40772 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10 a.m.–12 p.m., 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Surveys and Interviews With 

Investigational New Drug (IND) 

Sponsors To Assess Current 

Communication Practices With FDA 

Review Staff Under the Sixth 

Authorization of the Prescription Drug 

User Fee Act (PDUFA VI) 

OMB Control Number 0910—NEW 

In Fiscal Year (FY) 2017, FDA 

published guidance on communications 

between FDA review staff and drug 

sponsors during the IND phase of drug 

development. As part PDUFA VI, FDA 

committed to a third-party assessment 

of current IND-phase communication 

practices, which should reflect this 

guidance. The contractor for the 

assessment of IND communication 

practices is Eastern Research Group, Inc. 

(ERG). 

Therefore, in accordance with the 

PDUFA VI Commitment Letter, FDA 

proposes to have ERG conduct surveys 

and interviews with sponsors of up to 

150 active commercial INDs as follows: 

• For each formal meeting between 

FDA review staff and active commercial 

IND sponsors during the assessment 

period, send a survey to the sponsor to 

solicit specific feedback about 

communication practices employed for 

that meeting. For the purpose of this 

assessment, formal meetings are Type 

A, B, B (End of Phase), and C meetings 

during the IND phase of drug 

development. 

• For each active commercial IND in 

the assessment, conduct an interview 

with the sponsor to obtain broader 

feedback about all communications with 

FDA review staff during the study 

period, including telephone and email 

interactions in addition to meetings. 

The purpose of this information 

collection is to understand active 

commercial IND sponsor perspectives 

on communication during drug 

development with a focus on what is 

working well, ongoing challenges and 

pain points, lessons learned, and 

opportunities for improvement. The 

contractor will develop anonymized 

aggregated summaries of survey and 

interview responses, analyze this 

information to identify common themes, 

consider these results along with IND 

data and feedback from FDA review 

staff to develop a set of findings and 

recommendations, and prepare a report 

to be published on FDA’s website. The 

contractor will keep information 

collected private; ERG will not disclose 

personally identifying information to 

FDA or any other party. 

The number of commercial INDs with 

activity is approximately 4,000 per year. 

ERG will interview 1 to 3 sponsor 

representatives at a time for up to 150 

INDs during the annual assessment 

period. 

Thus, FDA estimates the burden of 

this collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

IND sponsors: Surveys ................................................ 150 1 150 0.17 (10 minutes) .. 25.50 

IND sponsors: Interviews ............................................. 450 1 450 1.5 ......................... 675 

Total ...................................................................... ........................ ........................ ........................ ............................... 700.50 

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

FDA estimates that it will take each 

IND sponsor a maximum of 10 minutes 

to complete a survey. Up to 150 

respondents will take part in the survey, 

yielding a maximum burden of 25.5 

hours. FDA estimates that it will take 

each IND sponsor up to 90 minutes to 

respond to requests for interviews and 

participate in interviews. Up to 450 

respondents will take part in interviews, 

yielding a maximum burden of 675 

hours. FDA’s burden estimates are based 

on experience with information 

collections for similar types of PDUFArelated assessments. 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17715 Filed 8–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2945] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices 40773 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

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. Members will 

participate via teleconference. 

DATES: The meeting will be held on 

October 3, 2018, from 11 a.m. to 3:30 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Avenue, 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/vrbpac1018. 

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/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–5771, 

serina.hunter-thomas@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 website 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 3, 2018, 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 

2019 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 website 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 website 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 26, 2018. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

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 18, 2018. 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 19, 2018. 

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 website at: 

https://www.fda.gov/Advisory

Committees/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: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17702 Filed 8–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Committee on Rural 

Health and Human Services 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The Secretary’s National 

Advisory Committee on Rural Health 

and Human Services (NACRHHS) has 

scheduled a public meeting. Information 

about NACRHHS and the agenda for this 

meeting can be found on the NACRHHS 

website at https://www.hrsa.gov/ 

advisory-committees/rural-health/ 

index.html. 

DATES: September 10, 2018, 8:30 a.m.– 

5:15 p.m. ET; September 11, 2018, 8:30 

a.m.–5:15 p.m. ET; September 12, 2018, 

8:30 a.m.–11:15 a.m. ET. 

ADDRESSES: On September 10, the 

address for the meeting is The Duke 

Endowment, 800 East Morehead Street, 

Charlotte, NC 28202. 

On the morning of September 11, 

NACRHHS will break into 

subcommittees. One subcommittee will 

travel to Happy Valley Medical Center, 

1345 NC Highway 268, Lenoir, NC 

28645. The other subcommittee will 

travel to Winnsboro Smiles Dental 

Clinic, 124 N Congress Street, 

Winnsboro, SC 29180. In the afternoon, 

at approximately 4:00 p.m. ET., 

NACRHHS will reconvene at the AC 

Hotel Charlotte City Center, 220 E Trade 

Street, Charlotte, NC 28202. 

On September 12, the address for the 

meeting is AC Hotel Charlotte City 

Center, 220 E Trade Street, Charlotte, 

NC 28202. 

FOR FURTHER INFORMATION CONTACT: 

Steven Hirsch, Administrative 

Coordinator at the Federal Office of 

Rural Health Policy, HRSA, 5600 

Fishers Lane, 17W59D, Rockville, 

Maryland 20857; 301–443–7322; or 

shirsch@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

NACRHHS provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning both rural 

health and rural human services. 

During the September meetings, 

NACRHHS will discuss the issues of 

chronic obstructive pulmonary disease, 

one of the leading causes of mortality in 

rural areas, and the provision of oral 

health services in rural areas. Agenda 

items are subject to change as priorities 

dictate. 

Members of the public will have the 

opportunity to provide comments. 


sradovich on DSK3GMQ082PROD with NOTICES