30226 Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: A title IV–E plan is 

required by section 471, part IV–E of the 

Social Security Act (the Act) for each 

public child welfare agency requesting 

federal funding for foster care, adoption 

assistance, and guardianship assistance 

under the Act. Section 479B of the Act 

provides for an Indian tribe, tribal 

organization, or tribal consortium (tribe) 

to operate a title IV–E program in the 

same manner as a state with minimal 

exceptions. The tribe must have an 

approved Title IV–E Plan. The Title IV– 

E Plan provides assurances the 

programs will be administered in 

conformity with the specific 

requirements stipulated in Title IV–E. 

The plan must include all applicable 

state or tribal statutory, regulatory, or 

policy references and citations for each 

requirement as well as supporting 

documentation. A title IV–E agency may 

use the pre-print format prepared by CB, 

or a different format, on the condition 

that the format used includes all of the 

Title IV–E Plan requirements. 

Title IV–E of the Act was amended by 

Public Law 115–123, which included 

the Family First Prevention Services Act 

(FFPSA). FFPSA authorized new 

optional Title IV–E funding for timelimited (1 year) prevention services for 

mental health/substance abuse and inhome parent skill-based programs for (1) 

a child who is a candidate for foster care 

(as defined in section 475(13) of the 

Act), (2) pregnant/parenting foster 

youth, and (3) the parents/kin caregivers 

of those children and youth (sections 

471(e), 474(a)(6), and 475(13) of the 

Act). Title IV–E prevention services 

must be rated as promising, supported, 

or well supported in accordance with 

HHS criteria and be approved by HHS 

(section 471(e)(4)(C) of the Act) as part 

of the Title IV–E Prevention Services 

Clearinghouse (section 476(d)(2) of the 

Act). A state or tribal Title IV–E agency 

electing to participate in the program 

must submit a 5-year Title IV–E 

Prevention Program Plan that meets the 

statutory requirements. (See Program 

Instructions ACYF–CB–PI–18–09 and 

ACYF–CB–PI–18–10 for more 

information.) 

FFPSA also amended section 

474(a)(7) of the Act to reimburse state 

and tribal Title IV–E agencies for a 

portion of the costs of operating kinship 

navigator programs that meet certain 

criteria. To qualify for funding under 

the Title IV–E Kinship Navigator 

Program, the program must meet the 

requirements of a kinship navigator 

program described in section 427(a)(1) 

of the Act. The Kinship Navigator 

Program must meet practice criteria of 

promising, supported, or well-supported 

in accordance with HHS criteria and be 

approved by HHS (section 471(e)(4)(C) 

of the Act). To begin participation in the 

Title IV–E Kinship Navigator Program, a 

Title IV–E agency must submit an 

attachment to its Title IV–E plan that 

specifies the kinship navigator model it 

has chosen to implement and the date 

on which the provision of program 

services began or will begin, and 

provide an assurance that the model 

meets the requirements of section 

427(a)(1) of the Act, as well as a brief 

narrative describing how the program 

will be operated. (Please see Program 

Instruction ACYF–CB–PI–18–11 for 

additional information: https://www.acf.

hhs.gov/cb/policy-guidance/pi-18-11.) 

Respondents: State and tribal title IV– 

E agencies. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Title IV–E Plan ................................................................................................. 17 1 16 272 

Title IV–E prevention services plan ................................................................. 12 1 5 60 

Attachment to Title IV–E plan for Kinship Navigator Program ........................ 15 1 1 15 

Estimated Total Annual Burden 

Hours: 347. 

Authority: Title IV–E of the Social 

Security Act as amended by Public Law 

115– 123 enacted February 9, 2018. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–10652 Filed 5–17–22; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0001] 

Science Board to the Food and Drug 

Administration Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Science Board to the Food and Drug 

Administration. The Science Board 

provides advice to the Commissioner of 

Food and Drugs and other appropriate 

officials on specific, complex scientific 

and technical issues important to FDA 

and its mission, including emerging 

issues within the scientific community. 

Additionally, the Science Board 

provides advice to the Agency on 

keeping pace with technical and 

scientific developments, including in 

regulatory science, input into the 

Agency’s research agenda, and on 

upgrading its scientific and research 

facilities and training opportunities. It 

will also provide, where requested, 

expert review of Agency-sponsored 

intramural and extramural scientific 

research programs. The meeting will be 

open to the public. 

DATES: The meeting will be held 

virtually on June 14, 2022, from 9 a.m. 

to 4 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm408555.

htm. 

FOR FURTHER INFORMATION CONTACT: 

Rakesh Raghuwanshi, Office of the 

Chief Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3309, Silver Spring, 

MD 20993, 301–796–4769, 

Rakesh.Raghuwanshi@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 30227 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The Science 

Board to the Food and Drug 

Administration will consider challenges 

in evaluating the safety of dietary 

supplement and food ingredients with 

predicted pharmacological activity, 

utilizing cannabinoids as a case study. 

The Science Board to the Food and Drug 

Administration will also hear about the 

Agency’s enhanced efforts to spur the 

development, qualification, and 

adoption of new alternative methods for 

regulatory use that can replace, reduce, 

and refine animal testing and have the 

potential to provide both more timely 

and more predictive information to 

accelerate product development and 

enhance emergency preparedness. The 

Science Board to the Food and Drug 

Administration will also hear about the 

Agency’s enhanced efforts to ensure 

optimal organization, infrastructure, and 

expertise for data science efforts in 

alignment with its regulatory scope and 

evidence-based decision making, in 

support of FDA’s public health 

priorities. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

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

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee meeting link. The 

meeting will include slide presentations 

with audio components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before June 7, 2022. Oral 

presentations from the public will be 

scheduled between approximately 11 

a.m. and 12 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before June 1, 

2022. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 7, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Rakesh 

Raghuwanshi (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10697 Filed 5–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0401] 

Safety Considerations for Container 

Labels and Carton Labeling Design To 

Minimize Medication Errors; 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 ‘‘Safety 

Considerations for Container Labels and 

Carton Labeling Design to Minimize 

Medication Errors.’’ The guidance 

focuses on safety aspects of the 

container label and carton labeling 

design for human prescription drug and 

biological products. The guidance 

provides sponsors of new drug 

applications (NDAs), biologics license 

applications (BLAs), abbreviated new 

drug applications (ANDAs), and 

prescription drugs marketed without an 

approved NDA or ANDA with a set of 

principles and recommendations for 

ensuring that critical elements of 

product container labels and carton 

labeling are designed to promote safe 

dispensing, administration, and use of 

the product. This guidance finalizes the 

draft guidance of the same title issued 

on April 24, 2013. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 18, 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’’). 


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