47536 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

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copies of the draft guidance to the 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

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Murray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6360, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Respiratory Syncytial Virus Infection: 

Developing Antiviral Drugs for 

Prophylaxis and Treatment.’’ This draft 

guidance addresses FDA’s current 

thinking regarding the overall drug 

development program for an indication 

for treatment and prevention of disease 

caused by RSV infection including 

nonclinical development, early phases 

of clinical development, and phase 3 

trial designs. This draft guidance 

focuses primarily on pediatric antiviral 

drug development for RSV but also 

discusses drug development for other 

populations. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Respiratory Syncytial Virus 

Infection: Developing Antiviral Drugs 

for Prophylaxis and Treatment.’’ 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. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 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. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: October 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22051 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–new] 

Agency Information Collection 

Request; 60-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 December 11, 

2017. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990-New-60D 

and project title for reference, to 

Sherrette.funn@hhs.gov, or call the 

Reports Clearance Officer. 

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: I Can Do It, 

You Can Do It! Program Evaluation. 

Type of Collection: New. 

OMB No. 0990–NEW–Office within 

OS—Office of the President’s Council 

on Fitness, Sports & Nutrition 

(OPCFSN), Office of the Assistant 

Secretary for Health. 

Abstract: Initiated by the former HHS 

Office on Disability, supported by the 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development and the former Division of 

Nutrition Research Coordination at the 

National Institutes of Health, and 

adopted by OPCFSN in 2011, the I Can 

Do It, You Can Do It! health promotion 

program is designed to provide access 

and opportunities for children and 

adults with a wide range of physical and 

cognitive disabilities to lead healthy, 

active lives. Approximately 56 million 

children and adults living in the United 

States have some level of disability. 

Despite physical activity and good 

nutrition being the cornerstones of 

evidence-based health promotion 

interventions for reducing the risk of 

comorbidities (e.g., diabetes, heart 

disease, stroke), many people with a 

disability or caregivers who have a child 

with a disability experience substantial 

difficulty accessing these programs. The 

program partners with K–12 schools and 

school districts, colleges and 

universities, and other communitybased entities that implement the 

program using a mentoring approach 

that has been well-documented in the 

research literature as efficacious in 

changing the attitudes, knowledge, and 

health behaviors of individuals with 

and without a disability. 

The information collected for the I 

Can Do It, You Can Do It! Program 

Evaluation will allow the OPCFSN and 

partners to assess the impact of the 

program and gather critical information 

for improvement. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47537 

ANNUALIZED BURDEN HOUR TABLE

Forms Respondents Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden 

hours 

Advocate Form ................................. Site Coordinator .............................. 10 1 20/60 3 

Advocate Annual Follow-Up Survey Site Coordinator .............................. 10 1 20/60 3 

End of Wave 1 Interview Script ....... Site Coordinator .............................. 10 1 1 10 

End of Wave 1 Feedback Survey .... Site Coordinator .............................. 10 1 45/60 8 

End of Wave 2 Interview ................. Site Coordinator .............................. 10 1 1 10 

End of Wave 2 Feedback Survey .... Site Coordinator .............................. 10 1 20/60 3 

Technical Assistance Assessment .. Site Coordinator .............................. 10 1 25/60 4 

Mentee Pre-Assessment .................. Mentee/Program Participant ............ 700 1 20/60 233 

Mentee Post-Assessment ................ Mentee/Program Participant ............ 700 1 20/60 233 

Mentor Feedback Survey ................. Mentor ............................................. 700 1 15/60 175 

Weekly Goal-Setting Guide ............. Mentor ............................................. 700 10 10/60 1166 

Mentee Focus Group Script ............. Mentee/Program Participant ............ 60 1 1 60 

Parent/Guardian Focus Group 

Script.

Mentee’s Parent/Guardian .............. 60 1 1 60 

Total .......................................... .......................................................... ........................ 22 ........................ 1968 

Terry S. Clark, 

Office of the Secretary, Asst Paperwork 

Reduction Act Reports Clearance Officer. 

[FR Doc. 2017–21983 Filed 10–11–17; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism, Special 

Emphasis Panel; NIAAA Fellowship Review. 

Date: November 2, 2017. 

Time: 8:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, Terrace Conference Room, 5635 

Fishers Lane, Bethesda, MD 20892. 

Contact Person: Richard A. Rippe, Ph.D., 

Scientific Review Officer, Extramural Project 

Review Branch, Office of Extramural 

Activities, National Institute on Alcohol 

Abuse and Alcoholism, National Institutes of 

Health, 5635 Fishers Lane, Room 2109, 

Rockville, MD 20852 301–443–8599, 

rippera@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel, SEP Review Member 

Conflict Applications. 

Date: November 14, 2017. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 5635 Fishers Lane, Rockville, 

MD 20892 (Telephone Conference Call). 

Contact Person: Anna Ghambaryan, M.D., 

Scientific Review Officer, Office of 

Extramural Activities, National Institute on 

Alcohol Abuse and Alcoholism, National 

Institutes of Health, 5635 Fishers Lane, 

Rockville, MD 20852, 301–443–4032, 

anna.ghambaryan@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards., National 

Institutes of Health, HHS). 

Dated: October 5, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21989 Filed 10–11–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: DNA-Based Vaccine for 

Prevention of Zika Virus Infection 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Allergy and Infectious Diseases (NIAID), 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Commercialization 

Patent License to PaxVax, Inc., located 

in Redwood City, California, to practice 

the inventions embodied in the patent 

applications listed in the 

SUPPLEMENTARY INFORMATION section of 

this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before November 

13, 2017 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive Commercialization Patent 

License should be directed to: Dr. Amy 

Petrik, Technology Transfer and Patent 

Specialist, Technology Transfer and 

Intellectual Property Office, National 

Institute of Allergy and Infectious 

Diseases, 5601 Fishers Lane, Suite 2G, 

MSC9804, Rockville, MD 20852–9804, 

phone number 301–496–2644, or 

petrika@mail.nih.gov. 


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