45642 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 

e. What are the implications of these 

contracting provisions and their changes 

for the probability, severity, and 

duration of drug shortages? 

f. How much competition exists 

throughout the supply chain? Over the 

past 15 years, have there been 

challenges to competition and if so, 

what factors are responsible for these 

challenges? For example, has 

consolidation in different parts of the 

supply chain created market barriers to 

entry and reduced competition? If so, 

what effect has the reduction in 

competition had on drug shortages? 

C. Identifying Strategies for Preventing 

or Mitigating Drug Shortages 

1. What policies could the Federal 

Government adopt, and what strategies 

could it implement, that would reduce 

the likelihood, severity, and duration of 

shortages? Would additional authorities 

be necessary or helpful? For example: 

a. Establish a list of ‘‘essential 

medicines’’ for use in preventing and 

mitigating shortages. If such a list were 

established, what should be the criteria 

for inclusion? And how should such a 

list be maintained and administered? 

b. Provide financial incentives, such 

as tax credits or revised reimbursement 

policies: e.g., to allow additional 

payments for drugs in or at risk of 

shortage or to encourage investment to 

expand manufacturing capacity or to 

modernize aging infrastructure, to 

enhance process capability and 

variability control, or to prevent 

manufacturing problems that affect 

product availability; 

c. Allow other entities (e.g., contract 

manufacturers) to fill gaps in supply; 

d. Require risk management plans to 

help manufacturers prepare to respond 

efficiently and effectively to potential 

shortages; 

e. Require the extension of expiration 

dates for drugs in shortage or at risk of 

shortage, where scientifically justified; 

f. Revise trade policies and 

authorities: e.g., to allow federal 

purchasers to buy imported drugs or 

raw materials to prevent or mitigate a 

shortage; 

g. Heighten scrutiny of proposed 

mergers and acquisitions that increase 

market concentration or the likelihood 

of shortages; 

h. Revise payment policies and 

authorities: e.g., that would be coupled 

with a requirement to establish 

contingency plans for supplying 

medicines that go into shortage; and 

i. Federal investment in production 

capacity for essential medicines directly 

related to national security, emergency 

preparedness, and defense. 

2. In designing new policies to 

prevent or mitigate shortages, how can 

the Federal Government avoid creating 

perverse incentives or negative 

cascading effects in the health care 

financing and delivery system? For 

example, how might changes to 

government payment and 

reimbursement affect the other sectors 

of the market? 

3. Are there lessons for the Federal 

Government, or practices that it can 

emulate, from strategies used to prevent 

or mitigate shortages in other 

commodity markets that face shortage 

issues? 

4. What challenges does the global 

nature of drug manufacturing and 

marketing pose for efforts to prevent 

shortages in the U.S. market? 

5. As drug shortages are a national 

problem, what are the sources of 

funding that can be applied to provide 

incentives to remedy the root causes? 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://healthpolicy.duke.edu/ 

events/drug-shortage-task-force. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. Registration is free and based 

on space availability, with priority given 

to early registrants. Persons interested in 

attending this public meeting must 

register by Wednesday, November 21, 

2018, midnight Eastern Time. There will 

be no onsite registration. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants from 

each organization. Registrants will 

receive confirmation when they have 

been accepted. If you are unable to 

attend the meeting in person, you can 

register to view a live webcast of the 

meeting. The Duke-Margolis Center for 

Health Policy will post on its website if 

registration closes before the day of the 

public meeting. 

If you need special accommodations 

due to a disability, please contact Sarah 

Supsiri at the Duke-Margolis Center for 

Health Policy (phone: 202–791–9561, 

email: sarah.supsiri@duke.edu) no later 

than November 20, 2018. 

Streaming webcast of the public 

workshop: This public workshop will be 

webcast live. Persons interested in 

viewing the live webcast may register 

ahead of the event by visiting https://

healthpolicy.duke.edu/events/drugshortage-task-force. The live webcast 

will also be available at the website 

above on the day of the event without 

pre-registration. Archived video footage 

will be available at the Duke-Margolis 

website following the workshop. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/Drugs/ 

DrugSafety/DrugShortages/default.htm. 

Other Issues for Consideration: A 1- 

hour lunch break is scheduled, but food 

will not be provided. There are multiple 

restaurants within walking distance of 

the Washington Marriott at Metro 

Center, 775 12th St. NW, Washington, 

DC 20005. 

All event materials will be provided 

to registered attendees via email prior to 

the workshop and will be publicly 

available at the Duke-Margolis Center 

for Health Policy website at https://

healthpolicy.duke.edu/events/drugshortage-task-force. 

Dated: September 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19612 Filed 9–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Vascular and 

Hematology Integrated Review Group; 

Hypertension and Microcirculation Study 

Section. 

Date: October 2–3, 2018. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Ai-Ping Zou, M.D., Ph.D., 

Scientific Review Officer, Center for 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 45643 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4118, 

MSC 7814, Bethesda, MD 20892, 301–408– 

9497, zouai@mail.nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Mechanisms of 

Sensory, Perceptual, and Cognitive Processes 

Study Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Ave. NW, Washington, DC 20037. 

Contact Person: Kirk Thompson, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5184, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1242, kgt@mail.nih.gov. 

Name of Committee: Interdisciplinary 

Molecular Sciences and Training Integrated 

Review Group; Enabling Bioanalytical and 

Imaging Technologies Study Section. 

Date: October 4–5, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Crystal City Marriott, 1999 Jefferson 

Davis Highway, Arlington, VA 22202. 

Contact Person: Kenneth Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3218, 

MSC 7717, Bethesda, MD 20892, 301–435– 

0229, kenneth.ryan@nih.hhs.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Interventions to Prevent and Treat 

Addictions Study Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Palomar Hotel, 2121 P Street NW, 

Washington, DC 20037. 

Contact Person: Miriam Mintzer, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3108, 

Bethesda, MD 20892, (301) 523–0646, 

mintzermz@csr.nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group; Biology of the 

Visual System Study Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Michael H Chaitin, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5202, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

0910, chaitinm@csr.nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Bioengineering, 

Technology and Surgical Sciences Study 

Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Khalid Masood, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5120, 

MSC 7854, Bethesda, MD 20892, 301–435– 

2392, masoodk@csr.nih.gov. 

Name of Committee: Emerging 

Technologies and Training Neurosciences 

Integrated Review Group; Neuroscience and 

Ophthalmic Imaging Technologies Study 

Section. 

Date: October 4–5, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Washington DC 

Downtown Hotel, 999 9th St. NW, 

Washington, DC 20001. 

Contact Person: Yvonne Bennett, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5199, 

MSC 7846, Bethesda, MD 20892, 301–379– 

3793, bennetty@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Cellular and Molecular 

Biology of Glia Study Section. 

Date: October 4–5, 2018. 

Time: 8:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: St. Gregory Hotel, 2033 M Street 

NW, Washington, DC 20036. 

Contact Person: Linda MacArthur, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4187, 

Bethesda, MD 20892, 301–537–9986, 

macarthurlh@csr.nih.gov. 

Name of Committee: Immunology 

Integrated Review Group; Cellular and 

Molecular Immunology—B Study Section. 

Date: October 4–5, 2018. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham Grand Chicago 

Riverfront, 71 E Wacker Dr., Chicago, IL 

60601. 

Contact Person: Betty Hayden, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4206, 

MSC 7812, Bethesda, MD 20892, 301–435– 

1223, haydenb@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 4, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19484 Filed 9–7–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 

Aging Special Emphasis Panel; Developing 

Infrastructure for Interdisciplinary Aging 

Research. 

Date: September 24, 2018. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2W–200, 7201 

Wisconsin Avenue, Bethesda, MD 20892. 

Contact Person: Anita H. Undale, Ph.D., 

MD, Scientific Review Branch, National 

Institute on Aging, Gateway Building, Suite 

2W200, 7201 Wisconsin Avenue, Bethesda, 

MD 20892, 240–747–7825, anita.undale@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: September 4, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19481 Filed 9–7–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Advisory Committee to 

the Deputy Director for Intramural 

Research, National Institutes of Health. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 


daltland on DSKBBV9HB2PROD with NOTICES