Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86333 

President) 1 Memorial Drive, Kansas 

City, Missouri, 64198–0001. Comments 

can also be sent electronically to 

KCApplicationComments@kc.frb.org: 

1. The Marital Trust created under 

Indenture of the James S. Birkbeck 

Revocable Trust, dated April 20, 1995, 

Holton, Kansas, Paula Birkbeck Taylor, 

Holton, Kansas, and J. Patrick Birkbeck, 

Topeka, Kansas, as co-trustees; Paula N. 

Birkbeck Taylor Revocable Trust UIT 

dated August 8, 2002, Holton, Kansas, 

Paula Birkbeck Taylor, as trustee; Paula 

Birkbeck as co-trustee of the Mary Lou 

Birkbeck Trust dated April 20, 1995, 

Holton, Kansas; J. Patrick Birkbeck 

Revocable Trust UIT dated March 31, 

2008, Topeka, Kansas, J. Patrick 

Birkbeck, as trustee; and Ryan Patrick 

Taylor, Holton, Kansas; to become 

members of the Birkbeck/Taylor Family 

Control Group, a group acting in 

concert, to retain voting shares of 

Denison Bancshares, Inc. of Holton, and 

thereby indirectly retain voting shares of 

Denison State Bank, both of Holton, 

Kansas. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2023–27357 Filed 12–12–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Interstate Administrative 

Subpoena and Notice of Lien (Office of 

Management and Budget OMB #: 

0970–0152) 

AGENCY: Office of Child Support 

Services, Administration for Children 

and Families, U.S. Department of Health 

and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

requesting a 3-year extension with 

proposed revisions to the Interstate 

Administrative Subpoena and Notice of 

Lien forms (Office of Management and 

Budget #0970–0152, expiration 6/30/ 

2024). The forms are updated to reflect 

the name change of the Federal child 

support program office from the Office 

of Child Support Enforcement to the 

Office of Child Support Services. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The Administrative 

Subpoena is used by State child support 

agencies to obtain income and other 

financial information regarding 

noncustodial parents for purposes of 

establishing, enforcing, and modifying 

child support orders. The Notice of Lien 

imposes liens in cases with overdue 

support and allows a State child support 

agency to file liens across State lines, 

when it is more efficient than involving 

the other State’s IV–D agency. 

Section 452(a)(11) of the Social 

Security Act requires the Secretary of 

the Department of Health and Human 

Services to promulgate forms for 

administrative subpoenas and 

imposition of liens used by State child 

support agencies in interstate cases. 

Section 454(9)(E) of the Social Security 

Act requires each State to cooperate 

with any other State in using the 

Federal forms for issuance of 

administrative subpoenas and 

imposition of liens in interstate child 

support cases. 

Respondents: State, local, or Tribal 

agencies administering a child support 

program under title IV–D of the Social 

Security Act. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden 

hours 

Administrative Subpoena ................................................................................. 54 462 .5 12,474 

Notice of Lien ................................................................................................... 54 29,762 .5 803,574 

Estimated Total Annual Burden 

Hours: 816,048. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 652; 42 U.S.C. 

654. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–27313 Filed 12–12–23; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4974] 

Advanced Manufacturing Technologies 

Designation Program; Draft Guidance 

for Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 


khammond on DSKJM1Z7X2PROD with NOTICES
86334 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

draft guidance for industry entitled 

‘‘Advanced Manufacturing Technologies 

Designation Program.’’ FDA encourages 

the early adoption of advanced 

manufacturing technologies (AMTs) that 

have the potential to benefit patients by 

improving manufacturing and supply 

dependability and optimizing 

development time of drug and biological 

products. These technologies can be 

integral to ensuring quality and 

supporting a robust supply of drugs that 

are life-supporting, life-sustaining, of 

critical importance to providing 

healthcare, or in shortage. AMTs can 

directly improve product quality 

through higher capability manufacturing 

designs and enhanced controls (e.g., 

leading to fewer human errors). This 

draft guidance provides 

recommendations to persons and 

organizations interested in participating 

in FDA’s Advanced Manufacturing 

Technologies Designation Program, 

which is intended to facilitate the 

development of drugs, including 

biological products, manufactured using 

an AMT that has been designated as 

such under the program. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 12, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

February 12, 2024. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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–D–4974 for ‘‘Advanced 

Manufacturing Technologies 

Designation Program.’’ 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, 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Ranjani Prabhakara, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6648, 

Silver Spring, MD 20993, 240–402– 

4652; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

With regard to the proposed collection 

of information: 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: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Advanced Manufacturing Technologies 

Designation Program.’’ On December 29, 

2022, the Food and Drug Omnibus 

Reform Act of 2022 (FDORA) amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) by adding section 506L 

(21 U.S.C. 356l), which requires the 

establishment of an Advanced 

Manufacturing Technologies 

Designation Program and the 

publication of a related guidance. FDA’s 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86335 

Advanced Manufacturing Technologies 

Designation Program offers a framework 

for persons or organizations (e.g., 

applicants, contract manufacturers, 

technology developers) to request 

designation of a method or combination 

of methods of manufacturing a drug as 

an AMT. The program is intended to 

facilitate the development of drugs that 

are manufactured using a designated 

AMT, submitted in an application under 

section 505 of the FD&C Act (21 U.S.C. 

355) or section 351 of the Public Health 

Service Act (PHS Act) (42 U.S.C. 262), 

and regulated by the Center for Drug 

Evaluation and Research (CDER) or the 

Center for Biologics Evaluation and 

Research (CBER). FDA will expedite 

development and assessment of an 

application, including supplements, for 

drugs that are manufactured using a 

designated AMT as described in section 

506L(d)(1) of the FD&C Act. 

The development of this guidance 

takes into consideration feedback 

provided at a public meeting (see 

section 506L(e) of the FD&C Act) and 

comments submitted to the public 

docket (Docket No. FDA–2023–N–1259) 

about the public meeting. The meeting 

was held on June 8, 2023 (April 24, 

2023, 88 FR 24807), to discuss the use 

of innovative manufacturing 

technologies for CDER- and CBERregulated products and to solicit 

industry and public feedback regarding 

the Advanced Manufacturing 

Technologies Designation Program. 

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 ‘‘Advanced Manufacturing 

Technologies Designation Program.’’ 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. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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 

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. 

Advanced Manufacturing Technologies 

Designation Program 

OMB Control Number 0910–0139— 

Revision 

This information collection supports 

implementation of requirements under 

section 506L of the FD&C Act. The 

Advanced Manufacturing Technologies 

Designation Program encourages early 

adoption of new technological advances 

in manufacturing processes by the 

pharmaceutical industry or other drug/ 

biologic developers to ensure that 

regulatory assessments and new drug 

and biologic development are based on 

state-of-the-art pharmaceutical science. 

Any request for AMT designation will 

be reviewed by a team of FDA experts 

in quality assessment to evaluate the 

data and information submitted and to 

determine if the method of 

manufacturing or combination of 

methods meets the criteria of an AMT 

in section 506L of the FD&C Act. If AMT 

designation is granted, then future new 

drug application (NDA), abbreviated 

new drug application (ANDA), or 

biologics license application (BLA) 

applicants may use or reference the 

designated AMT, noting specific 

application of the designated AMT to 

specific product development and 

inclusion in NDA, ANDA, or BLA 

submissions describing development 

and manufacturing processes. 

We are issuing a draft guidance for 

industry entitled ‘‘Advanced 

Manufacturing Technologies 

Designation Program,’’ which outlines 

the process for submitting an AMT 

designation request; when and how 

FDA will communicate receipt of and 

provide advice on AMT designation 

requests; when and how FDA will 

assess AMT designation requests; the 

process by which FDA will engage with 

designated AMT holders and applicants 

for drugs manufactured using, 

referencing, or relying upon a 

designated AMT; and benefits related to 

drug development and application 

assessment. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section 506L of the FD&C Act Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

AMT designation request; Guidance for industry section III.B ........ 20 1 20 10 200 

Total .......................................................................................... ........................ ........................ 20 .................... 200 

1There are no capital or operating and maintenance costs associated with the information collection. 

This draft guidance also refers to 

previously approved FDA collections of 

information. The collections of 

information in 21 CFR part 312 

regarding product development 

including chemistry, proposed 

manufacturing procedures and controls, 

and requests for meetings have been 

approved under OMB control number 

0910–0014. The collections of 

information in 21 CFR part 314 

regarding applicable manufacturing 

information for NDAs are approved 

under OMB control number 0910–0001; 

and the collections of information in 21 


khammond on DSKJM1Z7X2PROD with NOTICES
86336 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

CFR part 601 regarding applicable 

manufacturing information for BLAs are 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 8, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27309 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5022] 

Data Standards; Support and 

Requirement Begins for the Clinical 

Data Interchange Standards 

Consortium Version 2.0 of the Study 

Data Tabulation Model, Version 3.4 of 

the Study Data Tabulation Model 

Implementation Guide, and Version 1.0 

of the Standard for Exchange of 

Nonclinical Data Implementation 

Guide—Genetox; Requirement Ends 

for the Clinical Data Interchange 

Standards Version 3.2 of the Study 

Data Tabulation Model Implementation 

Guide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing that support begins for 

version 2.0 of the Clinical Data 

Interchange Standards Consortium 

(CDISC) Study Data Tabulation Model 

(SDTMv2.0), version 3.4 of the CDISC 

Study Data Tabulation Model 

Implementation Guide (SDTMIGv3.4), 

and version 1.0 of the Standard for 

Exchange of Nonclinical Data 

Implementation Guide—Genetox 

(SENDIG-Genetoxv1.0) and announcing 

the date that these version updates are 

required in certain submissions. CBER 

and CDER are also announcing the date 

that requirement ends for version 3.2 of 

the CDISC SDTMIG (SDTMIGv3.2). The 

Agency will update the FDA Data 

Standards Catalog (Catalog) to reflect 

these changes. The Agency will publish 

in the technical specifications document 

entitled ‘‘Study Data Technical 

Conformance Guide’’ additional details 

on how to implement new variables. 

DATES: Support for version CDISC 

SDTMv2.0, SDTMIGv3.4, and SENDIGGenetoxv1.0 begins December 13, 2023. 

The requirement for electronic 

submissions to be submitted using 

CDISC SDTMv2.0, SDTMIGv3.4, and 

SENDIG-Genetoxv1.0 begins March 15, 

2025, for new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), certain biologics license 

applications (BLAs), and certain 

investigational new drug applications 

(INDs). The requirement for electronic 

submissions to be submitted using 

version CDISC SDTMIGv3.2 ends 

December 13, 2023. 

ADDRESSES: You may submit comments 

as follows. 

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–5022 for ‘‘Data Standards; 

Requirement Begins for the Clinical 

Data Interchange Standards Consortium 

Version 2.0 of the Study Data 

Tabulation Model and Version 3.4 of the 

Study Data Tabulation Model 

Implementation Guide; Requirement 

Ends for the Clinical Data Interchange 

Standards Version 3.2 of the Study Data 

Tabulation Model Implementation 

Guide.’’ 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, 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 


khammond on DSKJM1Z7X2PROD with NOTICES