Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2449 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10494 Exchange Functions: 

Standards for Navigators and NonNavigator Assistance Personnel— 

CAC 

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. 

The term ‘‘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 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a previously 

approved collection; Title of 

Information Collection: Exchange 

Functions: Standards for Navigators and 

Non-Navigator Assistance Personnel— 

CAC; Use: Section 1321(a)(1) of the 

Affordable Care Act directs and 

authorizes the Secretary to issue 

regulations setting standards for meeting 

the requirements under title I of the 

Affordable Care Act, with respect to, 

among other things, the establishment 

and operation of Exchanges. Pursuant to 

this authority, regulations establishing 

the certified application counselor 

program have been finalized at 45 CFR 

155.225. In accordance with 

155.225(d)(1) and (7), certified 

application counselors in all Exchanges 

are required to be initially certified and 

recertified on at least an annual basis 

and successfully complete Exchangerequired training. Form Number: CMS– 

10494 (OMB control number: 0938– 

1205); Frequency: On Occasion; 

Affected Public: State, Local, or Tribal 

Governments, Private Sector (not-forprofit institutions); individuals or 

households; Number of Respondents: 

30,000; Total Annual Responses: 

30,000; Total Annual Hours: 7,500. For 

policy questions regarding this 

collection contact Deborah Bryant at 

301–492–5213. 

Dated: January 10, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–00632 Filed 1–16–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–1235] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AVYCAZ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for AVYCAZ and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 19, 2018. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

July 16, 2018. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 March 19, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 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– 

2016–E–1235 for ‘‘Determination of 


ethrower on DSK3G9T082PROD with NOTICES
2450 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 

Regulatory Review Period for Purposes 

of Patent Extension; AVYCAZ.’’ 

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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product AVYCAZ 

(ceftazidime pentahydrate and 

avibactam sodium). AVYCAZ is 

indicated for treatment of patients 18 

years or older with the following 

infections caused by designated 

susceptible microorganisms: 

• Complicated intra-abdominal 

infections used in combination with 

metronidazole and 

• Complicated urinary tract 

infections, including pyelonephritis. 

Subsequent to this approval, the 

USPTO received a patent term 

restoration application for AVYCAZ 

(U.S. Patent No. 7,112,592) from Forest 

Laboratories Holdings Ltd., and the 

USPTO requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

July 12, 2016, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of AVYCAZ 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

AVYCAZ is 2,579 days. Of this time, 

2,333 days occurred during the testing 

phase of the regulatory review period, 

while 246 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: 

February 5, 2008. FDA has verified the 

applicant’s claim that February 5, 2008, 

is the date the investigational new drug 

application (IND) became effective. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: June 25, 2014. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

AVYCAZ (NDA 206494) was initially 

submitted on June 25, 2014. 

3. The date the application was 

approved: February 25, 2015. FDA has 

verified the applicant’s claim that NDA 

206494 was approved on February 25, 

2015. 

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 1,411 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.) 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2451 

1FDA acknowledges that many databases may not 

use the term ‘‘administrator’’ or may have a 

committee of individuals that oversee the database. 

Therefore, for the purpose of this guidance, a 

genetic variant database administrator is the entity 

or entities that oversee database operations. 

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: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00678 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–7012] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Use of Public 

Human Genetic Variant Databases To 

Support Clinical Validity for Genetic 

and Genomic-Based In Vitro 

Diagnostics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

16, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Use of Public Human Genetic 

Variant Databases to Support Clinical 

Validity for Genetic and Genomic-Based 

In Vitro Diagnostics.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Use of Public Human Genetic Variant 

Databases To Support Clinical Validity 

for Genetic and Genomic-Based In 

Vitro Diagnostics—OMB Control 

Number 0910—NEW 

This information collection supports 

the above captioned Agency guidance 

document. In the Federal Register of 

July 8, 2016 (81 FR 44611), FDA 

announced the availability of a draft 

guidance for industry entitled ‘‘Use of 

Public Human Genetic Variant 

Databases To Support Clinical Validity 

for Next Generation Sequencing (NGS)- 

Based In Vitro Diagnostics,’’ and 

included an analysis of the associated 

information collection. 

The draft guidance described FDA’s 

considerations in determining whether a 

genetic variant database is a source of 

valid scientific evidence that could 

support the clinical validity of an NGSbased test. This draft guidance further 

outlines the process by which 

administrators 1 of genetic variant 

databases could voluntarily apply to 

FDA for recognition, and how FDA 

would review such applications and 

periodically reevaluate recognized 

databases. The draft guidance also 

recommends that, at the time of 

recognition, the database administrator 

make information regarding policies, 

procedures, and conflicts of interest 

publicly available and accessible on the 

genetic variant database’s website. 

Based on our experience and the 

nature of the information, we estimate 

that it will take an average of 80 hours 

to complete and submit an application 

for recognition. We estimate that 

maintenance of recognition activities 

will take approximately one-fourth of 

that time (20 hours) annually. We 

estimate that it will take approximately 

1 hour to post the information on the 

website. 

Respondents are administrators of 

genetic databases. Our estimate of five 

respondents per year is based on the 

current number of databases that may 

meet FDA recommendations for 

recognition and seek such recognition. 

FDA received 36 comments on the 

draft guidance, none of which pertained 

to the information collection burden 

estimate. 

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 

Application for recognition of genetic database .................. 5 1 5 80 400 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Maintenance of recognition activities ................................... 5 1 5 20 100 

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


ethrower on DSK3G9T082PROD with NOTICES