Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42485 

issuer offering group or individual 

health insurance coverage. Form 

Number: CMS–10788 (OMB control 

number: 0938–1405); Frequency: 

Annual; Affected Public: Private Sector; 

Number of Respondents: 356; Total 

Annual Responses: 356; Total Annual 

Hours: 1,684,080. (For policy questions 

regarding this collection, contact 

Christina Whitefield at 301–492–4172.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Recognition of 

Pass-Through Payment for Additional 

(New) Categories of Devices under the 

Outpatient Prospective Payment System 

and Supporting Regulations; Use: The 

transitional pass-through provision 

provides a way for ensuring appropriate 

payment for new technologies whose 

use and costs are not adequately 

represented in the base year claims data 

on which the outpatient PPS is 

constructed as required by law. 

Categories of medical devices will 

receive transitional pass-through 

payments for 2 to 3 years from the date 

payments are initiated for the category. 

However, the underlying provision is 

permanent and provides an on-going 

mechanism for reflecting timely 

introduction of new items into the 

payment structure. 

Interested parties such as hospitals, 

device manufacturers, pharmaceutical 

companies, and physicians apply for 

transitional pass-through payment for 

certain items used with services covered 

in the outpatient PPS. After we receive 

all requested information, we evaluate 

the information to determine if the 

creation of an additional category of 

medical devices for transitional passthrough payments is justified. We may 

request additional information related to 

the proposed new device category, as 

needed. We advise the applicant of our 

decision, and update the outpatient PPS 

during its next scheduled quarterly 

payment update cycle to reflect any 

newly approved device categories. We 

list below the information that we 

require from all applicants. The 

following information is required to 

process requests for additional 

categories of medical devices for 

transitional pass-through payments. 

Form Number: CMS–10052 (OMB 

control number: 0938–0857); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profits; 

Number of Respondents: 10; Number of 

Responses: 10; Total Annual Hours: 

160. (For questions regarding this 

collection contact Kimberly A. 

Campbell at 410–786–2289.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection: Title of 

Information Collection: Medicare 

Participating Physician or Supplier 

Agreement; Use: Form CMS–460 is the 

agreement a physician, supplier, or their 

authorized official signs to become a 

participating provider in Medicare Part 

B. By signing the agreement to 

participate in Medicare, the physician, 

supplier, or their authorized official 

agrees to accept the Medicaredetermined payment for Medicare 

covered services as payment in full and 

to charge the Medicare Part B 

beneficiary no more than the applicable 

deductible or coinsurance for the 

covered services. For purposes of this 

explanation, the term ‘‘supplier’’ means 

certain other persons or entities, other 

than physicians, that may bill Medicare 

for Part B services (e.g., suppliers of 

diagnostic tests, suppliers of radiology 

services, durable medical suppliers 

(DME) suppliers, nurse practitioners, 

clinical social workers, physician 

assistants). Institutions that render Part 

B services in their outpatient 

department are not considered 

‘‘suppliers’’ for purposes of this 

agreement. Form Number: CMS–460 

(OMB control number: 0938–0373); 

Frequency: Annually; Affected Public: 

Private Sector, Business or other forprofits; Number of Respondents: 36,000; 

Number of Responses: 36,000; Total 

Annual Hours: 9,000. (For questions 

regarding this collection contact Mark 

G. Baldwin at 410–786–8139.) 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: National 

Implementation of the In-Center 

Hemodialysis CAHPS Survey; Use: The 

national implementation of the ICH 

CAHPS Survey is designed to allow 

third-party, CMS-approved survey 

vendors to administer the ICH CAHPS 

Survey using mail-only, telephone-only, 

or mixed (mail with telephone followup) modes of survey administration. 

Experience from previous CAHPS 

surveys shows that mail, telephone, and 

mail with telephone follow-up data 

collection modes work well for 

respondents, vendors, and health care 

providers. Any additional forms of 

information technology, such as web 

surveys, is under investigation as a 

potential survey option in this 

population. 

Data collected in the national 

implementation of the ICH CAHPS 

Survey are used for the following 

purposes: 

• To provide a source of information 

from which selected measures can be 

publicly reported to beneficiaries as a 

decision aid for dialysis facility 

selection. 

• To aid facilities with their internal 

quality improvement efforts and 

external benchmarking with other 

facilities. 

• To provide CMS with information 

for monitoring and public reporting 

purposes. 

• To support the ESRD Quality 

Improvement Program. 

Form Number: CMS–10105 (OMB 

control number: 0938–0926); Frequency: 

Semi Annually; Affected Public: 

Individuals and Households; Number of 

Respondents: 103,500; Total Annual 

Responses: 621,000; Total Annual 

Hours: 55,890. (For policy questions 

regarding this collection contact Israel 

H. Cross at 410–786–0619.) 

Dated: July 12, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–15175 Filed 7–14–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–1615] 

Instructions for Use—Patient Labeling 

for Human Prescription Drug and 

Biological Products—Content and 

Format; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Instructions for Use—Patient Labeling 

for Human Prescription Drug and 

Biological Products—Content and 

Format.’’ This guidance provides 

recommendations for developing the 

content and format of an Instructions for 

Use (IFU) document for human 

prescription drug and biological 

products, as well as drug-led or 

biologic-led combination products 

submitted under a new drug application 

(NDA) or a biologics license application 

(BLA). The IFU is written for patients 

(or their caregivers) who use drug 

products that have complicated or 

detailed patient-use instructions. The 

recommendations in this guidance are 

intended to help ensure that patients 

receive clear and concise information 

that is easily understood for the safe and 


jspears on DSK121TN23PROD with NOTICES1
42486 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 

effective use of such products. This 

guidance finalizes the draft guidance 

issued on July 2, 2019, entitled 

‘‘Instructions for Use—Patient Labeling 

for Human Prescription Drug and 

Biological Products and Drug-Device 

and Biologic-Device Combination 

Products—Content and Format.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 15, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2019–D–1615 for ‘‘Instructions for 

Use—Patient Labeling for Human 

Prescription Drug and Biological 

Products.’’ 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 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 to the 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 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Wheeler, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3330, 

Silver Spring, MD 20993, 301–796– 

0151; 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, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Instructions for Use—Patient Labeling 

for Human Prescription Drug and 

Biological Products—Content and 

Format.’’ The recommendations in this 

guidance are intended to help ensure 

that patients receive clear and concise 

information that is easily understood for 

the safe and effective use of such 

products and to help provide 

consistency to the content and format of 

IFU documents. 

The IFU is a form of prescription drug 

labeling. For drugs for which selfadministration may be complicated 

(such as requiring the patient to perform 

multiple steps to prepare, administer, 

store, and/or dispose of the drug), the 

IFU is intended to give directions that 

are clear and understandable for 

patients, and therefore, promote the safe 

and effective use of that drug. For 

example, IFUs may be appropriate for a 

drug product with one set of dosing 

instructions for adult patients and 

another set for pediatric patients. The 

IFU is developed by the applicant, 

reviewed and approved by FDA, and 

provided to patients when the drug 

product is dispensed. 

This guidance finalizes the draft 

guidance entitled ‘‘Instructions for 

Use—Patient Labeling for Human 

Prescription Drug and Biological 

Products and Drug-Device and BiologicDevice Combination Products—Content 

and Format,’’ issued on July 2, 2019 (84 

FR 31598). FDA considered comments 

received on the draft guidance as the 

guidance was finalized. Changes from 

the draft to the final guidance include 

a change in title in addition to editorial 

changes to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42487 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Instructions for 

Use—Patient Labeling for Human 

Prescription Drug and Biological 

Products—Content and Format.’’ 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 201 have 

been approved under OMB control 

number 0910–0572; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: July 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15161 Filed 7–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3031] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Tobacco Products, 

User Fees, Requirements for the 

Submission of Data Needed To 

Calculate User Fees for Domestic 

Manufacturers and Importers of 

Tobacco Products 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by August 15, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0749. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonnalynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Tobacco Products, User Fees, 

Requirements for the Submission of 

Data Needed To Calculate User Fees for 

Domestic Manufacturers and Importers 

of Tobacco Products 

OMB Control Number 0910–0749— 

Extension 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (the Tobacco Control Act) 

(Pub. L. 111–31) was signed into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) and granted FDA authority 

to regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect public health generally and to 

reduce tobacco use by minors. 

FDA issued a final rule on May 10, 

2016 (81 FR 28707) that requires 

domestic manufacturers and importers 

of cigars and pipe tobacco to submit 

information needed to calculate the 

amount of user fees assessed under the 

FD&C Act (https://www.govinfo.gov/ 

content/pkg/FR-2016-05-10/pdf/2016- 

10688.pdf). FDA expanded its authority 

over tobacco products by issuing 

another final rule entitled ‘‘Deeming 

Tobacco Products To Be Subject to the 

Federal Food, Drug, and Cosmetic Act, 

as Amended by the Family Smoking 

Prevention and Tobacco Control Act; 

Restrictions on the Sale and Distribution 

of Tobacco Products and Required 

Warning Statements for Tobacco 

Products’’ (Deeming rule; May 10, 2016, 

81 FR 28974), deeming all products that 

meet the statutory definition of ‘‘tobacco 

product,’’ except accessories of the 

newly deemed tobacco products, to be 

subject to the FD&C Act (https://

www.govinfo.gov/content/pkg/FR-2016- 

05-10/pdf/2016-10685.pdf). The 

Deeming rule, among other things, 

subjected domestic manufacturers and 

importers of cigars and pipe tobacco to 

the FD&C Act’s user fee requirements. 

Consistent with the Deeming rule and 

the requirements of the FD&C Act, the 

user fee final rule requires the 

submission of the information needed to 

calculate user fee assessments for each 

manufacturer and importer of cigars and 

pipe tobacco to FDA. 

As noted, FDA issued a final rule that 

requires domestic tobacco product 

manufacturers and importers to submit 

information needed to calculate the 

amount of user fees assessed under the 

FD&C Act. The U.S. Department of 

Agriculture (USDA) had been collecting 

this information and provided FDA with 

the data the Agency needed to calculate 

the amount of user fees assessed to 

tobacco product manufacturers and 

importers. USDA ceased collecting this 

information in fiscal year 2015 (October 

2014). USDA’s information collection 

did not require OMB approval, per an 

exemption by Public Law 108–357, 

section 642(b)(3). Consistent with the 

requirements of the FD&C Act, FDA 

requires the submission of this 

information to FDA. FDA took this 

action to ensure that the Agency 

continues to have the information 

needed to calculate, assess, and collect 


jspears on DSK121TN23PROD with NOTICES1