dismissed
EB-2 NIW
dismissed EB-2 NIW Case: Pharmaceutical Data Management
Decision Summary
The appeal was dismissed because the petitioner failed to establish that the beneficiary's proposed endeavor has national importance. The AAO concluded that while the work has merit for the employing pharmaceutical company, the evidence did not demonstrate a broader prospective impact on the U.S. data, pharmaceutical, or healthcare industry at a national level.
Criteria Discussed
Substantial Merit And National Importance Well Positioned To Advance The Proposed Endeavor Balance Of Factors Favors Waiver
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U.S. Citizenship
and Immigration
Services
Non-Precedent Decision of the
Administrative Appeals Office
Date: NOV. 18, 2024 InRe: 34817513
Appeal of Texas Service Center Decision
Form 1-140, Immigrant Petition for Alien Worker (National Interest Waiver)
The Petitioner, a pharmaceutical company, seeks employment-based second preference (EB-2)
immigrant classification for the Beneficiary, a data engineer and manager, as an advanced degree
professional or a person of exceptional ability, as well as a discretionary national interest waiver of
the job offer requirement attached to this classification. Immigration and Nationality Act (the Act)
section 203(b )(2), 8 U.S.C. ยง l 153(b )(2).
The Director of the Texas Service Center denied the petition, concluding that although the Beneficiary
qualifies for the EB-2 classification as an advanced degree professional, the record did not establish
that a waiver of the required job offer, and thus labor certification, would be in the national interest.
This matter is now before us on appeal, which we review de novo. Matter of Christo 's, Inc.,
26 I&N Dec. 537, 537 n.2 (AAO 2015). Upon de novo review, we will dismiss the appeal.
I.LAW
To be eligible for a national interest waiver, a petitioner must first establish eligibility for the
underlying EB-2 visa classification, as an advanced degree professional or an individual of exceptional
ability in the sciences, arts, or business. Section 203(b )(2)(A), (B) of the Act; 8 C.F .R. ยง 204.5(k)( 1).
If a petitioner establishes eligibility for the underlying EB-2 classification, they must then demonstrate
that they warrant a discretionary waiver of the job offer requirement "in the national interest."
Section 203(b)(2)(B)(i) of the Act. Matter ofDhanasar, 26 I&N Dec. 884,889 (AAO 2016), provides
the framework for adjudicating national interest waiver petitions, which states that U.S. Citizenship
and Immigration Services (USCIS) may, as matter of discretion, 1 grant a national interest waiver if
the petitioner establishes that: (1) the proposed endeavor has both substantial merit and national
importance; (2) they are well positioned to advance their proposed endeavor; and (3) on balance,
waiving the job offer and thus labor certification requirements would benefit the United States. Id.
Petitioners bear the burden of establishing eligibility for the benefit sought by a preponderance of the
evidence. Matter of Chawathe, 25 l&N Dec. 369, 375-76 (AAO 2010).
1 See Flores v. Garland, 72 F.4th 85, 88 (5th Cir. 2023) (joining the Ninth, Eleventh, and D.C. Circuit Courts in holding
that USCIS ' decision on a national interest waiver is discretionary in nature).
IT. ANALYSIS
The Director determined, and the record-including a copy of a 2003 bachelor's degree from India,
university transcript, diploma evaluation, and letters from current or former employers-indicates,
that the Beneficiary qualifies for the EB-2 classification as an advanced degree professional holding a
U.S.-equivalent bachelor's degree with at least five years of progressive post-degree experience in the
field of specialty. 8 C.F.R. ยงยง 204.S(k)(l)-(2), (k)(3)(i)(B).
The remaining issue on appeal is whether he warrants a national interest waiver under the Dhanasar
framework and its requisite three prongs, any one of which is dispositive. The Director found that
although the Beneficiary's proposed endeavor has substantial merit, the record did not show that it has
national importance and thus did not satisfy Dhanasar's first prong. 2 On appeal, the Petitioner does
not submit any new evidence but reiterates the Beneficiary's eligibility for a national interest waiver,
and alleges that the Director failed to properly consider all relevant evidence and correctly apply the
Dhanasar framework. We conclude that the evidence does not demonstrate that the proposed
endeavor has national importance, and the appeal therefore will be dismissed on this ground.
The Beneficiary obtained a "Bachelor of Technology (Computer Engineering)" in 2003 from India
and he has worked for several information technology (IT) and data solution companies, initially as a
software and applications engineer in India; then as a solution architect manager from 2009 to 2014;
and subsequently as an applications manager for a nutritional supplements company. In August 2020,
he started working for the Petitioner, a pharmaceutical company 3, as a senior IT operations manager
and now works as "Associate Director, Master Data Management ["MDM"] Implementation Lead"
following a recent promotion. He intends to continue to work in this position and develop, implement,
and manage digital platforms by utilizing artificial intelligence ("AI") and machine learning, and help
optimize the Company's laboratory workflows and clinical trial data integration, ensure data security,
improve access to high-quality information, accelerate its drug research, development, and regulatory
approval processes, and facilitate its goal of efficiently producing innovative, effective therapeutics
and novel pharmaceutical treatments for patients. 4
Dhanasar's first prong, "substantial merit and national importance," focuses on the specific endeavor
the Beneficiary proposes to undertake, and its merit may be shown in a range of areas such as business,
entrepreneurialism, science, technology, culture, health, or education. Dhanasar, 26 I&N Dec. at 889.
In assessing whether the proposed endeavor has national importance, we consider and look for
evidence of its potential prospective impact. Id. Although the Beneficiary's proposed endeavor as a
lead MDM engineer and manager for the Company as described has merit, the evidence does not show
that it would have significant potential to employ U.S. workers, have substantial positive economic
impact in this country, broadly impact the U.S. data, pharmaceutical, or healthcare industry on national
or global level beyond his employer and its business partners, collaborators, and potential customers,
or otherwise have broader economic or societal implications rising to the level of national importance.
2 The Director did not reach Dhanasar' s second and third prongs.
3 For purposes of this decision, the term "Company" interchangeably refers to the Petitioner.
4 The record shows the Beneficiary works for the Petitioner, a pharmaceutical company, as an H-lB nonimmigrant worker.
But his resume only lists the dietary supplements company as his current employer, for whom it states he presently works
as a data manager. This employer previously sought EB-2 immigrant classification for him as an advanced degree
professional or a person of exceptional ability 'ยทwho is NOT seeking a National Interest Waiver," which was approved with
a 2015 visa priority date indicating three years of wait time until it becomes current, according to the latest visa bulletin.
2
Under the applicable evidentiary standard, we consider not only the quantity, but also the quality
(including relevance and probative value) of the evidence. Chawathe, 25 I&N Dec. at 375-76;
see also Matter of E-M-, 20 I&N Dec. 77, 79-80 (Comm'r 1989). In reasserting that the proposed
endeavor has national importance, the Petitioner relies on the Beneficiary's academic credentials and
experience as a data engineer specialist and manager, as indicated in his resume, personal statement,
support letters, and his Company records (including information on its financials, products,
implementation plans, clinical trial summaries and sites, journal articles, large market presence,
partnerships with other entities, and the Benecifiary's company role, projects, and presentations), as
well as the voluminous general industry articles noting the importance of the pharmaceutical,
healthcare, and AI industries. The Petitioner and the Beneficiary further continue to emphasize, as
indicated in part in their respective statements and other support ( or work verification) letters from his
former and current employers, his skills and past experiences as a data engineer and MDM specialist,
which they claim are critical to ensuring the quality and integrity of the Company's clinical trial data,
analysis, and application in the research and development phase of its new drugs. They reiterate that,
given his background and expertise, which highly qualify him for the Company's MDM role, and the
pharmaceutical industry's need and demand for individuals like him, his proposed endeavor will have
substantial positive economic and societal impact. However, these assertions and evidence primarily
focus on the Beneficiary's experience, skills, and the importance of his profession, and relates to
Dhanasar' s second prong, which "shifts the focus from the proposed endeavor to the foreign national"
and whether they are "well positioned" to advance their endeavor. Dhanasar, 26 I&N Dec. at 890.
For assessing the national importance of a proposed endeavor under Dhanasar's first prong, we look
to its "potential prospective impact" and evaluate whether the specific endeavor the Beneficiary
intends to undertake has broader national significance, rather than the importance of his profession or
industry in which he proposes to engage. Id. at 889. Here, he proposes to continue working as a lead
MDM engineer and manager for his Company, main duties of which include "clean[ing], organiz[ing],
and centraliz[ing] data" from its clinical trials for its research and development teams; enhancing
access to and use of secure and well-designed databases; and ensuring data quality and availability in
drug development decision-making process. As noted, he plans to continue to develop, implement,
and manage MDM systems and digital platforms with cutting-edge analytics capabilities and
automation by using AI and machine learning technologies, which he and the Petitioner reiterate will
optimize workflow integration, improve access to critical information, and facilitate safe data storage
and sharing, as well as high-impact knowledge generation, research, and communication they claim
will ultimately result in life-changing discovery and production of innovative and novel treatments for
patients and significantly impact the pharmaceutical, medical research, and healthcare industries.
The Petitioner also generally asserts that the Beneficiary "is recognized as a leading professional in
his field and he has made a tremendous impact on ensuring high-quality regulatory submission
compliance for innovative medicines." The Beneficiary's supervisor similarly highlights his
"instrumental role" and "substantial impact" based on his company project successes and the value of
his "recommendations and approaches to implementing MDM capacity" in advancing the Company's
research and development. The Petitioner also asserts that the Beneficiary's "innovative platforms"
and "technological innovations" facilitate "real-time collaboration" among scientists globally, help
disseminate clinical trial findings, and accelerate publication of scientific articles. But the Petitioner
does not claim, and the record contains no evidence, that the Company itself publishes scientific
articles or widely disseminates publicly its clinical studies and findings beyond its own business
3
interests and restrictions, or that the Beneficiary is directly involved in such enterprises. The record
also lacks objective evidence that he has in fact developed innovative data solution, applications, or
MDM models that are unique or novel and, if he did, they were or would be recognized or adopted by
the U.S. pharmaceutical industry or any other field that may be interested in his MDM strategies. The
record further lacks evidence of any particular interest of significance in his proposed data work ( other
than from his employer) that may otherwise indicate far-reaching, industry-wide importance of his
specific proposed endeavor or set it apart in a nationally distinguishable manner. Although we
acknowledge that the proposed endeavor could have a positive impact on the Beneficiary's career, his
Company, their business collaborators, and customers, the Petitioner has not persuasively explained,
and the record (primarily including the above assertions and documents) does not show how his
proposed work as a lead MDM specialist would have the national or global implications for the stated
industries as they claim, beyond the Beneficiary's Company, its business partners, and future clientele.
Further, the Petitioner does not claim that the Beneficiary himself will employee U.S. workers or that
his position within the Company has directly resulted in or will directly result in hiring of U.S. workers.
The Petitioner also does not specify, and the record lacks independent evidence as to, how the
Beneficiary's proposed work for the Company otherwise stands to impact U.S. economy or benefit
economically depressed areas. Dhanasar, 26 I&N Dec. at 890 (holding that proposed endeavors that
have "significant potential to employ U.S. workers" or "substantial positive economic effects,
particularly in an economically depressed area" may indicate national importance). The Petitioner
does not claim, for instance, and the record contains no evidence, that the Beneficiary's work as a lead
MDM specialist has directly benefited or will specifically benefit any economically depressed area.
Other than generally asserting the importance of his company role in the MDM field simply by virtue
of also being involved in the pharmaceutical industry and utilizing AI technologies, it is unclear how
his work as a lead data manager specifically facilitates and elevates its significance to a national level.
And his general assertions do not provide an objective basis for the claimed wide, indirect impact of
implementing and managing data solution, applications, and platforms as a single company employee.
The claimed significance of the pharmaceutical and AI markets thus does not directly evidence or
specifically relate to the claimed economic and societal impact of his proposed company MDM work.
Although the Petitioner reiterates the large sizes and potential economic impact of the multibillion
dollar pharmaceutical, healthcare, and AI industries, which various entities have generally described
as critical, the record lacks probative evidence that the potential impact of these industries would be
directly attributable to the Beneficiary's proposed endeavor. The Petitioner also does not explain or
delineate, and the record lacks competent evidence as to, the potential impact of the Beneficiary's
specific endeavor relative to the stated industries. The general significance or potential impact of these
industries therefore does not specifically inform the importance of the Beneficiary's own proposed
work within the Company, and does not necessarily evidence its claimed inherent national importance.
The Petitioner nonetheless continues to highlight, and we acknowledge, the Beneficiary's background
and past accomplishments as well as their value in other industries that rely on advanced data systems,
including the pharmaceutical industry, which as explained, pertain to Dhanasar's second prong and
thus do not show that his specific endeavor would have substantial positive economic or societal
effects at a national level. The importance of the proposed endeavor, as noted, is evaluated by its
specific potential prospective impact, rather than by the importance of the profession in which he
proposes to engage based on his skills that may position him well for future success ( or by the
4
importance of other industries that may rely on his expertise). Dhanasar, 26 I&N Dec. at. at 889-890.
The purpose of the national interest waiver therefore is not to ensure continued employment or
facilitate U.S. job search in industries that may also have national significance. Anyone seeking such
a waiver must show that the specific endeavor they propose to undertake has national importance. Id.
While we acknowledge his desire to continue to work for the Petitioner and contribute to the U.S. data,
IT, and pharmaceutical industries, the Petitioner has not established with probative evidence that the
Beneficiary's proposed endeavor as a lead MDM engineer and manager will specifically further its
objectives in a nationally significant manner, have broader implications in his field (or other
industries), have significant potential to employ U.S. workers, or have substantial positive economic
or societal effects. The Petitioner has not met Dhanasar's national importance prong and therefore
has not established that the Beneficiary is eligible for a discretionary national interest waiver.
As the identified ground for denial, the Petitioner's inability to satisfy Dhanasar's first prong is
dispositive of this appeal, we do not address here the second and third Dhanasar prongs for a
discretionary national interest waiver. See, e.g., INS v. Bagamasbad, 429 U.S. 24, 25 (1976) (stating
that agencies are not required to reach issues that are unnecessary to the ultimate decision).
ORDER: The appeal is dismissed.
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