Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 66853 

name of the technology for which they 

will be presenting. 

Registration for attendees not 

presenting at the meeting is not 

required. 

IV. Collection of Information 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–21186 Filed 9–27–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2030] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Food and Drug Administration 

Approval To Market a New Drug 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with applications 

for FDA approval to market a new drug 

or generic drug. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 27, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 27, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2020–N–2030 for ‘‘Application for Food 

and Drug Administration Approval to 

Market a New Drug.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 


ddrumheller on DSK120RN23PROD with NOTICES1
66854 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Applications for FDA Approval To 

Market a New Drug—21 CFR Part 314 

OMB Control Number 0910–0001— 

Revision 

This information collection supports 

implementation of statutory and 

regulatory authorities that govern new 

drugs. Under section 505(a) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(a)), a new 

drug may not be commercially marketed 

in the United States unless an approval 

of an application filed with FDA under 

section 505(b) or (j) of the FD&C Act is 

effective with respect to such drug. We 

have issued regulations in part 314 (21 

CFR part 314) that establish procedures 

and requirements for applications 

submitted in accordance with section 

505 of the FD&C Act. The regulations in 

subpart A (§§ 314.1 through 314.3) set 

forth general provisions, while 

regulations in subparts B and C 

(§§ 314.50 through 314.99) set forth 

content and format requirements for 

new drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs) respectively. The regulations 

include requirements for the submission 

of specific data elements along with 

patent information, pediatric use 

information, supplements and 

amendments, proposed labeling, and 

specific postmarketing reports (PMRs). 

Respondents to the information 

collection are sponsors of these 

applications. 

Regulations in subpart D (§§ 314.100 

through 314.170) explain Agency 

actions on applications and set forth 

timeframes for FDA review. The 

information collection includes 

provisions established through our 

Agency user fee programs, most recently 

authorized under the FDA User Fee 

Reauthorization Act of 2022. These 

provisions pertain to performance goals, 

expedited programs, review 

transparency, communications with 

FDA, dispute resolution, drug safety 

enhancements, and the allocation of 

Agency resources to align with these 

program objectives as agreed to with our 

stakeholders and set forth in our ‘‘User 

Fee Performance Goals for Fiscal Years 

2023–2027’’ Commitment Letters, which 

are available from our website at https:// 

www.fda.gov along with more 

information about specific FDA user fee 

programs. 

Included among the provisions in 

subpart G (§§ 314.410 through 314.445), 

§ 314.420 covers information to include 

in drug master files (DMFs). To assist 

respondents to this information 

collection we have prepared templates, 

guidance, forms, and resources available 

from our website at https://

www.fda.gov/drugs/forms-submissionrequirements/drug-master-files-dmfs. 

We have developed Form FDA 3938 and 

accompanying instructions on 

submitting DMFs in accordance with 

the applicable regulations. We are 

revising Form FDA 3898 and the 

accompanying instructions to allow for 

multiple selections of submission types 

and to clarify the number of digits to be 

entered for the holder and establishment 

registration numbers. 

In accordance with § 314.445, we also 

develop Agency guidance documents to 

assist respondents in complying with 

provisions in part 314. These guidance 

documents are issued consistent with 

our good guidance practice regulations 

at 21 CFR 10.115. To search available 

FDA guidance documents, visit our 

website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents. 

Applications submitted in accordance 

with subpart H (§§ 314.500 through 

314.560) pertain to accelerated approval 

of new drugs for serious or lifethreatening illnesses. 

Information collection and associated 

burden for the submissions in subpart I 

(§§ 314.600 through 314.650) pertain to 

approval of certain new drugs when 

human efficacy studies are not ethical or 

feasible. The regulations provide for the 

submission of specific data elements, 

animal studies of safety and efficacy to 

establish likely clinical benefit in 

humans and upon approval of the drug 

product, additional requirements and/or 

restrictions to ensure safe use of the 

product. Additional PMRs, safety 

reporting, and promotional material as 

well as requirements for withdrawal of 

these human drug applications, and 

FDA termination of requirements for 

these human drug applications are 

included in §§ 314.620 through 314.650. 

The estimated burden for these human 

drug applications is included in the 

reported submissions and burden under 

general human drug applications, 

§ 314.50, and other specific regulations 

in the table for human drug application 

requirements in general. 

Finally, we are also revising the 

collection to include the submission of 

information pursuant to the CREATES 

Act (enacted as part of the Further 

Consolidated Appropriations Act of 

2020 (21 U.S.C. 355–1(1) and 355–2)). 

Under the CREATES Act, developers of 

potential drug and biological products 

are enabled to use the CREATES 

pathway to obtain samples of brand 

products that are needed to support 

their applications. Relevant products 

include those submitted in generic drug 

applications under section 505(j) of the 

FD&C Act and NDAs submitted under 

section 505(b)(2) of the FD&C Act, and 

biosimilar products submitted under 

section 351(k) of the Public Health 

Service Act as amended by the Biologics 

Price Competition and Innovation Act of 

2009. One of the requirements for using 

the CREATES pathway for products that 

are subject to a Risk Evaluation and 

Mitigation Strategy with elements to 

assure safe use is to obtain a Covered 

Product Authorization (CPA) from FDA 

(21 U.S.C. 355–2(b)(2)). New 

information collection burden for CPAs 

for new drug and biologic applications 

is included in the burden table below. 

To assist respondents to the 

information collection we have 

developed the following forms: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 66855 

• Form FDA 356h (and instructions): 

Application to Market a New or 

Abbreviated New Drug or Biologic for 

Human Use 

• Form FDA 2252 (and instructions): 

Transmittal of Annual Reports for 

Drugs and Biologics for Human Use 

(§ 314.81) 

• Form FDA 2253 (and instructions): 

Transmittal of Advertisements and 

Promotional Labeling for Drugs and 

Biologics for Human Use 

• Forms FDA 3331/3331a (and 

instructions): Field Alert Reports 

• Form FDA 3542 (and instructions): 

Patent Information Submitted Upon 

and After Approval of an NDA or 

Supplement 

• FDA 3542a (and instructions): Patent 

Information Submitted with the Filing 

of an NDA, Amendment, or 

Supplement 

• Revised Form FDA 3938 (and revised 

instruction): DMF submission 

• Form FDA 3988 (and instruction): 

Transmittal of post marketing 

requirements (PMR)/postmarketing 

commitments (PMC) submissions for 

Drugs and Biologics 

• Form FDA 3989 (and instruction): 

Transmittal of PMR/PMC Annual 

Status Report Information 

Individuals requesting printed forms are 

instructed to contact the FDA Forms 

Manager by email at formsmanager@

oc.fda.gov. Certain fees may be 

applicable. 

Information collection pertaining to 

hearings and other administrative 

proceedings covered in 21 CFR subpart 

E are approved under OMB control 

number 0910–0191. Unless otherwise 

noted, information collection pertaining 

to postmarket safety reporting and 

associated recordkeeping is approved 

under OMB control numbers 0910–0230 

and 0910–0291. 

Respondents for this information 

collection include pharmaceutical 

industry entities who contribute to the 

preparation and marketing of 

pharmaceutical products to the U.S. 

public. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

Subpart B 

314.50(a)–(l)—Content and format of a 505(b)(1) or 505(b)(2) application .. 85 1.42 121 1,921 ............................. 232,441

314.50(i)(1)—Patent certifications: Form FDA 3542 ..................................... 170 6.55 1,113 10 .................................. 11,130 

314.50(i)(1)—Patent certifications: Form FDA 3542a ................................... 1 1 1 15 .................................. 15 

314.50(i)(6)—Amended patent certifications ................................................. 73 4.33 316 2 .................................... 632 

314.52(a), (b), and (e)—NDAs—Notice of noninfringement of patent certification.15 3 45 15 .................................. 675 

314.52(c)—Noninfringement of patent certification notice content ................ 22 3 66 0.33 (20 minutes) ......... 22 

314.53(f)(1)—Correction of patent information errors by persons other than 

the NDA holder.

7 1.14 8 10 .................................. 80 

314.53(f)(2)—Correction of patent information errors by the NDA holder .... 8 1.13 9 1 .................................... 9 

314.60—Amendments to unapproved NDA, supplement or resubmission ... 269 7.22 1,942 80 .................................. 155,360 

314.60(f)—Patent certifications for unapproved applications ........................ 6 1 6 2 .................................... 12 

314.65—Withdrawal of unapproved applications .......................................... 20 1.05 21 2 .................................... 42 

314.70 and 314.71—Supplements and other changes to approved application.501 5.13 2,570 150 ................................ 385,500 

314.72—Changes of ownership of NDAs ...................................................... 73 1.67 122 2 .................................... 244 

314.81—Other PMR 314.81(b)(1) [3331 and 3331a field alert reports and 

follow-ups].

532 18.5 9,834 8 .................................... 78,672 

314.81(b)(2)—[Form FDA 2252]—Annual reports ......................................... 692 4.46 3,090 40 .................................. 123,600 

314.81(b)(2)—[Form FDA 2253]—Promotional labeling ................................ 310 121 37,508 2 .................................... 75,016 

314.81(b)(2)(vii) Form FDA 3988—PMR/PMC .............................................. 737 0.87 642 24 .................................. 15,408 

314.81(b)(2)(vii) Form FDA 3989—PMR/PMC Annual Status Report for 

Drugs and Biologics.

737 0.29 216 24 .................................. 5,184 

Subpart C 

314.93—Suitability Petitions .......................................................................... 16 1.31 21 24 .................................. 504 

314.94(a) and (d)—ANDA content ................................................................. 213 4.02 857 480 ................................ 411,360 

314.94(a)(12)(viii)—Amended patent certifications before approval of 

ANDA.

153 1 153 2 .................................... 306 

314.95(c)—Noninfringement of patents (ANDAs) .......................................... 209 3 627 16 .................................. 10,032 

314.96(a)(1)—Amendments to unapproved ANDAs ..................................... 514 26.55 13,647 80 .................................. 1,091,760 

314.96(c)—Amendment for pharmaceutical equivalent to a listed drug 

other than reference listed drug.

1 1 1 300 ................................ 300 

314.96(d)—Patent certification requirements ................................................ 100 1 100 2 .................................... 200 

314.97—Supplements and other changes to ANDAs ................................... 343 17.57 6,027 80 .................................. 482,160 

314.97(b)—Supplements to ANDA for pharmaceutical equivalent to a listed 

drug other than RLD.

1 1 1 300 ................................ 300 

314.99(a)—ANDA Applicants: Withdrawal of unapproved ANDAs ............... 58 2.41 140 2 .................................... 280 

314.99(a)—ANDA Transfer of ownership ...................................................... 137 1.24 170 2 .................................... 340 

Subpart D 

314.101(a)—NDA or ANDA filing over protest .............................................. 1 1 1 0.5 (30 minutes) ........... 0.5 

314.107(e)—notification of court actions or written consent to approval ...... 54 1.98 107 0.5 (30 minutes) ........... 53.5 

Subparts G, H, and I 

314.420—Drug Master Files—original Form FDA 3938 ................................ 491 2.05 1,005 61 .................................. 61,305 

DMF Amendments—Technical ...................................................................... 1,335 18.71 24,979 8 .................................... 199,832 

DMF Amendments—REMS ........................................................................... 2 1 2 8 .................................... 16 

DM Amendments—administrative .................................................................. 1,024 9.67 6,851 6 .................................... 41,106 

DMFs—Annual reports ................................................................................... 1,836 6.04 11,097 4 .................................... 44,388 

314.550—Promotional material and subpart H applications 2 ....................... 69 5.84 403 120 ................................ 48,360 


ddrumheller on DSK120RN23PROD with NOTICES1
66856 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

(in hours) 

Total hours 

CPA Requests for NDA/Biologics License Application Products .................. 1 1 1 5 .................................... 5 

Total ........................................................................................................ .................... ........................ ........................ ....................................... 3,476,650 

1Total burden hours have been rounded. 

2We have included burden attendant to subpart H applications activity in our estimate of burden associated with § 314.50. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 642,293.5 hours. The 

reporting period for this information 

collection renewal includes the 3 years 

of the COVID–19 pandemic. We 

attribute this adjustment to a decrease in 

the number of submissions received 

during the public health emergency. We 

anticipate that the numbers of 

submissions to FDA will return to prepandemic levels as economic activity 

recovers. We also attribute a portion of 

the burden adjustment to improved 

operational efficiencies with regard to 

Agency data systems and digital 

submission processes. 

Dated: September 23, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21256 Filed 9–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3847] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Adverse 

Experience Reporting for Licensed 

Biological Products; and General 

Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the proposed 

extension of the collection of 

information applicable to required 

adverse experience reporting for 

licensed biological products, and 

general records associated with the 

manufacture and distribution of 

biological products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 27, 2023. 

ADDRESSES: 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 27, 

2023. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 27, 2023 

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– 

2023–N–3847 for ‘‘Adverse Experience 

Reporting for Licensed Biological 

Products; and General Records.’’ 

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, 240–402–7500. 

• 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 


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I I I I