Revised Procedures and Requests for Information During Adequacy Phase of Five-Year Reviews, 2847-2849 [E9-860]
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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations
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
sroberts on PROD1PC70 with RULES
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
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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 https://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
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2847
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).
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16:34 Jan 15, 2009
Jkt 217001
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
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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
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
sroberts on PROD1PC70 with RULES
Administrative practice and
procedure, investigations.
For the reasons stated in the preamble,
the Commission amends 19 CFR part
207 as follows:
■
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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
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2849
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
E:\FR\FM\16JAR1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Rules and Regulations]
[Pages 2847-2849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-860]
=======================================================================
-----------------------------------------------------------------------
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 https://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
[[Page 2848]]
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 five-year 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 ``mini-questionnaires'' 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 mini-questionnaires 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
[[Page 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.
0
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
0
1. The authority citation for part 207 continues to read as follows:
Authority: 19 U.S.C. 1336, 1671-1677n, 2482, 3513.
0
2. Amend Sec. 207.61 by revising paragraph (a) as follows:
Sec. 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
