Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Proposed Rules 54771 

26 17 CFR 230.157. 27Asset-Backed Securities, Release No. 33–8419 

(May 3, 2004) [69 FR 26650] (proposing release 

related to Regulation AB and other new rules and 

forms related to asset-backed securities). 

to which it applies. We do not believe 

that a one-year extension would impose 

a burden on competition. We also 

believe the extension of the filing 

accommodation would continue to 

promote efficiency and capital 

formation by permitting ABS issuers to 

disclose static pool information in a 

format that is more useful to investors 

and cost-effective and not unduly 

burdensome for asset-backed issuers. 

We request comment on whether the 

proposed amendment, if adopted, 

would promote efficiency, competition, 

and capital formation. Commenters are 

requested to provide empirical data and 

other factual support for their view to 

the extent possible. 

VI. Regulatory Flexibility Analysis 

Certification 

The Commission hereby certifies 

pursuant to 5 U.S.C. 605(b) that the 

proposed amendment contained in this 

release, if adopted, would not have a 

significant economic impact on a 

substantial number of small entities. 

The proposal relates to the disclosure 

requirements for ABS in Securities Act 

registration statements. Securities Act 

Rule 157 26 defines an issuer, other than 

an investment company, to be a ‘‘small 

business’’ or ‘‘small organization’’ if it 

had total assets of $5 million or less on 

the last day of its most recent fiscal year. 

In 2004, when we proposed the new and 

amended rules and forms to address the 

registration, disclosure and reporting 

requirements for ABS, we certified that 

the proposals would not have a 

significant economic impact on a 

substantial number of small entities. As 

the depositor and issuing entity are 

most often limited purpose entities in 

an ABS transaction, we focused on the 

sponsor in analyzing the potential 

impact of the proposals under the 

Regulatory Flexibility Act. The staff 

analyzed sponsors that conducted 

registered public offerings of ABS 

during 2003. No sponsor had total assets 

of $5 million or less.27 Based on staff 

experience, we continue to believe that 

few, if any, sponsors are small entities. 

In addition, even if some sponsors are 

small entities, the proposed amendment 

to Rule 312 would not have a significant 

economic impact on any such entities 

because it only extends a temporary 

filing accommodation that is currently 

in effect. As discussed above in Section 

III, we do not believe the proposed 

extension would impose any new or 

increased costs on ABS issuers. 

Accordingly, we do not believe that the 

extension, if adopted, would have a 

significant economic impact on a 

substantial number of small entities. 

We solicit written comments 

regarding this certification. We request 

comment on whether the proposals 

could have an effect that we have not 

considered. We request that commenters 

describe the nature of any impact on 

small entities and provide empirical 

data to support the extent of the impact. 

VII. Statutory Authority and Text of the 

Proposed Amendment 

The amendment described is being 

proposed under the authority set forth 

in Sections 6, 7, 10, 19 and 28 of the 

Securities Act of 1933 (15 U.S.C. 77f, 

77g, 77j, 77s and 77z–3). 

List of Subjects in 17 CFR Part 232 

Reporting and recordkeeping 

requirements, Securities. 

Text of the Proposed Amendment 

For the reasons set out in the 

preamble, the Commission proposes to 

amend title 17, chapter II, of the Code 

of Federal Regulations as follows: 

PART 232—REGULATION S–T— 

GENERAL RULES AND REGULATIONS 

FOR ELECTRONIC FILINGS 

1. The authority citation for part 232 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 

77s(a), 77z–3, 77sss(a), 78c(b), 78l, 78m, 78n, 

78o(d), 78w(a), 78ll, 80a–6(c), 80a–8, 80a–29, 

80a–30, 80a–37, and 7201 et seq.; and 18 

U.S.C. 1350. 

* * * * * 

§ 232.312 [Amended] 

2. Amend § 232.312 by removing 

‘‘December 31, 2009’’ and in its place 

adding ‘‘December 31, 2010’’ in the first 

sentence of paragraph (a). 

* * * * * 

Dated: October 19, 2009. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. E9–25496 Filed 10–22–09; 8:45 am] 

BILLING CODE 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: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the regulations regarding new 

animal drug applications (NADAs). 

Specifically, this proposed rule is being 

issued to provide that NADAs shall be 

submitted in the form and containing 

the information described, 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. This 

proposed rule is a companion document 

to the direct final rule published 

elsewhere in this issue of the Federal 

Register. 

DATES: Submit written comments on or 

before January 6, 2010. If FDA receives 

any significant adverse comments, the 

agency will publish a document 

withdrawing the direct final rule within 

30 days after the comment period ends. 

FDA will then proceed to respond to 

comments under this proposed rule 

using the usual notice and comment 

procedures. 

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 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 


CPrice-Sewell on DSKGBLS3C1PROD with PROPOSALS
54772 Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Proposed Rules 

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 proposed rule is being issued to 

amend § 514.1 (21 CFR 514.1) so as to 

provide that NADAs shall contain 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 proposed 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. 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 finalize the rule in the 

event that a significant adverse 

comment is received in response to the 

direct final rule and it 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. If no significant 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 document 

confirming the effective date 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 

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

seq.). The comment period for this 

companion proposed rule runs 

concurrently with the comment period 

for the direct final rule. 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 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 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 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/ucm125166.htm. 

III. Legal Authority 

FDA’s authority to issue this proposed 

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 proposed 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 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 

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 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 proposed rule 

would not impose any direct or indirect 

costs on industry or government 

through the amendment, but rather 


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Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Proposed Rules 54773 

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 proposes to 

certify that the 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. 

VI. Federalism 

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. 

VII. Paperwork Reduction Act of 1995 

This proposed rule refers to 

previously approved collections of 

information found in FDA regulations. 

The proposed rule would amend 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. 

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, it is proposed that 

21 CFR part 514 be 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. E9–25518 Filed 10–22–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

RIN 0648–AW72 

Magnuson-Stevens Fishery 

Conservation and Management Act 

Provisions; Fisheries of the 

Northeastern United States; Northeast 

(NE) Multispecies Fishery; Amendment 

16 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notice of availability of a fishery 

management plan amendment; request 

for comments. 

SUMMARY: NMFS announces that the 

New England Fishery Management 

Council (Council) has submitted 

Amdnement 16 to the NE Multispecies 

Fishery Management Plan (FMP) and its 

associated draft Final Environmental 

Impact Statement (FEIS) for Secretarial 

review and is requesting comments from 

the public. Amendment 16 was 

developed by the Council as part of the 

biennial adjustment process in the FMP 

to update status determination criteria 

for all regulated NE multispecies or 

ocean pout stocks; to adopt rebuilding 

programs for NE multispecies stocks 

newly classified as being overfished and 

subject to overfishing; and to revise 

management measures, including 

significant revisions to the Sector 

management and allocation measures, 

necessary to end overfishing, rebuild 

overfished regulated NE multispecies or 

ocean pout stocks, and mitigate the 

adverse economic impacts of increased 

effort controls. Amendment 16 would 

also implement new requirements for 

establishing allowable biological catch 

(ABC), annual catch limits (ACLs), and 

accountability measures (AMs) for each 

stock managed by the FMP, pursuant to 

the Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act). Finally, this 

action would add Atlantic wolffish to 

the list of species managed by the FMP. 

This action is necessary to address the 

results of the most recent stock 

assessment, which indicate that several 

additional NE multispecies regulated 

species are overfished and subject to 

overfishing and that some stocks 

currently classified as overfished 

require additional reductions in fishing 

mortality to rebuild by the end of their 

rebuilding periods. 


CPrice-Sewell on DSKGBLS3C1PROD with PROPOSALS