2024-27009. Hard Empty Capsules From Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam: Initiation of Less-Than-Fair-Value Investigations

Document Headings

Document headings vary by document type but may contain the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Commerce

International Trade Administration

1. [A-351-864, A-570-184, A-533-934, A-552-847]

AGENCY:

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

DATES:

Applicable November 13, 2024.

FOR FURTHER INFORMATION CONTACT:

Gemma Larsen at [phone] (Brazil), Rebecca Janz at [phone] (the People's Republic of China (China)), Luke Caruso at [phone] (India), and Jinny Ahn 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 antidumping duty (AD) 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 AD Petitions were accompanied by countervailing duty (CVD) 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 in supplemental questionnaires.^[3] The petitioner responded to Commerce's supplemental questionnaires between October 30 and November 6, 2024.^[4]

In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of hard empty capsules from Brazil, China, India, and Vietnam are being, or are likely to be, sold in the United States at less than fair value (LTFV) within the meaning of section 731 of the Act, and that imports of such products are materially injuring, or threatening material injury to, the hard empty capsules industry in the United States. Consistent with section 732(b)(1) of the Act, the Petitions were accompanied by information reasonably available to the petitioner supporting its allegations. ( print page 91685)

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 for the initiation of the requested LTFV investigations.^[5]

Periods of Investigation

Because the Petitions were filed on October 24, 2024, pursuant to 19 CFR 351.204(b)(1), the period of investigation (POI) for the Brazil and India LTFV investigations is October 1, 2023, through September 30, 2024. Because China and Vietnam are non-market economy (NME) countries, pursuant to 19 CFR 351.204(b)(1), the POI for the China and Vietnam LTFV investigations is April 1, 2024, through September 30, 2024.

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.^[6] On November 6, 2024, the petitioner provided clarifications and revised the scope.^[7] 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).^[8] Commerce will consider all scope 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,^[9] all such factual information should be limited to public information. 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 factual information, and should also be limited to public 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 these investigations be submitted during that 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 LTFV 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.^[10] An electronically filed document must be received successfully in its entirety by the time and date it is due.

Comments on Product Characteristics

Commerce is providing interested parties an opportunity to comment on the appropriate physical characteristics of hard empty capsules to be reported in response to Commerce's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors of production (FOP) or cost of production (COP) accurately, as well as to develop appropriate product comparison criteria.

Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) general product characteristics; and (2) product comparison criteria. We note that it is not always appropriate to use all product characteristics as product comparison criteria. We base product comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe hard empty capsules, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, Commerce attempts to list the most important physical characteristics first and the least important characteristics last.

In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all product characteristics comments must be filed by 5:00 p.m. ET on December 3, 2024, which is 20 calendar days from the signature date of this notice. Any rebuttal comments must be filed by 5:00 p.m. ET on December 13, 2024, which is 10 calendar days from the initial comment deadline. All comments and submissions to Commerce must be filed electronically using ACCESS, as explained above, on the record of each of the LTFV investigations.

Determination of Industry Support for the Petitions

Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(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 732(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 ( print page 91686) 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,^[11] 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.^[12]

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.^[13] 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.^[14]

In determining whether the petitioner has standing under section 732(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.^[15] We relied on data provided by the petitioner for purposes of measuring industry support.^[16]

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.^[17] 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).^[18] Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act 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.^[19] Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(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.^[20] Accordingly, Commerce determines that the Petitions were filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.^[21]

Allegations and Evidence of Material Injury and Causation

The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at LTFV. 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.^[22] With respect to Brazil, while the allegedly dumped imports do not exceed the statutory requirements for negligibility,^[23] 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; ^[24] 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.^[25] 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.^[26] 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.^[27]

( print page 91687)

Allegations of Sales at LTFV

The following is a description of the allegations of sales at LTFV upon which Commerce based its decision to initiate LTFV investigations of imports of hard empty capsules from Brazil, China, India, and Vietnam. The sources of data for the deductions and adjustments relating to U.S. price and normal value (NV) are discussed in greater detail in the Country-Specific AD Initiation Checklists.

U.S. Price

For Brazil, China, India, and Vietnam, the petitioner based export price (EP) on POI average unit values derived from official U.S. import statistics for imports of hard empty capsules produced in and exported from each country.^[28] For each country, the petitioner made certain adjustments to U.S. price to calculate a net ex-factory U.S. price, where applicable.^[29]

Normal Value  ³⁰

For Brazil and India, the petitioner stated that it was unable to obtain home market or third country pricing information for hard empty capsules to use as a basis for NV.^[31] Therefore, for Brazil and India, the petitioner calculated NV based on CV.^[32] For further discussion of CV for Brazil and India, see the section “Normal Value Based on Constructed Value,” below.

Commerce considers China and Vietnam to be NME countries.^[33] In accordance with section 771(18)(C)(i) of the Act, any determination that a foreign country is an NME country shall remain in effect until revoked by Commerce. Therefore, we continue to treat China and Vietnam as NME countries for purposes of the initiation of the China and Vietnam LTFV investigations. Accordingly, we base NV on FOPs valued in a surrogate market economy country in accordance with section 773(c) of the Act.

The petitioner claims that the Republic of Türkiye (Türkiye) is an appropriate surrogate country for China because it is a market economy that is at a level of economic development comparable to that of China and is a significant producer of comparable merchandise.^[34] The petitioner provided publicly available information from Türkiye to value all FOPs.^[35] Based on the information provided by the petitioner, we believe it is appropriate to use Türkiye as a surrogate country for China to value all FOPs for initiation purposes.

The petitioner claims that Indonesia is an appropriate surrogate country for Vietnam because it is a market economy that is at a level of economic development comparable to that of Vietnam and is a significant producer of comparable merchandise.^[36] The petitioner provided publicly available information from Indonesia to value all FOPs.^[37] Based on the information provided by the petitioner, we believe it is appropriate to use Indonesia as a surrogate country for Vietnam to value all FOPs for initiation purposes.

Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs within 30 days before the scheduled date of the preliminary determinations.

Factors of Production

Because information regarding the volume of inputs consumed by Chinese and Vietnamese producers/exporters was not reasonably available, the petitioner used its own production experience and product-specific consumption rates as a surrogate to value Chinese and Vietnamese manufacturers' FOPs.^[38] Additionally, the petitioner calculated factory overhead, selling, general, and administrative (SG&A) expenses, and profit based on the experience of Turkish and Indonesian producers of comparable merchandise, respectively.^[39]

Normal Value Based on Constructed Value

As noted above for Brazil and India, the petitioner stated that it was unable to obtain home market or third-country prices for hard empty capsules to use as a basis for NV. Therefore, for Brazil and India, the petitioner calculated NV based on CV.^[40]

Pursuant to section 773(e) of the Act, the petitioner calculated CV as the sum of the cost of manufacturing, SG&A expenses, financial expenses, and profit.^[41] For Brazil and India, in calculating the cost of manufacturing, the petitioner relied on its own production experience and product-specific consumption rates, valued using publicly available information applicable to the respective countries, where applicable.^[42] For Brazil and India, in calculating SG&A expenses, financial expenses, and profit ratios, the petitioner relied on the fiscal year 2023 financial statements of producers of comparable merchandise domiciled in the respective countries.^[43]

Fair Value Comparisons

Based on the data provided by the petitioner, there is reason to believe that imports of hard empty capsules from Brazil, China, India, and Vietnam are being, or are likely to be, sold in the United States at LTFV. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margins for hard empty capsules for each of the countries covered by this initiation are as follows: (1) Brazil—78.52 to 99.11 percent; (2) China—128.01 to 158.04 percent; (3) India—54.81 to 82.95 percent; (4) Vietnam—63.53 to 86.04 percent.^[44]

Initiation of LTFV Investigations

Based upon the examination of the Petitions and supplemental responses, we find that they meet the requirements of section 732 of the Act. Therefore, we are initiating LTFV investigations to determine whether imports of hard empty capsules from Brazil, China, India, and Vietnam are being, or are likely to be, sold in the United States at LTFV. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determinations no ( print page 91688) later than 140 days after the date of these initiations.

Respondent Selection

Brazil

In the Petitions, the petitioner identified two companies in Brazil ( i.e., ACG do Brasil S.A. and Genix Industria Farmaceutica LTDA (Qualicaps Brazil)) as producers/exporters of hard empty capsules and provided independent third-party information as support.^[45] We currently know of no additional producers/exporters of hard empty capsules from Brazil. Accordingly, Commerce intends to individually examine all known producers/exporters in the investigation from Brazil ( 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, if no comments are received, or if comments received further support the existence of only these two producers/exporters, we do not intend to conduct respondent selection and will proceed to issuing the initial AD 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 within 20 days of publication of this notice.

India

In the Petitions, the petitioner identified 14 companies in India as producers/exporters of hard empty capsules.^[46] Following standard practice in LTFV investigations involving market economy countries, in the event Commerce determines that the number of companies is large, and it cannot individually examine each company based upon Commerce's resources, where appropriate, Commerce intends to select mandatory respondents based on U.S. Customs and Border Protection (CBP) data for 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, 2024, Commerce released CBP data on imports of hard empty capsules from 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.^[47] 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.

China and Vietnam

In the Petitions, the petitioner identified 50 companies in China and two companies in Vietnam as producers and/or exporters of hard empty capsules.^[48] Our standard practice for respondent selection in AD investigations involving NME countries is to select respondents based on quantity and value (Q&V) questionnaires in cases where Commerce has determined that the number of companies is large, and it cannot individually examine each company based upon its resources. Therefore, considering the number of producers and/or exporters identified in the Petitions, Commerce will solicit Q&V information that can serve as a basis for selecting exporters for individual examination in the event that Commerce determines that the number is large and decides to limit the number of respondents individually examined pursuant to section 777A(c)(2) of the Act. Because there are 50 Chinese producers and/or exporters identified in the Petitions, Commerce has determined that it will issue Q&V questionnaires to the largest producers and/or exporters in China that are identified in the CBP POI entry data for which there is complete address information on the record.^[49] For Vietnam, because there are two producers and/or exporters identified in the Petitions, Commerce will issue a Q&V questionnaire to each potential respondent in Vietnam for which there is complete address information on the record.

Commerce will post the Q&V questionnaires along with filing instructions on Commerce's website at https://www.trade.gov/​ec-adcvd-case-announcements. Producers/exporters of hard empty capsules from China and Vietnam that do not receive Q&V questionnaires may still submit a response to the Q&V questionnaire and can obtain a copy of the Q&V questionnaire from Commerce's website. Responses to the Q&V questionnaire must be submitted by the relevant Chinese and Vietnamese producers/exporters no later than 5:00 p.m. ET on November 27, 2024, which is two weeks from the signature date of this notice. All Q&V questionnaire responses must be filed electronically via ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the deadline noted above.

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

Separate Rates

In order to obtain separate rate status in an NME investigation, exporters and producers must submit a separate rate application. The specific requirements for submitting a separate rate application in an NME investigation are outlined in detail in the application itself, which is available on Commerce's website at https://access.trade.gov/​Resources/​nme/​nme-sep-rate.html. The separate rate application will be due 30 days after publication of this initiation notice. Exporters and producers must file a timely separate rate application if they want to be considered for individual examination. Exporters and producers who submit a separate rate application and have been selected as mandatory respondents will be eligible for consideration for separate rate status only if they respond to all parts of Commerce's AD questionnaire as mandatory respondents. Commerce requires that companies from China and Vietnam submit a response both to the Q&V questionnaire and to the separate rate application by the respective deadlines to receive consideration for separate rate status. Companies not filing a timely Q&V questionnaire response will not receive separate rate consideration. ( print page 91689)

Use of Combination Rates

Commerce will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:

{w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that {Commerce} will now assign in its NME investigation will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the {weighted average} of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question and produced by a firm that supplied the exporter during the period of investigation.^[50]

Distribution of Copies of the Petitions

In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petitions have been provided to the governments of Brazil, China, India, and Vietnam 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 our initiation, as required by section 732(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.^[51] A negative ITC determination for any country will result in the investigation being terminated with respect to that country.^[52] Otherwise, these LTFV 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 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 ^[53] 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.^[54] 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.

Particular Market Situation Allegation

Section 773(e) of the Act addresses the concept of particular market situation (PMS) for purposes of CV, stating that “if a particular market situation exists such that the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost of production in the ordinary course of trade, the administering authority may use another calculation methodology under this subtitle or any other calculation methodology.” When an interested party submits a PMS allegation pursuant to section 773(e) of the Act ( i.e., a cost-based PMS allegation), the submission must be filed in accordance with the requirements of 19 CFR 351.416(b), and Commerce will respond to such a submission consistent with 19 CFR 351.301(c)(2)(v). If Commerce finds that a cost-based PMS exists under section 773(e) of the Act, then it will modify its dumping calculations appropriately.

Neither section 773(e) of the Act, nor 19 CFR 351.301(c)(2)(v), sets a deadline for the submission of cost-based PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a cost-based PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of a respondent's initial section D questionnaire response.

We note that a PMS allegation filed pursuant to sections 773(a)(1)(B)(ii)(III) or 773(a)(1)(C)(iii) of the Act ( i.e., a sales-based PMS allegation) must be filed within 10 days of submission of a respondent's initial section B questionnaire response, in accordance with 19 CFR 351.301(c)(2)(i) and 19 CFR 351.404(c)(2).

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.^[55] 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 submitting factual information in these investigations.^[56]

( print page 91690)

Certification Requirements

Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.^[57] Parties must use the certification formats provided in 19 CFR 351.303(g).^[58] 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 letter of appearance). Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f).^[59]

This notice is issued and published pursuant to sections 732(c)(2) 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 hard empty capsules 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 AD Supplemental Questionnaires: Brazil Supplemental, China Supplemental, India Supplemental, and Vietnam Supplemental, dated October 28, 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 AD Supplemental Responses: Brazil AD Supplement, China AD Supplement, India AD Supplement, and Vietnam AD Supplement, dated November 1 and 5, 2024; Petitioner's Letter, “Petitioner's Response to the Department's General Issues Scope Questionnaire,” dated November 6, 2024 (Scope Supplement); and Country-Specific Second AD Supplemental Responses: Second Brazil AD Supplement and Second India AD Supplement, dated November 6, 2024.

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

6.   See November 5, 2024, Memorandum.

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

8.   See Antidumping Duties; Countervailing Duties, Final Rule,62 FR 27296, 27323 (May 19, 1997) ( Preamble); see also19 CFR 351.312.

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

10.   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.

11.   See section 771(10) of the Act.

12.   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)).

13.  For a discussion of the domestic like product analysis as applied to these cases and information regarding industry support, see Checklists, “Antidumping 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 AD 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.

14.   See Attachment II of the Country-Specific AD Initiation Checklists.

15.   Id.

16.  For further discussion, see Attachment II of the Country-Specific AD Initiation Checklists.

17.   Id.

18.   Id.; see also section 732(c)(4)(D) of the Act.

19.   See Attachment II of the Country-Specific AD Initiation Checklists.

20.   Id.

21.   Id.

22.  For further information regarding negligibility and the injury allegation, see Country-Specific AD 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).

23.   Id.

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

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

26.   Id.

27.   Id.

28.   See Country-Specific AD Initiation Checklists.

29.   Id.

30.  In accordance with section 773(b)(2) of the Act, for the Brazil and India investigations, Commerce will request information necessary to calculate the constructed value (CV) and COP to determine whether there are reasonable grounds to believe or suspect that sales of the foreign like product have been made at prices that represent less than the COP of the product.

31.   See Country-Specific AD Initiation Checklists.

32.   Id.

33.   See, e.g.,Certain Freight Rail Couplers and Parts Thereof from the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Affirmative Determination of Critical Circumstances,88 FR 15372 (March 13, 2023), and accompanying Preliminary Decision Memorandum at 5, unchanged in Certain Freight Rail Couplers and Parts Thereof from the People's Republic of China: Final Affirmative Determination of Sales at Less-Than-Fair Value and Final Affirmative Determination of Critical Circumstances,88 FR 34485 (May 30, 2023); see also, e.g.,Raw Honey from the Socialist Republic of Vietnam: Final Results of Antidumping Duty Changed Circumstances Review,89 FR 64411 (August 7, 2024), and accompanying NME Analysis Memorandum at 5.

34.   See China AD Initiation Checklist.

35.   Id.

36.   See Vietnam AD Initiation Checklist.

37.   Id.

38.   See Country-Specific AD Initiation Checklists.

39.   Id.

40.   Id.

41.   Id.

42.   Id.

43.   Id.

44.   Id.

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

46.   See Petitions at Volume I (pages 10-11 and Exhibit I-8); see also General Issues Supplement at 1-3 and Exhibit I-S1.

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

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

49.   See Memorandum, “Release of U.S. Customs and Border Protection Entry Data,” dated November 7, 2024.

50.   See Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigation involving NME Countries,” (April 5, 2005) at 6 (emphasis added), available on Commerce's website at https://access.trade.gov/​Resources/​policy/​bull05-1.pdf.

51.   See section 733(a) of the Act.

52.   Id.

53.   See19 CFR 351.301(b).

54.   See19 CFR 351.301(b)(2).

55.   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.

56.   See19 CFR 351.302; see also, e.g., Time Limits Final Rule.

57.   See section 782(b) of the Act.

58.   See Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings,78 FR 42678 (July 17, 2013) ( Final Rule). Additional information regarding the Final Rule is available at https://access.trade.gov/​Resources/​filing/​index.html.

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