Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 16923 

(f) Inspection and Cleaning of No. 4 Bearing 

Compartment for Coking 

(1) Within 1,000 cycles-in-service (CIS) 

after the effective date of this AD, inspect and 

clean the No. 4 bearing compartment. 

(2) Thereafter, within every additional 

1,000 CIS, re-inspect and clean the No. 4 

bearing compartment. 

(g) Modification To Stop Buildup of Coking 

in the No. 4 Bearing Compartment, and 

Rerouting of the No. 4 Bearing Pressure and 

Scavenge Tubes 

At the next engine shop visit, but not to 

exceed 5 years after the effective date of this 

AD, do the following: 

(1) Replace the No. 4 bearing packing 

transfer tube assembly; 

(2) Replace the No. 4 bearing internal 

scavenge tube assembly; 

(3) Remove the No. 4 bearing shield, and 

the No. 4 bearing shield option; and 

(4) Install the new No. 4 bearing shield 

options. 

(5) Modify the turbine exhaust case to 

relocate the No. 4 bearing pressure and 

scavenge tube ports to below the engine 

centerline; 

(6) Replace the internal No. 4 bearing 

pressure and scavenge tubes; 

(7) Modify or replace the turbine case 

cooling brackets to support the new No. 4 

bearing pressure and scavenge tubes; 

(8) Replace the turbine case manifolds as 

necessary; and 

(9) Install the new brackets and clamps to 

support the new routing configuration. 

(h) Terminating Action to the Repetitive 

Inspections and Cleaning 

Performing the modifications specified in 

paragraphs (g)(1) through (g)(9) of this AD is 

terminating action for the repetitive 

inspections and cleanings specified in 

paragraph (f)(2) of this AD. 

(i) Definition of Shop Visit 

For the purpose of this AD, a shop visit is 

when the engine is inducted into the shop for 

any maintenance involving the separation of 

pairs of major mating engine flanges (lettered 

flanges). However, the separation of engine 

flanges solely for the purposes of transporting 

the engine without subsequent engine 

maintenance is not an engine shop visit. 

(j) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

may approve AMOCs for this AD. Use the 

procedures found in 14 CFR 39.19 to make 

your request. 

(k) Related Information 

(1) For more information about this AD, 

contact James Gray, Aerospace Engineer, 

Engine & Propeller Directorate, FAA, 12 New 

England Executive Park, Burlington, MA 

01803; phone: 781–238–7742; fax: 781–238– 

7199; email: james.e.gray@faa.gov. 

(2) Pratt & Whitney ASB No. PW4ENG– 

A72–436; SB No. PW4ENG–79–76; and SB 

No. PW4ENG–72–472, pertain to the subject 

of this AD. 

(3) For service information identified in 

this AD, contact Pratt & Whitney, 400 Main 

St., East Hartford, CT 06108; phone: 860– 

565–8770; fax: 860–565–4503. For 

information on the availability of this 

material at the FAA, call 781–238–7125. 

(l) Material Incorporated by Reference 

None. 

Issued in Burlington. Massachusetts, on 

March 19, 2012. 

Peter A. White, 

Manager, Engine & Propeller Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–6996 Filed 3–22–12; 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: Direct final rule. 

SUMMARY: This direct final rule makes 

technical changes that will update a 

requirement that many of our written 

agreements and memoranda of 

understanding (MOUs) with 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 direct 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. We 

are proceeding in accordance with our 

direct final rule procedures. 

We are publishing a companion 

proposed rule under our usual 

procedure for notice-and-comment 

rulemaking to provide a procedural 

framework to finalize the rule in the 

event we receive any significant adverse 

comments and withdraw this direct 

final rule. The companion proposed rule 

and this direct final rule are 

substantively identical. 

DATES: This rule is effective August 6, 

2012. Submit either electronic or 

written comments on or before June 6, 

2012. If we receive no significant 

adverse comments within the specified 

comment period, we will publish a 

document confirming the effective date 

of the final rule in the Federal Register 

within 30 days after the comment 

period on this direct final rule ends. If 

timely significant adverse comments are 

received, the Agency will publish a 

document in the Federal Register 

withdrawing this direct final rule before 

its effective date. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0205, by any of the following methods: 

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 or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2012–N–0205 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

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, 

email: daniel.sigelman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 3, 

1974 (39 FR 35697), we announced that 

copies of all our MOUs transacted with 


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16924 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

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. 

This direct 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 direct 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 

Food and Drug Administration (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/ 

MemorandaofUnderstandingMOUs/ 

OtherMOUs/default.htm. 

Because all publicly disclosable 

agreements and MOUs are posted on our 

Web site, it is no longer necessary to 

require, as does current § 20.108(b), that 

a permanent file of them be available for 

public review during working hours in 

the Agency’s Freedom of Information 

Public Room. Accordingly, this rule will 

revise current § 20.108(b). 

The public’s access to an FDA Web 

site that is regularly updated to include 

agreements and MOUs as they are 

completed has already greatly enhanced 

the speed, ease, and convenience with 

which stakeholders can obtain and 

review these documents. 

The rule’s technical changes will 

lessen demands on the time of our staff 

and reduce the government paperwork 

and printing costs associated with 

Federal Register publication of newly 

completed agreements and MOUs with 

other departments, Agencies, and 

organizations. At the same time, it will 

continue to ensure, consistent with the 

underlying intent of § 20.108, the 

accessibility of records of widespread 

interest to consumers, industry, 

professional groups, associations, 

educators, and other government 

Agencies. 

Currently, § 20.108(c) treats our 

cooperative work-sharing agreements 

with State or local government Agencies 

differently from our agreements and 

MOUs with other Agencies and 

organizations. Because these 

cooperative work-sharing agreements 

rarely vary significantly from one 

another, we decided against publishing 

their full texts in the Federal Register 

(51 FR 19851, June 3, 1986). Instead, 

since 1993, we have merely required 

them to be listed at least once every 2 

years in the Federal Register (58 FR 

48793, September 20, 1993). This direct 

final rule will end such disparate 

treatment. Revised § 20.108(b) will 

apply to all of our written agreements 

and MOUs with other departments, 

Agencies, and organizations, including 

cooperative work-sharing agreements 

with State or local government 

Agencies, except for signed agreements 

and MOUs relating to activities of our 

Office of Criminal Investigations, which 

are addressed in § 20.108(d), which will 

be revised and redesignated as 

§ 20.108(c). 

This direct rule does not amend 

§ 20.108(a) (stating that our written 

agreements and MOUs are available for 

public disclosure). 

II. Direct Final Rulemaking 

We have determined that the subject 

of this rulemaking is suitable and 

appropriate for a direct final rule 

because it is intended to make 

noncontroversial changes to existing 

regulations, and we do not anticipate 

receiving any significant adverse 

comments. In the Federal Register of 

November 21, 1997 (62 FR 62466), we 

announced the availability of the 

guidance document entitled ‘‘Guidance 

for FDA and Industry: Direct Final Rule 

Procedures.’’ This guidance document 

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

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

Consistent with our procedures on 

direct final rulemaking, we are 

publishing elsewhere in this issue of the 

Federal Register a companion proposed 

rule. The companion proposed rule 

provides the procedural framework 

within which the rule may be finalized 

in the event the direct final rule is 

withdrawn because of any significant 

adverse comment. The comment period 

for this direct final rule runs 

concurrently with the comment period 

of the companion proposed rule. Any 

comments received in response to the 

companion proposed rule will also be 

considered as comments regarding this 

direct final rule. 

We are providing a comment period 

on the direct final rule of 75 days after 

the date of publication in the Federal 

Register. If we receive any significant 

adverse comment, we intend to 

withdraw this direct final rule before its 

effective date by publication of a notice 

in the Federal Register within 30 days 

after the comment period ends. 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. In determining whether an 

adverse comment is significant and 

warrants withdrawing a direct final rule, 

we will consider whether the comment 

raises an issue serious enough to 

warrant a substantive response in a 

notice-and-comment process in 

accordance with section 553 of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553). Comments that are 

frivolous, insubstantial, or outside the 

scope of the rule will not be considered 

significant or adverse under this 

procedure. A comment recommending 

an additional change to the rule will not 

be considered a significant adverse 

comment, unless the comment states 

why the rule would be ineffective 

without the additional change. In 

addition, if a significant adverse 

comment applies to part of a rule and 

that part can be severed from the 

remainder of the rule, we may adopt as 

final those parts of the rule that are not 

the subject of a significant adverse 

comment. 

If any significant adverse comments 

are received during the comment 

period, we will publish, before the 

effective date of the direct final rule, a 

document withdrawing the direct final 

rule. If we withdraw the direct final 

rule, all comments received will be 

considered under the companion 

proposed rule in developing a final rule 

using the usual notice-and-comment 

procedures under the APA (5 U.S.C. 552 

et seq.). If we receive no significant 

adverse comment during the specified 


srobinson on DSK4SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 16925 

comment period, we intend to publish 

a document in the Federal Register 

confirming the effective date within 30 

days after the comment period ends. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this rule does not 

impose any significant costs, we certify 

that it will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. We do not expect 

this rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Paperwork Reduction Act of 1995 

We have concluded that this direct 

final rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520) is not required. 

V. Environmental Impact 

We have determined under 21 CFR 

25.33 that this direct final rule 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. 

VI. Federalism 

We have analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13132. We 

have determined that this direct 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, we 

have concluded this direct 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. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document, and they may 

be accompanied by a supporting 

memorandum or brief. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 20 

Confidential business information, 

Courts, Freedom of information, 

Government employees. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 20 is 

amended as follows: 

PART 20—PUBLIC INFORMATION 

■ 1. The authority citation for 21 CFR 

part 20 continues to read as follows: 

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 

U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401– 

1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 

243, 262, 263, 263b–263n, 264, 265, 300u– 

300u–5, 300aa–1. 

■ 2. Amend § 20.108 as follows: 

■ a. Revise paragraph (b); 

■ b. Remove paragraph (c); 

■ c. Redesignate paragraph (d) as 

paragraph (c); 

■ d. Revise newly redesignated 

paragraph (c). 

The revisions and redesignations read 

as follows: 

§ 20.108 Agreements between the Food 

and Drug Administration and other 

departments, agencies, and organizations. 

* * * * * 

(b) All written agreements and 

memoranda of understanding between 

FDA and any entity, including, but not 

limited to other departments, Agencies, 

and organizations will be made 

available through the Food and Drug 

Administration Web site at http:// 

www.fda.gov once finalized. 

(c) Agreements and understandings 

signed by officials of FDA with respect 

to activities of the Office of Criminal 

Investigations are exempt from the 

requirements set forth in paragraph (b) 

of this section. Although such 

agreements and understandings will not 

be made available through the FDA Web 

site, these agreements will be available 

for disclosure in response to a request 

from the public after deletion of 

information that would disclose 

confidential investigative techniques or 

procedures, or information that would 

disclose guidelines for law enforcement 

investigations if such disclosure could 

reasonably be expected to risk 

circumvention of the law. 

Dated: March 16, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6967 Filed 3–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2012–M–0206] 

Medical Devices; Neurological 

Devices; Classification of the Near 

Infrared Brain Hematoma Detector 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

Near Infrared (NIR) Brain Hematoma 

Detector into class II (special controls). 

The Agency is classifying the device 

into class II (special controls) in order 

to provide a reasonable assurance of 

safety and effectiveness of the device. 

DATES: This rule is effective April 23, 

2012. The classification is applicable 

beginning December 13, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Daryl Kaufman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2426, Silver Spring, 

MD 20993–0002, 301–796–6467. 

SUPPLEMENTARY INFORMATION: 


srobinson on DSK4SPTVN1PROD with RULES