53072 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 

Æ Reformat/separate Statutory 

Funding Preference data from Special 

Consideration data. 

• Table #2 has: 

Æ ‘‘Students’’ reworded to 

‘‘participants/trainees;’’ 

Æ One column labeled, ‘‘Budget 

Year,’’ to identify the project budget 

year; 

Æ One column to create a space for 

entering the sum for each row; 

Æ Rows to more clearly indicate the 

budget year for up to 5 years; and, 

Æ One final row to create a space for 

entering the total for each column. 

• Frequency of data collection: Data 

is collected (through the two tables) 

once during the application period for 

each funding announcement. 

• Information determines: 

Æ If applicants meet the funding 

preference or special consideration for 

funding, and 

Æ Projected target and baseline 

numbers of trainees/participants to be 

supported throughout the project 

period. 

Likely Respondents: Likely 

respondents will be current ANE 

Programs awardees and new applicants 

to the ANE Programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

(includes the ANE program specific tables and 

attachments) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

ANEW .................................................................................. 236 1 236 7 1,652 

NAT ...................................................................................... 115 1 115 7 805 

ANE–NPR ............................................................................ 101 1 101 7 707 

ANE–NPRIP ......................................................................... 15 1 15 7 105 

ANE–SANE .......................................................................... 54 1 54 7 378 

Total .............................................................................. 521 ........................ 521 ........................ 3,647 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–20653 Filed 9–23–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

OIG Modernization Initiative To 

Improve Its Publicly Available 

Resources—Request for Information 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

seeks input from the public on OIG 

resources and how OIG could enhance 

the usefulness and timeliness of such 

resources and improve their 

accessibility and usability. 

DATES: Please submit comments 

electronically at http://

www.regulations.gov. Follow the 

‘‘Submit a comment’’ instructions and 

refer to file code OIG–0922–N. 

Comments must be received no later 

than January 31, 2022, to ensure 

consideration. In light of the broad 

scope of the RFI and to provide 

adequate opportunity for input from a 

wide range of stakeholders, we are 

providing an extended comment period 

for this RFI. Thank you in advance for 

your valued input. For information on 

viewing public comments, please see 

the SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Susan Edwards, (202) 619–0335. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

I. Introduction 

The Department of Health and Human 

Services (HHS) Office of Inspector 

General (OIG) is working to modernize 

the accessibility and usability of our 

publicly available resources, including 

guidance, program integrity resources, 

publicly available data, and advisory 

opinions (collectively, resources). Given 

the significant passage of time since 

many of our resources launched and 

corresponding advancements in 

technology, we are looking holistically 

at where we can make improvements to 

delivering publicly available resources 

effectively and efficiently. We want to 

continue producing useful and timely 

resources that, among other things, 

advance the health care industry’s 

voluntary compliance and help prevent 

fraud, waste, and abuse. Further, we are 

mindful that stakeholders increasingly 

use new technologies to ingest, manage, 

and operationalize data and 

information, and we are interested in 

delivering data and information in ways 

that are compatible with the 

technologies used by stakeholders. To 

modernize our publicly available 

resources, we anticipate a multistep, 

multiyear process that prioritizes highvalue changes. Input collected from this 

RFI will help inform decisions about 

which areas to address first. By tailoring 

our resources in response to stakeholder 

Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 53073 

1Section 1128B(b) of the Social Security Act (the 

Act). 

2Section 1128A(a)(5) of the Act. 

input, and making it easier to use OIG’s 

resources, we hope to spur improved 

compliance and innovative approaches 

within the health care industry. 

Through this Request for Information 

(RFI), OIG seeks input from the health 

care industry and the public, including: 

• Health care providers and 

suppliers, pharmaceutical and medical 

device manufacturers, compliance 

professionals, attorneys, boards of 

directors, payors, health technology 

companies and professionals, 

companies and individuals providing 

health care-related services (such as 

social services or case management), 

industry associations, and health care 

compliance software vendors; 

• State officials who administer or 

oversee Medicaid and other State health 

care programs; 

• Tribal officials and providers and 

suppliers serving American Indian and 

Alaska Native communities; 

• health care consumers and their 

advocates; and 

• health care researchers and policy 

analysts. 

While our focus is generally on 

resources related to health care, we also 

offer resources related to HHS’s human 

services programs, including programs 

administered through grants and 

contracts, and would welcome input 

from stakeholders about resources 

related to those programs. Any changes 

we make will continue to ensure that 

our content and information remain 508 

compliant. 

We want to know whether and how 

you currently use the OIG resources 

listed below, and how we could 

enhance the value and timeliness of 

such resources and improve their 

accessibility and usability. We also are 

interested in input on additional types 

of OIG resources that would be useful, 

or additional subject areas for OIG 

resources. Specifically, we seek 

feedback on: 

• Advisory opinions; 

• fraud alerts (including special fraud 

alerts); 

• special advisory bulletins; 

• compliance program guidance; 

• frequently asked questions (FAQs), 

including COVID–19 FAQs; 

• other compliance guidance and 

resources; 

• corporate integrity agreements 

(CIAs); 

• the list of excluded individuals/ 

entities (LEIE); and 

• audits and evaluations. 

II. RFI Objectives 

For 45 years, OIG has provided 

objective, independent information to 

the public to foster an improved 

understanding of program integrity risks 

in HHS programs, enhance compliance 

practices by industry stakeholders 

participating in HHS programs, and 

protect against fraud and abuse. OIG 

issues audit and evaluation reports that 

contain findings and recommendations; 

conducts investigations; and provides 

compliance guidance, fraud alerts, and 

other information to promote program 

integrity and compliance. Through this 

RFI, we seek feedback from respondents 

about how they use OIG’s resources 

(and the related benefits and challenges 

of such uses) to improve the value and 

timeliness of, access to, and the 

usability of, such resources. 

This feedback will inform our efforts 

to modernize our publicly available 

resources. Our goals are to: (i) Continue 

producing useful and timely resources, 

(ii) deliver data and information to the 

public using modern technology, and 

(iii) spur improved compliance and 

innovative approaches that adapt to 

changes in the health care system and 

keep pace with technological change. 

The health care industry will 

continue to face many changes. More 

specifically, the health care delivery 

system is undergoing structural changes 

resulting from, for example, the COVID– 

19 public health emergency; the 

entrance of new health care 

stakeholders, such as digital health 

technology companies; the development 

and continuing proliferation of 

innovative treatments; and the evolution 

and increasing complexity of financial 

relationships within the health care 

industry. Ensuring that OIG’s publicly 

available resources continue to meet 

stakeholders’ needs as these and other 

changes unfold is important. 

Modernizing OIG’s publicly available 

resources will further OIG’s mission to 

promote the economy, efficiency, 

effectiveness, and integrity of HHS 

programs, as well as the health and 

welfare of the people they serve. 

This RFI is an opportunity for a range 

of stakeholders to suggest ways to 

improve the usefulness, timeliness, 

accessibility, and usability of OIG’s 

resources by: (i) Providing insights into 

how they use OIG resources, (ii) 

identifying the successes and challenges 

organizations have had using OIG 

resources, and (iii) identifying other 

potential opportunities for OIG to 

provide information to the public and 

other stakeholders. We recognize that 

many of the issues raised by this RFI 

may cross different professional 

disciplines or functions, and we 

encourage respondents to incorporate a 

broad perspective, as applicable. 

Through this RFI, we intend to elicit 

a more complete and nuanced 

understanding of how OIG resources are 

used by different stakeholders and how 

we may best improve upon them and 

their accessibility. We hope that 

respondents provide candid feedback, 

including examples of challenges 

related to any category of OIG resource 

listed in this RFI, as well as new 

opportunities for OIG to provide 

information and data more effectively. 

Feedback that we receive will inform 

OIG’s consideration and prioritization of 

potential updates to existing resources, 

modifications of processes for 

developing resources, changes in how 

data and information are provided to the 

public, and development of new 

materials or data sets, as appropriate. 

Notably, this RFI is just one action we 

are taking to gather input. We intend to 

conduct roundtables and are 

considering other ways to collect 

feedback, such as performing user 

surveys regarding targeted aspects of our 

data. We also are launching a new page 

on our website to provide information 

regarding this initiative. 

After reviewing comments submitted 

in response to this RFI and feedback 

received through any other mechanisms, 

OIG will consider what changes, if any, 

should be made to our resources and 

how to prioritize and implement those 

changes. Certain changes to the advisory 

opinion process may require 

amendments to OIG regulations that 

would be implemented via notice-andcomment rulemaking. Updated 

resources, new materials, or modified 

processes would be introduced 

incrementally and not according to any 

specific timeline. We anticipate that this 

initiative could be a multiyear 

undertaking. We will prioritize the 

highest value actions. 

III. Request for Information 

Historically, OIG has provided 

extensive publicly available resources 

across a range of compliance and 

program integrity topics and 

information types. For example, some 

resources provide guidance to the health 

care industry related to the Federal antikickback statute,1 OIG’s administrative 

enforcement authorities, such as the 

civil monetary penalty (CMP) provision 

prohibiting inducements to beneficiaries 

(the Beneficiary Inducements CMP),2

and other compliance and program 

integrity considerations. In addition, the 

purpose and goals of OIG’s resources 

vary: Some address trends in the health 

care industry that pose a fraud and 

abuse risk (e.g., fraud alerts), others 

53074 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 

3 62 FR 7350 (Feb. 19, 1997). 

4 63 FR 38311 (July 16, 1998). 

5 73 FR 15937 (Mar. 26, 2008); 73 FR 40982 (July 

17, 2008). 

provide information to encourage 

compliance best practices (e.g., 

compliance program guidance 

documents (CPGs) and compliancefocused toolkits), and others are 

intended to explain OIG’s legal 

interpretations of the Federal antikickback statute and the agency’s 

administrative enforcement authorities 

or to describe our enforcement priorities 

(e.g., policy statements). Some 

resources, such as the LEIE, provide 

data that industry stakeholders use for 

their own operations or compliance 

programs. Other resources, such as audit 

and evaluation reports, provide both 

findings and recommendations specific 

to a Federal agency, grantee, health care 

provider, or other entity, alongside 

broader takeaways that other 

stakeholders may use to improve their 

own operations. 

We recognize that the variety of 

purposes and goals of OIG’s resources 

mean that stakeholders access and use 

this information in a variety of ways. 

Respondents interested in providing 

information broadly across the 

categories should read the general 

questions in section III.A. Those 

questions solicit information on OIG’s 

general approach for providing publicly 

available resources and issues that may 

improve the usefulness, timeliness, 

usability, and accessibility of OIG’s 

resources. In addition, to ensure that we 

receive specific feedback relevant to 

each category of OIG resources 

described here, sections III.B through 

III.J each have two parts. First, we 

summarize each category of OIG 

resources to establish a common 

understanding. Second, we pose 

specific questions relevant to each 

category. For some categories, the RFI 

asks questions to assess how 

stakeholders access and use OIG’s 

resources, as well as questions to assess 

whether new or updated resources are 

needed. For other categories, such as 

OIG audit and evaluation reports, we 

ask questions only about the format of 

such information but do not request 

ideas for specific products (e.g., audits 

or evaluations). 

Respondents are urged to address 

those questions most relevant to them 

and do not need to respond to every 

question. 

To aid OIG’s review of responses, it 

would be helpful if respondents 

structured their responses using the 

same lettering and numbering system 

we use here. 

A. OIG Resources: General Questions 

The following questions seek input 

about OIG’s general approach to 

providing publicly available resources 

that may improve the usefulness, 

timeliness, usability, and accessibility of 

OIG’s resources across categories. 

Questions 1 through 8 relate to OIG’s 

current resources and web page. 

Questions 9 through 11 relate to how 

technology or modern approaches to 

data analysis could enhance the 

usability and accessibility of OIG’s 

public data and information. 

Subsequent sections of this RFI seek 

information about particular OIG 

resources, as described in each section. 

1. What OIG resources have you or 

your organization found most useful, 

and why are they most useful? Why 

have you and your organization found 

some resources more useful than others? 

2. What types of arrangements or 

practices, topical areas, or industry 

segments should OIG consider 

addressing in future resources? From 

your perspective, which of these are 

most important or urgent for OIG to 

address? 

3. What other forms or formats should 

OIG consider adopting in future 

compliance resources? Possible form 

and format of guidance and resource 

materials could include, for example, 

interactive content tools, guidance 

published in the Federal Register, video 

trainings, or podcasts. What do you 

suggest are effective ways for OIG to 

seek input from industry stakeholders 

and the public when developing 

resource materials? 

4. In addition to OIG’s annual 

solicitation of new safe harbors and 

special fraud alerts, do you have any 

suggestions for another formal 

mechanism for industry stakeholders 

and the public to request OIG guidance 

or resources on specific topics or for a 

particular industry sector? 

5. What type of data or other 

information could OIG provide to the 

health care industry to facilitate 

compliance and program integrity 

efforts? 

6. Please provide any suggestions to 

help improve accessibility and usability 

of our content for individuals with 

disabilities. 

7. OIG currently uses its website, 

email newsletter, and social media 

platforms to make the public aware of 

new resources. Are there any other 

methods of communication OIG should 

consider to inform the public regarding 

new or updated resources? 

8. Does your organization currently, 

or plan to, integrate OIG’s publicly 

available data and information related to 

compliance with other functional areas 

of your organization, such as 

organizational financial information? If 

so, please describe how OIG’s publicly 

available data and information is or 

could be most useful for such 

integration. 

9. How is your organization using 

application programming interfaces 

(APIs) to automate functions that may 

relate to compliance or similar issues? 

For example, have you automated preauthorization functions using APIs with 

payors? Would those functions benefit 

from automated functions related to use 

of OIG’s public data and information? 

10. Are there other types of 

technology that your organization is 

considering using to improve its 

compliance program or other related 

functions, such as using machine 

learning or artificial intelligence to 

automate assessment of claims for error 

before submission? Do these efforts use 

OIG’s public data and information, or 

would they benefit from such data if 

made more useable and accessible? 

B. OIG Advisory Opinions 

Pursuant to section 1128D of the Act, 

HHS, through OIG, publishes advisory 

opinions regarding the application of 

the Federal anti-kickback statute and the 

safe harbor provisions, as well as OIG’s 

administrative sanction authorities, to 

parties’ proposed or existing 

arrangements. More specifically, OIG, in 

consultation with the Department of 

Justice (DOJ), issues written advisory 

opinions to requesting parties with 

regard to: (i) What constitutes 

prohibited remuneration under the 

Federal anti-kickback statute; (ii) 

whether an arrangement or proposed 

arrangement satisfies the criteria in 

section 1128B(b)(3) of the Act, or 

established by regulation (i.e., safe 

harbors), for activities that do not result 

in prohibited remuneration; (iii) what 

constitutes an inducement to reduce or 

limit services to Medicare or Medicaid 

program beneficiaries under section 

1128A(b) of the Act; and (iv) whether an 

activity or proposed activity constitutes 

grounds for the imposition of sanctions 

under sections 1128, 1128A, or 1128B of 

the Act. 

To implement and interpret section 

1128D of the Act, OIG issued an interim 

final rule with comment period in 

1997.3 We revised and clarified our 

regulations in a final rule issued in 

1998.4 In 2008, we revised certain 

procedural requirements for submitting 

payments for advisory opinion costs.5

Since OIG implemented the advisory 

opinion process in 1997, OIG has issued 

nearly 400 advisory opinions, modified 

21 advisory opinions, terminated 4 

Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 53075 

6 42 CFR 1008.36. 

7 42 CFR 1008.15(c). 

8Section 1128D(b)(5)(B)(1) of the Act. 

9 42 CFR 1008.33, 1008.39, 1008.41, 1008.43. 

10 42 CFR 1008.40. 

11See 42 CFR 1008.47(a). 12 42 CFR 1008.45. 

opinions, and rescinded 1 opinion. 

During this time, OIG has received far 

more advisory opinion requests than 

these numbers may suggest, over 1,200 

requests. For various reasons, including 

a requestor’s withdrawal of a request or 

OIG’s rejection of a request pursuant to 

its regulatory authority, not all requests 

submitted ultimately result in a 

published advisory opinion. 

The procedures governing the 

submission of advisory opinion requests 

by an individual or entity in accordance 

with section 1128D of the Act are set 

forth in part 1008 of title 42 of the Code 

of Federal Regulations. These 

regulations impose content-oriented 

requirements for advisory opinion 

requests. For example, requests must 

contain certain information, such as ‘‘[a] 

complete and specific description of all 

relevant information bearing on the 

arrangement,’’ and specific 

certifications.6 The regulations also 

describe topics that are not appropriate 

for an advisory opinion and 

circumstances in which OIG will not 

accept a request or will not issue an 

opinion, such as when the same or 

substantially the same course of action 

is under investigation or is or has been 

the subject of a proceeding involving 

HHS or another governmental agency.7

Section 1128D(b) of the Act provides 

that advisory opinions will be issued no 

later than 60 days after the request is 

received.8 Notably, however, the 

regulations governing this process 

establish triggering events that toll the 

time period for issuing an advisory 

opinion.9 The length of time that it takes 

for OIG to issue an opinion varies based 

on a number of factors, including the 

complexity of the arrangement, the 

completeness of the request submission, 

and the promptness of requesting 

parties in responding to requests for 

additional information. 

As described above, not every request 

we receive results in an advisory 

opinion issued by OIG. For example, a 

requesting party may withdraw a 

request at any time before OIG issues an 

advisory opinion.10 If a request is not 

withdrawn or rejected, OIG prepares an 

advisory opinion in consultation with 

its Government partners, including DOJ. 

After issuing an opinion to the 

requesting party, OIG posts a redacted 

version of the opinion to its website,11

removing identifying information, such 

as the names of the parties. After an 

opinion is published, OIG has the right 

to reconsider the questions involved in 

the advisory opinion, and where the 

public interest requires, to rescind, 

terminate, or modify the advisory 

opinion.12

1. Please describe your or your 

organization’s experience, if any, with 

the current advisory opinion process. 

What has worked well, and what 

suggestions do you have for improving 

the process? 

2. If you have ever considered 

submitting an advisory opinion request 

and elected not to do so, why did you 

not submit a request? What concerns, if 

any, do you have about the process and 

how might OIG address those concerns? 

3. OIG advisory opinions currently 

include a thorough explanation of the 

facts and circumstances of the proposed 

or ongoing arrangement and a detailed 

analysis that comprehensively assesses 

the arrangement or proposed 

arrangement under the relevant 

authorities. In the past, OIG has 

received informal feedback that the 

advisory opinion process may be too 

restrictive, slow, or cumbersome. We are 

seeking your input on how to balance 

the value and utility of including 

detailed analyses in advisory opinions— 

which necessitates a more involved and 

time-consuming process—with the 

value and utility of a more expeditious 

process that does not necessarily 

include a detailed legal analysis in each 

published opinion. Please share your 

feedback on the approach that would be 

most valuable for you and your 

organization. For example, would a 

short-form advisory opinion that 

answers the legal questions posed to 

OIG without providing a comprehensive 

legal analysis be useful to you and your 

organization? If so, should OIG 

implement short-form advisory 

opinions: (i) For all advisory opinions; 

(ii) for unfavorable advisory opinions 

only; (iii) for any request for which the 

requesting party or parties elected, at 

the beginning of the advisory opinion 

process, to receive a short-form opinion; 

or (iv) for other categories of opinions? 

4. Are there types of arrangements or 

other circumstances in which an FAQ 

process, similar to the COVID–19 FAQ 

process, would be a preferable 

alternative to the advisory opinion 

process? From your perspective, what 

types of arrangements or what other 

circumstances would be amenable to an 

FAQ process as opposed to the existing 

advisory opinion process? If OIG 

implemented an FAQ process that 

functioned as an alternative to the 

advisory opinion process, should OIG 

charge for that process, and if so, how 

should OIG determine such charges? 

5. When requesting parties make 

significant modifications to the facts 

presented in the advisory opinion 

request during the advisory opinion 

process, such modifications can delay 

the process and result in the 

expenditure of additional OIG 

resources. To address this, OIG could 

require requesting parties to withdraw 

(with the opportunity to resubmit) a 

request when requesting parties make 

significant modifications to the facts 

presented in the initial request. 

Alternatively, OIG could restrict 

requesting parties from making any 

modifications to the original advisory 

opinion request. Please share your 

perspectives on the benefits or 

drawbacks of each approach. 

6. OIG is considering modifying its 

advisory opinion fee structure. 

Revisions could include, for example, a 

tiered-cost structure, such as set fee 

amounts for requests of low, medium, or 

high complexity; requesting a retainer or 

other initial payment upon submission 

of a request; and waiving fees for 

requests withdrawn before a certain 

point in the process. Please share any 

feedback or other ideas on how OIG 

might structure and apply fees for 

advisory opinions in the future. 

7. OIG is considering whether to set 

‘‘expiration dates’’ for advisory 

opinions, at which point the advisory 

opinion would no longer be in effect. 

Alternatively, OIG could require 

requesting parties to recertify that the 

facts presented in an advisory opinion 

are still true and correct and constitute 

a complete description of the facts 

regarding the arrangement for which an 

advisory opinion was sought, where the 

failure to submit a recertification would 

result in the advisory opinion being 

terminated. Please share your thoughts 

on the relative benefits or drawbacks of 

either approach as well as 

considerations in setting timeframes for 

expiration or recertification of advisory 

opinions. 

C. Fraud Alerts (Including Special 

Fraud Alerts) 

With respect to special fraud alerts, 

pursuant to section 1128D(c) of the Act, 

‘‘any person may present a request at 

any time to [OIG] for a [special fraud 

alert that would inform] the public of 

practices [that OIG] considers to be 

suspect or of particular concern under 

Medicare or a State health care 

program.’’ OIG may elect to issue 

special fraud alerts in response to such 

requests, or otherwise, at OIG’s 

discretion. For the most part, special 

fraud alerts have focused on national 

53076 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 

13OIG, Special Fraud Alert: Speaker Programs 

(Nov. 16, 2020), available at https://oig.hhs.gov/ 

fraud/docs/alertsandbulletins/2020/SpecialFraud

AlertSpeakerPrograms.pdf. 

14OIG, Fraud Alert: COVID–19 Scams (last 

updated on Aug. 16, 2021), available at https://

oig.hhs.gov/fraud/consumer-alerts/fraud-alertcovid-19-scams/. 

15OIG, Special Advisory Bulletin: Pharmaceutical 

Manufacturer Copayment Coupons (Sept. 2014), 

available at https://oig.hhs.gov/fraud/docs/ 

alertsandbulletins/2014/SAB_Copayment_

Coupons.pdf. 

16OIG, Updated Special Advisory Bulletin on the 

Effect of Exclusion from Participation in Federal 

Health Care Programs (May 8, 2013), available at 

https://oig.hhs.gov/exclusions/files/sab05092013.pdf. 

17E.g., OIG Supplemental Compliance Program 

Guidance for Nursing Facilities, 73 FR 56832 (Sept. 

30, 2008); OIG Supplemental Compliance Program 

Guidance for Hospitals, 70 FR 4848 (Jan. 31, 2005); 

OIG Compliance Program Guidance for 

Pharmaceutical Manufacturers, 68 FR 23731 (May 

5, 2003). 

18OIG, FAQs—Application of OIG’s 

Administrative Enforcement Authorities to 

Arrangements Directly Connected to the 

Coronavirus Disease 2019 (COVID–19) Public 

Health Emergency, available at https://oig.hhs.gov/ 

coronavirus/authorities-faq.asp. 

19The Secretary of HHS determined, through a 

January 31, 2020, determination, pursuant to 

section 319 of the Public Health Service Act, that 

a public health emergency exists and has existed 

since January 27, 2020. See U.S. Department of 

Health and Human Services, Determination that a 

Public Health Emergency Exists (Jan. 31, 2020), 

available at https://www.phe.gov/emergency/news/ 

healthactions/phe/Pages/2019-nCoV.aspx (COVID– 

19 Declaration). The Secretary has issued 

subsequent 90-day renewals of that original 

determination. The duration of the COVID–19 

public health emergency is tied to these 

determinations. 

fraud and abuse trends in health care 

and address potential violations of the 

Federal anti-kickback statute and 

Beneficiary Inducements CMP. In 

developing these special fraud alerts, we 

rely on a number of sources, such as 

studies or management and program 

evaluations conducted by OIG’s Office 

of Evaluation and Inspections (OEI). In 

addition, we may consult with experts 

in the subject field, including those 

within OIG, other HHS agencies, other 

Federal and State agencies, and others 

in the health care industry. Most 

recently, OIG released an alert in 2020 

highlighting the fraud and abuse risks 

associated with the offer, payment, 

solicitation, or receipt of remuneration 

relating to speaker programs by 

pharmaceutical and medical device 

companies.13

In addition to the foregoing, section 

1128D(a) of the Act requires HHS to 

develop and publish an annual 

notification in the Federal Register, 

which it does through OIG, formally 

soliciting proposals for the development 

of new special fraud alerts or adding to 

or modifying existing safe harbors to the 

Federal anti-kickback statute. 

OIG also issues a variety of other 

fraud alerts, including alerts that warn 

the public about fraud schemes OIG has 

identified (e.g., COVID–19 scams).14

1. Which fraud alerts, if any, have you 

or your organizations used as a resource, 

and how have you used them? 

2. What could OIG do differently to 

make our fraud alerts more meaningful, 

useful, or timely? 

D. Special Advisory Bulletins 

Special advisory bulletins cover a 

variety of topics, including discussions 

regarding: (i) Potentially abusive health 

care industry practices, similar to those 

described in special fraud alerts, but 

where OIG may lack the enforcement 

experience necessary to substantiate a 

special fraud alert; (ii) the importance of 

robust compliance measures, as applied 

to specific types of arrangements; (iii) 

arrangements that potentially implicate 

the Federal anti-kickback statute and 

OIG’s administrative enforcement 

authorities; and (iv) the scope and effect 

of certain legal prohibitions. Examples 

include a 2014 notice, issued 

concurrently with a related report by 

OEI, regarding pharmaceutical 

manufacturers’ offer of copayment 

coupons to insured patients 15 and a 

bulletin in 2013 describing the effect of 

exclusion from participation in Federal 

health care programs.16

1. Which special advisory bulletins, if 

any, have you or your organization used 

as a resource and how have you used 

them? 

2. What could OIG do differently to 

make our special advisory bulletins 

more meaningful, useful, or timely? 

3. If OIG were to update existing 

special advisory bulletins or publish 

additional special advisory bulletins on 

certain topic areas, how should OIG best 

obtain stakeholder input on areas in 

need of new guidance or refinements to 

existing guidance? 

E. Compliance Program Guidance 

As a general matter, CPGs set forth 

OIG’s views on the value and 

fundamental principles of a compliance 

program, in addition to elements for 

consideration when developing and 

implementing an effective compliance 

program. CPGs are intended to 

encourage the voluntary development 

and use of internal controls to monitor 

adherence to applicable statutes, 

regulations, and program requirements. 

Beginning in 1998, OIG developed a 

series of CPGs directed at a number of 

different segments of the health care 

industry, including, for example, 

nursing facilities, hospitals, and 

pharmaceutical manufacturers.17 As 

stated in each CPG, the suggestions 

included in the CPGs are not 

mandatory, and the CPGs are not 

intended to be an exhaustive discussion 

of beneficial compliance practices or 

relevant risk areas. 

1. How, if at all, do you or your 

organization use the CPGs to understand 

beneficial compliance practices or 

relevant risk areas? 

2. If OIG published additional or 

supplemental CPGs, or resources similar 

to CPGs, what industry segments would 

you find most useful for us to address? 

3. If OIG were to update or publish 

additional or supplemental CPGs, how 

should OIG best solicit stakeholder 

input about risk areas or other features 

to update or supplement? 

4. What suggestions, if any, do you 

have for the form, format, or content for 

CPGs to make them as useful, relevant, 

and timely as possible? For example, 

instead of a static document, would it be 

more useful, relevant, and timely to 

have a mobile-friendly web page that is 

updated at regular intervals to describe 

compliance best practices and current 

risk areas? 

F. Frequently Asked Questions, 

Including COVID–19 Frequently Asked 

Questions 

In response to the COVID–19 public 

health emergency, OIG developed a 

process to respond to inquiries from 

health care industry stakeholders 

regarding the application of the Federal 

anti-kickback statute and OIG’s 

administrative enforcement authorities 

to arrangements directly connected to 

the COVID–19 public health 

emergency.18 Through this FAQ 

process, OIG has received and reviewed 

questions submitted by a variety of 

health care stakeholders, and where OIG 

has determined that it would be 

appropriate and beneficial, we have 

provided informal feedback, time 

limited to the duration of the COVID– 

19 public health emergency,19

explaining OIG’s assessment of whether 

a particular arrangement poses a 

sufficiently low risk of fraud and abuse 

under the Federal anti-kickback statute, 

the Beneficiary Inducements CMP, or 

both. OIG developed this FAQ process 

consistent with the agency’s mission to 

promote economy, efficiency, and 

effectiveness in HHS programs and to 

further OIG’s commitment to protecting 

patients by ensuring that health care 

providers and others have the regulatory 

flexibility necessary to adequately 

respond to COVID–19 concerns. 

Recognizing the importance of 

expeditious feedback in the context of a 

public health emergency, when OIG has 

Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 53077 

20OIG, A Roadmap for New Physicians: Avoiding 

Medicare and Medicaid Fraud and Abuse, available 

at https://oig.hhs.gov/compliance/physicianeducation/roadmap_web_version.pdf. 

21E.g., HCCA-OIG Compliance Effectiveness 

Roundtable, Measuring Compliance Program 

Effectiveness–A Resource Guide (Mar. 27, 2017), 

available at https://oig.hhs.gov/compliance/ 

compliance-resource-portal/files/HCCA-OIGResource-Guide.pdf. 

22OIG, HEAT Provider Compliance Training 

Videos, available at https://oig.hhs.gov/newsroom/ 

video/2011/heat_modules.asp. 

23E.g., OIG, Podcasts, What Role Does Data Play 

in Fighting Healthcare Fraud, Waste, and Abuse? 

(June 7, 2016), available at https://oig.hhs.gov/ 

newsroom/oig-podcasts/what-role-does-data-playfighting-healthcare-fraud-waste-and-abuse. 

24OIG, Corporate Integrity Agreement 

Documents, available at https://oig.hhs.gov/ 

compliance/corporate-integrity-agreements/ciadocuments.asp. 

25E.g., OIG, Corporate Integrity Agreement FAQ, 

available at https://oig.hhs.gov/faqs/corporateintegrity-agreements-faq.asp. 

responded to questions, it has aimed to 

do so quickly. 

1. How, if at all, do you or your 

organization use the COVID–19 FAQ 

responses in assessing or structuring 

arrangements directly connected to the 

COVID–19 public health emergency that 

potentially implicate OIG’s 

administrative enforcement authorities? 

Do you have any feedback on how OIG 

can make the COVID–19 FAQ responses 

more useful? 

2. Would you or your organization 

find it valuable if OIG established an 

FAQ process modeled after the COVID– 

19 FAQ process that would continue 

after the COVID–19 public health 

emergency ends? What suggestions, if 

any, do you have for the structure of any 

FAQs, the process for submitting 

questions, or the topics such process 

would address? 

3. What could OIG do differently to 

make an FAQ process for public health 

emergencies or other inquiries more 

meaningful, useful, or timely in the 

future? 

G. Other Compliance Guidance and 

Resources 

OIG has published numerous other 

compliance-related documents that 

target various segments of the health 

care industry. For example, OIG 

published ‘‘A Roadmap for New 

Physicians: Avoiding Medicare and 

Medicaid Fraud and Abuse’’ 20 to help 

new physicians understand the 

application of certain Federal fraud and 

abuse laws, including OIG’s 

administrative enforcement authorities 

and how they protect Federal health 

care programs and their beneficiaries 

from fraud and abuse. We also have 

developed guidance documents specific 

to health care boards, including 

resources jointly published by OIG and 

professional associations.21 Although 

most of OIG’s resources are written 

materials, we also have published video 

trainings developed as part of the Health 

Care Fraud Prevention and Enforcement 

Action Team Provider Compliance 

Training initiative 22 and podcasts on 

various compliance topics.23

1. How, if at all, do you and your 

organization use OIG’s other compliance 

resources, like our video trainings and 

podcasts? If you or your organization do 

not use these resources, please explain 

why. 

2. What, if anything, could OIG do to 

make our other compliance resources 

more useful, relevant, and timely? 

H. Corporate Integrity Agreements 

OIG negotiates CIAs with individuals 

and entities as part of the settlement of 

Federal health care program 

investigations arising under a variety of 

civil false claims statutes. Individuals 

and entities agree to the obligations set 

forth in the CIAs, and in exchange, OIG 

agrees not to seek their exclusion from 

participation in Medicare, Medicaid, or 

other Federal health care programs 

under section 1128(b)(7) of the Act. OIG 

negotiates each CIA with the specific 

party or parties to the CIA, and each CIA 

is binding only on the party or parties 

to the CIA. However, OIG recognizes 

that industry stakeholders may review 

CIAs in the development or refinement 

of a compliance program and to 

facilitate an understanding of 

compliance best practices. In addition, 

OIG’s website includes various 

materials related to CIAs. For example, 

OIG posts all open CIAs and maintains 

a list of closed CIAs.24 In addition, OIG 

has issued CIA-specific FAQs and has 

published guidance on the 

independence and objectivity 

requirements relating to independent 

review organizations retained under 

CIAs.25 OIG publishes CIA documents 

on our website so that industry 

stakeholders can use them as a resource 

in developing the essential elements of 

a compliance program. As noted above, 

each CIA is negotiated as part of an 

individual civil settlement and is 

binding only on the parties to the CIA. 

1. How do you or your organization 

use the information in publicly 

available CIAs? 

2. What types of search capabilities 

for CIA documents (e.g., search by 

provider type) would be most useful for 

your or your organization? 

I. List of Excluded Individuals/Entities 

OIG has the authority to exclude 

individuals and entities from federally 

funded health care programs pursuant 

to section 1128 of the Act (and from 

Medicare and State health care 

programs under section 1156 of the Act) 

and maintains a list of all currently 

excluded individuals and entities called 

the LEIE. Anyone who hires an 

individual or entity on the LEIE may be 

subject to CMPs. To avoid CMP liability, 

health care entities need to routinely 

check the LEIE to ensure that new hires 

and current employees are not on the 

excluded list. 

The LEIE website receives 

approximately 26 million visits 

annually. Users can check the LEIE 

through two primary means: 

downloading a spreadsheet or using 

web queries for up to five providers at 

a time. We believe that the number of 

annual visits combined with the mostly 

manual interaction with the LEIE means 

there is considerable opportunity to 

reduce burden and lower costs 

associated with checking the LEIE. 

Additionally, modern data sharing 

practices, such as APIs and better 

structured data, provide options to 

improve how users can access and use 

the LEIE data. 

1. How can OIG best provide access 

to the LEIE? For example, if OIG 

publishes an API for the LEIE, would 

that be useful to you or your 

organization? Are there other access 

options or data formats that would make 

using the LEIE easier? 

2. What software or application, if 

any, do you currently use to check the 

LEIE? Is that software or application 

developed internally or by a third party? 

Does the software or application 

automate the process of checking the 

LEIE? 

3. Do you integrate the results of the 

LEIE with other information, such as 

information related to provider 

onboarding, licensure, credentialing, or 

privileging? If yes, please explain how. 

J. OIG Audits and Evaluations 

OIG audits examine the performance 

of HHS programs and/or its grantees, 

contractors, or providers in carrying out 

their respective responsibilities and 

provide independent assessments of 

HHS programs and operations. OIG also 

conducts national evaluations to 

provide HHS, Congress, the public, and 

other stakeholders with timely, useful, 

and reliable assessments of HHS 

programs and operations. OIG’s audits 

and evaluations provide detailed 

findings and often include 

recommendations to Federal and State 

agencies, health care providers, HHS 

grantees, contractors, and other entities. 

In addition, OIG’s reports can provide 

information, data, or methodologies that 

health care providers and other entities 

53078 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 

26HHS OIG Toolkits for Calculating Opioid 

Levels and Identifying Patients at Risk of Misuse or 

Overdose, available at https://oig.hhs.gov/oei/ 

reports/oei-02-17-00560.asp. 

27OIG, Geographic Disparities Affect Access to 

Buprenorphine Services for Opioid Use Disorder 

(OEI–12–17–00240) (Jan. 2020), available at https:// 

oig.hhs.gov/oei/reports/oei-12-17-00240.asp. 

28E.g., OIG, Concerns Persist About Opioid 

Overdoses and Medicare Beneficiaries’ Access to 

Treatment and Overdose-Reversal Drugs (OEI–02– 

20–00401) (Aug. 2021), available at https://

oig.hhs.gov/oei/reports/OEI-02-20-00401.asp. 

29E.g., OIG, National Review of Opioid 

Prescribing in Medicaid Is Not Yet Possible (OEI– 

05–18–00480) (Aug. 2019), available at https://

oig.hhs.gov/oei/reports/oei-05-18-00480.asp. 

30OIG Work Plan, available at https://

oig.hhs.gov/reports-and-publications/workplan/ 

index.asp. 

31OIG Semiannual Report to Congress, available 

at https://oig.hhs.gov/reports-and-publications/ 

semiannual/index.asp. 

32HHS OIG Toolkits for Calculating Opioid 

Levels and Identifying Patients at Risk of Misuse or 

Overdose, available at https://oig.hhs.gov/oei/ 

reports/oei-02-17-00560.asp. 

can use to support their own internal 

audit and evaluation programs. Most of 

OIG’s reports are made available 

publicly on OIG’s website. 

For some reports, OIG makes certain 

downloadable resources and 

applications available to the public, and 

OIG has published supplemental 

information to enable stakeholders to 

adapt the audit or evaluation 

methodology for their own use or to 

provide access to key data related to our 

findings. For example, OIG issued 

toolkits that provide detailed steps and 

programming code for using 

prescription drug claims data to analyze 

patients’ opioid levels to identify certain 

patients at risk of opioid misuse or 

overdose.26 In another example, OIG 

provided an interactive map online that 

enables users to see, by county, data on 

the need for opioid treatment services 

overlaid with data on the availability of 

buprenorphine services (medicationassisted treatment).27

OIG audit and evaluation reports are 

available on our website and can be 

downloaded as PDFs. In recent years, 

OIG has refreshed the format and layout 

of our reports with the goal of making 

them more user friendly; for example, 

most reports start with a ‘‘Report in 

Brief’’ that provides the key findings, 

recommendations, and context on the 

first page. We have also used different 

formats for certain types of reports, such 

as a ‘‘data brief’’ 28 and a ‘‘data 

snapshot,’’ 29 among others, with the 

intent of making the key results and 

takeaways clearer and more readily 

understood. 

OIG also publishes other information 

and resources describing forthcoming 

reports or summarizing published 

reports. For example, OIG publishes a 

Work Plan on our website, which is a 

searchable repository of our ongoing 

audits and evaluations, updated 

monthly, with archived information on 

completed work plan items that link to 

their resulting products.30 OIG also 

publishes the agency’s Semiannual 

Report to Congress.31 Finally, OIG is 

developing a new tracking system for 

our recommendations. We intend to 

make available on our website a 

searchable repository of OIG 

recommendations from our audits and 

evaluations, including information 

about the status of their 

implementation. 

1. How could OIG facilitate better 

utilization of data and data analysis 

through its toolkits or other resources? 

2. How could OIG use its toolkits or 

other resources to help providers and 

others identify compliance risks or 

improve upon their compliance 

programs? 

3. To facilitate the monitoring and 

automation of compliance best 

practices, would it be helpful to share 

the data methodology or programming 

codes employed by OIG in certain of its 

audit or evaluation reports, similar to 

OIG’s Toolkits for Calculating Opioid 

Levels and Identifying Patients at Risk 

of Misuse or Overdose? 32

4. Please share any feedback on 

accessing OIG audit and evaluation 

reports. For example, how easy is it for 

you to find specific reports when you 

look for them? How well does the 

downloadable PDF format work for you? 

Are there other file types or web-based 

formats that would be more accessible 

or useful to you? 

5. Please share any feedback on the 

ways we present information in OIG 

audit and evaluation reports, including 

our more standard reporting templates 

and our alternative formats, such as data 

briefs and data snapshots. For example, 

what types of information (e.g., key 

takeaways, findings, recommendations, 

methodology) are most useful to you? 

How easy is it to find and understand 

that information? What suggestions, if 

any, do you have for making our reports 

more useful or user friendly in their 

presentation? 

6. Please tell us about your 

experiences, if any, in using 

supplemental products such as OIG 

Toolkits or Interactive Maps that 

sometimes accompany audit or 

evaluation reports. What have you 

found most valuable, if anything, about 

these supplemental products? What 

could we improve to make these 

products more valuable to you? Please 

also share any ideas for other types of 

supplemental products for OIG to 

consider developing that would be 

useful to you. 

7. Please share feedback on your 

experiences, if any, in accessing and 

using the OIG Work Plan. For example, 

how well can you find the information 

that you are looking for? How, if at all, 

do you or your organization use the 

information in our Work Plan? 

8. As OIG develops our searchable 

repository of recommendations for our 

public website, we would appreciate 

any feedback you have on how to make 

this repository most useful to you or 

your organization. For example, what 

types of queries would you want to run, 

what types of information might you be 

looking for, and what functionalities 

would you want this system to have? 

Please note: This is a request for 

information only. This RFI is issued 

solely for information and planning 

purposes; it does not constitute a 

request for proposal, application, 

proposal abstract, or quotation. This RFI 

does not commit the U.S. Government 

to contract for any supplies or services 

or make a grant award. Further, OIG is 

not seeking proposals through this RFI 

and will not accept unsolicited 

proposals. Respondents are advised that 

the U.S. Government will not pay for 

any information or administrative costs 

incurred in response to this RFI; all 

costs associated with responding to this 

RFI will be solely at the interested 

party’s expense. Not responding to this 

RFI does not preclude participation in 

any future procurement, if conducted. It 

is the responsibility of the potential 

responders to monitor this RFI 

announcement for additional 

information pertaining to this request. 

Please note that OIG will not respond to 

questions about the policy issues raised 

in this RFI. Contractor support 

personnel may be used to review RFI 

responses. 

Responses to this RFI are not offers 

and cannot be accepted by the U.S. 

Government to form a binding contract 

or issue a grant. Information obtained as 

a result of this RFI may be used by the 

U.S. Government for program planning 

on a nonattribution basis. Respondents 

should not include any information that 

might be considered proprietary or 

confidential. This RFI should not be 

construed as a commitment or 

authorization to incur costs for which 

reimbursement would be required or 

sought. All submissions become U.S. 

Government property and will not be 

returned. OIG may publicly post the 

comments received or a summary 

thereof. 

Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 53079 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements 

under the Paperwork Reduction Act of 

1995 (PRA). However, section III of this 

document does contain a general 

solicitation of comments in the form of 

a request for information. In accordance 

with the implementing regulations of 

the PRA, specifically 5 CFR 

1320.3(h)(4), this general solicitation is 

exempt from the PRA. Facts or opinions 

submitted in response to general 

solicitations of comments from the 

public, published in the Federal 

Register or other publications, 

regardless of the form or format thereof, 

provided that no person is required to 

supply specific information pertaining 

to the commenter, other than that 

necessary for self-identification, as a 

condition of the agency’s full 

consideration, are not generally 

considered information collections and 

therefore not subject to the PRA. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the PRA. 

V. Response to Comments 

Because of the large number of public 

comments we normally receive in 

response to Federal Register 

documents, we are not able to 

acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, if we proceed with 

a subsequent document, we may 

respond to the comments in the 

preamble to that document. Publication 

of this RFI does not commit OIG to the 

promulgation of new regulations or 

issuance of new guidance. 

Christi A. Grimm, 

Principal Deputy, Inspector General. 

[FR Doc. 2021–20558 Filed 9–23–21; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Diabetes Mellitus Interagency 

Coordinating Committee Meeting 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The Diabetes Mellitus 

Interagency Coordinating Committee 

(DMICC) will hold a meeting on 

November 8, 2021. The topic for this 

meeting will be ‘‘Evolving Concepts in 

the Assessment and Management of 

Hypoglycemia.’’ The meeting is open to 

the public. 

DATES: The meeting will be held on 

November 8, 2021 from 12:00 p.m. to 

3:00 p.m. EDT. 

ADDRESSES: The meeting will be held 

via the Zoom online video conferencing 

platform. For details, and to register, 

please contact dmicc@mail.nih.gov. 

FOR FURTHER INFORMATION CONTACT: For 

further information concerning this 

meeting, including a draft agenda, 

which will be posted when available, 

see the DMICC website, 

www.diabetescommittee.gov, or contact 

Dr. William Cefalu, Executive Secretary 

of the Diabetes Mellitus Interagency 

Coordinating Committee, National 

Institute of Diabetes and Digestive and 

Kidney Diseases, 6707 Democracy 

Boulevard, Democracy 2, Room 6037, 

Bethesda, MD 20892, telephone: 301– 

435–1011; email: dmicc@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with 42 U.S. Code § 285c–3, 

the DMICC, chaired by the National 

Institute of Diabetes and Digestive and 

Kidney Diseases (NIDDK) comprising 

members of the Department of Health 

and Human Services and other federal 

agencies that support diabetes-related 

activities, facilitates cooperation, 

communication, and collaboration on 

diabetes among government entities. 

DMICC meetings, held several times a 

year, provide an opportunity for 

Committee members to learn about and 

discuss current and future diabetes 

programs in DMICC member 

organizations and to identify 

opportunities for collaboration. The 

November 8, 2021 DMICC meeting will 

focus on ‘‘Evolving Concepts in the 

Assessment and Management of 

Hypoglycemia.’’ 

Any member of the public interested 

in presenting oral comments to the 

Committee should notify the contact 

person listed on this notice at least 5 

days in advance of the meeting. 

Interested individuals and 

representatives or organizations should 

submit a letter of intent, a brief 

description of the organization 

represented, and a written copy of their 

oral presentation in advance of the 

meeting. Only one representative of an 

organization will be allowed to present; 

oral comments and presentations will be 

limited to a maximum of 5 minutes. 

Printed and electronic copies are 

requested for the record. In addition, 

any interested person may file written 

comments with the Committee by 

forwarding their statement to the 

contact person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Because of time constraints for the 

meeting, oral comments will be allowed 

on a first-come, first-serve basis. 

Members of the public who would 

like to receive email notification about 

future DMICC meetings should register 

for the listserv available on the DMICC 

website, www.diabetescommittee.gov. 

Dated: September 21, 2021. 

Bruce Tibor Roberts, 

Health Science Policy Analyst, Office of 

Scientific Program and Policy Analysis, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, National Institutes of 

Health. 

[FR Doc. 2021–20802 Filed 9–23–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Mental Health Initial Review Group; Mental 

Health Services Study Section. 

Date: October 21–22, 2021. 

Time: October 21, 2021, 12:00 p.m. to 5:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Time: October 22, 2021, 11:00 a.m. to 4:00 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Aileen Schulte, Ph.D., 

Scientific Review Officer, Division of