36752 Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘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. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Statement of 

Deficiency and Plan of Correction Use: 

The form CMS–2567 is the means by 

which State and CMS surveyors 

document findings of compliance or 

noncompliance (deficiencies) resulting 

from inspection of Medicare, Medicaid, 

and Clinical Laboratory Improvement 

Amendments (CLIA) laboratories. The 

form CMS–2567 is the legal, 

documentary basis for CMS’ 

certification of a facility’s compliance or 

noncompliance with the Medicare/ 

Medicaid Conditions of Participation or 

Coverage, and the requirements for 

Nursing Home participation and CLIA 

certification. 

In December, 2020, Congress passed 

the Consolidated Appropriations Act, 

2021 (CAA, 2021). Section 407 of CAA, 

2021, amended Part A of Title XVIII of 

the Social Security Act (the Act) at 

section 1822 establishing hospice 

program survey and enforcement 

requirements. This amendment, in part, 

now requires the Accrediting 

Organizations (AOs) that accredit 

hospice programs to include the form 

CMS–2567 to document the findings of 

their hospice program surveys 

beginning on October 1, 2021. As of 

June 2021, there are three AOs with 

CMS-approved hospice accreditation 

programs. The AOs survey 

approximately half of the over 5,000 

Medicare-certified hospice programs, 

while the SAs survey the remaining 

half. 

To enable AOs to use the form CMS– 

2567, we must revise it by adding fields 

for the AO name. Also, the instructions 

must be updated to include AOs as 

another group which utilizes the form 

CMS–2567. We have also included the 

burden calculations from CMS–1747–P 

(Medicare and Medicaid Programs; CY 

2022 Home Health Prospective Payment 

System Rate Update), related to the onetime update needed to each of AO’s 

proprietary electronic systems in order 

to use the form CMS–2567 as directed 

by the CAA, 2021. Form Numbers: 

CMS–2567 (OMB control number: 

0938–0391); Frequency: Yearly and 

Occasionally; Affected Public: Private 

Sector (Business or for-profits and Notfor-profit institutions); Number of 

Respondents: 65,948; Total Annual 

Responses: 65,948; Total Annual Hours: 

1,210,376. (For policy questions 

regarding this collection contact 

Caroline Gallaher at 410–786–8705.) 

Dated: July 8, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–14866 Filed 7–12–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0895] 

Issuance of Priority Review Voucher; 

Material Threat Medical 

Countermeasure Product 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a material threat medical 

countermeasure (MCM) product 

application. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that 

STRATAGRAFT (allogeneic cultured 

keratinocytes and dermal fibroblasts in 

murine collagen—dsat), manufactured 

by Stratatech, a Mallinckrodt Company, 

meets the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Shruti Modi, 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. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a material 

threat MCM priority review voucher to 

the sponsor of an approved material 

threat MCM product application. Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a), which was added by the 

Cures Act (Pub. L. 114–255), FDA will 

award priority review vouchers to 

sponsors of approved material threat 

MCM product applications that meet 

certain criteria upon approval of those 

applications. FDA has determined that 

STRATAGRAFT (allogeneic cultured 

keratinocytes and dermal fibroblasts in 

murine collagen—dsat), manufactured 

by Stratatech, a Mallinckrodt Company, 

meets the criteria for a material threat 

MCM priority review voucher. 

STRATAGRAFT is indicated for the 

treatment of adults with thermal burns 

containing intact dermal elements for 

which surgical intervention is clinically 

indicated (deep partial-thickness burns). 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further 

information about STRATAGRAFT 

(allogeneic cultured keratinocytes and 

dermal fibroblasts in murine collagen— 

dsat), go to the Center for Biologics 

Evaluation and Research Approved 

Cellular and Gene Therapy Products 

website at https://www.fda.gov/ 

vaccines-blood-biologics/cellular-genetherapy-products/approved-cellularand-gene-therapy-products. 

Dated: July 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14779 Filed 7–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1048] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 


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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices 36753 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with medical 

device labeling regulations. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 13, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 13, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 13, 2021. 

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 No. FDA– 

2014–N–1048 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Device Labeling Regulations.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

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

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

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Device Labeling Regulations 

OMB Control No. 0910–0485—Revision 

This information collection supports 

implementation of medical device 

labeling requirements governed by 

section 502 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

352), codified in Agency regulations, 

and discussed in associated Agency 

guidance. Medical device labeling 

requirements, among other things, 

provide for the label or labeling content 

of a medical device so that it is not 

misbranded and subject to regulatory 

action. Certain provisions under section 

502 of the FD&C Act require that 


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manufacturers, importers, and 

distributors of medical devices disclose 

information about themselves or the 

devices on the labels or labeling for the 

devices. Section 502 provides, in part, 

that a device shall be misbranded if, 

among other things, its label or labeling 

fails to bear certain required information 

concerning the device, is false or 

misleading in any particular way, or 

fails to contain adequate directions for 

use. Medical device labeling regulations 

in parts 800, 801, 809, and associated 

regulations in part 1040 (21 CFR parts 

800, 801, 809, and 1040), prescribe the 

disclosure of specific information by 

manufacturers, importers, and 

distributors of medical devices about 

themselves and/or the devices, on the 

label or labeling for the devices, to 

health professionals and consumers. 

In conjunction with provisions in part 

800, part 801, subpart A sets forth 

general labeling provisions applicable to 

all medical devices, including content 

and format requirements pertaining to 

intended uses, adequate directions for 

use, misleading statements, and the 

prominence of required labeling. 

Information collection provisions found 

in part 801, subpart B pertaining to 

labeling requirements for Unique Device 

Identification are currently approved 

under OMB control number 0910–0720 

and not covered in this information 

collection request. Information 

collection associated with labeling 

requirements for Over-the-Counter 

(OTC) Devices are found in part 801, 

subpart C, and cover principal display 

panel; statement of identity; declaration 

of net quantity of contents; and certain 

warning statement elements. 

Information collection associated with 

exemptions from adequate directions for 

use and other exemptions are found in 

part 801, subparts D and E, respectively. 

Information collection associated with 

special labeling requirements applicable 

to specific devices are found in part 801, 

subpart H. We also include information 

collection associated with labeling for in 

vitro diagnostic products for human use, 

as set forth in part 809, subpart B. 

Finally, in addition to the labeling 

requirements in part 801 and the 

certification and identification 

requirements of 21 CFR 1010.2 and 

1010.3, sunlamp products and 

ultraviolet lamps are subject to specific 

labeling requirements as set forth in part 

1040. 

We have revised the information 

collection to include reference to 

Agency guidance. The guidance 

documents were developed and issued 

consistent with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

Section 502(b) of the FD&C Act 

requires that, for packaged devices, the 

label must bear the name and place of 

business of the manufacturer, packer, or 

distributor; and an accurate statement of 

the quantity of the contents. Section 

502(f) of the FD&C Act requires that the 

labeling for a device must contain 

adequate directions for use. FDA may, 

however, grant an exemption if the 

Agency determines that the adequate 

directions for use labeling requirements 

are not necessary for the particular case 

as it relates to protection of the public 

health. Section 301 of the Medical 

Device User Fee and Modernization Act 

of 2002 (Pub. L. 107–250) amended 

section 502 of the FD&C Act to add 

paragraph (u) to section 502 to require 

devices (both new and reprocessed) to 

bear prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

Section 2(c) of the Medical Device 

User Fee Stabilization Act of 2005 

(MDUFSA) amended section 502(u) of 

the FD&C Act by limiting the provision 

to reprocessed single-use devices 

(SUDs) and the manufacturers who 

reprocess them. Under the amended 

provision, if the original SUD or an 

attachment to it prominently and 

conspicuously bears the name of the 

manufacturer, then the reprocessor of 

the SUD is required to identify itself by 

name, abbreviation, or symbol in a 

prominent and conspicuous manner on 

the device or attachment to the device. 

If the original SUD does not 

prominently and conspicuously bear the 

name of the manufacturer, the 

manufacturer who reprocesses the SUD 

for reuse may identify itself using a 

detachable label that is intended to be 

affixed to the patient record. MDUFSA 

required that FDA issue guidance 

identifying the circumstances in which 

the name, abbreviation, or symbol of the 

manufacturer of an original device is not 

‘‘prominent and conspicuous’’ under 

section 502(u) of the FD&C Act. 

Accordingly, we issued the guidance 

document entitled ‘‘Compliance with 

Section 301 of the Medical Device User 

Fee and Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices’’ (May 2006), available at 

https://www.fda.gov/media/71187/ 

download. The guidance document is 

intended to identify circumstances in 

which the name or symbol of the 

original SUD manufacturer is not 

prominent and conspicuous, as used in 

section 502(u) of the FD&C Act. We 

believe the information disclosures 

discussed in the guidance impose no 

burden beyond that which we attribute 

already to complying with disclosure 

provisions found in the applicable 

regulations; however, we include the 

guidance document for respondents’ 

instructional use and reference. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Symbols glossary ................................................................. 3,000 1 3,000 1 3,000 

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

Our figures are based on data from the 

FDA Unified Registration and Listing 

System and the OASIS shipment 

information. FDA allows the use of 

stand-alone graphical representations of 

information, or symbols, in the labeling 

for the medical devices, if the symbol 

has been established in a Standards 

Development Organization developed 

standard, provided that such symbol is 

explained in a symbols glossary that is 

included in the labeling for the medical 

device and otherwise complies with 

section 502 (misbranding) of the FD&C 

Act. 


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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Processing, labeling, or repacking agreement; 

801.150.

7,500 887 6,652,500 0.5 (30 minutes) ........... 3,326,250 

Impact resistant lenses; invoices, shipping documents, and records of sale or distribution; 

801.410(e) and (f).

1,591 47,050 74,856,550 0.0008 (0.048 minutes) 59,885 

Hearing aid records; 801.421 ............................... 10,000 160 1,600,000 0.25 (15 minutes) ......... 400,000 

Menstrual tampons, sampling plan for measuring 

absorbency; 801.430(f).

33 11 363 80 .................................. 29,040 

Latex condoms; justification for the application of 

testing data to the variation of the tested product; 801.435(g).

51 3.65 186 1 .................................... 186 

Total ............................................................... ........................ ........................ 83,109,599 ....................................... 3,815,361 

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

2 Numbers have been rounded. 

As set forth in § 801.150(a)(2) (21 CFR 

801.150(a)(2)), device manufacturers are 

required to retain a copy of the 

agreement containing the specifications 

for the processing, labeling, or repacking 

of the device for 2 years after the final 

shipment or delivery of the device. 

Section 801.150(a)(2) requires that 

copies of this agreement be made 

available for inspection at any 

reasonable hour upon request by any 

officer or employee of the Department of 

Health and Human Services (HHS). In 

§ 801.410(e) (21 CFR 801.410(e)) copies 

of invoices, shipping documents, and 

records of sale or distribution of all 

impact resistant lenses, including 

finished eyeglasses and sunglasses, are 

required to be maintained for 3 years by 

the retailer and made available upon 

request by any officer or employee of 

FDA or by any other officer or employee 

acting on behalf of the Secretary of HHS. 

Section 801.410(f) requires that the 

results of impact tests and description of 

the test method and apparatus be 

retained for a period of 3 years. Specific 

recordkeeping requirements applicable 

to hearing aid dispensers, manufacturers 

of menstrual tampons, and 

manufacturers of latex condoms are set 

forth in 21 CFR 801.421(d), 801.430(f), 

and 801.435(g), respectively. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Parts 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions 

Contact lens cleaning solution labeling; 800.10(a)(3) and 

800.12(c).

47 8 376 1 ..................... 376 

Liquid ophthalmic preparation labeling; 800.10(b)(2) .......... 25 8 200 1 ..................... 200 

Manufacturer, packer, or distributor information; 801.1 ...... 19,407 7 135,849 1 ..................... 135,849 

Adequate directions for use; 801.5 ..................................... 8,526 6 51,156 22.35 .............. 1,143,337 

Statement of identity; 801.61 .............................................. 8,526 6 51,156 1 ..................... 51,156 

Declaration of net quantity of contents; 801.62 .................. 8,526 6 51,156 1 ..................... 51,156 

Prescription device labeling; 801.109 ................................. 9,681 6 58,086 17.77 .............. 1,032,188 

Retail exemption for prescription devices; 801.110 ............ 30,000 667 20,010,000 0.25 ................ 5,002,500 

Processing, labeling, or repacking; non-sterile devices; 

801.150(e).

453 34 15,402 4 ..................... 61,608 

Part 801, subpart H: Special Requirements for Specific Devices 

Labeling of articles intended for lay use in the repairing 

and/or refitting of dentures; 801.405(b)(1).

35 1 35 4 ..................... 140 

Dentures; information regarding temporary and emergency 

use; 801.405(c).

35 1 35 4 ..................... 140 

Hearing aids professional and patient labeling; 801.420 .... 136 12 1,632 80 ................... 130,560 

Hearing aids, availability of User Instructional Brochure; 

801.421.

10,000 5 50,000 0.17 ................ 8,500 

User labeling for menstrual tampons; 801.430 ................... 16 8 128 2 ..................... 256 

User labeling for latex condoms; 801.437 .......................... 52 6 312 100 ................. 31,200 

Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products) 

Format and content of labeling for IVDs; 809.10 ................ 1,700 6 10,200 80 ................... 816,000 

Advertising and promotional materials for ASRs; 809.30(d) 300 25 7,500 1 ..................... 7,500 

Labeling of sunlamp products—1040.20(d) ........................ 30 1 30 10 ................... 300 


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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2—Continued 

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

FD&C Action Section 502(u) 

Establishments listing <10 SUDs ........................................ 161 2 322 0.1 (6 minutes) 32 

Establishments listing >10 SUDs ........................................ 14 45 630 0.1 (6 minutes) 63 

Total .............................................................................. ........................ ........................ 952 ........................ 95 

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

2 Numbers have been rounded. 

Because many labeling provisions 

correspond to specific recordkeeping 

requirements, we have accounted for 

burden attendant to the provisions 

enumerated in table 3 as third-party 

disclosures. These figures reflect what 

we believe to be the average burden 

incurred by respondents to applicable 

information collection activities. 

Overall, the information collection 

reflects changes and adjustments. For 

efficiency of operations, we have 

consolidated related information 

collection currently approved under 

OMB control numbers 0910–0577 and 

0910–0740 pertaining to 

recommendations found in Agency 

guidance and discussed in this notice. 

This results in an increase to the 

information collection by 30,482 burden 

hours annually. At the same time, we 

have reduced our estimate of the total 

responses by 53,143,810 annually. Upon 

review, we believe we previously 

double-counted burden ascribed to 

disclosures provisions having accounted 

for the same burden as that associated 

with recordkeeping activities. We invite 

comment on our estimates and these 

assumptions. 

Dated: July 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14768 Filed 7–12–21; 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; Information 

Collection Request Title: Advanced 

Nursing Education Program Specific 

Form OMB No. 0915–0375—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

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 September 13, 

2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Advanced Nursing Education (ANE) 

Program Specific Form OMB No. 0915– 

0375—Revision. 

Abstract: HRSA provides advanced 

nursing education grants to educational 

institutions to increase the supply, 

distribution, quality of, and access to 

advanced education nurses through the 

ANE Programs. The ANE Programs are 

authorized by Section 811 of the Public 

Health Service Act (42 U.S.C. 296j), as 

amended. This clearance request is for 

continued approval of the information 

collection OMB No. 0915–0375 with 

revisions. 

This revision request includes a title 

change from the Advanced Nursing 

Education Workforce (ANEW) ProgramSpecific Data Collection Forms to ANE 

Program Specific Form. This revision 

also merges forms used by the ANEW 

Program and adds several other new 

forms from the ANE Programs, 

including the Advanced Nursing 

Education Nurse Practitioner Residency 

(ANE–NPR) Program, Advanced 

Nursing Education Nurse Practitioner 

Residency Integration Program (ANE– 

NPRIP), Nurse Anesthetist Traineeship 

(NAT) Program, and Advanced Nursing 

Education Sexual Assault Nurse 

Examiners (ANE–SANE) Program. The 

revision of the ANE Program Specific 

Form incorporates elements from these 

four programs (ANE–NPR, ANE–NPRIP, 

NAT, and ANE–SANE) into the ANE 

Program Specific Form. 

Need and Proposed Use of the 

Information: Section 811 of the Public 

Health Service Act provides the 

Secretary of HHS with the authority to 

award grants to and enter into contracts 

with eligible entities to meet the costs 

of—(1) projects that support the 

enhancement of advanced nursing 

education and practice; and (2) 

traineeships for individuals in advanced 

nursing education programs. Under this 

section, HRSA makes awards to entities 

who train and support nurses 

characterized as ‘‘advanced education 

nurses.’’ In awarding such grants, 

funding preference is given to 

applicants with projects that will 


jbell on DSKJLSW7X2PROD with NOTICES