2021-03243. 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:

Submit written comments (including recommendations) on the collection of information by March 22, 2021.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0616. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [e-mail].

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 March 31, 2022, and OMB control number 0910-0001, expiring March 31, 2021; 21 CFR parts 312 and 601 (biological products), OMB control number 0910-0014, expiring March 31, 2022, and OMB control number 0910-0338, expiring February 28, 2023; 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, 2023.

Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (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 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. 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. FDA last updated this guidance in 2017.

Investigational New Drug Applications. FDA's Center for Drug Evaluation and Research (CDER) received 1,661 investigational new drug applications (INDs) and 11,328 clinical protocol IND amendments in calendar year (CY) 2019. 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 639 new INDs and 581 clinical protocol IND amendments in CY 2019. 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 12,989 for CDER plus 1,220 for CBER, or 14,209 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 a 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 2019, CDER and CBER received 252 new drug applications (NDA)/biologics license applications (BLA)/premarket approvals (PMA)/resubmissions and 701 NDA/BLA amendments for which certifications are needed. CDER and CBER received 295 efficacy supplements/resubmissions to previously approved NDAs/BLAs in CY 2019. CDER and CBER received 893 abbreviated new drug applications (ANDAs) in CY 2019. CDER received 765 bioequivalence amendments/supplements in CY 2019. 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 324 new applications for PMA, 510(k) submissions containing clinical information, PMA supplements, applications for humanitarian device exemptions (HDE) and amendments in CY 2019. CDRH anticipates that application, amendment, supplement, and annual report 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 May 14, 2020 (85 FR 28955), 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)	1,661		1	1,661	0.25 (15 minutes)	415
Clinical Protocol Amendments (IND)	11,328		1	11,328	0.25 (15 minutes)	2,832
New Marketing Applications/Resubmissions (NDA/BLA)		220	1	220	0.75 (45 minutes)	165
Clinical Amendments to Marketing Applications		701	1	701	0.75 (45 minutes)	526
Efficacy Supplements/Resubmissions		257	1	257	0.75 (45 minutes)	193
Abbreviated New Drug Applications (ANDA)—Original Applications		892	1	892	0.75 (45 minutes)	669
ANDA Bioequivalence Supplements/Amendments		765	1	765	0.75 (45 minutes)	573
CBER
New Applications (IND)	639		1	639	0.25 (15 minutes)	160
Clinical Protocol Amendments (IND)	581		1	581	0.25 (15 minutes)	145
New Marketing Applications/Resubmissions (NDA/BLA/PMA)		32	1	32	0.75 (45 minutes)	24
Clinical Amendments to Marketing Applications		0	1	0	0.75 (45 minutes)	0
Efficacy Supplements/Resubmissions (BLA only)		38	1	38	0.75 (45 minutes)	28
Abbreviated New Drug Applications (ANDA)—Original Applications		1	1	1	0.75 (45 minutes)	1
ANDA Bioequivalence Supplements/Amendments		0	1	0	0.75 (45 minutes)	0
CDRH
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data)		324	1	324	0.75 (45 minutes)	243
Total						5,974
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 11, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.