17450 Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 

a license, grant or other benefit. The 

other agency or licensing organization 

may then make a request supported by 

the written consent of the individual for 

further information if it so chooses. HHS 

will not make an initial disclosure 

unless the information has been 

determined to be sufficiently reliable to 

support a referral to another office 

within the agency or to another federal 

agency for criminal, civil, 

administrative, personnel, or regulatory 

action. 

8. Information may be disclosed to a 

Member of Congress or Congressional 

staff member in response to a written 

inquiry of the Congressional office made 

at the written request of the constituent 

about whom the record is maintained. 

The Congressional office does not have 

any greater authority to obtain records 

than the individual would have if 

requesting the records directly. 

9. Records may be disclosed to the 

U.S. Department of Homeland Security 

(DHS) if captured in an intrusion 

detection system used by HHS and DHS 

pursuant to a DHS cybersecurity 

program that monitors Internet traffic to 

and from federal government computer 

networks to prevent a variety of types of 

cybersecurity incidents. 

10. Disclosures may be made to 

appropriate federal agencies and 

Department contractors that have a need 

to know the information for the purpose 

of assisting the Department’s efforts to 

respond to a suspected or confirmed 

breach of the security or confidentiality 

of information maintained in this 

system of records, when the information 

disclosed is relevant and necessary to 

that assistance. 

Information about an individual data 

requester may also be disclosed from 

this system of records to parties outside 

HHS without the individual’s consent 

for any of the uses authorized directly 

in the Privacy Act at 5 U.S.C. 552a(b)(2) 

and (b)(4)–(11). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM— 

STORAGE: 

Records are stored in electronic 

databases and hard-copy files. DADSS, 

and its successors’, records may also be 

stored on portable media. 

RETRIEVABILITY: 

Records are retrieved by the data 

requester’s name, registrant/user name, 

User ID number, or data use agreement 

(DUA) number. 

SAFEGUARDS: 

Records are safeguarded in 

accordance with applicable laws, rules 

and policies, including the HHS 

Information Technology Security 

Program Handbook, all pertinent 

National Institutes of Standards and 

Technology (NIST) publications, and 

OMB Circular A–130, Management of 

Federal Resources. Records are 

protected from unauthorized access 

through appropriate administrative, 

physical, and technical safeguards. 

Safeguards conform to the HHS 

Information Security and Privacy 

Program, http://www.hhs.gov/ocio/

securityprivacy/. The safeguards include 

protecting the facilities where records 

are stored or accessed with security 

guards, badges and cameras, securing 

hard-copy records in locked file 

cabinets, file rooms or offices during offduty hours, limiting access to electronic 

databases to authorized users based on 

roles and the principle of least privilege, 

and two-factor authentication (user ID 

and password), using a secured 

operating system protected by 

encryption, firewalls, and intrusion 

detection systems, using an SSL 

connection for secure encrypted 

transmissions, requiring encryption for 

records stored on removable media, and 

training personnel in Privacy Act and 

information security requirements. 

RETENTION AND DISPOSAL: 

Records needed to enforce data use 

restrictions are retained for 20 years by 

AHRQ (see DAA–0510–2013–0003– 

0001) and 5 years by CMS (see N1–440– 

10–04) after the agreement is closed, 

and may be kept longer if necessary for 

enforcement, audit, legal, or other 

purposes. The equivalent SAMHSA 

records will be retained indefinitely 

until a disposition schedule is approved 

by the National Archives and Records 

Administration (NARA). SAMHSA 

anticipates proposing a 5 year retention 

period to NARA. Records of payments 

made electronically are transmitted 

securely to a Payment Card Industrycompliant payment gateway for 

processing and are not stored. Records 

of payments made by check, purchase 

order, or wire transfer are disposed of 

once the funds have been received. 

Records are disposed of using 

destruction methods prescribed by NIST 

SP 800–88. 

SYSTEM MANAGER(S) AND ADDRESS(ES): 

• AHRQ: HCUP Project Officer, 

Center for Delivery, Organization, and 

Markets, 540 Gaither Road, Rockville, 

MD 20850; Telephone: 301–427–1410; 

HCUP@AHRQ.GOV. 

• CMS: DADSS and its successor, 

Division of Data and Information 

Dissemination, Data Development and 

Services Group, Office of Enterprise 

Data and Analytics, Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Mailstop: B2–29– 

04, Office Location: B2–03–37, 

Baltimore, MD 21244–1870. 

• SAMHSA: SAMHDA Project 

Officer, CBHSQ, 1 Choke Cherry Road, 

Rockville, MD 20857. 

NOTIFICATION PROCEDURE: 

An individual who wishes to know if 

this system of records contains records 

about him or her should submit a 

written request to the relevant System 

Manager at the address indicated above. 

The individual must verify his or her 

identity by providing either a notarized 

request or a written certification that the 

requester is who he or she claims to be 

and understands that the knowing and 

willful request for acquisition of a 

record pertaining to an individual under 

false pretenses is a criminal offense 

under the Privacy Act, subject to a five 

thousand dollar fine. 

RECORD ACCESS PROCEDURE: 

Same as notification procedure. 

CONTESTING RECORD PROCEDURES: 

An individual seeking to amend the 

content of information about him or her 

in this system should contact the 

relevant System Manager and 

reasonably identify the record, specify 

the information contested, state the 

corrective action sought, and provide 

the reasons for the amendment, with 

supporting justification. 

RECORD SOURCE CATEGORIES: 

Information in this system of records 

is obtained directly from the individual 

data requester to whom it applies, or is 

derived from information supplied by 

the individual or provided by HHS 

officials. 

EXEMPTIONS CLAIMED FOR THIS SYSTEM: 

None. 

Celeste Dade-Vinson, 

Health Insurance Specialist, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2015–07444 Filed 3–31–15; 8:45 a.m.] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0964] 

Jun Yang: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 17451 

SUMMARY: The U.S. Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) debarring Jun Yang for a period of 

4 years from importing articles of food 

or offering such articles for importation 

into the United States. FDA bases this 

order on a finding that Mr. Yang was 

convicted, as defined in the FD&C Act, 

of one felony count under Federal law 

for conduct relating to the importation 

into the United States of an article of 

food. Mr. Yang was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. As 

of November 7, 2014 (30 days after 

receipt of the notice), Mr. Yang had not 

responded. Mr. Yang’s failure to 

respond constitutes a waiver of his right 

to a hearing concerning this action. 

DATES: This order is effective April 1, 

2015. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Division Of Enforcement, 

Office of Enforcement and Import 

Operations, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr. (ELEM–4144), Rockville, 

MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. 

On November 14, 2013, Mr. Yang was 

convicted, as defined in section 

306(l)(1)(B) of the FD&C Act, when the 

U.S. District Court for the Northern 

District of Illinois accepted his plea of 

guilty and entered judgment against him 

for the following offense: One count of 

smuggling goods into the United States, 

in violation of 18 U.S.C. 545. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: 

On or about February 10, 2012, Mr. 

Yang facilitated the sale of imported 

honey with a declared value of $92,800, 

knowing that the honey was of Chinese 

origin and was imported and brought 

into the United States contrary to law. 

As part of his fraudulent practice, Mr. 

Yang brokered the sale of two container 

loads of purported ‘‘100% pure Indian 

honey,’’ knowing that the honey was 

falsely and fraudulently imported and 

brought into the United States as a 

product of India in avoidance of U.S.- 

imposed anti-dumping duties, thereby 

causing losses to the United States of 

approximately $97,625. 

Mr. Yang admitted that he operated 

and controlled National Honey, Inc., 

which did business as National 

Commodities Company, and served as 

the principal point of contact for 

brokering the sale of honey between 

overseas honey suppliers and U.S. 

customers. Mr. Yang further admits that 

between 2009 and 2012 he sold 778 

container loads of honey valued at 

approximately $22,864,153 to Honey 

Holding and Honey Packer 1 (U.S. 

customers). This was part of a 

fraudulent practice to enter and 

introduce and cause others to enter and 

introduce transshipped Chinese-origin 

honey into the commerce of the United 

States in avoidance of U.S. imposed 

anti-dumping duties. Mr. Yang 

continued this practice even though he 

knew that the honey was falsely and 

fraudulently imported, entered, 

marketed, and sold as purely nonChinese honey, including as honey from 

Malaysia and India. This fraudulent 

practice caused losses to the United 

States of as much as $37,991,375. 

Mr. Yang also admitted that he 

ordered honey from Chinese honey 

suppliers, knowing that the Chinese 

honey suppliers would send the 

Chinese-origin honey to countries 

including Malaysia and India, where the 

honey was mislabeled as to the country 

of origin before it passed through a U.S. 

customhouse as non-Chinese origin 

honey. Mr. Yang and National 

Commodities caused the formation of at 

least three companies and used at least 

one other company to import and enter 

honey from a Chinese honey supplier 

knowing that some of the honey was 

Chinese in origin. Mr. Yang and 

National Commodities benefitted from 

the company’s filing custom entry forms 

that falsely and fraudulently declared 

all the honey as originating from 

Malaysia and India. Mr. Yang and 

National Commodities purchased honey 

imported by the companies despite 

knowing that some or all of the honey 

was Chinese in origin, but declared at 

the time of importation and entry as 

entirely originating from Malaysia and 

India. 

Mr. Yang also admitted that he 

obtained and circulated and caused 

others to obtain and circulate false and 

fraudulent bills of lading, invoices, 

packing lists, country of origin 

certificates, and other papers, which he 

knew to be false and fraudulent. These 

records were used to declare Chineseorigin honey as having originated from 

Malaysia and India. Mr. Yang also 

instructed an undercover law 

enforcement agent to destroy 

unfavorable test results that showed 

purported Vietnamese honey that he 

sold tested positive for the presence of 

chloramphenicol, an antibiotic. 

Residues of chloramphenicol in honey 

cause the honey to be adulterated under 

the FD&C Act. In anticipation of an 

investigation by U.S. Customs and 

Border Protection and FDA, Mr. Yang 

knowingly concealed and covered up 

three laboratory reports showing the 

presence of chloramphenicol. 

As a result of his conviction, on 

October 1, 2014, FDA sent Mr. Yang a 

notice by certified mail proposing to 

debar him for a period of 4 years from 

importing articles of food or offering 

such articles for import into the United 

States. The proposal was based on a 

finding under section 306(b)(1)(C) of the 

FD&C Act that Mr. Yang’s felony 

conviction for smuggling of goods into 

the United States in violation of 18 

U.S.C. 545 constitutes conduct relating 

to the importation into the United States 

of an article of food because he 

committed an offense related to the 

importation of Chinese honey into the 

United States. 

The proposal was also based on a 

determination, after consideration of the 

factors set forth in section 306(c)(3) of 

the FD&C Act, that Mr. Yang should be 

subject to a 4-year period of debarment. 

The proposal also offered Mr. Yang an 

opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Yang failed to respond within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement and Import Operations, 

Office of Regulatory Affairs, under 

section 306(b)(1)(C) of the FD&C Act, 

under authority delegated to the 

Director (Staff Manual Guide 1410.35), 

finds that Jun Yang has been convicted 

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17452 Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 

of one felony count under Federal law 

for conduct relating to the importation 

into the United States of an article of 

food and that he is subject to a 4-year 

period of debarment. 

As a result of the foregoing finding, 

Jun Yang is debarred for a period of 4 

years from importing articles of food or 

offering such articles for import into the 

United States, effective (see DATES). 

Pursuant to section 301(cc) of the FD&C 

Act (21 U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of an article of food by, with the 

assistance of, or at the direction of Jun 

Yang is a prohibited act. 

Any application by Mr. Yang for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2014– 

N–0964 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: March 26, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07439 Filed 3–31–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 80 FR 1417–1419, dated 

January 9, 2015) is amended to reflect 

the reorganization of the Office of Public 

Health Scientific Services, Centers for 

Disease Control and Prevention. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete in its entirety the title and 

functions statements for the Health 

Information Technology and 

Surveillance Strategy Unit (CPA3), 

Office of the Director (CPA), 

Delete in its entirety the title and the 

mission and function statements for the 

Center for Surveillance, Epidemiology 

and Laboratory Services (CPN) and 

insert the following: 

Center for Surveillance, Epidemiology 

and Laboratory Services (CPN) The 

mission of the Center for Surveillance, 

Epidemiology, and Laboratory Services 

(CSELS) is to provide scientific service, 

expertise, skills, and tools in support of 

CDC’s efforts to promote health; prevent 

disease, injury and disability; and 

prepare for emerging health threats. 

CSELS focuses on improving 

information and data quality, laboratory 

systems, and the public health 

workforce, through modernization, 

innovation, and service. To carry out its 

mission, CSELS (1) leads and executes 

a national public health surveillance 

strategy for human health that builds 

upon current resources, establishes 

priorities for the nation’s nextgeneration capability and provides 

timely, comprehensive, and accessible 

information to strengthen public health 

practice, and provide value to 

clinicians; (2) participates in the 

identification, development, evolution, 

and adoption of informatics standards; 

(3) facilitates and coordinates program 

and laboratory systems integration for 

the Agency; (4) provides leadership and 

support to strengthen the quality and 

safety of laboratory practices; (5) 

provides leadership for scientific 

workforce education and advances 

professional development; (6) provides 

leadership on public health genomics 

strategy, activities, and planning; (7) 

creates and promotes access to quality, 

timely and useful cross-cutting 

scientific guidance, products, and 

services to strengthen the science and 

practice of public health and to improve 

public health decision-making. 

Office of the Director (CPN1). (1) 

Provides strategic direction regarding 

surveillance, epidemiologic 

investigation, and data and information 

sciences; (2) supports OPHSS’s CDCwide coordination and strategic 

activities in areas of health informatics 

technology, including the meaningful 

use of electronic health records for 

public health surveillance and the 

coordination of partners and 

stakeholders for biosurveillance, 

genomics, and publication science; (3) 

leads the development of public health 

workforce training; (4) guides the 

development of laboratory systems 

standards for quality and safety, 

including the Clinical Laboratory 

Improvement Amendments (CLIA) and 

engagement with relevant federal 

advisory committees; (5) manages, 

directs, coordinates, and evaluates the 

activities of the Center; (6) defines goals 

and objectives for policy formation, 

scientific oversight, and guidance in 

program planning and development; (7) 

establishes and implements a 

communications strategy in support of 

CSELS overarching goals and priorities; 

(8) provides oversight for the evaluation 

of programmatic performance of all 

CSELS activities to ensure health 

impact; (9) plans, coordinates, and 

manages all aspects of program business 

services including human and fiscal 

resources, extramural activities, space, 

and all administrative services; (10) 

devises information technology 

practices and procedures, and provides 

direction, innovation, planning and 

evaluation for information technology 

systems, services, security, and 

resources for CSELS; (11) provides 

leadership on issues management, 

budget formulation and performance 

integration; (12) manages intergovernmental and external affairs and 

cultivates strategic partnerships; (13) 

ensures scientific quality, integrity, and 

clearance across the Center; (14) 

provides guidance and strategic 

oversight to the processes within the 

Center that access, collect, manage, 

analyze, and visualize data, including 

assistance for involvement with federal 

advisory committees and other high 

level groups; (15) monitors projects for 

effective focus on the analytical, 

informatics, data management, and 

statistical infrastructure to deliver 

quality data, accurate analysis services 

and dependable software products and 

systems to customers and partners; (16) 

collaborates and consults with other 

Centers, working groups, state and local 

health departments, other federal 

agencies, and other partners, to 

accomplish the mission of the Center; 

(17) reviews, prepares, coordinates, and 

develops Congressional testimony and 

briefing materials; and (18) represents 

the CSELS and at times CDC at 

professional and scientific meetings, 

within and outside CDC. 

Division of Laboratory Systems 

(CPNB). The mission of the Division of 

Laboratory Systems (DLS) is to provide 

leadership, support, and cross-cutting 

services to continually strengthen the 

capability, sustainability, and quality of 

laboratory science, policy, and practice 

at CDC, in clinical and public health 

laboratories, both in the United States 

and with international partners. DLS 

strives to strengthen and align the 

capacity and ability of both clinical and 

public health laboratories to perform 

their critical roles in protecting the 

public’s health. In this mission, DLS: (1) 

Fosters collaboration across the 

laboratory community; (2) strengthens 

integration of laboratory science, 

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