15828 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 

Juneau, WI, Dodge County, RNAV (GPS) 

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RWY 20, Orig 

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Juneau, WI, Dodge County, NDB RWY 2, Orig 

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Orig 

Juneau, WI, Dodge County, LOC RWY 26, 

Amdt 1 

Juneau, WI, Dodge County, GPS RWY 20, 

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Juneau, WI, Dodge County, NDB RWY 2, 

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Lone Rock, WI, Tri-County Regional, VOR/ 

DME RNAV OR GPS RWY 27, Amdt 6, 

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[FR Doc. E7–5952 Filed 4–2–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. 2005N–0471] 

Microbiology Devices; Reclassification 

of Herpes Simplex Virus Types 1 and 

2 Serological Assays 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

herpes simplex virus (HSV) types 1 and/ 

or 2 (HSV 1 and 2) serological assays 

from class III (premarket approval) to 

class II (special controls). FDA had 

earlier proposed this reclassification on 

its own initiative based on new 

information. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of a class II 

special controls guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Herpes Simplex Virus Types 

1 and 2 Serological Assays.’’

DATES: This rule is effective May 3, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Sally Hojvat, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0496. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (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), the 

Safe Medical Devices Act of 1990 

(SMDA) (Public Law 101–629), the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA) (Public Law 105–

115), and the Medical Device User Fee 

and Modernization Act (Public Law 

107–250), established a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, defined 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 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 

act). 

Under section 513 of the 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. A person may market a 

preamendments device that has been 

classified into class III through 

premarket notification procedures, 

without submission of a premarket 

approval application (PMA), until FDA 

issues a final regulation under section 

515(b) of the act (21 U.S.C. 360e(b)) 

requiring premarket approval. 

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 act) into 

class III without any FDA rulemaking 

process. Those devices remain in class 

III and require premarket approval 

unless and 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 act, as amended by FDAMA; or (3) 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the 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 a legally marketed device 

by means of premarket notification 

procedures in section 510(k) of the act 

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

Section 513(e) of the act governs 

reclassification of classified devices. 

This section provides that FDA may, by 

rulemaking, reclassify a device based 

upon ‘‘new information.’’ FDA can 

initiate a reclassification under section 

513(e) of the act or an interested person 

may petition FDA to reclassify a 

preamendments device. The term ‘‘new 

information,’’ as used in section 513(e) 

of the act, includes information 

developed as a result of a reevaluation 

of the data before the agency when the 

device was originally classified, as well 

as information not presented, not 

available, or not developed at that time 

(see, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(D.C. Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970);Bell v. Goddard, 

366 F.2d 177 (7th Cir. 1966)). 

Reevaluation of the data previously 

before the agency is an appropriate basis 

for subsequent regulatory action where 

the reevaluation is made in light of 

newly available regulatory authority 

(see Bell v. Goddard, supra, 366 F.2d at 

181; Ethicon, Inc. v.FDA, 762 F.Supp. 

382, 389–91 (D.D.C. 1991)), or in light 

of changes in ‘‘medical science’’ (see 

Upjohn v. Finch, supra, 422 F.2d at 

951). Whether data before the agency are 

past or new, the ‘‘new information’’ to 

support reclassification under section 

513(e) of the act must be ‘‘valid 

scientific evidence,’’ as defined in 

section 513(a)(3) of the act and 21 CFR 


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Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 15829 

860.7(c)(2) (see, e.g., General Medical 

Co. v. FDA, 770 F.2d 214 (D.C. Cir. 

1985); Contact Lens Assoc. v. FDA, 766 

F.2d 592 (D.C. Cir.), cert. denied, 474 

U.S. 1062 (1985)). 

FDA relies upon valid scientific 

evidence in the classification process to 

determine the level of regulation for 

devices. To be considered in the 

reclassification process, the valid 

scientific evidence upon which the 

agency relies must be publicly available. 

Publicly available information excludes 

trade secret and/or confidential 

commercial information, e.g., the 

contents of a pending PMA (see section 

520(c) of the act (21 U.S.C. 360j(c)). 

FDAMA added section 510(m) to the 

act that provides that a class II device 

may be exempted from the premarket 

notification requirements under section 

510(k) of the act if the agency 

determines that premarket notification 

is not necessary to assure the safety and 

effectiveness of the device. 

B. Regulatory History of the Device 

In the Federal Register of January 9, 

2006 (71 FR 1399), FDA published a 

proposed 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 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays’’ as the special 

control. Interested persons were invited 

to comment on the proposed rule by 

April 10, 2006 (the draft guidance was 

announced in the Federal Register of 

January 9, 2006 (71 FR 1432). A 

proposed rule correcting the reference 

section of the January 9, 2006, proposed 

rule was published on March 13, 2006 

(71 FR 12653). FDA received no 

comments on the proposed 

reclassification. 

II. FDA’s Conclusions 

Based on the information discussed in 

the preamble to the proposed rule (71 

FR 1399), FDA concludes that special 

controls, in conjunction with general 

controls, provide reasonable assurance 

of the safety and effectiveness of these 

devices. Elsewhere in this issue of the 

Federal Register, FDA is announcing 

the availability of the special controls 

guidance document. Following the 

effective date of this final classification 

rule, any firm submitting a 510(k) 

premarket notification for a HSV 1 and 

2 serological assay will need to address 

the issues covered in the special control 

guidance. However, the firm need only 

show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness. 

FDA is now codifying the 

classification and the special control 

guidance document for HSV 1 and 2 

serological assays by amending 

§ 866.3305 (21 CFR 866.3305). As stated 

in the proposed rule, FDA considered 

HSV 1 and 2 serological assays in 

accordance with section 510(m) of the 

act and determined that the device does 

need premarket notification to assure 

the safety and effectiveness of HSV 1 

and 2 serological assays. 

As stated in the preamble to the 

proposed rule (71 FR 1399), HSV 

serological assays of types other than 

type 1 and 2 will remain in class III. 

HSV nucleic acid amplification assays 

are not within the device type classified 

in § 866.3305. 

III. Environmental Impact 

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. 

IV. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

and the Regulatory Flexibility Act 

(Public Law 96–354) (as amended by 

subtitle D of the Small Business 

Regulatory Fairness Act of 1996 (Public 

Law 104–121), and the Unfunded 

Mandates Reform Act of 1995 (Public 

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 final rule is consistent 

with the regulatory philosophy and 

principles identified in the Executive 

order. In addition, the final rule is not 

a significant regulatory action as defined 

by the Executive order and so is not 

subject to review under 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. Reclassification of HSV 1 and 2 

serological assays from class III to class 

II will relieve manufacturers of the cost 

of complying with the premarket 

approval requirements in section 515 of 

the act. Furthermore, the special 

controls guidance document does not 

impose any new burdens on 

manufacturers; it advises manufacturers 

about ways to comply with the special 

controls that allow the agency to down 

classify these devices. By eliminating 

the need for premarket approval 

applications, reclassification will reduce 

regulatory costs with respect to these 

devices, impose no significant economic 

impact on any small entities, and may 

permit small potential competitors to 

enter the marketplace by lowering their 

costs. The agency therefore certifies that 

this 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 $122 

million, using the most current (2005) 

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. 

V. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VI. Paperwork Reduction Act of 1995 

FDA concludes that this final rule 

contains no new collections of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

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 


rwilkins on PROD1PC63 with RULES
15830 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 

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 revised 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. (1) Class II (special 

controls). The device is classified as 

class II (special controls) if the herpes 

simplex virus serological assay is type 1 

and/or 2. The special control for the 

device is FDA’s guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological 

Assays.’’ For availability of the guidance 

document, see § 866.1(e). 

(2) Class III (premarket approval). The 

device is classified as class III if the 

herpes simplex virus serological assay is 

a type other than type 1 and/or 2. 

(c) Date PMA or notice of completion 

of a PDP is required. No effective date 

has been established for the requirement 

for premarket approval for the devices 

described in paragraph (b)(2) of this 

section. See § 866.3. 

Dated: March 23, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–6167 Filed 4–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Part 126 

[Public Notice: 5740] 

Amendment of the International Traffic 

in Arms Regulations: Policy With 

Respect to Vietnam 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: Notice is hereby given that 

the Department of State is amending the 

International Traffic in Arms 

Regulations (ITAR) regarding Vietnam at 

22 CFR 126.1 to make it United States 

policy to consider on a case-by-case 

basis licenses, other approvals, exports 

or imports of non-lethal defense articles 

and defense services destined for or 

originating in Vietnam. The United 

States will deny licenses, other 

approvals, exports or imports of lethal 

defense articles and services destined 

for or originating in Vietnam. Under this 

policy, the exports of lethal-end items, 

components of lethal-end items (unless 

those components are non-lethal, safetyof-use spare parts for lethal-end items), 

non-lethal crowd control defense 

articles and defense services, and night 

vision devices to end-users with a role 

in ground security will not be approved. 

DATES: Effective Date: This rule is 

effective April 3, 2007. 

ADDRESSES: Interested parties may 

submit comments at any time by any of 

the following methods: 

• E-mail: 

DDTCResponseTeam@state.gov with an 

appropriate subject line. 

• Mail: Department of State, 

Directorate of Defense Trade Controls, 

Office of Defense Trade Controls Policy, 

ATTN: Regulatory Change, 12th Floor, 

SA–1, Washington, DC 20522–0112. 

• Fax: 202–261–8199. 

• Hand Delivery or Courier (regular 

work hours only): Department of State, 

Directorate of Defense Trade Controls, 

Office of Defense Trade Controls Policy, 

ATTENTION: Regulatory Change, SA–1, 

12th Floor, 2401 E Street, NW., 

Washington, DC 20037. 

Persons with access to the Internet 

may also view this notice by going to 

the regulations.gov Web site at: http:// 

www.regulations.gov/index.cfm. 

FOR FURTHER INFORMATION CONTACT: Ann 

K. Ganzer, Office of Defense Trade 

Controls Policy, Department of State, 

12th Floor, SA–1, Washington DC 

20522–0112; Telephone 202–663–2792 

or FAX 202–261–8199; e-mail: 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Change. 

SUPPLEMENTARY INFORMATION: On 

November 2, 2006, the Secretary of State 

modified the U.S. arms transfer policy 

toward Vietnam allowing the sale, lease, 

export, or other transfer of non-lethal 

defense articles and defense services to 

the country. Subsequently, the President 

issued a determination December 29, 

2006 that the furnishing of defense 

articles and services to Vietnam would 

strengthen the security of the United 

States and promote world peace. 

The new policy will not permit the 

export or other transfer to Vietnam of: 

(a) Lethal end items, (b) components of 

lethal end items, unless those 

components are non-lethal, safety-of-use 

spare parts for lethal end items, (c) nonlethal crowd control defense articles 

and defense services, and (d) night 

vision devices to end-users with a role 

in ground security. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

This amendment involves a foreign 

affairs function of the United States and, 

therefore, is not subject to the 

procedures required by 5 U.S.C. 553 and 

554. 

Regulatory Flexibility Act 

This rule does not require analysis 

under the Regulatory Flexibility Act. 

Unfunded Mandates Act of 1995 

This rule does not require analysis 

under the Unfunded Mandates Reform 

Act. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This amendment has been found not 

to be a major rule within the meaning 

of the Small Business Regulatory 

Enforcement Fairness Act of 1996. It 

will not have substantial direct effects 

on the States, the relationship between 

the national Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

Executive Orders 12372 and 13132 

It is determined that this rule does not 

have sufficient federalism implications 

to warrant application of the 

consultation provisions of Executive 

Orders 12372 and 13132. 

Executive Order 12866 

This amendment is exempt from 

review under Executive Order 12866, 

but has been reviewed internally by the 

Department of State to ensure 

consistency with the purposes thereof. 

Paperwork Reduction Act 

This rule does not impose any new 

reporting or recordkeeping requirements 


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