2024-27008. Hard Empty Capsules From Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam: Initiation of Countervailing Duty Investigations

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Department of Commerce

International Trade Administration

1. [C-351-865, C-570-185, C-533-935, C-552-848]

AGENCY:

Enforcement and Compliance, International Trade Administration, Department of Commerce.

DATES:

Applicable November 13, 2024.

FOR FURTHER INFORMATION CONTACT:

Seth Brown at [phone] (Brazil), Laura Delgado at [phone] and John Conniff at [phone] (the People's Republic of China (China)), Gorden Struck at [phone] (India), and Jonathan Schueler at [phone] (the Socialist Republic of Vietnam (Vietnam)), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

SUPPLEMENTARY INFORMATION:

The Petitions

On October 24, 2024, the U.S. Department of Commerce (Commerce) received countervailing duty (CVD) petitions concerning imports of hard empty capsules from Brazil, China, India, and Vietnam filed in proper form on behalf of Lonza Greenwood LLC (the petitioner), a U.S. producer of hard empty capsules.^[1] The CVD Petitions were accompanied by antidumping duty (AD) petitions concerning imports of hard empty capsules from Brazil, China, India, and Vietnam.^[2]

Between October 28 and November 5, 2024, Commerce requested supplemental information pertaining to certain aspects of the Petitions.^[3] Between October 30 and November 6, 2024, the petitioner filed timely responses to these requests for additional information.^[4]

In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of Brazil (GOB), Government of China (GOC), the Government of India (GOI), and the Government of Vietnam (GOV) (collectively, Governments) are providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of hard empty capsules from Brazil, China, India, and Vietnam and that such imports are materially injuring, or threatening material injury to, the domestic industry producing hard empty capsules in the United States. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating CVD investigations, the Petitions were accompanied by information reasonably available to the petitioner supporting its allegations.

Commerce finds that the petitioner filed the Petitions on behalf of the domestic industry because the petitioner is an interested party, as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the requested CVD investigations.^[5]

Periods of Investigation

Because the Petitions were filed on October 24, 2024, the periods of investigation for the Brazil, China, India, and Vietnam CVD investigations are January 1, 2023, through December 31, 2023.^[6]

Scope of the Investigations

The products covered by these investigations are hard empty capsules from Brazil, China, India, and Vietnam. For a full description of the scope of these investigations, see the appendix to this notice.

Comments on the Scope of the Investigations

On November 5, 2024, Commerce requested information and clarification from the petitioner regarding the proposed scope to ensure that the scope language in the Petitions is an accurate reflection of the products for which the domestic industry is seeking relief.^[7] On November 6, 2024, the petitioner provided clarifications and revised the scope.^[8] The description of merchandise covered by these investigations, as described in the appendix to this notice, reflects these clarifications.

As discussed in the Preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage ( i.e., scope).^[9] Commerce will consider all comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determinations. If scope comments include factual information, all such factual information should be limited to public information.^[10] To facilitate preparation of its questionnaires, Commerce requests that scope comments be submitted by 5:00 p.m. Eastern Time (ET) on December 3, 2024, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include ( print page 91681) factual information, must be filed by 5:00 p.m. ET on December 13, 2024, which is 10 calendar days from the initial comment deadline.

Commerce requests that any factual information that parties consider relevant to the scope of the investigations be submitted during that time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent AD and CVD investigations.

Filing Requirements

All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies.^[11] An electronically filed document must be received successfully in its entirety by the time and date it is due.

Consultations

Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified the Governments of the receipt of the Petitions and provided an opportunity for consultations with respect to the Petitions.^[12] Commerce held consultations with the GOV on November 7, 2024,^[13] the GOB on November 12, 2024,^[14] and the GOI on November 13, 2024.^[15] The GOC did not request consultations.^[16]

Determination of Industry Support for the Petitions

Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC apply the same statutory definition regarding the domestic like product,^[17] they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.^[18]

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” ( i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the petition).

With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigations.^[19] Based on our analysis of the information submitted on the record, we have determined that hard empty capsules, as defined in the scope, constitute a single domestic like product, and we have analyzed industry support in terms of that domestic like product.^[20]

In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petitions with reference to the domestic like product as defined in the “Scope of the Investigations,” in the appendix to this notice. To establish industry support, the petitioner provided its own production of the domestic like product in 2023 and compared this to the estimated total 2023 production of the domestic like product for the entire industry.^[21] We relied on data provided by the petitioner for purposes of measuring industry support.^[22]

Our review of the data provided in the Petitions, the General Issues Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petitions.^[23] First, the Petitions established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support ( e.g., polling).^[24] Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(i) of the Act ( print page 91682) because the domestic producers (or workers) who support the Petitions account for at least 25 percent of the total production of the domestic like product.^[25] Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petitions account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petitions.^[26] Accordingly, Commerce determines that the Petitions were filed on behalf of the domestic industry within the meaning of section 702(b)(1) of the Act.^[27]

Injury Test

Because Brazil, China, India, and Vietnam are “Subsidies Agreement Countries” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to these investigations. Accordingly, the ITC must determine whether imports of the subject merchandise from Brazil, China, India, and/or Vietnam materially injure, or threaten material injury to, a U.S. industry.

Allegations and Evidence of Material Injury and Causation

The petitioner alleges that imports of the subject merchandise are benefiting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioner alleges that subject imports from China, India, and Vietnam exceed the negligibility threshold provided for under section 771(24)(A) of the Act.^[28] With respect to Brazil, while the allegedly subsidized imports do not exceed the statutory requirements for negligibility,^[29] the petitioner alleges and provides supporting evidence that: (1) there is a reasonable indication that the data obtained in the ITC's investigation will establish that imports exceed the negligibility threshold; ^[30] and (2) there is the potential that imports from Brazil will imminently exceed the negligibility threshold and, therefore, are not negligible for purposes of a threat determination.^[31] The petitioner's arguments regarding the limitations of publicly available import data and the collection of scope-specific import data in the ITC's investigation are consistent with the SAA. Furthermore, the petitioner's arguments regarding the potential for imports from Brazil to imminently exceed the negligibility threshold are consistent with the statutory criteria for “negligibility in threat analysis” under section 771(24)(A)(iv) of the Act, which provides that imports shall not be treated as negligible if there is a potential that subject imports from a country will imminently exceed the statutory requirements for negligibility.

The petitioner contends that the industry's injured condition is illustrated by the significant and increasing volume of subject imports; reduced market share; underselling and price depression and/or suppression; lost sales and revenues; and decline in the domestic industry's production, U.S. shipments, net sales, and financial performance.^[32] We assessed the allegations and supporting evidence regarding material injury, threat of material injury, causation, cumulation, as well as negligibility, and we have determined that these allegations are properly supported by adequate evidence and meet the statutory requirements for initiation.^[33]

Initiation of CVD Investigations

Based upon the examination of the Petitions and supplemental responses, we find that they meet the requirements of section 702 of the Act. Therefore, we are initiating CVD investigations to determine whether imports of hard empty capsules from Brazil, China, India, and Vietnam benefit from countervailable subsidies conferred by the GOB, GOC, GOI, and GOV, respectively. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determinations no later than 65 days after the date of these initiations.

Brazil

Based on our review of the Petitions, we find that there is sufficient information to initiate a CVD investigation on 18 of the 18 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program, see the Brazil CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

China

Based on our review of the Petitions, we find that there is sufficient information to initiate a CVD investigation on 18 of the 19 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program, see the China CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

India

Based on our review of the Petitions, we find that there is sufficient information to initiate a CVD investigation on 22 of the 23 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program, see the India CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

Vietnam

Based on our review of the Petitions, we find that there is sufficient information to initiate a CVD investigation on 26 of the 26 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program, see the Vietnam CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

Respondent Selection

Brazil and Vietnam

In the Petitions, the petitioner identified two companies in Brazil ( i.e., ACG do Brasil S.A. and Genix Industria Farmaceutica LTDA (Qualicaps Brazil)) and two companies in Vietnam ( i.e., Cuu Long Pharmaceutical Joint Stock Company (DCL) and Suheung Vietnam Co., Ltd.) as producers/exporters of hard empty capsules and provided independent third-party information as support.^[34] We currently know of no ( print page 91683) additional producers/exporters of hard empty capsules from Brazil and Vietnam. Accordingly, Commerce intends to individually examine all known producers/exporters in the investigations for Brazil and Vietnam ( i.e., the companies cited above). We invite interested parties to comment on this issue. Such comments may include factual information within the meaning of 19 CFR 351.102(b)(21). Parties wishing to comment must do so within three business days of the publication of this notice in the Federal Register . Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety via ACCESS by 5:00 p.m. ET on the specified deadline. Because we intend to examine all known producers/exporters in Brazil and Vietnam, if no comments are received, or if comments received further support the existence of only these producers/exporters in Brazil and Vietnam, respectively, we do not intend to conduct respondent selection and will proceed to issuing the initial CVD questionnaires to the companies identified. However, if comments are received which create a need for a respondent selection process, we intend to finalize our decision regarding respondent selection for Brazil and Vietnam within 20 days of publication of this notice.

China and India

In the Petitions, the petitioner identified 50 companies in China and 14 companies in India as producers/exporters of hard empty capsules.^[35] Commerce intends to follow its standard practice in CVD investigations and calculate company-specific subsidy rates in this investigation. Following standard practice in CVD investigations, in the event Commerce determines that the number of exporters or producers is large such that Commerce cannot individually examine each company based on its resources, Commerce intends to select mandatory respondents based on U.S. Customs and Border Protection (CBP) entry data for U.S. imports under the appropriate Harmonized Tariff Schedule of the United States (HTSUS) subheading(s) listed in the “Scope of the Investigations,” in the appendix.

On November 7 and 8, 2024, Commerce released CBP data on imports of hard empty capsules from China and India under administrative protective order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment on CBP data and/or respondent selection must do so within three business days of the publication date of the notice of initiation of these investigations.^[36] Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety via ACCESS by 5:00 p.m. ET on the specified deadline. Commerce will not accept rebuttal comments regarding the CBP data or respondent selection.

Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at https://www.trade.gov/​administrative-protective-orders.

Distribution of Copies of the Petitions

In accordance with section 702(b)(4)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petitions has been provided to the GOB, GOC, GOI, and GOV via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petitions to each exporter named in the Petitions, as provided under 19 CFR 351.203(c)(2).

ITC Notification

Commerce will notify the ITC of its initiation, as required by section 702(d) of the Act.

Preliminary Determinations by the ITC

The ITC will preliminarily determine, within 45 days after the date on which the Petitions were filed, whether there is a reasonable indication that imports of hard empty capsules from Brazil, China, India, and/or Vietnam are materially injuring, or threatening material injury to, a U.S. industry.^[37] A negative ITC determination for any country will result in the investigation being terminated with respect to that country.^[38] Otherwise, these CVD investigations will proceed according to statutory and regulatory time limits.

Submission of Factual Information

Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors of production under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted ^[39] and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.^[40] Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in these investigations.

Extensions of Time Limits

Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce.^[41] For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, standalone submission; under limited circumstances we will grant untimely filed requests for the extension of time limits, where we determine, based on 19 CFR 351.302, that extraordinary circumstances exist. Parties should review Commerce's regulations concerning the extension of time limits and the Time Limits Final Rule prior to ( print page 91684) submitting factual information in these investigations.^[42]

Certification Requirements

Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.^[43] Parties must use the certification formats provided in 19 CFR 351.303(g).^[44] Commerce intends to reject factual submissions if the submitting party does not comply with the applicable certification requirements.

Notification to Interested Parties

Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in these investigations should ensure that they meet the requirements of 19 CFR 351.103(d) ( e.g., by filing the required letters of appearance). Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f).^[45]

This notice is issued and published pursuant to sections 702 and 777(i) of the Act, and 19 CFR 351.203(c).

Dated: November 13, 2024.

Abdelali Elouaradia,

Deputy Assistant Secretary for Enforcement and Compliance.

Appendix

Scope of the Investigations

The merchandise subject to the scope of these investigations is hard empty capsules, which are comprised of two prefabricated, hollowed cylindrical sections (cap and body). The cap and body pieces each have one closed and rounded end and one open end, and are constructed with different or equal diameters at their open ends.

Hard empty capsules are unfilled cylindrical shells composed of at least 80 percent by weight of a water soluble polymer that is considered non-toxic and appropriate for human or animal consumption by the United States Pharmacopeia—National Formulary (USP-NF), Food Chemical Codex (FCC), or equivalent standards. The most common polymer materials in HECs are gelatin derived from animal collagen (including, but not limited to, pig, cow, or fish collagen), hydroxypropyl methylcellulose (HPMC), and pullulan.

Hard empty capsules may also contain water and additives, such as opacifiers, colorants, processing aids, controlled release agents, plasticizers, and preservatives. Hard empty capsules may also be imprinted or otherwise decorated with markings.

Hard empty capsules are covered by the scope of these investigations regardless of polymer material, additives, transparency, opacity, color, imprinting, or other markings.

Hard empty capsules are also covered by the scope of these investigations regardless of their size, weight, length, diameter, thickness, and filling capacity.

Cap and body pieces of hard empty capsules are covered by the scope of these investigations regardless of whether they are imported together or separately, and regardless of whether they are imported in attached or detached form.

Hard empty capsules covered by the scope of these investigations are those that disintegrate in water within 2 hours under tests specified in Chapter 701 of the USP-NF, or equivalent disintegration tests.

Hard empty capsules are classifiable under subheadings 9602.00.1040 and 9602.00.5010 of the Harmonized Tariff Schedule of the United States (HTSUS). In addition, hard empty capsules may be imported under HTSUS subheading 1905.90.9090; gelatin hard empty capsules may be imported under HTSUS subheading 3503.00.5510; HPMC hard empty capsules may be imported under HTSUS subheading 3923.90.0080; and pullulan hard empty capsules may be imported under HTSUS subheading 2106.90.9998. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise covered by these investigations is dispositive.

Footnotes

1.   See Petitioner's Letter, “Petitions for the Imposition of Antidumping and Countervailing Duties,” dated October 24, 2024 (Petitions).

2.   Id.

3.   See Commerce's Letters, “Supplemental Questions,” dated October 28, 2024, see also Country-Specific CVD Supplemental Questionnaires: Brazil Supplemental, China Supplemental, India Supplemental, and Vietnam Supplemental, dated October 28, 29, and 30, 2024; and Memorandum, “Phone Call,” dated November 5, 2024 (November 5, 2024, Memorandum).

4.   See Petitioner's Letters, “Petitioner's Response to the Department's General Issues Questionnaire,” dated October 30, 2024 (General Issues Supplement); see also Country-Specific CVD Supplemental Responses: Brazil CVD Supplement, China CVD Supplement, India CVD Supplement, and Vietnam CVD Supplement, dated October 30, 2024, October 31, 2024, November 1, 2024, and November 4, 2024; and Petitioner's Letter, “Petitioner's Response to the Department's General Issues Scope Questionnaire,” dated November 6, 2024 (Scope Supplement).

5.   See section on “Determination of Industry Support for the Petitions,” infra.

6.   See19 CFR 351.204(b)(2).

7.   See November 5, 2024, Memorandum.

8.   See Scope Supplement at 1-8 and Exhibit I-92.

9.   See Antidumping Duties; Countervailing Duties; Final Rule,62 FR 27296, 27323 (May 19, 1997) ( Preamble).

10.   See19 CFR 351.102(b)(21) (defining “factual information”).

11.   See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures,76 FR 39263 (July 6, 2011); see also Enforcement and Compliance; Change of Electronic Filing System Name,79 FR 69046 (November 20, 2014), for details of Commerce's electronic filing requirements, effective August 5, 2011. Information on using ACCESS can be found at https://access.trade.gov/​help.aspx and a handbook can be found at https://access.trade.gov/​help/​Handbook_​on_​Electronic_​Filing_​Procedures.pdf.

12.   See Commerce's Letters, “Invitation for Consultation to Discuss the Countervailing Duty Petition,” dated October 25, 2024.

13.   See Memorandum, “Consultations with the Government of the Socialist Republic of Vietnam,” dated November 7, 2024; see also GOV's Letter, “Comments on Countervailing Duty Petition,” dated November 5, 2024.

14.   See Memorandum, “Consultations with the Government of Brazil,” dated November 13, 2024.

15.   See Memorandum, “Consultations with the Government of India,” dated November 13, 2024.

16.  The GOC submitted comments on the CVD petition from China. See GOC's Letter, “Comments on Countervailing Duty Petition,” dated November 8, 2024.

17.   See section 771(10) of the Act.

18.   See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd Algoma Steel Corp., Ltd. v. United States, 865 F.2d 240 (Fed. Cir. 1989)).

19.  For a discussion of the domestic like product analysis as applied to these cases and information regarding industry support, see Checklists, “Countervailing Duty Investigation Initiation Checklists: Hard Empty Capsules from Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam,” dated concurrently with, and hereby adopted by, this notice (Country-Specific CVD Initiation Checklists), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Hard Empty Capsules from Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam (Attachment II). These checklists are on file electronically via ACCESS.

20.   See Attachment II of the Country-Specific CVD Initiation Checklists.

21.   Id.

22.  For further discussion, see Attachment II of the Country-Specific CVD Initiation Checklists.

23.  For further discussion, see Attachment II of the Country-Specific CVD Initiation Checklists.

24.   Id.; see also section 702(c)(4)(D) of the Act.

25.   See Attachment II of the Country-Specific CVD Initiation Checklists.

26.   Id.

27.   Id.

28.  For further information regarding negligibility and the injury allegation, see Country-Specific CVD Initiation Checklists at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Hard Empty Capsules from Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam (Attachment III).

29.   Id.

30.   Id.; see also Statement of Administrative Action Accompanying the Uruguay Round Agreements Act, H.R. Doc 103-316, Vol. 1 (1994) (SAA).

31.   See Attachment III of the Country-Specific CVD Initiation Checklists; see also section 771(24)(A)(iv) of the Act.

32.   See Attachment III of the Country-Specific CVD Initiation Checklists.

33.   Id.

34.   See Petitions at Volume I (page 30 and Exhibits I-46, I-57, and I-60); see also General Issues Supplement at 1-2 and Exhibit I-46 (Revised).

35.   See Petitions at Volume I (page 30 and Exhibit I-46); see also General Issues Supplement at 1 and Exhibit I-46 (Revised).

36.   See Country-Specific Memoranda, “Release of U.S. Customs and Border Protection Entry Data,” dated November 7 and 8, 2024.

37.   See section 703(a)(1) of the Act.

38.   Id.

39.   See19 CFR 351.301(b).

40.   See19 CFR 351.301(b)(2).

41.   See19 CFR 351.302.

42.   See19 CFR 351.301; see also Extension of Time Limits; Final Rule,78 FR 57790 (September 20, 2013) ( Time Limits Final Rule), available at https://www.gpo.gov/​fdsys/​pkg/​FR-2013-09-20/​html/​2013-22853.htm.

43.   See section 782(b) of the Act.

44.   See Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings,78 FR 42678 (July 17, 2013) ( Final Rule); see also frequently asked questions regarding the Final Rule, available at https://enforcement.trade.gov/​tlei/​notices/​factual_​info_​final_​rule_​FAQ_​07172013.pdf.

45.   See Administrative Protective Order, Service, and Other Procedures in Antidumping and Countervailing Duty Proceedings,88 FR 67069 (September 29, 2023).