Federal Register / Vol. 77, No. 83 / Monday, April 30, 2012 / Rules and Regulations 25361 

requirements of this part, part 50, or 

part 56 of this chapter, or has repeatedly 

or deliberately submitted to FDA or to 

the sponsor false information in any 

required report, the Commissioner will 

notify the investigator, the sponsor of 

any investigation in which the 

investigator has been named as a 

participant, and the reviewing 

investigational review boards (IRBs) that 

the investigator is not eligible to receive 

test articles under this part. The 

notification to the investigator, sponsor 

and IRBs will provide a statement of the 

basis for such determination. The 

notification also will explain that an 

investigator determined to be ineligible 

to receive test articles under this part 

will be ineligible to conduct any clinical 

investigation that supports an 

application for a research or marketing 

permit for products regulated by FDA, 

including drugs, biologics, devices, new 

animal drugs, foods, including dietary 

supplements, that bear a nutrient 

content claim or a health claim, infant 

formulas, food and color additives, and 

tobacco products. 

(c) Each application or submission to 

FDA under the provisions of this 

chapter containing data reported by an 

investigator who has been determined to 

be ineligible to receive FDA-regulated 

test articles is subject to examination to 

determine whether the investigator has 

submitted unreliable data that are 

essential to the continuation of an 

investigation or essential to the 

clearance or approval of a marketing 

application, or essential to the 

continued marketing of an FDAregulated product. 

(d) If the Commissioner determines, 

after the unreliable data submitted by 

the investigator are eliminated from 

consideration, that the data remaining 

are inadequate to support a conclusion 

that it is reasonably safe to continue the 

investigation, the Commissioner will 

notify the sponsor, who shall have an 

opportunity for a regulatory hearing 

under part 16 of this chapter. If a danger 

to the public health exists, however, the 

Commissioner shall terminate the 

investigational device exemption (IDE) 

immediately and notify the sponsor and 

the reviewing IRBs of the termination. 

In such case, the sponsor shall have an 

opportunity for a regulatory hearing 

before FDA under part 16 of this chapter 

on the question of whether the IDE 

should be reinstated. The determination 

that an investigation may not be 

considered in support of a research or 

marketing application or a notification 

or petition submission does not, 

however, relieve the sponsor of any 

obligation under any other applicable 

regulation to submit to FDA the results 

of the investigation. 

(e) If the Commissioner determines, 

after the unreliable data submitted by 

the investigator are eliminated from 

consideration, that the continued 

clearance or approval of the product for 

which the data were submitted cannot 

be justified, the Commissioner will 

proceed to rescind clearance or 

withdraw approval of the product in 

accordance with the applicable 

provisions of the relevant statutes. 

(f) An investigator who has been 

determined to be ineligible under 

paragraph (b) of this section may be 

reinstated as eligible when the 

Commissioner determines that the 

investigator has presented adequate 

assurances that the investigator will 

employ all test articles, and will 

conduct any clinical investigation that 

supports an application for a research or 

marketing permit for products regulated 

by FDA, solely in compliance with the 

applicable provisions of this chapter. 

Dated: April 24, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–10292 Filed 4–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2012–0199] 

RIN 1625–AA00 

Safety Zone; Chicago Harbor, Navy 

Pier Southeast, Chicago, IL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the Navy Pier Southeast Safety Zone in 

Chicago Harbor during various periods 

from July 4, 2012 through July 28, 2012. 

This action is necessary and intended to 

ensure safety of life on the navigable 

waters of the United States immediately 

prior to, during, and immediately after 

fireworks events. Enforcement of this 

safety zone will establish restrictions 

upon, and control movement of, vessels 

in a specified area immediately prior to, 

during, and immediately after various 

fireworks events. During the 

enforcement period, no person or vessel 

may enter the safety zones without 

permission of the Captain of the Port, 

Sector Lake Michigan. 

DATES: The regulations in 33 CFR 

165.931 will be enforced at various 

times between 9:00 p.m. on July 4, 2012 

through 10:30 p.m. on July 28, 2012. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or email MST2 Rebecca Stone, 

Prevention Department, Coast Guard 

Sector Lake Michigan, Milwaukee, WI at 

414–747–7154, email 

Rebecca.R.Stone@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the Safety Zone; 

Chicago Harbor, Navy Pier Southeast, 

Chicago, IL listed in 33 CFR 165.931 for 

the following events: 

(1) Navy Pier Fireworks; on July 4, 

2012 from 9:00 p.m. through 11:00 p.m.; 

on July 7, 2012 from 10:00 p.m. through 

10:30 p.m.; on July 11, 2012 from 9:15 

p.m. through 9:45 p.m.; on July 14, 2012 

from 10:00 p.m. through 10:30 p.m.; on 

July 18, 2012 from 9:15 p.m. through 

9:45 p.m.; on July 21, 2012 from 10:00 

p.m. through 10:30 p.m.; on July 25, 

2012 from 9:15 p.m. through 9:45 p.m.; 

and on July 28, 2012 from 10 through 

10:30. 

All vessels must obtain permission 

from the Captain of the Port, Sector Lake 

Michigan, or his or her on-scene 

representative to enter, move within or 

exit the safety zone. Vessels and persons 

granted permission to enter the safety 

zone shall obey all lawful orders or 

directions of the Captain of the Port, 

Sector Lake Michigan, or his or her onscene representative. While within a 

safety zone, all vessels shall operate at 

the minimum speed necessary to 

maintain a safe course. 

This notice is issued under authority 

of 33 CFR 165.931 and 5 U.S.C. 552(a). 

In addition to this notice in the Federal 

Register, the Coast Guard will provide 

the maritime community with advance 

notification of these enforcement 

periods via broadcast Notice to Mariners 

or Local Notice to Mariners. The 

Captain of the Port, Sector Lake 

Michigan, will issue a Broadcast Notice 

to Mariners notifying the public when 

enforcement of the safety zone 

established by this section is suspended. 

If the Captain of the Port, Sector Lake 

Michigan, determines that the safety 

zone need not be enforced for the full 

duration stated in this notice, he or she 

may use a Broadcast Notice to Mariners 

to grant general permission to enter the 

safety zone. The Captain of the Port, 

Sector Lake Michigan, or his or her onscene representative may be contacted 

via VHF Channel 16. 


srobinson on DSK4SPTVN1PROD with RULES
25362 Federal Register / Vol. 77, No. 83 / Monday, April 30, 2012 / Rules and Regulations 

Dated: April 9, 2012. 

C.W. Tenney, 

Commander, U.S. Coast Guard, Captain of 

the Port, Lake Michigan, Acting. 

[FR Doc. 2012–10316 Filed 4–27–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2012–0008; A–1–FRL– 

9664–8] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Massachusetts; Determination of 

Attainment of the One-Hour Ozone 

Standard for the Springfield Area 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The EPA is making two 

separate and independent 

determinations. First, EPA is 

determining that the Springfield 

(Western Massachusetts) serious onehour ozone nonattainment area did not 

meet the applicable deadline of 

December 31, 2003, for attaining the 

one-hour National Ambient Air Quality 

Standard (NAAQS) for ozone. This final 

determination is based upon complete, 

quality-assured, certified ambient air 

monitoring data that show the area had 

an expected ozone exceedance rate 

above the level of the now revoked onehour ozone NAAQS for the 2001–2003 

monitoring period. Second, EPA is 

determining that the Springfield 

(Western Massachusetts) serious onehour ozone nonattainment area 

currently attains the now revoked onehour NAAQS for ozone, based upon 

complete, quality-assured, certified 

ambient air monitoring data for 2009- 

2011. The area first attained the onehour NAAQS during the 2007–2009 

monitoring period, and continued in 

attainment during the 2008–2010, and 

2009–2011 monitoring periods. 

DATES: Effective Date: This rule is 

effective on May 30, 2012. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R01–OAR– 

2012–0008. All documents in the docket 

are listed on the www.regulations.gov 

web site. Although listed in the index, 

some information is not publicly 

available, i.e., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the Office of Ecosystem Protection, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, Office of 

Ecosystem Protection, Air Quality 

Planning Unit, 5 Post Office Square— 

Suite 100, Boston, MA. EPA requests 

that if at all possible, you contact the 

contact listed in the FOR FURTHER

INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30, 

excluding legal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Richard P. Burkhart, Air Quality 

Planning Unit, U.S. Environmental 

Protection Agency, EPA New England 

Regional Office, 5 Post Office Square, 

Suite 100, Boston, MA 02109–3912, 

telephone number (617) 918–1664, fax 

number (617) 918–0664, email 

Burkhart.Richard@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. 

Organization of this document. The 

following outline is provided to aid in 

locating information in this preamble. 

I. What actions is EPA taking? 

II. What is the effect of these actions? 

III. Final Actions 

IV. Statutory and Executive Order Reviews 

I. What Actions is EPA Taking? 

EPA is making two separate and 

independent final determinations for 

the Springfield (Western Massachusetts) 

one-hour ozone serious nonattainment 

area (hereafter, ‘‘the Western 

Massachusetts area’’). 

A. Determination of Failure To Attain 

by Applicable Attainment Date 

EPA is determining that the Western 

Massachusetts area did not attain the 

one-hour ozone National Ambient Air 

Quality Standard (NAAQS) by the 

applicable attainment date, December 

31, 2003. This determination is based 

upon complete, quality-assured and 

certified air quality monitoring data for 

the 2001 through 2003 ozone seasons. 

B. Determination of Current Attainment 

In addition, EPA is determining that 

the Western Massachusetts area is 

currently attaining the one-hour ozone 

NAAQS based upon complete, qualityassured and certified ambient air 

monitoring data for 2009–2011 showing 

the area has attained the one-hour ozone 

NAAQS, and that it has done so 

continuously since the 2007–2009 

monitoring period. 

Additional information related to 

these determinations and the rationale 

for them are set forth in the Notice of 

Proposed Rulemaking (NPR) published 

on January 24, 2012 (77 FR 3417) and 

will not be restated here. EPA received 

no comments on the NPR. 

II. What is the Effect of These Actions? 

After revocation of the one-hour 

ozone standard, EPA must continue to 

provide a mechanism to give effect to 

one-hour ozone anti-backsliding 

requirements. See SCAQMD v. EPA, 472 

F.3d 882, at 903 (DC Cir. 2006). In 

keeping with this responsibility, EPA 

has determined that the Western 

Massachusetts area failed to attain the 

one-hour ozone standard by its 

applicable attainment date. Consistent 

with 40 CFR 51.905(e)(2), and the South 

Coast decision, upon revocation of the 

one-hour ozone NAAQS for an area, 

EPA is no longer obligated to determine 

whether an area has attained the onehour NAAQS, except insofar as it relates 

to effectuating the anti-backsliding 

requirements that are specifically 

retained. EPA’s determination here is 

linked solely to required one-hour antibacksliding, contingency measures. A 

final determination of failure to attain 

will not result in reclassification of the 

area under the revoked one-hour 

standard, nor is EPA identifying or 

determining any new one-hour 

reclassification for the area. EPA is no 

longer required to reclassify an area to 

a higher classification for the one-hour 

ozone NAAQS based upon a 

determination that the area failed to 

attain that NAAQS by its attainment 

date. See 40 CFR 51.905(e)(2)(i)(B). 

Moreover, EPA has previously approved 

the one-hour ozone attainment 

demonstration and Reasonable Further 

Progress (ROP) plans for this area, and 

in doing so noted that although there 

were no state implementation plan 

contingency measure reductions 

applicable to the Western Massachusetts 

area for failure to attain, there were 

federal measures the state had not 

accounted for in its attainment 

demonstration that provided more 

reductions than necessary to serve the 

purpose of contingency measures for 

this area. See 66 FR 666, January 3, 

2001. In addition, EPA has also 

determined that the Western 

Massachusetts area attained the onehour ozone standard in 2009, and 

continues to attain this standard. In this 

context, EPA has also determined that 

there are not any additional obligations, 

including those relating to one-hour 

ozone contingency measures, for the 

Western Massachusetts area under the 

one-hour ozone standard. 


srobinson on DSK4SPTVN1PROD with RULES