Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices 11077 

automatically be transferred to the grant 

recipient’s Performance Data Form; 

• Assisted households, regardless of 

the type(s) of LIHEAP assistance or 

funding source, excluding households 

that only receive nominal payments of 

$50 or less; 

• Assisted households, by type of 

LIHEAP assistance and funding source, 

having at least one vulnerable member 

who is at least 60 years or older, 

disabled, or 5 years old or younger; 

• Assisted households, by type of 

LIHEAP assistance and funding source, 

with at least one member age 2 years or 

under; 

• Assisted households, by type of 

LIHEAP assistance and funding source, 

with at least one member ages 3 years 

through 5 years; and 

• Assisted households, regardless of 

the type(s) of LIHEAP assistance or 

funding source, having at least one 

member 60 years or older, disabled, or 

5 years old or younger. 

Indian tribal grant recipients are 

required to submit data only on the 

number of households, by funding 

source, receiving heating, cooling, 

energy crisis, and/or weatherization 

benefits. 

In FFY 2020, OCS updated the form 

to allow for the reporting of households 

served by separate LIHEAP funding 

types and benefits provided by the 

following: (1) Funds from regular 

LIHEAP FFY appropriations acts, 

including any Continuing Resolutions 

and final appropriations acts, reallotted 

prior year funds, and federal LIHEAP 

funds carried-over to or expended in the 

current year; (2) supplemental funds 

from the Coronavirus Aid, Relief, and 

Economic Security Act (the CARES Act) 

(Pub. L. 116–136); and (3) funds from 

any subsequent supplemental LIHEAP 

appropriations acts. ACF proposes 

similar changes to the report for FFY 

2022, including the addition of lines 

that allow for the reporting of 

households served by LIHEAP funds 

from the American Rescue Plan Act of 

2021 (Pub. L. 117–2). OCS has also 

updated the request to reflect the 

current number of expected respondents 

and appropriate reporting dates. 

The information is being collected for 

the Department’s annual LIHEAP Report 

to Congress. The data also provides 

information about the need for LIHEAP 

funds. Finally, the data are used in the 

calculation of LIHEAP performance 

measures under the Government 

Performance and Results Act of 1993. 

The data elements will allow the 

accuracy of measuring LIHEAP targeting 

performance and LIHEAP cost 

efficiency. 

Respondents: State governments, 

tribal governments, U.S. territories, and 

the District of Columbia. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Assisted Household Report—Long Form ........................................................ 56 1 43 2,408 

Assisted Household Report—Short Form ....................................................... 151 1 2 302 

Estimated Total Annual Burden 

Hours: 2,710. 

Authority: U.S.C. 8629 and 45 CFR. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–04085 Filed 2–25–22; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–4247] 

Patient-Focused Drug Development: 

Methods To Identify What Is Important 

to Patients; Guidance for Industry, 

Food and Drug Administration Staff, 

and Other Stakeholders; 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, FDA staff, and 

other stakeholders entitled ‘‘PatientFocused Drug Development: Methods 

To Identify What Is Important to 

Patients.’’ This guidance (Guidance 2) is 

the second in a series of four 

methodological guidance documents 

that FDA committed to develop to 

describe how to collect and submit 

information from patients and 

caregivers to be used for medical 

product development and regulatory 

decision making. This guidance 

finalizes the draft guidance of the same 

title issued on October 1, 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 28, 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.’’ 


khammond on DSKJM1Z7X2PROD with NOTICES
11078 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–4247 for ‘‘Patient-Focused Drug 

Development: Methods To Identify 

What Is Important to Patients.’’ 

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, or to the 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Cole, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6306, 

Silver Spring, MD 20993–0002, 301– 

796–9208, Shannon.Cole@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 guidance for industry, FDA staff, and 

other stakeholders entitled ‘‘PatientFocused Drug Development: Methods 

To Identify What Is Important to 

Patients.’’ This guidance (Guidance 2) is 

the second in a series of four 

methodological patient-focused drug 

development guidance documents that 

FDA committed to develop to describe 

how stakeholders (patients, researchers, 

medical product developers, and others) 

can collect and submit information from 

patients and caregivers to be used for 

medical product development and 

regulatory decision making. This series 

of guidance documents is intended to 

facilitate the advancement and use of 

systematic approaches to collect and use 

robust and meaningful patient and 

caregiver input that can more 

consistently inform medical product 

development and regulatory decision 

making. The purpose of Guidance 2 is 

to present a range of methods and 

established best research practices to 

identify what is important to patients 

with respect to burden of disease, 

burden of treatment, and the benefits 

and risks in the management of the 

patient’s disease. In particular, the 

methods and best practices presented 

can help elicit relevant information 

from patients and other stakeholders, 

such as how their disease affects their 

daily lives; what they find most 

troublesome; and the challenges, 

problems, and burdens of the treatment 

for the disease. 

This guidance finalizes the draft 

guidance entitled ‘‘Patient-Focused 

Drug Development: Methods To Identify 

What Is Important to Patients’’ issued on 

October 1, 2019 (84 FR 52114). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include incorporating the 

definitions of relevant terms within the 

body of the document instead of as part 

of a glossary. In addition, editorial 

changes and methodological 

clarifications were made to improve 

clarity. 

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 ‘‘Patient-Focused 

Drug Development: Methods To Identify 

What Is Important to Patients.’’ 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 refers to collections of 

information from individuals under 

treatment or clinical examination in 

connection with research, which are not 

subject to review by the Office of 

Management and Budget (OMB) under 5 

CFR 1320.3(h)(5). Therefore, clearance 

by the OMB under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521) is not required for this 

guidance. This guidance also refers to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

information collections described in this 

guidance are submitted to FDA to 

support the medical product’s 

effectiveness and to support claims in 

approved medical product labeling (see 

21 CFR 314.50, 314.126, and 601.2). The 

information collections have been 

approved under OMB control numbers 

0910–0001 and 0910–0338. The 

collections of information in 21 CFR 

parts 50 and 56 have been approved 

under OMB control number 0910–0130. 

III. Additional Information 

Section 3002 of Title III, Subtitle A, of 

the 21st Century Cures Act (Pub. L. 114– 

255) directs FDA to develop patientfocused drug development guidance to 

address a number of areas including 

under section 3002(c)(2): 

Methodological approaches that may be 

used to develop and identify what is 

important to patients with respect to 

burden of disease, burden of treatment, 

and the benefits and risks in the 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices 11079 

management of the patient’s disease. In 

addition, FDA committed to meet 

certain performance goals under the 

sixth authorization of the Prescription 

Drug User Fee Act. These goal 

commitments were developed in 

consultation with patient and consumer 

advocates, healthcare professionals, and 

other public stakeholders, as part of 

negotiations with regulated industry. 

Section J.1 of the commitment letter, 

‘‘Enhancing the Incorporation of the 

Patient’s Voice in Drug Development 

and Decision-Making’’ (https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf), outlines work, 

including the development of a series of 

guidance documents and associated 

public workshops to facilitate the 

advancement and use of systematic 

approaches to collect and use robust 

and meaningful patient and caregiver 

input that can more consistently inform 

drug development, and, as appropriate, 

regulatory decision making. 

IV. 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/ 

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 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04152 Filed 2–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0002] 

New Animal Drugs; Withdrawal of 

Approval of New Animal Drug 

Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of a new animal drug 

application (NADA) at the sponsor’s 

request because the product is no longer 

manufactured or marketed. 

DATES: The approval is withdrawn as of 

February 28, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Sujaya Dessai, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5761, 

sujaya.dessai@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco US 

Inc., 2500 Innovation Way, Greenfield, 

IN 46140, has requested that FDA 

withdraw approval of NADA 093–329 

for use of a prolonged-release bolus 

containing sulfamethazine in cattle 

because the product is no longer 

manufactured or marketed. 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

and in accordance with § 514.116 Notice 

of withdrawal of approval of application 

(21 CFR 514.116), notice is given that 

approval of NADA 093–329, and all 

supplements and amendments thereto, 

is hereby withdrawn February 28, 2022. 

Elsewhere in this issue of the Federal 

Register, FDA is amending the animal 

drug regulations to reflect the voluntary 

withdrawal of approval of this 

application. 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03539 Filed 2–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0030] 

Fresenius Kabi USA, LLC, et al.; 

Withdrawal of Approval of Five 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of five 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

March 30, 2022 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 065408 .... Epirubicin Hydrochloride (HCl) Injection, 150 milligrams (mg)/ 

75 milliliters (mL) (2 mg/mL), 10 mg/5 mL (2 mg/mL), 50 

mg/25 mL (2 mg/mL), and 200 mg/100 mL (2 mg/mL).

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 

ANDA 065411 .... Epirubicin HCl Injection, 200 mg/100 mL (2 mg/mL) and 50 

mg/25 mL (2 mg/mL).

Do. 

ANDA 065440 .... Idarubicin HCl Injection, 1 mg/mL ............................................ Do. 

ANDA 077790 .... Fludarabine Phosphate for Injection, 50 mg/vial ..................... Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045. 

ANDA 091008 .... Gabapentin Capsules, 100 mg, 300 mg, and 400 mg ............ Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, 

Venus Pharmaceutical Laboratories Inc., 506 Carnegie 

Center, Suite 100, Princeton, NJ 08540. 


khammond on DSKJM1Z7X2PROD with NOTICES