11712 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

(over 3 years) 

Average 

burden hours 

per response 

Total 

burden 

hours 

Annual 

burden 

hours 

OCSE–75 for FY 2023 and forward ................................ 61 2 40 4,880 2,440 

Average Annual Burden Hours: 2,427. 

Authority: Title IV–D of the Social 

Security Act as required by 45 CFR 

309.170(b). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–04372 Filed 3–1–22; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1317] 

Appeal Options Available to 

Mammography Facilities Concerning 

Adverse Accreditation Decisions, 

Suspension/Revocation of Certificates, 

or Patient and Physician Notification 

Orders; 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 Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Appeal Options 

Available to Mammography Facilities 

Concerning Adverse Accreditation 

Decisions, Suspension/Revocation of 

Certificates, or Patient and Physician 

Notification Orders.’’ This guidance 

document describes the processes 

available to mammography facilities to 

request additional review of an adverse 

appeals decision on a facility’s 

accreditation, and/or a suspension or 

revocation of certificate, and/or a 

patient and physician notification order. 

This guidance supersedes section 4.5 of 

the Center for Devices and Radiological 

Health (CDRH) Appeals Processes 

guidance document dated July 2, 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 2, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency 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– 

2020–D–1317 for ‘‘Appeal Options 

Available to Mammography Facilities 

Concerning Adverse Accreditation 

Decisions, Suspension/Revocation of 

Certificates, or Patient and Physician 

Notification Orders.’’ 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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Appeal Options 

Available to Mammography Facilities 

Concerning Adverse Accreditation 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 11713 

Decisions, Suspension/Revocation of 

Certificates, or Patient and Physician 

Notification Orders’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Abiy Desta, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 4282, Silver Spring, 

MD 20993–0002, 301–796–5699. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Mammography Quality 

Standards Act (42 U.S.C. 263b), all 

mammography facilities, except 

facilities of the Department of Veteran 

Affairs, must be accredited by an 

approved accreditation body and 

certified by FDA (or an approved State 

certification agency) to provide 

mammography services (42 U.S.C. 

263b(b)(1) and (d)(1)(iv)). For a facility 

to be certified it must meet certain 

requirements including: (1) Be 

accredited by an FDA-approved 

accreditation body; (2) undergo periodic 

review of its clinical images by its 

accreditation body; (3) have an annual 

survey by a medical physicist; (4) meet 

federally developed quality standards 

for personnel qualifications, equipment, 

radiation dose, quality assurance 

programs, recordkeeping, and reporting; 

and (5) undergo periodic inspection to 

assure it meets the federally developed 

quality standards. 

This guidance document describes the 

processes available to mammography 

facilities to request additional review of 

an adverse appeals decision on a 

facility’s accreditation and/or a 

suspension or revocation of certificate, 

and/or a patient and physician 

notification order. It provides general 

information about each process, as well 

as guidance on how to submit related 

requests to the Division of 

Mammography Quality Standards and 

FDA. This guidance supersedes section 

4.5 of the CDRH Appeals Processes 

guidance document dated July 2, 2019 

(https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/center-devices-andradiological-health-cdrh-appealsprocesses). 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of July 21, 2020 (85 FR 44097). 

FDA received no comments and no 

substantive changes have been made in 

the final guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Appeal Options 

Available to Mammography Facilities 

Concerning Adverse Accreditation 

Decisions, Suspension/Revocation of 

Certificates, or Patient and Physician 

Notification Orders.’’ 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. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

CDRH guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Appeal Options 

Available to Mammography Facilities 

Concerning Adverse Accreditation 

Decisions, Suspension/Revocation of 

Certificates, or Patient and Physician 

Notification Orders’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 19004 and complete title to 

identify the guidance you are 

requesting. 

III. 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 the following FDA 

regulation and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control 

No. 

‘‘Guidance for Industry and Food and Drug Administration Staff; Center for Devices 

and Radiological Health Appeals Processes’’.

Appeals Process ....................................... 0910–0738 

900 ................................................................................................................................ Mammography Facilities ........................... 0910–0309 

Dated: February 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04405 Filed 3–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0482] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Animal Drug 

Applications and Veterinary Master 

Files 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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, 

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 the collection of 


lotter on DSK11XQN23PROD with NOTICES1