59670 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Proposed Rules 

participants in other physical 

commodity swaps/trade options? 

11. If so, why, and what should those 

protections be? 

12. Would additional protections for 

agricultural swaps purchasers unduly 

restrict their risk management 

opportunities? 

13. Should the Commission consider 

rules to make it easier for agricultural 

producers to participate in agricultural 

swaps—for example, by allowing 

producers who do not qualify as ECPs 

to purchase agricultural swaps? 

Designated Contract Markets 

14. Should agricultural swaps 

transactions be permitted to trade on 

DCMs to the same extent as all other 

swaps are permitted on DCMs? 

15. If yes, why? 

16. If no, what other requirements, 

conditions or limitations should apply? 

Swap Execution Facilities 

17. Should agricultural swaps 

transactions be permitted on SEFs to the 

same extent as all other swaps are 

permitted to transact on SEFs? 

18. If yes, why? 

19. If no, what other requirements, 

conditions or limitations should apply? 

Trading Outside of DCMs and SEFs 

20. Should agricultural swaps be 

permitted to trade outside of a DCM or 

SEF to the same extent as all other 

swaps? 

21. If yes, why? 

22. If no, what other requirements, 

conditions or limitations should apply? 

23. Should agricultural swaps be 

permitted to trade outside of a DCM or 

SEF to a different extent than other 

swaps due to the nature of the products 

and/or participants in the agricultural 

swaps market? 

24. In general, should agricultural 

swaps be treated like all other physical 

commodity swaps under Dodd-Frank? 

25. If yes, why? 

26. If no, are there any additional 

requirements, conditions or limitations 

not already discussed in other answers 

that should apply? 

27. If agricultural swaps are generally 

treated like swaps in other physical 

commodities, are there specific 

agricultural commodities that would 

require special or different protections? 

Issued in Washington, DC, on September 

21, 2010, by the Commission. 

David A. Stawick, 

Secretary of the Commission. 

[FR Doc. 2010–24198 Filed 9–27–10; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2010–N–0429] 

Immunology and Microbiology 

Devices; Reclassification of the Herpes 

Simplex Virus Serological Assay 

Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the special controls for the 

herpes simplex virus (HSV) serological 

assay device type, which is classified as 

class II (special controls). These device 

types are devices that consist of antigens 

and antisera used in various serological 

tests to identify antibodies to herpes 

simplex virus in serum, and the devices 

that 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. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of the 

revised draft guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological Assays’’ 

that would serve as the special control 

for the device, if FDA amends the 

special controls. Because FDA is 

proposing to amend the special control 

for this device type, the agency is 

publishing the proposed rule that 

designates the revised guidance 

document as the special control for HSV 

serological devices. 

DATES: Submit written or electronic 

comments on the proposed rule by 

November 29, 2010. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0429, by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by 

email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Haja 

Sittana El Mubarak, Center for Devices 

and Radiological Health, Bldg. 66, rm. 

5519, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–6193. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory Authorities 

The act (21 U.S.C. 301 et seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), Safe 

Medical Devices Act (SMDA) (Public 

Law 101–629), Food and Drug 

Administration Modernization Act 

(FDAMA) (Public Law 105–115), and 

the Medical Device User Fee and 

Modernization Act (MDUFMA) (Public 

Law 107–250), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360c) established three 

categories (classes) of devices, defined 

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Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Proposed Rules 59671 

by the regulatory controls needed to 

provide reasonable assurance of their 

safety and effectiveness. The three 

categories of devices are class I (general 

controls), class II (special controls), and 

class III (premarket approval). 

Under section 513 of the FD&C Act, 

FDA refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as preamendments 

devices. FDA classifies these devices 

after it takes the following steps: (1) 

Receives a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) publishes the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) publishes 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution before May 28, 1976, 

generally referred to as postamendments 

devices are classified automatically by 

statute (section 513(f) of the FD&C Act) 

into class III without any FDA 

rulemaking process. Those devices 

remain in class III until FDA does the 

following: (1) Reclassifies the device 

into class I or II; (2) issues an order 

classifying the device into class I or II 

in accordance with section 513(f)(2) of 

the FD&C Act; or (3) issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a legally 

marketed device that has been classified 

into class I or class II. The Agency 

determines whether new devices are 

substantially equivalent to previously 

marketed devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and 21 CFR part 807 of 

the regulations. 

Under the 1976 amendments, class II 

devices were defined as devices for 

which there was insufficient 

information to show that general 

controls themselves would provide 

reasonable assurance of safety and 

effectiveness, but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. SMDA broadened the 

definition of class II devices to mean 

those devices for which the general 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but for which 

there is sufficient information to 

establish special controls to provide 

such assurance, including performance 

standards, postmarket surveillance, 

patient registries, development and 

dissemination of guidelines, 

recommendations, and any other 

appropriate actions the Agency deems 

necessary (section 513(a)(1)(B) of the 

FD&C Act). 

II. Regulatory Background of the Device 

In the Federal Register of April 3, 

2007 (72 FR 15830), FDA published a 

final rule to reclassify HSV 1 and 2 

serological assays into class II. These 

assays are used as an aid in the clinical 

laboratory diagnosis of diseases caused 

by HSV 1 and 2. FDA identified the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays’’ as the special 

control. 

III. Summary of the Reasons for 

Revising Special Controls 

FDA believes that the special controls 

for HSV 1 and 2 serological assays 

should be revised because the new 

special controls, in addition to general 

controls, would provide reasonable 

assurance of the safety and effectiveness 

of the device. FDA believes there is 

sufficient additional safety and efficacy 

profile information to justify revising 

the special controls to better provide 

such assurance. We have revised the 

existing guidance by rewriting the 

method comparison section and the 

sample selection inclusion and 

exclusion criteria section. The revisions 

defined and differentiated the required 

studies and the study populations for 

the assessment of the safety and 

effectiveness of the different types of 

HSV 1 and HSV 2 serological assays. 

Additionally, we made several 

corrections and clarifications 

throughout the document to ensure 

accuracy, consistency, and ease of 

reading. 

IV. Special Controls 

In addition to general controls, FDA 

believes that the revised draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays’’ (the class II special 

controls guidance document) is a 

special control that is adequate to 

address the risks to health associated 

with the use of the device. FDA believes 

that the revised class II special controls 

guidance document, which incorporates 

voluntary consensus standards and 

describes labeling recommendations, in 

addition to general controls, provides 

reasonable assurance of the safety and 

effectiveness of the device. Elsewhere in 

this issue of the Federal Register, FDA 

is publishing a notice of availability of 

the revised draft class II special controls 

guidance document that the Agency 

would use as the special control for this 

device. 

The revised draft class II special 

controls guidance document sets forth 

the information FDA believes should be 

included in premarket notification 

submissions (510(k)s) for HSV 1 and 2 

serological assays. FDA believes that 

addressing these risks to health in a 

510(k) in the manner identified in the 

revised class II special controls 

guidance document, or in an acceptable 

alternative manner, is necessary to 

provide reasonable assurance of the 

safety and effectiveness of the device. 

V. FDA’s Findings 

As discussed previously in this 

document, FDA believes HSV 1 and 2 

serological assays should be classified 

into class II because special controls, in 

addition to general controls, provide 

reasonable assurance of the safety and 

effectiveness of the device and because 

there is sufficient information to 

establish special controls to provide 

such assurance. FDA, therefore, is 

proposing to establish the revised draft 

class II special controls guidance 

document as a special control for the 

device. 

Section 510(m) of the FD&C Act 

provides that a class II device may be 

exempt from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if the Agency determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this device, FDA believes that 

premarket notification is necessary to 

provide reasonable assurance of safety 

and effectiveness and, therefore, does 

not intend to exempt the device from 

the premarket notification requirements. 

VI. Effective Date 

FDA proposes that any final 

regulation based on this proposal 

become effective 30 days after its date 

of publication in the Federal Register. 

VII. Environmental Impact 

The agency has determined under 21 

CFR 25.34(b) that this proposed 

reclassification 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. 

VIII. Analysis of Impacts 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

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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