Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 57505 

Conclusion 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore—(1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 97: 

Air Traffic Control, Airports, 

Incorporation by reference, and 

Navigation (Air). 

Issued in Washington, DC on September 

23, 2005. 

James J. Ballough, 

Director, Flight Standards Service. 

Adoption of the Amendment 

■ Accordingly, pursuant to the authority 

delegated to me, under Title 14, Code of 

Federal Regulations, Part 97 (14 CFR 

part 97) is amended by establishing, 

amending, suspending, or revoking 

Standard Instrument Approach 

Procedures and Weather Takeoff 

Minimums effective at 0901 UTC on the 

dates specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44701, 

44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

* * * Effective 27 October 2005 

Searcy, AR, Searcy Muni, ILS OR LOC RWY 

1, Orig 

Searcy, AR, Searcy Muni, LOC RWY 1, Orig, 

CANCELLED 

Stuttgart, AR, Stuttgart Muni, ILS OR LOC 

RWY 36, Orig 

San Francisco, CA, San Francisco Intl, RNAV 

(RNP) Y RWY 28R, Orig 

Washington, DC, Ronald Reagan Washington 

National, RNAV (RNP) RWY 19, Orig-A 

St. Petersburg-Clearwater, FL, St. PetersburgClearwater Intl, RNAV (GPS)–A, Orig 

Tampa, FL, Tampa Intl, ILS OR LOC RWY 

18L, Amdt 39, ILS RWY 18L (CAT II), 

Amdt 39 

Covington, KY, Cincinnati/Northern 

Kentucky Intl, Takeoff Minimums and 

Textual DP, Orig 

Tallulah, LA, Vicksburg Tallulah Rgnl, LOC 

RWY 36, Amdt 2 

Minneapolis, MN, Minneapolis-St. Paul Intl/ 

Wold-Chamberlain, ILS PRM RWY 30L, 

Amdt 5A, (SIMULTANEOUS CLOSE 

PARALLEL) 

Minneapolis, MN, Minneapolis-St. Paul Intl/ 

Wold-Chamberlain, ILS PRM RWY 30R, 

Amdt 6A, (SIMULTANEOUS CLOSE 

PARALLEL) 

Minneapolis, MN, Minneapolis-St. Paul Intl/ 

Wold-Chamberlain, ILS OR LOC RWY 30L, 

ILS RWY 30L, (CAT II), Amdt 44A 

Minneapolis, MN, Minneapolis-St. Paul Intl/ 

Wold-Chamberlain, ILS OR LOC RWY 30R, 

Amdt 11A 

Tupelo, MS, Tupelo Regional, ILS OR LOC 

RWY 36, Amdt 8 

Santa Teresa, NM, Dona Ana County at Santa 

Teresa, RNAV (GPS) RWY 10, Orig 

Santa Teresa, NM, Dona Ana County at Santa 

Teresa, Takeoff Minimums and Textual DP, 

Orig 

Statesville, NC, Statesville Regional, ILS OR 

LOC/DME RWY 28, Orig 

Statesville, NC, Statesville Regional, LOC/ 

DME RWY 28, Amdt 1, CANCELLED 

Conway, SC, Conway-Horry County, RNAV 

(GPS) RWY 4, Orig 

Conway, SC, Conway-Horry County, NDB 

RWY 4, Orig 

Conway, SC, Conway-Horry County, NDB 

RWY 4, Amdt 2, CANCELLED 

Conway, SC, Conway-Horry County, NDB OR 

GPS–A, Amdt 2, CANCELLED 

Conway, SC, Conway-Horry County, GPS 

RWY 4, Orig, CANCELLED 

Conway, SC, Conway-Horry County, Takeoff 

Minimums and Textual DP, Amdt 1 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, CONVERGING ILS RWY 

17C, Amdt 5 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, CONVERGING ILS RWY 

35C, Orig 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, ILS OR LOC RWY 17C, ILS 

RWY 17C (CAT II), ILS RWY 17C (CAT III), 

Amdt 8 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, ILS OR LOC RWY 35C, ILS 

RWY 35C (CAT II), ILS RWY 35C (CAT III), 

Orig 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, ILS OR LOC RWY 35C, Orig, 

CANCELLED 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, CONVERGING ILS RWY 

35C, Orig, CANCELLED 

Dallas-Fort Worth, TX, Dallas-Fort Worth 

International, GPS RWY 17C, Orig, 

CANCELLED 

Houston, TX, Sugar Land Rgnl, NDB RWY 

17, Orig 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, RNAV (GPS) RWY 12, 

Orig 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, RNAV (GPS) RWY 30, 

Orig 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, LOC RWY 30, Amdt 4 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, NDB RWY 30, Amdt 4 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, VOR–A, Amdt 3 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, VOR/DME RNAV RWY 

12, Amdt 3 

Kerrville, TX, Kerrville Muni/Louis 

Schreiner Field, Takeoff Minimums and 

Textual DP, Amdt 1 

* * * Effective 22 December 2005 

Golovin, AK, Golovin, RNAV (GPS)–A, Orig 

Golovin, AK, Golovin, RNAV (GPS) RWY 2, 

Orig 

Golovin, AK, Golovin, Takeoff Minimums 

and Textual DP, Orig 

Middleton, WI, Middleton Muni-Morey 

Field, RNAV (GPS) RWY 10, Orig 

Middleton, WI, Middleton Muni-Morey 

Field, RNAV (GPS) RWY 28, Orig 

Middleton, WI, Middleton Muni-Morey 

Field, VOR RWY 10, Orig 

Middleton, WI, Middleton Muni-Morey 

Field, VOR RWY 28, Orig 

Middleton, WI, Middleton Muni-Morey 

Field, VOR/DME RNAV RWY 12, Orig, 

CANCELLED 

Middleton, WI, Middleton Muni-Morey 

Field, VOR–A, Orig, CANCELLED 

Middleton, WI, Middleton Muni-Morey 

Field, VOR–B, Orig, CANCELLED 

Middleton, WI, Middleton Muni-Morey 

Field, RNAV (GPS) RWY 12, Orig, 

CANCELLED 

Middleton, WI, Middleton Muni-Morey 

Field, RNAV (GPS) RWY 30, Orig, 

CANCELLED 

Middleton, WI, Middleton Muni-Morey 

Field, Takeoff Minimums and Textual DP, 

Amdt 1 

[FR Doc. 05–19746 Filed 9–30–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1 and 20 

[Docket No. 2002N–0276] (formerly Docket 

No. 02N–0276) 

RIN 0910-AC40 

Registration of Food Facilities Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

regulation that confirms the interim 

final rule entitled ‘‘Registration of Food 

Facilities Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002’’ (68 FR 

58894, October 10, 2003 (interim final 

rule) as corrected by a technical 

amendment (69 FR 29428, May 24, 

2004), and responds to comments 

submitted in response to the request for 

57506 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 

1The authorities of Treasury under section 701(b) 

of the act to prescribe regulations for the efficient 

enforcement of section 801 of the act were 

transferred to DHS when it was created by an act 

of Congress in 2002. 

comments in the interim final rule. This 

final rule affirms the interim final rule’s 

requirement that domestic and foreign 

facilities that manufacture/process, 

pack, or hold food for human or animal 

consumption in the United States be 

registered with FDA by December 12, 

2003. The interim final rule 

implemented the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act), which requires domestic and 

foreign facilities to be registered with 

FDA by December 12, 2003. This final 

rule does not make any changes to the 

regulatory requirements established by 

the interim final rule. 

DATES: The interim final rule published 

at 68 FR 58894 was effective on 

December 12, 2003. The technical 

amendment to the interim final rule 

published at 69 FR 29428 was effective 

May 24, 2004. This final rule, which 

adopts as final the interim rule as 

amended, is effective October 3, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Catherine L. Copp, Center for Food 

Safety and Applied Nutrition (HFS–

004), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1589. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legal Authority 

Section 305 of the Bioterrorism Act, 

which was enacted on June 12, 2002, 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) to require the 

Secretary to establish regulations 

requiring domestic and foreign facilities 

that manufacture, process, pack, or hold 

food for human or animal consumption 

in the United States to be registered 

with the Secretary (section 415 of the 

act (21 U.S.C. 350d)). Facilities were 

required to be registered by December 

12, 2003. Failure to register a facility in 

accordance with section 415 of the act 

is a prohibited act (section 301(dd) of 

the act (21 U.S.C. 331(dd))). Section 305 

of the Bioterrorism Act amended the act 

to prohibit the importation of food from 

a foreign facility that is required to 

register, but has not done so (section 

801(l) of the act (21 U.S.C. 381(l))). 

The Department of Health and Human 

Services (DHHS) and the Department of 

Treasury (Treasury) jointly published 

the proposed registration regulation in 

the Federal Register on February 3, 

2003 (68 FR 5378), for comment 

(proposed rule). On October 10, 2003, 

DHHS and the Department of Homeland 

Security (DHS) jointly issued the 

interim final rule1. The interim final 

rule implemented section 305 of the 

Bioterrorism Act, and required domestic 

and foreign facilities to be registered 

with FDA by December 12, 2003. The 

interim final rule responded to 

comments from the public on the 

proposed rule, and established a 75-day 

comment period on a limited set of 

issues identified in the interim final rule 

and also set out below. In order to 

ensure that those commenting on the 

interim final rule had the benefit of 

FDA’s outreach and educational efforts 

and had experience with the systems, 

timeframes, and data elements of the 

registration system, FDA reopened the 

comment period on the same limited set 

of issues for 30 days on April 14, 2004 

(69 FR 19766). FDA requested comment 

only on the following issues: 

1. The cost to foreign facilities of 

hiring and retaining a U.S. agent. 

Specifically, FDA invited comment, and 

the submission of data or other 

information, on the following: 

• The costs to a foreign facility of 

hiring a U.S. agent; 

• The number of foreign facilities that 

have hired a U.S. agent or negotiated 

additional duties from someone with 

whom they have an existing 

relationship in response to the interim 

final rule, instead of relying on an 

existing relationship with a person who 

qualifies as a U.S. agent; 

• The number of foreign facilities that 

have ceased exporting to the United 

States because they have decided not to 

hire/retain a U.S. agent for registration 

purposes. 

• The distribution of costs between 

submitting registrations and other 

services offered by the U.S. agent. 

• The assumptions underlying FDA’s 

estimates of the costs of hiring and 

retaining a U.S. agent. 

2. The effects on domestic small 

businesses, if any, if some foreign 

facilities cease exporting to the United 

States due to the U.S. agent requirement 

for registration. Specifically, FDA 

invited comment, and the submission of 

data or other information, on the 

following: 

• The number of domestic small 

businesses that have been adversely 

affected by trading partners that have 

ceased exporting to the United States 

due to the U.S. agent requirement for 

foreign facility registration; and 

• The costs incurred by these 

domestic small businesses due to the 

loss of these trading partners. 

In addition to the provisions of the act 

amended by section 305 of the 

Bioterrorism Act, FDA is relying on 

section 701(a) and (b) of the act (21 

U.S.C. 371(a) and (b)) in issuing this 

final rule. Section 701(a) authorizes the 

agency to issue regulations for the 

efficient enforcement of the act, while 

section 701(b) of the act authorizes FDA 

and Treasury jointly to prescribe 

regulations for the efficient enforcement 

of section 801 of the act. 

To the extent that 5 U.S.C. 553 applies 

to this action, the agency’s 

implementation of this action with an 

immediate effective date comes within 

the good cause exception in 5 U.S.C. 

553(d)(3) (21 CFR 10.40(c)(4)(ii)). As 

this final rule imposes no new 

regulatory requirements, a delayed 

effective date is unnecessary. 

II. Comments on the Interim Final Rule 

FDA received approximately 200 

timely submissions in response to the 

interim final rule. Approximately threequarters of the comments FDA received 

addressed issues outside the scope of 

the interim final rule’s request for 

comments. FDA did not consider 

nonresponsive comments in developing 

this final rule, and this final rule does 

not address comments that are beyond 

the scope of the issues on which FDA 

requested comment. Relevant comments 

did not cause FDA to significantly 

revise its economic analysis of the 

requirement that each foreign facility 

designate a U.S. agent. Because FDA’s 

responses to the comments below do not 

result in any changes to the regulatory 

requirements published in the interim 

final rule, the governing regulation 

continues to be set out in §§ 1.225 

through 1.243 and 20.100. 

All of the issues on which FDA 

requested comment were related to the 

assumptions in the economic analysis 

section of the interim final rule. 

Accordingly, FDA is responding to all 

comments in section III of this 

document. 

III. Analysis of Economic Impacts 

Benefit-Cost Analysis 

We have examined the economic 

implications of this final rule as 

required by Executive Order 12866. 

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). 

Executive Order 12866 classifies a rule 

as significant if it meets any one of a 

number of specified conditions, 

including having an annual effect on the 

Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 57507 

economy of $100 million, adversely 

affecting a sector of the economy in a 

material way, adversely affecting 

competition, or adversely affecting jobs. 

Executive Order 12866 also considers a 

rule as a significant regulatory action if 

it raises novel legal or policy issues. In 

the interim final rule, FDA determined 

that the rule was a significant regulatory 

action as defined by Executive Order 

12866. We have determined that this 

final rule is not a significant regulatory 

action as defined by Executive Order 

12866, because it is not imposing any 

new requirement on any entity beyond 

the requirements of the interim final 

rule. 

The scope of the analysis of economic 

impacts for this final rule is limited to 

the costs associated with the U.S. agent 

requirement. For a full discussion of all 

costs and benefits associated with the 

registration requirement, see the 

proposed and interim final rules. 

Summary of U.S. Agent Costs 

Section 415(a)(1)(B) of the act, as 

established by the Bioterrorism Act, 

requires that the owner, operator, or 

agent in charge of a foreign facility 

submit in the facility’s registration the 

name of the U.S. agent for the facility. 

Section 1.232(d) requires that all foreign 

facility registrations include information 

about the facility’s U.S. agent and 

implements the statutory requirement. 

Section 1.227(b)(13) requires that the 

U.S. agent be a person residing or 

maintaining a place of business in the 

United States, who is designated by the 

owner, operator, or agent in charge of a 

foreign facility as the facility’s agent. 

FDA recognizes only one U.S. agent per 

foreign facility for purposes of 

registration. (See 68 FR 58894 at 58915.) 

The U.S. agent acts as a 

communications link between FDA and 

the facility, and FDA considers 

providing information to the U.S. agent 

the same as providing information 

directly to the foreign facility 

(§ 1.227(b)(13)(ii)). A U.S. agent may 

submit a facility’s registration to FDA if 

the owner, operator, or agent in charge 

of the foreign facility authorizes the U.S. 

agent (if an individual) to register on 

behalf of the owner, operator, or agent 

in charge of the facility (§ 1.225(c)). 

In the economic analyses of the 

proposed and interim final rules, FDA 

estimated that more than 90 percent of 

foreign facilities did not currently have 

a U.S. agent and that foreign facilities 

currently without a U.S. agent would 

require 5 to 15 hours to find an agent 

and would pay an annual fee of $1,000 

(68 FR 5378 at 5396 and 68 FR 58894 

at 58943). The $1,000 fee estimated in 

the proposed rule was an estimate of an 

average fee for a U.S. agent under FDA 

regulations for drugs, biologics, and 

devices (21 CFR parts 207, 607, and 807, 

respectively), based on fees quoted over 

the phone and in Internet 

advertisements. During the period from 

the publication of the proposed rule to 

publication of the interim final rule, a 

number of companies began advertising 

their services as a U.S. agent for foreign 

food facilities on the Internet. These 

companies specified a range of costs, 

some with discounts for multiple 

facilities under the same ownership, 

fees that are a function of the number 

of shipments each year, or additional 

fees for registration updates. Based on 

the requirements in the proposed rule, 

the lowest fee quoted was $399 for 

representation by a U.S. agent for 1 year; 

other U.S. agents charged initial fees 

between $599 and $1,400. Many of the 

U.S. agents charged fees for additional 

registration-related services, such as 

registration updates or cancellations. 

Based on these estimates of fees, FDA 

concluded that $1,000 represented a 

reasonable estimate of a U.S. agent fee, 

including registering the foreign facility 

(68 FR 58894 at 58945). The total first 

year cost for foreign facilities was 

estimated to be $306 million, and 

annual costs were estimated to be $229 

million with a U.S. agent fee of $1,000. 

However, because there was a wide 

range of fees charged by U.S. agents, 

FDA also presented in the interim final 

rule an estimate of the cost of the rule 

with a U.S. agent fee of $700. Assuming 

this $700 fee, FDA estimated that the 

total first year cost for foreign facilities 

would be $247.6 million and annual 

costs would be $164.5 million (68 FR 

58894 at 58945). 

To improve the analysis involving the 

costs of hiring and retaining a U.S. 

agent, FDA requested comments on a 

number of specific components of the 

cost calculations, as summarized below. 

A. The Costs to a Foreign Facility of 

Hiring and Retaining a U.S. Agent 

(Comment 1) FDA received a number 

of comments about the costs of hiring 

and retaining a U.S. agent. FDA received 

estimates of U.S. agent fees ranging from 

$95 to $1400. Many comments 

mentioned a very wide range of fees, 

with differences as large as $800 

between the lowest and highest fees 

cited in a single comment. None of the 

comments stated whether there were 

differences in services between the low 

and high fee agents, other than lower 

fees for ‘‘farm’’ registrations. (The 

comments did not elaborate on the 

meaning of ‘‘farm’’ registrations.) The 

majority of the comments that estimated 

U.S. agent fees mentioned $700 or $750 

or included $700 in the range of fees. 

Some comments also noted that U.S. 

agents charged an hourly fee for any 

additional, but unspecified, services 

provided to the foreign facility. Some 

comments did not provide a dollar 

estimate of the U.S. agent fee, but 

asserted that FDA had underestimated 

the cost of a U.S. agent, while others 

claimed that FDA had overestimated the 

cost of hiring and retaining a U.S. agent. 

(Response) In the interim final rule, 

FDA estimated total costs using average 

U.S. agent fees of $700 and $1,000. 

Given the wide range of fees reported in 

the comments, we now conclude that 

the average fee for a U.S. agent is 

probably closer to $700, giving a total 

first year cost for foreign facilities of 

$247.6 million and annual costs of 

$164.5 million. Table 1 presents the 

revised present value and annualized 

total costs of the interim final rule for 

a U.S. agent fee of $700. 

TABLE 1.—PRESENT VALUE AND ANNUALIZED COSTS OVER 20 YEARS FOR A U.S. AGENT FEE OF $700 (IN MILLIONS) 

Discount Rate Present Value Annualized 

7% $2,144.1 $107.2 

3% $2,861.5 $143.1 

57508 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 

B. The Number of Foreign Facilities 

That Have Hired a U.S. Agent or 

Negotiated Additional Duties From 

Someone With Whom They Have an 

Existing Relationship in Response to the 

Interim Final Rule, Instead of Relying on 

an Existing Relationship With a Person 

Who Qualifies as a U.S. Agent 

(Comment 2) FDA did not receive any 

comments estimating the number of 

facilities that have hired a U.S. agent or 

have negotiated additional duties from 

someone with whom they have an 

existing relationship. However, we did 

receive individual comments from 

facilities and industry representatives 

reporting that some facilities have hired 

a new U.S. agent. FDA also received 

comments reporting that some facilities 

have used U.S. business partners, U.S. 

customers, or U.S. brokers as U.S. 

agents. 

(Response) From the comments we 

received it is clear that foreign facilities 

are complying with the U.S. agent 

requirement both by hiring new U.S. 

agents and by negotiating new duties 

with someone with whom they have an 

existing relationship. However, it was 

not possible to extrapolate from the 

comments how many facilities were 

hiring new U.S. agents or utilizing 

existing relationships. Therefore, FDA 

has not altered its analysis on this point. 

(See 68 FR 58894 at 58945.) 

C. The Number of Foreign Facilities 

That Have Ceased Exporting to the 

United States Because They Have 

Decided Not to Hire or Retain a U.S. 

Agent for Registration Purposes 

(Comment 3) FDA did not receive any 

estimates of the number of foreign 

facilities that have ceased exporting to 

the United States due to the U.S. agent 

requirement. FDA did receive comments 

from governmental agencies and 

industry groups reporting that some 

exporters of small value shipments may 

stop exporting or have stopped 

exporting to the United States as a result 

of the cost of hiring a U.S. agent. Other 

comments stated that they were 

unaware of any facilities that had 

stopped exporting to the United States 

in response to the cost of hiring a U.S. 

agent. 

(Response) Although some comments 

confirmed the assumption of the interim 

final rule economic analysis that some 

facilities would stop exporting to the 

United States due to costs associated 

with hiring a U.S. agent, the comments 

did not provide any information to 

estimate how many facilities would stop 

exporting. Therefore, FDA has not 

altered this portion of its analysis. (See 

68 FR 58894 at 58943.) 

D. The Distribution of Costs Between 

Submitting Registrations and Other 

Services Offered by the U.S. Agent 

(Comment 4) FDA received some 

comments separating the fee paid to a 

U.S. agent for registration services from 

fees paid for ongoing services. One 

comment assumed that the U.S. agent 

fees would be in addition to any 

existing fee for services the agent may 

be providing for the facility. Another 

comment stated that the fee to register 

a facility was $350 with an additional 

charge of $199 per year for acting as a 

facility’s U.S. agent, for a total fee of 

$549. Most comments that provided a 

U.S. agent fee did not specify what 

services were provided for the fee. 

(Response) FDA was unable to 

estimate based on the information in the 

comments the distribution of costs 

between submitting registrations and 

other services offered by the U.S. agent. 

Therefore, FDA has not altered this 

portion of its analysis. (See 68 FR 58894 

at 58945.) 

E. The Assumptions Underlying FDA’s 

Estimates of the Costs of Hiring and 

Retaining a U.S. Agent 

(Comment 5) FDA received comments 

questioning whether FDA had included 

all costs associated with hiring a U.S. 

agent. One comment stated that a firm 

had spent $1,800 per facility to register 

its foreign affiliates. 

(Response) The comment that 

provided specific costs of registration 

included many activities that FDA 

considered in other parts of its analysis, 

such as reading and understanding the 

rule and understanding the implications 

of the requirements for their business. If 

only activities related to the U.S. agent 

were considered, the comment’s cost 

estimates were consistent with FDA’s 

cost estimates for a U.S. agent. (See 68 

FR 58894 at 58945.) 

(Comment 6) Other comments that 

mentioned costs stated that FDA had 

failed to include costs associated with 

entering into a legal agreement with the 

U.S. agent. 

(Response) FDA did include an 

estimate of costs to find and hire a U.S. 

agent in the interim final rule, which 

would include the costs of establishing 

an agreement between the U.S. agent 

and the facility. Accordingly, FDA has 

not altered its assumptions about costs 

associated with entering into an 

agreement with the U.S. agent. (See 68 

FR 58894 at 58945.) 

F. The Effects on Domestic Small 

Businesses, if Any, if Some Foreign 

Facilities Cease Exporting to the United 

States Due to the U.S. Agent 

Requirement for Registration 

Specifically, FDA invited comment, 

and the submission of data or other 

information, on the following: The 

number of domestic small businesses 

that have been adversely affected by 

trading partners that have ceased 

exporting to the United States due to the 

U.S. agent requirement for foreign 

facility registration. 

FDA received no comments on the 

number of U.S. small businesses 

adversely affected by the loss of their 

trading partners, and thus, has not 

altered this portion of its analysis. (See 

68 FR 58894 at 58954 to 58955.) 

G. The Effects on Domestic Small 

Businesses, if Any, if Some Foreign 

Facilities Cease Exporting to the United 

States Due to the U.S. Agent 

Requirement for Registration 

Specifically, FDA invited comment, 

and the submission of data or other 

information, on the following: The costs 

incurred by these domestic small 

businesses due to the loss of these 

trading partners. 

(Comment 7) Some comments agreed 

that there was a potential for some 

foreign facilities to stop exporting to the 

United States as a result of the U.S. 

agent requirement. One comment listed 

the following several possible 

consequences for U.S. small businesses 

if foreign facilities stopped exporting: 

(1) Need to find new suppliers; (2) 

inability to supply existing customer 

base; (3) increase in cost of goods; and 

(4) increase in cost of goods that may be 

passed on to U.S. consumers. However, 

no comments provided any estimate of 

the costs of these effects. 

(Response) In the economic analysis 

of the interim final rule, FDA 

considered the impacts on small 

businesses. Because no comment 

provided an estimate of the costs to 

domestic small businesses if some 

foreign facilities cease exporting to the 

United States due to the U.S. agent 

requirement, FDA has not altered its 

estimate of the number of facilities that 

will stop exporting to the United States 

or its expectations of possible 

consequences for U.S. facilities. (See 68 

FR 58894 at 58954 to 58955.) 

IV. Regulatory Flexibility Analysis 

The Regulatory Flexibility Act (5 

U.S.C. 601–612) requires agencies to 

analyze regulatory options that would 

lessen the economic effect of the rule on 

small entities. Because this final rule 

Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 57509 

does not make any changes to existing 

requirements, and thus, does not impose 

any new costs on facilities, the agency 

certifies that this final rule will not have 

a significant impact on a substantial 

number of small entities. Full analysis 

of the effect of the registration 

requirement on small entities is 

provided in the analysis of economic 

impacts set out in the preceding 

analysis of economic impacts and in the 

preamble to the interim final rule at 68 

FR 58894 at 58954. 

V. Unfunded Mandates 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4) 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 (adjusted 

annually for inflation) in any one year.’’

The current threshold after adjustment 

for inflation is $115 million, using the 

most current (2003) Implicit Price 

Deflator for the Gross Domestic Product. 

FDA does not expect this final rule to 

result in any one-year expenditure that 

would meet or exceed this amount. 

VI. Federalism Analysis 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the final 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 concludes that the final 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. The Paperwork Reduction Act of 

1995 

This final 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 (44 U.S.C. 3501–

3520). The title, description, and 

respondent description of the 

information collection provisions and 

an estimate of the annual reporting 

burden were provided in the interim 

final rule issued October 10, 2003 (68 

FR 58894). Included in the estimate was 

the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. The final 

rule requires no new information 

collection. Individuals and 

organizations may submit comments on 

the burden estimates or on any other 

aspect of these information collection 

provisions, including suggestions for 

reducing the burden, and should direct 

them to the contact person identified in 

the FOR FURTHER INFORMATION CONTACT

section of this document. The 

information collection provisions in this 

final rule have been approved under 

OMB control number 0910–0502. This 

approval expires October 31, 2006. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. 

VIII. Analysis of Environmental Impact 

The agency 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. 

List of Subjects 

21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

21 CFR Part 20 

Confidential business information, 

Courts, Freedom of information, 

Government employees. 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

PART 20—PUBLIC INFORMATION 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, the interim rule 

amending 21 CFR parts 1 and 20, which 

was published at 68 FR 58894 (October 

10, 2003) and amended at 69 FR 29428 

(May 24, 2004), is adopted as a final rule 

without change. 

Dated: August 28, 2005. 

Michael Chertoff, 

Secretary of Homeland Security. 

Dated: September 20, 2005. 

Michael O. Leavitt, 

Secretary of Health and Human Services. 

[FR Doc. 05–19730 Filed 9–28–05; 1:53 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9226] 

RIN 1545–BD27 

Stock Held by Foreign Insurance 

Companies 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains final 

regulations relating to the determination 

of income of foreign insurance 

companies that is effectively connected 

with the conduct of a trade or business 

within the United States. The 

regulations provide that the exception to 

the asset-use test for stock shall not 

apply in determining whether the 

income, gain, or loss from portfolio 

stock held by foreign insurance 

companies constitutes effectively 

connected income. 

DATES: Effective Date: These regulations 

are effective on October 3, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Ramaswamy, (202) 622–3870 (not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

On June 25, 2004, a notice of 

proposed rulemaking (REG–117307–04) 

was published in the Federal Register 

(69 FR 35543). No requests for a public 

hearing were received, and no public 

hearing was held. The IRS received one 

written comment in response to the 

notice of proposed rulemaking. After 

consideration of the comment, the 

proposed regulation is adopted without 

change. 

Explanation of Provisions and 

Summary of Comments 

This Treasury decision adopts the 

language of the proposed regulation 

without change. 

The IRS received one comment in 

response to the proposed regulation. 

The commentator requested further 

clarification regarding what constitutes