32130 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 

Estimated Total Annual Burden 

Hours: 6,188. 

DATES: Comments due within 30 days of 

publication. OMB is required to make a 

decision concerning the collection of 

information between 30 and 60 days 

after publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: Desk 

Officer for the Administration for Children 

and Families. 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. Email address: 

OPREinfocollection@acf.hhs.gov. 

(Authority: Section 413 of the Social Security 

Act, as amended by the FY 2017 

Consolidated Appropriations Act, 2017 (Pub. 

L. 115–31) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–14793 Filed 7–10–18; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2434] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Meetings With 

Sponsors and Applicants for 

Prescription Drug User Fee Act 

Products 

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, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection contained in the guidance for 

industry on formal meetings with 

sponsors and applicants for Prescription 

Drug User Fee Act (PDUFA) products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 10, 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 September 10, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 10, 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–2434 for ‘‘Guidance for 

Industry on Formal Meetings with 

Sponsors and Applicants for PDUFA 

Products.’’ 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. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 32131 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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, 

including each proposed extension of an 

existing 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. 

Guidance for Industry on Formal 

Meetings With Sponsors and 

Applicants for Prescription Drug User 

Fee Act Products 

OMB Control Number 0910–0429— 

Extension 

This information collection supports 

the above captioned Agency guidance 

document. The guidance document was 

issued to help individuals with 

procedures on formal meetings between 

FDA and sponsors or applicants 

regarding the development and review 

of PDUFA products. The guidance 

describes procedures for requesting, 

scheduling, conducting, and 

documenting such formal meetings. The 

guidance provides information on how 

FDA interprets and applies section 

119(a) of the Food and Drug 

Administration Modernization Act of 

2007 (FDAMA) (Pub. L. 105–115), 

specific PDUFA goals for the 

management of meetings associated 

with the review of human drug 

applications for PDUFA products, and 

provisions of existing regulations 

describing certain meetings (§§ 312.47 

and 312.82 (21 CFR 312.47 and 312.82)). 

The collection of information described 

in the guidance reflects the current and 

past practice of sponsors and applicants 

to submit meeting requests and 

background information prior to a 

scheduled meeting. Agency regulations 

currently permit such requests and 

recommend the submission of an 

information package before an ‘‘end-ofphase 2 meeting’’ (§§ 312.47(b)(1)(ii) 

and (iv)) and a ‘‘pre-NDA meeting’’ 

(§ 312.47(b)(2)). While the information 

collection provisions of § 312.47 are 

currently approved under OMB control 

number 0910–0014, the guidance 

provides additional recommendations 

for submitting information to FDA in 

support of a meeting request. The 

guidance document is available on our 

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

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

UCM590547.pdf. 

Request for a Meeting—Consistent 

with recommendations found in the 

guidance, a sponsor or applicant 

interested in meeting with the Center for 

Drug Evaluation and Research (CDER) or 

the Center for Biologics Evaluation and 

Research (CBER) should submit a 

meeting request to the appropriate FDA 

component as an amendment to the 

application for the underlying product 

in accordance with our regulations 

(§§ 312.23, 314.50, and 601.2 (21 CFR 

312.23, 314.50, and 601.2)). Information 

provided to the Agency as part of an 

investigational new drug application 

(IND), NDA, or biological license 

application (BLA) must be submitted 

with an appropriate cover form. Form 

FDA 1571 must accompany IND 

submissions, and Form FDA 356h must 

accompany NDA and BLA submissions. 

These Agency forms are approved under 

OMB control numbers 0910–0014 and 

0910–0338, respectively. 

We recommend that a request be 

submitted in this manner to ensure that 

each request is kept in the 

administrative file with the complete 

application, and to ensure that pertinent 

information about the request is entered 

into appropriate tracking databases. 

Using information from our tracking 

databases enables us to monitor progress 

on activities attendant to scheduling 

and holding a formal meeting and to 

ensure that appropriate steps will be 

taken in a timely manner. 

The guidance recommends that 

meeting requests include the following 

information: 

• Information identifying and 

describing the product 

• the type of meeting being requested 

• a brief statement of the purpose of the 

meeting 

• a list of objectives and expected 

outcomes from the meeting 

• a preliminary proposed agenda 

• a draft list of questions to be raised at 

the meeting 

• a list of individuals who will 

represent the sponsor or applicant at 

the meeting 

• a list of Agency staff requested to be 

in attendance 

• the approximate date that the 

information package will be sent to 

the Agency 

• suggested dates and times for the 

meeting 

We use the information to determine 

the purpose of the meeting, the 

necessary participants, the proposed 

agenda, and to schedule the meeting. 

Information Package—The guidance 

also recommends that a sponsor or 

applicant submitting an information 

package provide summary information 

relevant to the product and 

supplementary information pertaining 

to any issue raised by the sponsor, 

applicant, or FDA. Information packages 

should generally include: 

• Identifying information about the 

underlying product 

• a brief statement of the purpose of the 

meeting 

• a list of objectives and expected 

outcomes of the meeting 

• a proposed agenda for the meeting 

• a list of specific questions to be 

addressed at the meeting 

• a summary of clinical data that will be 

discussed (as appropriate) 

• a summary of preclinical data that 

will be discussed (as appropriate) 

• chemistry, manufacturing, and 

controls information that may be 

discussed (as appropriate) 

The information package enables 

Agency staff to prepare for the meeting 

and allows appropriate time for 

reviewing relevant product data. 

Although FDA reviews similar 

information in the meeting request, the 

information package should provide 

updated data reflecting the most current 

and accurate information available to 

the sponsor or applicant. 

We estimate the burden of the 

information collection as follows: 


daltland on DSKBBV9HB2PROD with NOTICES
32132 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance recommendations Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Meeting Requests: 

CDER ............................................................................ 1,319 2.31 3,058 10 30,580 

CBER ............................................................................ 301 1.21 363 10 3,630 

Subtotal .................................................................. ........................ ........................ ........................ ........................ 34,210 

Information Packages: 

CDER ............................................................................ 1,149 2.19 2,522 18 45,396 

CBER ............................................................................ 187 1.12 210 18 3,780 

Subtotal .................................................................. ........................ ........................ ........................ ........................ 49,176 

Total ................................................................ ........................ ........................ ........................ ........................ 83,386 

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

Our estimated burden for the 

information collection reflects an 

overall increase since the previous OMB 

approval. We attribute this adjustment 

to an increase in the number of meeting 

requests and information packages 

received over the last few years. 

Based on Agency data, we estimate 

1,319 sponsors and applicants 

(respondents) request 3,058 formal 

meetings with CDER annually, and 301 

respondents request 363 formal 

meetings with CBER annually regarding 

the development and review of a 

PDUFA product. The hours per 

response, which is the estimated 

number of hours that a respondent 

spends preparing the information to be 

submitted with a meeting request in 

accordance with the guidance, is 

estimated to be 10 hours. We expect it 

takes this amount of time to gather and 

copy brief statements about the product 

as well as a description of the purpose 

and details of the meeting. 

Also consistent with Agency data, we 

estimate 1,149 respondents submitted 

2,522 information packages to CDER 

annually, and 187 respondents 

submitted 210 information packages to 

CBER annually, prior to a formal 

meeting regarding the development and 

review of a PDUFA product. We 

estimate 18 hours is needed to prepare 

the information package in accordance 

with the guidance. 

Dated: July 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14800 Filed 7–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0253] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarketing 

Adverse Drug and Biological Product 

Experience Reporting and 

Recordkeeping 

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, including 

each proposed extension of an existing 

collection of information, and to allow 

60 days for public comment in response 

to the notice. This notice solicits 

comments on the information collection 

provisions of FDA’s postmarketing 

adverse drug experience reporting and 

recordkeeping requirements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 10, 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 September 10, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 10, 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 


daltland on DSKBBV9HB2PROD with NOTICES