80 FR 8665 - Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 32 (February 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 32 (February 18, 2015)
| Page Range | 8665-8666 | |
| FR Document | 2015-03209 |
[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)] [Notices] [Pages 8665-8666] From the Federal Register Online [www.thefederalregister.org] [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 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 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 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
![Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 8665
a period of 12 years from importing Management between 9 a.m. and 4 p.m., Submit electronic comments on the
articles of food or offering such articles Monday through Friday. guidance to http://www.regulations.gov.
for import into the United States. The Dated: February 11, 2015. Submit written comments to the
proposal was based on a finding under Leslie Kux,
Division of Dockets Management (HFA–
section 306(b)(1)(C) of the FD&C Act 305), Food and Drug Administration,
Associate Commissioner for Policy.
that Ms. Lin’s felony convictions for 5630 Fishers Lane, Rm. 1061, Rockville,
entry of goods by means of false [FR Doc. 2015–03210 Filed 2–17–15; 8:45 am]
MD 20852. Identify comments with the
statements in violation of 18 U.S.C. 542 BILLING CODE 4164–01–P docket number found in brackets in the
constitute conduct relating to the heading of this document.
importation into the United States of an FOR FURTHER INFORMATION CONTACT:
article of food because she committed DEPARTMENT OF HEALTH AND
HUMAN SERVICES Patrick Hintz, Center for Devices and
an offense related to the importation of Radiological Health, Food and Drug
Chinese honey into the United States. Food and Drug Administration Administration, 10903 New Hampshire
The proposal was also based on a Ave., Bldg. 66, Rm. 4248, Silver Spring,
determination, after consideration of the [Docket No. FDA–2014–D–2245]
MD 20993–0002, 301–796–6927.
factors set forth in section 306(c)(3) of
Immediately in Effect Guidance SUPPLEMENTARY INFORMATION:
the FD&C Act, that Ms. Lin should be
subject to a 12-year period of Document: Classification and I. Background
debarment. The proposal also offered Requirements for Laser Illuminated
Projectors; Guidance for Industry and FDA is announcing the availability of
Ms. Lin an opportunity to request a
Food and Drug Administration Staff; a guidance for industry and FDA staff
hearing, providing her 30 days from the
Availability entitled ‘‘Immediately in Effect
date of receipt of the letter in which to
Guidance Document: Classification and
file the request, and advised her that AGENCY: Food and Drug Administration, Requirements for Laser Illuminated
failure to request a hearing constituted HHS. Projectors.’’ This guidance is being
a waiver of the opportunity for a hearing
and of any contentions concerning this ACTION: Notice. issued consistent with FDA’s good
action. Ms. Lin failed to respond within guidance practices (GGPs) regulation (21
SUMMARY: The Food and Drug CFR 10.115). The guidance is being
the timeframe prescribed by regulation Administration (FDA) is announcing the
and has, therefore, waived her implemented without prior public
availability of the guidance entitled comment because the Agency has
opportunity for a hearing and waived ‘‘Immediately in Effect Guidance
any contentions concerning her determined that prior public
Document: Classification and participation is not feasible or
debarment (21 CFR part 12). Requirements for Laser Illuminated appropriate (21 CFR 10.115(g)(2)). The
II. Findings and Order Projectors (LIPs).’’ This guidance Agency made this determination
describes FDA’s policy with respect to because the guidance presents a less
Therefore, the Director, Office of
certain LIPs that comply with burdensome policy consistent with the
Enforcement and Import Operations,
International Electrotechnical public health. Although this guidance is
Office of Regulatory Affairs, under
Commission (IEC) standards during immediately in effect, it remains subject
section 306(b)(1)(C) of the FD&C Act,
laser product classification under the to comment in accordance with the
under authority delegated to the
Electronic Product Radiation Control Agency’s GGPs regulation. This
Director (Staff Manual Guide 1410.35),
provisions of the Federal Food, Drug guidance describes FDA’s policy with
finds that Hung Yi Lin has been
and Cosmetic Act (the FD&C Act) that respect to certain LIPs that comply with
convicted of three felony counts under
apply to electronic products. IEC standards during laser product
Federal law for conduct relating to the
DATES: Although you can comment on classification under the Electronic
importation into the United States of an
article of food and that she is subject to any guidance at any time (see 21 CFR Product Radiation Control provisions of
a 12-year period of debarment. 10.115(g)(5)), to ensure that the Agency the FD&C Act that apply to electronic
As a result of the foregoing finding, considers your comment, submit either products. The regulations for classifying
Hung Yi Lin is debarred for a period of electronic or written comments on the laser products are set forth in part 1040
12 years from importing articles of food guidance by April 20, 2015. (21 CFR part 1040).
or offering such articles for import into ADDRESSES: An electronic copy of the For purposes of this guidance, the
the United States, effective (see DATES). guidance document is available for term ‘‘laser illuminated projector’’ refers
Under section 301(cc) of the FD&C Act download from the Internet. See the to a type of demonstration laser product
(21 U.S.C. 331(cc)), the importing or SUPPLEMENTARY INFORMATION section for regulated under § 1040.10(b)(13) that is
offering for import into the United information on electronic access to the designed to project full-frame digital
States of an article of food by, with the guidance. Submit written requests for a images. The term ‘‘demonstration laser
assistance of, or at the direction of Hung single hard copy of the guidance product’’ is defined under
Yi Lin is a prohibited act. document entitled ‘‘Immediately in § 1040.10(b)(13) to mean, ‘‘Any laser
Any application by Ms. Lin for Effect Guidance Document: product manufactured, designed,
termination of debarment under section Classification and Requirements for intended, or promoted for purposes of
306(d)(1) of the FD&C Act should be Laser Illuminated Projectors’’ to the demonstration, entertainment,
identified with Docket No. FDA–2013– Office of the Center Director, Guidance advertising display, or artistic
emcdonald on DSK67QTVN1PROD with NOTICES
N–1484 and sent to the Division of and Policy Development, Center for composition.’’ LIPs may be used in
Dockets Management (see ADDRESSES). Devices and Radiological Health, Food locations such as indoor or outdoor
All such submissions are to be filed in and Drug Administration, 10903 New cinema theaters, laser shows,
four copies. The public availability of Hampshire Ave., Bldg. 66, Rm. 5431, presentations at conventions, as image/
information in these submissions is Silver Spring, MD 20993–0002. Send data projectors in an office setting, or in
governed by 21 CFR 10.20(j). one self-addressed adhesive label to a home.
Publicly available submissions may assist that office in processing your Lasers are being used in LIPs as an
be seen in the Division of Dockets request. alternative to conventional lamps in
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![8666 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices
projectors. Although these LIPs emit of ‘‘Immediately in Effect Guidance Key Dates
laser light from extended sources and Document: Classification and Application Deadline Date: June 3,
their uncollimated beams do not present Requirements for Laser Illuminated 2015.
the same hazards as other lasers, they Projectors’’ may send an email request Review Date: June 10, 2015.
are laser products that present risks and to CDRH-Guidance@fda.hhs.gov to Earliest Anticipated Start Date: July 1,
must undergo classification in receive an electronic copy of the 2015.
accordance with § 1040.10(c). document. Please use the document Signed Tribal Resolutions Due Date:
Under § 1040.10(c), FDA recognizes number 1400056 to identify the June 10, 2015.
four major hazard classes (I to IV) of guidance you are requesting.
lasers, including three subclasses (IIa, I. Funding Opportunity Description
IIIa, and IIIb). Under this classification IV. Paperwork Reduction Act of 1995
Statutory Authority
procedure, higher laser classes This guidance refers to previously
correspond to more powerful lasers and The Indian Health Service (IHS)
approved collections of information
the potential to pose serious danger if Office of Tribal Self-Governance (OTSG)
found in FDA regulations. These
used improperly. is accepting limited competition
collections of information are subject to
As demonstration laser products, LIPs Negotiation Cooperative Agreement
review by the Office of Management and
cannot exceed class IIIa (which is applications for the Tribal Self-
Budget (OMB) under the Paperwork
comparable to IEC class 3R) emissions Governance Program (TSGP). This
Reduction Act of 1995 (the PRA) (44
limits as specified in § 1040.11(c) unless program is authorized under Title V of
U.S.C. 3501–3520). The collections of
granted a variance by FDA under the Indian Self-Determination and
information in 21 CFR parts 1002, 1010,
§ 1010.4. Many LIPs and applications Education Assistance Act (ISDEAA), 25
and 1040 are approved under OMB
for LIPs will exceed the class IIIa limits U.S.C. 458aaa–2(e). This program is
control number 0910–0025.
and therefore require a variance to described in the Catalog of Federal
The labeling referenced in section Domestic Assistance (CFDA), available
exceed those emission limits. (IV)(c)(ii) of the guidance does not
This guidance document describes at https://www.cfda.gov/, under 93.444.
constitute a ‘‘collection of information’’
FDA’s intent with regard to the Background
under the PRA because the labeling is
application of certain aspects of the
a ‘‘public disclosure of information The TSGP is more than an IHS
performance standard requirements in
supplied by the Federal Government to program; it is an expression of the
§ 1040.11(c) for LIPs. The IEC standards
the recipient for the purpose of government-to- government relationship
used to evaluate lamps are applicable to
disclosure to the public’’ (5 CFR between the United States and Indian
characterizing ocular hazards in LIPs,
1320.3(c)(2)). Tribes. Through the TSGP, Tribes
because a laser retinal hazard is related
to the radiance of the laser source and V. Comments negotiate with the IHS to assume
the radiant emission levels produced by Programs, Services, Functions and
Interested persons may submit either Activities (PSFAs), or portions thereof,
LIPs are comparable to conventional
electronic comments regarding this which gives Tribes the authority to
lamps. Because the radiant emission
document to http://www.regulations.gov manage and tailor health care programs
levels produced by LIPs can
or written comments to the Division of in a manner that best fits the needs of
scientifically be characterized by an
Dockets Management (see ADDRESSES). It their communities.
alternative IEC standard, FDA does not
is only necessary to send one set of Participation in the TSGP is one of
intend to consider whether LIP
comments. Identify comments with the three ways that Tribes can choose to
manufacturers that conform to these
docket number found in brackets in the obtain health care from the Federal
standards under the situations described
heading of this document. Received Government for their members.
in this guidance also comply with
comments may be seen in the Division Specifically, Tribes can choose to: (1)
§§ 1040.10(c) and 1040.11(c).
of Dockets Management between 9 a.m. Receive health care services directly
II. Significance of Guidance and 4 p.m., Monday through Friday, and from the IHS, (2) contract with the IHS
The guidance represents the Agency’s will be posted to the docket at http:// to administer individual PSFAs that the
current thinking on the classifications www.regulations.gov. IHS would otherwise provide (referred
and requirements for LIPs. It does not Dated: February 11, 2015. to as Title I Self-Determination
create or confer any rights for or on any Leslie Kux, Contracting), or (3) compact with the
person and does not operate to bind Associate Commissioner for Policy. IHS to assume control over healthcare
FDA or the public. An alternative PSFAs that the IHS would otherwise
[FR Doc. 2015–03209 Filed 2–17–15; 8:45 am]
approach may be used if such approach provide (referred to as Title V Self-
BILLING CODE 4164–01–P
satisfies the requirements of the Governance Compacting or the TSGP).
applicable statute and regulations. These options are not exclusive and
DEPARTMENT OF HEALTH AND Tribes may choose to combine options
III. Electronic Access based on their individual needs and
HUMAN SERVICES
Persons interested in obtaining a copy circumstances. Participation in the
of the guidance may do so by Indian Health Service TSGP affords Tribes the most flexibility
downloading an electronic copy from to tailor health care PSFAs to the needs
the Internet. A search capability for all Office of Tribal Self-Governance; of their communities.
emcdonald on DSK67QTVN1PROD with NOTICES
Center for Devices and Radiological Negotiation Cooperative Agreement The TSGP is a Tribally-driven
Health guidance documents is available initiative and strong Tribal/Federal
at http://www.fda.gov/MedicalDevices/ Announcement Type: New—Limited partnerships are essential for program
DeviceRegulationandGuidance/ Competition. success. The IHS established the OTSG
GuidanceDocuments/default.htm. Funding Announcement Number: to implement Tribal Self-Governance
Guidance documents are also available HHS–2015–IHS–TSGN–0001. authorities. The OTSG: (1) Serves as the
at http://www.regulations.gov. Persons Catalog of Federal Domestic primary liaison and advocate for Tribes
unable to download an electronic copy Assistance Number: 93.444. participating in the TSGP, (2) develops,
VerDate Sep<11>2014 19:32 Feb 17, 2015 Jkt 235001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1](https://thefederalregister.org/doc/80_FR_8697/page/2.svg)
Document Created: 2018-02-16 11:10:21
Document Modified: 2018-02-16 11:10:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 8665 |
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