69614 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Proposed Rules 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979), and 

3. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

You can find our regulatory 

evaluation and the estimated costs of 

compliance in the AD Docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new AD: 

The Boeing Company: Docket No. FAA– 

2010–1111; Directorate Identifier 2010– 

NM–129–AD. 

Comments Due Date 

(a) We must receive comments by 

December 30, 2010. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to The Boeing 

Company Model 747–200B, –300, –400, 

–400D, and –400F series airplanes, 

certificated in any category; equipped with 

Pratt and Whitney 4000 or General Electric 

CF6–80C2 series engines, as identified in 

Boeing Alert Service Bulletin 747–54A2232, 

dated April 15, 2010. 

Subject 

(d) Air Transport Association (ATA) of 

America Code 54: Nacelles/pylons. 

Unsafe Condition 

(e) This AD results from a report that the 

left and right spring beam mid-pivot bolt 

assembly access doors for the no. 1 strut were 

inadvertently installed in the incorrect 

position during strut modification. The 

Federal Aviation Administration is issuing 

this AD to detect and correct incorrectly 

installed mid-pivot bolt assemblies on the 

spring beam on the outboard struts. 

Incorrectly installed bolt assemblies could 

lead to fatigue cracking and consequent 

fracturing of the mid-pivot bolt assembly, 

which could lead to loss of the spring beam 

load path and the possible separation of a 

strut and engine from the airplane during 

flight. 

Compliance 

(f) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Inspection To Determine if Correct Door Is 

Installed 

(g) Within 24 months after the effective 

date of this AD, do an inspection to 

determine if the correct mid-pivot access 

door is installed, in accordance with the 

Accomplishment Instructions of Boeing Alert 

Service Bulletin 747–54A2232, dated April 

15, 2010. 

(h) If, during the inspection required by 

paragraph (g) of this AD, the correct midpivot door is found to be installed, before 

further flight, install a marker on the midpivot access door, in accordance with the 

Accomplishment Instructions of Boeing Alert 

Service Bulletin 747–54A2232, dated April 

15, 2010. 

(i) If, during the inspection required by 

paragraph (g) of this AD, the correct midpivot door is not found to be installed, before 

further flight, do the actions required by 

paragraphs (i)(1), (i)(2), and (i)(3) of this AD, 

in accordance with the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

747–54A2232, dated April 15, 2010. 

(1) Rotate the mid-pivot bolt assembly to 

the correct orientation and replace the midpivot access door with a new or serviceable 

mid-pivot access door. 

(2) Install a marker on the mid-pivot access 

door. 

(3) Do the actions required by paragraph 

(i)(3)(i) or (i)(3)(ii) of this AD. 

(i) (Option 1) Do an ultrasonic inspection 

for cracking of the mid-pivot bolt assembly. 

(A) If no cracking is found, do the actions 

required by paragraphs (i)(3)(i)(A)(1) and 

(i)(3)(i)(A)(2) of this AD. 

(1) Repeat the ultrasonic inspection for 

cracking of the mid-pivot bolt assembly 

thereafter at intervals not to exceed 24 

months until the action required by 

paragraph (i)(3)(i)(A)(2) of this AD is done. 

(2) Within 60 months after the effective 

date of this AD, replace the mid-pivot bolt 

assembly with a new mid-pivot bolt 

assembly. Replacement terminates the 

repetitive inspections required by paragraph 

(i)(3)(i)(A)(1) of this AD. 

(B) If any cracking is found, replace the 

mid-pivot bolt assembly with a new midpivot bolt assembly, before further flight. 

(ii) (Option 2) Replace the mid-pivot bolt 

assembly with a new mid-pivot bolt 

assembly. 

Alternative Methods of Compliance 

(AMOCs) 

(j)(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: 

Kenneth Paoletti, Aerospace Engineer, 

Airframe Branch, ANM–120S, FAA, Seattle 

Aircraft Certification Office (ACO), 1601 Lind 

Avenue, SW., Renton, Washington 98057– 

3356; telephone (425) 917–6434; fax (425) 

917–6590. Information may be e-mailed 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 the 

Boeing Commercial Airplanes Organization 

Designation Authorization (ODA) that 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 

November 2, 2010. 

Jeffrey E. Duven, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2010–28605 Filed 11–12–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 516 

[Docket No. FDA–2010–N–0534] 

New Animal Drugs for Minor Use and 

Minor Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulations regarding new 

animal drugs for minor use and minor 

species to update language and to clarify 

the regulations consistent with the 

explanations in the preambles to the 

proposed and final rules establishing 

them. This action is being taken to 

ensure accuracy and clarity in the 

Agency’s regulations. This proposed 

rule is a companion document to the 

direct final rule published elsewhere in 

this issue of the Federal Register. 

DATES: Submit electronic or written 

comments by January 31, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0534, by any of the following methods: 


hsrobinson on DSK69SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Proposed Rules 69615 

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. 

Instructions: All submissions received 

must include the Agency name and 

docket number 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 ‘‘Request for 

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: Meg 

Oeller, Center for Veterinary Medicine 

(HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9005. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Minor Use and Minor Species 

Animal Health Act of 2004 amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to establish new 

regulatory procedures that provide 

incentives intended to make more drugs 

legally available to veterinarians and 

animal owners for the treatment of 

minor animal species and uncommon 

diseases in major animal species. FDA 

published the final rule to implement 

these regulations (part 516 (21 CFR part 

516)) in the Federal Register of July 26, 

2007 (72 FR 41010). 

FDA is proposing to amend its 

regulations regarding new animal drugs 

for minor use and minor species 

(MUMS) in part 516 to update language 

and clarify the intent of the regulations 

consistent with the preambles to the 

proposed and final rules. 

In § 516.3(b), FDA is proposing to 

amend the definition of ‘‘Same dosage 

form’’ to make it clearer that the six 

dosage form categories listed in the 

regulations under § 516.3(b)(i) through 

(b)(vi) are the ‘‘categories’’ of dosage 

forms that the preamble to the proposed 

rule referenced as follows: ‘‘The second 

test of sameness which the statute 

establishes to determine eligibility of an 

animal drug for designation is ‘same 

dosage form.’ The agency proposes to 

use the long-established dosage form 

categories listed in Title 21 of the Code 

of Federal Regulations to implement 

this statutory requirement’’ (70 FR 56394 

at 56398, September 27, 2005). To 

accomplish this clarification, the 

amendment will add the word 

‘‘categories’’ after the phrase ‘‘dosage 

forms’’ and remove the ‘‘s’’ from ‘‘forms’’ 

in the first sentence of the definition. 

Section 516.20(b)(2) requires that 

requests for MUMS designation include 

‘‘* * * the generic and trade name, if 

any, of the drug * * *’’ intended to be 

designated and FDA is proposing to 

amend this language to replace the 

terms ‘‘generic’’ and ‘‘trade’’ with the 

terms ‘‘established’’ and ‘‘proprietary’’, 

respectively, because the latter are the 

terms used in the FD&C Act (see section 

502(e) (21 U.S.C. 352(e)). FDA is also 

proposing to revise this language to 

clarify that ‘‘drug’’ in the context of 

§ 516.20(b)(2) refers to the ‘‘active 

pharmaceutical ingredient (API)’’ name 

rather than to a formulated drug product 

name. The purpose of the information 

required in this provision of the 

regulation is to permit the Agency to 

determine whether a drug is eligible for 

designation on the basis that it is not the 

‘‘same drug’’ as a drug that is already 

designated, conditionally approved, or 

approved (see section 573(a)(2)(B) of the 

FD&C Act (21 U.S.C. 360ccc-2)) and, 

because the definition of ‘‘same drug’’ in 

§ 516.3(b) requires a knowledge of the 

drug’s ‘‘active moiety’’ in order to make 

this determination, a request for MUMS 

designation needs to include the API 

name. This is because the API name 

includes the active moiety and the drug 

product name normally does not. FDA 

is also proposing to clarify the 

relationship between established and 

proprietary names in this context with 

the use of parentheses. 

II. Companion Document to Direct 

Final Rulemaking 

This proposed rule is a companion to 

the direct final rule published in the 

final rules section of this issue of the 

Federal Register. The direct final rule 

and this companion proposed rule are 

substantively identical. This companion 

proposed rule provides the procedural 

framework to proceed with standard 

notice-and-comment rulemaking if the 

direct final rule receives significant 

adverse comment and is withdrawn. 

FDA is publishing the direct final rule 

because we believe the rule is noncontroversial and we do not anticipate 

receiving any significant adverse 

comments. 

A significant adverse comment is one 

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 

terminating 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 

Administrative Procedure Act (5 U.S.C. 

553). Comments that are frivolous, 

insubstantial, or outside the scope of the 

rule will not be considered significant 

or adverse under this procedure. A 

comment recommending a regulation 

change in addition to those in the rule 

would 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 an amendment, 

paragraph, or section of this rule and 

that provision can be severed from the 

remainder of the rule, we may adopt as 

final those provisions of the rule that are 

not the subject of a significant adverse 

comment. The comment period for the 

companion proposed rule runs 

concurrently with the comment period 

of the direct final rule. Any comments 

received on this companion proposed 

rule will also be treated as comments on 

the direct final rule. We will not provide 

additional opportunity for comment. 

If no significant adverse comment is 

received in response to the direct final 

rule, no further action will be taken 

related to this companion proposed 

rule. Instead, we will publish a 

document confirming the effective date 

within 30 days after the comment 

period ends, and we intend the direct 

final rule to become effective 30 days 

after publication of the confirmation 

notice. 

If we receive any significant adverse 

comments, 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. The Agency will address 

the comments in a subsequent final rule. 


hsrobinson on DSK69SOYB1PROD with PROPOSALS
69616 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Proposed Rules 

A full description of FDA’s policy on 

direct final rule procedures may be 

found in a guidance document 

published in the Federal Register of 

November 21, 1997 (62 FR 62466). The 

guidance document may be accessed at: 

http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

III. Legal Authority 

FDA’s authority to issue this proposed 

rule is provided by section 512(b)(1) of 

the FD&C Act (21 U.S.C. 360b(b)(1)). 

This section states that any person may 

file with the Secretary of Health and 

Human Services an application with 

respect to any intended use or uses of 

a new animal drug and sets forth the 

specific information that must be 

included in such an application. In 

addition, section 701(a) of the FD&C Act 

(21 U.S.C. 371(a)) gives FDA general 

rulemaking authority to issue 

regulations for the efficient enforcement 

of the FD&C Act. FDA is issuing this 

proposed rule under these authorities. 

IV. Environmental Impact 

FDA has determined under 21 CFR 

25.30(h) 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. 

V. 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 (Pub. L. 

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 this proposed rule 

would not impose any compliance costs 

on the sponsors of animal drug products 

that are currently marketed or in 

development, 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. 

VI. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would 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 tentatively 

concludes that the proposed 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. 

VII. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

this proposed rule have been approved 

by OMB in accordance with the PRA 

under the regulations governing 

designation of new animal drugs for 

MUMS (part 516, OMB control number 

0910–0605). Thus, § 516.20 as amended, 

does not constitute a new or additional 

paperwork burden requiring OMB 

approval. 

VIII. Request for 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 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

Therefore under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 516 is 

amended as follows: 

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

1. The authority citation for 21 CFR 

part 516 continues to read as follows: 

Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. 

2. Amend § 516.3(b), by revising the 

introductory text of the definition of 

‘‘Same dosage form’’ to read as follows: 

§ 516.3 Definitions. 

* * * * * 

(b) * * * 

Same dosage form means the same as 

one of the dosage form categories 

specified in the following parts of this 

chapter: 

* * * * * 

3. Amend § 516.20 by revising 

paragraph (b)(2) to read as follows: 

§ 516.20 Content and format of a request 

for MUMS-drug designation. 

* * * * * 

(b) * * * 

(2) The name and address of the 

sponsor; the name of the sponsor’s 

primary contact person and/or 

permanent-resident U.S. agent including 

title, address, and telephone number; 

the established name (and proprietary 

name, if any) of the active 

pharmaceutical ingredient of the drug; 

and the name and address of the source 

of the active pharmaceutical ingredient 

of the drug. 

* * * * * 

Dated: November 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28551 Filed 11–12–10; 8:45 am] 

BILLING CODE 4160–01–P 


hsrobinson on DSK69SOYB1PROD with PROPOSALS