Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42307 

Considerations for Chewable Tablets.’’ 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 collection of 

information in investigational new drug 

applications is approved by OMB under 

control number 0910–0014; the 

collection of information (including 

prescription drug labeling) in new drug 

applications and abbreviated new drug 

applications, as well as supplements to 

these applications, is approved by OMB 

under control number 0910–0001; the 

collection of biologics license 

applications is approved by OMB under 

control number 0910–0338; and the 

format and content of prescription drug 

labeling is approved by OMB under 

control number 0910–0572. 

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. 2018–17967 Filed 8–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5297] 

Microdose Radiopharmaceutical 

Diagnostic Drugs: Nonclinical Study 

Recommendations; 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 

‘‘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 finalizes the 

draft guidance of the same name issued 

on September 13, 2017. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 21, 2018. 

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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–5297 for ‘‘Microdose 

Radiopharmaceutical Diagnostic Drugs: 

Nonclinical Study Recommendations; 

Guidance for Industry; Availability.’’ 

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. 

• 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.gpo.gov/ 

fdsys/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. 

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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY


sradovich on DSK3GMQ082PROD with NOTICES
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