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
11714 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

information associated with new animal 

drug applications and veterinary master 

files. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 2, 2022. 

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 May 2, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 2, 2022. 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– 

2019–N–0482 for ‘‘New Animal Drug 

Applications and Veterinary Master 

Files.’’ 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. 

New Animal Drug Applications and 

Veterinary Master Files 

OMB Control Number 0910–0032— 

Extension 

This information collection supports 

implementation of section 512 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360b), which 

governs new animal drugs. Agency 

regulations in 21 CFR part 514 and 

associated regulations in 21 CFR part 

558, establish format and content 

requirements regarding new animal 

drug application (NADA) submissions, 

as well as provide for pre-application 

submissions, amended applications, and 

application supplements. This 

information collection also supports 

implementation of section 571 of the 

FD&C Act (21 U.S.C. 360ccc) regarding 

application for conditional approval of 

new animal drug (CNADA) submissions. 

As set forth in the FD&C Act and 


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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 11715 

1Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/cvmgfi-152-evaluating-safety-antimicrobial-new-animaldrugs-regard-their-microbiological-effects. 2Animal drugs intended for use in minor species, 

minor use in major species, or for serious or lifethreatening conditions or unmet animal or human 

health needs where a demonstration of effectiveness 

would require a complex or particularly difficult 

study or studies. 

Agency regulations, requisite elements 

include safety and effectiveness data, 

proposed labeling, product 

manufacturing information, and, where 

necessary, complete information on 

food safety (including microbial food 

safety) and any methods used to 

determine residues of drug chemicals in 

edible tissue from food producing 

animals. Applications must be prepared 

as appropriate to support the particular 

submission. Respondents to the 

information collection are persons 

developing, manufacturing, and/or 

researching new animal drugs. 

We developed Form FDA 356v 

(Application for Approval of a New 

Animal Drug (or Submission to Support 

New Animal Drug Approval)) to provide 

a uniform format for submitting 

requisite information and to ensure 

efficient processing by the Agency. 

Form FDA 356v is available for 

download from our website at https://

www.fda.gov/about-fda/reportsmanuals-forms/forms. We also develop 

Agency guidance documents that may 

assist respondents with understanding 

NADA/CNADA requirements and 

related information collection activity. 

This includes FDA Guidance #152,1

which outlines a risk assessment 

approach for evaluating the microbial 

food safety of antimicrobial new animal 

drugs and includes Agency 

recommendations in this regard. 

Under section 512(b)(3) of the FD&C 

Act, any person intending to file a 

NADA or supplemental NADA or a 

request for an investigational exemption 

under section 512(j) of the FD&C Act 

may request a conference prior to 

making a submission. Section 514.5 of 

our regulations (21 CFR 514.5) sets forth 

procedures for presubmission 

conferences and describes 

documentation associated with making 

requests, and preparing for and 

conducting meetings. We encourage 

sponsors to submit data for review at the 

most appropriate and productive times 

in the drug development process. Rather 

than submitting all data for review as 

part of a complete application, we have 

found that the submission of data 

supporting discrete technical sections 

during the investigational phase is most 

appropriate and productive. This 

‘‘phased review’’ of data submissions 

has created efficiencies for us and the 

animal pharmaceutical industry. 

We also encourage, as appropriate, the 

submission of a veterinary master file 

(VMF). For more information on VMFs, 

we invite you to visit https://

www.fda.gov/animal-veterinary/ 

development-approval-process/ 

veterinary-master-files. A VMF provides 

detailed information used in support of 

application submissions. Questions 

regarding VMF submissions may be 

directed to our Center for Veterinary 

Medicine at cvmesubmitter@

fda.hhs.gov. We have found that 

utilizing VMFs has increased the 

efficiency of the animal drug 

development and animal drug review 

processes for FDA and the animal 

pharmaceutical industry, providing for 

the confidential exchange of 

information with FDA and a process for 

reporting information outside of a 

NADA/CNADA or an investigational 

new animal drug file, as well as an 

opportunity for increased 

communication with FDA during the 

early stages of product development. A 

holder of a VMF may also authorize 

other parties to reference information 

included in the VMF without disclosing 

information in the file to those parties. 

VMFs can be used as repositories for 

information that can be referenced in 

multiple submissions to the Agency. 

Section 558.5(i) of FDA regulations 

(21 CFR 558.5(i)) describes the 

procedure for requesting a waiver of the 

labeling requirements in § 558.5(h) in 

the event that there is evidence to 

indicate that it is unlikely a new animal 

drug would be used in the manufacture 

of a liquid medicated feed. 

Finally, section 571 of the FD&C Act 

establishes requirements for the 

conditional approval of certain drugs 2

and the procedures for submitting 

applications for conditional approval. 

Although FDA receives fewer than one 

application submission under section 

571 of the FD&C Act annually when 

averaged over a 3-year period, we use a 

placeholder of one response and 1 hour 

annually to account for the burden 

associated with these submissions. 

Information collection associated with 

NADAs/CNADAs and related 

submissions is necessary to ensure that 

new animal drugs are in compliance 

with sections 512(b)(1) and 571 of the 

FD&C Act. We review the information, 

including data, labeling, and 

manufacturing controls and procedures, 

to evaluate the safety and effectiveness 

of the proposed new animal drug. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

§§ 514.1 and 514.6; applications and amended applications.187 0.07 13 212 ......................... 2,756 

§§ 514.1(b)(8) and 514.8(c)(1); 2 evidence to establish safety and effectiveness.187 0.44 82 90 ........................... 7,380 

§ 514.5(b), (d), and (f); requesting presubmission 

conferences.

187 0.67 125 50 ........................... 6,250 

§ 514.8(b); manufacturing changes to an approved 

application.

187 2 374 35 ........................... 13,090 

§ 514.8(c)(1); labeling and other changes to an approved application.187 0.06 11 71 ........................... 781 

§ 514.8(c)(2) and (3); labeling and other changes to 

an approved application.

187 0.84 157 20 ........................... 3,140 

§ 514.11; submission of data studies and other information.187 0.13 24 1 ............................. 24 

§ 558.5(i); requirements for liquid medicated feed ...... 187 0.01 2 5 ............................. 10 

Applications for conditional approval submitted under 

section 571 of the FD&C Act.

1 1 1 1 ............................. 1 


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11716 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Form FDA 356V .......................................................... 187 36.5 6,825 0.75 (45 minutes) ... 5,118 

VMF submissions ........................................................ 15 1 15 20 ........................... 300 

Total ...................................................................... ........................ ........................ 7,628 ................................ 38,849 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as 

part of the overall preapproval safety evaluation. 

Although we have characterized the 

information collection activity as a 

reporting burden, we include in our 

estimate time required for searching 

data sources, and preparing and 

maintaining necessary and applicable 

records. As stated above, although we 

receive fewer than one submission 

annually when averaged over a 3-year 

period, we attribute one response and 1 

hour annually to account for CNADA 

submissions 

We have adjusted our estimate of the 

information collection to reflect a 

decrease in burden associated with 

application submissions in 

acknowledgement of respondents’ 

preference in using FDA’s ‘‘eSubmitter’’ 

system, which automatically generates 

Form FDA 356v and allows respondents 

to complete the form and submit 

applications and associated information 

electronically. 

Dated: February 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04373 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–2013–D–0836] 

Pre-Launch Activities Importation 

Requests; 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 ‘‘PreLaunch Activities Importation Requests 

(PLAIR).’’ This guidance finalizes and 

updates the draft guidance of the same 

title issued on July 24, 2013. This 

guidance finalizes FDA’s approach for 

overseeing requests regarding the 

importation of unapproved finished 

dosage form drug products by 

applicants preparing products for 

market launch based on anticipated 

approval of a pending new drug 

application (NDA) or an abbreviated 

new drug application (ANDA). This 

guidance also applies to biologics 

licensing applications (BLAs) regulated 

by the Center for Drug Evaluation and 

Research. This guidance further 

describes the procedures for making 

these requests and FDA’s actions on 

such requests. Finalizing this policy 

will help increase efficiencies in 

ensuring timely access to drug products 

upon approval. 

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 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– 

2013–D–0836 for ‘‘Pre-Launch Activities 

Importation Requests (PLAIR).’’ 

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 


lotter on DSK11XQN23PROD with NOTICES1