Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices 40771 

authority of exemption 4 of the Freedom 

of Information Act (5 U.S.C. 552(b)(4)). 

Exemption 4 protects from disclosure 

trade secrets and privileged or 

confidential commercial or financial 

information. 

Current actions: On May 18, 2018, the 

Board published a notice in the Federal 

Register (83 FR 23276) requesting 

public comment for 60 days on the 

extension, with revision, of the FR 2420. 

The Board proposes to revise the FR 

2420 by adding Selected Deposits (Part 

D) and removing Selected Borrowings 

from Non-Exempt Entities (Part AA). 

Other minor edits in the reporting 

instructions are proposed to improve 

clarity. The first report for the proposed 

revisions to FR 2420 would be as of 

October 1, 2018. The comment period 

for this notice expired on July 17, 2018. 

The Board received one comment from 

a government entity supporting the 

continued collection of data on the FR 

2420. The revisions will be 

implemented as proposed. 

Board of Governors of the Federal Reserve 

System, August 13, 2018. 

Ann Misback, 

Secretary of the Board. 

[FR Doc. 2018–17670 Filed 8–15–18; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2970] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Surveys and 

Interviews With Investigational New 

Drug Sponsors To Assess Current 

Communication Practices With Food 

and Drug Administration Review Staff 

Under the Sixth Authorization of the 

Prescription Drug User Fee Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a proposed 

information collection involving 

surveys and interviews of sponsors of 

commercial investigational new drugs 

(INDs) to obtain feedback about 

communication practices with FDA 

review staff. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 15, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 15, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 15, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–2970 for ‘‘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).’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

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. 


sradovich on DSK3GMQ082PROD with NOTICES
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