (02970).
    (iv) Endodontic: Pulp cap-indirect (excluding final restoration) 
(03120); Therapeutic pulpotomy (excluding final restoration) (03220); 
Pulpal therapy (resorbable filling)-anterior, primary tooth (excluded 
final restoration) (03230); Pulpal therapy (resorbable filling)-
posterior, primary tooth (excluded final restoration) (03240); Anterior 
root canal (excluding final restoration) (03310); Bicuspid root canal 
(excluding final restoration) (03320); Molar root canal (excluding 
final restoration) (03330); Retreatment-anterior, by report (03346); 
Retreatment-bicuspid, by report (03347); Retreatment-molar, by report 
(03348); Apexification/recalcification-initial visit (apical closure/
calcific repair of perforations, root resorption, etc.) (03351); 
Apexification/recalcification-interim medication replacement (apical 
closure/calcific repair of perforations, root resorption, etc.) 
(03352); Apexification/recalcification-final visit (includes completed 
root canal therapy-apical closure/calcific repair of perforations, root 
resorption, etc.) (03353); Apicoectomy/Periradicular surgery-anterior 
(03410); Apicoectomy/Periradicular surgery-bicuspid (first root) 
(03421); Apicoectomy/Periradicular surgery-molar (first root) (03425); 
Apicoectomy/Periradicular surgery (each additional root) (03426); 
Retrograde filling-per root (03430); Root amputation-per root (03450); 
Hemisection (including any root removal), not including root canal 
therapy (03920).
    (v) Periodontic: Gingivectomy or gingivoplasty-per quadrant 
(04210); Gingivectomy or gingivoplasty-per tooth (04211); Gingival 
curettage, surgical, per quadrant, by report (04220); Gingival flap 
procedure, including root planing-per quadrant (04240); Mucogingival 
surgery-per quadrant (04250); Osseous surgery (including flap entry and 
closure)-per quadrant (04260); Bone replacement graft-single site 
(including flap entry and closure) (04263); Bone replacement graft-
multiple sites (including flap entry and closure) (04264); Guided 
tissue regeneration--resorbable barrier (04266); Guided tissue 
regeneration--nonresorbable barrier (04267); Pedicle soft tissue graft 
procedure (04270); Free soft tissue graft procedure (including donor 
site) (04271); Periodontal scaling and root planing-per quadrant 
(04341); Periodontal maintenance procedures (following active therapy) 
(04910);

[[Page 66995]]

Unscheduled dressing change (by someone other than treating dentist) 
(04920).
    (vi) Oral Surgery: Single tooth (07110); Each additional tooth 
(07120); Root removal-exposed roots (07130) Surgical removal or erupted 
tooth requiring elevation of mucoperiosteal flap and removal of bone 
and/or section of tooth (07210); Removal of impacted tooth-soft tissue 
(07220); Removal of impacted tooth-partially bony (07230); Removal of 
impacted tooth-completely bony (07240); Surgical removal of residual 
tooth roots (cutting procudure) (07250); Oral antral fistula closure 
(07260); Tooth reimplantation and/or stabilization of accidentially 
evulsed or displaced tooth and/or alveolus (07270); Surgical exposure 
of impacted or unerupted tooth to aid eruption (07281); Biopsy of oral 
tissue-hard (07285); Biopsy of oral tissue-soft (07286); Surgical 
repositioning of teeth (074290); Alveoloplasty in conjunction with 
extractions-per quadrant (07310); Suture of recent small wounds up to 5 
cm (07910); Complicated suture-up to 5 cm (07911); Complicated suture-
greater than 5 cm (07912); Excision of pericoronal gingiva (07971).
    (vii) Emergency: Limited oral evaluation--problem focused (00140); 
Palliative (emergency) treatment of dental pain-minor procedures 
(09110).
    (viii) Drugs: Therapeutic drug injection, by report (09610); Other 
drugs and/or medications, by report (09630).
    (ix) Postsurgical: Treatment of complications (post-surgical) 
unusual circumstances, by report (09930).
    (2) Codes listed in paragraph (f)(1) of this section may be 
modified by the Director, OCHAMPUS, to the extent determined 
appropriate based on developments in common dental care practices and 
standard dental insurance programs.
    (g) Maximum annual cap. TRDP enrollees will be subject to a maximum 
cap of $1,000.00 of paid allowable charges per enrollee per year.
    (h) Annual notification of rates. TRDP premiums will be determined 
as part of the competitive contracting process. Information on the 
premium rates will be widely distributed.
    (i) Authorized providers. The TRDP enrollee may seek covered 
services from any provider who is fully licensed and approved to 
provide dental care in the state where the provider is located.
    (j) Benefit payment. Enrollees are not required to utilize the 
special network of dental providers established by the TRDP contractor. 
For enrollees who do use these network providers, however, providers 
shall not balance bill any amount in excess of the maximum payment 
allowable by the TRDP. Enrollees using non-network providers may 
balance billed amounts in excess of allowable charges. The maximum 
payment allowable by the TRDP (minus the appropriate cost-share) will 
be the lesser of:
    (1) Billed charges; or
    (2) Usual, Customary and Reasonable rates, in which the customary 
rate is calculated at the 50th percentile of billed charges in that 
geographic area, as measured in an undiscounted charge profile in 1995 
or later for that geographic area (as defined by three-digit zip code).
    (k) Appeal and hearing procedures. All levels of appeals and 
grievances established by the Contractor for internal review shall be 
exhausted prior to forwarding to OCHAMPUS for a final review. 
Procedures comparable to those established under Sec. 199.13(h) of this 
part shall apply.
    (l) Preemption of State laws. (1) Pursuant to 10 U.S.C. 1103, the 
Department of Defense has determined that in the administration of 
chapter 55 of title 10, U.S. Code, preemption of State and local laws 
relating to health insurance, prepaid health plans, or other health 
care delivery or financing methods is necessary to achieve important 
Federal interests, including but not limited to the assurance of 
uniform national health programs for military families and the 
operation of such programs at the lowest possible cost to the 
Department of Defense, that have a direct and substantial effect on the 
conduct of military affairs and national security policy of the United 
States. This determination is applicable to the dental services 
contracts that implement this section.
    (2) Based on the determination set forth in paragraph (l)(1) of 
this section, any State or local law or regulation pertaining to health 
or dental insurance, prepaid health or dental plans, or other health or 
dental care delivery, administration, and financing methods is 
preempted and does not apply in connection with the TRICARE Retiree 
Dental Program contract. Any such law, or regulation pursuant to such 
law, is without any force or effect, and State or local governments 
have no legal authority to enforce them in relation to the TRICARE 
Retiree Dental Program contract. (However, the Department of Defense 
may, by contract, establish legal obligations on the part of the 
TRICARE Retiree Dental Program contractor to conform with requirements 
similar to or identical to requirements of State or local laws or 
regulations).
    (3) The preemption of State and local laws set forth in paragraph 
(l)(2) of this section includes State and local laws imposing premium 
taxes on health or dental insurance carriers or underwriters or other 
plan managers, or similar taxes on such entities. Such laws are laws 
relating to health insurance, prepaid health plans, or other health 
care delivery or financing methods, within the meaning of section 1103. 
Preemption, however, does not apply to taxes, fees, or other payments 
on net income or profit realized by such entities in the conduct of 
business relating to DoD health services contracts, if those taxes, 
fees or other payments are applicable to a broad range of business 
activity. For the purposes of assessing the effect of Federal 
preemption of State and local taxes and fees in connection with DoD 
health and dental services contracts, interpretations shall be 
consistent with those applicable to the Federal Employees Health 
Benefits Program under 5 U.S.C. 8909(f).
    (m) Administration. The Assistant Secretary of Defense (Health 
Affairs) or designee may establish other rules and procedures for the 
administration of the TRICARE Retiree Dental Program.

    Dated: December 15, 1997.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 97-33110 Filed 12-22-97; 8:45 am]
BILLING CODE 5000-04-M