Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 30963 

Application No. Drug Applicant 

ANDA 065301 ......... Cefadroxil Tablets, Equivalent to (EQ) 1 gram (g) base ...... Do. 

ANDA 065307 ......... Cefadroxil Oral Suspension, EQ 250 mg base/5 mL and 

EQ 500 mg base/5 mL.

Do. 

ANDA 065309 ......... Cefadroxil Capsules, EQ 500 mg base ................................. Do. 

ANDA 065326 ......... Cephalexin Oral Suspension, EQ 125 mg base/5 mL and 

EQ 250 mg base/5 mL.

Do. 

ANDA 076720 ......... Morphine Sulfate Extended Release Tablets, 30 mg, and 

60 mg.

Nesher Pharmaceuticals (USA) LLC., 13910 Saint Charles 

Rock Rd., Bridgeton, MO 63044. 

ANDA 076733 ......... Morphine Sulfate Extended Release Tablets, 15 mg ........... Do. 

ANDA 077855 ......... Morphine Sulfate Extended Release Tablets, 100 mg and 

200 mg.

Do. 

ANDA 080225 ......... Potassium Chloride Injection, 2 milliequivalent (mEq)/mL 

and 3 mEq/mL.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. 

ANDA 202393 ......... Diclofenac Sodium Topical Solution, 1.5% ........................... TWi Pharmaceuticals, Inc., 536 Vanguard Way, Brea, CA 

92821. 

ANDA 203581 ......... Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg .................... Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke 

Pines, FL 33027. 

ANDA 204137 ......... Omeprazole and Sodium Bicarbonate Capsules, 20 mg; 1.1 

g.

Unicorn Pharmaceuticals, 5 Links Circle, Durham, NC 

27707. 

ANDA 206588 ......... Dextroamphetamine Sulfate Tablets, 5 mg, and 10 mg ....... Nesher Pharmaceuticals (USA) LLC. 

ANDA 208263 ......... Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 

100 mg base.

Do. 

ANDA 209111 ......... Dextroamphetamine Sulfate Extended Release Capsules, 5 

mg, 10 mg, and 15 mg.

Do. 

ANDA 210079 ......... Oxycodone and Acetaminophen Tablets, 325 mg; 2.5 mg, 

325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg.

Do. 

ANDA 210080 ......... Dextroamphetamine Saccharate, Amphetamine Aspartate, 

Dextroamphetamine Sulfate, and Amphetamine Sulfate 

Extended Release Capsules, 1.25 mg; 1.25 mg; 1.25 

mg; 1.25 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 3.75 mg; 

3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg, 

6.25 mg; 6.25 mg; 6.25 mg; 6.25 mg, 7.5 mg; 7.5 mg; 

7.5 mg; 7.5 mg.

Do. 

ANDA 211543 ......... Butalbital, Acetaminophen, and Caffeine Tablets, 325 mg; 

50 mg; 40 mg.

Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of June 21, 2022. 

Approval of each entire application is 

withdrawn, including any strengths and 

dosage forms inadvertently missing 

from the table. Introduction or delivery 

for introduction into interstate 

commerce of products without 

approved new drug applications 

violates section 301(a) and (d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 331(a) and (d)). Drug 

products that are listed in the table that 

are in inventory on June 21, 2022, may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10924 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0277] 

Risk Management Plans To Mitigate 

the Potential for Drug Shortages; Draft 

Guidance for Industry; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Risk 

Management Plans to Mitigate the 

Potential for Drug Shortages.’’ This draft 

guidance is intended to help 

stakeholders develop, maintain, and 

implement, as appropriate, risk 

management plans (RMPs) to 

proactively assist in the prevention of 

human drug product and biological 

product shortages. In March 2020, with 

the enactment of the Coronavirus Aid, 

Relief, and Economic Security Act 

(CARES Act), the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) was 

amended to require certain 

manufacturers to develop, maintain, and 

implement, as appropriate, a 

‘‘redundancy risk management plan.’’ 

This draft guidance provides 

information about the development and 

content of RMPs for those 

manufacturers as well as for other 

stakeholders. This draft guidance 

recommends a framework and factors to 

consider that stakeholders can use to 

develop RMPs. This draft guidance is 

relevant for all stakeholders, including 

those with oversight and control 

responsibilities for drug quality and 

contract establishments, and for 

manufacturers of active pharmaceutical 

ingredients (APIs), approved or licensed 

drug and biological products, and drug 

products marketed without an 

application. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 19, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

July 19, 2022. 


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30964 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 

1For the purposes of this guidance, the term 

stakeholder includes each manufacturer of a drug 

described in section 506C(a) of the FD&C Act (21 

U.S.C. 356c(a)) or of any API included in such 

drugs. (See generally section 506C(j) of the FD&C 

Act.) The term stakeholder also broadly includes 

any person or entity who has oversight and control 

over the manufacture of drugs to ensure quality or 

owns or operates an establishment (as defined in 21 

CFR 207.1 and 600.3) that manufactures a drug or 

biological product. Examples of stakeholders 

include contract facilities as referenced in 21 CFR 

200.10(b); applicants with an approved new drug 

application, abbreviated new drug application, or 

an approved biologics license application; 

manufacturers of drug products marketed without 

an approved application; manufacturers of 

components, including APIs, intended for use in 

the manufacture of drug products; and 

manufacturers of drug-led, drug-device or biologicled, biologic-device combination products (as 

defined in 21 CFR 3.2(e)) regulated by the Center 

for Drug Evaluation and Research or the Center for 

Biologics Evaluation and Research. This guidance 

references specific stakeholders individually where 

appropriate (e.g., if a specific section of the 

guidance is relevant to specific stakeholders only); 

otherwise, recommendations that refer to the 

manufacture of drugs are generally relevant to all 

stakeholders with the roles described above with 

respect to human drug and biological products. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–D–0277 for ‘‘Risk Management 

Plans to Mitigate the Potential for Drug 

Shortages.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request or include a Fax number to 

which the draft guidance may be sent. 

See the SUPPLEMENTARY INFORMATION

section for information on electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT:

With regard to the draft guidance: 

Karen Takahashi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 6686, 

Silver Spring, MD 20993–0002, 301– 

796–3191; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

With regard to the proposed collection 

of information: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

5733, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Risk Management Plans to Mitigate the 

Potential for Drug Shortages.’’ This draft 

guidance is intended to help 

stakeholders 1 develop, maintain, and 

implement, as appropriate, RMPs to 

proactively assist in the prevention of 

human drug product and biological 

product shortages. In March 2020, with 

the enactment of the CARES Act (Pub. 

L. 116–136), Congress added section 

506C(j) to the FD&C Act, which requires 

certain manufacturers to develop, 

maintain, and implement, as 

appropriate, a ‘‘redundancy risk 

management plan that identifies and 

evaluates risks to the supply of the drug, 

as applicable, for each establishment in 

which such drug or active 

pharmaceutical ingredient of such drug 

is manufactured.’’ Section 506C(j) of the 

FD&C Act became effective September 

23, 2020. This guidance provides 

information about the development and 


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Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 30965 

content of RMPs for those 

manufacturers as well as for other 

stakeholders. 

Drug shortages pose a significant 

public health threat that can delay, and 

in some cases even deny, critically 

needed care for patients. FDA views 

RMPs as an important mechanism for 

stakeholders to proactively identify, 

assess, and mitigate the risks that might 

lead to a disruption in the supply of 

drug products, thus preemptively 

reducing the probability of a drug 

shortage, and preserving the private and 

public resources used in resolving the 

shortage. 

Based on recent publications and 

reports, the majority of drug shortages 

are associated with quality issues. This 

guidance proposes a framework 

stakeholders can use to develop RMPs 

that aligns with principles stated in the 

International Council for Harmonisation 

guidance for industry entitled ‘‘Q9 

Quality Risk Management’’ (available at 

https://www.fda.gov/media/71543/ 

download). In addition, FDA also 

recommends several factors to consider 

when developing the content of the 

RMPs. This guidance is relevant for all 

stakeholders, including those with 

oversight and control responsibilities for 

drug quality and contract 

establishments, and for manufacturers 

of APIs, approved or licensed drug and 

biological products, and drug products 

marketed without an application. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Risk Management Plans to Mitigate 

the Potential for Drug Shortages.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (PRA) (44 U.S.C. 3501–3521), 

Federal Agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

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

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

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

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

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, we invite 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Discontinuance or Interruption in the 

Production of Life-Saving Drugs 

OMB Control Number 0910–0045— 

Revision 

This information collection helps 

support implementation of requirements 

under section 506C(j) of the FD&C Act. 

Section 506C(j) of the FD&C Act 

requires manufacturers of drug products 

described in section 506C(a) of the 

FD&C Act or of any active 

pharmaceutical ingredient or any 

associated medical devices used for 

preparation or administration included 

in the drug to develop, maintain, and 

implement, as appropriate, a 

redundancy RMP that identifies and 

evaluates risks to the supply of the drug, 

as applicable, for each establishment in 

which such drug or active 

pharmaceutical ingredient of such drug 

is manufactured. 

For purposes of this analysis, 

respondents are those identified in the 

draft guidance, section III.A., 

Stakeholders in the Manufacturing 

Supply Chain. A primary stakeholders 

is generally the entity that determines 

which materials and services are 

necessary to produce a drug product. 

Secondary stakeholders are entities that 

are expected to have more detailed 

insight into specific segments of the 

supply chain for a drug product but may 

not have an understanding of its 

entirety. Finally, other stakeholders, 

such as inactive ingredient 

manufacturers, packagers, and 

distributors, are involved in other 

segments of the supply chain. In the 

draft guidance, section IV., RMP 

Framework and Development Strategy, 

we discuss specific recommendations 

regarding the RMP. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Section 506C(j) of the FD&C Act; 

recordkeeping activity 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total records Average burden per 

recordkeeping 2 Total hours 

Developing an RMP; Guidance for Industry 

section IV.B.

2,600 1 2,600 29.32 (range 25 to 250) ......... 76,250 

Updating an RMP ........................................ 5,200 1 5,200 2.93 (range 2.5 to 25) ............ 15,250 

Total ..................................................... ........................ ........................ ........................ ................................................ 91,500 

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

2Figure has been rounded. 

We assume a total of 2,600 

respondents will incur an initial burden 

associated with developing an RMP 

based on recommendations described in 

the draft guidance. This figure is 

comprised of 50 primary stakeholders; 

1,125 secondary stakeholders; and 1,425 

other stakeholders, and represents half 

the total number of respondents we 

identify for each of the three respective 

categories. 

For burden associated with updating 

an RMP, we include all respondents in 

the respective three categories, for a 

total of 5,200. 

We believe the overall burden for 

collecting information and preparing 


khammond on DSKJM1Z7X2PROD with NOTICES
30966 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 

RMPs depends on the stakeholder type 

(primary, secondary, or other 

stakeholder) and its operation. 

We anticipate that stakeholders will 

be able to leverage information across 

products, but we understand that the 

actual burden for a given stakeholder 

will depend on the portfolio of covered 

products and the complexity of their 

operations. Our estimate reflects what 

we believe is the average burden among 

all respondents. 

This draft guidance also refers to 

previously approved FDA collections of 

information found in FDA regulations. 

The collections of information found in 

21 CFR 310.306, 314.81(b)(3)(iii), and 

600.82 on notifying FDA of a permanent 

discontinuance or an interruption in 

manufacturing of certain drugs or 

biological products, and 21 CFR part 

314 new drug and abbreviated new drug 

applications, and 21 CFR part 600 

biologics license applications have been 

approved under OMB control numbers 

0910–0001 and 0910–0338, respectively; 

the collections of information in 21 CFR 

parts 210 and 211 on current good 

manufacturing practice have been 

approved under OMB control number 

0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

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

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

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

guidance-compliance-regulatoryinformation-biologics, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10698 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Medicare Rural 

Hospital Flexibility Program 

Performance, OMB No. 0915–0363— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than June 21, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the acting HRSA 

Information Collection Clearance Officer 

at paperwork@hrsa.gov or call (301) 

443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 

Information Collection Request Title: 

Medicare Rural Hospital Flexibility 

Program Performance OMB No. 0915– 

0363—Revision. 

Abstract: This information collection 

comment request is for continued 

approval of the Medicare Rural Hospital 

Flexibility Program Performance 

Measures. HRSA is proposing to 

continue this data collection with minor 

changes to the organization of the data. 

The current performance measures are 

collected electronically in the 

Performance Improvement and 

Measurement System which awardees 

access securely through the HRSA 

Electronic Handbooks. 

The Medicare Rural Hospital 

Flexibility Program (Flex Program) is 

authorized by Section 1820 of the Social 

Security Act (42 U.S.C. 1395i–4), as 

amended. The purpose of the Flex 

Program is to enable state designated 

entities to support critical access 

hospitals in quality improvement, 

quality reporting, performance 

improvement, and benchmarking; to 

assist facilities seeking designation as 

critical access hospitals; and to create a 

program to establish or expand the 

provision of rural emergency medical 

services. 

A 60-day notice published in the 

Federal Register, Vol. 87, No. 46, FR 

13300–13301 (March 9, 2022). There 

were no public comments. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were developed 

to provide data useful to the Flex 

program and to enable HRSA to provide 

aggregate program data required by 

Congress under the Government 

Performance and Results Modernization 

Act of 2010. These measures cover 

principal topic areas of interest to the 

Federal Office of Rural Health Policy, 

including: (a) Quality reporting, (b) 

quality improvement interventions, (c) 

financial and operational improvement 

initiatives, (d) population health 

management, (e) rural emergency 

medical services integration and (f) 

innovative care models. In addition to 

informing the Office’s progress toward 

meeting the goals set in Government 

Performance and Results Modernization 

Act of 2010, the information is 

important in identifying and 

understanding programmatic 

improvement across program areas, as 

well as guiding future iterations of the 

Flex Program and prioritizing areas of 

need and support. 

This submission includes the addition 

of minor revisions in the organization of 

the measures to align with the changes 

to the organization of the program areas 

within the Flex Program. The revisions 

include changes to align with current 

language and a broadening of scope for 

some activities. The measures will 

remain unchanged. For example, 

population health improvement 

activities were previously combined 

with rural emergency medical services 

integration, and these measures will be 

separated into two distinct program 

areas. The burden remains unchanged 

with these changes. 

Likely Respondents: Respondents are 

the Flex Program coordinators for the 

states participating in the Flex Program. 

There are currently 45 states 

participating in the Flex Program. 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES