Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 45753 

on December 5, 2016, at 81 FR 87686) 

(annualized costs of $154 million); and 

20. The FMCSA’s final rule on Minimum 

Training Requirements for Entry-Level 

Commercial Motor Vehicle Operators (RIN: 

2126–AB66) (published on December 8, 

2016, at 81 FR 88732) (annualized costs of 

$368 million). 

[FR Doc. 2017–21101 Filed 9–29–17; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket Nos. FDA–2012–N–1210 and FDA– 

2004–N–0258] 

RIN 0910–ZA49 

Food Labeling: Revision of the 

Nutrition and Supplement Facts Labels 

and Serving Sizes of Foods That Can 

Reasonably Be Consumed at One 

Eating Occasion; Dual-Column 

Labeling; Updating, Modifying, and 

Establishing Certain Reference 

Amounts Customarily Consumed; 

Serving Size for Breath Mints; and 

Technical Amendments; Proposed 

Extension of Compliance Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

proposing to extend the compliance 

dates by approximately 1.5 years for the 

final rules providing updated nutrition 

information on the label of food, 

including dietary supplements; defining 

a single-serving container; requiring 

dual-column labeling for certain 

containers; updating, modifying, and 

establishing certain reference amounts 

customarily consumed (RACCs); and 

amending the label serving size for 

breath mints. The final rules appeared 

in the Federal Register of May 27, 2016. 

We are taking this action because, after 

careful consideration, we have 

tentatively determined that additional 

time would help ensure that all 

manufacturers covered by the final rules 

have guidance from FDA to address, for 

example, certain technical questions we 

received after publication of the final 

rules, and that they are able to complete 

and print updated Nutrition Facts labels 

for their products before they are 

expected to be in compliance with the 

final rules. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by November 1, 2017. 

ADDRESSES: You may submit comments 

on the extension of the compliance 

period as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 1, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 1, 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 Nos. FDA– 

2012–N–1210 and FDA–2004–N–0258 

for ‘‘Food Labeling: Revision of the 

Nutrition and Supplement Facts Labels 

and Serving Sizes of Foods That Can 

Reasonably Be Consumed at One Eating 

Occasion; Dual-Column Labeling; 

Updating, Modifying, and Establishing 

Certain Reference Amounts Customarily 

Consumed; Serving Size for Breath 

Mints; and Technical Amendments; 

Extension of Compliance Date.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Paula Trumbo, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5001 Campus 


sradovich on DSK3GMQ082PROD with PROPOSALS
45754 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 

Dr., College Park, MD 20740, 240–402– 

2579. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Description of the Proposed Rule 

III. Proposed Compliance Dates 

IV. Economic Analysis of Impacts 

V. Analysis of Environmental Impact 

VI. Paperwork Reduction Act of 1995 

VII. Federalism 

VIII. References 

I. Background 

In the Federal Register of May 27, 

2016 (81 FR 33742 and 81 FR 34000), 

we published two final rules entitled 

‘‘Food Labeling: Revision of the 

Nutrition and Supplement Facts Labels’’ 

(the Nutrition Facts Label Final Rule) 

and ‘‘Food Labeling: Serving Sizes of 

Foods That Can Reasonably Be 

Consumed At One Eating Occasion; 

Dual-Column Labeling; Updating, 

Modifying, and Establishing Certain 

Reference Amounts Customarily 

Consumed; Serving Size for Breath 

Mints; and Technical Amendments’’ 

(the Serving Size Final Rule). The 

Nutrition Facts Label Final Rule revises 

the Nutrition Facts label by: 

• Removing the declaration of 

‘‘Calories from fat’’ because current 

science supports a view that the type of 

fat is more relevant than overall total fat 

intake in increased risk of chronic 

diseases; 

• Requiring the declaration of the 

gram amount of ‘‘Added Sugars’’ in a 

serving of a product, establishing a 

Daily Reference Value (DRV), and 

requiring the percent Daily Value (DV) 

declaration for added sugars; 

• Changing ‘‘Sugars’’ to ‘‘Total 

Sugars’’ and requiring that ‘‘Includes ‘X’ 

g Added Sugars’’ be indented and 

declared directly below ‘‘Total Sugars’’ 

on the label; 

• Updating the list of vitamins and 

minerals of public health significance. 

For example, the Nutrition Facts Label 

Final Rule requires the declaration of 

vitamin D and potassium and permits, 

rather than requires, the declaration of 

vitamins A and C; 

• Updating certain reference values 

used in the declaration of percent DVs 

of nutrients on the Nutrition Facts and 

Supplement Facts labels; 

• Revising the format of the Nutrition 

Facts and Supplement Facts labels to 

increase the prominence of the term 

‘‘Calories;’’ 

• Removing the requirement for the 

footnote table listing the reference 

values for certain nutrients for 2,000 

and 2,500 calorie diets; and 

• Requiring the maintenance of 

records to support the declarations of 

certain nutrients under specified 

circumstances. 

The Serving Size Final Rule requires 

all containers, including containers of 

products with ‘‘large’’ RACCs (i.e., 

products with RACCs of at least 100 

grams (g) or 100 milliliters (mL)), 

containing less than 200 percent of the 

RACC to be labeled as a single-serving 

container. Except for when certain 

exceptions apply, the Serving Size Final 

Rule further requires that containers and 

units that contain at least 200 percent 

and up to and including 300 percent of 

the RACC be labeled with a column of 

nutrition information within the 

Nutrition Facts label that lists the 

quantitative amounts and percent DVs 

for the entire container, in addition to 

the required column listing the 

quantitative amounts and percent DVs 

for a serving that is less than the entire 

container (i.e., the serving size derived 

from the RACC). The Serving Size Final 

Rule also updates, modifies, and 

establishes RACCs for certain foods and 

product categories. 

II. Description of the Proposed Rule 

We are proposing to extend the 

compliance date for manufacturers with 

$10 million or more in annual food sales 

in the final rules published on May 27, 

2016, from July 26, 2018, to January 1, 

2020, and the compliance date for 

manufacturers with less than $10 

million in annual food sales in the final 

rules published on May 27, 2016, from 

July 26, 2019, to January 1, 2021. 

We emphasize that this proposed rule 

would only extend the compliance 

dates. Therefore, comments to this 

proposed rule should pertain to the 

extension of the compliance dates only. 

We are proposing to extend the 

compliance dates for the Nutrition Facts 

Label Final Rule and the Serving Size 

Final Rule, consistent with our 

authority in sections 403(q) and 701(a) 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 343(q) 

and 371(a), respectively). 

III. Proposed Compliance Dates 

This proposed rule would extend the 

compliance date for manufacturers with 

$10 million or more in annual food sales 

in the final rules published on May 27, 

2016, from July 26, 2018, to January 1, 

2020, and the compliance date for 

manufacturers with less than $10 

million in annual food sales in the final 

rules published on May 27, 2016, from 

July 26, 2019, to January 1, 2021. We are 

taking this action because, after careful 

consideration, we have tentatively 

determined that additional time would 

help ensure that all manufacturers 

covered by the rules have guidance from 

FDA to address, for example, certain 

technical questions we received after 

publication of the final rules (see Docket 

No. FDA–2016–D–4414 (pertaining to a 

draft guidance entitled ‘‘Questions and 

Answers on the Nutrition and 

Supplement Facts Labels Related to the 

Compliance Date, Added Sugars, and 

Declaration of Quantitative Amounts of 

Vitamins and Minerals: Guidance for 

Industry’’)), and that they are able to 

complete and print updated Nutrition 

Facts labels for their products before 

they are expected to be in compliance 

with the rules. Companies and trade 

associations with members covered by 

the rules have informed us that they 

have significant concerns about their 

ability to update all their labels by the 

compliance dates due to issues 

regarding (among other things) the need 

for upgrades to labeling software, the 

need to obtain nutrition information 

from suppliers, the number of products 

that would need new labels, and a 

limited time for reformulation of 

products. Consequently, we are 

proposing to extend the compliance 

dates to provide more time to comply 

with the Nutrition Facts Label and the 

Serving Size Final Rules. We propose 

extending the compliance date by 

approximately 1.5 years for both 

categories of manufacturers as a means 

to balance the importance of ensuring 

that industry has sufficient time to 

comply with complex new 

requirements, and the importance of 

decreasing costs, against the importance 

of minimizing the transition period 

during which consumers will see both 

the old and the new versions of the label 

in the marketplace. 

We are taking this action consistent 

with Executive Orders 13771 and 13563 

and in response to the continued 

concern that companies and trade 

associations have shared with us 

regarding the time needed for 

implementation of the final rules and 

the need for FDA to provide further 

guidance to manufacturers subject to the 

final rules. Consistent with the policies 

set forth in these executive orders with 

respect to reducing burdens, reducing 

costs, maintaining flexibility, and 

improving effectiveness, we are 

therefore proposing to extend the 

compliance date for manufacturers with 

$10 million or more in annual food sales 

to January 1, 2020, and the compliance 

date for manufacturers with less than 

$10 million in annual food sales to 

January 1, 2021. 

Our goal is to complete this 

rulemaking as quickly as possible. 

However, we are aware that firms are 

working under the current compliance 

dates to come into compliance. Pending 


sradovich on DSK3GMQ082PROD with PROPOSALS
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 45755 

completion of this rulemaking, we 

intend to exercise enforcement 

discretion with respect to the current 

July 26, 2018, and July 26, 2019, 

compliance dates. 

IV. Economic Analysis of Impacts 

We have examined the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 13771, 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 and 13563 direct us to assess all 

costs and benefits 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). Executive Order 

13771 requires that the costs associated 

with significant new regulations ‘‘shall, 

to the extent permitted by law, be offset 

by the elimination of existing costs 

associated with at least two prior 

regulations.’’ We believe that this 

proposed rule is a significant regulatory 

action as defined by Executive Order 

12866. 

Executive Order 13771, entitled 

‘‘Reducing Regulation and Controlling 

Regulatory Costs,’’ was issued on 

January 30, 2017. Section 2(a) of 

Executive Order 13771 requires an 

Agency, unless prohibited by law, to 

identify at least two existing regulations 

to be repealed when the Agency 

publicly proposes for notice and 

comment or otherwise promulgates a 

new regulation. In furtherance of this 

requirement, section 2(c) of Executive 

Order 13771 requires that the new 

incremental costs associated with new 

regulations shall, to the extent permitted 

by law, be offset by the elimination of 

existing costs associated with at least 

two prior regulations. This proposed 

rule is expected to be an Executive 

Order 13771 deregulatory action. Details 

on the estimated cost savings of this 

proposed rule can be found in the rule’s 

economic analysis. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities when 

‘‘the agency publishes a general notice 

of proposed rulemaking’’ (5 U.S.C. 

601(2)). We have analyzed the proposed 

rule under the Regulatory Flexibility 

Act and propose to certify that, because 

the proposed rule only would extend 

the compliance dates for the Nutrition 

Facts Label and Serving Size Final 

Rules, the proposed rule would 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 an assessment of anticipated 

costs and benefits, 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 $148 million, 

using the 2016 Implicit Price Deflator 

for the Gross Domestic Product. We 

have determined that the proposed rule 

would not result in any expenditure by 

industry in any year that meets or 

exceeds this amount. 

The principal benefit of this proposed 

rule to extend the compliance dates is 

the reduction in the costs to industry of 

meeting the compliance dates of the 

Nutrition Facts Label Final Rule and the 

Serving Size Final Rule. This reduction 

in costs can be attributed to a reduction 

in the relabeling and reformulation costs 

of the Nutrition Facts Label and Serving 

Size Final Rules. We estimate that, at 

the mean, the present value of the 

benefits (i.e., cost savings) of this 

proposed rule to extend the compliance 

dates over the next 20 years is $1.0 

billion using either a 3 percent or 7 

percent discount rate (2016$). This is 

illustrated in table 1. Extending the 

compliance dates by approximately 1.5 

years would reduce the estimated 

benefits of the Nutrition Facts Label and 

Serving Size Final Rules because it 

would delay the realization by 

consumers of the full annual welfare 

gains of the Nutrition Facts Label and 

Serving Size Final Rules. More 

specifically, an extension of the 

compliance dates would delay the 

incorporation of the provisions of the 

Nutrition Facts Label and Serving Size 

Final Rules by food manufacturers into 

their products. We estimate that, at the 

mean, the present value of the forgone 

benefits of this proposed rule to extend 

the compliance dates over the next 20 

years is $0.9 billion using either a 3 

percent or 7 percent discount rate 

(2016$). This is also presented in table 

1. We estimate that, at the mean, the 

present value of the net benefits (that is, 

cost savings minus forgone benefits) of 

this proposed rule to extend the 

compliance dates over the next 20 years 

is $0.1 billion using either a 3 percent 

or 7 percent discount rate (2016$). This 

is shown in table 1. 

TABLE 1—SUMMARY OF THE COST SAVINGS TO INDUSTRY AND FOREGONE BENEFITS TO CONSUMERS OF THIS PROPOSED

RULE TO EXTEND THE COMPLIANCE DATES

[In billions of 2016] 

Discount rate 

(percent) Cost savings Foregone benefits 

Net benefits 

(cost 

savings¥ 

foregone 

benefits) 

Present Value .................................................................................................. 3 $1.0 $0.9 $0.1

7 1.0 0.9 0.1 

Annualized Amount .......................................................................................... 3 0.07 0.06 0.01 

7 0.09 0.08 0.01 

Notes: Cost savings to industry, foregone benefits to consumers, and net benefits reflect mean estimates. This proposed rule to extend the 

compliance dates would extend the compliance dates of the Nutrition Facts Label and Serving Size Final Rules by approximately 1.5 years. 

Annualized Amount = Amount/Annualizing Factor. 3 percent annualizing factor = 14.88. 7 percent annualizing factor = 10.59. The annualizing 

factors are calculated by summing the inverse of 1 plus the discount rate to the power of the year (t = 1 through t = 20). 

For purposes of this analysis, we use 

the same methodology for estimating 

costs and benefits that we used in the 

original Regulatory Impact Analysis for 

the Final Rules. We previously 

acknowledged potential shortcomings 

with that approach (see 2016 Regulatory 

Impact Analysis at 79 n.34) but have not 

received comments about ways to 


sradovich on DSK3GMQ082PROD with PROPOSALS
45756 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 

improve that analysis. We thus follow 

the same basic approach here. 

The full analysis of economic impacts 

is available in the docket for this 

proposed rule (Ref. 1) and at https://

www.fda.gov/AboutFDA/Reports

ManualsForms/Reports/Economic

Analyses. 

V. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(k) 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. 

VI. Paperwork Reduction Act of 1995 

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. 

VII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive Order requires 

Agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

Section 403A of the FD&C Act (21 

U.S.C. 343–1) is an express preemption 

provision. Section 403A(a) of the FD&C 

Act provides that: ‘‘* * * no State or 

political subdivision of a State may 

directly or indirectly establish under 

any authority or continue in effect as to 

any food in interstate commerce—(4) 

any requirement for nutrition labeling of 

food that is not identical to the 

requirement of section 403(q) * * *.’’ 

The express preemption provision of 

section 403A(a) of the FD&C Act does 

not preempt any State or local 

requirement respecting a statement in 

the labeling of food that provides for a 

warning concerning the safety of the 

food or component of the food (section 

6(c)(2) of the Nutrition Labeling and 

Education Act of 1990, Pub. L. 101–535, 

104 Stat. 2353, 2364 (1990)). If this 

proposed rule is made final, the final 

rule would create requirements that fall 

within the scope of section 403A(a) of 

the FD&C Act. 

VIII. References 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. United States Department of Health and 

Human Services. United States Food and 

Drug Administration. Preliminary 

Regulatory Impact Analysis, Preliminary 

Regulatory Flexibility Analysis for 

Proposed Rule on ‘‘Food Labeling: 

Revision of the Nutrition and 

Supplement Facts Labels and Serving 

Sizes of Foods That Can Reasonably Be 

Consumed At One Eating Occasion; 

Dual-Column Labeling; Updating, 

Modifying, and Establishing Certain 

Reference Amounts Customarily 

Consumed; Serving Size for Breath 

Mints; and Technical Amendments; 

Extension of Compliance Dates.’’ 

September 2017. Available from http://

www.fda.gov/AboutFDA/Reports

ManualsForms/Reports/Economic

Analyses. 

Dated: September 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21019 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AQ06 

Authority of Health Care Providers To 

Practice Telehealth 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) proposes to amend its 

medical regulations by standardizing 

the delivery of care by VA health care 

providers through telehealth. This rule 

would ensure that VA health care 

providers provide the same level of care 

to all beneficiaries, irrespective of the 

State or location in a State of the VA 

health care provider or the beneficiary. 

This proposed rule would achieve 

important Federal interests by 

increasing the availability of mental 

health, specialty, and general clinical 

care for all beneficiaries. 

DATES: Comments must be received on 

or before November 1, 2017. 

ADDRESSES: Written comments may be 

submitted through http://

www.Regulations.gov by mail or handdelivery to: Director, Regulation Policy 

and Management (00REG), Department 

of Veterans Affairs, 810 Vermont Ave. 

NW., Room 1063B, Washington, DC 

20420; or by fax to (202) 273–9026. 

(This is not a toll-free telephone 

number.) Comments should indicate 

that they are submitted in response to 

‘‘RIN 2900–AQ06-Authority of Health 

Care Providers to Practice Telehealth.’’ 

Copies of comments received will be 

available for public inspection in the 

Office of Regulation Policy and 

Management, Room 1068, between the 

hours of 8:00 a.m. and 4:30 p.m., 

Monday through Friday (except 

holidays). Please call (202) 461–4902 for 

an appointment. (This is not a toll-free 

telephone number.) In addition, during 

the comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Galpin, MD, Executive Director 

Telehealth Services, Veterans Health 

Administration Office of Connected 

Care, 810 Vermont Avenue NW., 

Washington, DC 20420. (404) 771–8794. 

(This is not a toll-free number.) 

Kevin.Galpin@va.gov. 

SUPPLEMENTARY INFORMATION: Section 

7301 of title 38, United States Code 

(U.S.C.), establishes the general 

functions of the Veterans Health 

Administration (VHA) within VA, and 

establishes that its primary function is 

to ‘‘provide a complete medical and 

hospital service for the medical care and 

treatment of veterans, as provided in 

this title and in regulations prescribed 

by the Secretary [of Veterans Affairs 

(Secretary)] pursuant to this title.’’ 38 

U.S.C. 7301(b). In carrying out this 

function, VHA must ensure that patient 

care is appropriate and safe and its 

health care providers meet or exceed 

generally accepted professional 

standards for patient care. In addition, 

because VA is a national health care 

provider, VHA must ensure that 

beneficiaries receive the same high level 

of care and access to care no matter 

where, in a State, a beneficiary or health 

care provider is located at the time the 

health care is provided. 

The Secretary is responsible for the 

proper execution and administration of 

all laws administered by the Department 

and for the control, direction, and 

management of the Department, 

including agency personnel and 

management matters. See 38 U.S.C. 303. 

To this end, Congress authorized the 

Secretary ‘‘to prescribe all rules and 

regulations which are necessary or 

appropriate to carry out the laws 

administered by the Department and are 


sradovich on DSK3GMQ082PROD with PROPOSALS