16742 Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 

Assistance, Administration for Children 

and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

requesting a 3-year extension of the 

form OFA–0086: NEW Plan Guidance 

and NEW Program Report (OMB #0970– 

0174, expiration 8/31/2022). There are 

minor changes requested to both 

documents. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The NEW Program Plan 

Guidance documents specify the 

information needed to complete a NEW 

program plan and explain the process 

for plan submission every third year and 

to complete the annual program report. 

The program plan is the application for 

NEW program funding and documents 

how the grantee will carry out its NEW 

program. ACF proposes a change in how 

draft plans are submitted. The program 

report provides HHS, Congress, and 

grantees information to document and 

assess the activities and 

accomplishments of the NEW program. 

ACF proposes to extend data collection 

with revisions that clarify that programs 

should not count more than once 

individuals who meet multiple 

categories; for example, persons age 20 

are both youth and adults, but they 

should be counted as one or the other, 

not both. 

Respondents: Indian tribes and tribal 

coalitions that operate NEW programs. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total number 

of respondents 

(over 3 yrs.) 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

NEW Program Plan Guidance ......................................................................... 40 1 .333 29 386 

NEW Program Report ...................................................................................... 40 1 15 600 

Total Estimated Annual Burden ............................................................... ........................ ........................ ........................ 986 

1We have used .333 responses per year to represent one submission of the NEW Program Plan Guidance during the 3-year approval period. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 612. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–06271 Filed 3–23–22; 8:45 am] 

BILLING CODE 4184–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0352] 

Secura Bio, Inc.; Withdrawal of 

Approval of New Drug Application for 

FARYDAK (Panobinostat) Capsules, 10 

Milligrams, 15 Milligrams, and 20 

Milligrams 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of the new drug 

application (NDA) for FARYDAK 

(panobinostat) Capsules, 10 milligrams 

(mg), 15 mg, and 20 mg, held by Secura 

Bio, Inc., 1995 Village Center Circle, 

Suite 128, Las Vegas, NV 89134. Secura 

Bio, Inc. has voluntarily requested that 

FDA withdraw approval of this 

application and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of 

March 24, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

February 23, 2015, FDA approved NDA 

205353 for FARYDAK (panobinostat) 

Capsules, 10 mg, 15 mg, and 20 mg, in 

combination with bortezomib and 

dexamethasone for the treatment of 

patients with multiple myeloma who 

have received at least two prior 

regimens, including bortezomib and an 

immunomodulatory agent, under the 

Agency’s accelerated approval 

regulations, 21 CFR part 314, subpart H. 

The accelerated approval of FARYDAK 

(panobinostat) Capsules, 10 mg, 15 mg, 

and 20 mg, for multiple myeloma 

included a required postmarketing trial 

intended to verify the clinical benefit of 

FARYDAK. 

On September 24, 2021, FDA 

published the Federal Register notice 

‘‘Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments,’’ 

announcing that FARYDAK 

(panobinostat) Capsules would be 

discussed at an Oncologic Drug 

Advisory Committee Meeting (ODAC) 

scheduled for December 2, 2021 (86 FR 

53067). On November 19, 2021, FDA 

met with Secura Bio, Inc. to discuss the 

planned ODAC meeting. The topics 

discussed included the lack of initiation 

of the postmarketing trial intended to 

verify clinical benefit. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 16743 

On November 22, 2021, Secura Bio, 

Inc. submitted a letter asking FDA to 

withdraw approval of NDA 205353 for 

FARYDAK (panobinostat) Capsules, 10 

mg, 15 mg, and 20 mg, pursuant to 

§ 314.150(d) (21 CFR 314.150(d)) and 

waiving its opportunity for a hearing. In 

the letter, Secura Bio, Inc. stated they 

are requesting withdrawal of approval of 

the NDA for FARYDAK because it was 

not feasible for them to complete the 

required postmarketing clinical trials. 

On November 26, 2021, FDA 

acknowledged Secura Bio, Inc.’s request 

for withdrawal of approval of the NDA 

and waiver of its opportunity for 

hearing. FDA also cancelled the ODAC 

meeting scheduled for December 2, 

2021, since the applicant’s withdrawal 

request made discussion at an advisory 

committee meeting moot. 

For the reasons discussed above, and 

in accordance with the applicant’s 

request, approval of NDA 205353 for 

FARYDAK (panobinostat) Capsules, 10 

mg, 15 mg, and 20 mg, and all 

amendments and supplements thereto, 

is withdrawn under § 314.150(d). 

Distribution of FARYDAK 

(panobinostat) Capsules, 10 mg, 15 mg, 

and 20 mg, into interstate commerce 

without an approved application is 

illegal and subject to regulatory action 

(see sections 505(a) and 301(d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(a) and 331(d)). 

Dated: March 18, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06182 Filed 3–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0371] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Accelerated 

Approval Disclosures on Direct-toConsumer Prescription Drug Websites 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 25, 

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 title 

of this information collection is 

‘‘Accelerated Approval Disclosures on 

Direct-to-Consumer Prescription Drug 

Websites.’’ Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Accelerated Approval Disclosures on 

Direct-to-Consumer Prescription Drug 

Websites 

OMB Control Number 0910–NEW 

Section 1701(a)(4) of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA regulated products 

in carrying out the provisions of the 

FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have 

consistently conducted research to 

evaluate the aspects of prescription drug 

promotion that are most central to our 

mission, focusing in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and disease and 

product characteristics impact the 

communication and understanding of 

prescription drug risks and benefits. 

Focusing on target populations allows 

us to evaluate how understanding of 

prescription drug risks and benefits may 

vary as a function of audience, and our 

focus on research quality aims at 

maximizing the quality of our research 

data through analytical methodology 

development and investigation of 

sampling and response issues. This 

study will inform the first topic area, 

advertising features, including content 

and format; and the second topic area, 

target populations. 

Because we recognize the strength of 

data and the confidence in the robust 

nature of the findings is improved 

through the results of multiple 

converging studies, we continue to 

develop evidence to inform our 

thinking. We evaluate the results from 

our studies within the broader context 

of research and findings from other 

sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

homepage, which can be found at: 

https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/ 

office-prescription-drug-promotionopdp-research. The website includes 

links to the latest Federal Register 

notices and peer-reviewed publications 

produced by our office. The website 

maintains information on studies we 

have conducted, dating back to a directto-consumer (DTC) survey conducted in 

1999. 

I. Background 

Pursuant to section 506(c) of the 

FD&C Act (21 U.S.C. 356(c)) and 21 CFR 

part 314, subpart H (or 21 CFR part 601, 

subpart E for biological products), FDA 

may grant accelerated approval to a drug 

product under section 505(c) of the 

FD&C Act (21 U.S.C. 355(c)) or a 

biological product under section 351(a) 

of the PHS Act (42 U.S.C. 262(a)). This 

pathway enables faster approval of 

prescription drugs intended to treat 

serious or life-threatening illnesses. 

Accelerated approval may be based on 

a determination that a drug product has 

an effect on a surrogate endpoint (for 

example, a blood test result) that is 

reasonably likely to predict clinical 

benefit, or on a clinical endpoint that 

can be measured earlier than 

irreversible morbidity or mortality, that 

is reasonably likely to predict an effect 

on irreversible morbidity or mortality or 

other clinical benefit (i.e., an 

intermediate clinical endpoint). In 

approving a drug under the accelerated 


khammond on DSKJM1Z7X2PROD with NOTICES