82 FR 45861 - Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 189 (October 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45861-45863 | |
| FR Document | 2017-21079 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Notices] [Pages 45861-45863] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21079] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-2245] Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff.'' When finalized, 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. When finalized, this document will supersede the ``Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs); Guidance for Industry and Food and Drug Administration Staff,'' issued February 18, 2015. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by December 1, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic submissions as follows:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' [[Page 45862]] Instructions: All submissions received must include the Docket No. FDA-2014-D-2245 for ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 draft guidance document entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff'' 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. FOR FURTHER INFORMATION CONTACT: Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927. SUPPLEMENTARY INFORMATION: I. Background When finalized, this guidance describes FDA's policy with respect to certain laser illuminated projectors that comply with IEC standards during laser product classification under the Electronic Product Radiation Control provisions of the FD&C Act (Pub. L. 90-602, amended by Pub. L. 103-80) that apply to electronic products. For purposes of this guidance, the term ``laser illuminated projector'' (LIP) refers to a type of demonstration laser product regulated under 21 CFR 1040.10(b)(13) that is designed to project full- frame digital images. 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. Under 21 CFR 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 a higher potential to pose serious danger if used improperly. As demonstration laser products, LIPs and applications for LIPs cannot exceed Class IIIa emission limits as specified in 21 CFR 1040.11(c) (which is comparable to IEC 60825-1 Ed. 2.0 Class 3R) unless granted a variance by FDA under 21 CFR 1010.4. Some 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 to clarify the application of certain aspects of the performance standard requirements in 21 CFR 1040.11(c) for LIPs. Because the radiant emission levels produced by LIPs can be scientifically characterized by an alternative IEC standard, IEC 62471-5:2015, FDA does not intend to consider whether LIP manufacturers that conform to these standards under the situations outlined in sections III and IV of this guidance also comply with 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c). For LIP manufacturers who choose not to conform to these standards under the situations outlined in sections III and IV of this guidance, such manufacturers should evaluate these laser products in accordance with FDA's guidance entitled ``Laser Products--Conformance with IEC 60825-1 and IEC 60601- 2-22 (Laser Notice No. 50); Guidance for Industry and FDA Staff'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094361.htm) or must continue to comply with 21 CFR 1040.10(c) and 21 CFR 1040.11(c), among other applicable requirements. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on classification and requirements for laser illuminated projectors. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the draft 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400056 to identify the guidance you are requesting. [[Page 45863]] 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 (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. Dated: September 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-21079 Filed 9-29-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45861
countermeasure priority review voucher tax identification number is 53– Product Radiation Control provisions of
user fees authorized by 21 U.S.C. 0196965. the Federal Food, Drug, and Cosmetic
360bbb–4a, shall be credited to this If paying by wire transfer, please Act (the FD&C Act) that apply to
account, to remain available until reference your unique user fee ID electronic products. When finalized,
expended.’’ (Pub. L. 115–31, Division A, number when completing your transfer. this document will supersede the
Title VI). The originating financial institution ‘‘Immediately in Effect Guidance
The material threat MCM priority may charge a wire transfer fee. If the Document: Classification and
review fee established in the new fee financial institution charges a wire Requirements for Laser Illuminated
schedule must be paid for any transfer fee, it is required to add that Projectors (LIPs); Guidance for Industry
application that is received on or after amount to the payment to ensure that and Food and Drug Administration
October 1, 2017, and submitted with a the invoice is paid in full. The account Staff,’’ issued February 18, 2015. This
priority review voucher. This fee must information is as follows: U.S. Dept. of draft guidance is not final nor is it in
be paid in addition to any other fee due Treasury, TREAS NYC, 33 Liberty St., effect at this time.
under PDUFA. Payment must be made New York, NY 10045, Account Number: DATES: Submit either electronic or
in U.S. currency by electronic check, 75060099, Routing Number: 021030004, written comments on the draft guidance
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card, or U.S. postal money order 8455 Colesville Rd., 14th Floor, Silver Agency considers your comment on this
payable to the order of the Food and Spring, MD 20993–0002. draft guidance before it begins work on
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redirected to Pay.gov. Note that Countries,’’ Health Affairs, vol. 25, no. 2, pp. including attachments, to https://
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the balance due. Payment by credit card Dated: September 28, 2017. the docket unchanged. Because your
is available for balances that are less Anna K. Abram, comment will be made public, you are
than $25,000. If the balance exceeds this Deputy Commissioner for Policy, Planning, solely responsible for ensuring that your
amount, only the ACH option is Legislation, and Analysis. comment does not include any
available. Payments must be made using confidential information that you or a
[FR Doc. 2017–21191 Filed 9–29–17; 8:45 am]
U.S. bank accounts as well as U.S. credit third party may not wish to be posted,
BILLING CODE 4164–01–P
cards. such as medical information, your or
FDA has partnered with the U.S. anyone else’s Social Security number, or
Department of the Treasury to use confidential business information, such
DEPARTMENT OF HEALTH AND
Pay.gov, a web-based payment as a manufacturing process. Please note
HUMAN SERVICES
application, for online electronic that if you include your name, contact
payment. The Pay.gov feature is Food and Drug Administration information, or other information that
available on the FDA Web site after the identifies you in the body of your
user fee ID number is generated. [Docket No. FDA–2014–D–2245]
comments, that information will be
If paying with a paper check the user posted on https://www.regulations.gov.
Classification and Requirements for
fee identification (ID) number should be
Laser Illuminated Projectors (Laser • If you want to submit a comment
included on the check, followed by the with confidential information that you
words ‘‘Material Threat Medical Notice No. 57); Draft Guidance for
Industry and Food and Drug do not wish to be made available to the
Countermeasure Priority Review.’’ All public, submit the comment as a
paper checks must be in U.S. currency Administration Staff; Availability
written/paper submission and in the
from a U.S. bank made payable and AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
mailed to: Food and Drug HHS. Submissions’’ and ‘‘Instructions’’).
Administration, P.O. Box 979107, St. ACTION: Notice of availability.
Louis, MO 63197–9000. Written/Paper Submissions
If checks are sent by a courier that SUMMARY: The Food and Drug Submit written/paper submissions as
requests a street address, the courier can Administration (FDA or Agency) is follows:
deliver the checks to: U.S. Bank, announcing the availability of the draft • Mail/Hand delivery/Courier (for
Attention: Government Lockbox 979107, guidance entitled ‘‘Classification and written/paper submissions): Dockets
1005 Convention Plaza, St. Louis, MO Requirements for Laser Illuminated Management Staff (HFA–305), Food and
63101. (NOTE: This U.S. Bank address is Projectors (LIPs) (Laser Notice No. 57); Drug Administration, 5630 Fishers
for courier delivery only. If you have Draft Guidance for Industry and Food
sradovich on DSK3GMQ082PROD with NOTICES
Lane, Rm. 1061, Rockville, MD 20852.
any questions concerning courier and Drug Administration Staff.’’ When • For written/paper comments
delivery, contact the U.S. Bank at 314– finalized, this guidance describes FDA’s submitted to the Dockets Management
418–4013. This telephone number is policy with respect to certain LIPs that Staff, FDA will post your comment, as
only for questions about courier comply with International well as any attachments, except for
delivery). The FDA post office box Electrotechnical Commission (IEC) information submitted, marked and
number (P.O. Box 979107) must be standards during laser product identified, as confidential, if submitted
written on the check. If needed, FDA’s classification under the Electronic as detailed in ‘‘Instructions.’’
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![Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45863
IV. Paperwork Reduction Act of 1995 public workshop by November 3, 2017. • Mail/Hand delivery/Courier (for
This guidance refers to previously See the SUPPLEMENTARY INFORMATION written/paper submissions): Dockets
approved collections of information section for registration date and Management Staff (HFA–305), Food and
found in FDA regulations. These information. Drug Administration, 5630 Fishers
collections of information are subject to ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852.
review by the Office of Management and • For written/paper comments
be held at FDA’s White Oak Campus,
Budget (OMB) under the Paperwork submitted to the Dockets Management
10903 New Hampshire Ave., Bldg. 31,
Reduction Act of 1995 (44 U.S.C. 3501– Staff, FDA will post your comment, as
Great Room, Silver Spring, MD 20993. well as any attachments, except for
3520). The collections of information in Entrance for the public workshop
21 CFR parts 1002, 1010, and 1040 are information submitted, marked and
participants (non-FDA employees) is identified, as confidential, if submitted
approved under OMB control number through Building 1 where routine
0910–0025. as detailed in ‘‘Instructions.’’
security check procedures will be Instructions: All submissions received
Dated: September 22, 2017. performed. For parking and security must include the Docket No. FDA–
Leslie Kux, information, please refer to https://www. 2017–N–5442 for ‘‘Leveraging
Associate Commissioner for Policy. fda.gov/AboutFDA/WorkingatFDA/ Quantitative Methods and Modeling to
[FR Doc. 2017–21079 Filed 9–29–17; 8:45 am]
BuildingsandFacilities/WhiteOak Modernize Generic Drug Development
BILLING CODE 4164–01–P
CampusInformation/ucm241740.htm. and Review.’’ Received comments, those
You may submit comments as filed in a timely manner (see
follows. Please note that late, untimely ADDRESSES), will be placed in the docket
DEPARTMENT OF HEALTH AND filed comments will not be considered. and, except for those submitted as
HUMAN SERVICES Electronic comments must be submitted ‘‘Confidential Submissions,’’ publicly
on or before November 3, 2017. The viewable at https://www.regulations.gov
Food and Drug Administration https://www.regulations.gov electronic or at the Dockets Management Staff
filing system will accept comments between 9 a.m. and 4 p.m., Monday
[Docket No. FDA–2017–N–5442]
until midnight Eastern Time at the end through Friday.
Leveraging Quantitative Methods and of November 3, 2017. Comments • Confidential Submissions—To
Modeling To Modernize Generic Drug received by mail/hand delivery/courier submit a comment with confidential
Development and Review; Public (for written/paper submissions) will be information that you do not wish to be
Workshop; Request for Comments considered timely if they are made publicly available, submit your
postmarked or the delivery service comments only as a written/paper
AGENCY: Food and Drug Administration, acceptance receipt is on or before that submission. You should submit two
HHS. date. copies total. One copy will include the
ACTION: Notice of public workshop; information you claim to be confidential
request for comments. Electronic Submissions
with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
SUMMARY: The Food and Drug following way: CONFIDENTIAL INFORMATION.’’ The
Administration (FDA, the Agency, or • Federal eRulemaking Portal: Agency will review this copy, including
we) is announcing the following public https://www.regulations.gov. Follow the the claimed confidential information, in
workshop entitled ‘‘Leveraging instructions for submitting comments. its consideration of comments. The
Quantitative Methods and Modeling to Comments submitted electronically, second copy, which will have the
Modernize Generic Drug Development including attachments, to https:// claimed confidential information
and Review.’’ The purpose of the public www.regulations.gov will be posted to redacted/blacked out, will be available
workshop is to engage stakeholders in a the docket unchanged. Because your for public viewing and posted on
discussion of current and emerging comment will be made public, you are https://www.regulations.gov. Submit
scientific approaches and applications solely responsible for ensuring that your both copies to the Dockets Management
for the conduct of quantitative modeling comment does not include any Staff. If you do not wish your name and
and simulations in generic drug confidential information that you or a contact information to be made publicly
development, especially for complex third party may not wish to be posted, available, you can provide this
and locally acting products, and to gain such as medical information, your or information on the cover sheet and not
input regarding opportunities and anyone else’s Social Security number, or in the body of your comments and you
knowledge gaps related to the use of confidential business information, such must identify this information as
quantitative modeling and simulation to as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
inform regulatory decision making that if you include your name, contact as ‘‘confidential’’ will not be disclosed
through the product lifecycle. FDA will information, or other information that except in accordance with 21 CFR 10.20
use the information gained through the identifies you in the body of your and other applicable disclosure law. For
workshop to support product-specific comments, that information will be more information about FDA’s posting
guidance development, improve pre- posted on https://www.regulations.gov. of comments to public dockets, see 80
abbreviated new drug applications • If you want to submit a comment FR 56469, September 18, 2015, or access
(ANDA) interactions with applicants, with confidential information that you the information at: https://www.gpo.gov/
increase the quality and efficiency of do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
regulatory reviews, and identify a next
sradovich on DSK3GMQ082PROD with NOTICES
public, submit the comment as a 23389.pdf.
generation modeling and simulation written/paper submission and in the Docket: For access to the docket to
toolset for complex and locally acting manner detailed (see ‘‘Written/Paper read background documents or the
products. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
DATES: The public workshop will be received, go to https://
held on October 2 and 3, 2017, from Written/Paper Submissions www.regulations.gov and insert the
8:30 a.m. to 4:30 p.m. Submit either Submit written/paper submissions as docket number, found in brackets in the
electronic or written comments on this follows: heading of this document, into the
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Document Created: 2017-09-30 04:41:51
Document Modified: 2017-09-30 04:41:51
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 1, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927. | |
| FR Citation | 82 FR 45861 |
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