50584 Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Eurocopter Emergency Alert Service 

Bulletin No. 04A009, Revision 1, dated June 

24, 2009. 

(ii) Eurocopter Service Bulletin No. 25– 

095, dated June 25, 2009. 

(3) For service information identified in 

this AD, contact American Eurocopter 

Corporation, 2701 N. Forum Drive, Grand 

Prairie, Texas 75052, telephone (972) 641– 

0000 or (800) 232–0323, fax (972) 641–3775, 

or at http://www.eurocopter.com/techpub. 

(4) You may review the referenced service 

information at the FAA, Office of the 

Regional Counsel, Southwest Region, 2601 

Meacham Blvd., Room 663, Fort Worth, 

Texas 76137. 

(5) You may also review copies of this 

service information that is incorporated by 

reference at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call (202) 741–6030, or go 

to: http://www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Fort Worth, Texas, on July 26, 

2012. 

Kim Smith, 

Manager, Rotorcraft Directorate, Aircraft 

Certification Service. 

[FR Doc. 2012–20342 Filed 8–21–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 400 

[Docket No.: FAA–2012–0318; Amdt. No. 

400–4] 

RIN 2120–AJ84 

Voluntary Licensing of Amateur 

Rocket Operations 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Direct final rule; request for 

comments. 

SUMMARY: The FAA is amending the 

scope of its regulations to allow launch 

operators that conduct certain amateur 

rocket launches an opportunity to 

voluntarily apply for a commercial 

space transportation license or 

experimental permit. 

DATES: Effective October 9, 2012. 

Submit comments on or before 

September 21, 2012. If adverse comment 

is received, the FAA will publish a 

timely withdrawal in the Federal 

Register. 

ADDRESSES: You may send comments 

identified by docket number FAA– 

2012–0318 using any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30; U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: The FAA will post all 

comments it receives, without change, 

to http://www.regulations.gov, including 

any personal information the 

commenter provides. Using the search 

function of the docket Web site, anyone 

can find and read the electronic form of 

all comments received into any FAA 

docket, including the name of the 

individual sending the comment (or 

signing the comment for an association, 

business, labor union, etc.). DOT’s 

complete Privacy Act Statement can be 

found in the Federal Register published 

on April 11, 2000 (65 FR 19477–19478), 

as well as at http://DocketsInfo.dot.gov. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions, contact Shirley 

McBride, Senior Transportation 

Industry Analyst, Regulations and 

Analysis Division, AST–300, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–7470; facsimile (202) 267–5463; 

email Shirley.McBride@faa.gov. 

For legal questions, contact Laura 

Montgomery, Senior Attorney for 

Commercial Space Transportation, 

Office of the Chief Counsel, Regulations 

Division, AGC–200, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone (202) 267–3150; facsimile 

(202) 267–7971, email 

laura.montgomery@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA’s authority to issue rules on 

commercial space transportation safety 

is found in Title 49 of the United States 

Codes, section 322(a), which authorizes 

the Secretary of Transportation to carry 

out Subtitle V, Chapter 509, 51 U.S.C. 

50901–50923, popularly referred to as 

the Commercial Space Launch Act or 

the CSLA. The CSLA authorizes the 

Department of Transportation (DOT) 

and thus the FAA, through delegations, 

to oversee, license, and regulate 

commercial launch and reentry 

activities, and the operation of launch 

and reentry sites as carried out by U.S. 

citizens or within the United States. 51 

U.S.C. 50904, 50905. The CSLA directs 

the FAA to exercise this responsibility 

consistent with public health and safety, 

safety of property, and the national 

security and foreign policy interests of 

the United States. 51 U.S.C. 50905. The 

FAA is also responsible for encouraging, 

facilitating, and promoting commercial 

space launches by the private sector. 51 

U.S.C. 50903. 

Direct Final Rule Procedure 

A direct final rule is a quicker way to 

issue rules that are not controversial. It 

is based on the Administrative 

Procedure Act’s good cause exception to 

notice and comment procedures. 5 

U.S.C. 553. We use this exception where 

we have found the public comment 

procedures to be unnecessary because 

we do not expect to receive adverse 

comment. It involves publishing a rule 

in the Federal Register with a statement 

that, unless we receive an adverse 

comment on the rule (or a notice of 

intent to file an adverse comment) 

within the comment period, the rule 

will become effective on a specified 

date. Normally, the effective date of a 

direct final rule is at least 30 calendar 

days after the end of the comment 

period. 

Adverse Comment 

An adverse comment explains why a 

rule would be inappropriate, or would 

be ineffective or unacceptable without a 

change. It may challenge the rule’s 

underlying premise or approach. In 

determining whether an adverse 

comment is significant enough to end a 

rulemaking, we consider whether the 

comment raises an issue that would 

warrant a substantive response in a 

notice of proposed rulemaking (NPRM). 

If we do not receive an adverse 

comment (or notice of intent to file an 

adverse comment), we publish a 

confirmation document in the Federal 

Register, generally within 30 calendar 

days after the comment period closes. 


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Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 50585 

1Class 3 as defined by § 101.22. 

2Amateur rocket as defined by § 1.1. 

3See 14 CFR 101.22. 

4NASA Calls for Commercial Suborbital Flight 

Services Proposals, Release 11–170. 

5NASA Selects Seven Firms To Provide NearSpace Flight Services, Release 11–258. 

6 51 U.S.C. 50914—Liability Insurance and 

Financial Responsibility requirements. 

The confirmation document tells the 

public the effective date of the direct 

final rule. 

If we do receive an adverse comment 

(or notice of intent to file an adverse 

comment), we publish a Notice of 

Withdrawal in the Federal Register 

before the effective date of the direct 

final rule. The document may withdraw 

the direct final rule in whole or in part. 

We may incorporate the commenter’s 

recommendation into another direct 

final rule or we may publish an NPRM. 

The Direct Final Rule 

The FAA anticipates that this 

regulation will not result in adverse or 

negative comment since its application 

is strictly voluntary. Therefore, the 

agency is issuing it as a direct final rule. 

This rule allows an operator of a Class 

3 1 amateur rocket 2 to voluntarily apply 

for a license or experimental permit 

under chapter III. Because these 

applications are purely voluntary, there 

should be no adverse effects of this rule. 

Operators of Class 3 amateur rockets 

who do not wish to apply for a license 

or permit need not do so. Such 

operators would continue to operate as 

they do now under part 101. 

Comments Invited 

The Regulatory Policies and 

Procedures of the Department of 

Transportation (DOT) (44 FR 1134; 

February 26, 1979) provide that to the 

maximum extent possible, operating 

administrations for the DOT should 

provide an opportunity for public 

comment on regulations issued without 

prior notice. Accordingly, the FAA 

invites interested persons to participate 

in this rulemaking by submitting written 

comments, data, or views. The agency 

also invites comments relating to the 

economic, environmental, energy, or 

federalism impacts that might result 

from adopting this final rule. The most 

helpful comments reference a specific 

portion of the document, explain the 

reason for any recommended change, 

and include supporting data. To ensure 

the docket does not contain duplicate 

comments, please send only one copy of 

written comments, or if filing comments 

electronically, please submit your 

comments only one time. 

The FAA will file all comments we 

receive in the docket, as well as a report 

summarizing each substantive public 

contact with FAA personnel concerning 

this rulemaking. Before acting on this 

direct final rule, the FAA will consider 

all comments received on or before the 

closing date for comments. The agency 

will consider comments filed after the 

comment period has closed if it is 

possible to do so without incurring 

expense or delay. The FAA may change 

this direct final rule in light of the 

comments we receive. 

Proprietary or Confidential Business 

Information 

Do not file in the docket information 

that you consider to be proprietary or 

confidential business information. Send 

or deliver this information directly to 

the person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

document. Mark the information that is 

considered proprietary or confidential. 

If the information is on a disk or CD 

ROM, mark the outside of the disk or CD 

ROM and also identify electronically 

within the disk or CD ROM the specific 

information that is proprietary or 

confidential. 

Under 14 CFR 11.35(b), when the 

FAA is aware of proprietary information 

filed with a comment, the agency does 

not place it in the docket. The FAA 

holds it in a separate file to which the 

public does not have access, and the 

agency places a note in the docket that 

it has received it. If the FAA receives a 

request to examine or copy this 

information, the FAA treats it as any 

other request under the Freedom of 

Information Act, 5 U.S.C. 552. The FAA 

processes such a request under the DOT 

procedures found in 49 CFR part 7. 

Availability of Rulemaking Documents 

You can get an electronic copy using 

the Internet by: 

(1) Searching the Federal 

eRulemaking portal at http:// 

www.regulations.gov; 

(2) Visiting the FAA’s Regulations and 

Policies web page at http:// 

www.faa.gov/regulations_policies/; or 

(3) Accessing the Government 

Printing Office’s web page at http:// 

www.gpo.gov/fdsys/. 

You can also get a copy by sending a 

request to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. Make sure to 

identify the docket and amendment 

numbers of this rulemaking. 

Background 

Currently, the FAA’s commercial 

space regulations specify that the 

requirements in chapter III do not apply 

to amateur rockets activities. This direct 

final rule amends § 400.2 of chapter III 

to allow operators of Class 3 amateur 

rockets to voluntarily apply to the FAA 

for a license or experimental permit. 

Chapter III contains the requirements 

that apply to commercial space 

transportation activities conducted in 

the United States or by a United States 

citizen. Section 400.2 (Scope) states that 

the requirements of chapter III do not 

apply to amateur rocket activities. 

Section 1.1 of chapter I defines an 

amateur rocket as an unmanned rocket 

propelled by a motor or motors having 

a combined total impulse of 889,600 

Newton-seconds (200,000 poundseconds) or less; and cannot reach an 

altitude greater than 150 kilometers 

(93.2 statute miles) above the earth’s 

surface. 

In 2008, the FAA amended its 

regulations governing amateur rocket 

activities to create three separate classes 

of amateur rockets.3

• Class 1 Model Rocket—Uses no 

more than 125 grams (4.4 ounces) of 

propellant; uses a slow-burning 

propellant; is made of paper, wood, or 

breakable plastic; contains no 

substantial metal parts; and weighs no 

more than 1,500 grams (53 ounces), 

including the propellant. 

• Class 2 High-Power Rocket—An 

amateur rocket other than a model 

rocket that is propelled by a motor or 

motors having a combined total impulse 

of 40,960 Newton-seconds (9,208 

pound-seconds) or less. 

• Class 3 Advanced High-Power 

Rocket—An amateur rocket other than a 

model rocket or high-powered rocket. 

On May 26, 2011, The National 

Aeronautics and Space Administration 

(NASA) issued Release 11–170,4 which 

sought proposals for services from 

commercial suborbital flight providers 

and others to support the agency’s 

Flight Opportunities Program. This 

program combines NASA’s Facilitated 

Access to the Space Environment for 

Technology and Commercial Reusable 

Suborbital Research efforts. 

On August 9, 2011, NASA issued 

Release 11–258 5 in which it selected 

seven companies to support its Flight 

Opportunities Program through 

launches to near space. In order for the 

financial responsibility requirements of 

the CSLA 6 to apply, NASA has required 

these operators to be licensed by the 

FAA. The suborbital launches under the 

NASA program typically involve 

smaller launch vehicles, some of whose 

launches would satisfy the amateur 

rocket definition, and thus would fall 


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50586 Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 

7Allentown Mack Sales & Serv. v. NLRB, 522 U.S. 

359, 373–74 (1998); United States v. Nixon, 418 

U.S. 683, 695–96 (1974); Nat’l Family Planning & 

Reprod. Health Ass’n v. Sullivan, 979 F.2d 227, 

235–41 (D.C. Cir. 1992). 8 51 U.S.C. 50901(a)(7), 50903(b). 

9Although NASA does not require a permit, the 

FAA sees no need to distinguish between the two 

authorizations. 

10 51 U.S.C. 50919(g). 

outside the scope of the FAA’s space 

transportation regulations in chapter III. 

At least one amateur rocket operator 

has sought to obtain an FAA license. 

The operator said it will not change its 

operational profile to otherwise fall 

within the authority of chapter III 

regulations. Without a rulemaking, the 

FAA may not entertain applications for 

the licensing or permitting of amateur 

rocket activities.7

The CSLA provides that the United 

States should encourage private sector 

launches, reentries, and associated 

services and, only to the extent 

necessary, regulate those launches to 

ensure compliance with international 

obligations of the United States and to 

protect the public health and safety, 

safety of property, and national security 

and foreign policy interests of the 

United States.8 Thus, because a license 

is necessary for a launch operator to be 

eligible for the NASA program, it is 

appropriate to issue this direct final rule 

to allow operators of specified amateur 

rockets to voluntarily submit an 

application for a chapter III license or 

experimental permit.9

This direct final rule amends § 400.2 

to allow operators of Class 3 amateur 

rockets to voluntarily apply to the FAA 

for a license or permit. 

New Requirements 

To accommodate NASA’s interest in 

funding only licensed launches, the 

FAA will allow launches of sufficient 

size to voluntarily apply for an FAA 

license and, therefore, fall under the 

financial responsibility requirements of 

the CSLA. The changes do not apply to 

launches involving a Class 1 or Class 2 

amateur rocket. Instead, they only apply 

to launch activities related to a Class 3 

amateur rocket. The FAA will not solicit 

such applications, because solicitation 

would call into question whether the 

application was, in fact, voluntary. 

Also, this rule only permits voluntary 

applications for a license from entities 

that are not part of the U.S. Government. 

The CSLA does not apply to activities 

the U.S. Government conducts for the 

government, which means the FAA does 

not have the authority to consider even 

voluntary applications for a license from 

other Federal agencies.10

Further, a prospective applicant must 

keep in mind that once it applies for 

and accepts an FAA license or permit, 

part 101 will not apply and the 

requirements of chapter III will apply to 

and govern its operations. These 

requirements govern not only the 

operational safety requirements of 

chapter III, but also requirements 

applicable to financial responsibility, 

the signing of reciprocal waivers of 

claims, environmental impacts, and 

civil penalties. 

Paperwork Reduction Act 

Information collection requirements 

in the amendment to the Commercial 

Space Transportation Licensing 

Regulations have been previously 

approved by the Office of Management 

and Budget (OMB) under the provisions 

of the Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)), and assigned OMB 

Control Number 2120–0608. This final 

rule allows launch operators that 

conduct certain amateur rockets 

launches an opportunity to voluntarily 

apply for a commercial space 

transportation license or experimental 

permit. 

Regulatory Evaluation, Regulatory 

Flexibility Determination, International 

Trade Impact Assessment, and 

Unfunded Mandates Assessment 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 and 

Executive Order 13563 directs that each 

Federal agency shall propose or adopt a 

regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

Second, the Regulatory Flexibility Act 

of 1980 (Pub. L. 96–354) requires 

agencies to analyze the economic 

impact of regulatory changes on small 

entities. Third, the Trade Agreements 

Act (Pub. L. 96–39) prohibits agencies 

from setting standards that create 

unnecessary obstacles to the foreign 

commerce of the United States. In 

developing U.S. standards, this Trade 

Act requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this direct final 

rule. We suggest readers seeking greater 

detail read the full regulatory 

evaluation, a copy of which we have 

placed in the docket for this rulemaking. 

In conducting these analyses, FAA 

has determined that this final rule: (1) 

Has benefits that justify its costs, (2) is 

not an economically ‘‘significant 

regulatory action’’ as defined in section 

3(f) of Executive Order 12866, (3) is not 

‘‘significant’’ as defined in DOT’s 

Regulatory Policies and Procedures; (4) 

will not have a significant economic 

impact on a substantial number of small 

entities; (5) will not create unnecessary 

obstacles to the foreign commerce of the 

United States; and (6) will not impose 

an unfunded mandate on state, local, or 

tribal governments, or on the private 

sector by exceeding the threshold 

identified above. These analyses are 

summarized below. 

Total Benefits and Costs 

The FAA does not require licensing of 

amateur rocket operators, who may 

continue to operate as before, without 

incurring the cost of obtaining a license. 

The FAA notes that an operator’s 

customers, including other agencies 

such as NASA, may require a license for 

an amateur rocket operator who wishes 

to provide launch services or to 

participate in programs, such as NASA’s 

Flight Opportunities Program. Since this 

license is not an FAA requirement, the 

FAA attributes the costs of operator 

compliance to the customer, not to this 

rule. Whenever a license or permit is 

issued, the FAA will incur a cost to 

produce the authorization. Operators 

who choose to obtain a license under 

this rule will also incur costs although 

we do not attribute these costs to the 

rule, because they are voluntary. 

The estimated cost associated with 

issuing licenses and experimental 

permits under this rule is $1.8 million 

($1.5 million present value using a 7 

percent discount rate and $ 1.7 million 

present value using a 3 percent discount 

rate) over 5 years for the cost to the 

government. Operator benefits are 

expected to equal or exceed their costs. 

The FAA is not able to quantify other 

societal benefits of this rule. To the 

extent the licensing requirements 

provide a societal benefit, those 

benefits, including any reduction in 

risk, may attend this rule. Those 

benefits are not quantifiable for launch 

vehicles of this size, but the benefits are 

present. 

Who is potentially affected by this rule? 

• Launch operators who would like to 

launch amateur rocket vehicles under a 

license or permit 

• Customers, including NASA 

• FAA 


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11NASA’s Flight Opportunities Program (FOP) 

has awarded contracts to seven operators. We find 

it reasonable to assume that in the first 2 years after 

the rule publishes, three amateur rocket licenses 

will be granted. Two more amateur rocket operators 

not involved with the FOP have inquired into the 

possibility of obtaining voluntary licenses for 

research and development and demonstration 

launches. It is reasonable to estimate that the FAA 

could issue up to 10 amateur rocket licenses in the 

first 5 years. 

Assumptions 

• All monetary values are expressed 

in 2011 dollars. 

• The time horizon for the analysis is 

5 years because this time period 

captures all of the relevant costs. 

• Present value costs are estimated at 

7 percent and 3 percent. 

• Hourly burdened government rate is 

$51.72. 

• Ten operator licenses for amateur 

rocket launches will be issued over the 

first 5 years.11

• Operator licenses for reusable 

launch vehicles are valid for 2 years. 

• Operators will begin license 

renewal process for each license the 

second year of the license. 

• Operators will renew with 

amendments to include additional 

configurations. 

• Cost of these renewals will be 70 

percent of the cost of the original license 

because configurations will be 

expanded beyond original license. 

• There will be multiple launches per 

year. 

• We assume amateur rocket 

operators who choose to obtain a license 

will decide to launch from a licensed 

launch site which will already have a 

completed environmental review or 

which will have a government grant for 

preparing an environmental review. 

This would result in minimal costs. 

Benefits 

Because the rule is voluntary, the 

FAA does not require amateur operators 

to obtain a license. Amateur rocket 

operators will choose to obtain an FAA 

license in order to launch rockets only 

if their expected benefits exceed their 

costs. An operator will seek a license 

only if the costs of obtaining a license 

are worth it. Any benefit to the operator 

associated with having a license will be 

realized only after an operator has 

incurred the cost of obtaining a license. 

This rule encourages rocket launches, 

which is consistent with the FAA 

mission. The FAA is not able to quantify 

other societal benefits of this rule, other 

than to note the expected benefits 

exceed the expected costs. 

Costs Associated With Licenses 

Although the FAA does not attribute 

such costs to this rule, the FAA notes 

that amateur rocket operators would 

incur costs to submit the data and 

analyses to the FAA for a license or 

experimental permit and for the cost of 

third party liability insurance. 

Assuming 10 licenses are issued in the 

first 5 years, operators will voluntarily 

expend a total of $2 million ($1.66 

million present value using a 7 percent 

discount rate and $ 1.85 million present 

value using a 3 percent discount rate) 

over 5 years for licenses. These costs are 

presented in the table below: 

The FAA would incur the cost of 

reviewing and processing the materials 

that the operators submit for a license or 

experimental permit. These costs are 

presented in the table below: 


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50588 Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Rules and Regulations 

Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives of the rule and of 

applicable statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide-range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. Agencies 

must perform a review to determine 

whether a rule will have a significant 

economic impact on a substantial 

number of small entities. If the agency 

determines that it will, the agency must 

prepare a regulatory flexibility analysis 

as described in the RFA. 

However, if an agency determines that 

a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) of the RFA provides that 

the head of the agency may so certify 

and a regulatory flexibility analysis is 

not required. The certification must 

include a statement providing the 

factual basis for this determination, and 

the reasoning should be clear. 

The FAA believes that this final rule 

will not have a significant impact on a 

substantial number of entities for the 

following reasons: The rule is voluntary 

and does not create costs on operators. 

Also, operators of amateur rockets 

would not willingly obtain licenses or 

experimental permits if the costs were 

to exceed the expected benefits. 

Therefore, as the Acting FAA 

Administrator, I certify that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

International Trade Impact Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended by the 

Uruguay Round Agreements Act (Pub. 

L. 103–465), prohibits Federal agencies 

from establishing standards or engaging 

in related activities that create 

unnecessary obstacles to the foreign 

commerce of the United States. 

Pursuant to these Acts, the 

establishment of standards is not 

considered an unnecessary obstacle to 

the foreign commerce of the United 

States, so long as the standard has a 

legitimate domestic objective, such as 

the protection of safety, and does not 

operate in a manner that excludes 

imports that meet this objective. The 

statute also requires consideration of 

international standards and, where 

appropriate, that they be the basis for 

U.S. standards. The FAA has assessed 

the potential effect of this final rule and 

determined that it will have only a 

domestic impact and therefore will not 

create unnecessary obstacles to the 

foreign commerce of the United States. 

Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more (in 

1995 dollars) in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector; such 

a mandate is deemed to be a ‘‘significant 

regulatory action.’’ The FAA currently 

uses an inflation-adjusted value of 

$143.1 million in lieu of $100 million. 

This direct final rule does not contain 

such a mandate; therefore, the 

requirements of Title II of the Act do not 

apply. 

Executive Order 13132, Federalism 

The FAA has analyzed this final rule 

under the principles and criteria of 

Executive Order 13132, Federalism. We 

determined that this action will not 

have a substantial direct effect on the 

States, or the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Therefore, we 

determined that this final rule does not 

have federalism implications. 

Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

Chapter 3, paragraph 312d, governing 

rulemakings such as this, and involves 

no extraordinary circumstances. 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use 

The FAA has analyzed this final rule 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use, 66 FR 28355 (May 

18, 2001). We have determined that it is 

not a ‘‘significant energy action’’ under 

the executive order because it is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866, and it is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

List of Subjects in 14 CFR Part 400 

Commercial space transportation, 

Licensing, Reporting and recordkeeping 

requirements. 


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The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends chapter III of Title 14, Code of 

Federal Regulations as follows: 

PART 400—BASIS AND SCOPE 

■ 1. The authority citation for part 400 

continues to read as follows: 

Authority: 51 U.S.C. 50901–50923. 

■ 2. Revise § 400.2 to read as follows: 

§ 400.2 Scope. 

These regulations set forth the 

procedures and requirements applicable 

to the authorization and supervision 

under 51 U.S.C. Subtitle V, chapter 509, 

of commercial space transportation 

activities conducted in the United States 

or by a U.S. citizen. The regulations in 

this chapter do not apply to— 

(a) Space activities carried out by the 

United States Government on behalf of 

the United States Government; or 

(b) The launch of an amateur rocket 

as defined in § 1.1 of chapter I unless— 

(1) The rocket is a Class 3 advanced 

high-power rocket as defined in § 101.22 

of chapter I; and 

(2) The operator of the Class 3 

advanced high-power rocket voluntarily 

submits an application for a license or 

a permit. 

Issued in Washington, DC, on July 31, 

2012. 

Michael P. Huerta, 

Acting Administrator. 

[FR Doc. 2012–20671 Filed 8–21–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 20 

[Docket No. FDA–2012–N–0205] 

Agreements and Memoranda of 

Understanding Between the Food and 

Drug Administration and Other 

Departments, Agencies, and 

Organizations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: This final rule makes 

technical changes that will update a 

requirement that many of the written 

agreements and memoranda of 

understanding (MOUs) between the 

Food and Drug Administration (FDA) 

and other departments, Agencies, and 

organizations be published in the 

Federal Register. Because we already 

post and will continue to post our 

ongoing agreements and MOUs with 

other departments, Agencies, and 

organizations on our Web site upon 

their completion, this requirement is no 

longer necessary. This final rule, 

accordingly, eliminates it. We are 

making these technical changes to 

conserve Agency time and resources, 

reduce government paperwork, and 

eliminate unnecessary Federal Register 

printing costs while continuing to afford 

public access to these documents. 

DATES: This rule is effective October 22, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Daniel W. Sigelman, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4706, FAX: 301–847–8616, 

daniel.sigelman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Rulemaking Procedure 

In the Federal Register of March 23, 

2012 (77 FR 16923), FDA published a 

direct final rule to eliminate the 

requirement that many of our written 

agreements and MOUs with other 

departments, Agencies, and 

organizations be published in the 

Federal Register. We explained that we 

issued this rule as a direct final rule 

because we believed it was 

noncontroversial and did not anticipate 

receiving significant adverse comments. 

We concurrently published in the 

Federal Register of March 23, 2012 (77 

FR 16971) a companion proposed rule, 

substantively identical to the direct final 

rule, that provided a procedural 

framework from which to proceed with 

standard notice-and-comment 

rulemaking in the event we were 

required to withdraw the direct final 

rule because of significant adverse 

comments. 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. Any 

comments received under the 

companion proposed rule were treated 

as comments regarding the direct final 

rule and vice versa. 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). This guidance document may be 

accessed at http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

We received one comment on the 

proposed rule, which we considered 

significantly adverse. Therefore, in the 

Federal Register of June 27, 2012 (77 FR 

38173), we withdrew the direct final 

rule. This final rule summarizes and 

responds to this comment on the direct 

final rule and proposed rule. See section 

IV of this document for a discussion of 

the comment and FDA’s response. 

II. Background 

In the Federal Register of October 3, 

1974 (39 FR 35697), we announced that 

copies of all our MOUs transacted with 

government Agencies and 

nongovernment organizations were 

available for public review at our offices 

during working hours and would be 

published in the Federal Register. We 

subsequently codified this policy in the 

Federal Register of December 24, 1974 

(39 FR 44602 at 44651) and recodified 

it where it currently appears at § 20.108 

(21 CFR 20.108) in the Federal Register 

of March 22, 1977 (42 FR 15616 at 

15625). 

Consumers, industry, professional 

groups, associations, educators, and 

other government Agencies had 

manifested widespread interest in the 

texts of these MOUs. The intent of 

§ 20.108 was to promote transparency 

by providing access to these 

stakeholders. 

III. Summary of the Final Rule 

This final rule will eliminate the 

requirement in current § 20.108(c) that 

our agreements and MOUs with other 

departments, Agencies, and 

organizations be published in the 

Federal Register on an individual basis 

and instead will require that they be 

posted on our Web site as completed. 

We increasingly rely on Internet-based 

communications to ensure and promote 

transparency in our operations and 

activities. So it is with this final rule, 

which merely recognizes and codifies 

our already established practice of 

making our ongoing agreements and 

MOUs with other departments, 

Agencies, and organizations publicly 

available on our Web site. At the time 

of this writing, each such publicly 

disclosable agreement and MOU can be 

accessed at one of the following three 

FDA Web site locations: http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 

MemorandaofUnderstandingMOUs/ 

DomesticMOUs/default.htm; http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 

MemorandaofUnderstandingMOUs/ 

AcademiaMOUs/default.htm; or http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 


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