Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Rules and Regulations 54749 

guaranteed debt to replace maturing 

senior unsecured debt as a result of 

market disruptions or other 

circumstances beyond the entity’s 

control, the participating entity may, 

with the FDIC’s prior approval under 

paragraph (h) of this section, issue 

FDIC-guaranteed debt after October 31, 

2009, and on or before April 30, 2010. 

Any such issuance is subject to all of the 

terms and conditions imposed by the 

FDIC in its approval decision as well as 

all of the provisions of this part, 

including without limitation, the 

payment of the applicable assessment 

and compliance with the disclosure 

requirements. 

* * * * * 

■ 4. Amend § 370.5 as follows: 

■ a. Revise paragraph (f); and 

■ b. Revise paragraph (h)(2), to read as 

follows: 

§ 370.5 Participation. 

* * * * * 

(f) Except as provided in paragraphs 

(g), (j), and (k) of § 370.3, participating 

entities are not permitted to select 

which newly issued senior unsecured 

debt is guaranteed debt; all senior 

unsecured debt issued by a participating 

entity up to its debt guarantee limit 

must be issued and identified as FDICguaranteed debt as and when issued. 

* * * * * 

(h) * * * 

(2) Each participating entity that is 

either an insured depository institution, 

an entity that has issued FDICguaranteed debt before April 1, 2009, an 

entity that has been approved pursuant 

to § 370.3(h) to issue FDIC-guaranteed 

debt after June 30, 2009, and on or 

before October 31, 2009, or a 

participating entity that has been 

approved pursuant to § 370.3(k) to issue 

FDIC-guaranteed debt after October 31, 

2009, must include the following 

disclosure statement in all written 

materials provided to lenders or 

creditors regarding any senior 

unsecured debt that is issued by it 

during the applicable issuance period 

and that is guaranteed under the debt 

guarantee program: 

This debt is guaranteed under the 

Federal Deposit Insurance Corporation’s 

Temporary Liquidity Guarantee 

Program and is backed by the full faith 

and credit of the United States. The 

details of the FDIC guarantee are 

provided in the FDIC’s regulations, 12 

CFR Part 370, and at the FDIC’s Web 

site, http://www.fdic.gov/tlgp. [If the 

debt being issued is mandatory 

convertible debt, add: The expiration 

date of the FDIC’s guarantee is the 

earlier of the mandatory conversion 

date or December 31, 2012]. [If the debt 

being issued is any other senior 

unsecured debt, add: The expiration 

date of the FDIC’s guarantee is the 

earlier of the maturity date of the debt 

or December 31, 2012.] 

* * * * * 

■ 5. Amend § 370.6 as follows: 

■ a. Revise paragraph (d)(1); and 

■ b. Add paragraph (i), to read as 

follows: 

§ 370.6 Assessments under the Debt 

Guarantee Program. 

* * * * * 

(d) Amount of assessments for debt 

within the debt guarantee limit 

(1) Calculation of assessment. Subject 

to paragraphs (d)(3) and (h) of this 

section, and except as provided in 

paragraph (i) of this section, the amount 

of assessment will be determined by 

multiplying the amount of FDICguaranteed debt times the term of the 

debt or, in the case of mandatory 

convertible debt, the time period from 

issuance to the mandatory conversion 

date, times an annualized assessment 

rate determined in accordance with the 

following table. 

For debt with a maturity or 

time period to conversion 

date of— 

The 

annualized 

assessment 

rate (in basis 

points) is— 

180 days or less (excluding 

overnight debt) .................. 50 

181–364 days ....................... 75 

365 days or greater .............. 100 

* * * * * 

(i) Assessment for debt issued under 

the Emergency Guarantee Facility. The 

amount of the assessment for FDICguaranteed debt issued pursuant to 

§ 370.3(k) of this part is equal to the 

amount of the debt times the term of the 

debt (or in the case of mandatory 

convertible debt, the time period to 

conversion) times an annualized 

assessment rate of 300 basis points, or 

such greater rate as the FDIC may 

determine in its decision approving 

such issuance. 

By order of the Board of Directors. 

Dated at Washington, DC, this 20th day of 

October 2009. 

Robert E. Feldman, 

Executive Secretary, Federal Deposit 

Insurance Corporation. 

[FR Doc. E9–25555 Filed 10–22–09; 8:45 am] 

BILLING CODE 6714–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 514 

[Docket No. FDA–2009–N–0436] 

New Animal Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

regulations regarding new animal drug 

applications (NADAs). Specifically, this 

direct final rule is being issued to 

provide that NADAs shall be submitted 

in the described form, as appropriate for 

the particular submission. Currently, the 

regulation requires that all NADAs 

contain the same informational sections 

and does not explicitly provide the 

appropriate flexibility needed to address 

the development of all types of new 

animal drug products. This amendment 

will allow the agency to appropriately 

review safety and effectiveness data 

submitted to support the approval of 

new animal drug products. FDA is 

amending the regulations in accordance 

with its direct final rule procedures. 

Elsewhere in this issue of the Federal 

Register, we are publishing a 

companion proposed rule, under FDA’s 

usual procedure for notice-andcomment rulemaking, to provide a 

procedural framework to finalize the 

rule in the event the agency receives any 

significant adverse comments and 

withdraws this direct final rule. The 

companion proposed rule and this 

direct final rule are substantively 

identical. 

DATES: This rule is effective March 8, 

2010. Submit written comments on or 

before January 6, 2010. If FDA receives 

no significant adverse comments within 

the specified comment period, the 

agency will publish a document 

confirming the effective date of the final 

rule in the Federal Register within 30 

days after the comment period on this 

direct final rule ends. If timely 

significant adverse comments are 

received, the agency will publish a 

document in the Federal Register 

withdrawing this direct final rule before 

its effective date. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2009–N– 

0436 by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
54750 Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Rules and Regulations 

• 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. 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, 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: Urvi 

Desai, Center for Veterinary Medicine 

(HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8297, email: urvi.desai@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This direct final rule is being issued 

to amend § 514.1 (21 CFR 514.1) so as 

to provide that NADAs shall include the 

information described in the section, as 

appropriate for the particular 

submission. Currently, the regulation 

requires that all NADAs contain the 

same informational sections and does 

not explicitly provide the appropriate 

flexibility needed to address the 

development of all types of new animal 

drug products. This amendment will 

allow the agency to appropriately 

review safety and effectiveness data 

submitted to support the approval of 

new animal drug products. In addition, 

the amendment is similar to the current 

provisions of the human new drug 

application regulations at 21 CFR 314.50 

and thus will make the new human and 

new animal drug regulations more 

consistent. 

II. Direct Final Rulemaking 

In the Federal Register of November 

21, 1997 (62 FR 62466), FDA announced 

the availability of 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/ 

ucm125166.htm. FDA believes that this 

rule is appropriate for direct final 

rulemaking because it is intended to 

make non-controversial changes to 

existing regulations. We anticipate no 

significant adverse comments. 

Consistent with FDA’s procedures on 

direct final rulemaking, we are 

publishing elsewhere in this issue of the 

Federal Register a companion proposed 

rule. The companion proposed rule 

provides the procedural framework 

within which the rule may be finalized 

in the event the direct final rule is 

withdrawn because of any significant 

adverse comment. The comment period 

for this direct final rule runs 

concurrently with the comment period 

of the companion proposed rule. Any 

comments received in response to the 

companion proposed rule will also be 

considered as comments regarding this 

direct final rule. 

FDA is providing a comment period 

on the direct final rule of 75 days after 

the date of publication in the Federal 

Register. If FDA receives any significant 

adverse comment, we intend to 

withdraw this direct final rule before its 

effective date by publication of a notice 

in the Federal Register within 30 days 

after the comment period ends. 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 

change. In determining whether an 

adverse comment is significant and 

warrants withdrawing a direct final rule, 

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 (APA) (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. 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. 

If any significant adverse comments 

are received during the comment 

period, FDA will publish, before the 

effective date of the direct final rule, a 

document withdrawing the direct final 

rule. If we withdraw the direct final 

rule, all comments received will be 

considered under the companion 

proposed rule in developing a final rule 

using the usual notice-and-comment 

procedures under the APA (5 U.S.C. 552 

et seq.). If we receive no significant 

adverse comment during the specified 

comment period, we intend to publish 

a document in the Federal Register 

confirming the effective date within 30 

days after the comment period ends. 

III. Legal Authority 

FDA’s authority to issue this direct 

final rule is provided by section 

512(b)(1) of the Federal Food, Drug, and 

Cosmetic Act (the 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 act (21 U.S.C. 371(a)) gives FDA 

general rulemaking authority to issue 

regulations for the efficient enforcement 

of the act. FDA is issuing this direct 

final rule under these authorities. 

IV. Environmental Impact 

FDA has carefully considered the 

potential environmental impacts of this 

rule and 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 Economic Impacts 

FDA has examined the impacts of the 

direct final 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 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Rules and Regulations 54751 

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 direct final 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 the direct final rule 

would not impose any direct or indirect 

costs on industry or government 

through the amendment, but rather 

would only clarify that sponsors must 

include in their applications the 

information described in § 514.1 that is 

appropriate for their particular 

submission, the agency certifies that the 

direct final rule would 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 direct final rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

VI. Federalism 

FDA has analyzed this direct 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. 

VII. Paperwork Reduction Act of 1995 

This direct final rule refers to 

previously approved collections of 

information found in FDA regulations. 

The direct final rule amends these 

previously approved collections of 

information by clarifying that NADAs 

must contain the information 

appropriate for the particular 

submission. Further, this amendment is 

based upon the Center for Veterinary 

Medicine’s previous experience with 

these submissions. Thus, § 514.1 as 

amended, does not constitute a new or 

additional paperwork burden requiring 

Office of Management and Budget 

(OMB) approval. 

Collections of information are subject 

to review by OMB under the Paperwork 

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

3520). The collections of information in 

§ 514.1 have been approved under OMB 

Control No. 0910–0032. This approval 

expires April 30, 2011. An agency may 

not conduct and a person is not required 

to respond to a collection of information 

unless it displays a valid OMB control 

number. 

VIII. Request for Comments 

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 514 

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 514 is 

amended as follows: 

PART 514—NEW ANIMAL DRUG 

APPLICATIONS 

■ 1. The authority citation for 21 CFR 

part 514 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

356a, 360b, 371, 379e, 381. 

■ 2. In § 514.1, revise the first sentence 

of paragraph (a) and the introductory 

text of paragraph (b) to read as follows: 

§ 514.1 Applications. 

(a) Applications to be filed under 

section 512(b) of the act shall be 

submitted in the form and contain the 

information described in paragraph (b) 

of this section, as appropriate to support 

the particular submission. * * * 

(b) Applications for new animal drugs 

shall be submitted in triplicate and 

assembled in the manner prescribed by 

paragraph (b)(15) of this section, and 

shall include the following information, 

as appropriate to support the particular 

submission: * * * 

* * * * * 

Dated: October 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25517 Filed 10–22–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[DOD–2009–OS–0141; RIN 0790–AI59] 

32 CFR Part 279 

Retroactive Stop Loss Special Pay 

Compensation 

AGENCY: Office of the Under Secretary of 

Defense for Personnel and Readiness, 

DoD. 

ACTION: Interim final rule. 

SUMMARY: This part provides for 

Retroactive Stop Loss Special Pay as 

authorized and appropriated in The 

Supplemental Appropriations Act, 

2009. 

The prompt implementation of the 

Interim Final Rule is of critical 

importance as Congress dictated the 

program be implemented within 120 

days following the signing of the ‘‘The 

Supplemental Appropriations Act, 

2009. It was signed June 24, 2009. 

Additionally, this program is of short 

duration, from October 21, 2009 to 

October 21, 2010. The last day for 

submission of claims to the Secretaries 

of the Military Departments for 

Retroactive Stop Loss Special Pay is 

October 21, 2010. The Secretaries 

concerned are not authorized to make 

payments on claims submitted after 

October 21, 2010. The statutory 

deadline provides good cause, pursuant 

to 5 U.S.C. 553(d)(3), to make this rule 

effective immediately upon publication. 

DATES: This rule is effective October 21, 

2009. Comments must be received by 

December 22, 2009. 

ADDRESSES: You may submit comments, 

identified by docket number and/or RIN 

number and title, by any of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 


CPrice-Sewell on DSKGBLS3C1PROD with RULES