3302 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

Annual Hours: 46,575. (For policy 

questions regarding this collection 

contact William Long at 410–786–7927.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Application and 

Triennial Re-application to Be a 

Qualified Entity to Receive Medicare 

Data for Performance Measurement; 

Use: The Patient Protection and 

Affordable Care Act (ACA) was enacted 

on March 23, 2010 (Pub. L. 111–148). 

ACA amends section 1874 of the Social 

Security Act by adding a new 

subsection (e) to make standardized 

extracts of Medicare claims data under 

Parts A, B, and D available to qualified 

entities to evaluate the performance of 

providers of services and suppliers. This 

is the application needed to determine 

an organization’s eligibility as a 

qualified entity. The information from 

the collection is used by CMS to 

determine whether an organization 

meets the criteria required to be 

considered a qualified entity to receive 

Medicare claims data under ACA 

Section 10332. CMS evaluates the 

organization’s eligibility in terms of 

organizational and governance 

capabilities, addition of claims data 

from other sources, and data privacy 

and security. This collection covers the 

application through which 

organizations provide information to 

CMS to determine whether they will be 

approved as a qualified entity. This 

collection also covers the triennial reapplication (CMS–10596; 0938–1317) 

through which organizations provide 

information to CMS to determine 

whether they are approved to continue 

as a qualified entity. Form Number: 

CMS–10394 (OMB control number: 

0938–1144); Frequency: Occasionally; 

Affected Public: Not-for-profits 

institutions and Business or other forprofits; Number of Respondents: 30; 

Total Annual Responses: 30; Total 

Annual Hours: 3,800. (For policy 

questions regarding this collection 

contact Kari A. Gaare at 410–786–8612.) 

Dated: January 18, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–01183 Filed 1–20–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0593] 

Collecting and Providing 702(b) 

Portions of Food and Drug 

Administration Official Samples— 

Questions and Answers; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

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 and FDA staff 

entitled ‘‘Collecting and Providing 

702(b) Portions of FDA Official 

Samples—Questions and Answers.’’ 

This draft guidance is intended to assist 

industry and FDA staff with issues and 

questions related to the requirements for 

FDA to collect and provide a part of an 

official sample of an article to any 

person named on the label of the article, 

or the owner thereof, or his attorney or 

agent. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 22, 2022 to ensure that we 

consider your comment on this draft 

guidance before we begin work on the 

final version of the guidance. 

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– 

2021–D–0593 for ‘‘Collecting and 

Providing 702(b) Portions and of FDA 

Official Samples—Questions and 

Answers.’’ 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

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

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


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 3303 

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 the draft guidance to the 

Division of Operational Policy, Office of 

Regulatory Affairs, Food and Drug 

Administration, Element Building, 

12420 Parklawn Dr., Rockville, MD 

20852. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Henderson, Office of Regulatory 

Affairs, Food and Drug Administration, 

Element Building, 12420 Parklawn Dr., 

Rockville, MD 20857 240–402–8186, 

Christopher.henderson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Collecting and Providing 

702(b) Portions of FDA Official 

Samples—Questions and Answers.’’ 

Section 702 of the FD&C Act (21 U.S.C. 

372) authorizes FDA to conduct 

examinations and investigations and to 

collect samples. Under section 702(b) of 

the FD&C Act, when FDA collects a 

sample of a food, drug, or cosmetic for 

analysis, FDA must, upon request, 

provide a part of such official sample for 

examination or analysis by any person 

named on the label of the article, or the 

owner thereof, or his attorney or agent. 

Additionally, FDA was authorized to 

establish, by regulation, reasonable 

exceptions to, and impose reasonable 

terms and conditions relating to, the 

requirement to collect and provide a 

702(b) portion of an official sample to 

the owner, as necessary for the proper 

administration of the provisions of the 

FD&C Act. FDA’s regulation at 21 CFR 

2.10 was issued to establish those 

reasonable exceptions, and terms and 

conditions, and to implement section 

702(b) of the FD&C Act. 

This draft guidance is intended to 

assist industry and FDA staff with 

issues and questions related to the 

requirements for FDA to collect and 

provide portions of official samples 

under section 702(b) of the FD&C Act 

and its implementing regulation in 21 

CFR 2.10. 

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 ‘‘Collecting and Providing 702(b) 

Portions of FDA Official Samples— 

Questions and Answers.’’ 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 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/search-general-and-crosscutting-topics-guidance-documents, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: January 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01143 Filed 1–20–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1137, FDA– 

2020–D–1138, FDA–2020–D–0987] 

Guidance Documents Related to 

Coronavirus Disease 2019; 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 FDA 

guidance documents related to the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE). This 

notice of availability (NOA) is pursuant 

to the process that FDA announced, in 

the Federal Register of March 25, 2020, 

for making available to the public 

COVID–19-related guidances. The 

guidances identified in this notice 

address issues related to the COVID–19 

PHE and have been issued in 

accordance with the process announced 

in the March 25, 2020, notice. The 

guidances have been implemented 

without prior comment, but they remain 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidances is published in the Federal 

Register on January 21, 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 name of the guidance 

document that the comments address 

and the docket number for the guidance 


jspears on DSK121TN23PROD with NOTICES1