Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 8665 

a period of 12 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 Ms. Lin’s felony convictions for 

entry of goods by means of false 

statements in violation of 18 U.S.C. 542 

constitute conduct relating to the 

importation into the United States of an 

article of food because she 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 Ms. Lin should be 

subject to a 12-year period of 

debarment. The proposal also offered 

Ms. Lin an opportunity to request a 

hearing, providing her 30 days from the 

date of receipt of the letter in which to 

file the request, and advised her that 

failure to request a hearing constituted 

a waiver of the opportunity for a hearing 

and of any contentions concerning this 

action. Ms. Lin failed to respond within 

the timeframe prescribed by regulation 

and has, therefore, waived her 

opportunity for a hearing and waived 

any contentions concerning her 

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 Hung Yi Lin has been 

convicted of three felony counts under 

Federal law for conduct relating to the 

importation into the United States of an 

article of food and that she is subject to 

a 12-year period of debarment. 

As a result of the foregoing finding, 

Hung Yi Lin is debarred for a period of 

12 years from importing articles of food 

or offering such articles for import into 

the United States, effective (see DATES). 

Under 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 Hung 

Yi Lin is a prohibited act. 

Any application by Ms. Lin for 

termination of debarment under section 

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

identified with Docket No. FDA–2013– 

N–1484 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: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03210 Filed 2–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2245] 

Immediately in Effect Guidance 

Document: Classification and 

Requirements for Laser Illuminated 

Projectors; Guidance for Industry and 

Food and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Immediately in Effect Guidance 

Document: Classification and 

Requirements for Laser Illuminated 

Projectors (LIPs).’’ This guidance 

describes FDA’s policy with respect to 

certain LIPs that comply with 

International Electrotechnical 

Commission (IEC) standards during 

laser product classification under the 

Electronic Product Radiation Control 

provisions of the Federal Food, Drug 

and Cosmetic Act (the FD&C Act) that 

apply to electronic products. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment, submit either 

electronic or written comments on the 

guidance by April 20, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Immediately in 

Effect Guidance Document: 

Classification and Requirements for 

Laser Illuminated Projectors’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Hintz, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4248, Silver Spring, 

MD 20993–0002, 301–796–6927. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Immediately in Effect 

Guidance Document: Classification and 

Requirements for Laser Illuminated 

Projectors.’’ This guidance is being 

issued consistent with FDA’s good 

guidance practices (GGPs) regulation (21 

CFR 10.115). The guidance is being 

implemented without prior public 

comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). The 

Agency made this determination 

because the guidance presents a less 

burdensome policy consistent with the 

public health. Although this guidance is 

immediately in effect, it remains subject 

to comment in accordance with the 

Agency’s GGPs regulation. This 

guidance describes FDA’s policy with 

respect to certain LIPs that comply with 

IEC standards during laser product 

classification under the Electronic 

Product Radiation Control provisions of 

the FD&C Act that apply to electronic 

products. The regulations for classifying 

laser products are set forth in part 1040 

(21 CFR part 1040). 

For purposes of this guidance, the 

term ‘‘laser illuminated projector’’ refers 

to a type of demonstration laser product 

regulated under § 1040.10(b)(13) that is 

designed to project full-frame digital 

images. The term ‘‘demonstration laser 

product’’ is defined under 

§ 1040.10(b)(13) to mean, ‘‘Any laser 

product manufactured, designed, 

intended, or promoted for purposes of 

demonstration, entertainment, 

advertising display, or artistic 

composition.’’ LIPs may be used in 

locations such as indoor or outdoor 

cinema theaters, laser shows, 

presentations at conventions, as image/ 

data projectors in an office setting, or in 

a home. 

Lasers are being used in LIPs as an 

alternative to conventional lamps in 


emcdonald on DSK67QTVN1PROD with NOTICES
8666 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 

projectors. Although these LIPs emit 

laser light from extended sources and 

their uncollimated beams do not present 

the same hazards as other lasers, they 

are laser products that present risks and 

must undergo classification in 

accordance with § 1040.10(c). 

Under § 1040.10(c), FDA recognizes 

four major hazard classes (I to IV) of 

lasers, including three subclasses (IIa, 

IIIa, and IIIb). Under this classification 

procedure, higher laser classes 

correspond to more powerful lasers and 

the potential to pose serious danger if 

used improperly. 

As demonstration laser products, LIPs 

cannot exceed class IIIa (which is 

comparable to IEC class 3R) emissions 

limits as specified in § 1040.11(c) unless 

granted a variance by FDA under 

§ 1010.4. Many LIPs and applications 

for LIPs will exceed the class IIIa limits 

and therefore require a variance to 

exceed those emission limits. 

This guidance document describes 

FDA’s intent with regard to the 

application of certain aspects of the 

performance standard requirements in 

§ 1040.11(c) for LIPs. The IEC standards 

used to evaluate lamps are applicable to 

characterizing ocular hazards in LIPs, 

because a laser retinal hazard is related 

to the radiance of the laser source and 

the radiant emission levels produced by 

LIPs are comparable to conventional 

lamps. Because the radiant emission 

levels produced by LIPs can 

scientifically be characterized by an 

alternative IEC standard, FDA does not 

intend to consider whether LIP 

manufacturers that conform to these 

standards under the situations described 

in this guidance also comply with 

§§ 1040.10(c) and 1040.11(c). 

II. Significance of Guidance 

The guidance represents the Agency’s 

current thinking on the classifications 

and requirements for LIPs. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Immediately in Effect Guidance 

Document: Classification and 

Requirements for Laser Illuminated 

Projectors’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number 1400056 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR parts 1002, 1010, 

and 1040 are approved under OMB 

control number 0910–0025. 

The labeling referenced in section 

(IV)(c)(ii) of the guidance does not 

constitute a ‘‘collection of information’’ 

under the PRA because the labeling is 

a ‘‘public disclosure of information 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)). 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03209 Filed 2–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Office of Tribal Self-Governance; 

Negotiation Cooperative Agreement 

Announcement Type: New—Limited 

Competition. 

Funding Announcement Number: 

HHS–2015–IHS–TSGN–0001. 

Catalog of Federal Domestic 

Assistance Number: 93.444. 

Key Dates 

Application Deadline Date: June 3, 

2015. 

Review Date: June 10, 2015. 

Earliest Anticipated Start Date: July 1, 

2015. 

Signed Tribal Resolutions Due Date: 

June 10, 2015. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) 

Office of Tribal Self-Governance (OTSG) 

is accepting limited competition 

Negotiation Cooperative Agreement 

applications for the Tribal SelfGovernance Program (TSGP). This 

program is authorized under Title V of 

the Indian Self-Determination and 

Education Assistance Act (ISDEAA), 25 

U.S.C. 458aaa–2(e). This program is 

described in the Catalog of Federal 

Domestic Assistance (CFDA), available 

at https://www.cfda.gov/, under 93.444. 

Background 

The TSGP is more than an IHS 

program; it is an expression of the 

government-to- government relationship 

between the United States and Indian 

Tribes. Through the TSGP, Tribes 

negotiate with the IHS to assume 

Programs, Services, Functions and 

Activities (PSFAs), or portions thereof, 

which gives Tribes the authority to 

manage and tailor health care programs 

in a manner that best fits the needs of 

their communities. 

Participation in the TSGP is one of 

three ways that Tribes can choose to 

obtain health care from the Federal 

Government for their members. 

Specifically, Tribes can choose to: (1) 

Receive health care services directly 

from the IHS, (2) contract with the IHS 

to administer individual PSFAs that the 

IHS would otherwise provide (referred 

to as Title I Self-Determination 

Contracting), or (3) compact with the 

IHS to assume control over healthcare 

PSFAs that the IHS would otherwise 

provide (referred to as Title V SelfGovernance Compacting or the TSGP). 

These options are not exclusive and 

Tribes may choose to combine options 

based on their individual needs and 

circumstances. Participation in the 

TSGP affords Tribes the most flexibility 

to tailor health care PSFAs to the needs 

of their communities. 

The TSGP is a Tribally-driven 

initiative and strong Tribal/Federal 

partnerships are essential for program 

success. The IHS established the OTSG 

to implement Tribal Self-Governance 

authorities. The OTSG: (1) Serves as the 

primary liaison and advocate for Tribes 

participating in the TSGP, (2) develops, 


emcdonald on DSK67QTVN1PROD with NOTICES