Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Rules and Regulations 40229 

eligible to meet the requirements of 

these exemptions is a small entity. 

VIII. Statutory Authority and Text of 

the Rules and Amendments 

The amendments described in this 

release are being adopted under the 

authority set forth in Sections 18, 19 

and 28 of the Securities Act; Sections 

12(h), 23(a) and 36 of the Exchange Act; 

and Section 304(d) of the TIA. 

List of Subjects in 17 CFR Parts 230, 

240 and 260 

Reporting and recordkeeping 

requirements, Securities. 

Text of the Rules and Amendments 

We are temporarily amending 17 CFR 

parts 230, 240, and 260 as follows and 

the expiration dates in the temporary 

rules and amendments published 

January 22, 2009 (74 FR 3967), extended 

in a release published on September 17, 

2009 (74 FR 47719), and further 

extended in a release published on 

November 26, 2010 (75 FR 72660), are 

further extended from July 16, 2011 to 

April 16, 2012. 

PART 230—GENERAL RULES AND 

REGULATIONS, SECURITIES ACT OF 

1933 

1. The authority citation for part 230 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77b, 77c, 77d, 77f, 

77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, 78c, 78d, 

78j, 78l, 78m, 78n, 78o, 78t, 78w, 78ll(d), 

78mm, 80a–8, 80a–24, 80a–28, 80a–29, 80a– 

30, and 80a–37, unless otherwise noted. 

* * * * * 

§§ 230.146 and 230.239T [Amended] 

■ 2. In § 230.146(c)T, in the last 

sentence, remove the words ‘‘July 16, 

2011’’ and add, in their place, the words 

‘‘April 16, 2012’’. 

■ 3. In § 230.239T(e), remove the words 

‘‘July 16, 2011’’ and add, in their place, 

the words ‘‘April 16, 2012’’. 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 4. The authority citation for part 240 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78o– 

4, 78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 

78mm, 80a–20, 80a–23, 80a–29, 80a–37, 80b– 

3, 80b–4, 80b–11, and 7201 et seq.; and 18 

U.S.C. 1350; and 12 U.S.C. 5221(e)(3) unless 

otherwise noted. 

* * * * * 

§§ 240.12a–10T and 240.12h–1 [Amended] 

■ 5. In § 240.12a–10T(b), remove the 

words ‘‘July 16, 2011’’ and add, in their 

place, the words ‘‘April 16, 2012’’. 

■ 6. In § 240.12h–1(h)T, in the last 

sentence, remove the words ‘‘July 16, 

2011’’ and add, in their place, the words 

‘‘April 16, 2012’’. 

PART 260—GENERAL RULES AND 

REGULATIONS, TRUST INDENTURE 

ACT OF 1939 

■ 7. The authority citation for part 260 

continues to read as follows: 

Authority: 15 U.S.C. 77eee, 77ggg, 77nnn, 

77sss, 78ll(d), 80b–3, 80b–4, and 80b–11. 

* * * * * 

§ 260.4d–11T [Amended] 

■ 8. In § 260.4d–11T, in the last 

sentence, remove the words ‘‘July 16, 

2011’’ and add, in their place, the words 

‘‘April 16, 2012’’. 

By the Commission. 

Dated: July 1, 2011. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2011–17132 Filed 7–7–11; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Change of Sponsor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for a new animal drug 

application (NADA) from Virbac AH, 

Inc., to Cross Vetpharm Group Ltd. 

DATES: This rule is effective July 8, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Virbac 

AH, Inc., 3200 Meacham Blvd., Ft. 

Worth, TX 76137, has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, NADA 092– 

150 for Purina Horse & Colt Wormer 

(pyrantel tartrate) to Cross Vetpharm 

Group Ltd., Broomhill Rd., Tallaght, 

Dublin 24, Ireland. Accordingly, the 

regulations are amended in 21 CFR 

520.2045 to reflect the transfer of 

ownership. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 520.2045 [Amended] 

■ 2. In paragraph (b)(2) of § 520.2045, 

remove ‘‘051311’’ and in its place add 

‘‘061623’’. 

Dated: July 1, 2011. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2011–17151 Filed 7–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Bureau of Prisons 

28 CFR Part 549 

[BOP–1088–F] 

RIN 1120–AB20 

Psychiatric Evaluation and Treatment 

AGENCY: Bureau of Prisons, Justice. 

ACTION: Final rule. 

SUMMARY: In this document, the Bureau 

of Prisons (Bureau) finalizes regulations 

on providing psychiatric treatment and 

medication to inmates. These revised 

regulations are clarified and updated to 

reflect current caselaw. 

DATES: This rule is effective on August 

12, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Qureshi, Office of General 

Counsel, Bureau of Prisons, phone (202) 

307–2105. 

SUPPLEMENTARY INFORMATION: The 

Bureau finalizes regulations on 


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40230 Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Rules and Regulations 

providing psychiatric treatment and 

medication to inmates. We first 

published a proposed regulation 

document on this subject in the Federal 

Register on December 29, 2003 (68 FR 

74892). We then withdrew that 

proposed regulation document and 

proposed revised regulations on June 

16, 2008 (73 FR 33957). We received 

four comments, which we address 

below. 

Two commenters addressed 

§ 549.45(b) of the proposed regulation, 

which states that, ‘‘[p]ursuant to 18 

U.S.C. § 4042, the Bureau is authorized 

to provide for the safekeeping, care, and 

subsistence, of all persons charged with 

offenses against the United States, or 

held as witnesses or otherwise. 

Accordingly, if an examiner determines 

pursuant to § 549.43 of this subpart that 

an inmate not subject to hospitalization 

pursuant to 18 U.S.C. Chapter 313 

should be hospitalized for psychiatric 

care or treatment, and the inmate is 

unwilling or unable to consent, the 

Bureau will provide the inmate with an 

administrative hearing to determine 

whether hospitalization for psychiatric 

care or treatment is warranted. The 

hearing will comply with the applicable 

procedural safeguards set forth in 

§ 549.46(a).’’ 

The commenters believe that ‘‘the 

administrative hearing process’’ under 

this section ‘‘is a standard that provides 

less procedural protection to the inmate 

than does a court determination.’’ The 

commenters felt that ‘‘such a standard is 

unreasonable and unfair to the inmates 

covered by § 549.45(b)’’ because these 

inmates may include ‘‘material 

witnesses and other detainees who may 

not have been convicted,’’ and are, 

therefore, ‘‘entitled to a level of review 

equal to or surpassing that of sentenced 

inmates.’’ 

In response, we note that proposed 

§ 549.45 states that a court 

determination is necessary for 

involuntary hospitalization or 

commitment of inmates pursuant to 18 

U.S.C. Chapter 313, who are in need of 

psychiatric care or treatment, but are 

unwilling or unable to voluntarily 

consent. Section 4245 in that chapter 

specifically provides for involuntary 

hospitalization by court order of a 

person serving a sentence of 

imprisonment if needed for psychiatric 

care or treatment. The necessity of a 

court determination for these types of 

inmates is, therefore, prescribed by 

statute. 

In contrast, however, no court 

determination is prescribed by statute 

with regard to involuntary 

hospitalization of inmates who are not 

subject to hospitalization under 18 

U.S.C. 4245 (because not serving a 

sentence of imprisonment), such as 

alien detainees subject to an order of 

deportation, exclusion or removal, 

material witnesses, contempt of court 

commitments, etc. 

Nevertheless, the Director has chosen 

to provide administrative due process 

with regard to involuntary 

hospitalization of such inmates, 

‘‘[b]ecause prisoners facing involuntary 

transfer to a mental hospital are 

threatened with immediate deprivation 

of liberty interests they are currently 

enjoying, and because of the inherent 

risk of a mistaken transfer,’’ adhering to 

the principles set forth in Vitek v. Jones, 

445 U.S. 480 at 495, 100 S.Ct. 1254 at 

1265 (1980). 

We note that the availability of this 

administrative hearing procedure in 

appropriate cases does not limit the 

Bureau’s ability to seek judicial 

hospitalization or commitment of 

inmates under any applicable provision 

of Chapter 313, such as judicial 

commitment of inmates, whether 

sentenced or unsentenced, as sexually 

dangerous persons under 18 U.S.C. 

4248. 

However, because the commenters 

appear to question or misunderstand the 

due process procedures that the Bureau 

implements through this final rule that 

specifically apply to the involuntary 

hospitalization of inmates who are not 

subject to hospitalization under 18 

U.S.C. 4245, we alter § 549.45(b) as 

follows: We delete the reference to the 

due process procedures in § 549.46(a) 

and simply restate them, tailored for 

reference to involuntary hospitalization 

instead of involuntary administration of 

psychiatric medication, in the relevant 

regulation, § 549.45(b). 

Also, the American Psychiatric 

Association (APA) and the American 

Civil Liberties Union (ACLU) 

commented regarding the Bureau’s use 

of the phrase ‘qualified health services 

staff’ in § 549.44 of the proposed 

regulation. The APA recommended that 

the Bureau ‘‘clarify this section by either 

revising the proposed language in the 

regulation or issuing a policy guide 

which defines which personnel are 

considered ‘qualified health services 

staff’ for the purposes of these sections.’’ 

The ACLU provided a similar comment. 

The Bureau will issue a policy guide, as 

suggested by the APA, which will 

clarify the qualifications for staff with 

regard to voluntary hospitalization in a 

suitable facility for psychiatric care or 

treatment, and voluntary administration 

of psychiatric medication. Bureau 

policy guides are called Program 

Statements, and are designed 

specifically to provide more detailed 

staff guidance with regard to 

implementing Bureau regulations, 

policies, and programs. Because 

Program Statements are the primary 

vehicle for staff guidance, it would be 

appropriate to detail health services 

staff qualifications in the relevant 

Bureau Program Statements. 

Also, the APA would ‘‘urge that [the 

Bureau] state that only licensed 

physicians are qualified to make 

decisions about the administration of 

psychopharmacologic medications and 

that, when possible, a psychiatrist 

should be consulted. This clarification 

would provide assurance that inmates 

are receiving appropriate mental health 

treatment and that consent to any 

hospitalization or medication is truly 

warranted and voluntary and meets 

state and Federal law requirements.’’ 

Likewise, the ACLU commented that 

‘‘the regulations should be amended to 

clarify that the exception authorizing 

more cursory procedures for 

emergencies requires that any treatment 

be ‘medically’ appropriate, even in an 

emergency.’’ 

In response, we state that Bureau 

policy currently requires that 

psychiatric medications be prescribed 

only by Bureau medical health 

professionals that have a permanent, 

full, and unrestricted license to practice 

medicine in a state, District of 

Columbia, the Commonwealth of Puerto 

Rico, or a territory of the United States. 

Bureau policy on pharmacy services is 

predicated on the requirement that the 

use of psychiatric medications and 

controlled substances be restricted to 

physicians only and prescribed only 

when medically appropriate. Further, if 

an order for psychiatric medication is 

prepared or written by a mid-level 

practitioner (Physician’s Assistant or 

Nurse Practitioner), it must be signed by 

a licensed physician before it can be 

filled by a pharmacist. 

Another commenter suggested that 

the Bureau ‘‘recognize psychiatric 

advance practice nurses as part of the 

treatment team in correctional 

facilities.’’ While the Bureau does 

utilize nurse practitioners, physician’s 

assistants, and nurses, as stated above, 

any prescription for psychiatric 

medication must be signed by a licensed 

physician. 

For the aforementioned reasons, we 

now finalize the proposed rule 

published on June 16, 2008 (73 FR 

33957), with minor changes for clarity. 

Executive Order 12866 

This regulation has been drafted and 

reviewed in accordance with Executive 

Order 12866, ‘‘Regulatory Planning and 

Review’’, section 1(b), Principles of 


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Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Rules and Regulations 40231 

Regulation. The Director has determined 

that this regulation is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866, section 3(f), and 

accordingly this regulation has not been 

reviewed by the Office of Management 

and Budget. 

Executive Order 13132 

This regulation will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, under 

Executive Order 13132, we determine 

that this regulation does not have 

sufficient Federalism implications to 

warrant the preparation of a Federalism 

Assessment. 

Regulatory Flexibility Act 

The Director, under the Regulatory 

Flexibility Act (5 U.S.C. 605(b)), 

reviewed this regulation and by 

approving it certifies that it will not 

have a significant economic impact 

upon a substantial number of small 

entities for the following reasons: This 

regulation pertains to the correctional 

management of offenders committed to 

the custody of the Attorney General or 

the Director, and its economic impact is 

limited to the Bureau’s appropriated 

funds. 

Unfunded Mandates Reform Act of 

1995 

This regulation will not result in the 

expenditure by State, local and Tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

in any one year, and it will not 

significantly or uniquely affect small 

governments. Therefore, no actions were 

deemed necessary under the provisions 

of the Unfunded Mandates Reform Act 

of 1995. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This regulation is not a major rule as 

defined by § 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996. This regulation will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 28 CFR Part 549 

Prisoners. 

Thomas R. Kane, 

Acting Director, Federal Bureau of Prisons. 

Under the rulemaking authority 

vested in the Attorney General in 5 

U.S.C. 552(a) and delegated to the 

Director, Bureau of Prisons, we amend 

28 CFR part 549 as follows. 

PART 549—MEDICAL SERVICES 

■ 1. Revise the authority citation for 28 

CFR part 549 to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. 876b; 

18 U.S.C. 3621, 3622, 3524, 4001, 4005, 4042, 

4045, 4081, 4082 (Repealed in part as to 

offenses committed on or after November 1, 

1987), Chapter 313, 5006–5024 (Repealed 

October 12, 1984 as to offenses committed 

after that date), 5039; 28 U.S.C. 509, 510. 

■ 2. Revise subpart C of part 549 to read 

as follows: 

Subpart C—Psychiatric Evaluation and 

Treatment 

Sec. 

549.40 Purpose and scope. 

549.41 Hospitalization in a suitable facility. 

549.42 Use of psychiatric medications. 

549.43 Transfer for psychiatric or 

psychological examination. 

549.44 Voluntary hospitalization in a 

suitable facility for psychiatric care or 

treatment and voluntary administration 

of psychiatric medication. 

549.45 Involuntary hospitalization in a 

suitable facility for psychiatric care or 

treatment. 

549.46 Procedures for involuntary 

administration of psychiatric 

medication. 

Subpart C—Psychiatric Evaluation and 

Treatment 

§ 549.40 Purpose and scope. 

(a) This subpart describes procedures 

for voluntary and involuntary 

psychiatric evaluation, hospitalization, 

care, and treatment, in a suitable 

facility, for persons in Bureau of Prisons 

(Bureau) custody. These procedures are 

authorized by 18 U.S.C. Chapter 313 

and 18 U.S.C. 4042. 

(b) This subpart applies to inmates in 

Bureau custody, as defined in 28 CFR 

part 500. 

§ 549.41 Hospitalization in a suitable 

facility. 

As used in 18 U.S.C. Chapter 313 and 

this subpart, ‘‘hospitalization in a 

suitable facility’’ includes the Bureau’s 

designation of inmates to medical 

referral centers or correctional 

institutions that provide the required 

care or treatment. 

§ 549.42 Use of psychiatric medications. 

Psychiatric medications will be used 

only for treatment of diagnosable mental 

illnesses and disorders, and their 

symptoms, for which such medication is 

accepted treatment. Psychiatric 

medication will be administered only 

after following the applicable 

procedures in this subpart. 

§ 549.43 Transfer for psychiatric or 

psychological examination. 

The Bureau may transfer an inmate to 

a suitable facility for psychiatric or 

psychological examination to determine 

whether hospitalization in a suitable 

facility for psychiatric care or treatment 

is needed. 

§ 549.44 Voluntary hospitalization in a 

suitable facility for psychiatric care or 

treatment, and voluntary administration of 

psychiatric medication. 

(a) Hospitalization. An inmate may be 

hospitalized in a suitable facility for 

psychiatric care or treatment after 

providing informed and voluntary 

consent when, in the professional 

medical judgment of qualified health 

services staff, such care or treatment is 

required and prescribed. 

(b) Psychiatric medication. An inmate 

may also provide informed and 

voluntary consent to the administration 

of psychiatric medication that complies 

with the requirements of § 549.42 of this 

subpart. 

(c) Voluntary consent. An inmate’s 

ability to provide informed and 

voluntary consent for both 

hospitalization in a suitable facility for 

psychiatric care or treatment, and 

administration of psychiatric 

medications, will be assessed by 

qualified health services staff and 

documented in the inmate’s medical 

record. Additionally, the inmate must 

sign a consent form to accept 

hospitalization in a suitable facility for 

psychiatric care or treatment and the 

administration of psychiatric 

medications. These forms will be 

maintained in the inmate’s medical 

record. 

§ 549.45 Involuntary hospitalization in a 

suitable facility for psychiatric care or 

treatment. 

(a) Hospitalization of inmates 

pursuant to 18 U.S.C. Chapter 313. A 

court determination is necessary for 

involuntary hospitalization or 

commitment of inmates pursuant to 18 

U.S.C. Chapter 313, who are in need of 

psychiatric care or treatment, but are 

unwilling or unable to voluntarily 

consent. 

(b) Hospitalization of inmates not 

subject to hospitalization pursuant to 18 

U.S.C. chapter 313. Pursuant to 18 


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40232 Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Rules and Regulations 

U.S.C. 4042, the Bureau is authorized to 

provide for the safekeeping, care, and 

subsistence, of all persons charged with 

offenses against the United States, or 

held as witnesses or otherwise. 

Accordingly, if an examiner determines 

pursuant to § 549.43 of this subpart that 

an inmate not subject to hospitalization 

pursuant to 18 U.S.C. chapter 313 

should be hospitalized for psychiatric 

care or treatment, and the inmate is 

unwilling or unable to consent, the 

Bureau will provide the inmate with an 

administrative hearing to determine 

whether hospitalization for psychiatric 

care or treatment is warranted. The 

hearing will provide the following 

procedural safeguards: 

(1) The inmate will not be 

involuntarily administered psychiatric 

medication before the hearing except in 

the case of psychiatric emergencies, as 

defined in § 549.46(b)(1). 

(2) The inmate must be provided 24- 

hours advance written notice of the 

date, time, place, and purpose, of the 

hearing, including an explanation of the 

reasons for the proposal to hospitalize 

the inmate for psychiatric care or 

treatment. 

(3) The inmate must be informed of 

the right to appear at the hearing, to 

present evidence, to have a staff 

representative, to request witnesses, and 

to request that witnesses be questioned 

by the staff representative or by the 

person conducting the hearing. If the 

inmate does not request a staff 

representative, or requests a staff 

representative with insufficient 

experience or education, or one who is 

not reasonably available, the institution 

mental health division administrator 

must appoint a qualified staff 

representative. 

(4) The hearing is to be conducted by 

a psychiatrist other than the attending 

psychiatrist, and who is not currently 

involved in the diagnosis or treatment of 

the inmate. 

(5) Witnesses should be called if they 

are reasonably available and have 

information relevant to the inmate’s 

mental condition or need for 

hospitalization. Witnesses who will 

provide only repetitive information 

need not be called. 

(6) A treating/evaluating psychiatrist/ 

clinician, who has reviewed the case, 

must be present at the hearing and must 

present clinical data and background 

information relative to the inmate’s 

need for hospitalization. Members of the 

treating/evaluating team may also be 

called as witnesses at the hearing to 

provide relevant information. 

(7) The psychiatrist conducting the 

hearing must determine whether 

involuntary hospitalization is necessary 

because the inmate is presently 

suffering from a mental disease or defect 

for the treatment of which he is in need 

of custody for care or treatment in a 

suitable facility. 

(8) The psychiatrist must prepare a 

written report regarding the initial 

decision. The inmate must be promptly 

provided a copy of the initial decision 

report, and informed that he/she may 

appeal it to the institution’s mental 

health division administrator. The 

inmate’s appeal, which may be 

handwritten, must be submitted within 

24 hours after receipt of the hearing 

officer’s report. Upon request of the 

inmate, the staff representative will 

assist the inmate in preparing and 

submitting the appeal. 

(9) If the inmate appeals the initial 

decision, hospitalization must not occur 

before the administrator issues a 

decision on the appeal. The inmate’s 

appeal will ordinarily be reviewed by 

the administrator or his designee within 

24 hours of its submission. The 

administrator will review the initial 

decision and ensure that the inmate 

received all necessary procedural 

protections, and that the justification for 

hospitalization is appropriate. 

(c) Psychiatric medication. Following 

an inmate’s involuntary hospitalization 

for psychiatric care or treatment as 

provided in this section, psychiatric 

medication may be involuntarily 

administered only after following the 

administrative procedures provided in 

§ 549.46 of this subpart. 

§ 549.46 Procedures for involuntary 

administration of psychiatric medication. 

Except as provided in paragraph (b) of 

this section, the Bureau will follow the 

administrative procedures of paragraph 

(a) of this section before involuntarily 

administering psychiatric medication to 

any inmate. 

(a) Procedures. When an inmate is 

unwilling or unable to provide 

voluntary written informed consent for 

recommended psychiatric medication, 

the inmate will be scheduled for an 

administrative hearing. The hearing will 

provide the following procedural 

safeguards: 

(1) Unless an exception exists as 

provided in paragraph (b) of this 

section, the inmate will not be 

involuntarily administered psychiatric 

medication before the hearing. 

(2) The inmate must be provided 24- 

hours advance written notice of the 

date, time, place, and purpose, of the 

hearing, including an explanation of the 

reasons for the psychiatric medication 

proposal. 

(3) The inmate must be informed of 

the right to appear at the hearing, to 

present evidence, to have a staff 

representative, to request witnesses, and 

to request that witnesses be questioned 

by the staff representative or by the 

person conducting the hearing. If the 

inmate does not request a staff 

representative, or requests a staff 

representative with insufficient 

experience or education, or one who is 

not reasonably available, the institution 

mental health division administrator 

must appoint a qualified staff 

representative. 

(4) The hearing is to be conducted by 

a psychiatrist other than the attending 

psychiatrist, and who is not currently 

involved in the diagnosis or treatment of 

the inmate. 

(5) Witnesses should be called if they 

are reasonably available and have 

information relevant to the inmate’s 

mental condition or need for psychiatric 

medication. Witnesses who will provide 

only repetitive information need not be 

called. 

(6) A treating/evaluating psychiatrist/ 

clinician, who has reviewed the case, 

must be present at the hearing and must 

present clinical data and background 

information relative to the inmate’s 

need for psychiatric medication. 

Members of the treating/evaluating team 

may also be called as witnesses at the 

hearing to provide relevant information. 

(7) The psychiatrist conducting the 

hearing must determine whether 

involuntary administration of 

psychiatric medication is necessary 

because, as a result of the mental illness 

or disorder, the inmate is dangerous to 

self or others, poses a serious threat of 

damage to property affecting the 

security or orderly running of the 

institution, or is gravely disabled 

(manifested by extreme deterioration in 

personal functioning). 

(8) The psychiatrist must prepare a 

written report regarding the initial 

decision. The inmate must be promptly 

provided a copy of the initial decision 

report, and informed that he/she may 

appeal it to the institution’s mental 

health division administrator. The 

inmate’s appeal, which may be 

handwritten, must be submitted within 

24 hours after receipt of the hearing 

officer’s report. Upon request of the 

inmate, the staff representative will 

assist the inmate in preparing and 

submitting the appeal. 

(9) If the inmate appeals the initial 

decision, psychiatric medication must 

not be administered before the 

administrator issues a decision on the 

appeal, unless an exception exists as 

provided in paragraph (b) of this 

section. The inmate’s appeal will 

ordinarily be reviewed by the 

administrator or his designee within 24 


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Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Rules and Regulations 40233 

hours of its submission. The 

administrator will review the initial 

decision and ensure that the inmate 

received all necessary procedural 

protections, and that the justification for 

administering psychiatric medication is 

appropriate. 

(10) If an inmate was afforded an 

administrative hearing which resulted 

in the involuntary administration of 

psychiatric medication, and the inmate 

subsequently consented to the 

administration of such medication, and 

then later revokes his consent, a followup hearing will be held before resuming 

the involuntary administration of 

psychiatric medication. All such followup hearings will fully comply with the 

procedures outlined in paragraphs (a)(1) 

through (10) of this section. 

(b) Exceptions. The Bureau may 

involuntarily administer psychiatric 

medication to inmates in the following 

circumstances without following the 

procedures outlined in paragraph (a) of 

this section: 

(1) Psychiatric emergencies. 

(i) During a psychiatric emergency, 

psychiatric medication may be 

administered only when the medication 

constitutes an appropriate treatment for 

the mental illness or disorder and its 

symptoms, and alternatives (e.g., 

seclusion or physical restraint) are not 

available or indicated, or would not be 

effective. If psychiatric medication is 

still recommended after the psychiatric 

emergency, and the emergency criteria 

no longer exist, it may only be 

administered after following the 

procedures in §§ 549.44 or 549.46 of this 

subpart. 

(ii) For purposes of this subpart, a 

psychiatric emergency exists when a 

person suffering from a mental illness or 

disorder creates an immediate threat of: 

(A) Bodily harm to self or others; 

(B) Serious destruction of property 

affecting the security or orderly running 

of the institution; or 

(C) Extreme deterioration in personal 

functioning secondary to the mental 

illness or disorder. 

(2) Court orders for the purpose of 

restoring competency to stand trial. 

Absent a psychiatric emergency as 

defined above, § 549.46(a) of this 

subpart does not apply to the 

involuntary administration of 

psychiatric medication for the sole 

purpose of restoring a person’s 

competency to stand trial. Only a 

Federal court of competent jurisdiction 

may order the involuntary 

administration of psychiatric 

medication for the sole purpose of 

restoring a person’s competency to 

stand trial. 

[FR Doc. 2011–17160 Filed 7–7–11; 8:45 am] 

BILLING CODE 4410–05–P 

DEPARTMENT OF DEFENSE 

Department of the Navy 

32 CFR Part 706 

Certifications and Exemptions Under 

the International Regulations for 

Preventing Collisions at Sea, 1972 

AGENCY: Department of the Navy, DoD. 

ACTION: Final rule. 

SUMMARY: The Department of the Navy 

(DoN) is amending its certifications and 

exemptions under the International 

Regulations for Preventing Collisions at 

Sea, 1972 (72 COLREGS), to reflect that 

the Deputy Assistant Judge Advocate 

General (DAJAG)(Admiralty and 

Maritime Law) has determined that USS 

PITTSBURGH (SSN 720) is a vessel of 

the Navy which, due to its special 

construction and purpose, cannot fully 

comply with certain provisions of the 72 

COLREGS without interfering with its 

special function as a naval ship. The 

intended effect of this rule is to warn 

mariners in waters where 72 COLREGS 

apply. 

DATES: This rule is effective July 8, 2011 

and is applicable beginning June 29, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant Jaewon Choi, (Admiralty and 

Maritime Law), Office of the Judge 

Advocate General, Department of the 

Navy, 1322 Patterson Ave., SE., Suite 

3000, Washington Navy Yard, DC 

20374–5066, telephone 202–685–5040. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the authority granted in 33 U.S.C. 

1605, the DoN amends 32 CFR part 706. 

This amendment provides notice that 

the DAJAG (Admiralty and Maritime 

Law), under authority delegated by the 

Secretary of the Navy, has certified that 

USS PITTSBURGH (SSN 720) is a vessel 

of the Navy which, due to its special 

construction and purpose, cannot fully 

comply with the following specific 

provision of 72 COLREGS without 

interfering with its special function as a 

naval ship: Rule 21 (a) pertaining to the 

centerline position of the masthead 

light. The DAJAG (Admiralty and 

Maritime Law) has also certified that the 

light involved is located in closest 

possible compliance with the applicable 

72 COLREGS requirements. 

Moreover, it has been determined, in 

accordance with 32 CFR parts 296 and 

701, that publication of this amendment 

for public comment prior to adoption is 

impracticable, unnecessary, and 

contrary to public interest since it is 

based on technical findings that the 

placement of lights on this vessel in a 

manner differently from that prescribed 

herein will adversely affect the vessel’s 

ability to perform its military functions. 

List of Subjects in 32 CFR Part 706 

Marine safety, Navigation (water), and 

Vessels. 

For the reasons set forth in the 

preamble, the Navy amends part 706 of 

title 32 of the Code of Federal 

Regulations as follows: 

PART 706—CERTIFICATIONS AND 

EXEMPTIONS UNDER THE 

INTERNATIONAL REGULATIONS FOR 

PREVENTING COLLISIONS AT SEA, 

1972 

■ 1. The authority citation for part 706 

continues to read as follows: 

Authority: 33 U.S.C. 1605. 

■ 2. Section 706.2 is amended in Table 

Two by amending, in alpha numerical 

order, by vessel number, an entry for 

USS PITTSBURGH (SSN 720) to read as 

follows: 

§ 706.2 Certifications of the Secretary of 

the Navy under Executive Order 11964 and 

33 U.S.C. 1605. 

* * * * * 


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