Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1363 

Board of Governors of the Federal Reserve 

System, January 8, 2018. 

Ann E. Misback, 

Secretary of the Board. 

[FR Doc. 2018–00341 Filed 1–10–18; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0275] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Certification To 

Accompany Drug, Biological Product, 

and Device Applications or 

Submissions 

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 

12, 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 0910–0616. 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. 

Certification To Accompany Drug, 

Biological Product, and Device 

Applications or Submissions (Form 

FDA 3674) 

OMB Control Number 0910–0616— 

Extension 

The information required under 

section 402(j)(5)(B) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

282(j)(5)(B)) is submitted in the form of 

a certification, Form FDA 3674, which 

accompanies applications and 

submissions currently submitted to FDA 

and already approved by OMB. The 

OMB control numbers and expiration 

dates for those applications and 

submissions are: 21 CFR parts 312 and 

314 (human drugs), OMB control 

number 0910–0014, expiring February 

28, 2019, and OMB control number 

0910–0001, expiring December 31, 2017; 

21 CFR parts 312 and 601 (biological 

products), OMB control number 0910– 

0014, expiring February 28, 2019, and 

OMB control number 0910–0338, 

expiring March 31, 2020; and 21 CFR 

parts 807 and 814 (devices), OMB 

control number 0910–0120, expiring 

June 30, 2020, and OMB control number 

0910–0231, expiring March 31, 2020. 

Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85) amended the PHS 

Act by adding section 402(j). The 

provisions broadened the scope of 

clinical trials subject to submitting 

information and required additional 

information to be submitted to the 

clinical trials databank (https://

clinicaltrials.gov) (FDA has verified the 

website address, but FDA is not 

responsible for any subsequent changes 

to the website after this document 

publishes in the Federal Register) 

previously established by the National 

Institutes of Health (NIH)/National 

Library of Medicine. This includes 

expanded information on applicable 

clinical trials and summary information 

on the results of certain clinical trials. 

The provisions include responsibilities 

for FDA as well as several amendments 

to the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

One provision, section 402(j)(5)(B) of 

the PHS Act, requires that a certification 

accompany human drug, biological, and 

device product submissions made to 

FDA. Specifically, at the time of 

submission of an application under 

sections 505, 515, or 520(m) of the 

FD&C Act (21 U.S.C. 355, 360e, or 

360j(m)), or under section 351 of the 

PHS Act (42 U.S.C. 262), or submission 

of a report under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)), such 

application or submission must be 

accompanied by a certification, Form 

FDA 3674, that all applicable 

requirements of section 402(j) of the 

PHS Act have been met. Where 

available, such certification must 

include the appropriate National 

Clinical Trial (NCT) numbers that are 

assigned upon submission of required 

information to the NIH databank at 

https://clinicaltrials.gov. 

The proposed extension of the 

collection of information is necessary to 

satisfy the previously mentioned 

statutory requirement. The importance 

of obtaining these data relates to 

adherence to the legal requirements for 

submissions to the clinical trials registry 

and results databank, and ensuring that 

individuals and organizations 

submitting applications or reports to 

FDA under the listed provisions of the 

FD&C Act or the PHS Act adhere to the 

appropriate legal and regulatory 

requirements for certifying to having 

complied with those requirements. The 

failure to submit the certification 

required by section 402(j)(5)(B) of the 

PHS Act, and the knowing submission 

of a false certification, are both 

prohibited acts under section 301 of the 

FD&C Act (21 U.S.C. 331). Violations are 

subject to civil money penalties. The 

Form FDA 3674 provides a convenient 

mechanism for sponsors/applicants/ 

submitters to satisfy the certification 

requirements of the statutory provision. 

To assist sponsors/applicants/ 

submitters in understanding the 

statutory requirements associated with 

Form FDA 3674, we have provided a 

guidance available at: https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125335.htm. This 

guidance recommends the applications 

and submissions FDA considers should 

be accompanied by the certification 

form, Form FDA 3674. The applications 

and submissions identified in the 

guidance are reflected in the burden 

analysis. In 2017, we updated the 

guidance to include references to the 

NIH Final Rule implementing 402(j) of 

the PHS Act (42 U.S.C. 282(j)). The final 

rule, published on September 21, 2016 

(81 FR 64982) (42 CFR part 11), clarifies 

the requirements for submission of 

clinical trial information to https://

clinicaltrials.gov. 

Investigational New Drug 

Applications. FDA’s Center for Drug 

Evaluation and Research (CDER) 

received 1,669 investigational new drug 

applications (INDs) and 15,285 clinical 

protocol IND amendments in calendar 

year (CY) 2016. CDER anticipates that 

IND and clinical protocol amendment 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Biologics Evaluation 

and Research (CBER) received 381 new 


srobinson on DSK9F5VC42PROD with NOTICES
1364 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 

INDs and 456 clinical protocol IND 

amendments in CY 2016. CBER 

anticipates that IND and clinical 

protocol amendment submission rates 

will remain at or near this level in the 

near future. The estimated total number 

of submissions (new INDs and new 

protocol submissions) subject to 

mandatory certification requirements 

under section 402(j)(5)(B) of the PHS 

Act is 16,954 for CDER plus 837 for 

CBER, or 17,791 submissions per year. 

The minutes per response is the 

estimated number of minutes that a 

respondent would spend preparing the 

information to be submitted to FDA 

under section 402(j)(5)(B) of the PHS 

Act, including the time it takes to enter 

the necessary information on the form. 

Based on its experience with current 

submissions, FDA estimates that 

approximately 15 minutes on average 

would be needed per response for 

certifications that accompany IND 

applications and clinical protocol 

amendment submissions. It is assumed 

that most submissions to investigational 

applications will reference only a few 

protocols for which the sponsor/ 

applicant/submitter has obtained an 

NCT number from https://

clinicaltrials.gov prior to making the 

submission to FDA. It is also assumed 

that the sponsor/applicant/submitter 

has electronic capabilities allowing 

them to retrieve the information 

necessary to complete the form in an 

efficient manner. 

Marketing Applications/Submissions. 

In CY 2016, CDER and CBER received 

252 new drug applications (NDA)/ 

biologics license applications (BLA)/ 

resubmissions and 1,067 NDA/BLA 

amendments for which certifications are 

needed. CDER and CBER received 253 

efficacy supplements/resubmissions to 

previously approved NDAs/BLAs in CY 

2016. CDER and CBER anticipate that 

new drug/biologic applications/ 

resubmissions and efficacy supplement 

submission rates will remain at or near 

this level in the near future. 

FDA’s Center for Devices and 

Radiological Health (CDRH) received a 

total of 330 new applications for 

premarket approvals (PMA), 510(k) 

submissions containing clinical 

information, PMA supplements, 

applications for humanitarian device 

exemptions (HDE) and amendments in 

CY 2016. CDRH anticipates that 

application, amendment, supplement, 

and annual report submission rates will 

remain at or near this level in the near 

future. 

FDA’s Office of Generic Drugs (OGD) 

received 1,036 abbreviated new drug 

applications (ANDAs) in 2016. OGD 

received 698 bioequivalence 

amendments/supplements in 2016. OGD 

anticipates that application, 

amendment, and supplement 

submission rates will remain at or near 

this level in the near future. 

Based on its experience reviewing 

NDAs, BLAs, PMAs, HDEs, 510(k)s, and 

ANDAs and experience with current 

submissions of Form FDA 3674, FDA 

estimates that approximately 45 minutes 

on average would be needed per 

response for certifications that 

accompany NDA, BLA, PMA, HDE, 

510(k), and ANDA marketing 

applications and submissions. It is 

assumed that the sponsor/applicant/ 

submitter has electronic capabilities 

allowing them to retrieve the 

information necessary to complete the 

form in an efficient manner. 

In the Federal Register of September 

22, 2017 (82 FR 44417), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA Center/Activity 

Number of respondents 

(investigational 

applications) 

Number of respondents 

(marketing applications) 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

CDER 

New Applications (IND) ................ 1,669 ........................ 1 1,669 0.25 (15 minutes) ...... 417 

Clinical Protocol Amendments 

(IND).

15,285 ........................ 1 15,285 0.25 (15 minutes) ...... 3,821 

New Marketing Applications/ Resubmissions (NDA/BLA)......................... 198 1 198 0.75 (45 minutes) ...... 149 

Clinical Amendments to Marketing Applications......................... 1,067 1 1,067 0.75 (45 minutes) ...... 800 

Efficacy Supplements/ Resubmissions......................... 219 1 219 0.75 (45 minutes) ...... 164 

CBER 

New Applications (IND) ................ 381 ........................ 1 381 0.25 (15 minutes) ...... 95 

Clinical Protocol Amendments 

(IND).

456 ........................ 1 456 0.25 (15 minutes) ...... 114 

New Marketing Applications/ Resubmissions (NDA/BLA)......................... 54 1 54 0.75 (45 minutes) ...... 41 

Clinical Amendments to Marketing Applications......................... 0 1 0 0.75 (45 minutes) ...... 0 

Efficacy Supplements/ Resubmissions (BLA only)......................... 34 1 34 0.75 (45 minutes) ...... 26 

CDRH 

New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to 

contain clinical data).

........................ 330 1 330 0.75 (45 minutes) ...... 247 


srobinson on DSK9F5VC42PROD with NOTICES
Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1365 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

FDA Center/Activity 

Number of respondents 

(investigational 

applications) 

Number of respondents 

(marketing applications) 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

OGD 

Original Applications .................... ........................ 1,036 1 ........................ 0.75 (45 minutes) ...... 777 

Bioequivalence Supplements/ 

Amendments.

........................ 698 1 ........................ 0.75 (45 minutes) ...... 524 

Total ...................................... ........................ ........................ ........................ ........................ .................................... 7,175 

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

Dated: January 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00354 Filed 1–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2016–E–3310 and FDA– 

2016–E–3341] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENTYCE 

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 ENTYCE and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that animal drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 12, 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 10, 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 12, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 12, 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 Nos. FDA– 

2016–E–3310 and FDA–2016–E–3341 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; ENTYCE.’’ 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 


srobinson on DSK9F5VC42PROD with NOTICES