7186 Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 

this draft guidance is primarily based on 

FDA’s experience with ADCs for 

oncology indications, the principles 

discussed in this guidance are also 

generally applicable to the development 

of ADCs for other indications. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Clinical Pharmacology 

Considerations for Antibody-Drug 

Conjugates.’’ 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While this draft guidance contains no 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 for submissions of 

investigational new drug applications, 

new drug applications, and biologic 

license applications in 21 CFR parts 

312, 314, and 601 have been approved 

under OMB control numbers 0910– 

0014, 0910–0001, and 0910–0338, 

respectively. In addition, the 

submission of prescription drug labeling 

under 21 CFR 201.56 and 201.57 has 

been approved under OMB control 

number 0910–0572. The collections of 

information in 21 CFR part 211 have 

been approved under OMB control 

number 0910–0139; and the collections 

of information regarding good laboratory 

practice in 21 CFR part 58 have been 

approved under OMB control number 

0910–0119. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02604 Filed 2–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0101] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

User Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by March 10, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0297. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Prescription Drug User Fee Program 

OMB Control Number 0910–0297— 

Revision 

This information collection supports 

implementation of the Food and Drug 

Administration Prescription Drug User 

Fee Act (PDUFA) program. PDUFA was 

enacted in 1992 and authorizes FDA to 

collect fees from companies that 

produce certain human drug and 

biological products. Under the 

prescription drug user fee provisions of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (sections 735 and 736 

(21 U.S.C. 379g and 379h)), we have the 

authority to assess and collect user fees 

for certain new drug applications 

(NDAs) and new biologics license 

applications (BLAs). Under this 

authority, pharmaceutical companies 

pay a fee for certain new NDAs and 

BLAs submitted to FDA for review. We 

have established a PDUFA page on our 

website at https://www.fda.gov/ 

forindustry/userfees/ 

prescriptiondruguserfee/ that includes 

resources and information regarding 

PDUFA topics at FDA. 

Because the submission of user fees 

concurrently with applications is 

required, review of an application by 

FDA cannot begin until the fee is 

submitted. To assist respondents in this 

regard, we developed Form FDA 3397 

entitled ‘‘PDUFA Cover Sheet.’’ 

Additional information and associated 

instructions may be found on our 

website at https://www.fda.gov/ 

industry/fda-user-fee-programs. The 

cover sheet (Form FDA 3397) need not 

be submitted for certain FDA-regulated 

products, e.g., generic drugs, and whole 

blood and blood components for 

transfusion. The list of exempted 

products is included under the 

instructions to Form FDA 3397. 

Relatedly, sections 735 and 736 of the 

FD&C Act also provide for waiver, 

reduction, refund, and reconsideration 

requests. We developed the guidance 

document entitled ‘‘Guidance for 

Industry—Prescription Drug User Fee 

Act Waivers, Reductions, and Refunds 

for Drug and Biological Products,’’ and 

Form FDA 3971 (Small Business Waiver 

and Refund Request), which can be 

found on our website at https://

www.fda.gov/media/131797/download. 

We are revising the collection to 

include our current commitment goals, 

as set forth in the document ‘‘PDUFA 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 Through 

2022,’’ also found on our website at 

https://www.fda.gov/media/99140/ 

download. PDUFA is currently 

authorized through September 30, 2022, 

with reauthorization activities currently 

underway. The commitment goals 

represent the product of FDA’s 

discussions with the regulated industry 

and public stakeholders, as mandated 

by Congress. FDA is committed to 

meeting these goals and to continuous 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 7187 

operational improvements associated 

with PDUFA implementation. The 

commitment goals provide for the 

development and issuance of topicspecific guidance. We maintain a 

searchable guidance database on our 

website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents. In publishing the 

respective notices of availability for 

each guidance document, we include an 

analysis under the PRA and invite 

public comment on the associated 

information collection 

recommendations. In addition, all 

Agency guidance documents are issued 

in accordance with our good guidance 

practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. 

In the Federal Register of November 

30, 2021 (86 FR 67958), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Prescription drug user fee activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Sections 735 and 736 of the FD&C Act (PDUFA waivers, 

not including small business waivers) .............................. 112 1.68 189 17 3,213 

Section 736(d)(1)(C) of the FD&C Act and Form FDA 

3971 (small business waivers) ......................................... 37 1 37 2 74 

Reconsideration Requests ................................................... 6 1.67 10 24 240 

Appeal Requests .................................................................. 1 1 1 12 12 

User Fee Cover Sheet Form FDA 3397 .............................. 174 1 174 0.5 (30 

minutes) 

87 

Total .............................................................................. ........................ ........................ 411 ........................ 3626 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of Agency records, 

we estimate that the number of initial 

waiver requests submitted annually 

(excluding small business waiver 

requests under section 736(d)(1)(C)) of 

the FD&C Act) will be 189, submitted by 

112 different applicants; and that 37 

respondents annually will each submit 

a small business waiver request. We 

have included in the burden estimate 

the time for preparation and submission 

of application fee waivers for small 

businesses, including completion of 

Form FDA 3971. Small businesses 

requesting a waiver must submit 

documentation to FDA, including the 

number of their employees, as well as 

information that the application is the 

first human drug application, within the 

meaning of the FD&C Act, to be 

submitted to the Agency for approval. 

We estimate receiving 10 requests for 

reconsideration annually (including 

small business waiver reconsiderations) 

and assume the average burden for 

preparing and submitting each request 

is 24 hours. In addition, we estimate 

receiving 1 request annually for appeal 

of user fee waiver determination, and 

assume the time needed to prepare an 

appeal is 12 hours. We have included in 

this estimate both the time needed to 

prepare the request for appeal to the 

Chief Scientist and User Fee Appeals 

Officer within the Office of the 

Commissioner, and the time needed to 

create and send a copy of the request for 

an appeal to the Director Division of 

User Fee Management within the Office 

of Management at FDA’s Center for Drug 

Evaluation and Research. 

We assume 87 hours of burden for 

completing and submitting Form FDA 

3397 (Prescription Drug User Fee 

Coversheet) for submission of a new 

drug application or biologics license 

application. 

The information collection reflects an 

overall increase since our last request 

for OMB review and approval. We 

attribute this to expected fluctuations in 

submissions to the Agency. 

Dated: February 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02617 Filed 2–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3815] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Establishment 

Registration and Device Listing for 

Manufacturers and Importers of 

Devices 

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 information 

collection associated with establishment 

registration and device listing for 

manufacturers and importers of devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 11, 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 April 11, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 11, 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. 


khammond on DSKJM1Z7X2PROD with NOTICES