Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42131 

protocols in fiscal year (FY) 2017, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 75 manufacturers 

submitted protocols under § 610.2 and 2 

manufacturers submitted protocols 

under the regulation (§ 660.6) for the 

other specific product. FDA received no 

submissions under §§ 660.36 or 660.46; 

however, FDA is using the estimate of 

one protocol submission under each 

regulation in the event that protocols are 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2017 for the various 

submission requirements of samples 

and protocols for the licensed biological 

products. The average burden per 

response is based on information 

provided by industry. The burden 

estimates provided by industry ranged 

from 1 to 5.5 hours. Under § 610.2, the 

hours per response are based on the 

average of these estimates and rounded 

to 3 hours. Under the remaining 

regulations, the average burden per 

response is based on the higher end of 

the estimate (rounded to 5 or 6 hours) 

since more information is generally 

required to be submitted in the other 

protocols than under § 610.2. 

In the Federal Register of May 11, 

2018, (83 FR 22081), we published a 

notice soliciting public comment of the 

information collection. No comments 

were received. 

We therefore estimate the burden of 

the information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.2—Requests for Samples and Protocols; Official Release ................................................................................. 75 86.267 6,470 3 19,410 

660.6(b)—Protocols ............................................................. 2 3.5 7 5 35 

660.36(a)(2) and (b)—Samples and Protocols .................... 1 1 1 6 6 

660.46(b)—Protocols ........................................................... 1 1 1 5 5 

Total .............................................................................. ........................ ........................ ........................ ........................ 19,456 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall increase of 764 hours and a 

corresponding increase of 262 

responses. We attribute this adjustment 

to an increase in the number of 

submissions we received over the last 

few years. 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17859 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0438] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before September 19, 

2018. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–New–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Office of 

Adolescent Health Teen Pregnancy 

Prevention, FY 2015–2020 Performance 

Measure Collection. 

Type of Collection: Extension. 

OMB No. 0990–0438. 

Abstract: The Office of Adolescent 

Health (OAH), U.S. Department of 

Health and Human Services (HHS), is 

requesting renewal by OMB of the 

existing information collection request 

for performance measures collection 

from the TPP grant recipients. 

Performance measure data collection is 

a requirement of TPP grants; the 

extension will allow for the completion 

of data collection from cohort 2. The 

collection will provide OAH with 

performance data to inform planning 

decisions; identify technical assistance 

needs for grantees; facilitate grantees’ 

continuous quality improvement in 

program implementation; and provide 

HHS, Congress, OMB, and the general 

public with information about the 

individuals who participate in TPPfunded activities. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

Grant Recipient—Dissemination Form ...................................................... 84 2 15/60 42 

Grant Recipient—Partnerships Form ........................................................ 84 2 15/60 42 


daltland on DSKBBV9HB2PROD with NOTICES
42132 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

ESTIMATED ANNUALIZED BURDEN TABLE—Continued 

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

Grant Recipient—Facilitator Training Form ............................................... 84 2 15/60 42 

Grant Recipient—Healthcare Linkages Form ............................................ 84 2 15/60 42 

Grant Recipient: Participant Reach Form .................................................. 84 2 168/60 470 

Grant Recipient: Dosage Form .................................................................. 84 2 102/60 286 

Grant Recipient Fidelity Form .................................................................... 84 2 102/60 286 

Grant Recipient: Cost Form ....................................................................... 84 1 30/60 42 

Total .................................................................................................... ........................ ........................ ........................ 1252 

Terry Clark, 

Office of the Secretary, Asst Paperwork 

Reduction Act Reports Clearance Officer. 

[FR Doc. 2018–17812 Filed 8–17–18; 8:45 am] 

BILLING CODE 4168–11–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Committee on 

Children and Disasters Public 

Teleconference 

AGENCY: Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services is hereby giving notice that the 

National Advisory Committee on 

Children and Disasters (NACCD) will 

hold a public teleconference on 

September 11, 2018. 

DATES: The NACCD Public 

Teleconference is September 11, 2018, 

from 2:00 p.m. to 3:00 p.m. Eastern 

Daylight Time (EDT). 

ADDRESSES: We encourage members of 

the public to attend the public meetings. 

To register, send an email to naccd@

hhs.gov with ‘‘NACCD Registration’’ in 

the subject line. Submit your comments 

to naccd@hhs.gov or via the NACCD 

Contact Form located at https://

www.phe.gov/Preparedness/legal/ 

boards/naccd/Pages/contact.aspx. For 

additional information, visit the NACCD 

website located at https://www.phe.gov/ 

naccd. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the Federal Advisory Committee Act 

of 1972 (5 U.S.C., Appendix, as 

amended), and Section 2811A of the 

Public Health Service (PHS) Act (42 

U.S.C. 300hh–10a), as added by Section 

103 of the Pandemic and All-Hazards 

Preparedness Reauthorization Act of 

2013 (Pub. L. 113–5), the HHS 

Secretary, in consultation with the 

Secretary of the U.S. Department of 

Homeland Security, established the 

NACCD. The purpose of the NACCD is 

to provide advice and consultation to 

the HHS Secretary with respect to the 

medical and public health needs of 

children in relation to disasters. 

Background: The September 11, 2018, 

public teleconference of the NACCD is 

dedicated to the presentation, 

deliberation, and vote on the Pediatric 

Disaster Training Work Group (PDTWG) 

and Identifying Metrics of Baseline 

Vulnerability (IMBV) reports. 

Established under the NACCD in 2017, 

the PDTWG met several times over the 

past year to evaluate progress since the 

2011 National Center for Disaster 

Medicine and Public Health consensus 

report and to develop recommendations 

to further improve pediatric training to 

ensure the safety and health of children 

in disasters. Separately, in 2018, the 

ASPR identified metrics of baseline 

community vulnerability as a topic he 

would like the NACCD to address and 

provide recommendations. On June 28, 

2018, the NACCD met publically and inperson to develop metrics via a 

facilitated discussion. Takeaways from 

this discussion served as the basis for 

the IMBV report. We will post 

modifications to the agenda on the 

NACCD meeting website, which is 

located at https://www.phe.gov/naccd. 

Availability of Materials: We will post 

all teleconference materials prior to the 

teleconference on September 11, 2018, 

at the website located at https://

www.phe.gov/naccd. 

Procedures for Providing Public Input: 

Members of the public may attend the 

public teleconference via a toll-free callin phone number, which is available on 

the NACCD website at https://

www.phe.gov/naccd. 

We encourage members of the public 

to provide written comments that are 

relevant to the NACCD public 

teleconference prior to September 11, 

2018. Send written comments by email 

to naccd@hhs.gov with ‘‘NACCD Public 

Comment’’ in the subject line. The 

NACCD Chair will respond to comments 

received by September 10, 2018, during 

the public teleconference. 

Dated: August 13, 2018. 

Robert P. Kadlec, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2018–17901 Filed 8–17–18; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Committee on 

Children and Disasters and National 

Biodefense Science Board Public 

Teleconference 

AGENCY: Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services is hereby giving notice that the 

National Advisory Committee on 

Children and Disasters (NACCD) and 

National Biodefense Science Board 

(NBSB), also known as the National 

Preparedness and Response Science 

Board (NPRSB), will hold a joint public 

teleconference on September 12, 2018. 

DATES: The NBSB and NACCD Joint 

Public Teleconference is September 12, 

2018, from 2:00 p.m. to 3:00 p.m. 

Eastern Daylight Time (EDT). 

ADDRESSES: We encourage members of 

the public to attend the public meetings. 

To register, send an email to naccd@

hhs.gov with ‘‘NACCD Registration’’ in 

the subject line, or to nprsb@hhs.gov 

with ‘‘NBSB Registration’’ in the subject 

line. Submit your comments to naccd@

hhs.gov, nprsb@hhs.gov, the NBSB 

Contact Form located at https://

www.phe.gov/Preparedness/legal/ 

boards/nprsb/Pages/RFNBSBComments.

aspx, or the NACCD Contact Form 


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