Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2847 

from the United States, including those 

that accompanied an individual outside 

the United States for personal use, if 

they are reimported into the United 

States by the same person who exported 

them, without having been advanced in 

value or improved in condition by any 

process or other means while outside 

the United States; and 

(2) Jadeite or rubies mined or 

extracted from a country other than 

Burma, and articles of jewelry 

containing jadeite or rubies mined or 

extracted from a country other than 

Burma that are imported by or on behalf 

of an individual for personal use and 

accompanying an individual upon entry 

into the United States. 

PART 163—RECORDKEEPING 

■ 3. The general authority citation for 

Part 163, CBP regulations, continues to 

read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 

1484, 1508, 1509, 1510, 1624. 

■ 4. The Appendix to Part 163 is 

amended by adding a new listing under 

section IV in numerical order to read as 

follows: 

Appendix to Part 163—Interim (a)(1)(A) 

List. 

* * * * * 

IV. * * * 

§ 12.151 Documentation supporting 

importer’s certification on jadeite, rubies, or 

articles of jewelry containing jadeite or 

rubies, including an exporter’s certification. 

* * * * * 

Jayson P. Ahern, 

Acting Commissioner, U.S. Customs and 

Border Protection. 

Approved: January 12, 2009 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. E9–786 Filed 1–15–09; 8:45 am] 

BILLING CODE 9111–14–P 

INTERNATIONAL TRADE 

COMMISSION 

19 CFR Part 207 

Revised Procedures and Requests for 

Information During Adequacy Phase of 

Five-Year Reviews 

AGENCY: United States International 

Trade Commission. 

ACTION: Final rulemaking. 

SUMMARY: The United States 

International Trade Commission (‘‘the 

Commission’’) amends its Rules of 

Practice and Procedure to require that 

responses to notices of institution of 

five-year reviews be filed within 30 days 

of publication of the notice, as opposed 

to the 50-day response period specified 

in its current rules. It also provides 

notice of its decision, which does not 

require a change in its rules, to seek 

additional information from interested 

parties at the institution of five-year 

reviews, and to seek information from 

purchasers during the adequacy phase 

of five-year reviews in certain 

circumstances. 

DATES: Effective Date: This regulation is 

effective February 17, 2009. 

Applicability Date: This regulation 

and the other changes to Commission 

procedures described in this notice will 

be applicable to five-year reviews 

instituted on or after March 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Marc A. Bernstein, Office of General 

Counsel, U.S. International Trade 

Commission, telephone 202–205–3087, 

or John Ascienzo, Office of 

Investigations, U.S. International Trade 

Commission, telephone 202–205–3175. 

Hearing-impaired individuals can 

obtain information on this matter by 

contacting the Commission’s TDD 

terminal at 202–205–1810. General 

information concerning the Commission 

may also be obtained by visiting its Web 

site at http://www.usitc.gov. 

SUPPLEMENTARY INFORMATION: On July 

17, 2008, the Commission published a 

notice of proposed rulemaking (NOPR) 

in the Federal Register. 73 FR 40992 

(July 17, 2008). In that notice the 

Commission proposed two sets of 

changes to the procedures it uses during 

the adequacy phase of five-year reviews 

that it conducts pursuant to 19 U.S.C. 

1675(c). First, the Commission proposed 

modifying the information it requests 

interested parties furnish in their 

responses to the notice of institution it 

publishes pursuant to section 207.60(d) 

of the Commission’s Rules of Practice 

and Procedure, 19 CFR 207.60(d), and 

proposed issuing short questionnaires to 

purchasers in some circumstances. This 

set of proposals did not require any 

amendment to the Commission’s 

regulations. The second proposal sought 

to amend section 207.61(a) of the 

Commission’s Rules of Practice and 

Procedure to require that responses to 

the notice of institution be filed within 

30 days after its publication. 

Although the Commission considers 

these rules to be procedural rules that 

are excepted from the notice and 

comment requirements of 5 U.S.C. 

553(b)(3)(A), the Commission invited 

the public to comment on the proposed 

rule amendment and the other proposed 

changes to its procedures within 60 

days of publication of the NOPR in the 

Federal Register. The Commission 

received substantive comments from the 

following: (1) The law firm of Wiley 

Rein on behalf of the Steel 

Manufacturers Ass’n (SMA); (2) the law 

firm of Skadden, Arps, Slate, Meagher & 

Flom (Skadden); (3) the law firm of 

Kelley Drye & Warren (Kelley); and (4) 

the law firm of Stewart and Stewart 

(Stewart). 

In adopting these changes to its rules 

and procedures, the Commission has 

fully considered the concerns expressed 

in the comments with respect to the 

potential burden on parties to reviews 

and the usefulness of the additional 

information sought by the Commission. 

These comments, and the Commission’s 

responses thereto, are discussed 

comprehensively below. In light of the 

comments, the Commission intends to 

review its new information requests and 

changes to its procedures once it has 

had sufficient experience with them. In 

particular, the Commission intends to 

examine the changes’ utility and 

relevance in attaining the desired 

objectives, as well as the rate of 

response by purchasers to the adequacy 

phase questionnaires. 

As required by the Regulatory 

Flexibility Act, the Commission certifies 

that the amendment to its regulation 

will not have a significant impact on 

small business entities. 

Changes in Commission Data Collection 

The Commission has decided to adopt 

the changes in data collection proposed 

in the NOPR. Accordingly, each notice 

of institution the Commission issues 

will contain the additional information 

requests indicated in Appendix A to the 

NOPR, and in those reviews in which 

the Commission does not receive 

responses to the notice of institution 

from both domestic interested parties 

and respondent interested parties, the 

Commission will transmit brief 

questionnaires to purchasers, in the 

format indicated in Appendix B to the 

NOPR, shortly after it receives responses 

to the notice of institution. These 

changes will become effective for 

reviews instituted on or after March 1, 

2009. 

The commenters opposed both of the 

Commission’s data collection proposals. 

With respect to the proposal to seek 

additional information in the notice of 

institution, commenters questioned the 

appropriateness of the Commission’s 

stated objective of obtaining a more 

complete record to better enable it to 

decide whether to expedite a review. 

Skadden contended that the 

Commission should expedite reviews 

whenever responses from an interested 

party group are inadequate and that 


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2848 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

Congress never intended the 

Commission to take considerations such 

as conditions of competition into 

account in deciding whether to expedite 

a review. Kelley expressed a similar 

view, maintaining that when parties 

have deliberately chosen not to 

participate in a review, it is a waste of 

resources for the Commission and other 

parties to undertake the costs of a full 

review. SMA asserted that the sole 

purpose of information requests in the 

adequacy phase is to ascertain sufficient 

commitment to participation in a fiveyear review.The Commission disagrees 

with the premise underlying these 

comments that an inadequate interested 

party group response should always 

result in an expedited determination. 

Neither the statute nor Commission 

practice dictates such a result. The 

statute states that ‘‘[i]f interested parties 

provide inadequate responses to the 

notice of institution * * * the 

Commission * * * may issue, without 

further investigation, a final 

determination based on the facts 

available.’’ 19 U.S.C. 1675(c)(3)(B) 

(emphasis added). The statutory 

language indicates that the Commission 

has the discretion whether to conduct 

an expedited review when it receives an 

inadequate response from an interested 

party group. While the Statement of 

Administrative Action (SAA) for the 

Uruguay Round Agreements Act states 

that the purpose of the expedited review 

procedure is ‘‘to eliminate needless 

reviews,’’ it does not suggest that all 

reviews in which an interested party 

group response may be inadequate are 

necessarily ‘‘needless.’’ H.R. Rep. 103– 

316, vol. I at 880 (1994). Indeed, in its 

1998 rulemaking notice, the 

Commission expressly indicated that it 

‘‘has the discretion to conduct a full 

review even when interested party 

responses are inadequate.’’ 63 FR 30599, 

30604 (June 5, 1998). The circumstances 

the Commission identified as justifying 

such an exercise of discretion included 

mixed responses in grouped reviews 

(i.e., adequate respondent interested 

party group responses for some subject 

countries but not others) and the 

existence of significant domestic like 

product issues. Id. at 30604. In recent 

years, the Commission has taken the 

position that changes in conditions of 

competition may also warrant 

conducting a full review even when a 

respondent interested party group 

response is inadequate. E.g., Certain 

Welded Stainless Steel Pipe from Korea 

and Taiwan, Inv. Nos. 731–TA–540–541 

(Second Review), USITC Pub. 3877 at 3 

(Aug. 2006). 

Commenters questioned whether the 

additional data requests would 

accomplish the Commission’s objective 

of improving the information available 

to it in expedited reviews. Three 

commenters contended that the 

additional information the Commission 

seeks will be too limited in temporal 

scope, because it will concern only one 

calendar year, to be particularly 

probative. They asserted that a single 

year’s worth of data may be misleading. 

The Commission acknowledges the 

limitations of a data set that contains 

data for only one year. Nevertheless, the 

other data the Commission currently 

seeks in the notice of institution 

similarly encompass only a single 

calendar year. The Commission believes 

that obtaining additional data 

concerning capacity, financial 

information concerning production of 

the domestic like product, and prices for 

the domestic like product and subject 

merchandise in the U.S. and other 

world markets will improve the quality 

of the record in the reviews it chooses 

to expedite. Indeed, none of the 

commenters directly challenged this 

proposition. Although commenters 

expressed concern about the burden of 

providing the additional information the 

Commission proposes to collect, the 

Commission believes that burden will 

be reasonable and will certainly be less 

onerous than that involved in supplying 

data for several years. 

Commenters further questioned 

whether any information purchasers 

may provide in the proposed ‘‘miniquestionnaires’’ will be useful to the 

Commission. Skadden and SMA 

contended that because purchasers 

cannot provide information pertinent to 

whether interested parties are willing to 

participate in a review and provide 

requested information to the 

Commission, the information they 

would supply would not be pertinent. 

Kelley and SMA expressed the concern 

that purchasers’ responses will be 

skewed by a desire to reduce the price 

of their inputs. Skadden and Stewart 

questioned whether the limited number 

of purchasers likely to receive the miniquestionnaires will be sufficiently 

representative to provide reliable 

information. Stewart also observed that 

the mini-questionnaires may prove 

burdensome to purchasers, who will be 

required to furnish the same 

information a second time should the 

Commission conduct a full 

investigation. 

The commenters’ central objection to 

this proposal is premised on the view 

that the only purpose of the adequacy 

phase of a five-year review is to 

ascertain whether there are sufficient 

responses to warrant conducting a full 

review, and if a group response is 

inadequate, the Commission must 

expedite the review. The Commission 

has previously disagreed with this 

premise and has reaffirmed the 

relevance of examining whether there 

have been significant changes in 

conditions of competition for the 

purpose of determining whether a full 

review is warranted, notwithstanding an 

inadequate group interested party 

response. The Commission 

acknowledges that the information the 

purchasers will provide in response to 

their mini-questionnaires will be 

limited in scope and may reflect the 

perspective of the submitter. 

Nevertheless, the Commission currently 

believes this limited information will 

provide a useful supplement to the 

information provided in the responses 

to the notices of institution as to how 

the current conditions of competition 

for the domestic like product and the 

subject merchandise may differ from 

those that the Commission examined in 

prior determinations. The Commission 

further notes that the responses to the 

notice of institution also reflect the 

perspective of the submitter. In 

addition, no purchaser interests 

submitted any comments objecting to 

the proposal. Nevertheless, as 

previously discussed, the Commission 

will further consider both the response 

rate to the mini-questionnaires and the 

utility of the information they provide 

once it has obtained experience issuing 

such questionnaires and analyzing 

responses to them. 

Change in Commission Rule 207.61(a) 

In the NOPR, the Commission 

proposed amending Commission Rule 

207.61(a) to require that responses to the 

notice of institution be submitted within 

30 days after publication of the notice, 

as opposed to the current 50 days. The 

Commission stated that this change 

would permit the Commission staff the 

additional time it would need to engage 

in the additional information collection 

and analysis that was contemplated 

under the proposed new data collection 

requests. Because the Commission has 

implemented the proposed new data 

collection requests, it has also 

determined to issue the proposed 

change to Commission Rule 207.61(a) in 

final form. The amended regulation will 

apply to all reviews instituted on or 

after March 1, 2009. 

Each of the commenters opposed the 

proposed change to Commission Rule 

207.61(a) on the grounds that a 30-day 

response period was insufficient. 

Skadden and Stewart contended that 

parties need the full 50 days currently 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2849 

provided in the rule to file their 

substantive responses to the 

Commission because they will be 

devoting the first 30 days of that period 

preparing responses to the Department 

of Commerce. SMA stated that current 

requirements for adequacy comments 

are arduous and that increasing the 

amount of information that must be 

provided while reducing the amount of 

time available to prepare a submission 

is problematic. Kelley asserted that 

domestic producers will put more 

detailed information in a notice of 

review if they are aware that no 

respondent interested parties will 

participate. Notices of appearance need 

not be filed until 21 days after the notice 

of institution, and Kelley asserted that 

nine days would be insufficient time for 

a domestic producer to compile this 

more detailed information. 

The commenters’ objections proceed 

largely from the premise that a domestic 

producer will not begin to prepare its 

responses to either the Commerce notice 

of initiation or the Commission notice of 

institution until these notices are 

published in the Federal Register. The 

Commission does not agree with this 

premise. Interested parties are in a 

position to begin compiling information 

needed for a five-year review well 

before the publication of notices in the 

Federal Register beginning the reviews. 

The parties typically know the date that 

Commerce and the Commission will 

publish their Federal Register notices 

many months in advance. The 

Commission requests standardized 

information in interested parties’ 

responses to notices of institution; the 

information requests are generally 

known prior to publication of the 

Federal Register notice. Similarly, the 

information that Commerce requires to 

be submitted in a notice of intent to 

participate in a sunset review is 

specified by regulation, and thus will be 

known well before initiation of the 

review. Kelley’s assertion that responses 

to the notice of institution contain more 

detailed information in uncontested 

reviews than in contested reviews is not 

consistent with the Commission’s 

experience. 

List of Subjects in 9 CFR Part 207 

Administrative practice and 

procedure, investigations. 

■ For the reasons stated in the preamble, 

the Commission amends 19 CFR part 

207 as follows: 

PART 207—INVESTIGATIONS OF 

WHETHER INJURY TO DOMESTIC 

INDUSTRIES RESULTS FROM 

IMPORTS SOLD AT LESS THAN FAIR 

VALUE OR FROM SUBSIDIZED 

EXPORTS TO THE UNITED STATES 

■ 1. The authority citation for part 207 

continues to read as follows: 

Authority: 19 U.S.C. 1336, 1671–1677n, 

2482, 3513. 

■ 2. Amend § 207.61 by revising 

paragraph (a) as follows: 

§ 207.61 Responses to notice of 

institution. 

(a) When Information Must Be Filed. 

Responses to the notice of institution 

shall be submitted to the Commission 

no later than 30 days after its 

publication in the Federal Register. 

* * * * * 

Issued: January 12, 2009. 

By order of the Commission. 

Marilyn R. Abbott, 

Secretary to the Commission. 

[FR Doc. E9–860 Filed 1–15–09; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 320 

[Docket No. FDA–2003–N–0209] (Formerly 

Docket No. 2003N–0341) 

RIN 0910–AC23 

Requirements for Submission of 

Bioequivalence Data; Final Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations on the submission of 

bioequivalence data to require an 

abbreviated new drug application 

(ANDA) applicant to submit data from 

all bioequivalence (BE) studies the 

applicant conducts on a drug product 

formulation submitted for approval. In 

the past, ANDA applicants have 

submitted BE studies demonstrating that 

a generic product meets bioequivalence 

criteria in order for FDA to approve the 

ANDA, but have not typically submitted 

additional BE studies conducted on the 

same drug product formulation, such as 

studies that do not show that the 

product meets these criteria. FDA is 

amending the regulation because we 

now believe that data from additional 

BE studies may be important in our 

determination of whether the proposed 

formulation is bioequivalent to the 

reference listed drug (RLD), and are 

relevant to our evaluation of ANDAs in 

general. In addition, such data will 

increase our understanding of how 

changes in components, composition, 

and methods of manufacture may affect 

product formulation performance. 

DATES: The rule is effective July 15, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Aida L. Sanchez, Center for Drug 

Evaluation and Research (HFD–650), 

Food and Drug Administration, 7520 

Standish Pl., Rockville, MD 20855, 240– 

276–8782. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 29, 

2003 (68 FR 61640), FDA proposed to 

amend its regulations in parts 314 and 

320 (21 CFR parts 314 and 320) to 

require an ANDA applicant to submit 

data from all BE studies that the 

applicant conducts on a drug product 

formulation submitted for approval. 

Section 505(j)(2)(A)(iv) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(j)(2)(A)(iv)) requires that 

ANDA applicants submit, among other 

things, information showing that the 

applicant’s drug is bioequivalent to a 

drug that has previously been approved 

by FDA. Under the regulations at 

§ 314.3(b), the approved drug product 

identified by FDA as the drug product 

on which an ANDA applicant relies for 

approval is the RLD. The requirement 

that an ANDA applicant submit 

information that shows the proposed 

product is bioequivalent to the RLD is 

described in FDA’s regulations at 

§ 314.94(a)(7). Section 320.24 sets forth 

the types of evidence acceptable to 

establish BE. The most common BE 

studies are those performed on solid 

oral dosage forms of drugs that are 

absorbed into the systemic circulation. 

BE data provide an estimate of the rate 

and extent of drug absorption for a test 

and reference product. These data are 

examined, using statistical procedures, 

to determine whether the test product 

meets BE limits. 

A BE study may fail to show that a 

test product meets BE limits because the 

test product has significantly higher or 

lower relative bioavailability (i.e., 

measures of rate and extent of 

absorption compared to the reference 

product). In some cases, BE will not be 

demonstrated because there are 

inadequate numbers of subjects in the 

study relative to the magnitude of 

intrasubject variability, and not because 


sroberts on PROD1PC70 with RULES