dismissed EB-2 NIW Case: Pharmaceutical And Regulatory Affairs

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PUBLIC COPY 
U.S. Department of Homeland Security 
20 Mass. Ave., N.W., Rrn. 3000 
Washington, DC 20529 
FILE: office: NEBRASKA SERVICECENTER Date~~p 
 2008 
LIN 06 185 52296 
PETITION: 
 Immigrant Petition for Alien Worker as a Member of the Professions Holding an Advanced 
Degree or an Alien of Exceptional Ability Pursuant to Section 203(b)(2) of the Immigration 
and Nationality Act, 8 U.S.C. 8 1 153(b)(2) 
ON BEHALF OF PETITIONER: 
SELF-REPRESENTED 
INSTRUCTIONS: 
This is the decision of the Administrative Appeals Office in your case. All documents have been returned to 
the office that originally decided your case. Any further inquiry must be made to that office. 
u 
xobert P. Wiernann, Chief 
Administrative Appeals Office 
Page 2 
DISCUSSION: The Director, Nebraska Service Center, denied the employment-based immigrant visa petition. 
The matter is now before the Administrative Appeals Office (AAO) on appeal. The appeal will be dismissed. 
The petitioner seeks classification pursuant to section 203(b)(2) of the Immigration and Nationality Act (the 
Act), 8 U.S.C. $ 1153(b)(2), as a member of the professions holding an advanced degree. The petitioner seeks 
employment as "a board certified pharmaceutical and regulatory affairs professional." The petitioner asserts that 
an exemption from the requirement of a job offer, and thus of a labor certification, is in the national interest of 
the United States. The director found that the petitioner qualifies for classification as a member of the 
professions holding an advanced degree, but that the petitioner has not established that an exemption from the 
requirement of a job offer would be in the national interest of the United States. 
On appeal, the petitioner submits a personal statement and a transcript from Temple University. On Form 
I-290B, Notice of Appeal, the petitioner checked a box indicating "No supplemental brief andlor additional 
evidence will be submitted," but the petitioner also underlined the phrase "additional evidence will be 
submitted." The petitioner stated: "I am requesting . . . 6-7 months to produce evidence of my diploma from 
Temple University school of Pharmacy. I owe the school an estimated $7000 and I expect to pay off the balance 
by mid or early June 2008. It is then the school will provide me with the diploma." The director, however, did 
not deny the petition in whole or in part based on the lack of a diploma from Temple University. Therefore, to 
suspend adjudication until the petitioner submits this diploma would not alter the ultimate outcome of the 
petition. 
Section 203(b) of the Act states, in pertinent part: 
(2) Aliens Who Are Members of the Professions Holding Advanced Degrees or Aliens of Exceptional 
Ability. -- 
(A) In General. -- Visas shall be made available . . . to qualified immigrants who are members 
of the professions holding advanced degrees or their equivalent or who because of their 
exceptional ability in the sciences, arts, or business, will substantially benefit prospectively the 
national economy, cultural or educational interests, or welfare of the United States, and whose 
services in the sciences, arts, professions, or business are sought by an employer in the United 
States. 
(B) Waiver of Job Offer. 
(i) . . . the Attorney General may, when the Attorney General deems it to be in the 
national interest, waive the requirements of subparagraph (A) that an alien's services in 
the sciences, arts, professions, or business be sought by an employer in the United 
States. 
The director did not dispute that the petitioner qualifies as a member of the professions holding an advanced 
degree, but the issue of the petitioner's degrees bears mentioning briefly. In an introductory statement submitted 
with the initial filing, the petitioner identified himself as "a member of the Pharmaceutical regulatory affairs 
profession holding two advanced degrees." He continued: "I hold a master of biomdcal science from Drexel 
University School of Biomedical Engineering, Science and Health Systems, class of 2003. I am also 
anticipating . . . a master of science of pharmaceutical quality assurance and regulatory affairs from Temple 
University's School of Pharmacy this summer, 2006." A May 22, 2006 letter from Temple University's Office 
of Graduate Studies indicated that the beneficiary was "currently a matriculated student . . . enrolled in two 
courses for the first summer session, and two courses in the second summer session." The letter is dated May 
22,2006, less than three weeks before the petition's June 9, 2006 filing date. Clearly, the petitioner had not yet 
completed the coursework for his second advanced degree, and therefore he was at best premature in describing 
himself as "holding two advanced degrees." 
Notwithstanding the above, the petitioner had earned an advanced degree prior to the petition's filing date, and 
his occupation meets the regulatory definition of a profession at 8 C.F.R. 5 204.5(k)(2). The petitioner therefore 
qualifies as a member of the professions holding an advanced degree. The sole issue in contention is whether 
the petitioner has established that a waiver of the job offer requirement, and thus a labor certification, is in the 
national interest. 
Neither the statute nor the pertinent regulations define the term "national interest." Additionally, Congress did 
not provide a specific definition of "in the national interest." The Committee on the Judiciary merely noted in 
its report to the Senate that the committee had "focused on national interest by increasing the number and 
proportion of visas for immigrants who would benefit the United States economically and otherwise. . . ." S. 
Rep. No. 55, lOlst Cong., 1st Sess., 1 1 (1989). 
Supplementary information to regulations implementing the Immigration Act of 1990 (IMMACT), published at 
56 Fed. Reg. 60897,60900 (November 29, 1991), states: 
The Service [now Citizenship and Immigration Services (CIS)] believes it appropriate to leave 
the application of this test as flexible as possible, although clearly an alien seeking to meet the 
[national interest] standard must make a showing significantly above that necessary to prove the 
"prospective national benefit" [required of aliens seeking to qualify as "exceptional."] The 
burden will rest with the alien to establish that exemption from, or waiver of, the job offer will 
be in the national interest. Each case is to be judged on its own merits. 
Matter of New York State Dept. of Transportation, 22 I&N Dec. 215 (Commr. 1998), has set forth several 
factors which must be considered when evaluating a request for a national interest waiver. First, it must be 
shown that the alien seeks employment in an area of substantial intrinsic merit. Next, it must be shown that the 
proposed benefit will be national in scope. Finally, the petitioner seeking the waiver must establish that the alien 
will serve the national interest to a substantially greater degree than would an available U.S. worker having the 
same minimum qualifications. 
It must be noted that, while the national interest waiver hinges on prospective national benefit, it clearly must be 
established that the alien's past record justifies projections of future benefit to the national interest. The 
petitioner's subjective assurance that the alien will, in the future, serve the national interest cannot suffice to 
establish prospective national benefit. The inclusion of the term "prospective" is used here to require future 
contributions by the alien, rather than to facilitate the entry of an alien with no demonstrable prior achievements, 
and whose benefit to the national interest would thus be entirely speculative. 
We also note that the regulation at 8 C.F.R. $204.5(k)(2) defines "exceptional ability" as "a degree of expertise 
significantly above that ordinarily encountered" in a given area of endeavor. By statute, aliens of exceptional 
ability are generally subject to the job offdabor certification requirement; they are not exempt by virtue of their 
exceptional ability. Therefore, whether a given alien seeks classification as an alien of exceptional ability, or as 
a member of the professions holding an advanced degree, that alien cannot qualify for a waiver just by 
demonstrating a degree of expertise significantly above that ordinarily encountered in his or her field of 
expertise. 
The bulk of the petitioner's initial submission concerned the importance of the pharmaceutical industry, health 
care, and related issues. This information establishes the intrinsic merit of his chosen field of endeavor. 
Nevertheless, the submitted documents are general background materials that are not specific to the petitioner 
(as opposed to others in the same field), and as such cannot suffice to demonstrate that the petitioner qualifies 
for the special benefit of a national interest waiver. For example, the petitioner submitted news articles about 
clinical trials of vaccines, but no evidence that he was involved in developing those vaccines or conducting the 
trials. 
The petitioner also established that he is "Regulatory Affairs Qualified" by the Regulatory Affairs Professionals 
Society. These credentials qualify him to work in his chosen field, but one does not qualify for a national 
interest waiver merely by being qualified to work in an important field. It is the position of CIS to grant national 
interest waivers on a case-by-case basis, rather than to establish blanket waivers for entire fields of 
specialization. Matter of New York State Dept. of Transportation at 217. 
On April 20,2007, the director issued a request for evidence, instructing the petitioner to submit documentation 
specific to the petitioner, for instance establishing his involvement in research projects, or authorship of 
scholarly publications. The director explained: "You must establish, in some capacity, your ability to serve the 
national interest to a substantially greater extent than the majority of your colleagues." 
In response, the petitioner stated: "In my field, regulatory affair and clinical research, scholars or experienced 
industry professionals seldom publish papers. In the field of regulatory affairs and clinical research, success is 
primarily based on masterly of guiding laws or regulations by the department of health and human services and 
implemented by the food and drug administration [sic]." Familiarity with pertinent statutes and regulations is, 
without a doubt, essential for success when one's field involves regulatory affairs. Nevertheless, at issue here is 
not whether the petitioner is qualified to work in a particular field, but whether he, in particular, qualifies for a 
waiver of the job offer requirement that, by law, typically applies to aliens in that field. The petitioner's asserted 
mastery of what appears to be a rather basic job requirement does not readily set him apart from others in his 
profession. 
The petitioner submitted documentation showing that his was one of 397 research projects displayed on 
"Research Day 2003" at Drexel University. The petitioner did not explain the relevance of this project (which 
concerned fluctuating glucose levels in diabetics) to his intended career in regulatory affairs, nor did he show 
that his project was in any way distinguished among the nearly 400 others displayed in what appears to have 
been a campus event. 
The director denied the petition on September 14, 2007, stating that the petitioner had failed to "establish that 
the petitioner's efforts have been national in scope or that he has had a degree of influence in the field," or that 
"the petitioner would serve the national interest to a substantially greater extent than the majority of his 
colleagues." 
On appeal, the petitioner states: "Due to the broad nature of the pharmaceutical profession, many people have 
[a] dearth of knowledge on the role clinical research scientist[s] or regulatory affairs professionals play." The 
petitioner then describes his "role in the drug development process" and lists reasons why he is "extremely 
competitive in this field." Once again, simply being qualified to work in a given profession does not establish 
eligibility for a national interest waiver. The petitioner appears to qualify for the underlying immigrant 
classification as a member of the professions holding an advanced degree, but that classification, by law, 
typically requires a job offer and a petition filed by the intending employer. The petitioner has filed this petition 
on his own behalf with no job offer, and therefore must show not only that he qualifies for the classification 
sought, but also that he qualifies for a separate, additional immigration benefit in the form of a national interest 
waiver. The petitioner has submitted no evidence to show that he, more than others in his field, qualifies for that 
additional benefit. Rather, the petitioner has listed his own qualifications and asserted, with no evidentiary 
support, that those qualifications should earn him the waiver. 
The petitioner asserts that his two master's degrees, including one that he finished well after the petition's filing 
date, "are by all accounts of immense influence in the field of drug development.'' This unsupported claim 
carries no weight in this proceeding. The petitioner has not provided even a single concrete example to show 
how he has influenced the field. The petitioner cannot simply declare, by fiat, that a master's degree influences 
the field by its very existence. Even if this were so, it would still fail to distinguish the petitioner in any 
meaningll way from the countless others who have also earned master's degrees in the same field. 
As is clear fiom a plain reading of the statute, it was not the intent of Congress that every person qualified to 
engage in a profession in the United States should be exempt from the requirement of a job offer based on 
national interest. Likewise, it does not appear to have been the intent of Congress to grant national interest 
waivers on the basis of the overall importance of a given profession, rather than on the merits of the individual 
alien. On the basis of the evidence submitted, the petitioner has not established that a waiver of the requirement 
of an approved labor certification will be in the national interest of the United States. 
The burden of proof in these proceedings rests solely with the petitioner. Section 291 of the Act, 8 U.S.C. 5 
1361. The petitioner has not sustained that burden. This denial is without prejudice to the filing of a new 
petition by a United States employer accompanied by a labor certification issued by the Department of Labor, 
appropriate supporting evidence and fee. 
ORDER: The appeal is dismissed.