Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 81533 

1The Department may also use constructed 

export prices, if appropriate. Because the use of 

export prices or constructed export prices is not 

relevant to the substance of this notice, the 

Department refers only to export prices hereafter. 

2Section 771(35)(A) of the Act defines the 

dumping margin as the amount by which normal 

value ‘‘exceeds’’ export price (or constructed export 

price). Section 771(35)(B) defines the weighted 

average dumping margin as the percentage 

determined by dividing the aggregate dumping 

margins determined for a specific exporter or 

producer by the aggregate export or constructed 

export price of that exporter or producer. 

3The Department’s regulations also state that the 

Department normally will compare weighted 

average normal values to weighted average export 

prices for comparable merchandise (the average-toaverage comparison method) in an investigation. 19 

CFR 351.414(c)(1). In response to prior WTO 

dispute settlement reports, the Department 

modified its methodology for calculating the 

weighted average margin of dumping in an original 

investigation to no longer use average-to-average 

comparisons without providing offsets for nondumped comparisons. Antidumping Proceedings: 

Calculation of the Weighted-Average Dumping 

Margin During an Antidumping Investigation; Final 

Modification, 71 FR 77,722 (December 27, 2006). 

4See Notice of Determination Under Section 129 

of the Uruguay Round Agreements Act; 

Antidumping Measures Concerning Certain 

Softwood Lumber Products From Canada, 70 FR 

22,636 (May 2, 2005). 

5United States-Laws, Regulations and 

Methodology for Calculating Dumping Margins 

(‘‘Zeroing’’) (‘‘US-Zeroing (EC)’’), WT/DS294/R, WT/ 

Continued 

DEPARTMENT OF COMMERCE 

International Trade Administration 

19 CFR Part 351 

[Docket No. 101130598–0598–01] 

RIN 0625–AA87 

Antidumping Proceedings: Calculation 

of the Weighted Average Dumping 

Margin and Assessment Rate in 

Certain Antidumping Duty Proceedings 

AGENCY: Import Administration, 

International Trade Administration, 

Department of Commerce. 

ACTION: Proposed Rule; Proposed 

Modification; Request for Comments. 

SUMMARY: The Department of Commerce 

(‘‘the Department’’) is requesting 

comments regarding the calculation of 

the weighted average dumping margin 

and antidumping duty assessment rate 

in certain antidumping duty 

proceedings. Currently, in a review of 

an antidumping duty order conducted 

under 19 CFR 351.213 (administrative 

review), 351.214 (new shipper review), 

and 351.215 (expedited antidumping 

review) (collectively ‘‘reviews’’), the 

Department usually makes comparisons 

between transaction-specific export 

prices and average normal values and 

does not offset any dumping that is 

found with the results of comparisons 

for which the transaction-specific export 

price exceeds the average normal value. 

In addition, in the most recent original 

antidumping duty investigation in 

which the Department calculated the 

weighted average margins of dumping 

using transaction-to-transaction 

comparisons, the Department did not 

grant offsets for non-dumped 

comparisons. Several World Trade 

Organization (‘‘WTO’’) dispute 

settlement reports have found that the 

United States application of these 

methodologies was inconsistent with 

our WTO obligations. In response to 

these reports, the Department proposes 

modification of its methodologies, 

including changes to certain provisions 

of the Department’s regulations. 

DATES: To be assured of consideration, 

comments must be received no later 

than January 27, 2011. 

ADDRESSES: All comments must be 

submitted through the Federal 

eRulemaking Portal at http:// 

www.regulations.gov, Docket No. ITA– 

2010–0011, unless the commenter does 

not have access to the internet. 

Commenters that do not have access to 

the internet may submit the original and 

two copies of each set of comments by 

mail or hand delivery/courier to Ronald 

K. Lorentzen, Deputy Assistant 

Secretary for Import Administration, 

Room 1870, Department of Commerce, 

14th Street and Constitution Ave., NW., 

Washington, DC 20230. The comments 

should also be identified by Regulation 

Identifier Number (RIN) 0625–AA87. 

The Department will consider all 

comments received before the close of 

the comment period. The Department 

will not accept comments accompanied 

by a request that part or all of the 

material be treated confidentially 

because of its business proprietary 

nature or for any other reason. All 

comments responding to this notice will 

be a matter of public record and will be 

available for inspection at Import 

Administration’s Central Records Unit 

(Room 7046 of the Herbert C. Hoover 

Building) and on the Department’s Web 

site at http://www.trade.gov/ia/. 

Any questions concerning file 

formatting, document conversion, 

access on the Internet, or other 

electronic filing issues should be 

addressed to Andrew Lee Beller, Import 

Administration Webmaster, at (202) 

482–0866, e-mail address: webmastersupport@ita.doc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Quentin M. Baird, U.S. Department of 

Commerce, 14th Street and Constitution 

Avenue, NW., Washington, DC 20230; 

telephone: (202) 482–0834. 

SUPPLEMENTARY INFORMATION: 

Background 

In antidumping proceedings, the 

Department determines margins of 

dumping by comparing normal value 

with the export price 1 of comparable 

merchandise. Pursuant to 19 CFR 

414(c)(2), in a review, the Department 

normally will compare normal value 

and export price using the average-totransaction method, which involves a 

comparison of the weighted average 

normal value to export price of 

individual transactions for comparable 

merchandise. When determining the 

weighted average margin of dumping in 

a review, the Department aggregates the 

results of these comparisons and has not 

allowed the results of the comparisons 

for which export price exceeds normal 

value to offset the results of 

comparisons for which export price is 

less than normal value.2 When 

determining importer-specific 

assessment rates in a review, the 

Department similarly aggregates the 

results of importer-specific comparisons 

and has not allowed the results of the 

comparisons for which export price 

exceeds normal value to offset the result 

of comparisons for which export price is 

less than normal value. 

Pursuant to section 777A(d)(1)(A) of 

the Tariff Act of 1930 (‘‘the Act’’), in an 

investigation, the Department may 

determine whether the subject 

merchandise is being sold at less than 

fair value by comparing normal values 

of individual transactions to the export 

prices of individual transactions for 

comparable merchandise (the 

transaction-to-transaction comparison 

method).3 The Department’s regulations 

state that Department will use the 

transaction-to-transaction method only 

in unusual situations, such as when 

there are very few sales of subject 

merchandise and the merchandise sold 

in each market is identical or very 

similar or is custom-made. 19 CFR 

351.414(c)(1). The Department has 

rarely applied the transaction-totransaction comparison method in 

investigations. In the most recent 

investigation in which the Department 

calculated the weighted average margins 

of dumping using transaction-totransaction comparisons, the 

Department did not grant offsets for 

non-dumped comparisons.4

The above methodologies have been 

challenged as being inconsistent with 

the World Trade Organization (‘‘WTO’’) 

General Agreement on Tariffs and Trade 

1994 (‘‘GATT 1994’’) and the Agreement 

on Implementation of Article VI of the 

GATT 1994 (‘‘Antidumping 

Agreement’’). In several disputes,5 the 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
81534 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 

DS294/AB/R, adopted May 9, 2006; United StatesMeasures Related to Zeroing and Sunset Reviews 

(‘‘US-Zeroing (Japan)’’), WT/DS322/R, WT/DS322/ 

AB/R, adopted Jan. 23, 2007; United States-Final 

Anti-Dumping Measures on Stainless Steel from 

Mexico (‘‘US-Stainless Steel (Mexico)’’), WT/DS344/ 

R, WT/DS344/AB/R, adopted May 20, 2008; United 

States-Continued Existence and Application of 

Zeroing Methodology (‘‘US-Continued Zeroing 

(EC)’’), WT/DS350/R, WR/DS350/AB/R, adopted 

Feb. 19, 2009. 

6US-Zeroing (EC), WT/DS294/R, WT/DS294/AB/ 

R, para. 263 (a)(i); US-Zeroing (Japan), WT/DS322/ 

R, WT/DS322/AB/R, para. 190 (c) & 190(e); USStainless Steel (Mexico), WT/DS344/R, WT/DS344/ 

AB/R, paras. 165 (a) & 165 (b); US-Continued 

Zeroing (EC), WT/DS350/R, para. 8.1(e), WT/ 

DS350/AB/R, paras. 395 (a)(v), 395 (d) & 395 (e)(ii). 

7US-Zeroing (Japan), WT/DS322/AB/R, para. 

190(b). 

8 Id., para. 190(d). 

9US-Zeroing (EC), WT/DS294/AB/RW, para. 

469(h)(iv) & (vi); US-Zeroing (Japan), WT/DS322/ 

AB/R, para. 190(f); US-Continued Zeroing (EC), WT/ 

DS350/R, para. 8.1(f), WT/DS350/AB/R, para. 

395(f). 

10Antidumping Proceedings: Calculation of the 

Weighted-Average Dumping Margin During an 

Antidumping Investigation; Final Modification, 71 

FR 77,722 (December 27, 2006). 

11US-Zeroing (Japan), WT/DS322/AB/R, paras. 

88, 138. 

WTO Dispute Settlement Body has 

adopted dispute settlement panel 

reports, as modified by the WTO 

Appellate Body, which found denial of 

offsets for non-dumped comparisons in 

reviews to be inconsistent with the 

United States’ WTO obligations. The 

WTO Appellate Body also found denial 

of offsets for non-dumped comparisons 

in original investigations using 

transaction-to-transaction comparisons 

to be inconsistent with the United 

States’ WTO obligations. In addition, 

certain of the Department’s 

determinations made pursuant to 

section 751(c) of the Act (five-year 

reviews) were found to be inconsistent 

with the United States’ WTO obligations 

insofar as those determinations relied 

on weighted average margins of 

dumping calculated using the 

methodologies found to be inconsistent 

with the United States’ WTO 

obligations. 

Proposal for Calculating the Weighted 

Average Dumping Margin and 

Assessment Rate in Certain 

Antidumping Duty Proceedings and 

Request for Comment 

Pursuant to section 123(g)(1) of the 

Uruguay Round Agreements Act (‘‘the 

URAA’’), ‘‘[i]n any case in which a 

dispute settlement panel or the 

Appellate Body finds in its report that 

a regulation or practice of a department 

or agency of the United States is 

inconsistent with any of the Uruguay 

Round Agreements,’’ certain 

requirements must be met before ‘‘that 

regulation or practice’’ may be 

‘‘amended, rescinded, or otherwise 

modified * * * .’’ Section 123(g)(1)(C) 

of the URAA requires that the 

Department provide opportunity for 

public comment by publishing ‘‘the 

proposed modifications and the 

explanation of the modification’’ in the 

Federal Register. 

Pursuant to section 123(g)(1) of the 

URAA, by this notice the Department is 

proposing modifications to its practice 

in response to the following WTO 

dispute settlement findings. The WTO 

Appellate Body in US-Zeroing (EC), USZeroing (Japan), US-Stainless Steel 

(Mexico), US-Continued Zeroing (EC) 

found denial of offsets for non-dumped 

comparisons in antidumping duty 

administrative reviews to be 

inconsistent with Article 9.3 of the 

Antidumping Agreement and Article 

VI:2 of the GATT 1994, either ‘‘as such,’’ 

or ‘‘as applied’’ in certain administrative 

reviews, or both.6 In US-Zeroing 

(Japan), the WTO Appellate Body also 

found denial of offsets for non-dumped 

comparisons in antidumping duty 

original investigations using 

transaction-to-transaction comparisons 

was inconsistent with Articles 2.4 and 

2.4.2 of the Antidumping Agreement.7

In addition, in US-Zeroing (Japan), the 

WTO Appellate Body found denial of 

offsets for non-dumped comparisons in 

antidumping duty new shipper reviews 

was inconsistent with Articles 2.4 and 

9.5 of the Antidumping Agreement.8

Finally, in US-Zeroing (EC), US-Zeroing 

(Japan), and US-Continued Zeroing 

(EC), the WTO Appellate Body found 

reliance on weighted average margins of 

dumping calculated without granting 

offsets for non-dumped comparisons as 

the basis for determinations made in 

certain five-year (sunset) reviews was 

inconsistent with Article 11.3 of the 

Antidumping Agreement.9

In response to prior findings of 

inconsistency with respect to the 

Department’s calculation of weighted 

average margins of dumping in original 

investigations, the Department 

previously modified its methodology 

such that it now provides offsets for 

non-dumped comparisons when using 

average-to-average comparisons in 

original investigations.10 In response to 

the findings of inconsistency identified 

above, the Department now proposes to 

modify its methodology for calculating 

weighted average margins of dumping 

and assessment rates to provide offsets 

for non-dumped comparisons while 

using monthly average-to-average 

comparisons in reviews in a manner 

that parallels the WTO-consistent 

methodology the Department currently 

applies in original investigations. In 

particular, except where the Department 

determines that application of a 

different comparison method is more 

appropriate, in reviews, the Department 

proposes to compare monthly weighted 

average export prices with monthly 

weighted average normal values and to 

grant an offset for such comparisons that 

show export price exceeds normal value 

in the calculation of the weighted 

average margin of dumping and 

assessment rate. Where the weighted 

average margin of dumping is zero or de 

minimis, no antidumping duties will be 

assessed. In addition, to the extent that 

any prior original antidumping duty 

investigations using transaction-totransaction comparisons could be 

considered as establishing a practice of 

the Department with respect to the 

granting or denial of offsets for nondumped comparisons when calculating 

the weighted average margin of 

dumping,11 the Department proposes to 

withdraw any such practice. With 

respect to the findings of inconsistency 

in certain of the Department’s five-year 

(sunset) reviews, the Department notes 

that the underlying issue is the 

methodology for calculating weighted 

average dumping margins in 

investigations and reviews, which is 

addressed by the modifications the 

Department has made with respect to 

investigations and is proposing herein 

to make with respect to reviews. 

Moreover, the Department recognizes 

that while section 752(c) of the Act 

provides that the Department shall 

consider the weighted average dumping 

margins determined in the investigation 

and subsequent reviews, among other 

factors, the Act does not require the 

Department to rely on the weighted 

average dumping margins, or any 

particular weighted average dumping 

margin, as the basis for its 

determinations in five-year (sunset) 

reviews where such reliance would 

render the determination inconsistent 

with the United States’ international 

obligations. 

The modified methodology for 

reviews requires the Department to 

revise certain provisions of the 

Department’s regulations. In particular, 

19 CFR 351.414(a) and (c) indicate a 

preference for making ‘‘average-totransaction’’ comparisons in 

administrative reviews. This proposed 

rule would revise these provisions to 

permit application of average-to-average 

comparisons in reviews in a manner 

that parallels the comparison methods 

used in original investigations. In 

addition, § 351.414(d)(3) and (e) of the 

Department’s regulations set forth the 

time periods over which weighted 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 81535 

averages are calculated. Section 

351.414(d)(3) provides that when 

applying the ‘‘average-to-average’’ 

method, the weighted averages will 

normally be calculated over the entire 

period of investigation or review, unless 

another averaging period is deemed 

appropriate. Section 351.414(e) provides 

that when applying the preferred 

‘‘average-to transaction’’ method in a 

review, the Department will calculate 

weighted average normal values on a 

monthly basis. The Department 

proposes to modify § 351.414(d)(3) to 

permit weighted averages to normally be 

calculated on a monthly basis in 

reviews, regardless of the comparison 

method used. Conforming changes to 

§ 351.414(e) will ensure § 351.414(d)(3) 

and (e) do not contain redundant 

language. Proposed language for the 

modified provisions is set forth at the 

end of this notice. 

Submission of Comments 

As specified above, to be assured of 

consideration, comments must be 

received no later than January 27, 2011. 

The Department will consider all 

comments received before the close of 

the comment period. The Department 

will not accept comments accompanied 

by a request that part or all of the 

material be treated confidentially 

because of its business proprietary 

nature or for any other reason. All 

comments responding to this notice will 

be a matter of public record and will be 

available for inspection at Import 

Administration’s Central Records Unit 

(Room 7046 of the Herbert C. Hoover 

Building) and on the Department’s Web 

site at http://www.trade.gov/ia/. 

Any questions concerning file 

formatting, document conversion, 

access on the Internet, or other 

electronic filing issues should be 

addressed to Andrew Lee Beller, Import 

Administration Webmaster, at (202) 

482–0866, e-mail address: webmastersupport@ita.doc.gov. 

Timetable 

After considering all comments 

received, the Department intends to 

publish in the Federal Register a Final 

Rule and Final Modification regarding 

the calculation of the weighted average 

dumping margin and assessment rate in 

certain antidumping duty proceedings. 

See section 123(g)(1)(F) of the URAA (19 

U.S.C. 3533(g)(1)(F)). Any changes in 

methodology will be applicable in any 

determinations made pursuant to 

section 129 of the URAA (19 U.S.C. 

3538) in connection with the abovereferenced WTO disputes, and in all 

reviews pending before the Department 

for which a preliminary results is issued 

more than 60 business days after the 

date of publication of the Department’s 

Final Rule and Final Modification. 

Classification 

Executive Order 12866 

The proposed rule has been 

determined to be not significant for 

purposes of Executive Order 12866. 

Regulatory Flexibility Act 

The Chief Counsel for Regulation has 

certified to the Chief Counsel for 

Advocacy of the Small Business 

Administration (‘‘SBA’’) under the 

provisions of the Regulatory Flexibility 

Act, 5 U.S.C. 605(b), that the proposed 

rule would not have a significant 

economic impact on a substantial 

number of small business entities. An 

explanation of the provisions that 

would be implemented by this rule is 

provided in the preamble and is not 

repeated here. The entities that could be 

impacted by this rulemaking include 

U.S. importers of merchandise subject to 

antidumping duty orders. Currently, the 

Department is not able to estimate the 

number of small entities that will be 

impacted by this proposed rule, but the 

Department anticipates that some of the 

entities affected by the proposed rule 

may be considered small entities under 

the SBA small business standard. 

However, the Department has 

determined that the proposed rule will 

not adversely impact small business 

entities. The proposed rule, by granting 

offsets in the calculation of the dumping 

margin and assessment rate, will not 

increase antidumping duty liability. 

Thus no Initial Regulatory Flexibility 

Act statement is required, nor has one 

been prepared. 

Paperwork Reduction Act 

The proposed rule does not contain a 

collection of information for purposes of 

the Paperwork Reduction Act of 1980, 

as amended (44 U.S.C. 3501 et seq.). 

List of Subjects in 19 CFR Part 351 

Administrative practice and 

procedure, Antidumping, Business and 

industry, Cheese, Confidential business 

information, Countervailing duties, 

Freedom of information, Investigations, 

Reporting and recordkeeping 

requirements. 

Dated: November 30, 2010. 

Ronald K. Lorentzen, 

Deputy Assistant Secretary for Import 

Administration. 

For the reasons stated, ITA proposes 

to amend 19 CFR part 351 as follows: 

PART 351—ANTIDUMPING AND 

COUNTERVAILING DUTIES 

1. The authority citation for part 351 

continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 1202 

note; 19 U.S.C. 1303 note; 19 U.S.C. 1671 et 

seq.; and 19 U.S.C. 3538. 

2. Section 351.414 is revised to read 

as follows: 

§ 351.414 Comparison of normal value 

with export price (constructed export price). 

(a) Introduction. This section explains 

when and how the Secretary will 

average prices in making comparisons of 

export price or constructed export price 

with normal value. (See section 777A(d) 

of the Act.) 

(b) Description of methods of 

comparison—(1) Average-to-average 

method. The ‘‘average-to-average’’ 

method involves a comparison of the 

weighted average of the normal values 

with the weighted average of the export 

prices (and constructed export prices) 

for comparable merchandise. 

(2) Transaction-to-transaction 

method. The ‘‘transaction-totransaction’’ method involves a 

comparison of the normal values of 

individual transactions with the export 

prices (or constructed export prices) of 

individual transactions for comparable 

merchandise. 

(3) Average-to-transaction method. 

The ‘‘average-to-transaction’’ method 

involves a comparison of the weighted 

average of the normal values to the 

export prices (or constructed export 

prices) of individual transactions for 

comparable merchandise. 

(c) Choice of Method. (1) In an 

investigation or review, the Secretary 

will use the average-to-average method 

unless the Secretary determines another 

method is appropriate in a particular 

case. 

(2) The Secretary will use the 

transaction-to-transaction method only 

in unusual situations, such as when 

there are very few sales of subject 

merchandise and the merchandise sold 

in each market is identical or very 

similar or is custom-made. 

(d) Application of the average-toaverage method—(1) In general. In 

applying the average-to-average method, 

the Secretary will identify those sales of 

the subject merchandise to the United 

States that are comparable, and will 

include such sales in an ‘‘averaging 

group.’’ The Secretary will calculate a 

weighted average of the export prices 

and the constructed export prices of the 

sales included in the averaging group, 

and will compare this weighted average 

to the weighted average of the normal 

values of such sales. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
81536 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 

1As an error, the authority citation we listed for 

the proposed amendments to part 570 (21 CFR part 

570) did not include an existing authority citation, 

i.e., section 408 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 346a). 

Nothing in the 1997 proposed rule would alter the 

citation to section 408. Therefore, the authority 

citation for part 570 will continue to include 

section 408. 

(2) Identification of the averaging 

group. An averaging group will consist 

of subject merchandise that is identical 

or virtually identical in all physical 

characteristics and that is sold to the 

United States at the same level of trade. 

In identifying sales to be included in an 

averaging group, the Secretary also will 

take into account, where appropriate, 

the region of the United States in which 

the merchandise is sold, and such other 

factors as the Secretary considers 

relevant. 

(3) Time period over which weighted 

average is calculated. When applying 

the average-to-average method in an 

investigation, the Secretary normally 

will calculate weighted averages for the 

entire period of investigation. However, 

when normal values, export prices, or 

constructed export prices differ 

significantly over the course of the 

period of investigation, the Secretary 

may calculate weighted averages for 

such shorter period as the Secretary 

deems appropriate. When applying the 

average-to-average method in a review, 

the Secretary normally will calculate 

weighted averages on a monthly basis 

and compare the weighted-average 

monthly export price or constructed 

export price to the weighted-average 

normal value for the contemporaneous 

month. 

(e) Application of the average-totransaction method—In applying the 

average-to-transaction method in a 

review, when normal value is based on 

the weighted average of sales of the 

foreign like product, the Secretary will 

limit the averaging of such prices to 

sales incurred during the 

contemporaneous month. 

(f) Contemporaneous Month. 

Normally, the Secretary will select as 

the contemporaneous month the first of 

the following months which applies: (1) 

The month during which the particular 

U.S. sales under consideration were 

made; 

(2) If there are no sales of the foreign 

like product during this month, the 

most recent of the three months prior to 

the month of the U.S. sales in which 

there was a sale of the foreign like 

product. 

(3) If there are no sales of the foreign 

like product during any of these 

months, the earlier of the two months 

following the month of the U.S. sales in 

which there was a sale of the foreign 

like product. 

[FR Doc. 2010–32632 Filed 12–27–10; 8:45 am] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 170, 184, 186, and 570 

[Docket No. FDA–1997–N–0020; Formerly 

Docket No. 1997N–0103] 

Substances Generally Recognized as 

Safe; Reopening of the Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening the 

comment period for the proposed rule 

published in the Federal Register of 

April 17, 1997 (the 1997 proposed rule). 

The 1997 proposed rule would replace 

the voluntary petition process to affirm 

the generally recognized as safe (GRAS) 

status of a substance intended for use in 

food for humans or animals with a 

voluntary notification procedure. FDA 

is reopening the comment period to 

update comments. The proposed rule 

would also clarify the criteria for 

exempting the use of a substance as 

GRAS. 

DATES: The comment period for the 

proposed rule published April 17, 1997 

(62 FR 18938), is reopened. Submit 

either electronic or written comments 

on the proposed rule by March 28, 2011. 

Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by February 28, 

2011, (see the ‘‘Paperwork Reduction 

Act of 1995’’ section of this document). 

ADDRESSES: You may submit comments, 

including comments regarding the 

proposed collection of information, 

identified by Docket No. FDA–1997–N– 

0020, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–1997–N–0020, 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: 

With regard to substances that would be 

used in human food: Paulette M. 

Gaynor, Center for Food Safety and 

Applied Nutrition (HFS–255), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1192. 

With regard to substances that would 

be used in food for animals: Geoffrey K. 

Wong, Center for Veterinary Medicine 

(HFV–224), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6879. 

With regard to the information 

collection: Denver Presley Jr., Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3793. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the 1997 proposed rule, FDA 

proposed to replace the voluntary GRAS 

affirmation petition process in 

§§ 170.35(c) and 570.35(c) (21 CFR 

170.35(c) and 570.35(c)) with a 

voluntary notification procedure 

whereby any person may notify us of a 

determination that a particular use of a 

substance in human food (proposed 

§ 170.36) or in food for animals 

(proposed § 570.36) is GRAS.1 We also 

proposed to clarify the criteria in 

§§ 170.30 (21 CFR 170.30) and 570.30 

(21 CFR 570.30) whereby the use of a 

substance is not subject to the premarket 

approval requirements of the FD&C Act 

because it is GRAS. To simplify the 

discussion in this document, in general, 


emcdonald on DSK2BSOYB1PROD with PROPOSALS