Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 9353 

10. Seiff, S. R., J. H. Sullivan, L. N. Freeman, 

and J. Ahn, ‘‘Pretarsal Fixation of Gold 

Weights in Facial Nerve Palsy,’’ 

Ophthalmic Plastic and Reconstructive 

Surgery, vol. 5, no. 2, pp. 104–109, 1989. 

11. Kartush, J. M., C. J. Linstrom, P. M. 

McCann, and M. D. Graham, ‘‘Early Gold 

Weight Eyelid Implantation for Facial 

Paralysis,’’ Otolaryngology—Head and 

Neck Surgery, vol. 103, no. 6, pp. 1016– 

1023, December 1990. 

12. Townsend, D. J., ‘‘Eyelid Reanimation for 

the Treatment of Paralytic 

Lagophthalmos: Historical Perspectives 

and Current Applications of the Gold 

Weight Implant,’’ Ophthalmic Plastic 

and Reconstructive Surgery, vol. 8, no. 3, 

pp. 196–201, 1992. 

13. Silver, A. L., R. W. Lindsay, M. L. 

Cheney, and T. A. Hadlock, ‘‘ThinProfile Platinum Eyelid Weighting: A 

Superior Option in the Paralyzed Eye,’’ 

Plastic and Reconstructive Surgery, vol. 

123, no. 6, pp. 1697–1703, June 2009. 

14. Schrom, T., A. Loch, M. Ho ̈lzl, and H. 

Scherer, Abstract: ‘‘Evaluation of a New 

Lid Implant for Rehabilitation of the 

Paralyzed Eye,’’ Laryngorhinootologie, 

vol. 85, no. 1, pp. 38–42, January 2006. 

15. Zwick, O. M. and S. R. Seiff, ‘‘Supportive 

Care of Facial Nerve Palsy with 

Temporary External Eyelid Weights,’’ 

Optometry, vol. 77, no. 7, pp. 340–342, 

July 2006. 

16. Williams, Z. R. and J. V. Aquavella, 

‘‘Management of Exposure Keratopathy 

Associated with Severe Craniofacial 

Trauma,’’ Journal of Cataract and 

Refractive Surgery, vol. 33, no. 9, pp. 

1647–1650, September 2007. 

17. Gautam, P, R. K. Adhikari, and B. R. 

Sharma, ‘‘A Profile of Eye-Lid 

Conditions Requiring Reconstruction 

Among the Patients Attending an 

Oculoplasty Clinic in Mid-Western 

Region of Nepal,’’ Nepalese Journal of 

Ophthalmology, vol. 3, no. 5, pp. 49–51, 

January 2011. 

18. Heier, J. S., R. W. Enzenauer, S. F. 

Wintermeyer, M. Delaney, and F. P. 

LaPiana, ‘‘Ocular Injuries and Diseases at 

a Combat Support Hospital in Support of 

Operations Desert Shield and Desert 

Storm,’’ Archives of Ophthalmology, vol. 

111, no. 6, pp. 795–798, June 1993. 

19. Mader, T. H., J. V. Aragones, A. C. 

Chandler, J. A. Hazlehurst, J. Heier, J. D. 

Kingham, and E. Stein, ‘‘Ocular and 

Ocular Adnexal Injuries Treated by 

United States Military Ophthalmologists 

During Operations Desert Shield and 

Desert Storm,’’ Ophthalmology, vol. 100, 

no. 10, pp. 1462–1467, October 1993. 

20. Morley, M. G., J. K. Nguyen, J. S. Heier, 

B. J. Shingleton, J. F. Pasternak, and K. 

S. Bower, ‘‘Blast Eye Injuries: A Review 

for First Responders,’’ Disaster Medicine 

and Public Health Preparedness, vol. 4, 

no. 2, pp. 154–160, June 2010. 

21. Blozan, C. F. and S. A. Tucker, 

‘‘Premarket Notifications: The First 

24,000,’’ Medical Device & Diagnostic 

Industry, pp. 59–69, January 1986. 

22. U.S. Department of Commerce, Bureau of 

Economic Analysis, National Income and 

Product Accounts Table 1.1.9 Implicit 

Price Deflators for Gross Domestic 

Product, http://www.bea.gov/iTable/

iTable.cfm?ReqID=9&step=1, accessed 

January 17, 2013; National Income and 

Product Accounts Table 1.1.4 Price 

Indexes for Gross Domestic Product, 

http://www.bea.gov/iTable/iTable.cfm?

ReqID=9&step=1, accessed January 17, 

2013. 

23. Geiger, D. R., ‘‘FY 2003 and 2004 Unit 

Costs for the Process of Medical Device 

Review,’’ September 2005, http://

www.fda.gov/downloads/Medical

Devices/DeviceRegulationandGuidance/

Overview/MedicalDeviceUserFeeand

ModernizationActMDUFMA/

ucm109216.pdf. 

List of Subjects in 21 CFR Part 886 

Medical devices, Ophthalmic goods 

and services. 

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 886 be amended as follows: 

PART 886—OPHTHALMIC DEVICES 

■ 1. The authority citation for 21 CFR 

part 886 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 886.5700 is added to 

subpart F to read as follows: 

§ 886.5700 Eyelid weight. 

(a) Identification. An eyelid weight is 

a prescription device made of gold, 

tantalum, platinum, iridium, or surgical 

grade stainless steel that is rectangular 

in shape and contoured to the shape of 

the eye. The device is intended for the 

gravity assisted treatment of 

lagophthalmos (incomplete eyelid 

closure). 

(1) The external eyelid weight is 

adhered to the outer skin of the upper 

eyelid. 

(2) The implantable eyelid weight is 

implanted into the upper eyelid. 

(b) Classification. (1) Class II (special 

controls) for the external eyelid weight. 

The external eyelid weight is exempt 

from the premarket notification 

procedures in subpart E of part 807 of 

this chapter subject to the limitations in 

§ 886.9. The special controls for the 

external eyelid weight are: 

(i) Testing demonstrating the 

biocompatibility of the device; 

(ii) Nonclinical testing evaluating the 

compatibility of the device in a 

magnetic resonance (MR) environment; 

(iii) Labeling to include all 

information required for the safe and 

effective use of the device as outlined in 

§ 801.109(c) of this chapter, including 

specific instructions regarding the 

proper placement, sizing, and removal 

of the device; and 

(2) Class II (special controls) for the 

implantable eyelid weight. The special 

controls for the implantable eyelid 

weight are: 

(i) Testing demonstrating the 

biocompatibility of the device; 

(ii) Testing demonstrating the sterility 

and shelf life of the device; 

(iii) Nonclinical testing evaluating the 

compatibility of the device in an MR 

environment. 

(iv) Patient labeling to convey 

information regarding the safety and 

compatibility of the device in an MR 

environment, the conditions under 

which a patient with the device can be 

safely scanned, and a mechanism for a 

healthcare provider to obtain detailed 

information about MR safety and 

compatibility if needed. 

Dated: February 1, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–02862 Filed 2–7–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Bureau of Prisons 

28 CFR Part 571 

[BOP–1090–P] 

RIN 1120–AA85 

Designation of Offenses 

AGENCY: Federal Bureau of Prisons, 

Department of Justice. 

ACTION: Proposed rule. 

SUMMARY: The Bureau of Prisons 

(Bureau) proposes to remove rules 

which designate various offenses as 

sexual offenses for purposes of U.S. 

Code because that provision, which 

necessitated regulations, has been 

repealed in relevant part. 

DATES: Comments are due by April 9, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Qureshi, Office of General 

Counsel, Bureau of Prisons, phone (202) 

307–2105. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at 

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

If you want to submit personal 

identifying information (such as your 


wreier-aviles on DSK7SPTVN1PROD with PROPOSALS
9354 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also locate 

all the personal identifying information 

you do not want posted online in the 

first paragraph of your comment and 

identify what information you want 

redacted. 

If you want to submit confidential 

business information as part of your 

comment but do not want it to be posted 

online, you must include the phrase 

‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment 

contains so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted on 

www.regulations.gov. 

Personal identifying information 

identified and located as set forth above 

will be placed in the agency’s public 

docket file, but not posted online. 

Confidential business information 

identified and located as set forth above 

will not be placed in the public docket 

file. If you wish to inspect the agency’s 

public docket file in person by 

appointment, please see the ‘‘For 

Additional Information’’ paragraph. 

Proposed Rule 

The Bureau proposes to remove rules 

which designate various offenses as 

sexual offenses for purposes of 18 U.S.C. 

4042(c) because that provision, which 

necessitated regulations, has been 

repealed in relevant part. The Bureau 

published an interim rule on this 

subject on December 16, 1998 (63 FR 

69386) (1998 interim rule). When this 

proposed rule is finalized, it will result 

in the retraction/deletion of the 1998 

interim rule. 

Previously, section 4042(c) of Title 18, 

United States Code, effective November 

26, 1998, provided for notification of 

sex offender release and certain related 

functions to facilitate effective sex 

offender registration and tracking. 

Notifications were required to be made 

for persons convicted of the federal 

offenses noted in subsection (c)(4)(A) 

through (D). Subsection (c)(4)(E) 

authorized the Attorney General to 

designate other offenses as sexual 

offenses for purposes of subsection (c). 

The Attorney General delegated this 

authority to the Director of the Bureau 

of Prisons. (See 63 FR 69386, December 

16, 1998.) 

The 1998 interim rule designated 

additional offenses which are to be 

considered sexual offenses for purposes 

of 18 U.S.C. 4042(c). These additional 

designations, listed in current § 571.72, 

include state sexual offenses, District of 

Columbia Code sexual offenses, and 

certain Uniform Code of Military Justice 

offenses. 

The current regulations, therefore, 

were specifically promulgated in 

accordance with language in 

§ 4042(c)(4)(E) providing that offenses in 

addition to those specifically 

enumerated at 4042(c)(4)(A)–(D) may be 

‘‘designated by the Attorney General as 

a sexual offense for the purposes of this 

subsection.’’ 

However, 18 U.S.C. 4042(c)(4) was 

repealed by the Sex Offender 

Registration and Notification Act 

(SORNA), which is Title I of the Adam 

Walsh Child Protection and Safety Act 

of 2006 (Pub. L. 109–248). Because the 

revised 18 U.S.C. 4042(c) requires 

release notice for persons required to 

register under SORNA, the Bureau no 

longer needs to separately designate 

sexual offenses in addition to those set 

forth by the statute. The offenses 

previously listed in the regulation are 

generally incorporated in SORNA’s 

comprehensive list of covered offenses, 

thereby rendering the Bureau’s current 

regulations in subpart H of 28 CFR part 

571 unnecessary. We therefore now 

propose to remove and reserve 28 CFR 

part 571, subpart H. 

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 

Regulation. The Director, Bureau of 

Prisons has determined that this rule is 

not a ‘‘significant regulatory action’’ 

under Executive Order 12866, section 

3(f), and accordingly this rule 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. Under Executive 

Order 13132, this rule does not have 

sufficient federalism implications for 

which we would prepare a Federalism 

Assessment. 

Regulatory Flexibility Act 

The Director of the Bureau of Prisons, 

under the Regulatory Flexibility Act (5 

U.S.C. 605(b)), reviewed this regulation. 

By approving it, the Director certifies 

that it will not have a significant 

economic impact upon a substantial 

number of small entities because: this 

rule is about the correctional 

management of offenders committed to 

the custody of the Attorney General or 

the Director of the Bureau of Prisons, 

and its economic impact is limited to 

the Bureau’s appropriated funds. 

Unfunded Mandates Reform Act of 

1995 

This rule will not cause State, local 

and tribal governments, or the private 

sector, to spend $100,000,000 or more in 

any one year, and it will not 

significantly or uniquely affect small 

governments. We do not need to take 

action under the Unfunded Mandates 

Reform Act of 1995. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This rule is not a major rule as 

defined by § 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996. This rule 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 571 

Prisoners. 

Charles E. Samuels, Jr., 

Director, Bureau of Prisons. 

Under rulemaking authority vested in 

the Attorney General in 5 U.S.C. 301; 28 

U.S.C. 509, 510 and delegated to the 

Director, Bureau of Prisons in 28 CFR 

§ 0.96, we propose to amend 28 CFR 

part 571 as set forth below. 

SUBCHAPTER D—COMMUNITY 

PROGRAMS AND RELEASE 

PART 571—RELEASE FROM 

CUSTODY 

■ 1. The authority citation for Part 571 

continues to read as follows: 

Authority: 5 U.S.C. 301; 18 U.S.C. 3565, 

3568–3569 (Repealed in part as to offenses 

committed on or after November 1, 1987), 

3582, 3621, 3622, 3624, 4001, 4042, 4081, 

4082 (Repealed in part as to offenses 

committed on or after November 1, 1987), 

4161–4166 and 4201–4218 (Repealed as to 

offenses committed on or after November 1, 

1987), 5006–5024 (Repealed October 12, 1984 

as to offenses committed after that date), 

5031–5042; 28 U.S.C. 509, 510; U.S. Const., 

Art. II, Sec. 2; 28 CFR 0.95–0.99, 1.1–1.10. 


wreier-aviles on DSK7SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 9355 

Subpart H [Removed and Reserved] 

■ 2. Subpart H, Designation of Offenses 

for Purposes of 18 U.S.C. 4042(c) is 

removed and reserved. 

[FR Doc. 2013–02765 Filed 2–7–13; 8:45 am] 

BILLING CODE 4410–05–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2013–0013; FRL–9777–6] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Maryland; Removal of the Mount Saint 

Mary’s College 1979 Consent Order 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the State of 

Maryland Department of the 

Environment (MDE) for the purpose of 

removing Mount Saint Mary’s College 

1979 Consent Order from the Maryland 

SIP. In the Final Rules section of this 

Federal Register, EPA is approving the 

State’s SIP submittal as a direct final 

rule without prior proposal because 

EPA views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this rulemaking 

action, no further activity is 

contemplated. If EPA receives adverse 

comments, the direct final rule will be 

withdrawn and all public comments 

received will be addressed in a 

subsequent final rule based on this 

proposed rule. EPA will not institute a 

second comment period. Any parties 

interested in commenting on this 

rulemaking action should do so at this 

time. 

DATES: Comments must be received in 

writing by March 11, 2013. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2013–0013 by one of the 

following methods: 

A. www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Email: mastro.donna@epa.gov. 

C. Mail: EPA–R03–OAR–2013–0013, 

Donna Mastro, Acting Associate 

Director, Air Protection Division, 

Mailcode 3AP30, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2013– 

0013. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through ww.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the 

electronic docket are listed in the 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in www.regulations.gov or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the Maryland Department of 

the Environment, 1800 Washington 

Boulevard, Suite 705, Baltimore, 

Maryland 21230. 

FOR FURTHER INFORMATION CONTACT: 

Maria Pino, Air Protection Division, 

Project officer, (215) 814–2181, or by 

email at pino.maria@epa.gov. 

SUPPLEMENTARY INFORMATION: For 

further information, please see the 

information provided in the direct final 

action, with the same title, that is 

located in the ‘‘Rules and Regulations’’ 

section of this Federal Register 

publication. 

Dated: January 25, 2013. 

W.C. Early, 

Acting Regional Administrator, Region III. 

[FR Doc. 2013–02814 Filed 2–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket: CDC–2012–0010] 

42 CFR Part 73 

Influenza Viruses Containing the 

Hemagglutinin From the Goose/ 

Guangdong/1/96 Lineage 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for information; 

reopening of comment period. 

SUMMARY: With this notice, the Centers 

for Disease Control and Prevention 

(CDC), located within the Department of 

Health and Human Services (HHS) 

announces the re-opening of a public 

comment period for a request for 

information and comment published on 

October 17, 2012. The request for 

information sought information and 

comments from the public regarding 

whether highly pathogenic avian 

influenza (HPAI) H5N1 viruses that 

contain a hemagglutinin (HA) from the 

Goose/Guangdong/1/96 lineage, and 

their potential to pose a severe threat to 

public health and safety. The comment 

period closed on December 17, 2012. 

We are reopening the comment period 

to allow interested persons additional 

time to prepare and submit comments. 

DATES: Written or electronic comments 

must be received on or before March 11, 

2013. 

ADDRESSES: You may submit comments, 

identified by Docket Number CDC– 

2012–0010, by any of the following 

methods 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Centers for Disease Control 

and Prevention, Select Agent Program, 

1600 Clifton Road NE., Mailstop A–46, 


wreier-aviles on DSK7SPTVN1PROD with PROPOSALS