Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices 42685 

Background on the Task Force: The 

Task Force is an independent, 

nonfederal panel whose members are 

appointed by the CDC Director. Task 

Force members represent a broad range 

of research, practice, and policy 

expertise in prevention, wellness, health 

promotion, and public health. The Task 

Force was convened in 1996 by the 

Department of Health and Human 

Services (HHS) to identify community 

preventive programs, services, and 

policies that increase healthy longevity, 

save lives and dollars, and improve 

Americans’ quality of life. CDC is 

mandated to provide ongoing 

administrative, research, and technical 

support for the operations of the Task 

Force. During its meetings, the Task 

Force considers the findings of 

systematic reviews on existing research 

and practice-based evidence and issues 

recommendations. Task Force 

recommendations are not mandates for 

compliance or spending. Instead, they 

provide information about evidencebased options that decision makers and 

stakeholders can consider when they are 

determining what best meet the specific 

needs, preferences, available resources, 

and constraints of their jurisdictions 

and constituents. The Task Force’s 

recommendations, along with the 

systematic reviews of the evidence on 

which they are based, are compiled in 

the Guide to Community Preventive 

Services (The Community Guide). 

Matters proposed for discussion: 

Cardiovascular Disease Prevention 

(Mobile Health Interventions for 

Cardiovascular Disease Prevention); 

Diabetes Prevention and Control 

(Lifestyle Interventions to Reduce Risk 

of Gestational Diabetes); Nutrition 

(Gardening-Based Interventions to 

Increase Fruit and Vegetable Intake); 

Obesity Prevention and Control (Schoolbased Diet and Physical Activity 

Interventions); and Women’s Health 

(Primary Prevention of Intimate Partner 

Violence and Sexual Violence Among 

Youth). The agenda is subject to change 

without notice. 

Roybal Campus Security Guidelines: 

The Edward R. Roybal Campus is the 

headquarters of the CDC and is located 

at 1600 Clifton Road NE., Atlanta, 

Georgia. The meeting is being held in a 

Federal government building; therefore, 

Federal security measures are 

applicable. 

All meeting attendees must register by 

the dates outlined under Meeting 

Accessability. In planning your arrival 

time, please take into account the need 

to park and clear security. All visitors 

must enter the Edward R. Roybal 

Campus through the front entrance on 

Clifton Road. Vehicles may be searched, 

and the guard force will then direct 

visitors to the designated parking area. 

Upon arrival at the facility, visitors must 

present government-issued photo 

identification (e.g., a valid federal 

identification badge, state driver’s 

license, state non-driver’s identification 

card, or passport). Non-U.S. citizens 

must complete the required security 

paperwork prior to the meeting date and 

must present a valid passport, visa, 

Permanent Resident Card, or other type 

of work authorization document upon 

arrival at the facility. All persons 

entering the building must pass through 

a metal detector. CDC Security 

personnel will issue a visitor’s ID badge 

at the entrance to Building 19. Visitors 

may receive an escort to the meeting 

room. All items brought to HHS/CDC 

are subject to inspection. 

Dated: September 6, 2017. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2017–19203 Filed 9–8–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4851] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC). The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. 

Members will participate via 

teleconference. 

DATES: The meeting will be held on 

October 4, 2017, from 1 p.m. to 4:30 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

For those unable to attend in person, the 

meeting will also be webcast and will be 

available at the following link: https:// 

collaboration.fda.gov/cbervrbpac2017. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas or Rosanna 

Harvey, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 6307C, Silver 

Spring, MD 20993–0002, 240–402–5771 

serina.hunter-thomas@fda.hhs.gov and 

240–402–8072, rosanna.harvey@

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 

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 Web site 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: On October 4, 2017, the 

VRBPAC will meet in an open session 

to discuss and make recommendations 

on the selection of strains to be included 

in an influenza virus vaccine for the 

2018 southern hemisphere influenza 

season. 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 Web 

site prior to the meeting, the background 

material will be made publicly available 

at the location of the advisory 

committee meeting, and the background 

material will be posted on FDA’s Web 

site after the meeting. Background 

material is available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. 

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 September 27, 2017. 

Oral presentations from the public will 

be scheduled between approximately 

1:15 p.m. and 2:15 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
42686 Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices 

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 September 19, 2017. 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 

September 20, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

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 Serina HunterThomas at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at: 

https://www.fda.gov/ 

AdvisoryCommittees/ 

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: September 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19129 Filed 9–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0809] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that KYMRIAH 

(tisagenlecleucel), manufactured by 

Novartis Pharmaceuticals Corporation, 

meets the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Gretchen Opper, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), which was 

added by FDASIA, FDA will award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that KYMRIAH 

(tisagenlecleucel), manufactured by 

Novartis Pharmaceuticals Corporation, 

meets the criteria for a priority review 

voucher. KYMRIAH (tisagenlecleucel) is 

indicated for the treatment of patients 

up to 25 years of age with B-cell 

precursor acute lymphoblastic leukemia 

(ALL) that is refractory or in second or 

later relapse. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go tohttps://www.fda.gov/ForIndustry/

DevelopingProductsfor

RareDiseasesConditions/

RarePediatricDiseasePriorityVoucher

Program/default.htm. For further 

information about KYMRIAH 

(tisagenlecleucel), go to the Center for 

Biologics Evaluation and Research 

cellular and gene therapy products Web 

site at https://www.fda.gov/Biologics

BloodVaccines/CellularGeneTherapy

Products/ApprovedProducts/

default.htm. 

Dated: September 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19130 Filed 9–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Vince Contreras, 240–669–2823; 

Vince.Contreras@nih.gov. Licensing 

information and copies of the patent 

applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Broadly Neutralizing Antibodies 

Against HIV–1 Directed to the CD4 

Binding Site of HIV Envelope Protein 

Description of Technology 

Inhibiting the ability of HIV–1, the 

virus that causes AIDS, to infect cells is 

one approach to both prevention and 

treatment of HIV. Scientists at the 

NIAID Vaccine Research Center have 

isolated and characterized neutralizing 

antibodies (VRC01, 02, 03, and 07) that 

bind to the CD4 binding site of HIV–1 

envelope glycoprotein gp120. These 

human monoclonal antibodies can 

potentially be used as a therapeutic to: 

(1) Treat an HIV infection, (2) decrease 

and prevent HIV-transmission from 

mother to infant, and (3) be effectively 

combined with anti-retroviral drug 

therapy. Additionally, the antibodies 

can be used for detection of HIV–1 

infection in biological samples, 

including body fluids; and tissues from 

biopsies, autopsies, and pathology 

specimens. 

VRC01 has been tested in several 

phase I clinical trials for safety and 

pharmacokinetics in infants, adults, and 


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