Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45861 

countermeasure priority review voucher 

user fees authorized by 21 U.S.C. 

360bbb–4a, shall be credited to this 

account, to remain available until 

expended.’’ (Pub. L. 115–31, Division A, 

Title VI). 

The material threat MCM priority 

review fee established in the new fee 

schedule must be paid for any 

application that is received on or after 

October 1, 2017, and submitted with a 

priority review voucher. This fee must 

be paid in addition to any other fee due 

under PDUFA. Payment must be made 

in U.S. currency by electronic check, 

check, bank draft, wire transfer, credit 

card, or U.S. postal money order 

payable to the order of the Food and 

Drug Administration. The preferred 

payment method is online using 

electronic check (Automated Clearing 

House (ACH) also known as eCheck). 

Secure electronic payments can be 

submitted using the User Fees Payment 

Portal at https://userfees.fda.gov/pay. 

(NOTE: only full payments are accepted. 

No partial payments can be made 

online.) Once you search for your 

invoice, select ‘‘Pay Now’’ to be 

redirected to Pay.gov. Note that 

electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA Web site after the 

user fee ID number is generated. 

If paying with a paper check the user 

fee identification (ID) number should be 

included on the check, followed by the 

words ‘‘Material Threat Medical 

Countermeasure Priority Review.’’ All 

paper checks must be in U.S. currency 

from a U.S. bank made payable and 

mailed to: Food and Drug 

Administration, P.O. Box 979107, St. 

Louis, MO 63197–9000. 

If checks are sent by a courier that 

requests a street address, the courier can 

deliver the checks to: U.S. Bank, 

Attention: Government Lockbox 979107, 

1005 Convention Plaza, St. Louis, MO 

63101. (NOTE: This U.S. Bank address is 

for courier delivery only. If you have 

any questions concerning courier 

delivery, contact the U.S. Bank at 314– 

418–4013. This telephone number is 

only for questions about courier 

delivery). The FDA post office box 

number (P.O. Box 979107) must be 

written on the check. If needed, FDA’s 

tax identification number is 53– 

0196965. 

If paying by wire transfer, please 

reference your unique user fee ID 

number when completing your transfer. 

The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee, it is required to add that 

amount to the payment to ensure that 

the invoice is paid in full. The account 

information is as follows: U.S. Dept. of 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Account Number: 

75060099, Routing Number: 021030004, 

SWIFT: FRNYUS33, Beneficiary: FDA, 

8455 Colesville Rd., 14th Floor, Silver 

Spring, MD 20993–0002. 

V. Reference 

The following reference is on display 

in the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. 

1. Ridley, D.B., H.G. Grabowski, and J.L. 

Moe, ‘‘Developing Drugs for Developing 

Countries,’’ Health Affairs, vol. 25, no. 2, pp. 

313–324, 2006. 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21191 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

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.’’ 


sradovich on DSK3GMQ082PROD with NOTICES
45862 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

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/Device

RegulationandGuidance/Guidance

Documents/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/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/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 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. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5442] 

Leveraging Quantitative Methods and 

Modeling To Modernize Generic Drug 

Development and Review; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Leveraging 

Quantitative Methods and Modeling to 

Modernize Generic Drug Development 

and Review.’’ The purpose of the public 

workshop is to engage stakeholders in a 

discussion of current and emerging 

scientific approaches and applications 

for the conduct of quantitative modeling 

and simulations in generic drug 

development, especially for complex 

and locally acting products, and to gain 

input regarding opportunities and 

knowledge gaps related to the use of 

quantitative modeling and simulation to 

inform regulatory decision making 

through the product lifecycle. FDA will 

use the information gained through the 

workshop to support product-specific 

guidance development, improve preabbreviated new drug applications 

(ANDA) interactions with applicants, 

increase the quality and efficiency of 

regulatory reviews, and identify a next 

generation modeling and simulation 

toolset for complex and locally acting 

products. 

DATES: The public workshop will be 

held on October 2 and 3, 2017, from 

8:30 a.m. to 4:30 p.m. Submit either 

electronic or written comments on this 

public workshop by November 3, 2017. 

See the SUPPLEMENTARY INFORMATION

section for registration date and 

information. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Great Room, Silver Spring, MD 20993. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://www.

fda.gov/AboutFDA/WorkingatFDA/ 

BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before November 3, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 3, 2017. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• 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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–5442 for ‘‘Leveraging 

Quantitative Methods and Modeling to 

Modernize Generic Drug Development 

and Review.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

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 


sradovich on DSK3GMQ082PROD with NOTICES