42308 Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Adebayo Laniyonu, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5400, 

Silver Spring, MD 20993–0002, 301– 

796–1392. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Microdose Radiopharmaceutical 

Diagnostic Drugs: Nonclinical Study 

Recommendations.’’ This guidance is 

intended to assist sponsors of microdose 

radiopharmaceutical diagnostic drugs 

on the nonclinical studies 

recommended to support human 

clinical trials and marketing 

applications. This guidance 

incorporates comments received and 

finalizes the draft guidance of the same 

name issued on September 13, 2017 (82 

FR 43025). The guidance includes a few 

editorial changes and a new sentence 

clarifying the definition of the term 

diagnostic radiopharmaceutical. 

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 nonclinical study 

recommendations for microdose 

radiopharmaceutical diagnostic drugs. 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. This guidance is not subject 

to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. The collection of 

information for radioactive drug 

research committees in 21 CFR 361.1 

has been approved under OMB control 

number 0910–0053. The collection of 

information for the regulations on in 

vivo radiopharmaceuticals used for 

diagnosis and monitoring in 21 CFR 

315.4, 315.5, and 315.6 has been 

approved under OMB control number 

0910–0409. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: August 15, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17961 Filed 8–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; The Maternal, Infant, and 

Early Childhood Home Visiting 

Program Statewide Needs Assessment 

Update 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted a Supplemental 

Information Request (SIR) to the Office 

of Management and Budget (OMB) for 

review and approval. A 60-day Federal 

Register Notice was published in the 

Federal Register on April 24, 2018. 

There were seven public comments. 

Comments submitted during the first 

public review of this SIR will be 

provided to OMB. OMB will accept 

further comments from the public 

during the review and approval period. 

DATES: Comments on this SIR should be 

received no later than September 20, 

2018. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request (ICR) Title, to the desk officer 

for HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

The Maternal, Infant, and Early 

Childhood Home Visiting Program 

Statewide Needs Assessment Update, 

OMB No. 0906–XXX, New. 

Abstract: HRSA is requesting 

approval to collect updated statewide 

needs assessments from Maternal, 

Infant, and Early Childhood Home 

Visiting (MIECHV) Program awardees. 

The previous statewide needs 

assessment that was approved under 

OMB control number 0915–0333 has 

been discontinued. Eligible entities that 

are states, the District of Columbia, and 

non-profit organizations will submit 

statewide needs assessment updates in 

response to a forthcoming SIR. The 

MIECHV Program, authorized by section 

511 of the Social Security Act, 42 U.S.C. 

711, and administered by HRSA in 

partnership with the Administration for 

Children and Families, supports 

voluntary, evidence-based home visiting 

services during pregnancy and to 

parents with young children up to 

kindergarten entry. States, territories, 

tribal entities, and in certain 

circumstances nonprofit organizations 

are eligible to receive funding through 

MIECHV and have the flexibility, within 

the parameters of the authorizing 

statute, to tailor the program to serve the 

specific needs of their communities. 

The statewide needs assessment is a 

critical and foundational resource that 

assists awardees in identifying and 

understanding how to meet the needs of 

eligible families living in at-risk 

communities in their states. 

After taking into consideration public 

comments in response to the 60-day 

Notice published in the Federal 

Register on April 24, 2018 (83 FR 

17826), HRSA is proposing final 

revisions to the SIR guidance for the 

needs assessment update by making the 

following changes: 

• Inserting references to the statutory 

requirements for each section of the 

guidance—specifically the sections of 

statute that require an assessment of 

state capacity to provide substance 

abuse treatment and counseling 

services. 

• Increasing the burden estimate for 

respondents from 95.57 to 120 in 

response to comments that the original 

estimate was too low. 

Need and Proposed Use of the 

Information: Congress, through 

enactment of the Social Security Act, 

Title V, Section 511 (42 U.S.C. 711), as 

amended, established the MIECHV 

Program. Section 50603 of the 

Bipartisan Budget Act of 2018 (Pub. L. 

115–123) amended section 511(b)(1) of 

the Social Security Act, and requires 

that states review and update their 

statewide needs assessments (which 

may be separate from, but in 

coordination with, the Title V statewide 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42309 

needs assessment) no later than October 

1, 2020. The Bipartisan Budget Act of 

2018 further establishes that conducting 

a MIECHV statewide needs assessment 

update is a condition of receiving Title 

V Maternal and Child Health Service 

(MCH) Block Grant funding; submission 

of the MIECHV needs assessment 

update in accordance with the guidance 

in the SIR will meet this requirement. 

In response to the forthcoming SIR, 

states will be required to submit an 

updated statewide needs assessment 

that identifies all of the following 

information, as required by the MIECHV 

authorizing statute: 

(1) Communities with concentrations 

of (a) premature birth, low-birth weight 

infants, and infant mortality, including 

infant death due to neglect, or other 

indicators of at-risk prenatal, maternal, 

newborn, or child health; (b) poverty; (c) 

crime; (d) domestic violence; (e) high 

rates of high-school drop-outs; (f) 

substance abuse; (g) unemployment; or 

(h) child maltreatment. 

(2) The quality and capacity of 

existing programs or initiatives for early 

childhood home visitation in the state 

including: The number and types of 

individuals and families who are 

receiving services under such programs 

or initiatives; the gaps in early 

childhood home visitation in the state; 

and the extent to which such programs 

or initiatives are meeting the needs of 

eligible families. 

(3) The state’s capacity for providing 

substance abuse treatment and 

counseling services to individuals and 

families in need of such treatment or 

services. 

The forthcoming SIR will provide 

further guidance to states in updating 

their statewide needs assessments and 

submitting the required information to 

HRSA. States that have elected not to 

apply or be awarded MIECHV funds are 

encouraged to work with nonprofit 

organizations that have received awards 

to provide MIECHV services within the 

state and indicate whether they will 

submit their needs assessments directly 

or through the nonprofit organization 

awardee. Nonprofit awardees will need 

to provide documentation to 

demonstrate that they have been 

authorized or requested by the state in 

which they provide services to submit a 

needs assessment on behalf of the state. 

Documentation, such as a letter, may 

come from a state’s Title V agency; an 

other health, education or human 

services state agency; or the governor’s 

office. 

HRSA, states, and nonprofits 

providing MIECHV services within 

states will use the information collected 

through the needs assessment update to 

reaffirm the provision of MIECHV home 

visiting services in at-risk communities. 

The information will also be used to 

support program planning, 

improvement, and decision-making. The 

purpose of updating the statewide needs 

assessments is for awardees to gather 

more recent information on community 

needs and ensure that MIECHV 

programs are being operated in areas of 

high need. However, the requirement for 

such an update should not be construed 

as requiring moving MIECHV-funded 

home visiting programs, defunding of 

programs for the sole purpose of moving 

services to other communities, or 

otherwise disrupting existing home 

visiting programs, their relationships in 

the community, and their services to 

eligible families. The statutory 

requiremenets of a needs assessment 

update also apply to territory awardees, 

but this ICR does not include guidance, 

nor a burden estimate, for these 

awardees. Recognizing potential 

challenges related to the availability of 

population health data for the 

territories, a separate SIR will provide 

guidance on the needs assessment 

update to territories eligible to apply for 

MIECHV funds. 

Likely Respondents: MIECHV Program 

Awardees that are states, territories, 

and, where applicable, nonprofit 

organizations providing services within 

states. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions and 

supporting materials; to collect and 

analyze data; engage with stakeholders 

and coordinate with state level partners; 

and to draft and submit the report. The 

table below summarizes the total annual 

burden hours estimated for this SIR. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden hours 

per response 

Total burden 

hours 

Maternal, Infant, and Early Childhood Home Visiting Program Statewide Needs Assessment Update ................... 51 1 51 120 6,120 

Total .............................................................................. 51 ........................ 51 ........................ 6,120 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–17972 Filed 8–20–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Government Performance and 

Results Act (GPRA) Client/Participant 

Outcomes Measure—(OMB No. 0930– 

0208)—Revision 

SAMHSA is requesting approval to 

add 13 new questions to its existing 

CSAT Client-level GPRA instrument. 

Grantees will only be required to answer 

no more than four additional questions, 

per CSAT grant awarded, in addition to 

the other questions on the instrument. 

Currently, the information collected 

from this instrument is entered and 

stored in SAMHSA’s Performance 


sradovich on DSK3GMQ082PROD with NOTICES