Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors; Guidance for Industry and Food and Drug Administration Staff; Availability, 8665-8666 [2015-03209]

Download as PDF Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices emcdonald on DSK67QTVN1PROD with NOTICES 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 VerDate Sep<11>2014 19:32 Feb 17, 2015 Jkt 235001 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. 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. SUMMARY: PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 8665 Submit electronic comments on the guidance to https://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 E:\FR\FM\18FEN1.SGM 18FEN1 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). emcdonald on DSK67QTVN1PROD with NOTICES 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy VerDate Sep<11>2014 19:32 Feb 17, 2015 Jkt 235001 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 https://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 https:// 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. PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 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, E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8665-8666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03209]


-----------------------------------------------------------------------

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 https://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 Sec.  1040.10(b)(13) that is designed to project full-frame 
digital images. The term ``demonstration laser product'' is defined 
under Sec.  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

[[Page 8666]]

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 Sec.  1040.10(c).
    Under Sec.  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 
Sec.  1040.11(c) unless granted a variance by FDA under Sec.  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 Sec.  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 Sec. Sec.  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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://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 https://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 https://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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.