7184 Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 

the proposed collection of information 

listed above has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance as 

required under section 506(c)(2)(A) of 

the Paperwork Reduction Act of 1995. 

This 30-Day notice collects comments 

on the information collection 

requirements related to the information 

collection requirements for the Process 

Evaluation of the Aging Network and its 

Return on Investment [OMB #0985– 

New]. 

DATES: Submit written comments on the 

collection of information by March 10, 

2022. 

ADDRESSES: Submit written comments 

and recommendations for the proposed 

information collection within 30 days of 

publication of this notice to 

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

Find the information collection by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. By mail to 

the Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Bldg., 725 17th St. NW, Rm. 10235, 

Washington, DC 20503, Attn: OMB Desk 

Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Bruyere, Office of Performance 

and Evaluation. Administration for 

Community Living Telephone: 202– 

795–7393 Email: caryn.bruyere@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. The 

Administration for Community Living 

(ACL) is requesting approval to collect 

data for the Process Evaluation of the 

Aging Network and its Return on 

Investment [OMB #0985–New]. Many 

older adults have unmet health care and 

social service needs, which require 

coordinated care across a range of 

services, including access to nutritious 

meals, transportation, preventive health 

care, home and community-based care, 

social interaction, support for family 

caregivers, and advocacy to help 

maintain older adults’ safety, dignity, 

and legal rights. This proposed data 

collection for the Process Evaluation of 

the Aging Network and its Return on 

Investment is intended to provide 

timely information on, (1) how agencies 

in the Aging Network collaborate to 

serve older adults and family caregivers, 

and (2) how agencies measure the 

effectiveness of their efforts with the 

goal of strengthening their reach and 

impact. Through this data collection 

ACL will investigate how states differ in 

their network structure, how agencies 

work together, and potential strategies 

for evaluating return on investments 

(ROI) of ACL programs. 

The Process Evaluation of the Aging 

Network and its Return on Investment 

will include: (1) A census of agencies in 

the Aging Network, and (2) key 

informant interviews with agencies that 

are evaluating ROI. The survey seeks to 

collect data from all State Units on 

Aging (SUAs), Area Agencies on Aging 

(AAAs) (including some Aging and 

Disability Resource Centers), and Older 

Americans Act Title VI Native American 

tribal organizations. Surveying these 

organizations will help ACL understand 

how and with whom agencies in the 

network collaborate to address the 

needs of older adults and family 

caregivers, partnerships that have 

formed or expanded because of COVID– 

19, and how agencies measure the 

effectiveness and ROI of their various 

programs. The study will also include 

key informant interviews with a subset 

of 10 agencies that responded to the 

survey whose responses indicate that 

their agency is evaluating ROI. The data 

collection team will ask in-depth 

questions about the costs and benefits 

included in ROI calculations, successes 

and challenges to evaluating ROI, and 

lessons learned that could benefit other 

agencies seeking to conduct their own 

assessment of ROI. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice published in the Federal 

Register on, August 30, 2021 in 86 FR 

48428. There were no substantive public 

comments received during the 60-day 

FRN. 

Estimated Program Burden: ACL 

estimates the burden associated with 

this collection of information as follows: 

The proposed data collection 

estimates the average burden per 

response to be 0.17 hours for the Aging 

Network survey. The average burden per 

response for the key informant 

interviews estimated as 1 hour. 

Data collection activity 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Total 

number of 

responses 

Average burden 

per response 

(in hours) 

Annual 

estimated 

burden hours 

Aging Network survey ...................................................... 864 1 ..................... 864 0.25 .................. 216 

Key informant interview guide .......................................... 10 1 ..................... 10 1 ....................... 10 

Total ........................................................................... 874 Varies ............. 874 0.26 (weighted 

mean).

226 

Dated: February 3, 2022. 

Alison Barkoff, 

Principal Deputy Administrator. 

[FR Doc. 2022–02578 Filed 2–7–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1051] 

Clinical Pharmacology Considerations 

for Antibody-Drug Conjugates; Draft 

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 draft 

guidance for industry entitled ‘‘Clinical 

Pharmacology Considerations for 

Antibody-Drug Conjugates,’’ which 

provides recommendations for the 

development of antibody-drug 

conjugates (ADCs). Specifically, this 

guidance addresses the FDA’s current 

thinking regarding clinical 

pharmacology considerations and 

recommendations for ADC development 

programs, including bioanalytical 

methods, dose selection and adjustment, 

dose- and exposure-response analysis, 

intrinsic factors, QTc assessments, 

immunogenicity, and drug-drug 

interactions (DDIs). Currently, there are 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices 7185 

no FDA guidances outlining the clinical 

pharmacology considerations for 

antibody-drug conjugates. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by May 9, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any 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– 

2021–D–1051 for ‘‘Clinical 

Pharmacology Considerations for 

Antibody-Drug Conjugates.’’ 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 the draft 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; or to Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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 draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Maxfield, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

209903, 301–348–1978, 

Kimberly.Maxfield@fda.hhs.gov; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Pharmacology Considerations 

for Antibody-Drug Conjugates.’’ An ADC 

is a type of therapeutic biologic product 

that is composed of a small-molecule 

moiety and an antibody moiety 

conjugated together by a chemical 

linker. An antibody or antibody 

fragment carrier is selected or 

engineered against a specific antigen of 

interest present on the target, which is 

ideally unique to the disease state being 

treated (e.g., a tumor-specific antigen). 

In general, when the antibody or 

antibody fragment binds to its target 

antigen, the ADC is internalized through 

physiological mechanisms (e.g., 

endocytosis), at which point the smallmolecule drug or payload moiety is 

released either upon exposure to the 

low pH of the lysosome or by 

degradation of the antibody/linker by 

lysosomal enzymes. The released smallmolecule drug then exerts its effect in 

the targeted cell (e.g., the cells 

expressing the specific antigen of 

interest) while, ideally, minimizing the 

effect on healthy cells (e.g., cells that do 

not express the specific antigen of 

interest). 

ADCs combine the selectivity of an 

antibody or antibody fragment with the 

potency of a small molecule. Therefore, 

development of ADCs requires careful 

consideration of the differences between 

the clinical pharmacology of the 

antibody or antibody fragment and the 

small molecule. This draft guidance 

addresses FDA’s current thinking 

regarding clinical pharmacology 

considerations and recommendations 

for ADC development programs, 

including bioanalytical methods, dose 

selection and adjustment, dose- and 

exposure-response analysis, intrinsic 

factors, QTc assessments, 

immunogenicity, and DDIs. Although 


khammond on DSKJM1Z7X2PROD with NOTICES
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