Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations 48717 

VIII. Federalism 

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 preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

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

518 U.S. 470 (1996); Riegel v. 

Medtronic, Inc., 552 U.S. 312 (2008). 

The special controls established by this 

final rule create ‘‘requirements’’ for 

specific medical devices under 21 

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

sponsors have some flexibility in how 

they meet those requirements. Cf. 

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

737, 740–742 (9th Cir. 1991). 

IX. 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 (PRA) (44 U.S.C. 

3501–3520) is not required. This final 

rule establishes as special controls a 

guidance document that refers to 

currently approved collections of 

information found in other FDA 

regulations. These collections of 

information are subject to review by 

OMB under the PRA. The analysis of the 

paperwork burden for the guidance 

document is included in its notice of 

availability. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratory, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

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

360j, 371. 

■ 2. Section 866.3305 is amended by 

revising paragraph (b) to read as follows: 

§ 866.3305 Herpes simplex virus 

serological assays. 

* * * * * 

(b) Classification. Class II (special 

controls). The device is classified as 

class II (special controls). The special 

control for the device is FDA’s revised 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays.’’ For availability of 

the guidance revised document, see 

§ 866.1(e). 

Dated: August 3, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20115 Filed 8–8–11; 8:45 am] 

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DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2011–0759] 

Drawbridge Operation Regulations; 

Long Island, New York Inland 

Waterway From East Rockaway Inlet to 

Shinnecock Canal, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Loop Parkway 

Bridge, mile 0.7, across Long Creek, and 

the Captree State Parkway (Robert 

Moses Causeway) Bridge, mile 30.7, 

across the State Boat Channel, at Long 

Island, New York. This deviation is 

necessary to facilitate the 2011 March of 

Dimes Motorcycle Run. The deviation 

allows the two bridges listed above to 

remain in the closed position during 

this public event. 

DATES: This deviation is effective from 

10:51 a.m. through 1:49 p.m. on 

September 25, 2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2011– 

0759 and are available online at 

http://www.regulations.gov, inserting 

USCG–2011–0759 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 Ms. Judy Leung-Yee, Project 

Officer, First Coast Guard District, 

telephone (212) 668–7165, judy.k.leungyee@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 Loop Parkway Bridge, mile 0.7, 

across Long Creek has a vertical 

clearance in the closed position of 21 

feet at mean high water and 25 feet at 

mean low water. The existing 

drawbridge operation regulations are 

listed at 33 CFR 117.799(f). 

The Captree State Parkway (Robert 

Moses Causeway) Bridge, mile 30.7, 

across the State Boat Channel has a 

vertical clearance in the closed position 

of 29 feet at mean high water and 31 feet 

at mean low water. The existing 

drawbridge operation regulations are 

listed at 33 CFR 117.799(i). 

Long Creek and the State Boat 

Channel both are both transited by 

commercial fishing and recreational 

vessel traffic. 

The owner of the two bridges, the 

State New York Department of 

Transportation, requested bridge 

closures to facilitate a public event, the 

March of Dimes Charity Motorcycle 

Run. 

Under this temporary deviation the 

Loop Parkway Bridge may remain in the 

closed position from 10:51 a.m. through 

11:49 a.m. and from 12:21 p.m. through 

1:49 p.m. on September 25, 2011, and 

the Captree State Parkway Bridge 

(Robert Moses Causeway) may remain in 

the closed position from 11 a.m. through 

1 p.m. on September 25, 2011, to 

facilitate a public event, the 2011 March 

of Dimes Motorcycle Run. 

Vessels that can pass under the closed 

draws during each respective closure 

may do so at any time. 

In accordance with 33 CFR 117.35(e), 

the bridge 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: July 29, 2011. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2011–20092 Filed 8–8–11; 8:45 am] 

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