77058 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 16 

[Docket No. FDA–2024–N–3654] 

RIN 0910–AI97 

Regulatory Hearing Before the Food 

and Drug Administration; General 

Provisions; Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

proposing to amend the Scope section of 

our regulation that provides for a 

regulatory hearing before the Agency to 

clarify when such hearings are 

available. We are proposing to revise the 

list of statutory provisions enumerated 

in the Scope section of the regulation by 

removing one statutory reference and 

adding a different statutory reference. 

DATES: Either electronic or written 

comments on the proposed rule or its 

companion direct final rule must be 

submitted by December 4, 2024. If FDA 

receives any timely significant adverse 

comments on the direct final rule with 

which this proposed rule is associated, 

we will publish a document 

withdrawing the direct final rule within 

30 days after the comment period ends, 

and we will then proceed to respond to 

comments under this proposed rule 

using the usual notice and comment 

procedures. 

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 

December 4, 2024. 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– 

2024–N–3654 for ‘‘Regulatory Hearing 

Before the Food and Drug 

Administration; General Provisions; 

Amendments.’’ 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, the plain 

language summary of the proposed rule 

of not more than 100 words as required 

by the ‘‘Providing Accountability 

Through Transparency Act,’’ 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: 

Robert Schwartz, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 1– 

877–287–1373, CTPRegulations@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Companion Document to Direct Final 

Rulemaking 

III. Background 

IV. Legal Authority 

V. Description of the Proposed Rule 

VI. Preliminary Economic Analysis of 

Impacts 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Consultation and Coordination With 

Indian Tribal Governments 

I. Executive Summary 

A. Purpose of the Proposed Rule 

We are proposing to amend § 16.1 (21 

CFR 16.1) to revise the list of statutory 

provisions enumerated in the Scope 

section of the regulation and thus clarify 

the circumstances under which the 

Agency intends to use the procedures in 

part 16 (21 CFR part 16) for regulatory 

hearings. We are also issuing a direct 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 77059 

1 ‘‘Further Amendments to General Regulations of 

the Food and Drug Administration to Incorporate 

Tobacco Products,’’ Food and Drug Administration, 

77 FR 5171, February 2, 2012. 

final rule revising the list in § 16.1 by 

removing one statutory reference and 

adding a different statutory reference 

under the same section of the same 

statute. Because we believe the rule 

contains noncontroversial changes and 

we do not expect significant adverse 

comment on the direct final rule, we are 

using direct final rulemaking 

procedures, as described in this 

document. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule, if finalized, would 

revise § 16.1, Scope, in order to clarify 

the circumstances under which the 

Agency intends to use the procedures in 

part 16 for regulatory hearings. The 

proposed rule amends the list of 

statutory provisions enumerated in 

§ 16.1. Specifically, the proposed rule 

removes the reference to section 

906(e)(1)(B) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

387f(e)(1)(B) (FD&C Act) (the statutory 

provision that requires FDA to afford an 

opportunity for an oral hearing prior to 

promulgating a tobacco product 

manufacturing practice (TPMP) 

requirements regulation) and adds a 

reference to section 906(e)(2)(E) of the 

FD&C Act (the statutory provision that 

provides a petitioner an opportunity for 

an informal hearing on an order issued 

on the petitioner’s request for temporary 

or permanent exemption or variance 

from TPMP requirements). 

C. Legal Authority 

FDA is issuing this rule under 

provisions of the FD&C Act related to 

regulations and hearings (21 U.S.C. 

371), and general provisions respecting 

control of tobacco products (21 U.S.C. 

387f(e)). 

D. Costs and Benefits 

If finalized, this proposed rule would 

clarify the circumstances under which 

the Agency intends to use the 

procedures in part 16 for a regulatory 

hearing. Potentially affected entities 

would include manufacturers of 

finished and bulk tobacco products who 

choose to request an exemption or 

variance from TPMP requirements and 

are afforded an opportunity for a 

hearing on orders regarding such 

requests. Because this rule would 

merely clarify which of its existing 

procedures FDA intends to use when 

conducting certain types of hearings 

under the FD&C Act, costs and benefits 

of this rule are expected to be minimal. 

II. Companion Document to Direct 

Final Rulemaking 

This proposed rule is a companion to 

the direct final rule published in the 

rule section in this issue of the Federal 

Register. This companion proposed rule 

provides the procedural framework to 

finalize the rule in the event the direct 

final rule receives any significant 

adverse comment and is withdrawn. 

The comment period for this companion 

proposed rule runs concurrently with 

the comment period for the direct final 

rule. Any comments received in 

response to this companion proposed 

rule will also be considered as 

comments regarding the direct final 

rule. FDA is publishing the direct final 

rule because we believe the rule 

contains noncontroversial changes and 

there is little likelihood that there will 

be significant adverse comments 

opposing the rule. 

A significant adverse comment is 

defined as a comment that explains why 

the rule would be inappropriate, 

including challenges to the rule’s 

underlying premise or approach, or 

would be ineffective or unacceptable 

without a change. In determining 

whether an adverse comment is 

significant and warrants terminating a 

direct final rulemaking, we will 

consider whether the comment raises an 

issue serious enough to warrant a 

substantive response in a notice-and 

comment process. Comments that are 

frivolous, insubstantial, or outside the 

scope of the rule will not be considered 

significant or adverse under this 

procedure. A comment recommending a 

regulation change in addition to those in 

the direct final rule would not be 

considered a significant adverse 

comment unless the comment states 

why the rule would be ineffective 

without the additional change. In 

addition, if a significant adverse 

comment applies to a part of the direct 

final rule and that part can be severed 

from the remainder of the rule, we may 

adopt as final those provisions of the 

rule that are not the subject of the 

significant adverse comment. 

If any significant adverse comments to 

the direct final rule are received during 

the comment period, FDA will publish, 

within 30 days after the comment 

period ends, a notice of significant 

adverse comment and withdraw the 

direct final rule. If we withdraw the 

direct final rule, any comments received 

will be considered comments on the 

proposed rule and will be considered in 

developing a final rule using the usual 

notice-and-comment procedure. 

If no significant adverse comment is 

received in response to the direct final 

rule during the comment period, no 

further action will be taken related to 

this proposed rule. Instead, we will 

publish a document confirming the 

effective date of the final rule within 30 

days after the comment period ends. 

Additional information about direct 

final rulemaking procedures is set forth 

in the document entitled ‘‘Guidance for 

FDA and Industry: Direct Final Rule 

Procedures,’’ announced and provided 

in the Federal Register of November 21, 

1997 (62 FR 62466). The guidance may 

be accessed at: https://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

III. Background 

Part 16 provides procedures for 

regulatory hearings held before FDA. 

The procedures in part 16 apply, among 

other circumstances, when a statute or 

regulation provides a person an 

opportunity for a hearing on a 

regulatory action. In 2012, FDA 

amended part 16 1 to add several 

statutory and regulatory provisions 

throughout 21 CFR parts 1, 7, and 16, 

to include reference to tobacco 

products, where appropriate, so that 

tobacco products would be subject to 

the same general requirements that 

apply to other FDA-regulated products. 

The 2012 amendments revised § 16.1, 

which governs the scope of part 16, to 

include references to certain sections of 

the FD&C Act that provide an 

opportunity for a hearing. Among other 

changes, the 2012 amendments added a 

reference to section 906(e)(1)(B) of the 

FD&C Act to § 16.1. This rule further 

amends § 16.1, as described below. 

The Agency is amending the list of 

statutory provisions enumerated in 

§ 16.1(b)(1) by removing the reference to 

section 906(e)(1)(B) and adding a 

reference to section 906(e)(2)(E) of the 

FD&C Act. The list of statutory 

provisions enumerated in § 16.1(b)(1) 

currently includes section 906(e)(1)(B) 

of the FD&C Act, which requires FDA to 

afford the public an opportunity for an 

oral hearing before issuing any TPMP 

requirements regulation. The purpose of 

an oral hearing under section 

906(e)(1)(B) is to allow the public to 

provide viewpoints, opinions, and 

information on proposed TPMP rules. 

The procedures under part 16 are not 

aligned with the purpose and goals of 

the oral hearing required under section 

906(e)(1)(B) of the FD&C Act. For 

example, part 16 includes procedures to 

resolve a ‘‘genuine and substantial issue 


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77060 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 

of fact’’ that is in dispute and the right 

to confront and cross-examine 

witnesses, which are not well suited for 

allowing the public to provide 

viewpoints, opinions, and information 

to FDA regarding TPMP rules. 

Accordingly, FDA is removing the 

reference to section 906(e)(1)(B) of the 

FD&C Act from part 16 as other 

available procedures are better suited to 

achieve its purposes. 

The Agency is also adding a reference 

to section 906(e)(2)(E) of the FD&C Act 

to § 16.1(b)(1). Section 906(e)(2)(E) of 

the FD&C Act provides an opportunity 

for an informal hearing after the 

issuance of an order related to a 

petitioner’s request for a temporary or 

permanent exemption or variance from 

TPMP requirements. The list of 

statutory provisions in § 16.1(b)(1) that 

specifies the statutory and regulatory 

provisions under which regulatory 

hearings under part 16 are available 

does not currently include section 

906(e)(2)(E) of the FD&C Act. FDA is 

adding this reference to clarify that it 

intends to use the procedures in part 16 

when conducting such hearings. 

FDA is proposing to amend § 16.1 to 

clarify when it intends to use the 

procedures in part 16 for regulatory 

hearings. If finalized, the amended rule 

would be more consistent with the 

statute by aligning the purposes of the 

two hearings referenced above with 

more appropriate hearing procedures 

under FDA’s regulations. It also clarifies 

the availability of hearings under part 

16 to tobacco product manufacturers. 

IV. Legal Authority 

FDA is issuing this rule under 

provisions of the FD&C Act related to 

regulations and hearings (21 U.S.C. 371) 

and general provisions respecting 

control of tobacco products (21 U.S.C. 

387f). Section 701 (21 U.S.C. 371) vests 

FDA with ‘‘the authority to promulgate 

regulations for the efficient enforcement 

of [the FD&C Act].’’ Section 906(e) of the 

FD&C Act includes provisions regarding 

TPMP requirements regulations, and 

temporary and permanent exemptions 

and variances from TPMP requirements. 

V. Description of the Proposed Rule 

We are proposing to revise § 16.1, 

Scope, to remove a reference to ‘‘Section 

906(e)(1)(B) of the FD&C Act relating to 

the establishment of good 

manufacturing practice requirements for 

tobacco products’’ and to add a 

reference to ‘‘Section 906(e)(2)(E) of the 

FD&C Act relating to exemptions or 

variances from tobacco product 

manufacturing practice requirements.’’ 

The proposed rule would clarify the 

availability of the procedures in part 16 

for regulatory hearings to include 

situations when a petitioner has 

requested a temporary or permanent 

exemption or variance from TPMP 

requirements. 

VI. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 14094, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866 Section 3(f)(1) (as amended by 

Executive Order 14094) if they ‘‘have an 

annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator of [the Office of 

Information and Regulatory Affairs 

(OIRA)] for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this proposed rule 

is not a significant regulatory action 

under Executive Order 12866 Section 

3(f)(1). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because this rule merely clarifies which 

of its existing procedures FDA intends 

to use when conducting certain types of 

hearings under the FD&C Act, we 

propose to certify that the proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes estimates of anticipated 

impacts, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $183 

million, using the most current (2023) 

Implicit Price Deflator for the Gross 

Domestic Product. This proposed rule 

would not result in an expenditure in 

any year that meets or exceeds this 

amount. 

If finalized, this proposed rule would 

clarify the procedures FDA intends to 

use when conducting certain types of 

hearings under the FD&C Act. When the 

TPMP rule becomes final and effective, 

potentially affected entities, including 

manufacturers of finished and bulk 

tobacco products, who choose to request 

an exemption or variance from TPMP 

requirements would be afforded an 

opportunity for a hearing on orders 

regarding such requests. 

We do not know how many 

manufacturers would pursue petitioning 

for an exemption or variance from 

TPMP requirements, once the Agency 

has published a final TPMP rule to 

establish such requirements and that 

rule is in effect, nor do we know how 

many requirements may be included in 

each petition. We reason that a 

manufacturer would petition for an 

exemption or variance from a TPMP 

requirement only if compliance with 

said requirement is not a financially 

viable choice compared to the cost of a 

filing a petition. Because this rule 

merely clarifies which of its existing 

procedures FDA intends to use when 

conducting certain types of hearings 

under the FD&C Act, costs and benefits 

of this rule are expected to be minimal. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 


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Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Proposed Rules 77061 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

X. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

List of Subjects in 21 CFR Part 16 

Administrative practice and 

procedure. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR part 16 be amended as follows: 

PART 16—REGULATORY HEARING 

BEFORE THE FOOD AND DRUG 

ADMINISTRATION 

■ 1. The authority citation for part 16 

continues to read as follows: 

Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 

141–149, 321–394, 467f, 679, 821, 1034; 28 

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. 

■ 2. Amend § 16.1 by revising paragraph 

(b)(1) to read as follows: 

§ 16.1 Scope. 

* * * * * 

(b) * * * 

(1) The statutory provisions are as 

follows: 

TABLE 1 TO PARAGRAPH (b)(1) 

Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of devices and drugs (see §§ 800.55(g) and 

1.980(g) of this chapter). 

Section 304(h) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of food for human or animal consumption 

(see part 1, subpart K of this chapter). 

Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to the modification or revocation of a variance from the requirements 

of section 419 (see part 112, subpart P of this chapter). 

Section 515(e)(1) of the Federal Food, Drug, and Cosmetic Act relating to the proposed withdrawal of approval of a device premarket approval 

application. 

Section 515(e)(3) of the Federal Food, Drug, and Cosmetic Act relating to the temporary suspension of approval of a premarket approval application. 

Section 515(f)(6) of the Federal Food, Drug, and Cosmetic Act relating to a proposed order revoking a device product development protocol or 

declaring a protocol not completed. 

Section 515(f)(7) of the Federal Food, Drug, and Cosmetic Act relating to revocation of a notice of completion of a product development protocol. 

Section 516(b) of the Federal Food, Drug, and Cosmetic Act regarding a proposed regulation to ban a medical device with a special effective 

date. 

Section 518(b) of the Federal Food, Drug, and Cosmetic Act relating to a determination that a device is subject to a repair, replacement, or refund order or that a correction plan, or revised correction plan, submitted by a manufacturer, importer, or distributor is inadequate. 

Section 518(e) of the Federal Food, Drug, and Cosmetic Act relating to a cease distribution and notification order or mandatory recall order concerning a medical device for human use. 

Section 520(f)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from device current good manufacturing 

practice requirements (see § 820.1(d)). 

Section 520(g)(4) and (g)(5) of the Federal Food, Drug, and Cosmetic Act relating to disapproval and withdrawal of approval of an application 

from an investigational device exemption (see §§ 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of this chapter). 

Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products. 

Section 906(e)(2)(E) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from tobacco product manufacturing 

practice requirements. 

Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a new tobacco product to be introduced or delivered for introduction into interstate commerce. 

Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a modified risk tobacco product to be 

introduced or delivered for introduction into interstate commerce. 

* * * * * 

§ 16.1 [Amended] 

■ 3. Effective December 18, 2025, in 

§ 16.1, amend paragraph (b)(2) by 

redesignating table 1 to paragraph (b)(2) 

as table 2 to paragraph (b)(2). 

Dated: September 6, 2024. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2024–21232 Filed 9–19–24; 8:45 am] 

BILLING CODE 4164–01–P 


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