Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 64309 

The City is requesting a waiver from 

the Buy American provision of ARRA 

for one Cleanair Designs Heat Recovery 

Ventilator for use in the proposed 

activated sludge treatment building. The 

unit is scheduled for installation on the 

roof. The unit will provide ventilation 

and heating to the building and the 

design includes an air-to-air heat 

exchanger. The exchanger will recover 

energy in the exhaust air stream and 

transfer it to the fresh air stream, 

reducing the energy consumption 

during the heating season, with zero 

cross-contamination between the air 

streams. 

The City has researched foreign and 

domestic manufacturers of fixed plate 

heat recovery ventilators and has 

determined that domestic manufacturers 

are not able to manufacture a unit that 

meets all the project specifications. The 

specifications require that the heat 

exchanger be constructed with a 

polypropylene plate. The polypropylene 

plate was specified because the 

atmosphere inside the building where 

the heat recovery ventilator will be 

installed will be very corrosive. The 

polypropylene plate will better resist 

the corrosive return air circulated 

through the heat exchanger than a 

standard aluminum plate. 

An evaluation of all of the submitted 

documentation by EPA’s technical 

review team supports and confirms the 

City’s claim that there are currently no 

domestic manufacturers that can 

provide a suitable fixed plate heat 

recovery ventilator to meet project 

specifications. The consulting engineer 

for the City identified two domestic 

manufacturers in the United States. 

Neither of the two companies currently 

manufactures heat recovery units that 

meet all the project specifications. An 

independent review of the submitted 

documentation by EPA’s national 

contractor found four possible domestic 

manufacturers. However, none of the 

manufacturers contacted currently 

provides a product that meets the 

specifications and project requirements. 

In addition, the evaluation of the 

supporting documentation 

demonstrated that foreign manufactured 

heat recovery ventilators are available 

and will be able to meet the proposed 

project design and specifications. 

Furthermore, the purpose of the 

ARRA is to stimulate economic recovery 

by funding current infrastructure 

construction, not to delay or curtail 

entirely projects that are ‘‘shovel ready’’ 

by requiring potential SRF eligible 

recipients, such as the City of Lowell, 

MA, to revise their design standards and 

specifications. To curtail entirely this 

construction would directly conflict 

with a fundamental economic purpose 

of ARRA, which is to create or retain 

jobs. 

The April 28, 2009 EPA HQ 

Memorandum, ‘‘Implementation of Buy 

American provisions of Public Law 

111–5, the ‘American Recovery and 

Reinvestment Act of 2009’ ’’ 

(‘‘Memorandum’’), defines reasonably 

available quantity as ‘‘the quantity of 

iron, steel, or relevant manufactured 

good is available or will be available at 

the time needed and place needed, and 

in the proper form or specification as 

specified in the project plans and 

design.’’ The same Memorandum 

defines ‘‘satisfactory quality’’ as ‘‘the 

quality of steel, iron or manufactured 

good specified in the project plans and 

designs.’’ 

The Municipal Assistance Unit (CMU) 

has reviewed this waiver request and 

has determined that the supporting 

documentation provided by the City 

establishes both a proper basis to 

specify a particular manufactured good, 

and that the domestically manufactured 

good that is currently available does not 

meet the design specifications for the 

proposed project. The information 

provided is sufficient to meet the 

following criteria listed under Section 

1605(b) of the ARRA and in the April 

28, 2009 Memorandum: Iron, steel, and 

the manufactured goods are not 

produced in the United States in 

sufficient and reasonably available 

quantities and of a satisfactory quality. 

The March 31, 2009 Delegation of 

Authority Memorandum provided 

Regional Administrators with the 

temporary authority to issue exceptions 

to Section 1605 of the ARRA within the 

geographic boundaries of their 

respective regions and with respect to 

requests by individual grant recipients. 

Having established both a proper 

basis to specify the particular good 

required for this project and that this 

manufactured good was not available 

from a producer in the United States, 

the City of Lowell, MA is hereby granted 

a waiver from the Buy American 

requirements of Section 1605(a) of 

Public Law 111–5. This waiver permits 

use of ARRA funds for the purchase of 

a non-domestically manufactured fixed 

plate heat recovery ventilator 

documented in City’s waiver request 

submittal dated July 14, 2010. This 

supplementary information constitutes 

the detailed written justification 

required by Section 1605(c) for waivers 

based on a finding under subsection (b). 

Authority: Pub. L. 111–5, section 1605. 

Dated: October 8, 2010. 

Ira W. Leighton, 

Acting Regional Administrator, EPA Region 

1—New England. 

[FR Doc. 2010–26260 Filed 10–18–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number NIOSH–220] 

Components for Evaluation of DirectReading Monitors for Gases and 

Vapors and Addendum 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of draft publication 

available for public comment. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) 

announces the availability of the 

following draft publication for public 

comment. The document and its 

addendum are entitled, respectively, 

‘‘Components for Evaluation of DirectReading Monitors for Gases and Vapors’’ 

and ‘‘Addendum to Components for 

Evaluation of Direct-Reading Monitors 

for Gases and Vapors: Hazard Detection 

in First Responder Environments.’’ The 

draft documents and instructions for 

submitting comments can be found at: 

http://www.cdc.gov/niosh/docket/ 

review/docket220. The document 

expands the 1995 method development 

and evaluation experimental testing 

methods to direct-reading monitors for 

gases and vapors. These Components 

are provided for laboratory users, 

consensus standard setting bodies, and 

manufacturers of direct-reading 

instrumentation and are compatible 

with the Instrumentation, Systems, and 

Automation Society guidelines. The 

addendum to the document expands the 

applicability of the Components by 

presenting methods to be used in 

evaluating direct-reading monitors for 

hazard detection in First Responder 

environments. The 1995 document, 

entitled ‘‘Guidelines for Air Sampling 

and Analytical Method Development 

and Evaluation,’’ can be viewed at: 

http://www.cdc.gov/niosh/docs/ 

95–117/. 

This guidance does not have the force 

and effect of the law. 

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64310 Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 

DATES: Public Comment Period: 

Comments must be received by 

December 20, 2010. 

ADDRESSES: Written comments may be 

submitted to the NIOSH Docket Office, 

identified by Docket Number NIOSH– 

220, by any of the following methods: 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, Ohio 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

All information received in response 

to this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, 4676 Columbia Parkway, 

Room 111, Cincinnati, Ohio 45226. A 

complete electronic docket containing 

all comments submitted will be 

available on the NIOSH web page at 

http://www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. All electronic 

comments should be formatted as 

Microsoft Word. Please make reference 

to Docket Number NIOSH–220. 

FOR FURTHER INFORMATION CONTACT: 

Stanley A. Shulman, PhD., telephone 

(513) 841–4258, e-mail mailto: 

sas2@cdc.gov, or Amy Feng, M.S., 

telephone (513) 841–4128, e-mail 

haf0@cdc.gov, NIOSH, MS–R3, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–26221 Filed 10–18–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0234] 

Determination That BUSPAR 

(Buspirone Hydrochloride) Tablets, 10 

Milligrams, 15 Milligrams, and 30 

Milligrams, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that BUSPAR (buspirone hydrochloride) 

Tablets, 10 milligrams (mg), 15 mg, and 

30 mg, were not withdrawn from sale 

for reasons of safety or effectiveness. 

This determination means that FDA will 

not begin procedures to withdraw 

approval of abbreviated new drug 

applications (ANDAs) that refer to this 

drug product, and it will allow FDA to 

continue to approve ANDAs that refer to 

the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Molly Flannery, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6237, 

Silver Spring, MD 20993–0002, 301– 

796–3543. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. Under § 314.161(a)(2), FDA must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness whenever a listed 

drug is voluntarily withdrawn from sale 

and ANDAs that refer to the listed drug 

have been approved. Section 314.161(d) 

provides that if FDA determines that a 

listed drug was withdrawn from sale for 

reasons of safety or effectiveness, the 

agency will initiate proceedings that 

could result in the withdrawal of 

approval of the ANDAs that refer to the 

listed drug. 

BUSPAR (buspirone hydrochloride) 

Tablets, 10 mg, 15 mg, and 30 mg, are 

the subject of NDA 18–731, held by 

Bristol-Myers Squibb, and initially 

approved on September 29, 1986 (10 mg 

strength), and April 22, 1996 (15 mg and 

30 mg strengths). BUSPAR is indicated 

for the management of anxiety disorders 

or the short-term relief of the symptoms 

of anxiety. BUSPAR (buspirone 

hydrochloride) Tablets, 10 mg, 15 mg, 

and 30 mg, are currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. There are 

approved ANDAs for buspirone 

hydrochloride tablets, 10 mg, 15 mg, 

and 30 mg; these ANDAs are listed in 

the Orange Book and, following the 

discontinuation of BUSPAR, one of 

them was designated as the reference 

listed drug to which new ANDAs 

should refer. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated May 

4, 2010 (Docket No. FDA–2010–P– 

0234), under 21 CFR 10.30, requesting 

that the agency determine whether 

BUSPAR (buspirone hydrochloride) 

Tablets, 15 mg and 30 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. Although the 

citizen petition did not address the 10 

mg strength, that strength has also been 

discontinued. On our own initiative, we 

have also determined whether that 

strength was withdrawn for safety or 

effectiveness reasons. 

After considering the citizen petition 

and reviewing agency records, FDA has 

determined under § 314.161 that 

BUSPAR (buspirone hydrochloride) 

Tablets, 10 mg, 15 mg, and 30 mg, were 

not withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that BUSPAR (buspirone 

hydrochloride) Tablets, 10 mg, 15 mg, 

and 30 mg, were withdrawn for reasons 

of safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of BUSPAR 

(buspirone hydrochloride) Tablets, 10 

mg, 15 mg, and 30 mg, from sale. We 

have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that this product was 

mstockstill on DSKH9S0YB1PROD with NOTICES