Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37861 

1https://www.fda.gov/medical-devices/howstudy-and-market-your-device/device-registrationand-listing. 

registration). Once the account is 

created, the owner or operator uses the 

account as long as the establishment is 

registered. If an owner or operator 

changes, the new owner or operator 

creates a new owner or operator account 

and transfers the ownership of the 

establishment to their owner or operator 

account. Once they create an owner or 

operator account, they use the account 

for as long as the company is registered. 

Under § 807.22(b)(4), changes to listing 

information may be made at times 

outside of the annual listing 

requirement period, such as when a 

change is made to a previously listed 

device. 

The draft guidance entitled ‘‘Transfer 

of a Premarket Notification (510(k)) 

Clearance—Questions and Answers’’ 

(December 2014), which contained 

instructions for the proposed voluntary 

information collection, has recently 

been withdrawn. While notification of 

transfer of ownership information is not 

currently required, our medical device 

registration and listing website 1

communicates procedures for notifying 

FDA of the transfer of a premarket 

notification (510(k)) clearance from one 

person to another. The notification is 

used to ensure public information in 

FDA’s databases about the current 

510(k) holder for a specific device(s) is 

accurate and up to date. Although 

submission of information regarding the 

transfer of a 510(k) clearance is not 

required under the regulations, we 

regularly receive such notifications from 

respondents. 

We estimate that annually 78 percent 

of 510(k)s may be initially listed or 

updated outside of the annual 

registration requirement (about 4,080 

510(k)s per year). We assume it will take 

15 minutes for each listing, for a total 

reporting burden of 1,020 hours. 

We estimate 2,033 instances of more 

than one party claiming to be a 510(k) 

holder for a specific device as part of 

annual registration and listing. We 

determined our estimate by identifying 

the average number of unique 510(k) 

device listings entered in FURLS 

between fiscal years 2017 and 2019 that 

conflict with a listing already entered by 

another party (5,304), dividing that 

number by the number of years (3) and 

multiplying by the average number of 

parties claiming to be the 510(k) holder 

when there is a conflict in the current 

FURLS database (2.3), then dividing the 

result by 2 (because only one company 

per listing will submit the appropriate 

documentation to show that they are the 

current 510(k) holder). 

The registration and listing website 

identifies potential documentation a 

party could submit to FDA to establish 

the transfer of a 510(k) clearance to a 

new owner or operator. Based on the 

amount of time to locate the 

information, copy it, and submit a copy, 

we assume it takes respondents an 

average of 4 hours to establish the 

transfer of a 510(k) clearance. 

The estimate for § 807.25(d) in table 2 

of this document (recordkeeping 

burden) reflects the requirement that 

owners or operators maintain a 

historical file containing the labeling 

and advertisements in use. The estimate 

for § 807.26 reflects the requirement that 

owners or operators keep a list of 

officers, directors, and partners for each 

establishment. Owners or operators will 

need to provide this information only 

when requested by FDA. However, it is 

assumed that some effort will need to be 

expended to keep such records current. 

The recurring burden for the data 

collection under § 807.41 (importrelated information provided by foreign 

companies exporting to the United 

States) was estimated based on data 

from previous years. Foreign companies 

identify readily available contact 

information at the time of registration. 

After completing their initial 

registration, they are required to review 

the importer information annually. 

When they review the importer 

information annually, they simply 

verify the importer information is 

accurate. If it is and no changes are 

needed, the foreign establishment’s 

official correspondent checks the 

certification and submits the annual 

registration. If they need to make 

changes to the importer information, 

they can do so at any time and use a 

spreadsheet to update more than one 

importer at a time to their registration. 

The use of the spreadsheet reduces the 

burden to the official correspondent of 

the foreign establishment. 

Our estimated burden for the 

information collection reflects an 

overall increase of 10,880 hours and a 

corresponding increase of 28,430 

responses/records. We attribute this 

adjustment to an increase in the number 

of submissions we received over the last 

3 years. 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13522 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4368] 

Assessing the Effects of Food on 

Drugs in Investigational New Drugs 

and New Drug Applications—Clinical 

Pharmacology Considerations; 

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 

‘‘Assessing the Effects of Food on Drugs 

in INDs and NDAs—Clinical 

Pharmacology Considerations.’’ This 

guidance provides recommendations to 

sponsors planning to conduct foodeffect (FE) studies for orally 

administered drug products as part of 

investigational new drug applications 

(INDs), new drug applications (NDAs), 

and supplements to these applications. 

This guidance finalizes the draft 

guidance of the same title issued on 

February 26, 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 24, 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 


jspears on DSK121TN23PROD with NOTICES1
37862 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

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– 

2018–D–4368 for ‘‘Assessing the Effects 

of Food on Drugs in INDs and NDAs— 

Clinical Pharmacology Considerations.’’ 

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. 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: 

Vikram Arya or Brian Booth, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–1499 or 301– 

796–1508. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Assessing the Effects of Food on Drugs 

in INDs and NDAs—Clinical 

Pharmacology Considerations.’’ Fooddrug interactions can have a significant 

impact on the safety and efficacy of the 

drug and can be manifested in different 

ways. In some cases, co-administration 

of a drug with food can increase the 

systemic exposure of the drug, leading 

to improved efficacy or higher rates of 

adverse reactions. In other cases, 

administration of a drug with food can 

lower the systemic absorption of a drug, 

thereby reducing the efficacy. Hence, 

assessing the effect of food on the 

absorption of a drug is critical to 

optimize the safety and efficacy of the 

product and to determine optimum 

instructions for drug administration in 

relation to food. 

During new drug development, 

pharmacokinetic studies to assess the 

effect of food on the systemic exposure 

of the drug are conducted to determine: 

(1) if, and to what extent, food impacts 

the systemic exposure of the drug; (2) 

whether food increases or decreases the 

variability of the systemic exposure of 

the drug; and (3) if the effect of food is 

different across meals with different fat 

or caloric contents. It is important to 

have as detailed an understanding of the 

exposure-response relationships of the 

drug as possible to interpret the results 

of FE studies. Additionally, an 

understanding of the various clinical 

dosing scenarios will be important to 

characterize the effect of food and to 

provide adequate instructions for use of 

the drug. 

This guidance finalizes the draft 

guidance entitled ‘‘Assessing the Effects 

of Food on Drugs in INDs and NDAs— 

Clinical Pharmacology Considerations’’ 

issued on February 26, 2019 (84 FR 

6151). FDA considered comments 

received on the draft guidance as the 

guidance was finalized. Changes from 

the draft to the final guidance include 

adding a discussion of model-informed 

drug development approaches to 

assessing the effects of food on drug 

exposures and the removal of specific 

language regarding the timing of food 

effect studies and food effect studies by 

population pharmacokinetic analysis. 

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 ‘‘Assessing the 

Effects of Food on Drugs in INDs and 

NDAs—Clinical Pharmacology 

Considerations.’’ 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 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. The collection of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130. The collections of 

information in 21 CFR 201.56 and 

201.57 have been approved under OMB 

control numbers 0910–0733 and 0910– 

0572, and the collections of information 

related to pharmacogenomic data have 

been approved under OMB control 

number 0910–0557. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37863 

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/ 

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

www.regulations.gov. 

Dated: June 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13520 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended by the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the 

issuance of priority review vouchers as 

well as the approval of products 

redeeming a priority review voucher. 

FDA has determined that the 

supplemental application for RINVOQ 

(upadacitinib), approved March 16, 

2022, meets the redemption criteria. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

which was added by FDASIA, FDA will 

report the issuance of rare pediatric 

disease priority review vouchers and the 

approval of products for which a 

voucher was redeemed. FDA has 

determined that the supplemental 

application for RINVOQ (upadacitinib), 

approved March 16, 2022, meets the 

redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDisease

PriorityVoucherProgram/default.htm. 

For further information about RINVOQ 

(upadacitinib), approved March 16, 

2022, go to the ‘‘Drugs@FDA’’ website at 

https://www.accessdata.fda.gov/scripts/ 

cder/daf/. 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13607 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; 510(k) Third-Party 

Review Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 510(k) ThirdParty Review Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 23, 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 August 23, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 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– 

2016–D–2565 for ‘‘Agency Information 

Collection Activities; Submission for 

Office of Management and Budget 

Review; Comment Request; 510(k) 

Third-Party Review Program.’’ 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. 


jspears on DSK121TN23PROD with NOTICES1