42810 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 

Paperwork Reduction Act (44 U.S.C. 3501 et 

seq.), the Office of Management and Budget 

(OMB) has approved the information 

collection requirements contained in this AD 

and has assigned OMB Control Number 

2120–0056. 

(1) If the inspection was done on or before 

the effective date of this AD: Send the report 

within 30 days after the effective date of this 

AD. 

(2) If the inspection was done after the 

effective date of this AD: Send the report 

within 30 days after the inspection is done. 

Alternative Methods of Compliance 

(AMOCs) 

(m)(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. Send information to ATTN: Ivan 

Li, Aerospace Engineer, Airframe Branch, 

ANM–120S, FAA, Seattle ACO, 1601 Lind 

Avenue, SW., Renton, Washington 98057– 

3356; telephone (425) 917–6437; fax (425) 

917–6590; Or, e-mail information to 9–ANM– 

Seattle–ACO–AMOC–Requests@faa.gov. 

(2) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Before using any approved AMOC on 

any airplane to which the AMOC applies, 

notify your principal maintenance inspector 

(PMI) or principal avionics inspector (PAI), 

as appropriate, or lacking a principal 

inspector, your local Flight Standards District 

Office. The AMOC approval letter must 

specifically reference this AD. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Seattle ACO, to 

make those findings. For a repair method to 

be approved, the repair must meet the 

certification basis of the airplane, and the 

approval must specifically refer to this AD. 

Issued in Renton, Washington, on August 

7, 2009. 

Stephen P. Boyd, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. E9–20382 Filed 8–24–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0393] 

RIN 0910–AF86 

Medical Device Reporting: Electronic 

Submission Requirements 

Correction 

In proposed rule document E9–19683 

beginning on page 42203 in the issue of 

Friday, August 21, 2009 make the 

following correction: 

On page 42204, in the first column, 

under the DATES section, in the first line, 

‘‘November 19, 2009’’ should read 

‘‘Submit written or electronic comments 

on the proposed rule by November 19, 

2009’’. 

[FR Doc. Z9–19683 Filed 8–24–09; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2009–N–0344] 

Microbiology Devices; Reclassification 

of Herpes Simplex Virus Types 1 and 

2 Serological Assays 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its device classification 

regulations by correcting the regulation 

classifying herpes simplex virus (HSV) 

serological assays by removing the 

reference to HSV serological assays 

other than type 1 and type 2. When 

reclassifying this device, FDA 

mistakenly distinguished between HSV 

serological assays type 1 and type 2 and 

all other HSV serological assays. At that 

time, and today, the only 

preamendments HSV serological assays 

FDA was aware of were type 1 and type 

2, and therefore, the classification of 

HSV assays other than type 1 and type 

2 was incorrect. FDA is correcting the 

classification of this device to eliminate 

possible confusion resulting from this 

error. Elsewhere in this issue of the 

Federal Register, we are publishing a 

companion direct final rule. This 

proposed rule will provide a procedural 

framework to finalize the rule in the 

event we receive significant adverse 

comment and withdraw the direct final 

rule. 

DATES: Submit written or electronic 

comments by November 9, 2009. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2009–N– 

0344, by any of the following methods: 

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: 

Scott McFarland, Center for Devices and 

Radiological Health WO/66, rm. 5543, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–6217. 

SUPPLEMENTARY INFORMATION: 

I. Why Is This Companion Proposed 

Rule Being Issued? 

This proposed rule is a companion to 

the direct final rule correcting 

§ 866.3305 (21 CFR 866.3305) by 

removing HSV serological assays other 

than type 1 and type 2 from the 

regulation. The direct final rule and this 

companion proposed rule are 

substantively identical. This companion 

proposed rule provides the procedural 

framework to finalize the rule in the 

event that the direct final rule receives 

any significant adverse comment and is 

withdrawn. We are publishing the direct 

final rule because we believe the rule is 

noncontroversial, and we do not 

anticipate receiving any significant 

adverse comments. If no significant 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42811 

adverse comment is received in 

response to the direct final rule, no 

further action will be taken related to 

this proposed rule. Instead, we will 

publish a confirmation document 

within 30 days after the comment 

period ends confirming when the direct 

final rule will go into effect. 

If we receive any significant adverse 

comment regarding the direct final rule, 

we will withdraw the direct final rule 

within 30 days after the comment 

period ends and proceed to respond to 

all of the comments under this 

companion proposed rule using usual 

notice-and-comment rulemaking 

procedures under the Administrative 

Procedure Act (APA) (5 U.S.C. 552a et 

seq.). The comment period for this 

companion proposed rule runs 

concurrently with the direct final rule’s 

comment period. Any comments 

received under this companion 

proposed rule will also be considered as 

comments regarding the direct final rule 

and vice versa. We will not provide 

additional opportunity for comment. A 

significant adverse comment is defined 

as a comment that explains why the rule 

would be inappropriate, including 

challenges to the rule’s underlying 

premise or approach, or would be 

ineffective or unacceptable without a 

change. In determining whether an 

adverse comment is significant and 

warrants withdrawing a direct final 

rulemaking, we will consider whether 

the comment raises an issue serious 

enough to warrant a substantive 

response in a notice-and-comment 

process in accordance with section 553 

of the APA (5 U.S.C. 553). 

Comments that are frivolous, 

insubstantial, or outside the scope of the 

rule will not be considered adverse 

under this procedure. For example, a 

comment recommending an additional 

change to the rule will not be 

considered a significant adverse 

comment, unless the comment states 

why the rule would be ineffective 

without the additional change. In 

addition, if a significant adverse 

comment applies to part of a rule, and 

that part can be severed from the 

remainder of the rule, we may adopt as 

final those parts of the rule that are not 

the subject of a significant adverse 

comment. 

In the Federal Register of November 

21, 1997 (62 FR 62466), you can find 

additional information about FDA’s 

direct final rulemaking procedures in 

the guidance document entitled 

‘‘Guidance for FDA and Industry: Direct 

Final Rule Procedures.’’ This guidance 

document may be accessed at http:// 

www.fda.gov/regulatoryinformation/ 

guidances.htm. 

II. What Is the Background of the Rule? 

The Federal Food, Drug, and Cosmetic 

Act (the act), 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 Modernization Act of 

1997 (FDAMA) (Public Law 105–115), 

and the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85), among other 

amendments, 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, depending on 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). 

Devices that were in commercial 

distribution before May 28, 1976 (the 

date of enactment of the 1976 

amendments), are commonly referred to 

as ‘‘preamendments devices.’’ Under 

section 513 of the act, FDA classifies 

preamendments devices according to 

the following steps: (1) FDA receives a 

recommendation from a device 

classification panel (an FDA advisory 

committee); (2) FDA publishes the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) FDA 

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, are 

commonly referred to as 

‘‘postamendments devices.’’ These 

devices are classified automatically by 

statute (section 513(f) of the act (21 

U.S.C. 360c(f)) into class III and require 

premarket approval, unless and until: 

(1) FDA reclassifies the device into class 

I or II; (2) FDA issues an order 

classifying the device into class I or II 

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

the act; or (3) FDA issues an order under 

section 513(i) of the act (21 U.S.C. 

360c(i)) finding the device to be 

substantially equivalent to a predicate 

device that does not require premarket 

approval. 

In the Federal Register of November 

9, 1983 (47 FR 50823), FDA classified 

the preamendments devices, herpes 

simplex virus serological reagents, into 

class III (21 CFR 866.3305). At the time 

FDA classified the device, the only 

preamendments HSV serological assays 

FDA was aware of were type 1 and type 

2 HSV serological assays. Since that 

time, FDA has not become aware of any 

other preamendments HSV serological 

assays, nor has it received a premarket 

notification for a HSV serological assay 

other than a type 1 or type 2 HSV 

serological assay. 

In the Federal Register of April 3, 

2007 (72 FR 15828), FDA published a 

final rule reclassifying the 

preamendments device HSV serological 

assays from class III to class II. In that 

rulemaking FDA identified the device 

being reclassified as type 1 and type 2 

HSV serological assays and identified 

other HSV serological assays as class III 

devices. However, as stated previously, 

the only preamendments HSV 

serological assays which FDA is aware 

of are type 1 and type 2 HSV serological 

assays. To avoid any possible confusion, 

FDA is correcting the regulation to 

accurately describe this generic type of 

device. This proposed final rule corrects 

the classification regulation by 

removing the reference to HSV 

serological assays other than type 1 and 

type 2. 

III. What Does This Companion 

Proposed Rule Do? 

In this proposed rule, FDA is 

correcting § 866.3305 by removing the 

reference to HSV serological assays 

other than type 1 and type 2 from the 

regulation. 

IV. What is the Legal Authority for This 

Proposed Rule? 

FDA is issuing this proposed rule 

under the device and general 

administrative provisions of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

321, 331, 351, 352, 360i, 371, and 374). 

V. What is the Environmental Impact of 

This Proposed Rule? 

FDA has determined under 21 CFR 

25.30(i) and 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. 

VI. What is the Economic Impact of 

This Proposed Rule? 

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 

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 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
42812 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 

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 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. Because we do not believe any 

companies are currently selling or 

producing these devices, 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 $133 

million, using the most current (2008) 

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. 

VII. How Does the Paperwork 

Reduction Act of 1995 Apply to This 

Proposed Rule? 

This proposed rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) is not required. 

VIII. What Are the Federalism Impacts 

of This Proposed Rule? 

FDA has analyzed this proposed 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. 

IX. How Do You Submit Comments on 

This Proposed Rule? 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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 

Biologics, Laboratories, and 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 to 

amend 21 CFR part 866 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 

removing paragraph (c) and 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 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). 

Dated: August 17, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20415 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Parts 40, 41, 44, and 45 

[Docket No. TTB–2009–0002; Notice No. 98; 

Re: Notice No. 95, T.D. TTB–78 and T.D. 

TTB–80] 

RIN 1513–AB72 

Implementation of Statutory 

Amendments Requiring the 

Qualification of Manufacturers and 

Importers of Processed Tobacco and 

Other Amendments Related To Permit 

Requirements, and the Expanded 

Definition of Roll-Your-Own Tobacco; 

Extension of Comment Period 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notice of proposed rulemaking; 

reopening of comment period. 

SUMMARY: In response to a request filed 

on behalf of several industry members, 

the Alcohol and Tobacco Tax and Trade 

Bureau is reopening the comment 

period for Notice No. 95, a notice of 

proposed rulemaking published in the 

Federal Register on June 22, 2009. The 

proposed rule seeks comments on a 

concurrently published temporary rule 

implementing permit requirements for 

manufacturers and importers of 

processed tobacco and an expansion of 

the definition of roll-your-own tobacco 

adopted in the Children’s Health 

Insurance Program Reauthorization Act 

of 2009. The text of the regulations 

contained in the temporary rule serves 

as the text of the proposed regulations. 

DATES: The comment period for the 

proposed rule (Notice No. 95) published 

June 22, 2009, at 74 FR 29433 is 

reopened. Written comments on Notice 

No. 95 must now be received on or 

before October 20, 2009. 

ADDRESSES: You may send comments on 

Notice No. 95 to one of the following 

addresses: 

• http://www.regulations.gov (via the 

online comment form for Notice No. 95 

as posted within Docket No. TTB–2009– 

0002 at ‘‘Regulations.gov,’’ the Federal 

e-rulemaking portal); 

• Director, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, P.O. Box 14412, 

Washington, DC 20044–4412; or 

• Hand Delivery/Courier in Lieu of 

Mail: Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street, NW., Suite 

200–E, Washington, DC 20005. 

See the Public Participation section of 

Notice No. 95 for specific instructions 

and requirements for submitting 


jlentini on DSKJ8SOYB1PROD with PROPOSALS