68974 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 

device, which contains information 

about the tissue adhesive with adjunct 

wound closure intended for topical 

approximation of skin that they intend 

to market. 

II. What is the environmental impact of 

this rule? 

The agency has determined under 21 

CFR 25.34(b) 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. 

III. What is the analysis impact of this 

rule? 

FDA has examined the impacts of the 

final 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 final 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 reclassification of this 

device from class III to class II will 

relieve manufacturers of the device of 

cost of complying with the premarket 

approval requirements of section 515 of 

the FD&C Act (21 U.S.C. 360e), and may 

permit small potential competitors to 

enter the marketplace by lowering their 

costs, the agency certifies 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 final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount. 

IV. Does this final rule have Federalism 

Implications? 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempt certain State 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

U.S.C. 360k; See Medtronic v. Lohr, 518 

U.S. 470 (1996); Riegel v. Medtronic, 

552 U.S. 312 (2008). The special 

controls established by this final rule 

create ‘‘requirements’’ to address each 

identified risk to health presented by 

these specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors have some flexibility in how 

they meet those requirements. Cf. 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–42 (9th Cir. 1997). 

V. How does this rule comply with the 

Paperwork Reduction Act of 1995? 

This final rule contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 is not required. 

Elsewhere in this issue of the Federal 

Register, FDA is issuing a notice 

announcing the availability of a 

guidance for the final rule. The 

guidance, ‘‘Class II Special Controls 

Guidance Document: Tissue Adhesive 

with Adjunct Wound Closure Device 

Intended for the Topical Approximation 

of Skin,’’ references previously approved 

collections of information found in 

FDA’s regulations. 

VI. What references are on display? 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Closure Medical 

Corp., March 23, 2009. 

List of Subjects in 21 CFR Part 878 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

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

360j, 3601, 371. 

■ 2. Section 878.4011 is added to 

subpart E to read as follows: 

§ 878.4011 Tissue adhesive with adjunct 

wound closure device for topical 

approximation of skin. 

(a) Identification. A tissue adhesive 

with adjunct wound closure device 

intended for the topical approximation 

of skin is a device indicated for topical 

application only to hold closed easily 

approximated skin edges of wounds 

from surgical incisions, including 

punctures from minimally invasive 

surgery, and simple, thoroughly 

cleansed, trauma-induced lacerations. It 

may be used in conjunction with, but 

not in place of, deep dermal stitches. 

Additionally, the adjunct wound 

closure device component maintains 

temporary skin edge alignment along 

the length of wound during application 

of the liquid adhesive. 

(b) Classification. Class II (special 

controls). The special control for this 

device is FDA’s ‘‘Guidance for Industry 

and FDA Staff; Class II Special Controls 

Guidance Document: Tissue Adhesive 

with Adjunct Wound Closure Device 

Intended for the Topical Approximation 

of Skin.’’ See § 878.1(e) for the 

availability of this guidance document. 

Dated: November 4, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–28356 Filed 11–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0998] 

Drawbridge Operation Regulation; 

Upper Mississippi River, Rock Island, 

IL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 


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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 68975 

SUMMARY: The Commander, Eighth 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the Rock 

Island Railroad and Highway 

Drawbridge across the Upper 

Mississippi River, mile 482.9, at Rock 

Island, Illinois. The deviation is 

necessary to allow the bridge owner 

time to perform preventive maintenance 

and critical repairs that are essential to 

the continued safe operation of the 

drawbridge. This deviation allows the 

bridge to be maintained in the closed to 

navigation position for fifty-six days. 

DATES: This deviation is effective from 

7:30 a.m., January 4, 2011 to 7:30 a.m. 

February 28, 2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0998 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0998 in the ‘‘Keyword’’ box 

and then clicking ‘‘Search’’. They are 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Eric A. Washburn, Bridge 

Administrator, Coast Guard; telephone 

314–269–2378, e-mail 

Eric.Washburn@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The U.S. 

Army Rock Island Arsenal requested a 

temporary deviation for the Rock Island 

Railroad and Highway Drawbridge, 

across the Upper Mississippi River, mile 

482.9, at Rock Island, Illinois to remain 

in the closed to navigation position for 

56 days from 7:30 a.m., January 4, 2011 

to 7:30 a.m., February 28, 2011 to allow 

the bridge owner time for critical repairs 

and preventive maintenance. In order to 

perform extensive repairs and required 

annual maintenance, the bridge must be 

kept inoperative and in the closed to 

navigation position. The Rock Island 

Railroad and Highway Drawbridge 

currently operates in accordance with 

33 CFR 117.5, which states the general 

requirement that drawbridges shall open 

promptly and fully for the passage of 

vessels when a request to open is given 

in accordance with the subpart. 

There are no alternate routes for 

vessels transiting this section of the 

Upper Mississippi River. 

The Rock Island Railroad and 

Highway Drawbridge, in the closed-tonavigation position, provides a vertical 

clearance of 23.8 feet above normal 

pool. Navigation on the waterway 

consists primarily of commercial tows 

and recreational watercraft. The 

drawbridge will not be able to open for 

emergencies during the repair period. 

This temporary deviation has been 

coordinated with waterway users. No 

objections were received. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: October 28, 2010. 

Eric A. Washburn, 

Bridge Administrator. 

[FR Doc. 2010–28326 Filed 11–9–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 62 

RIN 2900–AN53 

Supportive Services for Veteran 

Families Program 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) is amending its regulations 

to establish the Supportive Services for 

Veteran Families Program (SSVF 

Program). These amendments 

implement the provisions of section 604 

of the Veterans’ Mental Health and 

Other Care Improvements Act of 2008 

(Act). The purpose of the SSVF Program 

is to provide supportive services grants 

to private non-profit organizations and 

consumer cooperatives who will 

coordinate or provide supportive 

services to very low-income veteran 

families who are residing in permanent 

housing, are homeless and scheduled to 

become residents of permanent housing 

within a specified time period, or after 

exiting permanent housing, are seeking 

other housing that is responsive to such 

very low-income veteran family’s needs 

and preferences. The new SSVF 

Program is within the continuum of 

VA’s homeless services programs. 

DATES: This final rule is effective 

December 10, 2010. 

FOR FURTHER INFORMATION CONTACT: John 

Kuhn, National Center for Homelessness 

Among Veterans, Supportive Services 

for Veteran Families Program Office, 

4100 Chester Avenue, Suite 200, 

Philadelphia, PA 19104, (877) 737–0111 

(this is a toll-free number). 

SUPPLEMENTARY INFORMATION: In a 

document published in the Federal 

Register (75 FR 24514) on May 5, 2010, 

VA proposed to establish a new 38 CFR 

part 62 consisting of regulations 

captioned ‘‘SUPPORTIVE SERVICES 

FOR VETERAN FAMILIES PROGRAM’’ 

(referred to below as the proposed rule). 

This document adopts as a final rule, 

with changes discussed below, the 

proposed rule. This final rule 

establishes regulations concerning the 

SSVF Program and is necessary to 

implement section 604 of the Act, 

which is codified at 38 U.S.C. 2044. 

VA provided a 30-day comment 

period that ended on June 4, 2010. VA 

received four submissions during this 

comment period on the proposed rule. 

One submission consisted of an inquiry 

about the timing for the award of 

supportive services grants, but did not 

contain any substantive comments on 

the proposed rule. The subject matter of 

the other submissions can be grouped 

into several categories, and we have 

organized our discussion of the 

comments accordingly. 

Selecting Applicants To Receive 

Supportive Services Grants 

Two commenters provided 

recommendations regarding the scoring 

criteria used to rate applicants fulfilling 

the threshold requirements. Proposed 

§ 62.22 described the scoring criteria VA 

would use to score applicants fulfilling 

the threshold requirements. 

One commenter recommended that 

proposed § 62.22(b)(2), the scoring 

criterion regarding the applicant’s 

outreach and screening plan, include an 

examination of the thoroughness of 

coverage by using available data to 

estimate the total number of veterans 

who could be eligible for participation 

over the course of a year, and then to 

determine the percentage of veterans in 

the applicant’s area or community that 

will be contacted through outreach and 

screening. 

We agree that the estimated number of 

participants and percentage of very lowincome veterans served in an area or 

community should be considered when 

scoring the supportive services grant 

application; however, we think this can 

be better addressed through the scoring 

criterion relating to the need for 

program (§ 62.22(b)(1)) rather than the 

scoring criterion relating to the outreach 

and screening plan (§ 62.22(b)(2)). 

Section 62.20(a)(3) of the proposed rule 

stated that a complete supportive 

services grant application would 

include ‘‘an estimate with supporting 

documentation of the number of very 


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