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updates the draft guidance of the same 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 


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Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices 11717 

‘‘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. 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: 

Kathleen Joyce, Center for Drug 

Evaluation and Research, Bldg. 51, Rm. 

4236, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–3130, 

Kathleen.Joyce@fda.hhs.gov, or PLAIR 

Program, Office of Drug Security, 

Integrity and Recalls (ODSIR), CDEROC-PLAIR@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘PreLaunch Activities Importation Requests 

(PLAIR).’’ Historically, when applicants 

with a pending NDA, ANDA, or CDERregulated BLA sought to import 

unapproved finished dosage form drug 

products into the United States in 

preparation for market launch, we 

considered such requests, informally 

referred to as ‘‘PLAIRs,’’ on a case-bycase basis. In July 2013, FDA issued a 

draft guidance announcing the Agency’s 

approach for overseeing the import of 

some unapproved finished dosage form 

drug products regulated by CDER prior 

to their approval to facilitate the 

availability of those products to patients 

upon approval. This guidance largely 

tracks the July 2013 draft guidance. 

An applicant with a pending NDA, 

ANDA, or BLA that is nearing an FDA 

decision may submit a PLAIR to FDA 

seeking permission to import the 

unapproved finished dosage form drug 

product that is the subject of the 

application to prepare the product for 

market launch. If FDA grants the PLAIR, 

FDA intends to detain the unapproved 

finished dosage form drug product 

when the product covered by the PLAIR 

is offered for import. FDA will, 

however, consider the PLAIR 

submission to mean that the owner or 

consignee has requested to recondition 

the drug, as specified in the PLAIR 

request. FDA will thus detain the drug 

for up to 6 months pending a decision 

on the underlying application. The 

Agency will release the drug product if, 

and when, FDA approves the 

underlying NDA, BLA, or ANDA within 

6 months and the conditions of the 

PLAIR are otherwise met. If FDA refuses 

to approve the application or 6 months 

otherwise elapse without FDA approval, 

FDA may determine that the product is 

subject to refusal. 

FDA’s granting of a PLAIR does not 

represent an implicit or explicit 

statement of the approvability of the 

application. Rather, PLAIR facilitates 

the process of importing unapproved 

finished dosage form products to 

prepare for market launch based on the 

anticipated approval by FDA of the 

pending application. The PLAIR 

guidance outlines which products the 

PLAIR program covers, what 

information should be submitted to FDA 

in a PLAIR, when and how we 

recommend submitting a PLAIR, and 

the process for FDA’s action on a 

PLAIR. 

FDA considered comments received 

on the draft guidance as the guidance 

was finalized. One change we made in 

response to comments was to include 

recommended timeframes for earlier 

submission of certain PLAIR-eligible 

products subject to priority review. 

This guidance finalizes the draft 

guidance entitled ‘‘Pre-Launch 

Activities Importation Requests 

(PLAIR)’’ issued on July 24, 2013 (78 FR 

44572) and is being issued consistent 

with FDA’s good guidance practices 

regulation (21 CFR 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘Pre-Launch Activities 

Importation Requests (PLAIR).’’ 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 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The time required to complete 

this information collection is estimated 

to average 16 hours for the first 

submission, including the time to 

review instructions. We expect any 

additional PLAIRs submitted by the 

same firm to take less time. The 

collections of information pertaining to 

FDA’s Pre-Launch Activities 

Importation Requests have been 

approved under OMB control number 

0910–0046. The guidance also refers to 

other previously approved FDA 

collections of information. The 

collections of information in 21 CFR 

part 314 relating to new drug 

applications and abbreviated new drug 

applications have been approved under 

OMB control number 0910–0001; the 

collections of information in part 601 

relating to biologics license applications 

have been approved under OMB control 

number 0910–0338; the collections of 

information in 21 CFR part 207 relating 

to domestic and foreign facility 

registration, including assignment of a 

national drug code, have been approved 

under OMB control number 0910–0045; 

and the collections of information in 

parts 210 and 211 pertaining to current 

good manufacturing practice 

requirements have been have been 

approved under OMB control number 

0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

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

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: February 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04155 Filed 3–1–22; 8:45 am] 

BILLING CODE 4164–01–P 


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