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
Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 32135 

consideration by FDA. You may submit 

comments as follows: 

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–1917 for ‘‘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.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES section), 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.’’ FDA 

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 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 the 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: 

Philip A. Bautista, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

DSaRM@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 

FDA’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: The committees will discuss 

results from assessments of the 

transmucosal immediate-release 

fentanyl (TIRF) medicines’ risk 

evaluation and mitigation strategy 

(REMS), approved in December 2011. 

The TIRF REMS requires that healthcare 

providers who prescribe TIRF 

medicines for outpatient use are 

specially certified, that pharmacies that 

dispense TIRF medicines for inpatient 

and outpatient use are specially 

certified, and that completion of the 

prescriber-patient agreement form 

occurs prior to dispensing TIRF 

medicines for outpatient use. The 

Agency will seek the committees’ 

assessment as to whether this REMS 

with elements to assure safe use 

(ETASU) assures safe use, is not unduly 

burdensome to patient access to the 

drugs, and to the extent practicable, 

minimizes the burden to the healthcare 

delivery system. The Agency will also 

seek the committees’ input on any 

possible modifications to the TIRF 

REMS goals and requirements, as well 

as input on the adequacy of the 

evaluations conducted in the REMS 

assessments to determine whether the 

TIRF REMS goals are being met. 

Comments from the public can be 

submitted to the docket (see ADDRESSES

section) on a broad evaluation of the 

TIRF REMS and whether any aspect of 

the TIRF REMS should be modified as 

well as any proposed modifications. 

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 committees. All electronic 

and written submissions submitted to 

the Docket (see ADDRESSES section) on 

or before July 25, 2018, will be provided 

to the committee. Oral presentations 

from the public will be scheduled 

between approximately 1 p.m. and 2 

p.m. Those individuals interested in 


daltland on DSKBBV9HB2PROD with NOTICES
32136 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices 

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 July 19, 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 July 20, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

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 Philip A. 

Bautista (see FOR FURTHER INFORMATION

CONTACT) 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/ 

AdvisoryCommittees/ 

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: June 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14795 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–D–1835] 

Smallpox (Variola Virus) Infection: 

Developing Drugs for Treatment or 

Prevention; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Smallpox (Variola Virus) Infection: 

Developing Drugs for Treatment or 

Prevention.’’ The purpose of this draft 

guidance is to assist sponsors in all 

phases of development of antiviral 

drugs for the treatment or prevention of 

smallpox (variola virus) infection. This 

draft guidance revises the draft guidance 

for industry entitled ‘‘Smallpox 

(Variola) Infection: Developing Drugs for 

Treatment or Prevention’’ issued on 

November 23, 2007. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 10, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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–D–1835 for ‘‘Smallpox (Variola 

Virus) Infection: Developing Drugs for 

Treatment or Prevention; Draft 

Guidance for Industry; Availability.’’ 

Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 


daltland on DSKBBV9HB2PROD with NOTICES