Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 75819 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0144] 

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 January 20, 

2015. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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 is already approved by OMB. The 

OMB control numbers and expiration 

dates for submitting FDA 3674 under 

the following parts are: 21 CFR parts 

312 and 314 (human drugs) are 0910– 

0014, expiring April 30, 2015, and 

0910–0001, expiring September 30, 

2014; 21 CFR parts 312 and 601 

(biological products) are 0910–0014 and 

0910–0338, expiring January 31, 2017; 

21 CFR parts 807 and 814 (devices) are 

0910–0120, expiring January 31, 2017, 

and 0910–0231, expiring January 31, 

2017. 

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 require additional 

information to be submitted to the 

clinical trials data bank, http://www.

clinicaltrials.gov/ (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register), 

previously established by the National 

Institutes of Health/National Library of 

Medicine, including expanded 

information on clinical trials and 

information on the results of clinical 

trials. The provisions include 

responsibilities for FDA as well as 

several amendments to the Federal 

Food, Drug, and Cosmetic Act (the 

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. 

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 data bank 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. 

In January 2009, FDA issued 

‘‘Guidance for Sponsors, Industry, 

Researchers, Investigators, and Food 

and Drug Administration Staff— 

Certifications to Accompany Drug, 

Biological Product, and Device 

Applications/Submissions: Compliance 

With Section 402(j) of The Public Health 

Service Act, Added By Title VIII of the 

Food and Drug Administration 

Amendments Act of 2007’’ available at 

http://www.fda.gov/regulatory

Information/guidances/ucm125335.htm. 

This guidance identified the 

applications and submissions that FDA 

considered should be accompanied by 

the certification form, Form FDA 3674. 

The applications and submissions noted 

in the guidance are reflected in the 

burden analysis. 

Investigational New Drug Applications 

FDA’s Center for Drug Evaluation and 

Research (CDER) received 1,564 

investigational new drug applications 

(INDs) and 14,328 clinical protocol IND 

amendments in calendar year (CY) 2013. 

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 451 new 

INDs and 492 clinical protocol IND 

amendments in CY 2013. 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 15,892 for CDER plus 943 for 

CBER, or 16,835 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 which 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 a NCT 

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75820 Federal Register / Vol. 79, No. 244 / Friday, December 19, 2014 / Notices 

number from http://www.clinical

trials.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 2013, CDER and CBER received 

226 new drug applications (NDA)/

biologics license applications (BLA)/

resubmissions and 932 NDA/BLA 

amendments for which certifications are 

needed. CDER and CBER received 198 

efficacy supplements/resubmissions to 

previously approved NDAs/BLAs in CY 

2013. 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 530 new applications for 

premarket approvals (PMA), 510(k) 

submissions containing clinical 

information, PMA supplements, 

applications for humanitarian device 

exemptions (HDE) and amendments in 

CY 2013. 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 1,001 abbreviated new drug 

applications (ANDAs) in 2013. OGD 

received 989 bioequivalence 

amendments/supplements in 2013. 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 which 

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 July 9, 2014 

(79 FR 38905), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

We received no comments. 

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) .................. 1,564 ........................ 1 1,546 0.25 (15 minutes) .... 387 

Clinical Protocol Amendments 

(IND).

14,328 ........................ 1 14,328 0.25 (15 minutes) .... 3,582 

New Marketing Applications/Resubmissions (NDA/BLA)......................... 191 1 191 0.75 (45 minutes) .... 143 

Clinical Amendments to Marketing 

Applications.

........................ 932 1 932 0.75 (45 minutes) .... 699 

Efficacy Supplements/Resubmissions......................... 173 1 173 0.75 (45 minutes) .... 130 

CBER 

New Applications (IND) .................. 451 ........................ 1 451 0.25 (15 minutes) .... 113 

Clinical Protocol Amendments 

(IND).

492 ........................ 1 492 0.25 (15 minutes) .... 123 

New Marketing Applications/Resubmissions (NDA/BLA)......................... 35 1 35 0.75 (45 minutes) .... 26 

Clinical Amendments to Marketing 

Applications.

........................ 0 1 0 0.75 (45 minutes) .... 1 

Efficacy Supplements/Resubmissions (BLA only)......................... 25 1 25 0.75 (45 minutes) .... 19 

CDRH 

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

contain clinical data).

........................ 530 1 530 0.75 (45 minutes) .... 398 

OGD 

Original Applications ...................... ........................ 1,001 1 1,001 0.75 (45 minutes) .... 751 

BE Supplements/Amendments ...... ........................ 989 1 989 0.75 (45 minutes) .... 742 

Total ........................................ ........................ ........................ ........................ ........................ ................................. 7,114 

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

Dated: December 15, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29752 Filed 12–18–14; 8:45 am] 

BILLING CODE 4164–01–P 

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