67298 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: March 30, 2016. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

XERMELO (NDA 208794) was initially 

submitted on March 30, 2016. 

3. The date the application was 

approved: February 28, 2017. FDA has 

verified the applicant’s claim that NDA 

208794 was approved on February 28, 

2017. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,175 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–28218 Filed 12–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0197] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Shortages Data Collection System 

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 reinstatement 

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 

Shortages Data Collection System for 

certain medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 26, 2019. 

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 February 26, 

2019. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 26, 2019. 

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– 

2012–N–0197 for ‘‘Shortages Data 

Collection System.’’ 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67299 

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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, (301) 796–8867, 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 reinstatement 

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. 

Shortages Data Collection System 

OMB Control Number 0910–0491— 

Reinstatement 

Under section 1003(d)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 393(d)(2)), the 

Commissioner of Food and Drugs is 

authorized to implement general powers 

(including conducting research) to carry 

out effectively the mission of FDA. 

After the events of September 11, 

2001, and as part of broader 

counterterrorism and emergency 

preparedness activities, FDA’s Center 

for Devices and Radiological Health 

(CDRH) began developing operational 

plans and interventions that would 

enable CDRH to anticipate and respond 

to medical device shortages that might 

arise in the context of federally declared 

disasters/emergencies or regulatory 

actions. In particular, CDRH identified 

the need to acquire and maintain 

detailed data on domestic inventory, 

manufacturing capabilities, distribution 

plans, and raw material constraints for 

medical devices that would be in high 

demand, and/or would be vulnerable to 

shortages in specific disaster/emergency 

situations or following specific 

regulatory actions. Such data could 

support prospective risk assessment, 

help inform risk mitigation strategies, 

support real-time decision making by 

the Department of Health and Human 

Services during actual emergencies or 

emergency preparedness exercises, and 

mitigate or prevent harm to the public 

health. 

The data collection process will 

consist of an initial telephone call to 

firms who have been identified as 

producing an essential medical device. 

In this initial call, the intent and goals 

of the data collection effort will be 

described, and the specific data request 

made. Data will be collected, using least 

burdensome methods, in a structured 

manner to answer specific questions. 

After the initial outreach, we will 

request updates to the information on a 

quarterly basis to keep the data current 

and accurate. Additional followup 

correspondence may occasionally be 

needed to verify/validate data, confirm 

receipt of followup correspondence(s), 

and/or request additional details to 

further inform FDA’s public health 

response. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Shortages Data Collection ................ 500 4 2,000 0.5 (30 minutes) ............................... 1,000 

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

FDA based the burden estimates in 

table 1 on past experience with direct 

contact with the medical device 

manufacturers and anticipated changes 

in the medical device manufacturing 

patterns for the specific devices being 

monitored. FDA estimates that 

approximately 500 manufacturers 

would be contacted by telephone and/ 

or electronic mail 4 times per year either 

to obtain primary data or to verify/ 

validate data. Because the requested 

data represent data elements that are 

monitored or tracked by manufacturers 

as part of routine inventory management 

activities, it is anticipated that for most 

manufacturers, the estimated time 

required of manufacturers to complete 

the data request will not exceed 30 

minutes per request cycle. 

We adjusted our estimated burden for 

the information collection to reflect an 

increase in the number of submissions 

over the last few years. This adjustment 

results in an increase of 750 hours to the 

total burden estimate. 

Dated: December 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–28235 Filed 12–27–18; 8:45 am] 

BILLING CODE 4164–01–P 


amozie on DSK3GDR082PROD with NOTICES1