79320 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 

or Principal Avionics Inspector, as 

appropriate, or lacking a principal inspector, 

your local Flight Standards District Office. 

Related Information 

(j) For more information about this AD, 

contact Georgios Roussos, Aerospace 

Engineer, Systems and Equipment Branch, 

ANM–130S, FAA, Seattle Aircraft 

Certification Office, 1601 Lind Avenue, SW., 

Renton, Washington 98057–3356; telephone 

(425) 917–6482; fax (425) 917–6590. 

(k) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P.O. Box 3707, MC 2H–65, 

Seattle, Washington 98124–2207; telephone 

206–544–5000, extension 1; fax 206–766– 

5680; e-mail me.boecom@boeing.com; 

Internet https://www.myboeingfleet.com. You 

may review copies of the referenced service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, call 

425–227–1221. 

Issued in Renton, Washington, on 

December 10, 2010. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–31828 Filed 12–17–10; 8:45 am] 

BILLING CODE 4910–13–P 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR Parts 240 and 249 

[Release No. 34–63347; File No. S7–35–10] 

RIN 3235–AK79 

Security-Based Swap Data Repository 

Registration, Duties, and Core 

Principles 

Correction 

In proposed rule document 2010– 

29719 beginning on page 77306 in the 

issue of December 10, 2010, make the 

following corrections: 

1. On page 77320, in the third 

column, footnote 74, in the fourth line, 

‘‘recordkeeping’’ should read ‘‘record 

keeping’’. 

2. On page 77321, in the second 

column, below the heading Request for 

Comment, in the fifth bulleted 

paragraph, in the tenth line, ‘‘requiring’’ 

should read ‘‘require’’. 

3. On page 77324, in the third 

column, footnote 90, in the fifth line, 

‘‘recordkeeping’’ should read ‘‘record 

keeping’’. 

4. On page 77338, the last line of text 

in the third column, prior to footnote 

164 on the page, should read 

‘‘information maintained by the 

SDR,165’’. 

5. On the same page, in the same 

column, after footnote 164, add footnote 

165 to read as follows: 

165See Public Law 111–203 (adding 

Exchange Act Section 12(n)(5)(D)(i)). 

6. On page 77347, in the second 

column, in the tenth line from the 

bottom of the page, ‘‘conflict’’ should 

read ‘‘conflicts’’. 

7. On page 77356, in the third 

column, in thirty-first line, 

‘‘systematically’’ should read 

‘‘systemically’’. 

8. On the same page, in the same line 

of the same column, ‘‘Therefor’’ should 

read ‘‘Therefore’’. 

§ 249.1500 [Corrected] 

9. On page 77375, in § 249.1500, 

before the first line in the first column, 

insert the following text: 

EXHIBITS—BUSINESS ORGANIZATION 

13. List as Exhibit A any person as defined 

in Section 3(a)(9) of the 

10. On the same page, in the second 

column, in the fifth, eleventh, and 

fifteenth lines from the bottom of the 

page, ‘‘l5’’ should read ‘‘15’’. 

[FR Doc. C1–2010–29719 Filed 12–17–10; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 500 

[Docket No. FDA–2010–N–0612] 

Animal Drugs, Feeds, and Related 

Products; Regulation of Carcinogenic 

Compounds in Food-Producing 

Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulations regarding 

compounds of carcinogenic concern 

used in food-producing animals. 

Specifically, the Agency is clarifying the 

definition of ‘‘So’’ and revising the 

definition of ‘‘Sm’’ so that it conforms to 

the clarified definition of So. Other 

clarifying and conforming changes are 

also being made. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by March 7, 2011. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

January 19, 2011 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0612, by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

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 No. and Regulatory Information 

Number (RIN) (if a RIN number has been 

assigned) 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: 

Kevin Greenlees, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6975. 

e-mail: kevin.greenlees@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) contains three 

anticancer, or Delaney, clauses: Sections 

409(c)(3)(A), 512(d)(1)(I), and 

721(b)(5)(B)(i) (21 U.S.C. 348(c)(3)(A), 

360b(d)(1)(I), and 379e(b)(5)(B)(i)), 

pertaining to food additives, new animal 

drugs, and color additives, respectively. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 79321 

1The submission of such a method is approved 

as a collection of information under Office of 

Management and Budget (OMB) Control No. 0910– 

0032. 

These clauses prohibit approval of 

substances that have been shown to 

induce cancer in man or animals. 

However, each clause contains an 

exception, termed the ‘‘Diethylstilbestrol 

(DES) Proviso,’’ that permits 

administration of such substances to 

food-producing animals where: (1) The 

food additive, color additive, or new 

animal drug will not adversely affect the 

animal; and (2) no residue of the food 

additive, color additive, or new animal 

drug will be found in any edible portion 

of that animal by a method of 

examination prescribed or approved by 

the Secretary of Health and Human 

Services by regulation. The regulations 

under part 500 (21 CFR part 500), 

subpart E entitled ‘‘Regulation of 

Carcinogenic Compounds Used in FoodProducing Animals,’’ implement the 

DES Proviso. To elaborate on how to 

determine that there is no residue, and 

thus demonstrate that the second prong 

of the DES Proviso has been satisfied, 

the regulations define several terms, 

including So and Sm. 

So is currently defined as the 

concentration of the compound of 

carcinogenic concern in the total diet of 

test animals that corresponds to a 

maximum lifetime risk of cancer to the 

test animals of 1 in 1 million, and is 

calculated from tumor data of the cancer 

bioassays using a statistical 

extrapolation procedure. The definition 

of So also provides that FDA will 

assume that the So corresponds to the 

concentration of residue of carcinogenic 

concern in the total human diet that 

represents no significant increase in the 

risk of cancer to people. The 

concentration, derived from the So, of 

residues of carcinogenic concern in a 

specific edible tissue is termed the Sm. 

Sponsors are required to submit to FDA 

a regulatory analytical method that is an 

aggregate of all experimental procedures 

for measuring and confirming the 

presence of the marker residue of the 

sponsored compound in the target tissue 

of the target animal. FDA can be assured 

that there is no residue of carcinogenic 

concern when no residue of the 

compound is detectable (that is, the 

marker residue is below the limit of 

detection) using the approved regulatory 

analytical method.1 A marker residue is 

selected whose concentration is in a 

known relationship to the concentration 

of the residue of carcinogenic concern 

in the last tissue to deplete to its Sm.

This tissue is known as the target tissue 

and the concentration of the marker 

residues is known as the Rm. The limit 

of detection of the approved regulatory 

analytical method must be capable of 

measuring the selected marker residue 

at the Rm in the selected target tissue. 

When residues of carcinogenic concern 

are below the Rm in the target tissue as 

measured by the approved regulatory 

analytical method, the residues of 

carcinogenic concern in target tissue 

and all other edible tissues are below 

their respective Sm and therefore 

consumption of tissues containing these 

residues would not exceed the So. The 

detection of the marker residue in the 

target tissue below the Rm by the 

approved regulatory analytical method 

can be taken as confirmation that the 

residue of carcinogenic concern does 

not exceed Sm in each of the edible 

tissues and, therefore, that the residue of 

carcinogenic concern in the diet of 

people does not exceed So. However, 

any detectable concentration of the 

marker residue by the approved 

regulatory analytical method, even if 

below the Rm, fails to satisfy the 

statutory requirements of the DES 

Proviso. The detection of any 

concentration would mean that the 

second prong of the DES Proviso has not 

been satisfied because it has not been 

shown that no residue of the substance 

is present in any edible portion of the 

animal at issue. 

As described previously, the approach 

for evaluating compounds of 

carcinogenic concern currently set forth 

in § 500.84 utilizes a statistical 

extrapolation procedure that calculates 

a concentration of residue of 

carcinogenic concern that corresponds 

to a maximum lifetime risk to the test 

animal of 1 in 1 million. In addition, to 

provide flexibility, § 500.90 permits the 

use of alternative procedures to satisfy 

the DES Proviso, when the person 

requesting the use of alternative 

procedures clearly sets forth the reasons 

why the alternative procedures will 

provide a basis for concluding that 

approval of the compound satisfies the 

requirements of the Delaney Clause 

provisions of the FD&C Act, including 

the DES Proviso. 

In recent years, FDA has, at times, 

been asked to consider allowing the use 

of alternative procedures to satisfy the 

DES Proviso. Some of these proposed 

alternative procedures did not rely on a 

statistical extrapolation of the data to a 

1 in 1 million risk of cancer to test 

animals, but nevertheless the So, Sm, Rm,

and regulatory analytical method 

resulting from these alternative 

approaches would be expected to ensure 

that consumption of food derived from 

animals treated with the carcinogenic 

new animal drug would result in no 

significant increase in the risk of cancer 

to people. In the course of considering 

these proposed alternative procedures, 

FDA has also considered whether the 

term So, as currently defined, 

adequately addresses concentrations of 

residues of carcinogenic concern in the 

total human diet that are found to 

represent no significant increase in the 

risk of cancer to people, but which are 

not derived from a statistical 

extrapolation of data to a 1 in 1 million 

risk of cancer to test animals. 

The current definition in § 500.82 

primarily defines So as the 

concentration of the compound of 

carcinogenic concern that corresponds 

to the 1 in 1 million lifetime risk of 

cancer to the test animals and 

secondarily as corresponding to the 

concentration of residue of carcinogenic 

concern in the total human diet that 

represents no significant increase in a 

risk of cancer to people. Therefore, as 

presently constructed, the definition of 

So is not primarily defined as the 

concentration of residues of 

carcinogenic concern in the total human 

diet derived from procedures not 

involving the extrapolation of data to a 

1 in 1 million risk of cancer to the test 

animals. Thus, were FDA to allow the 

use of alternative procedures that do not 

rely on a statistical extrapolation of the 

data to a 1 in 1 million risk of cancer 

to test animals to satisfy the DES 

Proviso, it would have to develop a new 

set of terminology to describe the Center 

for Veterinary Medicine’s (CVM’s) 

approach for evaluating these 

compounds of carcinogenic concern. 

The proposed changes to the definitions 

of So and Sm are intended to enable 

CVM to consider allowing the use of 

alternative procedures to satisfy the DES 

Proviso without requiring the 

development of a second, alternative, 

set of terminology. 

FDA believes that a careful reading of 

the December 31, 1987, final rule (52 FR 

49572 at 49586), suggests that an 

emphasis on no significant increase in 

the risk of cancer to the human 

consumer, rather than on the specific 1 

in 1 million risk of cancer to the test 

animals approach, reflects the original 

intent of the regulation. (See, e.g., 52 FR 

49572 at 49575 and 49582.) FDA has 

concluded that the proposed 

redefinition of So is consistent with this 

original intent of the regulation. 

For clarification purposes, FDA is also 

proposing a redefinition of Sm in 

§ 500.82 to conform this definition with 

the redefinition of So as described 

previously. Specifically, Sm would mean 

the concentration of a residue of 

carcinogenic concern in a specific 

edible tissue corresponding to no 


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79322 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 

significant increase in the risk of cancer 

to the human consumer. However, the 

definition of Sm would also retain the 

existing reference to a maximum 

lifetime risk of cancer in the test 

animals of 1 in 1 million. 

Finally, FDA is proposing to amend 

§ 500.84(c) to clarify that for each 

compound that is regulated as a 

carcinogen, FDA will analyze the data 

submitted using either a statistical 

extrapolation procedure as provided in 

§ 500.84(c)(1) or an alternate approach 

as provided in § 500.90. 

FDA’s goal in these changes is to 

clarify that the terms So and Sm apply 

even when the alternative procedures 

provided for in § 500.90 are used to 

satisfy the DES Proviso, not to alter the 

usual process for approving compounds 

of carcinogenic concern. As such, in the 

absence of a waiver of the requirements 

of § 500.84(c)(1), FDA maintains that 

sponsors must meet the conditions for 

approval set for in § 500.84, including 

the default approach of a 1 in 1 million 

lifetime risk to the test animal. 

II. Legal Authority 

This rule, if finalized, would amend 

part 500, subpart E in a manner 

consistent with the Agency’s current 

understanding and application of these 

provisions. FDA was given authority in 

21 U.S.C. 348, 360b, and 379e to 

establish methods of examination to 

determine that no residue of a food 

additive, new animal drug, or color 

additive of carcinogenic concern would 

be found in any edible portion of 

animals after slaughter or in any food 

yielded by or derived from living 

animals. Furthermore, FDA has the 

authority to take the actions proposed in 

this rule under various statutory 

provisions. These provisions include 21 

U.S.C. 321, 331, 348, 360b, 371, and 

379e. 

III. Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Analysis of Economic Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

Agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this proposed rule 

is not a significant regulatory action as 

defined by the Executive order. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the proposed rule 

would not impose any direct or indirect 

costs on industry or government 

through the changes to the definitions of 

So and Sm and to § 500.84(c), but rather 

would clarify these definitions to enable 

FDA to consider using alternative 

procedures to satisfy the DES Proviso 

without requiring the development of a 

second, alternative, set of terminology, 

the Agency proposes to certify that the 

final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’ 

The current threshold after adjustment 

for inflation is $135 million, using the 

most current (2009) Implicit Price 

Deflator for the Gross Domestic Product. 

FDA does not expect this proposed rule 

to result in any 1-year expenditure that 

would meet or exceed this amount. 

V. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would have substantial direct 

effects on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, the Agency tentatively 

concludes that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VI. Paperwork Reduction Act of 1995 

This proposed rule refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in § 500.84 have been 

approved under OMB Control No. 0910– 

0032. 

VII. Request for Comments 

FDA requests comments to the 

proposed revisions to the definitions of 

Sm and So currently found in § 500.82(b) 

and to the proposed conforming changes 

to § 500.84(c). Specifically, the Agency 

requests that comments focus on the 

proposal to emphasize ‘‘no significant 

increase in the risk of cancer to the 

human consumer,’’ rather than the more 

specific ‘‘1 in 1 million risk of cancer to 

the test animals’’ approach currently 

found in the definitions of Sm and So. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

VIII. Proposed Effective Date 

The Agency is proposing that any 

final rule that may issue based upon this 

proposed rule become effective upon 

publication in the Federal Register. 

List of Subjects in 21 CFR Part 500 

Animal drugs, Animal feeds, Cancer, 

Labeling, Packaging and containers, 

Polychlorinated biphenyls (PCB’s). 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 500 be amended as follows: 

PART 500—GENERAL 

1. The authority citation for 21 CFR 

part 500 is revised to read as follows: 

Authority: 21 U.S.C. 321, 331, 342, 343, 

348, 351, 352, 353, 360b, 371, 379e. 

2. Revise the definitions of ‘‘Sm’’ and 

‘‘So’’ in paragraph (b) of § 500.82 to read 

as follows: 

§ 500.82 Definitions. 

* * * * * 

(b) * * * 

Sm means the concentration of a 

residue of carcinogenic concern in a 

specific edible tissue corresponding to 

no significant increase in the risk of 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 79323 

cancer to the human consumer. For the 

purpose of § 500.84(c)(1), FDA will 

assume that this Sm will correspond to 

the concentration of residue in a 

specific edible tissue that corresponds 

to a maximum lifetime risk of cancer in 

the test animals of 1 in 1 million. 

So means the concentration of a 

residue of carcinogenic concern in the 

total human diet that represents no 

significant increase in the risk of cancer 

to the human consumer. For the 

purpose of § 500.84(c)(1), FDA will 

assume that this So will correspond to 

the concentration of test compound in 

the total diet of test animals that 

corresponds to a maximum lifetime risk 

of cancer in the test animals of 1 in 1 

million. 

* * * * * 

3. Revise the introductory text of 

paragraph (c) of § 500.84 to read as 

follows: 

§ 500.84 Conditions for approval of the 

sponsored compound. 

* * * * * 

(c) For each sponsored compound that 

FDA decides should be regulated as a 

carcinogen, FDA will either analyze the 

data from the bioassays using a 

statistical extrapolation procedure as 

outlined in paragraph (c)(1) of this 

section or evaluate an alternate 

procedure proposed by the sponsor as 

provided in § 500.90. In either case, 

paragraphs (c)(2) and (c)(3) of this 

section apply. 

* * * * * 

Dated: December 15, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31887 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 63 

RIN 2900–AN73 

Health Care for Homeless Veterans 

Program 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

establish regulations for contracting 

with community-based treatment 

facilities in the Health Care for 

Homeless Veterans (HCHV) program of 

the Department of Veterans Affairs (VA). 

It would formalize VA’s policies and 

procedures in connection with this 

program, which is designed to assist 

certain homeless veterans in obtaining 

treatment from non-VA communitybased providers. It would also clarify 

that veterans with substance use 

disorders may qualify for the program. 

DATES: Comments on the proposed rule, 

including comments on the information 

collection provisions, must be received 

on or before February 18, 2011. 

ADDRESSES: Written comments may be 

submitted through http:// 

www.Regulations.gov; by mail or hand 

delivery to the Director, Regulations 

Management (02REG), Department of 

Veterans Affairs, 810 Vermont Ave., 

NW., Room 1068, Washington, DC 

20420; or by fax to 202–273–9026. 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AN73, Health Care for Homeless 

Veterans Program.’’ Copies of comments 

received will be available for public 

inspection in the Office of Regulation 

Policy and Management, Room 1063B, 

between the hours of 8 a.m. and 4:30 

p.m., Monday through Friday (except 

holidays). Please call (202) 461–4902 

(this is not a toll-free number) for an 

appointment. In addition, during the 

comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

http://www.Regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Robert Hallett, Healthcare for Homeless 

Veterans Manager, c/o Bedford VA 

Medical Center, 200 Springs Road, Bldg. 

12, Bedford, MA 01730; (781) 687–3187 

(this is not a toll free number). 

SUPPLEMENTARY INFORMATION: The 

HCHV program is authorized by 38 

U.S.C. 2031, under which VA may 

provide outreach as well as ‘‘care, 

treatment, and rehabilitative services 

(directly or by contract in communitybased treatment facilities, including 

halfway houses)’’ to ‘‘veterans suffering 

from serious mental illness, including 

veterans who are homeless.’’ One of 

VA’s national priorities is a renewed 

effort to end homelessness for veterans. 

For this reason, we are proposing to 

establish regulations that are consistent 

with the current administration of this 

program. 

The primary mission of the HCHV 

program is to use outreach efforts to 

contact and engage veterans who are 

homeless and suffering from serious 

mental illness or a substance use 

disorder. Many of the veterans for 

whom the HCHV program is designed 

have not previously used VA medical 

services or been enrolled in the VA 

health care system. 

Through the HCHV program, VA 

identifies homeless veterans with 

serious mental illness and/or substance 

use disorder, usually through medical 

intervention, and offers communitybased care to those whose conditions 

are determined, clinically, to be 

managed sufficiently that the 

individuals can participate in such care. 

We have assisted homeless veterans 

with substance use disorders through 

this program because, based on our 

practical understanding and experience, 

the vast majority of homeless veterans 

have substance use disorders. Treating 

substance use as a mental disorder is 

consistent with the generally accepted 

‘‘disease model’’ of alcoholism and drug 

addiction treatment, as well as the 

modern use of medical intervention to 

treat the condition. We believe that if a 

substance use disorder is a contributing 

cause of homelessness, then that 

disorder is serious; therefore, it is 

consistent to include such veterans in a 

program designed for ‘‘veterans suffering 

from serious mental illness, including 

veterans who are homeless.’’ 38 U.S.C. 

2031(a). 

Veterans who are identified and who 

choose to participate in this form of care 

as part of their treatment plan are then 

referred by VA to an appropriate nonVA community-based provider. In some 

cases, VA will continue to actively 

medically manage the veteran’s 

condition, while in other cases a VA 

clinician may determine that a veteran 

can be sufficiently managed through 

utilization of non-medical resources, 

such as 12-step programs. 

To provide the community-based 

care, VA contracts, via the HCHV 

program, with non-VA communitybased providers, such as halfway 

houses, to provide to these veterans 

housing and mental health and/or 

substance use disorder treatment. VA 

provides per diem payments to these 

non-VA community-based providers for 

the services provided to veterans. 

Service provision within these contracts 

is typically short-term, because during 

their stay veteran-participants are 

connected with other resources 

designed to provide longer-term 

housing. These contracts, and the per 

diem payment, are governed by the 

Federal Acquisition Regulations, and 

the VA supplements thereto contained 

in the Veterans Affairs Acquisition 

Regulations at chapter 8 of title 48, CFR. 

These are the rules that specifically 

govern requirements exclusive to VA 

contracting actions. 

We propose to establish a new 38 CFR 

part 63 for the HCHV program because 

the program is unique and the proposed 

rule would not apply to therapeutic 

housing or other VA programs designed 

to end homelessness. The primary 

purposes of this rulemaking are to 

establish eligibility criteria for veterans 


jlentini on DSKJ8SOYB1PROD with PROPOSALS