59672 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Proposed Rules 

Law 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 changes to the 

guidance are minimal, 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. 

The changes to the guidance include 

adding specific recommendations on 

appropriate comparators for tests for 

antibodies and antigens, as well as 

recommendations for sample selection 

inclusion and exclusion criteria to 

define the target populations for HSV 1 

and HSV 2 serological assays. These 

recommended changes would increase 

the usefulness of the guidance while 

imposing a minimal burden. 

IX. Federalism 

FDA has analyzed this proposed 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. (See 

section 521 of the FD&C Act (21 U.S.C. 

360k); Medtronic v. Lohr 518 U.S. 470 

(1996); and Riegel v. Medtronic, 128 S. 

Ct. 999 (2008)). If this proposed rule is 

made final, the special controls 

established by the final rule would 

create ‘‘requirements’’ for specific 

medical devices under 21 U.S.C. 360k, 

even though product sponsors have 

some flexibility in how they meet those 

requirements (see Papike v. Tambrands, 

Inc., 107 F.3d 737, 740–742 (9th Cir. 

1997)). 

X. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no new 

collections of information. Therefore, 

clearance by OMB under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520) is not required. 

This proposed rule designates a 

revised guidance document as a special 

control. FDA also tentatively concludes 

that the revised draft special control 

guidance document does not contain 

new information collection provisions 

that are subject to review and clearance 

by OMB under the PRA. Elsewhere in 

this issue of the Federal Register, FDA 

is publishing a notice announcing the 

availability of that revised draft 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays,’’ which contains an 

analysis of the paperwork burden for the 

draft guidance. 

XI. Comments 

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. 

List of Subjects in 21 CFR Part 866 

Medical devices. 

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 866 be 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. Revise § 866.3305 to read as 

follows: 

§ 866.3305 Herpes simplex virus 

serological assays. 

(a) Identification. Herpes simplex 

virus serological assays are devices that 

consist of antigens and antisera used in 

various serological tests to identify 

antibodies to herpes simplex virus in 

serum. Additionally, some of the assays 

consist of herpes simplex virus antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify herpes simplex virus directly 

from clinical specimens or tissue 

culture isolates derived from clinical 

specimens. The identification aids in 

the diagnosis of diseases caused by 

herpes simplex viruses and provides 

epidemiological information on these 

diseases. Herpes simplex viral 

infections range from common and mild 

lesions of the skin and mucous 

membranes to a severe form of 

encephalitis (inflammation of the brain). 

Neonatal herpes virus infections range 

from a mild infection to a severe 

generalized disease with a fatal 

outcome. 

(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 revised guidance document, see 

§ 866.1(e). 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23639 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Chapter I 

No Child Left Behind School Facilities 

and Construction Negotiated 

Rulemaking Committee—Notice of 

Meeting 

AGENCY: Bureau of Indian Affairs, 

Interior. 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS

Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Proposed Rules 59673 

1FR–9197–3; EPA–HQ–OAR–2009–0865; 

NHTSA–2010–0087. 

ACTION: Negotiated Rulemaking 

Committee meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

Bureau of Indian Affairs is announcing 

that the No Child Left Behind School 

Facilities and Construction Negotiated 

Rulemaking Committee will hold its 

fourth meeting in Bloomington, 

Minnesota. The purpose of the meeting 

is to continue working on reports and 

recommendations to Congress and the 

Secretary as required under the No 

Child Left Behind Act of 2001. 

DATES: The Committee’s fourth meeting 

will begin at 8 a.m. on October 12, 2010, 

and end at 12:30 p.m. on October 15, 

2010. 

ADDRESSES: The meeting will be held at 

the Ramada Mall of America Hotel, 2300 

East American Boulevard, Bloomington, 

Minnesota 55425. 

FOR FURTHER INFORMATION CONTACT: The 

Designated Federal Official, Michele F. 

Singer, Director, Office of Regulatory 

Affairs and Collaborative Action, Office 

of the Assistant Secretary—Indian 

Affairs, 1001 Indian School Road, NW., 

Suite 312, Albuquerque, NM 87104; 

telephone (505) 563–3805; fax (505) 

563–3811. 

SUPPLEMENTARY INFORMATION: The No 

Child Left Behind School Facilities and 

Construction Negotiated Rulemaking 

Committee was established to prepare 

and submit to the Secretary a catalog of 

the conditions at Bureau-funded 

schools, and to prepare reports covering: 

The school replacement and new 

construction needs at Bureau-funded 

school facilities; a formula for the 

equitable distribution of funds to 

address those needs; a list of major and 

minor renovation needs at those 

facilities; and a formula for equitable 

distribution of funds to address those 

needs. The reports are to be submitted 

to Congress and to the Secretary. The 

Committee also expects to draft 

proposed regulations covering 

construction standards for heating, 

lighting, and cooling in home-living 

(dormitory) situations. 

The following items will be on the 

agenda: 

• Review and approve July 2010 

meeting summary; 

• General update from September 

group meeting and progress made; 

• Discussion of workgroup drafts, 

including a section-by-section analysis 

and organization of content; 

• Drafting of full report; 

• Planning for January 2011 meeting; 

and 

• Public comments. 

Written comments may be sent to the 

Designated Federal Official listed in the 

FOR FURTHER INFORMATION CONTACT

section above. All meetings are open to 

the public; however, transportation, 

lodging, and meals are the responsibility 

of the participating public. 

Dated: September 20, 2010. 

Larry Echo Hawk, 

Assistant Secretary—Indian Affairs. 

[FR Doc. 2010–24107 Filed 9–27–10; 8:45 am] 

BILLING CODE 4310–W7–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 85, 86, and 600 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 575 

[EPA–HQ–OAR–2009–0865; FRL–9208–1; 

NHTSA–2010–0087] 

RIN 2060–AQ09; RIN 2127–AK73 

Public Hearing Locations for the 

Proposed Fuel Economy Labels 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of public hearings. 

SUMMARY: EPA and NHTSA are 

announcing the location addresses for 

the public hearings to be held for 

‘‘Revisions and Additions to Motor 

Vehicle Fuel Economy Label,’’ 

published in the Federal Register on 

September 23, 2010. The goal of a 

revised label will be to provide 

consumers with simple, straightforward 

comparisons across all vehicles types, 

including electric vehicles (EV), plug-in 

hybrid electric vehicles (PHEV), and 

conventional gasoline and diesel 

vehicles. NHTSA and EPA are 

proposing these changes in compliance 

with the Energy Independence and 

Security Act (EISA) of 2007, which 

imposes several new labeling 

requirements. Also, the agencies believe 

that the current labels can be improved 

to help consumers make more informed 

vehicle purchase decisions and to 

address the entrance of advanced 

technology vehicles into the U.S. 

market. The new labels are proposed to 

be displayed on new vehicles beginning 

with the 2012 model year. 

DATES: NHTSA and EPA will jointly 

hold two public hearings on the 

following dates: Thursday, October 14, 

2010, in Chicago, Illinois, and 

Thursday, October 21, 2010, in Los 

Angeles, California. The hearing 

sessions will be from 12 p.m. to 4 p.m. 

and 6 p.m. to 10 p.m. local time and 

continue until everyone has had a 

chance to speak. Note that the times 

have changed from those indicated in 

the proposed rule. 

ADDRESSES: NHTSA and EPA will 

jointly hold two public hearings at the 

following locations: Wyndham Hotel, 

633 North St. Clair St., Chicago, Illinois 

60611 on Thursday, October 14, 2010; 

and Sheraton Los Angeles Downtown 

Hotel, 711 South Hope Street, Los 

Angeles, California 90017 on Thursday, 

October 21, 2010. 

FOR FURTHER INFORMATION CONTACT: 

EPA: Lucie Audette, Office of 

Transportation and Air Quality, 

Assessment and Standards Division, 

Environmental Protection Agency, 2000 

Traverwood Drive, Ann Arbor, MI 

48105; telephone number: 734–214– 

4850; fax number: 734–214–4816; e-mail 

address: audette.lucie@epa.gov, or 

Assessment and Standards Division 

Hotline; telephone number (734) 214– 

4636; e-mail address: asdinfo@epa.gov. 

NHTSA: Gregory Powell, National 

Highway Traffic Safety Administration, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590. Telephone: 

(202) 366–5206; Fax: (202) 493–2990; email address: gregory.powell@dot.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of the public hearings is to 

obtain public testimony or comment on 

the Agency’s proposed revisions and 

additions to the motor vehicle fuel 

economy label.1 If you would like to 

present testimony at the public 

hearings, we ask that you notify the EPA 

and NHTSA contact persons listed 

under FOR FURTHER INFORMATION

CONTACT at least ten days before the 

hearing. Once EPA and NHTSA learn 

how many people have registered to 

speak at the public hearing, we will 

allocate an appropriate amount of time 

to each participant, allowing time for 

necessary breaks throughout the 

hearing. For planning purposes, each 

speaker should anticipate speaking for 

approximately ten minutes, although we 

may need to adjust the time for each 

speaker if there is a large turnout. We 

suggest that you bring copies of your 

statement or other material for the EPA 

and NHTSA panels and the audience. It 

would also be helpful if you send us a 

copy of your statement or other 

materials before the hearing. To 

accommodate as many speakers as 

possible, we prefer that speakers not use 

technological aids (e.g., audio-visuals, 

computer slideshows). However, if you 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS