712 Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 

B. New Business

• Auditors’ Report on FCA FY 2008/

2007 Financial Statements

• Registration of Loan Originators

Under the Secure and Fair

Enforcement for Mortgage Licensing

Act of 2008

C. Reports

• OE Quarterly Report

Closed Session * 

• Update on OE Oversight Activities

Dated: January 5, 2009.

Roland E. Smith, 

Secretary, Farm Credit Administration Board. 

[FR Doc. E9–121 Filed 1–5–09; 4:15 pm] 

BILLING CODE 6705–01–P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Notices 

AGENCY: Federal Election Commission. 

DATE AND TIME: Thursday, January 8, 

2009, at 10 a.m. 

PLACE: 999 E Street, NW., Washington, 

DC (Ninth Floor). 

STATUS: This meeting will be open to the 

public. 

ITEMS TO BE DISCUSSED: 

Correction and Approval of Minutes. 

Management and Administrative 

Matters. 

Individuals who plan to attend and 

require special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

contact Mary Dove, Commission 

Secretary, at (202) 694–1040, at least 72 

hours prior to the hearing date. 

DATE AND TIME: Friday, January 9, 2009, 

at 10 a.m. 

PLACE: 999 E Street, NW., Washington, 

DC. 

STATUS: This meeting will be closed to 

the public. 

ITEMS TO BE DISCUSSED: 

Compliance matters pursuant to 2 

U.S.C. 437g. 

Audits conducted pursuant to 2 

U.S.C. 437g, § 438(b), and Title 26, 

U.S.C. 

Matters concerning participation in 

civil actions or proceedings or 

arbitration. 

Internal personnel rules and 

procedures or matters affecting a 

particular employee. 

* Session Closed—Exempt pursuant to 5 U.S.C. 

552b(c)(8) and (9). 

PERSON TO CONTACT FOR INFORMATION: 

Robert Biersack, Press Officer, 

Telephone: (202) 694–1220. 

Darlene Harris, 

Deputy Secretary of the Commission. 

[FR Doc. E8–31465 Filed 1–6–09; 8:45 am] 

BILLING CODE 6715–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice Regarding Revisions to the 

Laboratory Protocol To Measure the 

Quantity of Nicotine Contained in 

Smokeless Tobacco Products 

Manufactured, Imported, or Packaged 

in the United States 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services. 

ACTION: Notice and Summary of Public 

Comments. 

SUMMARY: This notice amends the 

uniform protocol for the analysis of 

nicotine, total moisture, and pH in 

smokeless tobacco products 

(‘‘Protocol’’). The Protocol, originally 

published in the Federal Register in 

1999 (64 FR 14086) and revised in the 

Federal Register on March 14, 2008 (73 

FR 13903), implements the requirement 

of the Comprehensive Smokeless 

Tobacco Health Education Act 

(CSTHEA) of 1986 (15 U.S.C. 4401 et 

seq., Pub. L. 99–252) that each person 

manufacturing, packaging, or importing 

smokeless tobacco products shall 

annually provide the Secretary of Health 

and Human Services (HHS) with a 

specification of the quantity of nicotine 

contained in each smokeless tobacco 

product. CDC re-published the notice in 

the Federal Register on June 23, 2008 

(73 FR 35395) concerning the revision of 

the Protocol (1) To make a technical 

change to correct the date when the first 

report of information under the revised 

Protocol is due and (2) to solicit public 

comments concerning a change in the 

Protocol that increased the volume of 

water in the pH determination from 10 

mL to 20 mL, and (3) to solicit public 

comments concerning the addition of 

the following commercial smokeless 

tobacco product categories: dry snuff 

portion packs, snus, snus portion packs, 

and pellet or compressed. This Notice 

also includes a summary of public 

comments and CDC’s response to them. 

The Protocol as published in the 

Federal Register on March 14, 2008 (73 

FR 13903), remains in effect with the 

technical correction to the date as 

described in the Federal Register notice 

published on June 23, 2008 (73 FR 

35395). 

DATES: First report of information due 

June 30, 2009, with subsequent 

submissions due by March 31 of each 

year. 

FOR FURTHER INFORMATION, CONTACT: 

Matthew McKenna, M.D., Director, 

Office on Smoking and Health, Centers 

for Disease Control and Prevention, 

Telephone: (770) 488–5701. 

SUPPLEMENTARY INFORMATION: Since the 

implementation of the Protocol in 1999, 

several smokeless tobacco product 

categories have entered the U.S. 

smokeless tobacco market including 

snus, low moisture snuff sold in portion 

pouches, and smokeless tobacco sold in 

a compressed, pellet form. Some of the 

new smokeless tobacco product 

categories differ physically from 

previous smokeless tobacco categories, 

prompting a revision to the Protocol to 

reflect the current state of the 

marketplace. 

Through its review of the Protocol, 

CDC also determined that an increase in 

volume of deionized, distilled water 

would facilitate measurements of pH 

values. After evaluating information that 

was brought to the attention of CDC 

regarding low moisture smokeless 

tobacco products packaged in portion 

pouches, CDC conducted an 

independent comparison of pH 

measurements in a wide variety of low 

and high moisture smokeless tobacco 

products. The results of the comparison 

indicated an acceptable (less than 2%) 

level of change in pH values when 

measurements were taken with 20 mL 

deionized, distilled water compared to 

the volume of deionized, distilled water 

specified in the previous Protocol. 

Increasing the volume of water in the 

mixture ensured that the matrix was 

sufficiently fluid to facilitate ease of 

measure. Thus, it is anticipated that the 

change in the volume of liquid for pH 

determination will facilitate the ease of 

measure of smokeless tobacco pH for all 

currently marketed smokeless tobacco 

categories (i.e., plug, twist, moist snuff, 

dry snuff, snus, loose leaf, chew, moist 

snuff in portion pouches, smokeless 

tobacco compressed into a pellet, and 

dry snuff in portion pouches). 

Summary of Public Comments and 

CDC’s Response: On June 23, 2008, a 

notice (73 FR 35395) was published 

reflecting the above discussed revisions 

to the Protocol and to solicit public 

comment on these specific changes. Six 

comments were received by the CDC, a 

majority of which suggested alternative 

approaches. A summary of the 

Print Only

Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 713 

comments received and CDC’s response 

follows. 

One commenter expressed a concern 

for the Federal funding and overall 

direction of the ‘‘smokeless tobacco 

program.’’ 

The issues raised in this comment 

were beyond the scope of the Protocol 

and solicitation of public comment. 

One commenter, on behalf of several 

smokeless tobacco manufacturers, 

agreed with the proposed revision of 

Section IV(B) (see below for Protocol) of 

the Protocol to increase the volume of 

deionized, distilled water to be used in 

pH measurements from 10mL to 20mL. 

One commenter, on behalf of several 

smokeless tobacco manufacturers, 

suggested that ‘‘some flexibility be 

incorporated into Section IV(B) of the 

Protocol by providing that, as long as a 

minimum of 20 mL of liquid and 2 

grams of sample are utilized, then larger 

amounts of liquid and sample may be 

utilized provided they are in a 10 to 1 

ratio.’’ 

CDC appreciated the suggestion that 

there be flexibility in adjusting the 

quantity of liquid and sample so long as 

the ratio of liquid to sample is 10 to 1. 

In evaluating this suggestion, CDC 

determined that adopting such a change 

would deviate from principles of good 

scientific practice as it does not promote 

protocol consistency, contrary to the 

aims of a uniform analytical protocol. 

According to the Cooperative Centre for 

Scientific Research Relative to Tobacco 

(CORESTA), a central organization 

responsible for promoting tobaccorelated cooperative research, ‘‘[t]he 

development of standard methods is 

critically important in ensuring 

consistency and comparability of data 

reported by the association members 

and as part of regulatory reporting of 

data.’’ [Further details on CORESTA’s 

viewpoint and its objectives are 

available online at http:// 

www.coresta.org/Home_Page/ 

PresentationCORESTA(Oct08).pdf.] As 

the fundamental purpose of the Protocol 

is to implement a multi-site testing 

protocol, CDC concluded that the 

development of a uniform analytical 

protocol is paramount to ensuring 

sound scientific efforts. 

One commenter, on behalf of several 

smokeless tobacco manufacturers, raised 

the following point regarding the 

categorization of smokeless tobacco 

products in Section I(F) of the Protocol: 

‘‘* * * many of these separate product 

‘categories’ are essentially identical 

smokeless tobacco products for the purposes 

of sample preparation (e.g., Moist snuff and 

snus; Moist snuff portion packs and snus 

portion packs) * * * since a number of 

smokeless tobacco manufacturers have stated 

that they are developing new or ‘innovative’ 

smokeless tobacco products, an approach 

that creates a new ‘category’ and sample 

preparation instruction every time a 

smokeless tobacco product is introduced 

with a different name or description will 

result in a proliferation of smokeless tobacco 

product ‘categories’ and a need to constantly 

revise the Protocol to add new sample 

preparation instructions. Such revisions 

would trigger a notice and comment process 

under the Administrative Procedure Act.’’ 

CDC made the determination to 

include the four newly listed categories 

after having reviewed the number and 

types of smokeless tobacco products 

that had entered the market since 1999. 

In this review, CDC concluded that 

several new products would benefit 

from a separate categorization to not 

only better aid manufacturers in 

distinguishing their products in this 

protocol, but also reflect the variety of 

products being sold to and recognized 

by consumers. This review also 

determined that in the years since the 

implementation of the Protocol in 1999, 

the quantities of new products 

introduced to market requiring separate 

categorization had been fairly limited; 

thus, CDC did not believe that constant 

revisions to the Protocol would be 

necessary. However, CDC will continue 

to monitor the introduction of new 

smokeless tobacco products and provide 

assistance to reporting entities on the 

application of the Protocol as needed. 

One commenter, on behalf of several 

smokeless tobacco manufacturers, 

suggested an alternative approach that 

would ‘‘eliminate, or at the least 

minimize, the need for new ‘categories’ 

and sample preparation instructions.’’ 

This alternative proposal suggested 

that: 

‘‘The alternative approach would be to 

define the smokeless tobacco product 

categories based on physical characteristics 

relevant to sample preparation (essentially 

tobacco particle size and whether tobacco 

particles are in a pouch), rather than on a 

manufacturer’s package label statement or 

description * * * ’’ 

Three product categories were thus 

proposed. 

If any products did not fall into the 

three categories, the proposal suggested 

that: 

‘‘* * * in the event that a smokeless 

tobacco manufacturer or importer believes 

that a newly marketed smokeless tobacco 

product does not fit within any of the above 

categories, then samples should be prepared 

in a manner compatible with the above 

sample preparation instructions and the 

manufacturer or importer should describe the 

sample preparation procedures used when 

making its submissions to CDC.’’ 

After an evaluation of this alternative 

approach, CDC concluded that the 

current method of categorization is more 

appropriate for several reasons. First, 

the current method has been in place 

since 1999, with no noted difficulties 

associated with this product 

categorization. Second, CDC noted that 

other Federal agencies, such as the 

Federal Trade Commission (FTC) and 

United States Department of Agriculture 

(USDA), receive and review information 

on smokeless tobacco, not on the basis 

of physical size characteristics, but on 

these commonly accepted types of 

categories. Examples can be found in 

the FTC’s ‘‘Federal Trade Commission 

Smokeless Tobacco Report for the Years 

2002–2005,’’ available online at http:// 

www.ftc.gov/reports/tobacco/02-

05smokeless0623105.pdf, or in the 

USDA Economic Research Service’s 

‘‘Tobacco Situation and Outlook 

Yearbook’’, available online at http:// 

usda.mannlib.cornell.edu/usda/ers/ 

TBS-yearbook//2000s/2007/TBSyearbook-01-12-2007.pdf/. 

Furthermore, CDC viewed the existing 

categorization of products by traditional 

‘‘consumer-oriented’’ descriptions as 

useful in easily identifying issues that 

concern the general consumer and the 

overall public’s health. In contrast, 

adopting a method of categorization 

based solely on physical product 

characteristics would not be beneficial 

towards that goal. 

Finally, during its review of this 

alternate approach, CDC noted that 

there are only three existing methods to 

prepare smokeless tobacco products for 

analysis in this protocol, despite the 

varied physical characteristics of 

currently marketed smokeless tobacco 

products. 

One commenter, on behalf of several 

smokeless tobacco manufacturers, 

suggested that ‘‘the reporting provision 

of the FRN be amended to provide the 

following: (i) The revised Protocol shall 

take effect January 1, 2009, and (ii) the 

first report of information pursuant to 

the revised Protocol is due March 31, 

2010, with subsequent submissions due 

by March 31 of each year. This 

amendment would afford smokeless 

tobacco manufacturers a reasonable 

amount of time to prepare for the 

implementation of the revised Protocol, 

and would continue the current practice 

of manufacturers submitting a full year 

of data based on a consistent 

methodology.’’ 

For the purposes of this comment, 

CDC took into consideration a Federal 

Register Notice published in March 

2008 (73 FR 13903), which served as 

public notice about the changes in the 

Protocol. CDC regarded this duration of 

notice as sufficient for the first report of 

information to be due June 30, 2009, 

Print Only

714 Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 

with subsequent submissions due by 

March 31 of each year, as laid out in the 

June 23, 2008 Federal Register (73 FR 

35395). 

Collection of Information 

This proposed amendment does not 

call for any new collection of 

information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). 

Dated: December 29, 2008. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

Revised Protocol for Analysis of 

Nicotine, Total Moisture, and pH in 

Smokeless Tobacco Products 

I. Requirements 1 2

A. Reagents 3 

1. Sodium hydroxide (NaOH), 2N

2. Methyl t-butyl ether (MTBE)

3. (¥)-Nicotine (Fluka 72290) >99%

purity 45 

4. Quinoline (Aldrich)

5. Standard pH buffers; 4.01, 7.00, and

10.00 

6. Deionized distilled water

B. Glassware and Supplies

1. Volumetric flasks, class A

2. Culture tubes, 25 mm x 200 mm, with

Teflon-lined screw caps

3. Pasteur pipettes

4. Repipettors (10 mL and 50 mL)

5. Linear shaker (configured to hold

tubes in horizontal position) 6 7

6. Weighing dishes, aluminum

7. Teflon-coated magnetic stirring bars

8. Polypropylene containers, 50 mL

C. Instrumentation

1. Robot Coupe Model RSI 2V Scientific

Batch Processor

2. Capillary gas chromatograph, Hewlett

Packard, Model 6890, with split/

splitless injector capability, flame

ionization detector, and a capillary

column (Hewlett Packard HP–5,

Crosslinked 5% PH ME Siloxane, 30

m length x 0.32 mm ID, film thickness

0.25 or 0.52 μm)

3. Orion Model EA 940 pH meter

equipped with Orion 8103 Ross

combination pH electrode

D. Additional Equipment

Forced-air oven, Fisher Isotemp®,

regulated to 99 ± 1.0°C. Suggested 

dimensions: 18 x 18 x 20inches. 

E. Chromatographic Conditions 8 9

1. Detector temperature: 250°C

2. Injector temperature: 250°C

3. Flow rate at 100°C—1.7 mL/min; with

split ratio of 40:1 10 

4. Injection volume: 2 μl

5. Column conditions: 110–185°C at

10°C min¥1; 185–240°C at 6°C min¥1,

hold at final temperature for 10 min.

F. Sample Preparation 11 

There are ten different categories of

commercial smokeless tobacco 

products: 

1. Dry snuff;

2. Moist (wet) snuff;

3. Moist (wet) snuff portion packs;

4. Plug;

5. Twist;

6. Loose leaf;

7. Dry snuff portion packs;

8. Snus;

9. Snus portion packs; and

10. Pellet or Compressed.

Because of their physical

characteristics, some of the ten product 

categories must be ground (whole or in 

part) before nicotine, total moisture, and 

pH analyses can be conducted. The 

objective of grinding the samples is to 

obtain a homogeneous sample with 

particles measuring approximately 4 

mm. Grinding to achieve this particle

size should take no more than 3

minutes. To ensure proper grinding and

an adequate amount of the ground

sample for analysis, the minimum

sample size of all commercial products

to be ground should not be less than 100

grams.

To ensure precision of analyses for 

nicotine, total moisture, and pH, the 

samples that require grinding should be 

ground using a Robot Coupe Model RSI 

2V Scientific Batch Processor or its 

equivalent. This is a variable speed (0 to 

3000 RPM) processor. The variable 

speed motor is required to ensure 

proper grinding of the tobacco tissues 

(and in the case of pH determination, 

the portion pack). Elevated temperatures 

can result in moisture loss and an 

underestimated value for moisture 

content. Hence, care must be taken 

during grinding to avoid elevated 

temperatures. The bowl should be 

cleaned after each grinding to obtain 

accurate results. Freeze- or cryogrinding is also an acceptable grinding 

method. 

1. Dry snuff: Dry snuff samples do not

need to be ground since the product is 

a powder. The sample must be 

thoroughly mixed before weighing for 

nicotine, total moisture, and pH 

analysis. 

2. Moist (wet) snuff: Moist (wet) snuff

samples do not need to be ground. The 

sample must be thoroughly mixed 

before weighing for nicotine, total 

moisture, and pH analysis. 

3. Moist (wet) snuff portion packs:

The tobacco contents of the moist (wet) 

snuff portion packs do not need to be 

ground for nicotine, total moisture, or 

pH analysis. The tobacco packaging 

material (the ‘‘pouch’’) should be 

separated from the tobacco and ground 

to obtain particles measuring 

approximately 4 mm for pH analysis. 

The tobacco of the moist (wet) snuff 

portion pack and the ground pouch are 

combined and thoroughly mixed before 

pH analysis. 

4. Plug tobacco: Break or cut apart

plugs and add in portions to grinder at

2000 RPM. Reduce RPM or stop

grinding if sample bowl becomes warm.

Pulse the Robot Coupe, when needed, to

complete grinding. Grind samples until

approximately 4 mm in size. The total

grinding time should be no more than

3 minutes.

5. Twist tobacco: Separate twists, add

to grinder and grind at 2000 RPM. 

Reduce RPM or stop grinding if sample 

bowl becomes warm. Continue grinding 

until sample particles are approximately 

4 mm in size. The total time for grinding 

should be no more than 3 minutes. 

6. Loose leaf: Grind in the same

manner as described in 4 and 5 to obtain 

product with particle size of 

approximately 4 mm. 

7. Dry snuff portion packs: The

tobacco contents of the dry snuff portion 

packs do not need to be ground for 

nicotine, total moisture, or pH analysis. 

The tobacco packaging material (the 

‘‘pouch’’) should be separated from the 

tobacco and ground to obtain particles 

measuring approximately 4 mm for pH 

analysis. The tobacco of the dry snuff 

portion pack and the ground pouch are 

combined and thoroughly mixed before 

pH analysis. 

8. Snus: Snus samples do not need to

be ground since the product is a 

powder. The sample must be thoroughly 

mixed before weighing for nicotine, 

total moisture, and pH analysis. 

9. Snus portion packs: The tobacco

contents of the snus portion packs do 

not need to be ground for nicotine, total 

moisture, or pH analysis. The tobacco 

packaging material (the ‘‘pouch’’) 

should be separated from the tobacco 

and ground to obtain particles 

measuring approximately 4 mm for pH 

analysis. The tobacco of the snus 

portion pack and the ground pouch are 

combined and thoroughly mixed before 

pH analysis. 

10. Pellet or compressed: Break apart

compressed tobacco pellets and add in 

portions to grinder at 2000 RPM. Reduce 

RPM or stop grinding if sample bowl 

becomes warm. Pulse the Robot Coupe, 

when needed, to complete grinding. 

Grind samples until approximately 4 

mm in size. The total grinding time 

should be no more than 3 minutes. 

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EN07JA09.000</MATH> EN07JA09.001</MATH>

Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 715 

II. Nicotine Analysis 12 

A. Calibration Standards

1. Internal Standard (IS)

Weigh 10.00 grams of quinoline,

transfer to a 250 mL volumetric flask 

and dilute to volume with MTBE. This 

solution will be used for calibration of 

the instrument for the nicotine 

calibration curve (II.A.2), for the 

standards addition assay (II.B), and for 

preparation of the extracting solution 

(II.D). 

2. Nicotine Calibration Curve

a. Weigh 1.0000 gram of nicotine into

a clean, dry 100 mL volumetric flask 

and dilute to volume with MTBE. This 

gives a nicotine concentration of 10 mg/ 

mL for the stock solution. 

b. Accurately pipette 0.5 mL of IS

from stock solution (II.A.1) to five clean, 

dry 50 mL volumetric flasks. To prepare 

a nicotine standard corresponding to a 

concentration of 0.8 mg/mL, pipette 

exactly 4.0 mL of the nicotine standard 

(II.A.2.a) to a 50 mL volumetric flask 

containing the internal standard and 

dilute to volume with MTBE. To obtain 

nicotine concentrations equivalent to 

0.6, 0.4, 0.2, and 0.1 mg/mL, pipette 

precisely 3.0, 2.0, 1.0, and 0.5 mL, 

respectively, of the nicotine standard 

into the four remaining flasks and dilute 

to volume with MTBE. 

c. Transfer aliquots of the five

standards to auto sampler vials and 

determine the detector response for each 

standard using gas chromatographic 

conditions described in I.E. 

d. Calculate least squares line for

linear equation from these standards by 

obtaining the ratio of Areanicotine/ AreaIS. 

This ratio will be the Y value and the 

concentration of nicotine will be the X 

value for determining the linear 

equation of the line (Equation 1): 

Equation 1: 

Y a bX =+ ; 

Where: 

X = Concentration of nicotine in mg 

Y = Areanicotine/ AreaIS 

a = intercept on the ordinate (y axis) 

b = slope of the curve 

The final result will be reported in the 

following units: 

Concentration of nicotine = mg of 

nicotine/gram of tobacco sample. 

e. Determine the recovery of nicotine

by pipetting 10 mL of the 0.4 mg/mL 

nicotine standard to a screw capped 

tube containing 1.0 mL of 2 N NaOH. 

Cap the tube. Shake the contents 

vigorously and allow the phases to 

separate. Transfer an aliquot of the 

organic phase to an injection vial and 

inject. Calculate the concentration of 

nicotine using the equation of the line 

in II.A.2.d above. This should be 

repeated two more times to obtain an 

average of the three values. The 

recovery of nicotine can be obtained by 

using the following equation: 

Equation 2: 

Recov ery = Ni cot ine /Nicot ine calculated actual 

B. Standards Addition Assay

Prior to analyzing a smokeless tobacco

product for nicotine content, the testing 

facility must validate the system to 

verify that matrix bias is not occurring 

during nicotine extraction. This is done 

by analyzing the nicotine calibration 

standards in the same vegetable matrix 

as the smokeless tobacco. The first time 

each smokeless tobacco product is 

tested and whenever a change is made 

to the product formulation (including a 

change to the tobacco blend or cultivar), 

the Standards Addition Assay will be 

performed, and documentation of its 

performance and of the nicotine 

concentrations selected for the standard 

curve (II.B.2) will be submitted to the 

Centers for Disease Control and 

Prevention. 

1. Using an analytical balance,

accurately weigh 1.000 ± 0.020 gram of 

the homogeneous, prepared tobacco 

sample into a culture tube. Repeat this 

five times for a total of 6 culture tubes 

containing the smokeless tobacco 

product. Record the weight of each 

sample. 

2. Prepare a five-point standard curve

for the Standards Addition Assay. The 

standard curve must consist of nicotine 

concentrations that encompass the range 

of values expected from adding known 

concentrations of the nicotine standard 

(II.A.2.a) to a measured quantity of the 

smokeless tobacco product (1.000 ± 

0.020 gram, described in II.B.1). The 

sixth culture tube is not supplemented 

with nicotine and serves as an analytical 

blank. Allow the samples to equilibrate 

for 10 minutes. 

3. Pipette 5 mL of 2 N NaOH into each

tube. Cap each tube. Swirl to wet 

sample and allow to stand 15 minutes.13 

4. Pipette 50 mL of extraction solution

(II.D.1) into each tube. Cap each tube 

and tighten.14 

5. Place tubes in rack(s), place racks

in linear shaker in horizontal position 

and shake for two hours. 

6. Remove rack(s) from shaker and

place in vertical position to allow the 

phases to separate. 

7. Allow the solvent and nicotine

supplemented samples and the blank to 

separate (maximum 2 hours). 

8. Transfer aliquots of the five

standards and the blank from the 

extraction tubes to sample vials and 

determine the detector response for each 

using gas chromatographic conditions 

described in I.E. 

9. Subtract the Areanicotine/AreaIS of

the blank from the Areanicotine/AreaIS of 

each of the standards. 

10. Calculate least squares line for

linear equation from the corrected 

standards as described above (Equation 

1) in II.A.2.d. The final corrected result

will be reported in the following units:

Concentration of nicotine = mg of

nicotine/gram of tobacco sample.

11. Determine the recovery of nicotine

by pipetting 10 mL of the 0.4 mg/mL 

nicotine standard to a screw capped 

tube containing 1.0 mL of 2 N NaOH 

and 10 mL of extraction solution 

(II.D.1). Cap the tube and tighten. Shake 

the contents vigorously and allow the 

phases to separate. Transfer an aliquot 

of the organic phase to an injection vial 

and inject. Calculate the concentration 

of nicotine using the equation of the line 

above in II.A.2.d. This should be 

repeated two more times to obtain an 

average of the three values. The 

recovery of nicotine can be obtained by 

using Equation 2: Recovery = 

Nicotinecalculated/Nicotineactual. 

12. Compare the results of steps II.A.2

and II.B. If they differ by a factor of 10% 

or more, the recovery of nicotine from 

the aqueous matrix is not equivalent to 

recovery from the vegetable matrix of 

the smokeless tobacco product. In this 

instance, the nicotine concentration of 

the smokeless tobacco product must be 

determined from a nicotine calibration 

curve prepared from nicotine standards 

in a vegetable-based matrix. 

C. Quality Control Pools

At least two quality control pools at

the high and low ends of the expected 

nicotine values are recommended to be 

included in each analytical run. The 

pools should be analyzed in duplicate 

in every run. The quality control pools 

should be available in sufficient 

quantity to last for all analyses of a 

product. 

D. Sample Extraction Procedure 12 

1. Extraction solution is prepared by

pipetting 10 mL of the IS from the stock 

solution (II.A.1) to a 1000 mL 

volumetric flask and diluting to volume 

with MTBE. 

2. Using an analytical balance,

accurately weigh 1.000 ± 0.020 gram of 

prepared tobacco sample into culture 

tube and record weight.15 Sample each 

smokeless tobacco brand name 

according to the provided testing 

frequency schedule.19 The number of 

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EN07JA09.002</MATH>

716 Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 

products sampled should reflect an 

acceptable level of precision.16 The test 

material is to be representative of the 

product that is sold to the public and 

therefore should consist of sealed, 

packaged samples of finished product 

that is ready for commercial 

distribution. Samples are to be analyzed 

in duplicate. 

3. Pipette 5 mL of 2 N NaOH into the

tube. Cap the tube. Swirl to wet sample 

and allow to stand 15 minutes.13 

4. Pipette 50 mL of extraction solution

into tube, cap tube and tighten.14 

5. Place tubes in rack(s), place racks

in linear shaker in horizontal position 

and shake for two hours. 

6. Remove rack(s) from shaker and

place in vertical position to allow the 

phases to separate. 

7. Allow the solvent and sample to

separate (maximum 2 hours). Transfer 

an aliquot from the extraction tube to a 

sample vial and cap. 

8. Analyze the extract using GC

conditions as described above (I.E) and 

calculate the concentration of nicotine 

using the linear calibration equation. 

Correct percent nicotine values for both 

recovery and weight of sample by using 

Equation 3.17 

Equation 3:18 

(Area /Area ) − a nicotine IS Nicot ine (mg/g) = b Samp × le Wt × Recovery 

9. Report the final nicotine

determination as mg of nicotine per 

gram of the tobacco product (mg 

nicotine/gram), to an accuracy level of 

two decimal places for each brand name 

(e.g., Skoal Bandits Wintergreen, Skoal 

Long Cut Cherry, Skoal Long Cut 

Wintergreen, etc.). All data should 

include the mean value with a 95% 

confidence interval, the range of values, 

the number of samples tested, the 

number of lots per brand name, and the 

estimated precision of the mean. 

Information will be reported for each 

manufacturer and variety (including 

brand families and brand variations) 

and brand name (e.g., Skoal Bandits 

Wintergreen, Skoal Long Cut Cherry, 

Skoal Long Cut Wintergreen, etc.). 

III. Total Moisture Determination

A. This procedure is a modification of

AOAC Method 966.02 (1990) and is 

referred to as ‘‘Total Moisture 

Determination’’ because it determines 

water and tobacco constituents that are 

volatile at temperatures of 99 ± 1.0°C. 

B. Accurately weigh 5.00 grams of the

sample (ground to pass ≤ 4 mm 

screen) 20 into a weighed moisture dish 

and place uncovered dish in oven.21 

Sample each smokeless tobacco brand 

name according to the provided testing 

frequency schedule.19 The number of 

products sampled should reflect an 

acceptable level of precision.16 The test 

material is to be representative of the 

product that is sold to the public and 

therefore should consist of sealed, 

packaged samples of finished product 

that is ready for commercial 

distribution. Samples are to be analyzed 

in duplicate. 

C. Do not exceed 1 sample/10 sq in

(650 sq cm) shelf space, and use only 1 

shelf. Dry 3 hr at 99 ± 1.0°C. Remove 

from oven, cover, and cool in desiccator 

to room temperature (about 30 min). 

Reweigh and calculate percent moisture. 

D. Report the final moisture

determination as a percentage (%), to an 

accuracy level of one decimal place for 

each brand name (e.g., Skoal Bandits 

Wintergreen, Skoal Long Cut Cherry, 

Skoal Long Cut Wintergreen, etc.). All 

data should include the mean value 

with a 95% confidence interval, the 

range of values, the number of samples 

tested, the number of lots per brand 

name, and the estimated precision of the 

mean. Information will be reported for 

each manufacturer and variety 

(including brand families and brand 

variations) and brand name (e.g., Skoal 

Bandits Wintergreen, Skoal Long Cut 

Cherry, Skoal Long Cut Wintergreen, 

etc.). 

IV. pH Measurement 12 22 

A. Test samples as soon as possible

after they are received. Sample each 

smokeless tobacco brand name 

according to the provided testing 

frequency schedule.19 The number of 

products sampled should reflect an 

acceptable level of precision.16 The test 

material is to be representative of the 

product that is sold to the public and 

therefore should consist of sealed, 

packaged samples of finished product 

that is ready for commercial 

distribution. Samples are to be analyzed 

in duplicate. 

B. Accurately weigh 2.00 grams of the

sample. Place in a 50 mL polypropylene 

container with 20 mL deionized 

distilled water. 

C. Place Teflon-coated magnetic

stirring bar in container and stir mixture 

continuously throughout testing. 

D. Measure pH of sample after a twopoint calibration of the pH meter to an 

accuracy of two decimal places using 

standard pH buffers (4.01 and 7.00 or 

7.00 and 10.00) that will encompass the 

expected pH value of the smokeless 

tobacco product. 

E. The first time pH values are

determined for a smokeless tobacco 

product, measure the pH of the 

smokeless tobacco product at 5, 15, and 

30 minutes. If there is no systematic 

variation in pH values with time, all 

subsequent pH determinations are made 

at 5 minutes. If there is systematic 

variation in pH values, continue to 

measure the pH of the smokeless 

tobacco product until the pH value is 

stable and does not vary more than 10% 

over 15 minutes. Report the final pH 

value. 

F. Report the final pH determination

to an accuracy level of two decimal 

places for each brand name (e.g., Skoal 

Bandits Wintergreen, Skoal Long Cut 

Cherry, Skoal Long Cut Wintergreen, 

etc.). All data should include the mean 

value with a 95% confidence interval, 

the range of values, the number of 

samples tested, the number of lots per 

brand name, and the estimated 

precision of the mean. Information will 

be reported for each manufacturer and 

variety (including brand families and 

brand variations) and brand name (e.g., 

Skoal Bandits Wintergreen, Skoal Long 

Cut Cherry, Skoal Long Cut 

Wintergreen, etc.). 

G. Estimate the un-ionized (free)

nicotine content with the HendersonHassel Balch equation (Equation 4), 

based on measured pH and nicotine 

content. 

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EN07JA09.003</MATH> EN07JA09.004</MATH>

Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 717 

Equation 4:

[ ] B pH = pKa + log
 ⎡BH+ ⎤ ⎣ ⎦

B H+ + � BH+

[ ] B 

⎡BH+ ⎤ ⎣ ⎦ % un-ionized (free) nicotine = ×100 [ ] B 

+1 ⎡BH + ⎤ ⎣ ⎦

pKa = 8.02 (CRC Handbook of Chemistry and Physics, 1989-1990)

[B] = amount of un-ionized (free) nicotine

[BH+ ] = amount of ionized nicotine

H. Report the final estimated un- each brand name (e.g., Skoal Bandits mean. Information will be reported for 

ionized (free) nicotine as a percentage Wintergreen, Skoal Long Cut Cherry, each manufacturer and variety 

(%) of the total nicotine content, to an Skoal Long Cut Wintergreen, etc.). All (including brand families and brand 

accuracy level of two decimal places data should include the mean value variations) and brand name (e.g., Skoal 

and as mg of un-ionized (free) nicotine with a 95% confidence interval, the Bandits Wintergreen, Skoal Long Cut 

per gram of the tobacco product (mg un- range of values, the number of samples Cherry, Skoal Long Cut Wintergreen, 

ionized (free) nicotine/gram), to an tested, the number of lots per brand etc.). 

accuracy level of two decimal places for name, and the estimated precision of the Sample calculation: 

Mean total nicotine = 10.30 (mg/g) 

Mean pH = 7.50 

pKa = 8.02 

[ ] B

pH = pKa l + og ⎡BH + ⎤ ⎣ ⎦

[un-ionized (free) nicotine] 7 5. 0 = 8 02. + log [ionized nicotine] 

[un-ionized (free) nicotine] −0 5. 2 = log [ionized nicotine] 

[un-ionized (free) nicotine] 0 302. = [ionized nicotine] 

[ ] B 

⎡BH+ ⎤ ⎣ ⎦ % un-ionized (free) nicotine = ×100 [ ] B 

+1 ⎡BH+ ⎤ ⎣ ⎦

0.302 % un-ionized (free) nicotine = ×100

0.302+1

% un-ionized (free) nicotine = 23.20 

% un-ionized (free) nicotine Total free nicotine (mg/g) = total nicotine ×

100 

23.20 Total free nicotine (mg/g) = 10.30 × 

100 

Total free nicotine (mg/g) = 2.39 

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718 Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 

V. Assay Criteria for Quality Assurance

A. Establishing Limits for Quality

Control Parameters

All quality control parameters must 

be determined within the laboratory in 

which they are to be used. At least 10 

within-laboratory runs must be 

performed to establish temporary 

confidence intervals for the quality 

control parameters. Permanent limits 

should be established after 20 runs and 

should be reestablished after each 

additional 20 runs. 

B. Exclusion of Outliers from the

Calibration Curve 18 

The coefficient of determination 

between Areanicotine/AreaIS and nicotine 

concentration should be equal to 0.99 or 

higher. Any calibration standard having 

an estimated concentration computed 

from the regression equation (Equation 

1) which is different from its actual

concentration by a factor of 10% can be

excluded from the calibration curve. Up

to two concentrations may be excluded,

but caution should be used in

eliminating values, since bias may be

increased in the calibration curve. If an

outlier value is eliminated, its duplicate

value must also be discarded to avoid

producing a new bias. All unknowns

must fall within the calibration curve;

therefore, duplicate values excluded at

either end of the calibration curve will

restrict the useful range of the assay.

C. Quality Control Pools and Run

Rejection Rules

The mean estimated nicotine 

concentration in a pool should be 

compared with the established limits for 

that pool based on at least 20 

consecutive runs. An analytical run 

should be accepted or rejected based 

upon the following set of rules adapted 

from Westgard et al. (1981). 

1. When the mean of one QC pool

exceeds the limit of x ± 3 standard 

deviations (SD), then the run is rejected 

as out of control. Here, x and SD 

represent the overall mean and standard 

deviation of all estimated nicotine 

concentrations for a particular pool in 

the runs which were used to establish 

the control limits. 

2. When the mean nicotine

concentrations in two QC pools in the 

same run exceed the same direction, 

then the run must be rejected. The same 

direction is the condition in which both 

pools exceed either the x + 2 SD or the 

x -2 SD limits. 

3. When the mean nicotine

concentrations in one or two QC pools 

exceed their x ± 2 SD limits in the same 

direction in two consecutive runs, then 

both runs must be rejected. 

4. When the mean nicotine

concentrations in two QC pools are 

different by more than a total of 4 SD, 

then the run must be rejected. This 

condition may occur, for example, when 

one QC pool is 2 SD greater than the 

mean, and another is 2 SD less than the 

mean. 

Endnotes 

The comments and notes listed below 

can be described as Good Laboratory 

Practice guidelines; they are described 

in detail in this protocol to ensure 

minimal interlaboratory variability in 

the determination of nicotine, total 

moisture, and pH in smokeless tobacco. 1 This protocol assumes that the 

testing facility will implement and 

maintain a stringent Quality Assurance/ 

Quality Control program to include, but 

not be limited to, regular interlaboratory 

comparisons, determination of the 

quality and purity of purchased 

products, and proper storage and 

handling of all reagents and samples. 2 When a specific product or 

instrument is listed, it is the product or 

instrument that was used in the 

development of this method. Equivalent 

products or instruments may also be 

used. Use of trade names is for 

identification only and does not 

constitute endorsement by the Public 

Health Service or the U.S. Department 

of Health and Human Services. 3 All chemicals, solvents, and gases 

are to be of the highest purity. 4 Companies must ensure that the 

purity of the nicotine base is certified by 

the vendor and that the chemical is 

properly stored. However, nicotine base 

oxidizes with storage, as reflected by the 

liquid turning brown. If oxidation has 

occurred, the nicotine base should be 

distilled prior to use in making a 

standard solution. 5 A suggested method for the 

determination of nicotine purity is 

CORESTA Recommended Method No. 

39. 6 Horizontal shaking will allow more 

intimate contact of this three phase 

extraction. There is a minimal dead 

volume in the tube due to the large 

sample size and extraction volume. This 

necessitates horizontal shaking. 7 If a linear shaker is not available, a 

wrist action shaker using 250 mL 

stoppered Erlenmeyer flasks can be 

substituted. Values for nicotine are 

equivalent to those obtained from the 

linear shaker. 8 After installing a new column, 

condition the column by injecting a 

tobacco sample extract on the column, 

using the described column conditions. 

Injections should be repeated until areas 

of IS and nicotine are reproducible. This 

will require approximately four 

injections. Recondition column when 

instrument has been used infrequently 

and after replacing glass liner. 9 Glass liner and septum should be 

replaced after every 100 injections. 10 Most older instruments operate at 

constant pressure. To reduce confusion, 

it is suggested that the carrier gas flow 

through the column be measured at the 

initial column temperature. 11 The testing facility must ensure that 

samples are obtained through the use of 

a survey design protocol for sampling 

‘‘at one point in time’’ at the factory or 

warehouse. The survey design protocol 

must address short-, medium-, and longterm smokeless tobacco product 

variability (e.g., variability over time 

and from container to container of the 

tobacco product) in a manner equivalent 

to that described for cigarette sampling 

in Annex C of ISO Protocol 8243. 

Information accompanying results for 

each sample should include, but not be 

limited to: 

For each product—manufacturer and 

variety (including brand families and 

brand variations) and brand name (e.g., 

Skoal Bandits, Skoal Long Cut Cherry, 

Skoal Long Cut Wintergreen, etc.): 

1. Product ‘‘category,’’ e.g., loose leaf,

plug, twist, dry snuff, moist (wet) snuff, 

etc. 

2. Lot number.

3. Lot size.

4. Number of randomly sampled,

sealed, packaged (so as to be 

representative of the product that is sold 

to the public) smokeless tobacco 

products selected (sampling fraction) for 

nicotine, moisture, and pH 

determination. 

5. Documentation of method used for

random sample selection. 

6. ‘’’Age’’ of product when received

by testing facility and storage conditions 

prior to analysis. 12 Extraction of nicotine and pH 

determination must be performed with 

reagents and samples at a room 

temperature of 22–25°C. Room 

temperature should not vary more than 

1°C during extraction of nicotine or pH 

determination. 13 Use non-glass 10 mL repipette for 

transferring NaOH solution. 14 Use 50 mL repipette for transferring 

MTBE. 15 For dry snuff, use 0.500 ± 0.010 

gram sample. 16 The testing facility is referred to 

ISO Procedure 8243 for a discussion of 

sample size and the effect of variability 

on the precision of the mean of the 

sample (ISO 8243, 1991). 17 When analyzing new smokeless 

tobacco products, extract product 

without IS to determine if any 

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Federal Register / Vol. 74, No. 4 / Wednesday, January 7, 2009 / Notices 719 

components co-elute with the IS or 

impurities in the IS. This interference 

could artificially lower calculated 

values for nicotine. 

18 The calculated nicotine values for 

all samples must fall within the low and 

high nicotine values used for the 

calibration curve. If not, prepare a fresh 

nicotine standard solution and an 

appropriate series of standard nicotine 

dilutions. Determine the detector 

response for each standard using 

chromatographic conditions described 

in I.E. 

19 The testing frequency for each 

smokeless tobacco brand name (e.g., 

Skoal Bandits Wintergreen, Skoal Long 

Cut Cherry, Skoal Long Cut 

Wintergreen, etc.) is based on the 

manufacturing duration (refer to table 

below). Each smokeless tobacco brand 

name will be sampled and tested for 

nicotine, total moisture, and pH no 

fewer than twice and no more than four 

times during a calendar year. 

Manufacturing duration in Test 

weeks frequency* 

up to and including 4 ................ 2 

up to and including 28 .............. 3 

up to and including 52 .............. 4 

*Use a statistical program to determine random sampling dates based on the total manufacturing duration during a calendar year. 

Sampling dates should fall on actual manufacturing days for the product when test material 

that is representative of the product that is 

sold to the public (consisting of sealed, packaged samples) is available. If a statistically determined sampling date falls on a day that 

does not meet this criterion, sample the product on the next date that does meet the 

criteria. 

For smokeless tobacco brand names 

with episodic production during a 

calendar year, the total number of 

sampling dates is determined by the 

sum of the individual test frequencies, 

not to exceed four. For the purpose of 

the Protocol, episodic production is 

defined as manufacturing intervals 

separated by periods of 30 or more days 

when the smokeless tobacco brand 

name is not manufactured. 

Example 1: Within a single calendar year 

a smokeless tobacco brand name is 

manufactured from January 1 to March 31 

and from September 1 to December 15. The 

testing frequency for the first manufacturing 

interval is 3 and for the second 

manufacturing interval is 3. The Protocol 

allows that each smokeless tobacco brand 

name be tested for nicotine, total moisture, 

and pH no more than four times during a 

calendar year. Therefore, 4 random sampling 

dates, as described in the footnote to the 

above table, are determined for the smokeless 

tobacco brand name. The values for nicotine, 

moisture, and pH determinations, and 

unionized (free) nicotine calculations and the 

mean of the 4 data points for that smokeless 

tobacco brand name are reported. 

Example 2: Within a single calendar year 

a smokeless tobacco brand name is 

manufactured from April 5 to May 3 and 

from September 1 to December 15. The 

testing frequency for the first manufacturing 

interval is 2 and for the second 

manufacturing interval is 3. The values for 

nicotine, moisture, and pH determinations, 

and unionized (free) nicotine calculations 

and the mean of the 4 data points for that 

smokeless tobacco brand name are reported. 

Example 3: Within a single calendar year 

a smokeless tobacco brand name is 

manufactured from January 1 to January 15 

and from September 1 to September 22. The 

testing frequency for the first manufacturing 

interval is 2 and for the second 

manufacturing interval is 2. Four random 

sampling dates are selected to fall within the 

6 weeks of manufacturing for the smokeless 

tobacco brand name. The values for nicotine, 

moisture, and pH determinations, and 

unionized (free) nicotine calculations and the 

mean of the 4 data points for that smokeless 

tobacco brand name are reported. 

20 The method is a modification of 

AOAC Method 966.02 (1990) in that the 

ground tobacco passes through a 4 mm 

screen rather than a 1 mm screen. 21 When drying samples, do not dry 

different products (e.g., moist (wet) 

snuff, dry snuff, loose leaf) in the oven 

at the same time since this will produce 

errors in the moisture determinations. 22 The method is a modification of a 

method published by Henningfield et al. 

(1995). 

References 

AOAC (Association of Official 

Analytical Chemists). Official Methods 

of Analysis. 966.02: Moisture in 

Tobacco. (1990) Fifth Edition. K. 

Helrich (ed). Association of Official 

Analytical Chemists, Inc., Suite 400, 

2200 Wilson Boulevard, Arlington, 

Virginia 22201 USA. 

CORESTA (Centre de Coope ́ration 

pour les Recherches Scientifiques 

relatives au Tabac). Recommended 

Method No. 39: Determination of the 

purity of nicotine and nicotine salts by 

gravimetric analysis—Tungstosilic acid 

method. November, 1994. 87–90. 

CRC Handbook of Chemistry and 

Physics. R.C. Weast, D.R. Lide, M.J. 

Astle, and WH. Beyer (eds). 70th ed. 

Boca Raton, Florida: CRC Press (1989– 

1990) D–162. 

Henningfield, J.E., Radzius A., Cone 

E.J. (1995). Estimation of available 

nicotine content of six smokeless 

tobacco products. Tobacco Control 

4:57–61. 

ISO (International Organization for 

Standardization). IOS 8243: Cigarettes— 

Sampling. (1991). Second Edition. 

Prepared by Technical Committee ISO/ 

TC 126, Tobacco and tobacco products. 

International Organization for 

Standardization, Case Postale 56, CH– 

1211 Genve 20, Switzerland. 

Westgard J.O., Barry P., Hunt M., and 

Groth T. (1981). A multi-rule Shewhart 

chart for quality control in clinical 

chemistry. Clinical Chemistry 27:493. 

[FR Doc. E9–19 Filed 1–6–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review, Special Emphasis Panel, Member 

Conflict: Auditory Neuroscience. 

Date: January 22–23, 2009. 

Time: 6 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: John Bishop, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5180, 

MSC 7844, Bethesda, MD 20892, (301) 435– 

1250, bishopj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review, Special Emphasis Panel, 

Epidemiology and Genetics of Aging and 

Neurodegenerative Diseases. 

Date: January 23, 2009. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call) 

Contact Person: Fungai F. Chanetsa, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3135, 

MSC 7770, Bethesda, MD 20892, 301–435– 

1262, chanetsaf@csr.nih.gov. 

Name of Committee: Center for Scientific 

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