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
Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 32133 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2012–N–0253 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Postmarketing Adverse Drug and 

Biological Product Experience Reporting 

and Recordkeeping.’’ 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. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 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, 

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. 

Postmarketing Adverse Drug and 

Biological Product Experience 

Reporting and Recordkeeping 

OMB Control Number 0910–0230— 

Extension 

Sections 201, 502, 505, and 701 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 321, 352, 355, and 371) 

require that marketed drugs be safe and 

effective. To monitor the safety and 

efficacy of drugs that are on the market, 

FDA must be promptly informed of 

adverse experiences associated with the 

use of marketed drugs. FDA issued 

regulations at §§ 310.305 and 314.80 (21 

CFR 310.305 and 314.80) to implement 

reporting and recordkeeping 

requirements on the drug industry that 

would enable FDA to take the action 

necessary to protect the public health 

from adverse drug experiences. 

All applicants who have received 

marketing approval of drug products are 

required to report to FDA serious, 

unexpected adverse drug experiences 

(15-day ‘‘Alert reports’’), as well as 

followup reports (§ 314.80(c)(1)). This 

includes reports of all foreign or 

domestic adverse experiences as well as 

those based on information from 

applicable scientific literature and 

certain reports from postmarketing 

studies. Section 314.80(c)(1)(iii) pertains 

to such reports submitted by 

nonapplicants. 

Under § 314.80(c)(2), applicants must 

provide periodic reports of adverse drug 

experiences. A periodic report includes, 

for the reporting interval, reports of 

serious, expected adverse drug 

experiences and all nonserious adverse 

drug experiences and an index of these 

reports, a narrative summary and 

analysis of adverse drug experiences, an 

analysis of the 15-day Alert reports 

submitted during the reporting interval, 

and a history of actions taken because 

of adverse drug experiences. Under 

§ 314.80(j), applicants must keep for 10 

years records of all adverse drug 

experience reports known to the 

applicant. 

For marketed prescription drug 

products without approved new drug 

applications or abbreviated new drug 

applications, manufacturers, packers, 

and distributors are required to report to 

FDA serious, unexpected adverse drug 

experiences as well as followup reports 

(§ 310.305(c)). Section 310.305(c)(5) 

pertains to the submission of followup 

reports to reports forwarded to the 

manufacturers, packers, and distributors 

by FDA. Under § 310.305(g), each 

manufacturer, packer, and distributor 

shall maintain for 10 years records of all 

adverse drug experiences required to be 

reported. 

The primary purpose of FDA’s 

adverse drug experience reporting 

system is to enable identification of 

signals for potentially serious safety 

problems with marketed drugs. 

Although premarket testing discloses a 

general safety profile of a new drug’s 

comparatively common adverse effects, 

the larger and more diverse patient 

populations exposed to the marketed 

drug provide the opportunity to collect 

information on rare, latent, and longterm effects. Signals are obtained from 

a variety of sources, including reports 

from patients, treating physicians, 

foreign regulatory agencies, and clinical 

investigators. Information derived from 

the adverse drug experience reporting 

system contributes directly to increased 


daltland on DSKBBV9HB2PROD with NOTICES
32134 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 

public health protection because the 

information enables FDA to make 

important changes to the product’s 

labeling (such as adding a new 

warning), to make decisions about risk 

evaluation and mitigation strategies or 

the need for postmarketing studies or 

clinical trials, and when necessary, to 

initiate removal of a drug from the 

market. 

Respondents to this collection of 

information are manufacturers, packers, 

distributors, and applicants. The 

following estimates are based on FDA’s 

knowledge of adverse drug experience 

reporting, including the time needed to 

prepare the reports and the number of 

reports submitted to the Agency. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

310.305(c)(5) ......................................... 3 1 3 1 3 

314.80(c)(1)(iii) ....................................... 5 1 5 1 5 

314.80(c)(2) ........................................... 810 17.19 13,923.90 60 835,434 

Total ................................................ .............................. .............................. .............................. .............................. 835,442 

1The reporting burden for § 310.305(c)(1), (2), and (3), and § 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0291. 2The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per 

recordkeeping 

Total hours 

310.305(g) .............................................. 25 1 25 16 400 

314.80(j) ................................................. 352 1,870 658,240 16 10,531,840 

Total ................................................ .............................. .............................. .............................. .............................. 10,532,240 

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

2There are maintenance costs of approximately $22,000 annually. 

The burden associated with table 2 

has increased due to the electronic 

Safety Reporting Rule that mandated 

sponsors to submit ALL reports 

electronically by September 2016. Prior 

to this date, FDA did not enter all 

individual report data in document 

tracking systems or count some types of 

paper-based nonexpedited reports (i.e., 

those describing adverse events that are 

both nonserious and previously 

labeled). With required electronic 

reporting of all reports and each report 

counted separately, the total number of 

records and required recordkeeping also 

increased. 

Dated: July 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14799 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–2018–N–1917] 

Joint Meeting of the Drug Safety and 

Risk Management Advisory Committee 

and the Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Drug Safety and Risk 

Management Advisory Committee and 

the Anesthetic and Analgesic Drug 

Products Advisory Committee. The 

general function of the committees is to 

provide advice and recommendations to 

FDA on regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

August 3, 2018, from 8 a.m. to 5 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. 

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. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–1917. 

The docket will close on August 2, 

2018. Submit either electronic or 

written comments on this public 

meeting by August 2, 2018. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before August 

2, 2018. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

August 2, 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. 

Comments received on or before July 

25, 2018, will be provided to the 

committees. Comments received after 

that date will be taken into 


daltland on DSKBBV9HB2PROD with NOTICES