50740 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules 

be exhibited, at any location other than 

their designated primary facility. 

Estimated annual number of 

respondents: 300. 

Estimated annual number of 

responses per respondent: 8.66. 

Estimated annual number of 

responses: 2,600. 

Estimated total annual burden on 

respondents: 650 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

Copies of this information collection 

can be obtained from Mrs. Celeste 

Sickles, APHIS Information Collection 

Coordinator, at (301) 851–2908. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this proposed rule, please contact 

Mrs. Celeste Sickles, APHIS Information 

Collection Coordinator, at (301) 851– 

2908. 

List of Subjects in 9 CFR Part 2 

Animal welfare, Pets, Reporting and 

recordkeeping requirements, Research. 

Accordingly, we propose to amend 9 

CFR part 2 as follows: 

PART 2—REGULATIONS 

1. The authority citation for part 2 

continues to read as follows: 

Authority: 7 U.S.C. 2131–2159; 7 CFR 2.22, 

2.80, and 371.7. 

2. In § 2.126, the section heading is 

revised and a new paragraph (c) is 

added to read as follows: 

§ 2.126 Access and inspection of records 

and property; submission of itineraries. 

* * * * * 

(c) Any person who is subject to the 

Animal Welfare regulations and who 

intends to exhibit any animal at any 

location other than the person’s 

approved site(s) (including, but not 

limited to, circuses, traveling 

educational exhibits, animal acts, and 

petting zoos) shall submit a written 

itinerary to the Animal Care Regional 

Director. The itinerary shall be received 

by the Animal Care Regional Director no 

fewer than 2 days in advance of any 

travel and shall contain complete and 

accurate information concerning the 

whereabouts of any animal(s) intended 

for exhibition at any location other than 

the person(s) approved site(s). 

(1) The itinerary shall include the 

following: 

(i) The name(s) of the person(s) who 

intends to exhibit the animal(s) and 

transport the animal(s) for exhibition 

purposes, including any business 

name(s) and current AWA license or 

registration number(s) and, in the event 

that any animal is leased, borrowed, 

loaned, or under some similar 

arrangement, the name of the person 

who owns such animal; 

(ii) The name, identification number 

or identifying characteristics, species 

(common or scientific name), sex and 

age of each animal; and 

(iii) The names, dates, and locations 

(with addresses), where the animals will 

travel, be housed, and be exhibited, 

including all anticipated dates and 

locations (with addresses) for any stops 

and layovers. 

(2) The itinerary shall be promptly 

revised, as necessary, to account for any 

changes. 

Done in Washington, DC, this 25th day of 

September 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–23679 Filed 9–30–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

15 CFR Part 922 

[Docket No. 0907301210–91239–01] 

RIN 0648–AX83 

Gulf of the Farallones and Monterey 

Bay National Marine Sanctuaries 

Regulations on Introduced Species 

AGENCY: Office of National Marine 

Sanctuaries (ONMS), National Oceanic 

and Atmospheric Administration 

(NOAA), Department of Commerce 

(DOC). 

ACTION: Notice of proposed rulemaking; 

request for public comments. 

SUMMARY: The National Oceanic and 

Atmospheric Administration (NOAA) is 

proposing to revise its regulations on 

the introduction of introduced species 

into the Gulf of the Farallones and 

Monterey Bay national marine 

sanctuaries (GFNMS and MBNMS, 

respectively). This action is being taken 

in response to a letter received by the 

Governor of California on December 23, 

2008. The Governor certified that the 

terms of designation to regulate 

introduced species in these sanctuaries 

were unacceptable in State waters of the 

sanctuaries. In response to the 

Governor’s letter, NOAA is proposing to 

modify its regulations to except all 

State-permitted aquaculture activities in 

the two sanctuaries. 

DATES: Comments must be received by 

November 16, 2009. 

ADDRESSES: You may submit comments 

by any of the following methods: 

• Electronic submission (preferred 

method): http://www.regulations.gov 

(search for docket # NOAA–NOS–2009– 

0105). 

• Mail: John Armor, Office of 

National Marine Sanctuaries, 1305 EastWest Highway, Silver Spring, Maryland 

20910. 

Instructions: All comments received 

are a part of the public record and will 

be generally posted to http:// 

www.regulations.gov without change. 

All Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit confidential business 

information or otherwise sensitive or 

protected information. NOAA will 

accept anonymous comments (enter 

N/A in the required fields, if you wish 

to remain anonymous). Attachments to 

electronic comments will be accepted in 

Microsoft Word, Excel, WordPerfect, or 

Adobe PDF file formats only. 

FOR FURTHER INFORMATION CONTACT: John 

Armor, Office of National Marine 

Sanctuaries, 1305 East-West Highway, 

Silver Spring, MD 20910, or by phone 

at 301–713–3125. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. GFNMS and MBNMS Background 

NOAA established the GFNMS in 

1981 to protect and preserve a unique 

and fragile ecological community, 

including the largest seabird colony in 

the contiguous United States and 

diverse and abundant marine mammals. 

The GFNMS lies off the coast of 

California, to the west and north of San 

Francisco, and is composed of 1,279 

square statute miles (966 square nautical 

miles) of offshore waters and submerged 

lands thereunder. The sanctuary 

boundary extends out to and around the 

Farallon Islands and nearshore waters 

(up to the mean high water line) from 

Bodega Head to Rocky Point in Marin. 

For more information about the GFNMS, 

see http://farallones.noaa.gov. 

NOAA established the MBNMS in 

1992 for the purposes of protecting and 

managing the conservation, ecological, 


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recreational, research, educational, 

historical, and esthetic resources and 

qualities of the area. The MBNMS is 

located offshore of California’s central 

coast, adjacent to and south of the 

GFNMS. It encompasses a shoreline 

length of approximately 276 statute 

miles (240 nmi) between Rocky Pt. in 

Marin County and Cambria in San Luis 

Obispo County. The sanctuary spans 

approximately 6,094 square statute 

miles (4,602 square nautical miles) of 

ocean and coastal waters, and the 

submerged lands thereunder, extending 

an average distance of 30 statute miles 

(26 nmi) from shore. The Davidson 

Seamount is also part of the sanctuary, 

though it does not share a contiguous 

boundary. Supporting some of the 

world’s most diverse marine 

ecosystems, the MBNMS is home to 

numerous mammals, seabirds, fishes, 

invertebrates, sea turtles and plants in a 

remarkably productive coastal 

environment. For more information 

about the MBNMS, please see http:// 

montereybay.noaa.gov. 

B. Regulatory Background 

Pursuant to section 304(e) of the 

National Marine Sanctuaries Act (16 

U.S.C. 1434 et seq.) (NMSA), the Office 

of National Marine Sanctuaries (ONMS) 

conducted a joint review of the 

management plans for the Gulf of the 

Farallones, Monterey Bay and Cordell 

Bank national marine sanctuaries. This 

review resulted in revised management 

plans, regulations, and terms of 

designation for all three sanctuaries. On 

November 20, 2008, NOAA published 

the associated final rule and terms of 

designation (73 FR 70488) and released 

the revised management plans. 

Pursuant to section 304(b) of the 

National Marine Sanctuaries Act 

(NMSA), changes to a sanctuary’s terms 

of designation and the associated 

regulations do not become effective 

until after forty-five days of continuous 

session of Congress. After forty-five 

days, in this case on March 9, 2009, the 

regulations would become final and take 

effect, except that any term of 

designation the Governor certified as 

unacceptable would not take effect in 

the area of a sanctuary lying within the 

seaward boundary of the State (‘‘State 

waters’’). If exercised, the effect of a 

gubernatorial objection is that the 

term(s) of designation do not become 

effective in State waters. Any 

regulations that rely on the change in 

terms of designation also do not become 

effective in State waters. 

In the November 20, 2008 final rule, 

NOAA changed the terms of designation 

for the GFNMS and MBNMS to clearly 

allow regulation of introduced species. 

Pursuant to section 304(b) of the NMSA, 

the Governor could accept or reject 

those changes to the terms of 

designation. 

C. Certification by the Governor of 

California 

On December 23, 2008, during the 

forty-five day review period under the 

NMSA, the Governor of the State of 

California certified by letter to the 

Secretary of Commerce that certain 

terms of designation regarding 

regulation of the introduction of 

introduced species in State waters were 

unacceptable. The following is the text 

of the December 23, 2008, letter from 

the Governor of California to the United 

States Secretary of Commerce. 

December 23, 2008 

Honorable Carlos M. Gutierrez 

Secretary of Commerce 

1401 Constitution Avenue Northwest 

Washington, DC 20230. 

Dear Mr. Secretary: 

Since the designation of the Channel 

Islands National Marine Sanctuary in 1981, 

the National Oceanic and Atmospheric 

Administration’s Office of National Marine 

Sanctuaries (ONMS) and the State of 

California have been working together to 

ensure the protection of our special and 

unique national marine sanctuaries. 

California very much appreciates the strong 

working relationship we have with our 

Federal partners, and I think we’ve done a lot 

of good work together to protect our coastal 

and ocean resources and to educate 

Californians about the importance of these 

resources. 

In 2001, ONMS initiated a process to 

review and update the management plans 

and corresponding regulations of the three 

national marine sanctuaries off the California 

coast: Monterey Bay, Gulf of the Farallones 

and Cordell Bank. In October 2006, ONMS 

released the draft management plans and a 

draft environmental impact statement. In 

January 2007, the State of California 

submitted comments to ONMS. Since then, 

the State of California and ONMS have 

successfully resolved all concern regarding 

proposed regulations, with the exception of 

the following proposed regulations regarding 

introduced species: 

For Gulf of the Farallones National Marine 

Sanctuary § 922.82(10): 

Introducing or otherwise releasing from 

within or into the Sanctuary and introduced 

species except: 

(A) Striped bass (Morone saxatilis) released 

during catch and release fishing activity; or 

(B) Species cultivated by mariculture 

activities in Tomales Bay pursuant to a valid 

lease, permit, license or other authorization 

issued by the State of California and in effect 

on the effective date of the final regulation. 

For Monterey Bay National Marine 

Sanctuary § 922.132(12): 

Introducing or otherwise releasing from 

within or into the Sanctuary an introduced 

species, except striped bass (Morone 

saxatilis) released during catch and release 

fishing activity. 

We agree with ONMS’s assertion that 

introduced species can threaten our ocean 

and coastal ecosystems if not properly 

managed in the context of an aquaculture 

program. However, we object to the proposed 

regulations for several reasons: 

1. There is no authority in either State of 

Federal law for the proposition that all nonnative species are necessarily detrimental to 

native wildlife and must therefore be 

prohibited. 

2. The California State legislature has not 

granted any submerged lands to the Federal 

government that would enable a sanctuary to 

assert authority over aquaculture operations 

in State waters. 

3. The release of harmful non-native 

species is already controlled under State law, 

and any proposed introduction of non-native 

aquaculture species is subject to multiple 

agency review and to the California 

Environmental Quality Act. 

In our January 2007 comment letter, the 

State of California suggested the following 

changes to the proposed regulations 

(deletions noted in italics and additions in 

UPPERCASE font): 

For Gulf of the Farallones National Marine 

Sanctuary § 922.82(10): 

Introducing or otherwise releasing from 

within or into the Sanctuary and introduced 

species, except: 

(A) Striped bass (MORONE SAXATILIS) 

released during catch and release fishing 

activity; or 

(B) Species cultivated by mariculture 

activities in Tomales Bay pursuant to a valid 

lease, permit, license or other authorization 

issued by the State of California and in effect 

on the effective date of the final regulation. 

For Monterey Bay National Marine 

Sanctuary § 922.132(12): 

Introducing or otherwise releasing from 

within or into the Sanctuary and introduced 

species, except striped bass (MORONE 

SAXATILIS) released during catch and 

release fishing activity OR THROUGH 

MARICULTURE OR RESEARCH ACTIVITIES 

CONDUCTED PURSUANT TO A VALID 

LEASE, PERMIT, LICENSE OR OTHER 

AUTHORIZATION ISSUED BY THE STATE 

OF CALIFORNIA. 

These changes will allow us to protect 

sanctuary resources from introduced species 

without conflicting with State authority to 

manage aquaculture in State waters. 

Despite the concerns expressed by the 

State of California, ONMS included these 

proposed regulations in the final 

environmental impact statement dated 

September 15, 2008, and the notice in the 

Federal Register dated November 20, 2008. 

If ONMS in unable or unwilling to make 

the requested changes, I hereby use the 

authority given to me by the National Marine 

Sanctuaries Act (16 U.S.C. 1434(b)(1)) to 

certify that certain terms in the designation 

documents of the Gulf of the Farallones and 

Monterey Bay National Marine Sanctuaries 

are unacceptable. As a result, the 

unacceptable term of designation document 

shall not take effect in the area of the 

sanctuary lying within the seaward boundary 

of the State of California. 

For the Gulf of the Farallones National 

Marine Sanctuary, I certify that Article IV, 


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section 1(e) of the designation document is 

unacceptable. Article IV, section 1(e) reads, 

‘‘Introducing or otherwise releasing from 

within or into the Sanctuary an introduced 

species.’’ 

For the Monterey Bay National Marine 

Sanctuary, I certify that Article IV, section 

1(l) of the designation document is 

unacceptable. Article IV, section 1(l) reads, 

‘‘Introducing or otherwise releasing from 

within or into the Sanctuary an introduced 

species.’’ 

ONMS and the State of California have 

been working together for almost 30 years to 

ensure the protection of the national marine 

sanctuaries off California’s coast. In the spirit 

of this ongoing partnership, I urge ONMS to 

respect the State of California’s sovereign 

right to manage its resources in State waters, 

and I ask that ONMS make the requested 

changes in the Gulf of the Farallones and 

Monterey Bay National Marine Sanctuaries 

proposed regulations and designation 

documents. I look forward to continuing to 

work with you on this important issue. 

Sincerely, 

Arnold Schwarzenegger 

D. NOAA’s Response to the Governor 

In his letter, the Governor indicated 

that the State of California’s concerns 

were clearly articulated in its comments 

on the proposed rule (71 FR 59338, 

October 6, 2006). However, NOAA 

believes the State’s position on the 

introduced species regulation was not 

clear. During the comment period on the 

proposed rule, NOAA received 

comments from the California 

Department of Fish and Game (CDFG), 

the California Department of Boating 

and Waterways (CDBW), the California 

Coastal Commission (CCC), and 

California State Lands Commission. The 

CDFG and CDBW both opposed NOAA’s 

prohibition on the introduction of 

introduced species but the two 

commissions were either silent or 

explicitly supportive of it. To add 

further complexity to the State’s 

position, the CCC—exercising its 

authority under the Federal consistency 

provisions of the Coastal Zone 

Management Act—specifically, rejected 

the CDFGs requested change and stated 

that NOAA must maintain the 

prohibition on introduced species as it 

was written in the proposed rule or else 

the final regulations would not be 

consistent with the enforceable policies 

of the California Coastal Management 

Program, which NOAA complies with. 

Therefore, NOAA did not anticipate the 

State of California’s position on the 

matter when NOAA received the 

Governor’s objection letter after the final 

rule was issued. 

NOAA notes that the proposed and 

final regulations were drafted with a 

significant level of input from State 

agencies and commissions. The current 

language was developed following 

numerous consultations with State 

personnel when NOAA first began the 

process of changing the terms of 

designation and regulations for the 

sanctuaries. For example, during 

consultations with the State of 

California, concern was expressed that 

striped bass would qualify as an 

introduced species and that an angler 

who catches and then releases a striped 

bass to comply with State imposed site 

restrictions would be in violation of the 

proposed regulation. Because 

prohibiting such activity was not the 

intent of the regulation, to address this 

concern, NOAA drafted the regulation 

to except striped bass, the only 

introduced species for which there is an 

active fishery. 

After receiving the Governor’s letter, 

NOAA worked with staff from the 

California Natural Resources Agency 

and the California Department of Fish 

and Game to find solutions to the 

Governor’s concerns that would also 

meet NOAA’s goals. As such, NOAA 

agreed to modify the regulations on 

introduced species to except Statepermitted aquaculture in GFNMS. 

NOAA agreed to not enforce the 

invasive species provisions in the State 

waters of the GFNMS until NOAA could 

initiate a new rulemaking to consider 

the issue more closely and to consider 

public comment on the matter. 

NOAA did not agree, however, to 

allow the research exception involving 

the introduction of introduced species 

in the MBNMS, as the Governor 

requested. In subsequent discussions 

with the State, NOAA was not provided 

with a reason why such an exemption 

would be needed. Neither the Governor 

nor the agencies with which NOAA 

worked at the State of California 

provided any description of how this 

exception would be used, what types of 

research activities would qualify, or 

what the effect of it would be on 

sanctuary resources. 

NOAA noted to the State of 

California’s Natural Resources Agency 

that if, in the future, there were a 

research proposal that involved the 

introduction of introduced species, the 

regulations would still allow NOAA to 

issue a permit, in coordination with the 

relevant State agencies, that would 

allow the research project to proceed. 

Therefore, NOAA explained to the State, 

the potential consequences to the 

sanctuary of excepting research from the 

introduced species regulation far 

outweighed the potential administrative 

consequences of issuing a regulation 

that would require researchers to obtain 

a permit from NOAA for the 

introduction of introduced species. The 

State rejected this option and, because 

no compromise was attained, the 

Governor’s objection to the term of 

designation for the regulation of 

introduced species in the State waters of 

the MBNMS stands. As indicated in the 

notice of effective date (March 23, 2009; 

74 FR 12088), the regulation of the 

introduction of introduced species from 

within or into the MBNMS is valid and 

in effect in the area of the sanctuary 

lying beyond the seaward boundary of 

the State only. 

II. Summary of the Proposed Revisions 

to the Regulation of Introduction of 

Introduced Species in GFNMS 

The regulations for the GFNMS 

currently prohibit introducing or 

otherwise releasing from within or into 

the sanctuary (1) an introduced species, 

except striped bass (Morone saxatilis) 

released during catch and release 

fishing activity; and (2) species 

cultivated by mariculture activities in 

Tomales Bay pursuant to a valid lease, 

permit, license or other authorization 

issued by the State of California and in 

effect on the effective date of the final 

regulation. As proposed, the revised 

regulations for the GFNMS would 

remove the geographic reference to 

Tomales Bay and would revise the 

exception so as to allow the Statepermitted mariculture activities in the 

area of the sanctuary that is within the 

seaward boundary of the State. 

The term ‘‘introduced species’’ is 

defined as: (1) Any species (including, 

but not limited to, any of its biological 

matter capable of propagation) that is 

non-native to the ecosystems of the 

Sanctuary; or (2) any organism into 

which altered genetic matter, or genetic 

matter from another species, has been 

transferred in order that the host 

organism acquires the genetic traits of 

the transferred genes. 

NOAA issued this regulation due to 

the threats introduced species pose to 

endangered species and native species 

diversity. For example, a number of 

non-native species now found in the 

Gulf of the Farallones and Monterey Bay 

regions were introduced elsewhere on 

the west coast but have spread through 

vectors such as vessel hull-fouling, 

ballast water discharge, and accidental 

introductions. NOAA also stated that 

introduced species are a major 

economic and environmental threat to 

the living resources and habitats of a 

sanctuary as well as the commercial and 

recreational uses that depend on these 

resources. Once established, introduced 

species can be extremely difficult, if not 

impossible, to eradicate. Introduced 

species have become increasingly 

common in recent decades, and the rate 


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of invasions continues to accelerate at a 

rapid pace. Threatened and endangered 

species are particularly vulnerable to 

invasion. 

As such, NOAA continues to believe 

it is important to regulate the 

introduction of introduced species in a 

manner that is consistent with the 

sanctuary’s and NMSA’s goals. NOAA 

believes that the compromise language 

provided by the Governor of California 

would meet the objectives. Therefore, 

NOAA proposes to amend 

§ 922.82(a)(10) as requested by the 

Governor, to expand the geographic and 

temporal scope of the exception for 

introduced species through Statepermitted aquaculture in State waters. If 

adopted, these changes would change 

the geographic restriction of mariculture 

activities in Tomales Bay to all of the 

State waters. The new regulations 

would also remove the temporal 

component of the current regulations, 

allowing the State of California to issue 

additional permits for these activities. 

III. Summary of the Revisions to 

MBNMS Regulations 

In issuing the November 20, 2008 

final rule, NOAA revised the MBNMS 

terms of designation to modify the list 

of activities that may be regulated. As 

revised, the terms of designation clearly 

authorize the regulation of ‘‘introducing 

or otherwise releasing from within or 

into the sanctuary an introduced 

species.’’ This revision was intended to 

enable NOAA to more effectively and 

efficiently address new and emerging 

resource management issues, and was 

necessary in order to ensure protection, 

preservation, and management of the 

conservation, recreational, ecological, 

historical, cultural, educational, 

archeological, scientific, and esthetic 

resources and qualities of the MBNMS. 

However, this new term of designation 

does not apply to the State-waters part 

of the MBNMS due to the Governor’s 

objection. NOAA indicated this in the 

notice of effective date (March 23, 2009; 

74 FR 10488). As such, that specific 

term of designation should now read, 

‘‘introducing or otherwise releasing 

from within or into the Federal waters 

of the sanctuary an introduced species.’’ 

NOAA is proposing to modify the 

regulation associated with this term of 

designation to reflect the Governor of 

California’s certification of this term as 

unacceptable. 

NOAA proposes to update the 

regulations, at subpart M, § 922. 

132(a)(12), to conform with the 

Governor’s objection so the scope of this 

portion of the JMPR’s November 20, 

2008 final rule will only apply to the 

area of the Sanctuary lying beyond the 

seaward boundary of the State of 

California. 

IV. Miscellaneous Rulemaking 

Requirements 

A. National Marine Sanctuaries Act 

Section 301(b) of the National Marine 

Sanctuaries Act (16 U.S.C. 1434) 

provides authority for comprehensive 

and coordinated conservation and 

management of national marine 

sanctuaries in coordination with other 

resource management authorities. 

Section 304(a)(4) of the National Marine 

Sanctuaries Act requires the procedures 

specified in section 304 for designating 

a national marine sanctuary be followed 

for modifying any term of designation. 

This action does not propose to revise 

the terms of designation for either 

sanctuary. 

B. National Environmental Policy Act 

NOAA prepared a final environmental 

impact statement (FEIS) to evaluate 

regulating the introduction of 

introduced species off the California 

coast. NOAA identified a preferred 

action in that FEIS, but is now 

proposing to implement a different 

action based on the Governor’s letter of 

December 23, 2008. NOAA has analyzed 

the impacts of this action in the FEIS for 

the joint management plan review for 

the three national marine sanctuaries on 

the central California coast (availability 

of which was announced in the Federal 

Register on September 26, 2008; 73 FR 

55843). NOAA intends to issue a new 

record of decision (ROD) with regard to 

this action. Copies of the FEIS are 

available at http://sanctuaries.noaa.gov/ 

jointplan/feis/feis.html, or by contacting 

NOAA at the address listed in the 

Address section of this proposed rule. 

C. Executive Order 12866: Regulatory 

Impact 

This proposed rule has been 

determined to be not significant within 

the meaning of Executive Order 12866. 

D. Executive Order 13132: Federalism 

Assessment 

NOAA has concluded that this 

regulatory action falls within the 

definition of ‘‘policies that have 

federalism implications’’ within the 

meaning of Executive Order 13132. The 

changes will not preempt State law, but 

will simply update sanctuary 

regulations to comply with the 

Governor’s action. In keeping with the 

intent of the Executive Order, the 

NOAA consulted with a number of 

entities within the State which 

participated in development of the 

initial rule, including but not limited to, 

the California Department of Fish and 

Game, and the California Natural 

Resources Agency. 

E. Regulatory Flexibility Act 

The Chief Counsel for Regulation of 

the Department of Commerce certified 

to the Chief Counsel for Advocacy of the 

Small Business Administration this 

rule, if adopted, would not have a 

significant economic impact on a 

substantial number of small entities. 

The factual basis for this certification is 

as follows: 

Using the SBA’s Small Business Size 

Standards, NOAA determined that the 

small business concerns operating 

within the both of the sanctuaries 

include: Commercial fishermen who 

vary in number seasonally and annually 

from approximately 300 to 500 boats; 

twelve mariculture leaseholders in 

Tomales Bay (in GFNMS); 

approximately 25 recreational charterfishing businesses; and approximately 7 

recreational charter businesses engaged 

in wildlife viewing. The small 

organizations, as defined under 5 U.S.C. 

601(4), that would be impacted by this 

rule include approximately 3 small 

organizations operating within the 

GFNMS, which include nongovernmental organizations (NGOs) 

and/or non-profit organizations (NPOs) 

dedicated to environmental education, 

research, restoration, and conservation 

concerning marine and maritime 

heritage resources. The small 

governmental jurisdictions, as defined 

under 5 U.S.C. 601(5), that would be 

impacted by this rule are the Bodega, 

Bolinas and Tomales Bay settlements 

that are directly adjacent to the GFNMS. 

The prohibition on releasing or 

otherwise introducing from within or 

into the GFNMS and in the area of the 

MBNMS lying beyond the seaward 

boundary of the State an introduced 

species is not expected to significantly 

adversely impact small entities because 

this activity is not part of the business 

or operational practices associated with 

most of the small entities that would be 

impacted by this rule. Small entities 

whose operational practices may 

include catch and release of striped bass 

(Roccus saxatilis), (i.e., consumptive 

recreational charter businesses), would 

not be affected because the prohibition 

would not apply to the catch and release 

of fish already present in the 

sanctuaries. In fact, the prohibition 

against introduced species may result in 

indirect benefits for certain small 

entities since their activities could 

potentially be negatively impacted by 

the spread of introduced species. 

The mariculture leaseholders located 

adjacent to the GFNMS may, however, 

be potentially impacted by this 


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proposed rule. Under the current 

regulations, existing leaseholders are 

excepted from the introduced species 

prohibition if they have active lease 

agreements at the time of 

implementation of the regulation (the 

regulation took effect on March 9, 2009). 

Under the proposed rule for the 

GFNMS, this exemption will no longer 

contain a geographic restriction of 

Tomales Bay, and will no longer restrict 

new permits from being issued through 

the State (as opposed to through the 

ONMS). This prohibition would not put 

any current operations out of business, 

because they will not need to change 

anything about their current procedures 

to continue in their operations. A 

beneficial effect from this proposed 

action may result for existing and future 

lease holders, such as reduced 

administrative burden for issuance or 

renewal of a lease permit. Comments 

received on the economic impacts of 

this proposed rule will be summarized 

and responded to in the final rule. 

F. Paperwork Reduction Act 

This proposed rule does not contain 

information collections that are subject 

to the requirements of the Paperwork 

Reduction Act. Notwithstanding any 

other provision of the law, no person is 

required to respond to, nor shall any 

person be subject to a penalty for failure 

to comply with, a collection of 

information subject to the requirements 

of the PRA, unless that collection of 

information displays a currently valid 

OMB Control Number. 

V. Request for Comments 

NOAA requests comments on this 

proposed rule for 45 days after 

publication of this notice. 

List of Subjects in 15 CFR Part 922 

Administrative practice and 

procedure, Environmental protection, 

Fish, Harbors, Marine pollution, Marine 

resources, Natural resources, Penalties, 

Recreation and recreation areas, 

Research, Water pollution control, 

Water resources, Wildlife. 

Dated: September 24, 2009. 

William Corso, 

Deputy Assistant Administrator for Ocean 

Services and Coastal Zone Management. 

Accordingly, for the reasons set forth 

above, 15 CFR part 922 is amended as 

follows: 

PART 922—NATIONAL MARINE 

SANCTUARY PROGRAM 

REGULATIONS 

1. The authority citation for Part 922 

continues to read as follows: 

Authority: 16 U.S.C. 1431 et seq. 

Subpart H—Gulf of the Farallones 

National Marine Sanctuary 

2. Section 922.82(a)(10) is amended to 

read as follows: 

§ 922.82 Prohibited or otherwise regulated 

activities. 

(a) * * * 

(10) Introducing or otherwise 

releasing from within or into the 

Sanctuary an introduced species, 

except: 

(i) Striped bass (Morone saxatilis) 

released during catch and release 

fishing activity; or 

(ii) Species cultivated by a 

mariculture activity within the area of 

the sanctuary lying within the seaward 

boundary of the State of California and 

authorized by a valid lease, permit, 

license or other authorization issued by 

the State. 

* * * * * 

Subpart M—Monterey Bay National 

Marine Sanctuary 

3. Section 922.132(a)(12) is amended 

to read as follows: 

§ 922.132 Prohibited or otherwise 

regulated activities. 

(a) * * * 

(12) Introducing or otherwise 

releasing from within or into the area of 

the Sanctuary lying beyond the seaward 

boundary of the State of California an 

introduced species, except striped bass 

(Morone saxatilis) released during catch 

and release fishing activity. 

* * * * * 

[FR Doc. E9–23576 Filed 9–30–09; 8:45 am] 

BILLING CODE 3510–NK–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 4 

[Docket No. FDA–2008–N–0424] 

RIN 0910–AF82 

Postmarketing Safety Reporting for 

Combination Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) proposes to 

amend the combination product 

regulations to set forth postmarketing 

safety reporting requirements for 

combination products. Specifically, the 

rule will clarify the postmarketing safety 

reporting requirements that apply when 

regulated articles (drugs, devices, and 

biological products) are combined to 

create a combination product. The 

proposed rule is intended to promote 

and protect the public health by 

clarifying requirements for 

postmarketing safety reporting for 

combination products, and is part of 

FDA’s ongoing effort to ensure the 

consistency and appropriateness of the 

regulatory requirements for combination 

products. 

DATES: Submit written or electronic 

comments on the proposed rule by 

December 30, 2009. Submit comments 

on information collection issues under 

the Paperwork Reduction Act of 1995 by 

November 2, 2009, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N– 

0424 and/or RIN number 0910–AF82, by 

any of the following methods, except 

that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number and Regulatory 

Information Number (RIN) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 


jlentini on DSKJ8SOYB1PROD with PROPOSALS